belisomo, icu end of life care, voices in bioethics, vol. 1 (2014-15) © 2015 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. can fulfilling three wishes transform end of life care in the icu? randi belisomo keywords: end of life care, family, family members, icu, intensive care unit, three wishes introduction the solicitation and fulfillment of three simple wishes among patients nearing death within intensive care units and their families may bring peace to the end of life process and ease grief, according to a newly published study in the annals of internal medicine. analysis the canadian researchers invited patients and families in a 21-bed medical-surgical icu to participate in the “three wishes project” after a decision was made to withdraw life support (probability of death greater than 95 percent). clinicians inquired how patients ought to be honored and requested three wishes from the patients or families. they worked to implement these wishes—such as allowing a pet to visit, facilitating a skype reunion, hosting a wedding vow renewal, providing scottish bagpipe music at death, or deferring life support withdrawal until after a holiday. “we are trying to improve the quality of the dying experience in the cold, technological, efficiency-driven intensive care unit,” said deborah cook, a paper co-author and clinical epidemiologist at mcmaster university health sciences center in hamilton, ontario. “this is a time when compassion is called for from everybody.” the study enrolled 40 patients, and 159 of 163 wishes were implemented—ranging in cost from zero to 200 dollars per patient. wishes were classified into five categories: humanizing the patient (recreating date night in the icu), personal tributes (providing a final meal for the family in an icu conference room), family reconnections (dying with all family members present), rituals and observances (bedside memorial service) and “paying it forward” (organ donation). to determine the project’s efficacy, researchers interviewed at least one family member per patient within six months of death. three clinicians per patient responded to emailed questions within two weeks of death. a qualitative analysis of transcripts, letters and field notes reflects a personalization of death by dignifying the patient, extending families a voice and fostering clinician compassion. some examples of the qualitative data include the following: according to the paper, one mother reported that the program “honors the everyday hero: someone who may go unnoticed but whose life counted.” belisomo, icu end of life care, voices in bioethics, vol. 1 (2014-15) 2 a patient’s daughter responded that “it struck a chord because it allowed me to talk about her, and.... give the staff...a vision of who she was.” a nurse wrote, “this is putting the absolute human side into the whole experience. i think this project is so powerful.” anne woods, a co-author and palliative physician, told voices in bioethics that the project’s strength was in making the dying visible. “it let them be seen as people, not as patients,” she said. “the family knew they were seen, and the patients who were alert knew they were seen as people, and that they mattered.” however, the solicitation of patient wishes was rare: due to impaired consciousness, 33 of 40 dying patients could not express desires. family members requested wishes for them. bioethicist craig klugman, chair of depaul university’s department of health sciences told voices in bioethics that due to that fact—and the absence of a control group—the project is “worthwhile” but “proves little.” according to klugman, conclusions are not supported by the data. “they conclude that this does something for the dying person, but in fact, of 40 dying people, only seven were able to speak,” he said. “it’s impossible to claim any benefit for patients.” however, any intervention that allows families to feel cared for is valuable, according to patrick cullinan, medical director of critical care services at metropolitan methodist hospital in san antonio. “it’s giving a face to a faceless process,” cullinan, who was not involved in the study, said. “the patient is being told indirectly that we care about you, we care about your loved one, and we want to help you with the grieving process.” conclusion perhaps the project’s best result is the recognition among icu staff that they can offer meaningful gestures at any time. “they now know to ask ‘what can i do for you?’ and ‘what could make this a good day?’ and they do that,” woods said. “there’s never a time when someone can say now ‘there is nothing more i can do for you.’ there is always something more for you to do.” lee, a law student says “no” to freezing her eggs, voices in bioethics, vol. 1 (2014-15) © 2015 katarina lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a law student says "no" to freezing her eggs katarina lee keywords: bioethics, autonomy, reproductive ethics, egg freezing, women’s rights introduction tick-tock goes our biological clocks. a law professor who i admire greatly, only half-jokingly said to my class that the new gift for women graduating from law school would be our parents paying for us to freeze our eggs. the look on my fellow female classmates’ faces was a mixture of relief and panic. that moment was simply an illustration of what we were already thinking and talking about. these are the conversations that highly educated and accomplished women are having today. it is not an exaggeration to state that the majority of time when we discuss our future legal careers we are simultaneously wondering whether we will find someone to marry and when and/or if we are going to have children. analysis for those who are married the conversation focuses on putting off childbirth, fearing that it would interfere with their careers. my classmates who are dating question whether their significant other will propose lee, a law student says “no” to freezing her eggs, voices in bioethics, vol. 1 (2014-15) 2 and how much time they can justifiably allocate to waiting. lastly, for those that are single, anxiety increases as both statistics and anecdotes affirm that highly educated women are less likely to get married. this anxiety is further exasperated by our “standards.” we seek partners who are equally educated and partners that will also share our views on families, or more specifically when to have children. bring egg freezing to the table and the women in law school breathe a sigh of relief. it gives us more time, it takes the pressure off, and we don’t have to worry about that pesky career/childrearing balance. however, egg freezing frees us from our concerns only because we often do not and are not meant to understand the dangers of the procedure. firstly, the fertility industry has downplayed the risks associated with egg retrieval, the drugs that are used to hyperstimulate our ovaries, and the transvaginal aspiration needed to retrieve our eggs.123 secondly, the statistical chance of freezing eggs, fertilizing them in the future, and then having a successful implantation remain relatively low.4 fertility companies are profiting off of the anxiety of educated women. conclusion aside from the potential medical issues, it’s concerning that society is constantly inundating us with different values we are encouraged to ascribe to. the “women can have it all,” “women can’t have it all,” “lean in,” “lean out,” mantras we throw around in our regular conversations oppress the ability of women to make choices for themselves. there will always be women who choose to stay home, mothers who work, and those who choose not to have children. however, when companies such as apple, facebook, and citigroup provide “benefits” to women to freeze their eggs they send a clear message that educated and successful women should put off childbirth. messages like this prevent women from thinking for themselves about what they personally want and further feed into the personal and societal angst we have regarding our biological clocks. 1 “risks of in vitro fertilization (ivf),” society for assisted reproductive technology, last modified 2014,http://www.sart.org/factsheet_risks_of_in_vitro_fertilization/. 2 “about egg retrieval,” center for genetics and society ,http://www.geneticsandsociety.org/section.php?id=28. 3 “sindy’s testimony,” eggsploitation, http://www.eggsploitation.com/testimony-swm.htm. 4 pamela mahoney tsigdinos, “the sobering facts about egg freezing that nobody’s talking about,”wired, october 24, 2014,http://www.wired.com/2014/10/egg-freezing-risks/. http://www.sart.org/factsheet_risks_of_in_vitro_fertilization/ http://www.geneticsandsociety.org/section.php?id=28 http://www.eggsploitation.com/testimony-swm.htm http://www.wired.com/2014/10/egg-freezing-risks/ feldman and dreyfus, whose consent is it anyway?, voices in bioethics, vol. 3 (2017) © 2017 sharon feldman and tom dreyfus. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. whose consent is it anyway? a transgender child's right to transition sharon feldman and tom dreyfus keywords: consent, transgender ethics, children, transgender healthcare a landmark decision delivered by the full court of the family court of australia on november 30th, 2017 confirmed that a transgender child who is capable of giving informed consent can undertake gender affirming hormone treatment without applying to a court for authorization.1 kelvin, the child at the heart of the case, was assigned female at birth in 2000. he transitioned socially as a transgender person in 2014, and in april 2015 began to be known by his preferred name. however, kelvin’s transition was associated with significant mental health issues, including anxiety, depression and self-harm. throughout 2015 and into 2016, kelvin attended appointments with doctors and other healthcare professionals, culminating in a diagnosis of “gender dysphoria”; a term that describes the distress experienced by a person due to incongruence between their gender identity and the sex assigned to them at birth. kelvin’s doctors recommended hormone treatment. by this time, kelvin was 17 years old, and while he did not have full legal capacity, his doctors considered him to be capable of giving his informed consent. significantly for kelvin, both of his parents supported his decision to undergo treatment.2 however, a 2013 decision of the family court, re: jamie,3 stood in kelvin’s way. that case held that gender affirming hormone treatment for a child in response to a diagnosis of gender dysphoria requires the authorization of a court pursuant to a federal statute, the family law act 1975. this meant that kelvin could not access treatment without first applying for, and receiving, judicial authorization. his father therefore sought the requisite declaration from the court that kelvin was competent to consent to gender affirming hormone treatment, just as his doctors had already judged him to be. additionally, pursuing broader law reform in this vexed area, kelvin’s father also challenged re jamie, demanding an answer to the question of whether the treatment could be administered without the further authorization of a court. kelvin and his family, represented by sydney’s inner city legal centre, found support from a broad range of amici, including “a gender agenda,” a not-for-profit advocacy organization that works with, and on behalf of, intersex, transgender and gender diverse people to eliminate discrimination. led by a team of pro-bono counsel, kelvin’s case made its way to a hearing before the full court of the family court. in deciding the questions posed in kelvin’s favor, the court found it significant that a diagnosis of incongruence between one’s experienced or expressed gender and one’s assigned gender had been re-classified since re: jamie in the diagnostic and statistical manual of mental disorders: what was once “gender identity disorder” is now “gender dysphoria."4 putting to one side the jarring title of the manual (and the concomitant issues of pathologizing the heteroand cis-gender nonconformity that it might entail), the court made a significant finding that emphasized the lived experience of gender dysphoria. the court said: “the risks involved and the consequences which arise out of the treatment being at least in some respects irreversible, can no longer be said to outweigh the therapeutic benefits of the treatment, and court authorization is not required.”5 http://www.iclc.org.au/ http://genderrights.org.au/ feldman and dreyfus, whose consent is it anyway?, voices in bioethics, vol. 3 (2017) 2 this finding represents an important re-balancing of the perceived risk factors that attend gender affirming hormone treatment. the key ‘risk’ identified in earlier court decisions was the irreversibility of some forms of hormone treatment. on one view, the court’s emphasis on the irreversibility of the treatment revealed its ongoing discomfort with the notion that a child could ever wish to permanently change their gender identity or expression. in its reversal of that position, the court re-focused its attention on the risks of denying treatment, giving due credence to the wishes expressed by the child, the assent of their parents and the recommendation of their team of medical professionals. the case also presents a remarkable example of judicial restraint. as the court put it: we think it important to emphasize that the court in this case is concerned to examine … whether there is any role for the family court in cases where there is no dispute between parents of a child who has been diagnosed with gender dysphoria, and where there is also no dispute between the parents and the medical experts who propose the child undertake treatment for that dysphoria.6 (emphasis added) here, we have a court empowered to exercise its jurisdiction in matters of great personal significance. and yet, rather than continue its current practice, the court undertook a critical self-examination that centers the rights of the child and their parents, and is deferential to the expertise of the doctors and other healthcare practitioners charged with the child’s care. equally important was the court’s care not to undermine its jurisdiction and power to address situations in which there is a genuine dispute as to whether treatment should be administered, such as where parents or medical professionals are unable to agree.7 there remains an important role for courts in these difficult situations. kelvin’s case marks a significant step forward for the rights of transgender children and their parents in australia. transgender children whose sole barrier to gender affirming hormone treatment was court approval, now face a green light. and the future ‘kelvins’ of australia will not be made to endure the heavy psychological toll of a legal process in order to obtain the medical care they require. the court’s overdue demonstration of a more nuanced understanding of gender dysphoria and the risks and benefits of treatment bodes well for the future development of the australia’s gender and sexrelated jurisprudence. i re: kelvin [2017] famcafc 358. 2 id. at [24]-[41]. 3 (2013) flc 93-547. 4 fifth edition (dsm-5) (302.85 (f64.1) icd-10-cm f64.1). 5 supra (note i) at [162]. 6 supra (note i) at [116]. 7 supra (note i) at [124]. ducar, the dangers of early identification, voices in bioethics, vol. 1 (2014-15) © 2015 dallas m. ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the dangers of early identification dallas m. ducar mental health, child psychology, bioethics introduction it’s the end of a hard day of work and you arrive home to see your child alone, talking to herself. at first this may not seem odd, a child’s imagination can be quite active. over time, however, she begins to seclude herself more, engage in occasional violent outbursts, and presents variable mood swings. finally, after months of this, she begins to see things, but can still characterize them as hallucinations. she continues to maintain insight regarding the hallucinatory nature of such phenomenon. analysis according to mental health clinicians the loss of psychological insight is widely considered to signal the beginning of a psychotic break. while this has the potential to lead to a multitude of diagnoses, it will signal the onset of the disease. this psychotic break isolates, debilitates, and exposes the patient while opening the door to the possibility of future medical expenses and psychotic episodes. if it were possible to prevent a future psychotic break from occurring to your child, would you? researchers and clinicians have recently been examining this very question; whether early detection and intervention for the prevention of psychosis can be clinically effective.1 psychotic episodes generally occur in the late teens or early twenties. the goal of this research is to understand whether the impulsive and angry behavior, along with first-person reports, can signal to clinicians that a patient needs help before it is too late. the investigators concluded, after a two-year study, that the at-risk groups showed better functional outcomes after treatment. yet to treat potential patients, one must also detect such patients. programs such as the early detection and intervention for the prevention of psychosis program (edippp) contacts teachers, counselors, nurses, social workers, family members and other clinicians to increase the appropriate referrals of youth at risk. however, programs like edippp run the risk of both under-diagnosing and over-diagnosing. it may be possible that a worried parent can wrongly label and inadvertently stigmatize their child for what may simply be unruly behavior. this may result in inadvertent psychological damage of a vulnerable population, starkly contrasting the mantra “do no harm.” suppose one percent of the population is actually schizophrenic and half of them go to a mental health provider to report their symptoms while worried parents falsely refer 20 percent. out of a population of 100 people, one person will actually have schizophrenia and 99 will not. moreover ducar, the dangers of early identification, voices in bioethics, vol. 1 (2014-15) 2 there will be .5 true patients and 19.8 false patients that undergo evaluation. a prodromal questionnaire (pq), which is based on prodromal syndromes (sips), has a measure of 71 percent sensitivity and 81 percent specificity. 2 giving the benefit of the doubt, suppose a mental health clinician is better at early identification than the pq and has both a sensitivity and specificity of 85 percent. given the aforementioned sensitivity, specificity, and population of 100, the clinician will diagnose .425 true patients and 2.99 false patients, and possibly prescribe therapy and pharmaceuticals. therefore, the majority of people who are labeled and marked for treatment shouldn’t be and the majority of people who are not, should. with the probability of false positives and false negatives being what they are, even amongst a clinician who is better than psychological scales and questionnaires, there is a huge risk of incurring positive feedback, which could lead to behavioral confirmation. furthermore, a review of prodromal intervention programs determined that the efficacy of the interventions themselves were inconclusive. 3 early intervention, while different than early treatment, can still irreparably harm a patient. if a child is wrongly labeled it can affect the child’s identity for life. moreover, research on the effects of antipsychotic drugs on children is sparse and it may be possible that treatment could do more harm than good. conclusion the decision to handle mental conditions preventatively is a moral decision as any other. in an era where more healthcare models are moving to early detection it is important to remain aware of the hurdles that exist in psychiatry. parents may fear that the unorthodox behavior of their child, society may pressure disorderly youngsters to fall in line, and clinicians have the authority to diagnose and label. clinicians must recognize these pressures, limits to identification, and remain prudent in their diagnosis. perhaps in some cases, kids should just be kids. 1 mcfarlane, w. r., levin, b., travis, l., lucas, f. l., lynch, s., verdi, m., ... & spring, e. (2014). clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial. schizophrenia bulletin, sbu108. 2 lsen, k. a., & rosenbaum, b. (2006). prospective investigations of the prodromal state of schizophrenia: assessment instruments. acta psychiatrica scandinavica, 113(4), 273-282. 3 marshall, m., & rathbone, j. (2011). early intervention for psychosis. schizophrenia bulletin, 37(6), 1111-1114. introduction conclusion bolzon, another world congress of bioethics, voices in bioethics, vol. 2 (2016) © 2016 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. part i: another world congress of bioethics, to what avail? julia bolzon keywords: medical education, medicine, clinical ethics, medical profession introduction the 13th world congress of bioethics, hosted by the international association of bioethics (iab), is happening this june 14–17 in edinburgh, scotland. professor søren holm, president of the iab, has commented on the congress’ choice location of edinburgh as the birthplace of the scottish enlightenment, indicating that it is “characterized by a fruitful flow of ideas between different subject areas,” which he hopes this year’s congress will emulate.1 the iab was formed in 1992, with members spanning academic disciplines and the globe alike. as an international and cross-disciplinary association, it exists to foster open dialogue on “any and all” bioethical issues, and to develop the field of bioethics into “an inclusive global discourse.”2 to continue what he calls the “new enlightenment” emerging from edinburg, chairman professor graeme laurie wrote that the congress’ theme is to explore what bioethics can contribute to “individuals, public interests and public goods.” all delegates are encouraged to treat the congress in the spirit of “a festival of knowledge” rather than a traditional academic conference, seeking to discover what bioethics can offer to the pressing scientific, technological, global, and health issues of our time.3 analysis the reason for the congress’ theme is the recognition that increasing emphasis on “the primacy of the individual” downplays the interconnectedness between the individual and the other on a familial, local, and global level. the reality is that medical, scientific, and biotechnological advances do not just affect the person at hand, but have ramifications that reverberate throughout the public realms of family, community, and the globe. whether the issue is gene editing, global health pandemics, or reproductive tourism, the fields of bioethics, public health, and law have to increasingly account for realities that reverberate across time and space. what are the effects of proceeding with embryonic gene editing twenty, thirty, or fifty years in the future? what are the consequences of gestational surrogacy that is legal in one country but not in another? who will these realities affect, and how? in what way can we know (or not know) the ramifications in advance? with a focus on the relationship and differing values at play between individual and public interests/public goods, the thorny issues and conflicts that exist between “person-centric” and “community-centric” ethics should come to the fore. exactly what these issues are and how they will be discussed remains to be seen. the iab is currently undergoing a call for abstracts in the areas broadly titled arts + ethics; global bioethics; individuals, public interests and public goods; and public health, ethics and law. bolzon, another world congress of bioethics, voices in bioethics, vol. 2 (2016) 2 this congress is not the only international gathering to address the responsible use of biotechnology and the role that bioethics “can and should play for the benefit of future generations.”4 last may, 200 delegates from thirty countries gathered in atlanta, georgia, for a global summit called beings: biotechnology and the ethical imagination, to “reach consensus on the direction of biotechnology for the 21st century.”5 dr. paul wolpe, the director of the center for ethics at emory university and the summit’s founder, had been dreaming of this idea for years. his goal is to establish an aspirational vision for the future of biotechnology, through generating a “global consensus document” on “how we should think about, direct, or limit our biotechnological efforts.” 6 beings was held to stimulate as much discussion as possible between leading visionaries in the fields of science, policy, ethics, law, philosophy, humanities, religion, and the arts, to begin a process that would result in drafting an international consensus on the future of human cellular biotechnology. it’s a grossly ambitious task, guided by equally exemplary and wide-sweeping questions: • what should be the goals of biotechnology; is progress itself an ethical aim or obligation? • how do we honor the sanctity of life (assuming that “sanctity of life” continues to be a morally useful construct)? • what is “human flourishing” insofar as biotechnology can contribute to it? • how do we navigate the spectrum of differing perspectives on risk, such as those that take a more precautionary, risk-aversive approach to those that privilege provable harm approaches? • how do we protect vulnerable populations, honor global cultural differences, and respect and include diverse opinions? • who should ultimately regulate technologies (e.g., government, private sector, self-regulation)? • how do we assure fairness, justice, and global sharing of the fruits of modern biotechnology?7 conclusion the trouble with such global gatherings (as noble and necessary as they may be) lies not so much within their aim but within the heart of biotechnology itself, which makes the task of regulation frankly impossible. the floodgates of biotechnology have long since been opened, making regulation today less a matter of outright prohibition and more like a temporary yellow light that will eventually turn green once the going looks clear. this metaphor finds reality in the case of mitochondrial transfer and threeparent ivf in the uk last february, and more recently with the testing of crispr on human embryos. while beings may be asking the right questions, and the iab facilitating necessary global discussion, the challenges of biotechnology run much deeper than we are equipped to handle. in the next segment, i shall begin to outline the way in which biotechnology far surpasses our ability to control or even think about its ramifications. 1 søren holm, “welcome from the iab president,” international association of bioethics 2016 edinburgh, accessed on february 29, 2016: http://iab2016.com. 2 ibid. 3 graeme laurie, “welcome from the chair, iab2016 organising committee,” international association of bioethics 2016 edinburgh, accessed on february 29, 2016: http://iab2016.com. 4 international association of bioethics, “the 13thworld congress for the iab,” accessed on february 29, 2016: http://iab2016.com/about-iab2016/. 5 paul root wolpe, “beings 2015: biotech and the ethical imagination, a global summit,” accessed at: http://www.beings2015.org. 6 “beings update: where are we now and where are we headed?” accessed at: http://www.beings2015.org/about.html. 7 guiding questions, beings 2015 program. accessed at: http://www.beings2015.org/program.html. http://iab2016.com/ http://iab2016.com/ http://iab2016.com/about-iab2016/ http://www.beings2015.org/ http://www.beings2015.org/about.html http://www.beings2015.org/program.html introduction the 13th world congress of bioethics, hosted by the international association of bioethics (iab), is happening this june 14–17 in edinburgh, scotland. professor søren holm, president of the iab, has commented on the congress’ choice location of edinbu... analysis conclusion kiskadden-bechtel, triage and the israel-palestine conflict, voices in bioethics, vol. 2 (2016) © 2016 sarah kiskadden-bechtel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. triage and the israel-palestine conflict: a case of medical tourism sarah kiskadden-bechtel keywords: israel, palestine, organ donation, medical tourism introduction medical tourism widens the sphere of available medical care beyond a single country’s borders. patients who voluntarily leave their home country to seek treatment in other countries typically do so out of perceived medical necessity; these procedures—which are often poorly covered by insurance—range from mandatory heart surgery, to kidney or other organ transplants. in conflict-laden countries like israel, organ donation rates “are among the lowest in the developed world, about one-third the rate in western europe,”1 giving rise to advertisements for transplants due to inherent shortage. 2 although rabbis offer different opinions about whether organ transplantation should be permissible under jewish law, israeli citizens have been known to venture as far as south africa to undergo illegal kidney transplants.3 clearly, there is palpable incentive for israeli citizens to receive organ transplants; questions remain, however, regarding whether and how these organs are being obtained, and what should be done as a result. there is some evidence that israeli soldiers have harvested organs from captured palestinians. in november of 2015, the palestinian representative to the un dr. riyad mansour wrote an open letter to the un secretary general ban-ki moon claiming that, under israeli occupation in east jerusalem, palestinians killed and seized by israeli soldiers were being returned with “missing corneas and other organs.”4 as a counterpoint, israel’s un ambassador danny danon dismissed these claims ascribing them to “anti-semitic motives.”5 if there is any truth to mansour’s claims, there is little clarity about which organs were missing, or whether the individuals in question were peaceful citizens or more militant aggressors. and yet, ambassador danon’s response bypasses the clear and pressing issue: israel has not directly addressed this accusation of harvesting palestinian organs. analysis israel currently operates under a steady shortage of transplantable organs, a status that adds weight to mansour’s allegation of organ harvesting. mansour’s claims are likely heavily influenced by the plight of palestine in the current israeli-palestinian conflict; however, israel is indeed acknowledged to be a major organ-importing country. 6 importantly, the israeli government has taken steps to be transparent about potentially illicit organ donations: in 2006, responding to reports that israelis were buying kidneys in places like china and the philippines, the health ministry prohibited insurers from paying for illicit overseas transplants. in 2008, the israeli parliament passed legislation that criminalized organ brokering and established panels to scrutinize whether donors are kiskadden-bechtel, triage and the israel-palestine conflict, voices in bioethics, vol. 2 (2016) 2 being compensated. it also provided for government payments for a donor’s medical care and related monetary losses.7 five-year wait times for kidneys or other organs obtained from someone declared brain dead exemplify the rationale behind why israel goes to such great lengths in the global organ trade. kidney donations, for example, are extremely rare due to religious considerations: only 15 percent of israel’s population sign up to be kidney donors.8 given this context, mansour’s report suggests that israel conducts medical tourism at the expense of palestinian lives—though this claim remains circumstantial at best and is by no means a universal declaration of unethical behavior. although israel does acknowledge a shortage of kidneys and other organs, this does not mean that its doctors or soldiers harvest organs from palestinians. organ harvesting on palestinians by israeli soldiers would naturally be deemed by the united nations as extremely misguided and ethically inappropriate. ambassador danon’s response to mansour invokes the term “blood libel” – a weighted term evoking the medieval myth that jews once murdered christian children for their blood. danon’s rhetoric deflects any plausible notion of forced medical tourism by insinuating that palestine’s intentions are anti-semitic, which effectively bypasses any follow-up regarding the precedent against jews that is embedded within the blood libel construct. such a statement ultimately maintains diplomatic immunity for israel by establishing perceived insincerity on behalf of mansour as palestine’s representative. but danon is not wrong to defend israel. there is much good being done by israelis despite whether mansour’s claims are indeed correct. approximately four miles due west of the western wall stands jerusalem’s shaare tzedek hospital, where doctors treat trauma patients – both palestinian and israeli – who fall victim to arab terrorist attacks. 9 these physicians are selfless in their medical service, and initiate controversy when they choose to see beyond hatred and attempt to heal anyway. these physicians face significant ethical dilemmas due to a shortage of supplies and resources, and face moral conflicts of interest when opting to “treat the bad guy.” although these physicians don’t transfer precious organs to terrorists, their acts of healing signify their good intentions and the underlying ethical principles of autonomy and nonmaleficence that guide their behavior. conclusion still, the possibility of organ harvesting remains significantly problematic. although the legitimacy of mansour’s claims awaits confirmation, circumstantial claims suggest an existing ethical dilemma that must be addressed. if israeli soldiers have ever harvested organs from palestinians during wartime triage, these actions must stop immediately. because israel’s organ shortage creates a weakness in its healthcare supply system that makes it susceptible to these accusations, ambassador danon should specifically articulate this matter rather than deflect the allegation as a racist slur. insinuations of blood libel only bypass the real issue, and consequently mandate further investigation, perhaps by the international criminal court (icc). even though the nation of israel has historically been oppressed, it must in turn go to lengths to prevent converting its newly found state power into a form of oppression against other peoples. 1 rohter, larry. “the organ trade: a global black market; tracking the sale of a kidney on a path of poverty and hope.” the new york times: 23 may 2004. print. 2 hopkins, laura et al. “medical tourism today: what is the state of existing knowledge?” journal of public health policy. 2010; 31(2): 190. kiskadden-bechtel, triage and the israel-palestine conflict, voices in bioethics, vol. 2 (2016) 3 3 shimazono, yosuke. “the state of the international organ trade: a provisional picture based on integration of available information.” bulletin of the world health organization. december 2007; 85(12): 957. 4 mansour, riyad. “letter from palestinian representative to the un riyad mansour to un secretary general ban ki-moon: ‘israeli aggression and culture of hate against palestinians.’” 3 november 2015. http://palestineun.org/3-november-2015-israeli-aggression-and-culture-of-hate-against-palestinians/ (links to an external site.). 5 ziri, danielle. “danon asks un to condemn organ-harvesting ‘blood libel.’” 5 november 2015. http://www.jpost.com/arab-israeli-conflict/israel-blasts-palestinians-after-accusations-of-organ-harvesting432085 (links to an external site.) 6 shimazono, ibid. 7 sack, kevin. “a clash of religion and bioethics complicates organ donation in israel.” the new york times. 17 august 2014. http://www.nytimes.com/2014/08/17/world/middleeast/a-clash-of-religion-and-bioethicscomplicates-organ-donation-in-israel.html?_r=0 (links to an external site.). 8 sack, ibid. 9 aharon, eliran. “innocents take precedence over terrorists.” israel national news. 18 february 2016. http://www.israelnationalnews.com/news/news.aspx/208241#.vwhxyxmrlmv (links to an external site.). http://palestineun.org/3-november-2015-israeli-aggression-and-culture-of-hate-against-palestinians/ http://palestineun.org/3-november-2015-israeli-aggression-and-culture-of-hate-against-palestinians/ http://www.jpost.com/arab-israeli-conflict/israel-blasts-palestinians-after-accusations-of-organ-harvesting-432085 http://www.jpost.com/arab-israeli-conflict/israel-blasts-palestinians-after-accusations-of-organ-harvesting-432085 http://www.nytimes.com/2014/08/17/world/middleeast/a-clash-of-religion-and-bioethics-complicates-organ-donation-in-israel.html?_r=0 http://www.nytimes.com/2014/08/17/world/middleeast/a-clash-of-religion-and-bioethics-complicates-organ-donation-in-israel.html?_r=0 http://www.israelnationalnews.com/news/news.aspx/208241#.vwhxyxmrlmv introduction analysis conclusion still, the possibility of organ harvesting remains significantly problematic. although the legitimacy of mansour’s claims awaits confirmation, circumstantial claims suggest an existing ethical dilemma that must be addressed. if israeli soldiers have e... ramos, this crisis is not a war, voices in bioethics, vol. 6 (2020) * hector c. ramos md, ms, facs, hec-c, professor of clinical surgery, keck school of medicine of usc, chair bioethics pih good samaritan hospital, cha hollywood presbyterian hospital © 2020 hector ramos. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are cre dited. this crisis is not a war: it is what physicians are trained to do hector ramos* keywords: covid-19, bioethics, medical ethics, duty to provide care, figurative language as the uncommon combination of ethicist and surgeon, i have great compassion for my colleagues in the proverbial trenches. recent articles in social and print media have moved me by their emotion and passionate pleas for recognition of the current plight of healthcare workers. articles identifying the lack of personal protective equipment, physicians contracting “covid-19,” and a lack of action on the part of hospitals and government entities are commonplace in the media.[i] healthcare media predictions of a mass resignation by healthcare workers present seductive doomsday imagery. while i agree with many reports, others are specious and mere vacuous recriminations. i disagree with reports that compare covid-19 and its impact on humanity, mortality, and morbidity with war,[ii] and ebola, and that fail to articulate the obligations of physicians to provide care in a crisis. there is no rational reason for the comparison except to stoke fear of the contagion. in war, the enemy is not a natural event. in war, the enemy is human and the conflict is volitional, grounded in ideology, finances, power, or plain ego.[iii] unlike the manmade factors that lead to war, the virus is an unthinking entity living only for its survival; we happen to be in its way. i have seen and heard comparisons to soldiers in war such as, “allowing physicians and nurses to treat patients with covid-19 without proper personal protective equipment (ppe) is like sending soldiers to war without adequate equipment.” i take some pause at the latter as the father of two marine veterans. we currently find ourselves in an environment where reason is inconvenient, annoying, and aggravating. i read articles with emotional pleas “that any mortality is unacceptable.” however, reason is of great importance when making decisions that impact society. the comparison between war and covid-19 is an unintentional straw man argument. the premise is that the virus is somehow evil and has intent and purpose making it easier to hate and attack. comparisons made to ebola, which created great fear in this country partly due to models predicting millions of deaths,[iv] serve to emotionally impact the reader to support the author’s conclusions and recommendations. in the ebola panic, only two americans died, proving the model’s failings. covid-19 modelling has revealed a similar lack of accuracy.[v] perhaps the impact of ebola is an unfair comparison, but the fear was similar. comparing covid-19 to ebola is an “ends justify the means” argument, fraught with moral pitfalls, and uses inaccurate imagery creating anger and fear in an already vulnerable http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_edn1 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_edn2 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_edn3 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_edn4 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_edn5 ramos, this crisis is not a war, voices in bioethics, vol. 6 (2020) 2 population. another argument propelled by the media is an argument veiled and subdued in practically all current articles identifying the risk to physicians. the media fails to recognize the balance between physicians pressing hospitals to provide the right gear and the obligation of physicians to provide care. i have deliberately excluded other hospital workers that have never taken an oath for there is universal agreement that they are not bound by the same obligations. opinion 8.3 of the american medical association ( ama) code of medical ethics sets an ethical framework for physician action in epidemics, disasters, or terrorism. "first and foremost is the obligation to provide urgent medical care during disasters," an obligation that holds "even in the face of greater than usual risk to physicians' own safety, health or life."[vi] opinion 8.3 recognizes that the physician workforce itself is not an unlimited resource. “the risks of providing care to individual patients today should be evaluated against the ability to provide care in the future." it is rarely, almost never, acceptable to refuse to put yourself in harm’s way and especially unacceptable if no other physician is available. i suggest our colleagues are reminded of the duties imposed by the profession they chose. doctors can always stay home and find others to take up the torch, a phenomenon occurring throughout the world. refusal can be considered when the physician has a condition of such high risk that the doctor patient interaction would be a suicidal one. institutions, governing bodies, and administrative entities have responsibilities to physicians’ safety and we must hold them accountable. it is our obligation to take an activist role and request, even demand, assistance with ppe, isolation, and support from our superiors. however, we must interact in good faith and resist the appearance of self-indulgence and vacuous recrimination. society holds physicians, nurses, and all healthcare workers on a high pedestal. we should pay a price for that exalted position, although rarely with our life. no physician should be forced to risk his life but, in extraordinary circumstances, when the risk is accepted, we should accept it gracefully, humbly, and readily. i will try to counsel my anxious colleagues to the best of my ability but, i also must refer to our code of ethics above and fulfill my moral obligation. in the past 24 hours an evolving situation brought a mist to my eyes and is an example of courage and commitment to our vocation. a 35 year old man with a pregnant wife and no prior medical problems had not responded to conventional therapy. he was on a ventilator with no further increase of oxygen possible. all available medications used to treat covid-19 and one experimental medication on clinical trial had failed to improve his condition. his only chance to allow his lungs to heal was extracorporeal membrane oxygenation (ecmo), a complex, highly intense medical modality that provides oxygen directly to the bloodstream, bypassing the lungs. selfless acts by nurses, intensivists, social workers, administrators and, yes, ethicists created the environment for the young man’s survival. ten associates manually moved him from prone to supine until ecmo was initiated. i heard no complaints, i heard no recriminations, i heard no whining. i heard only, “let’s do it, doc.'' the ten individuals acting to save the young man epitomize the principles laid down in the ama code of medical ethics. i thank them for their service, and i pray they will someday be rewarded. we will not run out of providers. they will show up as they always have and provide patient care with dignity and compassion for their dedication to duty is boundless. [i] kirsch, thomas, md: “what happens if healthcare workers stop showing up?” , the atlantic march 24,2020, https://www.theatlantic.com/ideas/archive/2020/03/werefailing-doctors/608662/ [ii] stat reports, “we don’t send soldiers to war without weapons” https://www.statnews.com/2020/03/21/give-doctors-what-they-need-to-fight-covid-19/ [iii] optiv: “using “mice” to understand your adversary, https://www.optiv.com/blog/using-mice-to-understand-your-adversary [iv] ebola infections fewer than predicted by disease models https://www.scientificamerican.com/article/ebola-infections-fewer-thanhttp://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_edn6 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_ednref1 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_ednref2 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_ednref3 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_ednref4 ramos, this crisis is not a war, voices in bioethics, vol. 6 (2020) 3 predicted-by-disease-models/ [v] how mortality predictions in a leading coronavirus model dropped over time https://www.washingtonpost.com/politics/2020/04/14/how-mortality-predictionsleading-coronavirus-model-dropped-over-time/ [vi] ama(american medical association) code of ethics, 8.3, physicians’ responsibilities in disaster response and preparedness https://www.ama-assn.org/deliveringcare/ethics/physicians-responsibilities-disaster-response-preparedness http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_ednref5 http://www.voicesinbioethics.net/voices-in-bioethics/2020/5/1/this-crisis-is-not-a-war-it-is-what-physicians-are-trained-to-do#_ednref6 howard, assisted reproductive medicine, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the uncharted terrain of assisted reproductive medicine louisa howard keywords: reproductive rights introduction the high court in london recently made what is considered to be an unprecedented ruling on reproductive rights. the parents of a woman who died at 28 from bowel cancer sought custody of her frozen eggs, claiming their daughter wished for her mother to carry and give birth to her children (her mother’s biological grandchildren). initially, the daughter had her eggs frozen after a cancer diagnosis with hopes that she herself could one day have children. she signed a human fertilisation and embryology authority (hfea) form specifying her wish for egg storage after her death. she did not consent to allowing her eggs to perish, but checked a “yes” so that her eggs would be stored for later use. however, she did not fill out a crucial appendage that would have specified an outcome for her eggs posthumously. technically, her consent became invalid. analysis her parents maintained there were multiple conversations expressing wishes for the mother to serve as a surrogate if radiotherapy damaged the daughter’s womb. while she was living, the daughter may have wanted her mother to serve as her surrogate but evidence is unclear whether she intended her mother to be a surrogate if she did not survive her disease. the 59-year-old mother and her husband claimed that their daughter’s dying wish was to have her mother carry their grandchild. with only one daughter, this was their only chance to become grandparents. ivf hammersmith, where the patient’s eggs remain frozen, did not offer the mother treatment in the way she proposed. institution officials explained “that this is beyond what the patient might have consented to and [they could] not assume that these would have been her specific wishes, as there is no documented confirmation for them.”1 before reaching that conclusion, the unit had consulted the imperial college ethics committee, which had been unable to reach a consensus or definitive conclusion. the parents were unable to find a doctor in the uk agreeable to perform the implantation procedure using a donor sperm. however, a physician in new york city was willing to proceed with ivf. the claimants applied for a special direction from the hfe authority, requesting exportation of their daughter’s eggs to new york, where they would then be under united states jurisdiction. the hfea denied this request three times. under the 1990 hfea act, the eggs could not be exported because certain requirements could not be met, notably in relation to written informed consent. the hfea maintained that there was not enough legal evidence to prove the daughter’s intent for the eggs, as posthumous use of howard, assisted reproductive medicine, voices in bioethics, vol. 1 (2014-15) 2 gametes requires the effective consent of the gamete provider. the donor’s next of kin, the claimants, had no apparent right under the act to decide on the use or disposal of her gametes. the hfea also considered the context of this case, including the fact that the genetic material are eggs; they are not embryos. furthermore, she was neither married nor had a partner. once the hfea denied the couple’s application to export their daughter’s eggs, the couple sought legal action, arguing the hfea and the ivf clinic had both made a “disproportionate interference” on the family’s human rights.1 the claimants insisted their daughter did not know of another form required for clearer consent. the consent she signed, they claimed, stated she wanted her eggs to be kept “for later use,” which implied she wanted them to be implanted into her mother. however, the high court determined there was no evidence that the daughter had ever “contemplated or consented” to what the parents sought: export of her eggs to be fused with an anonymous overseas sperm donor or one selected by her parents.1 there was no evidence that the daughter had discussed the question of using a donor sperm with anyone. furthermore, there was no indication that she understood the implications for her mother’s health or the result of her mother acting as a surrogate. since there was a lack of written proof, the high court determined that the potential grandparents could not be granted ownership of the eggs. mr. justice ouseley, of the high court, fairly stated, “i must dismiss this claim, though i do so conscious of the additional distress which this will bring to the claimants, whose aim has been to honour their dying daughter’s wish for something of her to live on after her untimely death.”1 the high court specified that completion of the forms would have resolved the issues, but their “absence was not fatal at all to a positive decision.”1 it was instead the fact that so many issues were neither discussed nor resolved while the daughter was still alive. the committee gave examples of ways in which a more clear future for the eggs could have been defined. along with signing the necessary consent forms, the family could have undergone counseling in relation to the treatments in question; sought more information from others about what might be involved in such arrangements; spoken to others about these wishes and intentions; have others witness wishes and intentions; leave something as a token to the anticipated baby; have formal discussions with the doctors involved in her treatment; requested information about what might be involved in donor insemination, surrogacy, and the implications for parental responsibility. the committee was entitled to conclude that the daughter’s expression of her wishes was unclear in many areas where clarity was crucial. while the high court ruled against the couple, they could still take their case to the court of appeal. although the high court did not reach its decision on the basis of any adverse view about the mother carrying her daughter’s fertilized egg or the welfare of any future child, there are a myriad of ethical issues that come into question. most notably, this case sheds light on posthumous assisted reproductive medicine and asks whether a woman’s reproductive life should extend beyond its natural limits. with regard to using frozen eggs posthumously, one of the most significant aspects to consider is the psychological well being of the “pretermitted” child.2 one could argue that many children grow up without meeting one or both of their genetic parents. however, in this instance, the child would be conceived posthumously. there is a question of what psychological effect this might have on the child, who could learn the truth about his or her conception. in this case, the child would not only be without a genetic mother, but also the father would be anonymous. another important consideration is the health of the surrogate. in a report developed by the ethics committee of the american society for reproductive medicine published in fertility and sterility journal, members warn that the risk of gestational diabetes and pregnancy-induced hypertension increases with a woman’s age.3 they evaluate the many “physical and physiological risks” accompanied by postmenopausal pregnancy and encourage doctors to carefully consider each patient’s condition.3 generally, fertility clinics will not treat women over 50 due to the limited chances of successful implantation and gestation, as well as the many health risks. in the context of this specific case, the grandmother is well over the recommended age. howard, assisted reproductive medicine, voices in bioethics, vol. 1 (2014-15) 3 conclusion this specific case highlights the necessity of clear and comprehensive informed consent within assisted reproductive medicine and also brings up an important issue regarding ivf regulations in the us. it makes sense that an american clinic would be willing to perform this procedure, while clinics in the uk refused on ethical grounds. the us has little regulation—local, state or federal—regarding assisted reproductive medicine, leaving fertility specialists to make choices while relying solely on arsm recommendations and their own experiences. although it would be difficult in such an expansive country to have a governing body like the uk’s hfea, i believe the us could benefit from a similar establishment overseeing the complex and rapidly growing realm of reproductive medicine. 1 https://www.judiciary.gov.uk/wp-content/uploads/2015/06/m-v-hfea.pdf 2 nakhuda, gary. "posthumous assisted reproduction." srm-ejournal 10.1 (2012): 28-32. srm-ejournal. feb. 2012. 3 "oocyte donation to postmenopausal women." fertility and sterility 82.1 (2004): s254-255. american society for reproductive medicine. https://www.judiciary.gov.uk/wp-content/uploads/2015/06/m-v-hfea.pdf chase, covid-19 testing should be prioritized, voices in bioethics, vol. 6 (2020) * emily chase © 2020 emily chase. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and re production, provided the original author and source are credited. covid-19 testing should be prioritized for those most at risk for spreading the disease and those interacting with vulnerable populations emily chase keywords: covid-19 testing, vulnerable populations, scarce resources introduction “the more tests we run, the better,” said new york governor andrew cuomo in a recent press conference.1 testing is critical in isolating people with the virus and preventing further infection. on march 6th, as cases spread from local sources, new york city officials appealed for more testing supplies.2 the department of health and human services and the food and drug administration are now funding test development at private companies to supply enough tests to fill the massive demand.3 confirmed covid-19 cases have grown to over 54,000 in the united states.4 without widely available testing, these numbers will continue to climb exponentially without adequate isolation and self-quarantine. with limited testing supplies, healthcare workers, those who work with the elderly and immunocompromised, and those involved with the delivery of items must be prioritized for testing. analysis on friday march 13th, congress and trump decided on an emergency spending package that would include free virus testing for those without insurance.5 the trump administration also declared that drivethrough testing would begin, like those performed successfully in south korea.6 drive-through testing has since been set up at pharmacies, hospitals, clinics, and other locations in many states. a few weeks ago trump stated that anyone can get a test, but he has since limited his initial claim to people with symptoms, adding, “we don’t want people to take a test if we feel that they shouldn’t be doing it.”7 trump claims that production by private companies would add 5 million more tests by the end of march.8 however, 5 million would still fall short of the 160 to 214 million people projected by the cdc to be infected if measures of mitigation are not initiated.9 associate chief medical officer at rush university, dr. bala n. hota stated that as the infections increase so will the number of people who will need to be tested, requiring a much larger testing capacity.10 public officials in new york are now asking people to presume they are positive upon certain symptoms because widespread testing is not yet available, though new york is chase, covid-19 testing should be prioritized, voices in bioethics, vol. 6 (2020) 2 significantly boosting its testing capacity. people with on-site jobs necessary to the functioning of society should ideally have access to testing so, if negative, they would not need to stay home. with limited testing supplies, the question of triage for testing arises. dr. deborah l. birx, the trump administration’s covid-19 response coordinator, said that the administration is working with tech developers to create a website to help screen people for symptoms and direct them to a drive-through clinic if needed.11 google stated that verily, a part of alphabet inc.’s research organization on life sciences, is in the early stages of development of a website for use in the san francisco bay area.12 a representative for verily, carolyn wang, said that the site would help to triage people for testing and, if successful locally, they hope to move the operation nationwide.2 hospitals and doctors’ offices have also moved to online triage in an effort to encourage people to stay home rather than travel to appointments where they can infect others and to prioritize severe cases.13 with online testing triage sites, the allocation of limited testing supplies calls for prioritization of those who should be tested. some argue that the elderly and immunosuppressed should be the first to be tested, as they are the most vulnerable. however, since the current treatment for covid-19 is mostly symptom management, testing positive in someone with mild symptoms would not likely alter patient treatment. without symptoms or exposure, people do not need testing. with symptoms, online medical advice can be provided regardless of testing, keeping people with mild symptoms home and containing the spread. the main purpose of testing is not to determine treatment or provide cures but to prevent spread. hospitalized covid-19 patients may have access to different types of experimental treatment,14 such as cloroquine or remdesivir,15[xv] though there is still uncertainty as to the exact effectiveness of these drugs against covid19 in patients. for the sickest patients, testing for covid-19 would be helpful in determining whether to administer these experimental treatments. if these drugs are found to be efficacious, then testing in the elderly and immunosuppressed, even with mild symptoms, may be recommended. if there were tremendous numbers of tests, everyone, symptomatic and asymptomatic, could be tested in order to trace the transmission of the virus and stop the spread by quarantining only those who test positive or have known exposures. however, as testing remains limited, we need to consider narrowing the range of people outside the hospital we will test. the most important people to have tested in the community are those with exposure or symptoms who are most at risk of spreading the disease and those who are most likely to interact with vulnerable populations. these include: 1. healthcare and hospital workers 2. those working or living with the elderly or immunocompromised 3. those involved with the delivery of items others with symptoms or exposure who cannot work from home are on a lower tier than the above but should still be tested as more tests become available. those who are able to work from home and to immediately self-quarantine if they experience symptoms or have known exposures, are a lower priority. those traveling from areas of high risk to low risk, such as from new york city to another state, may want to receive testing to make sure they won’t spread the virus. instead of getting tested, these visitors should be careful to mitigate the spread of the virus by quarantining themselves for 14 days in the new location. unlike the three groups listed above, many of those relocating plan to work remotely. until more tests become available, social distancing must be required. communities can help those quarantined with the delivery of groceries and supplies to encourage people who might have the virus to remain quarantined. https://d.docs.live.net/b37c00fb4a29b9da/pictures/emilychasecovid19.editannemarch25readytopublish%20(1).docx#_edn15 chase, covid-19 testing should be prioritized, voices in bioethics, vol. 6 (2020) 3 conclusion to limit continued spread and to ensure protection of the vulnerable, healthcare workers, those working with the elderly and immunocompromised, and those involved in the delivery of products should have priority over the general population while tests are scarce. it is possible to mitigate the spread of covid-19 with triage testing protocols that focus on containing the disease. unnecessary tests should be avoided and self-quarantine preferred when the person has not been in contact with others known to have tested positive, has no symptoms, or has symptoms that can be managed without risk to others by staying home. prioritizing the distribution of tests must be balanced with providing enough tests to stop possible points of infection spread. as the virus proliferates, the dual approach of quarantining and testing based on priorities could slow the exponential growth and allow our hospitals to maintain enough beds and staff for those who need them. 1 de freytas-tamura, kimiko. “cuomo attacks c.d.c. over delays in coronavirus testing.” the new york times. march 8, 2020. https://www.nytimes.com/2020/03/08/nyregion/coronavirus-newyork.html. 2 ibid. 3 weiland, noah, and katie thomas. “trump administration moves to speed coronavirus testing.” the new york times, march 13, 2020. https://www.nytimes.com/2020/03/13/us/politics/trump-administration-coronavirustesting.html. 4 “cases in u.s.” centers for disease control and prevention. march 19, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-inus.html?cdc_aa_refval=https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. 5 “pelosi and trump reach deal on a relief package.” the new york times. march 13, 2020. https://www.nytimes.com/2020/03/13/world/coronavirus-news-live-updates.html. 6 weiland, noah, and katie thomas. 7 ibid. 8 ibid. 9 ibid. 10 ibid. 11 ibid. 12 ibid. 13 abelson, reed. “doctors and patients turn to telemedicine in the coronavirus outbreak.” the new york times. march 11, 2020. https://www.nytimes.com/2020/03/11/health/telemedicine-coronavirus.html 14 “therapeutic options for covid-19 patients.” centers for disease control and prevention. march 21, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html#r7. https://www.nytimes.com/2020/03/08/nyregion/coronavirus-newyork.html https://www.nytimes.com/2020/03/13/us/politics/trump-administration-coronavirus-testing.html https://www.nytimes.com/2020/03/13/us/politics/trump-administration-coronavirus-testing.html https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html?cdc_aa_refval=https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html?cdc_aa_refval=https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html https://www.nytimes.com/2020/03/13/world/coronavirus-news-live-updates.html https://www.nytimes.com/2020/03/11/health/telemedicine-coronavirus.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html#r7 chase, covid-19 testing should be prioritized, voices in bioethics, vol. 6 (2020) 4 15wang, manli, ruiyuan cao, leike zhang, xinglou yang, jia liu, mingyue xu, zhengli shi, zhihong hu, wu zhong, and gengfu xiao. “remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019ncov) in vitro.” cell research 30, no. 3 (april 2020): 269–71. https://doi.org/10.1038/s41422-020-0282-0. ninia, the case for in vitro meat, voices in bioethics, vol. 2 (2016) © 2016 james ninia. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the case for in vitro meat james ninia keywords: tissue, stem cells, animal ethics, meat introduction long gone are the days of hunting and gathering food or raising our own livestock. the first time american consumers see their food is usually on a supermarket shelf or a restaurant plate. it’s easy to not consider what goes into the preparation of milk, eggs, or pork chops. for meat in particular, the path from the source is not only bloody and unsanitary, but also terrible for the environment. in august 2013, a historic milestone was achieved: the first public tasting of in vitro meat (ivm).1 ivm is exactly what it sounds like: meat created by humans in laboratories. while this technology is still very much in development, this meat is created by painlessly harvesting stem or muscle cells from a living animal, and developing these tissues in a culture until edible meat is produced. if the medium used to create ivm is not fetal bovine serum, scientists could theoretically prepare meat without having to kill, or even harm, a single animal. analysis continued research and development of ivm and related technologies is morally imperative for ethical, environmental, and health reasons. the reasons this emerging technology gets an ethical thumbs-up are at once obvious and nuanced. for one, producing meat in this way does not necessitate the killing of an animal, instead requiring only taking a sample of cells from them. some might raise an eyebrow that harvesting these cells might still cause a pig or a cow pain or distress; however, that may not even be the case. it has been claimed, for example, that merely 10 pork muscle/stem cells could yield up to 50,000 metric tons of pork product.2 even if a completely harmless method of cell harvesting is not able to be used, surely a small biopsy on a few, healthy animals in humane conditions would be preferable to the inhumane and egregious conditions faced by animals in factory farms, where many live a tortured existence and subsequently get slaughtered by the scores. even prominent vegetarians such as peter singer appear to be excited by the idea of trying ivm, claiming that being a vegetarian or vegan is not an intrinsically valuable activity, but rather an instrumentally valuable one in light of the end goal of minimizing human and animal suffering. on this view, the introduction of ivm would allow those who are currently vegans and vegetarians a way to partake in meat consumption without supporting the suffering of animals.3 there are additionally salient, environmental concerns at play here that give even more impetus for pursuing ivm. currently, 30% of the world’s arable land is covered by pastureland for animals, while only 4% is used to directly feed humans. the total biomass of livestock on earth is currently double that of humans and uses 8% of global available freshwater. not to mention, 18% of greenhouse gas emissions are due to livestock production, which makes livestock a bigger contributor to global warming than all transportation occurring on the planet combined.4 ivm cuts down substantially on land use, water use, and greenhouse gas emissions when compared to conventional methods of beef, sheep, pork, and poultry production. in addition, ninia, the case for in vitro meat, voices in bioethics, vol. 2 (2016) 2 ivm takes less energy to produce than beef, pork, and sheep, but slightly more energy input than poultry production requires. ivm also has potential conservational benefits: animals who are over hunted or fished could see cuts of their meat grown in labs, potentially decreasing the hunting of that species.5 concerns about our health would also lead us to embrace this technology as well. conventional beef production is associated with salmonella, e. coli, mad cow disease, and other potentially harmful pathogens. pursuing ivm production over traditional methods of meat production entails less human-animal contact. in this way, ivm production could help mitigate the spread of zoonoses to humans, and the sterile laboratory environment where ivm is produced should also help to mitigate food-borne illness.6 moreover, the use of antibiotics in livestock has been identified as a potential source of antibiotic-resistant bacteria, and the introduction of ivm might diminish the evolution of these strains of bacteria. 7 additionally, thanks to advancements in tissue engineering techniques, the fat and nutritional content of ivm can be modulated. this might include fortifying meat with omega-3 fatty acids, adding certain vitamins, modulating the polyunsaturated fat content, and supplementing the meat with rare, but necessary, micronutrients such as iron and zinc.8 in this way, it seems as though ivm offers opportunities to augment the nutritional content of our own food and to produce meat in a way that minimizes the potential for disease. critics of ivm often argue against this technology on the grounds that it is unnatural. it appears, however, that this criticism fails under scrutiny. for one, humans regularly consume foods that are unnatural to some degree. we regularly consume gmos, pasteurize our dairy, and enjoy heavily processed foods like cheese whiz. even traditional delicacies, like foie gras, are created by forcing “unnatural” circumstances on animals such as force-feeding geese by gavage. judging from these everyday examples, it appears we have good reason to reject objections to this technology that are based on its purported “unnatural” state. others argue that the technology is simply too expensive to be economically viable. up until recently this was true: the patty tasted in august 2013 cost over £200,000 gbp.9 the steep price tag appears on the cusp of rapid decline, however, as dr. mark post, a scientist at the university of maastricht researching ivm, claimed in 2015 that he managed to get the cost of his ivm production down to about $11 usd per beef patty. 10 skeptics might additionally point to concerns with the possible taste of the meat or the fact that as of 2014, only one in every five americans was willing to try meat grown in a lab.11 this being said, however, most who have had the opportunity to taste these products have said they were hardly different from the taste of real meat,12 and public concerns regarding the technology could be overcome with adequate safety testing, regulations, and education. conclusion thus, ivm is but one promising technology emerging from the field of tissue engineering that demands further action. pursuing ivm is necessary out of concern for the environment, the protection of animals, and our own wellbeing. pursuing ivm will allow humans to continue their long-standing eating habits while catalyzing positive changes for the environment, sparing countless animals suffering and death, and potentially improving our own health. if we as humans are not willing to give up meat consumption altogether, it appears that pursuing ivm is a moral obligation; after all, why not, when you can have your meat and eat it too. 1 singer, peter. "the world's first cruelty-free hamburger." the guardian. aug 5 2013. web. accessed 19 sept. 2016 2 gayle, damien. “artificial meat grown in a lab could become a reality this year” the daily mail. jan 17, 2012. web. accessed october 14, 2016. 3 peter singer (2013). 4 tuomisto, hanna l., and m. joost teixeira de mattos. "environmental impacts of cultured meat production." environmental science & technology 45, no. 14 (june 17, 2011): 6117-123. accessed october 3, 2016. doi:10.1021/es200130u. 5 tuomisto and joost teixeira de mattos, 2011. ninia, the case for in vitro meat, voices in bioethics, vol. 2 (2016) 3 6 tuomisto and joost teixeira de mattos, 2011. 7 zaraska, marta. "lab-grown meat is in your future, and it may be healthier than the real stuff." the washington post, may 2, 2016. accessed october 15, 2016. <https://www.washingtonpost.com/national/healthscience/lab-grown-meat-is-in-your-future-and-it-may-be-healthier-than-the-real-stuff/2016/05/02/aa893f34e630-11e5-a6f3-21ccdbc5f74e_story.html>. 8 tuomisto and joost teixeira de mattos, 2011. 9 singer, peter. "the world's first cruelty-free hamburger." the guardian. aug 5 2013. web. accessed 19 sept. 2016 10 hanson, hilary. "‘world’s first’ lab-grown meatball looks pretty damn tasty." the huffington post, february 2, 2016. accessed october 20, 2016. <http://www.huffingtonpost.com/entry/lab-grown-meatball-memphismeats_us_56b12317e4b04f9b57d7a9b2>. 11 pew research center, “u.s. views of technology and the future,” april 17, 2014. accessed october 23, 2016. <http://www.pewinternet.org/2014/04/17/us-views-of-technology-and-the-future/>. 12 tuomisto and joost teixeira de mattos, 2011. http://www.pewinternet.org/2014/04/17/us-views-of-technology-and-the-future/ introduction analysis conclusion reaves, pedophilia, voices in bioethics, vol. 2 (2016) * michael reaves, m.s. in bioethics at columbia university © 2016 michael reaves. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. pedophilia: prevention or paternalism? michael reaves* keywords: pedophilia, treatment, neuropsychological, disorder introduction “there is no cure, so the focus is on protecting children.”1 harvard medical health letter, july 2010 pedophilia, or the sexual attraction to children who have yet to reach puberty, continues to perplex clinicians and researchers in the 21st century. there is often much confusion surrounding this term, as society commonly groups pedophiles alongside child molesters. however, not all persons with these sexual interests actually act on them. many individuals who have these sexual preferences stay celibate their entire lives. while there may be no cure for pedophilia, there are new treatment options that may be available to the public in 2018. analysis researchers at karolinska institute in sweden are attempting to fund a full-scale scientific drug trial that may provide hope for those seeking treatment. dr. christoffer ramm is the principal investigator of this research study; his background includes research on the neuropsychological aspects of psychosis. his team refers to their work with the acronym priotab, or “pedophilia at risk – investigations of treatment and biomarkers,” a collective that seeks to make society safer – both for children and those who suffer from these complex disorders. in their study proposal, priotab notes that in sweden 10% of boys and 5% of girls are sexually assaulted; and individuals with pedophilic disorder commit 50% of these assaults.2 the priotab team claims that they can repurpose the pharmaceutical drug degarelix, which has typically been used to treat prostate cancer. the team believes an effective treatment will reduce the social stigma associated with seeking treatment for pedophilia and also protect those who cannot protect themselves. according to dr. ramm, development and acceptance of treatments for pedophilia is the best route to reduce the incidence of crimes against children, and he believes his crowd-funded study is the best way to go about treating the sexual disorder. individuals who attempt to combat their disorder without treatment only increases the likelihood of pedophilia in society. consequently, preventing access to treatment only puts society at greater risk; therefore, crowdfunded research for the development of an effective treatment to help those struggling with pedophilia is a necessary step to protect society from this criminal behavior. prior to priotab’s study, degarelix was used to decrease the body’s production of testosterone, the dominant male hormone, with the intention of slowing the spread of acinar adenocarcinoma in male patients.3 since sexual aggression has been linked to excessive levels of testosterone in the human body, regulating testosterone levels may reduce the risk for sexually abusive behaviors.4 therefore, the priotab team believes degarelix may be the first evidence-based acute treatment – both psychological and pharmacological – to reduce the risk of child abuse in adults suffering from a pedophilic disorder by effectively castrating them via chemical pathways. reaves, pedophilia, voices in bioethics, vol. 2 (2016) 2 chemical castration is controversial given that it may obstruct personal autonomy and confidentiality. with regard to autonomy, many may feel that they no longer have control over their sexuality. others may protest therapy, arguing that chemical castration is contrary to naturally-occurring hormone levels in the human body. more serious ethical concerns come into play with confidentiality. some believe that listing pedophilia in their medical record will lend itself to a stigmatization if a patient seeks treatment. development of pharmacological therapies may encourage nations with more restrictive legal barriers surrounding confidential treatment, like in the uk or the us, to adopt legal protections for providers treating disorders that are both medical and psychological. some citizens of the uk are moving to other european nations for treatment where confidential psychiatric treatment for these disorders is taking place. for example, in germany, the dunkelfeld institute has pushed for patient protection and the facilitation of treatment options. starting in berlin, the institute now has centers in 10 cities across germany and is available to all who seeks treatment. an anonymous individual who made use of this treatment notes, “i did not have to give my name and address, and i was given a pin number to connect me to my diagnosis data […] therapists are forbidden from revealing anything that happens in the context of treatment.”5 it is frustrating for those who suffer from these disorders and seek out help, but cannot seek it because of both the stigma and future legal implications in their respective state. many privately combat the issue out of fear of exposure. institutes such as these provide a model for countries that have yet to promote these services for their citizens, a model which has the best interests of both the patient and society at heart. the primary opposition lies not in the discovery of treatment or access to treatment, but rather in the confidential nature of the treatment options. it can be assumed that the primary argument against anonymity is a need to monitor potential threats by keeping a list and informing communities of potential threats. this hypothetical list would be regulated much like a sex-offender index -a system that allows searching, or at the very least allows for warning a community of potential threats. concerned parents everywhere would encourage placing those who come forward for treatment on a list as a necessary step to protect society from this heinous form of abuse. emotional arguments follow suit: “wouldn’t you want to know if someone seeking treated for pedophilia was living on your block? someone who lives near where your children sleep and play?" keeping track of all individuals who attempt to seek treatment not only isolates a group of people who have yet to commit a crime, but also opens the door to tracking individuals with other mental health disorders. the potential to track others who may pose a risk to society is enticing to some, but a line must be drawn. any state intervention that seeks to publicly disclose any part of your medical record for the so-called greater good must be met with skepticism, especially when the information is sensitive enough to destroy an individual’s life, reputation, and career. tracking discourages individuals to seek out an effective treatment for their disorder out of fear of exposure, and may put society at greater risk. many professionals in the field agree that there is not much an individual can do to stop these urges without treatment. dr. james cantor is associate professor of psychiatry at the university of toronto and the editor-in-chief of sexual abuse: a journal of research and treatment. as dr. james cantor has noted in previous interviews, “one cannot choose to not be a pedophile, but one can choose to not be a child molester […] pedophilic men have significantly less white matter, which is the connective tissue that is responsible for communication between different regions in the brain.”6 sympathizing with an individual who has pedophilic tendencies does not condone child molestation, but may instead encourage individual protection and safety. those seeking treatment are often motivated by his or her biology to engage in these behaviors we deem unacceptable in our society. protecting individual privacy will establish trust between healthcare, government, and the populous so that an individual will not suffer merely for seeking assistance. conclusion crowd-funded research like that of priotab is necessary to promote unbiased research as well as to encourage global awareness on this often misunderstood issue. if individuals are suffering from a disorder and cannot seek assistance, the current framework of treatment is misaligned. we should not punish those who are trying to be productive members of society by keeping them on a list out of fear. this punishment tramples on the foundation of confidentiality and may further encourage individuals struggling with this disorder to refuse treatment options because of the lack of anonymity. facing the disturbing truths of pedophilia could help keep both children and society safer. pedophilia may never be met with a cure, but those suffering can obtain self-control with the help of therapy and risk-reducing medications. prevention via treatment is key when tackling this controversial ethical issue in society. reaves, pedophilia, voices in bioethics, vol. 2 (2016) 3 1 “pessimism about pedophilia.” harvard mental health letter, july 2010. web. http://www.health.harvard.edu/newsletter_article/pessimism-about-pedophilia 2 “plan to examine medical interventions for pedophilia to reduce the risk of child sexual abuse.” walacea. web. https://walacea.com/campaigns/priotab-to-treat-paedophilia/ 3 "degarelix injection: medlineplus drug information." u.s. national library of medicine, web. https://wwwqa.nlm.nih.gov/medlineplus/qa1/druginfo/meds/a609022.html 4 daryl b., o'connor, john archer, and frederick c.w. wu. "effects of testosterone on mood, aggression, and sexual behavior in young men: a double-blind, placebo-controlled, cross-over study.” the journal of clinical endocrinology & metabolism: vol 89, no 6. 14 jan. 2009. web. http://press.endocrine.org/doi/full/10.1210/jc.2003-031354 5 connolly, kate. "how germany treats paedophiles before they offend." the guardian. guardian news and media, 16 oct. 2015. web. https://www.theguardian.com/society/2015/oct/16/how-germany-treats-paedophilesbefore-they-offend 6 cantor, james, dr. cnn. cable news network, 21 june 2012. web. http://www.cnn.com/2012/06/21/opinion/cantor-pedophila-sandusky/ http://www.health.harvard.edu/newsletter_article/pessimism-about-pedophilia https://walacea.com/campaigns/priotab-to-treat-paedophilia/ https://wwwqa.nlm.nih.gov/medlineplus/qa1/druginfo/meds/a609022.html http://press.endocrine.org/doi/full/10.1210/jc.2003-031354 https://www.theguardian.com/society/2015/oct/16/how-germany-treats-paedophiles-before-they-offend https://www.theguardian.com/society/2015/oct/16/how-germany-treats-paedophiles-before-they-offend http://www.cnn.com/2012/06/21/opinion/cantor-pedophila-sandusky/ introduction analysis conclusion crowd-funded research like that of priotab is necessary to promote unbiased research as well as to encourage global awareness on this often misunderstood issue. if individuals are suffering from a disorder and cannot seek assistance, the current frame... ladha, the syrian refugee health crisis, voices in bioethics, vol. 2 (2016) sameer ladha, jd, ms © 2016 sameer ladha. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are cre dited. my country values you: the syrian refugee health crisis sameer ladha* keywords: syria, global ethics, refugee, bioethics some years ago, i had the opportunity to travel to damascus, syria, as part of a ziyarat, a pilgrimage to visit some of shi’ite islam’s most holy shrines. while i have had the good fortune to travel extensively in the developing world, i remember being acutely attuned to the great poverty that i was surrounded by in syria. each and every time i stepped out of our luxury hotel, i felt guilty that while i was cocooned inside my wellventilated air-conditioned hotel room, many more lay in deep poverty at the door of that very hotel. i also noticed that in the area of sayyeda zainab, a largely impoverished neighborhood, there appeared to be a disproportionate number of people suffering from various ailments, ranging from amputated limbs to gravely emaciated figures. i was deeply perturbed by this experience, and recall speaking with a local, asking him why so many looked undernourished and generally unhealthy. charmingly witty, and with a peculiar sense of optimism, he replied, “my country doesn’t value me the way your country values you.” and then he laughed, as if he was simply stating a fact that he had grown accustomed to. today, the neighborhood of sayyeda zainab has been largely destroyed, and many of its inhabitants make up the exodus of refugees seeking home elsewhere. in searching for new homes, these refugees require not only an open door to enter through but also systems that can cater to their burgeoning and urgent needs. to tend to the health needs of this population, countries should absorb refugees into existing national healthcare systems, providing necessary services to a displaced, desperate people. that is certainly the most basic, appropriate, and ethical means of assimilation. the health care challenges attached to this recent crisis cannot be handled uniformly within all nations. it appears that wealthy, industrialized western countries can play a large role in settling refugees and providing adequate access to basic healthcare. however, even among these nations, the provision of healthcare services is often at philosophical and practical impasse. countries such as canada and the uk adhere to the belief that healthcare, if it can even be considered a good, is truly a “special good” that should be universally accessible regardless of ability to pay. on the other hand, the united states largely abides by the principle that healthcare is a market-driven good, and not a universal right. and on the other end of the spectrum are developing countries that do not have sophisticated healthcare systems largely because they lack the financial means. it is within this complex, incongruent, and disparate global “health system” that the refugee crisis is unfolding. according to an amnesty international report published on february 3, 2016, more than 4.5 million syrian refugees have entered the countries of turkey, lebanon, jordan, iraq, and egypt; turkey has taken more syrian refugees than any other country in the world, lebanon hosts the equivalent of approximately 25 percent of its national population, jordan hosts the equivalent of 10 percent of its national population, and iraq hosts ladha, the syrian refugee health crisis, voices in bioethics, vol. 2 (2016) 2 245,022 syrian refugees while contending with 3.9 million internally displaced iraqis.1 arguably, a number of these countries do not have adequate health systems for even their national citizenry, and certainly do not have the ability to provide necessary healthcare provisions for the overwhelming influx of refugees. instead of further burdening already strained health systems, the international community needs to provide aid in the resettlement of refugees in these regions, with a primary focus on attending to the healthcare needs of this population. our response rate to the overall syrian refugee crisis has been dismal, with the un’s humanitarian appeal for 2015 funded at only 61 percent.2 if countries sincerely took on the burden of providing adequate funding, the humanitarian crisis, as well as health crisis, that is surmounting can be managed more effectively. turning to western nations, while clear doctrinal issues may exist with respect to access to healthcare, because of the humanitarian crisis at hand, basic healthcare provisions should be provided to the refugee population. this does not necessary imply that a permanent two-tier health system should exist, but simply that a temporary catering to this extremely disadvantaged population is only appropriate. in countries that have not adopted universal healthcare, critics may legitimately argue that such a system would deprive nationals of healthcare services while favoring a refugee population. this argument is difficult to counter, but a response may be that the humanitarian crisis is so grave that it would be unconscionable not to provide such basic healthcare. alternatively, countries should pay into an international fund that can disburse healthcare dollars to countries that choose to host refugees, thereby not impinging directly on financially strapped or inadequately developed national healthcare systems. the challenges to integrating a refugee population appear less complicated in nations that already subscribe to universal or nationalized healthcare. perhaps we simply need to look further up (both literally and, arguably, figuratively) to find an example of an appropriate response to the syrian refugee health crisis. on february 18, 2016, canada’s liberal government announced that all refugees will have the same access to healthcare that all canadians enjoy. such a bold pronouncement is more palatable under the canadian healthcare system, where all canadians are guaranteed healthcare (as determined at the provincial level); making the extension of healthcare to a refugee population, while presenting questions of cost and burden, is therefore logistically less challenging.3 by affording syrian refugees a basic level of healthcare, host countries are also safeguarding the health and security of their citizenry. refugee populations expose countries to a host of communicable and noncommunicable diseases, and it is therefore in the national best interest to address the health requirements of a large refugee population to prevent the spread of disease. additionally, if a sustainable mechanism is not in place, the refugee population may seek urgent care in the emergency rooms of hospitals, further driving up the cost of healthcare. in light of the trauma that the syrian refugees have sustained, it is highly probable that mental health services also need to be furnished. while this may seem unduly burdensome on a host country, the long-term benefits of successfully integrating a refugee population certainly outweigh potentially isolated and mentally impaired individuals posing a very real threat to themselves, others, and national security. those opposed to providing basic healthcare services to this refugee population may argue that such an endeavor is costand resource-prohibitive. however, the alternative of not providing basic health services would be more detrimental and costly, not only in very real financial terms, but also in terms of threats to human health and safety. it may be argued that the proposal is simplistic and does not take into consideration the complexities that are inherent to varied health systems. yes, certainly complexities exist, but integration of refugees into existing health systems does not necessarily require revamping health systems, but instead providing room for refugees to emerge within those health systems. others may argue that healthcare was not adequately provided to this population when they were in syria, and therefore they should not be afforded anything more as refugees. this argument fails on at least two fronts. first, under the united nations high commissioner for refugees (unhcr), “a refugee has the right to safe asylum. however, international protection comprises more than physical safety. refugees should receive at least the same rights and basic help as any other foreigner who is a legal resident, including freedom of thought, of movement, and freedom ladha, the syrian refugee health crisis, voices in bioethics, vol. 2 (2016) 3 from torture and degrading treatment.”4[4] second, by promulgating a separate substandard for refugees, the host country will be complicit in perpetuating a systemic inequality, heightening tension and encouraging further alienation of a population that it hopes to integrate. earlier this year, i attended the world leaders forum at columbia university, where his excellency sergio mattarella, the president of the republic of italy, somberly noted, “on the issue of refugees, italy is defending a need.” that is exactly what we need to do—defend the needs of those most vulnerable today. thereby, national governments will continue to uphold the long-standing principles of beneficence and justice, while safeguarding fundamental human dignity. our international system of governance is founded on noble words, such as those imbedded in the united nations’ universal declaration of human rights and other lofty texts that speak to our better selves. notions of “never again” rally us to our larger goals as a human population, often rooted in age-old iterations of maxims like the golden rule. today, it is essential that we transcribe the spirit of these words to the health crisis that syrian refugees are facing. integrating healthcare provisions for a refugee population gives voice and credence to our collective aspirations. national healthcare systems should responsibly absorb the healthcare needs of refugees, with the necessary international support and funding. the efforts may take some time, but they are nonetheless critical not only to refugees, but also to our collective well-being. if i were to ever meet that witty syrian local again, i hope that i can say—with an optimism that i have grown accustomed to—that “my country not only values me, but it also values you.” 1 “syria’s refugee crisis in numbers,” amnesty international, september 4, 2015, https://www.amnesty.org/en/latest/news/2015/09/syrias-refugee-crisis-in-numbers/. 2 ibid. 3 “liberal government fully restores refugee health care program,” cbc news, february 18, 2016, http://www.cbc.ca/news/politics/mcallum-philpott-interim-federal-health-program-refugees-1.3453397. 4 “protecting refugees: questions and answers,” the un refugee agency (unhcr), february 1, 2002, http://www.unhcr.org/3b779dfe2.html. https://courseworks2.columbia.edu/courses/5379/discussion_topics/26826#_ftn4 stevens, designer death, voices in bioethics, vol. 4 (2018) © 2018 carolyn e. stevens. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. designer death carolyn e. stevens keywords: quality of life, physician-assisted suicide, mortality introduction in today’s world, there are overwhelming and amazing technologies that can change, advance, and elongate life. from gene editing to stem cell therapy, the advancement of medical science seems almost to bring myth to life. some of the latest technologies, such as crispr, are at the forefront of ethical debate as they impact quality of life drastically. however, even with these advancements, the reality of being human is facing a mortal and finite existence. discussion no person wants to end up like the poor greek tithonus [*1], who lived forever with an eternal low quality of life. so, question we must ask ourselves: how do we face death in an ethical and selfempowering manner? who decides when and how you go? should it be you? such questions raise a host of ethical concerns, especially when scientific and genetic research have shown we have the capacity to live to 120 years old [1,2], and research is still pushing forward in an attempt to alter or even completely turn off our aging “switch” [6,7]. not to mention, with leaps in technology and further studies done on human consciousness, there is no telling how our world will grow and what types of staggering advances will change the world we live in. but, on the likely chance death will remain an integral part of our lives, even if we extend our life expectancy to 500 years of age, the question will still remain; how should we die and who should choose this? one of the primary concerns we see in aging and geriatrics today is the burden of cost [8]. while these scientific advancements are extending life, and to an extent maintaining quality within that extension, there are economic ramifications. retiring at 65 is not as realistic as it once was, especially when healthcare costs for people are rising with their age and the average lifespan of a person has doubled since the early 1900s [3,8]. furthermore, cultural and social changes have impacted the ratio of younger to older people in the united states. the cdc has noted the population of individuals over 65 is going to double from 2000 to 2030 [4]. while we are striving to maintain longevity of life, we have to address its ramifications, not just for individual patients and the quality of their lives, but also the broader consequences at play, from insurance coverage, availability of medical professionals specialized in geriatrics and eldercare, to organ donation and rationing. are we currently adequately supporting a society of people living into their 80s and 90s, and can we realistically continue to do so if the majority of the population lives to as late as 120 years of age? stevens, designer death, voices in bioethics, vol. 4 (2018) 2 as atul gawande noted in his new yorker article, “the way we age now,” america has yet to face the reality of its aging and changing demographic [9]. this becomes a conundrum when we are working on extending life but not understanding the full consequences of doing so. also, we must be realistic about extending life. if we do make it to 120 years old, what will it look like? will 50 become the new 20? and if not, if longevity only comes with increased burdens on both patients and society, then is it even responsible of us to push the bounds so far? is it ethically responsible to prolong life? and if it isn’t, then how do we go about ending it? in america, states like oregon have been practicing forms of physician-assisted suicide for over a decade, but only for those on the brink of death. the real question lies in the population somewhere in between; those who may live for longer than 6 months, but with a questionable quality of life. do people want to live an extra 40 years if that life is going to be full of sickness, weakness and decline? and furthermore, are we extending life, without addressing the consequences or quality, simply because we are scared of the great beyond? denmark has been at the forefront of the physician-assisted suicide movement and has faced scrutiny around the world for allegedly euthanizing people without valid consent. however, data has shown no slippery slope effects have occurred, and the laws have helped create legal certainty [10]. further, numerous public cases have demonstrated that peace and happiness come from knowing when, how, where and why a patient is going to die. this was true for andre verhoeven, who was able to celebrate his life with his family in his final days and take control of his situation of terminal cancer, which empowered him, and according to his family, made him happier, before his death at 64 years of age [11]. quality of life is certainly a subjective and personal measure, and if we are to step towards the idea of self-controlled designer death, we must do so critically. this method should evaluate a person’s personal standards but also be tempered with social and psychological considerations so as to prevent any erroneous or negligent actions. instead of worrying so much about how long we live, and fighting for extra years that may result in pain and undue burdens, we need to rework our ideologies and beliefs about death. we need to strive to understand it, accept its reality, and find ways of confronting it so that we are the ones in control of death rather than allowing our fears of death to control of us. as dr. gawande articulated in his article, people do not enjoy talking about their “decrepitude” even though health decline, despite all measures, seems to remain our fate. while all of these medical advancements are fascinating and innovative, in the area of life-extension, we need to ask how important these technologies are and how much they are helping. conclusion although vampirism and trends in popular culture glorify the existence of immortal life, one must ask themselves, what does such a life actually entail? even if a person was enabled to live an immortal life with permanent youth, would that life be as enticing as it seems? after 100, 500, 1,000 years, would it not get old? would it not be more difficult, harsh, and painful than a limited life span? as a species, we need to embrace mortality. we do not need to live forever to have a meaningful life; we have to accept our human mortality is what makes life worth living. perhaps we should focus our energies on designing what we feel should be our own personal end of life outcomes, rather than obsessing over life-extending technologies. this may be the path to a true quality of life. stevens, designer death, voices in bioethics, vol. 4 (2018) 3 1 avi roy phd student, university of buckingham. "lust for life: breaking the 120-year barrier in human ageing." the conversation. april 09, 2017. accessed april 09, 2017. http://theconversation.com/lust-for-life-breaking-the-120-year-barrier-in-human-ageing-14911. 2 nordrum, amy. "how to live longer: scientists are pushing to make 120 the new 70." international business times. december 05, 2015. accessed april 09, 2017. http://www.ibtimes.com/how-live-longer-scientists-are-pushing-make-120-new-70-1900609. 3 "1900-2000: changes in life expectancy in the united states." elderweb. accessed april 09, 2017. http://www.elderweb.com/book/appendix/1900-2000-changes-life-expectancy-united-states. 4 "public health and aging: trends in aging --united states and worldwide." centers for disease control and prevention. accessed april 09, 2017. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5206a2.htm. 5 nelson, bryan. "anti-aging pill could allow everyone to live over 120 years old." mnn mother nature network. december 01, 2015. accessed april 09, 2017. http://www.mnn.com/health/fitness-well-being/stories/anti-aging-pill-could-allow-everyone-live-over-120-years-old. 6 nield, david. "immortality is one step closer as scientists turn off the ageing process in worms." sciencealert. accessed april 09, 2017. http://www.sciencealert.com/immortality-is-one-step-closer-as-scientists-turn-off-the-ageing-process-in-worms. 7 fang, janet. "researchers discover off switch for ageing cells." iflscience. august 15, 2016. accessed april 09, 2017. http://www.iflscience.com/health-and-medicine/researchers-discover-switch-old-cells/. 8 jan 14, 2015 | tricia neuman follow @tricia_neuman on twitter , juliette cubanski, jennifer huang, and anthony damico, and jan 2015. "the rising cost of living longer: analysis of medicare spending by age for beneficiaries in traditional medicare." the henry j. kaiser family foundation. january 14, 2015. accessed april 09, 2017. http://kff.org/medicare/report/the-rising-cost-of-living-longer-analysis-of-medicarespending-by-age-for-beneficiaries-in-traditional-medicare/. 9 gawande, atul. "the way we age now." the new yorker. april 22, 2007. accessed april 09, 2017. http://www.newyorker.com/magazine/2007/04/30/the-way-we-age-now. 10 rietjens, judith a. c., paul j. van der maas, bregje d. onwuteaka-philipsen, johannes j. m. van delden, and agnes van der heide. "two decades of research on euthanasia from the netherlands. what have we learnt and what questions remain?" journal of bioethical inquiry. september 2009. accessed april 09, 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2733179/. 11 sue reid for the daily mail. "the country where death is now just a lifestyle choice: a mum with ringing ears. babies whose p arents don't want them to suffer. they've all been allowed to die by assisted suicide in holland." daily mail online. january 02, 2015. accessed april 09, 2017. http://www.dailymail.co.uk/news/article-2893778/as-debate-assisted-suicide-dispatch-holland-thousands-choose-die-year.html. 12 "ten great public health achievements in the 20th century." centers for disease control and prevention. april 26, 2013. acces sed april 09, 2017. http://www.cdc.gov/about/history/tengpha.htm. 13 "life expectancy." our world in data. accessed april 09, 2017. https://ourworldindata.org/life-expectancy/. http://theconversation.com/lust-for-life-breaking-the-120-year-barrier-in-human-ageing-14911 http://www.ibtimes.com/how-live-longer-scientists-are-pushing-make-120-new-70-1900609 http://www.elderweb.com/book/appendix/1900-2000-changes-life-expectancy-united-states https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5206a2.htm http://www.mnn.com/health/fitness-well-being/stories/anti-aging-pill-could-allow-everyone-live-over-120-years-old http://www.sciencealert.com/immortality-is-one-step-closer-as-scientists-turn-off-the-ageing-process-in-worms http://www.iflscience.com/health-and-medicine/researchers-discover-switch-old-cells/ http://kff.org/medicare/report/the-rising-cost-of-living-longer-analysis-of-medicare-spending-by-age-for-beneficiaries-in-traditional-medicare/ http://kff.org/medicare/report/the-rising-cost-of-living-longer-analysis-of-medicare-spending-by-age-for-beneficiaries-in-traditional-medicare/ http://www.newyorker.com/magazine/2007/04/30/the-way-we-age-now https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2733179/ http://www.dailymail.co.uk/news/article-2893778/as-debate-assisted-suicide-dispatch-holland-thousands-choose-die-year.html https://ourworldindata.org/life-expectancy/ introduction coyle & mckinstry, historical analysis of meat consumption, voices in bioethics, vol. 9 (2023) * cynthia coyle, oms-iv; do candidate, kansas city university, m.a. bioethics candidate, kansas city university ashley mckinstry, oms-iv; do candidate, kansas city university, m.a. bioethics candidate, kansas city university © 2023 coyle & mckinstry. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the benefits and burdens of meat consumption: a historical analysis cynthia coyle & ashley mckinstry* keywords: meat consumption, packing, processing, western diet, environmental degradation introduction human consumption of meat sits at the intersection of culture and health and has profound bioethical implications. here, we discuss how meat is interwoven with human history and traditions. we review the varied negative impacts of widespread modern meat consumption on health and the environment. finally, we address the role that the principle of justice plays in allocating this resource. we argue that reducing meat consumption has health and environmental benefits. i. historical background throughout history, some cultures have integrated meat into their traditions, from hunting rituals to religious celebrations to summer barbecues. while intimately connected to the human experience, meat consumption is not without consequences, ranging from increased incidence of chronic illness to environmental degradation. the mass production of meat began in the late 17th century as the rise of globalization led to widespread trade of goods, including meat products. while the sale and distribution of meat grew rapidly throughout the 18th century, it was not until 1818 that elisha mills opened the first mass-production plant to process pork. the advances made during the industrial revolution led to substantial technological improvements and greater efficiencies in meat processing and packing. during the 19th century, meat-packing plants flooded the united states, and eventually, meat became a staple grocery item for many americans. while consumers enjoyed plentiful access to meat, skeptics such as upton sinclair detailed the horrors of the meat-packing industry and the associated health threats to the consumer. this new awareness resulted in the institution of federal regulations and a new era of quality control. although meat safety has improved over the years, both human health and the environment remain profoundly affected by the externalities associated with meat consumption.1 coyle & mckinstry, historical analysis of meat consumption, voices in bioethics, vol. 9 (2023) 2 while mass production of meat is a relatively new phenomenon, regular yet limited meat consumption was an essential component of human evolution. historians characterize the diets of hunter-gatherer tribes as varied and highly nutritious foods, including meat, fruits, vegetables, nuts, and whole grains. anthropologists studying extant tribes have noticed significantly lower rates of heart disease, diabetes, and cancer, among other chronic illnesses when compared to populations with western diets. in contrast, as agriculture has expanded and flourished, people have become increasingly dependent on the food and cattle produced by farmers. they were less inclined to eat the highly nutritious and varied meals their ancestors did. this shift in diet has led to periodontal disease, novel infections and parasites from cattle, iron deficiencies, and other health challenges. as communities adopt western diets, rates of obesity, hypertension, and diabetes rise.2 ii. a global health crisis a global human health crisis has resulted from excessive meat consumption and its health impacts. recent research has found that the ten-year mortality risk for meat consumers increased by over a third and by almost 50 percent for those who consumed excessive quantities of red meat. other analyses demonstrated the relationship between meat consumption and colorectal cancer. oncologists have noticed an increased incidence of colorectal cancer and a shift in the age demographic most impacted by it. in one study, consumption of more than two ounces per day of processed meat correlated with an 18 percent increased risk of colorectal cancer.3 these adverse impacts on human health highlight the systemic complications that arise from meat consumption and the human cost. iii. environmental degradation in addition to impacting human health, these dietary changes have contributed to environmental degradation. humans conducted animal farming at a staggering scale: in 1961, the world had a standing population of 4.4 billion chickens, a number that increased to 37 billion chickens in 2020. livestock far outnumbers humans, with a standing population of roughly 46 billion today.4 deriving immense quantities of protein from animal sources consumes similarly large amounts of resources. in doing so, rearing animals for meat encroaches upon several planetary boundaries, defined as “boundaries within which we expect that humanity can operate safely,” and includes limits on global freshwater use, land-system change, and climate change.5 producing just 1,000 calories of beef consumes an estimated 1,600 liters of water, requires the occupation of an estimated 147 square meters of land for an entire year, and releases 10 kilograms of co2 equivalent.6 additionally, beef production consumes land that farmers could use to produce other protein sources, such as vegetables and grains. such strains on planetary boundaries and excessive use of environmental resources to produce protein is not sustainable, especially as the global population continues to expand. the united states has one of the highest rates of meat consumption, with the average american consuming over 250 pounds of meat per year.7 if the global population consumed meat at this rate, there would be a devastating impact on both global health and planetary boundaries. protein sources should be viewed as a health resource, as proper protein intake is vital to human health. if over-consuming communities such as the us decreased their intake of meat, the health of both over-consumers and those with limited access to dietary protein and meat would greatly benefit.8 coyle & mckinstry, historical analysis of meat consumption, voices in bioethics, vol. 9 (2023) 3 iv. ethical analysis since food is a limited resource, ethicists and physicians should approach conversations regarding meat through the lens of justice. the principle of distributive justice demands that “the benefits and burdens” of meat be “fair, equitable, and appropriate.”9 currently, marginalized communities bear the environmental burdens of meat-heavy diets, while not always having access to the benefits. encroachments upon planetary boundaries caused by meat production and poor health outcomes due to excessive consumption disproportionately impact the most disadvantaged communities. if we, as ethicists, are to encourage equitable distribution of resources around the world, we must also limit the distribution of harm. though we do not always abide by or apply utilitarian perspectives, in crisis we often adopt a harm reducing principle and work to maximize good and pleasure. when balancing the benefits and burdens of meat consumption, it is vital that we choose a path forward that produces the greatest good or pleasure for the greatest number of people. utilitarian philosopher peter singer, an advocate for animal rights and vegan diets, argues that decreasing meat consumption is “a means toward reducing both human and animal suffering, and leaving a more habitable planet for future generations.” 10 by drastically decreasing the number of cattle, fish, and birds killed and consumed every year, we limit greenhouse gas emissions and create a more sustainable environment—a benefit not only for ourselves, but also for subsequent generations. as we limit human intake of meat and improve the environment, we decrease the acute and chronic disease burden among the population. it is essential to approach discussions regarding meat consumption with an appreciation of both the benefits and burdens to create equitable and healthconscious meat policy that maximizes benefits for the greatest number of people. conclusion meat consumption is causing a crisis in human health and hurting the environment. while meat is often attached to cultural celebrations and daily traditions, decreasing meat consumption and directing land use to more efficient, healthy food production would help both human health and the environment. excessive consumption of animal protein negatively impacts public health both directly and indirectly through climate change, environmental degradation, and pollution. current innovations, such as cultured agriculture and plant-based meats, provide promising alternatives, yet these novel technologies face numerous hurdles in widespread global implementation. an ethical and holistic approach to medicine demands that we advocate for the health of humanity through a balanced and climate-conscious approach to diet. 1 lisa, andrew. history of america's meat-processing industry. 18 aug. 2020, https://stacker.com/stories/4402/history-americasmeat-processing-industry. 2 gibbons, ann, and matthieu paley. “the evolution of diet.” national geographic, https://www.nationalgeographic.com/foodfeatures/evolution-of-diet/. 3 battaglia richi e, baumer b, conrad b, darioli r, schmid a, keller u. health risks associated with meat consumption: a review of epidemiological studies. int j vitam nutr res. 2015;85(1-2):70-8. doi: 10.1024/0300-9831/a000224. pmid: 26780279. 4 chure, griffin, et al. “anthroponumbers.org: a quantitative database of human impacts on planet earth.” 2022, https://doi.org/10.1101/2022.03.04.483053. 5 rockström, j., steffen, w., noone, k. et al. a safe operating space for humanity. nature 461, 472–475 (2009). https://doi.org/10.1038/461472a 6 chure, griffin, et al. “anthroponumbers.org: a quantitative database of human impacts on planet earth.” 2022, https://doi.org/10.1101/2022.03.04.483053. coyle & mckinstry, historical analysis of meat consumption, voices in bioethics, vol. 9 (2023) 4 7 kuck, g. and g. schnitkey. "an overview of meat consumption in the united states." farmdoc daily (11):76, department of agricultural and consumer economics, university of illinois at urbana-champaign, may 12, 2021. 8 watts, nick, et al. “the 2020 report of the lancet countdown on health and climate change: responding to converging crises.” the lancet, vol. 397, no. 10269, 2021, doi:10.1016/s0140-6736(20)32290-x. 9 beauchamp, tom l., and james f. childress. principles of biomedical ethics. oxford university press, 2009. 10 singer, peter. ethics in the real world. princeton university press, 2016. dias, fentanyl overdoses in north america, voices in bioethics, vol. 2 (2016) * matt dias, ms bioethics, columbia university © 2016 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. fentanyl overdoses in north america: signaling the importance of prescription monitoring, treatment access, and addiction prevention matt dias* keywords: fentanyl overdoses, pharmaceutical ethics, addiction prevention introduction since march, a growing number of regions in the united states and canada have encountered an alarming increase in opioid drug overdoses. in most instances, the drugs causing the overdoses have been presented as either powerful painkiller pills or heroin, but mounting evidence suggests that the drugs were masked and of an extremely potent—and fatal—nature. according to reports, many victims of this epidemic—those who illicitly bought the drugs, overdosed, and several of whom subsequently died—had believed that they were purchasing either (i) norco, a prescription painkiller similar to vicodin and percocet, or (ii) a form of common heroin. in both contexts, authorities suspect that the drugs were doses of illegally manufactured fentanyl that resembled either norco tablets or heroin.1 fentanyl is a powerful synthetic opiate analgesic, primarily for treating patients with severe pain (e.g., those with terminal cancer) or for managing pain after surgery, though it can also treat individuals with chronic pain who are physically tolerant to opiates. in its prescription form, fentanyl is known as actiq, duragesic, and sublimaze; its many street names include apache, china girl, dance fever, goodfella, jackpot, murder 8, tango and cash, and tnt.2 as the most powerful painkiller available for medical treatment, fentanyl is considered the king of all opiates: indeed, it is about fifty times stronger than heroin and a hundred times stronger than morphine. since fentanyl is cheap to produce illicitly and efficient to transport, it can be used to contaminate other, less potent street drugs. once contamination occurs, users are unaware that they are inhaling or rejecting a perilous substance.3 ____________________________________________________________ analysis medical and law enforcement officials suspect that the drugs in question are smuggled into canada and https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn3 dias, fentanyl overdoses in north america, voices in bioethics, vol. 2 (2016) 2 the united states from china and through mexican drug cartels, according to collective reports. however, it is unknown as to how, exactly, the drugs are being disguised as painkiller pills or heroin. investigations into the matter are occurring on both local and federal levels.4 while historically, fentanyl sales and overdoses have been concentrated in the eastern united states (in places such as ohio and southern florida), the primarily affected regions of the emerging epidemic range from the greater chicago area to british columbia in western canada and california’s central valley. in response to the rising overdoses, the centers for disease control and prevention (cdc) have cautioned that a nationwide opiate epidemic is underway. in the central valley alone, more than fifty opioid-related overdoses have been reported since late march. sacramentan jerome butler, who ingested one such pill that he thought was a norco painkiller, was one of the latest fatal victims. after taking the pill, he lapsed into a coma with liver and kidney failure and was taken off life support just days later.5 strikingly, he obtained the pill from a trusted contact, whose supplier is unknown. his mother, natasha, said, “someone here in sacramento has the deadly pills. they are selling the deadly pills to our people.”6 and the fatal overdoses remain on the rise: drugs spiked with a powerful painkiller have been responsible for at least twelve reported deaths in the region between march 24 and april 22.7 as in sacramento, the recent sales and overdoses in british columbia have tended to resemble painkiller pills. this spring’s significant increase in fentanyl-related overdoses and deaths prompted the bc government to declare a public health emergency.8 in the chicago area, on the other hand, it seems that fentanyl is disguised as, and even combined with, heroin, in a liquid form. reports indicate that at least eighteen recent heroin-opioid overdoses have occurred this spring, with two of them being fatal fentanyl ingestions. investigators surmise that the buyers are in search of heroin, but that the street drugs are being combined with a more powerful-than-ever synthetic fentanyl.9 conclusion with these realities in mind, several suggestions should be considered as a means of confronting this epidemic. first, it is necessary to improve current systems for monitoring prescriptions. all too often, public health experts and bioethicists concentrate their attention on the interactions of doctors with current patients. while it is understandable that pain management doctors may not follow their patients after discharge, isn’t it possible, and perhaps even probable, that the individuals seeking the street drugs have developed an addiction that stemmed from legally provided prescriptions, but that has lacked thorough monitoring postdischarge? epidemiological reviews of the explosive 2014 fentanyl epidemic in ohio indicated that many of those seeking the opioids were suffering from bipolar disorder, depression, or other mental illnesses, and that the monitoring programs currently in existence suffer from notable shortcomings.10 this belief is supported in the literature. according to hospitalist marianne maumus, addiction psychiatry services “are excellent and can direct the withdrawal process, [but] they frequently do not have the daily encounters required to witness, manage, or document the aberrant behaviors or to understand the nature of the alleged painful medical condition [at hand].” such patients need increased monitoring in the outpatient setting to reduce diversion and supervise compliance.11 secondly, improvements to overdose treatment access should be sought. in canada, for instance, kits containing an overdose treatment called naloxone have been made available to paramedics, firefighters, and police, according to health minister terry lake. however, more action is needed, he said: “we have to do what’s needed to prevent overdoses and deaths, and what’s needed is real-time information … medical officers need immediate access to what’s happening and where so they can deploy the necessary strategies to prevent these tragedies.”12 thirdly, public health agencies and medical professionals should aim to reduce the demand for fentanyl and other opioids through addiction prevention efforts, including safer practices in prescribing painkillers, improved approaches to prescription monitoring, and by reinforcing evidence-based approaches to treating https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn5 https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn7 https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn8 https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn9 https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn11 https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn12 dias, fentanyl overdoses in north america, voices in bioethics, vol. 2 (2016) 3 pain in a way that spares the use of opioids. in light of the emerging epidemic, top officials at the fda published a special report last week in the new england journal of medicine with the intent of guiding a national response to the opioid crisis—galvanizing the medical community to commit to actively propose solutions and ultimately to upend the status quo, which “is clearly not acceptable.”13 1 soumya karlamangla and joseph serna, “painkiller fentanyl linked to six deaths and numerous overdoses in sacramento area,” los angeles times, april 15, 2016,http://www.latimes.com/local/lanow/la-me-ln-fentanyl-contaminated-street-drugs20160330-story.html. 2 national institutes of health: national institute on drug abuse. “the science of drug abuse and addiction: fentanyl.” december 2012.https://www.drugabuse.gov/drugs-abuse/fentanyl. 3 christine vestal, “cheaper and stronger than heroin, fentanyl deaths spike.” tribune news service’s health and human services column, april 5, 2016,http://www.governing.com/topics/health-human-services/sl-fentanyl-deaths-drugs.html. 4 christine vestal, “cheaper and stronger than heroin, fentanyl deaths spike.” tribune news service’s health and human services column, april 5, 2016,http://www.governing.com/topics/health-human-services/sl-fentanyl-deaths-drugs.html. 5 cnn wire and tribune media wire, “7th person dies as wave of fentanyl overdoses strikes california; cdc warns of epidemic,” wgn news, march 30, 2016,http://wgntv.com/2016/03/30/7th-person-dies-as-wave-of-fentanyl-overdoses-strikessacramento-county/. 6 abc 10 news staff, with dale schornack, “another possible death by fake norco pills in sacramento co.,” abc 10 news, april 4, 2016,http://www.abc10.com/news/local/sacramento/another-possible-death-by-fake-norco-pills-in-sacramentoco/119481013. 7 sarah heise, “12th fentanyl death reported in sacramento county,” kcra news, april 22, 2016,http://www.kcra.com/news/local-news/news-sacramento/12th-fentanyl-death-reported-in-sacramentocounty/39168802. 8 cbc news staff, “increase in overdose deaths prompts b.c. to declare public health emergency,” cbc news, april 14, 2016,http://www.cbc.ca/news/canada/british-columbia/bc-public-health-emergency-overdose-drugs-1.3535910. 9 warner todd huston, “fentanyl, a drug 200 times worse than heroin, is sweeping the chicago area,”breitbart, april 14, 2016, http://www.breitbart.com/big-government/2016/04/14/fentanyl-drug-200-times-worse-heroin-swamping-chicagoarea/. 10 christine vestal, “as fentanyl deaths spike, states and cdc respond,” the pew charitable trusts, stateline, april 1, 2016,http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/04/01/as-fentanyl-deaths-spike-states-andcdc-respond. 11 marianne maumus, “bioethics in practice—the ethics of opiate use and misuse from a hospitalist’s perspective,” the ochsner journal 2015; 15(2): 124–126. 12 tom fletcher, “b.c. declares fentanyl drug overdose emergency,” revelstoke review, april 14, 2016,http://www.revelstokereview.com/news/375740571.html. 13 robert m. califf, janet woodcock, and stephen ostroff, “a proactive response to prescription opioid abuse,” the new england journal of medicine 2016; 15(374): 1480–1485, doi: 10.1056/nejmsr1601307. https://michael-reaves-bkln.squarespace.com/newswire/2016/04/25/fentanyl-overdoses-in-north-america-signaling-the-importance-of-prescription-monitoring-treatment-access-and-addiction-prevention#_edn13 kiskadden-bechtel, skewed data for profit, voices in bioethics, vol. 2 (2016) © 2016 sarah kiskadden-bechtel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. skewed data for profit: fructose foods as public health risk sarah kiskadden-bechtel keywords: data ethics, food ethics, public health, fda introduction the food and drug administration (fda) systematically approves food that is mass-produced by companies, like coca cola or kraft cereals, which use sugar, corn syrup, or corn syrup derivatives because they are nontoxic preservatives. yet these sugar substitutes are making people sick. nationwide, over one-third—roughly 78.6 million—of the united states adult population is obese, in addition to 17 percent of the youth population.1 in response to claims that fructose-infused soft drink products are a significant factor in the obesity epidemic, companies like these tend to downplay the role of sugar in their drinks, and occasionally bury the data.2 as a result, ethical issues arise when coca cola and other branded, so-called “big food” companies fund scientific research that misrepresents the correlation between fructose consumption and obesity. although the correlation of fructose consumers developing obesity does not equal causation of this disease, falsifying data regarding these health consequences endangers the public’s health. analysis big food companies fund scientific studies that publish results favorable to big food, creating a conflict of interest on behalf of scientists reporting this data. conflict of interest may be defined as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).”3 little or no disclosure of conflicts of interest engenders a morass of potential reporting bias. via an analysis over a five-year period comprising 206 published scientific articles, “the likelihood of a conclusion favorable to the industry was 4-fold to 8-fold higher if the study received full rather than no industry funding, raising the possibility of systematic bias.”4 there is significant statistical association between big food funding these studies and pro-big food industry conclusions. in fact, in the five years in which these studies were published, from january 1999 to december 2003, “none of the interventional studies with all industry support had an unfavorable conclusion [toward big food].”5 results that favor pro-industry conclusions inherently prioritize large-scale industry over the individual. highly processed foods use fructose derivatives as a preservative, which adds appeal because they are cheap to manufacture. fast food companies reap a higher profit margin than those that sell whole, non-processed foods, which creates an economic incentive to market these to a significantly large kiskadden-bechtel, skewed data for profit, voices in bioethics, vol. 2 (2016) 2 population. the reality is that “food systems are not driven to deliver optimal human diets but to maximize profits. for people living in poverty, this means either exclusion from development (and consequent food insecurity) or eating low-cost, highly processed foods lacking in nutrition and rich in sugar, salt, and saturated fats (and consequent overweight and obesity).”6 big food companies, such as mcdonald’s, manufacture their hamburger buns and sauces with high fructose corn syrup,7 a practice that fuels cravings and increases the desire to order from these fast food chains. specifically, steady sugar and fructose consumption disrupts the body’s ability to regulate its secretion of leptin—our “stop eating” trigger—which destabilizes the ability to regulate intake and leads to overeating.8 consuming fructose-infused foods reinforces positive feedback in favor of overeating and therefore poses a risk of addiction to consuming the food of big food companies. high fructose corn syrup is just as sweet as—if not sweeter than—sugar. the liver metabolizes fructose into fat cells, and too much consumption of fructose leads to a fatty liver that stores excess cells in fat deposits around the body. fat cells can accumulate under the skin, or around organs such as the liver; excess accumulation of these fat cells can advance someone from being overweight to obese.9 daily consumption of these sweeteners can lead to significant health problems, such as high blood pressure, high blood sugar, fatty liver, diabetes, and obesity. further, overeating often leads to the incorrect assumption that someone who becomes overweight or obese is “lazy” or “should exercise more”—a stigma that reflects a value judgment of a greedy personal character. a significant factor behind the drive to market highly processed foods manufactured with fructose is the economic incentive for companies to expand profit—an ironic flip on the notion of greed. the economic quota is straightforward: per capita, the american food system manufactures roughly 4000 kilocalories per day. for companies to profit from sales, they either have to “convince consumers to eat more (contributing directly to obesity) or increase profit margins, especially by marketing reformulated or repackaged products (an indirect contribution).”10 if skewed results did not pose a harmful risk to the health and wellbeing of low socioeconomic populations—which, arguably, are a vulnerable population when given falsified food data—perhaps these studies could be dismissed as alternative advertising. however, when research studies falsely declare conclusions in favor of the big food industry, lowincome communities are susceptible to being misinformed about what they eat. this act suspends lowincome consumers’ capacity to voluntarily consent to the long-term health risks presented by consuming fast foods. similar to tobacco companies in the 1950s and 60s, today’s fast food industry actively covers up the long-term potential health risks associated with consumption of their products. there are several ethical concerns regarding mass-marketed, fructose-infused food products; the public health risk of obesity is merely symptomatic of the epidemic. consuming big food products increasingly leads to chronic disease, such as metabolic syndrome and obesity. children who are born into, and grow up in, low socioeconomic communities are increasingly susceptible to big industry foods simply because these foods are cheap, widely available, and heavily marketed in these areas. for example, “kraft … [has] remained heavily engaged in the marketing of unhealthful products to children despite promises to fight childhood obesity announced with great fanfare in 2003.”11 furthermore, food welfare programs such as supplemental nutrition assistance programs (snap) provide more than half of their assistance resources to households that include youth below age eighteen.12 consequently, big food companies that fund skewed scientific conclusions endanger susceptible consumers in these communities. ironically, health risks (e.g., obesity) that are associated with steady consumption of processed foods like these are ironically viewed as a “‘disease of affluence’ and a sign of progress in combating undernutrition.”13 minimally processed whole foods such as fresh fruits and vegetables are “rich [in] nutrient content and satiating properties, [but] they have low profit margins,” even though they promote a healthy weight balance; in contrast, fast foods that are highly processed and that are “primarily composed of refined starch, concentrated sugars, and low-quality fats” pose the kiskadden-bechtel, skewed data for profit, voices in bioethics, vol. 2 (2016) 3 counterpoint to a whole food diet, with high susceptibility to becoming overweight and obese, among other problems.14 conclusion the risk of obesity and obesity-related disease is an increasingly dangerous public health risk. uncritical scientific nutrition studies perpetuate misinformation, which only underscore the inequalities faced by lower socioeconomic populations. these communities are no more susceptible to developing a fatty liver than higher income areas; the only difference is the extent of fructose foods consumed on a daily basis. as a result, pro-industry misinformation creates vulnerability among susceptible communities because it has direct “health, disease, or disease marker” consequences to consumers.15 even though consuming big food is not immediately toxic, long-term obesity risk portends significant heightened morbidity due to compounding health complications. to begin to counteract these dangers, increased regulations on fast food products must be implemented, and the marketing of these products to impoverished areas must be reconsidered, rewritten, and ultimately removed from these vulnerable communities. 1 ogden, cynthia, and margaret d. carroll, et al. “prevalence of childhood and adult obesity in the united states, 2011-2012,” jama 311 (2014): 806–814. 2 boseley, sarah. “new evidence on fructose in coca cola, pepsi and other sodas in the us.” last modified june 4, 2014. http://www.theguardian.com/society/the-shape-we-are-in blog/2014/jun/04/obesity-food-and-drink. 3 thompson, dennis. “understanding financial conflicts of interest,” the new england journal of medicine 329 (1993): 573–576. 4 ludwig, david s., and marion nestle. “can the food industry play a constructive role in the obesity epidemic?” jama 300 (2008): 1809. 5 lesser, lenard, cara ebbeling, merrill goozner, et al. “relationship between funding source and conclusion among nutrition -related scientific articles.” plos medicine: 4 (2007): 44–45. 6 stuckler, david and marion nestle. “big food, food systems, and global health.” plos medicine 9 (2012): e1001242; 1. 7 “mcdonald’s usa ingredients listing for popular menu items,” accessed december 23, 2015,http://s3.amazonaws.com/us-east-prod-depshare s3/dna/pushlive/ingredientslist.pdf. 8 yang, ronghua and lili a. barouch. “leptin signaling and obesity: cardiovascular consequences.” american heart association journal 101 (2007): 545-559. http://circres.ahajournals.org/content/101/6/545.full.pdf+html. 9 cdc. “defining adult overweight and obesity,” accessed december 15, 2015, http://1.usa.gov/1plwn5n. 10 ludwig and nestle, “can the food industry play a constructive role in the obesity epidemic?” 1809. 11 ludwig and nestle, 1808–09. 12 fernandes, meenakshi m. “effect of the supplemental nutrition assistance program (snap) on frequency of beverage consumption among youth in the united states.” journal of the academy of nutrition and dietetics: 112 (2012): 1241. 13 stuckler and nestle, “big food, big systems, and global health,” 1–2. 14 ludwig and nestle, 1809. 15 lesser et al. “relationship between funding source and conclusion among nutrition-related scientific articles,” 42. http://www.theguardian.com/society/the-shape-we-are-in-blog/2014/jun/04/obesity-food-and-drink http://s3.amazonaws.com/us-east-prod-dep-share-s3/dna/pushlive/ingredientslist.pdf http://s3.amazonaws.com/us-east-prod-dep-share-s3/dna/pushlive/ingredientslist.pdf http://1.usa.gov/1plwn5n introduction analysis conclusion mackay, a brief consideration of indigenous bioethics, voices in bioethics, vol. 8 (2022) * ried mackay, ma bioethics, case western reserve university, ph.d. candidate, texas a&m university © 2022 ried mackay. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. tlacoqualli in monequi “the center good”: a brief consideration of indigenous bioethics ried mackay* keywords: indigenous, native american, diversity in bioethics, public health, sociology, philosophy introduction since its inception, bioethics has focused on western conceptions of ethics and science. this has provided a strong foundation to build bioethics as a field and discipline. however, it has largely failed to consider non-western systems of ethics and science like indigenous american thought frameworks. this has important implications for the treatment of indigenous americans in healthcare settings, something that i have considered as a mixed indigenous american researcher of sociology, global health and bioethics. while there has been recognition of other thought frameworks impacting bioethics, these have largely focused on differences among religions and their adherents. while religious frameworks are important, bioethics must also recognize, learn, and implement different cultural frameworks. bioethics cannot simply recognize these non-western frameworks; it must also legitimately incorporate them as frameworks. nonwestern conceptions have too often been used in a secondary status or as a historical outlier or curiosity which leads to failure in integrating non-western frameworks to their full extent and benefit. background indigenous american philosophy has strong foundations throughout north and south america1 that can provide a base for developing indigenous-focused bioethics. while indigenous americans cannot be considered a monolith, there are similarities across indigenous cultures in their approach to reality— developing indigenous bioethics will necessarily incorporate these shared philosophies.2 these similarities are present in the us philosophical tradition of pragmatism. pragmatism arises from the indigenous pragmatism which values interacting with other beings and the environment, plurality of thought, connections to the community, and growth from the other three dimensions.3 this shared pragmatism centers the actions of individuals as the defining feature of maintaining balance in all scenarios of socializing and work—achieving the “center good.” 4 tlacoqualli in monequi is a mexica (aztec) saying that translates to the “center good is required” and means “middle way of being” or consistently managing imbalances mackay, a brief consideration of indigenous bioethics, voices in bioethics, vol. 8 (2022) 2 and obligations to achieve a long-term balance. for example, indulging in excesses requires the opposite to follow: making do with less for a period or balancing receiving with giving.5 the actions of individuals must maintain the balance, which simultaneously encourages self-responsibility and responsibility to the community.6 additionally, the individual is not judged only by their actions but also by their omissions— failure to act either unintentionally or intentionally—and judged on the morality of their decision as if they had acted.7 there have been calls for developing indigenous bioethics,8 including analyses of important distinctions between western and indigenous ethical approaches to health care such as how indigenous patients understand core bioethical concepts like autonomy and non-maleficence.9 these differences in thought impact all aspects of indigenous health care and how providers approach fundamental tasks like revealing diagnoses or encouraging surgeries.10 indigenous ethics place great value on individual decisions made in the context of community input. failing to appreciate this cultural difference can prevent an indigenous patient from maintaining the center good and therefore violate a fundamental aspect of being.11 providers must also understand the nuances of religion and indigenous ethics. while many indigenous people adhere to elements of christianity or other religious philosophies, many indigenous people still maintain traditional cosmovisions. 12 these cosmovisions—ways that indigenous communities understand life, earth, the universe and its moral constructs—demand adherence not to a supreme ethereal deity but to indigenous pragmatism and, therefore, the “center good” so that an individual can live a happy and healthy life. failing to adhere to the cosmovisions results in the decay of that person, and even their community, on physical, emotional, and spiritual levels.13 analysis previous work on indigenous bioethics has referred to indigenous philosophies in a secondary way. this placement of indigenous ethics onto a second tier still demands that indigenous patients adhere to dominant western ethical discourses. indigenous pragmatism calls for a plurality of thought and method. this means that western ethics can apply in the treatment of indigenous patients, but that indigenous ethics must be on an equal plane or elevated above western ethics in the treatment of indigenous patients. the indian health service (ihs) in the us provides an example. this system is treaty-obligated to provide health care to indigenous americans, the only racialized group in the us to have federal governmentprovided healthcare. however, many providers in the expansive ihs system operate from a western ethic. this viewpoint leads to negative interactions and miscommunications. 14 it also adds to the persistent racism and ethnocentrism documented in the ihs by the us commission on civil rights.15 multiple paths to achieving indigenous health equity exist. however, a vital component is engaging a specific indigenous ethic based on indigenous philosophies rather than merely referencing them. indigenous patients of the ihs can receive more culturally sensitive and competent care if they are engaged on a cultural level. a brief hypothetical to illustrate: a non-indigenous ihs physician requests an ethics consult to convince a patient they need surgery; the provider views this as non-maleficence (a way to avoid harm to the patient) and is frustrated with the involvement of the patient’s family and close friends in the patient’s decision to delay the surgery; the doctor views the involvement of other people as a violation of the patient’s autonomy. the indigenous patient views the physician’s continued insistence as offensive and becomes frustrated that their decision to delay is not respected. the physician and the patient view both autonomy and non-maleficence differently. the indigenous patient views autonomy as a fundamental interaction between oneself and one’s communities, not as a purely individual choice. the patient also does not view the physician’s actions as doing no harm, as the violation of the indigenous worldview is causing distress to mackay, a brief consideration of indigenous bioethics, voices in bioethics, vol. 8 (2022) 3 the patient. in this hypothetical, the physician could alleviate the distress by understanding the patient’s ethics. the decision to delay the operation based on community feedback is an autonomous decision of the patient who does not view the delay as a harm but as a positive, since they are patiently exploring their options and ensuring that their community is equally comfortable with the decision. in this case, the insistence that the patient violate their indigenous pragmatism causes the harm and violation of autonomy. i. progress and considerations bioethics has made important strides toward cultural competency and many programs train students in medical disciplines. while there have been significant improvements in cultural competency training and recognition, programs still do not adequately consider care of indigenous patients, 16 and they do not sufficiently consider the complexities of indigenous decision making. us laws privilege the western conception of autonomy and the accompanying understanding of individualism.17 however, these laws and frameworks do not sufficiently consider complex indigenous nuances and communal social structures. while indigenous patients, or their proxy, will be the one to sign off on a decision, the process still centers a western understanding of individualism, autonomy, and body18 that constrains indigenous patients and often demands violation of their balanced “center good.” resolving this conflict conceptually and in practice is not easy and will continue to require patience and the necessary involvement of indigenous communities, bioethicists, and practitioners. conclusion indigenous philosophies often oppose traditional western ethics employed in us healthcare. the ihs provides care to indigenous people and could employ and further develop the use of indigenous pragmatism and ethics. an indigenous patient that is treated based on indigenous philosophies and ethics can receive care and consultations that incorporate their interactions and responsibilities to their families and communities and recognize that the indigenous patient will have a plurality of thought systems and requests based in multiple cultural contexts that may seem foreign to non-indigenous practitioners and ethicists. the center good here demands fully incorporating indigenous philosophies and bioethics. failing to maintain this center good and develop explicit indigenous ethics for all indigenous patients—inside and out of the ihs—only serves to continue the severe healthcare inequalities experienced by indigenous communities. 1 léon-portilla, miguel. 1963. aztec thought and culture: a study of the ancient nahuatl mind. norman, ok: university of oklahoma press; pratt, scott l. 2002. native pragmatism: rethinking the roots of american philosophy. bloomington, in: indiana university press. 2 ellerby, jonathan h., john mckenzie, stanley mckay, gilbert j. gariépy, joseph m. kaufert. 2000. “bioethics for clinicians: 18. aboriginal cultures”. canadian medical association journal 163(7):845-850; cordova, v.f. 2007. how it is: the native american philosophy of v.f. cordova. tucson, az: university of arizona press. 3 pratt 2002 4 dunbar-ortiz, roxanne. 2014. an indigenous peoples' history of the united states. boston, ma: beacon press; graeber, david and david wengrow. 2021. the dawn of everything: a new history of humanity. new york, ny: farrar, straus and giroux. 5 maffie, james. 2019. “weaving the good life in a living world: reciprocity, balance and nepantla in aztec ethics” science, religion and culture (https://dx.doi.org/10.17582/journal.src/2019.6.1.15.25). 6 maffie, james. 2022. “aztec philosophy” internet encyclopedia of philosophy. https://iep.utm.edu/aztec-philosophy/#h6 https://dx.doi.org/10.17582/journal.src/2019.6.1.15.25 https://iep.utm.edu/aztec-philosophy/#h6 mackay, a brief consideration of indigenous bioethics, voices in bioethics, vol. 8 (2022) 4 7 abarbanell, linda and marc d. hauser. 2009. “maya morality: an exploration of permissible harms” cognition 115(2010):207224. 8 ellerby et al. 2000; abarbanell & hauser 2009 9 kotalik, jaro and gerry martin. 2016. “aboriginal health care and bioethics: a reflection on the teaching of the seven grandfathers”. the american journal of bioethics 16(5):38-43 (https://doi.org/10.1080/15265161.2016.1159749); wescott, siobhan and beth mittelstet. 2020. “three levels of autonomy and one long-term solution for native american health care”. ama journal of ethics 22(10):856-861 (https://doi.org/10.1001/amajethics.2020.856) 10 ellerby et al. 2000 11 maffie 2022 12 leeming, ben. 2013. “’jade water, gunpowder water’: water imagery in nahuatl descriptions of heaven & hell”. presented at the american society for ethnohistory annual meeting. new orleans, la. (https://www.academia.edu/11810951/_jade_water_gunpowder_water_water_imagery_in_nahuatl_descriptions_of_heaven _and_hell). 13 maffie 2022 14 gurr, barbara. 2014. reproductive justice: the politics of health care for native american women. new brunswick, nj: rutgers university press. 15 us commission on civil rights. 2004. broken promises: evaluating the native american health care system. (https://www.usccr.gov/files/pubs/docs/nabroken.pdf). 16 nortjé, nico, kristen jones-bonofiglio and claudia r. sotomayor. 2021. “exploring values among three cultures from a global bioethics perspective”. global bioethics 32(1):1-14.; winters, alexandra. 2016. “trespass to culture: the bioethics of indigenous populations’ informed consent in mainstream genetic research paradigms”. american indian law review 41(1):231-251. 17 norjé et al. 2021 18 winters 2016 https://doi.org/10.1080/15265161.2016.1159749 https://doi.org/10.1001/amajethics.2020.856 https://www.academia.edu/11810951/_jade_water_gunpowder_water_water_imagery_in_nahuatl_descriptions_of_heaven_and_hell https://www.academia.edu/11810951/_jade_water_gunpowder_water_water_imagery_in_nahuatl_descriptions_of_heaven_and_hell https://www.usccr.gov/files/pubs/docs/nabroken.pdf gumer, the dubious benefits of germline editing, voices in bioethics, vol. 4 (2018) * jennifer mara gumer, ms, jd © 2018 jennifer mara gumer. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the dubious benefits of germline editing jennifer mara gumer* keywords: germline editing, crispr-cas9, crispr, clinical, human embryos, introduction this past summer, humankind took one step towards a gattaca-like future in which human beings may be genetically engineered before birth. as trumpeted by the headlines, researchers at the university of oregon became the first american scientists to genetically alter human embryos using crispr-cas9 (crispr).1 crispr is a naturally occurring bacterial immune response that can recognize and destroy the dna of invading viruses.2 in 2012, berkeley scientist jennifer doudna and team demonstrated that crispr could be reprogrammed to target and alter ostensibly any gene of any organism on earth.3 although not the first gene-editing tool to be discovered, crispr is much more precise and cost-effective than its predecessors.4 consequently, doudna’s discovery unlocked a plethora of unprecedented gene-editing applications including, but not limited to, the treatment of human disease, the study of human development, the more reliable creation of plants and animals with certain desirable characteristics, and the ability to alter the genomes of human embryos.5 it is this last application of crispr that researchers at the university of oregon explored when they reportedly eliminated the gene responsible for hypertrophic cardiomyopathy, a leading cause of death among young athletes, from viable human embryos last summer.6 although the researchers assert that these embryos were not intended for implantation—a move that would violate current law7 — the experiment may be a harbinger of things to come. analysis if made clinically available, this particular application of crispr may be used to alter human genomes in heritable ways, a practice known as germline modification. however, such alterations carry numerous, well-publicized risks.8 for example, researchers have identified several technical issues associated with the technology such as off-target edits, mosaicism (i.e., the uneven uptake of edits in embryonic cells),9 and, more recently, the possibility of causing cancer.10 these risks, however, arguably constitute just the tip of the iceberg when it comes to the potential harms related to germline editing. even if the technology can be made sufficiently effective from a technical standpoint, our relatively superficial understanding of the human genome renders attempts to modify the germline extremely risky. for instance, most diseases and disabilities are caused by a complex interplay of numerous genes11 an understanding of which still eludes us. without complete comprehension of these interactions, we are unable to predict what effect changing just a few genes will have on the expression of others. gumer, the dubious benefits of germline editing, voices in bioethics, vol. 4 (2018) 2 we also lack a clear understanding of the multiple functions that individual genes play, such that the removal of a so-called “bad” gene could inadvertently impact beneficial pathways and processes.12 such outcomes are particularly problematic given the heritability of germline edits and their potential to affect countless unborn individuals. germline editing also presents risks to society as a whole. for instance, the technology could be used to create children that conform to problematic societal ideals born from a history colored by discrimination and prejudice13. germline editing also has the potential to exacerbate problematic wealth and power disparities given the likely expense of the procedure. finally, the technology may detrimentally impact familial relations and the psyches of children designed to meet parental preferences.14 while supporters of the technology claim that the medical benefits will likely outweigh these anticipated risks, surprisingly little has been done to parse out what these benefits may actually be. to address this lacuna, let’s take a closer look at some of the technology’s promised benefits against which its concomitant risks are to be weighed. first, despite frequent overblown claims about the revolutionary medical potential of germline editing, it must be emphasized that the technology likely cannot prevent the vast majority of health conditions, which emanate from a myriad of genetic and environmental factors not yet understood.15 there is, however, a relatively small subset of diseases caused by single genes (e.g., huntington’s and tay sachs), which are much better understood than polygenetic conditions and therefore constitute the best candidates for germline editing1.16 in the overwhelming majority of cases, however, an embryo screening technique called preimplantation genetic diagnosis (pgd) can be used to prevent inheritance of these conditions 17 —an essential fact downplayed or even omitted in the discussions surrounding germline editing. pgd allows prospective parents who undergo in vitro fertilization—a procedure that would also accompany germline editing—to sequence the genomes of their embryos to identify the presence of any singlegene conditions (or other genetic risks, e.g., brca genes). given the rarity of single-gene diseases, most couples affected by such conditions can create some portion of healthy embryos that may be implanted to produce offspring. consequently, pgd can be used in most instances to prevent inheritance of single-gene conditions without the help of germline editing.18 it is only in the exceedingly unlikely event that one reproductive partner carries two copies of a given disease gene while the other also possesses two copies—or one if the disease is dominant, i.e., only requires one copy of the gene to manifest—that the potential value of germline editing obtains is realized.19 while such a couple could still raise healthy children by using third-party gametes (or, of course, via adoption), crispr could theoretically be used to edit the disease gene from the couple’s embryos to afford them an unaffected child, genetically related to both parents. while no doubt a desirable outcome, the number of individuals who may be uniquely helped by germline editing is 1 the application of germline editing to monogenetic conditions is also likely less ethically controversial than targeting genes such as brca 1 and 2 that signal a risk rather than a certainty that a given condition will develop. edits to such genes arguably constitute something beyond treatment—namely a genetic advantage conveyed by eliminating even the predisposition to disease—in a way that makes a slide toward pure enhancement uses of the technology more plausible. gumer, the dubious benefits of germline editing, voices in bioethics, vol. 4 (2018) 3 limited. the question thus remains: does this benefit outweigh the technology’s many medical and social risks? to answer the question affirmatively places an enormous amount of importance on having a biological child that is almost tantamount to asserting a right to do so. while the concept of procreative liberty does indeed bestow certain rights on prospective parents, such as the negative right to enjoin the state from preventing a woman from conceiving or carrying a pregnancy to term, no american court has found an affirmative right to have a biological child.20 it is also essential to note that enabling more people to have biological children for reasons unrelated to sterility is arguably a social, rather than a medical, benefit. consequently, it must be asked whether this social benefit outweighs the related social risks discussed above. if the costs of germline modification may outweigh the benefits, then why do we continue to pursue the technology? perhaps the answer is that we are pushing forward simply because we can. if that is indeed our approach to technological advancement, however, we may be headed for trouble. conclusion given the rapidity with which technology is evolving, we will likely find ourselves in a future that poorly reflects our shared values as a society and species if we pursue every technological enhancement possible. to ensure that our powerful scientific capabilities help build a fair and inclusive world, we must instead engage in honest discussions regarding the true risks and benefits of a given technology before it is pursued. in the case of germline editing, that means proponents need to be more forthcoming about the technology’s limited medical benefits. only then we will be able to responsibly decide whether and how to proceed with germline editing in a way that takes us closer to a future of our choosing. 1 heidi ledford, “crispr fixes disease gene in viable embryos,” nature, august 2, 2017, https://www.nature.com/news/crisprfixes-disease-gene-in-viable-human-embryos-1.22382. 2 jennifer a. doudna and samuel h. sternberg, a crack in creation, (houghton mifflin harcourt, 2017), 34-59. 3 ibid. 4 national academies of sciences, engineering, and medicine. 2017. human genome editing: science, ethics and governance. washington, dc: the national academies press 1-8, accessed july 31, 2017 https://doi.org/10.17226/24623. 5 ibid. 6 h. ma et al., “correction of a pathogenic gene mutation in human embryos”, nature (2017), accessed june 8, 2018, doi:10.1038/nature23305. 7 consolidated appropriations act of 2016, public law 114-113 (adopted december 18, 2015). 8 patrick skerret, “experts debate: are we playing with fire when we edit human genes?”, stat, november 15, 2017, https://www.statnews.com/2015/11/17/gene-editing-embryo-crispr/. https://www.nature.com/news/crispr-fixes-disease-gene-in-viable-human-embryos-1.22382 https://www.nature.com/news/crispr-fixes-disease-gene-in-viable-human-embryos-1.22382 https://doi.org/10.17226/24623 https://www.statnews.com/2015/11/17/gene-editing-embryo-crispr/ gumer, the dubious benefits of germline editing, voices in bioethics, vol. 4 (2018) 4 9 h. ma et al., “correction of a pathogenic gene mutation in human embryos”, nature (2017), accessed june 20, 2018, doi:10.1038/nature23305. 10 haapaneimi et al., “crispr-cas9 gene editing induces p53-mediated dna damage”, nature medicine (2018), accessed june 20, 2018, https://doi.org/10.1028/s41591-018-0049-z; r. ihry et al., “p53 toxicity is a hurdle to crispr/cas9 screening and engineering in human pluripotent stem cells”, biorxiv (2017), accessed june 20, 2018, https://doi.org/10.1101/168443. 11 “frequently asked questions about genetic disorders”, national human genome research institute, accessed july 31, 2017, https://www.genome.gov/19016930/faq-about-genetic-disorders/. 12 see e.g., moises velasquez-manoff, “the upside of bad genes”, new york times, june 17, 2017; “protective effect of sickle cell trait against malaria-associated mortality and morbidity”, cdc.gov, accessed june 20, 2018, https://www.cdc.gov/malaria/about/biology/sickle_cell.html; sheri e. gabriel et al., “cystic fibrosis heterozygote resistance to cholera toxin in the cystic fibrosis mouse model”, science 266 (1994): 107-109; l. kivela et al., “presentation of celiac disease in finnish children is no longer changing: a 50-year perspective,” j ped 167 (2015): 1109-1115, accessed july 31, 2017, doi: http://dx.doi.org/10.1016/j.jpeds.2015.07.057. 13 see e.g., jackie scully, “disability bioethics: moral bodies, moral difference”, (rowman & littlefield, 2008), chapter 2. 14 michael sandel, “the case against human perfection”, the atlantic, april 2004. 15 “frequently asked questions about genetic disorders”, national human genome research institute, accessed june 25, 2018, https://www.genome.gov/19016930/faq-about-genetic-disorders/. 16 hank greely, “of science, crispr-cas9, and asilomar”, stanford law and science blog, april 4, 2015, https://law.stanford.edu/2015/04/04/of-science-crispr-cas9-and-asilomar/. 17 ibid; e. lander, “brave new genome”, new england journal of medicine 2015, accessed june 8, 2018, doi: 10.1056/nejmp1506446. 18 ibid. 19 ibid. 20 meyer v. nebraska, 262 u.s. 390 (1923); pierce v society of sisters, 268 u.s. 510 (1925); farrington v. tokushige, 273 u.s. 284 (1927); prince v. massachusetts, 321 u.s. 158 (1944); wisconsin v. yoder, 406 u.s. 205 (1972). https://doi.org/10.1028/s41591-018-0049-z https://doi.org/10.1101/168443 https://www.genome.gov/19016930/faq-about-genetic-disorders/ https://www.cdc.gov/malaria/about/biology/sickle_cell.html http://dx.doi.org/10.1016/j.jpeds.2015.07.057 https://www.genome.gov/19016930/faq-about-genetic-disorders/ https://law.stanford.edu/2015/04/04/of-science-crispr-cas9-and-asilomar/ introduction analysis conclusion das, earning their trust: understanding the role of traditional healers, voices in bioethics, vol. 6 (2020) *sayantanee das, ms columbia university © 2020 sayantanee das. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. earning their trust: understanding the role of traditional healers and their role in approaching africa’s ebola epidemic sayantanee das* keywords: traditional medicine, bioethics, healers, ebola introduction traditional medicine is the oldest form of health care delivery that has stood the test of time.[1] according to the who, a traditional healer is someone recognized by their community who uses natural materials and resources to provide health care “based on social, cultural and religious practices.”[2] different societies have evolved different forms of indigenous healing methods, all of which are considered forms of traditional medicine (e.g. chinese, indian and african traditional medicines).[3] due to colonialism and cultural imperialism, indigenous health systems in africa were denied the opportunity to “systemize and develop,” often banning traditional medicine in colonized regions such as south africa in the 1950s.[4] in modern day africa, post independence, traditional methods of healing are still used after hundreds of years without much reported cases of adverse effects.[5] for example, in ghana, over 70% of the population relies on traditional medicine.[6] analysis for some of the most disadvantaged africans, healers can provide care that western medicine cannot. healers can spend significant time with the patient, speak in their home dialects; they will accept currencies or barters that modern medical systems will not accept, such as vegetables, alcohol, chicken, and goats, and provide remedies for curses and disasters that western medicine does not believe.[7] the dangers of traditional medicine are revealed from the presence of new fatal diseases, specifically viruses, which cannot be treated using natural remedies and alternative medicine. the incorporation and utilization of western, modern medicine has been crucial for african nations to combat deadly epidemics, particularly hiv/aids and ebola. evidence indicates that traditional healing practices are a prominent source and propagator of the ebola virus amongst rural african communities, however ethical issues arise in attempting to educate and reform the practices and rituals performed by traditional medicine healers. unfortunately, those that do seek traditional medicine, whether due to lack of access or their inherent beliefs, often do not inform the modern medical doctors when they go to seek treatment at hospitals or clinics; these patients are scared of punishment from the government, as it is still illegal in many countries of africa to seek alternative healing options.[8] though these healers have established valuable and meaningful relationships within their communities, these applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn1 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn2 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn3 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn4 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn5 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn6 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn7 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn8 das, earning their trust: understanding the role of traditional healers, voices in bioethics, vol. 6 (2020) 2 relationships may actually expose the community members to greater danger rather than aid them when ill. traditional healers may have misinformation about symptoms and preventative methods. new york times science reporter, donald g. mcneil jr., provides the case of 74 year old healer samuel muriisa from lake bunyonyi, uganda.[9] he is a widely respected omushaho wekishaka, or traditional healer, in the area, which is just 20 miles away from the democratic republic of congo, where ebola is rampant. one of his wives is a triage nurse, and she sends away patients with what she believes are key symptoms of ebola: bleeding eye sockets or fingernail beds (indicating hemorrhage, which is, in reality, rare and only in late-stage patients if present). the fear is that a patient may travel to see mr. muriisa, stay in the mud hut where he treats everyone, and lie beside someone who may actually have ebola. muriisa has no method to conduct an ebola test or even a malaria test, which may be confused for ebola when severe. he admits he cannot cure hiv or cancer, but treats snake bites and mental illnesses; when he is worried a patient is facing death, he will recommend they see a local public hospital. healers garner an enormous amount of respect and honor within their respective communities. however, with the ebola epidemic, rituals to show such respect can be incredibly harmful from a public health perspective. traditional funeral and burial ceremonies have caused rapid spreading of ebola. in fact, 60% of all cases in guinea have been linked to traditional burial practices.[10] a case next door in sierra leone linked as many as 365 deaths to the funeral of a well-known and widely-respected female healer, who worked around the city of kenema and had contracted ebola from one of her own patients. hundreds of mourners, even from other nearby towns, honored her memory with dignity by attending the funeral. similar cases are seen throughout western africa as well, and since then, many churches have abolished healing practices that require touching the patient, for it is a public health interest to protect healers.[11] in fact, traditional healers are beginning to admit their ignorance and lack of knowledge regarding ebola,[12] which up until now has been unethical to provide care they do not believe will provide benefit and may actually harm the patient. despite the greater availability of scientifically proven methods of combating the transmission of infectious diseases like ebola, communities will continue to seek their traditional healing options if these treatments are not culturally and religiously acceptable to a community, rendering them less effective and resisted by the majority. to align preventative measures with cultural norms and values of affected communities, humanitarian efforts are engaging traditional healers to raise ebola awareness.[13] however such projects require a great deal of ethical consideration. it provides the greatest benefit to teach traditional medicine healers, as they are interacting with the majority of rural communities, who may be at greatest risk of ebola exposure and at the greatest disadvantage in accessing treatment. not only is it important for them to protect their own health, for the sake of the patients that come to them, but also to understand the symptoms and preventative measures that they can then provide for their patients. empowering traditional healers will allow for ebola information and preventative measures to reach populations that were previously ignored or unable to be reached by public hospitals and cities, thus upholding the ethical principle of justice. patients will then be better informed to then seek western medical attention at public hospitals, as well as to isolate themselves from loved ones and take precaution. unfortunately, the residues of colonialism and western imperialism have left their mark on the health systems of many african nations. patients are scared to inform modern medicine doctors if they have sought treatment from traditional healers, and then feel they cannot disclose their whereabouts or self-medication. those in rural areas who cannot access or afford public hospitals and within societies that believe in the power and principles of traditional medicine deserve the applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn9 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn10 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn11 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn12 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn13 das, earning their trust: understanding the role of traditional healers, voices in bioethics, vol. 6 (2020) 3 autonomy to choose non-modern alternative medicine and, at the same time, still receive proper healthcare and prevention against ebola. there are few risks to empowering traditional healers. while some might worry that encouraging communities to continue seeing their respective traditional healers will continue to propagate scientifically-invalid information, such as perceived causation of disease and death,[14] it would be both paternalistic and imperialistic of westerners to impose our belief that our scientifically-proven medical approaches are superior to their culturally accepted practices. conclusion in approaching the ebola epidemic in africa, outsiders must respectfully earn the trust of the community at risk, and may succeed primarily by engaging the health providers that the community loyally trusts — traditional medicine healers. awareness campaigns, vaccination campaigns, and monitoring implementation of preventative measures will rely on the direct involvement of traditional and religious leaders.[15] traditional healers will be able to deliver information and help to change societal traditions, such as burials, in a way that is both respectful and accepted by the community but also aligned with public health interests to combat ebola. [1]ali arazeem abdullahi. "trends and challenges of traditional medicine in africa." african journal of traditional, complementary and alternative medicines 8, no. 5s (2011). [2] who, author. traditional and modern medicine: harmonising the two approaches western pacific region. geneva: world health organisation; 2000a. [3] abdullahi. "trends and challenges." african journ of trad comp and alt med 8, no. 5s (2011). [4] adila hassim, mark heywood, and jonathan berger. "health and democracy: a guide to human rights, health law and policy in post-apartheid south africa." (2014). [5] r. n. okigbo, and e. c. mmeka. "an appraisal of phytomedicine in africa." current applied science and technology 6, no. 2 (2006): 83. [6] hannah roberts. “accra. a way forward for mental health care in ghana?." the lancet 357, no. 9271 (2001): 1859. [7] donald g. mcneil jr. “diagnoses by horn, payment in goats: an african healer at work.” the new york times, march 4, 2019. accessed 31 march 2019. https://www.nytimes.com/2019/03/04/health/traditional-healer-africa-ebola.html. [8] mcneil. “diagnoses by horn, payment in goats.” the new york times, march 4, 2019. [9] ibid. [10] who. “sierra leone: a traditional healer and a funeral.” world health organization, 2019. [11] robyn dixon. ebola hits home for a liberian faith healer; 2014. http://www.latimes.com/world/great-reads/la-fg-c1-ebolafaith-healer-20141023-story.html#page=1. [12] katherine mueller. "turning to traditional healers to help stop the ebola outbreak in sierra leone." international federation of red cross and red crescent societies, 2014. applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn14 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftn15 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref1 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref2 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref3 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref4 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref5 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref6 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref7 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref8 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref9 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref10 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref11 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref12 das, earning their trust: understanding the role of traditional healers, voices in bioethics, vol. 6 (2020) 4 [13] “red cross engages traditional healers to raise ebola awareness.” the american national red cross, august 05, 2014. accessed 1 april 2019. https://www.redcross.org/about-us/news-and-events/news/red-cross-engages-traditional-healers-toraise-ebola-awareness.html [14] angellar manguvo, and benford mafuvadze. "the impact of traditional and religious practices on the spread of ebola in west africa: time for a strategic shift." the pan african medical journal 22, no. suppl 1 (2015). [15] manguvo and mafuvadze. "the impact of traditional and religious practices." the pan african medical journal (2015). applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref13 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref14 applewebdata://d887889e-a98b-4beb-8cf3-c4022fca35c3/#_ftnref15 trahan, covid-19 labor & delivery, voices in bioethics, vol. 6 (2020) * julie-marie trahan, md © 2020 julie trahan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. covid-19 labor & delivery: hospitals should determine their own temporary support person restrictions marie-julie trahan, md* abstract the decision should belong to the individual hospitals responsible for providing the best, safest environment for their patients and employees. these decisions must consider abilities to screen support persons, provide them with face masks, and implement surveillance measures to ensure they are following the unit’s rules. the decisions will depend on the strain of the workforce at each institution and the availability of ppe for hcps, which may be threatened as the outbreak progresses in certain areas like new york city. from following the covid-19 situation in both the united states and canada over the last few weeks, i observed that elected officials do not always have a clear sense of what is happening inside hospitals where resources may be scarce, elevating the dangers caused by a lack of ppe, limited testing capabilities, and extra staff to screen support persons. keywords: ppe, labor & delivery, bioethics introduction over the course of my training as an obstetrics and gynecology resident, i have performed numerous vaginal and cesarean deliveries. every time, it feels like an immense privilege to share this important moment with expectant parents and, in many cases, their chosen support person or persons. i, like many of my colleagues, never imagined a time when hospitals would ban partners and other support persons from the labor and delivery unit. i also never imagined a time when i could feel unsafe while working in a hospital. analysis the covid-19 pandemic represents an unprecedented modern-day global health crisis. while the majority of fatalities are in elderly persons, covid-related deaths have been reported among all demographics and have included doctors, nurses, and other essential healthcare professionals (hcps). in fact, in some of the most affected countries, such as china and italy, hcps have accounted for a significant portion of cases.1 [1],[2] the infection of healthcare workers has been attributed to delays in testing, inadequate personal protective equipment (ppe), and asymptomatic exposures. exposure of healthcare https://d.docs.live.net/b37c00fb4a29b9da/documents/trahan_oped_04_16_finaljulie.docx#_edn1 https://d.docs.live.net/b37c00fb4a29b9da/documents/trahan_oped_04_16_finaljulie.docx#_edn2 trahan, covid-19 labor & delivery, voices in bioethics, vol. 6 (2020) 2 workers to initially asymptomatic patients prompted new york-presbyterian hospital in new york city to institute a network-wide restriction extending hospital visitor prohibitions to all support persons in the labor and delivery unit on march 23. partners and birthing attendants, such as doulas, could no longer attend deliveries. indeed, breslin at al. from the division of maternal-fetal medicine at new york-presbyterian reported on their initial experience with sars-cov-2-positive obstetrical patients.2 notably, two patients, who were initially asymptomatic on admission, developed symptoms post-partum. in both cases, 15-20 healthcare providers were exposed to the patient without adequate ppe. following this experience, additional measures were taken to protect hcps and obstetrical patients, including requiring all members of the obstetrics care team and patients presenting to the labor and delivery unit to wear a surgical mask at all times with additional protections for sars-cov-2-positive deliveries, universal testing of all patients presenting to the labor and delivery unit, and, the most drastic measure, prohibiting support persons, including partners, from entering the unit. the decision to ban partners from the delivery room was met with significant backlash from the public, most notably from expectant parents. many other hospitals had also moved to restrict visitors, but had made exceptions for labor and delivery, permitting one designated support person to accompany the expectant mother. these policies were in line with the new york state department of health guidance published on march 21, which states, “for labor and delivery, the department considers one support person essential to patient care throughout labor, delivery, and the immediate postpartum period.” a change.org petition was launched in order to “safeguard the right of all laboring people to have support during covid19 crisis” amassing over 600,00 signatures. in response, on march 28, new york state governor andrew m. cuomo announced an executive order which would require all hospitals in new york to allow women to have one support person in the labor and delivery room. those against the restrictive visitor policies have quoted the american college of obstetricians and gynecologists committee opinion, which states that emotional support is associated with improved outcomes for women in labor, such as better pain management and lower caesarean section rates.3 others, such as renowned maternal-fetal specialist dr. vincenzo berghella, have argued, “i understand well both sides—i remember every minute of assisting emotionally during the birth of our two sons […] but saving lives now is more important,” an opinion that is shared by other hcps.4[5] in fact, in response to governor cuomo’s executive order, another change.org petition was created to “protect the lives of frontline medical staff during covid-19.” while this petition amassed far fewer signatures, a number of valuable arguments were presented, including increased exposure of hcps to covid-19 via support persons and their increased use of scarce ppe. indeed, according to new york-presbyterian’s safety measures for labor and delivery, partners would require valuable resources, as they would need to be screened for signs and symptoms of covid-19 prior to entering the labor and delivery unit and would need to wear a surgical mask at all times. across the border, in my hometown of montreal, quebec, a similar debate has unfolded. on april 4, the jewish general hospital, one of quebec’s designated covid-19 centers, made the difficult decision to extend their restrictive visitor policies to ban all support persons from the labor and delivery unit. this decision was made in response to members of the obstetrics care team being exposed to a partner who concealed symptoms of covid-19 to attend the birth of his child, and was later found to be infected.5 despite another petition, which amassed close to 100,000 signatures, this decision has not been overturned. quebec premier françois legault supported the jewish general hospital’s decision, stating, “at the jewish general hospital, there are many cases of covid-19, so there are good reasons for this rule, but i want to be very clear, there is no intention of the government [to] extend these bans to other hospitals.”6 the incident at the jewish general hospital reveals a further challenge to the one-person visitor policies: some people https://coronavirus.health.ny.gov/system/files/documents/2020/03/covid-19pregnancyguidanceforproviders3.21.20.pdf https://www.change.org/p/andrew-m-cuomo-safeguard-the-right-of-all-laboring-people-during-covid-19-crisis?recruiter=217300821&utm_source=share_petition&utm_medium=facebook&utm_campaign=psf_combo_share_initial&utm_term=psf_combo_share_initial&recruited_by_id=f04acbb0-a229-11e4-94e6-c34e67f205cb&utm_content=mit-20977409-10%3av1 https://www.change.org/p/andrew-m-cuomo-safeguard-the-right-of-all-laboring-people-during-covid-19-crisis?recruiter=217300821&utm_source=share_petition&utm_medium=facebook&utm_campaign=psf_combo_share_initial&utm_term=psf_combo_share_initial&recruited_by_id=f04acbb0-a229-11e4-94e6-c34e67f205cb&utm_content=mit-20977409-10%3av1 https://d.docs.live.net/b37c00fb4a29b9da/documents/trahan_oped_04_16_finaljulie.docx#_edn5 https://www.change.org/p/governor-andrew-cuomo-new-york-state-department-of-health-protect-the-lives-of-our-frontline-medical-staff-during-covid-19?original_footer_petition_id=21434160&algorithm=promoted&source_location=petition_footer&grid_position=9&pt=avbldgl0aw9ualw7rweaaaaaxpb2mr4yterjzja3zdm1yw%3d%3d https://www.change.org/p/people-of-montreal-stop-quebec-hospitals-from-limiting-support-person-during-labor-and-postpartum?signed=true trahan, covid-19 labor & delivery, voices in bioethics, vol. 6 (2020) 3 seem unable to put their personal interests aside for the safety of others. by lying about possible exposure and symptoms, patients and support persons not only put hcps at increased risk, but also put other mothers and babies on the labor and delivery unit at risk. while covid-19 does not appear to confer an increased risk to pregnant women compared to nonpregnant adults, a number of cases of severe illness requiring intensive care have been reported among previously healthy pregnant adults.7 furthermore, recent data also suggests that while disease manifestations are less severe in children than in adults, infants under the age of one may be more vulnerable to severe or critical disease.8 [9] there is no question that protecting mothers and babies should be the number one priority. however, protecting healthcare workers is crucial as well. while i see both sides of this issue, i believe the decision should belong to the individual hospitals responsible for providing the best, safest environment for their patients and employees. these decisions must consider abilities to screen support persons, provide them with face masks, and implement surveillance measures to ensure they are following the unit’s rules. the decisions will depend on the strain of the workforce at each institution and the availability of ppe for hcps, which may be threatened as the outbreak progresses in certain areas like new york city. from following the covid-19 situation in both the united states and canada over the last few weeks, i observed that elected officials do not always have a clear sense of what is happening inside hospitals where resources may be scarce, elevating the dangers caused by a lack of ppe, limited testing capabilities, and extra staff to screen support persons. conclusion decisions restricting visitors are not made lightly or unnecessarily. such policies profoundly affect expectant parents who are already subjected to increased anxiety due to the pandemic. they also have implications for members of the obstetrical care team, as the absence of support persons also affects their roles and responsibilities. to all the expectant parents, i just want to say, i’m sorry you are going through this. i promise that no matter the hospital policy, you will not be alone. the obstetrics care team, which includes highly trained labor and delivery nurses and doctors, will be there for you. they know how important these precious moments are to you and your loved ones. they know this is not what you had planned and feel your disappointment. they are trying their best to advocate for your safety and that of your newborn. they are advocating for more and better ppe, not only to protect themselves so they can stay healthy for you and all the other expectant mothers, but also so that labor and delivery units can return to their previous state of normalcy as soon as possible, and so that women can soon have the birthing experiences they had planned. 1 gawande, atul. keeping the coronavirus from infecting health-care workers. the new yorker. march 21, 2020. accessible at: https://www.newyorker.com/news/news-desk/keeping-the-coronavirus-from-infecting-health-care-workers; latza nadeau, barbie. coronavirus is killing italy’s doctors. the u.s. could be next. march 19, 2020. accessible at: https://www.thedailybeast.com/covid-19-is-killing-italys-doctors-the-us-could-be-next?ref=scroll. 2 breslin n, baptiste c, miller r, et al. covid-19 in pregnancy: early lessons. american journal of obstetrics & gynecology mfm. 2020. doi: https://doi.org/10.1016/j.ajogmf.2020.100111. 3 american college of obstetricians and gynecologists. approaches to limit intervention during labor and delivery. acog committee opinion no. 766. obstet gynecol. 2019;133: e164-73. doi: 10.1097/aog.0000000000003074. https://d.docs.live.net/b37c00fb4a29b9da/documents/trahan_oped_04_16_finaljulie.docx#_edn9 https://www.newyorker.com/news/news-desk/keeping-the-coronavirus-from-infecting-health-care-workers https://www.thedailybeast.com/covid-19-is-killing-italys-doctors-the-us-could-be-next?ref=scroll https://doi.org/10.1016/j.ajogmf.2020.100111 trahan, covid-19 labor & delivery, voices in bioethics, vol. 6 (2020) 4 4 van syckle, katie & caron, cristina. ‘women will not be forced to be alone when they are giving birth.’ the new york times. march 28, 2020. https://www.nytimes.com/2020/03/28/parenting/nyc-coronavirus-hospitals-visitors-labor.html. 5 scott, marian & tomesco, frédéric. jewish general bars spouses after covid-19-infected man attends birth. montreal gazette. april 4, 2020. accessible at: https://montrealgazette.com/news/local-news/jewish-general-bans-spouses-frommaternity-after-covid-19-infected-husband-attends-birth/. 6 canadian press staff. midwives, patients push for clarity on companions at childbirth during covid-19 crisis. ctv news. april 6, 2020. accessible at: https://montreal.ctvnews.ca/midwives-patients-push-for-clarity-on-companions-at-childbirth-duringcovid-19-crisis-1.4884994?cache=sazhusyrecmk%3fclipid%3d89926%3fautoplay%3dtrue%3fautoplay%3dtrue. 7 yang h, wang c, poon lc. novel coronavirus infection and pregnancy. ultrasound obstet gynecol. 2020; 55: 435–437. doi: 10.1002/uog.22006. 8 dong y, mo x, hu y, et al. epidemiological characteristics of 2143 pediatric patients with 2019 coronavirus disease in china. pediatrics. 2020. doi: 10.1542/peds.2020-0702. https://www.nytimes.com/2020/03/28/parenting/nyc-coronavirus-hospitals-visitors-labor.html https://montrealgazette.com/news/local-news/jewish-general-bans-spouses-from-maternity-after-covid-19-infected-husband-attends-birth/ https://montrealgazette.com/news/local-news/jewish-general-bans-spouses-from-maternity-after-covid-19-infected-husband-attends-birth/ https://montreal.ctvnews.ca/midwives-patients-push-for-clarity-on-companions-at-childbirth-during-covid-19-crisis-1.4884994?cache=sazhusyrecmk%3fclipid%3d89926%3fautoplay%3dtrue%3fautoplay%3dtrue https://montreal.ctvnews.ca/midwives-patients-push-for-clarity-on-companions-at-childbirth-during-covid-19-crisis-1.4884994?cache=sazhusyrecmk%3fclipid%3d89926%3fautoplay%3dtrue%3fautoplay%3dtrue bolzon, ivf and motherhood, voices in bioethics, vol. 2 (2016) © 2016 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ivf and motherhood julia bolzon keywords: ivf, motherhood, bioethics, reproductive ethics, gender ethics introduction on december 21, 2015, the ontario government’s public funding of the first round of in vitro fertilization (ivf) treatment for infertile persons was enacted. women will be able to receive the highly expensive procedure from 50 clinics across the province. yet it is a well-known secret that the success rate of each individual ivf round is incredibly low: a 29.5% live-birth rate after one cycle, compared to 20.5% after the fourth cycle, 17.4% after the sixth, and 15.7% after the ninth cycle.1 the study suggests that “persistence pays off” after the sixth attempt. for many, ivf is viewed as the only way to have a child. whether the procedure is “worth it” is unquestionable compared to the longing for a baby of one’s own. yet the accounts of women who undergo ivf are painful to read. longing, worry, anxiety, depression, and pain are the dominant emotions in their stories. even if they do end happily with a baby boy or girl, these women’s pregnancies and experiences as mothers are lived in the shadow of the pain of their former infertility. beneath the procedure are the highly sensitive phenomena of infertility, motherhood, childbearing, parenting, longing, and love. anne taylor fleming’s memoir, motherhood deferred: a woman’s journey (1994), offers a detailed look at her personal experiences with motherhood set to the backdrop of an exploration of her shifting cultural climate. her experiences offer a glimpse into the relationship between being a woman and a mother, the longing for a child of one’s own, and how ivf deeply affects these realities. analysis fleming grapples with the connection between being a woman and the desire for motherhood. what does it mean to be a mother? what is the desire for motherhood actually for? fleming writes of the 60s and 70s that: “abstaining from motherhood … was the boldest way to step out of the prescribed and proscribed sex role … [and] at that time had felt like the essence of being alive, the only chance of being fully alive, not being trapped.”2 motherhood was reconfigured as an option, but one that enslaved, rather than being the natural fulfillment of a woman’s inherent nature. from fleming’s own descriptions, however, we hear evidence to the contrary—that motherhood is not an extrinsic choice, but an inherent longing: “[i am] a babyless baby boomer now completely consumed by the longing for a baby, a feeling akin to heartbreak when you can’t breathe but for the sensation of loss.”3 in her late 30s and unable to conceive naturally, she is filled with a painful longing for the concrete flesh of a baby, despite her adamant rejection of maternity in her 20s. fleming describes herself as being: “in thrall to a tactile hunger that makes my fingers tingle around babies, eager to stroke their soft flesh, my breasts yearning toward their newborn mouths, longing to give sustenance, hungry for their hunger.” she muses: “our yard looks green, fertile, fecund, and i, achy and hopeful, long to join the life-giving cycle, to be part of a birth, to give birth, to be green and lifeful.”4 when she recalls the first prick of her desire bolzon, ivf and motherhood, voices in bioethics, vol. 2 (2016) 2 for motherhood—in spite of her deep reluctance—she says: it was not the first twinge of procreative longing so much as the first inkling of mortality. did i really want to face the grave womb-tight and woebegone? … did i not want to try something wholly new, court a different avenue of love—maternal love, now that this other kind, this man-woman kind had proved so thorny? mine was not a full-hearted embrace of motherhood at this point, not at all, just … an awareness of the womb urge deep down inside like the first rumbles of hunger or the first flicker of thirst.5 of her own accord, fleming acknowledges that this longing was for both something more and also something coming from within, pointing to the presence of a desire that is at once ‘inside’ inside her and yet something that she cannot give to herself. the “womb urge deep down inside,” akin to hunger or thirst, is something she experiences as a natural inclination and not something that she chose at random. motherhood is expressive of both a longing for and anopenness to something other than oneself. as fleming notes, this human desire cannot be met solely on one’s own, and satisfaction is sought in companionship, often leading to marriage. a natural fruit of this longing and openness manifests itself in the new ‘other’ of the child. 6 contrary to her initial ideas about womanhood and maternity, fleming’s experiences in marriage pointed to a connection between the two that ran deeper than her ideas, choices, and circumstances. since the advent of the pill, fleming is well aware that the “lovemaking urge” and the “babymaking urge” have been fundamentally wrenched apart. but her considerations point to a deeper consequence: the separation has also occurred in the psyche of women themselves: “sexual pleasure is now no longer an accidental byproduct of procreation, just as a baby is now no longer the byproduct of accidental afternoon lust. the very urges themselves … have become separated in women.” 7 in describing what sex was like between her and her husband after decades of contraception, fleming writes: “i began to have an inkling of what birth control had wrought in my psyche, of how completely sex and procreation had become separated, of how indeed estranged i had become from my own body.”8 but when their inability to conceive became apparent, “sex lost its life-making luster,” and she increasingly lost interest in it: “without the possibility of a baby, sex felt empty, laborious, clumsy.”9 when her ambition finally aligned with wanting a baby she couldn’t have, it manifested as an all-consuming desire for a biological baby. with the unity of the procreative and nuptial act unraveled, the relationship between her and her husband also became fragmented. there was no longer “one body” between them, as he became a mere tool—the consenting sperm-provider—for her now solo-endeavor at becoming pregnant. from her own experiences, fleming is apt to describe how the despair of infertility combined with the promising lure of technology affects women who embark on assisted reproduction. “at age thirty-eight, i have entered the high-tech world of post-sexual procreation where things are done in dishes and through catheters, not in bed … i am about to have some kind of sexual encounter, but of this weird new kind: not with a person, but with a syringe of sperm.”10 there are countless descriptions of the rounds of inseminations, hormone drugs and needles and failures that she undergoes, leaving her with a bruised and fragile body and heart/spirit. she explains how the drive to reproduce has “stunned” the infertile women “beyond the point of rationality,” and beyond the point of considering later repercussions, because of “the abject loneliness of non[biological]motherhood.”11 throughout her journey, she grapples with the moral questions about what she is doing as she confronts her realizations about the nature of the embryo and what it is to “make a baby.” the “teasing ability to make these embryos” is simultaneously “irresistible” and “heartbreaking,” because after being made they do not survive implantation, leading to disappointment. when she asks herself whether “life begins at conception,” she responds: “i must think no with part of my soul—else i could not do this; and yet i must think yes with another—else i could not do this—and there are many days i wish i had been born before any of this technology was available.” 12 this is revealing of the unprecedented moral quandaries that assisted reproduction puts men and women in: the decision over whether to use donor eggs, and deciding what to do with frozen embryos. for fleming, using donor eggs would be “conceptual adultery,” and asks if “all this sharing of bodies and body parts … [is] a transgression of some basic order, of nature itself, and of the very bolzon, ivf and motherhood, voices in bioethics, vol. 2 (2016) 3 notion of maternity,” and decides that she can’t succumb to buying another woman’s eggs. as for her frozen embryos, she does end up signing to have them donated for adoption, though she is “dazzled and bedeviled” by the thought that they can be “brought to life” by a stranger who will “suckle them, raise them, teach them to laugh and dance and look at the moon.”13 fleming’s memoir felt like reading an autobiographical version of margaret atwood’s the handmaid’s tale. both were difficult to digest because they present distortions of childbearing, male-female relationships, the body, and sex. the protagonist of atwood’s account longs for ‘true things’—her own child, the touch of another human being, a relationship that is mutual and lasting. her voice is eerily similar to that of fleming, in her aching for things that are “natural”—to have a baby in their womb that is the fruit of affection and love. from her lived experience, fleming acutely reveals the element of unity that exists between one’s body (including the sexual act) and one’s identity. she writes: you couldn’t just run up and down that freeway with a jar of sperm in your purse or lie in those stirrups day after day and not sort through memories. they came together, a compound package: baby making and soulsearching … [they put] you up against everything you had been before and who you would be after.14 she cannot enter this “post-sexual world” of “high-tech baby making” without considering who she is—her identity as it was past, present, and future. procreation profoundly affects the way you conceive who you are and your relationship to others. childbearing is thus not isolated from profound questions of being: what does it mean to give life? what does it mean to have a child? conclusion even within a dystopia, human longing remains. it is a longing for the truth of one’s being. for fleming, it was only through her struggle that she began to recognize the mystery and miracle of birth, and the extreme inadequacy of ivf: “i am just beginning to learn, to be humbled, to wonder how in the world anyone so easily gets pregnant and how inept we are at trying to duplicate the elegant choreography of nature.”15 her account speaks of all that is amiss in the world of post-sexual reproduction, and the hurt done to the women who seek redemption from their infertility in technology. the number of surgeries that women undergo and the physical and emotional tolls that the procedures take on their bodies is shocking and saddening to read—not to mention the way in which infertility doctors are often falsely ‘optimistic,’ dangling “dazzling new techniques” that hold promise to women. fleming describes how “the infertility business had a maddening momentum” despite its constant failure, and that “when you were in it, riding back and forth to the clinic, toting around needles and drugs like a junkie, having your ovaries prodded and peered at on the sonogram screen, day after day, you felt perversely alive, part of the baby-conjuring process.” however, as she “disappeared further and further into infertility, it started feeling less like a life-affirming process and more like an obsessional search for that embryo, that baby, that thing.”16 as a solution to infertility, fleming’s voice helps us see that ivf is not only profoundly inadequate, but also harmful to the women and families involved. 1 new study performed by the journal of the american medical association, on 157,000 women in the uk between 2003 and 2010, cited by the new york times, “with in vitro fertilization, persistence pays off,” december 23, 2015.http://www.nytimes.com/2015/12/23/health/with-in-vitro-fertilization-persistence-pays-off-study-suggests.html?_r=0 2 fleming, anne taylor. motherhood deferred: a woman’s journey. diane pub co. 1994. p 210–211. 3 ibid, 13. 4 ibid, 18–19. 5 ibid, 180. 6 what needs to be explored here is the philosophy of womanhood, which john paul ii takes up in his apostolic letter, “on the dignity and vocation of women.” see also colleen carrol campbell’s memoir, my sisters the saints, which is also about her http://www.nytimes.com/2015/12/23/health/with-in-vitro-fertilization-persistence-pays-off-study-suggests.html?_r=0 bolzon, ivf and motherhood, voices in bioethics, vol. 2 (2016) 4 struggle with infertility, but her exploration of the nature of womanhood and motherhood runs philosophically and anthropologically deeper. 7 fleming, 136. 8 ibid, 184. 9 ibid, 187. 10 ibid, 13. 11 ibid, 95. 12 ibid, 119. 13 ibid, 96. 14 ibid, 23. 15 ibid, 44. 16 ibid, 227. introduction analysis conclusion ng, egg donor identity, voices in bioethics, vol. 9 (2023) * gina ng, ms candidate columbia university © 2023 gina ng. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. zero or 18: at which age should uk’s fertility watchdog disclose egg donor identity to donorconceived children? gina ng* keywords: reproductive ethics, donor-conceived, fertilization, embryo, egg, genetic testing introduction 2023 will mark a major change to the uk’s egg donor anonymity laws. under rules in place since 2005, any child conceived using donated eggs, sperm or embryos and born after april 1, 2005 will be able to find out who their biological parents are when they turn 18, which occurs this year. at age 16, these children could access non-identifiable information about the donor, such as physical description or ethnicity.1 however, just last may, the uk fertility watchdog human fertilisation and embryology authority (hfea) proposed scrapping anonymity for future sperm and egg donors. peter thompson, the chief executive of the hfea, said the rapid rise of direct-to-consumer (dtc) genetic testing websites, such as 23andme and ancestrydna, could soon make it impossible to guarantee donor anonymity – and that the law needs to reflect this reality.2 although the hfea has not settled on a proposal around anonymity, one option under consideration is the hfea lifting the anonymity of donors at birth rather than when the donor-conceived individual reaches age 18. analysis the issue of if the hfea should disclose donor identity before the donor-conceived children reach 18 raises many ethical questions. it is important to consider the potential impact of such a decision on all parties involved, including the child, the donor, and the recipient parents. identity-release egg donation has been the only treatment option available to patients wishing to pursue this route to parenthood in the uk since 2005. this means that the donor is anonymous to the intended parents at the time of treatment, but the child has the right to access identifying information about the donor at the age of 18. despite strict hfea laws protecting the identity of donors until then, the hfea cannot guarantee donor anonymity anymore. in the age of ancestry websites, genetic disease screening, ng, egg donor identity, voices in bioethics, vol. 9 (2023) 2 and sibling registries, donor-conceived offspring can order an inexpensive saliva dna test and identify genetic relatives from worldwide genetic databases, as for example by using “relative finder” in 23andme.3 other tools exist to penetrate anonymity, including facial recognition software when agencies provide donor photos to recipient parents.4 one’s identity could be inferred by combining genetic information with other publicly available information, such as posts on social media.5 as a result, current hfea laws can no longer safely protect donor anonymity.6 children’s rights to know their biological origins are outlined in the united nations convention on the rights of the child under article 3 (putting the best interests of the child as the primary consideration) and article 7 (the right to birth registration) of the united nations convention on the rights of the child. 7 the un committee on the rights of the child has criticized the uk legal system for withholding such information from children born by donor conception.8 disclosing the donor's identity to the child at birth could be seen as a way to provide the child with a complete sense of identity and to give them the opportunity to establish a relationship with the donor and potentially their biological siblings from an early age. the child can also understand their genetic background and medical history. louise mcloughlin, a 30-year-old london based journalist, believes the hfea should revise the laws revealing donor identity to the offspring at 18 as current regulations feel "arbitrary and cruel."9 mcloughlin, who found her half-sister and biological father after signing up for 23andme, regrets not being able to know her family sooner. “the fertility industry is creating people, not children, and we have the right to know any and all genetic history,”10 she said in an interview with the guardian. others feel differently. in a study conducted with adolescents conceived using egg donation, some participants expressed concern that their interest in the donor might affect their non-genetic parent. one participant stated that she’d contact her donor only when she became 50 or 60 because her “mum might be a bit upset.”11 others, like chlöe woodmansternem, who was donor-conceived in 1992 when anonymity laws were still in place, have no desire to find her donor or any half-siblings. she questions the need for changes to the law. “i wonder if it wouldn’t be a little confusing for a younger child to have access to that information,” she said. “to have access to a donor, to be able to almost leverage that relationship against your own parents, could be a bit difficult.”12 there is also the issue of which aspects of donor information a child should have access to and at what age. at birth, the child should have access to medical information about the donor, including any genetic or hereditary conditions, as children can take actionable steps towards prevention or early detection of certain disorders. the child should also have access to non-identifying information, such as the donor’s age, ethnicity, physical description, interests, educational background, and occupation, as it can help the child understand their genetic heritage and provide a sense of identity. gamete recipient families benefit from open communication about the child’s genetic origins.13 the earlier children are informed, the better the outcome in terms of their emotional and identity development.14 in the uk, clinics and regulatory bodies encourage parents to begin telling their children about their method of conception around the age of four or five. however, it is unclear at what age children should have access to the donor’s identifying information or when parents should inform children about their right to do so. based on research, most children have an implicit understanding of biological inheritance of physical characteristics by age four, but they are not able to explain this concept and understand the role of genetic mechanisms until age seven. 15 this leads to the question of when children would develop the emotional maturity to handle the consequences of this information. ng, egg donor identity, voices in bioethics, vol. 9 (2023) 3 repealing anonymity at birth could put the egg donor’s privacy at risk. 18-year-olds who decide to contact their donors may be more mature than younger people conceived by donor eggs. they may have the capacity to consider whether they wish to disclose the donors’ identity to family members or others significant to them, or to honor the donors’ desire for a certain degree of anonymity. on the other hand, younger children may be less likely to fully comprehend the importance of confidentiality and could unintentionally reveal details about their donor without fully grasping the implications. if younger children divulge donor information on social media platforms, it could compromise the donor's privacy and erode the donor’s trust in the child. the family members of the donor or the recipient may not have been aware of the donor’s involvement in the egg donation process. egg donation is still a controversial and sometimes stigmatized practice in some cultures, and either party could be harassed or discriminated against based on their decision. additional factors to consider are whether the child is emotionally ready to initiate contact with the donor and how they would handle maintaining an ongoing relationship, acknowledging that not all donors may be open to communication or may be unavailable due to illness or death, considering how to proceed if family members oppose the child's desire to contact the donor, and taking into account the potential effects on the parents' psychological well-being. allowing the child access to the donor’s identity at an early age may also negatively influence family functioning as non-genetic mothers may perceive donors as an ongoing presence within the family, thus posing a threat to the mother-child relationship.16 while some recipient mothers feel confident in their position as the child’s mother and in their relationship with the child, others express concerns that a known donor could pose a threat to their maternal identity by the donor potentially feeling they have “a stake in [the child]’s upbringing” and by interfering in their parenting by “looking at you or disapproving of the way you were bringing up the child.”17 these concerns may affect parents’ sense of entitlement and confidence in their position as the child's parents and the future security of their family unit but may be particularly salient for mothers.18 conclusion removing egg donor anonymity laws at birth can have both positive and negative impacts on donor children’s wellbeing. it would allow them to have more autonomy in deciding whether to establish a relationship with the donor. yet, some children may find the information overwhelming or distressing, particularly if it affects their sense of identity, self-esteem, and relationships. the proposed new law would allow the donor to meet the child when they are still growing up but leaves them vulnerable to losing anonymity and confidentiality at an earlier stage. finally, the potential for the child to obtain the identity of the egg donor at an early age may put pressure on the parent-child relationship due to the absence of a genetic link between the mother and the child. regardless of which stage an egg donor would be identifiable to the child, it is essential that support services be available to the child, the egg donor, and the recipient parents. it may also be beneficial to allow for a diversity of donor conception arrangements, rather than imposing one model on everyone, as different individuals have varying preferences and perspectives. 19 any proposed change to the law needs to be very carefully thought through, with the involvement of all stakeholders. 1 human fertilisation and embryology authority. rules around releasing donor information. (2022, november 3). retrieved february 19, 2023, from https://www.hfea.gov.uk/donation/donors/rules-around-releasing-donor-information/ https://www.hfea.gov.uk/donation/donors/rules-around-releasing-donor-information/ ng, egg donor identity, voices in bioethics, vol. 9 (2023) 4 2 devlin, h. (2022, may 20). uk fertility watchdog could recommend scrapping donor anonymity law. the guardian. retrieved february 19, 2023, from https://www.theguardian.com/society/2022/may/20/uk-fertility-watchdog-could-recommendscrapping-donor-anonymity-law 3 harper, j. c., kennett, d., &amp; reisel, d. (2016). the end of donor anonymity: how genetic testing is likely to drive anonymous gamete donation out of business. human reproduction, 31(6), 1135–1140. https://doi.org/10.1093/humrep/dew065 4 woodward, j. t. (2015). third-party reproduction in the internet age: the new, patient-centered landscape. fertility and sterility, 104(3), 525–530. https://doi.org/10.1016/j.fertnstert.2015.05.030 5 human fertilisation and embryology authority. rules around releasing donor information. (2022) 6 pasch, l. a. (2018). new realities for the practice of egg donation: a family-building perspective. fertility and sterility, 110(7), 1194–1202. https://doi.org/10.1016/j.fertnstert.2018.08.055 7 the rights of the child save the children. a summary of the united nations convention on the rights of the child. (n.d.). retrieved february 19, 2023, from https://www.savethechildren.org.uk/content/dam/gb/reports/humanitarian/uncrc19summary2.pdf; besson, s. (2007). enforcing the child's right to know her origins: contrasting approaches under the convention on the rights of the child and the european convention on human rights. international journal of law, policy and the family, 21(2), 142–143. https://doi.org/10.1093/lawfam/ebm003 8 clark, b. (2012). a balancing act? the rights of donor-conceived children to know their biological origins. retrieved february 19, 2023, from https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?httpsredir=1&amp;article=1001&amp;context=gjicl 9 devlin. uk fertility watchdog could recommend scrapping donor anonymity law. (2022) 10 devlin. uk fertility watchdog could recommend scrapping donor anonymity law. (2022) 11zadeh s, ilioi ec, jadva v, golombok s. the perspectives of adolescents conceived using surrogacy, egg or sperm donation. hum reprod. 2018 jun 1;33(6):1099-1106. doi: 10.1093/humrep/dey088. pmid: 29701833; pmcid: pmc5972639. 12 devlin, “uk fertility watchdog” 13 gurtin, z. (2023, january 3). at last, britain's donor-conceived children can know the truth about their origins. the guardian. retrieved february 19, 2023, from https://www.theguardian.com/commentisfree/2023/jan/03/children-donor-conceivedorigins-sperm-egg-donations 14 hershberger, p. e., gallo, a. m., adlam, k., driessnack, m., grotevant, h. d., klock, s. c., pasch, l., &amp; gruss, v. (2021). parents’ experiences telling children conceived by gamete and embryo donation about their genetic origins. f&amp;s reports, 2(4), 479–486. https://doi.org/10.1016/j.xfre.2021.08.002 15 williams, j. m., &amp; smith, l. a. (2010). concepts of kinship relations and inheritance in childhood and adolescence. british journal of developmental psychology, 28(3), 523–546. https://doi.org/10.1348/026151009x449568 16 imrie, s., jadva, v., fishel, s., &amp; golombok, s. (2018). families created by egg donation: parent-child relationship quality in infancy. child development, 90(4), 1333–1349. https://doi.org/10.1111/cdev.13124 17 imrie, s., jadva, v., &amp; golombok, s. (2020). “making the child mine”: mothers’ thoughts and feelings about the mother– infant relationship in egg donation families. journal of family psychology, 34(4), 469–479. https://doi.org/10.1037/fam0000619 18 imrie, jadva, fishel & golombok, “families created by egg donation: parent-child relationship quality in infancy”, 1333–1349. 19 devlin, “uk fertility watchdog” https://www.theguardian.com/society/2022/may/20/uk-fertility-watchdog-could-recommend-scrapping-donor-anonymity-law https://www.theguardian.com/society/2022/may/20/uk-fertility-watchdog-could-recommend-scrapping-donor-anonymity-law https://doi.org/10.1093/humrep/dew065 https://doi.org/10.1016/j.fertnstert.2015.05.030 https://doi.org/10.1016/j.fertnstert.2018.08.055 https://www.savethechildren.org.uk/content/dam/gb/reports/humanitarian/uncrc19-summary2.pdf https://www.savethechildren.org.uk/content/dam/gb/reports/humanitarian/uncrc19-summary2.pdf https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?httpsredir=1&amp;article=1001&amp;context=gjicl https://www.theguardian.com/commentisfree/2023/jan/03/children-donor-conceived-origins-sperm-egg-donations https://www.theguardian.com/commentisfree/2023/jan/03/children-donor-conceived-origins-sperm-egg-donations https://doi.org/10.1016/j.xfre.2021.08.002 https://doi.org/10.1348/026151009x449568 https://doi.org/10.1111/cdev.13124 https://doi.org/10.1037/fam0000619 kim, the need for stricter control of social media, voices in bioethics, vol. 6 (2020) © 2020 jiseop kim. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the need for stricter control of social media by the us government during the covid-19 epidemic jiseop kim keywords: social media, free speech, covid-19, health claims, ethics introduction “spraying chlorine or alcohol on skin kills viruses in the body!” “hand dryers kill coronavirus.” “coronavirus kills everyone.”[i] these are just some examples of misleading content that are being spread during the covid-19 pandemic. with fear around the virus building as the number of cases grows, people are taking advantage of the internet for research. many posts are drowning out the scientific facts and evidence that others depend on for essential health information, such as prevention methods or symptoms of the disease. major social media companies have stated that they are working toward limiting the spread of false and deceiving misinformation like fake news because social media platforms are the medium predominantly responsible.[ii] however, this strategy of allowing the corporations to bear the responsibility for taking down misleading content is having limited success. given that social networking companies can only do so much, the u.s. should consider imposing more stringent regulations and consequences relating to fake news and false information, especially during times of an epidemic or disaster. health claims should not be restricted unless they would cause imminent harm or have been thoroughly researched and disproven. this article’s firm stance refers to dangerous claims and claims proven to be false. analysis the number of covid-19 cases has been increasing at a wild pace, especially in the united states.[iii] unfortunately, the amount of fake news relating to the disease has also been spreading like wildfire. disconnect between scientific consensus and members of the public is increasingly on the rise in the divided political climate of today.[iv] a study using trending twitter hashtags found that 24.8 percent of twitter posts included fake/false information and 17.4 percent included unverifiable information, demonstrating a significant amount of content found on social media platforms is unreliable.[v] unfortunately, fake news or misinformation on social media is allowed to propagate without constraints, does not entail any curation or peer review, and does not require any professional verifications.[vi] the lack of oversight and government action makes the spread and amplification of misinformation by the https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn1 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn2 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn3 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn4 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn5 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn6 kim, the need for stricter control of social media, voices in bioethics, vol. 6 (2020) 2 “information silos and echo chambers of personally tailored content on social media ideal” for those posting it, particularly during times of public tension like the current covid-19 epidemic.[vii] as a result, people are starting to follow “unfounded recommendations to prevent infection by taking in excessive amounts of vitamin c and avoiding spicy foods.”[viii] while suggestions of taking vitamin c and avoiding spicy foods are relatively harmless and not worthy of censor, some unfounded suggestions, such as snorting cocaine to battle the effects of the virus, are harmful. a prime example of the potential negative impact of misinformation on social media involves mixing sodium chlorite solution with citric acid, generating chlorine dioxide solution. the instructions then state for this powerful bleaching agent to be consumed, promising antimicrobial, antiviral, and antibacterial actions. the us food and drug administration (fda) has previously served severe warnings that chlorine dioxide causes severe vomiting, life-threatening low blood pressure, and acute liver failure.[ix] the world's largest social media platforms are said to have been pulling out all the stops to “combat the wave of false reports, hacking attempts, and outright lies about covid-19.”[x] in an effort to combat fraudulent and harmful content on their platforms, companies signed a joint statement which states that they will “elevate authoritative content on our platforms, as well as share critical updates in coordination with global government health agencies.”[xi] as a result, facebook and twitter stated that they will work to ban content about coronavirus that can cause harm. google is imposing similar actions stating that the company formed a response team that would work to remove misinformation and promote accurate information from health agencies. however, there are doubts as to whether companies are able to handle the so-called “infodemic.”[xii] according to newsguard, a site that ranks websites by trustworthiness, "health care hoax sites" received more than 142 times as much social-media engagement in the past 90 days as the websites for the centers for disease control and prevention (cdc) and the world health organization (who) combined.[xiii] in other words, posts from the who and the cdc were considerably eclipsed by hoax and conspiracy theory sites: several hundred thousand engagements versus over 52 million.[xiv] of course, the degree to which the truth is eclipsed might be overstated because people can get access to information from the cdc and who through other websites such as online newspapers, university websites, or even good-willed social media posts. however, people visiting the websites that are not trustworthy likely follow links to more of the same and are not in the habit of verifying with legitimate sources putting them at risk. the abundance of online platforms that make use of information from the cdc and who to slightly tweak the information can lead people to false content as well. the sheer amount of information makes it impossible to track down all such content, especially since some are in private social media groups which are much harder to track. simply put, spreading more factual information and taking down other content is not enough to prevent the extant “infodemic.” currently, other nations such as south korea are imposing strict guidelines relating to fake news being spread about covid-19. in south korea, the cyber unit of a national police agency is “stamping out” false information and is stating those spreading fake news relating to covid-19 will be prosecuted.[xv] the korean national police agency stated that it planned to conduct investigations including arrests. the prosecutor’s office also stated that it would respond.[xvi] singapore and germany have been taking part in investigations relating to fake news and misinformation. germany passed a law in october 2017 that requires social media to remove fake news promptly.[xvii] part of the us public health sphere is at a high risk of being misinformed and harmed as a result fake news and misinformation. https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn7 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn8 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn9 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn10 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn11 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn12 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn13 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn14 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn15 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn16 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn17 kim, the need for stricter control of social media, voices in bioethics, vol. 6 (2020) 3 when we discuss imposing restrictions on any type of information including misleading information, we consider whether our first amendment rights -freedom of speech and freedom of the press -are violated. a recent study on fake news under the first amendment states that “permitting the government to tell society what is and is not true is treacherous, for it vests officials temporarily in charge of the country with the power to twist narratives to serve their own purposes. that is disturbingly akin to the function of the ministry of truth in george orwell's nineteen eighty-four. its purpose was to dictate and protect the government's version of reality.”[xviii] in other words, the first amendment exists to allow free exchange of opinions and facts whether the government verifies them or not. it also permits the people to have a say about the government and its officials. government stepping in to force social media to pull content must be narrowly construed to pull only those claims that are dangerous or proven false. one may argue people just need to be more responsible and more cautious about the information they collect from the internet. however, it is important to note that fake news and/or misinformation, especially during times of an epidemic, can cause people with clouded judgment to engage in actions that put them at a great risk. these examples include panic buying that can prevent other people who are in dire need of supplies from retrieving them or a dangerous intake of bleach that can result in poisoning.[xix] as seen by the misleading content on social media, it is simply not enough, and seemingly impossible, to just take down the content. there must be a threat of consequences that will discourage people from posting potentially harmful content. otherwise, there will be a continuous production leading to an increase in fake news, and even wiggle room for politicians to politicize a pandemic. false harmful publications are actionable if they were made with “knowledge of falsity or with reckless disregard for the truth.”[xx] conclusion with the increasing presence of covid-19, we as a community must take every precaution and step necessary to prevent further damage. a good starting point is to prevent fake news and other misleading content that can inflict harm on individuals’ and the general public’s well-being. the current methods set forth by google and facebook are strictly limited, leaving room for malicious internet users to spread fake information. imagine, for example, the spread of news such as the government giving the ‘ok’ for people to go out in the public. the news would put the public at risk of getting infected, further spreading the disease, and slowing down efforts to contain the pandemic. the us, which currently lacks a specific legal action to prevent the spread of deceiving and potentially dangerous information through social media, needs to take a more rigorous role in protecting its citizens during serious public health disasters. heraclitus once said, “justice will overtake fabricators of lies.” there seems no better time than now for justice to protect the american public. [i] tim newman, “coronavirus myths explored,” medical news today, march 23, 2020, https://www.medicalnewstoday.com/articles/coronavirus-myths-explored. [ii] sabrina tavernise, “as fake news spreads lies, more readers shrug at the truth,” the new york times, december 6, 2016, https://www.nytimes.com/2016/12/06/us/fake-news-partisan-republican-democrat.html. [iii] nicole chavez, holly yan, madeline holcombe, “us has more known cases of coronavirus than any other country,” cnn health, march 27, 2020, https://www.cnn.com/2020/03/26/health/coronavirus-thousand-deathsthursday/index.html. [iv] areeb mian, shujhat khan, “the spread of misinformation,” bmc medicine 18, no. 89 (2020), https://link.springer.com/article/10.1186/s12916-020-01556-3. https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn18 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn19 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_edn20 https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref1 https://www.medicalnewstoday.com/articles/coronavirus-myths-explored https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref2 https://www.nytimes.com/2016/12/06/us/fake-news-partisan-republican-democrat.html https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref3 https://www.cnn.com/2020/03/26/health/coronavirus-thousand-deaths-thursday/index.html https://www.cnn.com/2020/03/26/health/coronavirus-thousand-deaths-thursday/index.html https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref4 https://link.springer.com/article/10.1186/s12916-020-01556-3 kim, the need for stricter control of social media, voices in bioethics, vol. 6 (2020) 4 [v] ramez kouzy et. al., “coronavirus goes viral: quantifying the covid-19 misinformation epidemic on twitter,” cureus 12, no. 3 (2020), https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19misinformation-epidemic-on-twitter. [vi] ramez kouzy et. al., “coronavirus goes viral: quantifying the covid-19 misinformation epidemic on twitter,” cureus 12, no. 3 (2020), https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19misinformation-epidemic-on-twitter. [vii] ramez kouzy, et. al., “coronavirus goes viral: quantifying the covid-19 misinformation epidemic on twitter,” cureus 12, no. 3 (2020), https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19misinformation-epidemic-on-twitter. [viii] robert h. shmerling, “be careful where you get your news about coronavirus,” harvard health publishing, february 1, 2020, https://www.health.harvard.edu/blog/be-careful-where-you-get-your-news-about-coronavirus2020020118801. [ix] areeb mian, shujhat khan, “the spread of misinformation,” bmc medicine 18, no. 89 (2020), https://link.springer.com/article/10.1186/s12916-020-01556-3. [x] tyler sonnemaker, “facebook, google, microsoft, reddit, and twitter just said they’re working together to fight coronavirus misinformation,” business insider, march 16, 2020, https://www.businessinsider.com/facebook-googleyoutube-microsoft-reddit-twitter-fight-coronavirus-covid19-misinformation-2020-3. [xi] tyler sonnemaker, “facebook, google, microsoft, reddit, and twitter just said they’re working together to fight coronavirus misinformation,” business insider, march 16, 2020, https://www.businessinsider.com/facebook-googleyoutube-microsoft-reddit-twitter-fight-coronavirus-covid19-misinformation-2020-3. [xii] tyler sonnemaker, “facebook, google, microsoft, reddit, and twitter just said they’re working together to fight coronavirus misinformation,” business insider, march 16, 2020, https://www.businessinsider.com/facebook-googleyoutube-microsoft-reddit-twitter-fight-coronavirus-covid19-misinformation-2020-3. [xiii] areeb mian, shujhat khan, “the spread of misinformation,” bmc medicine 18, no. 89 (2020), https://link.springer.com/article/10.1186/s12916-020-01556-3. [xiv] areeb mian, shujhat khan, “the spread of misinformation,” bmc medicine 18, no. 89 (2020), https://link.springer.com/article/10.1186/s12916-020-01556-3. [xv] justin mccurry, “south korea cracks down on fake news about spread of coronavirus,” the guardian, january 29, 2020, https://www.theguardian.com/world/2020/jan/30/south-korea-cracks-down-on-fake-news-about-spread-ofcoronavirus. [xvi] ji-young lee, “severe lung damage even after treatment of coronavirus?,” jungang ilbo, february 27, 2020, https://news.joins.com/article/23717147. [xvii] ahran park, kyu ho youm, “fake news from a legal perspective: the united states and south korea compared,” southwestern journal of international law 25, (2019): 100-119, https://heinonline.org/hol/landingpage?handle=hein.journals/sjlta25&div=8&id=&page=. [xviii] clay calvert et. al., “fake news and the first amendment: reconciling a disconnect between theory and doctrine,” university of cincinnati law review 86, no. 1 (2018), https://scholarship.law.uc.edu/uclr/vol86/iss1/3. [xix] john p. a. ioannidis, “coronavirus disease 2019: the harms of exaggerated information and non-evidence-based measure,” european journal of clinical investigation (2020) https://doi.org/10.1111/eci.13222. [xx] n.y. times co. v. sullivan, 376 u.s. 254, 279-80 (1964). https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref5 https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19-misinformation-epidemic-on-twitter https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19-misinformation-epidemic-on-twitter https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref6 https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19-misinformation-epidemic-on-twitter https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19-misinformation-epidemic-on-twitter https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref7 https://www.cureus.com/articles/28976-coronavirus-goes-viral-quantifying-the-covid-19-misinformation-epidemic-on-twitter 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https://d.docs.live.net/b37c00fb4a29b9da/pictures/jiseopkimsocialmedia.final422020.docx#_ednref20 kim, the need for stricter control of social media, voices in bioethics, vol. 6 (2020) 5 oshotse, global medical brain drain, voices in bioethics, vol. 5 (2019) * christiana oshotse, duke university; voices in bioethics global ethics essay contest winner © 2019 christiana oshotse. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an ethical analysis of the global medical brain drain christiana oshotse* keywords: brain drain, healthcare workers, bioethics, resources, labor market introduction the ‘medical brain drain’ refers to the mass movement of health care workers from low and middle-income countries (lmics) to high-income countries, resulting in gross shortages of health care workers in lmics.1 strong notions of medical workers’ duty-to-stay in their home country and of equal rights to the life and health of citizens in source countries are important arguments in emphasizing the unethicality of the medical brain drain. i spent part of my childhood in lagos, nigeria, and i witnessed some of the detrimental health outcomes individuals experienced when they did not have access to health care. analysis current statistics show that there are 1.95 medical workers per 1,000 individuals in nigeria.4 lagos is a major city, but in the midst of the daily movement of millions, no reliable network of emergency care exists. as a result, fatalities from car accidents and other medical emergencies are frequent. when individuals sick with chronic or communicable diseases are able to reach one of the few major public hospitals, there are long lines to receive care. there are no policies regulating the distribution of workers, so public agencies deploy workers at their own discretion, which complicates the shortage because these agencies often have conflicting interests in where to assign workers.4 driving forces such as poverty and political instability intensify the mass emigration of health care workers from lmics, resulting in critical shortages of remaining workers to meet the basic health needs of citizens in these countries. medicals workers emigrate for better employment opportunities, to earn higher wages, and to secure the future of their family.3, 6 other factors include a desire for safer working conditions with greater resources. this is relevant especially in sub-saharan african countries whose immense burden of hiv/aids and resource limited settings overburden medical staff, who work long hours in conditions often lacking proper protective medical equipment.3, 7, 9 paradoxically, the emigration of these medical workers further exacerbates the problems that served as the initial driving forces for their migration. political instability and war are other significant factors that spark high migration rates from medical workers. widespread agreement exists that the medical brain drain severely undermines the capacity of lmics to develop competent health care systems.2-4 efforts at the national and international levels to impose policies oshotse, global medical brain drain, voices in bioethics, vol. 6 (2019) 2 encouraging against the medical brain drain have lacked implementation and remain largely ignored.2 as lmics increasingly suffer the harmful effects of the medical brain drain, a debate continues over the morality and legality of international health care workers migration and of the policies used to address this phenomenon. a number of important questions are raised in this debate including: who is to blame for the recruitment of skilled medical workers to high-income countries such as the united states? is it wrong for medical workers to emigrate or are they rightfully exercising their human rights? do migrating medical workers have a responsibility to remain in their home country? the migration of medical workers is part of the current global-health workforce crisis characterized by the severe shortage of health care workers in countries suffering from high burdens of disease.5 the world health organization (who) estimates that over 4.3 million health care workers are needed to effectively combat hiv/aids and other diseases, reduce child mortality and improve maternal health.3, 6-7 the who’s estimate only accounts for shortages of health care workers in 57 countries experiencing “critical shortages,” and does not account for countries experiencing shortages in the capacity to provide basic health services (see figure 1).5-6,8 36 of the 57 countries are in africa, a continent experiencing 25% of the global burden of disease yet possessing far less of a capacity to provide care to its inhabitants (see table 1).6 the far-reaching realities of the medical brain drain are not entirely captured by existing data. the conflicting fundamental moral units (fmus) of important stakeholders contribute to differing views held about which policies are morally justifiable to address the medical brain drain and is cause for the objections of some against viewing the medical brain drain as an unethical (see table 2 for further elaboration). 9 objectors claim that medical workers have the right to leave their country and to choose their profession (see article 13, udhr). 16 but the effects of these individuals’ decisions raise significant ethical issues when aggregated at the societal level. one of the questions frequently raised in this debate is whether the freedom of movement of health care workers to migrate for professional reasons should be limited. it is important to acknowledge the conflicting fundamental moral units of two stakeholders involved: that of the health care worker is at odds with that of the source country and its inhabitants. least restrictive means approaches should be used to limit the migration of health care workers. these approaches are ethical on the grounds that when healthcare workers emigrate from source countries, thousands of individuals are left without access to adequate health care, which is a violation of their right to life and well-being. rawl’s justice theory offers the veil of ignorance as a thought experiment that allows us to consider what principles to govern life individuals would choose if we were all in an original position of equality to make this decision.14 from this position, all would choose principles that guarantee equal basic liberties for all, to avoid later ending up in the oppressed minority. the injustice evident in the context of the medical brain drain are grounds for employing non-restrictive policies, such as a compulsory service requirement, to curb the emigration of health care workers while preserving everyone’s liberties.5 source and destination countries disproportionately experience the distributions of benefits and burdens of the medical brain drain. destination countries experience numerous benefits of added medical workers to strengthen their health systems without undergoing the cost of training these professionals. these benefits include: less need to meet the growing demand of health care workforce, added stability of health systems, and less need to invest in national medical education.9 the medical brain drain has been referred to as “reverse foreign aid” because it is a movement of health care workers from lmics to support high-income destination countries.5 others have described the medical brain drain as a sort of “theft” from poor countries by rich countries. oshotse, global medical brain drain, voices in bioethics, vol. 6 (2019) 3 objections have been raised against these claims, stating that destination countries long stopped actively recruiting health care workers and thus have no obligation to address the effects of the medical brain drain. though these destination countries may not participate in active recruitment of health care workers from lmics, they participate in “passive recruitment” of health care workers. passive recruitment occurs when health care workers indicate their interest to emigrate due to attractive factors in the destination country that make the emigration process easier: the creation of new points systems for immigrants and the establishment of entrance exams in lmics to medical schools in destination countries.21, 22 passive recruitment still has detrimental effects on the capacity of source countries to meet the health needs of its inhabitants, and this makes destination countries obligated to rectify the effects of their passive actions. others point to the difficulty of documenting the effects that migration of healthcare workers has on health systems and outcomes. they believe that the effects of the medical brain drain are difficult display and slow to perceive.5 they provide alternative factors, such as internal geographical misdistributions of medical workers, as “better” reasons for the poor health outcomes in source countries.23 fixation on alternate factors distracts from the fact that passive recruitment actions of destination countries results in a disproportionate distribution of health care workers to destination countries. this inequality is an issue of distributive justice, in which the policies and programs of destination countries exist as a pull for foreign health care workers to emigrate. source countries have not received any remuneration for the losses in human and social capital experienced, thus destination countries are obligated to rectify these losses. conclusion the international community has taken an important step in adopting the who global code to tackle worker shortages in lmics by acknowledging that ethical norms must be used to guide cooperation on the issue of the migration of health care workers. the code has been ineffective though because of its nonbinding nature and lack of incentives to guide destination countries to adopt national policy changes consistent with the code.12 when asked about the impact of the code, a sudanese official remarked that, “as far as the who code is voluntary and as far as beneficiary countries in the region do not have media or civil groups pressures, they will not be part of this code, i do not think there is hope! ” 2 the who must employ pressure through the media to mobilize national civil groups as a tactic to prompt destination countries to employ policy changes that address these countries’ roles as passive recruiters of foreign health care workers.2 oshotse, global medical brain drain, voices in bioethics, vol. 6 (2019) 4 figure 1. expatriation rate of doctors8 table 1. global health workforce by density6 oshotse, global medical brain drain, voices in bioethics, vol. 6 (2019) 5 table 2. specific ethical challenges in the medical brain drain9 references 1. brain drain. (2014, march 05). retrieved april 15, 2018, from https://openborders.info/brain-drain/ 2. abuagla, a., & badr, e. (2016). challenges to implementation of the who global code of practice on international recruitment of health personnel: the case of sudan. human resources for health, 14(s1). doi:10.1186/s12960-016-0117-8 3. h. (2008, september 01). adding insult to injury: the healthcare brain drain. retrieved april 15, 2018, from http://jme.bmj.com/content/34/9/684#ref-5 4. adeloye, d., david, r. a., olaogun, a. a., auta, a., adesokan, a., gadanya, m., . . . iseolorunkanmi, a. (2017, may 12). health workforce and governance: the crisis in nigeria. retrieved april 15, 2018, from https://human-resources-health.biomedcentral.com/articles/10.1186/s12960-017-0205-4 5. ethics and policy of medical brain drain: a review. (n.d.). retrieved april 15, 2018, from https://smw.ch/article/doi/smw.2013.13845#5fc19d85b9d38250521c4d212ba358f0d7e9232f https://openborders.info/brain-drain/ oshotse, global medical brain drain, voices in bioethics, vol. 6 (2019) 6 6. serour, g. i. (2009, june 16). healthcare workers and the brain drain. retrieved april 15, 2018, from https://obgyn.onlinelibrary.wiley.com/doi/full/10.1016/j.ijgo.2009.03.035 7. misau, y. a., al-sadat, n., & gerei, a. b. (2010). brain-drain and health care delivery in developing countries. journal of public health in africa,1(1). doi:10.4081/jphia.2010.e6 8. database on immigrants in oecd and non-oecd countries: dioc. (n.d.). retrieved april 15, 2018, from http://www.oecd.org/els/mig/dioc.htm 9. aluttis, c., bishaw, t., & frank, m. w. (2014). the workforce for health in a globalized context – global shortages and international migration. global health action,7(1), 23611. doi:10.3402/gha.v7.23611 10. yuksekdag, y. (2017, february 21). health without care? vulnerability, medical brain drain, and health worker responsibilities in underserved contexts. retrieved april 15, 2018, from https://link.springer.com/article/10.1007/s10728-017-0342-x 11. eiu digital solutions. (n.d.). healthcare. retrieved april 15, 2018, from http://www.eiu.com/industry/article/1365863120/preventing-the-brain-drain/2017-09-06 12. taylor, a. l., hwenda, l., larsen, b., & daulaire, n. (2011). stemming the brain drain — a who global code of practice on international recruitment of health personnel. new england journal of medicine,365(25), 2348-2351. doi:10.1056/nejmp1108658 13. haidt, j. (2012). the righteous mind: why good people are divided by politics and religion. london: penguin books. 14. sandel, m.j. (2009). justice: what’s the right thing to do? new york, us: farrar, straus and giroux. 15. gautam, r., & acharya, p. (2016). human resource for health migration: an analysis from the perspective of utilitarianism. online journal of health ethics,12(1). doi:10.18785/ojhe.1201.05 16. udhr. (n.d.). universal declaration of human rights. retrieved april 15, 2018, from http://www.un.org/en/universal-declaration-human-rights/ 17. brudney, d. theor med bioeth (2016) 37: 249. https://doi.org/10.1007/s11017-016-9376-6 18. ferracioli, l., & de lora, p. (n.d.). primum nocere : medical brain drain and the duty to stay ... retrieved april 15, 2018, from https://www.bing.com/cr?ig=13c1ec9f095d45d086b43850b9be02c3&cid=31296026ae1f69dd26f36bf4 afb068af&rd=1&h=6uxrpjwfoomhxtk0nbebn9ufqo7-jjpw2y-iokpuhs&v=1&r=https://www.researchgate.net/publication/280601790_primum_nocere_medical_brain_drain_a nd_the_duty_to_stay&p=devex,5066.1 19. list, j. m. (2009). justice and the reversal of the healthcare worker “brain-drain.” the american journal of bioethics : ajob, 9(3), 10–12. http://doi.org/10.1080/15265160802654186 20. nussbaum, m. c. (2013). creating capabilities: the human development approach. cambridge, mass: belknap press of harvard university press. 21. medical "brain drain" and health care worker shortages: how should international training programs respond?, july 16. (2016, july 01). retrieved april 15, 2018, from http://journalofethics.amaassn.org/2016/07/ecas1-1607.html http://www.oecd.org/els/mig/dioc.htm https://link.springer.com/article/10.1007/s10728-017-0342-x http://doi.org/10.1080/15265160802654186 oshotse, global medical brain drain, voices in bioethics, vol. 6 (2019) 7 22. labonte, r., packer, c., klassen, n., kazanjian, a., apland, l., adalikwu, j., . . . zakus, d. (2007). no. 2: the brain drain of health professionals from sub-saharan africa to canada. retrieved april 15, 2018, from http://scholars.wlu.ca/samp/16/ 23. hildago j. the active recruitment of health-workers: a defence. j med ethics [internet], 2012 [accessed 2018 april 15]. available from http://jme.bmj.com/content/early/2012/10/29/medethics-2012-100927.full. 24. antwi j, phillips d. wages and health worker retention in ghana: evidence from public sector wage reforms. washington: the international bank for reconstruction and development; 2011. 25. who. (2011, june 08). first global conference on task shifting. retrieved april 15, 2018, from http://www.who.int/healthsystems/task_shifting/en/ http://jme.bmj.com/content/early/2012/10/29/medethics-2012-100927.full puccio, (mis)treating substance use disorder with prison, voices in bioethics, vol. 5 (2019) kaitlin puccio, jd georgetown university, ms columbia university © 2019 kaitlin puccio. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, di stribution, and reproduction, provided the original author and source are credited. (mis)treating substance use disorder with prison kaitlin puccio* keywords: prison, bioethics, substance abuse, incarceration, rehabilitation, ethics introduction it is largely unethical to sentence individuals who are addicted to drugs to prison. while substance use can be a crime, it must be treated differently from other crimes because addiction is a psychiatric disorder. prisons are penal institutions. legitimate goals of penal sanctions include retribution, deterrence, rehabilitation, and incapacitation.1 most of these goals do not speak to those with substance use disorder, and incarceration may be counterproductive given the wide availability of drugs and feeble rehabilitation efforts in prison. further, it may be the case that substance use disorder impairs an addict’s autonomy, calling into question his criminal culpability. our understanding of substance use disorder has evolved and our prison sentencing practices must do the same. this paper will first provide background on substance use disorder as a psychiatric disorder. then, the need to focus on rehabilitating rather than punishing those with substance use disorder who commit crimes will be explored. finally, this paper will address whether an individual with substance use disorder can be considered culpable for any crime—regardless of severity—and whether that individual’s autonomy is impaired due to his addiction. i conclude that culpability should depend on whether the serious crime would have occurred in the absence of the drug addiction. in most cases, it is unethical to sentence an individual with substance use disorder to prison where other options such as home confinement are available. ii. background the fifth and most recent edition of the diagnostic and statistical manual of mental disorders (dsm-5)— published nearly twenty years after the previous edition was published in 1994—includes a section on substance use disorder.2 in prior editions, substance abuse and substance dependence were listed as separate categories. abuse was conceptualized as “mild or early phase” (dangerous substance use) and dependence as the “more serious manifestation” (regular substance use).3 the recently combined category of substance use disorder is measured on a spectrum of severity, reflecting two decades of clinical research. this is a significant development, because it recognizes that what was once considered “substance abuse” is not simply a “mild” vice, but a serious disorder. this new understanding warrants changes to the existing penal system in the united states as applied to those who are addicted to drugs. puccio, (mis)treating substance use disorder with prison, voices in bioethics, vol. 5 (2019) 2 iii. analysis a. punishment versus rehabilitation given our recent understanding of the genetic components underlying addiction, it is clear that substance use disorder requires treatment rather than punishment. the three most relevant goals of penal sanctions are deterrence, rehabilitation, and incapacitation. deterrence is the idea that mandatory minimum sentences will prevent addicts from violating drug laws because the threatened loss of freedom outweighs the perceived benefits (from the addict’s perspective) of drug use. if deterrence were effective, states with higher rates of incarceration for drug crimes would have lower rates of drug use.4 this is not the case. further, shorter sentences have not led to higher recidivism rates.5 the correlation between prison sentences and drug use is thin. prisons in the united states have a more punitive than rehabilitative focus. over 75 percent of inmates released from prison are reincarcerated within five years due to the lack of rehabilitative programs, which include educational and reintegration programs.6 rehabilitation programs in prison targeted at substance use disorder are utilized by only 40-50 percent of the prison population with drug addictions. despite the availability of these programs in most prisons, drugs are also widely available in prisons. 7 those with substance use disorder are less likely to be able to resist using drugs when exposed to them; this is now acknowledged as a symptom of the disorder as opposed to a weakness of character.8 confining an addict to an environment that challenges his self-control is not conducive to his successful rehabilitation. b. easy cases incapacitation embodies the idea that incarcerating drug offenders increases public safety. here the analysis splits into two paths: the easy cases and the hard cases. first, i will address the easy cases. while drug use is itself a crime and often leads to other crimes, petty crimes in conjunction with drug use must be considered differently than more serious crimes. lesser crimes such as shoplifting often co-occur with drug use (for example, a heroin addict stealing needles). in these cases, it is likely that but for the addiction, the crime would not have occurred. drug use alone and drug use in conjunction with petty crimes should not involve prison time because there are minimal associated public safety concerns. other penal options that achieve the goals of incapacitation, retribution, and deterrence include home confinement and fines, in addition to the completion of a court-ordered drug treatment program that achieves the penal goal of rehabilitation. for example, german prisons emphasize reintegration rather than punishment; the conditions of confinement are not part of the punishment. rather, the punishment is “the incarceration, the imprisonment itself…the loss of freedom, that’s it.” 9 prisoners—including those who have committed violent crimes—have the keys to their own private cells, complete with a private bathroom. they can decorate how they wish and play darts in common areas throughout what resembles a college campus. the conditions are luxurious compared to prison conditions in the united states, yet the recidivism rate is lower.10 the loss of freedom is the key, which acts as both a punishment and a deterrent. similarly, in the case of mandatory drug treatment programs that we might impose on those with substance use disorder instead of prison, the loss of freedom is the punishment: an addict is removed from his family and forced into a rehabilitation program. extracting him from his environment is a critical step as well, because it is important to extinguish environmental cues when treating substance use disorder. for example, an individual may associate heroin with the people he is with or the apartment he is in when using puccio, (mis)treating substance use disorder with prison, voices in bioethics, vol. 5 (2019) 3 the drug. environmental experiences can trigger a drug craving. such environmental cues are a type of memory. it would be difficult to extinguish such cues in a prison environment where drugs are rampant and new cues are able to evolve before the individual has been treated for addiction. further, drug use often co-occurs with other psychiatric disorders like ptsd. punishing a self-medicating, traumatized individual with punitive action that may contribute to additional trauma is reinforcing. for example, a female victim of domestic violence and sexual abuse may use drugs to alleviate the stress of her situation. if she is imprisoned for drug possession, sexual assault and violence while incarcerated, and the presence of male guards in a position of authority, may add to her trauma.11 a focus on rehabilitation rather than punishment speaks more to the needs of those with substance use disorder and more successfully achieves the apparent aims of the penal system. c. difficult cases there are more difficult cases where drug use co-occurs with more serious crimes such as murder. the balance in these cases weighs more heavily in favor of prison for incapacitation purposes due to concerns over public safety. however, the rehabilitative goal should not be disregarded simply because prison is appropriate. to move beyond the challenges that a prison environment presents for those with substance use disorder, the conditions of confinement must improve. an individual who is released from prison after a long sentence may be more difficult to treat due to what is recognized among psychologists and criminologists as “post-incarceration syndrome.”12 researchers at vrije universiteit amsterdam used neuropsychological tests to show that even after a short incarceration, prisoners demonstrated increased impulsivity and decreased attentional control, and concluded that “released prisoners may be less capable of living a lawful life than they were prior to their imprisonment.”13 compounding this with substance use disorder that is unlikely to have been treated in prison may leave addicts prone to even greater dependence on drugs than before entering prison. d. autonomy and culpability one remaining question is whether an individual with substance use disorder can be said to be culpable for any crime—regardless of severity—if his autonomy is impaired due to his addiction. punishment for crimes committed by those with other psychiatric disorders may provide some clarity. since 1955, the number of patients housed in psychiatric institutions has declined by 95 percent.14 this is not due to a decline in the number of people with psychiatric illnesses, but because psychiatric hospitals have largely gone out of existence. many of the mentally ill ended up homeless or in prison. indeed, 15 percent of state prison inmates suffer from a psychotic disorder.15 prior to this deinstitutionalization, an individual with schizophrenia, for example, who committed murder because voices in his head ordered him to do so would be sent to a psychiatric institution for both mental health care and incapacitation purposes. now, this same individual would likely be incarcerated. even though pleading insanity may reduce his sentence, prison conditions—for example, being placed in solitary confinement—may exacerbate this issue.16 individuals with antisocial personality disorder (psychopaths and sociopaths) are treated differently in that the insanity defense does not apply.17 on a spectrum, these individuals are the most culpable. their behavior and lack of remorse does not fit the model penal code test of insanity, where an “individual is not liable for criminal offenses if, when he or she committed the crime or crimes, the individual suffered from a mental disease or defect that resulted in the individual lacking the substantial capacity to appreciate the puccio, (mis)treating substance use disorder with prison, voices in bioethics, vol. 5 (2019) 4 wrongfulness of his or her actions…”18 under this test, schizophrenics are less culpable because while they committed the crime, they suffered from volitional impairment. those with substance use disorder suffer from a similar volitional impairment, though the insanity defense is not available to them. however, the availability of the insanity defense to a defendant does not determine culpability; volitional impairment, which provides the legal basis for the insanity defense, is the key. the nervous system of an individual with substance use disorder reacts to drugs in a way that is reinforcing. all addictive drugs stimulate the release of dopamine in the nucleus accumbens. an individual may inherit an atypical response to opiates, for example, where the drug makes him feel euphoric and thus is highly reinforcing. by contrast, another individual who has been prescribed opiates after a traumatic physical injury may find that they don’t make him feel anything other than a decrease in pain—i.e. there is no feeling of euphoria, or “high.” the former has an inherited risk of developing substance use disorder. even if he desires to stop using heroin, he may be unable to do so as a result of genetic or biological predispositions. he is stripped of his autonomy in this sense. because of this volitional impairment, it is unethical to find him culpable for using drugs. his culpability with regard to other crimes may depend on whether he would have committed the crime if he did not suffer from substance use disorder. conclusion research has shown that addiction is a psychiatric disorder. although substance use can be a crime, it must be treated differently than other crimes. the current penal system in the united states focuses on punishment rather than rehabilitation. this does not speak to the needs of those with substance use disorder, and likely thwarts efforts at reintegrating prisoners into society. without proper treatment, those with substance use disorder will likely continue to use drugs. their genetic makeup leaves them vulnerable to addiction and threatens their autonomy. this loss of autonomy means that—like those who suffer from other psychiatric disorders and are volitionally impaired—they are not culpable for the crime of substance use. cases in which drug use co-occurs with other crimes are more difficult, but an individual’s culpability should depend on whether the additional crime would have occurred in the absence of drug addiction. even if an individual with substance use disorder is incarcerated for the purpose of incapacitation in the context of a serious crime, the institution to which he is sentenced must provide proper rehabilitation. in most cases, it is unethical to sentence an individual with substance use disorder to prison where other options are available. 1 graham v. florida, 130 s.ct. 2011 at 2012 (2010). 2 american psychiatric association, diagnostic and statistic manual of mental disorders, 5th edition, “substance use disorder” 3 see generally hasin, deborah s. et. al, am. j. psychiatry, “dsm-5 criteria for substance use disorders: recommendations and rationale” (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3767415/ 4 pew trusts, “more imprisonment does not reduce state drug problems,” march 8, 2018, https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2018/03/more-imprisonment-does-not-reduce-state-drugproblems 5 u.s. sentencing commission, “u.s. sentencing commission votes unanimously to apply amendment retroactively for crack cocaine offenses,” news release, dec. 11, 2007, http://www.ussc.gov/about/news/press-releases/december-11-2007; kim http://www.ussc.gov/about/news/press-releases/december-11-2007 puccio, (mis)treating substance use disorder with prison, voices in bioethics, vol. 5 (2019) 5 steven hunt and andrew peterson, “recidivism among offenders receiving retroactive sentence reductions: the 2007 crack cocaine amendment” (2014), u.s. sentencing commission, http://www.ussc.gov/sites/default/files/pdf/research-andpublications/research-projects-and-surveys/miscellaneous/ 20140527_recidivism_2007_crack_cocaine_amendment.pdf. 6 university of pennsylvania, wharton public policy initiative, “the economic impact of prison rehabilitation programs,” august 17, 2017, https://publicpolicy.wharton.upenn.edu/live/news/2059-the-economic-impact-of-prison-rehabilitation/forstudents/blog/news.php 7 welsh-huggins, andrew, associated press, “prison staff in 2 states treated for exposure to drugs,” august 29, 2018, https://www.usnews.com/news/best-states/ohio/articles/2018-08-29/report-prison-guards-inmates-treated-for-exposure 8 hartney, elizabeth, phd, “a guide to dsm 5 criteria for substance use disorders,” september 26, 2018, https://www.verywellmind.com/dsm-5-criteria-for-substance-use-disorders-21926 9 cbs 60 minutes presents: behind bars, https://www.cbsnews.com/news/60-minutes-presents-behind-bars-prison/ 10 the marshall project, “prison without punishment,” september 25, 2015, https://www.themarshallproject.org/2015/09/25/prison-without-punishment 11 see also hogenboom, melissa, bbc, “locked up and vulnerable: when prison makes things worse,” april 16, 2018, http://www.bbc.com/future/story/20180411-locked-up-and-vulnerable-when-prison-makes-things-worse, discussing how women who are victims of trauma are re-victimized by prison. 12 jarrett, christian, bbc, “how prison changes people,” may 1, 2018, http://www.bbc.com/future/story/20180430-theunexpected-ways-prison-time-changes-people 13 id. 14 kozlowska, hanna, the atlantic,”should the u.s. bring back psychiatric asylums,” january 27, 2015, https://www.theatlantic.com/health/archive/2015/01/should-the-us-bring-back-psychiatric-asylums/384838/ 15 id. 16 id. 17 cornell university legal information institute, “insanity defense,” https://www.law.cornell.edu/wex/insanity_defense 18 cornell university legal information institute, “model penal code insanity defense,” https://www.law.cornell.edu/wex/model_penal_code_insanity_defense kim, patients choosing healthcare provider based on race, voices in bioethics, vol. 6 (2020) © 2020 melina kim. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and re production, provided the original author and source are credited. patients choosing healthcare provider based on race: ethical issues and considerations melina kim keywords: bioethics, medical racism, philosophy, utilitarianism, patient choice introduction to encourage patient welfare, patients are allowed to make requests for a healthcare provider of a specific race, gender, or religious group. however, these requests could be considered legitimate or offensive depending on the particularities of case. the american medical association (ama) code of medical ethics bans doctors from refusing to treat people based on race, gender and other criteria, but there are no specific policies for handling race-based requests from patients.1 while it is ethical for patients to request for a physician based on gender or religious needs in some cases, it is unethical for patients to want their bigotry to be accommodated. this paper examines the argument by considering different philosophical models, laws, and research. analysis utilitarian ethics can be considered when approaching how to handle a patient’s request for a certain healthcare provider. in this philosophical model, “an action is not inherently ‘right’ or ‘wrong’; rather, the moral value of the action is determined by its contribution to achieving the greatest good.”2 various factors including whether another provider is readily available, how urgently the patient requires treatment, and how strongly the patient makes a particular request are factors that are considered before making a decision to accommodate the request.3 in cases where the request is based on religious beliefs such as the muslim women’s request for a female medical provider doctors often employ “deontological or duty based ethics, feeling a sense of duty or obligation to accommodate the patient's wishes, regardless of the utilitarian balance of greatest good.”4 on the one hand, it is ethical to accommodate such preferences when it is based on a patient’s deeply rooted cultural background, as it can lead to higher quality healthcare. an analysis in the ucla law review further supports this argument, stating “accommodating a patient’s preference for a physician of a particular race or ethnicity is consistent with most prevailing medical ethical principles, including informed consent and respect for autonomy, and that no existing civil rights legislation could be used to bar this practice.”5 in fact, studies indicate that “newcomers to a country are more likely to obtain potentially life-saving health-care services from contraception to diabetes prevention if it is culturally sensitive.”6 patient requests and preferences can often be accommodated in non-urgent situations. however due to various restrictions in kim, patients choosing healthcare provider based on race, voices in bioethics, vol. 6 (2020) 2 healthcare and possible delays in service, muslim female patients may be faced with increased risks for several diseases, including breast cancer and cervical cancer due to a reluctance to discuss reproductive and gynecological health with a male physician.7 although it is important to respect patients’ preferences, a delay in care can lead to less-quality healthcare, particularly if there is a time-sensitive medical issue. if we were to allow muslim women to choose their provider based on sex, another question arises; do patients have the right to choose providers based on race? soliciting and honoring patient preferences has become an increasing focus of our healthcare system based on the core of tenet patient-centered care.8 dr. angela rowe, a non-white third-year pediatrics resident, shares her experience of a white parent who refused to allow her to treat their daughter and even requested that she not touch their daughter due to her race. some would argue that honoring such request for a white physician complies with the ethical principle of patient autonomy.9 when a female muslim patient requests a female physician, most physicians comply without any debate or questions, a clear demonstration of cultural sensitivity.10 when a spanish-speaking patient requests a spanish-speaking physician, a similar accommodation would be made if possible. thus, the principle of valuing patient preference is applied inconsistently dependent of individual circumstances and contexts. patients requesting a provider of the same race can be interpreted differently when the request is made by a minority population. a study found that patient requests for care were more likely to be accommodated by a physician when made by racial minority patients.11 for example, “an african american patient, ms. smith, expresses greater comfort with an african american physician, dr. simms, than with dr. chen, her longstanding asian primary care doctor.”12 alongside anecdotal and qualitative evidence, studies indicate that african americans patients tend to pick physicians of the same race or ethnicity when they are allowed to choose their physicians; this research supports the hypothesis that having a physician who is the same race as the patient can positively influence a physician’s empathy.13 a national survey demonstrated that black physicians only make up 4% of the physician workforce, but they care for more than 20% of the black americans in the united states.14 developing trust in a doctor-patient relationship, where the patient can effectively and frankly discuss their medical concerns and questions is essential, particularly in primary care.15 patients are not required to feel equally comfortable with all clinicians and providers should help patients find ways to ease patient discomfort whenever possible.16 not all requests from patients for a different healthcare provider are necessarily due to explicit bigotry.17 indeed, many individuals conclude that there is a spectrum of justifiable requests when asking for a change in physician.18 thus, it is important for providers to explore the patients’ reasons for making a discriminatory request. for example, a muslim female patient’s request to be seen by a female physician due to her religious practices or a female victim of sexual assault requesting to be seen by a female clinician would fall under what is considered an ethical requests.19 ethically appropriate requests for clinicians based on gender, religion, or ethnicity should be generally accommodated under the ama requirements and general ethical principles. even if discriminatory requests are in theory justified, it does not mean that they can always be accommodated, especially in emergency situations. the context of being in a patient-physician relationship where ethical responsibilities prohibit a physician from forcing unwanted care on a patient adds substantial complexity to this issue.20 in addition, the ethical duty to “protect patients against the threat of unwanted or poorly understood care by empowering them to refuse care or to refuse to be cared for by a particular physician,” the law of battery prohibits providers from caring for patients against their will.21 while doctors are not allowed to discriminate against their patients, hospitals’ commitment to patient care can encourage patients to discriminate against healthcare providers. kim, patients choosing healthcare provider based on race, voices in bioethics, vol. 6 (2020) 3 race-based requests could be considered more problematic given the long history of slavery and institutional racism in the united states. racial discrimination is unethical and violates title ii of the civil rights act.22 it is not always easy to recognize discrimination as it requires an understanding of the context of the particular situation but recognizing the difference in patient requests is important. when discrimination is deeply rooted in a society, it can occasionally be difficult to identity instances of discrimination but this should not be taken as a reason to ignore institutional inequities in the healthcare delivery. these issues will never be addressed if they are not reported on. the hippocratic oath prevents doctors from rejecting a patient based on his or her value system but there is no oath that allows a doctor to refuse to see patients based on personal discriminations, which limits a doctor’s personal autonomy and choices. in order to address the lack of training for dealing with instances of discrimination, dr. dorothy r. novick, a pediatrician in philadelphia stated that, “in my seven years of training and 14 years of continuing medical education, i have never encountered a teaching module on addressing racial intolerance in my patients” and further explains that there is no evidence based-guidelines or practice tools for physician’s to utilize. these modules should be part of general medical education in order for practitioners to “practice and model tolerance, respect, open-mindedness, and peace for each other.”23 conclusion there is still a long road ahead to eliminating latent racism and religious discrimination throughout american society, but ensuring that hospitals are safe spaces and cultivating an environment where both healthcare providers and patients can discuss how cultural and religious differences impact care would be a much-needed improvement. although having conversations with colleagues and patients on bias are difficult and uncomfortable, open discussion is a necessary step to revising policies to better support minority physicians. a hospital is a unique setting where healthcare professionals have the ethical and legal duty to treat patients of all races, genders, and religion.24 medical practices should strive for patient-centered care, matching patients with physicians with whom they feel the most comfortable and will be able to form strong relationships for the best health outcomes.25 although there is no standard answer for every patient request, whether it is based on sex, race, or religion, it is important to address unethical discrimination by patients. in an ideal world, hospitals would be able to standardize which patient requests are appropriate and which fall under discriminatory attitudes and practices. providing more in-depth training on “how to facilitate dialogue that can productively challenge a patient’s racist or biased behavior” could help improve a physician’s ability to manage instances of discrimination well.26 factors such as race and culture have complex interlinkages in healthcare but addressing issues of discrimination more transparently could improve quality and reduce disparities in healthcare. references attum, basem, and zafar shamoon. “cultural competence in the care of muslim patients and their families.” in statpearls. treasure island (fl): statpearls publishing, 2018. http://www.ncbi.nlm.nih.gov/books/nbk499933/. crutcher, rodney a., olga szafran, wayne woloschuk, fatima chatur, and chantal hansen. “family medicine graduates’ perceptions of intimidation, harassment, and discrimination during residency training.” bmc medical education 11, no. 1 (october 24, 2011): 88. https://doi.org/10.1186/1472-6920-11-88. kim, patients choosing healthcare provider based on race, voices in bioethics, vol. 6 (2020) 4 “doctor’s dilemma: confronting racist patients newsy story.” accessed november 1, 2018. https://www.thedenverchannel.com/newsy/doctors-dilemma-confronting-racist-patients. february 25, cbs/ap, 2013, and 12:21 pm. “patients refusing care from nurses of different race one of medicine’s ‘open secrets.’” accessed november 1, 2018. https://www.cbsnews.com/news/patients-refusing-care-from-nurses-of-different-raceone-of-medicines-open-secrets/. “how to respond to a discriminatory request for a different clinician the asco post.” accessed november 1, 2018. http://www.ascopost.com/issues/april-10-2018/how-to-respond-to-a-discriminatory-request-for-a-different-clinician/. kreisberg, jeffrey i., phd | patient | august 14, and 2011. “why developing trust with your doctor is important.” kevinmd.com, august 14, 2011. https://www.kevinmd.com/blog/2011/08/developing-trust-doctor-important.html. “patients shouldn’t be allowed to choose doctor based on race, medical group says.” accessed november 1, 2018. http://www.edmontonjournal.com/health/patients+shouldn+allowed+choose+doctor+based+race+medical+group/9066963/story. html. powers, brian w., and sachin h. jain. “the prejudiced patient.” ama journal of ethics 16, no. 6 (june 1, 2014): 434–39. https://doi.org/10.1001/virtualmentor.2014.16.6.ecas3-1406. reynolds, k. l., j. d. cowden, j. p. brosco, and j. d. lantos. “when a family requests a white doctor.” pediatrics 136, no. 2 (august 1, 2015): 381–86. https://doi.org/10.1542/peds.2014-2092. saha, somnath, sara h. taggart, miriam komaromy, and andrew b. bindman. “do patients choose physicians of their own race?” health affairs 19, no. 4 (july 1, 2000): 76–83. https://doi.org/10.1377/hlthaff.19.4.76. tackett, sean, j. hunter young, shannon putman, charles wiener, katherine deruggiero, and jamil d. bayram. “barriers to healthcare among muslim women: a narrative review of the literature.” women’s studies international forum 69 (july 1, 2018): 190–94. https://doi.org/10.1016/j.wsif.2018.02.009. waseem, muhammad, and aaron j. miller. “patient requests for a male or female physician.” ama journal of ethics 10, no. 7 (july 1, 2008): 429–33. https://doi.org/10.1001/virtualmentor.2008.10.7.ccas1-0807. “when the patient is racist, how should the doctor respond?” stat, june 12, 2017. https://www.statnews.com/2017/06/12/racism-bias-patients-doctors/. 1 cbs/ap february 25, 2013, and 12:21 pm, “patients refusing care from nurses of different race one of medicine’s ‘open secrets,’” accessed november 1, 2018, https://www.cbsnews.com/news/patients-refusing-care-from-nurses-of-different-raceone-of-medicines-open-secrets/. 2 muhammad waseem and aaron j. miller, “patient requests for a male or female physician,” ama journal of ethics 10, no. 7 (july 1, 2008): 429–33, https://doi.org/10.1001/virtualmentor.2008.10.7.ccas1-0807. 3 waseem and miller. 4 waseem and miller. 5 powers and jain. kim, patients choosing healthcare provider based on race, voices in bioethics, vol. 6 (2020) 5 6 “patients shouldn’t be allowed to choose doctor based on race, medical group says,” accessed november 1, 2018, http://www.edmontonjournal.com/health/patients+shouldn+allowed+choose+doctor+based+race+medical+group/9066963/stor y.html. 7 tackett et al., “barriers to healthcare among muslim women.” 8 powers and jain, “the prejudiced patient.” 9 k. l. reynolds et al., “when a family requests a white doctor,” pediatrics 136, no. 2 (august 1, 2015): 381–86, https://doi.org/10.1542/peds.2014-2092. 10 reynolds et al. 11 february 25, 2013, and pm, “patients refusing care from nurses of different race one of medicine’s ‘open secrets.’” 12 powers and jain, “the prejudiced patient.” 13 powers and jain. 14 somnath saha et al., “do patients choose physicians of their own race?,” health affairs 19, no. 4 (july 1, 2000): 76–83, https://doi.org/10.1377/hlthaff.19.4.76. 15 jeffrey i. kreisberg, phd | patient | august 14, and 2011, “why developing trust with your doctor is important,” kevinmd.com, august 14, 2011, https://www.kevinmd.com/blog/2011/08/developing-trust-doctor-important.html. 16 powers and jain, “the prejudiced patient.” 17 “how to respond to a discriminatory request for a different clinician the asco post,” accessed november 1, 2018, http://www.ascopost.com/issues/april-10-2018/how-to-respond-to-a-discriminatory-request-for-a-different-clinician/. 18 “how to respond to a discriminatory request for a different clinician the asco post.” 19 “how to respond to a discriminatory request for a different clinician the asco post.” 20 reynolds et al., “when a family requests a white doctor.” 21 reynolds et al. 22 “doctor’s dilemma: confronting racist patients newsy story,” accessed november 1, 2018, https://www.thedenverchannel.com/newsy/doctors-dilemma-confronting-racist-patients. 23 “doctor’s dilemma: confronting racist patients newsy story.” 24 reynolds et al., “when a family requests a white doctor.” 25 powers and jain, “the prejudiced patient.” 26 “when the patient is racist, how should the doctor respond?” dale, a critique of principlism, voices in bioethics, vol. 9 (2023) * samuel dale, bsc university of toronto, bioethics and human biology © 2023 samuel dale. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a critique of principlism: virtue and the adjudication problem in bioethics samuel dale* keywords: bioethics, principlism, action guidance, moral philosophy, normative ethics, utilitarian introduction bioethics does not have an explicitly stated and agreed upon means of resolving conflicts between normative theories. as such, bioethics lacks an essential feature – action guidance ― an effective translation from theory to practice. while the normative approaches and historical precedents of bioethics may discourage overtly egregious acts, the bioethical discipline does not offer decisive guidance in situations with multiple competing normative approaches. for example, utilitarians and kantians offer diametrically opposed guidance in emblematic cases like the trolley problem in which saving a greater number of people conflicts with the imperative to treat persons as ends-in-themselves rather than a means to an end. the predominant framework in bioethics, principlism, also suffers from a lack of action guidance.1 the consequences of a ‘toothless’ bioethics impeded by misaligned principles and conflicting normative theories are disastrous – not only in death count but also in moral injury and societal fracture. this paper argues that while there is no ‘one theory to rule them all,’ a virtue-based approach to bioethics can ameliorate the adjudication problem. bioethics ought to embody moral strength but has often provided indecisive guidance due to its awkward theoretical architecture. in defence of bioethics, many actors control societal level decision making. thus, the onus does not rest entirely on bioethicists but also leaders in government and healthcare. this paper critiques principlism as internally incongruous, as it is composed of elements from multiple ethical theories. understanding this, it is seen that the entirety of theoretical bioethics, as composed of conflicting normative approaches, also suffers from this action-guidance problem.2 dale, a critique of principlism, voices in bioethics, vol. 9 (2023) 2 i. the birth of bioethics amid tragedy bioethics was born out of tragedy. during the nuremberg trials of 1946-47, a cohort of french, american, british, and soviet judges forced the nazi doctors and architects of the holocaust to stand trial for their egregious actions and feel the firm hand of justice. in an example of ex post facto law, the global community identified unethical action and indicted germans for breaking natural law.3 as a result, the nuremberg code arose to prevent crimes against human research subjects. it outlines the parameters of ethical research and is a foundational document of modern bioethics.4 early bioethics pronounced immorality and offered decisive guidance, laying the groundwork for an internationally unified theory of negative morality – that which is never permissible. tuskegee was another foundational tragedy in the history of bioethical discipline. in 1932, the us public health service recruited six hundred african american men from macon county, alabama for a study on the effects of untreated syphilis. 5 the researchers failed to obtain informed consent and intentionally withheld information regarding the disease or the nature of the study. the researchers did not offer any men the cure, penicillin, which was discovered midway through the experiment. many men died during the study. the perpetrators evaded justice until 1972. tuskegee sparked a new paradigm of bioethics, including the us federal policies, the establishment of ethics review boards, and informed consent as a core tenet of biomedical practice.6 the national research act of 1974 and the belmont report of 1978 laid new ground for research ethics and set the tone for the contemporary practice of bioethics. ii. the rise of principlism these two cases demonstrate the nature of the early days of bioethics. it largely lacked high-level theory and appealed more to generally agreed upon moral facts and common-sense morality. however, as medicine advanced, increasingly complex biomedical issues created problems that required greater appeals to theory. 7 the “heroic” phase of bioethics saw “theorists aspire to construct symmetrical cathedrals of normative thought.”8 in the wake of the tuskegee syphilis study, tom beauchamp and james childress helped draft the belmont report, a bulwark intended to prevent future atrocities in human research trials. the document aimed to curtail the utilitarianism implicit in medical research and add essential considerations of the subjects themselves, including respect for persons, beneficence, and justice.9 it also served as the bedrock of the theoretical architecture of principlism. in 1979, beauchamp and childress’ published principles of biomedical ethics, which is arguably the most influential text in bioethics scholarship. it attempts to incorporate some main theoretical approaches to ethics in a unified moral theory: autonomy reflects the work of kant; beneficence aligns with utilitarianism; non-maleficence is reminiscent of hippocrates; and justice borrows heavily from rawls. 10 these four principles have become canonical in academic bioethics. however, doubts remain as to their effectiveness in guiding action toward ethical aims given how scholars contend that “ethical expertise cannot be codified in principles.”11 iii. a critique of principlism clouser & gert say: at best, ‘principles’ operate primarily as checklists naming issues worth remembering when considering a biomedical moral issue. at worst ‘principles’ obscure and confuse moral dale, a critique of principlism, voices in bioethics, vol. 9 (2023) 3 reasoning by their failure to be guidelines and by their eclectic and unsystematic use of moral theory.12 to this point, principlism is no more than a flashlight – a tool to illuminate the ethical landscape. viewing cases through the lens of moral principles can reveal the salient moral features, but it ultimately provides no guidance for adjudication, hereby referred to as the adjudication problem. consequently, the doctor’s moral intuition has de facto weight, and the principles are merely a post hoc justification for any given action they choose. using the four principles to decide the right course of moral action is “tantamount to using two, three, or four conflicting moral theories to decide a case.”13 principlism attempts to reap the benefit of multiple ethical theories, each with unambiguous goals. when blended, the result is discordant directives. these conflicting principles “provide no systematic guidance” for real world dilemmas.14 other ethical theories have faults too. kantians leave no room for exceptions for exigency, and utilitarianism ‘crosses the line’ far too often. at least these theories decisively guide action and provide unambiguous justification for doing so. utilitarianism is quite measurable: “provide the greatest good for the greatest number” – sure! done. kant’s ethical imperative has a clear rule: “never treat humans as a mere means to an end” – certainly, will do. principlism merely provides “a check list of considerations” that doctors can cross off one by one before going about their originally intended course of action.15 worse, the internally disharmonious nature of principlism allows doctors to justify ethically dubious decisions. an important goal of bioethics is avoiding the following scenario: a doctor faces with a moral dilemma. he can choose option a or option b. let’s say b is morally preferrable on a consensus view. however, his moral intuition guides him toward option a. having completed his required course on biomedical ethics in medical school, he recalls a few theories which are relevant to his case. he considers the four principles but autonomy conflicts with beneficence, which does not yield a straightforward, practical directive, so he disregards principlism for the case at hand. kantian ethics disagrees with his intuition, but utilitarianism may support it. he goes ahead with option a, claiming utilitarianism supported his actions. he, therefore, provides post hoc justification for option a, using whichever theory agrees with his judgment. reliance on intuition when the principles conflict is an intractable problem “unless one is willing to grant privileged epistemological status to the moral judgments (calling them "intuitions") or to the moral principles (calling them "self-evident" or otherwise a priori”). 16 neither deserves a privileged epistemological status. moral intuitions can possess prejudice or ignorance, and moral principles can demonstrably conflict, offering no guidance. realistically, most people “pay little attention to theories when they make moral decisions,” and when they do, post hoc rationalization often follows. when discipline is used as an afterthought, it provides justifications for potentially unethical actions. iv. virtue ethics: a provisional solution virtue ethics may provide a workaround. it emphasizes the disposition and character of the moral agent instead of abstract theories, making it a practical choice. as jacobson writes, “ethical dictates cannot be codified in general rules applicable to particular situations by someone who lacks virtue.”17 ethical theories can still highlight moral lapses and dilemmas, but since they do not decisively guide action, bioethics must focus on moral agents’ decision-making abilities. aristotelian virtue as a provisional solution to the adjudication problem also accounts for the “multiple and heterogeneous” particularities which other theories often neglect.18 aristotle said that "phronesis [practical dale, a critique of principlism, voices in bioethics, vol. 9 (2023) 4 wisdom] deals with the ultimate particular and this is done by perception (aisthesis) rather than science (episteme).” 19 scientific knowledge in the case of bioethics may appropriately refer to medical facts. perception refers to the moral intuition of an individual agent as applied to a given scenario. jonsen goes further, however, interpreting this perception as “the appreciative sight of a constellation of ideas, arguments, and facts about the case, seen as a whole.”20 phronesis, or practical wisdom, is the cardinal virtue of aristotelian virtue ethics. it enables the agent to consider the relevant facts and act in the most prudent, courageous, or tempered manner. this paper proposes that in the face of intractable theoretical disagreements, the only way forward for bioethics is to educate bioethics practitioners and students in this tradition. v. counterargument so far, this paper has argued that bioethics is relatively toothless and needs to give clear guidance due to theoretical disagreements and the intractable differences between normative approaches. and yet, some may object to the notion that bioethics ought to have these proverbial teeth. in this view, bioethics merely acts as a sounding board for those in executive roles (doctors, lawyers, politicians) to better understand the moral landscape of the problem. to them, bioethics’ failure to decisively guide action is acceptable because it should not. if this is the case, then bioethics need not speak with one voice and should cherish the long-standing, obstinate disagreements between different theoretical camps. but this paper contends the opposite. if bioethics continues to offer conflicting imperatives and fails to demonstrably guide individuals, hospitals, and society toward clear ethical aims and outcomes, it has failed as a discipline. one might argue that virtue theory is not an ideal framework to replace principlism because individuals approach ethical problems in many ways based on features of their character and background. injecting one’s character into moral decisions can lead to bias. as carl elliot writes, “how a moral problem is described will turn on an array of variables: the role and degree of involvement in the case of the person who is describing it, the person’s particular profession or discipline, her religious and cultural inheritanceindeed, with all of the intangibles that have contributed to her character.”21 self-awareness may counteract personal biases in moral decision making. vi. limitation virtue ethics is only a provisional solution to the adjudication problem for two reasons. one, not everyone is inherently virtuous, and two, theoretical differences may be resolved. if deontology and consequentialism can be incorporated into a unified theory for bioethics, then virtue ethics may not be necessary. on a certain view, it would be ideal for ethics to be computational – plug in the relevant variables and receive the morally correct answer. arguably, principlism was an attempt at such a matrix, but it ultimately failed as a unified theory. rather than waiting for a perfect unified theory, we must count on the genuine virtue of the moral agents who make ethically important decisions from policy to bedside. if practical wisdom is not a characteristic of these agents, then their decisions will not be as ethical as they ought to be, and no theory is the panacea to such a problem. conclusion bioethics emerged out of unified responses to clear cases of moral depravity, like the holocaust and tuskegee, and perhaps bioethics is most appropriate for such cases which are conducive to moral certitude. at minimum, bioethics offers meaningful guidance in cases where the relevant duties align with beneficent consequences. for example, in both the nuremberg and tuskegee cases, abrogating fundamental duties dale, a critique of principlism, voices in bioethics, vol. 9 (2023) 5 to humanity led to grievous consequences. the principles developed in the wake of such problems led to a conflict between autonomy and beneficence, which perhaps mirror the conflict between kantian deontology and utilitarianism. bioethics excels when deontology and utilitarianism are aligned, but most of the time, they are not. in such instances, virtue is needed to adjudicate conflicting normative approaches and resolve theoretical tensions with practical wisdom and courage. 1 clouser, k. d., & gert, b. (1990). a critique of principlism, the journal of medicine and philosophy: a forum for bioethics and philosophy of medicine, volume 15, issue 2, april 1990, pages 219–236, https://doi.org/10.1093/jmp/15.2.219 2 clouser, k. d., & gert, b. (1990). 3 annas, g. j. (2010). the legacy of the nuremberg doctors’ trial to american bioethics and human rights. in medicine after the holocaust (pp. 93-105). palgrave macmillan, new york. https://scholarship.law.umn.edu/mjlst/vol10/iss1/4 4 annas, g. j. (2010). the legacy of the nuremberg doctors’ trial to american bioethics and human rights. in medicine after the holocaust (pp. 93-105). palgrave macmillan, new york. https://scholarship.law.umn.edu/mjlst/vol10/iss1/4 5 barrett, l. a. (2019). tuskegee syphilis study of 1932-1973 and the rise of bioethics as shown through government documents and actions. dttp, 47, 11. https://heinonline.org/hol/landingpage?handle=hein.journals/dttp47&div=36&id=&page= 6 barrett, l. a. (2019). 7 annas, g. j. (2010). 8 annas, g. j. (2010). 9 adashi, e. y., walters, l. b., & menikoff, j. a. (2018). the belmont report at 40: reckoning with time. american journal of public health, 108(10), 1345-1348. https://doi.org/10.2105/ajph.2018.304580 10 beauchamp, t. l., & childress, j. f. (2001). principles of biomedical ethics. oxford university press, usa. 11 jacobson, d. (2005). seeing by feeling: virtues, skills, and moral perception. ethical theory and moral practice, 8(4), 387-409. https://doi.org/10.1007/s10677-005-8837-1 12 clouser, k. d., & gert, b. (1990). 13 clouser, k. d., & gert, b. (1990). 14 clouser, k. d., & gert, b. (1990). 15 clouser, k. d., & gert, b. (1990). 16 daniels, n. (1979). wide reflective equilibrium and theory acceptance in ethics. the journal of philosophy, 76(5), 256-282. https://doi.org/10.2307/2025881 17 jacobson, d. (2005). 18 jonsen, a. r. (1991). of balloons and bicycles—or—the relationship between ethical theory and practical judgment. hastings center report, 21(5), 14-16. https://doi.org/10.2307/3562885 19 jonsen, a. r. (1991), p. 15. 20 jonsen, a. r. (1991), p. 15. 21 elliott, c. (1992). where ethics comes from and what to do about it. hastings center report, 22(4), 28-35. https://onlinelibrary.wiley.com/doi/pdf/10.2307/3563021 https://doi.org/10.1093/jmp/15.2.219 armstrong, the gender gap in pharmaceutical research, voices in bioethics, vol. 4 (2018) * elisabeth armstrong, ms © 2018 elisabeth armstrong. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the gender gap in pharmaceutical research elisabeth armstrong abstract women had been overdosing on ambien for more than 20 years – leaving them at greater risk for everything from impaired driving to addled decision-making. as it turns out, the fda and makers of ambien, sanofi-aventis, were aware of the issue. these attitudes produced a nexus of issues now referred to as the “gender gap.” the significant lack of data on how various drugs affect women leads to serious complications for patients to whom those drugs are prescribed. solutions include adequate female participation and sex-stratified findings should be mandated with an emphasis on female inclusion. objections to these solutions may be gender bias, arguments on the basis of sexual differences between men and women. bioethical considerations such as the belmont report is a valuable resource to overcome these objections. keywords: women’s health, pharmaceutics, research introduction i did what?!” that’s the question more than 1,350 people asked1 when reporting adverse effects of ambien.2 the accounts became increasingly bizarre – sleep-eating, sleep-walking, sleep-driving. ultimately, these resulted in enough serious accidents, prompting court cases and sparking “the ambien defense” as a response to everything from violent crimes to duis, even a sex offense.3 a lexis nexis search in december of 2011 turned up more than 25 relevant legal cases in which this defense4 was used.5 strikingly, the majority of these cases involved women, with adverse effects resulting in er visits almost twice as often for women than men. however, no research into the discrepancy was pursued.6 it took until 2013 for the fda to address the issue – halving the recommended dose for women, after discovering that men and women metabolize the active ingredient in ambien, zolpidem, very differently.7 i. today’s problems women had been overdosing on ambien for more than 20 years – leaving them at greater risk for everything from impaired driving to addled decision-making. as it turns out, the fda and makers of ambien, sanofi-aventis, were aware of the issue.8 in the original 1992 fda review of ambien, a researcher observed drug levels in the bloodstream were, “almost 45% higher in females than in males.” larry cahill, a neuroscientist at uc irvine, told 60 minutes, “it appears to say that they found a significant difference in how this drug is being processed in the body. and then the question is, ‘what did they do with that?’ and the answer appears to be, ‘eh.’ they rationalized it away”.9 armstrong, the gender gap in pharmaceutical research, voices in bioethics, vol. 4 (2018) 2 even as recently as the early 1990’s, the term “women’s health” was relegated to “bikini medicine” – breast and ovarian cancer, pregnancy, and menstrual cycles.10 for the body parts that men and women shared, most of the studies were conducted on men. researchers often viewed women as either smaller versions of men, or as too complicated because of their hormones.11 in either case, researchers considered incorporating women into studies as difficult and superfluous.12 this mentality was transferred to every class of researchers and physicians who studied the archetypal “70 kilogram man”13 in biology and pharmacology courses. these attitudes produced a nexus of issues now referred to as the “gender gap.” while researchers may cite logistical issues, the benefits of including women in research and improving female health outcomes overwhelmingly outweigh any concerns, and could help eliminate some of these health disparities between the sexes. after the fda halved the recommended dose of ambien for women, researchers began to understand the scope of the “gender gap” issue. dr. janine clayton, director for the office of research on women’s health at the national institute of health highlighted that “this is not just about ambien — that’s just the tip of the iceberg… there are a lot of sex differences for a lot of drugs, some of which are well known and some that are not well recognized”.14 part of the issue is the lack of female inclusion in clinical trials. another problem many emphasize is the lack of sex-based analysis of each drug, resulting in both an ignorance of adverse effects and a lack of sex-specific dosage recommendations. most fda-funded studies and institutional review boards (irbs) require inclusion of female participants; however, this requirement is often perfunctory and inadequate. this is particularly pronounced in research surrounding cardiovascular disease the number one killer of women. cardiovascular disease affects men and women differently on every level including symptoms yet just one third of trial participants are women. furthermore, just 31% of cardiovascular clinical trials that include women report results by sex.15 the significant lack of data on how various drugs affect women leads to serious complications for patients to whom those drugs are prescribed. for example, problems arose with the cardiovascular medication posicor, the antihistamines hismnal and seldane, the gastrointestinals propulsid and lotronex, the appetite suppressants pondimin and redux, and the diabetic rezulin, which were all ultimately pulled off the market after resulting in serious side effects and even deaths in female patients.16 a government accountability office study found that most of these drugs carried a major health risk for torsades de pointes and valvular heart disease in females.17 sex-specific data analysis could have minimized the frequency of these adverse reactions. yet evidence suggests that many drugs currently on the market may cause arrhythmia, including certain “antiarrhythmics, gastrokinetics, antipsychotics, antihistamines and antibacterials” 18. one study found a greater propensity for adverse events in twelve of 31 pharmaceuticals analyzed, concluding that “women are more prone to experiencing drug-induced adverse effects. some of the reasons for this are the greater degree of polypharmacy, the increased bioavailability of drugs and a greater sensitivity of their target organs”.19 their recommendations stated that “study of gender specificity should also be a goal of preclinical and clinical development of drugs potentially prolonging the qt interval”,20 highlighting the need for sex-specific data analysis during clinical trials. even today, none of these drugs have sex-specific dosage recommendations or warnings3. researchers have furthermore long suspected even over-the-counter drugs like acetaminophen carry higher risks for women. some researchers have hypothesized that women’s bodies break down armstrong, the gender gap in pharmaceutical research, voices in bioethics, vol. 4 (2018) 3 acetaminophen’s toxic by-product more slowly, which might explain why 74% of those hospitalized with acetaminophen-related acute liver failure were women.21 at this point, the dosage recommendations for women and men remain the same – particularly important, as studies have shown that women take more of these drugs than men.22 a final issue that many researchers fail to account for is that drugs will produce different reactions at different points of a female’s life. prior to 1993, women of childbearing age were excluded from the trials of new drugs.23 following the fda’s decision to lift that ban, scientists were unsure if aspirin, for example, would be effective for women in preventing heart disease or stroke, as they had not been included in any studies. today, puberty, pregnancy, and menopause are often ignored as factors in disease or considerations for drugs. their role in depression or alzheimer’s, for instance, is not considered in current research: a recent report from brigham and women’s hospital found that just 45% of animal studies include female lab animals.24 ii. possible solutions in “sex-specific medical research: why women’s health can’t wait,” researchers from brigham and women’s hospital highlight several ways to address the “gender gap.” while congress required that all federally funded clinical studies include women in the 1993 nih revitalization act, there are no specifications for how many subjects must be women, or requiring an analysis of differences between the sexes. it is imperative that the spirit of this policy be respected and enforced through an expansion of this act: adequate female participation and sex-stratified findings should be mandated (where relevant) in proposals and prior to labelling of approved drugs.25 proposals that include a robust plan for inclusion and reporting should be fast-tracked for approval or funding.26 for drugs already on the market, labels should be included for products that were not adequately tested on female subjects/female animals.27 extra consideration should be given to the inclusion of minority females. in emphasizing female inclusion, it is also imperative that researchers improve both recruitment and retention – ensuring that women who work, are the primary caregivers for their families, and those who do both are included in a study’s design. minimizing time and safety concerns can have a significant effect on increasing female participation28. researchers can also boost participation by opening study sites on evenings/weekends, providing childcare, and ensuring a safe waiting area.29 beyond new mandates, a cultural shift is also necessary for improving research. academic journals requiring sex-stratified data and analysis for publication, irbs assessing the study requirements surrounding inclusion and reporting for institutional approval, and medical colleges prioritizing education surrounding women’s health in research, are all viable way for establishments to effect change. iv. possible objections a. women’s research comes at the expense of men in “sex & gender: the politics, policy, and practice of medical research,” sarah keitt points out that some researchers viewed the nih revitalization act’s mandate of female subjects as a prioritization of women’s health over men’s. a 2000 study by curtis meinert indicated that women had armstrong, the gender gap in pharmaceutical research, voices in bioethics, vol. 4 (2018) 4 not been excluded from clinical trials prior to 1993, prompting vocal opponents to decry the new policies as promoting a female agenda.30 while the findings in meinert’s studies are refuted by a plethora of other research highlighting a bias against the inclusion of women,31 it is important to highlight that equity in research is essential for quality outcomes and value. as public investment in healthcare increases, it is imperative that research on sex and gender differences becomes a priority.32 without that commitment, there is a strain on the healthcare system: treatments are never explored for women, perpetuating poor health and ineffective or dangerous drugs that produce adverse reactions, prompting the need for further treatment. each of these outcomes induces inefficient use of resources, and the value of public investment is not met. emphasizing women in research marks advancement in healthcare for all. to put it another way, “a rising tide lifts all boats.” b. differences and politics there are many examples of sex differences beyond the reproductive system, including differences in immune function, cardiovascular disease, response to toxins, brain organization, metabolism, and psychiatric disorders.33 in fact, at a cellular level, the difference between males and females “[exists] within every cell of their [bodies]”.34 yet in some circles, suggesting that there are significant biological differences between men and women is considered taboo.35 some researchers point out that highlighting these differences could make a political statement and result in decreased funding. while sex and gender-identity issues and their consequences for medicine are important, their conflation with the lack of female representation in research is illogical. if one accepts sex differences for research purposes, it does not follow that there is an immediate implication for any political or social issue. it’s important that the medical community does not ignore women’s health issues out of fear of making an unconnected statement. c. bioethical considerations the belmont report written by the national commission for the protection of human subjects of biomedical and behavioral research summarizes core ethical principles for research: respect for autonomy, beneficence (non-maleficence), and justice. working to minimize the gender gap is in accordance with these bioethical norms. the principle of autonomy calls for researchers and healthcare providers to respect an individual’s rule of self. it’s imperative that patients have the ability to make meaningful decisions with full understanding of the risks and benefits of a course of action. to respect their autonomy, women must have accurate information about a treatment’s effects in order to make the best choice for themselves. the principle of beneficence entails acting in the best interests of a patient; this entails having accessible/attainable information about how a drug will interact with a woman’s body in order to promote the best possible health outcome. on the flipside, the principle of non-maleficence necessitates avoiding an adverse event due to a lack of data. lastly, the principle of justice demands acknowledging the historical dismissal of women’s health, and working to alleviate that from today’s research. conclusion continuing to exclude women from research – when there is overwhelming evidence to support the necessity of their inclusion – is an implicit rejection of bioethical principles. biological, economic, and ethical considerations further compel inclusion of women in research. armstrong, the gender gap in pharmaceutical research, voices in bioethics, vol. 4 (2018) 5 references 1 between january 2004 and september 2011. 2 falkenberg, kai. "while you were sleeping." marie claire, 27 sept. 2012. accessed 8 dec. 2017. 3 daley, christopher, dale e. mcniel, and renee l. binder. "“i did what?” zolpidem and the courts." journal of the american academy of psychiatry and the law, vol. 39, no. 4, dec. 2011, pp. 535-42. 4 occasionally, drugs work more effectively in women than in men. some pharmaceuticals like the arb verapamil or antibiotic ery thromycin have been shown to be more successful in treating certain conditions in females [34]. these drugs also lack sex-specific dosage recommendations. 5 ibid. 6 liao, joshua. "ambien: the good, the bad, the reality." the atlantic, 18 june 2013. accessed 8 dec. 2017. 7 falkenberg, kai. "fda takes action on ambien; concedes women at greater risk." forbes, 10 jan. 2013. accessed 8 dec. 2017. 8 "sex matters: drugs can affect sexes differently." produced by shari finkelstein and leslie stahl, 60 minutes, cbs, 10 jan.accessed 9 feb. 2014. 9 ibid. 10 ibid. 11 keitt, sarah k. "sex & gender: the politics, policy, and practice of medical research," yale journal of health policy, law, and ethics, vol. 3, no. 2, february 2003, pp. 1-26. 12 ibid. 13 ibid. 14 rabin, roni c. "the drug-dose gender gap." new york times, jan. 2013. accessed 17 december 2017. 15 westervelt, amy. "the medical research gender gap: how excluding women from clinical trials is hurting our health." the guardian, 30 apr. 2015. accessed 9 dec. 2017. 16 keitt, sarah k. "sex & gender: the politics, policy, and practice of medical research," yale journal of health policy, law, and ethics, vol. 3, no. 2, february 2003, pp. 1-26. 17 u.s. gen. accounting office, “gao-0 i -286r, drug safety: most drugs withdrawn in recent years had greater health risks for women 2.” 2001. 18 drici, md. & clément, n. drug-safety (2001) 24: 575. https://doi.org/10.2165/00002018-200124080-00002 19 ibid. 20 ibid. 21 davis, lisa, beverly burmeier, and andreas von bubnoff. "the best and worst drugs for women." prevention, 3 nov. 2011. accessed 9 dec. 2017. https://doi.org/10.2165/00002018-200124080-00002 armstrong, the gender gap in pharmaceutical research, voices in bioethics, vol. 4 (2018) 6 22 rabin, roni c. "the drug-dose gender gap." new york times, jan. 2013. accessed 17 december 2017. 23 ibid. 24 gahagan, jacqueline, kimberly gray, and ardath whynacht. “sex and gender matter in health research: addressing health inequit ies in health research reporting.” international journal for equity in health 14 (2015): 12. pmc. web. 17 dec. 2017. 25 ibid. 26 ibid. 27 ibid. 28 keitt, sarah k. "sex & gender: the politics, policy, and practice of medical research," yale journal of health policy, law, and ethics, vol. 3, no. 2, february 2003, pp. 1-26. 29 ibid. 30 ibid. 31 ibid. 32 gahagan, jacqueline, kimberly gray, and ardath whynacht. “sex and gender matter in health research: addressing health inequit ies in health research reporting.” international journal for equity in health 14 (2015): 12. pmc. web. 17 dec. 2017. 33 haifei shi, lynda m. brown, and roshanak rahimian, “sex/gender differences in metabolism and behavior: influence of sex chrom osomes and hormones,” international journal of endocrinology, vol. 2015, article id 245949, 2 pages, 2015. 34 page, david c. "every cell has a sex: x and y and the future of health care." yale center for clinical investigation, yale university, 30 aug. 2016. accessed 9 dec. 2017. 35 westervelt, amy. "the medical research gender gap: how excluding women from clinical trials is hurting our health." the guardian, 30 apr. 2015. accessed 9 dec. 2017. 34 rabin, roni c. "the drug-dose gender gap." new york times, jan. 2013. accessed 17 december 2017. abstract introduction i. today’s problems ii. possible solutions conclusion references isguven, an ethical argument for regulated cognitive enhancement in adults, voices in bioethics, vol. 2 (2016) © 2016 selin isguven. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an ethical argument for regulated cognitive enhancement in adults: the case of transcranial direct current stimulation (tdcs) selin isguven abstract abstract— human enhancement consists of methods to surpass natural and biological limitations, usually with the aid of technology. treatment and enhancement are considered to be different in that treatment aims to cure an existing medical condition and restore the patient to a normal, healthy, or species-typical state whereas enhancement aims to improve individuals beyond such a state. this article aims to demonstrate the case in favor of the regulated use of cognitive enhancement by examining a technique called transcranial direct current stimulation (tdcs), while addressing common ethical arguments against cognitive enhancers as well as the ethical obligation for proper regulation. keywords: bioethics, human enhancement, tdcs, ethical enhancement, regulation introduction human enhancement, enhancement vs. treatment human enhancement consists of methods to surpass natural and biological limitations, usually with the aid of technology. treatment and enhancement are considered to be different in that treatment aims to cure an existing medical condition and restore the patient to a normal, healthy, or species-typical state whereas enhancement aims to improve individuals beyond such a state. however, the line between treatment and enhancement remains debatable. there is no one agreed-upon definition of the normal human condition; this definition depends on factors such as time period and location, among many. in fact, the debate stems from discussions about the scope of medicine and the definition of ‘healthy.’ for some, like norman daniels, a healthy state is the absence of disease whereas for others, such as the world health organization (who), it is “a state of complete physical, mental and social well-being.”1 these two definitions of a healthy state are clearly not identical and there exist similarly differing opinions on what is considered ‘beyond’ healthy, as well.1 this article aims to demonstrate the case in favor of the regulated use of cognitive enhancement by examining a technique called transcranial direct current stimulation (tdcs), while addressing common ethical arguments against cognitive enhancers as well as the ethical obligation for proper regulation. the case for regulated use is primarily articulated through a lens of safety and a comparison is drawn between enhancement and treatment in terms of cost-benefit analysis. although the aim is to extend regulated use to other similar cognitive enhancers by showing tdcs as a case example, it would be wise to evaluate each technique individually. 1 isguven, an ethical argument for regulated cognitive enhancement in adults, voices in bioethics, vol. 2 (2016) 2 analysis cognitive enhancement cognitive enhancement, also known as neuroenhancement, is the improvement of cognitive functions such as memory, attention, wakefulness, and alertness.2 cognitive enhancement can even include drinking coffee or doing memory-training exercises, and thus achieving improvement through natural or more traditional means. on the other hand, the term is also often used to refer specifically to technologies developed for improving cognitive capacities, such as the use of attention deficit hyperactivity disorder (adhd) drugs without having the medical condition. cognitive improvement is particularly controversial since we do not have a firm grasp of how the brain works, in neither its healthy nor diseased state. furthermore, there is no straightforward, quantitative, and objective way to define mental diseases compared to other medical conditions. we cannot test for depression as easily as we can for cancer. likewise, for traits such as introversion, it is hard to measure and determine if it is within the natural range.3 the current regulations for defining normal cognitive function are not optimal. for instance, while the diagnostic and statistical manual of mental disorders (dsm) is used to diagnose mental illness, there are individuals who suffer from psychological diseases without fulfilling the designated criteria and vice versa.4 this lack of clear, universally agreed-upon criteria makes it difficult to establish what counts as an improvement ‘beyond’ a healthy or normal range. our cognitive qualities, such as shyness, are also closely associated with our personalities, so improving one’s muscle strength and one’s mental capacities are not considered to be equivalent. of course, the controversy around the acceptance of either form of enhancement, physical or mental, is also due to disagreement over the methods used to achieve enhancement. regardless, the use of technology to improve cognitive capacities is always received with more skepticism and concern than the use of technology for other types of enhancement. safety: a cost-benefit analysis one of the most pressing concerns of any technological enhancement is safety. ever since the hippocratic oath, non-maleficence has been one of the central tenets of bioethics: “first, do no harm.”5 since many of the currently proposed neuroenhancers consist of drugs for disorders like adhd, which have side effects, an argument can be made that their use for enhancement can never be ethical. this view conflates enhancement practices with the burden of performing surgery on someone who does not need the procedure, as is the case with voluntary cosmetic surgery. defining need becomes an important question. however, an evidence-based comparison of advantages and disadvantages of a particular enhancement may show the benefits derived to be so great that they offset the harm. this is generally how medications for disorders are evaluated. for instance, although chemotherapeutic drugs have serious harmful side effects, they do more good than harm by successfully battling cancer cells.3 naturally, compared to cancer drugs, the benefits of enhancement techniques would need to be greater and the harm smaller, since there is not a deadly disease in the picture, but this does not exclude the possibility of making a comparative evaluation. some bioethicists thus argue that enhancement should be permitted to be tested in the same way as current medical technologies.6 situating enhancers within a similar framework as that of medications can be beneficial for regulation purposes too, as will later be discussed for tdcs. the medicalization of cognitive enhancement would come at a cost and may result in over-regulation, as is the case with many medical issues today. medicalization and regulation may limit accessibility, yet it would be irresponsible to do so since the creation of a black market would be inevitable.7 we should carefully focus on how enhancements can be regulated in a similar manner to medical items since both affect human capacity and health, even if enhancers don’t intend to cure per se. isguven, an ethical argument for regulated cognitive enhancement in adults, voices in bioethics, vol. 2 (2016) 3 transcranial direct current stimulation (tdcs) tdcs is a good case example to explore the possibilities of cognitive enhancement. greely and others see great promise in the future of cognitive enhancement, but since chemical drugs are currently the most well-known neuroenhancers, their significant side effects prevent progress from the start. 6 these effects include addiction, headache, and blood pressure changes. furthermore, the shortand long-term effects of these drugs, for the most part, have not been tested for healthy individuals since they were designed to treat diseases; the sheer lack of knowledge calls for caution. 8 on the other hand, tdcs belongs to another class of interventions called neuromodulation and has a completely separate mechanism of action. neuromodulation is the application of electricity to modulate brain function. there are various kinds of neuromodulation that work with different mechanisms than tdcs. transcranial magnetic stimulation (tms), for example, is a technique that uses electricity to induce a magnetic field and thus manipulate function. tdcs, on the other hand, uses electricity to facilitate the firing of neurons, i.e. increase excitability. tdcs consists of the application of low intensity (~1-2 ma) currents positioned to be passed between scalp electrodes for around 20 minutes. the effect is directional; anodal stimulation (current that flows from anode (+) to cathode (-)) results in enhancement, whereas cathodal stimulation would do the opposite.9 tdcs increases excitability and plasticity.10 experiments have also shown post-application changes in learning and memory processes. overall, numerous studies cite the enhancement effects of tdcs in “motor and sensorimotor skills, vision, decision making and problem solving, mathematical [abilities], language, memory, and attention.”11 tdcs carries many more positive qualities, such as being non-invasive, portable, well tolerated (painfree), relatively inexpensive,11 and having potential long-term effects (up to 12 months).12 still, the most important and unique quality for the focus of this paper is its safety. the usual disadvantage of neuromodulation techniques is the risk of seizure and yet to this day, there has been no documented case of seizure with tdcs .9 nevertheless, this is not to say tdcs is incapable of causing harm. iuculano and kadosh found the “mental cost” of tdcs, which showed that an enhancement in a certain function was accompanied by impairment in another. for instance, application to the posterior parietal cortex improved numerical learning, while automaticity for the learned content was impaired.13 the case for regulated cognitive enhancement the imperfection of tdcs is far from a valid reason against cognitive enhancement. instead, it is an example of the need for proper regulation, which is to treat enhancement devices the same as medical devices. the current availability of tdcs devices demonstrates the case in favor of properly regulated access. right now, there are two ways a healthy individual can obtain a tdcs device. for one, he can simply do it himself since there are many do-it-yourself (diy) communities sharing information on this topic online. the risks are manifold for this approach; the effects of tdcs, like other neuromodulation techniques, depend significantly on dosage, position and other parameters. even a mistake as simple as changing the direction of the current can result in a complete reversal of the effect. the ease of production of a tdcs device, including its relative cheapness, as well as the ease of use show that not offering an official, tested, and approved version of tdcs can do more harm than good. alternatively, a healthy individual can buy a tdcs device from one of the several commercial companies that produce them. a look at the frequently asked questions webpage of one of the most popular tdcs device companies, foc.us, shows the potential complications clearly. foc.us is designed for gamers to improve mental skills for gaming performance, such as focus and reaction time. for the very first question on their webpage, the question about food and drug administration (fda) approval, the answer is “no. the foc.us gamer headset offers no medical benefits, is not a medical device, and is not regulated by the fda.”14 as for safety, they state, “the foc.us headset has been tested to all required regulatory standards including….”14 although these statements are correct by current standards, the headsets are as safe as they sound. because they are not regulated as medical devices, the safety standards that they must adhere to are very low and, in fact, consist of only product safety regulations. the problem is not with the company or the customers, but with the regulations. isguven, an ethical argument for regulated cognitive enhancement in adults, voices in bioethics, vol. 2 (2016) 4 the foc.us device is designed for and marketed to gamers, but there is no way of controlling who uses it or for what purpose, creating a health hazard. just like any other electronic device, it will also be good for use for quite some time, increasing the possibilities for usage. 11 of course, even if it is used exclusively for improving gaming performance, it remains a health hazard because it does affect a biological capacity in a significant way. foc.us thus neglects to account for the full spectrum of effects of tdcs. iuculano and kadosh demonstrated that the enhancement of one function was achieved at the expense of another.13 individuals need to receive proper counseling or a sufficient level of guidance before they sign up for altering one of their cognitive functions. then, individuals can decide how to proceed; this process would be similar to making an informed medical choice. devices such as tdcs should not be allowed to remain on the market as a non-medical device. they do not “cure” a disease in the traditional sense, but they do alter the workings of one’s brain, which is arguably different than the effect a computer or a calculator has on a customer. in fact, fda’s official website provides a definition for medical device along the same lines: “intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”15 the only crucial detail not included in this definition is how such a medical device can have the described effect on an individual in the absence of disease, without the goal of curing a medical condition. from an ethical standpoint, it can be considered the responsibility of medicine to provide this type of “enhancement counseling” to individuals who would be considered healthy by medical standards. the debate returns to how we define health, whether it is absence of disease or overall well-being. there is also the issue of how we evaluate future harm, i.e. prevention of disease in relation to responsibility of medicine. if cognitive enhancers can cause harm to individuals, healthy or not, it may be medicine’s duty to regulate them. the role of medicine cannot start only when the individual finds himself harmed, i.e. becomes a ‘patient.’ 1 previously in this paper, an argument against (cognitive) enhancement was discussed by referring to non-maleficence. yet another traditional goal of medicine is to prevent foreseeable disease or injury and optimize the situation for the patient; in other words, beneficence.16 since unguided use of these tdcs devices can result in harm, and appropriate use can result in benefit, it is not ethical to allow such devices to go unchecked by an fda-like agency. it is also paternalistic, against the autonomy principle, for doctors to refuse to discuss options of neuroenhancement with individuals. autonomy in this context refers to the right of an individual to make choices about their cognitive capacity. a doctor’s responsibility depends on a mutual relationship between the ‘patient’ and the doctor, and the patient’s wishes for what happens to her body. autonomy does not override non-maleficence and beneficence but in case of tdcs and devices of the same safety caliber, supplements non-maleficence and beneficence principles as well. when the risk-benefit analysis of tdcs, as discussed above, results in more benefit than risk, the doctors would be disrespecting the autonomy of the individual by rejecting offering this method of enhancement simply because it is not a cure for an underlying disease or disorder.16 conclusion tdcs and beyond in conclusion, tdcs proves to be representative of many possible cases where the enhancement technique may not result in significant negative side effects. however, tdcs still has effects on cognitive capacities. it is therefore not appropriate for it to go unchecked by an agency similar to the fda, if not the fda itself, simply because it does not address an existing disease. regulation by an fda-like agency would be focused on making it safer for use. the potential users would be aware of the pros and cons, especially of the fact that they are changing their cognitive capacities. it is important to make sure this regulation does not result in a barrier to use since especially through diy methods, it is not impossible to manufacture these devices in the comfort of one’s home. for better or worse, the idea and practice of cognitive enhancement has been accepted by parts of society and regulation will guarantee responsible use.3 more regulation can also be seen as overburdening the already busy healthcare isguven, an ethical argument for regulated cognitive enhancement in adults, voices in bioethics, vol. 2 (2016) 5 system but cognitive function is not a light matter and is worth the time and effort to protect it. furthermore, a discussion of the goals and principles of medicine as well as of the definition of health shows ample reasoning in favor of medicine assuming responsibility in the regulation and administration of tdcs and similarly safe techniques. 1 parens e. is better always good?: the enhancement project. hastings center report. 1998;28:s1-s17. 2 lucke jc, bell s, partridge b, hall wd. deflating the neuroenhancement bubble. ajob neuroscience. 2011;2:38-43. 3 farah mj, illes j, cook-deegan r, gardner h, kandel e, king p, et al. neurocognitive enhancement: what can we do and what should we do? nature reviews neuroscience. 2004;5:421-5. 4 hyman se. cognitive enhancement: promises and perils. neuron. 2011;69:595-8. 5 omonzejele pf. obligation of non-maleficence: moral dilemma in physician-patient relationship. 2005. 6 greely h, sahakian b, harris j, kessler rc, gazzaniga m, campbell p, et al. towards responsible use of cognitiveenhancing drugs by the healthy. nature. 2008;456:702-5. 7 bostrom n, sandberg a. cognitive enhancement: methods, ethics, regulatory challenges. science and engineering ethics. 2009;15:311-41. 8 sack d. are smart drugs a smart way to get ahead? physchology today. 9 maslen h, douglas t, kadosh rc, levy n, savulescu j. the regulation of cognitive enhancement devices: extending the medical model. journal of law and the biosciences. 2014;1:68-93. 10 venkatakrishnan a, sandrini m. combining transcranial direct current stimulation and neuroimaging: novel insights in understanding neuroplasticity. journal of neurophysiology. 2012;107:1-4. 11 kadosh rc, levy n, o’shea j, shea n, savulescu j. the neuroethics of non-invasive brain stimulation. current biology. 2012;22:r108-r11. 12 dockery ca, hueckel-weng r, birbaumer n, plewnia c. enhancement of planning ability by transcranial direct current stimulation. the journal of neuroscience. 2009;29:7271-7. 13 iuculano t, kadosh rc. the mental cost of cognitive enhancement. the journal of neuroscience. 2013;33:4482-6. 14 foc.us. foc.ustranscranial direct stimulation for gamers. 15 fda. is the product a medical device? 16 larriviere d, williams ma, rizzo m, bonnie rj. responding to requests from adult patients for neuroenhancements guidance of the ethics, law and humanities committee. neurology. 2009;73:1406-12. abstract introduction analysis conclusion tdcs and beyond in conclusion, tdcs proves to be representative of many possible cases where the enhancement technique may not result in significant negative side effects. however, tdcs still has effects on cognitive capacities. it is therefore not appropriate for it... it is important to make sure this regulation does not result in a barrier to use since especially through diy methods, it is not impossible to manufacture these devices in the comfort of one’s home. for better or worse, the idea and practice of cognit... masters, feminist theory reveals a need for justice over autonomy in research ethics, voices in bioethics, vol. 4 (2018) © 2018 alix e. masters. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. feminist theory reveals a need for justice over autonomy in research ethics alix e. masters abstract feminist scholarship has remained similarly engaged in questions surrounding consent, with particular focus on sex and sexuality. this year, in the wake of the #metoo movement, we have witnessed a cultural shift towards a willingness to address the perils of sexual consent under patriarchy. in the context of this cultural reckoning, i see no better time to apply feminist epistemology to the fraught nature of consent to a bioethical framework. feminist bioethicists, such as susan sherwin, have long argued for a wider consent model that privileges justice over a focus on autonomy. using radical feminist theorist catherine mackinnon’s work on consent and sexual harassment, i will support sherwin’s claim by arguing for a more nuanced understanding of power and structural social hierarchy that exists in every aspect of our society, including research. keywords: feminism, autonomy, informed consent, justice introduction informed consent has remained one of the more debated topics within research ethics. many scholars and bioethicists have wondered the best way to obtain it, who should give it, and if it is even necessary at all. feminist scholarship has remained similarly engaged in questions surrounding consent, with particular focus on sex and sexuality. this year, in the wake of the #metoo movement, we have witnessed a cultural shift towards a willingness to address the perils of sexual consent under patriarchy. in the context of this cultural reckoning, i see no better time to apply feminist epistemology to the fraught nature of consent to a bioethical framework. feminist bioethicists, such as susan sherwin, have long argued for a wider consent model that privileges justice over a focus on autonomy. using radical feminist theorist catherine mackinnon’s work on consent and sexual harassment, i will support sherwin’s claim by arguing for a more nuanced understanding of power and structural social hierarchy that exists in every aspect of our society, including research. analysis it should be noted i am not trying to conflate engagement in sex/sexual violence with engagement in research. however, i am attempting to find useful parallels to dissect the broader issue that applies equally to both, which is an issue of meaningful agreement across power differentials. there is a false idea, within research ethics and our society at large, that consent is the gatekeeper of a just and masters, feminist theory reveals a need for justice over autonomy in research ethics, voices in bioethics, vol. 4 (2018) 2 reciprocal experience. as feminist theorist catherine mackinnon writes, “the presence of consent does not make an interaction equal. it makes it tolerated, or the less costly of alternatives out of the control, or beyond the construction, of the one who consents”.1 a new model incorporating radical feminist scholarship and focusing on structural inequality as opposed to individual choice is necessary to ensure truly ethical research practices. informed consent is a widely discussed topic in research ethics, one that presents many challenges. according to u.s. law and the principles of bioethics, physicians, scientists and researchers are required to obtain the informed consent of their patients or subjects before initiating treatment or collecting scientific data. true informed consent, as defined in bioethics, requires the disclosure of all relevant information to a competent participant who is capable and permitted to make a totally voluntary and educated choice. typically, as paul appelbaum writes, “such disclosure includes the nature of the patient’s condition, the nature and purpose of the proposed treatment, and the risks and benefits of the proposed treatment and of alternative treatments, including the option of no treatment at all” [2]. in other words, the participant is supposedly free to utilize their full autonomy in determining what they do, and do not, want to be done with their body. informed consent in research ethics is often framed under the specific lens of the preservation of autonomy, and, consequentially, autonomy is usually heralded as the most important of bioethical principles with regards to consent. there are obvious cases in which informed consent, as defined, cannot be reasonably given due to limited autonomy. traditional bioethics tends to focus on cases of limited autonomy as individual circumstances of language barrier, cognitive impairment, or mental instability. as appelbaum writes, “when patients lack the competence to make a decision about treatment, substitute decision makers must be sought. hence, the determination of whether patients are competent is critical in striking a proper balance between respecting the autonomy of patients who are capable of making informed decisions and protecting those with cognitive impairment”.2 typically, the determination of limited autonomy is defined on individualistic terms based on a subject’s specific health limitations. i propose this is not a useful enough starting point, as this idea of individualistic autonomy has many limitations, namely, the exaltation of autonomy assumes falsely that every individual has the same operational ‘access’ to it. we need to be considering autonomy in a structural, rather than individualistic framework. furthermore, the recognition on the part of traditional bioethicists that autonomy is not universally equally distributed already reveals a soft admission to the fact that autonomy is not the best model upon which to rely. however, by choosing to focus only on the more ‘obvious’ examples of limited autonomy such as dementia, and mental capacity, as opposed to larger social determinants of a type of compromised autonomy such as in the case of gender, race, and class, traditional bioethics reveals an unwillingness to address larger societal issues of justice and power. arguably, the space in which the most prolific theorizing on the role and perils of consent and autonomy in society has been feminist theory. radical feminist theory, a line of thought emerging out of the second-wave feminist movement, specifically has grappled with the concept of “consent” and “free-choice” under uneven power structures. as radical feminist scholarship considers the mechanisms underlying rape and sexual harassment, the notion of consent as a fraught concept is brought into unique focus. catherine mackinnon, one of the most prominent radical feminist and legal scholars, and the inventor of the term “sexual harassment” has written prolifically on this subject. in her work, mackinnon theorizes on the illusion of female choice under patriarchy given gender oppression and uneven power structures and argues that the presence of consent is not a robust enough concept to differentiate rape from sex because women are not truly free to make unencumbered choices with regard to their sexuality. she writes, masters, feminist theory reveals a need for justice over autonomy in research ethics, voices in bioethics, vol. 4 (2018) 3 the law of rape presents consent as free exercise of sexual choice under conditions of equality of power without exposing the underlying structure of constraint and disparity…if rape is less a question of unwanted sex than of unequal sex, if equality not autonomy is its primary issue, if internal psychology is less determinant of these criminal acts than leverages external conditions and gendered social behaviors, the existing conceptual framework together with its lexicon of examples, has been fundamentally beside the point all along”.3 according to mackinnon, the concept of consent is beside the point: in order for consent to even be possible, the two actors entering into an agreement must be equal in power. since this equality is non-existent, the discussion should instead involve the levelling of the playing field before we can worry about coming to an agreement. these ideas from second wave feminist theory have recently re-emerged as a way to discuss the fallout from the revelations of the #metoo movement. as brit marling published in the atlantic in response to the harvey weinstein sexual assault scandal, “the things that happen in hotel rooms and board rooms all over the world (and in every industry) between women seeking employment or trying to keep employment and men holding the power to grant it or take it away exist in a gray zone where words like ‘consent’ cannot fully capture the complexity of the encounter. because consent is a function of power. you have to have a modicum of power to give it”.4 this reiterates mackinnon’s claim that obtaining consent is inadequate in addressing inequality across power differentials. without an equality of power positions, consent is not only meaningless, but presents a red herring. even if we falsely accept the equality of the two parties, consent as a concept inherently implies a differential in power, as one agent necessarily initiates as another acquiesces. in fact, the oxford english dictionary defines consent as the “voluntarily acquiesce in what another proposes or desires” [3]. similarly, black’s law dictionary defines consent as “voluntarily yielding the will to the proposition of another” [3]. therefore, using consent as a marker for an equal exchange is a fundamental misconception. as mackinnon writes, “intrinsic to consent is the actor and the acted-upon, with no guarantee of any kind of equality between them, whether of circumstance or condition or interaction [3]. while some may argue discussions of sexual consent are too specific to be applied to issues of research consent, this is not the case. research, like gender dynamics under a patriarchal social system, is rife with inequities of power. doctors and researchers similarly occupy a traditionally masculine role of paternalism and authority over their subjects, just as men hold power over women under patriarchy. it is also important to note the history of colonial abuses in academic and biomedical research that has contributed to this contemporary power imbalance. as indigenous theorist lina tuhiwai smith writes, “from the vantage point of the colonized…the term ‘research’ is inextricably linked to european imperialism and colonialism” [5]. she continues: research is one of the ways in which the underlying code of imperialism and colonialism is both regulated and realized. it is regulated through the formal rules of individual scholarly disciplines and scientific paradigms, and the institutions that support them (including the state). it is realized in the myriad of representations and ideological constructions of the other in scholarly and ‘popular’ works, and in the principles which help to select and re-contextualize those constructions in such things as the media, official histories and school curricula.5 research is not a neutral truth-seeker, but rather a historically situated institution built off the values of imperialism. much of the establishment of research as a field has relied heavily on the stratification of the colonizers (researchers) from the colonized (subjects). masters, feminist theory reveals a need for justice over autonomy in research ethics, voices in bioethics, vol. 4 (2018) 4 while the goal of this paper is not to argue for the conflation of sexual consent with research consent, it should be noted that there are meaningful historical and contemporary examples of patients, particularly women, who have been taken advantage of in the name of science in manners that are sexual in nature. consider the performance of pelvic exams by medical students on anesthetized women without their consent: according to an article published in 2012, women undergoing gynecological surgeries were asked to give consent to allowing medical students be involved in their care, but not explicitly allowing them to do educational exams on them while unconscious. as a medical student stated, “for three weeks, four to five times a day, i was asked to, and did, perform pelvic examinations on anesthetized women," whom had only given implicit consent to his presence during surgery [6]. according to the united states department of justice the legal definition of rape is "penetration, no matter how slight, of the vagina or anus with anybody part or object without the consent of the consent of the victim”.6 accepting this definition, what these patients endured was ostensibly a form of rape. in the united states, there are only four states (hawaii, california, illinois and virginia) “where doctors are legally required to obtain specific consent for pelvic exams under anesthesia”.7 furthermore, a study found that medical students who had completed a clerkship in obstetrics or gynecology did not believe consent for pelvic exams under anesthesia were warranted.8 these attitudes suggest that while issues surrounding sexual consent and research consent are distinct, there are important overlaps that point to a larger structural problem in society. research is not created in a vacuum. it is created by and for the culture in which it is produced; in this case, the same culture that also permits and encourages gendered sexual abuse. taking a cue from feminist theory, we can see that by focusing only on autonomy and ignoring issues of structured oppression and violence, the current model of informed consent in medical research is fundamentally skewed in favor of the powerful. as feminist bioethicist susan sherwin writes, “autonomy language is often used to hide the workings of privilege and mask the barriers of oppression”.9 by choosing to focus only on issues of autonomy we artificially make research ethics an individualistic issue rather than a systemic one. like mackinnon, sherwin too argues that the idea of choice under systems of oppression is illusory. she writes, the “illusion of ‘choice’ in the context of informed consent can operate as a mechanism to insure compliance with care provider’s preferences”.9 not only is the ontology of choice illusory, the framework of emphasizing autonomy often serves to blame victims for their own mistreatment. according to sherwin, in emphasizing choice as the gatekeeper of impartiality, advocates “not only fail to deflect responsibility from victims, but rather attribute it to them”.9 this phenomenon can be clearly seen in the recent discussion surrounding the prevalence of sexual assault in the work place. in response to harvey weinstein’s outspoken victims, many have asked questions to the tune of, “if she felt uncomfortable, why didn’t she just leave” or “why didn’t she tell anyone?” not only does this unimaginatively ignore the realities of power differentials, it also serves to blame victims for being victimized. focusing on the victims’ choices as if they were as free and unencumbered as weinstein’s is wrong, and misses the point entirely. the emphasis on women’s autonomy here insidiously and paradoxically serves not to embolden, but rather undermine, their subjectivity. sherwin writes that “the concept of autonomy, rather than working to empower the oppressed and exploited among us, in practice often serves to protect the privileges of the most powerful”.9 additionally, sherwin writes that “theories that place priority on autonomy—at least as the concept is commonly interpreted—must be understood as primarily protecting the autonomy of those who are already well-situated, while sacrificing the necessary prerequisite for autonomy for others”.10 assuming both parties have ‘equal’ access to autonomy in this situation is not only callously inappropriate, it also relies on clumsy reasoning that serves only to bolster power differentials rather than level them. and this, of course, does not merely apply to women subjects but to other marginalized groups be they based on race, class, sexuality, etc. masters, feminist theory reveals a need for justice over autonomy in research ethics, voices in bioethics, vol. 4 (2018) 5 an emphasis on autonomy not only serves to unfairly place blame on the victim, it also obscures structural oppression that limits autonomy in the first place. as sherwin explains, this individualistic approach to autonomy makes it very easy for people of privilege to remain ignorant of the social arrangements the support their own sense of independence, such as the institutions that provide them with the exceptionally good education and a relatively high degree of personal safety. encouraged to focus on their own sense of individual accomplishment, they are inclined to blame less well-situated people for their lack of comparable success rather than to appreciate the cost of oppression. this familiar sort of thinking tends to interfere with people’s ability to see the importance of supportive social conditions for fostering autonomous action.11 our project as bioethicists should rely less on maintaining and bolstering what is ultimately the golden rule of autonomy myth, and focus rather on enlightening and unmasking the various power structures at play that limit various groups’ access to power. rather than a focus on individual choice, “we need to question how much control individual patients really have over the determination of their treatment within the stressful world of health care services” [11]. conclusion overall, the current model of informed consent as it is currently understood at best misses the point, and at worst promotes damaging neoliberal notions that place blame on individuals rather than on structural inequality. in the case of research ethics, consent and its function as a measurement of autonomy fails because the power between the researcher and subject is inherently unequal. this is not to suggest that in this scenario autonomy is actively stripped from the subject by the researcher, but rather that the dice were loaded before either entered the room. autonomy, regardless of the efforts of bioethics, is simply not equally accessed in our society as it stands today. the incorporation of feminist theory serves to challenge the current model by accurately and forcefully confronting the realities of our unequal world. not only does this application reveal parallels in how power is negotiated similarly throughout different realms in society, it also helps to illuminate the larger ethical issues that warrant attention. as sherwin writes, “feminist health care ethics does not only change the way we handle traditional bioethical problems; it also changes the agenda of the discipline by making visible a whole range of new ethical problems [11]. taking a feminist approach to bioethics reveals a need to move toward a justice model and away from an autonomy model in order to more vigorously account for structural inequality within biomedical research. 1 mackinnon, catherine. “rape: on coercion and consent .” www.julietdavis.com, www.julietdavis.com/oldsite/wst383/rape.pdf. 2 appelbaum, paul s. “assessment of patients' competence to consent to treatment — nejm.” new england journal of medicine, www.nejm.org/doi/full/10.1056/nejmcp074045. 3 mackinnon, catherine. “rape redefined.” http://harvardlpr.com/wp-content/uploads/2016/06/10.2_6_mackinnon.pdf. 4 marling, brit. “harvey weinstein and the economics of consent.” the atlantic, atlantic media company, 23 oct. 2017, www.theatlantic.com/entertainment/archive/2017/10/harvey-weinstein-and-the-economics-of-consent/543618/. 5 smith , linda tuhiwai. “decolonizing methodologies.” google books, books.google.com/books/about/decolonizing_methodologies.html?id=nad7afstdr8c. 6 rowan, karen. “pelvic exams while under anesthesia sparks debate.” livescience, purch, 5 oct. 2012, www.livescience.com/23749-pelvicexams-anesthesia-medical-students.html./.latest_citation_text http://www.julietdavis.com/oldsite/wst383/rape.pdf http://www.nejm.org/doi/full/10.1056/nejmcp074045 http://harvardlpr.com/wp-content/uploads/2016/06/10.2_6_mackinnon.pdf masters, feminist theory reveals a need for justice over autonomy in research ethics, voices in bioethics, vol. 4 (2018) 6 7 “an updated definition of rape.” the united states department of justice, 6 jan. 2012, www.justice.gov/archives/opa/blog/updateddefinition-rape./.latest_citation_text 8 ubel, peter a.; jepson, christopher; silver-isenstadt, ari. “don't ask, don't tell: a change in medical student attitudes after obstetrics/gynecology clerkships toward seeking consent for pelvic examinations on an anesthetized patient, american journal of obstetrics and gynecology.” deepdyve, elsevier, 1 feb. 2003, www.deepdyve.com/lp/elsevier/don-t-ask-don-t-tell-a-change-in-medical-student-attitudesafter-ty00xbcuea./.latest_citation_text 9 humphreys, janice. “family violence and nursing practice, second edition 2nd edition.” family violence and nursing practice, second edition: 9780826118288: medicine & health science books @ amazon.com, www.amazon.com/family-violence-nursing-practicesecond/dp/0826118283. 10 berg, jessica w. “informed consent: legal theory and clinical practice 2nd edition.” informed consent: legal theory and clinical practice: jessica w. berg, paul s. appelbaum, lisa s. parker, charles w. lidz: 9780195126778: amazon.com: books, www.amazon.com/informedconsent-theory-clinical-practice/dp/0195126777. 11 sherwin, susan. “the politics of women's health.” google books, books.google.com/books/about/the_politics_of_women_s_health.html?id=xlsup -zmenkc. http://www.amazon.com/family-violence-nursing-practice-second/dp/0826118283 http://www.amazon.com/family-violence-nursing-practice-second/dp/0826118283 http://www.amazon.com/informed-consent-theory-clinical-practice/dp/0195126777 http://www.amazon.com/informed-consent-theory-clinical-practice/dp/0195126777 abstract introduction analysis conclusion maydan, truth that matters, voices in bioethics, vol. 9 (2023) * danielle maydan, candidate for bsc, columbia university fu foundation school of engineering and applied science © 2023 danielle maydan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. truth that matters: the role of family caregivers in the care of people with dementia danielle maydan* abstract this research paper explores the family caregivers' role in resolving the ethical dilemma of deception in dementia care. family members possess the unique capability to engage in "white lies" in a manner that both respects and upholds an individual with dementia's identity. keywords: family caregiver, dementia, autonomy, truth, identity, ethical deception, personhood introduction it was our usual family shabbat dinner: golden flames flickered in crystal candleholders, and the smell of warm challah permeated the air. “where is elena?” my great-grandmother anxiously asked, scanning the doorway. “i am here, sitting right next to you, babushka!’’ my mother affectionately reassured her. having raised my mother in russia, my great-grandmother tsilya, then in her early nineties, had resided in our riverdale home for several years. “no, i know you are here, but where is the little elena?” any attempt to explain that “little elena” had grown into an adult only agitated my great-grandmother. she eventually calmed down, distracted by the promise of a scrumptious meal. as tsilya’s mind wandered back into the reality of her past, where my mother elena was a young girl living in tsilya’s modest flat in leningrad, what we then believed was a temporary moment of confusion turned out to be the first glimpse into tsilya’s future. over the next few years, as alzheimer’s disease brought on tsilya’s cognitive decline, erasing her memories and taking her identity with them, tsilya’s concerns about the “little elena” transformed into attempts at leaving the house to attend parties hosted by television celebrities. she would also cry and ask for her own mother at night. in the beginning, my mother always tried to uphold the truth and reorient my greatgrandmother to the reality of her situation. however, as tsilya’s cognitive decline advanced, my mother often had to redirect her attention to family photo albums or, in moments of extreme distress, resort to occasional “white lies” to validate some of her inaccurate beliefs. my mother’s actions provided such solace and felt so instinctive that i never questioned the legitimacy of her strategies to mitigate my great maydan, truth that matters, voices in bioethics, vol. 9 (2023) 2 grandmother’s distress. nevertheless, over the last two decades, the issue of truthfulness in dementia care has become the object of study and contemplation by both medical professionals and ethicists alike. i. person-centered care for people with dementia most current discussions about the care of people with dementia begin with the principles of personcentered care, a revolutionary new philosophy of care introduced in the 1990s by tom kitwood, an english social psychologist and gerontologist. rather than treating a person with dementia in a medical, protocol, and task-based fashion, kitwood advocates approaching the care of such patients through a more holistic method that considers social and environmental factors, rather than only the patients’ biochemical brain changes. 1 the main tenets of person-centered care include the awareness of the uniqueness and individuality of each person, the recognition of the subjective nature of experiences of people with dementia, and the maintenance of close relationships with people with dementia, allowing them to uphold bonds and lasting attachments to their loved ones.2 this philosophy of care highlights the importance of social interactions and interpersonal relationships in dementia care. “[t]o care for others,” kitwood writes, “means to value who they are; to honor what they do; to respect their unique qualities and needs; to help protect them from harm and danger; and – above all – to take thoughtful and committed action that will help to nourish their personal being.”3 kitwood also emphasizes the need for people with dementia to have “a standing or status that is accorded by others.”4 however, the emphasis on conferring personhood onto individuals through their relationships with others introduces a challenge in implementing person-centered care. if a caretaker acknowledges and respects the subjective reality of a person with dementia, who may perceive a reality disconnected from their present, the caretaker may have to compromise their commitment to absolute truth-telling. on the other hand, if a caretaker solely adheres to the objective truth, they implicitly delegitimize the subjective reality and experiences of people with dementia. ii. truthfulness versus therapeutic lying in dementia care scholars contemplating truthfulness versus therapeutic lying in dementia care hold different views. some believe that maintaining the selfhood of people with dementia justifies occasional deception, while others claim that only uncompromised truth-telling can offer people with dementia the respect they deserve from others. this dichotomy of opinion presents a moral dilemma for individuals and institutions involved in the care of people with dementia. however, family members caring for individuals with dementia possess a unique capability to navigate this dilemma. 5 they have a profound understanding of their loved ones' identities and personal stories, allowing them to preserve the selfhood of people with dementia through occasional therapeutic lying without compromising the integrity of their relationships. as a result, the inclusion of family caregivers in the conversation about the permissibility of therapeutic lying in dementia care can facilitate the implementation of true person-centered care for people with dementia.6 while a central argument for the necessity of uncompromised truth-telling to people with dementia rests on the importance of truth in maintaining human bonds, family members can uphold this value despite occasional deception. in her article “truthfulness and deceit in dementia care: an argument for truthful regard as a morally significant human bond,” dr. philippa byers, an ethics researcher, rejects the validity of lying for therapeutic purposes in dementia care. byers argues that truth-telling is a moral value that establishes trustful relationships and therefore should not be denied to people with dementia. she grounds her argument in the notion of “truthful regard,” which she defines as the “regard for another person as one for whom truth matters, just as it does for oneself.” as a result, byers contends that lying must be maydan, truth that matters, voices in bioethics, vol. 9 (2023) 3 avoided to maintain truthful regard, rather than paternalism or condescension, in the caretaker’s relationship with a person with dementia. despite her seemingly uncompromising stance, byers does approve of refraining from truth-telling in interactions with a friend sharing the same story over and over again. 7 byers claims that if one cares for their friend, one can forgo the truth-telling of informing the friend that one has heard the story before by making decisions “involving the judgment, discretion, and tact that is characteristic of (most) respectful communication with one another…without suspending our truthful regard” for the other person. in communicating with people with dementia, family caregivers embody the role of such friends. as a result, due to close social relationships with a person with dementia, family caregivers can eschew blunt truth-telling without compromising the truthful regard they hold for the person. when my great-grandmother would get upset and agitated in her desire to attend a party hosted by a television celebrity and when all efforts at redirecting her attention failed, my mother occasionally had to offer “white lies” in telling her that the host cancelled the party due to inclement weather. while not truthful, such statements did not undermine my mother’s truthful regard for my great-grandmother but served as a measure of last resort to ensure my great-grandmother’s safety by preventing her from leaving the house alone at night. byers states that truthful regard for other people “does not require close affiliative bonds.” 8 yet, it is precisely the existence of such close bonds that imparts special privileges on family members in their relationships with people with dementia, similarly to the way byers affords such privileges to close friends. family caregivers, therefore, may introduce the necessary “white lies” if their respectful judgment demands them. iii. the inclusion of family caregivers’ perspectives in navigating truth-telling despite the demonstrated significance of family caregivers in navigating truth-telling in the care of people with dementia, current discourse on justifying deception in dementia care often overlooks the perspectives of family caregivers. dr. matilda carter, a lecturer in philosophy at king’s college london, claims that an insistence on truth delegitimizes the subjective experiences and undermines the current identities of people with dementia. 9 carter contends that the norm of truth-telling to dementia patients, whose cognitive decline and memory loss lead them to exist in their own version of reality, is an ableist construction that disrespects the perceived realities of people with dementia. therefore, carter argues that “withholding the truth from and, in limited circumstances, lying to people living with dementia is not only morally permissible, but morally required.” “ethical deception” is morally justified as an act of respect in seeing people with dementia through the lens of “the type of person that they are.” however, carter’s justification of ethical deception overlooks the significance of careful judgment in the use of deception in dementia care, violating the personhood of people with dementia. an example illustrating carter’s perspective on ethical deception and the negative consequences of neglecting the voices of family members of individuals with dementia can be found in the medical case study “how much a dementia patient needs to know” by dr. oliver sacks.10 in this short work, sacks, a neurologist and a best-selling author, describes mr. q., a nursing home resident with dementia. having been employed as a janitor in his earlier years, mr. q. continued performing his “duties” in the nursing home. while the nursing home staff realized that his adherence to his former identity was a delusion, they “respected and even reinforced” mr. q.’s identity by encouraging his actions and providing him with instruments and supplies for his janitorial duties. initially questioning whether mr. q. should have been told the truth about the reality of his condition, sacks ultimately concludes that the objective reality holds little meaning for mr. q and that truth-telling would be “pointless” and “cruel.” the story of mr. q. aligns with carter’s concept of ethical deception, as the residential care facility staff knowingly upheld mr. q.’s erroneous identity. maydan, truth that matters, voices in bioethics, vol. 9 (2023) 4 however, carter’s philosophical framework overlooks the attitudes of family caregivers towards such ethical deception, considering the caregivers’ deep understanding of the wishes and identities of their relatives. mr. q.’s facility caregivers could have encouraged his janitorial activities for their own convenience, such as to minimize the time needed to attend to his care. additionally, mr. q. could have believed in holding onto the truth until the very end. if not for the nursing home staff’s deception, mr. q.’s family could have had the opportunity to reorient him to reality. this highlights the importance of caregivers’ meticulous deliberation on the use of deception in their interactions with individuals with dementia. without such consideration, deception may be driven by ulterior motives or may disregard the wishes of people with dementia and their family caregivers. a 2020 study demonstrated that telling a “white lie” was found acceptable if intended solely to minimize harm to a person with dementia and particularly if introduced by a caregiver who really “‘kn[e]w the person.’”11 this acceptance was rooted in the belief that “the deep knowledge [caregivers] had about the person, their past, and their current experience allowed them to use lying in a genuinely caring and respectful manner.” 12 even more significantly, people with dementia emphasized the importance of consulting family members in decision-making during later stages of disease because these family members “knew what mattered to them the most.”13 since there are no clear references to mr. q.’s personal beliefs or his family’s wishes, one cannot fully confirm the moral validity of the nursing staff’s approach. conversely, my mother’s extensive years of caring for my great-grandmother, coupled with her understanding of her beliefs, provides moral justification for her use of ethical deception to ensure my great-grandmother’s safety. therefore, family caregivers’ profound understanding of the identities and circumstances of individuals with dementia allows them to utilize deception in a manner that upholds the selfhood of people with dementia without diminishing the importance of truth. iv. artificially constructed realities for people with dementia regardless of the caregiver's type or intentions, some critics reject deception on the grounds that it leads to the construction of artificial realities for people with dementia. 14 such critics claim that deception inherently contradicts the innate human desire for experiences grounded in true reality, a philosophical idea developed by american political philosopher robert nozick.15 nozick introduces the concept of an “experience machine,” a device that would provide desired experiences through targeted brain stimulation. nozick claims that while the machine can allow people to feel good “‘from the inside,’” people would reject it because they want to “do certain things, and not just have the experience of doing them… to be a certain way, to be a certain sort of person.”16 proponents of nozick’s ideas might draw a parallel between mr. q.’s existence and a person hooked up to the experience machine since the nursing home staff’s treatment of mr. q. is not grounded in objective reality. however, people with dementia already live in their own subjective realities due to cognitive decline and frequent reversion to past identities. therefore, upholding these realities differs from constructing them de novo. furthermore, while the experience machine offers a passive existence, mr. q. can physically attend to the expected responsibilities of his believed identity. as a result, when artificially constructed realities are introduced with the well-being of individuals with dementia in mind, and by those who understand what that well-being entails, they offer genuine experiences that enable people with dementia to realize their individuality within the bounds of their cognitive abilities. artificially constructed realities and the importance of family caregivers in upholding the personhood of individuals with dementia living within such realities come into focus in de hogeweyk, the first dementia village for people with advanced dementia.17 de hogeweyk, which opened its doors in weesp, netherlands maydan, truth that matters, voices in bioethics, vol. 9 (2023) 5 in 2009, is a gated community with a single entrance and exit where its residents receive twenty-four-seven care.18 the village aims to maintain continuity with the residents’ past lives by grouping them into themed homes based on their previous lifestyles and by offering familiar social events and physical activities. 19 through thoughtful planning and design, the founders of de hogeweyk have integrated all the “deceptive” aspects of their institutional reality into the village’s infrastructure, including residences that look like real homes, a supermarket that does not use money, and a restaurant and hair salon staffed by trained caregivers who do not require payment for their services.20 although it is a closed facility, de hogeweyk welcomes both family members and outside volunteers of all ages to interact with its residents.21 while critics of de hogeweyk have likened it to the truman show, multiple family members report their satisfaction with de hogeweyk’s model of care. 22 ada picavet, whose husband ben is a resident at de hogeweyk, shares her experience of visiting him daily, playing the piano, and singing songs together. these activities serve as an attempt to preserve a sense of normalcy and continuity with their life before his dementia diagnosis.23 while some might claim that their relationship is deceptive due to ben’s limited cognitive abilities, ada’s visits demonstrate a profound respect for her husband's subjective reality. she recognizes that his dementia shapes his perception of the world and maintains the continuity of his identity by allowing him to engage in activities they enjoyed together in the past, such as singing. by portraying ada and other family members visiting their loved ones at de hogeweyk as true partners in care, dr. sanjay gupta, in his cnn report on de hogeweyk, underscores the importance of family caregivers in addressing the moral dilemmas in dementia care through their understanding of the personal preferences and experiences of their loved ones with dementia. de hogeweyk aligns with kitwood’s person-centered care model that emphasizes the recognition of individuality, dignity, and well-being of individuals with dementia. the infrastructure and social environment provided at de hogeweyk contribute to an immersive world that resonates with the residents’ personal histories and identities. despite the constructed nature of the residents’ world, its depth and significance come from the interpersonal connections between residents and their family members outside the dementia village. as a result, family caregivers can occasionally employ carefully considered acts of beneficent deception without undermining the importance of truth-telling in dementia care. they can also transcend the limitations of cognitive decline by providing love and dedication as the fundamental truths that matter. conclusion at the end of her life, my great-grandmother tsilya could no longer recognize or communicate with family members. she would sit quietly, staring at the wall. yet, my family members and i continued to spend time with her every day, simply holding her hand or stroking her hair. while it may be true that these visits might not have mattered to my great-grandmother, who no longer had an awareness of the outside world, they upheld her selfhood in the eyes of our family and to everyone else around her. family caregivers, like my mother, have the knowledge and experience to navigate moral dilemmas surrounding truth and deception in dementia care. as the number of people suffering from dementia continues to rise, future studies should examine new ways to engage family caregivers in helping to establish the true meaning of person-centered care. 1 matthew tieu, “truth and diversion: self and other-regarding lies in dementia care,” bioethics 35, no. 9 (2021): 858, https://doi.org/10.1111/bioe.12951. https://doi.org/10.1111/bioe.12951 maydan, truth that matters, voices in bioethics, vol. 9 (2023) 6 2 tom kitwood, “the concept of personhood and its relevance for a new culture of dementia care.,” in care-giving in dementia: research and applications, ed. bere m.l. miesen and gemma m.m. jones, vol. 2 (routledge, 1997), 10-11. 3 kitwood, 3. 4 kitwood, “the concept of personhood and its relevance for a new culture of dementia care,” 4, 11. 5 see “holding one another (well, wrongly, clumsily) in a time of dementia,” an essay where hilde lindemann, a philosopher and a bioethicist, examines the role of family caregivers in upholding their loved ones with dementia’s identities. 6 this essay is specifically concerned with informal family caregivers, such as children, close relatives, or romantic partners, as opposed to formal paid caregivers in the medical establishment. for people with dementia who have no informal caregivers and end up in institutional care early on, the lessons learned from family caregivers can contribute to creating guidelines for institutional person-centered care. see the united kingdom’s mental health foundation 2016 report “what is truth: an inquiry about truth and lying in dementia care” for a further discussion regarding the necessity for non-family caregivers to understand the life stories and values of people with dementia. 7 byers, “truthfulness and deceit in dementia care: an argument for truthful regard as a morally significant human bond,” 231232. 8 byers, 234. 9 matilda carter, “ethical deception? responding to parallel subjectivities in people living with dementia,” disability studies quarterly 40, no. 3 (2020), . 10 oliver sacks, “how much a dementia patient needs to know,” the new yorker, february 25, 2019, www.newyorker.com/magazine/2019/03/04/how-much-a-dementia-patient-needs-to-know. 11 dympna casey et al., “telling a ‘good or white lie’: the views of people living with dementia and their carers,” dementia 19, no. 8 (2020): 2583. 12 casey et al., 2593-1594. 13 casey et al., 2595. 14 robert sparrow and linda sparrow, “in the hands of machines? the future of aged care,” minds and machines 16 (2006): 155, https://doi.org/10.1007/s11023-006-9030-6. 15 sparrow and sparrow, 155. 16 richard nozick, anarchy, state, and utopia (basic books, 1974), 42-43.cnn’s world’s untold stories: dementia village (cnn, 2013), www.youtube.com/watch?v=lwioblywpko. 17 cnn’s world’s untold stories: dementia village (cnn, 2013), 02:00-02:13, www.youtube.com/watch?v=lwioblywpko. 18 cnn’s world’s untold stories: dementia village, 03:45-03:53. 19cnn, 05:10-06:00. 20 cnn, 14:45-15:30. 21 cnn, 20:20-20:40 22 cnn, 06:50-07:55. 23 cnn, 10:20-12:20 https://doi.org/www.newyorker.com/magazine/2019/03/04/how-much-a-dementia-patient-needs-to-know https://doi.org/10.1007/s11023-006-9030-6 http://www.youtube.com/watch?v=lwioblywpko preston, leaked documents raise questions, voices in bioethics, vol. 1 (2014-15) © 2015 joshua p. preston. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. leaked documents raise questions over defense department’s forced medication of detainees joshua p. preston bioethics, wikileaks, department of defense introduction released as part of wikileaks’ 2012 “the detainee policies,” classified documents from the u.s. department of defense (dod) ought to raise bioethical concerns over detainee treatment. although some documents are in draft form, others bear the signature of secretary rumsfeld and reflect the military’s standard operating procedures (sop) in both iraqi detainment facilities and guantanamo bay. addressing everything from the assignment of detainee numbers to restraint, its guidelines on the forced medication raise many questions. specifically: what those guidelines even are. analysis in one document the dod outlines its policies on “the ethical and safe use of restraints on detainee patients in medical treatment facilities within iraq.” when leather restraints do not work, it suggests forced medication: (3) if mechanical restraints fail to maintain the appropriate medical effect and/or safe environment, pharmacologic agents (e.g. haldol, ativan, etc.) may will be used in accordance with jcaho guidelines [what are these guidelines? should they be listed as references?] medical standards, and ethics. patients requiring pharmacologic restraint will be monitored for 12 hours after dosing. (emphasis in original, p.2) the two drugs mentioned – haldol and ativan – are the trademark names of haloperidol and lorazepam, the first an antipsychotic used to treat schizophrenia and the second a sedative. both have their side-effects and, with long-term use can cause cognitive impairment. of the 100+ leaked documents, this is one of the few where either the author or a reviewer made a note to the original text (in bold). what is astounding is that the military’s own guidelines on forced medication are so vague that someone felt compelled to note as much. to further confuse the matter, it is unclear whether such jcaho (joint commission on accreditation of healthcare organization) guidelines even exist. searching online for the jcaho’s (now the joint commission) uncited policies on forced medication, i found nothing. when i reached out to a media representative of the commission’s standards interpretation group, i was told it currently has no such guidelines. additionally, they were “not able to pull up any old standards.” when i asked for clarification as to whether they ever existed, i was not given a direct answer and my follow-up emails were ignored. it is no secret that both torture and forced medication were regularly practiced at guantanamo bay. in fact, the very author of the bush administration’s legal rationale for torture, john yoo, went so far as to argue that the army field manual allowed the use of drugs to torture. in august 2013, an attorney filed an appeal on the part of six former guantanamo prisoners who, in 2001 and 2002, were wrongly detained as enemy preston, leaked documents raise questions,, voices in bioethics, vol. 1 (2014-15) 2 combatants. while detained, “the guards … neither let [one prisoner] refuse the medication nor tell him what they were giving him” (p.28 of the appeal). when another resisted, he was forcibly medicated by an extreme reaction force (“erf”) team. as is typical in such circumstances, a group of soldiers in riot gear burst into his cell, threw him to the ground and restrained him, carried him out of the cell, and forced him to either take pills or an injection (p.40). conclusion sadly, with the government’s classification bias, it is only through wikileaks and (some) court documents that these human rights abuses will come to light. for all we know, the dod’s guidelines on restraint may have been clarified, but it will be a generation before the public can see them—long after they are of any use but to historians. introduction analysis conclusion hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) © 2017 kaitlynd hiller and rachel f. bloom. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. interview with arthur caplan kaitlynd hiller and rachel f. bloom keywords: art caplan, bioethics, transplant ethics, public health introduction it is a difficult task to succinctly describe the professional accomplishments of arthur caplan, phd. for the uninitiated, dr. caplan is perhaps the most prominent voice in the conversation between bioethicists and the general public, as well as being a prolific writer and academic. he is currently the drs. william f. and virginia connolly mitty professor of bioethics at nyu langone medical center and nyu school of medicine, having founded the division of bioethics there in 2012. additionally, he co-founded the nyu sports and society program, where he currently serves as dean, and heads the ethics program for nyu’s global institute for public health. prior to joining nyu, he created the center for bioethics and department of medical ethics at the university of pennsylvania perelman school of medicine, serving as the sidney d. caplan professor of bioethics. dr. caplan is a hastings center fellow, also holding fellowships at the new york academy of medicine, the college of physicians of philadelphia, the american association for the advancement of science, and the american college of legal medicine. he received the lifetime achievement award of the american society of bioethics and humanities in 2016. dr. caplan’s experience is not at all limited to the academic realm: he has served on numerous advisory counsels at the national and international level, and is an ethics advisor for organizations tackling issues from synthetic biology to world health to compassionate care. dr. caplan has been awarded the mcgovern medal of the american medical writers association, the franklin award from the city of philadelphia, the patricia price browne prize in biomedical ethics, the public service award from the national science foundation, and the rare impact award from the national organization for rare disorders; he also holds seven honorary degrees. kaitlynd hiller and rachel bloom, both m.s. bioethics graduates of columbia university, had the opportunity to meet with dr. caplan last winter to conduct a candid exploration of his career as a bioethicist. their conversation touched on moments in dr. caplan’s personal history that planted the seeds for his future professional involvement with bioethics, discussing his evolving views over time. reflecting on his own hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 2 impact to the field, dr. caplan leaves us with wisdom for bioethicists beginning their career in the public sphere. a lightly-edited transcript can be found below. interview initial interest in bioethics rachel: can you tell us anecdotally how you became interested in bioethics as a field? caplan: there is sort of a deep psychoanalytic kind of reason and then more of a recent causation kind of reason. when i was little i had polio and i was in the hospital for a long time. i was six -a little, little kid - in boston where i grew up. at that time, it was so long ago, your parents couldn’t stay over. in fact, your parents didn’t visit that much. i think i saw them three times a week and i liked my parents, at least at that time. i didn’t see my dog, ever, for nine months. they managed to get me my homework, which didn’t seem great, but the main things were kids were dying, they wouldn’t tell us the truth. we knew they were dying because they looked so bad. they said they went home. they didn’t really listen to complaints about, you know, why’re the visiting hours are so strict. why can’t my friends come and see me? that sort of stuff. it definitely got me thinking about what we would now call ethics issues, although they certainly didn’t call them that back then, they were just issues. and even as a little, little kid, it was bothersome. so i’m sure that got my interest going. later, i was going to go to med school. i was a premed at brandeis, outside of boston, and i went to columbia [for medical school] briefly and saw all kinds of interesting ethical things going on. i started to talk to the deans and other people about when we could explore this stuff. and they said, “well you just talk about it with your attending.” which you were never going to do, ever, because they would consider that an insult and they would have you washing bedpans for weeks. so – rachel: questioning the ethicality of their actions? caplan: or even say, explain it. i didn’t know about the field of bioethics, although it was getting underway. we’re talking mid ’70s, so the hastings center and the kennedy institute already existed; i just didn’t know it. and i went down to the columbia philosophy department and said i would like to get a master’s degree in ethics and take time off to do that and they said, “well, first of all, we don’t have a master’s degree in ethics, because we only take phd students. and second of all, we aren’t interested in” - i think the phrase was “the ethics of plumbers.” meaning doctors. and i said, “ok. i’ll sign up for it anyway.” and so i went into the phd program, but i thought i’m just going to dropout and then get a master’s degree and it’ll be all good. not really interested in philosophy, but the issues were fun, other students were smart, and i liked it. so i thought i’m going to do the degree and then go back, but i never really went back. i went back as the medical ethics guy and sort of started the program that you guys are now in, except by a long, twisty course. what is bioethics? rachel: i was just going to comment, i think a lot of people are thinking about bioethical issues without necessarily knowing the name to attach to it. caplan: yes. i often say, “i do bioethics,” and people are like, “what’s that?” and then you say, “well, you know, end of life care; terri schiavo; jack kevorkian; cloning; stem cells; genetic engineering.” and they’re hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 3 just, “oh. oh. i get it.” yeah, absolutely true. you know, “should we quarantine people, should we give people drugs without testing them?” they get that. they understand right away that there are good ethics issues there. sometimes they’re also a little afraid of “ethics,” so you have to be careful how you use that word because ethics could also mean people who are going to church or you’re going to yell at me for being a derelict, or whatever it is; people also confuse ethics with what i’ll call politeness or manners. personal interest and transplantation rachel: when you entered the field, were your goals more along the lines of drawing on your personal experiences, focused on patients having different, better experiences in the future? caplan: well, despite the motivation of wanting it to be nicer for kids, that wasn’t really what was driving me by the time i got into this. i was interested in the theory. and i began almost by writing about things like, what sort of concepts of health and disease should drive medicine? how do you define them? what are medicine’s goals? what we now call philosophy of medicine, which i’m still interested in and i still write about; what is health, what is illness, what is disease-type stuff. but nobody ever seems to ask me about it – they just don’t find it as interesting as, should the surrogate mother have to get an abortion if the commissioning couple wants her to? it’s like, that gets them. “what is health” is like, you know, call me when you figure it out. so it was more theoretical stuff. but i began to get interested in this new area that was emerging of transplants. and it was sort of high tech and very risky and a lot of the people who got the first transplants died. and some hospitals actually prohibited people from doing transplants, they were so dangerous. and that just got my attention and then i began to wonder -because i was still going to columbia -why weren’t we doing more transplants? because we had a lot of people with kidney failure and only a small dialysis unit to take care of them. and it turned out that one problem was there weren’t enough organs. so that was a very practical problem and i said, “ok. you go and try and examine that, why aren’t there more organs to transplant?” because we had the capability, we just didn’t have the parts. and that led me to still be interested in transplant ethics, you know, 30 years later. and i did some very practical things there, if you want to talk practical. we figured out the people at hospitals were not asking about organs when people died. you have to ask for them to get them, so i wrote up a law and got it through the new york state legislature called required request, which was you had to ask when somebody died. they didn’t have to give, but you at least had to ask them. and that became law in most states and then it became a hospital accreditation requirement, then it became part of medicare funding eligibility. so, it’s everywhere and people have to do it. then i also realized that [institutions] weren’t sharing organs. they weren’t playing nicely with each other. they got an organ, if they couldn’t use it, they threw it away, literally. so they would, like, say, “well, if we can’t use it at nyu, then we’re not giving it to columbia. they’re our competition, so we’re not going to send it there.” so, eventually i hooked up with al gore, who was a congressman from tennessee and interested in medicine and science and technology, and we worked out with his staff the united network for organ sharing. we built the system that became the distributor of organs and that was a lot of work; very interesting, and it stood the test of time. so those were two very early experiences, practical bioethics, changing laws, sitting down in the real world and saying, “you’re going to get a kidney and you’re not. here’s why and these are the criteria and this is how we do it. and if you don’t like it, you can complain, but these are the rules until we change them.” hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 4 bioethicist as expert rachel: how has your experience been shaped being a bioethicist, but not a healthcare professional? have you found particular challenges from this? caplan: yes. when i first started out, i was not only not a doc, but i was too young. so, going after somebody’s ethics who’s senior, who’s a very established doc, is a real challenge. you have to be very political about it and very diplomatic about it. it’s always been an issue in terms of making sure that you know enough medicine and science to be credible to the group you’re talking to and i came as a premed and i did spend a lot of time at the columbia hospital, sort of a long internship. most people assume i’m a doctor today because i sound the jargon and do the walk and in the transplant community, i’m like an honorary member of the international transplant society. i mean, i’m treated like a transplant doc and that’s all been good and very helpful, but without acquiring that mastery of one of the sub-disciplines and knowing the jargon and knowing what’s going on at the bedside, it would be very hard to be taken seriously, even to this day. so we tried to force students to spend at least a little time learning how the hospital functions, what people do, how it operates. issues in bioethics kaitlynd: what issues in bioethics today do you think are overemphasized or talked too much about? and which ones are not discussed enough, but are really important? caplan: the stuff i’m not interested in gets talked about too much and what i’m interested in doesn’t get talked about enough. i would say there’s a shift that will surprise you. there’s a lot of interest in public health ethics overseas that gets talked about a little too much. there’s plenty of public health problems here. you don’t have to go overseas. part of me gets a little irritated when somebody says, i’m going to go solve the problem of poor people in sierra leone, if there’s a bunch of poor people in the bronx. it’s sort of like, can we do them first? it’s easier to deal with people who won’t talk back or are going to give you a hard time. i like public health ethics, but i don’t think it all has to be in the poorest places on earth where the great white saviors arrive. there’s probably too much attention to some of the weird reproductive technology stuff, because it’s rare. it doesn’t impact that many people. i get the interest, it’s just eternally fascinating, but it gets overemphasized. underutilized: nursing home ethics, rehab ethics, mental health. last year i put out a reader on mental health ethics to try and get people interested in that area. the only time people seem interested in mental health ethics is when there’s a mass shooting, otherwise they don’t seem to care a whole lot. chronic illness doesn’t get a ton of attention. acute stuff does. high tech gets a ton of attention and i pay attention to high tech and i pay attention to cutting edge, whether it’s crispr or stem cells, but i try to be across the board with it. i think i’ve probably written two-thirds of the literature on rehab ethics, because i’ve written about six papers on it. you know, it’s not a big area. i try to get people to pay attention, but it’s not drama. it’s sort of like – it was once said we should develop a cardboard box and put lights in it and tell people they had to stick their head in it and charge them a lot and say this is the rehabitron. and then people would say, “oh! we’ve got to pay attention to rehab. should we pay for the rehabitron?” past ideology http://mitpress.mit.edu/books/applied-ethics-mental-health-care http://mitpress.mit.edu/books/applied-ethics-mental-health-care hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 5 kaitlynd: you’ve written extensively over many, many years – are there any positions that you took in past debates that you might disagree with today or go back on or change? caplan: yes. i’ll give you a current example: i was an early critic of oregon’s assisted suicide law. i thought it would get abused. i thought people would get coerced into selecting death. i thought people would have their families pressure them to not spend all their money. empirically, it just didn’t happen. i know people still say it does, but i try to look very hard and i don’t see any evidence of coercion or forcing people or any discontent at all with the law. so i’ve switched and become a supporter, at least of terminal illness as a trigger to allowing people physician-assisted suicide. i was a believer for a long time that if we switched from an opt-in system to get organs to an opt-out system that that would get us more organs. i’m not sure the evidence bears that out either. so i’ve slowly shifted - it’s not that i’m against presumed consent, but i don’t think it’s going to have the impact that i once dreamed of because families and doctors still behave the same whether it’s opt-in or opt-out. they still go and ask the family, they just do, you know, when somebody dies. so i think you have to find ways to expand the donor pool. maybe bring people who are dying to the icu and put them on machines. if you don’t expand the pool, whether you have a market or a presumed consent, i don’t think it’s going to matter much, and i used to. it’s also funny when you change your mind or shift, because people are often citing you on their side, so i’m like, “i’m not on that side anymore.” future issues kaitlynd: what are the next issues you see yourself focusing on? caplan: i’m definitely starting to pay attention to germline genetic engineering. i’ve been long interested in genetics, was interested in gene therapy, and you didn’t ask me this, but when jesse gelsinger died, that became a big crisis -here’s this young man and he dies and his father doesn’t think the consent is very good and they’re off protocol in terms of what they were doing in the study and it was a mess and so, trying to figure out: how do i respond to that as the house ethicist? i hadn’t been at penn that long, so i had to work through sort of thinking about what do you do when you get a sort of catastrophe in your own institution. that early experience around genetics stuff, i didn’t lose that. you probably know too that i’ve written an awful a lot about nazi science and the holocaust and how it shaped experimentation. well, germline engineering, you know, when you’re starting to edit hereditary traits, it gets us back to a place where a lot of scientists said we’ll never go; we’re not going to touch the germline, which i always thought was utter bullshit, because they didn’t know how to do it, but now we do know how. so that theme there is very interesting for me. it’s pretty clear that rationing scarce resources is going to be a big issue for a variety of reasons; cost, aging population. this experiment with unapproved drugs is going to lead to a continuing interest on my part in how to allocate resources fairly. i’m very interested in research ethics issues and particularly things like what trial designs are the most ethical, depending on whether it’s an emergency or just some boring hair growth remedy thing -how do you design the trials? if informed consent -written informed consent isn’t working all that well, then what will? for profit irbs are here. what’s that going to look like? so i’m interested in all of that. hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 6 i would say still, because of the recent experience with ebola and pandemic flu, i’m interested in the ethics of humanitarian emergencies, the ethics of what to do when there’s a sort of a massive threat. peer impact kaitlynd: is there someone, a clinician or another academic, whose work has had an impact on your career? caplan: oh yeah, many. i was lucky. i had pretty good mentors. in the philosophy department at columbia, ernest nagel, a famous philosopher of science, definitely encouraged me. he didn’t know what i was doing, but encouraged me and said, “you know, you’re a good speaker, you can explain things well, you should think about more of a public role, not just wind up in the classroom or in the ivory tower like a philosopher.” when i got to columbia, there was a guy named bernard schoenberg, david rothman, this guy i mentioned is the bernard schoenberg professor. schoenberg was one of the guys who said, “why don’t you go down and see if you can get a master’s degree in philosophy. i support you in your interest in medical ethics.” he was supportive and he would offer good comments and tips how to deal with doctors and that sort of stuff. dan callahan and will gaylin at the hastings center were very influential for me because dan was a good writer and he edited me to the extent that i can write clearly and well. dan was the kind of person who would edit your lunch order; if you sent it to him and it had typos, he would fix them. so he was pretty committed. will was an early pioneer in bioethics in the public. he did the first tv show on public television about bioethics. he would talk to journalists and i watched him and thought, i could do that, and i think that’s important to do. and so he was useful that way. and there were others; there was a woman at hastings named ruth macklin. you’ve probably run across ruth -so i was a junior graduate student at the hastings, she was there as one of the first staff members, and i watched her make arguments and interact with people and i thought, ah, that’s pretty cool. she was very friendly. i got to know her very well. and she was an influence in terms of seeing how you could argue and use persuasive argument to change people’s minds about things. finding a public platform rachel: we had a question just asking about your general ubiquity in the mainstream media when it comes to issues of bioethics. you were mentioning your advisor said you shouldn’t want to be a part of the ivory tower, so how did you come to find a public platform? caplan: well, it’s interesting. it was deliberate, not an accident. after watching will do this back in the ’80s at the hastings center, bioethics was still struggling to try and be legitimate, get grants, be in journals, not just bioethics journals, but get into the new england journal, get into jama, places where routinely there are bioethics articles today. in fact, i don’t put a lot of my articles into bioethics journals; i put them into medical journals because they have a bigger audience. but it also seemed to me that if we were going to talk to patients and then have a practical impact, that wasn’t going to work through the journals because it just doesn’t. and the only way you can change policy, which i knew from my transplant experience, was to get the attention of politicians, and they watch the media. so the media becomes important as a vehicle to talk to patients, talk to politicians. so, i said, “you know, when i get the opportunities, i’m going to do this.” i taught a couple of guest lectures in the columbia school of journalism science class. volunteered to do it with a guy i knew named ken goldstein. then a couple of events like the barney clark artificial heart, the loma linda university baboon heart transplant hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 7 came into public attention and i wrote some bad articles about them and sort of muscled my way forward and said, “you know, these are scientifically interesting, but they raise all kinds of important ethical issues. you should think about the ethics.” i did that with answering journalists’ calls when they came; no one else at hastings wanted to do it, so i did it, or sometimes actually calling them up and saying, “you know, i read your story, but you don’t have a word in here about ethics and you should pay attention to the cost or the who gets it or the why are we doing this at all because it didn’t work on animals, so.” and then, as i said, there were big issue cases, baby doe, the fights about handicapped infants that were just sort of presenting themselves and i thought, these are natural teaching opportunities. [to build a public platform], you have to be good at it. most bioethicists are not. you got to be quick, witty, on point, succinct. these are not traits that capture a lot of bioethics. i quickly moved to starting to write my own stuff. you’ll see me doing op-eds all the time and i started doing a syndicated newspaper column back when i moved to minnesota. it ran in like 150 papers, but then i had my own voice. so taking control and having a footprint where people started to say, i see this guy writing opinion pieces. i would try to keep my scholarship going so that people couldn’t dump on me as just a carl sagan or steven gould popularizer. so of all the people in bioethics, i believe it’s true that i’ve written more period papers than anybody. that said, a) academics don’t like popularization; and b) they are envious of it. i can’t tell you the number of people who say, “well, i don’t own a tv, so i don’t really care what you do.” but then they would say, “but i heard you on public radio or i saw you in the new york times.” kaitlynd: well not only would you get flak from people, but has anybody given you criticism about you being the sort of spokesperson for the bioethics community as a whole? caplan: constantly. my attitude and my answer has always been, “take what you get. you only get a minute thirty, so, you don’t want to do it, don’t do it. but if you think you’re going to build in seven distinctions in your 20-second sound bite, probably not doing that.” i hear some of the criticisms of, “why are you the public face of bioethics?” part of me says, “because i know how to do it.” and that’s why. it’s pretty simple. they’ll go to people they think can do it. if i wasn’t good at it, they wouldn’t come back. impact on the field rachel: if you may be so bold, what impact do you think your work has had on the field? caplan: well, it’s funny in a couple of ways. in setting up bioethics programs at minnesota, at penn, and here [at nyu], that definitely has an impact because people watch the penn program; a lot of people are training with me, so i can see the stanford bioethics program is all people that were at penn with me, junior people then, now they run it; peter ubel at duke, david at louisville. upstate new york did a lot of programs that have spun out from my teaching, and i try pay attention to mentoring. i think it’s very important. i had good mentors; i want to be a good mentor. part of my job is to make new scholars and new people for the field,it isn’t just to throw my name onto their papers or steal their research, which does go on and i don’t like it. the field is known around policy circles and by at least some people around the world and i think i drove that. nobody writes articles anymore on medicine science without paying attention to ethics. that wasn’t true when i started. it’s true now. they always have something. they feel guilty if they don’t say something hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 8 about, you know, there’s an ethical issue with whatever stupid new technology it is; the new thermometer. i think that’s been good. i think i perfected public policy in some useful ways. transplant, absolutely. built a way to get organs. built a way to distribute them. now working on this compact idea with j&j to distribute unapproved drugs. it’s drawing on the transplant experience; i think that’s going to work. i could cite four of five other policy places, but i definitely had a direct impact on change in terms of fixing a problem or trying to get something solved that wasn’t solved and i like that. i think that’s -bioethics should do that. and it’s funny because it’s similar to when i first got into it. when somebody says, “do you want to try and implement it?” we should say, “yes.” not, “gosh. i’m too afraid.” or, “i’m hiding now.” or, “why don’t you read my articles.” or something. so, yeah, in a lot of ways. i fought stupid things like quarantining ebola and sort of beat that to death. helped patient groups a lot behind the scenes. i mean, i -it’s funny, it’s like egomaniacal hour, but i helped set up the national marrow donor program. made sure we protected the donors and that sort of thing. ran the blood safety advisory committee. eventually got them to flip the ban on gay men donating blood, although it took 15 years, but finally got it. i like to think i set a tone that is somewhat lighter than the usual dreary world of academia, which very much matters to me. i’m friendly with my critics for the most part. it takes a lot to get me to really jump down somebody’s throat in an angry way, but i’m trying to say, you know, we can argue about these things. i could be wrong, but we can kind of enjoy the whole thing. we don’t have to sort of, you know, treat ourselves like we’re having an argument amongst the minor greek gods. advice to bioethics students rachel: in the interest of broadening this field of which you’re currently at the head, what advice would you give to people who want to take the issues they’re learning about and make it more public? kaitlynd: to be part of the societal conversation about bioethics. caplan: oh, i think i’ve wedged open the idea that there is a conversation. so that’s out there to be used. second, you’ve got to be scholarly to be credible. so there is no shortcut. you can’t just go out there and say, i’m going to write op-eds all day on twitter and share my views because eventually someone’s going to say, what is this based on? there is relatively little that i comment on that i haven’t written something about. you know, i write a lot, so, it gets me a big portfolio, but if you hang around long enough, pretty soon you’ve written about everything. but you’ve got to have that foundation. decide what you can credibly comment on and stick to it. third, you’ve got to practice, which means write some of your own opinion pieces, try blogs, see what works and learn. ask for feedback. show stuff to your peers; what do you like about it? show stuff to your mother; what do you like about it? you know, try it out. i do that. my dad and my mother are still big commentators on things i do. they hear me on public radio in boston every week now and they feedback to me vigorously at 95 and 92. i think it’s also important to realize that people are not interested in the same thing that a bioethics colloquium would be interested in. they don’t really want your reasons. they want to know what their hiller and bloom, interview with art caplan, voices in bioethics, vol. 3 (2017) 9 options and alternatives are. so it’s a little bit more translational in terms of what you’re trying to achieve. then if they ask, you supply them with arguments. lastly, you know, a lot of what i do, i take positions on lots of things and i’m not afraid to do that, but often all i’m trying to say is crispr [or another biomedical shift] is coming, it raises a whole slew of issues, and you ought to pay attention. that’s what i call the prophetic mode. we try to look ahead and say, “this thing is going to make issues and here’s what some of them i think are.” and that’s it. that’s useful in the conversation; it isn’t just having answers; it’s sometimes raising questions in the socratic way, if you want to think of socrates in the marketplace. there’s some of that that goes on and it’s very important to be ahead of the game. i mean, we were talking about cloning 15 years before dolly appeared. stem cells, same thing. and that means being on top of science. so, you got to know where it’s going so you can flag it in a timely manner. sobeck, false hope, voices in bioethics, vol. 2 (2016) * karin sobeck, rn, msn, cnn, cctc, candidate ms bioethics, columbia university. © 2016 karin sobeck. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, dist ribution, and reproduction, provided the original author and source are credited. false hope: when waiting your turn isn’t fair karin sobeck* keywords: transplant ethics, transplant coordinator, narrative medicine, bioethics introduction mr. x is a vibrant seventy-eight-year-old patient who would be exultant on a sunny day. he is an enthusiastic sailor who owns his own boat and regularly competes in regattas. his friends and family are amazed at how defiant he is to being classified as elderly. but, elderly he is. the only thing that keeps him from more competitions is the interference of dialysis treatments three times per week. mr. x has kidney failure and needs a kidney transplant. mrs. g. is an eighty-one-year-old college student, having returned to college to advance her passion for learning. despite her age, she commutes regularly to campus and demonstrates that “where there is a will, there is a way”. but, mrs. g. is starting to fail because she also needs a kidney transplant and the reality of imminent dialysis hovers over her life. both mr. x. and mrs. g. were patients under my care until last july when i retired as a transplant coordinator, after forty-three years of nursing, twelve years as a kidney transplant coordinator, and fifteen years as a dialysis supervisor. both of my parents were on dialysis for many years until their deaths. therefore, from my perspective i feel appropriate speaking from both “sides of the fence” regarding the ethics of kidney transplantation, the effects of dialysis on the health and psyche of the patient whose kidney is failing, and the hidden discriminations that influence which patients are transplanted and those who linger with false hope. ____________________________________________________________ analysis it is a complicated allocation system to find equity for all those who need a kidney. the united network for organ sharing (unos) recently introduced a system that attempts to provide the top 20 percent of aboveaverage kidneys to the top 20 percent of patients most likely to survive transplantation. the remaining 80 percent of kidneys are distributed among the recipients based on their age, years on dialysis, and other complicating medical co-morbidities, such as heart disease and blood type. the scientific registry of transplant recipients, a federally funded report keeping statistics on potential transplants, indicates that there are more than 100,000 patients waiting for organs with more than 30,000 new patients added every year. so why the title “false hope”? when did the old adage we were taught as children, “be patient and wait your turn,” become less than truthful when applied to kidney transplantation? you first need to understand how a kidney failure patient gets listed. anyone can refer oneself for sobeck, false hope, voices in bioethics, vol. 2 (2016) 2 transplant to a center, normally done by the patient’s nephrologist. the center arranges an interview with the members of the transplant team to determine how strong a given candidate is. the transplant coordinator presents the candidate’s data to a selection committee, composed of all the members of the team. a decision is made to list the patient, defer the patient, or deny the patient for listing. transplant coordinators advocate for their patients, often fiercely. when an organ becomes available, the transplant surgeon on call reviews the patients at the top of the computerized list and instructs the coordinator on which patients he or she wants to cross-match in order to determine if the patient is compatible. this is where the discrimination often occurs! the transplant surgeon desires the best results. this means that the surgeon wants both the transplanted organ and the patient to survive as long as possible. the transplant center wants its statistics to excel when compared to other transplant centers. this hope is not only humanitarian, but has implications with insurance companies that decide to restrict the patient from listing at centers with lower than average survival. it is the surgeon’s choice as to which patient is chosen, not the amount of time that the patient has been waiting. medical professionals and the lay public might argue that this is as it should be. the transplanting surgeon should be confident that he or she made a judicious decision about which patient to transplant and the transplant recipient would obviously share that desire. but what about mr. x and mrs. g when their names come to the top of the list? because of their age, they are often overlooked and never given a chance to be cross-matched. or, if they get lucky enough to be included in the cross-match, they are not selected due to age bias from the surgeon, who may have never met the patient. conclusion how do we correct this bias when our population is growing older in greater numbers than ever before? the ethical dilemma is transparency. the solution is twofold: first, do not list a patient and give him or her false hope unless every surgeon on call agrees not to eliminate patients based on age alone, and, second, hold surgeons accountable for those whom they passed over by regular reviews of cross-match lists. until then, mr. x and mrs. g will believe that the system is equitable when, in fact, it is nontransparent. lee, ectogenesis, voices in bioethics, vol. 2 (2016) © 2016 katarina lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ectogenesis katarina lee keywords: ectogenesis, reproductive ethics, artificial reproductive technologies, developmental biology introduction is growing babies in tanks really possible? recent developments in uterine transplantation in sweden, the united kingdom, and the united states have opened up the conversation about ectogenesis, also known as artificial wombs or extracorporeal gestation.1 ectogenesis is the process of creating an environment that will simulate that of a womb in which a human fetus can develop. individuals focused on ectogenesis typically argue that this process has three purposes: (1) a medical treatment to support further gestation of premature fetuses in an artificial environment; (2) an elective art (assisted reproductive technology), in which an embryo is created through in vitro fertilization and is gestated externally; and (3) a viable “solution” to the abortion debate. analysis ectogenesis is not a new technology. in a study published in 1982, researchers reported they were able to incubate a mouse fetus for eleven to twelve days out of the nineteento twenty-day gestational period of a mouse. 2 furthermore, a six-year study conducted by yoshinori kuwabara, a japanese scientist, has been the most significant study of record. in that study,3 goat fetuses were removed from their mothers by caesarean section before viability. after removal, an extracorporeal membrane oxygenation (ecmo) unit supported (gestated) the fetuses. investigations into ectogenesis stagnated after the 1980s, but since 2001, experimental research has rebounded, resulting in successfully “growing mouse embryos in wombs attached to ‘placenta machines.’”4 additionally, human testing of ectogenesis has already begun as scientists have grown a human embryo in an artificial environment for approximately eleven days.5 there are many ethical concerns associated with ectogenesis, including appropriate human subjects research protections, concerns about impacting the parent-child relationship, potential societal risks to women, and creating a larger socioeconomic divide between the wealthy and the poor. while these ethical issues need to be addressed, the purpose of this article is to address the impact ectogenesis may have on the abortion debate. while ectogenesis may pose a viable alternative to terminating pregnancies, it is unlikely to conclude the abortion debate given current american law. lee, ectogenesis, voices in bioethics, vol. 2 (2016) 2 the ability to procure a legal abortion in the united states is based upon an interpretation of a liberty interest in the us constitution permitting a woman’s right to choose what is done to her body. according to the united states supreme court in roe vs. wade (and subsequent cases), a woman’s autonomy is legally protected.6 significantly, much of the dicta justifying these case decisions, as well as the laws that have developed as a result of these decisions, focus on a fetus’s viability outside of a mother’s womb. notably, the guttmacher institute states that there are forty-three states that prohibit abortions after a certain point in gestation, “most often [after] fetal viability.”7 this begs the question of what legally happens when a fetus has the capability of being grown outside of a mother’s womb? pro-life advocates may argue that ectogenesis is the end of abortion, because there is no longer a trumping of the rights of a woman’s body over the rights of a fetus. proponents can base this argument on the fact that once outside of a womb, a fetus (or child) begins to have its own set of rights. this argument, however, does not account for whether there would be enough artificial wombs to meet the abortion demand in the united states. additionally, who would pay for these artificial wombs and facilities to “grow” these fetuses (children)? abortion advocates argue that abortion is not solely about avoiding giving birth to a fetus or child, but rather for many, it is also about not having a genetic child in existence. arguably, if it were as simple as not giving birth to a child, more women may give their children up for adoption. some may argue that part of the reason that women procure abortions is shame or concern about revealing that they are pregnant. for those women, ectogenesis may provide a helpful solution. they can undergo a procedure such that their fetus is removed and “grown” in an artificial womb. in these situations, women can allow their fetus (child) to exist, while potentially reducing some social and economic anxieties. a third issue that pro-life advocates who support ectogenesis must account for is that women still have to undergo a medical procedure. this runs into contradiction with roe (and subsequent cases), as it may impact a woman’s ability to make decisions over her body. as a result, removing a fetus and then placing it into an artificial womb, while providing a “solution” for some women, would unlikely become a “solution” to the abortion debate. opponents would likely argue that requiring women to undergo fetal removal instead of an abortion (1) would be an undue burden on women and (2) creates a coercive or discriminatory practice solely impacting women. as a result, in order for ectogenesis to be a “solution” to the abortion debate, there would have to be a drastic shift in united states law addressing maternal and fetal rights. conclusion while “growing” fetuses in artificial environments and removing fetuses prior to viability and placing them in these artificial wombs is many years into the future, it is still worthwhile to note some of the legal roadblocks that american society will have to address. although ectogenesis will not drastically impact the abortion debate, it does provide an opportunity to further engage in fruitful discussions regarding the rights of fetuses and those of women. whose rights come first? 1 eleanor robertson, “feminist, get ready: pregnancy and abortion are about to be disrupted,” the guardian, october 12, 2015,http://www.theguardian.com/commentisfree/2015/oct/12/feminists-get-ready-pregnancy-and-abortion-are-about-to-bedisrupted. 2 nobuya unno, “development of an artificial placenta,” symposium, 62,http://90.146.8.18/en/archiv_files/20001/e2000_062.pdf. 3 id. at 64. 4 victoria woollaston, “would you grow your child in an artificial womb outside of a human body? ectogenesis could be widely used in 30 years,” mail online, august 14, 2014,http://www.dailymail.co.uk/sciencetech/article-2724823/would-you-grow-childartificial-womb-outside-human-body-ectogenesis-widely-used-30-years.html. http://www.theguardian.com/commentisfree/2015/oct/12/feminists-get-ready-pregnancy-and-abortion-are-about-to-be-disrupted http://www.theguardian.com/commentisfree/2015/oct/12/feminists-get-ready-pregnancy-and-abortion-are-about-to-be-disrupted http://90.146.8.18/en/archiv_files/20001/e2000_062.pdf http://www.dailymail.co.uk/sciencetech/article-2724823/would-you-grow-child-artificial-womb-outside-human-body-ectogenesis-widely-used-30-years.html http://www.dailymail.co.uk/sciencetech/article-2724823/would-you-grow-child-artificial-womb-outside-human-body-ectogenesis-widely-used-30-years.html lee, ectogenesis, voices in bioethics, vol. 2 (2016) 3 5 paula mejia, “fetuses in artificial wombs: medical marvel or misogynist malpractice,” newsweek, august 6, 2014, http://www.newsweek.com/fetuses-artificial-wombs-medical-marvel-or-misogynist-malpractice-263308. 6 roe v. wade, 410 u.s. 113 (1973) holding modified byplanned parenthood of se. pennsylvania v. casey, 505 u.s. 833 (1992). 7 guttmacher institute, state policies in brief: an overview of abortion laws, march 1, 2016,http://www.guttmacher.org/statecenter/spibs/spib_oal.pdf. http://www.newsweek.com/fetuses-artificial-wombs-medical-marvel-or-misogynist-malpractice-263308 http://www.guttmacher.org/statecenter/spibs/spib_oal.pdf introduction is growing babies in tanks really possible? recent developments in uterine transplantation in sweden, the united kingdom, and the united states have opened up the conversation about ectogenesis, also known as artificial wombs or extracorporeal gestati... analysis conclusion aurora, no mers vaccine, voices in bioethics, vol. 1 (2014-15) © 2015 pranav aurora. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. why we don’t need a mers vaccine pranav aurora keywords: vaccine development, mers, global outbreak, prevention, public health introduction on the heels of the ebola outbreak, the globe is confronting another potential pandemic – the middle eastern respiratory syndrome (mers) virus. with reported cases now reaching at least 26 countries1 and the death total climbing towards 500,2 mers has surfaced to international attention since its initial outbreak in saudi arabia in 2012. in particular, the global scale of this infectious disease has moved the scientific community to antagonize big pharmaceutical companies for not developing a vaccine.3 analysis however, is the attention on the need for a vaccine truly warranted? below are three critiques for why a mers vaccine is not necessary. 1. according to the un, mers is not a global threat.4 mers transmission is substantially lower than the severe acute respiratory virus (sars), a virus in the same family as mers that claimed over 800 lives globally in 2003. 5 despite being about four times more fatal than sars, mers is 90 times less transmissive.6 in addition, according to officials in saudi arabia and south korea, where the outbreak is most prevalent, the death rate from mers is slowing.78 also, there is no evidence that the mers virus is mutating into more dangerous forms. 2. the global outbreak is the result of ill-prepared public health systems. about half of the cases in south korea have been linked back to a single hospital, where a delayed diagnosis resulted in 900 people coming into contact with an infected individual.9 additionally, the deadly impact of mers in saudi arabia, which claims 30% of deaths worldwide, is largely due to the saudi kingdom’s resistance to accept foreign assistance.10 experts believe that the spread of mers both within saudi arabia and globally could have been mitigated, and even stopped entirely, had saudi authorities been willing to cooperate with public health entities, such as the world health organization (who). given this context, the call for a vaccine may actually be undeserved, and rather the global outbreak unveils systemic failings in the international preparedness for infectious disease outbreaks. aurora, no mers vaccine, voices in bioethics, vol. 1 (2014-15) 2 3. vaccine development and deployment present substantial challenges. from research and discovery to product registration, it takes about us$200-900 million11 and 10 years12 to deliver a final, licensed vaccine. also, only about 6% of vaccines will successfully progress through preclinical testing and enter the market.13 in addition, having a ready vaccine does not guarantee that all individuals will have access to it. failed vaccine campaigns are all too prevalent.14 these issues make clear that vaccines cannot replace, only augment, public health systems. vaccines are incredible public health tools for combating infectious disease. however, they are not a silver bullet. public health preparedness for infectious disease requires a comprehensive strategy for prevention and mitigation. according to the who’s international health regulations emergency committee, the mers outbreak in south korea is a “wakeup call.”15 the main factors contributed to the rapid spread of the infection included a lack of awareness among health workers and the general public about mers, poor prevention and control measures, crowded emergency rooms, infected patients seeking care at multiple hospitals, and the custom of allowing many visitors to be at the bedside of patients. a vaccine cannot fix these problems. in response to the outcry from the scientific community that “there’s no excuse for our lack of a mers vaccine,”]16 i argue that their emphasis is misdirected. i believe there are two virtues that offer valuable insight into the issue. the first is responsibility. what mers has highlighted is that there is no excuse for ill-prepared, unequipped, and underfunded public health systems. while pharmaceutical companies may have a moral obligation to develop life-saving medicines, the burden of responsibility falls on national and international officials to protect its citizens. in this case, pharmaceutical companies should not be held responsible, but the public health systems and officials that have failed their citizens. the second is prudence. while vaccines are often the most cost-effective intervention to combat infectious disease, not all infectious diseases warrant a vaccine. the evidence supporting immunization is skewed by vaccines that have brought seven major diseases under control – smallpox, diphtheria, tetanus, yellow fever, whooping cough, polio, and measles.17 the smallpox vaccine alone prevents five million deaths a year. with fewer than 500 deaths globally over 3 years, mers is simply not in the same category. currently, the big three diseases – hiv/aids, malaria, and tuberculosis – claim millions of lives annually and neglected tropical diseases affect more than a billion individuals. the limited resources available for global public health investment should be focused on those causes. additionally, it is estimated that less than one percent of microbes have been identified by scientists.18 it will not be feasible to develop a vaccine for each and every deadly pathogen that arises in the future. conclusion i believe the 2002-2003 sars outbreak provides an optimistic outlook to end on. in as fast as it gripped the world, sars was virtually eradicated as a threat and without a vaccine.19 if those responsible take ownership over their mistakes and the international community prudently invests in protecting its citizens from infectious diseases, it may be possible for mers to have the same fate. 1 http://www.who.int/csr/disease/coronavirus_infections/faq/en/ 2 http://www.cnn.com/2015/06/25/asia/south-korea-mers-toll/ https://michael-reaves-bkln.squarespace.com/newswire/2015/07/23/why-we-dont-need-a-mers-vaccine#_edn16 http://www.who.int/csr/disease/coronavirus_infections/faq/en/ http://www.cnn.com/2015/06/25/asia/south-korea-mers-toll/ aurora, no mers vaccine, voices in bioethics, vol. 1 (2014-15) 3 3 http://www.reuters.com/article/2015/06/15/health-mers-vaccine-idusl5n0yy2gg20150615 4 http://www.usnews.com/news/world/articles/2015/06/17/un-spread-of-mers-in-south-korea-isnt-global-emergency 5 http://www.who.int/csr/sars/country/2003_07_11/en/ 6 http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7b422866a7-0445-49b3ac14-54b39bebbba6%7d/mers-vs-sars-compare-and-contrast 7 http://english.alarabiya.net/en/news/middle-east/2015/03/23/mers-infection-death-rates-slowing-down-says-saudi-govt.html 8 http://www.ndtv.com/world-news/rate-of-mers-infections-in-south-korea-slows-with-1-new-case-773136 9 http://www.reuters.com/article/2015/06/23/us-health-mers-southkorea-outbreak-iduskbn0p300920150623 10 http://www.reuters.com/article/2014/05/22/us-saudi-mers-specialreport-idusbrea4l03d20140522 11 http://www.ncbi.nlm.nih.gov/pubmed/12477303 12 http://www.ncbi.nlm.nih.gov/pubmed/21722688 13 http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3603987/ 14 http://blogs.plos.org/speakingofmedicine/2011/09/12/failed-vaccine-campaigns-are-a-global-issue/ 15 http://www.who.int/mediacentre/news/statements/2015/ihr-ec-mers/en/ 16 http://www.huffingtonpost.com/2015/06/15/why-no-mers-vaccine-lack_n_7584380.html 17 http://www.unicef.org/pon96/hevaccin.htm 18 http://bioscience.oxfordjournals.org/content/54/12/1064.full 19 http://www.huffingtonpost.ca/2013/03/11/sars-2013_n_2854568.html http://www.reuters.com/article/2015/06/15/health-mers-vaccine-idusl5n0yy2gg20150615 http://www.usnews.com/news/world/articles/2015/06/17/un-spread-of-mers-in-south-korea-isnt-global-emergency http://www.who.int/csr/sars/country/2003_07_11/en/ http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7b422866a7-0445-49b3-ac14-54b39bebbba6%7d/mers-vs-sars-compare-and-contrast http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7b422866a7-0445-49b3-ac14-54b39bebbba6%7d/mers-vs-sars-compare-and-contrast http://english.alarabiya.net/en/news/middle-east/2015/03/23/mers-infection-death-rates-slowing-down-says-saudi-govt.html http://www.ndtv.com/world-news/rate-of-mers-infections-in-south-korea-slows-with-1-new-case-773136 http://www.reuters.com/article/2015/06/23/us-health-mers-southkorea-outbreak-iduskbn0p300920150623 http://www.reuters.com/article/2014/05/22/us-saudi-mers-specialreport-idusbrea4l03d20140522 http://www.ncbi.nlm.nih.gov/pubmed/21722688 http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3603987/ http://blogs.plos.org/speakingofmedicine/2011/09/12/failed-vaccine-campaigns-are-a-global-issue/ http://www.who.int/mediacentre/news/statements/2015/ihr-ec-mers/en/ http://www.huffingtonpost.com/2015/06/15/why-no-mers-vaccine-lack_n_7584380.html http://www.unicef.org/pon96/hevaccin.htm http://bioscience.oxfordjournals.org/content/54/12/1064.full http://www.huffingtonpost.ca/2013/03/11/sars-2013_n_2854568.html cohen, enlisting patients to reduce medical errors, voices in bioethics, vol. 2 (2016) * jennifer p cohen, jd st. john’s university, m.s. candidate in bioethics columbia university © 2016 jennifer p cohen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. enlisting patients to reduce medical errors jennifer cohen* keywords: medical errors, reporting, ethics, patient experience introduction two recent reports on patient safety reinforce a compelling yet fairly obvious claim: doctors can reduce medical error by enlisting patients as participants in that process. such a participation would mean more frank, proactive disclosure by healthcare professionals of the risks of medical error to patients, but by doing so, patients themselves may improve the chances of error-free care. analysis medical error made headlines this summer when a team at johns hopkins university claimed that 250,000 deaths per year are attributable to medical error.1 if this claim is true,2 medical error would be the third leading cause of death in the united states, surpassed only by heart disease and cancer. a recent piece in jama explained that it is difficult to measure the magnitude of this issue because “there is no comprehensive, nationwide system for reporting or capturing all types of medical errors.”3 even defining what constitutes medical errors is controversial. a 2006 report by the institute of medicine (iom) concluded that “there are at least 1.5 million preventable [adverse drug events] that occur in the united states each year.”4 should these events be counted as “errors”? although there is still debate regarding how to define, quantify, and regulate this problem, all stakeholders agree that medical errors need to be reduced. much of the literature surrounding disclosure of error to patients, including the ama’s code of ethics, is premised on three concerns: the ethical duty related to the patient’s autonomy, i.e., full disclosure of an error allows a patient “to make informed decisions regarding future medical care,”5 the maintenance of trust in the doctor-patient relationship, and the reduction of legal liability. while these are all important goals, can this patient disclosure requirement intersect with the goal of reducing errors themselves? in 2009, president obama asked the department of health and human services (hhs) to conduct research into projects that would put “patient safety first” by reducing preventable injuries, i.e. medical errors. seven programs were put in place focusing on, among other areas, improving communication with patients in order to enhance patient safety, specifically with respect to acknowledging medical errors. in may of 2016 the agency for healthcare research and quality (ahrq) submitted a report evaluating the various initiatives. one of the programs at the university of texas (ut) focused primarily on how hospitals could better their practices by utilizing patients’ experience with medical error. unlike many programs that focus on disclosure of medical error in light of conflict resolution and litigation prevention, the program at ut also aimed at “incorporating patient and family input into efforts to understand why errors occur.”6 to that end the program undertook two initiatives, (1) questioning the medical staff to assess ut hospitals’ ‘disclosure culture’ and (2) using a structured interview guide for gathering information from patients and family members after an adverse event.7 the authors noted that healthcare professionals that underwent training in how to disclose errors “had significantly more positive attitudes about error disclosure and perceived disclosure as less damaging to patient and peer trust.”8 by speaking to 72 patients and family members who had experienced harm after an adverse event, the authors learned that most “would like to participate in the hospital’s adverse event analysis process.”9 though many had no intention of pursuing litigation, they reported that they had considered litigation in order to receive information about what happened, and to get assurance that someone cohen, enlisting patients to reduce medical errors, voices in bioethics, vol. 2 (2016) 2 was addressing the problem.10 this finding is promising, as it strongly suggests that patients’ concerns over the investigation of medical errors can be utilized by healthcare professionals to make progress toward reducing errors. in addition, the program seemed to show that training medical staff on how to disclose errors was highly effective in changing attitudes and fears toward disclosure. presumably, the more that healthcare professionals can be encouraged and trained to honestly and proactively disclose the risk of medical errors to patients, the more the patient can be enlisted to prevent them. so-called “patient identification error” was the subject of a recent report by ecri institute pso, an independent non-profit focused on patient care. the report looked at data from more than 180 healthcare organizations from january 2013 through august 2015 and determined that at least 7,000 “wrong patient errors” had occurred and that most, if not all, of them were preventable.11 the ecri report’s recommendations made it clear that patient education and engagement is a critical component of reducing “patient misidentification.” they recommended that healthcare providers engage patients and their family to take an active role in their safety by speaking up to staff if patient identification procedures are not followed, questioning unexpected tests, and requesting to see their registration forms and charts.12 conclusion the ama requires that errors be disclosed after an adverse event if harm occurs. perhaps if the ethical obligation to disclose the risks of common medical errors was extended to include all interactions with patients regardless of harm, patients could then be on notice for those mistakes. these two reports suggest that medical staff who forthrightly disclose the risks of medical errors to patients may find themselves with powerful allies—the patients themselves. 1 martin a. markary and michael daniel, “medical error – the third leading cause of death in the us,” bmj. 2016;353:i239. 2 many articles dispute the claim. see, e.g. gerard j. gianoli, m.d., “medical error epidemic hysteria,” the american journal of medicine, doi: http://dx.doi.org/10.1016/j.amjmed.2016.06.037, and david gorski, “are medical errors really the third most common cause of death in the u.s.?” science-based medicine, last modified may 9, 2016. https://www.sciencebasedmedicine.org/are-medical-errors-really-the-third-most-common-cause-ofdeath-in-the-u-s/ 3 jennifer abbasi, “headline-grabbing study brings attention back to medical errors,” jama 316, no. 7 (2016): 699. 4 philip aspden, et al., institute of medicine report brief: preventing medical errors(washington, d.c.: institute of medicine, national academy of sciences, 2006) 1. accessed october 12, 2016. http://www.nationalacademies.org/hmd/~/media/files/report%20files/2006/preventing-medicationerrors-quality-chasm-series/medicationerrorsnew.ashx 5 the ama code of medical ethics’ opinions on patient safety, opinion 8.12 – patient information virtual mentor 13, no. 9: 626-628. . accessed october 11, 2016. http://journalofethics.ama-assn.org/2011/09/coet11109.html 6 michelle pillen, et al., longitudinal evaluation of the patient safety and medical liability reform demonstration project: demonstration grants final evaluation report. (rockville, md: agency for healthcare research and quality,2016.) 16. accessed october 13, 2016. http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient-safetyresources/resources/candor/psml-demo-grants-final-report.pdf. 7 ahrq, 16. http://dx.doi.org/10.1016/j.amjmed.2016.06.037 http://www.nationalacademies.org/hmd/~/media/files/report%20files/2006/preventing-medication-errors-quality-chasm-series/medicationerrorsnew.ashx http://www.nationalacademies.org/hmd/~/media/files/report%20files/2006/preventing-medication-errors-quality-chasm-series/medicationerrorsnew.ashx cohen, enlisting patients to reduce medical errors, voices in bioethics, vol. 2 (2016) 3 8 ahrq, 16. 9 ahrq, 17. 10 ahrq, 17. 11 jason adelman, et al, ecri institute pso deep dive: patient identification executive summary, (pennsylvania: ecri institute pso, 2016) 5. accessed october 12, 2016. https://www.ecri.org/resources/whitepapers_and_reports/pso%20deep%20dives/deep%20dive_pt_id_2016_e xec%20summary.pdf 12 ecri, 11. introduction analysis conclusion the ama requires that errors be disclosed after an adverse event if harm occurs. perhaps if the ethical obligation to disclose the risks of common medical errors was extended to include all interactions with patients regardless of harm, patients could... lee, shifting surrogacy laws and legal parenthood, voices in bioethics, vol. 1 (2014-15) © 2015 katarina lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. shifting surrogacy laws and legal parenthood katarina lee keywords: baby gammy, donor, legal parenthood, parenthood, surrogacy, surrogacy laws introduction both international and domestic surrogacy suffers from a vast lack of legal regulation. looking abroad, most countries do not possess laws that address surrogacy and, domestically, there are huge variances amongst the states. this lack of legalization or criminalization has resulted in fertility clinics and practitioners setting up shop without any consistency, standards or protections. in recent history, surrogacy hot spots have included countries such as india, thailand and mexico. why these countries? there are two reasons why intended parents typically procure a foreign surrogate: (1) reduced cost and/or (2) surrogacy is illegal in the home country of the intended parent(s). however, as recently portrayed in the media, going abroad to procure a surrogate can open up a plethora of legal issues when countries’ laws conflict or new legislation is passed, most specifically with determining legal parenthood of the child.1 analysis one of the most public changes in surrogacy regulation was the recent decision in thailand to prohibit international commercial surrogacy. the primary catalyst for the thai government to act was the recent baby gammy case.2 baby gammy is a child born to a thai surrogate with australian intended parents. she and her twin were born in thailand, but when baby gammy’s intended parents discovered that she was born with down syndrome, her parents abandoned her and took her “healthy” twin back to australia. further adding to the horror of the baby gammy case, was that the twins’ intended father is a previously convicted child sex offender.3 notably, commercial surrogacy is illegal in australia, meaning that baby gammy’s intended parents went to thailand to circumvent australian law.4 under australian law, when an intended parent uses a foreign paid surrogate they are not recognized as the legal parent of the child in australia, regardless if the intended parent and child are genetically related. 5 furthermore, the intended parents risk potential criminal charges.6 these laws are in place to act as a deterrent for australians wishing to use a commercial surrogate abroad. the baby gammy scandal, along with other media exposes of surrogacy scandals in thailand resulted in thailand changing its law.7 as of july 30th 2015, thailand will only permit “thai heterosexual couples married for more than three years” to procure a surrogate.8 those who violate the new law may be subject to “10 years in prison and a fine of up to 200,000 baht ($6,200).”9 notably, the new law also grants intended parents full parental rights of the child when the child is born. 10 determining parenthood is often the main legal lee, shifting surrogacy laws and legal parenthood, voices in bioethics, vol. 1 (2014-15) 2 concern regarding surrogacy. prior to the new law, the previous thai law granted that the surrogate mother was the legal mother of the child, regardless of the genetic mother or intended parent(s).11 this has left a male homosexual couple in thailand unable to take their intended child out of thailand because the thai surrogate refuses to sign the necessary paperwork. the child was born to the surrogate under the old law granting her legal motherhood over the child.12 thailand is unlike many countries in that there is a clear ruling on who is the legal parent in surrogacy situations. however, the clear switch in granting legal parenthood evidences the difficulty in determining who the legal parent should be. regardless of how one views surrogacy from an ethical perspective, it is important to discuss who should be the legal parent of a child born through surrogacy. there are three scenarios with gestational surrogacy and legal parenthood: (1) the intended child is the full genetic child of the intended parents; (2) the intended child is created through the donation of a sperm or egg cell fused with a sperm or egg cell of an intended parent, thus the child is only genetically related to one of the intended parents or a single intended parent; or (3) the child is not genetically related to the intended parent(s) because both a sperm and egg donor were used. as a result there can be up to three different parties with “interests” in a child: (1) the intended parent(s); (2) the surrogate; and (3) the gamete donor(s). weighing the interests of these parties is needed to determine what is in the best interest of the child. in situations where the child is the full genetic child of the intended parents there are two parties who have an “interest” in the child: (1) the surrogate and (2) the intended parents who are also the genetic parents. firstly, the intended parents have gone through the effort of contracting, paying for and using reproductive technologies because they intended to raise a child. this is not to diminish the importance and sacrifice of the surrogate, but given that the surrogate presumably did not intend to raise this child, as she consented to be a surrogate, the intended parents’ interest supersede those of the surrogate. secondly, in this scenario the child is also the genetic child of the intended parents, thus even if one wishes to argue that genetics supersede intention, the legal parents of the child would be the intended parents. it is the second and third scenarios that are more open to debate. these situations require the procurement of donor gametes, usually anonymously “donated” gametes. donated is in quotation marks as those who donate their gametes are typically financially compensated. please also note that depending on the country or state, donating one’s gametes actually still grants legal parenthood to the donor, even if the gametes have been anonymously donated.13 this means that an individual who donates their sperm or eggs to a fertility clinic can still be the legal father or mother of a child that was created through artificial reproductive technologies. however, this is rarely enforced and thus the assumption in most surrogacy contracts is that the donors have rescinded their legal rights. therefore, even though they have a genetic tie, these donors did not intend to raise the children resulting from their donations. those who support the practice of gestational surrogacy argue that the surrogate is financially compensated and is not genetically related to the child; therefore, the surrogate should rescind their legal rights to the child. this argument is less controversial in the second situation because one or the sole intended parent(s) is also the genetic parent. therefore, the intended parent(s) also have a genetic tie to the child, in tandem with their intention to raise the child. however, in the third scenario, where no known parties in the surrogacy arrangement are genetically related to the child it initially seems that all parties have a similar amount of “interest” in the child. the surrogate gestates and gives birth to the child, and she arguably has a more intimate relationship with the child at birth. however, similar to the other two scenarios, the intended parents agreed to financially compensate her to give them the child they intend to raise. intended parents would not contract with surrogates that they believe would not allow them to be the legal parents of the child created. therefore, the intended parents should be the legal parents of the child, regardless of the lack of genetic or biological tie. lee, shifting surrogacy laws and legal parenthood, voices in bioethics, vol. 1 (2014-15) 3 conclusion the ethical and legal questions of surrogacy are two separate concerns. i am opposed to surrogacy in all situations due to ethical and health concerns of surrogates and children. however, given that surrogacy continues to be prevalent in today’s society, children that result from surrogacy should be protected through legal recourses in order to grant them safety in surrogacy transactions. this safety includes allowing them to be raised by their intended parents. note that these intended parents need to be appropriately vetted similarly to parents who adopt, in order to avoid any potential child abuse. furthermore, in the situations where intended parents abandon their children, like baby gammy, intended parent(s) should be required to financially support their child, or provide recourses to place that child up for adoption. the responsibility of the child should not be left to the surrogate. 1 http://www.cnn.com/2015/05/08/americas/mexico-us-couple-surrogacy-snafu/ 2 http://www.independent.co.uk/news/world/australasia/baby-gammy-australian-father-who-abandoned-down-syndromesurrogate-child-now-tries-to-access-funds-donated-for-his-care-10261916.html 3 http://www.independent.co.uk/news/world/australasia/husband-in-thai-surrogacy-row-served-jail-time-for-indecently-dealingwith-a-child-9648200.html 4 http://www.smh.com.au/comment/should-commercial-surrogacy-be-legal-in-australia-20150514-gh1ead.html 5 https://aifs.gov.au/publications/families-policy-and-law/8-use-surrogacy-australians-implications-policy-and-law-reform 6 https://aifs.gov.au/publications/families-policy-and-law/8-use-surrogacy-australians-implications-policy-and-law-reform 7 http://www.washingtontimes.com/news/2015/aug/7/thailand-bans-commercial-surrogacy-for-foreign-par/?page=all 8 http://www.lgbtqnation.com/2015/08/thailand-bans-commercial-surrogacy-for-lgbts-singles-foreigners/ 9 http://www.lgbtqnation.com/2015/08/thailand-bans-commercial-surrogacy-for-lgbts-singles-foreigners/ 10 http://www.washingtontimes.com/news/2015/aug/7/thailand-bans-commercial-surrogacy-for-foreign-par/?page=all 11 http://uk.reuters.com/article/2015/07/24/uk-thailand-usa-baby-idukkcn0px13f20150724 12 http://www.cnn.com/2015/07/22/asia/thailand-surrogacy-gay-couple/ 13 http://dlslibrary.state.md.us/publications/opa/i/licar_2012.pdf lee, what happens to the leftovers, voices in bioethics, vol. 3 (2017) * katarina lee is pursuing her jd at the university of minnesota, specializing in health law & bioethics. © 2017 katarina lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distr ibution, and reproduction, provided the original author and source are credited. what happens to the leftovers? is compassionate transfer ethical? katarina lee* keywords: bioethics, ivf, embryos, compassionate transfer introduction the washington post recently published an article discussing ivf and one woman’s journey in the creation of her child.1 unlike other articles that often focus on the process of ivf, sarika chawla highlighted an often forgotten and diminished aspect of ivf, the obligations to “left-over” embryos. chawla discussed five options for these embryos: (1) destroy them; (2) donate them to medical research; (3) donate them to an infertile woman; (4) keep them frozen; and (5) engage in compassionate transfer. while chawla did not address a sixth option in her article, it should be noted that there are also fertile women who will gestate “left-over” embryos out of a sense of moral and often religious obligation. analysis ivf not only poses financial and physical tolls on intended parent(s), but it places an enormous emotional burden on the parties involved. in the excitement and desire to have children, many individuals often overlook questions regarding “left-over” embryos. in any given round of ivf, several ovum are fertilized resulting in several embryos. while standards are consistently in flux, typically two embryos are transferred at a time. this leaves several frozen embryos as “back-up” if the previous transfers are unsuccessful. many intended parent(s) choose not to address what will happen to the remaining embryos until after family completion, but by then they are left with embryos they often consider to be future children and siblings to their livebirth children. while the accurate number of frozen embryos is unknown due to lack of reporting requirements, in 2011, it was estimated that there were more than 600,000 in the us. considering that ivf now accounts for 1.5% of all babies born in the us, it seems likely that the number is significantly greater.2 while there are several choices for what intended parents can do with these embryos, chawla’s article mentions compassionate transfer. compassionate transfer is the process of transferring remaining embryos into the uterus of a woman when it is highly unlikely to result in pregnancy. the general rationale for such a procedure is that a woman is “open” to the potentiality that these embryos could implant and therefore it is lee, what happens to the leftovers, voices in bioethics, vol. 3 (2017) 2 less morally problematic than intentionally destroying these embryos or leaving them frozen indefinitely. moreover, proponents argue that the embryo’s passing is more akin to a miscarriage compared to an intentional destruction of the embryo. additionally, many intended parent(s) do not feel comfortable with others gestating their embryos. practically, while compassionate transfer may be an option to alleviate intended parent(s)’ concerns, it is not an option for males who are not procreating with a female partner, nor do all fertility specialists offer the procedure. while sympathetic to the moral predicament these intended parent(s) find themselves in, compassionate transfer is not an ethically supportable enterprise. the two primary arguments validating compassionate transfer are (1) alleviating intended parents’ moral distress and (2) permitting intended parent(s) to fulfill an autonomous choice. the first argument runs into individuals misusing the notion of double effect. while some intended parents may believe that transferring embryos is not intending for their destruction, this argument is patently false. the premise of compassionate transfer is that embryos are transferred at an opportunity when it is highly likely a woman cannot conceive. moreover, these women are not undergoing a typical transfer in which the woman’s body is hormonally induced to facilitate a pregnancy. therefore, the intention remains the same whether an embryo is transferred to pass or the embryo is unthawed – destruction of the embryo. the second argument in favor of compassionate transfer is autonomy. while respecting autonomy is one of the pillars of bioethics in general, there are limits to autonomy. often, these limits are based on a utilitarian or consequentialist framework, meaning that if there is an option that will provide greater good, then autonomy may be limited. similarly if the consequences do not outweigh the benefits of a given autonomous choice, autonomy can be limited. the autonomy argument is rebutted by the following ethical concerns in opposition to compassionate transfer: (1) access; (2) resource allocation; and (3) futile treatment concerns from the perspective of the practitioner. first, compassionate transfer from a fairness and access concern is simply not feasible. as was noted above, males do not have the option of compassionate transfer, as they cannot have an embryo transferred to them, nor would it be ethically permissible for them to utilize a woman simply for transfer purposes (given potential risks). additionally, not all practitioners may offer this as a service resulting in inherent disparities. second, while the vast majority of fertility treatments are not medically necessary, transferring embryos for the sole purpose of allowing the embryos to naturally pass is not how medical resources should be allocated. practitioners could be utilizing that time and resources for purposeful activities; this in its purest form is medical waste. while some may argue that the fertility industry is so privatized that individuals should be able to pay for the services they wish rendered, there needs to be appropriate limits on this as well. lastly, medical and fertility practitioners are ethically required to provide treatments that provide some benefit. while the determination of “beneficence” is arguable, the benefit of compassionate transfer stems on intention, and given that the intention is truly the same regardless of how one chooses to destroy an embryo, compassionate transfer is not ethically appropriate. conclusion the most ethically appropriate solution in regard as to what to do with the “left-overs” is to have fertility practitioners refrain from creating an excess of embryos. while embryos have historically cryopreserved better than ova, technologies are improving to the point where it is advisable that practitioners create only the embryos they intend to transfer. lee, what happens to the leftovers, voices in bioethics, vol. 3 (2017) 3 1 sarika chawla, “how my ivf baby made me reconsider my view of ivf.” washington post, october 20, 2016. https://www.washingtonpost.com/news/parenting/wp/2016/10/20/how-my-ivf-babymade-me reconsider-myview-ofivf/?utm_term=.c2db8cdbcfc2) 2 jen christensen, “record number of women using ivf to get pregnant.” cnn. february 18,2014. http://www.cnn.com/2014/02/17/health/record-ivfuse/; karen kaplan. “more than 1.5% of american babies own their births to ivf, report says.” la times. march 3, 2015. http://www.latimes.com/science/sciencenow/lascisn-ivflive-birthssuccess-rate20150303-story.html; tamar levin, “industry’s growth leads to leftover embryos, and painful choices.” june 17, 2015. http://www.nytimes.com/2015/06/18/us/embryos-eggdonorsdifficultissues.html_r=0. http://www.nytimes.com/2015/06/18/us/embryos-egglaskin, another side of rental violations, voices in bioethics, vol. 2 (2016) © 2016 elie laskin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. another side of rental violations elie laskin keywords: financial ethics, surrogacy, contracts, reproductive ethics introduction movies, music, hotels, apartments, parking spots, and the list goes on. almost anything you can dream of owning can be yours for at least a short period of time. but we do not think much about the ethics of renting movies and apartments, do we? so long as we follow the renter’s agreement, we feel okay. sometimes even violating these contracts does not cause much unrest. my family had a running joke when i was growing up: there was the mortgage, the weekly food bills, and the long-standing blockbuster late fee. i can say with all candor though, that being late to return my movies never kept me up at night. there are, however, examples of more egregious violations of a renter’s agreement—ones that i cannot simply dismiss like i did my family’s long-standing late-fee. analysis enter: surrogacy. surrogacy is just one of many options available within the scope of assisted reproductive technology (art) that allows struggling couples to have a child. the term itself can mean different things, depending upon how it is carried out. traditional surrogacy involves either artificial insemination or in vitro fertilization of sperm from the donor using the surrogate’s own egg. gestational surrogacy, in contrast, is a method by which the surrogate carries a pregnancy that has been made possible from the egg and sperm of the intended parents (and/or a donor egg and/or donor sperm). the latter method ensures that the surrogate herself is not genetically related to the child; she is only carrying the pregnancy to term. all things considered, it is not out of the question to draw a comparison between surrogacy and rental agreements. unfortunately, this simplistic comparison ends there. there are so many reasons that surrogacy is not simply a “womb” rental, why no surrogate transaction is easy, and why the practice itself has drawn up so much controversy. in recent news, a case involving surrogacy has brought up this controversy once again. in early 2015, a forty-seven-year-old woman was hired as a surrogate to carry a pregnancy for a single man in the state of georgia. the rental agreement in this case was as follows: the woman was promised approximately $33,000 from the sperm donor if she promised to carry his child to term and relinquish all parental rights following the child’s birth. she was implanted with three embryos, which is typical because not all embryos are expected to be laskin, another side of rental violations, voices in bioethics, vol. 2 (2016) 2 successful. the embryos contained the donor’s sperm and a twenty-year-old egg donor. in a highly unlikely event, all three embryos were successful and the woman found herself carrying triplets. when the intended father learned that all three embryos were growing successfully he asked the woman to terminate one or more of them. the rationale for this request is unclear and not represented uniformly across all news sources. while the u.k.’s daily mail cited that the donor father became nervous at the idea of triplets, both the new york post and the washington post reported that he grew nervous at the idea of fetal complications. historically, multiples are known to have lower birth weight and a higher likelihood of medical problems.1,2,3 though the background of this specific case is unique, i believe it speaks to something more important about the way surrogacy is regulated in the united states. namely, that there is far too much uncertainty surrounding the surrogate-parent contract. generally, the united states is recognized as a fairly liberal country regarding the use of surrogacy. countries such as germany, italy, france, spain, and portugal prohibit all forms of surrogacy. this one aspect of american liberalism, however, has not translated into what should be uniform policies about all aspects of surrogacy across jurisdictions. different jurisdictions have different rules about surrogacy. some have declared the entire activity illegal while others have vested the legal rights with the intended parents.4 some jurisdictions have even required that the surrogate mother relinquish her parental rights upon giving birth so that the intended parents are able to adopt the child.5 add to this complexity the issue of paying the surrogate (as in the case of the woman who expected to receive $30,000 for her services) and the issues within surrogacy become riddled with myriad complexities. conclusion while there are many noteworthy aspects of this particular case, such as the fact that the woman was much older (forty-seven years old) than the typical gestational surrogate, the central concern is this: in the united states, the law has not entirely caught up with the science of art, especially surrogacy. an unsettling comparison between surrogacy and body rentals is not an absurd analogy. in this case, the woman was hired as a gestational surrogate, only there to carry a child. she was, by some crude measure, the means to an end, i.e., a uterus to be rented. the most important aspect of this comparison, however, lies in its social, political, and legal implications. are women being ‘commodified’ when they become surrogates? is surrogacy on par with ‘baby buying’? does a woman have more claim to a child she carried for nine months, regardless of its genetic origin? these implications – and questions that follow – must be acknowledged and debated in order for a consistently safe, transparent, and ethical surrogacy practice to emerge. more importantly, the us needs to find a way to approach the question of surrogacy more uniformly. 1 carl campanile, "dad demands abortion after surrogate learns she's having triplets." new york post. 2015. accessed february 19, 2016.http://nypost.com/2015/11/25/surrogate-carrying-triplets-says-dad-demanding-she-abort-one/ 2 ashley collman, "pro-life surrogate files lawsuit against postal service worker who hired her to get pregnant and then demanded she abort one of the triplet embryos.", daily mail 2016. accessed february 19, 2016. http://www.dailymail.co.uk/news/article-3385416/pro-life-surrogate-files-lawsuit-against-postal-service-worker-hiredpregnant-demanded-abort-one-triplet-embryos.html. 3 lindsey bever, "‘i am pro life': a surrogate mother’s stand against ‘reducing’ her triplets." washington post.accessed february 19, 2016.https://www.washingtonpost.com/news/morning-mix/wp/2016/01/07/i-am-not-having-an-abortion-a-surrogatemothers-stand-against-reducing-her-triplets/. 4 "u.s. surrogacy law by state | the surrogacy experience confidence & care from decision to delivery." the surrogacy experience confidence care from decision to delivery. accessed february 25, 2016.http://www.thesurrogacyexperience.com/surrogate-mothers/the-law/u-s-surrogacy-law-by-state/. http://nypost.com/2015/11/25/surrogate-carrying-triplets-says-dad-demanding-she-abort-one/ http://www.dailymail.co.uk/news/article-3385416/pro-life-surrogate-files-lawsuit-against-postal-service-worker-hired-pregnant-demanded-abort-one-triplet-embryos.html http://www.dailymail.co.uk/news/article-3385416/pro-life-surrogate-files-lawsuit-against-postal-service-worker-hired-pregnant-demanded-abort-one-triplet-embryos.html https://www.washingtonpost.com/news/morning-mix/wp/2016/01/07/i-am-not-having-an-abortion-a-surrogate-mothers-stand-against-reducing-her-triplets/ https://www.washingtonpost.com/news/morning-mix/wp/2016/01/07/i-am-not-having-an-abortion-a-surrogate-mothers-stand-against-reducing-her-triplets/ http://www.thesurrogacyexperience.com/surrogate-mothers/the-law/u-s-surrogacy-law-by-state/ laskin, another side of rental violations, voices in bioethics, vol. 2 (2016) 3 5 john k. ciccarelli, and janice c. ciccarelli. "the legal aspects of parental rights in assisted reproductive technology." journal of social issues 61, no. 1 (2005): 127-137. introduction analysis conclusion rivera-agosto, final rule, voices in bioethics, vol. 2 (2016) © 2016 jorge luis rivera-agosto. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. final rule: hhs and nih’s new information requirements for clinical trials: is more information beneficial and for whom? jorge luis rivera-agosto keywords: bioethics, clinical trials, government, transparency introduction on september 16, 2016, the u.s. department of health and human services (hhs) presented a final rule, in conjunction with a complementary policy of the national institutes of health (nih), amending tile 42, chapter 1 of the code of federal regulations[1]. this final rule will bring about a new era for the different stakeholders in the health care industry: patients, providers, researchers and our government[2]. it represents a big step toward increased access to information about certain clinical trials, a topic that affects subjects’ informed consent directly. the regulation’s aim is to specify “how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to clinicaltrials.gov”. as such, it does not create new requirements on data, design, or conduct of clinical trials[3]. all stakeholders in the field of research ethics have engaged in continuous debate regarding the need for “increased access to information about clinical trials”[4]. the lack of publications[5] (researchers that don’t publish their findings for a variety of reasons such as that their data won’t be of benefit to the whole community) of clinical trials and biased literature[6],[7] (when researchers publish positive rather than negative findings) concerning clinical trials outcomes are major concerns. the problems previously mentioned are what this regulation tackles. analysis first, section 11.22 of the final rule explains which clinical trials must be registered in the webpage. it states that all clinical trials initiated after september 27, 2007, or any clinical trial initiated before or continued after such date, must figure in clinicaltrials.gov[8]. therefore, all clinical trials initiated after january 18, 2017 –the ruling’s official effective date– must meet certain criteria to enter the site. for device clinical trials, they must be a pediatric postmarket surveillance of a device product or an interventional, non-feasibility study with one or more subjects[9]. for drug clinical trials, they must be an interventional, non-phase 1 study with one or more subjects[10]. as the comments and response section of the final rule suggests, this sections aims to broaden the spectrum of clinical trials that enter the site while specifying what kind of trial they are. revealingly, this poses problems, because not all clinical trials can fit into the categories that the nih has created; and thus, will become a major procedural problem for sponsors during registration. in addition, this undermines the final rule’s spirit, because it anticipates that the information on the site will not necessarily be correct or accurate; undermining subjects’ access to information and, ultimately, their informed consent. rivera-agosto, final rule, voices in bioethics, vol. 2 (2016) 2 second, the most notable section of the new ruling is section 11.28. it contains all the information that must be disclosed for each clinical trial. studies that started before january 18, 2017 will submit the information required by section 402(j)(2)(a)(ii) of the public health service act[11] as usual[12]. this means that this ruling’s information requirement won’t affect them directly. however, for studies after the effective date, a plethora of information must be disclosed. some of these requirements include: when stating the primary purpose of the study, the study’s sponsor must select, as to clarify, what is the study’s aim. they can be for future treatment, prevention, diagnosis, supportive care, screening, health services research, basic science, device feasibility or other aim[13]. in addition, when stating study type, the party must declare if it’s an interventional, observational, or expanded access program study[14] (even though the hhs understands that these three criteria don’t reflect the nature of all studies). finally, the study completion date[15] and specification of primary and secondary outcomes[16] are also in the final rule. the hhs, nih, and jama[17] see in this new regulation a better way for potential research subjects to access information about trials. they argue four points: (a) there is more access to information about clinical trials[18]; (b) there are better references about clinical trials for investigators and irbs[19]; (c) there is more information about unapproved products; and (d) for people looking into certain trials, there is more information about similar marketed products[20]. again, they argue that this will help patients and researchers in knowing more in general about the clinical trials that affect them. conclusion although this may seem like we are a entering “new era” of clinical trial disclosure, several questions remain: will more information be beneficial for subjects? will subjects be able to understand this new information? will parties in a subject trial explain the new rule to their subjects? i think that this new rule lacks the subject’s voice, their understanding. it falls short on what information they need to give an informed consent. as noted by the bmj in 2012, there hasn’t been a lot studies about what subjects want to know about clinical trials and in the limited studies conducted, it has been showed that subjects have different information needs[21]. nonetheless, the 2012 study demonstrated that most were interested in information, among other things, about investigators’ conflicts of interest and subjects’ voluntariness and confidentiality –all missing in this final rule. certainly, this will pave the way for data exchange and greater transparency in the scientific community. but again, the question lingers: will it be of benefit for subjects? and if it does benefit subjects, how exactly? as stat investigated[22] last year, there’s a widespread behavior towards non-compliance and non-penalization, will it be different this time? ___________________________________________________________________________________________________ [1] clinical trials registration and results information submission, 81 fr 64981 (september 21, 2016). [2] collins, francis s. and kathy l. hudson “clinical trials: sharing of data and living up to our end of the b argain.” national institutes of health. september 16, 2016. accessed september 29, 2016. https://directorsblog.nih.gov/2016/09/16/clinical-trials-sharing-of-data-and-living-up-to-our-end-of-the-bargain/. [3] 81 fr 64982. [4] steinbrook r. “registration of clinical trials—voluntary or mandatory?” n engl j med. 2004 oct 28;351(18):1820– 2. rivera-agosto, final rule, voices in bioethics, vol. 2 (2016) 3 [5] evans t, gülmezoglu m, pang t. “registering clinical trials: an essential role for who.” lancet. 2004 may 1;363(9419):1413–4. [6] dickersin k, davis br, dixon do, george sl, hawkinse bs, lachin j, peduzzi p, pocock s; “the society for clinical trials supports united states legislation mandating trials registration.” clinical trials. 2004;1(5):417 –20. [7] scherer rw, langenberg p, von elm e. “full publication of results initially presented in abstracts.” cochrane database of systematic reviews. 2007 apr 18;(2):mr000005. [8] 81 fr 65143; §11.22(a)(1) & §11.22(a)(2). [9] 81 fr 65143; §11.22(b)(1). [10] 81 fr 65143; §11.22(b)(2). [11] codified as 42 u.s.c. 282(j)(2)(a)(ii). [12] 81 fr 65143-65144; §11.28(a)(1). [13] 81 fr 65144; §11.28 (a)(2)(d). [14] 81 fr 65144; §11.28 (a)(2)(e). [15] 81 fr 65144; §11.28 (a)(2)(t). [16] 81 fr 65144; §11.28 (a)(2)(w) & 81 fr 65144; §11.28 (a)(2)(x). [17] hudson kl, lauer ms, collins fs. “toward a new era of trust and transparency in clinical trials.” jama. doi:10.1001/jama.2016.14668. [18] mccray at. “better access to information about clinical trials.” ann intern med. 2000 oct 17;133(8): 609-14. [19] berlin ja, morris s, rockhold f, askie l, ghersi d, waldstreicher j. “bumps and bridges on the road to responsible sharing of clinical trial data.” clinical trials. 2014 feb;11(1):7-12. [20] rogawski ma, federoff hj. “disclosure of clinical trial results when product development is abandoned.” sci transl med. 2011 sep 28;3(102):102cm29. [21] see kirkby hm, calvert m, draper h, et al. what potential research participants want to know about research: a systematic review. bmj open 2012;2: e000509. doi:10.1136/ bmjopen-2011-000509. [22] piller, charles “law ignored, patients at risk.” stat. december 13, 2015. accessed september 30, 2016. https://www.statnews.com/2015/12/13/clinical-trials-investigation/. introduction analysis conclusion although this may seem like we are a entering “new era” of clinical trial disclosure, several questions remain: will more information be beneficial for subjects? will subjects be able to understand this new information? will parties in a subject trial... certainly, this will pave the way for data exchange and greater transparency in the scientific community. but again, the question lingers: will it be of benefit for subjects? and if it does benefit subjects, how exactly? as stat investigated[22] last ... ___________________________________________________________________________________________________ messina, covid-19 shortages: clear guidelines and advanced directives, voices in bioethics, vol. 6 (2020) * sarah messina, sarah messina, research assistant, pediatric neuromuscular center, columbia university © 2020 sarah messina. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. covid-19 shortages: clear guidelines and advanced directives could ease allocation decisions sarah messina* abstract the ethics that guide decisions on how to distribute scarce resources varies among countries and within the us. uniformity and encouraging medical directives would ensure more fairness and a better allocation of resources. keywords: covd-19, shortages, advanced directives introduction life-saving treatments represent the heart of all medical intervention. doctors are instructed and pledge to do no harm and to help save all patients to the best of their ability, a difficult task when life-saving treatments require scarce resources. distributional fairness is of the utmost importance when a pandemic like covid-19 roars into emergency rooms causing a nonstop pressure for more ventilators. the production of more ventilators is a looming necessity. with so many healthcare workers struggling to maintain any semblance of work life balance, it is with great admiration that we look to them to have answers for us in this time. the ethics that guide decisions on how to distribute scarce resources varies among countries and within the us. uniformity and encouraging medical directives would ensure more fairness and a better allocation of resources. messina, covid-19 shortages: clear guidelines and advanced directives, voices in bioethics, vol. 6 (2020) 2 analysis emergency room doctors in new york, which has become the united states’ epicenter of the virus, are already struggling. new york has yet to reach the peak of the covid-19 pandemic’s consequences, but the limitations of its hospitals are being exposed. invasive ventilators are used typically for trauma victims, mostly in emergency situations where the outcome might be unknown. during the pandemic, however, the outcome is starting to show a pattern. with 25 percent of patients requiring ventilation upon icu admission at new york presbyterian, the risk of falling short of resources necessary to save lives seems inevitable. in new york, elmhurst hospital in queens has shortages already; critically ill patients died waiting for beds and hospital staff.1 thankfully, some efforts have been made to double the capacity for existing ventilators. novel protocols have been developed at presbyterian hospital to use one ventilator for two patients. these improvements are critically important and will save lives. with limited numbers of ventilators being provided by the federal government and/or the state, hospitals will reach capacity regardless of efforts to expand resources. hospitals will need to prioritize patients and decide who will be placed on ventilators.2 the factors that are likely to contribute to these difficult decisions will test the foundational principles of bioethics. age, underlying comorbidities, and whether they are a healthcare worker or not are factors that may very well change the course of treatment once there is an extremely limited number of ventilators left for sick patients. many patients who are infected with the novel virus are experiencing symptoms for more than 14 days. their ability to breath can be affected and as we near the apex, more of them may turn to clinical ethicists to allocate ventilators. arthur caplan, head of the medical ethics division at new york medical school, is working to develop a rationing plan that will guide doctors. as more legal protections are granted to doctors and malpractice is less of a worry, it is important that all healthcare workers look to guiding principles that ensure the integrity of care they provide to patients. guidelines established in new york help to identify patients who have a higher likelihood of surviving the acute incident as decided by a triage committee. evaluating patients who are most likely to benefit leads to less futile treatment and more successful intervention, potentially maximizing the number of lives saved.3 outbreaks of other viruses should have prepared us a bit more, but the us did not experience cases of sars or mers, a known impetus for other countries to boost pandemic preparation. plans to allocate ventilators or medical care are not often shared throughout the us leaving differences between states. striking a balance between beneficence and utility, ventilator allocation depends on factors that could limit a patient’s likelihood to recover. the fewer factors, the better chance at recovery warranting use of a ventilator. well, some states have guidelines in place already that might unfairly place more weight on some comorbidities than others. those with aids or mental disabilities in alabama would be denied a ventilator for reasons discussed in state issued guidelines from 2010. thomas cunningham, director of bioethics at kaiser permanente west los angeles, attempted to gather all guidelines issued across the us in order to solidify some form of national agreement. another question that has been raised is how long to allow a ventilator to be used by a single patient when there are patients in critical condition waiting to use it. these issues have yet to be solved in the us and elsewhere, but there seems to be an unwillingness to withdraw ventilators once patients are relying on them. in the us, withdrawal of ventilators is common in icus when further usage is deemed futile. however, in the midst of the pandemic, withdrawal of a ventilator may come even when there is still a small chance of improvement. making these decisions can be extremely distressful for clinicians who are otherwise not accustomed to distributing critically low resources.4 in the netherlands, citizens have been made acutely aware that rationing will become a reality soon. doctors have conducted phone calls to screen patients about their end-of-life decisions and some have been accused of age-based bias that has led to improper questioning. senior citizens made complaints about calls from doctors whom they claimed were advising against covid-19 treatment for the elderly. however, the health minister, hugo de jonge, maintains the claims are false.5[v] advanced care planning is crucial and actually occurs more often in the netherlands than in the us. these conversations often have nothing to do with the age of the individual. importantly, the phone calls occur before http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/24/covid-19-shortages-clear-guidelines-and-advanced-directives-could-ease-allocation-decisions#_edn5 messina, covid-19 shortages: clear guidelines and advanced directives, voices in bioethics, vol. 6 (2020) 3 the emergency and the requirement for ventilation, and therefore the people called are not subject to undue influences or fear. invasive ventilation and covid-19 treatment are not appropriate for everyone. those who would opt out would be giving their spot to another patient in need. phone calls reaching people before an emergency to encourage health directives are important measures that all countries might want to begin implementing. with many healthcare workers working from home and waiting for redeployment, the phone calls could be made in order to gain a clear picture of where the us population stands on advanced care planning. upon admission to the icu, those who wish to be ventilated if needed and those who do not can be placed in separate areas even. sometimes, end of life care decisions are accidentally ignored, a problem that could occur more in the mayhem of covid-19 hospital admissions. in a situation like covid-19 where the risk of providing someone life-saving treatments who would have refused them would also harm another who must continue to wait is unacceptable. hospitals must make sure they are doing absolutely everything to honor health directives while saving the lives they can and should. conclusion next time a pandemic hits the us, national policies should be in place to address allocation of life-saving medical resources. other countries have battled somewhat alone in the covid-19 pandemic, forcing them to develop strategies to manage their own resources. some countries have received help from the international community and within the us states can encourage sharing resources. however, in the covid-19 pandemic, in some countries, the entire health care system is being suffocated and there is neither time nor resources available to rely on neighbors for help. the us should make nationwide decisions soon furthering uniformity of emergency healthcare and fair distribution of scarce resources. april 24, 2020 1 gregory barber, “in crowded hospitals, who will get life-saving equipment?” wired, march 31, 2020. https://www.wired.com/story/in-crowded-hospitals-who-will-get-life-saving-equipment/) 2 sarah kliff et al., “there aren't enough ventilators to cope with the coronavirus,” the new york times, march 18, 2020. https://www.nytimes.com/2020/03/18/business/coronavirus-ventilator-shortage.html 3 robert d. truog, christine mitchell, and george q. daley, “the toughest triage — allocating ventilators in a pandemic,” new england journal of medicine, 2020. https://doi.org/10.1056/nejmp2005689 4 truog. 5 stephanie van den berg, “dutch end-of-life debate flares as coronavirus tests healthcare limits,” reuters, april 2, 2020. https://www.reuters.com/article/us-health-coronavirus-netherlands-elderl/dutch-end-of-life-debate-flares-as-coronavirustests-healthcare-limits-iduskbn21k2b6?feedtype=rss&feedname=healthnews zimmerman, the precautionary principle in mask wearing, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, fordham university school of law, candidate for ms at columbia university. © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the precautionary principle in mask-wearing: when waiting for explicit scientific evidence is unwise anne zimmerman* keywords: precautionary principle, masks, covid-19, public health introduction science magazine interview with george gao, director-general of the chinese center for disease control and prevention (cdc):1 q: what mistakes are other countries making? a: the big mistake in the u.s. and europe, in my opinion, is that people aren’t wearing masks. this virus is transmitted by droplets and close contact. droplets play a very important role—you’ve got to wear a mask, because when you speak, there are always droplets coming out of your mouth. many people have asymptomatic or presymptomatic infections. if they are wearing face masks, it can prevent droplets that carry the virus from escaping and infecting others. analysis china and hong kong have specific universal mask recommendations for the general population, mostly concerning those in crowded places or at increased risk. early in the pandemic in the us, there was a bright line claim that seemed suspicious to me: masks that are not n95 offer no protection. another follow up claim: masks are only to prevent the spread by the wearer and do not protect the wearer. neither claim is exactly proven and the veracity with which they were spoken may have undermined protection. the absence of incontrovertible scientific studies supporting widespread mask use is not the same as evidence that masks are ineffective. there is not evidence that masks worn by the general public are ineffective. however, many us scientists have made that very claim. healthcare professionals who publicly said masks are ineffective or not recommended include: jerome adams, us surgeon general; the us cdc; david heymann, epidemiologist with who at the time of sars (because of fear of improper use); emily landon, university of chicago medical school (because of improper use and because n95 are the only masks prove effective)2; hyo-jick choi, chemical engineer, university of alberta (because masks are for large droplets only); eric toner, johns hopkins (“no harm in it but it is not likely to be very effective”)3; alax azar, hhs secretary, (masks should be just for healthcare workers); amesh adalja, johns hopkins (masks may give false sense of security); nancy messonier, cdc.4 this list could continue as others echoed these sentiments. zimmerman, the precautionary principle in mask wearing, voices in bioethics, vol. 6 (2020) 2 from the beginning, i felt people on the subway or in crowded neighborhoods were smart to wear a mask. if i said that out loud, medical people would say “no evidence of that.” their logic bothered me for two reasons: it was a failure to play it safe (could we not recommend those over 65 or immune compromised wear one just in case it helps?), and the claimed ineffectiveness seemed not to have been proven. furthermore, the harms of wearing an ill-fitting mask or removing it incorrectly have been overstated without proof. it would be simple to demonstrate proper mask removal in a similar manner to the new cdc commercials on television instructing basic protective techniques. while no one wants to advocate civilians buying the limited supply of specialized respiratory masks like the n95 mask, the stance that no other masks serve any protective benefits is incorrect and unhelpful. some suggest a need to prevent a false sense of security that would encourage people, whether healthcare workers or not, to behave otherwise recklessly. were we all going to ignore social distancing because the mask made us feel so secure? aside from healthcare workers, it is doubtful the people in masks would be the people taking risks. those not following recommended procedures for social distancing or hand washing are probably not wearing masks. while most would continue their safety habits, even if some slacked off momentarily, for example, in the check-out line at a store, the mask might be helpful. conclusion while so many doctors and public health advocates in the us took the anti-mask for prevention stance, in other countries mask-wearing is recommended and some scientists are even recommending scarves in public to cover the nose and mouth. there is some evidence that wearing a mask can be outcomedeterminative. in 2008, one review of controlled studies of sars demonstrated that masks were protective5 alone and were more protective when part of a regimen of hand-washing, and wearing gloves and gowns, a finding more relevant to healthcare situations than public ones. a 2013 study found surgical masks somewhat protective and possibly worthwhile when better ones are not available for healthcare workers to prevent spread of influenza.6 while data did generate numbers to estimate prevention in lives saved or disease prevented, studies of mask use by the public require largescale epidemiology and may need to be retrospective. finally, today a journal article agrees with me.7 in the lancet, the authors argue that recommendations on masks should be rational and that recommending universal mask wearing is within logic if there is availability. after recommending masks for the vulnerable, those with preexisting conditions, and older adults, the article concludes, “universal use of face masks could be considered if supplies permit.” 1 cohen, jon. “not wearing masks to protect against coronavirus is a ‘big mistake,’ top chinese scientist says,” science magazine. mar. 27, 2020. see also https://www.nytimes.com/2020/03/27/health/us-coronavirus-face-masks.html 2 https://www.cnbc.com/2020/03/02/coronavirus-do-face-masks-work-and-how-to-stop-it-from-spreading.html 3 https://www.businessinsider.com/coronavirus-face-mask-safe-prevention-2020-2 4 https://www.marketwatch.com/story/the-cdc-says-americans-dont-have-to-wear-facemasks-because-of-coronavirus-202001-30 5 jefferson, tom et al. “physical interventions to interrupt or reduce the spread of respiratory viruses: systematic review.” bmj (clinical research ed.) vol. 336,7635 (2008): 77-80. doi:10.1136/bmj.39393.510347.be 6 makison, c., et al, “effectiveness of surgical masks against influenza bioaerosols,” journal of hospital infection vol. 84, no. 1, may 2013. https://www.sciencedirect.com/science/article/abs/pii/s0195670113000698 https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2190272/ https://doi.org/10.1016/j.jhin.2013.02.007 https://www.nytimes.com/2020/03/27/health/us-coronavirus-face-masks.html https://www.cnbc.com/2020/03/02/coronavirus-do-face-masks-work-and-how-to-stop-it-from-spreading.html https://www.businessinsider.com/coronavirus-face-mask-safe-prevention-2020-2 https://www.marketwatch.com/story/the-cdc-says-americans-dont-have-to-wear-facemasks-because-of-coronavirus-2020-01-30 https://www.marketwatch.com/story/the-cdc-says-americans-dont-have-to-wear-facemasks-because-of-coronavirus-2020-01-30 https://www.sciencedirect.com/science/journal/01956701 https://d.docs.live.net/b37c00fb4a29b9da/documents/vol.%2084,%20no.%201 https://d.docs.live.net/b37c00fb4a29b9da/documents/vol.%2084,%20no.%201 https://www.sciencedirect.com/science/article/abs/pii/s0195670113000698 zimmerman, the precautionary principle in mask wearing, voices in bioethics, vol. 6 (2020) 3 7 feng, shuo, et al. “rational use of face masks in the covid-19 pandemic” the lancet. published: march 20, 2020doi:https://doi.org/10.1016/s2213-2600(20)30134-x https://doi.org/10.1016/s2213-2600(20)30134-x misra, adaptability: a prerequisite for medicine, voices in bioethics, vol. 2 (2016) © 2016 priya misra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. adaptability: a prerequisite for medicine priya misra keywords: adaptability, medical education, bioethics introduction in medical school, classes are usually graded on an honors, high pass, pass, or low pass scale. when i first began medical school i wanted to do the very best i could—i wanted to honor every class that was possible. once school actually started, however, that thought quickly fled my mind. it came to the point where i was barely keeping up with my schoolwork; i constantly felt behind and didn’t know how to study anymore. analysis in college, i was a chemistry major, so i was used to taking hard classes; the information was always just hard enough that although i spent many hours studying, i still felt confident and prepared for the exam. there was always an end point to my studying, a finite amount of information that i was expected to know. after completing a certain number of questions, i was confident that i could close my book and squeeze in a few hours for my friends and family on the weekend. but in medical school, the studying never seemed to end— whenever you thought you knew enough, there was always more information to know. sometimes i felt like i could study for 24 hours straight and still not know enough for the exam. and because the breadth of knowledge was so vast, you truly had to use your time wisely, whereas in college i liked to write out all my notes, but i just didn’t have time to do that anymore. i had to learn how to just read and absorb information quickly, but in an effective way so that i could apply it in the future. even though i could admit that my study habits had to change, i was so set in my old ways that it was hard to actually alter them. but, after my first anatomy exam i learned that i had no choice except to listen to the advice that the second years had for me, like start with questions first and read necessary materials after, which was alien to me. i knew i had to change my study habits as quickly as i could. that was probably one of the hardest things for me to come to terms with when transitioning from college to medical school: there’s just not enough time to continue with old study habits and the information you will learn here is extremely different than what you learned in undergrad—both in content and in volume. and most daunting of all, you actually need to remember this stuff for life— you can’t just learn something and push it out of your brain after the test was over. in college, i knew that if i forgot the exact mechanism of balancing a reductionoxidation reaction, people were not going to die; i could easily look it up, practice it again, and continue with my experiment. but once i become a pediatrician, if i forget the symptoms and criteria for kawasaki’s disease, then my 5-year-old patient with a rash could end up developing heart failure if left it untreated. it didn’t take long for me to realize that yes, there is a lot of information for me to learn, and unfortunately yes, i need to misra, adaptability: a prerequisite for medicine, voices in bioethics, vol. 2 (2016) 2 remember and understand everything i’m reading because it determines whether or not i can effectively treat my patients. as i reflect on what helped me in school and what hurt me, i realize that adaptability is a huge part in one’s success in medicine. we learn from day one in anatomy lab that things are not always going to go the way we hoped they would; most of the time we are wrong, and just when we think we have the hang of something it slips away from our grasp. i cannot begin to recount how many times my anatomy group changed our study plans. it went from idealistic: “okay, let’s all read tonight to be totally prepared for tomorrow’s lab” to frantic: “well, maybe we can just learn the information while we’re in lab tomorrow” to realistic: “whatever, if the professor comes over and asks me something and i don’t know the answer, then i’ll be honest and he can teach me while i’m there.” anatomy lab was a beast of a course, and the sooner we realized that it was normal not to know everything immediately, and refined our individual study plans, the easier it was to actually learn the information. i truly feel like the ability to adapt to a new and uncomfortable situation is vital in medical school. after every exam i think it’s important to ask yourself which study tactics worked for you and which didn’t. as a doctor, when you are in the er or the or and a patient starts coding, you won’t have time to think or feel sad about the way things ended up; it’s vital that you are able to think on your feet and quickly adapt to the situation and save your patient’s life. but it’s not just how you study that has to change, it’s also what you expect of yourself and your perspective on reality that has to adapt. it’s funny how quickly i abandoned my “honoring plan” and reverted to my “passing plan.” biochemistry is not and has never been one of my strengths; i remember telling myself before taking my first exam that if i got in the mid 80s i would be proud of myself. i did, and i was overjoyed. then i saw the average of the class… i had done right around the average and immediately i felt deflated. why was i so upset? i got the score i had set out to get, but now just because it was around the average i felt that it wasn’t good enough anymore. it is extremely hard getting used to the idea that whereas in college you were near the top of your classes, which is what helped you get into medical school, now you are nearer to the middle or bottom because you are studying with the cream of the crop; everyone here was the best at where they were. it is so hard to come to terms with that fact, and getting used to the idea that no, most of the time you won’t know what is going on in class, and no, you may not be at the top of your class. the sad thing is that we will never take a step back and realize that even though we may just be “passing” in medical school, that in itself is an extremely difficult thing to do and is something that we should all be so proud of. however, the unspoken competition, the extremely high averages, the never-ending pressure of having to get into a good residency program, never lets us just be happy and thankful that we passed all of our classes. conclusion there are a lot of changes that hit you all at once when you start medical school, whether it’s accepting misra, adaptability: a prerequisite for medicine, voices in bioethics, vol. 2 (2016) 3 that your study habits have to change, or realizing that your academic performance may not be as great as it was in college—that is just the nature of medical school, and the more you have an open mind, the easier it will be to adapt to these changes. in my opinion, medical school prepares you for your future as a physician through more than just teaching you the basic science of medicine: it teaches you how to think like a doctor, how to conduct yourself like a professional, and how to deal with the emotions that come with this career. for example, through its difficulty and breadth of information, medical school teaches you how to address failure, stress, and change on an academic level, arming you with tools to use when you face these emotions on a clinical level. it shows you how to multitask, face your own shortcomings, and step outside of your comfort zone, so that when you are expected to do so as a physician, these skills have already been developed. but at the heart of this multidimensional education is your ability to adapt, to accept, and to stay open-minded. only with these qualities will you be able to embrace medical school for what it is and be prepared for the real world that lies ahead. introduction analysis conclusion zimmerman, it could happen again, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, fordham university school of law, ms candidate, columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. it could happen again: reducing comorbidity as a tactic for long term preparation for novel viruses anne zimmerman* keywords: covid-19, comorbidity, preexisting conditions introduction cardiovascular disease, diabetes, obesity, chronic respiratory disease, hypertension, and cancer all correlate to higher mortality rates from covid-19. the uk has also added pregnancy, neurologic diseases, and kidney and liver conditions and asserts that those with organ transplants, blood cancers, and kidney disease requiring dialysis are at even higher risk.1 initiatives to improve health outcomes during future pandemics must include a long-term plan to reduce preventable diseases that are likely to contribute to death and severity of future novel respiratory viruses. policies that promote or fail to reduce widespread health challenges in the us should be changed in response to the current pandemic. while better preparation, access to test kits, quarantining, contact tracing, vaccines, and new anti-viral medicines are all understandable immediate priorities, a healthier population would fare better. it is the government’s ethical duty to support health initiatives that address the social determinants of health. such initiatives include paid sick leave, ending subsidies for unhealthy foods, and implementation of federal workplace requirements that ensure workers have breaks, stress relief tools, and wages sufficient to purchase healthy foods, safe housing, and health insurance. government policy can alleviate stress by expanding healthcare coverage for those living paycheck to paycheck and by taking measures to alleviate poverty. analysis early mortality data from china presented by the world health organization from february 2020 indicate the devastation of preexisting conditions. below are data for preexisting conditions followed by death rate for confirmed cases and death rate for all cases: • cardiovascular disease / 13.2% / 10.5% • diabetes / 9.2% / 7.3% zimmerman, it could happen again, voices in bioethics, vol. 6 (2020) 2 • chronic respiratory disease / 8.0% / 6.3% • hypertension / 8.4% / 6.0% • cancer / 7.6% / 5.6% • no pre-existing conditions 0.9% *death rate = (number of deaths / number of cases) = probability of dying if infected by the virus (%). the percentages do not have to add up to 100%, as they do not represent share of deaths by condition.2 • currently, all countries collecting covid-19 data are reporting higher death rates for those with preexisting conditions. one hospital in new jersey expressed surprise that younger patients are coming in with severe cases. “dr. adam jarrett, the center's chief medical officer, told nbc news on monday, adding he was surprised patients' ages skewed younger than he'd expected. all but one had underlying health conditions, such as heart or lung disease, diabetes and obesity.” jarrett specifically noted the impact of obesity on lung capacity.3 data from italy implies that obesity is a major risk factor.4 according to the american heart association, approximately 168.1 million people (71.1 percent of the us population) are obese or overweight.5 the cdc estimates 42 percent of people are obese. 9.2 percent of adults are severely obese.6 the cdc estimates one in every four people with diabetes does not know they have it. 100 million people have either diabetes or prediabetes, while 9.8 percent of the population have confirmed cases of diabetes.7 in a study evaluating an array of respiratory viruses including influenza and coronavirus, researchers concluded the obese and morbidly obese have more hospital stays and more severe illness.8 the uk is warning that those with body mass index >40 are most at risk.9 obesity causes both cardiovascular disease and high blood pressure, increasing the odds of one person having several preexisting conditions when a novel virus appears. solving the obesity crisis would also reduce the incidence of heart disease, hypertension, some cancers, and some liver and kidney problems. high blood pressure is prevalent in the us population. 116.4 million people have it10 and the stress of the pandemic itself may cause more cases. in addition to high blood pressure, some blood pressure medications such as angiotensin-converting enzyme (ace) inhibitors may contribute to the severity of italy’s coronavirus cases.11 in china, almost a quarter of the population has hypertension and an additional forty percent show signs of early stage hypertension.12 whether the underlying condition or the medications are the source of the more severe cases, decreasing the incidence of high blood pressure could decrease the impact of future novel viruses. the world health organization in its social determinants of health recommend policies, habits, and conditions that promote good health. who advocates proven ways to prevent or reduce obesity, stress related diseases, and cardiovascular problems.13 in the short term, the experts might be right to identify the comorbidity without attempting to remedy it. for now, scarce resources are devoted to urgent cases of the coronavirus. people at risk should use extra caution, practice social distancing and isolation, and follow suggested guidelines for hand hygiene. in the long term, the us must investigate the habits that create the comorbidity. the next big pandemic may have the same characteristics. sars and mers were both respiratory coronaviruses with characteristics similar to covid-19. people with obesity, high blood pressure, and heart disease would likely do worse than those without preexisting conditions regardless of the specifics of a future pandemic. zimmerman, it could happen again, voices in bioethics, vol. 6 (2020) 3 conclusion if covid-19 continues to spread and remains devoid of reliable treatments, there is no evidence that it is too late to cure a preexisting condition even within a few months. the influenza of 1918 had a virulent second wave.14 if covid-19 mutates or persists longer than expected, improving people’s basic health wherever possible should be a priority. weight loss and gradual exercise improvements can stave off diabetes, decrease blood pressure, and prevent strokes and heart disease. those on the verge of diabetes or cardiovascular issues may improve their outcome by changing habits now with the support of public policy. with comorbidity prevention in mind as well as socially-conscious strategies to address the next novel virus, public policy will lessen the severity and mortality of future novel viruses. 1 sharma, sonia. “from pregnant to obese list of those most at risk from coronavirus.” chronicle live uk. march 17, 2020. https://www.chroniclelive.co.uk/news/north-east-news/coronavirus-most-at-risk-pregnant-17936541 2 https://www.worldometers.info/coronavirus/coronavirus-age-sex-demographics/ based on both: the report of the whochina joint mission published on feb. 28 by who, which is based on 55,924 laboratory confirmed cases. the report notes that “the joint mission acknowledges the known challenges and biases of reporting crude cfr early in an epidemic" (see also a paper by the chinese ccdc released on feb. 17, which is based on 72,314 confirmed, suspected, and asymptomatic cases of covid-19 in china as of feb. 11, and was published in the chinese journal of epidemiology.) 3 edwards, erika. “not just older people: younger adults are also getting the coronavirus. simply looking at the age ranges of the infected, however, doesn't provide any insights into the severity of the illness.” nbc news. march 17, 2020. https://www.nbcnews.com/health/health-news/not-just-older-people-younger-adults-are-also-getting-coronavirus-n1160416 4 o’regan, eilish. “from risks due to obesity to how children are affected: coronavirus lessons from front-line medics.” independent.ie. march 18, 2020. https://www.independent.ie/world-news/coronavirus/from-risks-due-to-obesity-to-howchildren-are-affected-coronavirus-lessons-from-front-line-medics-39054089.html 5american heart association. https://www.ahajournals.org/doi/10.1161/cir.0000000000000757 6 hales cm, carroll md, fryar cd, ogden cl. prevalence of obesity and severe obesity among adults: united states, 2017–2018. nchs data brief, no 360. hyattsville, md: national center for health statistics. 2020 https://www.cdc.gov/nchs/products/databriefs/db360.htm 7 https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html 8 moser js, galindo-fraga a, ortiz-hernández aa, et al. underweight, overweight, and obesity as independent risk factors for hospitalization in adults and children from influenza and other respiratory viruses. influenza other respir viruses. 2019;13(1):3– 9. doi:10.1111/irv.12618 finding “in adults with coronavirus, metapneumovirus, parainfluenza, and rhinovirus, participants that were underweight (or: 4.07) and morbidly obese (or: 2.78) were more likely to be hospitalized as compared to normal‐weight adults.” 9 https://www.mirror.co.uk/news/uk-news/coronavirus-severely-obese-warned-among-21704686 10american heart association. https://www.ahajournals.org/doi/10.1161/cir.0000000000000757 11 fang, lei, george karakiulakis, and michael roth, “are patients with hypertension and diabetes mellitus at increased risk for covid-19 infection?” the lancet march 11, 2020 doi:https://doi.org/10.1016/s2213-2600(20)30116-8 https://www.thelancet.com/journals/lanres/article/piis2213-2600(20)30116-8/fulltext https://www.chroniclelive.co.uk/news/north-east-news/coronavirus-most-at-risk-pregnant-17936541 https://www.worldometers.info/coronavirus/coronavirus-age-sex-demographics/ https://www.nbcnews.com/health/health-news/not-just-older-people-younger-adults-are-also-getting-coronavirus-n1160416 https://www.independent.ie/world-news/coronavirus/from-risks-due-to-obesity-to-how-children-are-affected-coronavirus-lessons-from-front-line-medics-39054089.html https://www.independent.ie/world-news/coronavirus/from-risks-due-to-obesity-to-how-children-are-affected-coronavirus-lessons-from-front-line-medics-39054089.html https://www.ahajournals.org/doi/10.1161/cir.0000000000000757 https://www.cdc.gov/nchs/products/databriefs/db360.htm https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html https://www.mirror.co.uk/news/uk-news/coronavirus-severely-obese-warned-among-21704686 https://www.ahajournals.org/doi/10.1161/cir.0000000000000757 https://doi.org/10.1016/s2213-2600(20)30116-8 https://www.thelancet.com/journals/lanres/article/piis2213-2600(20)30116-8/fulltext zimmerman, it could happen again, voices in bioethics, vol. 6 (2020) 4 12 minter, adam, “to treat pandemics, start by treating hypertension: controlling common ailments is the first step for low and middle-income countries looking ahead to what comes after the coronavirus crisis.” bloomberg news. march 19, 2020. https://www.bloomberg.com/opinion/articles/2020-03-19/high-blood-pressure-is-risk-for-countries-after-coronavirus-ends 13 wilkinson, richard and michael marmot, world health organization, social determinants of health, the solid facts. (2003). updated and explained by marmot in “the social determinants of health inequities” world health organization, the lancet vol 365 march 19, 2005, and marmot m, allen j. social determinants of health equity. am j public health. 2014;104 suppl 4: s517– s519. doi:10.2105/ajph.2014.302200 14 institute of medicine (us) forum on microbial threats; knobler sl, mack a, mahmoud a, et al., editors. the threat of pandemic influenza: are we ready? workshop summary. washington (dc): national academies press (us); 2005. 1, the story of influenza. available from: https://www.ncbi.nlm.nih.gov/books/nbk22148/ https://www.bloomberg.com/opinion/articles/2020-03-19/high-blood-pressure-is-risk-for-countries-after-coronavirus-ends http://www.the/ dias, mycetoma & neglected tropical diseases, voices in bioethics, vol. 2 (2016) * matt dias, ms bioethics candidate columbia university © 2016 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. mycetoma and neglected tropical diseases: a medical, scientific, and moral duty to care matt dias* keywords: disease incidence, duty to care, mycetoma, neglected tropical diseases, plos, who introduction by now, most everyone knows that the zika virus is a menacing global adversary. an array of governmental health agencies, reporters, and infectious disease experts have warned about its ramifications, presented statistical outcomes, and issued travel advisories.1 but why hasn’t this coverage been extended to other infectious diseases ravaging similarly developing regions of the world—including neglected tropical diseases (ntds)? as the name suggests, ntds are a group of diverse yet neglected diseases that cause significant morbidity and mortality worldwide. historically, they have received limited attention from the developed regions of the world, despite the fact that more than a billion people—one-sixth of the world’s population—suffer from at least one ntd, often resulting in severe disabilities and even disfigurement. most affected individuals are members of vulnerable populations—generally destitute and powerless peoples residing in the urban slums and rural zones of low-income countries.2 ____________________________________________________________ analysis among ntds sits mycetoma, a destructive fungal or bacterial infection of a body part (most commonly, the foot) that results in disfigurement and social stigma. it overwhelmingly occurs in impoverished areas of the “mycetoma belt” that extends worldwide but is concentrated between the equator and tropic of cancer, with most cases reported from india, mexico, sudan, africa, somalia, and yemen.3 mycetoma is so neglected that until may 2016, it was not even on the world health organization’s (who) neglected tropical diseases list.4 troublingly, this longstanding omission has fallen short of the who’s articulated aims of (i) acting as the preeminent directing and coordinating authority on international health work and (ii) stimulating and advancing work on the prevention and control of endemic diseases.5 in response, one might ask: is a disease deemed less worthy of research, reporting, and treatment if it affects only a small, poor population? relatedly, to what extent (if any) is it valid to diminish the medical, scientific, and moral duty to care as a http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn1 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn2 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn3 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn4 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn5 dias, mycetoma & neglected tropical diseases, voices in bioethics, vol. 2 (2016) 2 function of disease incidence?6 while the logical response is that an ethical duty to care certainly exists, the dearth of scientific data and infinitesimal medical resources devoted to those with mycetoma bears a distressing narrative, and one that bioethicists, the who, and other influential public health entities ought to profile and address with increasing rigor. in recent years and months, several news outlets and scientific organizations have brought mycetoma before the public consciousness, exposing current conceptualizations of its trajectory and the currently inadequate treatment approaches. in 2013, the mycetoma consortium was founded by a number of experts, and research priorities were identified. the consortium has promoted advocacy that resulted in the disease’s inclusion on the who’s list of “other conditions” within the neglected diseases continuum.7 in perhaps the most comprehensive public assemblage of mycetoma-related facts, the public library of science (plos) research collections have demonstrated that the key neglect is in treatment—outcomes tend to be poor, and amputation of the affected body part is routine. to this point, zijlstra et al. relayed in a recent editorial that even though mycetoma has “all the ingredients of neglect,” there is uncertainty about its route of transmission, which contributes to a lack of effective national control programs. additionally, the associated stigma of mycetoma has severe socioeconomic consequences: children drop out of school, young adults encounter difficulties finding a job or a life partner, and psychological effects resonate well into adulthood due to a lack of health services.8 in addition to plos, reporter amy maxmen’s recent series has shed further light on the mycetoma knowledge gap through profiling the experiences of those suffering with mycetoma—ultimately highlighting the urgency to confront this disease, and what is at stake if the status quo remains. in her december 2015 npr article, maxmen tells the story of twenty-six-year-old mustafa alnour alhassan of sudan, who lost his leg to mycetoma and is dying.9 alhassan was to be the first member of his rural village to attend college; instead, fungal spores caused his knee to swell. at a sudanese clinic, doctors prescribed an antifungal drug to alhassan, but its high price tag, potential for liver damage, and lack of results eventually led to the amputation of his leg above the knee. since the fungus has remained in his body, his promise for a future life remains compromised.10 in reviewing this course of events, maxmen astutely points out that “had alhassan lived in a developed country, it’s unlikely [that] the flesh-eating fungus assaulting his body would have taken such a toll.” indeed, in a developed country, physicians might (i) experiment with high-caliber drugs that would modulate the inflammatory response and (ii) prescribe a variety of treatments that kill off other fungal infections.11 indubitably, what happened to alhassan is problematic, especially since there is currently no recourse to prevent it from recurring. according to maxmen, almost nothing has been learned about mycetoma since there is virtually zero funding for it. indeed, according to a 2014 policy cures report issued by the health analysis firm g-finder, public funding for neglected diseases is at a seven-year low.12 the outlook for mycetoma is not wholly grim, however. in fact, there are several glimmers of hope in the pipeline of mycetoma research and awareness. for one (and most likely in response to the efforts of plos and maxmen), the who announced in january that it would consider adding the flesh-eating, bonedestroying disease to the organization’s neglected disease list.13 and in fact, this month, the january resolution was considered during the world health assembly (wha) meeting in switzerland. in an important step forward for mycetoma, the wha approved, meaning that the disease will officially be added to the who’s neglected diseases list—making it more likely that funding organizations will support epidemiologic and other research.14 furthermore, the drugs for neglected diseases initiative (dndi), a switzerland-based organization, has launched the first clinical trial of a drug to treat mycetoma. the study is occurring at the mycetoma research center in khartoum, sudan.15 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn6 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn8 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn9 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn10 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn11 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn12 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn13 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn14 http://www.voicesinbioethics.net/opeds/2016/05/31/mycetoma-and-neglected-tropical-diseases-a-medical-scientific-and-moral-duty-to-care#_edn15 dias, mycetoma & neglected tropical diseases, voices in bioethics, vol. 2 (2016) 3 conclusion the ethical reasons to foster attention to, and care for, mycetoma victims should be taken seriously. if respected health organizations continue to dismiss mycetoma and other ntds as a low priority initiative, an egregious ethical oversight will be perpetuated instead of corrected—and to what end? to neglect is to fail to care for properly, or even to abandon. that the who has knowledge of this neglected disease, yet has been reluctant to include it on the neglected tropical diseases list until just this month, is unconscionable. in this vein, bioethicists, physician-researchers, and global public health experts ought to reevaluate the current lackluster approach to understanding and treating mycetoma and other ntds. relatedly, the who, the un, and other affluent, leading healthcare organizations around the globe should leverage existing resources and extend outreach programs to the mycetoma belt. if the poor and powerless victims of mycetoma are provided with basic access to healthcare and medical education through funded research developments, education workshops, and the implementation of clinical trials, then it will be possible to procure beneficence and justice for these unjustly suffering populations. 1 for more details, see my recent op-ed on the ramifications of the zika outbreak, at http://www.voicesinbioethics.net/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-relatedrecommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance?rq=matt%20dias. 2 see usaid’s ntd program, “about the neglected tropical disease program,” june 16, 2014, http://www.neglecteddiseases.gov/about/. 3 public library of science (plos), “plos collections: mycetoma,” http://collections.plos.org/mycetoma. 4 world health organization, “neglected tropical diseases—summary,” 2016, http://www.who.int/neglected_diseases/diseases/summary/en/. 5 world health organization, “trade, foreign policy, diplomacy and health” and who mission statement, 2016, http://www.who.int/trade/glossary/story096/en/. 6 while “duty to care” ethics traditionally refers to a legal obligation, this piece uses that term in an expanded sense—e.g., requiring adherence to a reasonable standard of medical care in the context of mycetoma and its sufferers. 7 eduard e. zijlstra, wendy w. j. van de sande, and ahmed h. fahal, “mycetoma: a long journey from neglect,” plos neglected tropical diseases 10(1): e0004244, doi: 10.1371/journal.pntd.0004244. 8 ibid. 9 mustafa alnour alhassan is shown on the cover image of this piece. 10 amy maxmen, “a disease so neglected it’s not even on ‘most-neglected’ lists,” npr, december 28, 2015, http://www.npr.org/sections/goatsandsoda/2015/12/28/461171017/a-disease-so-neglected-its-not-even-on-most-neglectedlists. 11 ibid. 12 see g-finder’s 2014 policy cures report, “neglected disease research and development: emerging trends,” http://www.policycures.org/downloads/y7%20gfinder%20full%20report%20web%20.pdf. while mycetoma was not explicitly addressed in this report, thirty-four other neglected diseases were analyzed in the context of seven years of global data, gathered by g-finder, a health analysis firm. http://www.voicesinbioethics.net/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance?rq=matt%20dias http://www.voicesinbioethics.net/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance?rq=matt%20dias http://www.neglecteddiseases.gov/about/ http://collections.plos.org/mycetoma http://www.who.int/neglected_diseases/diseases/summary/en/ http://www.who.int/trade/glossary/story096/en/ http://www.npr.org/sections/goatsandsoda/2015/12/28/461171017/a-disease-so-neglected-its-not-even-on-most-neglected-lists http://www.npr.org/sections/goatsandsoda/2015/12/28/461171017/a-disease-so-neglected-its-not-even-on-most-neglected-lists http://www.policycures.org/downloads/y7%20gfinder%20full%20report%20web%20.pdf dias, mycetoma & neglected tropical diseases, voices in bioethics, vol. 2 (2016) 4 13 brian w. simpson, “good news from geneva,” johns hopkins bloomberg school of public health, global health now, january 29, 2016, http://www.globalhealthnow.org/news/good-news-from-geneva. 14 see amy maxmen, “attention finally for a neglected disease,” johns hopkins bloomberg school of public health, global health now, may 28, 2016, http://www.globalhealthnow.org/news/attention-finally-for-a-neglected-disease, and drugs for neglected diseases initiative (dndi), “dndi response to the addition of mycetoma to the who list of ‘neglected tropical diseases,’” may 28, 2016, http://www.dndi.org/2016/media-centre/press-releases/mycetoma-who-ntd-list-response/. 15 drugs for neglected diseases initiative (dndi), 2016, http://www.dndi.org/diseases-projects/mycetoma/. http://www.globalhealthnow.org/news/good-news-from-geneva http://www.globalhealthnow.org/news/attention-finally-for-a-neglected-disease http://www.dndi.org/2016/media-centre/press-releases/mycetoma-who-ntd-list-response/ http://www.dndi.org/diseases-projects/mycetoma/ cosmer, assisted suicide heads to colorado, voices in bioethics, vol. 3 (2017) * tyler cosmer is pursuing a master’s in bioethics at columbia university and works in finance for hbo. © 2017 tyler cosmer. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribu tion, and reproduction, provided the original author and source are credited. assisted suicide heads to colorado tyler cosmer* keywords: end of life, palliative care, terminal illness, bioethics introduction while the outcome of our recent election cycle has represented a country with polarized viewpoints of america’s future policies, one ballot initiative has emerged as a force of consensus. voters in colorado overwhelmingly passed proposition 106 with a clear 64.6 percent in favor to 35.4 percent not in favor.1 proposition 106, more commonly known as the “end of life options act,” now gives eligibility for self-administered aid-indying medication to terminally ill coloradans, provided they only have six months or less to live and that they are mentally competent.2 colorado is now the sixth in the united states to sanction physician-assisted suicide for terminally ill citizens, joining oregon, washington, california, montana, and vermont.3 this vote is pivotal for colorado, marking the latest opportunity for public reflection and debate centered upon how we think about the end of life. ____________________________________________________________ cosmer, assisted suicide heads to colorado, voices in bioethics, vol. 3 (2017) 2 analysis medical error is the third leading cause of death, behind heart disease and cancer. 4 opponents to proposition 106 cite the possible scenario in which an individual is given access to end of life medication, and prematurely ends their life when they might have been able to overcome their prognosis. yet, as access to physician-assisted suicide continues to grow, richer data sets regarding impacts of the practice have become available. a 2007 inquiry on how physician -assisted suicide impacts vulnerable populations found no evidence of heightened risks in end of life decision making in oregon and in the netherlands.5 proposition 106 borrows heavily upon oregon’s pioneering death with dignity act of 1997.6 similar to oregon’s act, colorado’s version indicates that the request to receive life -ending medication must be the sole initiative of the patient. this process mandates two verbal requests for life-ending medication that must occur with a minimum of fifteen days waiting period between the two requests. in addition to these verbal requests, a written request must also be provided by the patient with two witnesses present. at least one witness cannot be a relative, an heir, an employee of the medical facility, or anyone who may have an interest in seeing that the individual’s wish is fulfilled.7 the physician’s side of the equation adheres to a strictly regimented list of responsibilities. beyond initial qualifications -being a legal citizen over the age of 18 who has received a prognosis of terminal illness, with life expectancy of six months or less -two separate physicians must independently conclude that the patient individual is of sound decision -making capacity and is able to fully understand the consequences of their actions. 8 the physician is obligated to present comprehensive information and treatment options to the individual, including alternatives such as hospice and palliative care. the patient will always have the ability to opt out of their request at any point, even after procuring the lethal dose. physician-assisted suicide (pas) has become a polarizing healthcare topic, especially since cases like karen ann quinlan and dr. kevorkian arose in controversy. support for pas has largely originated from individuals with a terminal illness and the loved ones around them. palliative care, hospice care, and pain relief treatment are not always successful at mitigating the tremendous suffering caused by end-stage terminal illness.9 quality of life can decline to a level where pain abatement, whether physically or mentally, is simply not possible. in addition to p ain abatement, advocates stress the immeasurable value of peace of mind and sense of control provided by end of life medication.10 the diagnosis of a terminal illness and a prognosis of six months or less to live can strip any sense of control from such an individual. the ability to say goodbye on one’s own terms and in a dignified manner allows the individual autonomous influence and control. this freedom can be one of the scant silver linings in the midst of a tragedy. proponents of legal access to end of life medication often point out that in states where this treatment is prohibited, terminally ill individuals may resort to suicide attempts, often unsuccessfully and in an inhumane way. 11 a principal source of opposition to assisted suicide derives from religious arguments in favor of the right to life. in addition, common objections are found in the conceptual role of a physician assisting a patient in suicide, given the potential for abuse towards vulnerable populations, and the frequency of incorrect prognosis and medical error. assisted suicide is often interpreted as a contradiction to the core responsibility of doctors: to preserve life through healing. to large segments of medical professionals, incorporating physician-assisted suicide would fundamentally alter the physician-patient relationship and potentially undermines public trust in the medical profession.12 beneficence is a core principle of medical practice; and, to many, physician -assisted suicide would erode this core tenet of physician practice. opponents in colorado fear that legalizing physician-assisted suicide would disproportionately affect the elderly, physically disabled, and populations of low socioeconomic status. the expensive, life -prolonging treatment usually prescribed to a terminally ill patient can place a disproportionately heavy burden on the uninsured cosmer, assisted suicide heads to colorado, voices in bioethics, vol. 3 (2017) 3 and low-income population which might influence their decision making to favor the assisted suicide route.13 conclusion both sides of the debate raise key ethical concerns about legalizing physician-assisted suicide. the principle of beneficence seems to be in direct conflict with anything that would terminate the life of a patient. yet, in tragic situations where a patient suffers from a terminal illness that will drastically reduce quality of life, prolonging life while increasing the risk for harm shifts away from beneficial intent. at this moment, beneficence could be reinterpreted to view death as a method of ameliorating pain and suffering, and that life-ending medication could function as a complement to palliative care. laws that prevent helping a terminally ill individual die in a dignified and humane manner seem to unnecessarily extend suffering and violate another core principle of medical ethics: the importance of patient autonomy. autonomy, or self-governance, is of utmost importance in modern bioethics. to deny any individual -who must be of sound mental capacity - the ability to determine his or her treatment plan in response to their own terminal illness clearly violates patient autonomy. moral progress is often calibrated by how effectively health care practices and policies reduce suffering. avoidable suffering should be the first type we should aspire to eliminate. protracted suffering caused by impeding access to end of life medication is an instance where avoidable suffering perpetuates. maintaining this stance removes the choice from the patient’s hands. extending life in defiance of the harms inflicted, with no regard to the quality of life of a patient, seems pointlessly unethical. 1 new york times. (2017, january 4). colorado election results. retrieved from http://www.nytimes.com/elections/results/colorado 2 b. t. s. board, "proposed initiative #145," 08 april 2016. [online]. available: ballot title setting board. "proposed initiative #145." april 08, 2016. http://www.sos.state.co.us/pubs/elections/initiatives/titleboard/filings/2015-2016/145original.pdf. 3 "state-by-state guide to physician-assisted suicide," procon, 05 10 2015. [online]. available: http://euthanasia.procon.org/view.resource.php?resourceid=000132#legal_states. 4 m. makary, "medical error—the third leading cause of death in the us," bmj, 03 may 2016. [online]. available: http://www.bmj.com/content/353/bmj.i2139. 5 m. battin, a. van der heide, l. ganzini and g. van der wal, "legal physician‐assisted dying in oregon and the netherlands: evidence concerning the impact on patients in “vulnerable” groups," journal of medical ethics, vol. 33, no. 10, pp. 591-597, 2007. 6 oregon state legislature, "chapter 127.800-995 the oregon death with dignity act," [online]. available: https://www.oregonlegislature.gov/bills_laws/ors/ors127.html. 7 ballotpedia, "colorado "end of life options act", proposition 106," [online]. available: https://ballotpedia.org/colorado_"2end_of_life_options_act,"_proposition_106_(2016). 8 new york times., colorado election results. 9 c. zimmermann, r. riechelmann and m. kryzyzanowska, "effectiveness of specialized palliative care: a systematic review," jama, vol. 299, no. 14, pp. 1639-1738, 2008. 10 colorado public radio, "debate: coloradans will vote on medically assisted death proposal (transcript)," 26 september 2016. [online]. available: http://www.cpr.org/news/story/debate-coloradans-will-vote-on-medically-assisted-death-proposal. 11 s. greene, "without medical aid-in-dying, some patients choose to die violently. sheryl randall was one of them.," the colorado independent, 02 september 2016. [online]. available: http://www.coloradoindependent.com/161029/withouthttp://www.nytimes.com/elections/results/colorado http://www.sos.state.co.us/pubs/elections/initiatives/titleboard/filings/2015-2016/145original.pdf http://euthanasia.procon.org/view.resource.php?resourceid=000132#legal_states http://www.bmj.com/content/353/bmj.i2139 https://www.oregonlegislature.gov/bills_laws/ors/ors127.html https://ballotpedia.org/colorado_%222end_of_life_options_act,%22_proposition_106_(2016) http://www.cpr.org/news/story/debate-coloradans-will-vote-on-medically-assisted-death-proposal http://www.coloradoindependent.com/161029/without-medical-aid-in-dying-some-patients-end-their-suffering-violently-sheryl-randall-was-one-of-them-assisted-suicide-death-with-dignity cosmer, assisted suicide heads to colorado, voices in bioethics, vol. 3 (2017) 4 medical-aid-in-dying-some-patients-end-their-suffering-violently-sheryl-randall-was-one-of-them-assisted-suicide-death-withdignity. 12 j. daley, "colorado wrestles with ethics of aid in dying as vote looms," npr, 11 october 2016. [online]. available: http://www.npr.org/sections/health-shots/2016/10/11/497540453/colorado-wrestles-with-ethics-of-aid-in-dying-asvote-looms. 13 t. d. p. e. board, "no on proposition 106: aid-in-dying measure lacks proper safeguards," the denver post, 11 october 2016. [online]. available: http://www.denverpost.com/2016/10/11/no-on-proposition-106-aid-in-dying-measure-lacks-propersafeguards/. http://www.coloradoindependent.com/161029/without-medical-aid-in-dying-some-patients-end-their-suffering-violently-sheryl-randall-was-one-of-them-assisted-suicide-death-with-dignity http://www.coloradoindependent.com/161029/without-medical-aid-in-dying-some-patients-end-their-suffering-violently-sheryl-randall-was-one-of-them-assisted-suicide-death-with-dignity http://www.npr.org/sections/health-shots/2016/10/11/497540453/colorado-wrestles-with-ethics-of-aid-in-dying-as-vote-looms http://www.npr.org/sections/health-shots/2016/10/11/497540453/colorado-wrestles-with-ethics-of-aid-in-dying-as-vote-looms http://www.denverpost.com/2016/10/11/no-on-proposition-106-aid-in-dying-measure-lacks-proper-safeguards/ http://www.denverpost.com/2016/10/11/no-on-proposition-106-aid-in-dying-measure-lacks-proper-safeguards/ kumar, hacking disease, voices in bioethics, vol. 6 (2020) © 2020 ishaan kumar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hacking disease: the ethics of diy medicine ishaan kumar keywords: biohacking, open science, diy medicine introduction imagine a life of strict diets, no cake and champagne on your birthday, lest you suffer incapacitating pain, jaundice, and diabetes, with the threat of pancreatic failure always looming overhead. this was the inevitable life of a patient with lipoprotein lipase deficiency (lpld), a rare genetic disease, until glybera burst onto the scene. glybera was a veritable scientific breakthrough – the world’s first gene therapy to be approved for use in the european union, and a one-time cure.1 however, glybera came with a caveat – a price tag of $1 million. it was developed at university of british columbia (ubc) and marketed by uniqure, and while it was on the market, only one insurer covered the drug, and only one patient received the drug outside of clinical trials. this resulted in glybera being a commercial failure, haemorrhaging $2 million a year. 2 uniqure tried to save the drug by entering the american market, but the burden of further post-market evaluations and risk-benefit analyses proved to be too much for uniqure.3 it failed to receive fda approval and was pulled from the european market in 2017. this was going to be the end of what was then the world’s most expensive drug, until a group of biohackers based across the united states and europe announced that they would reverse engineer the drug and release it to any patient who needed it for free. the biohacked “slybera” is to be, we’re told, the same drug, synthesized using published literature to be an inexpensive gene therapy. while we await evidence that this can be done, the biohackers claim that slybera is in development, and that it will be delivered soon, pending further testing.4 analysis it’s easy to assess this situation and immediately level accusations of unethicality towards the biohackers, for a multitude of reasons. for one thing, their actions violate the intellectual property of uniqure, and for another, it is difficult to validate if biohackers can synthesize slybera in a safe and effective form. however, i believe that the biohackers are carrying out their ethical duty, by trying to release this drug to patients who need it. while there have been instances when pharmaceutical companies and the fda have acted heroically, against their own financial interests to save patients’ lives, in this specific instance, the fda and uniqure are acting unethically by decreasing access to medicine through financial and regulatory means. underlying this controversy is the question of access, and the role of social justice in medicine. the biohackers present themselves as the answer to this situation, in which a slighted patient population has had kumar, hacking disease, voices in bioethics, vol. 6 (2020) 2 its only chance at a cure stripped of them through overregulation by the fda and pharmaceutical mismanagement of glybera by uniqure. biohackers purposefully exist outside of established research systems, to sidestep the regulatory and ethical barriers that slow scientific research down. this ‘outside-the system’ experience gives biohackers a great opportunity, not only to help a struggling patient population, but also to disrupt and reform the current drug regulation system in the united states. the aim of expediency for a suffering patient population is a morally admirable one, but we must be critical of the biohackers, and demand rigour and safety from them, if they want to be viewed as a legitimate force for change. to make decisions about the moral acceptability of the invested parties’ actions, we have to consider these principles. first, are they trying to alleviate suffering? second, are they respecting all people? finally, are they exploiting vulnerable populations? moreover, we must also consider the actions of the fda and uniqure, as they are instrumental to understanding the systemic backdrop surrounding slybera. the fda has taken a hard-line stance against such biohacking initiatives, with recent directives warning that the “sale of these products is against the law.”5 biohackers have circumnavigated this law by promising to release slybera for free. it is no secret that there is disdain towards the extensive drug approval process (which can take up to ten years), which has been criticized for depriving patients of life-saving treatments.6,7 in cases such as glybera, where there is no alternative treatment, an inefficient drug approval system causes harm to all the patients who can’t access the medications they need. the delayed release of drugs not only has a social, physiological, and economic cost, it harms patients and has an ethical cost associated. however, the fda is not the only ethically compromised body – uniqure, the pharmaceutical company that developed glybera also holds significant blame. ubc’s michael hayden led the original glybera research team, noting that when glybera was first formulated and shown to be effective in mice, uniqure was formed in order to market the drug, which is when the mismanagement began. “as the clinician scientists, we lost control of the project completely [...] [uniqure executives] decided that they were going to charge a million dollars a shot.”4 uniqure tried and failed to uphold its fiduciary responsibility to its investors and in the process hurt both its own revenue as well as lpld patients. since withdrawing glybera, uniqure has reinvested the money into a promising haemophilia b gene therapy which is in phase iii studies right now. 2 however, this doesn’t mitigate the fact that they slighted the members of the lpld community through the financial mismanagement of glybera. now, we can turn our attention to the biohackers themselves. in the case of injury, they would be legally culpable, but this doesn’t equate with moral responsibility. unlike uniqure and the fda, they are upholding the no harm principle—alleviating suffering through the drug that they are trying to develop. however, it is not clear whether they are respecting people’s right to autonomy, and whether they are exploiting vulnerable populations. in previous years, biohacking has comprised of self-experimentation in order to determine toxicity, efficacy and other relevant clinical factors.8 if slybera were in this stage of development when it was released, they would not be able to supply an exhaustive evidence-based list of risks and benefits of the treatment to the patient, violating the patient’s right to informed consent. moreover, patients with lpld are members of a vulnerable class, as there are no other treatment options for them; hence, presenting a glorified research project as a treatment option can easily be seen as abusive, selfserving, and exploiting a vulnerable patient population. thus, biohackers and other open-science enthusiasts who insist on operating outside of the purview of the regulatory system must self-regulate in a manner that both encourages research expediency, as well as respecting the rights of the patients. crucially, this involves acknowledging the intellectual and physical kumar, hacking disease, voices in bioethics, vol. 6 (2020) 3 limitations that being outside the pre-established system of research places on them. encouragingly, the issue of standards and self-regulation have been raised at biohacking conventions, with gabriel licina, one of the lead scientists on the slybera project, warning the community that preliminary data doesn’t license them to run straight to patients with their diy treatments. in licina’s words “this is the time for us to stop playing around with our petty self-centred little projects and actually do something that matters.”9 since then, licina has started a peer-review system of independent biologists, and said he will begin a dialogue with the fda and traditional biological science researchers in order to ensure that patients have access to the best drug possible.10 given the lack of action from the pharmaceutical side, the biohackers should work with institutions in order to test efficacy and safety, and share their science with those with the funding to deliver it to regulatory bodies to manufacture the drug safely. however, they can no longer hide behind the thin shroud of anti-establishment rhetoric – if they would like to make a difference to patients, they need to engage in a mature conversation with the current systems at play. conclusion the biohacking movement is currently at a crossroads, straddling the line between ethical and unethical practise, and their choices will define the movement and its legitimacy in years to come. it’s no secret that the fda and pharmaceutical companies need reform in order to return to their supposed primary aim – serving the patient population. open science has, on occasion, shown itself to be immature and overzealous, however, it has successfully resisted some of the regulatory issues that plague our current system. history has taught us in graphic terms that bioethics needs to be central to clinical practise, and the slybera researchers should consider ethics as important, if not more important, as the science they are doing. 1 warner, evelyn. “goodbye glybera! the world's first gene therapy will be withdrawn.” labiotech.eu, september 2, 2019. https://www.labiotech.eu/medical/uniqure-glybera-marketing-withdrawn/. 2 “uniqure announces it will not seek marketing authorization ...” uniqure.com, april 20, 2017. http://www.uniqure.com/gl_pr_glybera withdrawal_final_pdf.pdf. 3 sagonowsky, eric. “with its launch fizzling out, uniqure gives up on $1m gene therapy glybera.” fiercepharma, april 20, 2017. https://www.fiercepharma.com/pharma/uniqure-gives-up-1m-gene-therapy-glybera. 4 pearlman, alex. “biohackers are pirating a cheap version of a million-dollar gene therapy.” mit technology review. mit technology review, september 3, 2019. https://www.technologyreview.com/s/614245/biohackers-are-pirating-a-cheap-versionof-a-million-dollar-gene-therapy/. 5 “information about self-administration of gene therapy.” u.s. food and drug administration. fda: center for biologics evaluation and research, november 21, 2017. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapyproducts/information-about-self-administration-gene-therapy. 6 “how long does the fda take to approve a drug?” hiv. us department of veteran affairs, april 5, 2007. https://www.hiv.va.gov/patient/clinical-trials/drug-approval-process.asp. 7 kenneth a. young, "of poops and parasites: unethical fda overregulation," food and drug law journal 69, no. 4 (2014): 555574 https://www.labiotech.eu/medical/uniqure-glybera-marketing-withdrawn/ kumar, hacking disease, voices in bioethics, vol. 6 (2020) 4 8 brown, kristen v. “what does an infamous biohacker's death mean for the future of diy science?” the atlantic. atlantic media company, may 7, 2018. https://www.theatlantic.com/science/archive/2018/05/aaron-traywick-death-ascendancebiomedical/559745/. 9 carlough, nicholas. “scihouse goes to biohack the planet 2019.” scihouse inc. 501(c)(3), september 4, 2019. https://www.scihouse.space/scihouse-goes-to-biohack-the-planet-2019/. 10 “'i propose we grow up a little bit': biohackers grapple with when to reject mainstream science–and when to embrace it.” bioethics.com, september 3, 2019. https://bioethics.com/archives/48006. wilkes, involuntary hospitalization, voices in bioethics, vol. 5 (2019) © 2019 tara wilkes. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. involuntary hospitalization: a personal ethics narrative tara wilkes keywords: involuntary hospitalization, autonomy, mental health, bioethics, personal narrative would you rather your loved ones be treated effectively or taken to the hospital against their will? involuntary hospitalization, a legal process by which the mentally ill are forced into treatment at hospitals, is highly contested. some medical and legal scholars believe those with mental health disorders should not have their personal autonomy restricted or infringed. in contrast, other organizations such as the american medical association believe that although mentally ill individuals are often able to make their own decisions, involuntary hospitalization can be a very quintessential tool to stimulate recovery. involuntary hospitalization should be executed when individuals pose harm to themselves or others, regardless of whether the cause is mental illness or substance abuse. imagine someone who you love is kicking, screaming, and threatening the lives of others or yourself. this was my reality before my brother was involuntarily hospitalized. my 16-year-old, younger brother, declan, has bipolar two, adhd, and nonverbal learning disorder. these mental health disorders cause my brother to be violent and impulsive, characteristic of hyper-mania. occasionally, he also has hypomanic episodes at times because of bipolar two, regardless of his medications. in one incomprehensible situation, declan violently burst into a rage after a disagreement with our parents; he started throwing vases, punching holes in the walls, and cursing loudly. my single mom, younger sister, and i were endangered in the unstructured setting of my house because of my brother’s instability. in my brother’s case, hospitalization was necessary to ensure the safety of my brother and others surrounding him. hospitalization allowed psychiatrists to stabilize or modify his medications and open new avenues of treatment. this included transfer to an out-ofstate facility last summer. without hospitalization, declan would not have found the valuable resources he has today. involuntary hospitalization was the clear solution to save declan and my family from a dangerous situation. wilkes, involuntary hospitalization, voices in bioethics, vol. 5 (2019) 2 my family and i view involuntary hospitalization through different lenses than my brother. declan believes that his hospitalization was unnecessary and that his violent outburst was just a “one-time mistake.” however, all of declan's peers and family members could see his emotional and physical improvements following his release from alexian brothers. for example, hospitalization taught declan new coping skills and helped stabilize his medications in an effort to prevent another violent outbreak. although difficult, declan’s hospitalization was a necessary result of the violent situation he put my family and me through. in contrast to declan, other mentally ill individuals involuntarily placed in hospitals are grateful for their experiences. patients, generally, have a positive view of involuntary hospitalization after being released, especially if “they experienced the hospital environment as warm, friendly, accommodating to their individual needs, [and feel] safe…” the hospital environment should be a comfortable place for individuals to be treated. i truly believe declan, as he matures, will also be thankful for the intensive therapy and treatment he received. the public’s general view of involuntary hospitalization is circumstantial and disorder-dependent as evidenced by the 1996 general social survey, conducted by the national opinion research center at the university of chicago. according to the social survey, the public agrees that troubled people have the capacity to make their own treatment decisions; however, they recommend that individuals who have severe mental disorders, like schizophrenia, should be involuntarily hospitalized. additionally, “respondents were slightly more likely to condone coercion, if others, rather than the person himself or herself, are seen as in danger” because they can picture themselves in a dangerous situation. coercion, performing an action against a patient’s free will or resistance, is the most serious consideration in involuntary hospitalization. it is comforting to realize most respondents shrug it off in severe, violent scenarios. the public’s view of involuntary hospitalization corresponds with my view: involuntary hospitalization is necessary under certain circumstances. involuntary hospitalization is warranted if mentally ill individuals are capable of harming those around them. as the clinical manual of psychiatry and law states, “the person must have a mental illness that causes his or her potential for violence” to be appropriately involuntarily hospitalized. some may suggest that the offender should be managed by the police when violence is involved. when declan hurt my family and me, police intervention made him more scared, angry, and upset. although the police did their job to the best of their ability, healthcare professionals are better qualified to treat and regulate disorders. in the healthcare environment, mentally ill individuals who are capable of violence can receive the care they need. involuntary hospitalization should be utilized whenever a mentally ill person poses a serious threat to his or her community. involuntary hospitalization is also necessary when individuals with mental health disorders express consistent suicidal thoughts. although suicidal individuals may regard hospitalization as harmful to their wellbeing, this harm is minor in comparison to the outcome of self-harm. although hospitalization may not prevent suicide, “a person’s right to be treated in the least restrictive environment must be balanced against his or her potential dangerousness to self or others.” the hospital provides a structured setting where suicidal individuals can express their feelings and engage in social support systems. declan successfully worked through suicidal thoughts and emotions that appeared during his violent outbursts. since involuntary means hospitalization is only performed with the patient’s best interest at heart, it should be implemented for suicidal individuals. wilkes, involuntary hospitalization, voices in bioethics, vol. 5 (2019) 3 in addition, a frequent substance abuser who is at risk of posing imminent harm to themselves or others should be involuntarily hospitalized, since addiction to drugs or alcohol can change the brain in fundamental ways. violence to self and others should be regarded on the same level of concern as substance abuse because both could lead to death or harm. however, a person who is simply intoxicating themselves with no harm to others does not always warrant violating their civil rights. it’s when they pose a harm to others, through an act like drunk driving, that involuntary hospitalization should be implemented. it is a personal choice to harm the body with alcohol or drugs, but if that action poses harm to others, it is justified to violate the abuser’s civil rights. for instance, involuntary hospitalization allowed declan to be educated on the risks of drugs after he immersed himself into a group of peers that abused drugs. involuntary hospitalization should not be implemented for every single person who suffers from substance abuse disorder, but it should be utilized for severe substance abusers who are at risk of causing harm to themselves or others. there are some who believe that involuntary hospitalization is coercive, harmful, and diminishes the patient’s self-esteem, leading to mental instability because of its coercive nature. to suggest the benefits of voluntary hospitalization, the northwestern university law review says, “making the patient responsible for his own treatment, rather than committing him forcibly to an institution, is said to increase his feelings of self-worth and his receptivity to treatment.” however, one must ask: how do feelings of self-worth and increasing one’s self-esteem compare to the fact that the individual could die without treatment? increasing self-esteem is a benefit to voluntary hospitalization, but involuntary hospitalization has the potential to save lives. similarly, opponents to involuntary hospitalization believe that to eliminate coercion, less restrictive means such as outpatient centers should be utilized to treat the mentally ill. this line of reasoning ignores the importance of involuntary hospitalization. these opponents state, “there is little reason why the prescription of medication or the provision of convulsive, psychological, and social therapies also cannot be accomplished on an outpatient.” although some of these therapies can be accomplished in an outpatient facility, the ease with which this can be done is overstated. the current lack of communication between courts and outpatient centers inhibits the use of outpatient resources. additionally, community-based care will not be effective until there are more facilities and the public has more acknowledgment of the stigma surrounding mental illness. therefore, hospitals need to intervene and provide the proper care to the mentally ill while more outpatient services develop. the more medical professionals address this healthcare resource issue, the less they must violate patient civil rights. although outpatient systems are preferable, the current lack of resources in the mental healthcare system renders involuntary hospitalization necessary. involuntary hospitalization is indicated for those with the potential to commit violent acts, high-risk suicidal actions, and pose a risk to themselves or others as a result of substance abuse disorder. although involuntary hospitalization can be coercive, it exists to treat the mentally ill who do not realize they need help or refuse to take the necessary treatment steps for their health. other outpatient resources may be used, but with limited resources available involuntary hospitalization is the most feasible option. hospitalization stabilized my brother and removed my family and i from a dangerous situation. for that, i am forever thankful. references gilboy, janet a., and john r. schmidt. “voluntary hospitalization of the mentally ill.” northwestern university law review 66, no. 4 (1971-1972): 429–53. wilkes, involuntary hospitalization, voices in bioethics, vol. 5 (2019) 4 american medical association. “patient-physician relationships.” in code of medical ethics of the american medical association, 1st ed. american medical association, 2016.; council on psychiatry and law. “apa official actions: resource document on involutnary outpatient commitment and related programs of assisted outpatient treatment,” 2015. danzer, graham, and asha wilkus-stone. "the give and take of freedom: the role of involuntary hospitalization and treatment in recovery from mental illness." bulletin of the menninger clinic 79, no. 3 (2015): 255–80. pescosolido, b. a., j. monahan, b. g. link, a. stueve, and s. kikuzawa. "the public’s view of the competence, dangerousness, and need for legal coercion of persons with mental health problems." american journal of public health 89, no. 9 (1999): 1339–345. simon, robert i., and daniel w. shuman. clinical manual of psychiatry and law. washington, dc: american psychiatric pub., 2007. glick, rachel lipson. emergency psychiatry: principles and practice. philadelphia: wolters kluwer, 2008. gilboy, janet a., and john r. schmidt. "voluntary hospitalization of the mentally ill." northwestern university law review 66, no. 4 (1971-1972): 429–53. morse, stephen j. "a preference for liberty: the case against involuntary commitment of the mentally disordered." california law review 70, no. 1 (1982): 54–106. . dallas, dental therapists, voices in bioethics, vol. 9 (2023) * angelica dallas, bs michigan state university © 2023 angelica dallas. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the push to integrate mid-level providers into dentistry angelica dallas* keywords: mid-level providers, dental therapy, dentistry, restorative care, access to care, bioethics introduction mid-level providers are not new to the field of medicine. nurse practitioners and physician assistants have been providing direct care for patients with the oversight of licensed physicians for many years. as a result of their assistance, physicians can focus on complex cases and oversee a larger patient base. this, in turn, creates a more accessible healthcare system. although many gaps remain between medicine and dentistry, mid-level providers may be the answer to expanding access to dental healthcare needs. recently, mid-level providers have entered the field of dentistry in multiple states in the us. people commonly refer to this role as a dental therapist. a dental therapist works under a licensed dentist providing preventive and routine restorative care to expand dental healthcare to underserved populations.1 this new addition to the workforce has proven to be beneficial in some regions but has opened a door to ethical debate among dentists and public health officials. in 2009 minnesota approved the first state-wide legislation in the us to legalize the role of dental therapists after seeing a drastic decline in their dentist-to-population ratio. the congregation of dentists in highincome and highly populated areas have left many communities in the us in need of dental care but unable to receive it locally. a case study performed by dental hygienists minnesota, from 2003 to 2007, concluded that one in four primary school children presented with visible decay, and half of these cases were deemed urgent due to symptoms including toothaches and other oral pain. 2 minnesota health professionals performed another case study which presented results that they believed to further strengthen the need for dental reform in the state. over the course of a year, health professionals surveyed seven hospitals in the minneapolis-st. paul metropolitan area. the results showed over 10,000 emergency room visits were from dental-related problems such as abscesses or toothaches. these patients had untreated oral health problems, eventually leading to infection and unbearable pain. the total cost for these emergency room visits exceeded $4.7 million in out-of-pocket payments and insurance costs.3 these issues surrounding dallas, dental therapists, voices in bioethics, vol. 9 (2023) 2 dental health care are evident on a national level as well. to visualize the need for expanded oral care on a larger scale, in 2022 researchers recorded that over 69 million people in the us live in areas that have a dental health professional shortage. according to federal regulations, a shortage of providers indicates a population-to-provider ratio that meets or exceeds 5,000:1.4 integrating the role of dental therapists into the healthcare system has solved similar issues elsewhere. alaskan native communities and countries including the uk, canada, and new zealand have used dental therapists for decades. 5 in recent years maine, oregon, washington, arizona, michigan, idaho, new mexico, connecticut, and nevada joined this list. 6 as of 2022, there are five dental therapy licensing programs in the us, located in alaska, washington and minnesota. dental therapists are required to have a bachelor’s degree in dental therapy and can pursue a master’s in dental therapy to extend their license and perform more advanced procedures.7 differences in education, allowed procedures, and state-specific requirements in minnesota are depicted in table 1 (state-to-state specifics may vary). table 1: the varying degrees of dental therapy dental therapist advanced dental therapist education bachelor’s degree: 28-month post-high school program. students work alongside dental and hygiene students in a dental school’s patient clinic. master’s degree: 26 month program requiring a bachelor’s degree in dental hygiene or 28 month program requiring a bachelor’s degree plus 2,000 clinical practice hours. allowed procedures • take x-rays • administer local anesthesia • apply fluoride varnish and sealants • prepare and restore decayed primary and permanent teeth (fillings) • place temporary stainless-steel crowns • perform primary tooth pulpotomies • extract primary teeth all procedures a dental therapist can perform, in addition to: • complete an oral evaluation • develop a treatment plan • extract permanent teeth (nonsurgically) supervision procedures including preparing cavities, restoring and extracting teeth require a dentist’s presence in the office. taking x-rays and applying fluoride varnish and sealants) do not require supervision. advanced dental therapists can work without a dentist in the same location. any procedures that may require approval by the supervising dentist are noted in a collaborative management agreement. other information the underserved population must make up at least half of a dental therapist’s patients. the underserved population must make up at least half of an advanced dental therapist’s patients. *state of minnesota, minnesota administrative rules, 150a.105, https://www.revisor.mn.gov/ statutes/?id=150a.105; state of minnesota, minnesota session laws (2009), regular session, chapter 95—s.f. no. 2083, http://www.dentalboard.state.mn.us/portals/3/licensing/dental%20therapist/dtleg.pdf; and minnesota board of dentistry, “dental therapist scope of practice,” http://www.dentalboard.state.mn.us/portals/3/licensing/dental%20 therapist/dtscope.pdf. dallas, dental therapists, voices in bioethics, vol. 9 (2023) 3 i. regional outcomes of employing dental therapists the goal of integrating dental therapists was to increase access to care in underserved areas. results from a 2017 data collection on dental therapists in alaska provide evidence that the region met this goal. residents in communities where dental therapists practiced presented with more restorative care and fewer extractions than in communities without.8 another statistic reported an increase in private practices opening their doors to medicaid patients after the addition of a dental therapist to their team. one practice recorded that their dental therapist treated over 200 medicaid patients and earned nearly $24,000 in additional profit for the practice that year. 9 expanding dental care to patients enrolled in medicaid programs has been an ongoing issue. according to the american dental association, in 2018, around 30 percent of practicing dentists accepted medicaid. in 2012, a case study was conducted in alaska, which collected the statistics produced by rochelle furry, a certified dental therapist. over the course of a year, furry saw 750 patients and performed 5,000 procedures. furry’s addition to the team cost the supervising dentist $180,009 in overhead. furry’s collections totaled $385,338, with a yearly net profit of $205,329.10 another benefit reported by dentists when integrating a dental therapist into their team was the ability to prioritize their focus toward more complex cases, leaving routine fillings and other minimally invasive procedures in the hands of the dental therapist. with the reduced education of dental therapists comes reduced costs per procedure. this may encourage patients who are uninsured or owe out-of-pocket payments and entice them to follow through with the diagnosed treatment. ii. areas of debate despite providing benefits to patients and supervising dentists, dental therapists are not prevalent throughout the us. similar to the debate regarding mid-level providers like physician’s assistants and nurse practitioners, there are disputes between healthcare officials on whether the addition of dental therapists is an ethical solution to the disparities in access to oral care. the different levels of education between dentists and dental therapists spark debates on whether dental therapists have enough training to treat patients. dentists are required to complete both a bachelor’s and a doctorate program, as well as pass rigorous board exams usually totaling eight years of additional education after a high-school degree. although dental therapists perform more routine procedures that are minimally invasive, they are primarily working with populations that have received minimal oral care in the past, usually presenting with larger amounts of decay. this increases the complexity of cases that a healthcare worker with minimal training compared to a dds or dmd attends to. while some patients prefer the low costs of procedures done by a dental therapist, others prioritize quality of treatment and believe only dentists are well-trained enough to provide it. some argue that a doctorate-level medical professional should do irreversible procedures involving the permanent removal of the tooth surfaces, such as fillings, crowns, or extractions. this position also brings up the issue of a two-tiered healthcare system in which patients of low socioeconomic status are treated by providers with less training, while mid to upper class patients are treated by doctors. some public health professionals argue there are better solutions. for example, the academy of general dentistry “white paper on increasing access to and utilization of oral health care services” suggests that one of the biggest challenges in achieving optimal oral health for all is “underutilization of available oral health care.”11 this argument addresses the noneconomic barriers in seeking professional care, including the patient's behavioral factors, levels of oral health literacy, transportation, location, and cultural or linguistic preferences. this author concludes that increased access can be achieved with the current dentist supply, dallas, dental therapists, voices in bioethics, vol. 9 (2023) 4 if optimally utilized, along with public health officials increasing public knowledge and awareness regarding oral health.12 conclusion the remaining question is what may be the best way forward for the health of the us population. the goal of equal and accessible healthcare is not easily obtainable. the introduction of dental therapists to the workforce has provided a possible solution to this problem by expanding access to healthcare to affected populations. some regions have documented benefits from this addition, but disagreements remain among healthcare professionals on whether this is the ethical solution to the problem of oral health disparities. the practice of integrating dental therapists into all regions with oral health care shortages throughout the us comes down to whether licensed dental therapists are competent in rendering quality treatment in underserved areas. some are content with the addition of dental therapists, while others continue to look for other solutions, such as better dental education on prevention and optimizing access to already established practices. 1 corr, allison. “what are dental therapists?” the pew charitable trusts, the pew charitable trusts, 9 oct. 2019, www.pewtrusts.org/en/research-and-analysis/articles/2019/10/09/what-are-dental-therapists. 2 the pew center on the states. “the state of children’s dental health: making coverage matter.” pew children’s dental campaign, sept. 2010. https://www.pewtrusts.org/~/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/state_policy/childrensdental50statereport 2011pdf.pdf. 3 pew center on the states (2010). 4 health workforce shortage areas, health resources and services administration (hrsa), 31 mar. 2023, https://data.hrsa.gov/topics/health-workforce/shortage-areas. 5 david a. nash, jay w. friedman, kavita r. mathu-muju, peter g. robinson, julie satur, susan moffat, rosemary kardos, edward c.m. lo, anthony h.h. wong, nasruddin jaafar, jos van den heuvel, prathip phantumvanit, eu oy chu, rahul naidu, lesley naidoo, irvi. “a review of the global literature on dental therapists.” community dentistry and oral epidemiologyvolume 42, issue 1 p. 1-10, wiley library online , 3 may 2013, https://doi.org/10.1111/cdoe.12052. 6 corr (2019). 7 urahn, s. and schuler, a. (2014) expanding the dental team. the pew charitable trust. https://www.pewtrusts.org//media/assets/2014/06/27/expanding_dental_case_studies_report.pdf 8 corr (2019). 9 corr (2019). 10 nash, et al. (2013). 11 white paper on increasing access to and utilization of oral health care services, academy of general dentistry, july 2008, https://www.agd.org/docs/default-source/advocacy-papers/agd-white-paper-increasing-access-to-and-utilization-of-oral-healthcare-services.pdf?sfvrsn=2%20. 12 burton l. edelstein, dds, mph. “examining whether dental therapists constitute a disruptive innovation in us dentistry.” american journal of public health, american public health association, oct. 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3222362/. http://www.pewtrusts.org/en/research-and-analysis/articles/2019/10/09/what-are-dental-therapists. https://www.pewtrusts.org/~/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/state_policy/childrensdental50statereport2011pdf.pdf https://www.pewtrusts.org/~/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/state_policy/childrensdental50statereport2011pdf.pdf https://data.hrsa.gov/topics/health-workforce/shortage-areas https://doi.org/10.1111/cdoe.12052 https://www.pewtrusts.org/-/media/assets/2014/06/27/expanding_dental_case_studies_report.pdf https://www.pewtrusts.org/-/media/assets/2014/06/27/expanding_dental_case_studies_report.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3222362/ beer, googling patients, voices in bioethics, vol. 8 (2022) * emily beer, ms candidate columbia university © 2022 emily beer. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. googling patients – it’s not about privacy, it’s about respect emily beer* keywords: clinical ethics, data privacy, patient-targeted googling, confidentiality, clinician-patient relationship introduction huge amounts of public data on the internet and the ease with which we regularly search it have resulted in the phenomenon called patient-targeted googling (ptg). ptg occurs when a clinician conducts an online search for information about a patient through any search engine, internet database, or social media site. the practice has provoked ethical discussion and the creation of practical guidelines to ensure clinicians use ptg ethically. one common theme in ptg literature is privacy and confidentiality. however, given that the relevant information is publicly accessible, privacy and confidentiality may not be applicable or accurate. in health and medicine, correctly applying the concepts of privacy and confidentially is important because these terms have rigid legal definitions that are often confusing and misunderstood. by refraining from legitimizing claims that patients’ publicly accessible data is “private” information, we can avoid the risks of inappropriately applying privacy and confidentiality concepts and further muddying the waters. i. privacy and confidentiality in ptg literature the literature on ptg consistently raises patient privacy and confidentiality concerns. for example, the article “patient-targeted googling: the ethics of searching online for patient information” mentions the concept of privacy over a dozen times in its ethical and practical framework, designed for psychiatrists to use prior to engaging in a patient-targeted search.1 a later work, begins with a statement that “[m]any physicians would agree that seeking information about their patients via google seems to be an invasion of privacy . . .” 2 informal guidelines continue to address privacy and confidentiality when analyzing ptg and frame consent as necessary to respect patient privacy.3 research articles reporting investigations of ptg also categorize privacy violations as a risk to privacy and dignity.4 the ama does not have a ptg ethics policy, but an article on the ama website about ptg by a staff writer stated that “physicians have a fundamental ethical responsibility to respect patient privacy.”5 ethical beer, googling patients, voices in bioethics, vol. 8 (2022) 2 and practical discussions of ptg often involve concerns for privacy and confidentiality. however, the information found in ptg searches is not private or confidential. ii. the information at issue is not actually private or confidential the information at issue in ptg is not hidden or secured from public view and is available to anyone conducting an internet search. thus, it cannot be said to be private or confidential. yet, privacy and confidentiality routinely come up in analyses of ptg. perhaps this is because the information feels private. the thought of clinicians digging through the internet to find information about the patient feels like an invasion. they are trying to access information that the patient did not share with them in an unexpected way. people commonly associate privacy and confidentiality concepts with personal data access issues, so it is not surprising that privacy and confidentiality find their way into discussions on ptg. while much of the literature focuses on privacy, some of the literature does acknowledge that this information is not really private or confidential. one article describes the patient experience as possibly a “perceived privacy” that stems from an assumption that clinicians will not conduct online searches for information about them just like they may assume “their psychiatrists would not eavesdrop on their conversations in restaurant.”6 another acknowledges that there is a difference between legal definitions of privacy and confidentiality and “the layperson’s notion.”7 so, though looking up a patient’s facebook profile does not legally violate the patient’s privacy, the patient may still consider it “private” in a layperson’s sense. it is important for clinicians to be sensitive to actions that may feel violating to a patient. clinicians should be aware that patients may consider ptg a breach of privacy. but literature geared towards ethics in clinical practice ought not confuse lay and legal definitions because doing so risks legitimizing an incorrect position. it is also not necessary to use privacy and confidentiality concepts to justify concerns and practice guidelines concerning ptg. iii. ptg as a potential violation of the clinician-patient relationship a better way to frame ptg is as a potential violation of the trust and respect inherent in the clinician-patient relationship. patients understand and respect the traditional ways clinicians gather information about them. clinicians simply ask their patients directly for most types of information, especially personal information. when done with sensitivity and patient understanding that the information is relevant to the interaction, collecting personal information does not feel inappropriately invasive (even if the process may be uncomfortable). this is partially because the questioning occurs within the confines of the clinician-patient relationship. some information a clinician may discover in an online search can also be gathered by “legitimate” means (like by asking the patient). yet, accessing this information via ptg can still violate the clinician-patient relationship. this shows that it is not the nature of the information that makes the clinician’s access feel like an invasion, but the method they use to gather it. if the information clinicians seek is clinically relevant, patients expect that the clinician will ask for it. during that conversation, patients can ask why and how the information is relevant to their health care. it is the act of gathering this information outside the accepted boundary of the clinician-patient relationship that makes ptg potentially violating. the use of ptg to gather information that is not clinically relevant is also problematic. without resorting to privacy claims, the ethical analysis should identify the nature of the problem more accurately. patients accept that clinicians ask them personal questions to serve their best interests. once clinicians step outside that boundary by asking patients for clinically irrelevant information out of some voyeuristic or beer, googling patients, voices in bioethics, vol. 8 (2022) 3 inappropriate interest, they break the trust and respect inherent in the relationship. a clinician that purposefully seeks out clinically irrelevant information is doing something problematic because the exercise does not connect to the clinician’s professional duties and patient interests. when clinicians ask for clinically irrelevant information during a patient visit, the patient has the opportunity to evaluate the questioning and respond accordingly (perhaps responding to an inquiry that seems purely conversational or designed to relieve stress or not answering an invasive, irrelevant question). with ptg, patients cannot evaluate and respond to the clinician or the inquiry, as they are unlikely to know it is occurring. patients are not necessarily concerned that their doctor knows where they went to brunch last sunday. patients are concerned that clinicians are purposefully seeking out information neither connected to their health nor covered by the clinician-patient relationship and are likely doing so to satisfy their own interests. if the purpose of ptg does not serve the patient’s interests, clinicians should not conduct the search.8 even if it does serve the patient’s interest, ptg may not be ethical. the ethical significance does not hinge on whether the information is clinically relevant or not. what makes ptg potentially unethical is how it circumvents the methods of information gathering patients accept as appropriate in the clinician-patient relationship. whether the information is or is not clinically relevant or in the patient’s best interests, the mode of collection is ethically problematic, nor addresses privacy. iv. accurately applying concepts of privacy and confidentiality is important privacy and confidentiality are not accurate concepts to apply to ptg. this point about privacy and confidentiality is worth making, even if it does not change the way ptg should be approached in clinical practice. the concepts and legal definitions of privacy and confidentiality are extremely important in health and medicine. thus, it is crucial that privacy not be misconstrued to protect publicly available information. one of the most important (and often misunderstood) examples is the health insurance portability and accountability act of 1996 (hipaa) privacy rule. this rule protects only certain statutorily defined “individually identifiable health information” and “covered entities.” 9 violation of the privacy rule is grounds for statutory penalties.10 while there is room to criticize how well the privacy rule protects patients today, covered entities must follow it. the privacy rule remains an important component in protecting both patients and healthcare entities. despite this, misunderstandings about hipaa abound, even among clinicians.11 it has even been reported that some inaccurately claim that ptg violates hipaa .12 other statutes also protect health data in a variety of ways. for example, the ftc act creates an obligation to maintain appropriate security of health data and requires entities to keep promises they make about privacy.13 the health breach notification rule contains notice requirements for data breaches involving certain health information.14 additionally, the doctor-patient privilege protects confidential information from disclosure, and the exact confines of the privilege depend on the applicable statutes.15 as these examples demonstrate, there are many different legal requirements that concern privacy and confidentiality in the health sphere. these varying legal definitions and requirements create grounds for sincere confusion, even without adding nonlegal definitions or perceptions into the equation. apart from the rigid context of existing statutes and laws, discussions surrounding the ethics of data, privacy, and security are occurring, and privacy laws are undergoing a period of rapid change. while patients and health entities can be reasonably sure what protections apply to medical records created by providers, there is significant uncertainty about the increasing amounts of health-related information generated and beer, googling patients, voices in bioethics, vol. 8 (2022) 4 shared in our digital world by various entities. while it is clear that information located through a google search is public, the actual (and ideal) legal and moral status of much of this new information is less certain. for example, a multitude of health-related apps are available to consumers, many of which collect information that would be a part of a medical record if collected by a clinician. numerous wearable devices collect data on consumers’ heart rates, exercise patterns and sleep patterns. in-home smart devices can track when users are active and what they are doing in their homes. it is often difficult for consumers to understand whether data collected about them is private and confidential, whether it is shared with or sold to third parties, and whether any legal protections apply. people may waive their right to privacy without fully understanding what companies may do with the data. an important part of our social discourse on health, data security, and privacy involves how we treat or ought to treat that data and what protections we should afford to patients as consumers. it can be difficult to determine which health data is truly private or confidential. in our collective effort to decide how to categorize and use data, it is important not to muddy the waters unnecessarily by applying concepts of privacy and confidentiality to data that definitely does not meet those criteria and simply is not private. this is especially true in the healthcare context when there is already confusion on what is private and confidential. getting it wrong can result in legal consequences and significant patient harm. conclusion literature on ptg often references or applies the concepts of privacy and confidentiality. however, the information found through ptg is publicly accessible. while patients may perceive ptg as a breach of privacy, patient perception is not a reason for the literature to claim that publicly accessible information is also private. instead, ptg is better conceptualized as a potential breach of the trust and respect inherent in the clinician-patient relationship. privacy and confidentiality are incredibly important in health and medicine and often have strict legal definitions. data security and privacy issues are becoming increasingly important as we undergo a digital health revolution. we should be careful to avoid confusing these conversations by applying concepts of privacy and confidentiality to public information. 1 clinton, brian k., et al. “patient-targeted googling: the ethics of searching online for patient information.” harvard review of psychiatry, vol. 18, no. 2, 2010, pp. 103–112., https://doi.org/10.3109/10673221003683861. 2 baker, maria j., et al. “navigating the google blind spot: an emerging need for professional guidelines to address patienttargeted googling.” journal of general internal medicine, vol. 30, no. 1, 17 sept. 2014, pp. 6–7., https://doi.org/10.1007/s11606014-3030-7. 3 geppert, cynthia. “to google or not to google? is ‘patient-targeted’ googling ethical?” psychiatric times, vol. 34, no. 1, jan. 2017, pp. 1–4, https://www.psychiatrictimes.com/view/google-or-not-google-patient-targeted-googling-ethical. 4 chester, aaron n., et al. “patient-targeted googling and social media: a cross-sectional study of senior medical students.” bmc medical ethics, vol. 18, no. 1, 2017, https://doi.org/10.1186/s12910-017-0230-9. 5 “should physicians google patients?” american medical association, 9 mar. 2015, https://www.ama-assn.org/deliveringcare/patient-support-advocacy/should-physicians-googlepatients#:~:text=although%20ama%20has%20no%20ethics,responsibility%20to%20respect%20patient%20privacy. 6 clinton, “patient-targeted googling: the ethics of searching online for patient information.” 7 lehavot, keren, et al. “ethical considerations and social media: a case of suicidal postings on facebook.” journal of dual diagnosis, vol. 8, no. 4, 2012, pp. 341–346., https://doi.org/10.1080/15504263.2012.718928. beer, googling patients, voices in bioethics, vol. 8 (2022) 5 8 clinton, b.k., “patient-targeted googling: the ethics of searching online for patient information.” this paper provides an excellent framework for those interested in a deeper analysis of potential uses of ptg. 9 45 c.f.r. § 160.103. 10 “summary of the hipaa privacy rule.” hhs.gov, office for civil rights, u.s. department of health & human services, 26 july 2013, https://www.hhs.gov/hipaa/for-professionals/privacy/lawsregulations/index.html#:~:text=the%20privacy%20rule%20protects%20all,health%20information%20(phi).%22. 11 lo, bernard, et al. “hipaa and patient care: the role for professional judgment.” jama, vol. 293, no. 14, 13 apr. 2005, pp. 1766–1771., https://doi.org/10.1001/jama.293.14.1766. 12 geppert, “to google or not to google? is ‘patient-targeted’ googling ethical?” 13 “health privacy.” federal trade commission, https://www.ftc.gov/business-guidance/privacy-security/health-privacy. 14 “complying with ftc's health breach notification rule.” federal trade commission, jan. 2022, https://www.ftc.gov/businessguidance/resources/complying-ftcs-health-breach-notification-rule-0. 15 “doctor-patient privilege.” legal information institute, cornell law school, https://www.law.cornell.edu/wex/doctorpatient_privilege. hawkins, australian asylum law, voices in bioethics, vol. 1 (2014-15) © 2015 andrew hawkins. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. australian asylum law: advocacy in medicine andrew hawkins abstract in the united states since the 1970s, formal ethical guidelines make it a professional obligation for healthcare institutions to protect the human rights of patients. the legal system in australia currently lacks these safeguards. the concern of this paper will be to define these professional responsibilities with respect to medical ethics in an effort to understand public policy and its direct effects on human health. keywords: bioethics, autonomy, confidentiality, human rights, policy introduction the international bioethics retreat, hosted by cambridge university press, brings together the leading bioethics experts for a three-day discussion of the most pertinent issues in healthcare, technology, and public policy. there, i had the pleasure of meeting dr. deborah zion, an associate professor at victoria university and clinical ethics professor at deakin medical school, whose primary focus in the past decade has been assuring human rights for asylum seekers and government accountability in australia. in the united states since the 1970s, formal ethical guidelines make it a professional obligation for healthcare institutions to protect the human rights of patients. the legal system in australia currently lacks these safeguards. from a policy standpoint, asylum law raises issues concerning medical ethics and the limits of professional obligation. zion argues that it is “an intrinsic conflict between the desire to provide appropriate care, and the compromising of this by supporting a pathological system.”[1] the concern of this paper will be to define these professional responsibilities in an effort to understand public policy and its direct effects on human health. certainly, this will broaden the scope of our current understanding of bioethics with regard to the patient-physician relationship. the traditional concept of bioethics, which stems from the “georgetown mantra” in tom beauchamp and james childress’s principles of biomedical ethics, is that patient autonomy and confidentiality are to be respected throughout the healthcare process.[2] it is quite evident, however, that this argument is limited to the legal structures present in the united states. a novel concept that bypasses this constraint is relational autonomy, the idea that autonomy is socially dependent and that relevant contexts such as political structures are what allow for the exercise of this right. indeed that is why an analysis of policy history is so pertinent. an adequate rendering of how human rights are either supported or neglected in legal structures is necessary to guide reform. bioethics cannot truly exist in isolation from questions of social justice. severe deprivation of human rights is linked to poor health outcomes. recent asylum-seeker research has suggested an association between time in detention and mental health. in three us states, 70 percent of detainees reported https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn1 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn2 hawkins, australian asylum law, voices in bioethics, vol. 1 (2014-15) 2 that their mental health had worsened in detention with a significant correlation between length of time in detention and levels of anxiety, depression, and post-traumatic stress disorder.[3] how does an understanding of an inherent relationship between policy and health outcomes shape the responsibilities of healthcare providers for these vulnerable populations? professional obligations must be expanded into the realm of advocacy. i. legal and policy history those seeking asylum from violence or persecution from countries beset by sectarian conflict and persecution such as afghanistan, iraq, iran, and myanmar are imperiled by australia’s immigration policy. migrants are labeled “unauthorized boat arrivals” by australian media, and politicians campaign on narrow slogans (i.e. “stop the boats).”[4] both contribute to a culture of prejudice. violation of human rights, arbitrary incarceration, and reported harm to health in relation to this policy is deeply rooted in australia’s political past. under australia’s migration act, which was adopted in 1992 by the australian labor party government, any “unlawful noncitizen[1] is to be detained, regardless of circumstances, until they are granted a visa or leave the country.”[5] the present crisis stems from strict immigration policy forwarded by former prime minister john howard after his administration responded to popular xenophobic sentiments in 2001.[6] commonly known as the “pacific solution,” the introduced regulations excised offshore detention centers on the islands of manus, papua new guinea (png), and nauru from the australian migration zone. all those landing on australia proper would be sent to these centers for “offshore processing” so that no individual would gain an advantage over those already waiting in the camps. asylum seekers could be deprived of work, access to health care, and the ability to apply for their families to join them in detention because their location was not within australian territory. these regulations successfully evaded an international obligation to the united nations convention relating to the status of refugees and facilitated the violation of many of its precepts against maltreatment, including mandatory detention, detention of children, and indefinite detention.[7] that is, asylum seekers have the option to leave detention centers and must be processed in a timely manner. in 2008, the detention centers in nauru and png were closed following a report released by the un arbitrary detention group that cited inhumane conditions.[8]prime minister tony abbott (of the liberal party), facing political pressure to avoid “softness” on “illegal maritime arrivals,” reopened these detention centers in 2013, after which all asylum operations were placed under military control. ii. uncertainty, neglect, and health outcomes a 2013 report released by amnesty international detailed the conditions at offshore detention centers visited by researchers.[9] it noted that detainees are housed in a “hodgepodge of world war ii-era buildings and newer units, many of which are assembled from converted shipping containers. these accommodations offer almost no natural light, fresh air, or personal space.” other flagrant abuses include isolation of detainees from family and friends due to lack of access to phones and internet, families queued in the sun for hours at the nauru facility for meals, and excessive use of force in a manner described as “prison-like.” a nurse named “elizabeth” (changed for privacy) described conditions at the curtin detention center as follows: there was nowhere that you could ever not be viewed by guards, where you could get privacy, where you could ever sit quietly, where you could have a private conversation with somebody (or where you could have a row with somebody). for a family not to be able to have a good argument, for a parent not to be able to talk to a child, to discipline a child, or have anything for intimacy... there was nothing. even as a nurse there was nowhere where i could sit and have a chat to a patient. there was nowhere i could sit with a group of women and just have a chat, where people weren’t watching and listening. according to asylum seekers, the most damaging effect of internment is the uncertainty about how long they will remain in detention, whether they will be resettled in papua new guinea instead of australia, and if they can safeguard their families’ well-being. these are the same individuals who have escaped torture and ill treatment prior to attempting their journey to australia who are now subjected to additional psychological distress. in august https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn3 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn4 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ftn1 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn5 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn6 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn7 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn8 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn9 hawkins, australian asylum law, voices in bioethics, vol. 1 (2014-15) 3 2014, 190 experts signed a “j’accuse” statement citing “clear evidence that it [current asylum policy] causes psychiatric disorders, self-harm and suicide.”[10] furthermore, it states that the current policy violates the rights of children by “exposing them to violence, trauma and to poor medical and psycho-social care, with no access to independent monitoring.” the evidence is clear that the “inherently toxic” conditions in these detentions centers are harmful to detainees’ physical and mental health. [11] the bottom line, according to dr. zion, is: “if a person has not committed a crime, it is a serious violation of basic human rights to incarcerate them…it’s a human rights abuse to incarcerate someone who is seeking to be protected.”[12] according to dr. peter young, the former director of mental health at the international health and medical services, a third of asylum seekers are identified as having a significant mental disorder; whether those diagnoses originate from treatment while in detention cannot be confirmed. psychiatric mitigation and treatment are often unsuccessful because the causes of disorder are from the environment rather than the individual. a study published in 2009 that analyzed the detention health database held by the australian department of immigration and citizenship found a correlation between incidence rate of mental health problems and reason for, and time in, detention.[13]researchers, however, have not gained sufficient access to gather longitudinal data to confirm these assertions. objective information regarding the effects of detention is needed to challenge government claims about safety but the data collection itself produces ethical concerns. issues of medical ethics and patient rights in refugee research abound. jacobsen and landau argue that research into asylum seekers and other populations is only justifiable if the results obtained contribute to an abatement of their suffering.[14] zion acknowledged that the process of rigorous data collection in coercive settings might pose a threat to detainee informed consent. these studies are often conducted by social workers who are also intimately involved in the provision of services that refugees rely upon. individuals and families in detention centers must provide informed consent without coercion or while under duress—a difficult ethical dilemma to avoid when subjects are incarcerated. one key study conducted by zachary steel elucidated psychiatric status of asylum seeker families in australia’s remote facilities.[15] the group supported the objectivity of the patient’s response by conducting interviews independent of the private corrections company through the detainee’s legal worker. detainees provide information to researchers in anticipation of it being used to improve their situation. however, patient advocacy is often not the purpose of these observational refugee studies and participants feel that their information is treated like a commodity. a refugee explains: “we are really fed up with people just coming and stealing our stories, taking our photos and we never get anything back, not even a copy of the report. nothing ever changes”.[16]. how can research be structured as a reciprocal relationship where information gained by researchers is equally balanced by the potential benefits for participants? the utilitarian point of view that patients suffer risks for the benefit of future patients, which is associated with the biomedical model does not promote social justice in detention centers. a suitable alternative known as the participatory, relational model recognizes that capacity for consent is affected by social context and seeks to provide tangible benefits for partipants.[17] iii. ethics of refugee research there are issues linked to vulnerability and exploitation in researching the health conditions of asylum seekers. this returns to the classic concept of informed consent and whether basic rights in such a deprived environment can be upheld. deborah zion argues that autonomy requires rationality and freedom for its exercise, both of which are often absent in protracted displacement situations.[18] the solution may necessitate a redefinition of the clinical contract that extends beyond “do no harm” to a position of patient advocacy. doctors serving asylum seekers in remote detention centers where public disclosure is limited are a critical source of unbiased information concerning detainee safety. zion argues that a less formalized research practice that involves gathering information from advocates and medical and nonmedical professionals can mediate the issues of false hope and the powerful incentive to participate while in detention.[19] when a patient’s illness is derived from an https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn10 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn11 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn12 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn13 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn14 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn15 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn16 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn17 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn18 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn19 hawkins, australian asylum law, voices in bioethics, vol. 1 (2014-15) 4 unhealthy environment enforced by political factors, it is the duty of the clinician to advocate against maltreatment. an expansion of physician duties is the next logical step. the australian border force act, enacted on july 1st, 2015, makes it an offense for an “entrusted person to make a record of or disclose protected information.”[20]a violation can result in up to two years of imprisonment and the burden of proof rests upon border force health workers to prove that the disclosure was necessary to prevent a threat to the health of an individual. this legislation prohibits healthcare workers who treat asylum seekers from providing essential information due to fear of retribution and counteracts the alterative research techniques previously described. despite possible conviction, a group of forty current and former workers at australia’s detention centers on nauru and manus island challenged tony abbott and peter dutton to prosecute them under new secrecy laws.[21] the immigration situation in australia is at a serious crossroads that requires an increase in the public’s political awareness. that is why it is critical to discuss the conditions that asylum seekers face and support repeal of legislation that prevents healthcare professionals from assuming advocacy roles. conclusion a coherent resolution to the problem in australia requires further discussion that would be far too extensive for the purposes of this article. however, the united states must acknowledge the mistakes made in public policy in australia and take steps to avoid a similar tragic situation. there exists growing xenophobic sentiments in the united states, as evidenced by current republican presidential candidate donald trump’s recent remark, “when mexico sends its people, they’re not sending their best...they’re bringing drugs. they’re bringing crime. they’re rapists.”[22]while the united states has a slightly less harsh immigration policy than australia’s, this type of rhetoric can engender such governmental injustice. since 2014, the obama administration has supported the expansion of family detention centers on the us border with mexico as a deterrent for asylum seekers. a private corrections company, corrections corporation of america, managed a 2,400-bed facility in dilley, texas— unnervingly similar to offshore detention centers in australia. human rights watch documented that “indefinite detention of asylum-seeking mothers and their children in the united states takes a severe psychological toll”.[23] on july 24th, 2015, however, a united states district court ruled that the us government may not detain children and their parent(s), and mothers and children who are not deemed a security risk are to be released. fortunately, the ideological interests supporting an immigration detention regime were stopped in this case. the specifics of the immigration policies in both australia and the united states are important to an ethical discussion of our treatment of these vulnerable individuals. although these are unseemly, complicated issues, it is essential for those in the medical field to be engaged in them. according to the american public health association, “public health should advocate and work for the empowerment of disenfranchised community members.”[24] thus, the dissemination of crucial information and publicly denouncing harmful rhetoric are important responsibilities for the medical community. physicians must be prepared to deal with a greater scope of practice and must adopt an activist stance besides providing individual care. this may be the only means of improving the health of vulnerable populations. ____________________________________________________________ [1] person who is not an australian citizen and does not have permission to be in the county [1] zion, d. (2004) caring for detained asylum seekers, human rights and bioethics. australian and new zealand journal of public health. vol. 28 no. 6 [2] beauchamp t, childress j. (1989) principles of biomedical ethics, oxford university press. 3rd edition [3] acer, e., & chicco, j. (2009). us detention of asylum seekers: seeking protection, finding prison. human rights first. https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn20 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn21 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn22 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn23 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_edn24 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ftnref1 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref1 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref2 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref3 hawkins, australian asylum law, voices in bioethics, vol. 1 (2014-15) 5 [4] price, m. e. (2009). rethinking asylum: history, purpose, and limits (pp. 157-8). cambridge university press. [5] migration act 1958.https://www.comlaw.gov.au/details/c2012c00331 [6] magner, tara. (2004) less than pacific solution for asylum seekers in australia. int’l j. refugee l. 15, 53 [7]convention and protocol relating to the status of refugees http://www.unhcr.org/3b66c2aa10.html [8] a more comprehensive timeline of the history of australia’s refugee and humanitarian program can be found here:http://www.asrc.org.au/resources/statistics/detention-and-refugee-statistics/ . [9] this is breaking people. human rights violations at australia’s asylm seeker processing centre on manus island (2013). amnesty international.http://www.amnesty.org.au/images/uploads/about/amnesty_international_manus_island_report.pdf [10]j’accuse statement: convened by professor louise newman am.https://d68ej2dhhub09.cloudfront.net/825j'accuse_open_letter.pdf [11] marr, david. laughland, oliver. australia's detention regime sets out to make asylum seekers suffer, says chief immigration psychiatrist. the guardian.http://www.theguardian.com/world/2014/aug/05/-sp-australias-detention regime-sets-out-to-make-asylum-seekers-suffer-says-chief-immigration-psychiatrist [12] interview with deborah zion, an academic from the international school of public health at monash university, melbourne, about australia's treatment of refugees and asylum seekers.https://www.youtube.com/watch?v=ysks5vjrfso [13] green, j. p., & eagar, k. (2010). the health of people in australian immigration detention centres. med j aust,192(2), 65-70. [14] jacobsen, k. and landau, l. b. (2003) ‘the dual imperative in refugee research: some methodological and ethical considerations in research on forced migration’,disasters, 27(3), pp. 185–206. [15] steel x. momartin s. et al. (2004) psychiatric status of asylum seeker families held for a protracted period in a remote detention centre in australia. aust n z j public health 28:527-536 [16] pittaway, e. brtolomei, l. (2003). women at risk field research report: thailand. centre for refugee research, university of new south wales. [17] hugman, r., pittaway, e., & bartolomei, l. (2011). when ‘do no harm’is not enough: the ethics of research with refugees and other vulnerable groups. british journal of social work, 41(7), 1271-1287. [18] zion, d. (2005). does autonomy require freedom? the importance of options in international hiv/aids research. health care analysis, 13(3), 189-202. [19] zion, d. (2004). caring for detained asylum seekers, human rights and bioethics. australian and new zealand journal of public health, 28(6), 510-512. [20]http://www.aph.gov.au/parliamentary_business/bills_legislation/bills_search_results/result?bid=r5408 [21] open letter on the border force act: ‘we challenge the department to prosecute’. the gurdian. june 30 2015. http://www.theguardian.com/australia-news/2015/jul/01/open-letter-on-the-border-force-act-we-challenge-thedepartment-to-prosecute [22] https://www.washingtonpost.com/blogs/fact-checker/wp/2015/07/08/donald-trumps-false-comments-connectingmexican-immigrants-and-crime/ https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref4 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref5 https://www.comlaw.gov.au/details/c2012c00331 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref6 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref7 http://www.unhcr.org/3b66c2aa10.html https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref8 http://www.asrc.org.au/resources/statistics/detention-and-refugee-statistics/ https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref9 http://www.amnesty.org.au/images/uploads/about/amnesty_international_manus_island_report.pdf https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref10 https://d68ej2dhhub09.cloudfront.net/825-j'accuse_open_letter.pdf https://d68ej2dhhub09.cloudfront.net/825-j'accuse_open_letter.pdf https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref11 http://www.theguardian.com/world/2014/aug/05/-sp-australias-detention-regime-sets-out-to-make-asylum-seekers-suffer-says-chief-immigration-psychiatrist http://www.theguardian.com/world/2014/aug/05/-sp-australias-detention-regime-sets-out-to-make-asylum-seekers-suffer-says-chief-immigration-psychiatrist https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref12 https://www.youtube.com/watch?v=ysks5vjrfso https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref13 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref14 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref15 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref16 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref17 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref18 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref19 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref20 http://www.aph.gov.au/parliamentary_business/bills_legislation/bills_search_results/result?bid=r5408 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref21 http://www.theguardian.com/australia-news/2015/jul/01/open-letter-on-the-border-force-act-we-challenge-the-department-to-prosecute http://www.theguardian.com/australia-news/2015/jul/01/open-letter-on-the-border-force-act-we-challenge-the-department-to-prosecute https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref22 https://www.washingtonpost.com/blogs/fact-checker/wp/2015/07/08/donald-trumps-false-comments-connecting-mexican-immigrants-and-crime/ https://www.washingtonpost.com/blogs/fact-checker/wp/2015/07/08/donald-trumps-false-comments-connecting-mexican-immigrants-and-crime/ hawkins, australian asylum law, voices in bioethics, vol. 1 (2014-15) 6 [23] us: release detained migrant children, mothers. (2015, july 27). retrieved august 5, 2015.https://www.hrw.org/news/2015/05/15/us-trauma-family-immigration-detention-0 [24] thomas, j. c., sage, m., dillenberg, j., & guillory, v. j. (2002). a code of ethics for public health. american journal of public health, 92(7), 1057-1059. https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref23 https://www.hrw.org/news/2015/05/15/us-trauma-family-immigration-detention-0 https://michael-reaves-bkln.squarespace.com/features/2015/10/19/australian-asylum-law-advocacy-in-medicine#_ednref24 woodward, an assessment of mitochondrial replacement therapy, voices in bioethics, vol. 3 (2017) * alexa woodward, ms bioethics, columbia university © 2017 alexa woodward. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an assessment of mitochondrial replacement therapy alexa woodward* keywords: bioethics, mitochondrial replacement therapy, gene editing, crispr, regulation introduction last year, a baby boy was born from an embryo that had undergone mitochondrial replacement therapy (mrt). mrt was used to prevent this child from inheriting a mitochondrial disease from his mother, specifically infantile subacute necrotizing encephalomyelopathy – a disease that affects the central nervous system and usually results in death within the first few years of life. while controversial, assisted reproductive technologies (arts) such as mrt provide prospective parents with additional options and have the potential to improve the quality of human life by preventing disease. this story is significant for bioethical consideration because this technique results in germline modification -the alteration of dna in human reproductive cells that will be passed on to their offspring. implementing mrt in humans has consequentially garnered much criticism, from simple health-related implications, such as unknown harms to potential offspring and eugenics concerns, to a potential next step of scientific intervention: directly editing the nuclear genome. ____________________________________________________________ woodward, an assessment of mitochondrial replacement therapy, voices in bioethics, vol. 3 (2017) 2 analysis with mrt, modifications affect the mitochondrial genome (mtdna) but not the nuclear genome. researchers emphasize the lack of significance that mtdna has on personal characteristics and overall maintenance of “genetic integrity,” especially when compared to using a whole donor egg with an “unrelated” nuclear genome.1 even so, additional concerns arise regarding the longterm anthropological effects, blurring the distinction between therapy and enhancement, and issues of resource allocation. mutations and deletions in the mitochondrial genome can result in mitochondrial diseases affecting the neurological, musculoskeletal, cardiac, gastrointestinal, renal, and other systems, all of which are incurable. mrt uses the intended parents’ nuclear dna in conjunction with a donor’s mitochondria. mrt would affect the gametes of female babies born from this technique, who could then pass the donor mitochondria to subsequent generations. unlike other contro versial germline modification techniques -notably, crispr/cas9 and talen -the safety and efficacy of mrt has been repeatedly demonstrated in pre-clinical animal studies.2 mrt is used in conjunction with in-vitro fertilization (ivf) and inevitably results in the destruction of fertilized eggs when the pro-nuclear transfer method is used. scientifically defined, a fertilized egg does not become an embryo until after implantation into the uterine wall, but others disagree and consider the fusion of sperm and egg a sufficient criterion. the latter definition raises a multitude of issues and objections to most, if not all, experimental embryonic research. critics also raise a concern about a slippery slope, fearing that this type of research will lead to “de humanizing practices, such as embryo farms, cloned babies, the use of fetuses for spare parts, and the commodification of human life.” interestingly, research in bioenergetics shows that mitochondria may play a key role in nuclear gene expression – for example, in protein synthesis– appearing to bolster critics’ claims that mrt could have unknown phenotypic outcomes. genome-wide association studies (gwas) have analyzed the variance of certain single base pairs in mtdna and have found disease risk separate from known monogenic mitochondrial diseases. mitochondrial content also correlates with some histone modifications and chromatin activation, and may influence the epigenome. the extent to which mitochondria play a direct role in influencing phenotypic outc omes further legitimizes the issues of unanticipated health and psychosocial outcomes, including fertility and neurodevelopmental problems. these are not trivial concerns, and research should continue to attempt to understand the mechanisms by which the mt dna influences the transcription and the epigenome; but this presents a scientific problem, not one of principle. other technologies, such as ivf and preimplantation genetic diagnosis (pgd), are routinely used to screen and choose embryos based on genetic characteristics –– i.e., lack of predisposition to disease. prospective parents whose eggs and/or sperm are not viable may choose to use donor gametes to produce a child. in both cases, the nuclear genome of the resulting child is not the same as it would have been had the parents conceived naturally. more likely, there would be no child at all. hence, if techniques like ivf, pgd, and mrt are available, safe, and effective, they should be appropriately utilized to promote procreative liberty and help incre ase the chances of the birth of a healthy, disease-free baby. concerns of distributive justice, monopolization, commodification, cloning, protections for donors, and other ethical hurdles surrounding mrt can be resolved by enacting regulations and instituting relevant policies. to the dismay of many researchers, the 2016 consolidated appropriations act included a proviso that prevents the fda from reviewing applications “for an woodward, an assessment of mitochondrial replacement therapy, voices in bioethics, vol. 3 (2017) 3 exemption for investigational use […] in research in which a human embryo is int entionally created or modified to include a heritable genetic modification” through the fiscal year 2016. perhaps influenced by political or religious ideals, this legislation fails to recognize the overarching goals of medical research to improve health, prevent disease, and advance scientific knowledge. under the new administration, it is unlikely that this will change, given the emerging restrictions on reproductive rights, antipathy towards scientific evidence, and the proposed health care replacement plan that is projected to dramatically decrease coverage. the united kingdom’s human fertilization and embryology authority (hfea), on the other hand, determines the safety, efficacy, feasibility, and the psychosocial factors of arts, having “launched a pub lic consultation process on the social and ethical implications of mrt prior to its approval.” the house of commons approved the new legislation allowing experimental mrt procedures, based on a solid understanding of scientific research and overall public support.3 conclusion earlier this year, the institute of medicine (iom) produced a report on mrt at the request of congress. while the report recommends that the federal government allow clinical investigation and application of mrt, it fails to recognize the progress made in the uk and suggests ethically and legally troubling methodologies relating to sex-selection and procreative liberty by recommending pursuit of mrt in male embryos only. this recommendation results in a larger ethical dilemma than previously existed. in doing so, boys may be subject to more potential harm, girls may be simultaneously deprived of preventative measures, and potential parents may have no choice in this sex-selection – a process which is itself ethically controversial. the report repeatedly mentioned the “novel ethical, social, and policy issues” that mrt presents, but mentions only existing dilemmas that are prevalent in the use of ivf, donor gametes, and new medical procedures more generally. 4 the only “novel” consideration concerns the introduction of a third party’s mtdna, and as mentioned, presents a scientific dilemma, rather than an ethical one. society has become increasingly accepting of the use of donor gametes, use of arts by gay and l esbian couples, and adoption of biologically un-related children. our notions of parentage are already so diverse; such concern over a mitochondrial donor seems unwarranted. in addition, the united states lags behind the uk in encouraging public engagement with these issues.5 perpetuating the “three parent” misnomer and other propaganda will continue to stagnate progress in arts, especially in more controversial therapies such as mrt, which can invoke the ethical debate between enhancement and therapy. the goal of mrt is to re pair a physiological dysfunction, not to enhance an individual’s physiology. mitochondrial diseases affect approximately 4,000 children a year in the united states, diseases for which there are no cure; mrt is a promising method for preventing premature death. the exceptional nature of genetics has deeply rooted itself in the public’s perception; while trepidation is unnecessary, extreme care is advisable in pursuing therapies that affect not only our children, but also our descendants for years to come. references baltimore, david, paul berg, michael botchan, dana carroll, r. alta charo, george church, jacob e. corn et al. "a prudent path forward for genomic engineering and germline gene modification." science 348, no. 6230 (2015): 36-38. falk, marni j., alan decherney, and jeffrey p. kahn. "mitochondrial replacement techniques — implications for the clinical community." new england journal of medicine 374, no. 12 (2016): 1103-1106. gallagher, james. "mps say yes to three-person babies." bbc news. february 3, 2016. accessed woodward, an assessment of mitochondrial replacement therapy, voices in bioethics, vol. 3 (2017) 4 september 30, 2016. http://www.bbc.com/news/health-31069173. findlay, j. k., m. l. gear, p. j. illingworth, s. m. junk, g. kay, a. h. mackerras, a. pope, h. s. rothenfluh, and l. wilton. "human embryo: a biological def inition." human reproduction 22, no. 4 (2007): 905-911. muir, rebecca, alan diot, and joanna poulton. "mitochondrial content is central to nuclear gene expression: profound implications for human health." bioessays 38, no. 2 (2016): 150 156. cohen, i. glenn, julian savulescu, and eli y. adashi. "transatlantic lessons in regulation of mitochondrial replacement therapy." science 348, no. 6231 (2015): 178-180. g. vogel, mitochondrial gene therapy passes final u.k. vote, science science insider, 24 february 2015, http://news.sciencemag.org/biology/2015/02/mitochondrial-gene therapy-passes-final-u-k-vote10.1126/science.aaa7899 national academies of sciences, engineering, and medicine. mitochondrial replacement techniques: ethical, social, and policy considerations. national academies press, 2016. dondorp, wybo, g. de wert, guido pennings, f. shenfield, p. devroey, b. tarlatzis, p. barri, and k. diedrich. "eshre task force on ethics and law 20: sex selection for non -medical reasons." human reproduction 28, no. 6 (2013): 1448-1454. 1 ishii, tetsuya. "potential impact of human mitochondrial replacement on global policy regarding germline gene modification." reproductive biomedicine online 29, no. 2 (2014): 150-155. 2 ibid. 3 baylis, françoise. "the ethics of creating children with three genetic parents." reproductive biomedicine online 26, no. 6 (2013): 531-534. 4 "american health care act." congressional budget office. march 16, 2017. accessed march 21, 2017. https://www.cbo.gov/publication/52486. 5 cohen, i. glenn, and eli y. adashi. "mitchochondrial replacement therapy: the iom report and its aftermath." nature reviews genetics (2016). batra and caplan, the ethics of using de-identified medical data, voices in bioethics, vol. 5 (2019) *prag batra and art caplan, phd, new york university school of medicine, new york, ny © 2019 batra ad caplan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the ethics of using de-identified medical data for research without informed consent prag batra, bs and arthur l. caplan, * keywords: de-identification, privacy, medical data, bioethics, confidentiality introduction a recent publication by ludvigsson et al1 attempted to explain and justify the nature of health registries in nordic countries. these registries contain de-identified medical information from each of the individuals who interact with the nationally-run healthcare system and are used for research and quality improvement purposes. according to current laws in these countries, individual informed consent is generally not required for large-scale, registry-based studies that are deemed ethical by an ethics committee (ec). in nordic countries, these regional ethics committees (recs) essentially perform the role of irbs for human subjects research including clinical research but have less formal regulation to guide their practice.2 as this holds similarities to laws in other countries such as the united states, this is an issue of global relevance. ludvigsson et al. made several philosophical arguments to justify the option of informed consent, including the social contract theory of government, the ability of a representative ethics committee to serve as a proxy for individual interests, the principle of social justice, and the principle of utilitarianism. here, we present an alternative point of view to these arguments made in support of the use of deidentified medical data in the form of health registries for research purposes without informed consent.3 though the argument ludvigsson et al. puts forth specifically focuses on national health registries in nordic countries, regulations in the us also permit the use of de-identified health information in research without informed consent. as such, the ethicality of using de-identified medical data for research studies without informed consent is relevant both in the us and abroad. argument and response the first argument posited by ludvigsson et al involves the social contract theory of government. this theory states that individuals who are part of a given society have a set of moral obligations according to a contract, or agreement, between the individuals of that society which allows the society as an entity to exist. by choosing to remain part of a society, individuals are therefore agreeing to these obligations. in the case of ludvigsson et al’s argument, individuals have an assumed agreement to contribute their personal data for research in exchange for receiving free or reduced-cost healthcare from the state. consequently, participation is compulsory and informed consent is not necessary. this parallels other government batra and caplan, the ethics of using de-identified medical data, voices in bioethics, vol. 5 (2019) 2 requirements that aim to support society in exchange for the benefits of living in the society, such as drafting individuals to serve in the armed forces and requiring individuals to pay taxes. one practical caveat to this argument involves individuals who obtain private health insurance in the us. in this case, an argument could be made that because these individuals’ healthcare is not paid for by government-funded insurance such as medicare or medicaid, these individuals are not subject to the same agreement to contribute their data as those whose healthcare is provided by the state. a similar argument could be made for relatives of individuals who reside in a different country. in this case, certain medical data about an individual who resides in a given country may be used to infer medical information about the individual’s family members or relatives. examples of this may include hereditary medical conditions or individual dna sequence data. if the individual’s information is then used in a research study, this could also lead to indirect inclusion of relatives’ medical data in that research study, yielding potential violations of the relatives because they are not subject to the same social contract theory. furthermore, their information is being used in research studies without their informed consent. in each of these cases, however, ludvigsson et al’s argument falls short if we consider individual privacy as a fundamental human right. in this case, a government or other agency’s use of personal data without permission represents a violation of this right, whereas requiring individuals to serve in the armed forces or pay taxes does not. a counterargument may posit that because the medical data stored in these registries is “de-identified” and thus cannot be used to uniquely identify an individual, storage and use of this data without consent does not violate an individual’s right to privacy. while this argument appears sound, there are two important technical and philosophical considerations: (1) whether an individual’s medical data can be truly de-identified, and (2) whether new technologies in the future might enable re-identification of data that was believed to be de-identified. for instance, given that dna sequence data is unique for each individual, creating a registry of this data on its own could conceivably be linked back to specific individuals in the future, even if this cannot be done at present. furthermore, because there is greater similarity between genome sequence data of closely related family members, family trees could conceivably be created using the genome sequence data of individuals in a population-level registry, leading to potential identification of the genome sequence data of specific families that are outliers in some way. a similar technique could be applied to identify minority groups with known patterns in their genome sequence data. combining these data analyses with other information such as census reports or demographic surveys could enable researchers to further identify specific groups and individuals from “de-identified” data, leading to privacy violations. from a philosophical standpoint, if we cannot truly de-identify medical data while retaining sufficient accuracy to conduct scientifically valid research studies, any use of data for research studies could potentially be used to personally identify individuals and thus would require informed consent in order to protect privacy . as a result, ludvigsson et al’s argument that individuals have an assumed agreement to contribute their personal data for research in exchange for free or reduced-cost government healthcare falls short if we value privacy rights and acknowledge that individual medical data cannot be truly de-identified. a second argument posed by ludvigsson et al. stipulates that research study approval from an ethics committee may replace individual informed consent regarding the use of medical data in a national registry because ethics committees are believed to represent the general public. while this argument is plausible in cases where there is unanimous public agreement regarding use of registry medical data for clinical research, it falls short when there is disagreement. in such cases, an ethics committee’s blanket statement concerning medical data in a registry that includes data from individuals who do not agree with the ethics committee’s position would violate their autonomy. therefore, preserving individual autonomy would require us to ask each individual whether he/she approves of the use of his/her data for a particular research batra and caplan, the ethics of using de-identified medical data, voices in bioethics, vol. 5 (2019) 3 study, which is essentially informed consent. as such, ludvigsson et al’s argument that ethics committee approval may replace individual informed consent for the use of medical registry data in the context of clinical research only holds weight if public opinion surrounding a particular study is unanimous. a third argument posed by ludvigsson et al. involves the principle of social justice. here, social justice connotes a fair distribution of wealth, opportunity, and social privileges among the members of a society. the argument is as follows: informed consent may be especially challenging to obtain from high-risk populations. informed consent protocol for a given research study would therefore exclude these populations, resulting in selection bias and publication of research findings that may not be relevant to these populations. the unequal publishing of research findings relevant to these populations could lead to further marginalization of these populations, further perpetuating social inequalities. this represents a violation of the principle of social justice. a potential counterargument involves violation of individual autonomy in research studies performed without informed consent. this may represent a violation of social justice if informed consent is obtained from some individuals but not others if we consider the opportunity to exercise one’s individual autonomy through the informed consent process to be a social privilege. however, this counterargument does not apply if informed consent is not obtained. a fourth argument posed by ludvigsson et al is a utilitarian argument. in this case, utilitarianism refers to the principle of maximizing utility, or producing the greatest benefit to the greatest number of individuals. specifically, requiring informed consent would drastically reduce the number of study participants and thus statistical power of national population-level studies. furthermore, the cost required to obtain consent from millions of individuals as part of a national health data registry would be exorbitant. because this research has the potential to benefit many of the individuals whose data are being used, requiring informed consent would conflict with the principle of utilitarianism because it would prevent such research from being conducted. one counterargument here involves the nature of research. given the inherent uncertainty of research studies, it is possible that the results of large-scale research studies using national registries would not yield results that benefit many of the individuals whose data was used additionally, while conducting large-scale research studies may maximize benefits to society, it may not maximize benefits to the individuals whose data was used to conduct these studies. if there is a greater risk of harm than benefit to some individuals and we choose to conduct the research without allowing these individuals to choose whether their data is used, we set a dangerous precedent that justifies harming a few individuals in order to benefit society. this also represents a potential violation of the research ethics principle of favorable riskbenefit ratio, which states that the potential benefits of a research study should be proportional to or outweigh the potential risks, if we assume that this principle should apply to each individual participant as well as to society as a whole. one possible response to this objection is that if each research study must be approved by an ethics committee, it would be this committee’s responsibility to ensure that the research would not result in harm to a few individuals in order to benefit the many. thus, ludvigsson et al’s argument is sound if we value the principle of utilitarianism over individual autonomy and assume that large-scale research studies are likely to confer the maximum benefits to society. indeed, from a utilitarian point of view the potential harms to the people whose data are used are quite low, particularly when protections are in place, while the potential benefits to society are quite large. this tends to tip the scale in favor of utilitarianbased violations of privacy rights.4 discussion and concluding remarks ludvigsson et al’s arguments regarding social justice and utilitarianism appear to be sound. however, ludvigsson et al’s arguments regarding the social contract theory of government and ethics committees batra and caplan, the ethics of using de-identified medical data, voices in bioethics, vol. 5 (2019) 4 serving as a substitute for individual informed consent appear to be flawed. in order to determine whether use of de-identified medical data for research purposes is ethical in the absence of informed consent, we must consider whether the principles of social justice and utilitarianism supplant individual autonomy. several additional considerations are warranted in the context of de-identified individual medical data for research studies. these include potential benefits to data subjects as a result of de-identification of data, additional tools that can be used to protect de-identified data from the risk of individual privacy violations in addition to or instead of informed consent, and protection of both de-identified and personally identifiable research data from unauthorized access and use. specific additional tools include technical tools to assess the level of de-identification of data and statistical risk of re-identification, additional legal regulations on the use of individual medical data to prevent potential consequences of privacy violations such as employment discrimination or insurance discrimination, more granular access controls for researchers and research groups working with potentially re-identifiable data sets, and increased education and awareness of best practices for research personnel working with potentially re-identifiable data. each of these considerations will now be discussed. the first additional consideration includes potential benefits to research subjects as a result of deidentification of data. even if there is a risk that the data cannot be completely de-identified, using deidentified data as opposed to personally identifiable data in research studies, whether these studies involve informed consent or not, reduces the risk of individual privacy violations if there is a data breach. while data may need to remain individually identifiable in order to perform certain analyses in some research studies, individuals should be made aware of the level of de-identification of their data as part of the informed consent process and the data should be kept as de-identified as possible to minimize participant risk. in particular, given that there are multiple ways to de-identify data and de-identification exists along a spectrum,5 explaining what steps, if any, will be taken to de-identify a participant’s data and the associated risks of re-identification as part of the informed consent process for a given research study will enable participants to make a truly informed decision regarding use of their data in a given research study. the second important consideration involves whether informed consent is the only tool that can be used to protect “de-identified” data from the risk of individual privacy violations. clearly, requiring a participant to consent to use of his/her data in a research study protects against potential privacy violations because the participant has given permission for his/her data to be used in this manner. if the participant has not given informed consent, however, whether or not a given use of the participant’s data as part of a research study constitutes a privacy violation depends on whether the data may be used to re-identify the participant. as such, developing technical tools to better assess the re-identifiability of a given set of data, both alone and in conjunction with other information, may help assess the risk to individual privacy of using a given set of data as part of a research study. legal regulations could serve as another potential tool to protect against privacy violations. for instance, laws preventing discrimination for employment or insurance coverage on the basis of individual health data such as genetic information could protect individuals from unauthorized use of their health data by employers or insurance companies in the event that their “de-identified” data is able to be reidentified. current laws such as the genetic information nondiscrimination act of 2008 (gina) already exist to protect against genetic discrimination from employers and for health insurance coverage.6 another potential tool involves restricting access of specific research groups or research personnel to different data sets to reduce the likelihood of a single group or researcher obtaining complementary data sets that could be used to re-identify individual study participants. this may be analogous to conventional checks and balances used across large organizations and in government to prevent any single individual from wielding too much power. finally, increased education of research personnel regarding the risks of working with de batra and caplan, the ethics of using de-identified medical data, voices in bioethics, vol. 5 (2019) 5 identified data and a set of best practices for storing and analyzing this data may also reduce the risk of inadvertent data breaches or re-identification. thus, while informed consent is a valuable tool to protect deidentified data from posing a risk to individual privacy, it is not the only tool that can be used for this purpose. the third consideration involves protection of research data, both “de-identified” and personally identifiable, from unauthorized access. given that de-identified data can be re-identified and the likelihood of re-identification depends on the ethics of the entity analyzing the data and the other data the entity has access to, maintaining controlled access to de-identified data is crucial. determining who is able to access this data requires both technical safeguards and approval from an ethics committee regarding which research studies and research groups are permitted to access and use a given set of data, along with how the data may be used as part of a given research study or by a particular research group. 1 jonas f ludvigsson et al., “ethical aspects of registry-based research in the nordic countries,” clinical epidemiology 7 (november 23, 2015): 491–508, https://doi.org/10.2147/clep.s90589. 2 r. froud et al., “research ethics oversight in norway: structure, function, and challenges,” bmc health services research 19 (january 10, 2019), https://doi.org/10.1186/s12913-018-3816-0. 3 “privacy and security conditions required for research using ehr and other electronic health data,” aspe, november 23, 2015, https://aspe.hhs.gov/report/feasibility-using-electronic-health-data-research-small-populations/privacy-and-securityconditions-required-research-using-ehr-and-other-electronic-health-data. 4 luke gelinas, alan wertheimer, and franklin g. miller, “when and why is research without consent permissible?,” the hastings center report 46, no. 2 (april 2016): 35–43, https://doi.org/10.1002/hast.548. 5 mark a. rothstein, “is deidentification sufficient to protect health privacy in research?,” the american journal of bioethics : ajob 10, no. 9 (september 2010): 3–11, https://doi.org/10.1080/15265161.2010.494215. 6 “the genetic information nondiscrimination act of 2008,” national human genome research institute (nhgri), accessed december 16, 2018, https://www.genome.gov/27568492/the-genetic-information-nondiscrimination-act-of-2008/. https://doi.org/10.1002/hast.548 dauber, an analysis of new york state’s medical aid in dying act (a. 2383a s. 3151), voices in bioethics, vol. 4 (2018) © 2018 michael dauber. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an analysis of new york state's medical aid in dying act (a. 2383a s. 3151) michael dauber abstract medical aid in dying act (a. 2383a s. 3151) was recently filed with the new york state legislature1. the bill is designed to legalize a form of voluntary euthanasia for patients with terminal illnesses who wish to end their lives rather than experience unbearable suffering and decline. the bill is modelled after a similar act that legalized physician-assisted suicide in oregon in 1997, the death with dignity act.2,3 this article will provide a brief sketch of the legislative climate surrounding the bill, the content of the bill itself, and an analysis of the views of proponents and critics. keywords: medical aid in dying act, new york, end of life, legislature, physician-assisted suicide introduction medical aid in dying act (a. 2383a s. 3151) was recently filed with the new york state legislature 4. the bill is designed to legalize a form of voluntary euthanasia for patients with terminal illnesses who wish to end their lives rather than experience unbearable suffering and decline. the bill is modelled after a similar act that legalized physician-assisted suicide in oregon in 1997, the death with dignity act.5,6 this article will provide a brief sketch of the legislative climate surrounding the bill, the content of the bill itself, and an analysis of the views of proponents and critics. ii. discussion a. history and legislative climate while physician assisted suicide remains a controversial issue in both theory and practice, there has been a steady trend toward legalization over the past twenty years, starting most famously with oregon, which became the first state to legalize physician-assisted suicide in 1997. since then, montana, washington state, vermont, colorado, and washington d.c., and california have joined oregon in legalization, with each passing legislation except for montana, in which the practice was legalized judicially in baxter v. montana.7 over the years, many medical organizations have also shifted their stances on physician-assisted suicide [5], as have bioethicists, individual physicians, and the general public. this year’s medical aid in dying act follows a ruling in a court of appeals case last year, myers v. schneiderman (2017) [6], in which the new york state court of appeals ruled that new york law does in fact make physician-assisted suicide illegal despite the fact that the practice is not explicitly dauber, an analysis of new york state’s medical aid in dying (a. 2383a s. 3151) voices in bioethics, vol. 4 (2018) 2 forbidden by name. the case follows a long history of precedent against a legal right to physician assisted suicide, most popularly referred to in the supreme court cases washington v. glucksberg (1997) [7] and vacco v. quill (1997) [8]. the two cases have the effect of acknowledging that physician assisted suicide is a moral right of self-determination. however, this right is never acknowledged as a legal right or entitlement because there is a compelling state interest against the practice that can be explained by the concern for the erosion of trust in the medical profession. the state also has an overriding interest in protecting the value and continuation of life. the cases also accept that there is a fundamental ethical difference between the withdrawal or withholding of life-sustaining treatment and physician assisted suicide. this distinction has been at the crux of the debate for decades. peter singer delineated a fine distinction between the different kinds of euthanasia in practical ethics in 1979 [9], writing that there are ethical differences between voluntary, non-voluntary, and involuntary euthanasia. voluntary euthanasia occurs when the patient actively wishes to have his or her life terminated; involuntary euthanasia, which is illegal everywhere, occurs when a patient objects to having his or her life terminated, but an individual terminates the patient’s life anyway; and non-voluntary euthanasia occurs when an individual is incapable of consenting to have his or her life terminated, but their life is terminated anyway. all physician-assisted suicide laws and cases concerning the legalization of the practice specifically concern voluntary euthanasia. the same year, james rachels wrote his seminal essay active and passive euthanasia [10], in which he argued that there is no ethical difference between active and passive actions if the intended goal is the same; there ought not to be an ethical or legal difference between withdrawing life-support and other medical interventions, a practice generally considered ethical, and actively administering medications that will end the patient’s life. he goes a step further, suggesting that it is immoral to prohibit active (voluntary) euthanasia, because doing so forces patients to undergo further pain and suffering. the courts have traditionally only acknowledged what rachels would call passive euthanasia (i.e. letting a terminal patient die in accordance with his or her wishes or the consent of a surrogate, by withdrawing life-sustaining treatments or declining to initiate further interventions), and so physician-assisted suicide legislation is designed to legalize active euthanasia. because precedent is so set against judicial acknowledgment, especially in the supreme court, the main push for legalization comes from state legislatures. while many states are currently considering enacting their own bills and some surveys suggest that a significant majority of individuals favor legalization [11-13], it is by no means certain that the medical aid in dying act will be legalized in new york. an earlier version of the bill was filed last year but was not adopted, and some individuals familiar with the situation suggest that it is unlikely to pass this year either. b. a note on terms before delving into the main analysis of the bill itself, it is important to take note of the terms used in the bill and in this article. one of the key points of contention in the debate revolves around terminology: proponents of physician-assisted suicide and some medical organizations often prefer the term “medical aid in dying,” rather than any language involving the term “suicide” to capture two unique aspects of the practice. first, medical aid in dying appears to be phenomenologically different than stereotypical cases of suicide: patients who chose medical aid in dying do so in order to avoid the prospect of severe physical and psychological suffering that may come with terminal diagnoses and disease progression. this practice is substantially different from otherwise healthy individuals who wish to die from a sense of hopelessness, meaninglessness, or depression. it reflects a fundamentally different experience of one’s relationship to oneself, one’s physician and family, and the world as a whole, and occurs as a staged, regulated, reflective choice in response to the fact that one’s physical maladies cannot be fully treated or cured. for the purposes of this article, the concept of a possible “end-stage” of mental illness is ignored, as current medical policies do not acknowledge mental illness dauber, an analysis of new york state’s medical aid in dying (a. 2383a s. 3151) voices in bioethics, vol. 4 (2018) 3 as terminal in the same manner as physiological/metabolic disorders. this distinction is acknowledged by the american society of suicidology, which issued a statement in october 2017 affirming that the phenomena are conceptually and ethically distinct [14]. second, “medical aid in dying” serves to better capture the fact that patients with terminal illness will die regardless of medical intervention. with medical aid in dying, patients receive aid in controlling the manner, timing, and quality of their deaths, regaining some measure of control over their fates. on the other hand, opponents criticize the use of the term as a way to euphemize in an attempt persuade medical practitioners, politicians, and the general public that the practice isn’t really morally wrong. typical of debates in bioethics and philosophy, no side is truly correct: the semantic issue largely boils down to one’s individual intuitions. while i personally see the distinction between the actions of individuals with depression or other psychiatric distress who would otherwise be metabolically capable of long-term survival and the actions of the terminally ill, suicide itself refers in raw terms to the act of terminating one’s life. the wider issue is that the term “suicide” has rightfully come to have a negative moral connotation, such that its use frequently causes an automatic moral prejudice on the part of the listener. so, while i personally see no issue with using the term “suicide” to describe medical aid in dying, it is understandable why many individuals wish to use less morally-charged terms. the point is not to sneak an immoral action into law and to render participants in the debate ignorant; rather, proponents of the terms “medical aid in dying” are trying both to accurately describe the phenomenon and to use terms that do not automatically carry negative connotations. c. the bill based on the act that legalized physician-assisted suicide in oregon, the medical aid in dying act allows mentally competent patients with terminal illness to request medications that will end their lives. physicians will be legally permitted to prescribe and dispense medications that the patient may voluntarily consume. in order to obtain a prescription a patient must be at least 18 years old and have a terminal illness (as defined by the law). two physicians must confirm both the diagnosis and that the patient meets the legal requirements to make a request (the attending physician on the case and an additional consulting physician). patients will be required to make both oral and written requests. the written request must be witnessed by “at least two adults who, in the presence of the patient, attest that to the best of his or her knowledge and belief the patient has capacity, is acting voluntarily, and is not being coerced to sign the request” [15]. at least one witness cannot be related to the patient, entitled to receive any of his or her estate or any other benefit upon the individual’s death, an employee of the institution in which the patient is being treated, or a member of the medical team responsible for determining the patient’s capacity. patients with uncertain capacity for decisionmaking must be referred to a separate mental health professional for evaluation. perhaps most crucially, patients can revoke their request for medical aid in dying at any point during the process, and patients must self-administer the drugs, distinguishing the proposal from laws that would directly involve the physician in the act. physicians are responsible for confirming the patient’s diagnosis and prognosis, and that the patient is over the age of 18. additionally, physicians must determine that the patient is mentally competent and has the capacity to choose medical aid in dying. the duties of the physician include verifying that the request is free of coercion or undue influence, referring the patient to outside mental health professionals when necessary, documenting each step in the process specified under the law (including the relevant paperwork, listed in the text of the law along with sample forms), and prescribing the medications and informing the patient of the associated risks, expected effects, and possible complications (i.e. that the drugs might not work as intended). dauber, an analysis of new york state’s medical aid in dying (a. 2383a s. 3151) voices in bioethics, vol. 4 (2018) 4 the bill also importantly specifies that doctors, nurses, mental health professionals, the institution in which the patient is being treated, and other members of the care team are not criminally, professionally, or civilly liable for the patient’s death. the patient’s death will not be legally considered suicide, which protects rights of inheritance upon the patient’s death, which might otherwise be compromised if the patient were deemed to have committed suicide. finally, the act also includes a “conscientious objector” clause that states that no health care professionals are legally required to participate in medical aid in dying in any capacity. iii. analisys as mentioned above, the bill is largely based on legislation that legalized medical aid in dying in oregon in 1997. as such, any positive or negative commentary on this bill could largely be directed towards that bill as well. however, it is important to carefully go over what this specific bill does well and what it might be able to do better. on the positive end, the medical aid in dying act provides a measured, thorough process for ensuring that patients have capacity for decision-making and that they truly wish to pursue medical aid in dying. it builds on legislation that has worked well in oregon for twenty years; oregon has not seen any cases of alleged abuse of medical aid in dying, nor have fears that the number of suicides per year would skyrocket or that elderly or poor individuals would be systematically pressured to choose medical aid in dying come to fruition. assume for the purposes of this analysis that medical aid in dying cases are actually considered suicides (the oregon state government does not [16]). while the total number of suicides has indeed risen in states in which physician assisted suicide is legal [17], the overall rate of deaths from physician-assisted suicide has remained relatively low (37.2 for every 10,000 deaths in oregon in 2016[18]), suggesting that fears of systematic, disastrous consequences are unwarranted, especially given the numerous safety checks in place. while it is true that accurate statistics on potential abuses or pressures are inherently difficult to obtain, the fact that no verified, systematic evidence has appeared is encouraging, and new york advocates are wise to follow the model set by the oregon law. that being said, there are two areas in which the bill might be improved, both of which concern additional safeguards to prevent abuses. the first issue lies in witness documentation of the patient’s capacity and desire for medical aid in dying. in an effort to prevent coercion, undue influence, and other conflicts of interest, the bill requires that at least one witness cannot be an individual who stands to benefit from the patient’s choice in any way. however, the bill also allows one such individual to be present. it is still possible that the presence of one such individual could present an undue influence. admittedly, this scenario is highly unlikely, given the number of interactions that the care team will have with patients requesting medical aid in dying. if a patient truly did not wish to pursue medical aid in dying, he or she would almost certainly have an opportunity to approach his or her physician or another health care professional alone and ask for help. however, no such isolated interactions are required under the law, at least not explicitly. while many might not think such interactions are necessary and could be undesirable from the perspective of some patients, isolated interactions are sometimes required to gauge the patient’s true wishes. clinical ethicists frequently note that patients will sometimes ask for one thing in the presence of family members and another when discussing their situation without family presence. although not an end of life case, i had one such case myself. a patient was being asked which of his children he would like to be discharged home to. when one of his dauber, an analysis of new york state’s medical aid in dying (a. 2383a s. 3151) voices in bioethics, vol. 4 (2018) 5 daughters was present (let’s call her emily), he expressed a desire to live with her; when we asked her to step out, he asked us not to send him home with her, as she abused him. again, while such cases are admittedly rare, it would widely be considered good practice for a clinician to talk to the patient at least once without family present in medical aid in dying cases. however, the law proposed would not explicitly require such an interaction or documentation that such a conversation occurred. it is likely that clinicians will hold these conversations anyway, but an often-repeated legal maxim is “get it in writing”: the medical aid in dying act could only be strengthened by including an explicit reference to the need for such conversations. a second safeguard that could be added to the bill comes from a case cited by medical aid in dying critic margaret dore. at a recent event held at hofstra university, she described a case in which a patient’s son may have slipped him the medications in a “special drink” after the two had been drinking for a while [19]. the allegation is that the patient’s son had wanted the patient to die, and that the patient was having second thoughts upon receiving news of a better prognosis. now, the facts of the case are anything but confirmed, partly by definition: unless one was present that night, it would be impossible to truly know what happened. additionally, dore’s opponent at the event david leven noted that the case was never brought to trial, and as such the fact remains that there have not been any cases that have ever shown that medical aid in dying medications have been administered without patient consent. still, one might worry that cases like the one she described are theoretically possible under the current medical aid in dying policies legalized around the country, given the fact that patients are given the medications as a take-home prescription. there are two possible solutions to this problem. first, policy-makers might reconsider the idea of giving the patient the medications as an open-ended take-home prescription, and instead dispense the drugs only by request of the patient when they are ready to consume them. patients would not be able to store the drugs at home without a predetermined date of use, but would be given the drugs on the day they plan to use them, either by selecting a date in advance or by calling their doctor for the drugs once they are ready to consume them. this would reduce the likelihood of abuse against the patient or of accidental consumption or abuse by a third party, and serve as a final check that the patient wishes to choose medical aid in dying. alternatively, legislators could require either the presence of a health care professional or a brief visit by a health care professional on the day the patient wishes to consume the medications. while the extra visit would not entirely eliminate the risk of abuse, the additional check would allow clinicians to verify the patient’s state of mind on the date of consumption. it would also provide a check that may be a clear point of investigation if abuse is suspected: skipping the check could raise red flags for regulators. of the two additional regulations, involving a healthcare professional would be preferable, as logistical issues with pharmacies might prevent a patient from obtaining the medications themselves in a timely manner. health care professionals are usually available, or could reasonably be made available to support such a policy if it were enacted. one might reasonably object to my suggestions by pointing to the fact that no evidence of abuses has been gathered or verified, or that my suggestions present an undue, unwelcome burden on both patients and their families. it is also possible that patients may innocently forget to wait for a health care provider check-in before consuming the medications, raising suspicion on family members despite the absence of wrongdoing. i certainly see the strength of both criticisms. however, given the stakes involved in physician-assisted suicide legislation and that such policies provide legal sanction for clinicians and individuals to end lives, it does not seem unreasonable to take additional precautions to ensure that medications are administered ethically. dauber, an analysis of new york state’s medical aid in dying (a. 2383a s. 3151) voices in bioethics, vol. 4 (2018) 6 conclusion the medical aid in dying act will be reviewed by the new york state legislature some time this year. the bill, based on the oregon death with dignity act, is in line with other major legislation to legalize and regulate physician-assisted suicide and presents widely recognized policies. while the bill does appear to meet the best practices of states in which physician-assisted suicide is legal, there are a few areas in which additional regulations could be added as further safeguards for ethical implementation and regulation. references 1 medical aid in dying act (a. 2383a s. 3151). new york state assembly. accessed 25 march 2018. accessible here: http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=a10059&term=2015&summary=y&actions=y&floor%26n bspvotes=y&memo=y&text=y. the page contains the full text of the proposed bill. 2 chin, arthur e., katrina hedberg, grant k. higginson, and david w. fleming. "legalized physician-assisted suicide in oregon— the first year's experience." new england journal of medicine 340, no. 7 (1999): 577-583. 3 “death with dignity act” (1997). oregon health authority. accessed 25 march 2018. accessible here: http://www.oregon.gov/oha/ph/providerpartnerresources/evaluationresearch/deathwithdignityact/pages/ors.aspx 4 medical aid in dying act (a. 2383a s. 3151). new york state assembly. accessed 25 march 2018. accessible here: http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=a10059&term=2015&summary=y&actions=y&floor%26n bspvotes=y&memo=y&text=y. the page contains the full text of the proposed bill. 5 chin, arthur e., katrina hedberg, grant k. higginson, and david w. fleming. "legalized physician-assisted suicide in oregon— the first year's experience." new england journal of medicine 340, no. 7 (1999): 577-583. 6 “death with dignity act” (1997). oregon health authority. accessed 25 march 2018. accessible here: http://www.oregon.gov/oha/ph/providerpartnerresources/evaluationresearch/deathwithdignityact/pages/ors.aspx 7 baxter v. montana, 2009 w.l. 5155363 (2009). http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=a10059&term=2015&summary=y&actions=y&floor%26nbspvotes=y&memo=y&text=y http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=a10059&term=2015&summary=y&actions=y&floor%26nbspvotes=y&memo=y&text=y http://www.oregon.gov/oha/ph/providerpartnerresources/evaluationresearch/deathwithdignityact/pages/ors.aspx http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=a10059&term=2015&summary=y&actions=y&floor%26nbspvotes=y&memo=y&text=y http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=a10059&term=2015&summary=y&actions=y&floor%26nbspvotes=y&memo=y&text=y http://www.oregon.gov/oha/ph/providerpartnerresources/evaluationresearch/deathwithdignityact/pages/ors.aspx abstract introduction ii. discussion a. history and legislative climate b. a note on terms iii. analisys conclusion references cyphers & kuflik, liberal-egalitarian solution to healthcare dilemmas, voices in bioethics, vol. 9 (2023) * eric cyphers, ms candidate columbia university arthur kuflik, ph.d., princeton university, lecturer, columbia university © 2023 eric cyphers & arthur kuflik. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. responsibility in universal healthcare: a liberal-egalitarian solution? eric cyphers & arthur kuflik* abstract the coverage of healthcare costs allegedly brought about by people’s own earlier health-adverse behaviors is certainly a matter of justice. however, this raises the following questions: justice for whom? is it right to take people’s past behaviors into account in determining their access to healthcare? if so, how do we go about taking those behaviors into account? these bioethical questions become even more complex when we consider them in the context of a commitment to publicly funded, universal healthcare coverage. keywords: justice, liberal, egalitarian, healthcare, responsibility, morality, ethics, equality, universal healthcare introduction healthcare coverage of lifestyle-related conditions is certainly a matter of justice. however, this raises the following justice-related question: is it right to consider people’s past behaviors in determining their access to healthcare? if so, the methods of taking those behaviors into account must be fair and justifiable. this bioethical question becomes even more complex when we consider it in the context of a commitment to publicly funded, universal healthcare coverage. this paper takes an old, classic debate, evaluates newer approaches, and offers an argument favoring a combined approach which alters the liberal-egalitarian solution to account for social justice. cyphers & kuflik, liberal-egalitarian solution to healthcare dilemmas, voices in bioethics, vol. 9 (2023) 2 analysis i. causes of disease if healthcare coverage were universal, irrespective of socioeconomic status and lifestyle, people would contribute to the cost of remedying the lifestyle-induced health problems of others. in the west, lifestylerelated diseases are burdensome. 1 this paper approaches this concern from a western lens that incorporates both a european tradition of “social safety nets” and an american tradition of personal freedoms. by taking such an approach, solutions to the consequences of one’s past behavior burdening others must consider an individual’s personal freedom to choose to act as he or she wishes, with the distributive social and economic equality of the many. the concept of disease caused by lifestyle and diet is proven. many health conditions include behavioral risk factors. multi-pack smoking increases the risk of chronic lung disease, while obesity increases the risk of type 2 diabetes. inattention to high blood pressure, high cholesterol, and a lack of exercise leads to increased risks of coronary artery disease.2 while poor lifestyle choices certainly influence these conditions, their causes are multifactorial, and it is difficult to say that any single string of poor choices led to their development. in a scenario where two men excessively eat fast food for 20 years, several discrete factors impact whether any of them might suffer an ischemic-embolic stroke or not. genetics, circumstances, and activity will also contribute to outcomes. ii. alcohol-related end-stage liver disease one paper suggests that alcohol-related end-stage liver disease (aresld) differs from other multifactorial disorders as alcohol alone causes the disease.3 it justifies attributing personal responsibility to patients with aresld because the condition develops only after the cumulative effects of large quantities of alcohol consumed from years to decades.4 however, the paper undermines its position by admitting that even the susceptibility to becoming an alcoholic has some degree of genetic predisposition. 5 given the extreme scarcity of donor livers, some patients may be prioritized over others on the transplant waiting list. since donor livers cannot be given to everyone, transplanting a liver into an alcoholic may result in death for competing candidates whose liver disease was not their fault. all else being equal, if bioethicists avoid claiming moral deficiency or judgment, those with apparently self-inflicted aresld will not be deprived of treatment but will have a lower priority for transplant.6 in contrast, another position suggests that it is often difficult to define what behaviors are punishable as these are largely personal and value-laden. 7 still, people do not support using their own resources to support the consequences of others’ poor choices, no matter how objective.8 in democratic societies, one must take into consideration community morals and values.9 even if we were to punish people for their health-adverse behaviors, we could not logistically employ the vigorous and sustained efforts necessary to determine whose actions are morally weak.10 iii. the liberal-egalitarian proposal one past argument proposes a liberal-egalitarian solution to manage personal responsibility for so-called “lifestyle diseases.”11 this rawlsian system combines the european-style “social safety net” commitment to social and economic equality with the american liberal notion of pluralist toleration and personal freedoms. this idealized system aims to hold people responsible for their choices rather than the consequences to mitigate the downside of blaming those who might not be blameworthy. the approach avoids determining the questionable nature of luck and personal responsibility for health outcomes, fairness in the distribution of economic burden, and the intrusiveness required to practically determine who acts in a morally wrong and health-adverse way. cyphers & kuflik, liberal-egalitarian solution to healthcare dilemmas, voices in bioethics, vol. 9 (2023) 3 the liberal-egalitarian model, a theory of distributive justice, has two facets: the liberal principle that people should be held accountable for their choices and the egalitarian principle that people who make the same choices should have the same outcomes.12 this model attempts to fuse responsibility with equity by seeking to reward good behavior and tax bad behavior rather than punish the consequences of the action and navigate who deserves treatment. for instance, the hospital bedside is not the appropriate place to introduce responsibility for one’s health outcomes.13 this appeals to the reality that, at that time, discerning the true causes of disease was not plausible and to humanity in avoiding a heartless and cruel approach. an argument in favor of the liberal-egalitarian model considers its method of implementation. this approach assumes that the healthcare system treats all individuals regardless of their choices or ability to cover costs. the liberal-egalitarian model also assumes that a certain adverse health condition is related, statistically speaking, to the consumption of a certain good and that good can be taxed. as such, it proposes to tax the consumption of that good to finance the collective burden which arises from that good’s consumption rather than require individuals to pay for their own treatment. in the example of aresld, the recommended solution would be taxing all alcohol. while a systematic infrastructure is not explicit, there is the implication that a per-unit tax can be imposed on alcohol so the total tax revenue would make up for the additional healthcare costs due to consumption.14 upholding the principle that all people who make the same choices should face the same costs, all consumers of alcohol would pay the same tax, regardless of factors such as genetic predisposition to alcoholism, lifestyle, or expected cost of treatment. upholding the principle of individual responsibility, this model does not deny treatment to anyone, neutralizing factors outside that individual’s control by imposing the tax ex-ante. other people are not burdened by those who consume the good. people who consume alcohol face a burden proportional to the amount consumed. this tax-based implementation is justified so long as the tax is not prohibitively high for the average consumer. further, the model mitigates concerns over the intrusiveness of ascribing morality to health-adverse behaviors. iv. moral and social arguments against the liberal-egalitarian position arguments against the liberal-egalitarian model concerns its many assumptions. first, this model assumes that consumption of such goods is directly related to the health outcome and that these goods can be taxed. 15 certain people genetically predisposed to alcoholism would be predisposed to consume more alcohol. the model falls short when applied to scenarios where health outcomes are not consumptionbased, such as engaging in unsafe sex or abstaining from healthy lifestyle choices like exercise. second, some might argue that the liberal-egalitarian model fails to remain neutral. residual moral judgments tied to consumption choices introduce non-neutrality. although taxation in free societies is determined by democratic procedures rather than by individuals in the healthcare system, moral and valuebased judgments will be implicit in deciding what behaviors are taxable, such as the purchase of cigarettes. third, the liberal-egalitarian model fails to determine whether one’s behavior is autonomous, as sociocultural-economic factors may influence it and behavior is more a product of society, peer pressure, or income. those also may reflect systemic inequalities. therefore, this model, which rewards, or taxes based solely on decisions, regardless of their consequences and motivations, fails to consider that a person’s decisions may not be completely autonomous. cyphers & kuflik, liberal-egalitarian solution to healthcare dilemmas, voices in bioethics, vol. 9 (2023) 4 v. libertarian arguments against the liberal-egalitarian model a. state intrusiveness as counter to the liberal-egalitarian model last, there is a libertarian worry that if the state guarantees universal healthcare coverage to all people, the state will have to become highly intrusive and investigate people’s morals.16 at least one-third of all disease burden in north america, europe, and the asia-pacific is attributable to lifestyle measures such as tobacco smoking, alcohol consumption, high cholesterol, and obesity.17 with these various lifestyles, it is not likely to agree on what conduct to tax or condemn.18 the fine-toothed comb required to determine whether each citizen has been engaging in these behaviors would intrude on daily life and personal freedom. libertarians champion the argument that impractical intrusiveness would result from universal healthcare, and such a degree of intrusiveness would likely be universally unacceptable.19 the liberal-egalitarian model mitigates the libertarian worry about state intrusiveness as it does not involve prying into one’s life and choices other than taxing goods. a liberal state should ideally be neutral to how people decide to live their lives. in all, libertarians can rest assured that the liberal-egalitarian tax-based model, through its ex-ante implementation, will require no prying state eyes. states that provide universal healthcare coverage and wish to condemn certain misconduct do not need to become overly intrusive to carry out measures to hold individuals accountable. b. fairness another libertarian worry regarding the guarantee of universal healthcare coverage in the context of lifestyle-driven diseases is that the public will be burdened unfairly with covering others’ ill-advised mistakes or bad luck. an ideal system to address this worry would link treatment or payment for treatment with whatever behavior caused that need. 20 the distribution of burdens should be linked to how different individuals contributed to the creation of those burdens. applied to health policy, we should ask how the need for a certain treatment arose when determining how to distribute its cost.21 the liberal-egalitarian model aspires to hold individuals responsible for their choices, not for the consequences of such choices. this model significantly mitigates the libertarian worry over unfair burdens for covering other people’s mistakes or social conditions, which lead to those bad outcomes, by ensuring to not burden others with any of the costs for the treatment of people who decide to engage in certain healthadverse behaviors. the aforementioned taxation-based system would only tax those who also engage in the health-adverse behavior through consumption, and that tax directly pays for the necessary collective treatment. as such, those who do not consume the good are not involved with the payment scheme, while those who do consume the good are responsible for payment in a matter proportional to the amount of the good they have consumed. vi. universal coverage taking a step back, one should consider whether these worries regarding the coverage of apparently selfinflicted health conditions in the context of universal healthcare are worthwhile issues. one perspective raises what is called the culturally imagined objection — an idea erroneously held by many that sick people, especially those who are poor and uneducated, bring these illnesses upon themselves due to poor decisionmaking and irresponsible risk-taking.22 this perspective critiques the uniquely american view that, since individuals are free to choose their lifestyles, they should bear the costs of their lifestyle. 23 taking this argument further, some (perhaps the strongly libertarian) would say that the poor health status among many individuals is the price individuals must pay for their american way of life and the liberty and freedom to live as they wish. however, people should not completely punish individuals for their health-adverse behaviors because these choices are largely pre-determined by a person’s socioeconomic influences.24 the cyphers & kuflik, liberal-egalitarian solution to healthcare dilemmas, voices in bioethics, vol. 9 (2023) 5 outcomes from these allegedly ill-advised behaviors, which largely affect poorer people, are not just poor behavior but rather a public health crisis. perhaps the state and its people should take collective responsibility and cover the costs of treatment for those health outcomes without question, as a form of public service. rather than worrying about accountability and taxing bad behavior or intrusiveness into personal decisions, some might argue that people need to collectively take responsibility for reducing the overarching systemic inequalities and covering the associated treatment costs as a measure of public health. vii. proposed solution given the strengths of the liberal-egalitarian model and taking into account libertarian and social justiceoriented objections, an ideal solution for the coverage of lifestyle-related health problems needs to consider the complex relationship between a person’s behaviors and their apparent health outcomes. it must consider how society as a whole passes judgment on behaviors and how to take into account that many health-adverse decisions are not truly autonomous decisions, as various genetic and socioeconomic factors influence them. an ideal solution combines the liberal-egalitarian tax-based model with the social justice concerns of universal coverage. whatever the cost for the treatment of medical issues resulting in part or entirely from lifestyle and diet, taxes collected from spending associated with the behavior (like the purchase of alcohol, junk food, and cigarettes) ex-ante should fund 50 percent of the cost of treatment, while the universal healthcare taxation scheme should include the other 50 percent. such a system would provide an incentive to avoid the purchases that can lead to unhealthy consumption and make healthier choices, slightly punish and discourage such purchases through taxation, yet not overly punish people whose outcomes may have more to do with socioeconomic factors and genetics. adding public responsibility demonstrates acknowledgement that health care is in the public interest and can mitigate public health inequalities. this solution would fuse personal responsibility with the public responsibility of state-sponsored social improvement while ensuring that all people have fair access to necessary treatment, no matter their ability to pay. conclusion the 50-50 system this paper proposes reflects both justice and personal responsibility in covering healthcare costs allegedly brought about by people’s own health-adverse behaviors. by allocating tax revenue from consumption that contributes or even alone causes poor health outcomes, such a system incorporates personal responsibility. by using general tax revenue for health care, such a system would meet the libertarian requirement of providing care without any moral investigation of past behaviors and the social justice consideration of providing health care to those who may have unwittingly ventured into ill-health due to systemic injustice, socioeconomics, or genetics. 1 cappelen, a. w. (2005). responsibility in health care: a liberal egalitarian approach. journal of medical ethics, 31(8), 476–480. https://doi.org/10.1136/jme.2004.010421 2 moss, a. h. (1991). should alcoholics compete equally for liver transplantation? jama: the journal of the american medical association, 265(10), 1295–1298. https://doi.org/10.1001/jama.1991.03460100097032 3 moss, p. 1295-1298. cyphers & kuflik, liberal-egalitarian solution to healthcare dilemmas, voices in bioethics, vol. 9 (2023) 6 4 moss, p. 1296. 5 moss, p. 1295-1298. 6 moss, p. 1295-1298. 7 cohen, c. is this supposed to be cohen and benjamin (1991). alcoholics and liver transplantation. jama: the journal of the american medical association, 265(10), 1299–1301. https://doi.org/10.1001/jama.1991.03460100101033 8 cohen, p. 1299-1301. 9 moss, p. 1297. 10 cohen, p. 1300. 11 cappelen, p. 478-480. 12 cappalen, p. 478-480. 13 cappelen, p.479. 14 cappelen, p. 479. 15 cappelen, p. 479 16 cohen, p. 1301. 17 cappelen, p. 478. 18 cohen, p. 1299-1301. 19 cohen, p. 1301. 20 cappelen, p. 476-480. 21 cappelen, p. 476-480. 22 kawachi, i. (2005). why the united states is not number one in health. healthy, wealthy, and fair, 18–33. https://doi.org/10.1093/acprof:oso/9780195170665.003.0013 23 kawachi, p. 18-33. 24 kawachi, p. 18-33. ducar, scott panetti on death row, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. scott panetti on death row dallas ducar death row, scott panetti, bioethics introduction on december 3rd, 2014 a texas man was scheduled to be put to death at the decision of the state. the pendulum of time swung back and forth, only hours remained before scott panetti would be pronounced dead. analysis less than 12 hours before the state of texas was set to execute mr. panetti the u.s. circuit court of appeals issued a stay of execution. this decision does not mean that this man will not be executed, but rather, that the appellate court issued a delay in carrying out the execution until the appeal is resolved.1 in this case, the death sentence can be lifted if new evidence is discovered that will exonerate mr. panetti. the stay was issued after former virginia attorney general ken cuccinelli, former texas rep. ron paul, former texas gov. mark white, and even united nations human rights officials stepped in and urged the government to spare his life. yet mr. panetti's life continues to hang in the balance, with the decision resting in the hands of the appellate court and the pendulum continuing to tick. mr. panetti was convicted of killing his mother-in-law, father-in-law, and holding his wife and daughter hostage until finally surrendering to police. when tried for capital murder in 1995 panetti wished to represent himself and the court proceeded by ordering a psychiatric evaluation. psychiatrists found that he suffered from fragmented personality, delusions, and hallucinations. according to a report issued by the texas attorney general's office, “the evaluation noted that [panetti] had been hospitalized numerous times for these disorders. evidence later revealed that doctors had prescribed medication for [panetti]’s mental disorders that, in the opinion of one expert, would be difficult for a person not suffering from extreme psychosis even to tolerate.”2 moreover, mr. panetti has had previous psychotic episodes. one particular psychotic episode lead to mr. panetti burying many of his valuables next to his house after being convinced it was possessed by the devil.3 there is also evidence of mr. panetti asking for mental-health care on three occasions when incarcerated, despite the state denying any records exist. so what happens if the court recognizes incompetency? what if mr. panetti undergoes mental-health treatment and shows signs of his psychological state improving? he could then become competent enough to be again eligible for execution, thus forcing him and his lawyers to choose between insanity or execution. the united states is a country rooted in retributive justice. does killing the convicted really make the hurt ducar, scott panetti on death row, voices in bioethics, vol. 1 (2014-15) 2 go away? would restorative justice do more for those affected? perhaps encouraging dialogue and reparation allow for healing and forgiveness to take place for the families and communities involved. in this case particularly, how can one fully blame mr. panetti for the actions committed if he was under the influence of a brain grasping at reality? even if he eventually is able to become competent enough for execution, should the government be killing a citizen for an action committed due to a dysfunctional organ? if we cannot blame a patient for having an arrhythmia or a genetic disorder, why is it that we can blame someone for having an altered mental status dependent on physiological dysfunction? instead, the united states government should be focused on restoring individuals to competency and encourage human flourishing. no human being should be given the choice between death and insanity, rather, there should be true incentive for healing. if we truly want communities that strive for justice, we must work for rehabilitation and well-being. murder does not simply affect those that have had their lives taken, nor does solely affect the family, the ripples resonate throughout communities and nations. closure is a myth, these effects never end, they change our humanity and deserve genuine discussion and reflection. conclusion for now, the decision of the appellate court has bought some time for scott panetti, but he, and the community at large, need more than time, we need change. change needs to begin now. no government should ever execute it's own civilians, and especially, never come so close to executing the mentally ill. we should focus on healing wounds, not causing more. 1 http://www.law.cornell.edu/wex/stay_of_execution 2 https://www.texasattorneygeneral.gov/oagnews/release.php?id=4900 3 ibid. introduction analysis conclusion abbate, “i feel it in my bones”, voices in bioethics, vol. 2 (2016) * skya abbate, md of oriental medicine in new mexico, doctoral student in bioethics at loyola university. © 2016 skya abbate. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. "i feel it in my bones:" when medicare doesn't cover treatment skya abbate* keywords: medicare, insurance, marginalized, chronic illness introduction good afternoon,” i chimed to the young girl at the reception desk. “i am here to see the doctor at 1:30.” “hi, are you skya?” “yes,” i replied. she routinely asked, “has anything changed since your last appointment?” accustomed to saying no i paused then recalled, “yes, my insurance has changed.” she inquired, “what is it now?” “medicare and medicare supplement,” i responded. she got up from her seat and turned her back to me. “oh, the doctor doesn’t take medicare. it’s so much paperwork and she’s cutting down on her patients. do you still want to stay for your appointment? depending upon how long she sees you it will cost you about $150 for ten minutes.” i shrunk in stature from my newfound vulnerability, not at the cost but at what seemed like a dare. i tried not to be overly sensitive to these explanations and her proffer -and perhaps, also, the awkwardness of the encounter. i retreated from the counter, head down, eyes averted inward as i asked myself how much the results of the test meant to me over walking out, ashamed somehow that i no longer belonged here after a twenty-five year relationship with the doctor. intellectually, i could understand the doctor’s position as i ran off a litany of rationales. “the paperwork of bureaucracy demands a lot of time.” “the doctor has a choice in which insurance she wants to accept.” “my husband would not be back for a half hour to pick me up but i could wait outside.” “what was more important to memy health or my self-righteousness?” “was my autonomy relegated to leaving or paying without insurance assistance? those answers rang hollow in my fragile bones. i told the girl i would stay. abbate, “i feel it in my bones”, voices in bioethics, vol. 2 (2016) 2 analysis slowly i took a seat in the large empty waiting room, my eyes gazing upward somewhere between supplication and incomprehension. the bright wooden beams and soft blush colored walls of the southwestern style office that normally beckoned light and warmth now seemed sterile and devoid of any promise. shock, then low-level anger, paralyzed me. my mind froze. the phone rang and a similar conversation ensued between the receptionist and the other party. the dialogue was short, less apologetic, perhaps absorbed by the barrier of the phone. “the doctor does not take medicare,” echoed back at me and dug deeper into my mood. i questioned further, “why couldn’t the policy be listed in an office brochure or handled in advance through a phone call to improve communication, avoid embarrassment, and prevent hurt?” i was quickly ushered into an exam room to have my vital signs taken by a young girl who mumbled her name as she took my blood pressure. my normally friendly demeanor withheld further conversation. at this point i was thinking how inept the staff was at facilitating patient comfort, rapport, and caring attitude. my normally low blood pressure rose to reflect the tumultuousness i felt inside. quietly, i followed her to the exam room to get the results of a recent bone density test i had requested earlier than usual because of four years of intermittently being on steroids for surgeries. with high risk factors such as being a thin, postmenopausal woman of caucasian descent with osteopenia and a family history of osteoporosis, those results mattered to me. the doctor walked in and after a brief greeting turned to my paperwork. she reported that my bone mass had slightly declined and she wanted to keep me from developing osteoporosis in the next five years. she outlined the next step to rule out any metabolic disorders that might affect calcium levels. as usual, i agreed and appreciated her expertise and the healing relationship that we had engaged in over the last two decades. abruptly, she turned and left and a girl came into the room and said i could leave. as i left the exam room i went to the front desk to pay for my visit, the prophesied $150.00. my husband was waiting at the counter. still off center, i nervously fumbled to find my credit card as i told him the office did not take medicare or the medicare supplement. he too was taken aback then replied – as if to make a point in front of the receptionist that the doctor might have forfeited a patient -“well you’ll have to find somewhere else to go,” he retorted. of course, i knew, and he quickly told me in the car, that i could keep going to that doctor if i liked her. still, now my trust was more fractured than my delicate bones. still shaken and debating my next course of action, i asked for a referral in case i decided not to return to the office. the receptionist chirpily responded that there were no other obstetrician-gynecologists in our small town that took medicare, but i could go to the only hospital in town because “they have to take everyone.” i was in disbelief at how a quickly a beautiful summer day and my normally optimistic mood darkened as i was relegated to being the “other.” i carefully pondered, then chose to emote, “i just have to say, i feel abandoned.” “i’m sorry,” the young girl replied. despite my ability to pay for yearly visits with the doctor, i felt i had been marginalized. feelings of despair enveloped me. i felt bewildered and betrayed. i was now on the other side of the healthcare spectrum. i got into the car, despondency overshadowing me with this new experience of what felt like rejection. then, with characteristic resiliency my thoughts went to the undocumented persons in my city who suffer from chronic illness, injury, age and lack of timely or preventive care. i asked myself: what about the millions who have no health insurance at all or who, like undocumented workers, only have emergency access to healthcare? what about the unsuspecting women who had been the doctor’s patients and whose age bracket had now changed? did they have to start over again with finding a new doctor and endure lack of continuity of care? i was like so many others who would be told the same thing from other medical doctors. i was a citizen in a world i did not personally know but had only read about. what was different about me now that was not true six months ago when i was 64? i was now reframed but not the same. abbate, “i feel it in my bones”, voices in bioethics, vol. 2 (2016) 3 conclusion i knew that access to healthcare is a central ethical issue in the united states. racial, ethnic, age, gender, socioeconomic and political disparities exist in healthcare exist and i want to help correct them in some small way. the following week when i returned to teaching my elementary medical ethics class to acupuncturists, i relayed this story as a hypothetical case. my students shook their heads incredulously and proffered reasons as to how this scenario could be averted. as always, i encouraged a reaction that blended the rational and the emotional as a lever to move their thoughts about ethical behavior to a new place of action and common ground. they understood the doctor’s prerogative about medicare. yet they felt the failure to communicate in an appropriate manner did not promote beneficence, autonomy, or social justice; in fact, harm had been done. the gold standard of medical ethics— a caring response— had been tarnished. when i then told them the person was me they looked at their teacher with eyes rounded in empathy. they beseeched me to tell the doctor this story the next time i was to see her. yet for me it was more important was that they knew what type of practitioner they wanted to be, their model not limited to policy but founded upon our communal nature and a communitarian ethic of compassion. i left that last class of the semester with a smile that grew from within. they had listened and responded to their lessons. “class dismissed!” introduction analysis conclusion i knew that access to healthcare is a central ethical issue in the united states. racial, ethnic, age, gender, socioeconomic and political disparities exist in healthcare exist and i want to help correct them in some small way. the following week when... they understood the doctor’s prerogative about medicare. yet they felt the failure to communicate in an appropriate manner did not promote beneficence, autonomy, or social justice; in fact, harm had been done. the gold standard of medical ethics— a ca... i left that last class of the semester with a smile that grew from within. they had listened and responded to their lessons. “class dismissed!” menconi, ny hospitals issue problematic ban, voices in bioethics, vol. 6 (2020) * michael menconi is pursuing his ms in bioethics and mph at columbia university. © 2020 michael menconi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ny hospitals issue problematic ban on birthing support persons from labor & delivery units michael menconi* keywords: bans, labor and delivery, bioethics, hospital visitors, covid-19 introduction on monday, march 23 the new york presbyterian hospital updated its visitation guidelines in response to the covid-19 pandemic. while targeted restrictions of non-essential persons, including visitors, during this crisis are appropriate given the current crisis, hospital guidelines restricting all support persons, including spouses and partners, from labor and delivery units has created a multitude of ethical concerns. currently, new york presbyterian has not stipulated an end date for this policy, nor have plans for reevaluating the policy been established. other new york healthcare institutions have since followed suit, including member hospitals of the mount sinai and northwell health systems. these policies have been met with extensive public backlash, evidenced by the creation of a change.org petition asking governor andrew cuomo to take immediate action to repeal the policies. the petition has garnered over a half million signatures. analysis it remains patently unclear that the purported benefits outweigh the harms. currently, there is no conclusive evidence that newborns are subjected to increased risk of complications from covid-19. furthermore, currently available data suggests that pregnant women are not at increased risk of complications from the virus, and the most recent cdc clinical guidelines permit breastfeeding in covidpositive mothers provided they follow recommended hygiene protocols. consequently, complete bans on support persons lack scientific and clinical justification. while the ban may have been justified on the grounds that it protects healthcare workers, the nyp policy explicitly states that its purpose is to “protect patient safety.” in fact, the ban may exacerbate the current healthcare worker shortage as birthing unit staff attempt to fill the void of support persons for patients in labor. the lack of clinical evidence for support person bans is juxtaposed by an extensive body of evidence on the therapeutic and psychosocial benefits of physically present support persons during labor, delivery, and the immediate postpartum period. in person support provided by a doula or family member during labor and delivery has been associated with improved birth outcomes, including reduced incidence of fetal compromise and decreased use of pharmacological pain management. furthermore, the physical presence https://www.nyp.org/documents/nyp/covid19-visitingguidelines.pdf https://www.change.org/p/andrew-m-cuomo-safeguard-the-right-of-all-laboring-people-during-covid-19-crisis?recruiter=217300821&utm_source=share_petition&utm_medium=facebook&utm_campaign=psf_combo_share_initial&utm_term=psf_combo_share_initial&recruited_by_id=f04acbb0-a229-11e4-94e6-c34e67f205cb&utm_content=mit-20977409-10%3av1 https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/03/novel-coronavirus-2019 https://www.cdc.gov/coronavirus/2019-ncov/hcp/inpatient-obstetric-healthcare-guidance.html https://www.acog.org/-/media/project/acog/acogorg/clinical/files/committee-opinion/articles/2019/02/approaches-to-limit-intervention-during-labor-and-birth.pdf menconi, ny hospitals issue problematic ban, voices in bioethics, vol. 6 (2020) 2 of support persons has proven effective in managing emotional stress on the part of the pregnant patient, as well as decreasing labor time and c-section rates. implementing telehealth technology to allow live video connection with support persons, as proposed by some hospitals ignores the clinical advantages of in-person support. the bans also risk increasing the incidence of home births, a practice the american college of obstetrics and gynecology has advised against due to its association with increased perinatal mortality rates. complete support person bans additionally ignore a crucial element of public health ethics—the notion of implementing the least restrictive measures possible to achieve a desired goal. less restrictive support person policies that account for the safety of pregnant patients have been published by public health authorities for weeks. the new york department of health (nydoh) has refrained from recommending a complete ban on support persons during labor and delivery, instead issuing guidelines that allow for one support person to be present. the nydoh has deemed the support person (a spouse, partner, sibling, doula, or other person of the patient’s choosing) to be “essential to patient care throughout labor, delivery, and the immediate postpartum period.” exceptions include only those who are exhibiting symptoms of covid-19. additionally, the nydoh policy suggests screening all support persons for symptoms, both initially and every twelve hours thereafter, a reasonable request that prioritizes the safety of healthcare workers, patients, and the public. nyu langone medical center has implemented this policy. conclusion the complete restriction of support persons from inpatient birthing units represents a scientifically unfounded draconian measure that stands to impart more harm than benefit. all new york hospitals must immediately enact the common-sense precautionary measures proposed by the nydoh that allow one prescreened support person of the patient’s choice to accompany them during and immediately following the birthing process. failure to do so unjustly infringes on the autonomy of the pregnant patient and unnecessarily increases risk for pregnant patients and neonates without scientific justification. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4175537/ https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/04/planned-home-birth https://coronavirus.health.ny.gov/system/files/documents/2020/03/covid-19pregnancyguidanceforproviders3.21.20.pdf reaves, self-tracking pills, voices in bioethics, vol. 2 (2016) © 2016 mike reaves. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. self-tracking pills: medical adherence in the twenty-first century mike reaves keywords: medical adherence, surveillance, pharmacological ethics, autonomy introduction what if your prescription pill contained a microchip inside of it? yes, a microchip inside of a pill. a piece of silicon, magnesium, and copper no more than one millimeter wide. a combination that creates an electrical circuit when exposed to stomach acid. within minutes of reacting to gastric acid, the microchip relays electric pulses to a stick-on patch attached to the patient's navel. the patch wirelessly syncs to the patient's mobile device and the data is automatically transmitted to the physician. in essence, a doctor can now track a patient's medical adherence electronically. analysis self-tracking pills will no doubt improve the ability of medical professionals to monitor patients and their prescription use, an effort that has failed in recent history. in the united states, 50 percent of all prescriptions are not taken as prescribed by the physician. 1 nonadherence has been a problem in primary and secondary healthcare; individuals with chronic issues such as diabetes or high cholesterol are at a higher risk of developing serious health complications if they take prescriptions irregularly. furthermore, some populations with mental illness are more likely to hurt themselves or others if they do not abide by their prescription regimen.2 proteus digital health, the developer of the self-tracking pill and patch, has set its sights on combating medical nonadherence with the release of proteus discover, which gained patent approval in 2012. 3 proteus insists that using this new technology will cut costs and reduce waste in the healthcare industry. a doctor who knows whether his or her patient is taking the correct dosage will be able to diagnose and treat that patient more efficiently. improving tracking efforts will allow preventative and secondary care to become more seamless for both the patient and physician. not futuristic enough for you? try pill #2. the us patent and trademark office is reviewing a new patent submitted by inventor and chairman reaves, self-tracking pills, voices in bioethics, vol. 2 (2016) 2 of new york college, donald spector. so what is different about spector's magic pill? similarly sized micro-tracers are placed inside of the pill. however, when digested, these tracers transmit the exact blood concentration of a particular drug in the patient's system directly to nearby supercomputers. no intermediary device or patch is required with spector's pill, unlike that of proteus discover. the exact science behind these microprocessors and how they transmit the data on the digestion of drugs has not yet been released to the public, as it is still pending approval in 2016.4 spector has also filed patents to monitor the state of individuals via a biological sensor attached to the wrist. in this way, a remote receiver can track the health status of an individual and send alerts to various entities in the case of an emergency.5 the most prolific living inventor you have never heard of, spector holds patents in hundreds of products in areas ranging from toys and crafts to telecommunications and healthcare science. he has resources at his disposal as well, filing inventions under new york college's intellectual property (ip) policy. spector believes that the introduction of this technology will greatly reduce both death attributed to nonadherence as well as instances of violence in susceptible populations. as he stated shortly after the newtown tragedy of 2012, "everyone mourns in their own way; for me, i find hope in trying to change the future and prevent these kinds of tragedies. the massive problems of our society in medicine, economics, and energy are not going to be solved by politicians; they will ultimately be solved by science."6 however, how the public and politicians receive this health advance will determine the scope of its impact. will pill-tracking become a staple in primary and secondary care, or is something about these technologies ethically troubling? medical paternalism is one concern that appears to stand out. technology such as this can be implemented into state monitoring programs to ensure medical adherence. some bioethicists, such as arthur caplan of nyu, believe there are valid concerns regarding the use of systems like proteus or spector's super pills. in an interview with abc in 2013 that covered the filing of spector's patent, caplan presented a slippery-slope argument for why acceptance of the practice may lead to ethical violations.7 using this technology for conditions like heart disease and diabetes are incredibly valuable, but what about other conditions in which the patient and the public will benefit? what are the limits? caplan contends that this technology may be used to target individuals with a criminal past, a history of violence, or who are mentally ill. these practices, he contends, may lead to an encroachment on the civil liberties of privacy and confidentiality. keeping tabs on ex-convicts or those with a mental illness may be beneficial to society, but enforcing an individual to take a pill seems to go against the traditional concept of patient autonomy. furthermore, invasion of privacy may discourage patients from being compliant in their medical care and may encourage distrust between a patient and medical professional. conclusion while caplan’s points are well taken, there are legal protections guarding citizens that assuage many of his concerns. a majority of patients who will end up taking advantage of this technological advance will do so voluntarily after giving informed consent. additionally, it would require a court order to force any patient who is non-adherent to follow a prescription regimen. public opinion may be swayed on this topic when instances of violence take place in society. for example, the public is likely to favor legislation requiring those who exhibit signs of violence to adhere to their prescription regimen after a tragedy or mass shooting. donald spector believes that his patents will be utilized to the extent that public policy allows. it is not up to him, he believes, to decide the limits of his innovations. as he notes, "who the supercomputer reaves, self-tracking pills, voices in bioethics, vol. 2 (2016) 3 delivers that information to is more going to be the result of legislation rather than the invention."8 as these advances in healthcare science become more prevalent, public perception and reception, along with the help of those trained in medical ethics, will decide the limits of these technologies. 1 brown, marie t., and jennifer k. bussell. "medication adherence: who cares?" mayo clinic proceedings vol. 86 (4): 304–314 (april 2011). mayo foundation for medical education and research. doi: http://dx.doi.org/10.4065/mcp.2010.0575. 2 fazel, seena, johan zetterqvist, henrik larsson, niklas långström, and paul lichtenstein. "antipsychotics, mood stabilizers, and risk of violent crime." the lancet 384.9949 (2014): 1206–214. 3 body-associated receiver and method. proteus biomedical, inc., assignee. united states patent #8114021. february 14, 2012.http://patents.justia.com/patent/8114021 4 stuart, hunter. "pill-tracking device could monitor whether you're taking your medication." the huffington post.http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html 5 "sensor with remote communications capability." us patent application for patent application (application #20130241728, issued september 19, 2013).http://patents.justia.com/patent/8823512 6 "following newtown tragedy, inventor takes aim at controlling violence from mental illness." december 20, 2012. prnewswire.http://www.prnewswire.com/news-releases/following-newtown-tragedy-inventor-takes-aim-at-controllingviolence-from-mental-illness-184252131.html 7 lupkin, sydney. "invention would track meds in mentally ill patients, but is it ethical?" abc news. abc news network, january 21, 2013.http://abcnews.go.com/blogs/health/2013/01/21/invention-would-track-meds-in-mentally -ill-patients-but-is-it-ethical/ 8 stuart, hunter. "pill-tracking device could monitor whether you're taking your medication." the huffington post.http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html http://patents.justia.com/patent/8114021 http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html http://patents.justia.com/patent/8823512 http://www.prnewswire.com/news-releases/following-newtown-tragedy-inventor-takes-aim-at-controlling-violence-from-mental-illness-184252131.html http://www.prnewswire.com/news-releases/following-newtown-tragedy-inventor-takes-aim-at-controlling-violence-from-mental-illness-184252131.html http://abcnews.go.com/blogs/health/2013/01/21/invention-would-track-meds-in-mentally%20-ill-patients-but-is-it-ethical/ http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html introduction analysis conclusion armstrong, it’s a boy, voices in bioethics, vol. 3 (2017) * elisabeth armstrong is a master's candidate in columbia university's bioethics program. elisabeth currently works as a broadcast journalist and anchor at the abc-affiliate in little rock, arkansas. © 2017 elisabeth armstrong. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. it’s a boy: ethical implications of the first spindle nuclear transfer birth elisabeth armstrong* keywords: bioethics, leigh syndrome, spindle nuclear transfer, medical tourism introduction on september 27, 2016 people across the world looked down at their buzzing phones to see the ap alert: “baby born with dna from 3 people, first from new technique.” it was an announcement met with confusion by many, but one that polarized the scientific community almost instantly. some celebrated the birth as an advancement that could help women with a family history of mitochondrial diseases prevent the transmission of the disease to future generations; others held it unethical, citing medical tourism and consequences for the future of the therapy. analysis the child in question was actually born a few months earlier on april 6, 2016, but the research was published a few months later in the october edition of fertility and sterility. the mother carries dna that could have given the baby leigh syndrome, a severe neurological disorder characterized by psychomotor regression that typically results in death between ages two and three.1 also known as subacute necrotizing encephalomyelopathy, leigh syndrome is caused by genetic mutations in mitochondrial dna, which causes defective oxidative phosphorylation. because people with this condition cannot re-form atp, “demyleniation, gliosis, necrosis, spongiosis, or capillary proliferation”2 can occur, thereby producing bilateral lesions across the central nervous system. the 36-year-old mother previously had four miscarriages and successfully birthed two children, both of whom survived less than six years due to the syndrome. for religious reasons, the mother opted for spindle nuclear transfer instead of pronuclear transfer,3 which many religious organizations oppose because it entails the destruction of fertilized eggs.4 in pronuclear transfer, both the parent and donor egg are fertilized. the parent’s nuclear material is then removed from the egg containing mutated mitochondria and inserted into the fertilized donor egg—from armstrong, it’s a boy, voices in bioethics, vol. 3 (2017) 2 which the original nuclear material has been removed and destroyed. spindle nuclear transfer, on the other hand, removes the mother’s nuclear material from the egg with unhealthy mitochondria, then implants it into a donor’s egg (which has had its nuclear material removed and destroyed). the newly created egg is then fertilized with the father’s sperm. this spindle nuclear transfer was performed in mexico by a team of doctors led by dr. john zhang, the founder of the new hope fertility center in new york city. in their report, the doctors outline that five oocytes were successfully reconstituted, four of which developed into blastocysts. only one was euploid: containing 46 xy chromosomes. researchers then biopsied that blastocyst and found that the transmission rate of maternal mtdna was, “5.10 ± 1.11% and the heteroplasmy level for 8993t>g was 5.73%.”5 this indicates that at the blastocyst stage, around five percent of the mitochondria are from the original maternal egg with the mutation for leigh syndrome. after birth, they biopsied different tissues (to account for replicative segregation) and found that they had an average of less than 1.60 ± 0.92% of transmitted mtdna from the original maternal egg. the baby is reportedly doing well and the team of doctors concluded that “[h]uman oocytes reconstituted by snt are capable of producing a healthy live birth. snt may provide a novel treatment option in minimizing pathogenic mtdna transmission from mothers to their babies."6 even when considered theoretically, spindle nuclear transfer is controversial. many doctors believe that the risks at this stage of research are too great. dr. trevor stammers, a bioethicist at st. mary’s university in london, points out: “we do not yet have a clear picture of the interaction between nuclear dna and mitochondria.”7 others hold that faulty mitochondrial dna can still be transferred during the procedure. still more argue this technology could create problems because of germline modification.8 dr. paul knoepfler, a cell biologist at the uc davis school of medicine, explains: “since this is uncharted territory and the children born from this technology would have heritable genetic changes, there are also significant unknown risks to future generations.”9 however, proponents counter these arguments. they say the benefits outweigh the risks, as “mitochondrial replacement techniques [like spindle nuclear transfer] would eliminate maternal transmission of mitochondrial disease… allowing a woman with a family history of mitochondrial diseases to ensure her children would not be affected.”10 additionally, experts say that no symptoms will occur if less than 20% of the transferred mitochondrial dna is faulty.11 and while opponents see potential germline modification as a problem, advocates answer that this could stop a family history of mitochondrial disease, which they deem a more serious concern. in this case specifically, however, there are more issues at hand. while the team of doctors did eliminate the possibility of germline modification by selecting a male embryo, there are other ethical concerns. some argue that this case could be described as “medical tourism.” while new hope medical clinic does maintain a branch in mexico, dr. zhang stated that mexico has “no rules.”12 it is a country with underdeveloped regulations, making it difficult to confirm that doctors adhere to widely-held medical and ethical standards. furthermore, while it is highly unlikely that the child will develop leigh’s syndrome, dr. dietrich egli of the new york stem cell foundation says the 5% mitochondrial transfer rate indicates that the technique “was not carried out well.”13 he points to studies of embryos where the rate of mtdna transfer was almost ten times lower. conclusion spindle nuclear transfer is currently legal in the uk,14 and many are hoping to see it legalized in the us, although congress currently prohibits the fda from considering applications that would entail trials in people.15 while dr. zhang’s work is arguably revolutionary, many wonder if the manner in which this study was performed—in mexico and with a high mitochondrial transfer rate—will impact the technology’s future in the us. armstrong, it’s a boy, voices in bioethics, vol. 3 (2017) 3 last week, dr. zhang presented the report to scientists gathered in salt lake city, saying that while science isn’t a race, it is “in a sense, a race for the family to find a cure, to find hope.”16 only time will tell if this study set back other families racing and hoping for a cure. 1 "leigh syndrome." genetics home reference, us national library of medicine, 25 oct. 2016. accessed 26 oct. 2016. 2 mckusick, victor a., and ada hamosh. "leigh syndrome; ls." online mendelian inheritance in man, johns hopkins university, 20 jan. 2016. accessed 30 oct. 2016. 3 zhang, j, h liu, s luo, a chavez-badiola, and z liu. "first live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial dna mutation causing leigh syndrome." fertility and sterility, vol. 106, no. 3, 2016, pp. e375-76. accessed 30 oct. 2016. 4 sample, ian. "‘three-parent’ babies explained: what are the concerns and are they justified?" the guardian, 2 feb. 2015. accessed 30 oct. 2016. 5 zhang, et al. 6 ibid. 7 knapton, sarah. "three-parent babies: the arguments for and against." the telegraph, 3 feb. 2015. 8 ibid. 9 ibid. 10 "mitochondrial replacement therapy faqs." new york stem cell foundation research institute, new york stem cell foundation. accessed 30 oct. 2016. 11 reardon, sara. "‘three-parent baby’ claim raises hopes — and ethical concerns." nature, 28 sept. 2016. accessed 30 oct. 2016. 12 hamzelou, jessica. "exclusive: world’s first baby born with new “3 parent” technique." new scientist, 27 sept. 2016. accessed 30 oct. 2016. 13 reardon, sara. "‘three-parent baby’ claim raises hopes — and ethical concerns." nature, 28 sept. 2016. accessed 30 oct. 2016. 14 "3-person ivf: a resource page." center for genetics and society, 24 oct. 2016. accessed 30 oct. 2016. 15 ritter, malcolm. "baby born with dna from 3 people, first from new technique." associated press, 27 sept. 2016. accessed 30 oct. 2016. 16 chen, daphne. "controversy swirls around first three-parent baby." deseret news, 19 oct. 2016. accessed 30 oct. 2016. klim, an institutional right to die, voices in bioethics, vol. 2 (2016) © 2016 casimir klim. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an institutional right to die: neither coercive nor immoral casimir klim keywords: right to die, health law, end of life introduction the question of whether or not the terminally ill should be granted an institutional right to die rose to the forefront of the national consciousness recently, due in large part to the efforts of the late brittany maynard. diagnosed with untreatable brain cancer, maynard decided to end her life last fall in oregon, where state law permits physician-assisted suicide.1 in an editorial for cnn, maynard wrote: “having this choice at the end of my life has … given me a sense of peace during a tumultuous time that otherwise would be dominated by fear, uncertainty, and pain” (“my right to death with dignity at 29”). having the option to end her life gave maynard back her sense of agency and allowed her to die on her own terms. analysis laws like oregon’s death with dignity act are not without their critics, however. prominent among them is philosopher j. david velleman, who makes a case against these laws in his essay “against the right to die.” velleman challenges those—like maynard—who claim that state-sanctioned assisted suicide can preserve the dignity of the terminally ill. he claims that dignity and autonomy are intertwined in such a way that someone lacking dignity also necessarily lacks the ability to rationally choose suicide. velleman also argues that the presence of an institutional right to die places an undue pressure on the terminally ill to exercise such a right. in this essay, i will argue that velleman’s first claim does not adequately account for the ability of rational adults to make binding decisions about their future selves. i will also argue that while velleman’s second concern is valid, it is not a sufficient reason to oppose legislation like the death with dignity act. velleman’s initial claim hinges on the concepts of dignity and autonomy—specifically as defined by immanuel kant in his ethical writings. in the groundwork of the metaphysics of morals, kant claims that a person’s dignity is predicated upon his ability to make autonomous decisions and, more specifically, by his ability to use reason (kant 48, 43). assisted suicide, velleman claims, is only morally permissible in situations where one’s dignity is compromised andwhere one is able to rationally choose to die. based on kant’s definition, though, if a person is able to rationally determine that he wants to die, he must necessarily still have his dignity—due to his ability to exercise reason. it also follows that if a person lacks dignity, he must also lack the ability to rationally choose suicide. therefore, those without dignity (who would be justified in choosing death) should not be allowed to do so even if they so choose, as they are not doing so rationally. on the other hand, those who are able to rationally choose suicide lack the grounds to do so as they still possess their dignity (velleman ). klim, an institutional right to die, voices in bioethics, vol. 2 (2016) 2 this argument, that all instances of assisted suicide are either irrational or unjustified, ignores the ability of human beings to make binding decisions regarding their future selves. velleman assumes that the terminally ill patient must choose whether he will live or die ‘right then and there’ at his moment of greatest suffering—which is unrealistic. maynard, for example, decided to end her life well before her illness robbed her of her dignity or autonomy; but she did so in confidence that it inevitably would. she wrote: “because the rest of my body is young and healthy, i am likely to physically hang on for a long time even though cancer is eating my mind … and my family would have had to watch that” (maynard, “my right to death with dignity at 29”). in maynard’s case, suicide was a prophylactic measure, ensuring that her dignity and autonomy remained intact for the remainder of her life. velleman could claim that maynard represents a special case, in that she was forewarned about what was to come—but what about those who suddenly fall ill? a sudden stroke or head injury could steal away one’s capacity to reason in seconds, and with it, the ability to rationally choose death. surely euthanasia would not be justified for these patients, even if they requested it. in these cases, however, it is informative to consider advance directives—a commonly employed legal device that allows people to decide ahead of time whether or not they want specific life-saving interventions, like cpr or intubation. it is not a stretch to imagine these directives being expanded to include a clause that calls for euthanasia in certain circumstances—such as a devastating but not-immediately-fatal illness or injury. again, in this situation, the person signing the advance directive is in full possession of her faculties, an adult making a binding decision about her future—just as maynard did. next, velleman argues that institutionalizing the right to die has a coercive effect on the terminally ill. such a right, he says, exerts an unwelcome pressure on the dying to justify their continued existence. the presence of this option, he says, deprives the terminally ill of the ability to “the status quo without choosing it” (velleman 84). in other words, an expectation of continued existence is currently the norm for these individuals. once a law permitting physician-assisted suicide is in place, that is no longer the case—these patients could be held accountable for their decision to continue living and be required to justify it. thus, when the state gives a human being the institutional right to die, it also forces her to actively justify her existence (86). this is a valid concern. brittany maynard and her family moved to oregon from california in order to take advantage of the death with dignity act. this fact, as well as her outspoken activism in favor of assisted suicide for the terminally ill, makes it clear that she was not acting under duress or out of guilt when she took her own life. however, for people living in places where physician-assisted suicide is already legal, things are not so clear-cut. they may, as velleman fears, feel forced to give reasons for not ending their lives. considering the financial and emotional strain their condition may cause their loved ones, some may find this difficult to do. nevertheless, these concerns are not insurmountable. in oregon, patients like maynard must follow an extensive protocol, which includes multiple physician visits and (at their doctor’s discretion) a psychological examination.2 as such, those who take advantage of the death with dignity act must make a strong and concerted effort to do so—minimizing, if not eliminating, the concern that these patients are being called on to justify their continued existence. on the contrary, they are asked—again and again—to justify their decision to end it. still, it’s crucial that these safeguards be included in any future legislation that provides a legal avenue for assisted suicide. conclusion velleman’s view of the terminally is, ultimately, paternalistic and condescending. furthermore, it reflects a larger tendency in america to view these individuals as frail, helpless, and confused, rather than as adults klim, an institutional right to die, voices in bioethics, vol. 2 (2016) 3 capable of making important decisions. brittany maynard’s advocacy highlights our need to cast off this fallacious outlook. “who,” maynard asked, “has the right to tell me that i don’t deserve this choice?” the dying are already forced to give up so much. to return to them a measure control over their lives is an act of compassion that we as a society ought to take. 1 the oregon health authority uses the term ‘physician-assisted suicide’ to refer to the practice of “ending life through the voluntary self-administration of lethal medications prescribed by a physician for that purpose” ("frequently asked questions about the death with dignity act."). 2 "frequently asked questions about the death with dignity act." oregon health authority. web. 6 sept. 2015. introduction analysis conclusion bolzon, on bioethics & art, voices in bioethics, vol. 2 (2016) © 2016 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. what do sci-fi, literature, and art have to do with bioethics?: on bioethics and art julia bolzon keywords: bioethics & literature, bioethics & art introduction last may, 200 delegates from thirty countries gathered in atlanta, georgia, for “beings 2015: biotechnology and the ethical imagination global summit,” a three-day conference aimed at cultivating global consensus on the future of biotechnology. dr. paul wolpe, the director of the center for ethics at emory university and the summit’s founder, had been dreaming of this idea for years. the last time such a gathering of experts happened was in asilomar, california, in 1975, on occasion of the emergence of recombinant dna technology and its unknown implications regarding the future of society. by bringing together some of the “greatest minds in science, policy, philosophy, ethics, religion, and the arts and humanities,” wolpe recognizes that biotechnology is a profoundly cross-disciplinary inquiry, and cannot be relegated to strictly science or philosophy as such.1 in the summit’s opening session on the aspirations and goals of biotechnology, psychologist steven pinker presented the view that the goal of biomedical research is (or should be) to promote human flourishing and to reduce suffering, disability, and premature death. he advocates that the aspirations of bioethics should be the same, and thus should “focus on real harms, not nebulous mission statements or speculative futurology.”2 pinker argues that when considering the potential harms of biotechnology, bioethicists should not base their thoughts on speculative fears about harms occurring in the distant future—such as those displayed in bioethical dystopias: a truly ethical bioethics should not bog down research in red tape, moratoria, or threats of prosecution based on nebulous but sweeping principles such as “dignity,” “sacredness,” or “social justice.” nor should it thwart research that has likely benefits now or in the near future by sowing panic about speculative harms in the distant future. these include perverse analogies with nuclear weapons and nazi atrocities, science-fiction dystopias like “brave new world’’ and “gattaca,’’ and freak-show scenarios like armies of cloned hitlers, people selling their eyeballs on ebay, or warehouses of zombies to supply people with spare organs.3 bolzon, on bioethics & art, voices in bioethics, vol. 2 (2016) 2 analysis although he raises much to discuss about the meaning and purpose of human flourishing and suffering, i wish to focus on an interesting line of thought that emerges from his mentality: that of dismissing and calling for an end to the comparisons made with science fiction and dystopian literature and film. this idea maintains that the advancement of biotechnology is hindered by fears that have been instilled in the public mind specifically through futuristic and dystopian sci-fi themes in literature, such as in frankenstein or brave new world. one such “tired trope” is gattaca, a 1997 film set in a genetically engineered future that is almost guaranteed to come up in any conversation about technological interventions in human genetics. case in point: science writer carl zimmer blogged: “if we’re going to talk about international bans, i’d like an international ban on invoking gattaca in these discussions.”4 recurring is the idea that “the public has been ‘conditioned by a pop culture filled with dystopian fiction—not to mention many a hollywood blockbuster— that has instilled a common wariness for the unintended outcomes that can accompany scientific progress.’”5 pinker is not the only scientist to hold this view. upon its foundation in 2001, the president’s council on bioethics devoted one of its first sessions to a discussion of nathaniel hawthorne’s short story “the birthmark,” about a scientist who possessively tries to concoct a cure that will rid his beautiful wife of the one blemish on her body: a tiny birthmark on her cheek. medical doctor jerome groopman critiqued this as beginning “not with facts but with fiction,” writing somewhat in disdain for chairman leon kass’s approach of “using literature to warn against the scientific search for perfection.” 6 like pinker, groopman is a strong advocate for continued research on the advancement of biotechnology, as it contains the promise of future treatments and cures waiting to be discovered. and like pinker, groopman scoffs at the prevention of these treatments from being discovered through guidelines shaped by speculative fears over harm rooted in science fiction, as opposed to the “real harms” of scientific fact. thus groopman writes that “while kass conjures a world of lab-bred james bonds, two hundred thousand americans live with spinal-cord injuries, a million and a half have parkinson's, and four million have alzheimer's,” suggesting that they are waiting to be cured by the work going on in the nation’s laboratories on cloned stem cells, that “may one day provide treatments for scores of currently incurable diseases, including juvenile diabetes, parkinson's, alzheimer's, and spinal-cord paralysis.”7 this view maintains that medical guidelines should be shaped always on “fact, not on literature or aesthetics—one that distinguishes real science from science fiction.”8 this view holds an aversion to the use of literature (both dystopian or otherwise) as a tool for discussing the uses, aims, and advances of biotechnology. as gilbert meilaender of the original president’s council describes, it is a view that holds that “there is no bioethical wisdom to be gained through the study of literature.”9 but what is contained within this mindset? is it something deeper than a worry about instilling unnecessary and unrealistic fear in the public mindset? what is at the root of this view against exploring works of literature when it comes to questions of biotechnology? and furthermore, what is at stake in exploring science fiction and other forms of art when it comes to thinking about biotechnology? conclusion the question of the place or role of art, beauty, and the imagination in bioethical inquiry is a central interest of mine. how does one articulate the relevance of beauty, the aesthetic experience, and the exploration of works of art to questions of biotechnology and human dignity? i think that one of the keys lies in understanding art’s pedagogic role—whether literature, poetry, film, or science fiction—as a form of allegory. “to enjoy allegory,” writes holly ordway, a professor of english literature, “one must be able to simultaneously appreciate both the rational and the imaginative components of it: to hold together the story as a story and the message as a message, not switching between one and the other, but allowing each to enrich the other. if a reader has a highly compartmentalized mind, then all literature is difficult to read, but allegory most of all.”10 story, allegory, and analogy contain the methodology of the parable. a parable is a fabricated story about bolzon, on bioethics & art, voices in bioethics, vol. 2 (2016) 3 a reality that could happen—that is, it bears a resemblance to reality so much so that the listener could imagine him or herself in the story; the story could happen to himor herself. a parable is told to signify a meaning or convey a message without imposing that message onto the interlocutor, but rather allowing the listener to come to it themselves. instead of stating the moral as a matter-of-fact, a story is told so that the interlocutor can enter into it and experience it, allowing one to receive the truth that is hidden or veiled within the parable, which the parable itself only conceals or signifies. consider the experience of “reading” art: in literature, film, or perhaps even an artwork, we undergo or experience the work, letting it work on us inasmuch as we are the ones to read or watch it. this concept of art being a symbol or sign, signifying a veiled meaning, is central to seeing the value and necessary role of art in the study of bioethics, which is what i intend to illustrate throughout this series. 1 “beings update: where are we now and where are we headed?” http://www.beings2015.org/about.html. 2 beings 2015, topic a: aspirations and goals, july 27, 2015: https://www.youtube.com/watch?v=5np5umktlrm. 3 pinker, steven. “the moral imperative for bioethics,” the boston globe, august 1, 2015: https://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for bioethics/ jmekoyzltau9o qv76jrk9n /story.html. 4 “during a recent hour-long npr program titled re-engineering human embryos, for example, host tom ashbrook played a clip from the 1997 film gattaca; later that day, carl zimmer blogged, “i’d like an international ban on invoking gattaca in these discussions.” quoted in: darnovsky, marcy. “tired tropes and new twists in the debate about human germline modification,” biopolitical times, may 28, 2015: http://www.biopoliticaltimes.org/article.php?id=8618. see zimmer’s original post, where he says that invoking the film is like saying, “we shouldn’t genetically engineer people because we will end up with an army of flying monkeys who will enslave the rest of us.” zimmer, carl. “talking about editing human embryos on the radio,” phenomena: a science saloon, april 28, 2015: http://phenomena.nationalgeographic.com/2015/04/28/talking-about-editing-human-embryos-on-the-radio/ 5 darnovsky, marcy. “tired tropes and new twists in the debate about human germline modification,” biopolitical times, may 28, 2015: http://www.biopoliticaltimes.org/article.php?id=8618. 6 groopman, jerome. “science fiction,” the new yorker, february 4, 2002, http://www.newyorker.com/magazine/2002/02/04/science-fiction. 7 “cloned stem cells may one day provide treatments for scores of currently incurable diseases, including juvenile diabetes, parkinson's, alzheimer's, and spinal-cord paralysis.” see: groopman, jerome. “science fiction,” the new yorker, february 4, 2002, http://www.newyorker.com/magazine/2002/02/04/science-fiction. 8 ibid. 9 meilaender, gilbert. “on bioethics in public,” the new atlantis. fall 2009/winter 2010, 39–59. 10 ordway, holly. “the canary in the coalmine? thoughts on allegory,” transpositions: theology, imagination, and the arts, accessed october 14, 2015: http://www.transpositions.co.uk/the-canary-in-the-coal-mine-thoughts-on-allegory/. http://www.beings2015.org/about.html https://www.youtube.com/watch?v=5np5umktlrm https://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for-bioethics/jmekoyzltau9oqv76jrk9n/story.html https://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for-bioethics/jmekoyzltau9oqv76jrk9n/story.html http://www.biopoliticaltimes.org/article.php?id=8547 http://phenomena.nationalgeographic.com/2015/04/28/talking-about-editing-human-embryos-on-the-radio/ http://www.biopoliticaltimes.org/article.php?id=8618 http://phenomena.nationalgeographic.com/2015/04/28/talking-about-editing-human-embryos-on-the-radio/ http://www.biopoliticaltimes.org/article.php?id=8618 http://www.newyorker.com/magazine/2002/02/04/science-fiction http://www.newyorker.com/magazine/2002/02/04/science-fiction http://www.transpositions.co.uk/the-canary-in-the-coal-mine-thoughts-on-allegory/ prunty, the very early embryo, voices in bioethics, vol. 3 (2017) © 2017 andrew j. prunty. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the very early embryo & its moral significance andrew j. prunty keywords: reproductive ethics, early embryo, zygote, clonote, embryonic stem cells, stem cell ethics abstract by clarifying and correlating beginning of life biomarkers with those already established and accepted for end of life, we can begin to facilitate discussion about when life begins and the ethical and legal limits of medical research and practice. there is an ethical imperative to establish consistency and develop parameters to guide appropriate research and medical practice that is ethically acceptable. if ethical standards of embryonic rights and beginning of life remain undefined or debated, it will remain difficult to establish sufficient guidelines to regulate new scientific medical technology. introduction as technology and biological research continue to develop in the twenty-first century, it is necessary to address and further define the ethical considerations of embryonic research and the appropriate rights that may limit the extent of human research on zygotes, blastocysts, and fetal scientific advancement. because the area of harvesting embryonic stem cells remains significantly undefined, both legally and morally, there are vastly different opinions between researchers and bioethicists, mainly because of ethical limitations, on the rights that should be granted to cells with the potential to develop into human beings and the consequences of neglecting significant scientific research or advancement. analysis current laws in the united states differ at the federal and state level, but there is no consistency in recognizing human embryos as humans, or affording them the same legal rights granted to a child; in fact, legal precedent actually detracts certain rights from developing embryos, favoring a human’s ability to destroy a potential human being (i.e. roe v. wade1) or the categorization of embryos as property (i.e. davis v. davis, a.z. v. b.z., marriage of dahl, or reber v. reiss).2 these case law samples suggest the courts’ inability to reach a conclusion as to what is the status of an embryo. the debate is not only circumscribed to matters of research, but to fundamental controversial and intertwined issues of bioethics such as: when life begins, embryonic stem cells, fetal rights, abortion, et cetera. all these topics are contentious and when one topic arises, they begin to comingle. prunty, the very early embryo, voices in bioethics, vol. 3 (2017) 2 embryonic stem cells are valuable to medical research and advancement because of the plasticity of the embryoblast – that is, the ability to adapt in response to changes in the environment.3 compared to somatic stem cells, which have less plasticity and at this point have little ethical controversy, embryonic stem cells are much more versatile and able to develop into a broader range of potential cells.4 therefore, despite somatic stem cells having qualities that allow it to develop into multiple variants of tissue cells, they are significantly limited compared to embryonic stem cells. future development and research surrounding the abilities of somatic stem cells may change if current research is successful in attempting to improve the pluripotent potential of somatic cells. cell potency is the cell’s ability to differentiate into various types of cells; the more variations in which a cell can differentiate, the greater the potency. cell potency is a scale, where if a stem cell has the ability to differentiate into every type of cell, it is pluripotent, whereas if it can only differentiate into one type of cell, it is unipotent. the potential for cell potency is the most significant factor in utilization of stem cells and pluripotency is the primary factor embryonic stem cells are desired for medical research and advancement. in response to the legal ambiguities surrounding the morals and ethics of this new scientific technology, robert p. george authored the 2005 article acorns and embryos, which states an imperative that zygotes and blastocysts be afforded rights comparable to those of humans. because these cellular clusters may eventually develop into human beings, he finds it a necessity to develop a set of ethical standards that limit scientific research and establish restrictive guidelines to protect the rights of embryos, future human beings, that are congruent with generally accepted practices of human testing and research. george’s argument is developed on the grounds that embryos are humans, but in a different stage of life. similar to how infants and adolescents are all humans, but in different stages of physical and mental development, so too are human embryos, but in the embryonic stage of development. to understand how george believes embryos should be afforded human rights, he voices the following opinion: specifically, those who support destruction of human embryos fail to understand that they support a blind injustice towards human beings who happen to be in the embryonic stage. according to george, this represents a form of ageism – that is, discrimination and the withholding rights based solely on age of an embryo’s state of maturation. george further argues that our society, “would not tolerate the killing of a retarded child, …a person suffering from brain cancer, [or]…the killing of infants,” implying that we should therefore not tolerate the blatant destruction of humans in the embryonic stage.5 however, as our society changes, we are in fact starting to become more accepting of these scenarios. multiple states have passed “death with dignity” legislation allowing a variant of euthanasia for those suffering from a terminal illness;6 our society tolerates the killing of infants born with significant genetic birth defects by withholding pediatric nutrition and hydration,7 and continues to stand behind the legalization of abortion. in closely related ethical similarities, our society also allows and supports in-vitro fertilization, where 97% of fertility clinics reported fertilizing more eggs than would be implanted in a given cycle and 84% of those clinics dispose of the extra embryos. 8 despite his push to increase limitations on research involving the creation of embryos with no differentiation in the zygote’s cellular composition, a morula comprising a spherical cell mass 3-4 days post fertilization, and blastocysts 4-5 days evolved from fertilization into embryo, george contends that individual gametes should not be afforded the same rights or treated the same as embryos. he argues that an individual gamete does not have the potential to develop into a human being on its own accord as there has yet to be a case of spontaneous human parthenogenesis. however, just as a sperm cannot develop into an embryo independently, an embryo cannot develop into a human independently either; in the context of both, they are in need of ‘another half’ to successfully develop: a sperm cannot develop into an embryo without an egg, prunty, the very early embryo, voices in bioethics, vol. 3 (2017) 3 and an embryo cannot mature into a human without a suitable environment to grow and develop. while the two are different in the context of being a haploid versus diploid cell – that is, one complete set of chromosomes such as a sperm or egg versus two complete sets of chromosomes represented by every cell in the body besides sex cells – the fact remains that neither is viable independently. george also asserts that individuals do not first exist without any rights and only later acquire certain features that qualify us to become the bearers of rights. however, every person passes through phases of development and these stages also bring changes in their rights. further consistent with george’s viewpoint, just as a child has fewer rights than an adult (due to age and maturation), an embryo would certainly have fewer rights than a newborn infant. since the moment of conception cannot be known with any sense of certainty, the beginning of the rights for an assemblage of cells can also not be certain. therefore, an arbitrary timeframe needs to be established where rights would be conferred progressively to coincide with the development of the embryo, fetus, and infant. acorns and embryos was written to counter michael sandel and paul mchugh’s perspectives written in their 2004 new england journal of medicine articles, embryo ethics – the moral logic of stem-cell research and zygote and “clonote” – the ethical use of embryonic stem cells, respectively, in response to questions raised by the president’s council on bioethics regarding federal funding of embryonic stem cell therapies. both sandel and mchugh, to different extents, support the development and use of embryoblasts to further medical research. mchugh poses a distinction between the ethical considerations given to a blastocyst derived from natural production or in-vitro fertilization compared to one derived from somaticcell nuclear transfer (scnt) – dubbing it a ‘clonote.’ contrary to most viewpoints from members of the president’s council on bioethics, mchugh believes there to be a distinct difference between the ethics of a zygote versus a clonote: a zygote (regardless of derivation from natural fertilization or ivf) being protected from harvesting embryoblasts from blastocysts for use in stem cell research and therapies, and a clonote being free for use in stem cell research or therapies. stem cells are only controversial when they are embryonic – and thus potential human beings. there is no ethical opposition to stem cells derived from an umbilical cord, bone marrow, adipose tissue, etc.9 thus, the solution to solving the ethical qualms of embryonic stem cells lies not within arguing the ethics surrounding embryonic stem cells, but instead defining the parameters about the beginning of life and associated fetal rights. mchugh emphasizes that, “if a source other than embryos can provide pluripotent stem cells – and harvesting them requires no killing – then this shadow vanishes.”10 if we can define when human life begins, we can effectively define the rights associated with a human at that stage of development.11 with the lack of clarity encompassing moral and ethical acceptability of beginning of life issues, it often seems easiest to establish standards through correlation to similar topics. therefore, if congruency is defined between beginning and end of life ethics, and similar criteria established, it would allow ethicists and researchers to further formalize appropriate guidelines and regulations surrounding embryonic stem cell research and therapies. current law, the uniform determination of death act (udda),12 states that life ends at the irreversible cessation of organismic functioning; the two accepted death criteria are cardiorespiratory arrest and absence of brain stem function. using these criteria for end of life, we can identify correlating biological markers to help determine the beginning of life. three significantly distinct markers that correlate to accepted end of life definitions are: when the heart begins to beat, neuromaturation – functional development of the central nervous system – which can be separated into whole brain or higher brain ‘birth’, and fetal viability. prunty, the very early embryo, voices in bioethics, vol. 3 (2017) 4 fetal viability is the measurement of a fetus that has reached such a stage of development as to be capable of living, under normal conditions, outside the uterus. this marker of fetal viability is a comparable marker to assist in defining the beginning of human life. markers of neuromaturation and the appearance of lower and higher brain waves in fetal development parallel whole and higher brain death. the first appearance of brain waves from the brain stem appear at the six to eight-week mark and higher brain waves in the cerebral cortex appear after approximately 22-24 weeks of gestation. available evidence suggests that the neocortex does not become a functional part of the neuraxis until at least mid-gestation, and it is not until then that the thalamus – the major gateway for sensory input to the cerebrum – makes its first afferent contacts with the neocortex.13 if life is unsustainable in an adult, it will inevitably result in one of the two criteria discussed earlier under the udda. similarly, despite embryonic cardiac or neurological development and detectable biological markers, embryonic viability and fetal life may still be unsustainable even if these criteria are met. according to studies conducted by breborowicz and tyson, et al, results showed that only 20-35% of babies born at 23 weeks gestation survived, while 50-70% survived when born at 24-25 weeks.14 unfortunately, fetal viability is not limited to biological factors, but significantly linked to technological abilities and therefore exists only as a function of biomedical and technological capabilities. consequently, fetal viability in developed countries is significantly different from that found in underdeveloped parts of the world. furthermore, as technology and medical abilities develop and continue to improve, this may change premature fetal survival rates. while biological markers remain unchanged for embryonic development, it is hard to develop a set of ethical standards based on a specific stage of development associated with current technological limitations. this ability to show significant differentiation in fetal viability based on geographic location, economic status, and technological medical care available make fetal viability a difficult criterion to use. robert george and those who agree with the theory that human life begins at conception believe that because there is one living cell with the potential to develop into a human being, the embryo should be protected and afforded the same rights as a human being after birth. however, in applying this logic to end of life, death would be defined when the last human cell has lysed. while the time for complete cellular death to occur is insignificant compared to the time associated with fetal development, studies have shown that 5% of leukocytes are still alive 70 hours after clinical death, skin cells can live for days, and neurological electrical activity can occur in brain dead patients as much as 168 hours after clinical onset.15 it is imperative to keep the definition of beginning and end of life criteria congruent, otherwise it appears to be random ad hoc choices of when human life begins and ends. it is difficult to determine which side has a stronger argument when no basic standard exists for fetal rights. while it is difficult to agree with the notion that a human being begins existing at the precise moment of zygote formation, there should be limitations on research, clinical application, and non-reproductive use of embryos past a certain stage of development. dr. mchugh suggests limiting blastocyst development not past the 14th day, although he does not cite specific reasons as to why he chose the 14-day mark as a limit when he discussed clonote development limitations. at the latest, one could conclude that development should be allowed until, at most, 22 weeks because it not only marks neuromaturation to higher brain function, but also because of current limitations of fetal viability. however, despite any support of embryonic development to 22 weeks for non-reproductive purposes and regardless of what maturation timeline is chosen, embryonic development should be limited only to that necessary for embryoblast harvesting. if limitations allowed embryonic development to 22 weeks, but successful research and embryoblasts could be prunty, the very early embryo, voices in bioethics, vol. 3 (2017) 5 harvested by the 14th day, there should be no support for further unnecessary embryonic development – hence, the pressing need for standards. despite the significance and untapped potential of this research and clinical abilities, it is necessary to develop standards and limitations prior to authorization and potential federal funding of such research. while this work is rich in therapeutic promise, we cannot allow it to proceed before establishing a set of morals and ethics to guide the research. therefore, practitioners and clinical ethicists should support a moratorium on further embryonic stem cell research until those within the community can agree on ethical limitations of new science. even though this paper was not intended or designed to address the ethics of defining beginning or end of life criteria, it is crucial to understand its necessity and integration into other concepts, such as embryonic stem cells and embryonic rights, to help us adequately discuss the morals and ethics of surrounding concepts. conclusion by clarifying and correlating beginning of life biomarkers with those already established and accepted for end of life, we can begin to facilitate discussion about when life begins and the ethical and legal limits of medical research and practice. there is an ethical imperative to establish consistency and develop parameters to guide appropriate research and medical practice that is ethically acceptable. if ethical standards of embryonic rights and beginning of life remain undefined or debated, it will remain difficult to establish sufficient guidelines to regulate new scientific medical technology. as scientific capabilities increase and new research develops, it is compulsory to ensure discussion of ethical tolerability in a prompt manner to allow researchers the ability to understand and develop increased potential of new research. 1 roe v. wade, 410 u.s. 113, (1973) 2 davis v. davis, 842 s.w.2d 588 at 597, tennessee (1992); a.z. v. b.z., 725 n.e.2d 1051, 1059, massachusetts (2000); marriage of dahl, 194 p.3d 834, oregon (2008); reber v. reiss 38 flr 1279, (2012) 3 hans r. schöler. (2007). “the potential of stem cells: an inventory”. in nikolaus knoepffler; dagmar schipanski; stefan lorenz sorgner. human biotechnology as social challenge. ashgate publishing, ltd. p. 28. isbn 978-0-7546-5755-2. 4 illmensee k, mintz b. totipotency and normal differentiation of single teratocarcinom cells cloned by injection into blastocysts. proc. natl acad. sci. usa. 1976;73:549–553. 5 george, r.p., lee, p. (2005). acorns and embryos. the new atlantis, 90-100. 6 abx2-15 end of life option act, california, (2015); proposition 106: end of life options act, colorado, (2016); dc act 21577 death with dignity act of 2016, district of columbia, (2016); baxter v montana, mont. sup. ct., 2009 mt 449, 354 mont. 234, 224 p.3d 1211 (2009); ballot measure 51: death with dignity act. oregon, (2008); gonzales v oregon, (04-623) 546 u.s. 243 (2006) 368 f.3d 1118; act no. 39. an act relating to patient choice and control at end of life. vermont. (2013); ballot initiative 1000: death with dignity act. washington. (2008). 7 johnson, j., mitchell, c. (2000). responding to parental requests to forego pediatric nutrition and hydration. the journal of clinical ethics, 11(2), 128-135; barber v. superior court, 147 cal.app.3d 1006 (1983) 195 cal. rptr. 484. 8 gurmankin, a.d., sisti, d., & caplan, a.l. (2004). embryo disposal practices in ivf clinics in the united states. university of pennsylvania center for bioethics. prunty, the very early embryo, voices in bioethics, vol. 3 (2017) 6 9 lo, b., parham, l. (2009). ethical issues in stem cell research. endocrine reviews, 30(3), 204-213. 10 mchugh, p.r. (2004). zygote and “clonote” – the ethical use of embryonic stem cells. the new england journal of medicine, 351(3), 209-211. 11 sandel, m.j. (2004). embryo ethics – the moral logic of stem-cell research. the new england journal of medicine, 351(3), 207-209. 12 uniform determination of death act, national conference of commissioners on uniform state laws, (1981). 13 fowler, m.j. (1985). neuromaturation and the moral status of human fetal life. j med philos, 10(3). 237-252. 14 breborowicz, g.h. (2001). limits of fetal viability and its enhancement. early pregnancy, 5(1). 49-50; tyson, j.e., et al. (2008). intensive care for extreme prematurity – moving beyond gestational age. the new england journal of medicine, 358, 16721681. 15 can, i., et al. (2014). distinctive thanatomicrobiome signatures found in the blood and internal organs of humans. journal of microbiological methods, 106, 1-7; bernat, j.l., et al. (2006). report of a national conference on donation after cardiac death. american journal of transplantation, 6: 281–291. doi:10.1111/j.1600-6143.2005.01194.x; grigg, m.m., et al. (1987). electroencephalographic activity after brain death. arch neurol, 44 zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, fordham university school of law, ms candidate columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are cre dited. at the intersection of public and private morality: an ethical framework for aggressive covid-19 policies anne zimmerman* abstract democracy in a federalist society should not allow the least reasonable laws to prevail when the fallout will cross state lines. divisions in society and different preconceptions of what is moral can be resolved by appealing to the framework of the democratic system: use the least restrictive means to reach an articulated goal in an efficacious way and then restore any right that was temporarily suspended. the systemic reinstitution and lasting continuity of those rights must be a pillar of democratic systems. if the common good as projected in public policy could never trump rights, and the public does not engage in the private morality for the common good, then, as george smith argues, the healthcare crisis could turn the constitution into “a suicide pact.” keywords: morality, private morality, public morality, philosophy of bioethics, covid-19, emergency powers, civil liberties, stay-at-home orders introduction covid-19 represents a crisis at the intersection of personal conviction and public policy. the pandemic challenges the essence of what it means to be a member of a society that highly values civil liberties, and is governed by traditions and social norms, as well as rules and regulations. when government acts decisively using the least restrictive methods to manage the crisis, it is essential that people act ethically and follow recommendations to avoid inviting government to abuse emergency powers. the people and policy makers both must strive for the common good. the power to enact stay-at-home orders,1 which 42 states have issued, while technically justified by the mere fact that an emergency has arisen, must be backed up with reason and an appeal to morality. in accountable societies, an explicit ethical justification (usually necessity) for each emergency provision is necessary. understanding the justification for uniform action as resting on a myriad of reasons reflecting diverse points of view should provide a basis for creating a better framework for the next national emergency. zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 2 ii. public and private morality: does covid-19 response belong exclusively to either? the sphere of private morality should compel behavior for the good of others. yet people have vastly different views on what is good for others. to many, it is as reasonable to feel obligated to remain working in order to earn money and support a household as to stay at home to reduce the spread of disease at the risk of being unable to support a household. people both unreasonable (even in denial about the scope of the pandemic) as well as reasonable may have a valid reason not to stay at home. liberal democracy supports variance in the view of what is reasonable. emergencies cannot allow everyone who holds a reasonable opinion on how to proceed to proceed as they wish. management of covid-19 policy is properly in the public sphere where government must impose on the reasonable in society to be reasonable the same way and on the unreasonable to follow suit against their will. private morality can overlap with government policy: many people who understand the gravity of covid-19 will follow the orders as they would if the orders were mere recommendations, and the recommendations as if they were orders. a private morality failure can occur when people do not want to sacrifice for the good of others. to achieve either the utilitarian goal of maximizing happiness or to take a humanistic approach maximizing social good while minimizing suffering, the people must follow the orders as long as the orders are reasonable.2 arguably, capitalist society relies on incentives, even greed, and people are not easily moved to make personal and financial sacrifices. if stay-at-home recommendations remained a private morality issue, covid-19 would thrive due to differing points of view. norms and social pressure were not enough to achieve social distancing where the government has not insisted on it. for example, in florida, beaches, bars, and restaurants remained crowded until this week while in new york, orders that became stricter progressively did change behavior using the law. those with preexisting conditions should stay at home for their own protection aligning their actions with best practices regardless of the motive, creating an opportunity for overlapping consensus. the safety of healthcare workers is another moral impetus for individual’s precautionary actions. a shortage of personal protective equipment is well established. staying at home benefits healthcare workers just like using good judgment in recreational activities saves rescue workers. fewer severe cases of covid-19 would be safer for healthcare workers. some people who do not want to stay home for other reasons might be compelled to out of respect for healthcare workers. private morality is intertwined with public morality. in california, the general population may have been more supportive of the measures than people in other states would be. some governors did not fear that most of their constituents would not understand the need for action. while skeptics exist even in new york and california, and many do find the stay-at-home order too restrictive, the overall acceptance is shored up by a prevailing view that the order is aligned with the correct solution. private morality eases the need for punishment in enforcement. in reshaping the common good in times of health emergencies, george smith argues an educated electorate will understand the need for intrusive public health measures in emergencies.3 arguably, even an undereducated electorate is certainly capable of understanding the necessity of staying home and limiting social contact. the scope of government action can be condensed by a broader willingness of the people to participate in the actions set forth in stay-at-home orders and recommendations. zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 3 public morality also varies: governors have overseen covid-19 statewide actions differently. some states took decisive action early while others have kept businesses open and made no statements about social distancing, staying home, or even encouraging recommended behaviors set forth by who and the cdc. california moved quickly to establish a stay-at-home order while some states’ governors have still failed to act. (national conference of state legislatures and the national association of counties have maps showing state and county orders.4) florida’s new stay-at-home order does not prohibit religious groups from worship services, a known risk. some states have been steadfast in their inaction for various reasons: their skepticism of action is fueled by misinformation about the severity of the pandemic; and, their governors and local officials fear the political cost of temporarily shutting down non-essential businesses, forcing non-essential workers to stay home, and limiting personal freedom. their approaches are outside the scope of scientific reasoning and must be overridden. there is debate about the best course of action but the do-nothing approach is not within reason. governors of the eight states without an order, arkansas, iowa, nebraska, north dakota, south carolina, south dakota, utah, and wyoming reflect the prevailing views of their states’ residents. governor noem of south dakota argues people are responsible for their safety, absolving government of the public health responsibility. most of the other governors assert that changing personal behavior through recommendations is more important than executing an order.5 if the people in those states were more willing to change their own behavior, more invested in making moral decisions within the scope of scientific reason for the common good, the governors would be proven right: urging behavior would be enough. however, the prevailing mindset in those states might be that because the government is not making a strict order, covid-19 does not pose a major public health threat. the lack of orders also reflects a phenomenon: the public and the state governments do not really believe the science. if they did, reducing deaths through public policy would probably trump notions of freedom. the public policy makers are reflecting social norms that do not define the common good in an emergency appropriately and that ignore that government is the entity that should act for safety and the general welfare. a libertarian or small government tradition should not be an excuse for the unrealistic expectation that all people will converge to protect public health. idaho has a more severe local problem: a lapse in both public and private morality based specifically on the constitution and legal arguments regardless of the science. the governor, brad little, issued a stay-athome order on march 25.6 northern idaho has representatives in its state legislature condoning and encouraging boycotting the order and drumming up enthusiasm for the idea that the constitution guarantees an unconditional right to assemble.7 ammon bundy, known for taking over a federal wildlife reserve in oregon on similar anti-government grounds, spearheaded a movement to ignore the stay-athome order encouraging people to attend meetings and even a 1,000 person church service on easter. he aims to create a civilian militia to “physically stand in defense.”8 while other states also have civil liberties extremists operating in a sphere well to the right of libertarians, the documented reasons to ignore a stay-athome order or not issue them at all tend to have some link to advisors giving unscientific recommendations and people failing to believe the developing science supporting the high risk. the bundy formula violates the us body of constitutional law that fully supports the exercise of emergency powers as well as the many noted exceptions to first amendment rights. the northern idaho community’s view is indifferent to the high risk of deaths from covid-19 and values civil liberties decisively. in a polarized political climate, it is easy to argue that the differences between states’ reactions are political. in 2016, trump won the eight states that are now without stay-at-home orders with a wide margin. however, just weeks ago, many new yorkers were uncertain of what would be necessary to slow the spread of covid-19. the virus had reached a nursing home in washington state. new york may have taken action zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 4 sooner if the physical distance and the targeted age group of the first cluster of the virus were different. it did not hit close to home. although schools and government officials did take action, many felt they overreacted at first. now, information from who, other countries including italy and south korea, and states that have addressed covid-19 can educate others about which policies are most likely to succeed. there are states and counties where the actions that are reasonable may vary but at this point it looks like even rural states are experiencing cases of covid-19 which would spread through schools, social interactions, and businesses if not contained. emergencies that do not recognize state borders call for consensus in the action of government. weather events, wildfires, mass shootings, and even terrorism are manageable because resources can be moved from state to state. the army corps of engineers and fema can be instrumental in overseeing logistics of resource movement. presidential power is at its greatest in times of an emergency9 yet the current president, after failing to act in a timely manner, has deferred to states to manage the virus. the balance of power is three-pronged: individuals, states, and the federal government vie for power yet the federal government is not promoting compelling public health orders. without federal action, governors should agree on the best course of action for covid-19. without consensus, the states that fail to take action will undermine the measures taken in other states. the states failing to act may face worse economic conditions in the long run as covid-19 spreads. keeping businesses thriving longer now will come with a human cost soon. if states will not act, the president should act and his actions must be within “reason.”10 in germany, angela merkel’s actions were decisive despite a fear of powerful governments stemming from her own communist east german upbringing. yet her “appeal to reason” and her attributing “absolute necessity” as a justification were well received.11 there are many government rationales for taking swift action that can be invoked to spark action by governors failing to act so far. david fidler sees multiple rationales for government power in the public health sphere: health, international relations, national security, macroeconomics, and international trade, among others. he introduced two paradigms. the first, the “power paradigm” asserts governments have multiple completely different motives for power. the cia, the world trade organization, and humanitarian organizations might all promote public health for international relations for different reasons. the second, “the paradise paradigm” sees public health policy as humanitarian, viewing “power in terms of health” rather than “health in terms of power,” and is more likely to recognize health as a human right. fidler finds it difficult to reach consensus. an “axis of illness” that recognizes combined causes for the spread of dangerous pathogens calls for some cohesive policies regardless of the many motives behind them. his axis calls attention to factors ranging from microbial resilience to social determinants of health.12 overlapping consensus among governors should help: if a governor does not care about the people’s health, the governor might care about any one of the economic catastrophe, the effect of the virus on trade, savings accounts, the strain on the healthcare system, and jobs. the government has the ability to regulate businesses and places as well as people’s actions. heavier regulation of businesses can alleviate the need to heavily regulate individuals. closing places of employment, beaches, and public parks, and regulating how restaurants may serve people (takeout and delivery only), and changing the maximum number of people allowable in grocery stores (something fire codes already govern for many spaces) would encourage social distancing and staying home: having nowhere to go helps. the eight states resisting the best policy (stay-at-home orders) need to expand their limited policies and invoke regulatory powers more. zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 5 iii. clear goals and absolute necessity: what is the common good and how do we achieve it? the goals of the stay-at-home orders should be reducing deaths. doctors and officials say to stay home to prevent the spread of covid-19 and invoke the term “flatten the curve” referring to an effort to decrease the number of new diagnoses which would help hospitals handle patients slowing the number of cases with immediate needs. people may be less accepting of sacrifices for the public good when the public good is for the collective benefit rather than for the benefit of known individuals. public schools benefit individuals and thus society as a whole while many environmental laws exist for the collective good but often do not benefit distinct predictable individuals.13 similarly, social security has buy-in from the public because known predictable individuals benefit from it while healthcare reform has been fraught with controversy over how much some should subsidize the healthcare of others. covid-19 stay-at-home orders fall in murky space between collective benefit (an interest in saving lives) and an unpredictable individual benefit. while high risk categories have been identified, it is impossible to predict who will contract the virus and what outcome they will have. utilitarianism in determining the goal in an emergency might not be the best framework to decide how the burden is shared. if maximizing happiness maximizes utility, and there is an assumption that the maximum happiness is happiness for the most people, then other important values could be inadvertently set aside. strict utilitarianism could lead to every single person staying home regardless of personal risks, fairness, or justice. wiggle room is needed even in an emergency. a goal of minimizing harm could focus differently on those at the most risk.14 the same action (staying home) would extend to the general public by appealing to people’s moral and ethical reasons for also wanting to protect the vulnerable and reduce suffering. john locke expressed concern for executive overreach in emergencies partly because it could set a precedent that is abused later making it difficult for “people…[to] recover their original right.”15 if the goal is not only maximizing happiness, and reducing suffering, but also doing so as fairly and with as little intrusion into rights as possible, the goal might better represent the intersection of private and public morality. buy-in is key to attaining success without relying on unlimited emergency powers, especially police power. stay-at-home orders have huge benefits to unknown individuals and a distinct collective benefit in society’s goal of preventing death. to justify the inconvenience, the loss of income, the sacrifice of freedom, an effort to convey the benefits should be more extensive. the public in some states clearly understands the risks and wants to do the recommended actions. where there is not buy-in, justification must be delineated more clearly. instead of dismissing each person weighing a right to work, to travel, and to socialize, a larger more important public health goal must be clear. other people should not have to die for any one person’s right to work, to travel, or, especially, to socialize in person. necessity is the appropriate excuse: there is no known solution that would impinge on freedom less so staying at home is an acceptable requirement. the life and death aspect should be exploited in a responsible way: governments must justify stay-at-home orders as necessary to reduce death. iv. efficacy and the least restrictive means in china, a single party decides everything and has no nationally expressed legal obligation to consider individual rights when it makes policies. in the us, elected officials are expected to act within the bounds of the constitution and in accordance with public morality but presidential power does extend to the temporary suspension of normally recognized rights for the sake of public health.16 the public should zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 6 understand the rationales for strong action to decrease the human cost of the covid-19. there is also a human cost to closing schools and businesses. the appropriate policy must see public morality as able to address many types of human cost weighing the benefits and harms. exceptions (even some unforeseen) to stay-at-home orders will be necessary. for example, domestic abuse victims must be permitted to join other households if they can. stay-at-home orders do include exceptions for leaving the household to purchase food or medicines, for medical care, and to go outside for walks and exercise in public spaces as long as social distancing rules are followed. the exceptions recognize that orders that outstep the bounds of liberal society must be narrow and reasonable. people should only be asked to sacrifice what might be their entire savings as well as their freedom to move about if stay-at-home orders actually prevent transmission of covid-19. to argue stay-at-home orders are a necessity for the common good, leaders should demonstrate a “substantial relationship to the public health, the public morals, or the public safety.”17 18most stay-at-home orders allow people to be outdoors. evidence of the efficacy of the us style restrictions is developing. earlier action is best: south korea19 followed a social distancing regimen without closing down schools and businesses to the extent of italy which fared worse. italy and france have already fined people and some countries also threaten prison time for those violating quarantines. france has added police who are tasked with issuing fines if people leave their apartments without proper paperwork attesting to an allowable reason. the shift in power must be controlled. covid-19 must not be an excuse for increasing centralized power that could be abused. the least restrictive means should not need to include imprisonment for violating quarantines. many local mayors have made efforts not to detain people for minor offenses in order to decrease prison populations and prevent transmissions of covid-19 in prisons. populations in europe so far seem amenable to sacrificing rights for the covid-19 emergency orders: they want to save lives so they are willing to be subject (or to have others be subject to) to fines and imprisonment. in the us, we should take measures to protect democracy. opposition to fines and imprisonment should remain strong. instead, stay-at-home orders should be free of punitive measures that fall into criminal rather than civil actions. “public health police powers are an expression of the civil, not criminal, authority of the state.”20 for those in public and not social distancing very low fines should prevail or possibly future community service, not new york city’s proposed $1,000 fines. incentives to follow the orders should be strong enough to ensure new crimes are not written in criminal codes where they can be rehashed in lesser emergencies. neighborhood watch programs should manage the stay-at-home orders ensuring that private morality is a driving force partnered with government orders that reflect the best public health recommendations. v. power grabs with weak or no relationship to covid-19 prevention in new york, hospitals tried to forbid pregnant women from being accompanied by a partner or spouse while giving birth but new york’s governor overrode the measure. texas is forbidding abortions during the covid-19 pandemic unless they are to save the life or health of the mother. most abortions in texas are medical rather than surgical and the performance of medical abortions are not as complex and would not free up hospital beds or healthcare workers. a narrower restriction could be reasonable but even ohio’s restriction on surgical abortions is unnecessarily restrictive. “the american college of obstetricians and gynecologists and the american board of obstetrics and gynecology recently issued a statement saying that abortion should not fall into the category of procedures that can be delayed during the coronavirus outbreak, calling it “an essential component of comprehensive health care.””21 ending the two visit https://www.acog.org/news/news-releases/2020/03/joint-statement-on-abortion-access-during-the-covid-19-outbreak zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 7 requirement imposed for abortions would help decrease transmissions if the texas governor’s motive were to decrease transmission of the virus. the justice department asked congress for the power to detain people without a trial in a move contrary to many localities trying to halt arrests in an effort to decrease the prison population.22 23 the trump administration has also tried to violate habeas corpus rights by pausing judicial proceedings, yet the same result (closing courts that do arraignments) could be easily accomplished by choosing not to make an arrest. the ends do not justify the means when other options are available. trump also looked to closing borders, restricting flights, and rejecting asylum seekers some of which may be substantially correlated to controlling the pandemic and should be priorities if there is a proven relationship to public health. conclusion democracy in a federalist society should not allow the least reasonable laws to prevail when the fallout will cross state lines. divisions in society and different preconceptions of what is moral can be resolved by appealing to the framework of the democratic system: use the least restrictive means to reach an articulated goal in an efficacious way and then restore any right that was temporarily suspended. the systemic reinstitution and lasting continuity of those rights must be a pillar of democratic systems. if the common good as projected in public policy could never trump rights, and the public does not engage in the private morality for the common good, then, as george smith argues, the healthcare crisis could turn the constitution into “a suicide pact.”24 reason must be the basis of governmental public health decisions so that the skeptics cannot stand in the way of the solution and the government cannot outstep its powers. when a novel contagious pathogen appears in the world, absent presidential action, governors must agree on reasonable science-based action. some technique to garner consensus or override governors that fail to act should be developed. elections were the chance to decide who would make difficult decisions. a new paradigm could be in place in time for the next pandemic. it should not matter who the president is or which political party is in power in each state: the new paradigm must follow reason and public morality. private morality must support a government that is acting within the bounds of reason, informed by renowned scientific organizations. the odd problem in the us remains a president not using his powerful post to take steps necessary to stop the virus but stealthily seeking to change other policies under the guise of necessity. private and public morality call for the same goal: eradicating covid-19 with rights intact. 1 in this paper, stay-at-home orders, safer-at-home orders, and shelter-in-place orders are encompassed by the term stay-athome orders. the varying specifics among the orders are discussed when relevant. 2 smith, george p., ii. "re-shaping the common good in times of public health emergencies: validating medical triage," 18 annals of health law 1 (2009). 3 joshua l. friedman, emergency powers of the executive: the president’s authority when all hell breaks loose, 25 journal of law and health, vol 25:265 (2012) at 296 quoting george p. smith. https://www.law.csuohio.edu/sites/default/files/academics/jlh/friedman_final_version_of_article-2.pdf 4 national conference of state legislators https://www.ncsl.org/research/health/state-action-on-coronavirus-covid-19.aspx national association of counties map of counties https://ce.naco.org/?dset=covid19&ind=emergency%20declaration%20types 5 https://www.cnn.com/2020/04/04/politics/republican-governors-stay-at-home-orders-coronavirus/index.html https://www.law.csuohio.edu/sites/default/files/academics/jlh/friedman_final_version_of_article-2.pdf https://www.ncsl.org/research/health/state-action-on-coronavirus-covid-19.aspx https://ce.naco.org/?dset=covid-19&ind=emergency%20declaration%20types https://ce.naco.org/?dset=covid-19&ind=emergency%20declaration%20types https://www.cnn.com/2020/04/04/politics/republican-governors-stay-at-home-orders-coronavirus/index.html zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 8 6 https://coronavirus.idaho.gov/statewide-stay-home-order/ 7 some state representatives, including heather scott, a republican from northern idaho, argue people should ignore the order. a local sheriff, darryl wheeler, spreads the idea that the state can only legally restrict the movement of the sick. tim remington a pastor with a seat in the state legislature also claims the order violates constitutional rights. baker, mike. “a ‘liberty’ rebellion in idaho threatens to undermine coronavirus orders.” new york times. april 7, 2020. 8 baker. 9 friedman, 267 quoting alexander hamilton, “the federalist.” “there can be no limitation of that authority which is to provide for the defense and protection of the community in any matter essential to its efficacy.” 10 friedman, 178 and 279. friedman favors strong presidential powers but his analysis presupposes a president willing to take bold action. 11 rising, david and moulson, geir. (of associated press). “germany’s merkel shines in virus crisis even as power wanes.” pbs newshour online. mar 29, 2020. https://www.pbs.org/newshour/world/germanys-merkel-shines-in-virus-crisis-even-as-powerwanes?fbclid=iwar0poamjul6e_d7ctahh97zgedbdqzhf3xqg_lz3y0cbfaxbqhq_lwelbsk; bennhold, katrin. “a german exception? why the country’s coronavirus death rate is low.” new york times. april 4, 2020. https://www.nytimes.com/2020/04/04/world/europe/germany-coronavirus-death-rate.html?smtyp=cur&smid=fbnytimes&fbclid=iwar2_u204r7gxueiaggtz6a6etro47rmux6qs4bgdwnyrkfnlzcf8sdb_g-q 12 fidler, david p., “caught between paradise and power: public health, pathogenic threats, and the axis of illness.” mcgeorge law rev, 2004; 35(1):45-104. 13 environmental laws can help individuals by removing pollution from their area or by imposing workplace protections but regulations to do with largescale items like carbon cap and trade or protection of endangered species are for the collective good. they tend to face more scrutiny without well defined beneficiaries although all benefit. 14 smith, george p., 14. smith favors a balanced approach recognizing society values actions based on fairness and justice not just maximum utility. smith also professes a balance of public health benefit and civil liberties arguing in times of emergency the equilibrium shifts temporarily. smith, 34. 15 friedman, 269-70 quoting john locke. 16 friedman. 17 friedman citing jacobson v. massachusetts, 197 us 11, 25 (1905). 18 jonathan smith, lecturer in epidemiology of microbial diseases and global health yale university school of public health, argues to get the public health benefit of social distancing all members of the household must keep a distance from all nonmembers of the household. the smallest transgressions spread the virus. “if your son sneaks to see his girlfriend, and you later sneak to have coffee with a neighbor, your neighbor is now connected to the infected office worker that your son’s girlfriend’s mother shook hands with.” social distancing done early enough could break chains of viral transmission. looking at each family as an individual unit and separating each unit from all others, as recommended by epidemiologists, should be achievable without mandatory government action. ladra, “epidemiologist explains why social distancing is #1 weapon vs covid19.” political cortadito blog.march 24, 2020. http://www.politicalcortadito.com/2020/03/24/epidemiologist-explains-why-socialdistancing-is-1-weapon-vs-covid19/ 19 south korea ramped up testing early and tracked cases more accurately allowing it to be less restrictive in its response. as a result of testing both the symptomatic and the asymptomatic, south korea was able to quarantine large groups immediately. while quarantines are severely restrictive, south korea never needed to have the entire population stay at home except for essential workers. the united states did not have enough tests to implement strategic quarantines. to slow the spreading virus, cities and states in the us had to issue orders to the general population. the less restrictive means used in north korea required tests, fever testing, and spreading knowledge of how the asymptomatic may also be identified and quarantined. south korea suggested young people who lose their sense of taste and smell should be tested for the virus and isolated. to address https://coronavirus.idaho.gov/statewide-stay-home-order/ https://www.pbs.org/newshour/world/germanys-merkel-shines-in-virus-crisis-even-as-power-wanes?fbclid=iwar0poamjul6e_d7ctahh97zgedbdqzhf3xqg_lz3y0cbfaxbqhq_lwelbsk https://www.pbs.org/newshour/world/germanys-merkel-shines-in-virus-crisis-even-as-power-wanes?fbclid=iwar0poamjul6e_d7ctahh97zgedbdqzhf3xqg_lz3y0cbfaxbqhq_lwelbsk https://www.nytimes.com/2020/04/04/world/europe/germany-coronavirus-death-rate.html?smtyp=cur&smid=fb-nytimes&fbclid=iwar2_u204r7gxueiaggtz6a6etro47rmux6qs4bgdwnyrkfnlzcf8sdb_g-q https://www.nytimes.com/2020/04/04/world/europe/germany-coronavirus-death-rate.html?smtyp=cur&smid=fb-nytimes&fbclid=iwar2_u204r7gxueiaggtz6a6etro47rmux6qs4bgdwnyrkfnlzcf8sdb_g-q http://www.politicalcortadito.com/2020/03/24/epidemiologist-explains-why-social-distancing-is-1-weapon-vs-covid19/ http://www.politicalcortadito.com/2020/03/24/epidemiologist-explains-why-social-distancing-is-1-weapon-vs-covid19/ zimmerman, at the intersection of public and private morality, voices in bioethics, vol. 6 (2020) 9 covid-19, the least restrictive way still must cover more people because of the lack of available tests. https://www.wired.com/story/a-south-korean-covid-19-czar-has-some-advice-for-trump/ 20 galva, jorge, christopher atchison, and samual levy, “public health strategy and the police powers of the state.” public health reports (2005 supplement) vol. 120, p 25. 21 bazelon, emily. “the coronavirus becomes an excuse to restrict abortions: texas and ohio say the procedures are nonessential and must yield to the pandemic.” new york times. march 26, 2020. 22 politico https://www.politico.com/news/2020/03/21/doj-coronavirus-emergency-powers-140023 23 https://www.theatlantic.com/ideas/archive/2020/03/when-disease-comes-leaders-grab-more-power/608560/ citing this https://www.latimes.com/world-nation/story/2020-03-18/israel-coronavirus-netanyahu 24 smith, george p., citing terminiello v. chicago, 337 us 37 (1949) (jackson, j., dissenting). smith also refers to posner, richard a., not a suicide pact: the constitution in a time of national emergency, oxford university press (2006). https://www.wired.com/story/a-south-korean-covid-19-czar-has-some-advice-for-trump/ https://www.politico.com/news/2020/03/21/doj-coronavirus-emergency-powers-140023 https://www.theatlantic.com/ideas/archive/2020/03/when-disease-comes-leaders-grab-more-power/608560/ https://www.latimes.com/world-nation/story/2020-03-18/israel-coronavirus-netanyahu zimmerman, forced organ donation, voices in bioethics, vol. 9 (2023) * anne zimmerman, jd, ms, editor-in-chief, voices in bioethics, columbia university, and founder of modern bioethics disclaimer: anne zimmerman is the editor-in-chief of voices in bioethics. this article went through the same peer review process as all articles do. © 2023 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. forced organ harvesting: expanding the dead donor rule anne zimmerman* keywords: organ transplantation, harvesting, china, dead donor rule, brain death, prisoners introduction the nonconsensual taking of a human organ to use in transplantation medicine violates ethical principles, including autonomy, informed consent, and human rights, as well as criminal laws. when such an organ harvesting is not just nonconsensual, but performed in a way that causes a death or uses the pretense of brain death without meeting the criteria, it also violates the dead donor1 rule.2 the dead donor rule is both ethical and legal. it prevents organ retrieval that would predictably cause the death of the organ donor.3 retrieval of a vital organ is permissible only after a declaration of death.4 forced organ harvesting may breach the dead donor rule as it stands. a reimagined, broader dead donor rule could consider a larger timeframe in the forced organ harvesting context. in doing so, the broad dead donor rule could cover intent, premeditation, aiding and abetting, and due diligence failures. a broad definition of forced organ harvesting is ‘‘the removal of one or more organs from a person by means of coercion, abduction, deception, fraud, or abuse of power. . .’’5 a more targeted definition is “[t]he killing of a person so that their organs may be removed without their free, voluntary and informed consent and transplanted into another person.”6 in the global organ harvesting context, forced organ harvesting violates the world health organization (who) guiding principle 3, which says “live organ donors should be acting willingly, free of any undue influence or coercion.”7 furthermore, who states live donors should be “genetically, legally, or emotionally” attached to the recipient. guiding principle 1 applies to deceased donors, covers consent, and permits donation absent any known objections by the deceased.8 principle 7 says, “physicians and other health professionals should not engage in transplantation procedures, and health insurers and other payers should not cover such procedures if the cells, tissues or organs concerned have been obtained through exploitation or coercion of, or payment to, the donor or the next of kin of a deceased donor.” 9 there are underground markets in which organ hunters prey on the local poor in zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 2 countries with low wages and widespread poverty10 and human trafficking that targets migrants for the purpose of organ harvesting.11 this paper explores forced harvesting under the backdrop of the dead donor rule, arguing that a human rights violation so egregious requires holding even distant participants in the chain of events accountable. by interfering with resources necessary to carry out bad acts, legislation and corporate and institutional policies can act as powerful deterrents. a broader dead donor rule would highlight the premeditation and intent evidenced well before the act of organ retrieval. i. background and evidence in china, there is evidence that people incarcerated for religious beliefs and practices (falun gong) and ethnic minorities (uyghurs) have been subjects of forced organ harvesting. a tribunal (the china tribunal) found beyond a reasonable doubt that china engaged in forced organ harvesting.12 additionally, eight un special rapporteurs found a system of subjecting political prisoners and prisoners of conscience to blood tests and radiological examinations to determine the fitness of their organs. 13 as early as 2006, investigators found evidence of forced organ harvesting from falun gong practitioners. 14 over a million uyghurs are in custody there, and there is ample evidence of biometric data collection.15 an uyghur tribunal found evidence of genocide.16 “china is the only country in the world to have an industrial-scale organ trafficking practice that harvests organs from executed prisoners of conscience.”17 witnesses testified to the removal of organs from live people without ample anesthesia,18 summonses to the execution grounds for organ removal, 19 methods of causing death for the purpose of organ procurement,20 removing eyes from prisoners who were alive,21 and forcing live prisoners into operating rooms.22 the current extent of executions to harvest organs from prisoners of conscience in china is unknown. the chinese press has suggested surgeons in china will perform 50,000 organ transplants this year.23 doctors against forced organ harvesting (dafor) concluded, “[f]orced organ harvesting from living people has occurred and continues to occur unabated in china.”24 china continues to advertise in multiple languages to attract transplant tourists.25 wait times for organs seem to remain in the weeks.26 in the united states, it is common to wait three to five years.27 ii. the nascent system of voluntary organ donation in china in china, throughout the 1990s and early 2000s, the supply of organs for transplant was low, and there was not a national system to register as a donor. a 1984 act permitted death row prisoners to donate organs.28 in 2005, a vice minister acknowledged that 95 percent of all organ transplants used organs from death row prisoners.29 in 2007 the planning of a voluntary system to harvest organs after cardiac death emerged. according to a chinese publication, china adopted brain death criteria in 2013.30 there had been public opposition due partly to cultural unfamiliarity with it.31 cultural values about death made it more difficult to adopt a universal brain death definition. both buddhist and confucian beliefs contradicted brain death.32 circulatory death was traditionally culturally accepted.33 the ministry of health announced that by 2015 organ harvesting would be purely voluntary and that prisoners would not be the source of organs.34 there are cultural barriers to voluntary donation partly due to a confucian belief that bodies return to ancestors intact and other cultural and religious beliefs about respect for the dead.35 an emphasis on family and community over the individual posed another barrier to the western approach to organ donation. public awareness and insufficient healthcare professional knowledge about the process of organ donation zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 3 are also barriers to voluntary donation.36 although the chinese government claims its current system is voluntary and no longer exploits prisoners, 37 vast evidence contradicts the credibility of the voluntary transplant program in china.38 iii. dead donor rule: a source of bioethical debate it seems tedious to apply this ethical foundation to something as glaring as forced organ harvesting. but the dead donor rule is a widely held recognition that it is not right to kill one person to save another.39 it acts as a prohibition on killing for the sake of organ retrieval and imposes a technical requirement which influences laws on how death is declared. the dead donor rule prevents organ harvesting that causes death by prohibiting harvesting any organ which the donor agreed to donate only after death prior to an official declaration of death. there is an ongoing ethical debate about the dead donor rule. many in bioethics and transplant medicine would justify removing organs in specific situations prior to a declaration of death, abandoning the rule.40 some use utilitarian arguments to justify causing the death of someone who is unconscious and on life support irreversibly. journal articles suggest that the discussion has moved to one of timing and organ retrieval.41 robert truog and franklin miller are critics of the dead donor rule, arguing that, in practice, it is not strictly obeyed: removing organs while a brain-dead donor is still on mechanical ventilation and has a beating heart and removing organs right after life support is removed and cardio-pulmonary death is declared both might not truly meet the requirement of the dead donor rule, making following the rule “a dubious norm.”42 miller and truog question the concept of brain death, citing evidence of whole body integrated functions that continue indefinitely. they challenge cardio-pulmonary death, asserting that the definition includes as dead, those who could be resuscitated. their hearts could resume beating with medical intervention. stopping life support causes death only in those whose lives are sustained by it. some stipulate that the organ retrieval must not itself cause the death. some would rejigger the cause of death: daniel callahan suggests that the underlying condition causes the death despite removal of life support.43 but logically, a person could continue life support and be alive, so clearly, removing life support does cause death. something else would have caused brain death or the circumstance that landed the person on mechanical ventilation. to be more accurate, one could say x caused the irreversible coma and removing life support caused the death itself. miller and truog take the position that because withdrawal of life support does cause death, the dead donor rule should be defunct as insincere. to them, retrieving vital organs from a technically alive donor should be permissible under limited conditions. they look to the autonomous choices of the donor or the surrogate (an autonomy-based argument). they appreciate the demand for organs and the ability to save lives, drawing attention to those in need of organs. live donor organ retrieval arguably presents a slippery slope, especially if a potential donor is close to death, but not so close to label it imminent. they say physicians would not be obligated to follow the orders of a healthy person wishing to have vital organs removed, perhaps to save a close friend or relative. similarly, radcliffe-richards, et al. argue that there is no reason to worry about the slippery slope of people choosing death so they can sell their vital organs, whether for money for their decedents or their creditors.44 the movement toward permissibility and increased acceptance of medical aid in dying also influence the organ donation arena. the slippery slope toward the end of life has potential to become a realistic concern. older adults or other people close to death may want to donate a vital organ, like their heart, to a young relative in need. that could greatly influence the timing of a decision to end one’s life. zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 4 iv. relating the dead donor rule to forced organ harvesting there is well documented evidence that in china organs have been removed before a declaration of death.45 but one thing the dead donor rule does not explicitly cover is intent and the period prior to the events leading to death. it tends to apply to a near-death situation and is primarily studied in its relationship to organ donation. it is about death more than it is about life. robertson and lavee investigated data on transplantation of vital organs in china and they document cases where the declaration of death was a pretense, insincere, and incorrect. their aim was to investigate whether the prisoners were in fact dead prior to organ harvesting.46 (the china tribunal found that organs have been removed from live prisoners and that organ harvesting has been the cause of death.) they are further concerned with the possible role of doctors as executioners, or at least as complicit in the execution as the organ harvesting so closely follows it. v. a broader dead donor rule a presumed ethical precursor to the dead donor rule may also be an important ethical extension of the rule: the dead donor rule must also prohibit killing a person who is not otherwise near death for the purpose of post-death organ harvesting. in china, extra-judicial killings of prisoners of conscience are premeditated ― there is ample evidence of blood tests and radiology to ensure organ compatibility and health.47 to have effective ethical force, the dead donor rule should have an obvious application in preventing intentional killing for an organ retrieval, not just killing by way of organ retrieval. when we picture the dead donor rule, bioethicists tend to envision a person on life support who will either be taken off it and stop breathing or who will be declared brain dead. but the dead donor rule should apply to healthy people subject to persecution at the point when the perpetrator lays the ground for the later killing. at that point, many organizations and people may be complicit or unknowingly contributing to forced organ harvesting. in this iteration of the dead donor rule, complicity in its violations would be widespread. the dead donor rule could address the initial action of ordering a blood or radiology test or collecting any biometric data. trained physicians and healthcare technicians perform such tests. under my proposed stretch of the dead donor rule, they too would be complicit in the very early steps that eventually lead to killing a person for their organs. i argue these steps are part of forced organ harvesting and violate the dead donor rule. the donor is very much alive in the months and years preceding the killing. a conspiracy of indifference toward life, religious persecution, ethnic discrimination, a desire to expand organ transplant tourism, and intent to kill can violate this broader dead donor rule. the dead donor rule does not usually apply to the timing of the thought of organ removal, nor the beginning of the chain of events that leads to it. it is usually saved for the very detailed determination of what may count as death so that physicians may remove vital and other organs, with the consent of the donor.48 but i argue that declaring death at the time of retrieval may not be enough. contributing to the death, even by actions months or years in advance, matter too. perhaps being on the deathbed awaiting a certain death must be distinguished from going about one’s business only to wind up a victim of forced organ harvesting. both may well be declared dead before organ retrieval, but the likeness stops there. the person targeted for future organ retrieval to satisfy a growing transplant tourism business or local demand is unlike the altruistic person on his deathbed. while it may seem like the dead donor rule is merely a bioethics rule, it does inform the law. and it has ethical heft. it may be worth expanding it to the arena of human trafficking for the sake of organ removal zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 5 and forced organ harvesting.49 the dead donor rule is really meant to ensure that death was properly declared to protect life, something that must be protected from an earlier point. vi. complicity: meaning and application human rights due diligence refers to actions that people or institutions must take to ensure they are not contributing to a human rights violation. to advise on how to mitigate risk of involvement or contribution to human rights violations, global rights compliance published an advisory that describes human rights due diligence as “[t]he proactive conduct of a medical institution and transplant-associated entity to identify and manage human rights risks and adverse human rights impacts along their entire value and supply chain.”50 many people and organizations enable forced organ harvesting. they may be unwittingly complicit or knowingly aiding and abetting criminal activity. for example, some suppliers of medical equipment and immunosuppressants may inadvertently contribute to human rights abuses in transplantation in china, or in other countries where organs were harvested without consent, under duress, or during human trafficking. according to global rights compliance, “china in the first half of 2021 alone imported ‘a total value of about 24 billion u.s. dollars’ worth of medical technology equipment’, with the united states and germany among the top import sources.”51 the companies supplying the equipment may be able to slow or stop the harm by failing to supply necessary equipment and drugs. internal due diligence policies would help companies analyze their suppliers and purchasers. corporations, educational institutions, and other entities in the transplantation supply chain, medical education, insurance, or publishing must engage in human rights due diligence. the global rights compliance advisory suggests that journals should not include any ill-gotten research. laws should regulate corporations and target the supply chain also. all actors in the chain of supply, etc. are leading to the death of the nonconsenting victim. they are doing so while the victim is alive. the stop forced organ harvesting act of 2023, pending in the united states, would hold any person or entity that “funds, sponsors, or otherwise facilitates forced organ harvesting or trafficking in persons for purposes of the removal of organs” responsible. the pending legislation states that: it shall be the policy of the united states— (1) to combat international trafficking in persons for purposes of the removal of organs; (2) to promote the establishment of voluntary organ donation systems with effective enforcement mechanisms in bilateral diplomatic meetings and in international health forums; (3) to promote the dignity and security of human life in accordance with the universal declaration of human rights, adopted on december 10, 1948; and (4) to hold accountable persons implicated, including members of the chinese communist party, in forced organ harvesting and trafficking in persons for purposes of the removal of organs.52 the act calls on the president to provide congress a list of such people or entities and to sanction them by property blocking, and, in the case of non-us citizens, passport and visa denial or revocation. the act includes a reporting requirement under the foreign assistance act of 1961 that includes an assessment of entities engaged in or supporting forced organ harvesting.53 the law may have a meaningful impact on forced organ harvesting. other countries have taken or are in the process of legal approaches as well.54 zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 6 countries should consider legislation to prevent transplant tourism, criminalize complicity, and require human rights due diligence. an expanded dead donor rule supports legal and policy remedies to prevent enabling people to carry out forced organ harvesting. vii. do bioethicists mention human rights abuses and forced organ harvesting enough? as a field, bioethics literature often focuses on the need for more organs, the pain and suffering of those on organ transplant waitlists, and fairness in allocating organs or deciding who belongs on which waitlist and why. however, some bioethicists have drawn attention to forced organ harvesting in china. notably, several articles noted the ethical breaches and called on academic journals to turn away articles on transplantation from china as they are based on the unethical practice of executing prisoners of conscience for their organs.55 the call for such a boycott was originally published in a lancet article in 2011.56 there is some acknowledgement that china cares about how other countries perceive it, 57 which could lead to either improvements in human rights or cover-ups of violations. ill-gotten research has long been in the bioethics purview with significant commentary on abuses in tuskegee and the holocaust. 58 human research subjects are protected by the declaration of helsinki, which requires acting in the best interests of research subjects and informed consent among other protections. 59 the declaration of helsinki is directed at physicians and requires subjects enroll in medical research voluntarily. the declaration does not explicitly cover other healthcare professionals, but its requirements are well accepted broadly in health care. conclusion the dead donor rule in its current form really does not cover the life of a non-injured healthy person at an earlier point. if it could be reimagined, we could highlight the link between persecution for being a member of a group like falun gong practitioners or uyghurs as the start of the process that leads to a nonconsensual organ retrieval whether after a proper declaration of death or not. it is obviously not ethically enough to ensure an execution is complete before the organs are harvested. it is abuse of the dead donor rule to have such a circumstance meet its ethical requirement. and obviously killing people for their beliefs or ethnicity (and extra-judicial killings generally) is not an ethically acceptable action for many reasons. the deaths are intentionally orchestrated, but people and companies who may have no knowledge of their role or the role of physicians they train or equipment they sell are enablers. an expanded dead donor rule helps highlight a longer timeframe and expanded scope of complicity. the organ perfusion equipment or pharmaceuticals manufactured in the united states today must not end up enabling forced organ harvesting. with an expanded ethical rule, the “donor is not dead” may become “the donor would not be dead if not for. . .” the host of illegal acts, arrests without cause, forced detention in labor camps, extra-judicial killings, lacking human rights due diligence, and inattention to this important topic. the expanded dead donor rule may also appeal to the bioethics community and justify more attention to laws and policies like the stop forced organ harvesting act of 2023. 1 the word “donor” in this paper describes any person from whom organs are retrieved regardless of compensation, force, or exploitation in keeping with the bioethics literature and the phrase “dead donor rule”. 2 robertson, m.p., lavee j. (2022). execution by organ procurement: breaching the dead donor rule in china. am j transplant, vol.22,1804– 1812. doi:10.1111/ajt.16969. 3 robertson, j. a. (1999). delimiting the donor: the dead donor rule. hastings center report, 29(6), 6-14. zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 7 4 retrieval of non-vital organs which the donor consents to donate post-death (whether opt-in, opt-out, presumed, or explicit according to local law) also trigger the dead donor rule. 5 the stop forced organ harvesting act of 2023, h.r. 1154, 118th congress (2023), https://www.congress.gov/bill/118thcongress/house-bill/1154. 6 do no harm: mitigating human rights risks when interacting with international medical institutions & professionals in transplantation medicine, global rights compliance, legal advisory report, april 2022, https://globalrightscompliance.com/project/do-no-harm-policy-guidance-and-legal-advisory-report/. 7 who guiding principles on human cell, tissue and organ transplantation, as endorsed by the sixty-third world health assembly in may 2010, in resolution wha63.22 https://apps.who.int/iris/bitstream/handle/10665/341814/who-htp-eht-cpr2010.01-eng.pdf?sequence=1. 8 who guiding principles on human cell, tissue and organ transplantation (2010). 9 who guiding principles on human cell, tissue and organ transplantation (2010). 10 promchertchoo, pichayada (oct. 19, 2019). kidney for sale: inside philippines’ illegal organ trade. https://www.channelnewsasia.com/asia/kidney-for-sale-philippines-illegal-organ-trade-857551; widodo, w. and wiwik utami (2021), the causes of indonesian people selling covered kidneys from a criminology and economic perspective: analysis based on rational choice theory. european journal of political science studies, vol 5, issue 1. 11 van reisen, m., & mawere, m. (eds.). (2017). human trafficking and trauma in the digital era: the ongoing tragedy of the trade in refugees from eritrea. african books collective. 12 the independent tribunal into forced organ harvesting from prisoners of conscience in china (china tribunal) (2020). https://chinatribunal.com/wp-content/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf 13 un office of the high commissioner, press release, china: un human rights experts alarmed by ‘organ harvesting’ allegations (un othchr, 14 june 2021), https://www.ohchr.org/en/press-releases/2021/06/china-un-human-rights-experts-alarmed-organharvesting-allegations. 14 david matas and david kilgour, bloody harvest. the killing of falun gong for their organs (seraphim editions 2009). 15 how china is crushing the uyghurs, the economist, video documentary, july 9, 2019, https://youtu.be/grbcp5brffi. 16 uyghur tribunal, judgment (9 december 2021) (uyghur tribunal judgment) para 1, https://uyghurtribunal.com/wpcontent/uploads/2022/01/uyghur-tribunal-judgment-9th-dec-21.pdf. 17 ali iqbal and aliya khan, killing prisoners for transplants: forced organ harvesting in china, the conversation published: july 28, 2022. https://theconversation.com/killing-prisoners-for-transplants-forced-organ-harvesting-in-china-161999 18 testimony demonstrated surgeries to remove vital organs from live people, killing them, sometimes without ample anesthesia to prevent wakefulness and pain. china tribunal (2020), p. 416-417. https://chinatribunal.com/wpcontent/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf; robertson mp, lavee j. (2022), execution by organ procurement: breaching the dead donor rule in china. am j transplant, vol.22,1804– 1812. doi:10.1111/ajt.16969. 19 doctors reported being summoned to execution grounds and told to harvest organs amid uncertainty that the prisoner was in fact dead. china tribunal (2020), p. 52-53. 20in testimony to the china tribunal, dr. huige li noted four methods of organ harvesting from live prisoners: incomplete execution by shooting, after lethal injection prior to death, execution by removal of the heart, and after a determination of brain death prior to an intubation (pretense of brain death). china tribunal (2020), pp. 54-55. https://chinatribunal.com/wpcontent/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf 21 a former military medical student described removing organs from a live prisoner in the late 1990s. he further described his inability to remove the eyes of a live man and his witnessing another doctor forcefully remove the man’s eyes. china tribunal (2020), p. 330. https://www.congress.gov/bill/118th-congress/house-bill/1154 https://www.congress.gov/bill/118th-congress/house-bill/1154 https://globalrightscompliance.com/project/do-no-harm-policy-guidance-and-legal-advisory-report/ https://www.channelnewsasia.com/asia/kidney-for-sale-philippines-illegal-organ-trade-857551 https://chinatribunal.com/wp-content/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf https://www.ohchr.org/en/press-releases/2021/06/china-un-human-rights-experts-alarmed-organ-harvesting-allegations https://www.ohchr.org/en/press-releases/2021/06/china-un-human-rights-experts-alarmed-organ-harvesting-allegations https://youtu.be/grbcp5brffi https://uyghurtribunal.com/wp-content/uploads/2022/01/uyghur-tribunal-judgment-9th-dec-21.pdf https://uyghurtribunal.com/wp-content/uploads/2022/01/uyghur-tribunal-judgment-9th-dec-21.pdf https://chinatribunal.com/wp-content/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf https://chinatribunal.com/wp-content/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf https://chinatribunal.com/wp-content/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf https://chinatribunal.com/wp-content/uploads/2020/03/chinatribunal_judgment_1stmarch_2020.pdf zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 8 22 in 2006, a nurse testified that her ex-husband, a surgeon, removed the eyes of 2,000 falun gong practitioners in one hospital between 2001 and 2003. she described the falun gong labor-camp prisoners as being forced into operating rooms where they were given a shot to stop their hearts. other doctors removed other organs. dafoh special report, 2022. https://epochpage.com/wp-content/uploads/sites/3/2022/12/dafoh-special-report-2022.pdf 23 robertson mp, lavee j. (2022), execution by organ procurement: breaching the dead donor rule in china. am j transplant, vol.22,1804– 1812. doi:10.1111/ajt.16969. 24 dafoh special report, 2022. https://epochpage.com/wp-content/uploads/sites/3/2022/12/dafoh-special-report-2022.pdf; dafoh’s physicians were nominated for a nobel prize for their work to stop forced organ harvesting. šućur, a., & gajović, s. (2016). nobel peace prize nomination for doctors against forced organ harvesting (dafoh) a recognition of upholding ethical practices in medicine. croatian medical journal, 57(3), 219–222. https://doi.org/10.3325/cmj.2016.57.219 25 robertson and lavee (2022). 26 stop organ harvesting in china, website (organization of the falun dafa). https://www.stoporganharvesting.org/short-waitingtimes/ 27 national kidney foundation, the kidney transplant waitlist – what you need to know, https://www.kidney.org/atoz/content/transplant-waitlist 28 wu, y., elliott, r., li, l., yang, t., bai, y., & ma, w. (2018). cadaveric organ donation in china: a crossroads for ethics and sociocultural factors. medicine, 97(10). 29 wu, elliott, et al., (2018). 30 su, y. y., chen, w. b., liu, g., fan, l. l., zhang, y., ye, h., ... & jiang, m. d. (2018). an investigation and suggestions for the improvement of brain death determination in china. chinese medical journal, 131(24), 2910-2914. 31 huang, j., millis, j. m., mao, y., millis, m. a., sang, x., & zhong, s. (2012). a pilot programme of organ donation after cardiac death in china. the lancet, 379(9818), 862-865. 32 yang, q., & miller, g. (2015). east–west differences in perception of brain death: review of history, current understandings, and directions for future research. journal of bioethical inquiry, 12, 211-225. 33 huang, j., millis, j. m., mao, y., millis, m. a., sang, x., & zhong, s. (2015). voluntary organ donation system adapted to chinese cultural values and social reality. liver transplantation, 21(4), 419-422. 34 huang, millis, et al. (2015). 35 wu, x., & fang, q. (2013). financial compensation for deceased organ donation in china. journal of medical ethics, 39(6), 378379. 36 an, n., shi, y., jiang, y., & zhao, l. (2016). organ donation in china: the major progress and the continuing problem. journal of biomedical research, 30(2), 81. 37 shi, b. y., liu, z. j., & yu, t. (2020). development of the organ donation and transplantation system in china. chinese medical journal, 133(07), 760-765. 38 robertson, m. p., hinde, r. l., & lavee, j. (2019). analysis of official deceased organ donation data casts doubt on the credibility of china’s organ transplant reform. bmc medical ethics, 20(1), 1-20. 39 miller, f.g. and sade, r. m. (2014). consequences of the dead donor rule. the annals of thoracic surgery, 97(4), 1131–1132. https://doi.org/10.1016/j.athoracsur.2014.01.003 40 for example, miller and sade (2014) and miller and truog (2008). 41 omelianchuk, a. how (not) to think of the ‘dead-donor’ rule. theor med bioeth 39, 1–25 (2018). https://doiorg.ezproxy.cul.columbia.edu/10.1007/s11017-018-9432-5 https://epochpage.com/wp-content/uploads/sites/3/2022/12/dafoh-special-report-2022.pdf zimmerman, forced organ harvesting, voices in bioethics, vol. 9 (2023) 9 42 miller, f.g. and truog, r.d. (2008), rethinking the ethics of vital organ donations. hastings center report. 38: 38-46. 43 miller and truog, (2008), p. 40, citing callahan, d., the troubled dream of life, p. 77. 44 radcliffe-richards, j., daar, a.s., guttman, r.d., hoffenberg, r., kennedy, i., lock, m., sells, r.a., tilney, n. (1998), the case for allowing kidney sales, the lancet, vol 351, p. 279. (authored by members of the international forum for transplant ethics.) 45 robertson and lavee, (2022). 46 robertson and lavee, (2022). 47 china tribunal (2020). 48 consent varies by local law and may be explicit or presumed and use an opt-in or opt-out system and may or may not require the signoff by a close family member. 49 bain, christina, mari, joseph. june 26, 2018, organ trafficking: the unseen form of human trafficking, acams today, https://www.acamstoday.org/organ-trafficking-the-unseen-form-of-human-trafficking/; stammers, t. (2022), "2: organ trafficking: a neglected aspect of modern slavery", modern slavery and human trafficking, bristol, uk: policy press. https://bristoluniversitypressdigital.com/view/book/978144736. 50 do no harm: mitigating human rights risks when interacting with international medical institutions & professionals in transplantation medicine, global rights compliance, legal advisory report, april 2022, https://globalrightscompliance.com/project/do-no-harm-policy-guidance-and-legal-advisory-report/. 51 global rights compliance, p. 22. 52 the stop forced organ harvesting act of 2023, h.r. 1154, 118th congress (2023). https://www.congress.gov/bill/118thcongress/house-bill/1154. 53 the stop forced organ harvesting act of 2023, h.r. 1154, 118th congress (2023), https://www.congress.gov/bill/118thcongress/house-bill/1154. 54 global rights compliance notes that belgium, france (passed law on human rights due diligence in the value supply chain), united kingdom, united states, canada, australia, and new zealand have legal approaches, resolutions, and pending laws. p. 45. 55 for example, caplan, a.l. (2020), the ethics of the unmentionable journal of medical ethics 2020;46:687-688. 56 caplan, a.l. , danovitch, g., shapiro m., et al. (2011) time for a boycott of chinese science and medicine pertaining to organ transplantation. lancet, 378(9798):1218. doi:10.1016/s0140-6736(11)61536-5 57 robertson and lavee. 58 smolin, d. m. (2011). the tuskegee syphilis experiment, social change, and the future of bioethics. faulkner l. rev., 3, 229; gallin, s., & bedzow, i. (2020). holocaust as an inflection point in the development of bioethics and research ethics. handbook of research ethics and scientific integrity, 1071-1090. 59 world medical association declaration of helsinki: ethical principles for medical research involving human subjects, adopted by the 18th wma general assembly, helsinki, finland, june 1964, and amended multiple times, most recently by the 64th wma general assembly, fortaleza, brazil, october 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethicalprinciples-for-medical-research-involving-human-subjects/ https://www.acamstoday.org/organ-trafficking-the-unseen-form-of-human-trafficking/ https://bristoluniversitypressdigital.com/view/book/9781447363668/ch002.xml https://globalrightscompliance.com/project/do-no-harm-policy-guidance-and-legal-advisory-report/ https://www.congress.gov/bill/118th-congress/house-bill/1154 https://www.congress.gov/bill/118th-congress/house-bill/1154 https://www.congress.gov/bill/118th-congress/house-bill/1154 https://www.congress.gov/bill/118th-congress/house-bill/1154 dinelli, conscientious objection based on patient identity, voices in bioethics, vol. 8 (2022) * john a. dinelli, albany medical college © 2022 john a. dinelli. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. conscientious objection based on patient identity: a virtue ethics argument against lgbtq+ discrimination john a. dinelli* keywords: lgbtq+, virtue, conscientious objection, hippocratic oath, moral objection, nicomachean ethics introduction across the country, states are enacting legislation that curtails lgbtq+ rights and liberties.1 in march 2021, arkansas enacted senate bill 289, titled the medical ethics and diversity act (the “act”).2 the act permits medical practitioners, healthcare institutions, and insurance companies to refuse to treat, or, in the case of insurance companies, to cover, a non-critically ill person if treating the individual violates their religious or personal beliefs. though masked as protecting religious liberties, the act discriminates against lgbtq+ patients. while the act purports to protect different types of healthcare workers, i frame my discussion of the act to discuss the physician’s obligations given the changes to arkansas law. even if legally permissible, i believe virtuous physicians do not consider patients’ sexual orientation or gender identity when deciding whether to treat them. i will explain why a virtuous physician would never conscientiously object to treating a patient based on the patient’s sexual orientation or gender identity, even if allowed, like in arkansas. conscientious objection based on sexual orientation or gender identity, even if permitted under state law, is always unvirtuous. i. senate bill 289 and the lgbtq+ patient on march 29, 2021, governor hutchinson adopted the act by signing senate bill 289 into arkansas state law. to protect a “right of conscience” in health care, the act invokes traditions of the united states and the hippocratic oath, stating: dinelli, conscientious objection based on patient identity, voices in bioethics, vol. 8 (2022) 2 [t]he right of conscience was central to the founding of the united states, has been deeply rooted in the history and tradition of the united states for centuries, and has been central to the practice of medicine through the hippocratic oath for millennia. as used in the act, conscience means “religious, moral, or ethical beliefs.” the act protects medical practitioners, healthcare institutions, or healthcare payors when they act from their conscience and extends this protection to include the following: (1) the right not to participate in a healthcare service that violates his, her, or its conscience; (2) no requirement to participate in a healthcare service that violates his, her, or its conscience; and (3) no civil, criminal, or administrative liability for declining to participate in a healthcare service that violates his, her, or its conscience. the act limits which services physicians can refuse to perform: it permits conscientious objection only if the patient requires non-emergency care. under arkansas state law, an emergency is defined as an “immediate threat to the life or health of a patient.”3 before the act, conscientious objection was limited in medical practice in the united states. the american medical association’s (“ama”) code of medical ethics states physicians can act as moral agents. the ama’s code supports conscientious objection if it is based on a moral objection to a treatment rather than discrimination against patients.4 from the church amendments to the affordable care act, federal law has protected practitioners’ rights to object to participating in treatments contrary to their religious or moral beliefs, such as abortions, sterilization, euthanasia, or physician-assisted suicide.5 however, the language of these laws emphasizes treatment-based objection; the laws protect healthcare workers who are unwilling to participate in medical practices based on a moral objection to a treatment. in addition, the laws specifically name procedures like sterilization, euthanasia, or physician-assisted suicide as permissible grounds for objection. the act extends physicians’ rights to conscientious objection by removing the treatment-specific language. in arkansas, the broad language of the law could permit conscientious objection based on a patient’s lgbtq+ identity because it does not limit objections based on type of treatments. the act broadened conscientious objection in arkansas to include treatment-based and patient-based objections. ii. virtue ethics virtue ethics is an ethical framework that focuses on the character of the individual performing actions during the individual’s life and career. in nicomachean ethics, aristotle writes that virtue is a state of being, such as a courageous or amiable person, rather than a system for ethical action selection. 6 society understands these virtues as falling at the mean—or between— a deficiency and an excess. for example, the virtue of courage lies between the deficiency of cowardness and excess of rashness, never in abundance or excess. a virtuous person exemplifies the virtues required of the person’s role and performs the required functions well. aristotle writes, “[w]e become just by doing just actions, temperate by doing temperate actions, brave by doing brave actions.” in this way, we must live our virtues to become virtuous. a. the virtuous physician the virtuous physician exemplifies virtue and practices medicine in congruence with medicine’s ethos. since an individual can practice and learn virtue, it provides a unique ethical framework to distinguish between the virtuous or “good” physician and the unvirtuous or “bad” physician. aristotle writes that life’s dinelli, conscientious objection based on patient identity, voices in bioethics, vol. 8 (2022) 3 virtues are courage, temperance, generosity, magnificence, magnanimity, mildness, amiability, truthfulness, wit, and shame.7 individuals possessing these traits are virtuous, but virtuous physicians must also demonstrate traits integral to their professional duties. a virtuous physician’s qualities include empathetic listening, emotional sensitivity, and respect for patients. these additional qualities create trust and comfort patients. 8 also, the virtuous physician exemplifies trustworthiness, integrity, discernment, compassion, patience, and conscientiousness.9 others even include theological virtues such as faith, hope, and charity as important characteristics in a physician’s practice.10 while not an exhaustive list of the values that compose a virtuous physician, these standards are the basic requirements for physician to exemplify virtue and perform the job’s functions well. one may argue that theological virtues like faith, hope, and charity support the conscientious objection because physicians are virtuous when they are faithful, or loyal to their religious beliefs. however, this argument fails to consider the four principles of medical ethics. using conscientious objection to withhold care from even non-critically ill patients can cause harm that is physical and emotional. a physician cannot act virtuously and simultaneously undermine non-malfeasance and beneficence. the virtuous physician must also practice medicine in congruence with medicine’s ethos, acting for the patient’s benefit and taking a patient-centered approach. the patient’s benefit has multiple elements, such as the medically defined good outcome, the patient’s definition of a good outcome, what is dignifying to the patient, and what is considered universally good.11 if a physician acts against a patient’s good or the physician does not exemplify virtue in their own life, the physician would be considered unvirtuous. b. unvirtuous conscientious objection through the act conscientious objection is a debated topic. some argue that physicians’ values should not influence the care they provide. 12 in addition, the legalization of conscientious objection is seen by some to violate medicine’s central ethos of caring for the patient.13 others do not view conscientious objection as wholly wrong. despite the debate over the role of conscientious objection in the physician’s practice, conscientious objection based on a patient’s lgbtq+ identity under the act is unvirtuous. the act extends the understood norm of treatment-based objections to objections based on any component of health care, including a patient’s lgbtq+ identity. this patient-based objection is discriminatory and unrelated to the patient’s requested medical service which may conflict with the physician’s morals.14 a virtuous physician would never refuse to treat a patient based on the patient’s race, color, religion, sex, sexual orientation, gender identity, or national origin. refusing to treat a patient because of the patient’s lgbtq+ identity is unvirtuous because it defies a physician’s duty, is discriminatory, and displays a lack of respect for patients, amiability, and compassion. even if permitted under the act, a virtuous physician must never object to treating a patient based on the patient’s sexual orientation or gender identity. one may argue a physician can be virtuous while conscientiously objecting if the physician clearly communicates all limitations and refers the patient to another medical provider. this is the american college of obstetricians and gynecologists’ view. 15 under this view, physicians maintain respect for themselves as agents but ultimately provide proper care for the patient, even if their hands do not perform the service. however, to be virtuous, this objection must never be discriminatory. even with prerequisites, objection based on gender identity and sexual orientation is discriminatory and indicates deficiencies in the physician’s virtue. the simple act of objection can cause psychological pain to a patient. lgbtq+-based discrimination and rejection causes unnecessary physiological harm like anxiety, depression, and suicidal dinelli, conscientious objection based on patient identity, voices in bioethics, vol. 8 (2022) 4 ideations, whereas social acceptance increases feelings of self-esteem. 16 the virtuous physician would never cause pain to the patient, as this violates the principle of non-maleficence. regardless of actions taken before or after the objection, a physician is unvirtuous when the physician inflicts pain on a patient by conscientiously objecting to treating the patient based on lgbtq+ status. conclusion to avoid discrimination, a physician must have a valid reason for employing conscientious objection. the medical ethics and diversity act extends physicians’ rights from treatment-based objection to patientbased objection. arkansas’s lgbtq+ community is at risk of suffering from discriminatory healthcare practices. the physician who objects based on lgbtq+ identity is unvirtuous because the physician’s action causes psychological harm to the patient, displays deficiencies in virtues, and opposes the central ethos of medicine. 1 for examples of senators and state representatives passing laws affecting lgbtq+ rights to protect religious liberties and fairness, see aclu. (2021). legislation affecting lgbtq rights across the country 2021. https://www.aclu.org/legislationaffecting-lgbtq-rights-across-country-2021 2 medical ethics and diversity act, ark. acts 462 §§17-80-501-06 (2021). https://www.arkleg.state.ar.us/acts/ftpdocument?path=%2facts%2f2021r%2fpublic%2f&file=462.pdf&ddbienniumsession= 2021%2f2021r 3 emergency medical care act, ark. a.c.a. § 20-9-309 4 ama. (n.d.) physician exercise of conscience. https://www.ama-assn.org/delivering-care/ethics/physician-exercise-conscience 5 u.s. department of health and human services (2021). your conscience rights. https://www.hhs.gov/conscience/conscienceprotections/index.html 6 aristotle. (1999). nicomachean ethics. (irwin, 2nd ed.). hackett publishing company, inc. 7aristotle. (1999). nicomachean ethics. (irwin, 2nd ed.). hackett publishing company, inc. 8 bain, l. e. (2018). revisiting the need for virtue in medical practice: a reflection upon the teaching of edmund pellegrino. philosophy, ethics, and humanities in medicine, 13(1), 4. https://doi.org/10.1186/s13010-018-0057-0 9 gardiner, p. (2003). a virtue ethics approach to moral dilemmas in medicine. journal of medical ethics, 29(5), 297-302. https://doi.org/10.1136/jme.29.5.297 10 toon, p. d. (1999). towards a philosophy of general practice: a study of the virtuous practitioner. occasional paper royal college of general practitioners, (78), iii-vii, 1-69. 11 shelp, e. e. e., & pellegrino, d. (1985). the virtuous physician and the ethics of medicine virtue and medicine explorations in the character of medicine, 17, 237-255. 12 savulescu, j. (2006). conscientious objection in medicine. bmj, 332(7536), 294-297. https://doi.org/10.1136/bmj.332.7536.294 13 stahl, r. y., & emanuel, e. j. (2017). physicians, not conscripts conscientious objection in health care. new england journal of medicine, 376(14), 1380-1385. https://doi.org/10.1056/nejmsb1612472 14 reis-dennis, s., & brummett, a. l. (2021). are conscientious objectors morally obligated to refer? journal of medical ethics, medethics-2020-107025. https://doi.org/10.1136/medethics-2020-107025 dinelli, conscientious objection based on patient identity, voices in bioethics, vol. 8 (2022) 5 15 acog. the limits of conscientious refusal in reproductive medicine. (n.d.). retrieved september 12, 2022, from https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2007/11/the-limits-of-conscientious-refusal-inreproductive-medicine 16 meanley, s., flores, d. d., listerud, l., chang, c. j., feinstein, b. a., & watson, r. j. (2021). the interplay of familial warmth and lgbtq+ specific family rejection on lgbtq+ adolescents' self-esteem. journal of adolescent health, 93, 40-52. https://doi.org/10.1016/j.adolescence.2021.10.002 ; ruben, m. a., livingston, n. a., berke, d. s., matza, a. r., & shipherd, j. c. (2019). lesbian, gay, bisexual, and transgender veterans' experiences of discrimination in health care and their relation to health outcomes: a pilot study examining the moderating role of provider communication. health equity, 3(1), 480-488. https://doi.org/10.1089/heq.2019.0069. ; sutter, m., & perrin, p. b. (2016). discrimination, mental health, and suicidal ideation among lgbtq people of color. journal of counseling psychology, 63(1), 98-105. https://doi.org/10.1037/cou0000126 https://doi.org/10.1016/j.adolescence.2021.10.002 https://doi.org/10.1089/heq.2019.0069 https://doi.org/10.1037/cou0000126 lee, don’t examine without me, voices in bioethics, vol. 6 (2020) *david lee, md, pg department of obstetrics and gynecology, beaumont health, royal oak, michigan © 2020 david lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. don’t examine without me – the role of the patient in learning pelvic exams david lee* keywords: gynecology, medical students, informed consent, bioethics introduction consent is indispensable to everyday society, enabling proper stewardship of people and resources whether used in general verbal communications or complex functions and transactions.1 in healthcare, a patient requesting treatment must provide informed consent, which is defined as “a process of communication whereby a patient is enabled to make an informed and voluntary decision about accepting or declining medical care.”2 informed consent can only be given once a patient fully understands all relevant details pertaining to the medical options at hand, recommendations on interventions, and the potential risks, benefits, and consequences.3 in reality some patients hardly think twice about what informed consent fully entails, what it allows, and what might call for detailed extra consent documents. it could be that they simply trust physicians to provide care and make relevant recommendations. patients in hospitals complete forms providing general consent to treatment upon registration and admission. they may also acknowledge on their forms that students from various professions (medical, nursing, physiotherapy, etc) may take part in their treatment. in teaching hospitals specifically, medical students are often entrusted with the responsibility of interviewing and examining patients, synthesizing differential diagnoses, and recommending lab and imaging tests to their clinical preceptors as part of their learning processes.4 they can learn, through their preceptors’ examples, how to empower patients in making informed decisions and how to balance evidence-based recommendations with each individual patient’s treatment preferences.5 by agreeing to work with students, patients not only enable teaching experiences to be incorporated within their own healthcare experiences, they also help guide students in growing into their roles as integral members of a patient’s care team.6 patients are protected by guidelines set by the joint commission on accreditation of healthcare organizations, and by tenets of biomedical ethics which include as basic principles the four pillars: autonomy, beneficence, nonmaleficence, and justice.7 the principle of autonomy dictates that patients have the right to accept a treatment plan as is, to request changes to the plan, and/or to decline care from any treatment programs, teams, or participating members including students. there may be instances where patients do not want students involved despite agreeing to work with them in other capacities. a particular scenario arises when care involves more intimate areas such as sexual health. patients may restrict who may do what, especially if the value of the exam or intervention seems unclear. lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 2 evolution of informed consent the concept of consent for treatment extends at least as far back to the ancient greek and byzantine empires.8 hippocrates and plato both suggested the importance of patient buy-in prior to conducting an intervention, despite the then-status quo of not inviting patient involvement. this was further developed by alexander the great who after being wounded on the battlefield expressed his understanding of his situation to his doctors and asked them to treat him.9 the middle ages largely continued previous attitudes about patient participation and consent in decisionmaking, and they shifted only minimally toward increased patient inclusion during the enlightenment period.10 today’s informed consent policy structure derives significantly from english common law surrounding assault which is commonly described as one individual threatening physical harm to another and battery which is one individual physically contacting another without permission. slater v baker & stapleton (1767) marked the first decision pertaining to informed consent in medicine, and further progress slowly continued through the nineteenth century.11 the twentieth century laid foundations addressing the medical battery component of informed consent through cases including mohr v. williams (1905), pratt v. davis (1906), rolater v strain (1913), and scholendorff v society of new york hospitals (1914).12 in scholendorff, chief justice cardozo notably established the need for consent and reinforced a patient’s right to self-determination. society’s expectations around consent were further stimulated in the post-nuremberg trial era. the case of salgo v. leland stanford jr university board of trustees (1957) formally marked the birth of the term “informed consent”.13 the process of informed consent was further refined through natanson v. kline (1960) which marked physician liability through negligence, cobbs v. grant (1972) which shifted the standard of disclosure from physician-based to patient-based, and canterbury v. spence (1972) which established a duty to disclose risks and the reasonable-person standard.14 together, they lend agency to the integral role of the four pillars of biomedical ethics in healthcare and guide the ongoing evolution of medical practice and medical education. at the intersection of sexual health and medical education whether a patient signing a general consent for treatment constitutes permission for students to perform pelvic exams for educational purposes is an ongoing debate. in general, the pelvic exam is a clinical skill and an indispensable component of a physical exam. this is especially important when a patient presents with a relevant chief complaint such as abnormal vaginal bleeding, pelvic pain, or ruptured membranes in pregnancy.15 normally, these patients possess decision-making capacity and are able to choose whether they consent to a medical student performing a pelvic exam under proper supervision. the student then uses patient and preceptor feedback to further guide their examination, including terminating an exam at the patient’s request. concern arises though when patients are incapacitated, or unable to provide or withdraw consent, such as when under anesthesia for a surgical procedure.16 patients have the right to voice their approval or disapproval of their care and generally have a say over who is on their care team and what functions they perform.17 however, medical students historically learned how to conduct pelvic exams by practicing on patients under anesthesia without their prior knowledge or approval.18 some of these sessions included students who may not have been part of the patient’s care team and patients whose surgical indications may not have warranted a pelvic exam under anesthesia.19 normally, physicians perform a pelvic exam under anesthesia prior to proceeding with a gynecologic surgery to understand the patient’s anatomy and assess for abnormalities. for generations of medical students, these patients were a crucial means of acquiring experience in performing pelvic exams and progressing toward being ready to help patients upon their graduation. however, the lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 3 lack of patient consent to an education-based exam rather than or in addition to a medically-indicated exam violates today’s informed consent standards and the principles guiding them. social change driving changes in society’s culture in response to how engrained educational pelvic exams under anesthesia were in medical education, women in the 1980s demanded additional consent requirements prior to undergoing educational pelvic exams in the operating room.20 they asserted that performing them without additional consent constituted physical assault. yet, the practice persisted even after the turn of the millennium: in the early 2000s medical students were still conducting educational pelvic and rectal exams without prior additional consent on anesthetized or unconscious patients.21 this fueled new efforts to address concerns through the legislative process. as a result, various states passed legislation with requirements for additional consent for pelvic exams performed under anesthesia.22 the association of american medical colleges (aamc) and the american college of obstetricians and gynecologists (acog) similarly emphasized that pelvic exams performed under anesthesia solely for educational purposes should only be done with a patient’s informed consent obtained beforehand.23 medical education programs responded to calls for change as well. additional simulation components were incorporated into undergraduate medical education curricula, and students now work with standardized patients who specialize in the instruction of sexual health exams in clinical simulation encounters to develop their confidence and competence.24 therefore, without any non-consensual patient interaction, students acquire necessary experience and a faculty-appraised skill set to perform examinations on their clinical rotations. yet, concern persists that educational pelvic exams done under anesthesia, regardless of consent, yield more educational value for the learner than diagnostic or therapeutic value for the patient. in response to this and other relevant concerns, society is witnessing an increasing number of blanket bans on student-conducted pelvic exams on anesthetized patients, regardless of patient consent. rather than support or participate in the development of these bans, healthcare and medical education should continue encouraging design of meaningful processes for obtaining informed consent that both respect the rights of the patient and continue opportunities for student involvement. balancing service versus education patients may perceive working with students as taking on more risk or burden without changes in their primary outcomes, i.e., their health status, despite enabling desirable secondary outcomes, i.e., further refining student skills to better serve future patients. another way of framing this is that exams performed by students provide little to no direct benefit to the patient in the course of their own recovery, and continuing to do them has ongoing potential for unnecessary physical and psychological harm. while emotional appeals can be made to patients that today’s doctors learned from yesterday’s patients and that teaching today’s students will benefit tomorrow’s patients, healthcare does not mandate them to do so to receive care. as a result, students may continue to be excluded from various components of their patients’ care in recognition of their preferences. this deference is supported by the american medical association (ama) code of medical ethics which opines that patient participation “in medical education is to the mutual benefit of patients and the health care system; nonetheless, patients’ (or surrogates’) refusal of care by a trainee should be respected in keeping with ethics guidance.”25 medical student opportunities for performing these exams are further limited by pelvic exam-related legislation as well. in some states, legislation even mandates not only medical students but surgeons as well to obtain specific informed consent prior to performing pelvic exams under anesthesia even when routinely indicated as part of a lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 4 surgical procedure.26 on one hand, this is a reflection of the law being purposed to err on the side of patients’ rights. on the other hand, the mandating of procedure-specific consent risks impeding delivery of quality and expedient patient care.27 for instance, if an alert and stable female patient in the emergency department is diagnosed with an unruptured ectopic pregnancy and elects for surgical management, normally, the physician performing the surgery will obtain consent from the patient to perform the recommended surgery. unless instructed otherwise, medical students on their team are expected to ask permission to be part of her surgery as well. they could reasonably request, with minimal additional difficulty, additional consent to perform an educational pelvic exam under anesthesia under the supervision of the operating physician. if the same patient presented altered and hemodynamically unstable, the physician would likely intervene through surgery under the premise of implied consent. a pelvic exam under anesthesia would similarly be performed prior to initiation of surgery for reasons as previously described. however, whether implied consent applies to medical students on the team to perform an educational pelvic exam under anesthesia is not clear. at least until medical and bioethical guidelines in this area are better defined, students should avoid participation in these circumstances. the road moving forward if medical students are expected to obtain additional consent from patients to perform pelvic exams for educational purposes, it is unclear whether they themselves would be expected to complete appropriate documentation with patients independently or under direct physician supervision. there may be novel legal risks that could impact cost of a medical school’s student liability insurance and, in effect, exacerbate the fiscal burden of an already costly medical school education. furthermore, if additional physician time is needed to supervise student acquisition of additional consent, there does not yet seem to be a clear solution to adapting existing workflows to promote both medical education and patient care without overburdening physician preceptor workloads. patient consent is essential to quality patient care. as suggested by hippocrates, plato, and alexander the great, a patient-physician relationship functions best when physicians pro-actively involve patients in the decision-making process.28 it is also well-established that patient buy-in positively impacts patient care and health outcomes. given the lessons learned through the evolution of tenets of biomedical ethics including the four pillars, it is incumbent upon students to consult patients beforehand for permission to perform educational physical exams under anesthesia. furthermore, the healthcare system should positively incentivize the implementation of protocols for obtaining patient consent for performing educational physical exams under anesthesia. this should be done even if legislation mandating this informed consent did not exist. doing so promotes both respect for the dignity and values of today’s patient and the quality and integrity of tomorrow’s physician. lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 5 references acog committee on ethics. “acog committee opinion no. 439: informed consent.” obstetrics & gynecology 114, no. 2, part 1 (2015): 401–8. https://doi.org/10.1097/aog.0b013e3181b48f7f. ———. “professional responsibilities in obstetric–gynecologic medical education and training.” international journal of gynaecology and obstetrics: the official organ of the international federation of gynaecology and obstetrics, june 2017. https://www.acog.org/clinical-guidance-and-publications/committee-opinions/committee-onethics/professional-responsibilities-in-obstetric-gynecologic-medical-education-and-training?ismobileset=false. ama council on ethical and judicial affairs. “ama code of medical ethics: chapter 1opinions on patient-physician relationships,” 2016. https://www.ama-assn.org/delivering-care/ethics/code-medical-ethics-patient-physicianrelationships. ———. “ama code of medical ethics: chapter 2opinions on consent, communication, and decision making,” 2016. https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/code-of-medical-ethics-chapter-2.pdf. american medical association. council on ethical and judicial affairs. ethics standards group. “ask the virtual ethicist. medical student involvement in patient care: report of the council on ethical and judicial affairs.” the virtual mentor : vm, march 2001, e2. http://www.ncbi.nlm.nih.gov/pubmed/15612132. american medical association. “h-320.951 ama opposition to ‘procedure-specific’ informed consent,” 2010. https://policysearch.ama-assn.org/policyfinder/detail/ama opposition to procedure-specific informed consent h320.951?uri=%2famadoc%2fhod.xml-0-2623.xml. bhoopatkar, harsh, andy wearn, and anna vnuk. “medical students’ experience of performing female pelvic examinations: opportunities and barriers.” the australian & new zealand journal of obstetrics & gynaecology 57, no. 5 (october 2017): 514–19. https://doi.org/10.1111/ajo.12634. bibby, j, n boyd, c w redman, and d m luesley. “consent for vaginal examination by students on anaesthetised patients.” lancet (london, england) 2, no. 8620 (november 12, 1988): 1150. http://www.ncbi.nlm.nih.gov/pubmed/2903370. bury, rg. plato laws. london: heinemann, 1926. california state legislature. ab-663 pelvic examinations (2003). http://leginfo.legislature.ca.gov/faces/billhistoryclient.xhtml?bill_id=200320040ab663. carson-stevens, andrew, myfanwy m. davies, rhiain jones, aiman d.pawan 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(1914). schniederjan, stephanie, and g kevin donovan. “ethics versus education: pelvic exams on anesthetized women.” the journal of the oklahoma state medical association 98, no. 8 (august 2005): 386–88. http://www.ncbi.nlm.nih.gov/pubmed/16206868. sedig, laura. “what’s the role of autonomy in patientand family-centered care when patients and family members don’t agree?” ama journal of ethics 18, no. 1 (january 1, 2016): 12–17. https://doi.org/10.1001/journalofethics.2016.18.1.ecas2-1601. silver-isenstadt, a, and p a ubel. “erosion in medical students’ attitudes about telling patients they are students.” journal of general internal medicine 14, no. 8 (august 1999): 481–87. http://www.ncbi.nlm.nih.gov/pubmed/10491232. lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 8 teunissen, pim w. “an inconvenient discussion.” medical education 52, no. 11 (2018): 1104–6. https://doi.org/10.1111/medu.13689. totura, christine m wienke, krista kutash, christa d labouliere, and marc s 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voices in bioethics, vol. 6 (2020) 9 1 ulrich et al., “everyday ethics: ethical issues and stress in nursing practice.”; haussen et al., “utilization of a smartphone platform for electronic informed consent in acute stroke trials.”; totura et al., “evaluating active parental consent procedures for school programming: addressing the sensitive topic of suicide prevention.” 2 acog committee on ethics, “acog committee opinion no. 439: informed consent.” 3 ama council on ethical and judicial affairs, “ama code of medical ethics: chapter 2opinions on consent, communication, and decision making”; weiner, “what ‘informed consent’ really means”; hall, prochazka, and fink, “informed consent for clinical treatment.” 4 uchida et al., “teaching the physical examination : a longitudinal strategy for tomorrow ’ s physicians.” 5 uchida et al., “resources used to teach the physical exam to preclerkship medical students : results of a national survey.” 6 ama council on ethical and judicial affairs, “ama code of medical ethics: chapter 2opinions on consent, communication, and decision making”; centers for medicare and medicaid services, “regulations and interpretive guidelines for hospitals.” 7 cohen et al., “the ethical implications of medical student involvement in the care and assessment of patients in teaching hospitals--informed consent from patients for student involvement. part i: a description of the origin and implementation of policies governing medi”; goldstein, “practice vs. privacy on pelvic exams”; mccormick, “principles of bioethics”; sedig, “what’s the role of autonomy in patientand family-centered care when patients and family members don’t agree?” 8 bury, plato laws; jones, hippocrates, vol ii. 9 lascaratos and dalla-vorgia, “defensive medicine: two historical cases.” 10 murray, “the history of informed consent.” 11 english reports, slater v baker & stapleton (95 eng. 860, k.b. 1767). 12 minnesota supreme court, mohr v williams 104 n.w. 12 (minn. 1905); pratt v. davis, 224 ill. 300, 79 n.e. 562 (1906); rolater v. strain, 39 okla. 572, 137 p. 96, 97 (1913); schloendorff v. society of new york hospital, 211 n.y. 125, 105 n.e. 92, 93 (1914). 13 salgo v. leland stanford jr. university board of trustees, 317 p.2d 170, 173 (1957); katz, “informed consent a fairy tale? law’s vision.” 14 natanson v. kline, 186 kan. 393, 350 p.2d 1093, 1095 (1960); cobbs v grant, 502 p.2d 1 (cal 1972); united states court of appeals, canterbury v. spence (464 f.2d. 772, 782 d.c. cir. 1972). 15 dugoff et al., “pelvic and breast examination skills curricula in united states medical schools : a survey of obstetrics and gynecology clerkship directors.” 16 american medical association. council on ethical and judicial affairs. ethics standards group, “ask the virtual ethicist. medical student involvement in patient care: report of the council on ethical and judicial affairs.” lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 10 17 ama council on ethical and judicial affairs, “ama code of medical ethics: chapter 1opinions on patientphysician relationships.” 18 walker, the origins of the history and physical examination. in: walker hk, hall wd, hurst jw, editors. clinical methods: the history, physical, and laboratory examinations. 3rd edition. boston: butterworths; 1990. chapter 1. 19 friesen, “educational pelvic exams on anesthetized women: why consent matters.” 20 bibby et al., “consent for vaginal examination by students on anaesthetised patients.” 21 goldstein, “practice vs. privacy on pelvic exams”; ubel, jepson, and silver-isenstadt, “don’t ask, don’t tell: a change in medical student attitudes after obstetrics/gynecology clerkships toward seeking consent for pelvic examinations on an anesthetized patient”; schniederjan and donovan, “ethics versus education: pelvic exams on anesthetized women.” 22 dube, “non-consensual pelvic exams”; oregon state legislature, ors 676.360 pelvic examinations; california state legislature, ab-663 pelvic examinations; hawaii state legislature, 453-18 pelvic examinations on anesthetized or unconscious female patients; virginia state legislature, 54.1-2959. supervised training programs; students enrolled in schools of medicine or chiropractic schools allowed to engage in certain activities; prohibition of unauthorized pelvic exams; iowa state legislature, 147.114 prior informed consent relative to pelvic examinations — patient under anesthesia or unconscious — penalties; mcday and coleman, s.b. 188 consent for medical procedure amendments; feldman, s.b. 0909 health care practitioners medical examinations on anesthetized or unconscious patients. 23 acog committee on ethics, “professional responsibilities in obstetric–gynecologic medical education and training”; weiner, “what ‘informed consent’ really means.” 24 wolfberg, “the patient as ally--learning the pelvic examination.”; pradhan et al., “evaluating pelvic examination training : does faculty involvement make a difference ? a randomized controlled trial evaluating pelvic examination training : does faculty involvement make a difference ? a randomized controlled trial”; nitsche et al., “effectiveness of labor cervical examination simulation in medical student education.”; dumont et al., “does an advanced pelvic simulation curriculum improve resident performance on a pediatric and adolescent gynecology focused objective structured clinical examination? a cohort study.” 25 ama council on ethical and judicial affairs, “ama code of medical ethics: chapter 1opinions on patientphysician relationships.” 26 dube, “non-consensual pelvic exams”; oregon state legislature, ors 676.360 pelvic examinations; california state legislature, ab-663 pelvic examinations; hawaii state legislature, 453-18 pelvic examinations on anesthetized or unconscious female patients; virginia state legislature, 54.1-2959. supervised training programs; students enrolled in schools of medicine or chiropractic schools allowed to engage in certain activities; prohibition of unauthorized pelvic exams; iowa state legislature, 147.114 prior informed consent relative to pelvic examinations — patient under anesthesia or unconscious — penalties; mcday and coleman, s.b. 188 consent for medical procedure amendments; feldman, s.b. 0909 health care practitioners medical examinations on anesthetized or unconscious patients. 27 american medical association, “h-320.951 ama opposition to ‘procedure-specific’ informed consent.” lee, don’t examine without me, voices in bioethics, vol. 6 (2020) 11 28 bibby et al., “consent for vaginal examination by students on anaesthetised patients.”; silver-isenstadt and ubel, “erosion in medical students’ attitudes about telling patients they are students.”; ubel and silver-isenstadt, “are patients willing to participate in medical education?”; wainberg et al., “teaching pelvic examinations under anaesthesia: what do women think?” disclaimer: the content herein solely represents the author’s viewpoint and not that of their residency program nor their affiliated academic institution. hawkins, crispr-cas9 genomic editing, voices in bioethics, vol. 2 (2016) © 2016 andrew hawkins. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. crispr-cas9 genomic editing is an ethical frontier: insert…backspace…delete… fix typo…cure disease andrew hawkins keywords: genetic ethics, crispr, gene editing, genomic technology introduction on february 1st, 2016, a team of scientists at the francis crick institute received approval from the uk human fertilization and embryology authority (hfea) to use crispr-cas9 to edit the genetic makeup of human embryos.1 this monumental “first” in biology opens a door that has been closed since the isolation of embryonic stem cells in 1998. according to sarah chan, a bioethicist at the university of edinburg, the approval sets precedent for how to regulate research and reproduction.2 this decision may also embolden scientists in the united states to call for a review of the nih stem cell guidelines that have largely remained unchanged since 2001. analysis for those new to the current debate, scientists in the field of synthetic biology have pioneered a novel method to cut and paste dna—microsoft word meets genetic engineering—known as crispr (clustered regularly interspaced short palindromic repeats)/cas (crispr-associated system). 3 these tools have a programmable binding module and a second domain responsible for cleaving the bonds between the adenine-cytosine-guanine-thymine bases in dna. this process creates breaks that allow for novel insertions and deletions to be introduced into the target genome, thereby enabling any scientist with a modern laboratory to make alterations. essentially, genes can be moved around, transferred from one organism to another, or knocked-out to study how they function within the cell. it is fast, cheap, and easy. the possible applications are endless. but what happens when we meddle with the source code of life? what are the unintended consequences of introducing artificial modifications to our species? crispr-cas coupled with the power of induced pluripotent stem cells (ipscs) provides researchers with the ability to model human disease in a dish in order to learn the underlying mechanism and how to reverse its progression. 4 a brilliant example of such application is the in-vitro modeling of rett syndrome, a rare and severe form of autism that affects only young girls. 5 in a single experiment, alysson muotri and his team displayed that tissue derived from patients all had a single genetic error that could be isolated as a therapeutic target. if these defects are edited via crispr -cas at the embryologic stage, children could be born without the devastating neurodevelopmental disease. this potentiality is not so far-fetched. as proof of concept, a chinese group published evidence of successful hawkins, crispr-cas9 genomic editing, voices in bioethics, vol. 2 (2016) 2 crispr/cas9-mediated gene editing in “non-viable” human embryos. 6 we are on the precipice of a fundamental shift in medicine. why must we be so cautious about genetic engineering? it seems irrational to deny access to a technology that has the potential to eliminate disease. when discussing the ethics of crispr/cas, it is important to differentiate clinical therapies that modify the genetic material of somatic cells and those that affect fertilized embryos. lanphier and colleagues, all of whom are involved in the genome-editing industry, have stated that “established methods, such as standard prenatal genetic diagnostics or in vitro fertilization (ivf),” are better options for parents who carry disease mutations. 7 furthermore, they assume that producing safe and reproducible outcomes for crispr-cas therapies will be a significant barrier to their adoption. this argument seems quite narrow given the dramatic advancements that have been made in recent years. there is no reason to believe that genetic engineering cannot be adapted for highly effective use in human embryos. it is only a matter of whether it is philosophically or ethically justifiable to do so.8 but many argue that once we decide to fix genetic aberrations we will continue down the “slippery slope” into making heritable enhancements. in a time of escalating health care costs and worsening public health due to diseases of excess such as diabetes and obesity, should we consider genetic editing of human embryos? according to recent obesity statistics, more than two-thirds of adults (68.2 percent) and approximately 30 percent of children and teenagers (ages 2 to 19) are either overweight or obese.9 the costs of obesity range from $147 billion to $210 billion per year in the united states and health care expenditures per capita are 42 percent higher for obese adults.10 in 2014, a team of researchers at the university of michigan published evidence that knockout of the sra gene associated with regulation adipose tissue mass and function had a protective effect against diet-induced obesity.11 if genetic engineering of human embryos were permissible, the economics of sra knockout as a preventative measure would be favorable in comparison to an investment in public health infrastructure and education resources to promote healthy habits.12 a philosophical dilemma, however, is introduced when we decide to quantify human life according to cost-benefit analyses. in the case of sra-knockout, a cost-effective germline “fix” underestimates the value of addressing the environmental causes of obesity (i.e. lack of proper nutrition and exercise). there are significant flaws in the logic supporting germline modifications, which are due to a lack of scientific evidence for genomic editing over multiple generations and limited philosophical inquiry on the subject. as with any new therapeutic, longitudinal data displaying safety and efficacy are required before governmental approval. in a recent article published in the american journal of bioethics, evitt et al. attempt to navigate these issues in their proposed regulatory framework for human germline crispr-cas modification by requiring institutional ethics approval, proven reversal mechanisms for gene edits, and rigorous testing in animal models before research proposals are funded. the authors concede, however, that the issue of informed consent in clinical trials of crispr germline therapeutics is tentative given that unborn children do not have a legal voice. another issue is the financial incentive insurance companies may provide to those who receive germline editing, which will unfortunately create further health disparity between parents of low socioeconomic status and those that can afford editing. the greatest danger is that we may not be able to reverse the changes made in a germline editing experiment unless we wish to prevent crispr children from reproducing or require them to edit out the errors made. since we, also, do not know whether eliminating rare mendelian diseases such as sicklecell anemia will have a negative effect on the fitness of our species, we cannot fully predict the outcome of gene elimination.13 will purging human imperfection actually leave us more vulnerable? conclusion hawkins, crispr-cas9 genomic editing, voices in bioethics, vol. 2 (2016) 3 in a joint statement released following the international summit on human gene editing held on december 1-3, 2015, in washington, d.c., the clinical use of germ line editing was regarded as an inappropriate use of crispr/cas9 technology. 14 this consensus, however, is by no means a final decision. the members of the summit concluded: “as scientific knowledge advances and societal views evolve, the clinical use of germline editing should be revisited on a regular basis.” the advent of genomic editing technology holds great promise for lifting the burden of disease from millions but it also produces ethical dilemmas that require further debate. no controversial technology of the past such as nuclear fission had the potential to change the physical makeup of who we are as humans. we must tread with caution as we venture into this grand experiment with evolution. a 3-d artist's rendering of the powerful genome editing tool, crispr/cas9. (stephen dixon) retrieved fromhttps://www.washingtonpost.com/news/speaking-ofscience/wp/2015/12/15/pluto-poop-and-the-perils-of-gene-editing-this-years-bestscience-stories/ 1 francis crick institute. 01 february 2016. “hfea approval for new “gene editing” techniques”. https://www.crick.ac.uk/news/science-news/2016/02/01/hfea-decision/ 2 callaway, e. (2016). “uk scientists gain licence to edit genes in human embryos”. nature, 530(7588), 18-18. 3 cong, l., ran, f. a., cox, d., lin, s., barretto, r., habib, n., … zhang, f. (2013). “multiplex genome engineering using crispr/cas systems”. science (new york, n.y.), 339(6121), 819–823. http://doi.org/10.1126/science.1231143 4 cai, m., & yang, y. (2014). “targeted genome editing tools for disease modeling and gene therapy”. current gene therapy, 14(1), 2-9. 5 marchetto, maria c. n. et al. “a model for neural development and treatment of rett syndrome using human induced pluripotent stem cells”. cell 143.4 (2010): 527–539. pmc. web. 1 mar. 2016. 6 liang, p., xu, y., zhang, x., ding, c., huang, r., zhang, z., ... & sun, y. (2015). “crispr/cas9-mediated gene editing in human tripronuclear zygotes”. protein & cell,6, 363-372. 7 lanphier, e., urnov, f., haecker, s. e., werner, m., & smolenski, j. (2015). "don't edit the human germ line".nature, 519(7544), 410. 8 see mali, p., l. yang, k. m. esvelt, j. aach, m. guell, j. e. dicarlo, j. e. norville, and g. m. church. 2013. “rna-guided human genome engineering via cas9”. science 339(6121): 823–86. 9 fryar dc, carroll md, ogden cl. “prevalence of overweight, obesity, and extreme obesity among adults: united states, 19601962 through 2011-2012”. national center for health statistics health e-stat. 2014. (accessed may 2015).; ogden cl, carroll md, kit bk, flegal km. "prevalence of obesity among adults: united states, 2011-2012". nchs data brief, 131, 2013. 10 cawley j and meyerhoefer c. “the medical care costs of obesity: an instrumental variables approach”. journal of health economics, 31(1): 219-230, 2012; and finkelstein, trogdon, cohen, et al. "annual medical spending attributable to obesity". health affairs, 2009.; finkelstein ea, trogdon jg, cohen jw, dietz w. “annual medical spending attributable to obesity: payerand service-specific estimates”. health affairs, 28(5): w822-831, 2009. 11 liu, s., sheng, l., miao, h., saunders, t. l., macdougald, o. a., koenig, r. j., & xu, b. (2014). “sra gen e knockout protects against diet-induced obesity and improves glucose tolerance”. the journal of biological chemistry, 289(19), 13000–13009. http://doi.org/10.1074/jbc.m114.564658 12 a crispr/cas9 sra knockout kit for mouse cells: ranges from $300 to about $1000. (santa cruz biotechnology http://datasheets.scbt.com/sc-423972.pdf). whole genome sequencing to ensure safety and that modification is only made at the target sequence: $1000 (illumina sequencing technologies, hayden, e. c. (2014). “the $1,000 genom e”. nature,507(7492), 294-5). average cost of in-vitro fertilization and pre-implantation diagnosis: $12,000-13,000. a conservative estimate of crispr/cas9 modification of human embryo is $15,000 and is equivalent to the 15-year incremental cost of overweight and obesity ($1023 per-person); tsai, a. g., williamson, d. f., & glick, h. a. (2011). “direct medical cost of overweight and obesity in the united states: a quantitative systematic review”. obesity reviews : an official journal of the international association for the study of obesity, 12(1), 50–61. http://doi.org/10.1111/j.1467-789x.2009.00708.x) 13 although it was previously thought to be exclusively detrimental, the sickle-cell trait has been preserved in the human gene pool due to its protective effect against malaria-associated mortality. aidoo m, terlouw dj, kolczak ms, mcelroy pd, ter kuile fo, kariuki s, nahlen bl, lal aa, udhayakumar v. “protective effects of the sickle cell gene against malaria morbidity and mortality”. lancet 2002; 359:1311-1312. https://www.washingtonpost.com/news/speaking-of-science/wp/2015/12/15/pluto-poop-and-the-perils-of-gene-editing-this-years-best-science-stories/ https://www.washingtonpost.com/news/speaking-of-science/wp/2015/12/15/pluto-poop-and-the-perils-of-gene-editing-this-years-best-science-stories/ https://www.washingtonpost.com/news/speaking-of-science/wp/2015/12/15/pluto-poop-and-the-perils-of-gene-editing-this-years-best-science-stories/ http://www.cdc.gov/nchs/data/hestat/obesity_adult_11_12/obesity_adult_11_12.htm#table3 http://www.cdc.gov/nchs/data/hestat/obesity_adult_11_12/obesity_adult_11_12.htm#table3 hawkins, crispr-cas9 genomic editing, voices in bioethics, vol. 2 (2016) 4 14 baltimore, d, baylis, f, berg, p. et al. (dec 3 2015). “on human gene editing: international summit statement”. national academy of sciences.http://www8.nationalacademies.org/onpinews/newsitem.aspx?recordid=12032015a introduction on february 1st, 2016, a team of scientists at the francis crick institute received approval from the uk human fertilization and embryology authority (hfea) to use crispr-cas9 to edit the genetic makeup of human embryos. this monumental “first” in bi... analysis conclusion reaves, sb-17: friend or folly?, voices in bioethics, vol. 4 (2018) *michael reaves © 2018 michael reaves. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. sb-17: friend or folly michael reaves keywords: healthcare, intellectual property, profit introduction rising health-care costs continue to crush consumer confidence in the american healthcare system. the prices of drugs and medical technology largely contribute to these increased overall costs. while the president has tweeted on the issue, claiming big pharma is “getting away with murder” with respect to their drug prices, only lackluster attempts to curb the problem of rising costs have been made.1 however, new requirements on price transparency have been gaining traction. california governor brown signed sb 17 into law in october 2017. analysis the law has three primary requirements. the first requirement impacts health insurers. all plans must justify premium hikes by listing any increases in the price of prescription drugs and medical technology. the second requirement mandates that manufacturers report to the government any drug that has increased in price over 16% within a three-year span. the final and most controversial of the requirements requires that a 60-day notice must be given by the firm in advance of a pricing hike if the second requirement is met. the goal is to alert insurance plans, consumers, and other pharmaceutical firms to the decisions by pharmaceutical firms who raise the market price of a given drug. supporters of the bill believe it will achieve a net benefit to consumers by making drugs accessible while keeping the market as transparent as possible. a state senator from california and the original author of the bill, ed hernandez, even boasted the legislation would be “a monumental achievement for the entire nation […] i believe health care is a human right, and that’s why i have dedicated my life to policies that make it more accessible and affordable for all californians. we must continue the fight against skyrocketing drug prices”.2 supporters often argue that drug companies attempt to hide price gouging practices by helping consumers with their co-payments or providing discounts to the uninsured while the aggregate costs rise. this legislation will address those claims by requiring the manufacturer to defend price increases by publicly stating their reasoning for price increases that meet the requirements of sb 17. opponents to the bill counter that demands for transparency are, for the most part, a useless exercise in bullying big pharma. as priscilla vanderveer, deputy vice president of public affairs at phrma, stated in an interview with drugtopics, “there is no evidence that sb 17 will lower drug costs for patients because it does not shed light on the large rebates and discounts insurance companies and pharmacy benefit managers are receiving”.3 this legislation will only apply to changes in the listing reaves, sb-17: friend or folly?, voices in bioethics, vol. 4 (2018) 2 price of drugs. the listing price is what wholesale buyers of drugs are paying, which often does not include the discounts and rebates that they may be given by the manufacturer to sweeten the deal. those working in large scale distribution can now more easily anticipate price rises and purchase more stock of drugs that are already in high demand. transparency allows wholesalers to more easily pass these hikes in cost down to the consumer as discounts are not required to be reported. a more sinister consequence of the law is the increased likelihood of price fixing among firms. sb 17 facilitates a strategic opening for firms to collaborate on price hikes. in such an open market where changes in price are announced two-months in advance under certain criteria, industry coordination is a serious threat to the integrity of the market. while these practices clearly violate the anti-trust laws of the united states, leaders in the industry will most certainly be looking at alterations in price strategy that the competition is taking. firms need not even directly communicate with each other to consider their next move, making price fixing a threat to what is an already broken pricing system. with no evidence of direct discussions of price-fixing, it would be extremely difficult to prosecute unethical behavior in an industry which often appears to have free reign on pricing. instead of focusing on band-aid solutions to this price problem, focusing on the root causes of price hikes may yield better results for consumers nationwide. the key to price reduction may lie in the patent laws which dictate a firm’s pricing strategy after receiving fda approval. when a firm comes out with a new patented device or drug, that firm must set a price that incorporates several overhead variables such as research, approval, and marketing costs. it may, therefore, be necessary to take a hard look at how our intellectual property laws contribute to rising costs in healthcare. the pharmaceutical industry develops new drugs and medical devices as a solution for a variety of illness and conditions. these goods are either considered “brand name” or “generic.” brand name drugs are discovered and developed by an innovator company, or the original company that created the drug’s molecular structure and paid the costs of research and development. under the current laws administered by the u.s. patent and trademark office, an innovator company has a monopoly hold on the good for 20 years via a patent, but that term is measured from the filing date of the patent application.4 this 20-year period includes the often-rigorous approval of the food and drug administration (fda) which can take close to a decade. consequently, this lengthy process can leave the innovator company with a limited window to manufacture, market, and sell the drug or medical device absent of competition. after this patent life expires, generic equivalents can be produced and sold by other companies such as the generic drugs that combat erectile dysfunction or hair loss.5 generic medication is a bioequivalent to the original brand name but is often cheaper and more accessible for consumers to obtain. before a company can sell a generic, they must file an “abbreviated new drug application” (anda) with the fda and a similar process of approval takes place. the innovator company will no longer hold a monopoly on the drug they originally produced, allowing other companies to obtain a market share of the good when the patent period expires. due to prior work by the innovator company in the development of a drug, companies producing generics need not spend much money on developing and introducing bioequivalent drugs into the market. the cost of manufacturing is the only significant expense that these firms incur. the profitability of these generics, therefore, is much less because the price point must be set lower due to competitive constraints imposed by the newly open market. the dysfunction in drug pricing arises out of this patent system that keeps drugs from entering the generic market for 20 years. the company will set the price of a drug or device at a level that maximizes profits to not only cover costs of failed drugs, but also to provide financial rewards for their employees, obtain capital for future investments, and please stockholders. as johnson and johnson’s reaves, sb-17: friend or folly?, voices in bioethics, vol. 4 (2018) 3 credo states: “we believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services […] we are responsible to the communities in which we live and work and to the world community as well [. . .] our final responsibility is to our stockholders. businesses must make a sound profit”.6 the average cost to win marketing approval from the federal government for a new drug is close to $2.9 billion.7 rising drug costs have been driven mainly by the increases in capital necessary to discover new drugs for chronic and degenerative diseases as well as increase clinical trial complexity. as a reaction to this expensive process, innovator companies decide to develop new drugs primarily based on the ability to recoup their investments and make a profit, not on what may help combat persistent chronic and degenerative diseases conclusion the current model of intellectual property law encourages profit-driven behaviors. adjusting u.s. patent law for pharmaceutical goods is a much more effective solution to incentivize innovation and to encourage ethical behavior than demanding transparency for price hikes. instead of allowing 20 years of patent life on a new drug or device from the point of filing, allow a pharmaceutical company to retain privilege or confidentiality of a drug’s molecular structure until after the fda gives its approval for consumption. this amended process can be broken into four steps. first, a new drug or device is discovered by an innovator company to have potential value and efficacy. second, the company interacts with the fda and the public is notified that they are reviewing the drug or device for a use without disclosure of details that would jeopardize privacy. the molecular structure or “blueprints” for the drug or device must be kept private until the approval process is completed. third, the fda checks the research data and approves of marketing the drug to specific patient populations, the patent will be issued and the countdown on patent life begins. fourth, the company then has 20 years to manufacture and sell the drug to approved populations only. firms will then have an appropriate window of time to be able to market and sell the drug at more appropriate prices. as their marketing window has expanded, prices reduce, and their base of consumers expands. with respect to the goals these lawmakers in california aspire to meet, sb 17 will not help the consumer’s wallet. it may, in-fact, make them more vulnerable to the profit-driven behavior of the industry. states should take note of the shortcomings of sb 17 before adopting so hastily a bill that may encourage unsavory consequences for the american consumer. representatives should seek to adopt policies that focus on fixing systematic problems that influence drug prices. 1humer, caroline and rodrigo campos. “trump says pharma 'getting away with murder,' stocks slide,” reuters, january 8, 2017, https://www.reuters.com/article/us-usa-trump-drugpricing/trump-says-pharma-getting-away-with-murder-stocks-slideiduskbn14v24j. 2 california senate. “release: senator hernandez’ sb 17 signed into law.” accessed april 10, 2018, http://sd22.senate.ca.gov/news/2017-10-09-release-senator-hernandez-sb-17-signed-law. 3 hamm, nicholas. “california passes controversial drug pricing bill.” last modified october 11, 2017. http://drugtopics.modernmedicine.com/drug-topics/news/california-passes-controversial-drug-pricing-bill. https://www.reuters.com/article/us-usa-trump-drugpricing/trump-says-pharma-getting-away-with-murder-stocks-slide-iduskbn14v24j https://www.reuters.com/article/us-usa-trump-drugpricing/trump-says-pharma-getting-away-with-murder-stocks-slide-iduskbn14v24j http://sd22.senate.ca.gov/news/2017-10-09-release-senator-hernandez-sb-17-signed-law http://drugtopics.modernmedicine.com/drug-topics/news/california-passes-controversial-drug-pricing-bill reaves, sb-17: friend or folly?, voices in bioethics, vol. 4 (2018) 4 4 united states food and drug administration. “drug development & approval process.” accessed april 10, 2018. http://www.fda.gov/drugs/developmentapprovalprocess/default.htm (accessed april 10, 2018) 5 hurley, adam. “hims: the company that wants to disrupt e.d. and hair growth pills.” last modified december 5, 2017. https://www.gq.com/story/subscription-boner-and-hair-growth-pills-hims. 6 johnson & johnson. “johnson & johnson credo.” accessed april 10, 2018. https://www.jnj.com/about-jnj/jnj-credo. 7 dimasi, joseph a., henry g. grabowski, ronald w. hansen. “innovation in the pharmaceutical industry: new estimates of r&d costs,” journal of health economics 47 (may 2016): 20-33. http://www.fda.gov/drugs/developmentapprovalprocess/default.htm https://www.gq.com/story/subscription-boner-and-hair-growth-pills-hims https://www.jnj.com/about-jnj/jnj-credo introduction analysis conclusion dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) * lachelle dufresne, mbs rowan graduate school of biomedical science © 2023 lachelle dufresne. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. pregnant prisoners in shackles lachelle dufresne* abstract shackling prisoners has been implemented as standard procedure when transporting prisoners in labor and during childbirth. this procedure ensures the protection of both the public and healthcare workers. however, the act of shackling pregnant prisoners violates the principles of ethics that physicians are supposed to uphold. this paper will explore how shackling pregnant prisoners violates the principle of justice and beneficence, making the practice unethical. keywords: prisoners, justice, beneficence, incarceration, discrimination, reproductive healthcare introduction some states allow shackling of incarcerated pregnant women during transport and while in the hospital for labor and delivery. currently, only 22 states have legislation prohibiting the shackling of pregnant women.1 although many states have anti-shackling laws prohibiting restraints, these laws also contain an “extraordinary circumstances” loophole.2 under this exception, officers shackle prisoners if they pose a flight risk, have any history of violence, and are a threat to themselves or others. 3 determining as to whether a prisoner is shackled is left solely to the correctional officer. 4 yet even state restrictions on shackling are often disregarded. in shackling pregnant prisoners during childbirth, officers and institutions are interfering with the ability of incarcerated women to have safe childbirth experiences and fair treatment. moreover, physicians cannot exercise various ethical duties as the law constrains them. in this article, i will discuss the physical and mental harms that result from the use of restraints under the backdrop of slavery and discrimination against women of color particularly. i argue that stereotypes feed into the phenomenon of shackling pregnant women, especially pregnant women of color. i further assert that shackling makes it difficult for medical professionals to be beneficent and promote justice. dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) 2 background female incarceration rates in the united states have been fast growing since the 1980s. 5 with a 498 percent increase in the female incarceration population between 1981 and 2021, the rates of pregnancy and childbirth by incarcerated people have also climbed. 6 , 7 in 2021, over 1.2 million women were incarcerated in the united states.8 an estimated 55,000 pregnant women are admitted to jails each year.9,10 many remain incarcerated throughout pregnancy and are transported to a hospital for labor and delivery. although the exact number of restrained pregnant inmates is unclear, a study found that 83 percent of hospital prenatal nurses reported that their incarcerated patients were shackled.11 i. harms caused by shackling shackling has caused many instances of physical and psychological harm. in the period before childbirth, shackled pregnant women are at high risk for falling.12 the restraints shift pregnant women’s center of gravity, and wrist restraints prevent them from breaking a fall, increasing the risk of falling on their stomach and harming the fetus.13 another aspect inhibited by using restraints is testing and treating pregnancy complications. delays in identifying and treating conditions such as hypertension, pre-eclampsia, appendicitis, kidney infection, preterm labor, and especially vaginal bleeding can threaten the lives of the mother and the fetus.14 during labor and delivery, shackling prevents methods of alleviating severe labor pains and giving birth.15 usually, physicians recommend that women in labor walk or assume various positions to relieve labor pains and accelerate labor.16 however, shackling prevents both solutions.17 shackling these women limits their mobility during labor, which may compromise the health of both the mother and the fetus. 18 tracy edwards, a former prisoner who filed a lawsuit for unlawful use of restraints during her pregnancy, was in labor for twelve hours. she was unable to move or adjust her position to lessen the pain and discomfort of labor.19 the shackles also left the skin on her ankles red and bruised. continued use of restraints also increases the risk of potentially life-threatening health issues associated with childbirth, such as blood clots.20 it is imperative that pregnant women get treated rapidly, especially with the unpredictability of labor. epidural administration can also become difficult, and in some cases, be denied due to the shackled woman’s inability to assume the proper position.21 time-sensitive medical care, including c-sections, could be delayed if permission from an officer is required, risking major health complications for both the fetus and the mother.22 after childbirth, shackling impedes the recovery process. shackling can result in post-delivery complications such as deep vein thrombosis.23 walking prevents such complications but is not an option for mothers shackled to their hospital beds.24 restraints also prevent bonding with the baby post-delivery and the safe handling of the baby while breast feeding.25 the use of restraints can also result in psychological harm. many prisoners feel as though care workers treat them like “animals,” with some women having multiple restraints at once— including ankles, wrists, and even waist restraints.26 benidalys rivera describes the feeling of embarrassment as she was walking while handcuffed, with nurses and patients looking on, “being in shackles, that make you be in stress…i about to have this baby, and i’m going to go back to jail. so it’s too much.” 27 depression among pregnant prisoners is highly prevalent. the stress of imprisonment and the anticipation of being separated from their child is often overwhelming for these mothers.28 the inhumane action has the potential to add more stress, dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) 3 anxiety, and sadness to the already emotionally demanding process of giving birth. shackling pregnant prisoners displays indifference to the medical needs of the prisoner.29 ii. safety as a pretense while public safety is an argument for using shackles, several factors make escape or violence extremely unlikely and even impossible. 30 for example, administering epidural anesthesia causes numbness and eliminates flight risk.31 although cited as the main reason for using shackles, public safety is likely just an excuse and not the main motivator for shackling prisoners. i argue that underlying the shackling exemplifies the idea that these women should not have become pregnant. the shackling reflects a distinct discrimination: the lawmakers allowing it perhaps thought that people guilty of crimes would make bad mothers. public safety is just a pretense. the language used to justify the use of restraint of shawanna nelson, the plaintiff in nelson v. correctional medical services, discussed below, included the word “aggressive.”32 in her case, there was no evidence that she posed any danger or was objectively aggressive. officer turnesky, who supervised nelson, testified that she never felt threatened by nelson.33 the lack of documented attempts of escape and violence from pregnant prisoners suggests that shackling for flight risk is a false pretense and perhaps merely based on stereotypes.34 in 2011, an amnesty international report noted that “around the usa, it is common for restraints to be used on sick and pregnant incarcerated women when they are transported to and kept in hospital, regardless of whether they have a history of violence (which only a minority have) and regardless of whether they have ever absconded or attempted to escape (which few women have).”35 in a 2020 survey of correctional officers in select midwestern prisons, 76 percent disagreed or strongly disagreed with restraining pregnant women during labor and delivery. 36 if a correctional officer shackles a pregnant prisoner, it is not because they pose a risk but because of a perception that they do. this mindset is attributed to select law enforcement, who have authority to use restraints. 37 in 2022, the tennessee legislature passed a bill prohibiting the use of restraints on pregnant inmates. however, legislators amended the bill due to the tennessee sherriff association’s belief that even pregnant inmates could pose a “threat.”38 subjecting all prisoners to the same “precautions” because a small percentage of individuals may pose such risks could reflect stereotyping or the assumption that all incarcerated people pose danger and flight risk. to quell the (unjustified) public safety concern, there are other options that do not cause physical or mental harm to pregnant women. for example, san francisco general hospital does not use shackles but has deputy sheriffs outside the pregnant women’s doors.39 iii. historical context and race a. slavery and post-civil war the treatment of female prisoners has striking similarities to that of enslaved women. originally, shackling of female slaves was a mechanism of control and dehumanization. 40 this enabled physical and sexual abuses. during the process of intentionally dehumanizing slaves to facilitate subordination, slave owners stripped slave women of their feminine identity.41 slave women were unable to exhibit the victorian model of “good mothering” and people thought they lacked maternal feelings for their children.42 in turn, societal perception defeminized slave women, and barred them from utilizing the protections of womanhood and motherhood. during the post-civil war era, black women were reversely depicted as sexually promiscuous and were arrested for prostitution more often than white women.43 in turn, society excluded black women; they were seen as lacking what the “acceptable and good” women had.44 some argue that the historical dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) 4 act of labeling black women sexually deviant influences today’s perception of black women and may lead to labeling them bad mothers.45 over two-thirds of incarcerated women are women of color.46 many reports document sexual violence and misconduct against prisoners over the years. 47 male guards have raped, sexually assaulted, and inappropriately touched female prisoners. some attribute the physical abuse of black female prisoners to their being depicted or stereotyped as “aggressive, deviant, and domineering.” 48 some expect black women to express stoicism and if they do not, people label them as dangerous, irresponsible, and aggressive.49 the treatment of these prisoners mirrors the historical oppression endured by black women during and following the era of slavery. the act of shackling incarcerated pregnant women extends the inhumane treatment of these women from the prison setting into the hospital. one prisoner stated that during her thirty-hour labor, while being shackled, she “felt like a farm animal.”50 another pregnant prisoner describes her treatment by a guard stating: “a female guard grabbed me by the hair and was making me get up. she was screaming: ‘b***h, get up.’ then she said, ‘that is what happens when you are a f***ing junkie. you shouldn’t be using drugs, or you wouldn’t be in here.”51 shackling goes beyond punishing by isolation from society – it is an additional punishment that is not justified. b. reproductive rights and “bad mothers” as with slaves not being seen as maternal, prisoners are not viewed as “real mothers.” a female prison guard said the following: “i’m a mother of two and i know what that impulse, that instinct, that mothering instinct feels like. it just takes over, you would never put your kids in harm’s way. . . . women in here lack that. something in their nature is not right, you know?”52 this comment implies that incarcerated women lack maternal instinct. they are not in line with the standards of what society accepts as a “woman” and “mother” and are thought to have abandoned their roles as caretakers in pursuit of deviant behaviors. without consideration of racial discrimination, poverty issues, trauma, and restricted access to the child right after delivery, these women are stereotyped as bad mothers simply because they are in prison. reminiscent of the treatment of female black bodies post-civil war and the use of reproductive interventions (for example, norplant and forced sterilization) in exchange for shorter sentences, i argue that shackles are a form of reproductive control. justification for the use of shackles even includes their use as a “punitive instrument to remind the prisoner of their punishment.”53 however, a prisoner’s pregnancy should have no relevance to their sentence. 54 using shackles demonstrates to prisoners that society tolerates childbirth but does not support it.55 the shackling is evidence that women are being punished “for bearing children, not for breaking the law.” 56 physicians and healthcare workers, as a result, are responsible for providing care for the delivery and rectifying any physical problems associated with the restraints. the issues that arise from the use of restraints place physicians in a position more complex than they experience with regular healthy pregnancies. dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) 5 c. discrimination in the case of ferguson v. city of charleston, a medical university subjected black woman to involuntary drug testing during pregnancy. in doing so, medical professionals collaborated with law enforcement to penalize black women for their use of drugs during pregnancy.57 the court held the drug tests were an unreasonable search and violated the fourth amendment. ferguson v. city of charleston further reveals an unjustified assumption: the medical and legal community seemed suspicious of black women and had perhaps predetermined them more likely to use drugs while pregnant. their fitness to become mothers needed to be proven, while wealthy, white women were presumed fit.58 the correctional community similarly denies pregnant prisoners’ medical attention. in the case of staten v. lackawanna county, an african american woman whose serious medical needs were treated indifferently by jail staff was forced to give birth in her cell.59 this woman was punished for being pregnant in prison through the withholding of medical attention and empathy. iv. failure to follow anti-shackling laws despite 22 states having laws against shackling pregnant prisoners, officers do not always follow these laws. in 2015, the correctional association of new york reported that of the 27 women who gave birth under state custody, officers shackled 23 women in violation of the anti-shackling laws.60 the lawyer of tracy edwards, an inmate who officers shackled unlawfully during her twelve-hour labor stated, “i don’t think we can assume that just because there’s a law passed, that’s automatically going to trickle down to the prison.”61 even with more restrictions on shackling, it may still occur, partly due to the stereotype that incarcerated women are aggressive and dangerous. v. constitutionality the eighth amendment protects people from cruel and unusual punishment. in brown vs. plata, the court stated, “prisoners retain the essence of human dignity inherent in all persons.”62 in several cases, the legal community has held shackling to be unconstitutional as it violates the eighth amendment unless specifically justified. in the case of nelson v. correctional medical services, a pregnant woman was shackled for 12 hours of labor with a brief respite while she pushed, then re-shackled. the shackling caused her physical and emotional pain, including intense cramping that could not be relieved due to positioning and her inability to get up to use a toilet.63 the court held that a clear security concern must justify shackling. the court cited a similar dc case and various precedents for using the eighth amendment to hold correctional facilities and hospitals accountable.64 an arkansas law similarly states that shackling must be justified by safety or risk of escape.65 if the thirteenth amendment applied to those convicted of crimes, shackling pregnant incarcerated people would be unconstitutional under that amendment as well as the eighth. in the civil rights cases, congress upheld the right “to enact all necessary and proper laws for the obliteration and prevention of slavery with all its badges and incidents.” 66 section two of the thirteenth amendment condemns any trace or acts comparable to that of slavery. shackling pregnant prisoners, stripping them of their dignity, and justification based on stereotypes all have origins in the treatment of black female slaves. viewed through the lens of the thirteenth amendment, the act of shackling would be unconstitutional. nonetheless, the thirteenth amendment explicitly excludes people convicted of a crime. dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) 6 vi. justice as a result of the unconstitutional nature of shackling, physicians should have a legal obligation, in addition to their ethical duty, to protect their patients. the principle of justice requires physicians to take a stand against the discriminatory treatment of their patients, even under the eye of law enforcement. 67 , 68 however, “badge and gun intimidation,” threats of noncompliance, and the fear of losing one’s license can impede a physician’s willingness to advocate for their patients. the american college of obstetricians and gynecologists (acog) finds the use of physical restraints interferes with the ability of clinicians to practice medicine safely. 69 acog, the american medical association, the national commission on correctional health care, and other organizations oppose using restraints on pregnant incarcerated people. 70 yet, legislators can adopt shackling laws without consultation with physicians. the acog argues that “state legislators are taking it upon themselves to define complex medical concepts without reference to medical evidence. some of the penalties [faced by obgyns] for violating these vague, unscientific laws include criminal sentences.”71 legislation that does not consider medical implications or discourages physicians’ input altogether is unjust. in nullifying the voice of a physician in matters pertaining to the patient’s treatment, physicians are prevented from fulfilling the principle of justice, making the act of shackling patients unethical. vii. principle of beneficence the principle of beneficence requires the prevention of harm, the removal of harm, and the promotion of good.72 beneficence demands the physician not only avoid harm but benefit patients and promote their welfare.73 the american board of internal medicine foundation states that physicians must work with other professionals to increase patient safety and improve the quality of care.74 in doing so, physicians can adequately treat patients with the goal of prevention and healing. it is difficult to do good when law enforcement imposes on doctors to work around shackles during labor and delivery. law enforcement leaves physicians and healthcare workers responsible not only to provide care for the delivery, but also rectify any ailments associated with the restraints. the issues arising from using restraints place physicians in a position more complex than they experience with other pregnancies. doctors cannot prevent the application of the shackles and can only request officers to take them off the patient.75 physicians who simply go along with shackling are arguably violating the principle of beneficence. however, for most, rather than violating the principle of beneficence overtly, physicians may simply have to compromise. given the intricate nature of the situation, physicians are tasked with minimizing potential harm to the best of their abilities while adhering to legal obligations.76 it is difficult to pin an ethics violation on the ones who do not like the shackles but are powerless to remove them. some do argue that this inability causes physicians to violate the principle of beneficence.77 however, promoting the well-being of their patients within the boundaries of the law limits their ability to exercise beneficence. for physicians to fulfill the principle of beneficence to the fullest capacity, they must have an influence on law. protocols and assessments on flight risks made solely by the officers and law enforcement currently undermine the physician’s expertise. these decisions do not consider the health and well-being of the pregnant woman. as a result, law supersedes the influence of medicine and health care. conclusion people expect physicians to uphold the four major principles of bioethics. however, their inability to override restraints compromises their ability to exercise beneficence. although pledging to enforce these ethical principles, physicians have little opportunity to influence anti-shackling legislation. instead of being dufresne, pregnant prisoners in shackles, voices in bioethics, vol. 9 (2023) 7 included in conversations regarding medical complexities, legislation silences their voices. policies must include the physician's voice as they affect their ability to treat patients. officers should not dismiss a physician's request to remove shackles from a woman if they are causing health complications. a woman's labor should not harm her or her fetus because the officer will not remove her shackles.78 a federal law could end shackling pregnant incarcerated people. because other options are available to ensure the safety of the public and the prisoner, there is no ethical justification for shackling pregnant prisoners. an incarcerated person is a human being and must be treated with dignity and respect. to safeguard the well-being of incarcerated women and the public, it is essential for advocates of individual rights to join forces with medical professionals to establish an all-encompassing solution. 1 ferszt, g. g., palmer, m., & mcgrane, c. 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(1999, march). “not part of my sentence” violations of the human rights of women in custody. amnesty international usa. retrieved march 12, 2023, from https://www.amnestyusa.org/reports/usa-not-part-of-mysentence-violations-of-the-human-rights-of-women-in-custody/ https://abimfoundation.org/what-we-do/physician-charter#:~:text=principle%20of%20social%20justice.&text=physicians%20should%20work%20actively%20to,or%20any%20other%20social%20category https://abimfoundation.org/what-we-do/physician-charter#:~:text=principle%20of%20social%20justice.&text=physicians%20should%20work%20actively%20to,or%20any%20other%20social%20category https://abimfoundation.org/what-we-do/physician-charter#:~:text=principle%20of%20social%20justice.&text=physicians%20should%20work%20actively%20to,or%20any%20other%20social%20category https://abimfoundation.org/what-we-do/physician-charter#:~:text=principle%20of%20social%20justice.&text=physicians%20should%20work%20actively%20to,or%20any%20other%20social%20category https://doi.org/10.1097/aog.0000000000004429 https://doi.org/10.1159/000509119 https://doi.org/10.7326/0003-4819-136-3-200202050-00012 galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) © 2016 elizabeth galt. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an interview with tom beauchamp, early bioethics innovator elizabeth galt abstract abstract— tom beauchamp, phd, has been a principle pioneer in the field of bioethics. in 1975, he was recruited by the newly formed national commission for the protection of human subjects of biomedical and behavioral research, where he wrote the bulk of the belmont report, the first federal document outlining the ethical principles and guidelines for research on human subjects. at seventy-six years of age, dr. beauchamp is professor of philosophy and senior research scholar at the georgetown kennedy school of ethics. he has authored many volumes on bioethics, and he continues to influence and contribute substantially to the field. what follows is an edited and condensed version of an interview between elizabeth galt and tom beauchamp. keywords: bioethics, four principles, the belmont report, interview, animal research ethics introduction tom beauchamp, phd, has been a principle pioneer in the field of bioethics. as a young philosophy professor at georgetown, he created the first applied ethics program in the united states. in 1975, he was recruited by the newly formed national commission for the protection of human subjects of biomedical and behavioral research, where he wrote the bulk of the belmont report, the first federal document outlining the ethical principles and guidelines for research on human subjects. dr. beauchamp and his collaborator, james childress, were the foremost exponents of ethical decision making known as “principlism.” in their seminal work, principles of biomedical ethics (1979), they laid out the guidelines of autonomy, beneficence, non-maleficence, and justice as the framework for bioethical evaluation. these were to serve as “action guides” to dictate the types of actions that are permitted, required, or prohibited in certain situations. the idea is that no one principle is, prima facie, ultimate or absolute. rather, biomedical ethical dilemmas are best resolved through the balancing and specification of the various principles in their application to clinical research situations. these principles continue to be the basis of bioethics today. at seventy-six years of age, dr. beauchamp is professor of philosophy and senior research scholar at the georgetown kennedy school of ethics. he has authored many volumes on bioethics, and he continues to influence and contribute substantially to the field. in 2004, dr. beauchamp received the lifetime achievement award from the american society of bioethics and humanities in recognition of his outstanding contributions and significant publications in bioethics and the humanities. galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 2 i had the pleasure of talking with dr. beauchamp recently. we covered a range of topics from his role in the belmont report to his more recent serious interest in animal research ethics. dr. beauchamp is a very articulate man, who speaks with passion about his life’s work. he talks poignantly about how the climate in america and the civil rights movement informed his work. he is also a man of warmth and compassion, evident in many moments during of our conversation. what follows is an edited and condensed version of what we shared. analysis q: can you tell me how you entered the field of bioethics? a: that question has a rather complicated answer. when i was an undergraduate, two fields attracted my attention. one was religious studies, hence the degree from yale, and the other was philosophy. finally, i had to choose between the two. like all other students, i was trying to figure out what my career path would be. i was struggling to see what i was going to do with my life. i was pretty sure i wanted to be a university professor. i was more attracted to the field of philosophy by virtue of its content and its scope than i was to religious studies. but i had a problem: i couldn’t understand philosophy. it was a field that had a wonderfully long and rich history of studying and discussing ethics more thoroughly, carefully, and analytically than any other field, but there was no application to the practical world. this was in the 1960s. at that time philosophers were not interested in normative ethics or applied ethics. applied ethics did not even really exist. this was bothersome to me, because one of the reasons i was attracted to religious studies was because that’s where my understanding of ethics had come from. maybe it would help to understand where my drive towards ethics began. i was quite interested in the civil rights movement. civil rights largely informed my desire to study ethics. i examined the little rock high school situation very carefully. i was in high school myself at the time. i was glued to the television. it was circumstances like that, going on all over america that really drove my interest. later, i myself would become involved in the movement. so, i had a dilemma: go into religious studies or to go into philosophy. and i chose to do something that was in between. there was a graduate program in the divinity school at yale. it was called teaching and research in religion. it allowed you to pursue whatever interest you had related to religion, and at the same time to take courses from any department in the graduate school. it was a highly unusual program. i’m not sure it exists anymore. but it was great for me at the time and it confirmed my view that my future was in philosophy. i decided to the extent that normative ethics deals with practical problems i would have to invent a curriculum around that field on my own. there was really no literature at the time. i made the decision in 1965 that i would go into philosophy. i would finish the program at yale, and get my phd in philosophy and i would find my way to a form of normative ethics. that turns out to have been a very good decision for a lot of reasons. q: so you were going into a field that you would need to invent to suit your needs? that was courageous… a: yes, i guess that’s true. i moved from yale to johns hopkins, which i went to primarily because hopkins had professors who were almost perfect for my other interests in philosophy. one of my major interests was and still is the history of philosophy. and there was a great history of philosophy tradition at hopkins. there was, however, no interest in normative ethics. and that is true today. i took more or less the kind of standard things that graduate students take in ethics courses. none of it was very normatively inclined, let alone running toward applied ethics. and as soon as i got out, and had my phd, i went to georgetown and i created a course called freedom and dissent. freedom and dissent was the first applied ethics course at georgetown. i put it together from nothing, because there really wasn’t anything on the basis of which to teach that course. galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 3 q: i know you were hired by georgetown, joining the philosophy department there. can you talk a little about your expansion into the kennedy school of ethics? a: at georgetown, i met a man who had been in my same yale program, leroy walters, although we had not know each other there. he was a few years behind me. leroy had been hired by andre hellegers at georgetown to start the kennedy institute of ethics. it was 1971. the institute was conceived as a center for the new field of bioethics. leroy walters and i got to know one another quite well and he introduced me to andre hellengers. this was just after andre had officially opened the doors at the kennedy institute. andre and i both worked on saturdays. most university professors did not, and we took to having lunch together. after a while, it became clear that andre was recruiting me. there were definite reasons he wanted me. i had the theology training, which he was deeply interested in, and i had philosophy training and i had graduate level work in both. i also had a tremendous interest in applied ethics. i was, so to speak, perfect for him. i was in the philosophy department at the time, so he recruited me away from the philosophy department offices, not away from the department. the philosophy department continued to be my home base, where i would have tenure. we continued to have our lunches on saturday, and andre became my tutor in bioethics. he was a physician by training. he talked about an enormous number of things that had bothered him in medicine for a long time. he believed that doctors were ill prepared for what was coming. he believed they had no idea of the number of ethical issues that were about to be dumped on their plate. and he was so right. in the early 70s there was very little evidence that people saw the ethical dilemmas coming in medicine. in fact, what did exist were largely ill-informed replies by physicians to legal cases, particularly around things like informed consent, which doctors really did not want. andre, fortunately, had a broader vision. and he was loading problems into me. and the line that he always took was that i knew ethics and he knew medicine. he told me that he would teach me about the problems and would look to me for the solutions. q: how did that progress in the early years? a: the truth is, we didn’t really know very much about how to solve problems in medicine. but we did know how to think ethically, meaning we knew how to deal with the literature and make ethical arguments. so i went to the kennedy institute with leroy, andre hellinger, roy branson, warren reich, and father richard mccormick. it was andre who put all of us together. q: was this around the time you got your call from michael yesley at the national commission? a: yes. michael yesley called me one day and asked me if i knew anything about the mandate of the national commission. patricia kane had been working with the commission and she was a colleague of mine in the law school. michael explained that the commission was working on ethical principles and needed people like me to inform them about each of the principles they wanted to know about. he told me the commission would like me to write a paper on justice. that was my initial contact with the commission. then, about six months later, after i wrote the paper, i got a call from stephen toulmin, who was the philosopher on staff, although he was really more like a consultant than a staff member. he had decided to go back to the university of chicago full time. he had been looking for the right person to take on the job of staff philosopher and consultant, and that was me, right? he had been calling around to people and asking whether they knew anyone with an interest in applied ethics and might be able to take the job. my name kept coming up. so he and michael yesley decided i was the person for the job. i don’t think they even asked the commissioners. i was a bit of an odd duck because there were still very few philosophers who were interested in applied ethics. the second day i was on the commission staff, michael called me into his office and said he wanted to talk to me about what i would be working on. strangely this had never been mentioned in the interview. galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 4 q: so you actually did not know that you would be framing the belmont report? a: no. michael called me into his office and told me that the commission had a document to write. at the time it was referred to as the belmont report. as you know, it was a response to the federal law that created the commission. he told me we were commissioned to surface and publish an account of the general principles of bioethics. actually, he did not use the term bioethics, because that word had just barely come into use. but i got the idea and he knew i got the idea. i remember saying to him, “what are these principles and what do they mean?” and he said, “well, the principles are respect for persons, justice, and beneficence.” and i said, “and exactly what does the commission mean by these principles?” and his answer was, “i think they’re looking to you to tell them that.” q: that must have taken you by surprise… a: yes. i was hired to tell them what the principles meant, which was pretty much exactly what happened. yesley told me they had about fifty pages of material that had been collected in a file by barbara mishkin. she was the associate director of the commission. she was a real workhorse at pushing things along. she had assembled all the material that had been recorded. the oddity of it is there was basically nothing about ethical principles in that material. yelsey and i were both quite surprised by this because that was the assignment. but that was the case. barbara mishkin told me if i was interested i could go back in the archives and probably find a large amount of the material that would have surfaced in the meeting books. over the course of the next six months, i threw away all fifty pages except for one short part, about four pages, which remained in the first section of the belmont report. the rest of it seemed to have nothing to do with ethical principles. i was on my own, writing the material. once i produced a draft, it went to the commissioners. over a period of time, i started getting feedback and that was helpful. q: i think there may be confusion about the connection between the belmont report and the work you and dr. childress did, which produced your extremely important book, principles of biomedical ethics. can you tell me about the distinction between the work you did for the commission and the work you did with dr. childress? a: that answer involves several different considerations. childress and i began our book well before i went to the commission. we were working primarily in clinical medicine. we had given lectures on the subject that we planned to turn into a book. the work we were doing was almost entirely on clinical medicine and public policy. we really didn’t know much about research ethics then, and there is a good reason for that because there wasn’t much written on research ethics. one exception was that jay katz had written a monumentally wonderful volume on experimentation with human beings. that did preexist both my work with jim and the national commission. our principles are not, as you know, the same as those of the commission. personally, i think we have a better set. i tried to convince the commission of that, actually, but was unsuccessful. the director of the commission told me explicitly they had already been through the principles; that part of the work was finished and they were not going to go back over it. they had formulated what the three principles were going to be, even though they had not yet been defined. i was just too late, so to speak, to have impact on expanding their vision of the principles. q: which work was completed first? a: both of these works, principles of biomedical ethicsand the belmont report, were finished in 1978. both were completed and went to their respective publishers. the publisher for the belmont report was not the government press, as is sometimes reported. in fact, we typeset it with lexitron. lexitron was the first basic word processor, a very crude computer. the report went directly from there to the government press and it was published instantly. jim’s and my book went to oxford university press galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 5 where it took a year to publish. if you look on the original publication ofthe belmont report, it was published late in 1978. so the concise answer is that this was all happening contemporaneously. all my work with the national commission and anything i was doing with jim insofar as it pertained to research ethics was done completely simultaneously, and one piece of work influenced the other. these works were like two ropes being intertwined. q: in the origins, goals, and core commitments of the belmont report and in the principles of biomedical ethics, you say that the principles were never intended to be a full moral system or theory, but a framework that is abstract and spare and that allows for a lot of interpretation. on balance, do you think the principles have been used in the way in which you intended? a: i think the answer is yes and no. let me try to put that into context. a lot of people who use the four principles don’t really know our work or the book. so, they don’t really know the argumentative structure out of which the principles come or the ways in which the principles are applied. it becomes a little bit like what irbs do when they look at federal regulations and they need to check off several things pertaining to these principles, insofar as they found a way into federal regulations. in any event, they don’t really understand the background of the work. and the result is that there really are two principlisms. you have the principlism that’s in our book, which really is a kind of -ism—that is to say, it’s a theory, and a framework of principles. and then you have what people see on the slide when somebody goes to a convention and says, “and here are the four principles.” and then they give a oneor twominute explanation of what the four principles are. q: so for some it has become more of a checklist? a: yes, i think some people really do use it as a checklist. so that part of it, i don’t think, has gone all that well. people who are knowledgeable about bioethics resent the way that kind of principlism works. i had a lengthy discussion at the international association of bioethics with a man from pakistan. he said, “look, we have to learn these principles in order to pass our medical exams. but what really happens is that nobody really knows what these principles imply. there’s no deep philosophical substructure at all.” and he seemed really pretty angry about it. and i said, “well, ok, just don’t be angry with me. i mean, if the people don’t read the book, i can’t be held responsible.” it is true, i think, that there are a lot of abuses in the use of these principles. many people in medicine and research don’t even know where they come from. q: however, no matter what else is said, the principles have held up for over thirty years as the world of medicine has changed tremendously. have you considered adding any new principles to address these rapid changes? a: we don’t take that view. we take the view that there’s a great need for more careful attention to how these four principles become specified. i don’t think we need another principle. the critical thing factor is how much you can get out of the principles we have defined. so we are constantly adding more clarity there. q: would you say that the search for further clarity in the principles has been your biggest professional challenge? a: yes, i think my greatest professional challenge or struggle has been the seven revisions that childress and i have been through. we’re undergoing another one now, so i’ll count it as seven. the eighth edition won’t be out for a couple years. but we are working on it. the biggest struggle has been galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 6 to realize where we were either wrong about something or have said it so badly that it has to be significantly recast. or we realize we need a new section on the book. a good example of that is global justice. we had basically conceived that principle in terms of accounts of justice that were state-oriented rather than globally oriented. so, that was a significant revision in the volume, and i think that made that chapter much better. we have had to struggle at one time with each of our chapters since 1979 to continually make them better. one of the reasons it was a significant struggle was that bioethics was being formulated as a field as we were making revisions to our book. i don’t mean our revisions changed the field. i mean the changes in the field changed the way we conceived what had to be done in the book. at this moment, i’d say the biggest challenge is in what is in chapter 10. for some years, there were only eight chapters. in chapter 10, we lay out our philosophical theory. it has been a tremendous challenge because we have been pushed the hardest there, particularly by philosophers, and especially by bernard gert and dan klauser. they pushed us for greater clarity. they pushed us because they thought we were wrong. we tried to explain why we did not think we were wrong. so, we had a lot of disagreements, but they were really good critics and exposed some big gaps. the biggest change in terms of content was that we came up with the theory of a common morality. we mentioned it in the third edition, and then we began to analyze it in the fourth edition, and have been working on it ever since. that has been the biggest struggle in terms of the nature of our theory. and it continues to be so. q: a few years ago, you received a lifetime achievement award from the hastings center, and in your acceptance speech, you talk about the conceptual distinction between research and practice. you felt that this has been somewhat overlooked and is becoming increasingly important. could you elaborate on that? a: i have been publishing fairly prolifically on this subject with a group i was only beginning to be associated with at the time i received the award. most of them were at johns hopkins, which, of course, is my graduate school. the connection was largely because my wife is the director of bioethics at the berman institute at hopkins. so, we formed a group and we have published a number of things about the research/practice distinction. the first two articles people really sat up and took notice of were in the hastings center report. they were back-to-back articles on different dimensions of this problem. the first question was how exactly to distinguish research from practice in various settings—and is it really a meaningful distinction anymore? the idea first arose with the national commission. i asked the commission why should there be review committees for research and not for practice. in these papers we are trying to show the great similarity between research and practice when it comes to the need for ethical review. and we found there was a major prejudice operating and the historical reason for the prejudice is fairly simple. doctors do not want to be regulated. if this kind of review were to begin to take place, they would need further regulation. this is not to say these reviews never happen in any institution. the hospital ethics committees usually deal with an issue once it has already become an issue. but to go into detail and have backup checks for ethics in clinical institutions is nowhere near what it is in research. and we think that has to change. when i was working on the belmont report i thought it was critically important. some bioethicists question why this did not come out of the national commission. the truth is we had many discussions within the commission about whether or not we needed to get into the regulation of medicine, given all the things that we had discussed. and we were thinking particularly, at this point, about risks, because risk/benefit, under the principle of beneficence, is an enormous consideration. obviously, informed consent was a major part of what the national commission had done. we were importing that problem into the clinical area and questioning whether there were significant problems of risks to patents. we wondered, for example, whether there is a similarly significant problem about informed consent. and the answer that we came to in the national commission was “yes.” so, now that we had come to that conclusion, the next thing is for us to propose the regulation of medicine. right? wrong? why not? because if we had proposed this to congress, to whom we were reporting, and to the department of health, education, and welfare, we knew they would have totally rejected it. and in rejecting it, they probably would have rejected everything that we had done over the course of the four years of work. we knew we would be considered nuts if we wanted to regulate medicine. so, we came to paradoxical but realistic conclusion. yes, we should regulate medicine. but no, we will not recommend that, because it would be our undoing if we did. in other words, it was political. q: i know you have now written quite a bit about informed consent in clinical medicine. is that your biggest concern? that informed consent is happening in an inconsistent and unregulated way in medicine? galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 7 a: i think in those articles that we published on the research/practice distinction, we surface a number of questions we think need to be resolved about informed consent. we think there is a deep lack of clarity there. we think the whole system should be restructured. this means not just the system with research, but the system with clinical practice, as well. we think you have an incoherent world out there. why in the world, given what we now know about risks in clinical practice, should clinical practice not be regulated and research be regulated? and why wouldn’t informed consent be looked at very, very carefully in terms of the forms that are given out, and the kind of explanations or disclosures that are made? why in the world should there be this difference? because there’s no difference in the level of risk. in fact, most of us now think, most of us who work in this area now think that clinical practice is much riskier than research. so we talk about the regulation of medicine. if you want a nicer term, the word that we used in those publications was oversight. we need to substantially change the view about what needs oversight in medicine. q: are there other aspects of the future of medicine that worry you? a: there’s no doubt in my mind that many of the technologies under development will come from pharmaceutical companies. pharmaceutical companies are private corporations, and they are global institutions. if you want to bring about the kind of reforms we’ve been talking about—reforms in the adequacy of informed consent as well as a framework for ethical oversight—that’s one place where it really needs to happen– in pharmaceutical companies. this has happened in one or two pharmaceutical companies. eli lilly, with whom i’ve worked, is one. we are going to have to try to figure out a way for pharmaceutical companies to ethically be doing the right thing, to be more in line with companies like eli lilly. and that has really not happened. q: what about pricing? a: pricing is another major issue. it is extremely difficult to understand how pricing is done. commissioners at the fda say they don’t understand it, and i know people at pharmaceutical companies who say they don’t understand it. and they mean they really don’t understand it. so that is another aspect that needs a lot of attention. and i don’t even see that beginning to happen yet. q: how do you think the landscape of bioethics has been transformed over the last, say, twenty years? and what does that mean for the way in which it will be transformed in the future? a: well, at the beginning, there were just a few people who were more or less in control of scholarly work on the normative side as well as actively involved in practical work. my colleague bob leach would fall in that category. he is an excellent example, i think, because he’s always been involved in both the theoretical and the practical side. these individuals tended to be mostly in philosophy and religious studies. there were people who had other interests as well. there were a handful of lawyers and i think bioethics is a natural for the law. a few doctors came into bioethics kicking and screaming at first, but they got it after a while, and they became very attracted to it. but the field has changed dramatically. after a while, the philosophers and the people in religious studies, and even the law, stopped being at the center of things. and those forming the largest the number were coming from medical institutions. so bioethics has been transformed very significantly over the last twenty years, in the direction of people in medical institutions being in control of what happens in the field. my view is it will no longer be the case that philosophers, religious studies people, lawyers, and so on, who are external to medical institutions, will have a big a role in shaping the field. the bioethics programs in those institutions are now operated by people who came out of training in medicine and public health. that is going to increase in the future. so i believe the field of bioethics is going to change very dramatically. there’s no predicting exactly what will occur. i believe that deans in medical schools, just to take one example, will assert their control over the kind of people who are hired in major bioethics positions. and philosophers and religious studies people will be a very distinct minority. that is the biggest change that is going to occur, in fact, has already begun to occur. galt, an interview with tom beauchamp early bioethics innovator, voices in bioethics, vol. 2 (2016) 8 a fairly good example of that is the university of chicago, where virtually all of the people in bioethics come from clinical medicine. but they did a nice thing for a while in chicago. they hired people who have double degrees, in philosophy and medicine. dan sulmasy, who is still there, is one of those with a double degree. but that is going to change, too, i think. there will always be a few people like me around, but it’s not going to be philosophers in control of these bioethics institutes for very much longer. q: philosophy is still a big part of the columbia bioethics program. perhaps we can affect universities to continue focusing on the discipline as an important part of the training. a: yes, i think that is part of the answer. in the masters programs in bioethics that have come around in the last twenty years or so, which you mentioned earlier, there are still a lot of philosophers involved. and that’s because, i believe, many people in bioethics are not trained in the philosophical material and perhaps are a little intimidated by what they’re expected to teach. they prefer to have a philosopher handle the ethical and theoretical side, which turns out to be pretty significant in the way many of these programs are structured. it wouldn’t surprise me if that continues to be the case over the short term. but the heads of these programs, the heads of the ethics institutes and think tanks, are no longer predominantly philosophers. q: i know that animal ethics has been a particular area of interest for you. in the oxford handbook of ethics and animals, you describe the work as a comprehensive, state-of-the-art presentation to the field, which was not possible until very recently. can you explain this? a: that particular work is in a philosophy series. and the reason we said that is because in philosophy, until very recently, there was no interest in the area of applied ethics for animal research among significant philosophers. i am talking about figures with big reputations in philosophy. the literature’s quite clear on this. these figures only started publishing on this topic in recent years. i am referring to people like chris korsgaard at harvard, who wrote a piece in the book. but, she has only been doing this for ten years or so, because there was no environment in philosophy before then. exactly how that environment was created is difficult to say. a lot of people would give big credit to peter singer, and i do, although most philosophers don’t agree with much of what he has to say. it would be mostly his pioneering efforts that made a difference. finally, we have philosophers who not only are looking at animals on the ethical side, but also on the cognitive side. they are coming from the cognitive sciences, or they are philosophers interested in the cognitive sciences. by 2008, we finally had a nucleus out of which this book could be done. all of the essays are completely original. i realized it could finally be done and we could have a comprehensive work by significant philosophers. that never happened before. i think a book by first-rate philosophers on what animal ethics is quite significant. to that extent, i’m really proud of it. conclusion q: dr. beauchamp, thank you so much for spending the time with me today. i think our readers will find your reflections on the history as well as the future of bioethics most interesting. a: you are most welcome. abstract introduction analysis conclusion burlile, bioethics poetry, voices in bioethics, vol. 5 (2019) * this piece of creative writing was originally published in writers without margins vol. 4. © 2019 andrew burlile. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. bioethics poetry "what writing is" andrew burlile* keywords: poetry, bioethics do you experience intense feelings of doom? overwhelming emotions? racing thoughts? if so then you may be eligible to participate in a two-week study on anti-anxiety medication overseen by the words are slight. sans-serif. nonthreatening, a dark grey font nearly indistinguishable from black printed on an off-white banner, placed carefully just above commuters’ heads on the t. i glance back from the ad to the other passengers. they pack closely together, standing, or sitting, either staring out the window or oscillating between their phone or book to the outside and back. a few sway with the car’s gravity. i sway with them. the t stops. we cluster to let more on. i felt bad for the woman who stood under my arm; i had showered, but i hadn’t washed my shirt in a week. the car jolts on. we all watch the trees roll up behind concrete as we descend into kenmore. underground the b-line sheds brownstone for a bright blackness. all you have to look at is your phone, or the darkness outside the window which reflects your own image. or the ads. i hadn’t seen this one before. i first noticed it when i got on in allston, where, next to me, with me, pushing into the trolley, others held up their wallets and flashed their charlie cards and i did the same knowing full well i didn’t have the fare if the driver were to ask me to come to the front. the ad continued. for participation you may be eligible for a cash compensation up to $300. up to. what made someone eligible for the full amount? to what would you need to agree? when i worked as a linguistic researcher at virginia tech, i took an irb certification course which forbade unethical practices, such as offering financial compensation that was “undeniable.” i make $11 hour. my net pay comes to perhaps $400 biweekly. not including tips. the same year i earned irb certification a friend of mine at another university, studying in one of the country’s top biomedical programs, called to ask my opinion about sperm donation. when i pressed him for a reason he responded that it’s “more enjoyable than donating plasma.” the b-line ends at park street. it doesn’t venture into the financial district. you won’t see anyone wearing suits on the b-line unless they got on at hynes (having taken from harvard the #1 bus – one: superlative, generative, capital). the green line intersects at park street with the red line, which veins all the way from alewife to braintree. for $2.25 you could observe the creep of gentrification from north to south, east to west. burlile, bioethics poetry, voices in bioethics, vol. 5 (2019) 2 was this ad for me? because it felt “undeniable.” $300 was grocery money for three months. or it was a fifth of one month’s rent. i did not come to boston impoverished. i came with savings. i came, i thought, ready for its challenges. but coming to boston is like riding the b-line. you get on in allston, riding through the gentrified grit of performative punk and you feel empowered by a diversity which feels comfortable to a white southern boy like you, because it’s diversity in moderation. the orthodox jewish neighborhood and the orthodox russian butcher, the korean barbecues and three starbucks are all a type of familiarity which affords a comfortable participation in gentrification under another umbrella term: “just getting by.” i joke at work that i’m not wealthy enough to have ethics. i can’t buy reusable bags. i moonlight in my head that i write a polemic about the microplastics found in oysters. op-eds for the globe. which lead to a book deal at knopf. a pen/faulkner. eventually a national book award. at the same time i imagine writing this piece i also imagine eating the oyster. relishing the brine. i like to know my oysters were bottom-feeders. but then the b-line slips out of allston and into boston, past the theatres of bu, by the sanctuary of the mfa you were not accepted into. the ramen place you’ve wanted to try but can’t afford. and then you descend into that lambent darkness. when the windows go dark, i won’t lie, i look at the reflections of others. i see others glance above my head. they linger. i linger on them. how they turn their whole bodies away from the banner. i know they’re also from allston by how they linger, as if they’re waiting for the change of stoplight to cross. after ending the call with my friend, who ultimately backed out of donating sperm, i looked up clinics nearby. one of them offered up to $1000 a month for regular donations. up to. a phrase that indicates potential, but with no promise of achieving it. it’s the american dream in a word. it’s also an idiom; what are you up to? (oh, just getting by.) lastly it’s an implication of collusion. up to something. the suspicion of artifice, of subterfuge, of clever misdirection. the very same sleight-of-hand i used to design the linguistic research project. irb protocol permitted outright equivocation to the participant so long as they were not harmed. and so long as the compensation was never undeniable. what is the threshold at which an offer becomes undeniable? at what price are we willing to sell our neurochemistry? what risks are we willing to incur? by advertising on the t – to those who can afford allston, but suffer it – the ad suggests those who can be bought are coming from allston, from roxbury, from forest hills. and that researchers know how to coerce them. is that what research is? the practice of displacing your own curiosity on the bodies of others. a type of voyeurism that is hypothetically consensual. another brand of gentrification. pretending to look out the window to look back at those around you. i write down the number. at the bottom of the ad, in a crimson banner, harvard medical printed their seal: ve ri tas. misra, on starting medical school, voices in bioethics, vol. 1 (2014-15) © 2015 priya misra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. on starting medical school priya misra keywords: medical school, mindset, self-reflection introduction when i first found out that i was accepted into medical school, i felt like i was on top of the world; i was overjoyed and extremely excited to pursue this rare and special opportunity. i didn’t think for one second of all the endless hours, personal changes, and emotional turbulence that would follow that 8.5 x 11 piece of paper that explained my fate. i figured that i worked hard in high school and undergrad and this would be just another step in my education. obviously, medical school would be difficult, but it’s just school—i had been studying my entire life, so how different could medical school actually be? analysis in your first semester of medical school, you are expected to take biochemistry and anatomy together. i still remember my first day of class: there i was, sitting in a biochemistry lecture with 120 other medical students. the class was structured very similar to a college course—there was a powerpoint presentation posted online for each lecture that contained all of the information you needed to know for the test. just study the powerpoints, and you will be fine. thankfully, i had taken a similar course in undergrad so i was confident that i already knew a lot of the information. this was going to be a piece of cake. i could have never been more wrong. within just one hour, my professor had reviewed almost everything i spent months learning in college. i spent so many hours trying to memorize this information, and he reviewed it like it was common knowledge. immediately i felt uneasy—i had assumed this first semester in medical school would be tough, but at least i had a cushion of knowledge from college that would help me transition. but all of that flew out the window when i realized that cushion only lasted for one day! and just like that, the true weight of medical school was finally starting to set in. to make matters worse, my next class was anatomy—now i felt completely confused because i had never studied human anatomy before, and i was already nervous about having to dissect a human corpse in order to learn the information. what if i fainted in front of everyone? do i really want to start off my career by embarrassing myself and proving i’m too weak for medicine? so there i sat, listening to the professor emphasize the importance of knowing and understanding anatomy regardless of what field of medicine each of us chose to pursue. he must have known that each of us was nervous about the lab portion of the class, so he reassured us by claiming it would take us “ten minutes” to misra, on starting medical school, voices in bioethics, vol. 1 (2014-15) 2 overcome the fear of dissecting a human body: “i promise you, after ten minutes you won’t even notice it anymore.” and with that, he simply moved on to teaching us the anatomy of the spine. i felt like i had just been dropped into the deep end of the pool and told to swim. it just seemed so ridiculous how he breezed over our emotions and acted like it was nothing to cut up a dead body. and then he just started teaching and quizzing us, expecting all of us to have read the information beforehand and already know it. wasn’t there going to be some grace period, some introduction to help me get my feet wet before just diving into the material? i looked at the clock: it was only 10:30 a.m. on the first day of medical school, and i already felt behind, lost, and confused. it finally hit me: i completely underestimated medical school. i was a fool to think it would be just another step in my career, and that the studying i had done in my life would be similar to the breadth of knowledge i would be expected to accumulate. i was no longer learning just to get by on an exam or to do well in school; whether or not i understood this material would determine my ability to treat patients in the future. as time went on, i slowly learned how to study and started accepting the dedication, hard work, and sacrifice that medical school demands. during my second semester, i applied to be on the committee of admissions, in which i would help interview new applicants for the school of medicine. during my interview, the dean of admissions had asked us all a question that i had never considered before: how will you deal with the fact and pressure that you are holding an individual’s life decision in your hands? before that moment, i had never thought that by interviewing someone for medical school i would be altering that person’s life. this was also the first moment that i realized that since the first day of medical school my life had been completely altered in ways that i never would have imagined. the more i reflected on my time in medicine thus far, the more i discovered how my personality and mindset had already changed. i realized that medical school is unlike anything else that an individual will do in her life. it’s not just another step in one’s education; it’s not just a “career path.” it is truly a life-altering decision. from the moment we enter medical school to the moment we become practicing physicians, and arguably even afterwards, our lives are completely planned and structured. we are no longer the people we used to be, and we have little time to develop into the people we would like to become. the mental and emotional switch that must occur within ourselves in order to be successful physicians isolates us from those outside of medicine. we will see and do things in our lives that very few in this world will ever get to do. under the hippocratic oath, we are obliged, even if against our moral will, to help those in need, whether or not they are our patients or if we are supposed to be working that hour; we are required to keep an open, unbiased, mind toward everyone we encounter. and we are doctors from the moment we enter medical school until the moment we retire. i won’t lie—there were times during my first year of medical school when i questioned whether this is truly what i want to do. i completely underestimated the time, money, and mental toll that this career choice would take on me. i thought about all of the extremely important family events that i was missing and would miss in the future as a doctor; i thought about the ways in which my life was already completely different than my friends’ who were the same age as me. i had no time to go out and meet people, and i had nothing to say to those who could never understand what i do and why i am so busy. i couldn’t look at people the same way; i had less patience than i did before, and even though i had only been in school for one year, i had a brand new definition for suffering, after seeing what so many patients had to endure. but what upset me more than this realization was the way that everyone around me was acting, as if they were totally okay with everything—why weren’t other students acknowledging that they too were unprepared for all of these changes? i knew i couldn’t be alone in my feelings, but if we are going to be in this together, why is no one else willing to admit that they too feel lost? misra, on starting medical school, voices in bioethics, vol. 1 (2014-15) 3 conclusion one of the most important things i have learned in medical school is that self-reflection is an amazing and vital tool for any successful physician. given the multitude of emotions that we experience every day, it is extremely important that we introspect and come to terms with what is happening around us. sometimes it is difficult, even embarrassing to admit how you are feeling when faced with the responsibilities of a medical student. no one likes to admit that they are lost or confused, especially when everyone around them refuses to do so. but in all reality, medical school is a journey, and more than the knowledge base, it forces us to multitask, teaches us how to process emotions, and instills in us the lifestyle and mentality required of a physician. for that reason, i have undertaken the complete documentation of my medical school experience. my personal endeavor is to explore and highlight the various experiences, transformations, and hardships unique to medical students, both inside and outside the realm of academics. my hope is that incoming, current, or aspiring medical students can read my work and feel prepared for what is coming ahead, and know that they are not alone in what they are feeling and experiencing. hopefully, my writing will spark similar reflection in my peers, heightening our personal development on this journey. there are so many things about school that i wish i had known before i started, and i hope that this can be an emotional guide for students, because choosing medicine is truly a lifestyle choice, not just a career. medical school is an amazing and bizarre experience; sometimes it’s great and sometimes you want to quit. however, i don’t know of too many other opportunities out there that will let you learn so much about yourself and the boundaries of human strength as medicine does. nevertheless, it is important to understand what is expected of you and what sacrifices you will have to make if you decide to become a doctor. i also believe it would be a shame if you simply pass through these four years of school, never once reflecting on the way it has changed you. even though there are mornings when i don’t want to get out of bed and face the hospital, at the end of the day i am always thankful for everything that this journey has offered me. ____________________________________________________________ bhoopatiraju, why jesuit universities should provide birth control, voices in bioethics, vol. 5 (2019) © 2019 sweta bhoopatiraju. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. why jesuit universities should provide contraception sweta bhoopatiraju keywords: jesuit, reproductive health, reproductive freedom, bioethics, contraception, discrimination introduction jesuit universities often espouse a goal of care for the entire person’s mind, body, and spirit. however, some jesuit institutions contradict this goal, since they do not currently provide contraceptives and birth control prescriptions for pregnancy prevention, and some do not provide contraceptive educational resources for students. despite the merits of some arguments that requiring jesuit universities to provide on-campus contraception violates religious freedom, jesuit universities should provide on-campus contraception. the high rates of unintended pregnancies in college-aged students, women’s generally positive perceptions of contraception, the need to combat discrimination against women, and women’s rights as detailed by international treatises all necessitate such a decision. analysis even though jesuit universities’ health insurance plans abide by the patient protection and affordable care act’s (ppaca’s) contraceptive mandate, which requires employers and health insurers to cover contraceptive costs within insurance plans, some universities’ policies prevent students from reaping the plan’s benefits on campus. these policies can be better understood through the example of saint louis university’s (slu) on-campus contraception policies, since slu is a jesuit university. for example, slu’s student health center claims to abide by “jesuit catholic beliefs regarding family planning” and does not provide contraceptives or prescription medication for pregnancy prevention. if a student wishes to receive birth control for pregnancy prevention, the person must obtain it off-campus. even if a student is interested in obtaining birth control off-campus, however, the person often cannot receive on-campus education on bhoopatiraju, why jesuit universities should provide birth control, voices in bioethics, vol. 5 (2019) 2 proper birth control use or options. for example, the slu wellness initiative is prohibited from providing information about contraception. by denying students on-campus access to contraceptive services, jesuit universities deny students full bodily autonomy and restrict their ability to act upon decisions they feel will enhance their bodily and mental health, both of which are central to core jesuit principles. unintended pregnancies are prevalent in college-aged women, constituting 58.5% of all pregnancies for women aged 20-24. college-aged women also have the highest rates of abortions (henshaw 1998). however, as access to contraceptives increased in recent years, unintended pregnancy rates declined, implying that increased contraceptive usage may play a role in successfully preventing pregnancies. one study concluded that to decrease the abortion rate, access to contraception should be promoted (henshaw 1998). the catholic background of jesuit universities sanctifies the life of the unborn and condemns abortion. pope francis, leader of the catholic church, stated that birth control, when compared to abortions, is “the lesser of two evils” and “not an absolute evil.” if jesuit universities seek to lower the abortion rate in their student populations, they should make contraception and more accessible to students. apart from easily accessible birth control, education on birth control is fundamental for effective use and lower unintended pregnancy and abortion rates. one study showed that 65% of unplanned pregnancies occurred when contraception was used. reasons for this included contraception misuse or failure to withdraw (bajos, leridon, goulard, oustry, & job-spira 2003). if university programs that are effective in their outreach, like the slu wellness initiative, provide education on birth control, then students might become aware of resources available to them so that they can make informed decisions about their bodies, curbing abortion rates. like all universities, jesuit universities have an obligation to serve the interests of their students and provide for their well-being. women, who university contraception policy disproportionately affects, generally share positive attitudes about contraception. women feel that bodily and reproductive control are important to some degree and should be available to women. this sentiment may explain why women report more benefits of condom use and costs of unprotected sex than vice versa (parsons, halkitis, bimbi, & borkowski 2000). also, students at universities whose college health centers provide emergency contraceptive pills (ecps) praised these services and expressed gratitude to the clinical staff, noting the convenience and inexpensiveness of the on-campus services. though it is true that sexually active female students are less likely to use contraception if they are religious, many religious college-aged women still feel that reproductive control is important to some degree and should be available to women. among religious female students, 48% chose abortions as a solution to an unwanted pregnancy (notzer, levran, mashiach, & soffer 1984). thus, allowing access to birth control will allow jesuit universities to better serve their students. even though jesuit universities’ catholic principles and ideals focus on serving the most vulnerable and marginalized communities, some on-campus contraception policies discriminate disproportionately against women and even more harshly against vulnerable groups of women, including those with disabilities. women with invisible and/or visible disabilities face difficulties when seeking contraceptive care and report a lack of access to health information. this lack of access can impact these women’s ability to obtain appropriate birth control, especially since they live in a culture that questions their sexuality, as well as their capacity and desire for sexual activity (kaplan 2006). additionally, people with disabilities face barriers, physical and otherwise, that make receiving contraception and information at farther off locations bhoopatiraju, why jesuit universities should provide birth control, voices in bioethics, vol. 5 (2019) 3 inconvenient. on-campus contraception, however, might make contraception more accessible and convenient for students. this policy would be less discriminatory towards students with disabilities. by not providing contraception on campus, universities also discriminate against women of lower socioeconomic status, many of whom are women are color. these women have a higher risk than others of contraceptive misuse and nonuse, since they are less likely to have received proper education of birth control options and methods and are less likely to have afforded and used contraception previously. they are also more likely to receive abortions. increasing access to and promoting long-acting reversible contraceptives, however, have been effective in lowering fertility and abortion rates among young women of low socioeconomic status (forrest 1994). the women involved in programs promoting contraceptive use expressed a higher level of well-being, noting improved ability to continue and complete their education and obtain jobs without having to care for children (forrest 1994). if jesuit universities wish to achieve their ideals and combat systemic disadvantages women of color and low socioeconomic status face in both higher education and the job market, they must provide resources like birth control and birth control education so that these women can reap the value of their education and better control their futures. providing contraceptives and contraceptive education also protects the religious freedoms of students who may not identify with the christian faith. jesuit universities are often diverse communities of people from different religious and nonreligious backgrounds. preventing easy access to birth control and appropriate education permits the more powerful administration to force its religious views onto less powerful students and deny them useful services they might have otherwise utilized. to truly embrace and serve their diverse student body, universities must protect the religious freedoms of its less powerful students and allow them to act according to their own beliefs in choosing to use or not use contraception (corbin & smith 2013). it does not suffice that some students seeking to obtain contraception have the means to obtain it offcampus and have costs covered by insurance. denying service to someone based on that person’s identity is humiliating, frustrating, and dehumanizing, all of which are characterizations of discrimination (lim & melling 2014). the remedy for this sort of injustice, then, is recognition rather than redistribution. in the context of jesuit universities’ contraception policy, women are discriminated against. refusal to provide contraception and educational resources through campus directives can be humiliating to the lifestyle choices of women, whose sexual and reproductive health needs have historically been neglected. instead of denying services on-campus and simply providing birth control elsewhere (a policy that stigmatizes a woman’s choice to use contraceptives by limiting its accessibility), universities must recognize the dignity in a woman’s choice to control her body and offer contraceptives on-campus. in considering the rights of vulnerable groups, it is also important to consider the conclusions of revered international organizations like the united nations. the united nations’ convention on the elimination of all forms of discrimination against women of 1979 and the united nations’ international conference on population and development of 1994 both responded to historical and systemic discrimination against women globally (shalev 2000). they identified women’s rights as human rights and stressed the importance of rights to easy access to contraception, access to health care and education, and rights to liberty and foundation of families (cook 1993). the refusal of some universities to not provide on-campus contraceptives for pregnancy prevention limits contraception accessibility and prohibits preventative family planning measures and contraceptive education, which are central to the united nations’ conclusions. thus, the historical and systemic discrimination against women is perpetuated through some jesuit universities’ refusal to provide on-campus contraception. bhoopatiraju, why jesuit universities should provide birth control, voices in bioethics, vol. 5 (2019) 4 additionally, while it is true that jesuit universities’ missions and goals are grounded in and shaped by jesuit principles and ideals, the institutions do not function primarily as a space for people to express their religion through community, as is done in houses of worship like churches and mosques. the university consists of students and staff from diverse religious (or nonreligious) backgrounds, and slu’s main purpose is to provide students with an education in exchange for their money. thus, jesuit universities arguably function more like corporations than houses of worship, and their religious freedom is not violated under the religious freedom and restoration act (rfra), a federal law that protects interests in religious freedom. this is because only individuals can have substantial burden of religious conscience (corbin & smith 2013). this interpretation is supported by the supreme court, which has repeatedly ruled that first amendment rights of corporations differ from those of humans. for example, even though the supreme court ruled in citizens united v. fec that the free speech clause protects corporate speech, it did so to affirm people’s right to hear all points of view regardless of source—not because corporations have a first amendment-protected right to speak (corbin & smith 2013). also, corporations and owners are separate legal entities, as ruled in cedric kushner promotions, ltd. v. king (corbin & smith 2013). this implies that the catholic founders of jesuit universities and the university itself are different legal entities, and that because of this, its founders cannot speak on behalf of the institution. the university’s rights are not the founders’ or administration’s rights. thus, because universities function less like houses of worship and more like corporations, which cannot experience substantial burden of religious conscience, accessibility to on-campus contraception does not violate religious freedom protected by the rfra. conclusion requiring on-campus accessibility to contraceptives and contraceptive education is necessary for jesuit universities to ensure that all students are treated fairly and that their needs are attended to. while it is true that some catholic beliefs clash with modern mainstream feminism, values like serving the most vulnerable populations and working towards the greater good, seem to connect well with feminism. as the catholic church slowly embraces increasingly modern interpretations of catholic theology, jesuit schools must reevaluate their commitments and policies and understand that the manifestation of the jesuit goal of care for the entire person can be different for everyone. bibliography bajos, nathalie, henri leridon, helene goulard, pascale oustry, nadine job-spira. “contraception: from accessibility to efficiency,” human reproduction 18, no. 5 (may 2003): 994-999 https://doi.org/10.1093. cook, rebecca. “international human rights and women's reproductive health,” studies in family planning 24, no. 2 (1993): 73-86. https://doi.org:10.2307/2939201. corbin, caroline mala and steven d. smith. “debate: the contraception mandate and religious freedom,” university of pennsylvania law review online 161, no. 261 (2013). forrest, jacqueline darroch. “epidemiology of unintended pregnancy and contraceptive use,” american journal of obstetrics & gynecology 170, no. 5 (1994): 1485-9. https://doi.org/10.1016/s0002-9378(12)91804-9. henshaw, stanley k. “unintended pregnancy in the united states,” family planning perspectives 30, no. 1 (1998): 24-29. kaplan, clair. “special issues in contraception: caring for women with disabilities,” journal of midwifery & women’s health 51, no. 6 (2006): 450-456. https://doi.org:10.2307/2939201 https://doi.org/10.1016/s0002-9378(12)91804-9 bhoopatiraju, why jesuit universities should provide birth control, voices in bioethics, vol. 5 (2019) 5 lim, marvin and louise melling. “inconvenience or indignity religious exemptions to public accommodations laws,” journal of law and policy 22, no. 2 (2014): 705-726. miller, laura. “emergency contraceptive pill (ecp) use and experiences at college health centers in the midatlantic united states: changes since ecp went over-the-counter,” journal of american college health 59, no. 8 (2001): 683689. notzer, notzer, david levran, shlomo mashiach, sarah sqffer. “effect of religiosity on sex attitudes, experience and contraception among university students,” journal of sex and marital therapy 10, no. 1 (2008): 57-62. https://doi.org/10.1080/00926238408405790. parsons, jeffrey, perry halkitis, david bimbi, thomas borkowski. “perceptions of the benefits and costs associated with condom use and unprotected sex among late adolescent college students,” journal of adolescence 23, no. 4 (2000): 377391. shalev, carmel. “rights to sexual and reproductive health: the icpd and the convention on the elimination of all forms of discrimination against women,” health and human rights 4, no. 2 (2000): 38-66. https://doi.org/10.2307/4065196. https://doi.org/10.1080/00926238408405790 beguš, the identity problem in prenatal testing, voices in bioethics, vol. 6 (2020) nina beguš, ph.d. candidate, department of comparative literature, harvard university © 2020 nina beguš. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “the identity problem” in prenatal testing nina beguš keywords: gattaca, prenatal testing, bioethics, enhancement, pgd, reproductive technology introduction geneticist you've already specified blue eyes, dark hair and fair skin. i have taken the liberty of eradicating any potentially prejudicial conditions – premature baldness, myopia, alcoholism and addictive susceptibility, propensity for violence and obesity – maria (interrupting, anxious) – we didn't want—diseases, yes. antonio (more diplomatic) we were wondering if we should leave some things to chance. geneticist (reassuring) beguš, the identity problem in prenatal testing, voices in bioethics, vol. 6 (2020) 2 you want to give your child the best possible start. believe me, we have enough imperfection built-in already. your child doesn't need any additional burdens. and keep in mind, this child is still you, simply the best of you. you could conceive naturally a thousand times and never get such a result.1 analysis few inventions in science and technology have not previously been imagined in film and literature. the scene from andrew niccol’s 1997 film gattaca reveals what i call “the identity problem”: the discomfort of the couple and the dissonance between them and the geneticist is palpable. maria and antonio naturally conceived their first child who was born with a heart defect, which is why they decided to take the in vitro fertilization (ivf) route with preimplantation genetic testing (pgd) for their second child. in the futuristic world of gattaca, ivf with pgd is an ordinary way of procreating. by conceiving their first son naturally, the couple went against the norm. have maria and antonio wronged their first son? the notorious nonidentity problem2 confirms harm if we account for the non-person affecting principle, which states that harm exists if a child is born when another child could have been born instead with better prospects.3 indeed, the life this couple had given their first son by default offers him less opportunities and more hardship, which is especially obvious in comparison to their second son. we could also argue they did not do harm if we assume that their first son, had he been conceived in vitro and tested before implanting, would likely not been chosen among the available embryos due to his heart defect. alternatively, the pregnancy might result in selective termination due to his prenatal testing results. in a futuristic scenario, his heart defect might be fixed before or during the pregnancy, which would ultimately eliminate the nonidentity paradox. it would not, however, eliminate the identity problem if the defect would be treated after the birth. prenatal information burdens patients and clinicians not only in science fiction and the real-world future—it is an issue they face today. when a prenatal test claims that an embryo or a fetus has a heart defect, spina bifida, short stature or eleven fingers, it crosses into a physician-patient discourse where at least five value systems meet: the patient’s, their partner’s, and the clinician’s, as well as that of the institution and wider society. in gattaca, the mainstream ethical values are obvious: the couple is able to choose superfluous features while the society, with the geneticist as its proxy, takes over to eliminate the undesirable ones. in the usa, it is widely believed that the right decision is made when the patient considers it right for themselves, as long as it does not harm anyone. not choosing against deafness or down’s syndrome is a controversial decision at the pgd stage of ivf (in the uk, for example, it is forbidden to transfer an embryo with known aneuploidy). physicians might view this choice as voting for non-health over health, thus going against the essence of medicine.4 it is in such cases where the borderline lies and where we need to listen to individual stories and contexts, many of which are find in fiction and nonfiction. beguš, the identity problem in prenatal testing, voices in bioethics, vol. 6 (2020) 3 i. a brief history of the identity problem the identity problem has existed even before the ultrasound first offered a peak into the uterus, revealing the sex and health status of the fetus. in a broader sense, it has been around at least since the idea of eugenics was discussed in fictional utopias, such as samuel butler’s erewhon: or, over the range (1872)5 and francis galton’s kantsaywhere (1910),6 both highly influenced by darwin’s ideas. yet, the identity problem grows larger and more obvious with advanced technology of prenatal diagnostic and screening tests as well as with assisted reproductive technologies. granted, people already make choices about their potential child’s genetic, cultural, and partly environmental characteristics when choosing their partner. yet, when these decisions are made in the realm of assisted reproductive technologies, they are much more rational and intentional – and sometimes agonizing. choosing a donor is a task that cannot be taken easily. the commercialization of sperm and eggs tells us that. for example, ivy league donors are paid better, even if everyone is aware this money is only buying a chance of the progeny being similar to the donor. another set of issues comes from the fact that these patients are disproportionally wealthy, white, and older, while donors and surrogates are all the contrary. various prenatal tests offer more certainty about the forming individual in vitro or in the uterus, but are, despite similar results, a target of vastly different levels of controversy. pgd and chromosome blood testing are such an example: they often reveal the same information on aneuploidies and sex of the embryo, but pgd gets more controversy while chromosome blood tests receive little reflection on their ramifications (see kaposy).7 from the ethical perspective, prenatal blood tests often result in heavier consequences for the patients. chromosome blood testing takes place at the end of the first trimester of pregnancy and prospective parents, who opt to terminate a previously wanted pregnancy, must undergo an abortion. pgd, on the other hand, takes place days before the embryo is ready to implant in the womb, at the point when the woman is not actually pregnant yet. by virtue of pgd, a three-day-old embryo can have its identity revealed, in some aspects, more clearly than that of a child or even adult whose genetic predispositions show up only through the course of life or, perhaps, never at all. such embryos can be identified as female or male, abled or disabled, blue, brown, or green-eyed, right and wrong. new tests open new ethical questions. we will soon be able to point out other relevant and irrelevant genetic factors as well, for example, later-onset diseases, such as brca1 and 2 mutations which greatly increase the risk of developing certain types of cancer later in life.8 ii. what does literature say about prenatal tests? beguš, the identity problem in prenatal testing, voices in bioethics, vol. 6 (2020) 4 a technology similar to pgd was depicted in aldous huxley’s brave new world (1932), a satirical novel that never really went out of style. in the hatchery, a factory in which all human beings are created via technology similar to a combination of ivf and artificial wombs, each embryonic and fetal information chart is labeled with information of “[h]eredity, date of fertilization, membership of bokanovsky group [a caste].” the narrator makes an argument that the knowledge of fetal characteristics makes the prospective human “[n]o longer anonymous, but named, identified”.9 information about their identity alleviates the human, individual, and personal statuses of these embryos and fetuses: it might be a fetus, but we also know that she is a female with perfect pitch who will experience an early onset of alzheimer’s disease. we thus estimate and evaluate the individual’s identity and future on the basis of their genes. like huxley, i argue that there is a profound difference in our relationship to an embryo or a fetus that is a blank slate vs. an embryo with identity markers of medical prognostics. “even queer theorists are sobered to learn the sex of an embryo,” writes andrea long chu, queer theorist and transwoman.10 another issue with sex selection is that embryos of transgender people can, so far, render only their sex but not gender; it is not difficult to imagine consequences if studies examining transgender genetics prove fruitful for prenatal testing. no information is simple and straightforward in prenatal life, not even the sex, as widely attested by sexual discrimination against female fetuses in many cultures. ivf allows, by the mere protocol of the technology, for a manipulation of the birth and sex orders of potential siblings. while this choice may simply be a collateral luxury secondary to treatment (such as the physical features maria and antonio chose via pgd) and possibly the last thing on the mind of patients suffering the pain of infertility, this is not the case for everyone. those willing to undergo ivf with pgd, and can afford it, are able to choose from a growing repertoire of features. where to draw the line, then? “diseases, yes,” says maria, unaware of the many repercussions of her simple answer. authors of genetic utopias imagine a world without any pathology or diversity. maria and antonio’s first child exhibits extreme will and ability by (illegally) penetrating into the group of genetically modified people. on the contrary, some genetically superior people in gattaca as well as brave new world fail at genetically conditioned prospering or have unexpected health issues. the only guarantee these two dystopias offer is that the world will get grimmer and more stratified, more scientific and superficial – overall, less of what makes us human. the suffering and harm are still there, in a different form. humans are there in a different form. principles of beneficence and non-maleficence serve a noble goal, but not all suffering and harm is to be alleviated at the stage of prenatal life. there are better ways of dealing with deafness and some types of heart defects after, rather than before, birth and as technology progresses, there will always be newer and better solutions at all stages. in vitro gene editing is developing faster than predicted, eliminating undesirable conditions from an already-identified embryonic or fetal individual. ivf thus serves at least two roles: treatment of prospective parents’ infertility (as restitution ad integrum) and selection (and potential treatment) of prospective children’s genetics (as transformation ad optimum, an access point of the man-led evolution). conclusion the quest for perfection is in human nature. all the same, the very essence of human nature is diversity and pathology (diseases, yes). pathology, per george canguilhem,11 is not a deviance of the norm, but rather a beguš, the identity problem in prenatal testing, voices in bioethics, vol. 6 (2020) 5 different kind of norm. in octavia butler’s lilith’s brood: the xenogenesis trilogy (1987-89),12 every genetic anomaly is treated. yet, humanity is doomed due to a human contradiction—a lethal combination of “intelligence at the service of hierarchical behavior” that is essential for our species.13 in the buzzing biotechnological (r)evolution we are undergoing, we should turn to fictional and (auto)biographical narratives before we make any decisions on behalf of other human beings, nascent or not. 1 gattaca, dvd, directed by andrew niccol (1997 jersey films), dvd. 2 first devised by derek parfit in reasons and persons (oxford: clarendon press, 1987). 3 buchanan, a., d. brock, n. daniels and d. wikler, from chance to choice: genetics and justice (cambridge: cambridge university press, 2000). 4 galarneau, charlotte, “many ‘ways of looking’: physician refusal of embryo transfer” (harvard medical school bioethics journal summer 2019) accessed sep 13, 2019. bioethicsjournal.hms.harvard.edu/summer-2019/many-“ways-looking”-physician-refusal-embryo-transfer 5 butler, samuel, erewhon: or, over the range (london: trübner, 1872). 6 galton, francis, the eugenic college of kantsaywhere 1910. (digitized by university college london, 1996.) 7 kaposy, chris, choosing down’s syndrome: ethics and new prenatal testing techniques (cambridge: the mit press, 2018). 8 robertson, j. a., ‘extending preimplantation genetic diagnosis: medical and non-medical uses’ (journal of medical ethics 29/4 (2003): 213-216), 214. 9 huxley, aldous, ‘brave new world,’ brave new world and brave new world revisited. (new york: harper collins, 2004), 20-21. 10 chu, andrea long, ‘extreme pregnancy’ once and future feminist (boston review forum), (ed. merve emre, cambridge, ma: the mit press, 2018, 66-79), 67. 11 canguilhem, georges, knowledge of life [la connaisance de la vie], tran. paola marrati, todd meyers. (new york: fordham university press, 2018). 12 butler, octavia, dawn. (new york: warner books, 1987.) adulthood rites. (new york: warner books 1988.) imago. (new york: warner books, 1989). 13 butler, octavia, adulthood rites (new york: warner books 1988), 467. http://bioethicsjournal.hms.harvard.edu/summer-2019/many-%e2%80%9cways-looking%e2%80%9d-physician-refusal-embryo-transfer cohen, why we should care that men die first, voices in bioethics, vol. 4 (2018) * jennifer cohen, jd. © 2018 jennifer cohen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. time’s up: why we should care that men die firsts jennifer cohen* introduction for hundreds of years, mortality rates have been the single most relevant indicator of the public’s health. happily, the modern age has ushered in a life expectancy that could not have been imagined by our forebears. from the emergence of homo sapiens as a species some tens of thousands of years ago to the early 1800s, human life expectancy barely budged. for most members of our fragile species, living for 30-40 years was the most we could hope for. then the modern age introduced a number of public health measures such as vaccination, safer and healthier foods, and control of infectious diseases1 and our life expectancy nearly doubled, with a six-year gain just since 1990.2 now most of us can count on living out what the bible promised: threescore and ten to fourscore, i.e. 70-80 years3,4. if mortality rates are evidence of the public’s health, the extension of the human lifespan by decades means the human species has broken through what had seemed an impenetrable ceiling. but a stubborn obstacle remains for nearly half the species: men die before women. keywords: gender, mortality, life expectancy, male, female, men, women analysis men die before women in every culture across the globe, but understanding why that pattern persists has proven difficult. the current focus in public health on the role of social determinants in health outcomes faces a compelling challenge with respect to the lifespan gap as the consistency of the data is striking: women significantly outlive men in every culture regardless of wealth, race, or geography, and have done so since the beginning of record-keeping. higher mortality rates for males exist even in premature babies and in other primates5,6. researchers state definitively that “a robust, often underappreciated, feature of human biology is that women live longer than men not just in technologically advanced, low-mortality countries such as those in europe or north america, but across low-and high-mortality countries of the modern world as well as through history”.7 the example of sweden is instructive: in 1800, life expectancy was 33 years for women and 31 years for men. in 2016, the advantage for women persists; women live on average 83.5 years while men live on average 79.5 years.8 at both historical moments, women live approximately 5% longer than men. women are not living longer because they are immune from certain diseases that afflict men: women die at lower rates than men from virtually all the most common causes of death, except for alzheimer’s disease.9 despite the definitive documentation of the longevity gap, there is no conclusive argument to explain its existence. theories include that high numbers of men die in war, as victims of violence, or through risky behaviors; male genetics are more prone to malfunction; the larger size of cohen, why we should care that men die first, voices in bioethics, vol. 4 (2018) 2 most males accumulate more wear and tear, compounded by the higher amounts of testosterone and lower levels of estrogen; and finally, the “jogging heart” of a menstruating woman provides more cardiovascular benefit.10 the bottom line is that we don’t know why men die before women, only that it is treated as an inevitable fact that they do. but is this fact an ethical concern? i argue that it is and that the bioethical principles of beneficence, non-maleficence and justice call for more attention and research into this issue. any consistently unequal health outcome demands ethical analysis. just as unequal rates of tuberculosis and hiv infection in a population require bioethicists and public health advocates to question research priorities, the lifespan gap between men and women should sound ethical alarms. underlying the fundamental bioethical principles of beneficence and non-maleficence is the understanding that more life is a basic good and less life is generally a harm. one may argue that the true measure of health is quality of life rather than quantity of life, and indeed every effort should be made to maintain a good quality of life for the time one is alive. but there is no quality of life if one is dead, and most people strive to stave off death as long as possible, even if that means a diminished quality of life. a commitment to the principles of beneficence and non-maleficence in our society therefore demands attention to the relatively reduced lifespan of men. the application of the bioethical principle of justice to this issue is also worthy of consideration. admittedly, justice is usually interpreted to mean equal treatment to patients in similar situations rather than a guarantee of equal health outcomes, but certainly the principle of justice means that equal outcomes should be a goal. fewer years of life is a burden that men around the world suffer and shortening the lifespan gap is a global health goal consistent with the principle of justice. as discussed above, research has documented the reduced lifespan of men and generated a number of theories as to why men die before women, but very little research has been conducted with the express aim of reducing the lifespan gap (a review of clinicaltrials.gov found no research on reducing the lifespan gap between the sexes).11,12 this is unfortunate given that beneficence, nonmaleficence and justice suggest that this problem should be taken more seriously. admittedly, while i have not found a significant body of researchers attending to this issue, i also have not come across arguments against reducing the lifespan gap. nevertheless, a number of counter-arguments could be raised. conclusion the paucity of research into closing the lifespan gap may be a result of legitimate concerns for other pressing global health problems. many may argue that historically men have been the primary beneficiaries of much of medical research and that funding priorities for research are more appropriately directed toward women and children’s health than extending male lives. for example, although women live longer than men, women’s health globally is poorer throughout their lives13; therefore funding priorities directed toward improving women’s health rather than extending male lifespan is appropriate. similarly, many might argue that reducing child mortality is a more pressing goal. over 11 million children die each year, most from preventable causes.14 these deaths at the beginning of life are particularly horrible because they represent lost lifetimes of productive, healthy lives, not just a few years at the end of life. while there are certainly compelling arguments for improving women’s health and reducing children’s mortality, that does not mean that the lifespan gap should be overlooked or accepted as inevitable. finally, some, such as daniel callahan or ezekiel emmanuel, argue that the elderly will put an unsustainable strain on resources15,16. but such an argument starts down a treacherous, slippery slope: if people should not live as long as they can, why cohen, why we should care that men die first, voices in bioethics, vol. 4 (2018) 3 not bring back smoking, or eliminate funding for treating diseases of the elderly such as parkinson’s or alzheimer’s? none of these arguments are persuasive for continuing to accept the lifespan gap as an unfortunate fact that men must stoically accept. it’s time to move this global disparity up to the forefront of our concerns. 1 “ten great public health achievements -united states, 1900-1999,” morbidity and mortality weekly report, centers for disease control, april 02, 1999 / 48(12);241-243. https://www.cdc.gov/mmwr/preview/mmwrhtml/00056796.htm 2 lee goldman, “too much of a good thing: how four key survival traits are now killing us,” new york: little, brown & company, 2015, 5. 3 psalm 90:10, kjv. note that in areas that still suffer from extreme poverty, as in sub-saharan africa, life expectancy remains low at between 40-50 years. this actually represents a drop in life expectancy from 30 years ago: un index, 9 november 2006, https://news.un.org/en/story/2006/11/199062-life-expectancy-sub-saharan-africa-lower-now-30-years-ago-un-index 4 pijnenburg, martien a. m., and carlo leget. “who wants to live forever? three arguments against extending the human lifespan.” journal of medical ethics, vol. 33, no. 10, 2007, pp. 585–587., www.jstor.org/stable/27719955. 5 dongying zhao, lile zou, xiaoping lei & yongjun zhang, “gender differences in infant mortality and neonatal morbidity in mixed-gender twins,” scientific reports, volume 7, article number: 8736 (2017) doi:10.1038/s41598-017-08951-6 6 susan alberts, “lifespan equality in humans and other primates,” university of notre dame, amboseli baboon research project, published: november 23, 2016. https://amboselibaboons.nd.edu/news/lifespan-equality-in-humans-and-other-primates/ 7 steven austad, andrzej bartke, “sex differences in longevity and in responses to anti-aging interventions: a mini-review,” gerontology 2016;62:40-46. 8 david robson, “why do women live longer than men?” bbc, october 2, 2015. http://www.bbc.com/future/story/20151001 -why-womenlive-longer-than-men 9 austad, gerontology. 10 robert krulwich, “why men die younger than women: the ‘guys are fragile’ thesis,” robert krulwich on science, npr, june 17, 2013. https://www.npr.org/sections/krulwich/2013/06/17/192670490/why-men-die-younger-than-women-the-guys-are-fragile-thesis 11 a french study claimed to document a reduction in the lifespan gap (f meslé, “gender gap in life expectancy: the reasons for a reduction of female advantage,” rev epidemiol sante publique. 2004 sep;52(4):333-52.), a chinese study on the subject concluded there was not enough data available to draw strong conclusions (le, yan et al. “the changing gender differences in life expectancy in chinese cities 2005-2010.” ed. irene petersen. plos one 10.4 (2015): e0123320. pmc. web. 24 mar. 2018.) 12 a notable exception is a 2016 canadian study that affirmed the lifespan gap but noted that it seemed to be narrowing. rosella lc, calzavara a, frank jw, et al, “narrowing mortality gap between men and women over two decades: a registry-based study in ontario, canada,” bmj open 2016;6:e012564. doi: 10.1136/bmjopen-2016-012564. 13 austad, gerontology. 14 unicef millennium development goals, unicef/hq99-0611/pirozzi, https://www.unicef.org/mdg/childmortality.html 15 daniel callahan, “on living to 100 or more” the hastings center, april 6, 2016 https://www.thehastingscenter.org/on-living-to-100-ormore/; ezekiel emmanuel, “why i hope to die at 75” october 2014, the atlantic, https://www.theatlantic.com/magazine/archive/2014/10/why-i-hope-to-die-at-75/379329/ 16 callahan, the hastings center. https://www.thehastingscenter.org/on-living-to-100-or-more/ https://www.thehastingscenter.org/on-living-to-100-or-more/ https://www.theatlantic.com/magazine/archive/2014/10/why-i-hope-to-die-at-75/379329/ introduction conclusion ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) © 2017 dallas ducar and louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. careers in bioethics: an interview with james childress dallas ducar and louisa howard abstract the following interview with james childress discusses careers in bioethics, his conception of the principles of biomedical ethics, and other pertinent issues in the field of bioethics. keywords: careers in bioethics, james childress, bioethics careers, bioethics introduction james f. childress received his b.a. from guilford college, his b.d. from yale divinity school, and his m.a. and ph.d. from yale university. childress has authored numerous articles and several books in biomedical ethics and in other areas of ethics. his books in biomedical ethics include principles of biomedical ethics (with tom l. beauchamp), now in its 7th edition and translated into several languages; priorities in biomedical ethics, who should decide? paternalism in health care, and practical reasoning in bioethics. he is also co-editor of belmont revisited: ethical principles for biomedical research (with eric meslin and harold shapiro), and organ donation: opportunities for action (with catharyn liverman). dr. childress recently retired from the university of virginia, where he taught for over 40 years. he held the titles of university professor and john allen hollingsworth professor of ethics as well as director of the institute for practical ethics and public life. he was also a professor of religious studies, professor of public policy, and professor of research in medical education in the school of medicine. dr. childress has been actively involved in several national committees examining ethics and public policy. he was vice chair of the national task force on organ transplantation, has served on the board of directors of the united network for organ sharing (unos), the unos ethics committee, the recombinant dna advisory committee, the human gene therapy subcommittee, the biomedical ethics advisory committee, and several data and safety monitoring boards for nih clinical trials. he was a member of the national bioethics advisory commission during the clinton administration. he also chaired the health sciences policy board of the institute of medicine. dr. childress is an elected member of the national academy of medicine, formerly named the institute of medicine, and an elected fellow of the american academy of arts and sciences. in 1990 he was named professor of the year in the state of virginia by the council for the advancement and support of education; in 2002 he received the university of virginia’s highest honor—the thomas jefferson award; in 2004 he received the lifetime achievement award from the ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 2 american society of bioethics and humanities; in 2010 he received the henry knowles beecher award from the hastings center. he has held a guggenheim fellowship, an american council of learned societies fellowship, and a postdoctoral liberal arts fellowship at harvard law school. in 2010, he was the carey and ann maguire chair in american history and ethics at the library of congress. he has been the joseph p. kennedy sr. professor of christian ethics at the kennedy institute of ethics at georgetown university (1975-79) and a visiting professor at the university of chicago divinity school, princeton university, and a visiting scholar at the national institutes of health. he remains a fellow at the hastings center. his research currently focuses on two major areas: biomedical ethics, with particular attention to theory and method, religion and bioethics, and public bioethics, and just-war theory and pacifism. he taught both undergraduate courses on biomedical ethics, religion and public policy, as well as graduate seminars on love and justice in christian ethics, just-war theory and pacifism, and legal and ethical reasoning in public policy. his esteemed undergraduate lecture, theology, ethics & healthcare drew students from all disciplines as it thoroughly examines the myriad ethical issues surrounding modern medicine. childress’ ability to tease through the most nuanced topics without bias, allowing each student to drawn his or her own conclusions, serves as a testament to his edifying and highly-respected approach to teaching. as a professor at the university of virginia, when not teaching, dr. childress was writing, or contributing to his many committee involvements. he could also be found in his office, generously giving his time to advise budding ethicists on curriculum selections, internship opportunities, and beyond. as university of virginia alumni, dallas and louisa have had the honor of interacting with dr. childress both within the classroom and through extracurricular engagements. a. on entering the field of biomedical ethics d: how did you start your personal journey into bioethics, and how did you become interested in the field? c: i started teaching at the university of virginia in 1968, the second year the department of religious studies existed. i was teaching in areas of religion and politics – specifically, courses on civil disobedience, political obligation, just war theory and the like, as well as broader courses. in 1970, during my second year of teaching, the center for the study of science and technology in society— which was located in the law school— set up a seminar on artificial and transplantable organs. this was mainly for faculty, but also a few students. they had enough law and medical faculty, but they had no one from the humanities involved. however, it just happened that the chair of that center was a former yale college classmate of the chair of the department of religious studies. the chair of the center reached out to my departmental chair and said that he needed someone in humanities, preferably someone in ethics, to participate. my departmental chair told me, "i really want you to take part in that." i protested that i was too busy. it was my second year of teaching, and i was teaching three courses a semester, including a large lecture class. however, he persuaded me. it’s hard for a junior faculty member to say no to the departmental chair. that seminar on artificial and transplanted organs was a life-changing event. i wrote a faculty paper for the seminar on "who shall live when not all can live?" which examined different criteria for allocating scarce artificial and transplantable organs, with particular attention to the value of fair equality of opportunity. it was soon accepted for publication in the interdisciplinary journal soundings (vol. 53, 1970, pp. 339-355). the editors wanted to include a response to the paper, and the head of the nephrology unit at uva, who was also a member of the seminar, agreed to respond, reflecting some of the debate we had in the seminar. that particular paper ended up getting a lot of attention. not immediately, but very quickly. it was subsequently published in 25 or so anthologies. but keep in mind: these were the very early days of bioethics. then four years ago, soundings (vol. ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 3 96, no. 3, 2013) had a retrospective on the piece with five commentators. this paper, my first significant publication, has had a good, long life. one of the things that really interested me about that seminar was the exchange with medical and legal professionals around topics of fundamental human interest: how can we increase the supply of artificial and transplanted organs? how can we distribute the ones we have in a fair and equitable way? these two questions still persist, and require on-going reflection and resolution in light of important ethical values and technological, professional, and societal changes. i started thinking about these questions with others who were serious and wanted to make a difference in policies and practice, which i really found quite exciting. this led to other interactions with medical and health professionals, including a psychiatrist who was also a member of the seminar. over the next few years, i published a few articles related to bioethics. the term “bioethics” wasn't even coined until that very year, 1970 — a time still early in the development of the field. then, in 1974, georgetown university invited me to fill the new chair in protestant ethics, the “joseph p. kennedy professorship in christian ethics,” located in the kennedy institute of ethics; a roman catholic chair was held by richard mccormick, a jesuit. because my little article was getting a fair amount of attention, i was invited to apply for the position. i wasn't particularly interested, because i really loved it at uva in the new department, which was growing rapidly from the two faculty when i interviewed for the position in 1967. l: what a neat thing to be a part of. c: yes, i was part of something that seemed to be developing very well. i had already become department chair in 1972 at a very early age but, having arrived so early in the department's development, i had been around for several years and had some seniority. nevertheless, i was finding it difficult to delegate tasks to others, some of whom had been my teachers in graduate school at yale, and i felt overworked. the research chair at georgetown had no official obligations. i could teach if i wanted to teach, but there was no requirement to do so. this seemed to be an attractive opportunity that i should at least consider. and my late wife was also interested in the d.c. area. so, i applied. because i wasn't particularly interested, i had a hell of an interview! d: we would love to hear more about it. c: nothing really hinged on it for me, since i wasn’t seeking to leave uva. and so, i was very relaxed throughout the interview process. when the chair was offered, i did accept it and stayed there for four years. however, a major reason i hesitated at first to accept the chair is that i thought bioethics might be a passing fad and there wouldn't be a lot of interest in it long term; so i wanted to continue my other interests, as well. i should also add that i do not think of myself as a bioethicist. i'm a person who is interested in ethics and public policy. public policy goes in several directions. many of the issues that concern me relate to biomedicine and healthcare, but also to questions of war and peace, among others. i consider these as two subsets of my major interest. i don't do much in clinical bioethics; what i am really focused on is public policy. my first actual experience in public policy related to bioethics came in 1975 on a topic that still hasn't been resolved: compensation for injured research subjects. building on this experience, i wrote a paper arguing for justice-based compensation for research-related injuries. it still hasn't happened. b. on developing the principles of biomedical ethics d: what led you to exploring the field of medical ethics further? c: one of my early tasks at georgetown was to teach in an intensive bioethics course, which had been offered once before i got there. a philosopher at georgetown, tom beauchamp, was also teaching in it, and we had very ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 4 different views. in the parlance of the time, he was a rule utilitarian, and i was a rule deontologist. and yet, we found areas of fundamental agreement. i had known tom at yale divinity school, before he pursued his ph.d. degree in philosophy at johns hopkins. i had stayed at yale to pursue my ph.d. degree in religious ethics. so, we came to bioethics from different perspectives. we decided that we could develop something that might be of interest in the field, because there were very few methodological discussions at the time. early contributors to the emerging field in the 1960’s were people like paul ramsey and john fletcher. they had already done a lot. i by no means consider myself a pioneer. and there was a lot of work in religious communities on medical ethics: protestant, catholic, and jewish. the background was already there and so i considered myself in the beginning of the next generation of people working in the field. at the time, there were only a few systematic books in medical ethics. particularly important were those written from religious perspectives by such thinkers as joseph fletcher, paul ramsey, jakob jakobovitz, gerald kelly and john ford among others. i recall only one systematic book looking at medical ethics from a philosophical perspective—howard brody wrote a physician-philosopher's book. most of the books that were available were anthologies, organized around problem areas, such as abortion, euthanasia, allocation of resources. tom and i wanted to offer something different. coming from two different ethical theories, we felt we could get agreement about some important principles. we believed it was possible to get more agreement on these principles than on why we affirm them, and more agreement on these principles than on how they apply in practice. in short, we wanted to offer an ethical framework for thinking about biomedicine and health care. tom and i published the first edition of principles of biomedical ethics in 1979; seven editions have now been published and about a dozen translations into other languages have been published or are being published. at georgetown, then, i was not forced, but rather led into working more in bioethics. d: i was curious— you said that you don't consider yourself a bioethicist. can you elaborate just a little more on that? c: i don't like the term “bioethics,” even though i often use it now for shorthand purposes (as in this interview). the original conception of bioethics, when the term was coined by rensselaer potter in 1970, was a very, very broad conception. the term i use most often, when i'm not seeking a shorthand expression, is “biomedical ethics.” i have a particular reason for that. i think of biomedical ethics as parallel to business ethics, political ethics, and so forth. but to call the field bioethics— or to identify specific subsets such as neuroethics or genethics— is actually to suggest, by having using the combined words, that this is some kind of independent enterprise. i don’t accept that conception. instead, we should reflect on ethical principles, rules, and values that then get brought into play in the particular problem areas of business, politics, public policy, and biomedicine. so, that's one reason i prefer “biomedical ethics” to “bioethics,” even though i know it's a losing battle because shorthand expressions are often useful. another reason for my reluctance to call myself a bioethicist is that, again, i think of myself more as working on ethics and public policy, with biomedicine and health care being one of the subsets of this dominant interest. c. contributions to the field d: you talked a little bit about how this a gradual evolution of your career. you also mentioned some of the writings that you've done and the things that you published at the very beginning. what would you consider some of your major successes within your career? c: there are some publications that i really like, including, among others, that very first little article, principles of biomedical ethics (new york: oxford university press, several editions, 1979, 1983, 1989, 1994, 2001, 2009, 2013), and an article on just-war theories (theological studies 39, 1979) as well as articles on conscience, organ procurement and allocation, public health ethics, etcetera. so, there are several things that i've done that i really, ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 5 really like; i'm particularly proud of those. others, i think, have been useful. i also believe my work in public policy to be important. i've been heavily involved in public policy over a number of years since that first foray in 1975. it just happens i do most of it in relation to biomedicine and healthcare. i served on president clinton's national bioethics advisory commission (nbac) as well as on a number of other governmental committees addressing bioethical issues. some of these were bioethical in content even if their labels do not indicate this. for example, i served on the human fetal tissue transplantation research panel and i was vice-chair of the federal taskforce on organ transplantation, as well as a number of committees for the institute of medicine (now the national academy of medicine). i would also consider the undergraduate courses i've taught, including theology, ethics, and medicine, which i have loved teaching, to be a highlight of my career. i have also really enjoyed teaching my graduate seminars. in the spring semester, 2015, i had one of the most interesting seminars i've ever taught on just war theory. i had five students from philosophy, five from religious studies, two from politics and international relations, three had military backgrounds, and at least two were pacifists. it was such a rich seminar. d: do you choose your major topics or did they choose you? l: it seemed to happen pretty organically. c: “organically” is an interesting way to put it, because certainly the first topic that lured me into the field came from the outside. it was not self-chosen and it came from the outside in more ways than one. i have definitely gravitated towards certain kinds of topics in method and theory and i've probably concentrated the most on organ transplantation—in regard to both procurement and allocation. and more recently i have focused much of my work in public health ethics. d: from writing that very first publication to going to georgetown and being there with basically free reign at that time, what really propelled you towards organ transplantation? c: as i mentioned, the seminar that lured me into bioethics was on artificial and transplanted organs, so even though i wrote mainly on distribution of artificial organs, kidney dialysis in particular, i also paid attention to organ transplantation. i found that just fascinating in terms of the ways we think and feel about the human body and transfer of body parts from both living and deceased individuals. i taught a course on human bodies and parts as property several times in the 1990s and 2000s dealing with a wide range of uses of human bodies and parts, not only in transplantation, but also in research, education, and other ways, including reproduction (e.g., donor sperm and eggs and surrogacy) and plastinated body exhibits. i'm fascinated by these topics. l: do you have a particular piece of work that you think has had the biggest impact on the biomedical ethics field? c: well, i again think that principles of biomedical ethics had the biggest influence. i would say the book has had the biggest impact simply because the first edition came out in 1979, it is now in the seventh edition (perhaps there will be one more!), and it has appeared in about a dozen translations into other languages. our critics play an important role in our willingness to revise the book as we try to take account of their arguments, accept what we find helpful, and offer counterarguments where needed. d: are there particular things that you focus on when you're making a new edition, to tweak or change? c: the way we start with a new edition is to see which one of us has been working on some area, and then that person develops the new draft of that specific part of a chapter or a whole chapter, based on what he's been doing. our changes grow out of thoughts that we have developed since the previous edition and the ways we've been teaching or writing, as well our efforts to respond to critics. so, that gets the process started and then we go through draft after draft until we get the book that we together like. that's basically it. d: so, the paths harmonize? c: generally, but some differences get hidden in the language. we each have an independent life. this is the only work we really collaborate on. but it has made a strong impact. the late john arras, whom i miss a great deal, ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 6 commented at one point that principles of biomedical ethics was like the “borg.” this is because resistance is futile, “we're going to capture and assimilate.” i was always amused by that comment. however, my counter would be that, “no, we actually try to learn from others first and see how we can adjust or refine our position rather than try to ‘conquer and assimilate.’” d: do you feel like you also learned from beauchamp, too, when you were both writing this together? that there were some areas where you might find some disagreement and have to find some common place? c: of course, we have our differences, and we sometimes paper over them, we sometimes convince the other, we sometimes wear the other out. when we started planning this book, we originally had another co-author, a psychiatrist, seymour perlin, working with us but he ended up not being able to continue because of other professional commitments. he was part of our early discussions and put us in contact with his editor at oxford university press, jeffrey house, who had worked with him on a book on suicide. oxford had not published any books in bioethics by the late '70s. principles of biomedical ethics was its first book in bioethics, and now i can't even read all the books it publishes in this field. one nice thing about starting in 1970 was that i could read everything in a particular area in a day or so. i still probably have the eight or ten articles in a file that i read for “who shall live when not all can live?”— so i had to draw from other areas. for example, i didn't know that paul ramsey was working on similar issues at the same time --he built his reflections into his book that came out later in 1970 – patient as person: explorations in medical ethics (new haven, ct: yale university press, 1970). but at the time i was drawing from ramsey's other work on triage on the high seas, that is, throwing some passengers overboard in order to keep a lifeboat afloat. this was another allocation of a scarce resource. i not only worked with the modest literature in bioethics, but i also drew from a variety of other works to try to cast light on this particular area. d: at the time, were you surprised that principles of biomedical ethics garnered so much attention? c: yes, of course. d: what do you think surprised you about that? c: well, i mean, you never know, when you put something out there, what kind of response it will get. some of the best things i've written haven't received much response. some of the more modest things have. you just never know, right? not until it gets out there and strikes a chord—what might be useful and why something takes off and gets a lot of attention, while something else does not. it's all very puzzling. i can look back now and see why, given the fact that, again, so little had been written from a philosophical perspective that tried to offer a systematic framework for thinking about bioethics. so, that was one thing. a second thing is that both tom and i were contributing to the work of the national commission for the protection of human subjects of biomedical and behavioral research, which produced the belmont report, with its famous principles, during these years. tom was actually a staff philosopher for the national commission at the time and worked on the belmont principles, which still play such an important role in research involving human subjects. “principles” became part of the air we breathe, as it were. principles became a helpful way to organize ethical discourse and reflection. ours were similar, with important differences. principles have a downside too, because as critics sometimes note, some practitioners engage in a mechanical application of the four principles. two of our critics, bernie gert and dan clouser, said others were chanting the “mantra” of autonomy, beneficence, non-maleficence, and justice— our four principles—without really grappling with those principles. that can be a problem. d. formative influences ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 7 l: have you had any major influences in your life during your career and was there any work that inspired you or any people in the field or outside the field that really influenced you? c: there were several indirect formative influences—i use the term “indirect” here because they're not so directly related to biomedical ethics but nevertheless shaped my choices, personal career, and academic life. i come from a quaker background, but north carolina quakerism is a lot like any other southern protestant denomination. there are hired ministers, there's programmed worship with music, not what we often think of as the more traditional quaker silent unprogrammed meeting for worship, with participants speaking out of silence. in college—at guilford college, a quaker school—i was further exposed to this tradition, including its critical perspective on a number of social issues, and i found it quite appealing. also at guilford college, i worked with several faculty members in a strong department in religious studies. i decided that i would like to teach in religious studies, preferably religious ethics. this led me to yale divinity school. at that time, virtually everyone interested in pursuing a ph.d. degree in religious studies went first to divinity school. at yale divinity school i became even more interested in an academic career in religious ethics. several faculty members there, as well as faculty members in college, were important. but james gustafson was the biggest influence. he ended up being one of the key figures in the development of modern bioethics or biomedical ethics. he was part of the group with paul ramsey and hans jonas and others who helped will gaylin and dan callahan develop the hastings center. his influence as a teacher and a scholar was very, very important for me. but then there were many others, including david little who advised my dissertation on civil disobedience. in divinity school and graduate school, i also learned much from my peers, such as stanley hauerwas. and once i started teaching, i continued to learn from colleagues and from students, both undergraduate and graduate students. l: that is always important to keep in mind. c: so, yes, i learned from them. then the various other influences really came in more direct way, especially from working with tom beauchamp from whom i have learned so much, through debates, and through interactions with colleagues at the kennedy institute of ethics at georgetown university where i held a research chair for four years. l: along with colleagues, how have your students helped to shape your opinions and beliefs on certain issues? c: my basic conception of ethics in relation to public policy is that of public justification. ethics involves critically reflecting on the kinds of reasons we give for the kinds of actions we propose and undertake, whether individually or publicly. i learned a lot through this reflective practice. one of the important people i learned from was joanne lynn, a physician-bioethicist, and a fellow at the hastings center. she had participated in a summer seminar i taught under the auspices of the national endowment for the humanities. we published an article that played an important role in the debate regarding artificial nutrition and hydration. that article really depended a great deal on her work as a very thoughtful physician. i do think dialectically, and i found our interaction to be quite valuable. i should also add, in that regard, i do a lot of team teaching. probably more than most people. i'm not even sure i can count up the number of team taught courses. l: oh, that must be very fun. d: what do you find that's valuable about team teaching? c: it is an approach to a class that depends in part on the other person's views. and i gain a lot of insight from the other person. and, as in the seminar i took part in on artificial and transplanted organs, what i find so fascinating and illuminating is the interaction, the dialogue, and the exchange. d: that’s wonderful. c: it fits well with part of what i find in the public policy context, where we're trying to develop a consensus statement or come as close to a consensus as possible on important matters. it's a willingness to say “i don't ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 8 think that i have to have the answer, so let's together see if we can come up with an answer that's justifiable given the range of values at stake.” d: so, in this, it's affecting everyone's life. it's public policy. i can only imagine some of the very long debates or at least discussions that were had. c: yes, definitely. e. future directions d: returning back to the field and your own goals, what do you see yourself focusing on next? do you have any plans for, for instance, an issue you might want to tackle or anything? c: well, i'm finishing a long overdue book on public bioethics, which includes several articles i've previously produced or published, along with several new chapters as well. and, again, tom beauchamp and i may do another edition. but the next thing i want to do after public bioethics is a book on just war theory. i published a book on civil disobedience and public obligation and another on moral responsibility in conflicts. so, i’ve already published some materials related to this topic, but i want to pick up the 1978 article on just-war theories as well as some other articles i have written since then and rework those into a book, and, here again, respond to critics, because that one article has also been subject to a fair amount of criticism. i'll try to straighten the critics out as best as i can! d: big plans, as always. f. current developments within bioethics l: now we wanted to move into more about the field and your thoughts on certain topics. d: of course, a lot has happened since the beginning. but, specifically, in terms of the whole scope of the field, how do you think bioethics has changed over the scope of your career? c: it's changed a lot in terms of expansion. and obviously, it got started in part because of the expanding questions that couldn't be handled well in existing frameworks. after all, medical ethics has been around a long time. nursing ethics is not so young, either. and religious traditions have long reflected on these topics. so, why in the '60s and early '70s did bioethics develop as an area of critical reflection? well, in part because there were new questions that had to be addressed. i think that’s what was occurring in research, in developments in genetics and reproductive technology, and in organ and tissue transplantation, for example. the 1968 harvard statement on determination of death was developed in part because of the need to be able to determine death for purposes of deceased organ donation before the organs deteriorate. we needed a way to determine death that would allow us to take the organs, with consent, in a timely way. and we had to consider the patients whose hearts were still beating because of the attached machinery. these were issues that, again, expanded the field and that expansion hasn't stopped. and so, that's where i was mistaken back in the 1970’s—bioethics was not a passing fad. i didn’t fully appreciate that there would continue to be new pressing issues that would require attention. for example, the last version of my theology, ethics and medicine course had to be revised, because i had to discuss the new and promising gene editing techniques. topics such as human genetic engineering continue to develop. to take another example, we thought that brain death issues were settled. they aren't; in some ways they've unraveled. things fall apart, new things develop, and so on. ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 9 expansion in a second sense has also occurred. the global scale or scope of bioethics has become very important in a variety of different ways through concerns about human rights and global justice. the interest in global public health is a good example—what happens in south korea, for instance, doesn't stay in south korea. expansion also occurs in devoting more attention to certain topics or areas over time. even though i've always been interested in public policy, more attention is now paid to the public policy implications of bioethics, beyond the clinical implications. i think we have seen a broadening out to public policy combined with attention to the larger sociocultural context of bioethics, which brings into play the work of sociologists and anthropologists and others. and i think that's been a part of broadening the field. so, those are some of the kinds of changes that i think are important. i think it is also important to recognize that bioethics has been, in many ways, limited by its origin in the u.s. with its strong individualistic thrust. in the u.s. context, for several reasons, respect for autonomy tends to be particularly emphasized. you can see why it's important, but the u.s. also tends to give it a very individualistic cast that looks very different if you're approaching this from most other countries in the world, even the u.k., with which we share a lot. i think we need more attention to community and relationships, especially relational autonomy as emphasized by feminist thinkers. l: when you first entered the bioethics field, you mentioned organ transplantation and dialysis were the big issues that seemed to be the most pressing— the ones that need to be addressed at that time. were there any others? c: there were a lot of other issues related to behavior modification and emerging mental health issues that led to de-institutionalization in the '70s—so huge changes were occurring, for better or worse. to take another example, in 1973, the end-stage renal disease program was anticipated to be the first step in the direction of the universal health care in the u.s. but it turned out to be an aberration because the estimates were just wrong, and the costs were much higher than anticipated. we’re still struggling and failing to provide universal access to health care. d: speaking a little bit about that, during that era, there were obviously some technological changes, too, that were really driving some of those issues. and technology is always changing. going off of that, what technologies now do you really think are going to change the way that this dialogue goes? what might change the face of medicine or nursing? c: what's going to change or what has the potential for blowing everything up is gene editing. l: yes, you mentioned that earlier, why do you think that? c: in an on-going effort to make sure that genetic interventions didn't pose too much risk, scientists, ethicists, and others developed a set of distinctions that are still important. one is between somatic cell gene therapy and germ line intervention. somatic cell alterations remain in a particular person's body; they are not passed on to others while the germ line alterations can be passed onto offspring and future generations. the other distinction is between therapy and enhancement, specifically between gene therapy and genetic enhancement. gene editing certainly threatens the first set of distinctions, and it will probably be difficult to restrict it to therapeutic interventions, in part because the lines are not totally clear. so, gene editing is potentially transformative but also risky. several committees and forums have addressed—and will continue to address—these topics. it's exciting, but also troubling. l: that was actually our next question— as medicine and healthcare become more global, what do you think will be one of the really emergent issues in global ethics? i know we had ebola in 2015, but it's interesting how the media can sort of hype something up— and then now it's not as talked about anymore. but do you foresee anything in the future? ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 10 c: no doubt there will be terrifying things to keep us anxious and active. but i think large questions about global justice are here as well. they include how we think about not only protecting ourselves from infectious diseases that might emerge and put us at risk, but also how we think about this in a global community that requires attention to health needs and threats in other countries. how can we meet broad needs on a global scale? i think those are critical questions. i don't have an easy way to address them. i think the work of thomas pogge points us in an important direction, by pushing us to ask what have we done to create these desperate circumstances. this framework will generate a greater obligation to try to meet needs in the global context—there are ways in which we've contributed to global problems that increase our responsibility. it's much easier to state that point than to say exactly how we should go about addressing it. l: is there a particular biomedical ethics issue that you feel has been under addressed by the field, specifically, or that remains the most unresolved? c: at different times, i think it's been easier (and i’ve been guilty of this too) to concentrate on some “hot button topics,” and not to attend as much to, say, public health infrastructure or to health equity in the u.s. or globally. for example, we don't yet have equitable access to healthcare in the united states despite obamacare. and obviously, some of these issues have become so technical that bioethicists need to know more economics, for example, than i and most bioethicists know. i think that having people in the field who can work in different areas, but also can engage in collaborative partnerships with others to address some of these complex policies is more practical. moreover, we find it difficult to develop a good, deliberative, and public way to deal with complex issues like gene editing. so, i think we still have a long way to go on a lot of topics. l: to follow up, what challenges loom largest for the field right now as a whole—whether it's funding or people's differing opinions and the difficulty with coming to a consensus? c: i'd say i've been amazed, as you probably have, too, by some of the changes that have occurred. socially and culturally we've moved in new directions in recent years—for example, on gay marriage. and look how far we've moved, say, on physician-assisted suicide; almost every year, a new state is added to the list of states accepting it. so, it's fascinating from a sociological and anthropological standpoint to step back and consider how these changes occur over time. d: speaking a little bit more about the future of biomedical ethics, what do you anticipate the field looking like in the next five or ten years? can you anticipate that at all? and do you have any caveats about looking towards the future? c: remember, i predicted bioethics wouldn't be around long. you probably shouldn’t ask me for predictions. i’m an unreliable predictor! d: but now you have more experience, so at least your knowledge-base to make any prediction might be more informed. c: there is no such thing as bioethics or biomedical ethics— as you know, there are many different approaches, and many people are doing many different kinds of things under this rubric. so, a lot depends on which area one is looking at. i worry that too many entering the field are engaged in a kind of scholastic endeavor of working out further what has been done before or critiquing it. i'm more interested in how fresh perspectives come into the field. so, that's one reason i'm interested in a lot of what's happening in anthropology, for example. different kinds of perspectives are important to keep the field fresh. i am also concerned, especially, that people narrow in on bioethics too quickly as their area of concentration. they may not get enough breadth or depth in some other areas that actually may be the ones that will shape bioethics in the future. so, that's, i guess, a sort of cautionary note. d: on that note, what do you think makes a thorough ethicist? what sort of aspects are they considering? ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 11 c: those of us who came into the field when i did, did not come in as bioethicists. we came in from other areas. i'd like to keep those areas fertile and add other neglected perspectives. so, that would be one of my major concerns. but i also think familiarity with the traditions of philosophical and religious reflection and with the legal context is very important. and obviously we need attention to the biological sciences and medicine and health care to be able to address bioethical issues. if bioethicists are not scientists or medical professionals, then they need to choose a few scientific or medical areas where they can gain enough competence to be able to really contribute to the discussion. there are some areas i won't lecture on in a public lecture, because i'm not sufficiently grounded to be able to avoid major misunderstandings of the problems. d: following up with that, when you were talking about lecturing in class, what do you think makes a good teacher of bioethics? c: i think passion for the area can generate enthusiasm on the part of students. for instance, my course theology, ethics, and medicine is aimed at creating informed citizens. changes are occurring in education that require the teaching profession to be much more interactive than it was years ago. and so the challenge in my course has been to build in weekly film sessions and to plan the weekly discussion sections focused on cases so that even though there are two lectures a week, we can keep the course as interactive as possible. i also think that familiarity with traditions of ethical reflection, specifically in the biomedical arena, but also more broadly, is important for effective teaching. l: regarding what you mentioned before about new perspectives coming into the field, though it's a very diverse field, what voices do you think, if any, are not sufficiently represented today in the biomedical ethics field? and who do we need to bring in to help contribute? c: while there is some minority participation, bioethics is a heavily white field. so, that's one fundamental issue: diversity needs to be addressed. over time, the field has done a much better job incorporating women and women’s voices than it did at the beginning. but that's in part because, insofar as physicians are contributing to bioethics, many more women are now in medicine. yet, this is not happening to the same extent in relation to minorities. l: have you seen any other specific professional groups that haven't been brought in that might serve to enhance the field? a: i like the fact that nursing students have been about 10% of my undergraduate course on bioethics. this has been important for pedagogical reasons. . l: since dallas and i are both going into the healthcare, we are interested to hear if you have any advice, specifically, for medical or nursing students at the beginning years of their practice. c: since the demands are so heavy now on the individuals going through training, my advice is to try to keep alive the reflective and imaginative dimensions. consider a study out of the university of pennsylvania about how medical students thought about pelvic exams in medical training and the kind of consent needed for those exams. this study showed that the students’ ethical judgments about these matters were worse after their third year than they were in their first two years of medical school. d: in conclusion, what legacy, if any, do you want to leave in biomedical ethics? c: i think the late paul ramsey, whose book the patient as person in 1970 was very important in the further development of medical ethics, said it best when he described writing as contributing to a conversation. so i hope i've contributed to a conversation that will continue, and i look forward to following that conversation. i hope that the students i've worked with--undergraduates, graduate students, and postgraduates—will want to contribute to that conversation too. i think there are few easy answers and in many cases no answers at all. but we have to continue to discuss and think together and try to come up with responses that appear to be justifiable ducar and howard, an interview with james childress, voices in bioethics, vol. 3 (2017) 12 in the particular circumstances. and so we contribute to the conversation... that's what i consider most important. d: well, you definitely have two people in this room who feel that your class and the environment that you and professor arras created at the university of virginia, the bioethics culture, has been amazing, and definitely impacted a lot of people. c: good. we miss john, though. d: yes. l: we do. d: well, we covered a lot of ground. d: and i can just say that we are very honored to have been able to talk with you about this and thank you so much for contributing to this conversation. ___________________________________________________________ zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, fordham university school of law, ms candidate columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. vigilante grocers: is temperature screening of customers by retailers an ethical and valuable restriction on privacy and freedom? anne zimmerman* abstract “government has a unique role in public health”1 which now calls for extraordinary means to control the spread of covid-19. in the absence of clear governmental guidance, companies must navigate public health and implement fair policies to promote safety, acting in what is traditionally government’s realm. keywords: temperature screening, covid-19, privacy, civil liberties, public health introduction before the covid-19 pandemic, the protection of consumer privacy had reached a milestone with the enactment of the california consumer privacy act (ccpa).2 stores that screen customers for elevated temperatures challenge the basic ethical underpinnings of the new law: that personal private medical data is to be controlled by oneself. the pinnacle of privacy and control over personal data, the ccpa as it applies to data being collected new ways could impede covid-19 public health goals.3 yet there is precedent to release personal medical information in other public consumer arenas. “government has a unique role in public health”4 which now calls for extraordinary means to control the spread of covid-19. in the absence of clear governmental guidance, companies must navigate public health and implement fair policies to promote safety, acting in what is traditionally government’s realm. customers, as opposed to employees, would arguably be subject to data collection but not storage.5 customers will be subject to actions that violate traditional notions of the doctor patient relationship, data privacy, and freedom. the actions can be justified as noncoercive, a public health necessity, and as less restrictive than keeping businesses closed. the justification does not necessarily imply that companies should be managing the public health task themselves. temperature screening, important now as some stores selling essential goods are implementing it, will become more crucial as more indoor public spaces, malls, retail stores, and service industries reopen. ____________________________________________________________ zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) 2 analysis a. is temperature screening worth the sacrifice? “in a liberal, pluralistic democracy, the justification of coercive policies, as well as other policies, must rest on moral reasons that the public in whose name the policies are carried out could reasonably be expected to accept.”6 temperature screening is not coercive: staying home is an option for customers (not employees). another option is to arrive at the store, deny the screening, and be denied entrance to the normally open-to-the-public space, also negating the coercive aspect. the customer, having made the decision, would be free to leave. in certain industries, businesses have rules that more severely restrict people’s freedom and include the collection of personal medical information. in most cases, there is a legal requirement for the action. airport scans, recently adapted to reveal less and preserve more privacy, are tsa-driven and not imposed on customers by airlines themselves. airlines do have a lot of power to ensure that flights are safe, on balance, giving them power over personal data. amusement parks are governed by rules and regulations by state, local, and the federal government that include height and weight requirements; they ensure safety by following laws as well as internal and industry guidelines. even bungee jumping and zip-lining are regulated to promote safety in ways that may require demonstrating an absence of certain medical conditions. customers must divulge personal information and medical histories. the permitting process in many industries requires proof of safety measures and agreement to hold inspections. from the customer perspective, the laws and regulations matter less than the action. customers benefit from safe airlines and amusement parks and willingly give medical information in exchange for participation in air travel or amusement park entertainment. temperature screening is within accepted standards of requirements to participate, justified by the public health it would promote and its non-coercive nature. while many stores have nondiscrimination policies, the potentially contagious customer does not have any fundamental right to access that would override the public health concern. it is reasonable to accept and even embrace temperature screening knowing others inside the space will also have been screened. temperatures often indicate the most contagious time in a viral stage and even non-covid-19 temperatures can indicate contagious conditions. temperature is usually protectable data: it is to be kept private if it is a product of a hospital or doctor’s appointment. covid-19 disproportionately affects certain populations including, most notably, the elderly. reopening stores and businesses is an opportunity for those without special vulnerabilities wanting to go back to public space. immunocompromised individuals may choose to protect themselves by staying home, wearing additional personal protective gear, or avoiding crowds. my own immunocompromised postchemotherapy daughter is incredibly cautious, going to great lengths to protect herself regardless of government directives. she benefits from those directives because other members of our household are less likely to bring the virus home if public spaces are closed or engaging in temperature screening and enforcing social distancing and mask recommendations. stay-at-home orders combined with other nonpharmaceutical interventions like closing schools and wearing masks in crowded spaces should work for flattening the curve.7 the strain on the economy and on personal liberty makes them unsustainable in the long term. a solution like temperature screening makes public spaces safer but may work best in conjunction with particularly vulnerable people continuing to avoid crowded public spaces. there is an urgency to addressing the ethical basis for retail stores performing temperature screening as some stores have already begun. in connecticut, labonne’s grocery stores began checking temperatures without recording data.8 atlanta’s city zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) 3 farmer’s market chain is also screening its customers. walmart has chosen to stay out of what it considers a public policy issue, refraining from testing customers’ temperatures.9 greenburgh, new york, a municipality, is requiring grocery stores and pharmacies to check temperatures.10 temperature screening is a valid and effective way of controlling the spread of covid-19, and will become especially important when more businesses reopen.11 it is reasonable to conclude that no one should be permitted entry into enclosed spaces with a fever. the efficacy of temperature checks has been debated with many public health experts in favor.12 other countries that have successfully contained the virus have used temperature checks.13 this paper assumes enough efficacy to warrant some temperature screening policy -some benefit or containment would derive from screening those entering public indoor spaces and barring those with a temperature of 100.4 or higher from entrance. temperature screening of customers has two rationales: under osha, such precautions protect employees by limiting exposure to customers who may carry the virus; and, the precautions serve the public health goal of transmission prevention. if reporting requirements or tracking ensued, the public health benefits would grow at the expense of control over one’s own data. websites usually offer data restriction choices by using a pop-up. an in-person temperature screening is a new data point that companies (especially small retail companies) are not prepared to deal with. if any data is collected, customers should be notified about how the temperature would be used, who can access it, and how the customer would remain deidentified. failing to track the febrile customer who might transmit the virus seems more ethically problematic than the privacy violation. without government directives, stores would have trouble justifying saving or sharing the data for the sake of public health. public health initiatives required by law, permitted by law, and ones not addressed by law have different ethical implications. efficacy alone would not allow stores to impede freedom and privacy more severely. stores cannot detain those who display a symptom or refuse to wear a mask. temperature screening must be within reason to be considered permissible. stores like walmart are using the absence of a governmental directive as an excuse to avoid an efficacious and sensible policy. walmart is permitted to remain open as essential, a huge economic benefit. customers may see walmart’s stance as more ethical: valuing customer privacy and freedom. stores like labonne’s are managing risk themselves to protect employees and the public. in greenburgh, store employees can simply argue they are following a local government directive. temperature screening should be accepted within a rightsdriven, liberty-oriented society because it is a reasonable safety measure that creates the possibility of cautiously reopening many stores and public spaces. some freedom is gained by a small loss of privacy and a different freedom. b. privacy in public temperature screening privacy in the doctor patient relationship enhances value by promoting trust. confidentiality promotes open communication with doctors and healthcare professionals. in covid-19 customer temperature screening, the person taking the temperature is likely not trained in confidentiality and not hipaa educated. customers, traditionally not seen as patients, are operating outside of the traditional scope for the sake of the common good, allowing a non-invasive screening. stores that screen customers should have a non-invasive thermometer that hovers and does not touch the customer. evaluated by the principles of efficacy, necessity, and the least restrictive means, temperature screening may allow more freedom to move about and more businesses to open. strict stay-at-home orders prevent the necessity for widespread screening, yet reopening stores creates a situation ripe for more pervasive temperature screening. companies, stores, the local government, or police have little to no experience with personal medical data collection in the sphere of retail goods and services. in some cases, people might ask for a private space for the temperature screening. zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) 4 stores should provide such a space but realistically they probably will not, making the screening a public event. labonne’s is not storing the data but arguably an elevated temperature would be witnessed by others outside the store who may know the identity of the febrile customer as many shop among their friends and neighbors. yelling the temperature over to a different employee would be a serious breach of privacy; the employee taking customer temperatures should be trained to be discreet. c. an ethical lapse: the failure to record data that could improve public health and the economy the results (a high or normal temperature) bring up the ethical conundrum: if the customers are asked to leave, the data and the customer are still in limbo. as covid19 testing becomes more readily available, the customers could be referred to a covid-19 testing site. failure to track them could allow them to try their luck at another store, spreading the virus if in fact they do have it. for privacy, it would be best not to store any temperature data creating no metadata for the event. for public health, tracking those with an elevated temperature is worthwhile and has been helpful in other countries. the right thing for a business to do probably lies in between: for an elevated temperature, recommend an online doctor’s appointment or send the customer home to consider seeking medical advice. a government directive to report elevated temperatures for legitimate public health purposes like tracking is reasonable and would be an appropriate directive for stores to follow. absent government use of the data, companies and stores should not be operating vigilante public health schemes that track and ban certain customers for extended periods, behavior that risks producing scarlet-letter-style stigma. who goals to find, isolate, test, and treat every case would be furthered by tracking and testing those with elevated temperatures.14 south korea has in place a mechanism through apps and electronic bracelets to track those who test positive.15 while their policies conflict with privacy and freedom, more businesses could reopen and more people could go more places while following social distancing and maskwearing recommendations. the us population might be amenable to a model like south korea’s when it is key to exercising freedom to move about in public, allowing workers to return to work, and consumers to enjoy stores and businesses. who seems not to envision its goals being handled by companies rather than public health authorities. the return to retail businesses and in-person services should be commensurate with a distinct protocol that fairly applies to all customers. the tradeoff for forgoing privacy is allowing stores to open, people to work, and consumers to consume. d. ethical baseline: notice and informed consent notice of policies affecting customers is an ethical obligation. companies should make a statement on a website and install signs announcing that temperature screening will begin on a certain date (official notice) and what the screening will entail. businesses that require temperature taking could provide exceptions based on proof of antibodies or a current negative covid-19 test, especially if the “immunity cards” considered by anthony fauci become widely circulated.16 otherwise, there is no obvious expeditious way to request, accept, or deny an exception if the interaction is taking place outside on the curb instead of online.17 kinsa, the thermometer company now well known for gathering temperature data, zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) 5 sells the data to pharmacies who use it for commercial purposes, specifically, to boost sales of products people with an elevated temperature might want.18 through a builtin feature, kinsa avoids any type of consent of the unwitting customer. while no personal data accompanies the temperature data, kinsa is profiting from the data in unexpected ways and stores’ notice to customers should include that type of data collection as well. conclusion government entities should weigh in on stores and businesses imposing temperature screening as a condition of entry. the stores are ensuring employee safety and contributing to public health by conducting temperature screening. absent government directive, companies should agree not to store or use customer medical information, despite the data’s valuable role in public health. a government order requiring reporting for the sake of tracking and isolating those with covid-19 would be a proper use of government authority ensuring ethical data protocols. the data is essentially wasted in the absence of any reporting requirements. hopefully, companies and customers will participate freely in screening to make shopping safer. as stay-athome orders expire, government should oversee the uniform application of tracking and testing those with elevated temperatures. for now, the government vacuum in retail temperature screening is handing power to retailers and grocers who do not know quite what to do with it. 1 childress, james f., faden, ruth r., et al., “public health ethics: mapping the terrain,” journal of law, medicine, and ethics, 30 (2002):170-178. 2 ab375, title 1.81.5, the california consumer privacy act of 2018. california civil code, part 4, division 3. 3 gavin newson plans to enforce the ccpa beginning in july. “…in an email to forbes, an “advisor” to the california attorney general seemingly made it clear that the office intends to stick with the enforcement deadline of july 1, further issuing a stern warning to california businesses: “we’re all mindful of the new reality created by covid-19 and the heightened value of protecting consumers’ privacy online that comes with it. we encourage businesses to be particularly mindful of data security in this time of emergency.”” robert b. milligan, john tomaszewski, & darren dummit, “the impact of covid-19 on the california consumer privacy act,” trading secrets blog, april 6, 2020. https://www.tradesecretslaw.com/2020/04/articles/privacy-2/theimpact-of-covid-19-on-the-california-consumer-privacy-act/ 4 childress, james f., faden, ruth r., et al., “public health ethics: mapping the terrain,” journal of law, medicine, and ethics, 30 (2002):170-178. 5 employees and customers call for different treatment: employees rightly subject to some tracking and stored data. there is some government input with respect to employee temperature screening. the american with disabilities act (ada) governs and the equal employment opportunity commission (eeoc), occupational safety and health administration (osha), some states, and the cdc have given broad guidance urging temperature screening in certain cases but not giving procedural advice. wilmer hale (law firm website), “covid-19: screening employee temperatures: what employers need to know,” april 3, 2020. https://www.wilmerhale.com/en/insights/client-alerts/20200403-screening-employee-temperatures-what-employers-need-toknow; and see justine phillips, paul cowie, and kelly hensley, “employee privacy forecast: temperature checks,” labor and employment law blog, march 25, 2020. https://www.laboremploymentlawblog.com/2020/03/articles/coronavirus/employeeprivacy-forecast-temperature-checks/ 6 childress, p. 171. http://www.seyfarth.com/robertmilligan http://www.seyfarth.com/johnptomaszewski https://www.seyfarth.com/people/darren-w-dummit.html https://www.tradesecretslaw.com/2020/04/articles/privacy-2/the-impact-of-covid-19-on-the-california-consumer-privacy-act/ https://www.tradesecretslaw.com/2020/04/articles/privacy-2/the-impact-of-covid-19-on-the-california-consumer-privacy-act/ https://www.wilmerhale.com/en/insights/client-alerts/20200403-screening-employee-temperatures-what-employers-need-to-know https://www.wilmerhale.com/en/insights/client-alerts/20200403-screening-employee-temperatures-what-employers-need-to-know http://www.sheppardmullin.com/jphillips http://www.sheppardmullin.com/pcowie http://www.sheppardmullin.com/khensley https://www.laboremploymentlawblog.com/2020/03/articles/coronavirus/employee-privacy-forecast-temperature-checks/ https://www.laboremploymentlawblog.com/2020/03/articles/coronavirus/employee-privacy-forecast-temperature-checks/ zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) 6 7 markel, howard, “what history revealed about cities that socially distanced during a pandemic,” pbs newshour online, april 20, 2020. https://www.pbs.org/newshour/health/what-history-can-teach-us-about-flattening-thecurve?fbclid=iwar1cqzbfhilm-1hmb586kt6rscbpci5q8kwkaomln_pyn9kkkposasojvgs 8 “labonne’s markets to take customers’ temperatures,” nbcconnecticut.com april 8, 2020. https://www.nbcconnecticut.com/news/coronavirus/labonnes-markets-to-take-customers-temperatures/2251765/ 9 nathaniel meyersohn, “why stores could start taking customers' temperatures,” cnn business, april 9, 2020. “dr. luciana borio, former director for medical and biodefense preparedness at the national security council under president donald trump and former acting chief scientist at the fda. "even a modest benefit can be of value when our public health options are so limited in the absence of diagnostic tests, capacity for large scale contact tracing or a vaccine." matthew freeman, associate professor of environmental health and epidemiology at emory university's rollins school of public health, said it "makes sense for businesses to take the temperatures of shoppers to protect employees and patrons, but what would be the response if someone did indeed have a fever? a plan of action is critical."” https://www.cnn.com/2020/04/09/business/walmart-amazonhome-depot-whole-foods-temperatures/index.html see also https://sacramento.cbslocal.com/2020/04/09/coronavirusgrocery-stores-taking-temperature-reading/ 10 propper, david, “supermarkets and pharmacies in greenburgh could start taking temperatures of workers, customers,” rockland/westchester journal news, april 9, 2020. https://www.lohud.com/story/news/coronavirus/2020/04/09/greenburghsupervisor-wants-customers-and-workers-get-temperature-taken-before-entering-store/2974662001/ “next week, when i extend the order i intend (unless otherwise directed by the state) to also require the non invasive taking of temperature of employees and customers. i don’t believe that people with temperature should be allowed into the stores --we all worry about the risk of being infected or infecting others. many people in westchester are dying from the covid-19 -partially because people are careless or inconsiderate of others. although nys law authorizes me to issue the order the town board unanimously approved a resolution endorsing the contents.” greenburgh supervisor, paul feiner. https://greenburghny.com/civicalerts.aspx?aid=433 see also kimmel, robert, “strict new rules for groceries and pharmacies in unincorporated greenburgh to combat covid-19,” the hudson independent. https://thehudsonindependent.com/strict-new-rules-for-groceries-and-pharmacies-inunincorporated-greenburgh-to-combat-covid-19/ 11 meyersohn. 12 meyersohn. 13 “covid-19: drones take italians’ temperature and issue fines,” the star, april 11, 2020. https://www.thestar.com.my/tech/tech-news/2020/04/11/covid-19-drones-take-italians-temperature-and-issue-fines italy is using drones to enforce strict policies that ensure those with elevated temperatures are not out in public. 14 boseley, sarah, “who urges countries to 'track and trace' every covid-19 case,” the guardian, march 13, 2020. https://www.theguardian.com/world/2020/mar/13/who-urges-countries-to-track-and-trace-every-covid-19-case ““you can’t fight a virus if you don’t know where it is,” the who’s director general, dr. tedros adhanom ghebreyesus, said at a briefing on friday. “find, isolate, test and treat every case to break the chains of covid transmission. every case we find and treat limits the expansion of the disease.”” 15 josh smith, hyonhee shin, and sangmi cha, “ahead of the curve: south korea's evolving strategy to prevent a coronavirus resurgence,” reuters, april 15, 2020. https://www.reuters.com/article/us-health-coronavirus-southkorea-respons/ahead-of-the-curve-south-koreas-evolvingstrategy-to-prevent-a-coronavirus-resurgence-iduskcn21x0mo 16 anthony fauci, director of the national institute of allergy and infectious diseases (niaid, part of the nih), is considering an antibody test immunity card to be carried as proof one has developed antibodies. forgey, quint, “fauci: coronavirus immunity cards for americans are ‘being discussed,’” politico, april 10, 2020. https://www.politico.com/news/2020/04/10/faucicoronavirus-immunity-cards-for-americans-are-being-discussed-178784 17 milligan. https://www.pbs.org/newshour/health/what-history-can-teach-us-about-flattening-the-curve?fbclid=iwar1cqzbfhilm-1hmb586kt6rscbpci5q8kwkaomln_pyn9kkkposasojvgs https://www.pbs.org/newshour/health/what-history-can-teach-us-about-flattening-the-curve?fbclid=iwar1cqzbfhilm-1hmb586kt6rscbpci5q8kwkaomln_pyn9kkkposasojvgs https://www.nbcconnecticut.com/news/coronavirus/labonnes-markets-to-take-customers-temperatures/2251765/ https://www.cnn.com/profiles/nathaniel-meyersohn https://www.cnn.com/2020/04/09/business/walmart-amazon-home-depot-whole-foods-temperatures/index.html https://www.cnn.com/2020/04/09/business/walmart-amazon-home-depot-whole-foods-temperatures/index.html https://sacramento.cbslocal.com/2020/04/09/coronavirus-grocery-stores-taking-temperature-reading/ https://sacramento.cbslocal.com/2020/04/09/coronavirus-grocery-stores-taking-temperature-reading/ https://www.lohud.com/story/news/coronavirus/2020/04/09/greenburgh-supervisor-wants-customers-and-workers-get-temperature-taken-before-entering-store/2974662001/ https://www.lohud.com/story/news/coronavirus/2020/04/09/greenburgh-supervisor-wants-customers-and-workers-get-temperature-taken-before-entering-store/2974662001/ https://greenburghny.com/civicalerts.aspx?aid=433 https://thehudsonindependent.com/strict-new-rules-for-groceries-and-pharmacies-in-unincorporated-greenburgh-to-combat-covid-19/ https://thehudsonindependent.com/strict-new-rules-for-groceries-and-pharmacies-in-unincorporated-greenburgh-to-combat-covid-19/ https://www.thestar.com.my/tech/tech-news/2020/04/11/covid-19-drones-take-italians-temperature-and-issue-fines https://www.theguardian.com/world/2020/mar/13/who-urges-countries-to-track-and-trace-every-covid-19-case https://www.reuters.com/journalists/josh-smith https://www.reuters.com/journalists/hyonhee-shin https://www.reuters.com/journalists/sangmi-cha https://www.reuters.com/article/us-health-coronavirus-southkorea-respons/ahead-of-the-curve-south-koreas-evolving-strategy-to-prevent-a-coronavirus-resurgence-iduskcn21x0mo https://www.reuters.com/article/us-health-coronavirus-southkorea-respons/ahead-of-the-curve-south-koreas-evolving-strategy-to-prevent-a-coronavirus-resurgence-iduskcn21x0mo https://www.politico.com/news/2020/04/10/fauci-coronavirus-immunity-cards-for-americans-are-being-discussed-178784 https://www.politico.com/news/2020/04/10/fauci-coronavirus-immunity-cards-for-americans-are-being-discussed-178784 zimmerman, vigilante grocers, voices in bioethics, vol. 6 (2020) 7 18 “taking people’s temperatures can help fight the coronavirus,” the economist, march 26, 2020. https://www.economist.com/science-and-technology/2020/03/26/taking-peoples-temperatures-can-help-fight-thecoronavirus users of kinsa apps which offer medical advice based on temperature data are likely aware the company stores and sells the data. thermometer users probably do not realize their temperatures are recorded or that the company can narrow down their location to the zip code. https://www.economist.com/science-and-technology/2020/03/26/taking-peoples-temperatures-can-help-fight-the-coronavirus https://www.economist.com/science-and-technology/2020/03/26/taking-peoples-temperatures-can-help-fight-the-coronavirus zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) * jake zaikowski, © 2018 jake zaikowski. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. careers in bioethics: interview with dr. paul wolpe jake zaikowski* introduction paul root wolpe is a bioethicist with sprawling interests. he is currently the raymond f. schinazi distinguished research chair in jewish bioethics at emory university, and his biography there lists over a dozen areas of expertise ranging from death and dying to corporate ethics. before he was at emory, dr. wolpe was on the faculty of the university of pennsylvania’s departments of psychiatry, sociology, and medical ethics for over 20 years. in that time he also spent 15 years as senior bioethicist for nasa, where he still serves as a consultant. i sat down with dr. wolpe to discuss his time at nasa and the bioethical issues he faced there. he thinks that the desire to explore is part of human nature and space is simply the next step. that view of exploration guides his thinking on bioethical issues in space. we learned about the most pressing medical issue facing astronauts, why he thinks of risk in a “fuzzy” way, and what teflon has to do with justice. interview jz: hi dr. wolpe, thank you so much for joining me. the first thing we always like to ask is how did you get into bioethics? prw: there are a lot of ways to tell that story. i was always interested in medicine, i was interested in culture and the way we culturally transmit knowledge, why we think we know what we think we know. when you put those two things together, i realized that medicine was probably the single most fertile area of social life for understanding how culture thinks about itself. because it deals with life and death, with healing, with power, with technology. so i became very interested in studying medicine, and actually studied medical sociology – i’m a sociologist. and as i was studying medical sociology at university of pennsylvania, i met renée fox, who was my mentor and one of the first people who thought about bioethics from a sociological perspective. put all that together and that’s how i started out to become a bioethicist. zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 2 jz: i know you’ve got a wide range of interests, from simulation-based medical education to neuroethics. how do you see space exploration and the ethical issues around that fitting into how a culture understands itself? prw: i became the bioethicist for nasa not because i was interested in space ethics; instead, i became interested in space ethics as i became the bioethicist for nasa. nasa needed somebody who really understood research ethics and i was recommended to them. i was in philadelphia, and it was a fairly easy commute to nasa headquarters in washington. and as i began to work with nasa i became more and more interested in some of the ethical issues that the chief health and medical officer had to deal with. so that’s how i got into it. jz: let’s talk about specific medical issues that arise. there’s a huge range of those too, from things like bone demineralization, to radiation, to mental health effects. do you think there’s one or several of these that really stands out and demands the most attention? prw: well clearly, in terms of long-duration spaceflight, if we’re going to go to mars and beyond, clearly radiation is the single most problematic issue. bone loss and muscle loss are both things that happen in space. there are some ways to think about how we might mitigate these issues on longduration spaceflight. you create centrifugal force and use it to apply constant force over all of your body – not so possible on something like the space station – but that’s why just exercise in microgravity doesn’t work. if you just bungee cord yourself down to a treadmill you’re not getting uniform, universal muscle resistance. you’re just getting it at the point of contact. so there are ways to think about that. those problems are significant, but probably surmountable. the problem with radiation in space is that we can’t figure out how to significantly block radiation without adding significant weight to the ship. it seems denser materials block radiation, and denser materials are heavier which is a problem for getting them into space. there are some suggestions about how to do that too, but that probably is the primary problem. jz: what should be the focus in terms of reducing risk? should it be for elements we know will cause a serious effect down the line, like cancer due to exposure in 10 years? or should we be focused on short-term things like acute radiation syndrome from solar particle events – where you’ll become nauseated, you might vomit, you’ll get some skin burns, but it won’t have that same lasting effect? but it will happen during a mission as opposed to, you know, cancer after a mission. prw: it’s interesting because risk reduction for environmental hazards is not that different from another question i spent a lot of time on, which is: how we stock a ship in long-duration spaceflight with medical equipment? especially with drugs. think of it as three elements that vary. first is likelihood of occurrence, the second is severity of occurrence, and the third is effectiveness of countermeasures. so if you think of disease or injury, what’s the likelihood the person will get this disease or this injury, how severe will it be if they got it – how much will it affect them and the mission, and then how good are our countermeasures? and if you think of those three all as sliding scales from 0 to 100, you can move each one and make any of them higher or lower and change the configuration. it’s the same way you think about risks from environmental hazards. what’s the likelihood of something, severity depends how long they’re up there, depends on what kind of countermeasures they have, and it also depends in part on people’s physiology, which brings us to interesting other questions about things like genetically testing astronauts. and then, how effective are our countermeasures? and zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 3 you can’t – it’s hard to choose what is the one thing you need to concentrate on. you really need to try to come up with a strategy that mitigates as much as possible for as long as possible. but there is a principle at nasa they call alara, which is as low as reasonably achievable. and when you have an alara standard, there is some point at which you say, “ok, we’ve done the most that we can, the best that we can, so now, is this risk worth taking?” there’s no one answer to that of course, that’s a judgment call. jz: when you get a situation where you think, “ok, we’ve done everything that we think is reasonably possible,” what do you think would make for a borderline case where you might say “i’m not really sure if it’s worth the risk at this point”? what might be the circumstances for that? prw: sure, long-term irreversible health risks that mean significantly earlier death or significant chance of life-threatening disease. i’ll give you an example. according to nasa and the national council on radiation protection and measurements, the amount of occupational radiation that’s allowed for astronauts is the amount that would raise someone’s lifetime risk of cancer by 3%. now that measure is arbitrary. i don’t know exactly how they came up with 3% they could have come up with 2%, they could have come up with 4%. they just settled on 3%. everybody would agree that something that increased an astronaut’s risk of death or serious disease to 50% is not acceptable, and 1% is acceptable. and then – what about 2 , 3, 5, 10, 15, 20 – i mean, there is no magic moment over which risk becomes unacceptable. it’s very much a negotiated level of tolerance. and it also depends on the importance of the mission itself. so we set up these standards, they’re arbitrary, they’re hard to defend, in that if someone says “i’ve reached my lifetime allowable occupational radiation exposure, but you need me for this really difficult task, so it’ll raise my lifetime risk to 3.25%,” it’s very hard to say “absolutely not, that’s outrageous, we can’t tolerate it.” it just doesn’t make any sense because 3.25% is just as arbitrary as 3%. there really is a significant philosophical problem with risk assessment in that sense, in that human beings, when they think about risk, think about it in a kind of fuzzy way…because it is fuzzy. that is, these numbers don’t have real meaning, there’s no way to make any kind of definitive determination that one number or another number is where we should draw the line. that’s why i think of the ethics of these kinds of things as negotiated. and also, importantly, an organization like nasa, which has a responsibility for the safety of the astronauts and of all its employees, has to take a harder line than often the astronauts take themselves. there is a kind of appropriate paternalism, which by the way often really annoys the astronauts. there is a point at which nasa says “i know you’re willing to take this risk, but we can’t allow it because we as an agency have a responsibility to you as an employee, even if you’re willing to take the risk.” jz: that is really interesting, because one of the next topics i wanted to talk about was astronauts as research subjects. in some ways they’re participants like anyone else. they have to receive basic protections, they have a right to be informed, etc., but at the same time they’re clearly unique as a group of research participants. they experience significant harms that don’t offer them direct benefits, and you can’t really imagine any irb on earth approving any sort of study for non-astronaut participants on earth in those circumstances. but of course the ones for astronauts get approved all the time. how do you think that we should think of astronauts as their own type of research participant? zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 4 prw: astronauts of course are subject to the same regulations as everyone else: they have a right to withdraw from participation at any time without penalty, they have the right to refuse participation, but that’s problematic for space research because the kind of research that’s done in space has very, very low sample sizes. you might do it on one or two or three astronauts, especially these days because so few astronauts go into space. and then there was a whole other problem that arose about astronaut participation in research – confidentiality. if you do a study on astronauts with a sample size of three, it’s very hard to anonymize the data. if one is 5’3” and 150 pounds and male and the other is 6” and 190 pounds and male and the other is female, you can’t give any demographic data to try to correlate with your findings because immediately you’ll know which astronaut it is. and that became a very big problem. so you have the problem of withdrawal, of refusal, of confidentiality. these are all in some ways unique to the astronaut situation. this came to a head with the safe passage report, where the institute of medicine was asked to look into research by nasa, came up with a suggestion that for astronauts we should “reinterpret” the common rule, which is the regulation that protects all human subjects involved in research in the us. what they were basically saying was we should make astronaut participation in research much more difficult for them to avoid and withdraw from. i think that that’s a very misguided approach. i think a far better approach is, and this is actually the approach they ended up taking, to simply get astronauts far more involved in the research process. it’s one thing for the powers that be in houston to just tell you what research you will conduct and participate in. it’s quite another thing if you’ve got astronaut scientists who are part of the review panel because studies in space go through an irb review but they also go through a scientific merit review. so getting astronauts involved from the beginning, seeing it as a shared common enterprise, does a lot to keep them from withdrawing or refusing to participate and they care less about confidentiality. this is a much longer, more complicated issue than we have time to talk about now. there are a bunch of other issues around confidentiality that, one of the things that i did was help solve those issues. but the bottom line is yes, they’re unique research subjects, but there are a lot of unique research subjects in the world. if you want to cure an orphan disease that only has a few thousand people in the world who get that disease, and you have a drug you want to test because you think it might treat or cure this disease, well those few thousand people are just as rare and just as valuable as astronauts are to nasa. that is, you can’t find out if this drug works without their participation, and they’re the only ones who can participate. so that’s the first thing. the second thing is you made what i think is the important point here, which is when irbs think about the research that they do, they think about the risk-benefit ratio. in medicine it’s usually really clear what the benefit is. in space it’s not. and i once asked when i first started at nasa, i asked the irb at the johnson space center to describe to me the benefit standard that they used when they were doing risk/benefit analysis of studies, and they couldn’t. that’s because there are a lot of different ways to think of that benefit. is the main benefit of research in space the benefit to the next astronauts that go up? is it to the space program as a whole? is it to the country or to mankind as a whole because when the asteroid hits we’re going to need it? if you think of the benefit of space research in the broadest terms, ultimately it’s there to assure the future of mankind because we need to colonize other planets because the earth will be destroyed at zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 5 some point. then there is no risk that’s not worthy of taking. on the other hand, if it’s just so that the next astronauts will be marginally more comfortable, the next group up, then you have a very high bar. you have to decide what is the benefit against which this research is being measured. and i have my opinion of what it should be, and different people think about it differently, but i think the real challenge there is that nobody was really sure what it was. jz: that’s interesting as well because of something else you’ve spoken about in other interviews in the past, the idea of “exploration” being a good and a principle in and of itself. prw: and it is. and i believe that. and there are a lot of goods in the world that aren’t worthy of risking people’s lives for. jz: i read the remarks you gave at the interfaith platform speech, where you had mentioned the good of exploration, but noted that exploration can cause really bad things, your example being the colonization of america and the millions of deaths caused by that. what were your thoughts on that? prw: the exploration itself wasn’t harmful. the colonization of the united states wasn’t an inevitable result of exploration, it was a result of exploration accompanied by an imperialistic ideology. so, you know, we now engage in certain kinds of exploration in order to protect tribes. there are tribes in various countries where the countries don’t allow outsiders to interact with those tribes as a way to try and preserve them and their way of life. so exploration was required to identify those tribes. but human beings are innately curious creatures and we’re not going to stop exploring. the issue isn’t explore or not explore. the issue is what kind of an ideological position do we take with us. do we use the prime directive and not harm others, not involve ourselves with or disturb, if we were to discover intelligent life that was less advanced than us on another planet? who knows? we haven’t made those decisions yet and they are still far in the future – we can barely get off this planet. but you know, those are really important questions to have a conversation about and think about standards for before we start looking around the universe. jz: the idea of trying to categorize exploration as a good – do you think that would fall under one of the 4 principles of bioethics – beneficence, non-maleficence, justice, and autonomy? do you think exploration falls under one of those four or would be its own fifth principle? prw: i don’t use those principles, i don’t think of them as the basic principles of bioethics. they were principles that were created in the 70s and i think bioethics has gone way past them. but i will say that all of them, and others that were not included in beauchamp and childress’ principles, have an impact on exploration. human beings have the autonomy to explore, they need to do it with an eye not just towards not harming human beings but not harming other animals. our exploration on this planet has resulted in extinctions of species, so it’s not just about human beings. justice of course, we were just talking about colonizing the united states. so all of them are relevant. but the question of exploration, again for me, really isn’t that different than other human activities, in the sense that it isn’t the activity itself, but it’s the principles and the moral structure we bring to the activity that’s really the issue. i would really be interested to see what happens if we find even microbial life on mars. there is an office at nasa whose job it is to make sure that all spacecraft that land on mars and the moon are sterilized to the degree possible so that we don’t inoculate mars with bacteria we bring from spacecraft that we send there. zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 6 that has two kinds of reasons. one is scientific, we don’t want to send bacteria up there and then discover it and think it’s indigenous. the second is ethical. there was an office there – i think they’ve changed the name of it now – when i first got there, a guy there named john rummel was the head of that office. and his title was chief of planetary protection. which i think is like the coolest title a human being can have. jz: you think he might be shooting down asteroids, right? prw – yeah imagine “what do you do, dad? well i protect planets, my job is to protect planets.” but i was talking to him one day and he really said something that fascinated me. he said, “my job is to protect the ecosystem of the moon and mars.” and i said, the moon doesn’t have an ecosystem, it’s barren rock. and he said “well, you say it doesn’t have an ecosystem, to me it has an ecosystem because i have to believe it has an ecosystem if i’m going to protect it. if it’s just a rock there’s nothing to protect.” i thought about that a lot, it’s a fascinating moral statement. because what he’s really saying is “i need to think of this as something i can have a relationship to, i can’t have a relation to a rock, i just don’t have the emotional framework to have a relation to a rock. but i can have a relation to a living ecosystem. so i need to, in my mental construct, think of it as a living ecosystem if i’m going to really protect it properly.” and i think it’s a brilliant moral statement in many ways. that question of what are the ethics of the way we explore, i can’t think of a more articulate and profound statement of that than the one he made. jz: one of the recurring themes i keep hearing from you so far is that, there’s a sense that this is going to happen and it’s a matter of making sure we do it in the most ethical manner possible. even the acronym of alara, as low as reasonably achievable, is ultimately recognizing that in some cases we’re just not going to be able to get this to what we consider a “safe” level, but we just have to accept that. prw: but that was always true of human exploration. human exploration always caused death and disability and disease and injury. you know, we are very risk averse, in the way we think in the united states these days in many ways. but we’re not going to explore the world with a totally risk-averse attitude. there are people who believe taking risks is worth it and do things in their lives – extreme sports and other things – where they think of proximate rewards being worth the risks. and as a society, eventually we’re going to have to figure out what risks we are willing and not willing to take. but given the very, very compelling human desire to explore, i believe we’re going to find a way to make the risks as low as possible but accept them finally so that we can continue to explore. jz: there’s been a big rise lately in private companies doing more and more to increase the frequency of going to space. spacex obviously, united launch alliance, and others. do you have thoughts on new ethical issues to think about when there are private companies going to space? prw: with public companies like nasa, their activities were at the behest of congress, so they were always worried about what congress would think about what they were doing, because congress ultimately allocated their budget. so whenever there was a disaster of some kind or some problem at nasa, a part of the concern was how is this going to affect our budget and what congress thinks of us. that’s not true with private companies, but what is true about private companies is they are responsive to the general public. private companies can collapse and fall just based on the perception by the public that they’re unethical. so there are some things that can strain private companies, but they almost certainly will engage in certain activities that nasa deems too risky for them to try. it worries me zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 7 in the sense that it’s possible that private companies, especially if there are few of them and if they’re competing with each other, will take risks that might be inappropriate risks, safety level risks. that could happen, i’m not convinced it will. i think we give private companies a bad rap and often i’ve seen private companies be more safety conscious than not-for-profits and other kinds of places. so i’m not convinced that’s what’s going to happen, but it is something that we need to be vigilant about. jz: do you see big issues coming up bioethicists will have to deal with regarding human spaceflight? prw: i think that the big issues that we’ll have to deal with have to do with the privatization and commercialization of space. it’s going to be a while before we start mining asteroids and mining the moon, and maybe mining mars, but it is going to happen. there are two kinds of financial incentives for going into space. one is surveillance or communications. can we stay in low earth orbit and somehow reflect back down on the earth with communications or other technologies, and will going into space help us figure out how to do that? atmospheric manipulation and other things like that. but the other one is to try to find materials that are valuable to bring back to earth. now that’s still far in the future but we have some pretty long-term thinkers right now like elon musk and others that are working on this. even the oceans aren’t as inhospitable to human beings as space. i mean we came from the oceans. and so you really have a tension there between the desire to move this forward and the fact that the human body isn’t designed for that. there are two possible solutions for that. one is robotics and thinking of space exploration and space activity not as a human-based activity but as a robotics-based activity. and there are really some reasons to think that would be the best way to go for a lot of this. but then there’s both that insatiable desire for human beings to go out and explore, and also there really are some things that only human beings can do. so i think that’s where the great problem will arise, the degree to which we, especially at the beginning while we’re still bad at it, send people into work environments in space and end up hurting them. and it’s going to happen, the question is just to what degree can we avoid it, try and mitigate it. jz: the last topic i’d like to discuss is technology transfer. when you go to space, there’s a lot of technology that gets created for it with a lot of useful applications on earth, but there is also this big interesting issue around justice too, of what types of technology are being produced and who does it benefit. prw: well you know if you talk to nasa, one of nasa’s raps is that, when you talk about “we’re putting all this money into space travel, and what are we getting out of it?” they’ll be very happy to trot out teflon and other things– jz: –tang. prw: yeah, tang. things that came out of space exploration. you know tech transfer is one of their big success stories from their perspective. and i think it’s true, but the counter to that is yeah there’s a lot of interesting tech that came out of space exploration, but if you took the money for space exploration and you just put it into technological development, you’d get a lot more out of it. so that’s nice, but i’m not sure it zaikowski, careers in bioethics: interview with dr. paul wolpe, voices in bioethics, vol. 4 (2018) 8 justifies – i think there are other things that justify it – but i’m not sure that tech transfer is what justifies the space program. that being said, all of these explorations, going to space, all of the technology that’s developed, a lot of it will have applications outside the immediate reason for which it was developed. but i’m not worried about it because the companies that develop that will want to leverage it anyway. so it goes out onto the market the way all technology development goes out onto the market. i don’t think there’s anything special about it. you know, we can criticize how we do technology distribution and dispersal in general. i don’t think there’s anything particular about the space program. jz: dr. wolpe, thank you so much for your time. prw: happy to be able to help. ___________________ introduction weisburg, the psychos are coming, voices in bioethics, vol. 2 (2016) * edmund weisburg, senior science writer, john’s hopkins medicine, ms bioethics, ms international development © 2016 edmund weisburg. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the psychos are coming, the psychos are coming…they’re already here: contagion of corporation edmund weisberg* abstract american director steven soderbergh’s contagion wastes no time in laying out the context of his film on the contemporary interconnectedness of the earth’s inhabitants and the concomitant susceptibility to catastrophe that such relationships imply. despite the apparent incongruity in equating corporate and human rights, human beings—albeit ones often far removed from the typical quotidian struggles of most of our species—are at the reins of corporations. films such as contagion and the corporation imply that the human-made monstrosities—the corporation and its coursing lifeblood, unbridled capitalism—act as the most formidable behemoths, and the greatest threats to the continued existence of our species, not to mention scores of others. keywords: pandemic anxiety, contagion, mental health guidelines introduction american director steven soderbergh’s contagion wastes no time in laying out the context of his film on the contemporary interconnectedness of the earth’s inhabitants and the concomitant susceptibility to catastrophe that such relationships imply. likewise, the frenetic opening sequence of flashing corporate logos in canadian filmmakers mark achbar and jennifer abbott’s the corporation, juxtaposed with the poster image of a silhouetted businessman with a scrawled devil’s tail and halo floating above the hat, potently hints to the argument ahead. on the surface, the two films appear to have little in common. the former, a quintessential contagion film, is a fictional thriller explicitly focusing on and extrapolating the effects of a global viral pandemic. the latter is a trenchant documentary scrutinizing the prime directive of the corporation—to maximize profit for its shareholders—in the light of human behavior. the canadian directors ask not what the implications would be if individuals acted like corporations, but, rather, how we should characterize and even diagnose corporate behavior according to standards used to evaluate individual humans. both films surprisingly arrive at a thematic nexus, however, raising central questions relevant to intersecting film genres and, more significantly, similar commentaries on the human condition. ____________________________________________________________ analysis contagion by corporation contagion begins on day 2 of what we quickly learn is an emerging epidemic. with the narrative bouncing from major star to major star in an ensemble celebrity cast reminiscent of 1970s disaster movies, the soderbergh vehicle deftly moves at a throbbing, pulsating, breakneck pace paralleling the alacrity of its mysterious virus. the characters, carefully selected to anchor the proper vantage points from which to convey an infectious disease narrative, are developed sufficiently to service the plot but not as full-blown individuals on whose plight viewers are inclined to expend much emotional energy. in fact, two of the principal characters, beth emhoff and dr. erin mears, portrayed respectively by gwyneth paltrow and kate winslet, serve as vectors of weisburg, the psychos are coming, voices in bioethics, vol. 2 (2016) 2 disease propelling the story forward but whose deaths do not likely elicit tears. the momentum of the movie, as reflected by the unremitting transmission of the virus, marginalizes such characters. more cinematic time concentrates on the investigation of the advancing virus and unraveling of the mystery, theoretically before the contagion fells all of humanity. before her death, dr. mears works remotely, but in tandem, with laurence fishburne’s centers for disease control and prevention character. their fevered attempt to understand and mitigate the spiraling epidemic is matched by marion cotillard’s diligent world health organization epidemiologist, who ultimately acts in service to one of the main messages of the film. through cotillard’s character, viewers learn that many of the world’s citizens, particularly nonwhite ones in less developed countries, perceive that world health officials view the wellbeing of those in western developed countries as more important. this is certainly not unfounded. recent cases of western pharmaceutical company pfizer’s malfeasance in a nigerian meningitis outbreak and nestlé’s ongoing efforts to foist baby formula and now bottled water on the african indigent are but the tip of the now rare non-melting iceberg.12 the jude law character, a conspiracy blogger, proffers a plausible argument on big pharma greed and governmental subterfuge in developing and hoarding a vaccine. but he appears to have ulterior, self-serving motives. in its potential explosiveness, his storyline sets the staccato pace of the narrative but, like most of the subplots, diverts attention from the sick and dying. in fact, mitch emhoff, initially bewildered by his wife’s hospitalization and unexpected death, becomes the focal point of the film as caretaker for who we soon learn after he rapidly succumbs to the virus is his stepson. after his isolation due to apparent immunity to the microbe, his arc shifts from what could be a lugubrious period as his daughter arrives—following the deaths of his wife and stepson—and mitch and his daughter segue into pure survival mode, in an increasingly bleak, dystopian, and pre-vaccine landscape. but we are not finished with beth emhoff. despite her minuscule screen time, she plays a pivotal role. her character is among the prime suspects for being patient zero—the first to be infected—along with the three unnamed characters in london, hong kong, and tokyo whose accelerating symptom manifestations we observe. in the early exposition, paltrow’s character stops in chicago for a tryst with an old flame before returning home to minneapolis. this potential red herring provokes the viewer to question whether beth is liable for spreading the lethal disease and if she warrants sympathy. soderbergh’s invocation to the all-toohuman penchant for casting aspersions is likely a subtle allusion to hiv/aids, the most significant global pandemic in the last 40 years. homosexual males, identified as a high-risk group, bore the brunt of societal bigotry at the onslaught and through much of the epidemic, though others at high risk, including haitians, hemophiliacs, and heroin addicts (intravenous drug users)—leading to the 4hs designation of the denigrated (with “hookers” sometimes substituted for hemophiliacs)—were not spared.3 although withering judgments have moderated with time and hiv has become more of a chronic than acute condition for those with access to the proper drugs, the discovery of the cause of the virus—a zoonotic infection transmitted from chimpanzee to human in colonial cameroon over 100 years ago—is certainly decades too late in most senses for those who were maligned for having contracted the disease.4 even today, the u.s. food and drug administration effectively bars donations of blood from gay and bisexual men, despite vast improvements in blood screening for hiv.5 once a stigma is placed, it becomes easily entrenched. so, does beth deserve our undying condemnation? in the concluding scenes, while he prepares to photograph his daughter’s private prom in their home with her vaccinated boyfriend, mitch scrolls through his digital camera, finding the last photos his wife took for him while on a business trip for her company, the mining firm aimm alderson. roughly six months after her death, she is clearly still mourned. also, as we see in a flashback to day 1, she is patient zero. in the film’s final revelation, we learn that her employer cut down the trees that displaced the infected bat, facilitating its flight path to the farm where it dropped the piece of fruit that served as the conduit for viral transmission. so, beth’s association with alderson, and not her sexual indiscretion, positioned her to set off a global calamity. in an eerie, ominous ending, soderbergh implies that the rapacious actions of aimm alderson, which took aim only at felling trees to maximize its profits with no apparent malevolence, is responsible for weisburg, the psychos are coming, voices in bioethics, vol. 2 (2016) 3 propelling the pestilence. unleashing the monster the tag line for contagion is “nothing spreads like fear.” indeed, mortal dread catalyzes several film genres and is even the emotion most exploited by the powerful to manipulate the behavior of others. fear, in contagion films, is as rampantly contagious as the infection in question. while the disease depicted in the film is contained within its limits, panic transcends its boundaries, viscerally affecting many audience members long after the closing credits. but what is it that we’re afraid of? fear of an invisible microbe that wipes out millions, such as the spanish flu of 1918 cited in contagion, hiv/aids, or the virus that drives the film, represents an understandable aversion to disease and death present in our psyches, but also to premature death in uncontrollable circumstances. human arrogance and avarice interact, providing ample examples and fodder for film to illustrate concern that evolves into anxiety or fear. for instance, our persistent belief in our dominion over nature and simultaneous push for profit has permitted multiple corporations to run roughshod over the earth, generating the perfect storm for unleashing anthropogenic climate disruption (acd; better known as climate change or global warming). on a small scale, the exxon valdez calamity in prince william sound, alaska, in 1989 and the bp deepwater oil disaster in the gulf of mexico in 2010 fit this toxic bill. considered by many to be the seminal horror novel, frankenstein, penned by the precocious mary shelley, terrified readers and eventually inspired a veritable cottage industry of cinematic adaptations. the story is a horrific tale of hubris run amok, as dr. victor frankenstein succeeds in synthesizing a “creature” from cadaveric body parts. despite popular culture identifying “frankenstein” as “the monster,” the imposing, formidable but misunderstood “fiend” is not as truly monstrous as its creator dr. frankenstein. indeed, contagion sparks primal fear of a monstrous microbe threatening the world. but the lethal virus itself is unleashed by dint of the avarice demonstrated by the aimm alderson colossus. as contagion makes clear, the object of our apprehension is not always visible. the movie monster is a facile metaphor for and manifestation of our deepest fears. but where do we turn when unable to discern what poses us the greatest harm? the original and first remake of invasion of the body snatchers and john carpenter’s the thing, perfect metaphors for “illegal aliens,” speak to xenophobia, prejudice, and fear of the other—particularly those that can pass, such as homosexuals, religious minorities, and patients, in many cases—and the consequent confusion over identity and terror when it is realized that the other is just like oneself. the object of abject dread hides in plain sight and lives among us. corporate contagion the corporation, by canadian filmmakers mark achbar, jennifer abbott, and writer joel bakan, begins by intimating at the pervasive power of big business. corporations undeniably wield significant influence in our daily lives. the documentary details the birth of the modern corporation, also laying the groundwork for validating the examination of the corporation as a psychiatric patient. it proceeds to describe the activities of corporations intrinsic to their nature and assesses them according to guidelines appearing in the psychiatric/psychological industry international statistical classification of diseases and related health problems, 10th revision (icd-10) standard diagnostic and statistical manual (dsm) of mental disorders iv. in this respect, the corporation belongs among the canon of health care films, particularly psychological health. specifically, the corporation may be aptly considered a contagion film, and somewhat prescient at that. by seven years, the corporation preceded the citizens united v. federal election commission decision of the u.s. supreme court that codified corporate personhood.6 while seemingly a landmark case, it enshrined an insidious, protracted intrusion of corporations into the realm of personal or civil rights that began, as the filmmakers argue, shortly after the u.s. civil war. lawyers used the 14th amendment to the u.s. constitution to argue for the personhood of corporations. as a legal “person,” corporations are “special weisburg, the psychos are coming, voices in bioethics, vol. 2 (2016) 4 kinds of persons, with no moral conscience,” opined noam chomsky, groundbreaking linguist and political philosopher from the massachusetts institute of technology, who was interviewed in the film. the derisive response to such a notion following the citizens united supreme court decision in 2010 was epitomized in a protesting wag’s placard that read: “i’ll believe corporations are people when texas executes one.”7 the corporation takes a logical step by evaluating corporate behavior according to human standards and checking off diagnostic criteria in the dsm. using intermittent strains of menacing music, occasional humor, and interviews with reformed chief executive officer ray anderson—who describes the deleterious effects of his own company and seeing the errors of his ways—and liberal luminaries such as chomsky, naomi klein, the late howard zinn, vandana shiva, and michael moore, the film presents a balanced emotional palette while detailing the inherently amoral structure of the corporation and its frequently nefarious actions. thus, the film frames the modern corporation as an entity that routinely shows callous disregard for the feelings and safety of others, harms animals and the environment, exhibits deceitfulness but no capacity to experience or admit guilt (or limited liability, one might say), and fails to “conform to social norms with respect to lawful behaviors.” the dsm and its many contributors, as any human enterprise, are hardly infallible. after all, previous editions of the oft-cited work once labeled homosexuality as an illness. but the nimble use of the dsm-iv in this context makes a cogent case for diagnosing corporations as psychopathic. truly pernicious examples abound and the movie highlights various transgressions against the biosphere—multiple arboreal clear cuts, carbon dioxide emissions, and production of nuclear waste— courtesy of several corporations, acts that might upset most sensibilities if widely known. for instance, during world war ii, to ensure a steady stream of profits from nazi germany, atlanta-based coca-cola concocted fanta orange and purveyed it to the third reich. currently, nestlé bottles and sells water extracted from drought-stricken california, marketing it back for astronomical profits to residents living with government-mandated water restrictions.8 the inexorable corporate search for profits knows no limits, moral or otherwise, save the various regulatory schema that some governments try to impose, and companies incessantly try to outmaneuver, often finding gaping loopholes. such safeguards are also under merciless attack even from governments beholden to corporations and colluding with them to advocate for the secretly negotiated trans-pacific partnership (tpp). this purported “trade” agreement—which includes 30 chapters only six of which pertain to trade—and similar pacts, such as the transatlantic trade and investment partnership (ttip), would shield corporate accountability from sovereign countries, allowing corporate rights to transcend those of nations and, especially, individual citizens.9 the corporation evokes unease in suggesting that corporate malfeasance, committed by pharmaceutical or any variety of companies, can cause widespread human suffering. contagion turns the concept of scapegoating on its head in demonizing a faceless, amorphous entity that, the u.s. supreme court notwithstanding, hardly seems human or deserving of compassion while managing to elude accountability. the corporation suggests one potential psychotherapy: governmental action to revoke corporate charters. the prognosis proposed by the film comes from documentary filmmaker michael moore. he notes the irony of his movies being distributed by studios or corporate networks whose work and very ethos he attacks— thus supporting the contention that such entities display an amoral, valueless attraction to profit. they know that regardless of the views he espouses, he will earn them money. moore concludes, and the filmmakers agree, that cognizance of how depraved corporations behave may spur real human beings to act, contravene, or resist as appropriate. as the corporation offers at least a glimmer of hope, contagion also provides a slightly encouraging nod for humanity. while it ends menacingly on day 1, the picture follows multiple altruistic efforts and ultimate success in curing a global affliction. conclusion the corporation definitively and defiantly analyzes and diagnoses the modern corporation through the prism of guidelines designed to gauge the mental health of individual patients. by putting the corporation on the couch and subjecting it to a clinical gaze, the filmmakers deliver a refreshing take on highly influential weisburg, the psychos are coming, voices in bioethics, vol. 2 (2016) 5 actors on the world stage. in the grand tradition of horror, monster, and disaster films, they present a genuine cause for alarm—a threatening invader is in our midst. despite copious evidence to justify pessimism or despair in the face of an epic battle against a paradoxically brash, omnipresent, insidious entity that imperceptibly encroaches on our lives, they suggest rather than curing the psychotic patient, healing its likely victims. awareness is the first step toward combating an affliction or an addiction to intrinsically harmful practices, but is it too late to surmount the contagion of corporation and all that it has wrought? is it better to lose oneself in a scary movie than to contemplate the horrors human beings have inflicted upon one another and the planet? might one leave such films more unsettled than entertained, but moved to act? contagion concludes on a note of flagrant foreboding. the corporation, perhaps unexpectedly, ends with a ray of optimism. contradictory and conflicted as we are in the human condition, we likely need to contend with despair and hope as we wrestle with our real (manmade or not) and imaginary demons. despite the apparent incongruity in equating corporate and human rights, human beings—albeit ones often far removed from the typical quotidian struggles of most of our species—are at the reins of corporations. human beings are capable of creating great beauty and appreciating the wonders of the natural world just as we are culpable for engendering abominations, ineffable horrors, and wanton destruction. our species’ haughtiness, which spurs reckless self-aggrandizement and unremitting avarice for ever more riches, helps to render us unable or loath to admit that we pose the greatest risk to our planet’s diversity of life. films such as contagion and the corporation imply that the human-made monstrosities—the corporation and its coursing lifeblood, unbridled capitalism—act as the most formidable behemoths, and the greatest threats to the continued existence of our species, not to mention scores of others. do we have the capacity to rein in the violence and virulence of corporations, to tame the beasts that we have created and continue to feed, before their amoral, indifferent machinations for profit perpetuation drive us, and them, to extinction? 1 d. smith, “pfizer pays out to nigerian families of meningitis drug trial victims.” the guardian, august 12, 2011. 2 m. muller, “nestlé baby milk scandal has grown up but not gone away,” the guardian, february 13, 2013. 3 s. gupta, “change in law necessary to address hiv discrimination,” the hill.com, november 6, 2012. 4 t. maugh ii, “book review: ‘tinderbox’ by craig kimberg and daniel halperin. los angeles times, march 18, 2012. 5 fda news release, “fda updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the u.s. blood supply.” december 21, 2015. retrieved from:http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm478031.htm. 6 a. germanos, “citizens united at three: grassroots fight against ‘corporate personhood’ swells. common dreams. january 22, 2013. retrieved from:http://www.commondreams.org/news/2013/01/22/citizens-united-three-grassroots-fight-againstcorporate-personhood-swells. 7 d. kurtzman, funny political protest signs.about.com. retrieved from:http://politicalhumor.about.com/od/funnypictures/ig/funny-protest-signs/i-ll-believe-corporations-are-people.htm. 8 c. davis, “protesters tell nestlé to stop bottling california water.” alternet. may 22, 2015. retrieved from:http://www.alternet.org/environment/protesters-tell-nestle-stop-bottling-california-water. 9 public citizen. “trans-pacific partnership (tpp): more job offshoring, lower wages, unsafe food imports.” retrieved from: http://www.citizen.org/tpp. becker, covid-19 as a call to responsibility for the vulnerable, voices in bioethics, vol. 6 (2020) © 2020 sarah becker. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. covid-19 as a call to responsibility for the vulnerable sarah becker keywords: nursing homes, care for the elerly, old age, bioethics introduction the high covid-19 death rate among elderly individuals living in nursing homes has been attributed to overworked staff, poor infection control, limited resources, and the transfer of infected individuals into longterm care facilities. while these circumstances have certainly contributed to the problem, we should view them as symptoms—rather than root causes—of a deeper, more significant ethical problem: our tendency to shun responsibility for the weakest and most vulnerable individuals among us. as a former nursing home and hospice aide, i acknowledge the intensely unnerving nature of human suffering, especially when it afflicts the elderly and dying. spending hours caring for patients who are unable to move their limbs, control their bowel functions, or breathe without the assistance of morphine is difficult for even the most compassionate and generous caregivers. analysis frailty and dependency are challenging phenomena to encounter, and thus it is unsurprising that we treat the process of aging and eventually dying as an awkward, shameful appendix to the busy, productive, and efficient years which constitute our “real lives.” though any of us might be diagnosed with incurable, stage four cancer tomorrow, or suddenly become the victim of a severe car accident, we collectively prefer to ignore our mortality. when it finally and unavoidably stares us in the face, we pray it passes as rapidly, painlessly, and privately as possible to minimize its inconveniences and undignified details. avoiding death is easier than facing it head on; outsourcing care is more comfortable than providing it within the context of our own families and communities; and, it is more convenient to offer cheap, expedient methods of care rather than work towards high-quality compassion. our hesitance to encounter intense suffering and the raw realities of death have caused us to place a low priority on caring for our elderly population. when i worked as a nursing assistant long before the pandemic, this was painfully obvious to me: i was offered more overtime than i could possibly accept, worked with staff poorly trained in infection control, accepted the frequent staff turnover as normal, and often left completely exhausted. some nights, after an becker, covid-19 as a call to responsibility for the vulnerable, voices in bioethics, vol. 6 (2020) 2 especially intense shift, i sat in the parking lot and cried, both for my lonely, frustrated patients, and for my own inability to remedy suffering which could have been avoided. it is true that the elderly often require lower levels of care, yet it is an illusion to believe this justifies providing low-quality care. a nursing home is no icu: bathing and dressing replace intubations and intensive monitoring. end-of-life care is composed of a thousand basic tasks which demand relatively minimal amounts of medical skill. nevertheless, these patients are no less worthy of care than someone undergoing more intensive treatment, nor is their multifaceted humanity as physical, emotional, and spiritual beings any less complex. if anything, addressing the innumerable dimensions of human wellness is more difficult and more important as death approaches than at any other point in the human lifespan. old age inevitably brings a unique set of challenges and dying is always difficult. how our society approaches the responsibility of caring for the elderly and dying, however, reveals our most fundamental beliefs about what it means to care for the vulnerable. either we will continue to perceive this obligation as nothing more than an endless string of mundane tasks which fall outside the serious consideration of public health policy, or we will view it as a profound opportunity to accompany our fellow human beings during some of the most important days of their lives. the consequences of our choice are not merely death or life. though we certainly must avoid causing the premature death of others, the primary goal is not indefinite life expansion. instead, what is ultimately at stake is whether we will craft a society which views everyone as equal members who are worthy of dignified support regardless of age, ability, or any other characteristic. conclusion the covid-19 tragedy sweeping through nursing homes not only requires the prompt action of public health officials, but also demands that we as a society open our eyes to a hidden, underlying tragedy: these inequities that plague our approach to caring for the vulnerable lead us to treat the elderly with mediocrity and neglect rather than integrity and good medicine. the process of growing old and facing death does not need to be a depersonalized, undignified experience. instead, it can be full of joy, community, and deep bonds of friendship, though this manner of caring for our elders will be difficult at times. this is to be expected— building a just, compassionate, and authentic human society is never an easy task. it will challenge us to not only wear masks and stay home, but also to undertake the difficult tasks of re-evaluating our most fundamental beliefs about what it means to care for those who need us the most and remedying our failure to do so. burkard, the importance of using deferred proxy consent, voices in bioethics, vol. 4 (2018) © 2018 jake burkard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the importance of using deferred proxy consent in emergency clinical research jake burkard keywords: proxy consent, surrogate consent, research, clinical trials introduction obtaining informed consent from potential research subjects can be fraught with difficulty at the best of times. in emergency and critical care settings, informed consent from patients themselves is seldom obtained because they often lose decision-making capacity as a result of their severe illness. although proxies are commonly recognized as the first party to represent an incapacitated patient in emergency situations, it is not always logistically possible to obtain their consent. furthermore, time pressures and overwhelming emotions may decrease the value of surrogate consent in emergencies. to overcome these problems deferred proxy consent, or retrospective proxy consent, has been implemented as an alternative for informed proxy consent. although there are inherent ethical challenges in applying deferred proxy consent, i will demonstrate that its application is crucial to protect patient populations in emergency clinical trials when following appropriate ethical guidelines. analysis retrospective surrogate consent is applied when inclusion into emergency research involves randomization at the discretion of the investigator or the physician in charge. after inclusion of the patient into the study and after starting the study procedures, the proxy is informed, and subsequent consent for continuation in the study is requested. research without informed patient or surrogate consent raises concerns about unethical practices and the loss of individual autonomy. the major objection to deferred informed consent, therefore, is that it erodes patient autonomy. according to bioethicists, retrospective proxy consent is ethically dubious when study procedures are finished before proxies can be informed and consent obtained. a patient may die, for example, after being enrolled in a clinical trial but before the surrogate can provide retrospective consent. deferred proxy consent, therefore, most clearly violates principle 28 of the declaration of helsinki: for a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorized representative. these individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden. based on the premise that investigators need to seek informed consent from a surrogate but fail as a result of logistical impossibilities, some bioethicists conclude that the patient has been used as a burkard,, the importance of using deferred proxy consent, voices in bioethics, vol. 4 (2018) 2 means to an end and that patient integrity is lost. based on principle 28, these same bioethicists argue that retrospective proxy consent is unethical because informed proxy consent should be obtained before enrollment in clinical trials. thus, they conclude that the principle of respect for persons is violated. although their ethical considerations are well intended, i believe bioethicists who subscribe to it use a too weak standard of autonomy and do not consider the patient’s best interests. under the best interests standard, a proxy must determine the highest likely net benefit among the available options. a patient’s relevant autonomous preferences, however, often remain unknown to designated surrogates. if a patient’s preferences are unknown, we should subscribe to the most suitable medical treatments that, on balance, provide greater probable benefits than harms for the patient. we should trust “physicians [to] use judgments about the ethical acceptability of research involving human subjects.” physicians routinely make judgments based on the most suitable medical treatments on the balance of probable benefits and harms for patients. furthermore, the declaration of helsinki makes it clear that one of the many duties of a physician is “to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research” (see principle 4 in world medical association, 2191). it is, therefore, justifiable for a physician to invoke soft paternalistic actions, such as enrolling a critical patient in a clinical trial. if deferred informed consent were found to be unethical, the inaction of a physician resulting from their inability to obtain informed proxy consent in an emergency situation would result in a far worse outcome⎯the death of the patient. deferred proxy consent is also morally acceptable on the principles of justice and beneficence by providing a vulnerable patient access to novel treatments that may ultimately benefit their health and well-being. as i have demonstrated, the principle of respect for persons is a primary concern in deferred proxy consent. it is important to recognize that autonomy of the patient is lost due to injury when a proxy is utilized; therefore, this can no longer be a guiding principle. however, the investigators should remind the surrogate that they should act as the patient, if competent, would have decided. by making decisions in this manner, the proxy ultimately respects the wishes of the patient to the best of their ability. it is also important to remember the elements of informed consent when implementing deferred proxy consent. once the surrogate has been located by the investigator, they should be disclosed of the material information and recommendations of the plan. afterwards, the investigator should perform a check to see if the surrogate understands these elements. the proxy should then be allowed to make an uncoerced decision and ultimately grant authorization of a chosen plan. looking at the lens of beneficence is complicated. although there is hope that an individual patient will benefit, this is not more certain than the chance of non-benefit. consequently, before an investigator decides to implement a clinical trial using an incapacitated patient, they must weigh risks and harm of the research subjects to the potential benefits of the trial to science and society. conducting clinical trials in the context of an emergency or critical care situation may result in novel treatments that benefit vulnerable patient populations; therefore, if retrospective proxy consent is obtained, investigators should utilize the data appropriately. clinical trials should only be implemented if they are projected to confer a potential benefit to the patient directly. when considering nonmaleficence, investigators have a duty to relieve and prevent the suffering of patients, their relatives, and society. confronting a bereaved surrogate after a patient has died following a clinical trial can add more harm to the situation. clinical practitioners should aim to relieve undue burdens on all parties involved in the medical process. we should, therefore, adopt policies that prevent seeking deferred proxy consent after the death of the patient. if a surrogate withdraws burkard,, the importance of using deferred proxy consent, voices in bioethics, vol. 4 (2018) 3 consent retrospectively, all collected trial data should be discarded. the purpose of such a rule allows the investigator to avoid introducing bias that could harm future patients. moreover, we should act to expose subjects to minimal risks throughout the trial. we need to ensure patients are not being invited to undergo higher than minimal risks in the clinical trials without any chance for direct benefit. holds should be placed on studies that confer greater than minimal risks to protect subjects from unnecessary harm. because we are considering persons in vulnerable states as a result of their emergency or critical care situation, the principle of justice is also relevant to this discussion. frequently, vulnerable persons in emergencies are incapable of protecting their interests because of debilitation or cognitive impairment. thus, the use of a proxy is paramount to providing consent to participate in clinical trials. we need to ensure that the trials and recovery do not place undue burdens on these populations. additionally, we also need to ensure research is appropriately distributed equitably across patient populations. we should not withhold innovative therapies from these patient populations as opportunities to gain insight from these procedures is rare in emergency settings. conclusion although utilizing research subjects to conduct emergency clinical trials is challenging, this opinion piece has demonstrated that when we fulfil ethical conditions regarding deferred proxy consent, it is a viable option in clinical research. physicians routinely make judgments based on the most suitable medical treatments on the balance of probable benefits and harms for patients. having a physician decide to enroll a patient in a clinical trial through reliance on deferred proxy consent is a form of soft paternalism. respect for patients is maintained so long as the investigator abides by the wishes of the surrogate once they retrospectively grant or withdraw consent to continue the trials. if a proxy decides to keep the patient enrolled in the study, new insights may be made regarding emergency medical treatments. it is imperative we strike a balance between risks and benefits among invested parties, so subjects are adequately protected in emergency clinical trials. _____________________________ 1 ahmed ammar and mark bernstein, eds. neurosurgical ethics in practice: value-based medicine. (berlin, heidelberg: springer berlin heidelberg, 2014): 191. doi:10.1007/978-3-642-54980-9. 2 tim c. jansen, et al., “deferred consent in emergency intensive care research: what if the patient dies early? use the data or not?” intensive care medicine 33, no. 5 (april 24, 2007): 894–900. doi:10.1007/s00134-007-0580-8. 3 world medical association. “world medical association declaration of helsinki.” the journal of the american medical association 310, no. 20 (november 27, 2013): 2193. doi:10.1001/jama.2013.281053. 4 tom l. beauchamp and james f. childress. principles of biomedical ethics. 7th ed. (new york: oxford university press, 2013): 230. 5 tim c. jansen, erwin j. o. kompanje, and jan bakker. “deferred proxy consent in emergency critical care research: ethically valid and practically feasible.” supplement critical care medicine 37, no. s1 (2009): s65–68. doi:10.1097/ccm.0b013e3181920851. introduction analysis conclusion reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) © 2016 michael reaves. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. interview with dr. marcia angell, former editor-in-chief of the new england journal of medicine michael reaves abstract abstract— dr. marcia angell is an american physician, author, and the first woman to serve as editor-inchief of the new england journal of medicine. she is currently on the faculty of the department of global health and social medicine at harvard medical school in boston, massachusetts. she has written a number of influential works on the healthcare industry and large-scale pharmaceutical business practices. the following is a transcription of the interview conducted by michael reaves with dr. marcia angell. keywords: bioethics, affordable care act, new england journal of medicine, interview, government introduction dr. marcia angell is an american physician, author, and the first woman to serve as editor-in-chief of the new england journal of medicine. dr. angell joined the journal’s staff in 1979, became executive editor in 1988, and served as editor-in-chief of the journal until june of 2000. she is currently on the faculty of the department of global health and social medicine at harvard medical school in boston, massachusetts. her most popular work, the truth about the drug companies: how they deceive us and what to do about it (2004), is critical of big industry in healthcare and its role in research and medicine. in april of 2016, i had the opportunity to sit down with dr. angell for a discussion about some of the most controversial topics in healthcare economics, regulation, journalism, and politics. i solicited dr. angell’s opinion on a recent decision regarding pharmaceutical companies, amarin pharma, inc. v. united states. this decision holds that the first-amendment protects off-label drug promotion by pharmaceutical companies. dr. angell indicated that it is difficult to prove that unethical behavior occurs in the promotion of off-label drugs because it is hard to monitor the behavior. she believes there will not be much success in the prosecution of individuals responsible for pushing these marketing strategies, and that jail time will likely be the only deterrent in an industry that incurs fines as a cost of doing business. i asked dr. angell about the journal’s recent policy changes regarding conflict of interest. the current editor of the journal, jeffery drazen, has loosened the conflict of interest policy, which now allows authors of editorials and review articles to receive up to $10,000 from each drug company. dr. angell holds firm that a zero-tolerance policy, or no allowance of payment between companies and writers, is the only way to eliminate conflict of interest in medical journalism. she discusses why the policy change is problematic and may incentivize unethical promotions. in the conclusion of the interview, dr. angell discussed how, in her view, obamacare will unravel if not altered or amended. she blames the affordable care act (aca) for not limiting provider profits, arguing that reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) 2 deregulation is the biggest driver of increasing costs – a step in the wrong direction. dr. angell argues that the aca is not a sustainable model for healthcare delivery and that a non-profit single-payer system should be our healthcare goal – especially in comparison to other, more successful healthcare systems worldwide. given the recent presidential election of donald trump, there is growing uncertainty about what will become of the aca. only time will tell. analysis q: good afternoon, dr. angell. let me begin at the begin ning. why did you get into the medical profession? a: i was passionate about it. i was swimming against the tide, because when i went to medical school, women didn’t do that. if you were going into science, you were going to get a ph.d. and do research, and for a while i thought i would do that. i was interested in virology. but from the time i was a small child, it seemed to me that the worst thing that could happen to anyone was to be seriously ill. i always had that feeling. i did not grow up in an intellectual or scholarly household, so among the few books in the house that i read and enjoyed reading was the red cross manual of first aid. i read that a lot. i wanted to take care of sick people and i didn’t want to be a nurse. for a while i thought i would be a medical technologist, and then as i went through college i got more ambitious, and i decided i would do graduate work in virology. i was nibbling around the edges, and finally i thought, no, becoming a physician is what i really want t o do, so i did. q: during your lecture on death and dying, you indicated that your specialization was pathology after medical school. what made you choose that route? a: my parents did not send me to medical school, and these were the days when it was possible to send yourself, but you had to do a lot of work to do that. the chairman of the pathology department at boston university school of medicine (busm) had a very successful textbook in pathology. his name was stanley robbins. he asked me whether i would read for him. he always did that with each edition of his book. it was a bestselling book, and one of his tricks was to get a student to read and tell him what was understandable, and what wasn’t – to help him with it. i was doing well in his class, and when he asked me whether i would read for him, i did. later on, he decided to create a smaller, more clinically oriented textbook, and he asked me whether i would be a co-author. together we created this book, and the first edit ion was in 1971. it was called basic pathology. 1 the textbook came out, i had done two years of a residency in internal medicine, but i hadn’t gone any further than that. i wasn’t a pathologist; i was basing the clinical aspects of this book mainly on what i’d learned as a resident in internal medicine. when it was time for me to finish my residency -by then i had two children, i wanted to be a nephrologist -a kidney specialist. when i came back to the fellowship, one of my daughters had been very ill the night before and i was up all night with her, and then the other one woke up in the morning, and i realized that if i had to take care of living patients, i just couldn’t do it. so i decided to go into pathology because you didn’t have living patien ts and nobody could make the point that there’s an emergency that you have to tend to. you would do autopsies or look at specimens after surgery. i had also written a textbook in the subject, and so i was able to get one year of credit for that. so i did my residency in pathology really on the basis of this book that i had worked on and created with robbins. i went at it backwards when i became a resident in pathology. i was using my own textbook, which was really kind of odd. q: how long was the gap between residency and your time with the new england journal of medicine? a: there were two residencies at busm – the first was in internal medicine. then i spent several years out, working on the book and having babies and taking care of them. i finished the first residency around ’69; then i went back and i did the residency in pathology beginning in ’77, so about an eight -year gap between the two residencies. i was in my second residency when my late husband, arnold relman, took over as editor of the new england journal of medicine, which would have been in ’77. i had known him in medical school. in fact, stanley robbins, arnold relman, and i wrote a paper together when i was an intern that was published in the new england journal of medicine, so i knew both of them. he, relman, and i had some contact over reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) 3 the years, and relman hired me to work at the new england journal of medicine in 1979. i was still doing my residency in pathology; i hadn’t finished that yet. so when i came to work, i worked part-time at the journal and part-time finishing a year’s residency, which i did in two years. work for women in those days was just made up as you went along. it was like mao tse-tung said, you just seize the moment. relman said to me, “ok, you can do this half-time thing for one year, but at the end of the year you have to go one way or the other. either you come full time to the new england journal of medicine and give up your textbook,” because i’d done a third edition of the textbook, “or you go into pathology. it was a difficult decision, but by the end of the year i really loved being at the new england journal, so i gave up the textbook. somebody else took over my part of that. q: i am a big fan of your late husband, arnold relman. i read his paper on the medical-industrial complex 2 when i was 15. in 2011, he stated that the journal lacked discretion in approving particular publications, and specifically mentioned a case regarding the blood-thinning drug, warfarin.3 from reading your book on the pharmaceutical industry, i know that you have issues with conflict of interest impeding ethical research and the delivery of drugs. 4 did the flaws in that study change the legitimacy of the study in general? the new editor-in-chief, jeffery drazen, loosened the journal’s conflict -of-interest policy that your late husband set forth. how do you feel about that move? a: i recently wrote an op-ed about that in the boston globe.5 the boston globe published a front page story, saying a lot of the criticisms that both bud (arnold’s nickname) and i had was the weakening the conflict-of-interest policy that bud put into effect. after bud retired, his successor, jerome kassirer continued his strong conflict-of-interest policies for the eight years that he was there, and i then continued for the one year i was editor-in-chief. all three of us continued the most stringent conflict -of-interest policies of any medical journal. when drazen came in, one of the first things he did was to weaken them. in recent years, he has been arguing essentially in favor of conflicts of interest as though the pharmaceutical industry and academic medicine were in the same business somehow, and we ought to support each other. so this created controversy about drazen’s policies -policies that neither bud, nor i, nor jerry kassirer approved of. the boston globe asked me whether i would like to respond to this article. i said i would like to respond, because conflicts of interest are no t a mere nicety; there’s a reason for them. one of the biggest problems, among many, is that if industry-supported research does not find a benefit of the drug, the results are never published; they’re put into a black hole. only positive studies are publi shed, creating the impression among both doctors and the public that prescription drugs are much safer and more effective than they really are. so this was a part of bud’s objection to the studies on these new warfarin replacements. they have a serious side effect in that they can’t be reversed. if you’re taking these drugs and you start to hemorrhage, there’s nothing that can be done about it. whereas if you’re taking warfarin, hemorrhage can be reversed with vitamin k. bud experienced that first hand in 2013 when he fell down the stairs in our front hall and broke his neck. the bleeding from the fracture compressed his windpipe, and he had three cardiac arrests. if you’re an admirer of him, you ought to read his piece in the new york review of books, whe re he wrote about this experience. it was published in 2014, called “on breaking one’s neck,” and it’s seen through the point of view of a patient who was not thought to survive. 6 it was a terrible, terrible accident, with the cardiac arrests. he was 90 years old, and he did survive. he took warfarin for atrial fibrillation, and he would not have survived if he had been taking one of the newer drugs, because the first thing they did was to give him a lot of vitamin k to reverse the warfarin. so the criticisms of the study were exactly right, he would not have published it, nor would i. he experienced the worst side effect of these drugs. they have no particular benefit and exhibit significant risk. q: drazen argued that your husband’s policy was one that has constrained editors from publishing the best possible information for doctors, but he seems to put a number value on what is acceptable in terms of financial ties to authors. the new policy allows drug companies to pay a writer $10,000 an nually for editorial reviews. yet, writers may receive payments from multiple companies, and a company may pay more than one writer, which gives writers multiple sources of income and thus presents a conflict of interest. given this, is any amount acceptable? do you think there should be a zero-tolerance policy? a: zero. people are very odd in how much money they consider trivial and how much they don’t. also, it creates a kind of misleading collegiality between senior faculty members, the kind of people who write these particular types of articles -editorials and review articles. in terms of the original articles that contained primary data, no, we just disclosed conflicts of interest. we didn’t forbid them. but we prohibited reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) 4 them for the authors of articles that had no original data and relied solely on judgment and opinion, and said that no conflict of interest is ok in these cases. it throws the burden on the reader to discern whether the author was biased or not. it rewards senior faculty for having financial ties to not just one but multiple companies whose fortunes are influenced by their work. one person said that what the senior faculty really likes, in addition to money, is food, friendship, and flattery, and you see how that works an d how that co-opts people who think they’re objective and who want to be objective, but who are in fact so closely allied with the big drug companies that they start to feel their pain. (laughs) so we felt that this was where we were going to hang tough. q: a decision in the southern district of new york in august of 2015, amarin pharma, inc. v. united states, 7 held that first amendment protections for true or factual speech in off -label drug promotion is permitted. the case concerns the fda’s ability to forbid drug promotion for off-label use. the court held that prohibiting truthful speech in off-label promotion is a violation of the first amendment. does this open the door to more unethical behavior in the industry? a: there’s absolutely no way to tell whether off-label promotion is truthful, because there are no data. if there’s no evidence, who is going to say what is truthful? everything depends on the quality of the evidence. if there were evidence, they would have gone to th e fda to get it labeled, to have it approved. so this is how they sell drugs that cannot get approval. the court's decision is absurd because it shows ignorance of how you would know whether the promotion is 'truthful or misleading.' it’s clearly an indust ry-sponsored decision. q: turning to industry, i wanted to discuss a recent case in the last year. johnson & johnson (j&j) was caught pushing risperdal on unapproved patient populations. 8 when there are key cases like this, it seems that the added first amendment protections would exacerbate the problems that exist already. a: absolutely. even so, even before this decision, i suspect that they would appeal. even before this decision, i think j&j were fined around six billion. that’ s just the cost of doing business. it’s dwarfed by the profits they make from these illegal activities. q: j&j was fined $2 billion in penalties back in august, and some people estimate that that may go up to $6 billion.9 however, they’ve made up to $30 billion on risperdal both domestically and abroad. it’s a drop in the bucket. it’s almost as if we are incentivizing criminal behavior: the profit that drug companies receive far exceeds the penalty of the fine that they’ll have to pay, like y ou said. a: yes. if you look at any of the big drug companies, i think every one of them, i can’t think of one that hasn’t been successfully prosecuted for fraud, and many of them, i think j&j was one, admit criminal charges. they get a fine that’s hundreds of millions or a few billion, pay it, and do the same thing again. they agree to some compliance activities and repeat the behavior. that’s what they do in their business, and business is good. q: the ceo of j&j, alex gorsky, was awarded a social responsibility award by the appeal of conscience foundation, an interfaith organization, one month after the outcome of this case. 10 he had a direct connection to the management of the risperd al account. do you think he was aware of often -illegal strategies put forward to push the drug on vulnerable populations? a: yes. reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) 5 q: so how do we go about reforming the justice department, or is that even the best step to combat these behaviors? a: well, it is. the problem is that it’s not going to happen. you would have to put some people in jail, and until you do that, nothing will happen. the problem is that the pharmaceutical industry and other health industries basically own congress, and congress essentially owns the food and drug administration. nothing is going to happen when there’s that much money weighing in on the other side. one of the reasons that i enjoy talking, in a certain grim sense, about assisted dying is that there’s no appreciable money at stake on either side. so when you talk about that, you’re talking about something that people have some feeling about because almost everyone has seen someone die either a bad death or a good death -usually the first. and so you can reason together, discuss the ethics and morals. when you’re talking about the pharmaceutical industry or about single-payer health care, there is a lot of money against you. one of the things that we are unfortunately learning, and that i’ve learned over a long lifetime, is that you come up against big money, and it’s like throwing grains of sand into the sea. you have to keep doing it, because it’s the only thing you can do. but it really is distressing, and i think this is a good exampl e. pharmaceutical companies put drugs on the market that are more expensive than the drugs before them and are no better, as far as we know, and probably worse in certain cases. people usually don’t have direct experience of it that they can analyze. they feel that drug companies are out there trying to discover new drugs and doing the best they can -being innovative. but people accept the propaganda from these innovative companies and accept the notion that these companies have to charge outrageous prices to cover their research and development (r&d) costs. q: the me-too drugs are certainly a cause of concern, and treating r&d as a cash -cow isn’t sustainable. i’m glad that you brought up big-money and the single-payer system. i know you’re a fan of the single-payer system. a: yes. q: do you believe that obamacare – also known as the affordable care act (aca) – has led us in the wrong direction, or do you think it will eventually lead us to the single -payer system? a: it continues us in the same direction because the two drivers of high costs and cost inflation were not touched by it. those two drivers are, first of all, the profit-driven delivery system – the providers. hospitals are either for-profit or behave as though they’re for-profit. all of the for-profit imaging centers - for example, outpatient facilities, clinics, the specialists and super specialists – get to perform as many highcost procedures as they want; if they’re, say, a cardiologist, they can make a couple of million dollars a year. doctors vary in terms of their income; super specialists, in turn, perform high -tech procedures and get a lot of money for it. providers are profit driven, and that’s probably the biggest driver of increasing c osts. they charge whatever the market will bear, and it will bear a lot with third-party payers. the second driver is the private insurance industry, and the hundreds of private insurance companies that compete by avoiding sick people and refusing claims. so those two things together have made the us health-care system extraordinarily expensive and inflationary compared with other countries. so what did obamacare do? it continued that. the private insurance industry got millions of new customers because people were required to enter a treacherous market and buy insurance. obamacare did nothing about the profit-driven delivery system. that is still in place. instead, obamacare expanded coverage, but at a cost that simply cannot be afforded. these new patients who now have insurance cost a lot of money, so what you’re seeing is the insurance slowly being hollowed out: the deductibles and co -payments are going up, so you have people who, yes, now have insurance, who weren’t insured before, but can’t afford to use it because the deductible is so high or it doesn’t cover everything. so you’re seeing more people with insurance, but the insurance is not as good. sooner or later something is going to have to happen there. bud and i spent a lot of our breakfast table conversation centered on the direction that obamacare would take the nation. we disagreed as to whether the policy was a step in the right direction or the wrong direction. he said, “look, this is a step in the right direction. peo ple will realize it. they will start to move toward a single-payer system. they will realize that it can’t continue, but it’s a step in the right direction. it was an attempt -albeit an inadequate attempt -and so there will be steps to make it adequate.” i felt it was a step in the wrong direction because it gave the illusion of having reformed the system without any actual reform. when it fails, it becomes a third rail, just like after the clintons tried to reform it. we can’t touch this again, we tried it, it didn’t work, we give up. i still feel that was the real danger. that was our reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) 6 breakfast-table conversation. conclusion q: how feasible will it be to get congress to step up? it seems like our representatives collectively are the biggest barriers to getting a single-payer system. a: i don’t think congress will accept anything at all. so that’s why, when people say it’s unrealistic to promote a single-payer system because congress won’t pass it, i say, “so what will they pass?” nothing. so you might as well argue for the things that you want and hope that congress will change, that circumstances will change. i think it’s a mistake to outsmart yourself by saying that we’ll do what we can do. you have to see that with this congress, particularly with the house, nothing will happen. you stake out what you think is the best position and hope that you will persuade enough people to eventually put pressure on congress. in my opinion, you need medicare for all, and i would be willing to start one decade at a time, have the qualifying age drop from 65 to 55, and wait a few years, drop it another decade, until everybody is on medicare for all. but it would have to also be in a non-profit delivery system. europe does not have a for-profit delivery system. a few countries like switzerland or the netherlands have private insurance companies, but they’re very different from what they are here. they are tightly regulated. the benefits are uniform, the prices are uniform. so you need a single-payer system in a non-profit delivery system. you argue that, you argue the merits, and you hope and pray that someday it will happen. q: another important, and often controversial, part of obamacare is the individual mandate -the requirement that all americans be enrolled in health insurance or otherwise pay an annual penalty. do you believe that the individual mandate should be repealed out of the plan? do you think the individual mandate was economically incentivizing? a: well, i don’t like it. it’s part of an impossible system, and i don’t like it because it requires people to get insurance at whatever price the company charges. i think that’s wrong. q: it’s essentially playing into the hands of the insurance market if you’re forcing the purchase of a particular good or commodity to get covered, and then inflating enrollment totals. a: yes, the insurance industry loves it. you have to pay what they charge you, and wonder if you have to pay a co-pay along with deductibles. it makes you powerless before them. q: thank you for taking the time for this interview. it was lovely talking to you today. a: you too. good luck, mike. 1 basic pathology 1st edition (1971, robbins, stanley leonard; angell, marcia); 2nd ed. (1973, robbins, s.l.; angell, m.); 3rd ed. (1981, robbins, s.l.; angell, m. kumar, vinay). 2 relman, arnold. “the new medical-industrial complex.” the new england journal of medicine. 1980; 303: 963970, doi: 10.1056/nejm198010233031703. <http://www.nejm.org/doi/full/10.1056/nejm198010233031703>. https://en.wikipedia.org/wiki/vinay_kumar_(pathologist) http://www.nejm.org/doi/full/10.1056/nejm198010233031703 reaves, interview with dr. marcia angell, voices in bioethics, vol. 2 (2016) 7 3 husten, larry. “former nejm editor criticizes publication and peer review of aristotle trial.” forbes. september 23, 2011, <http://www.forbes.com/sites/larryhusten/2011/09/23/former-nejm-editorcriticizes-publication-and-peer-review-of-aristotle-trial/#30b4775c6aa1>. 4 angell, marcia. the truth about the drug companies: how they deceive us and what to do about it. random house, inc. 2004. 5 ornstein, charles. “new england journal of medicine increasingly targeted by critics.” boston globe. april 5, 2016, <https://www.bostonglobe.com/metro/2016/04/05/new-england-journal-medicine-increasingly-targetedcritics/9h3jfkztnjpcsoqqiunxjp/story.html>. 6 relman, arnold. “on breaking one’s neck.”. the new york review of books. february 6, 2014, <http://www.nybooks.com/articles/2014/02/06/on-breaking-ones-neck/>. 7 united states district court: southern district of new york, <http://www.nysd.uscourts.gov/cases/show.php?db=special&id=478>. 8 kristof, nicholas. “when crime pays: j&j’s drug risperdal.” the new york times. september 17, 2015, <http://www.nytimes.com/2015/09/17/opinion/nicholas-kristof-when-crime-pays-jjs-drug-risperdal.html>. 9 ibid. 10 press release. “appeal of conscience foundation to honor alex gorsky, chief executive officer of johnson & johnson, with 2015 appeal of conscience award.” market watch. september 10, 2015, <http://www.marketwatch.com/story/appeal-of-conscience-foundation-to-honor-alex-gorsky-chiefexecutive-officer-of-johnson-johnson-with-2015-appeal-of-conscience-award-2015-09-10>. http://www.forbes.com/sites/larryhusten/2011/09/23/former-nejm-editor-criticizes-publication-and-peer-review-of-aristotle-trial/%2330b4775c6aa http://www.forbes.com/sites/larryhusten/2011/09/23/former-nejm-editor-criticizes-publication-and-peer-review-of-aristotle-trial/%2330b4775c6aa https://www.bostonglobe.com/metro/2016/04/05/new-england-journal-medicine-increasingly-targeted-critics/9h3jfkztnjpcsoqqiunxjp/story.html https://www.bostonglobe.com/metro/2016/04/05/new-england-journal-medicine-increasingly-targeted-critics/9h3jfkztnjpcsoqqiunxjp/story.html http://www.nybooks.com/articles/2014/02/06/on-breaking-ones-neck/ http://www.nysd.uscourts.gov/cases/show.php?db=special&id=478 http://www.nytimes.com/2015/09/17/opinion/nicholas-kristof-when-crime-pays-jjs-drug-risperdal.html http://www.marketwatch.com/story/appeal-of-conscience-foundation-to-honor-alex-gorsky-chief-executive-officer-of-johnson-johnson-with-2015-appeal-of-conscience-award-2015-09-10 http://www.marketwatch.com/story/appeal-of-conscience-foundation-to-honor-alex-gorsky-chief-executive-officer-of-johnson-johnson-with-2015-appeal-of-conscience-award-2015-09-10 abstract introduction analysis conclusion cyphers et al., ai and incidental findings, voices in bioethics, vol. 9 (2023) * eric cyphers, ms candidate, columbia university venkatesh krishnasamy, attending physician, division of vascular and interventional radiology, columbia university irving medical center joshua weintraub, chief of the division of vascular and interventional radiology, executive vice chairman of the department of radiology, columbia university irving medical center © 2023 cyphers et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ai and incidental findings: a retrospective duty? eric cyphers, venkatesh krishnasamy, joshua weintraub* keywords: natural language processing, artificial intelligence, incidental findings, radiology, follow-up introduction delayed and missed follow-up on incidental findings threatens patient health and is a major financial risk for healthcare systems. the healthcare industry spends $43 million annually settling lawsuits for missed follow-ups on lung findings alone. 1 radiology reports document incidental findings, but they often go unnoticed. the practitioner who ordered the radiology may fail to inform the patient and recommend the follow-up, allowing the patient’s disease to develop unchecked. natural language processing (nlp) makes it possible to review documents for missed incidental findings. by saving time, nlp changes an important ethical calculus. radiologists now can more easily detect incidental findings that were in the report but not conveyed specifically and find and disclose actionable incidental findings noted in recent past radiology reports. we argue that the duty of a practitioner or radiologist to rescue a patient by informing them of recent actionable incidental findings exists due to this technological ease. this paper argues that nlp used on existing radiology reports can catch overlooked incidental findings and ensure that the practitioners who ordered the reports note the incidental finding, inform the patient, and oversee the scheduling of follow-up. i. background and definitions incidental findings are masses or lesions detected on imaging performed for a reason unrelated to the reason for the imaging.2 for example, radiologists may see a lung nodule on the first slices of an abdominal ct performed for abdominal pain. radiology guidelines define the incidental finding characteristics for which disclosure and follow-up would provide a potential medical benefit. for example, decades of cyphers et al., ai and incidental findings, voices in bioethics, vol. 9 (2023) 2 research demonstrate that incidentally discovered simple pancreatic cysts should be initially re-imaged in six months, while incidentally discovered renal masses less than one centimeter should be initially reimaged in three to six months.3 fortunately, the radiology community developed advancements in artificial intelligence (ai) to streamline the screening, reporting, and tracking of follow-up on incidental findings based on best practice advisories.4 a recent study at northwestern university established the usefulness of prospectively applying ai to screen, report, and track certain incidental findings warranting follow-up.5 ai can easily be applied to look back at recent imaging studies lying dormant in hospital databases to ensure that all significant incidental findings warranting follow-up care have been reported and tracked to completion. however, retrospective applications of ai have not been widely implemented. natural language processing (nlp) is a subfield of ai in which computers are programmed to analyze a text’s contents and context.6 nlp can be programmed into electronic health records to identify radiology reports containing incidental findings requiring follow-up based on best practice advisories. additionally, nlp can automatically guide reporting of these findings to referrers, patients, and tracking to confirm if patients have received follow-up care.7 a recent study from northwestern university found that after one year of prospective implementation, the ai nlp software flagged 5.15 percent of all images (68 per day) as containing lung follow-up recommendations.8 results demonstrated 77.1 percent sensitivity, 99.5 percent specificity, and 90.3 percent accuracy for follow-up on lung findings.9 nlp has the potential to significantly improve reliable follow-ups of incidental findings.10 ii. the duty to report actionable incidental findings when radiologists discover significant incidental findings, they have a duty to disclose them and recommend follow-up and further screening.11 radiologists have this ethical duty due to beneficence and non-maleficence: a duty to do good and prevent harm. there is also a duty as part of the physician-patient relationship. the physician-patient relationship in radiology is unique as radiologists often do not have direct contact with patients and therefore do not report abnormal imaging findings directly to them. rather, radiologists read and interpret imaging studies in a non-patient area of the hospital or even remotely and then dictate their findings. the radiology report should include any incidental findings and recommendations for follow-up care. it used to be that the radiologist uploaded this document to the patient’s medical record for the ordering provider to read and relay to the patient. alternatively, the radiologist could directly contact the ordering provider regarding his or her findings depending on the urgency of the finding or the nature of the radiologist’s professional relationship with the ordering provider. recently, due to both patient advocacy and the 21st century cures act, the reports are generally uploaded to a patient portal. the availability of the report to the patient does not mean the patient would notice or understand an incidental finding in the report. physicians must protect the interests of patients whose health depends on their decisions. the simple act of a radiologist dictating the significant incidental finding on his or her report and attempting to communicate the finding with referring physicians can have massive benefits for protecting patient health. however, radiologists are not tasked with closing the loop to ensure their recommendations for follow-up are pointed out directly to patients or seeing that the patient completes the recommended follow-up care. some centers have used nlp technology on newly dictated studies to pick up actionable incidental findings that the referring physician could overlook. the technology also can track the follow-up care to completion. there is a positive impact on patient health if the findings are more consistently communicated and follow cyphers et al., ai and incidental findings, voices in bioethics, vol. 9 (2023) 3 up care is obtained.12 thus, nlp technology can help radiologists fulfill their duties to report actionable incidental findings. however, radiologists do not usually look back in their imaging study databases to check that the ordering provider closed the communication loop to patients for incidental findings on previous imaging studies that warrant follow-up or to ensure that the patient completed previous recommendations for follow-up care. iii. the duty to easy rescue while the duty to easy rescue is not the basis for reporting incidental findings normally, it may provide an ethical basis for the retrospective use of nlp to find actionable incidental findings that were not properly communicated or that did not lead to follow-up care. philosopher peter singer described the duty to easy rescue through this famous thought experiment: “if i am walking past a shallow pond and see a child drowning in it, i ought to wade in and pull the child out. this will mean getting my clothes muddy, but this is insignificant, while the death of a child would presumably be a very bad thing.”13 the duty to easy rescue, a refinement of the rule of rescue which is an imperative people feel to rescue individuals facing avoidable death,14 specifically asserts that when the benefits of performing an act for someone are significant and the cost to the person performing the act is minimal, then the person should perform the act.15 we can apply the duty to easy rescue to situations where we see a child drowning in a shallow pond or broadly to any situation where we can offer others a significant benefit at a nominal cost to ourselves. like the drowning child example, using nlp to review documents does not take much employee time or financial resources. retrospectively applying ai to screen past patient imaging studies can be an easily automated task, and its application may improve patient access to their healthcare information and protect patient health. iv. the duty to retrospectively screen, report, and track this paper argues that the duty to easy rescue compels radiologists to apply nlp to screen, report, and track the follow-up on recent studies in their databases. using nlp to address incidental findings could add another degree of transparency, ensuring patients have all the information they should. the extra effort could close the loop on dropped communications and may help guide follow-up care and therapies for past care that patients didn’t receive. if initial experiences reveal that retrospectively applying ai helps improve patient autonomy and health outcomes while bolstering the beneficent and non-maleficent goals of radiologists, then continuing to do so may be ethically justified. based on how well the technology works for current radiology reports, we expect that some retrospective applications will be useful, and even lifesaving. before the nlp developments, reviewing past radiology reports was prohibitively burdensome, and would subvert the radiologist’s duties to current patients. a technologist or other employee might run the nlp technology. the ethical justifications arise from the ease with which the nlp performs these tasks. therefore, the duty to easy rescue calls for radiologists to go beyond their normal responsibilities and retrospectively apply nlp. how far back radiologists apply ai to screen past reports for actionable incidental findings should be considered in the context of the physician-patient duties and the duty to easy rescue. reporting actionable incidental findings they missed on studies interpreted years ago, for example, may preclude the cyphers et al., ai and incidental findings, voices in bioethics, vol. 9 (2023) 4 radiologist’s duty to beneficence as the incidental finding may have developed into a malignancy that already caused them grave harm. at that point, the rescue may not be that easy. similarly, incidental findings on studies interpreted years ago may preclude the radiologist’s duty to non-maleficence, as many of these findings may have ended up being benign and reporting them now may cause the patient great angst. however, there may be real benefit to screen more recent studies radiologists can ensure patients get the care they need. v. limitations on the duty additionally, if the “catch-up” follow-up care and communications are too time-consuming and would distract radiologists from their current patients’ needs, arguably, the retrospective look would no longer fall within a duty of easy rescue. at smaller or less-resourced centers, radiologists may be inundated with patient follow-up care requests and referring physicians regarding those abnormalities, which may subvert their duties to current patients. further, an inundation of follow-up care requests has the potential to overwhelm referring physicians and the healthcare system. we would expect to find few missed incidental findings compared to the current number of total incidental findings found by nlp, assuming most past incidental findings were reported and followed-up. our duty to easy rescue ethically justifies consideration of previous imaging only if the measures we take neither impose unreasonable costs nor cause greater harm than good. in all, radiologists and institutions do not have a duty to screen previous imaging studies if the resource cost is disproportionately high and subverts our duties to current patients. conclusion the duty to screen, report, and follow up on significant incidental findings on the studies that come across our workstations today might be the same duty to screen, report, and follow up on incidental findings on previous studies sitting dormant in our databases. applying nlp will make checking old radiology reports for unreported incidental findings easier and may benefit patients. due to the ease with which radiology entities can run the ai to scan recent reports, radiologists should have a duty to do so. however, we acknowledge that the duty of radiologists to look back has limits and must not distract from our duty to current patients. 1 pr newswire.com. using artificial intelligence to solve one of health care’s most enduring problems [internet]. 2022. available from: https://www.prnewswire.com/news-releases/using-artificial-intelligence-to-solve-one-of-health-cares-mostenduring-problems-301504387.html 2 american college of radiology clinical resources. incidental findings [internet]. available from: https://www.acr.org/clinicalresources/incidental-findings 3 berland, l. l., silverman, s. g., gore, r. m., mayo-smith, w. w., megibow, a. j., yee, j., brink, j. a., baker, m. e., federle, m. p., foley, w. d., francis, i. r., herts, b. r., israel, g. m., krinsky, g., platt, j. f., shuman, w. p., & taylor, a. j. (2010). managing incidental findings on abdominal ct: white paper of the acr incidental findings committee. journal of the american college of radiology, 7(10), 754–773. https://doi.org/10.1016/j.jacr.2010.06.013 4 pr newswire.com, p.1; carrodeguas e, lacson r, swanson w, khorasani r. use of machine learning to identify follow-up recommendations in radiology reports. journal of the american college of radiology. 2019 mar;16(3):336–43; domingo j, galal g, huang j, soni p, mukhin v, altman c, et al. preventing delayed and missed care by applying artificial intelligence to trigger radiology imaging follow-up. nejm catalyst [internet]. 2022 mar 16 [cited 2022 oct 18];3(4). available from: http://catalyst.nejm.org/doi/10.1056/cat.21.0469 cyphers et al., ai and incidental findings, voices in bioethics, vol. 9 (2023) 5 5 pr newswire, p. 1; domingo, p. 1 6 ibm cloud education. ibm cloud learn hub what is natural language processing? natural language processing (nlp) [internet]. 2020. available from: https://www.ibm.com/cloud/learn/natural-language-processing 7 domingo, et al., p. 1 8 domingo, p. 1 9 domingo, p. 1 10 domingo, p. 1 11 mabotuwana t, hall cs, tieder j, gunn ml. improving quality of follow-up imaging recommendations in radiology. amia annu symp proc. 2017;2017:1196–204. 12 domingo, p. 1 13 singer, p (2016). famine, affluence, and morality. oxford university press: 231 14 jonsen, a. (1986). bentham in a box: technology assessment and health care allocation. law med health care; 14(34): 172174 15 singer, p, 231-232 zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, fordham university school of law, ms candidate, columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. marketing madness: the disingenuous use of free speech by big data and big pharma to the detriment of medical data privacy anne zimmerman* keywords: free speech, corporate free speech, us constitution, sorrell v. ims health, confidentiality, medical data, prescribers, pharmaceutical data abstract the right to free speech has become more expansive covering pharmaceutical free speech in ways uncharacteristic of the long-accepted fundamental right. the purpose of purchasing the data is detailing, a form of personalized sales and marketing directed at the practitioners most likely to prescribe certain drugs. the sorrel decision is based on the notion of corporate free speech, a concept that encompasses two conditions: first, that corporations are speakers entitled to first amendment protection; and, second, that advertising and marketing constitute “speech.” citizens united and sorrell opened a floodgate for corporations to declare free speech rights that undermine advertising and marketing regulations. introduction in sorrell v. ims health, the supreme court struck down a vermont regulation requiring pharmacies to obtain prescriber consent to release prescriber-identifying information1 to data miners for marketing research purposes.2 since sorrell, legislators in the us have shied away from traditional commercial regulations limiting corporate speech, many of which would support bioethical principles.3 the right to free speech has become more expansive covering pharmaceutical free speech in ways uncharacteristic of the long-accepted fundamental right.4 as a result, pharmaceutical companies increasingly influence patients and skew the judgment of doctors in prescribing decisions, now through the use of data without the authorization of the doctor or patient. the expansive view of commercial free speech has grown beyond the voicing of personal or political opinions, the suppression of which challenges liberal society. patients’ autonomy should extend to control over personal data. an ethical system would protect private data, preserve doctor-patient confidentiality, and promote justice by leveling the playing field so that generic drugs and changes to lifestyle and diet are not drowned out by the already advantaged pharmaceutical industry’s aggressive marketing. i. background a vermont statute imposed a consent requirement so that pharmacies selling prescriber-identifying information including the practitioner and the drug prescribed to data miners who then sell mined data to pharmaceutical companies would need explicit consent from the prescriber.5 the purpose of purchasing the zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 2 data is detailing, a form of personalized sales and marketing directed at the practitioners most likely to prescribe certain drugs. the sorrel decision is based on the notion of corporate free speech, a concept that encompasses two conditions: first, that corporations are speakers entitled to first amendment protection; and, second, that advertising and marketing constitute “speech.” corporations argue free speech should be broadly construed to include accessing data or information necessary to the action of later speech. the prescriber-identifying information in sorrell creates a way to create an audience for the speech that the respondents argue is constitutionally protected overextending commonly recognized free speech. the supreme court case was brought by manufacturers of brand name pharmaceuticals and data miners (respondents) who argued that free speech protects the ability to purchase, use, and resell the data, that the data collected served their commercial interest in targeting specific audiences for pharmaceuticals, and that requiring doctors’ consent violated the respondents’ right to free speech. the court held that the vermont statute was unconstitutional because it violated free speech rights by imposing both content-based and speaker-based obstacles on the respondents.6 since the sorrell case, legislators have been hesitant to regulate corporate speech while technological advancements in data have increased the use of personal data in marketing. as noted in the new york times, among developed countries, the u.s. is noteworthy for its absence of a comprehensive consumer data protection body of law and enforcement agency.7 corporations are coopting control over data absent government checks on their power. technological advances in data mining and reidentification (the ability to rematch personal information with medical prescription data) serve to make deidentification less meaningful giving more reason to protect seemingly anonymous data. ii. analysis: the conflict between pharmaceutical marketing research and regulatory power protecting medical data a. the pharmaceutical corporations and data miners’ arguments pharmaceutical companies argue that they are helping doctors by presenting details of drugs to help doctors treat patients. there is no evidence that without personalized prescriber data, drug reps would no longer target likely prescribers. they did so before data mining and will do so as long as it is legal.8 however, legality does not imply ethical marketing practices. to argue detailing is a driving force in their effort to disseminate helpful information as if the financial benefits are merely ancillary to an altruistic act is insincere.9 the pharmaceutical industry can express speech in a myriad of ways. contrary to the court’s interpretation, this is not a case of a state trying to keep people “in the dark” about the availability of prescription drugs.10 regulations effecting corporate speech used to be encouraged for the public good. for example, laws regulating the advertising of cigarettes and alcohol were well accepted by the public. the erosion of both privacy and the individual voice’s power correspond with the uptick in recognizing previously undeclared corporate constitutional rights.11 the pharmaceutical companies’ marketing efforts take place at the expense of data privacy and confidentiality within the doctor patient relationship. doctors’ offices are awash in drug reps while televisions and social media are erupting with pharmaceutical direct-to-consumer ads. pharmaceutical manufacturers are already allowed to infiltrate offices, hospitals, continuing medical education conferences, and sometimes medical schools. they are zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 3 permitted to advertise directly to consumers, planting brand names and rosy pictures of health in the minds of all desperately seeking cures. the respondents did not show anything more than potential financial harm. without the data, they could continue their other extremely lucrative sales and marketing techniques. the data grab undermines beneficence. patients are neither compensated directly for their own data nor are they afforded access to an array of pharmaceuticals at reasonable prices. with the patient’s voice absent from the court’s opinion, patients and practitioners lose autonomy and control over personal and confidential data. b. the state’s regulatory goals protect traditional bioethics principles vermont’s regulatory interest behind the law included both data privacy and healthcare cost containment. the privacy argument was dismissed prematurely and should be presented differently.12 the respondents point out that the government requires that the data be collected by the pharmacies. it is also available for other uses including communication with insurers, and state and academic research. respondents claim these uses render the data public. the opinion is flawed in that researchers and others privy to the data in noncommercial spheres have their own professional and legal standards and nondisclosure requirements. the sorrell court seemed to see the patient and physicians’ right to privacy as inadvertently waived. vermont argued that the statute would be better for the public by decreasing healthcare costs and increasing health.13 in healthcare, these policy goals would be welcome by almost every politician or candidate for president in either political party. containing healthcare costs and improving health are so large a government priority that federal laws themselves confirm a legitimate government purpose.14 affordable healthcare is a well-established justice-based healthcare issue. for the court to find that this state law’s purpose is not substantial enough holds implications for broad healthcare policy and demonstrates favoritism to the pharmaceutical industry at the expense of the people. the government’s goal of affordable healthcare will often conflict with pharmaceutical lobbying and marketing practices. the court held that vermont favored a specific viewpoint by placing a hurdle in the promotion of the brand name pharmaceuticals. brand name drugs are marketed using detailing based on prescriberidentifying data. it is possible that pharmaceutical companies’ lack of access to the data for detailing could make more room for generic drug sales. the lack of access to the data also might reel in overprescribing in general by limiting access of drug reps to specifically vulnerable patients and to doctors who may prescribe drugs for profit rather than medical necessity. the vermont law leveled a playing field rather than actively promoting generics or limiting the overuse of prescription drugs. state governments wanting to expand healthcare for more people have an immediate need to reduce costs. the court indicated that academic institutions would have the same ability to approach doctors’ offices and decrease brand name drug sales.15 academic medical centers do not engage in expensive counter-detailing. instead, they work with manufacturers of brand name drugs for research and development and they already have a built-in bias favoring brand names. the court’s majority opinion leaned toward accusing vermont of a conspiracy to promote an anti-pharmaceutical viewpoint, a point that is not convincing without explicit evidence.16 while it should be legal to promote the ethical view that access to generics or other medical solutions is a proper use of the data, no evidence was presented that any program resembling the marketing prowess of big pharma was impending. the marketing of generics arguably has a beneficial public purpose compared to the marketing of expensive brand name drugs. the law’s educational use provision included ways to increase awareness of brand-name drugs about to expire and alternative generics, but not to the exclusion of brand zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 4 name drugs, just in the context of less costly alternatives.17 the ethical principle of healthcare justice requires disseminating all relevant information about the availability of affordable care. unlike the laws traditionally subject to free speech scrutiny, the vermont statute did not suppress religious, hate, or political speech, yet the court held it quieted an unwelcome viewpoint, the essence of important free speech cases.18 the use of pharmaceutical marketing data does not rise to the heightened analysis ascribed by the court.19 as the dissenting opinion notes, the ethical concerns underlying free speech do not apply to freedom in this highly regulated industry’s marketing tools. the dissenting justices also noted that all regulations reflect some point of view and that the court is undermining democratically elected regulators by imposing on their legislative responsibilities. iii. counterarguments discounting data privacy the most common counterargument specific to pharmaceutical research is that deidentified material found in metadata is not special to the patient. however, this argument ignores modern data storage, access, research techniques, and bioethics principles. reidentification is simpler than is commonly understood.20 while medical researchers are unlikely to reidentify, pharmaceutical companies arguably would benefit from some reidentification especially because they market to consumers directly. linking data points through voting registration or hospital stays can lead to other personal information.21 even liens, court dates, and social media accounts all become fair game for marketers in the medical data reidentification process. there is a snowball effect because data miners benefit from selling data to multiple industries and the government. data mining does not reflect the true cost of the data. pharmacies, data miners, and ultimately pharmaceutical companies are subsidized by decisions like sorrell that fail to require patient and prescriber consent. while each person’s data is arguably worth pennies in the system, the total is worth a great deal.22 autonomy can include the power to sell one’s medical data. iv. controlled use of medical data many people prefer directing how their data is used. when a school or hospital system asks permission to use photographs or data, parents can certainly sign “yes” for one use and “no” for another, e.g., “yes” on print but “no” on website. similarly, hospitals ask for signatures before releasing medical data for certain purposes, including research. there is an understanding and usually a legal obligation to ensure the data would not be otherwise used. the dissenting opinion aptly points out that “a car dealership that obtains credit scores for customers who want car loans can be prohibited from using credit data to search for new customers.”23 the court impinged on individuals’ privacy rights by expanding free speech so much that any limits on how data can be used will be evaluated as discriminatory by use. in jolt digest, katie booth fears that commercial privacy laws and do-not-track legislation will fail the sorrell standard which treats use as binary: either the data is available for every use or private and unavailable regardless of use. however, she suggests market forces might lead to corporate responsibility despite a lack of regulations.24 she recognizes that consumers do want to share data “categorically” and an inability of legislatures to provide ways to do that may force complete dependence on “private market data privacy policies.” booth is right that, for now, urging corporate ethics reform might be a workable option in certain cases. bonnie kaplan of yale school of medicine also readily speaks against the sorrell decision citing its ethical and legal ramifications. kaplan’s moderate position understands the logistical need for access to data by insurers, a point the vermont statute acknowledges. kaplan does not believe deidentification is foolproof and expects that patients would opt out of sharing data for marketing. to her, transparency about the data’s zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 5 uses would help patients discern when to allow data sharing for research that might benefit their own healthcare quality. kaplan would prefer “flexibility in thinking” and a system more ethical than that propelled by sorrell. kaplan’s ethical criteria and analysis present the reader with ideas about the complexity but they do not adhere to binding supreme court precedent under sorrell. her ethical analysis calls for limiting or overruling sorrell, an unlikely scenario for now. there is a distinct partisan divide in amicus briefs filed in sorrell.25 pharmaceutical trade groups and companies favored the respondents’ point of view while a preponderance of academic literature and thirtyfive other states supported vermont’s position.26 similar to the backdrop of citizens united when the supreme court altered important traditional checks on corporate power, partisanship is glaring in the sorrell decision.27 working toward a middle ground means a willingness to reasonably limit pharmaceutical corporate free speech for the sake of patient privacy. v. reconciling sorrell, privacy, and bioethics beverly cohen argues that, despite sorrell, hipaa28 currently precludes the sale of the data to the data mining companies.29, 30 in a nod to hipaa, the sorrell court noted that a broader law limiting even more speech would have better demonstrated vermont’s desire to protect privacy.31 but a broader law arguably would offend free speech more. the court limited cohen’s expansive view of hipaa through sorrell. hipaa has a narrower exception for routine use of data to ease healthcare delivery and payment. yet hipaa and data mining coexist now reflecting a failure to apply hipaa cohen’s way. cohen’s ethical defense of privacy is significantly more in keeping with bioethics principles than the court’s view of privacy. in a landmark supreme court case delineating a right to privacy, griswold v. connecticut,32 the court was careful not to trample on regulatory power unless it interfered with a fundamental right. the regulation in griswold, a case about the doctor patient relationship and the right to contraception, not only overstepped a private relationship but also interfered with deeply personal beliefs about becoming pregnant. griswold established that rights not explicitly enumerated are worthy of protection and that privacy is of “comparable magnitude to the fundamental rights that are constitutionally protected.”33 the sorrell court was unwilling to focus on any belief deeper than a financial belief in the ability to market a product using the data in question. griswold should apply to the data because, like in the griswold case, the data is a consequence of a confidential relationship. the court created uncertainty of whether medical data remains personal pursuant to the griswold chain of cases, undermining autonomy in private decisions. reconciling griswold and sorrell is difficult. while sorrell undermines regulatory authority aiding patient data privacy, there is room for solutions to use the law to promote the ethical considerations. first, statutes like vermont’s can be drafted according to the suggestion made in dicta in sorrell allowing only minor exceptions: insurance and billing purposes. all other uses should require consent by the patient. second, a class action brought directly by patients recognizing traditional privacy rights outside the hipaa regulatory framework must be brought to challenge or limit sorrell. not only do patients not know their prescription data is being used this way, doctors tend to be unaware of the intricacies of data mining as well.34 laws protecting patients rather than prescribers would have more strength in court because the direct privacy interest in protecting one’s own data certainly trumps the prescribers’ privacy interest which, to the court, stems from not wanting to be bothered by marketers and drug reps. the data means more to the patient than to the doctor; in a breach, the patient would bear the burden of the stigma of a condition made public. the nature of the data itself is private and personal. in rural areas, even without any type of reidentification, the patient’s identity can easily be ascertained. pharmacies distribute personal prescriptions zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 6 to treat stigmatized conditions including hiv, schizophrenia, depression, and to terminate pregnancy. some of the data could be subject to subpoena. data in the hands of more organizations is more vulnerable to leaks or unforeseen uses. the doctor patient relationship hinges on patients’ open discussion with doctors. if data can be sold, mined, and even reidentified, patients might avoid use of certain prescriptions to their medical detriment. if a legal approach cannot overcome sorrell, then booth might be correct that corporate policy will eventually succumb to societal pressures and step in to protect the doctor patient relationship. privacy should protect confidentiality between doctor and patient and self-direction in personal matters. a high level of scrutiny must be applied to data mining that challenges privacy. when constitutionally protected privacy meets the boundary of the now constitutionally elevated commercial right to free speech, the analysis concerns two competing constitutional rights: privacy and free speech. the california consumer data privacy act (ccpa) which went into effect january 1, 2020 will test the waters of data privacy. so far, hannah anderson and salesforce are being sued for privacy breaches. if those corporations challenge the law’s provisions, booth’s assertion that corporations want to treat data ethically could be proven wrong. however, if the ccpa leads to significant litigation by people who suffer from data breaches, corporations will likely find it less costly to comply regardless of their will. practicality and efficiency may prevail regardless of whether the corporation would prefer to protect privacy. corporate ethics could become irrelevant under the weight of a strict law. the right to privacy and right to commercial free speech are not objects with equal force. when corporations argue the ccpa violates commercial free speech, courts will be forced to define the point at which the right to privacy and the right to commercial free speech meet on a continuum, reconciling the two fundamental constitutional rights and defining modern privacy law. conclusion there is a fundamental ethical challenge left by sorrell. pharmaceutical companies are using the data for profit-making. that is marketing: it is not the government’s duty or place to ensure unfettered access to private data. the failure of government protection allows data miners to expand to new uses of data with little oversight. the patient’s explicit consent to the use of data for marketing purposes should be required out of respect for personal autonomy and privacy concerns. privacy is the backbone of successful doctor patient relationships. citizens united and sorrell opened a floodgate for corporations to declare free speech rights that undermine advertising and marketing regulations. broad implications from sorrell are seeping into everything from alcohol, tobacco, and vaping products and possibly headed toward the marketing and advertising of guns. on this trajectory, factory discharge of carbon and toxins into the air could be labeled “speech,” a viewpoint on climate change in a politically charged atmosphere. autonomy, justice, and beneficence are served by data protection. free speech in the realm of political, religious, and societal opinions cannot be impeded without the strictest scrutiny. marketing drugs can. 1 prescriber-identifying information links prescribers (e.g., doctors, nurse practitioners, physician’s assistants) to prescriptions which can be used with metadata, deidentified patient data, and public records to build a detailed analysis used for sales and marketing. 2 sorrell v. ims health inc., 564 u.s. 552 (2011) ims et al. are referred to as “respondents” while the state of vermont is the “petitioner.” zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 7 3 within a year of sorrell, federal courts began to strike down ordinary advertising regulations, some designed to protect children’s health. in massachusetts, a court struck down an ordinance limiting tobacco advertising near schools, and the sixth circuit court of appeals struck down part of a law governing colorful cigarette packaging. “one year later: the consequences of sorrell v. ims, inc.” alliance for justice, justice watch blog. july 2, 2012. https://www.afj.org/blog/one-year-later-theconsequences-of-sorrell-v-ims-health-inc 4 citizens united v. federal election commission, 558 u.s. 310 (2010) opened the floodgate to sorrell, giving unprecedented corporate power and severely limiting the scope of regulation of corporations. 5 vt. stat. ann., tit. 18, §4631. 6 sorrell. the court examined the free speech right compared to the regulatory priorities of the state of vermont. deciding to apply heightened rather than intermediate scrutiny, the court broke from precedent on commercial free speech and held the statute unconstitutional. the departure from the norm is part of a pattern increasingly elevating the right to commercial free speech after citizens united. the dissent, in keeping with past cases regarding commercial free speech, applied the central hudson three-pronged test and found the regulation acceptable. central hudson looks to whether the regulation is based on a substantial government interest, that it truly advances the interest, and that it does so in as narrow a way as possible. central hudson gas and elec. corp. v. public service commission of n.y., 447 u.s. 557 (1980). 7 singer, natasha, “the government protects our food and our cars. why not our data?” new york times, nov. 2, 2019. beckerman, michael, “americans will pay a price for state privacy laws,” new york times, oct. 14, 2019. 8 whitney, jake, “big (brother) pharma,” new republic, august 29, 2006. https://newrepublic.com/article/84056/health-care-elililly-pfizer-ama 9 financial benefits are the result of the aggressive marketing practices. 10 by omission, the court implies without marketing based on the prescriber-identifying information, a viewpoint would be suppressed. 11 for an example of corporate free speech, citizens united v. fec, 558 u.s. 310 (2010) allowed corporations to support political candidates. 12 in “selling health data: de-identification, privacy, and speech,” bonnie kaplan notes the court’s failure to evaluate the sorrell case as a constitutional privacy case. she concedes that “the state deciding which speech is permitted and which data users are favored over others is detrimental to both personal freedom and the marketplace of ideas.” kaplan, bonnie, “selling health data: de-identification, privacy, and speech,” isps bioethics working paper, yale interdisciplinary center for bioethics, oct. 7, 2014. i assert that, in sorrell, the state deciding is detrimental to neither: personal freedom is irrelevant except for the personal freedom to protect one’s own data; the marketplace of ideas is not furthered by using data to promote detailing, a one-sided marketing tool promoting brand names. 13 sorrell, 17. 14patient protection and affordable care act, 42 u.s.c. § 18001 et seq. (2010) 15 “for example, it appears that vermont could supply academic organizations with prescriber-identifying information to use in countering the messages of brand-name pharmaceutical manufacturers and in promoting the prescription of generic drugs…” “the law on its face burdens disfavored speech by disfavored speakers.” sorrell, p. 8. in “two more from the supreme court”, the drug and device law blog mischaracterizes the court’s statement saying “…the statute provided for state-financed ‘counterdetailing’-pushing cheaper, often generic, competing drugs.” bexis, “two more from the supreme court,” the drug and device law blog (june 23, 2011). https://www.druganddevicelawblog.com/2011/06/two-more-from-supreme-cour.html the court acknowledged vermont has no state-run counter-detailing effort but does collect the data. sorrell, p. 4. the statute’s “evidence based prescription drug education program” should not be mischaracterized as counter-detailing despite its inclusion of cost-effective options. 16 sorrell, p. 4 and 8. 17 sorrell, p. 4. https://www.afj.org/blog/one-year-later-the-consequences-of-sorrell-v-ims-health-inc https://www.afj.org/blog/one-year-later-the-consequences-of-sorrell-v-ims-health-inc https://newrepublic.com/article/84056/health-care-eli-lilly-pfizer-ama https://newrepublic.com/article/84056/health-care-eli-lilly-pfizer-ama https://www.druganddevicelawblog.com/2011/06/two-more-from-supreme-cour.html zimmerman, marketing madness, voices in bioethics, vol. 6 (2020) 8 18 sorrell, p. 8. 19 sorrell, dissent, p. 3-4, arguing the central hudson test would be sufficient for the commercial free speech claim at hand and that the majority’s elevated scrutiny of the speech was not appropriate. 20rothstein, mark a. “is deidentification sufficient to protect health privacy in research?.” american journal of bioethics, vol. 10,9 (2010): 3-11. doi:10.1080/15265161.2010.494215 21 us department of health and human services. https://aspe.hhs.gov/report/minimizing-disclosure-risk-hhs-open-datainitiatives/re-identification-individuals-data-released-public 22 ornstein, charles, “big data + big pharma = big money,” propublica, jan. 10, 2014. tanner, adam, “this little known firm is getting rich off your medical data,” fortune, feb. 9, 2016. both articles cite ims revenues of which approximately 2 billion come from selling the data gotten from pharmacies. ims develops patient dossiers (over 500 million of them now) without transparency as to its methods. ims purchases data from pharmacies, electronic medical records companies, and insurers among others. 23 sorrell, dissent, p. 7, citing trans union llc v. ftc, 536 u.s. 915 (2002). 24 booth, katie, “the all-or-nothing approach to data privacy: sorrell v. ims health, citizens united, and the future of online data privacy legislation,” jolt digest harvard law school, aug. 7 2011. 25for a list of all 27 amicus briefs filed see https://www.scotusblog.com/case-files/cases/sorrell-v-ims-health-inc/ for example, in support of the vermont law, the aarp, new england journal of medicine, the electronic privacy information center, the vermont medical society, berkeley media studies, public health law and policy filed amicus curiae briefs. in support of ims, the cato institute, the biotechnology council, the association of national advertisers, and mcgraw hill and hearst (both rely on similar data for marketing) filed amicus curiae briefs. 26 one outlier in the think tank reports on sorrell, see the libertarian goldwater institute’s “restoring fee speech in medicine,” june 6, 2017 https://goldwaterinstitute.org/article/restoring-free-speech-in-medicine/ 27 sorrell, p. 9 finding intent “to impose a content-based burden” and discussion on p. 10-11 where the majority opinion refers to the message the speech conveys with an underlying theme that the type of corporate speech is worthy of heightened scrutiny. the justices post citizens united are significantly more open to arguments that frame commercial speech in the language of personal speech. 28 the health insurance portability and accountability act of 1996. pub. l. 104-191. stat. 1936. web. 11 aug. 2014. 29 cohen, beverly, “regulating data mining post sorrell: using hipaa to restrict marketing uses of patients’ private information,” wake forest law review, 2013. http://wakeforestlawreview.com/2013/04/regulating-data-mining-post-sorrell-using-hipaa-torestrict-marketing-uses-of-patients-private-medical-information/ 30 cohen, on how evaluating the statute in sorrell under hipaa would create a different result. 31 sorrell, p. 17. “and the measure permits insurers, researchers, journalists, and the state itself, and others to use the information.” 32griswold v. connecticut, 381 u.s. 479 (1965). (marital privacy). 33hartman, gary, landmark supreme court cases, facts on file (2004) p. 293, referring to griswold. 34 kaplan, p. 16. https://aspe.hhs.gov/report/minimizing-disclosure-risk-hhs-open-data-initiatives/re-identification-individuals-data-released-public https://aspe.hhs.gov/report/minimizing-disclosure-risk-hhs-open-data-initiatives/re-identification-individuals-data-released-public https://www.scotusblog.com/case-files/cases/sorrell-v-ims-health-inc/ https://goldwaterinstitute.org/article/restoring-free-speech-in-medicine/ http://wakeforestlawreview.com/2013/04/regulating-data-mining-post-sorrell-using-hipaa-to-restrict-marketing-uses-of-patients-private-medical-information/ http://wakeforestlawreview.com/2013/04/regulating-data-mining-post-sorrell-using-hipaa-to-restrict-marketing-uses-of-patients-private-medical-information/ malavé, politicize my bioethics, voices in bioethics, vol. 2 (2016) © 2016 celina malavé. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. politicize my bioethics: compensation for egg cells celina malavé keywords: bioethics, egg donation, politics, safety, reproduction introduction this is my first piece in a series i’m thinking about calling “politicize my bioethics,” a series that works to give us examples upon which it is absolutely crucial to bring in politics (or really just notice because they are already there), particularly when we are thinking critically about a bioethical issue. in a perfect world, we would be able to have every single identity represented at the table when we are thinking critically about the intersection of medicine, technology, and ethics, but since that is not the case, we must then acknowledge and be aware of the identities each of us is bringing to the table as we work to be future leaders in bioethics." celina malavé egg donation is a recent development in the field of reproductive medicine in which healthy women voluntarily provide around 10-20 mature eggs, or oocytes, for research or assisted reproduction, in exchange for compensation. prior to donating, donors undergo blood tests—which check hormone levels, blood type, and other markers—a pelvic exam, medical exam, and other evaluations to ensure mental preparedness for donation.1 legal consent forms must also be signed and agreed upon by all parties involved. to begin the donation process, the donor takes birth control to regulate her menstrual cycle. she is then given a series of powerful hormones injections for weeks prior to donation. a first round of hormones halts ovarian function while a second causes the woman to over-ovulate in order to produce multiple eggs. a final round of injections causes her to release the mature eggs before a minor, yet invasive surgery, is performed to collect the oocytes. the eggs are either used for research or are fertilized and inserted in-vitro into an ivf recipient. aside from ovarian hyperstimulation syndrome (ohss), a side effect in which too many hormones are injected causing ovaries to become swollen and painful, not much is known about the long-term effects of egg donation. due to a lack of regulation, breakthroughs in technology, and no shortage of desperate parents, the reproductive technology industry has managed to overly compensate women for their egg donation services. women receive compensation ranging from $5,000 to $100,000 per egg donation.2 because of the high prices future parents are willing to pay, the ethics behind informed consent are violated, many potential parents are disadvantaged, and the health of young women is put at unknown risks. given these serious issues with the current system, reproductive policies should ban compensation for ivf egg donations. analysis an informed consent form is given to a patient after she is made aware of all the risks and implications involved in a procedure and is allowed to make a voluntary decision without clouded judgment. bioethicist josephine johnston raises concerns regarding informed consent for egg donations, asking, “how much is that [young student in need of money] actually giving informed consent about the medical procedure and really listening and thinking as it’s being described and its risks are explained?”3 because of poor tracking of egg malavé, politicize my bioethics, voices in bioethics, vol. 2 (2016) 2 donors’ post-donation health and a lack of research regarding long-term effects, little is known about future health complications related to egg donations. women who are in college are the most targeted and, often times, the most in need of compensation. thus, informed consent becomes jeopardized when a college student has other pressing financial demands – student loans to pay off – and agrees to give away her eggs in exchange for cash. in other words, high compensation can drive women to overlook potential risks. informed consent is, therefore, illegitimate when little is known about the future health implications of egg donation and donors are paid for their eggs. the reproductive industry is a free market. those who can afford ivf undergo the procedure; meanwhile, the high demand for eggs continues to drive-up their market value. egg donation was originally needed for research but has expanded to assisted reproduction.4 however, the high prices placed on eggs, make ivf inaccessible to a large group of potential parents. unlike organ donations where there is a waiting list and no discrimination based on economic status of recipients, the compensation given to egg donors makes ivf available only to couples that can afford it. if the goal of ivf is to enable otherwise infertile couples to have children, then economic status should not determine access to the procedure. this lucrative field is regulated far less than other donation industries, even though the procedures involved in egg donation are similar to those for organ donations. there are precautions in place to ensure that organ donors -in particular, kidney donors -are fully informed when making decisions. many donors consult their families before performing any procedures, while protocols ensure that no conflicts of interest exist and that patients voluntarily make their own decisions.5 even though many of the same concerns apply to both organ and egg donations, most of the policies in place for egg donations concern the safety of the recipient, rather than the donor. however, many conflicts of interest exist in egg donation because it is a lucrative and money-driven industry. additionally, many egg donors do not consult their families before making decisions, while compensation challenges the voluntary nature of egg donation. the american society for reproductive medicine, an organization that sets guidelines for ivf, acknowledges the potential coercive effect on women and recommends that women do not undergo the procedure more than six times. however, these rules are difficult to enforce. conclusion it is unacceptable that this industry can continue to grow without greater regulation in place to ensure the safety of all parties involved. until more research is done into the long-term effects of egg donation and laws are put in place to ensure the voluntary consent of donors, compensation for egg donations should be banned by law. the health and safety of women is more important than meeting the high demands of the reproductive industry. 1 "egg donation." wikipedia. wikimedia foundation, 05 july 2014. web. 21 may 2014. 2 ibid. 3 rabin, roni caryn. "as demand for donor eggs soars, high prices stir ethical concerns." the new york times. the new york times, 14 may 2007. web. 21 may 2014 4 "egg donation: ethical implications and controversy. " infertility treatment. n.p., n.d. web. 21 may 2014. <http://www.fertilityproregistry.com/article/egg-donation-ethical-implications-and-controversy.html> 5 petty, elaine. "women for sale/eggs needed: is the market for egg donation developing without oversight that protects organ donors."<http://pqdtopen.proquest.com/pqdtopen/doc/304648302.html?fmt=ai>. http://www.fertilityproregistry.com/article/egg-donation-ethical-implications-and-controversy.html http://pqdtopen.proquest.com/pqdtopen/doc/304648302.html?fmt=ai introduction egg donation is a recent development in the field of reproductive medicine in which healthy women voluntarily provide around 10-20 mature eggs, or oocytes, for research or assisted reproduction, in exchange for compensation. prior to donating, donors ... to begin the donation process, the donor takes birth control to regulate her menstrual cycle. she is then given a series of powerful hormones injections for weeks prior to donation. a first round of hormones halts ovarian function while a second cause... due to a lack of regulation, breakthroughs in technology, and no shortage of desperate parents, the reproductive technology industry has managed to overly compensate women for their egg donation services. women receive compensation ranging from $5,000... analysis conclusion it is unacceptable that this industry can continue to grow without greater regulation in place to ensure the safety of all parties involved. until more research is done into the long-term effects of egg donation and laws are put in place to ensure the... poleksic, gender discrimination disorder, voices in bioethics, vol. 2 (2016) *jelena poleksic is an msc candidate in global health at mcmaster university. © 2016 jelena poleksic. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. diagnosing the culture of medicine: gender discrimination disorder jelena poleksic* keywords: gender discrimination disorder, narrative medicine ethics, anti-harassment introduction an article on gender discrimination in academic medicine that was recently published in the journal of the american medical association has revealed a disturbing conclusion: 30 percent of female physicians report having experienced sexual harassment.1 this discrepancy was first formally noted twenty years ago when 52 percent of women in academic medicine reported experiencing some form of harassment, which prompted the introduction of complaint mechanisms, anti-harassment policies, and professional ethics modules in medical curricula.2 it was also thought that an increased female presence in medicine would, over time, reduce the magnitude of gender inequality. despite efforts to improve gender balance and mitigate discrimination in the medical profession, harassment rates remain unacceptably high. gender discrimination is either overt or covert. overt discrimination is comprised of inappropriate sexual advances and remarks based on an individual’s gender whereas covert discrimination constitutes an “unconscious bias,” which permits differential treatment with respect to opportunities and career prospects.3 this gender bias is inculcated through the hidden curriculum—unspoken values and attitudes in medicine transmitted over the course of medical education—that can be as harmful as overt discrimination.4 the subtle bias fostered by this hidden curriculum makes it difficult to report and eliminate because it does not explicitly violate institutional policies. this also explains why many women pursue pediatric and geriatric subspecialties, disciplines that require a traditionally feminine caretaker role, rather than surgery where they may encounter prejudice in an “old boy’s club.”5 ____________________________________________________________ analysis the consequences of gender discrimination and, more broadly, the pervasive mistreatment of medical trainees due to gender, race, and age cannot be ignored. the verbal, physical, and sexual harassment that appear to be endemic to medicine are correlated with burnout and depression among practitioners.6 this abuse is more serious than women being deterred from pursuing a male-dominated specialty or a female trainee being humiliated by an attending, because it affects both individual and public health. mistreatment in the professional setting cannot be isolated from the public sphere because a practitioner’s wellbeing has a direct impact on the wellness of their patients. sexual harassment can trigger dissatisfaction, low mood, and even suicidality in physicians, all of which can seriously compromise the quality of care received by their patients.7 moreover, discriminatory attitudes that become internalized over the course of medical education can introduce gender bias in diagnosis and threaten the respect between practitioners and patients. it is reasonable to assume that the conduct of mentors, whom trainees must mimic to develop their clinical skills, influences the attitudes of future physicians and thereby produces a transgenerational cycle of abuse. these long-term consequences make a https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn1 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn2 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn3 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn4 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn5 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn6 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn7 poleksic, gender discrimination disorder, voices in bioethics, vol. 2 (2016) 2 compelling argument in support of institutional policies that seek to curb the incidence of harassment in academic medicine. not only must physicians reduce gender discrimination in order to avoid legal action, but they ought to make this concerted effort because of their commitment to the ethical imperative of nonmaleficence toward their patients and their peers. the gender inequality encountered by female physicians is a product of our misogynistic society and the patriarchal hierarchy in medicine. of course, sexual harassment is not unique to medicine and is prevalent in other settings.8 however, the abuse inherent in medical culture is disconcerting because medicine is presumably held to a higher standard than most professions. if medicine is heralded as the bastion of compassion, empathy, and social justice, how can we reconcile the reality of widespread abuse in a profession that is supposed to set a moral precedent? upon learning of the high incidence of harassment in medicine, some practitioners defend their profession by insisting that colleagues and peers are too sensitive and are confusing attempts to build resilience as mistreatment. for instance, while randomly bombarding medical students with questions to test their knowledge has educational value, there is a clear distinction between trying to create “tougher” doctors and purposefully creating a toxic environment that facilitates the erosion of self-esteem through physical, verbal, and sexual abuse.9 this culture of denial serves as a deterrent for individuals who have been directly affected by discrimination and wish to report a transgression. indeed, many women are put off from reporting incidents in order to avoid being labeled as “hypersensitive” or “dramatic.” other victims of discrimination minimize their experiences and accept harassment as status quo.10 conclusion it cannot be said that strides in gender equity in both medicine and society have not been achieved. nonetheless, a revised, multifaceted approach is needed to further mitigate instances of discrimination. supportive counseling programs should be developed to help individuals affected by the abuse. in turn, these programs can facilitate conversations between faculty members as well as students. it is incumbent upon the medical profession to create a working environment where all members can feel safe. a sense of security and inclusivity will hopefully inspire victims to access complaint mechanisms. reassuring complainants that punitive action will be reinforced and that they are not jeopardizing their career prospects is paramount. ultimately, it is the duty of medical practitioners to remember the sympathy and understanding they pledged to offer their patients is also conducive to the wellbeing of their students and colleagues. 1 reshma jagsi et al., “sexual harassment and discrimination experiences of academic medical faculty,” the journal of the american medical association315, no. 19 (may 2016): 2120, doi: 10.1001/jama.2016.2188. 2 henry k. silver and anita duhl glicken, “medical student abuse: incidence, severity, and significance,”the journal of the american medical association 263, no. 4 (january 1990): 527, doi: 10.1001/jama.1990.03440040066030. 3 alexandra sifferlin, “30% of female doctors have been sexually harassed,” time, may 17, 2016,http://time.com/4337372/30of-female-doctors-have-been-sexually-harassed/. 4 sally c. mahood, “beware the hidden curriculum,”canadian family physician 57, no. 9 (september 2011): 983, http://www.cfp.ca/content/57/9/983.full. 5 victoria reed and barbara buddeberg-discher, “career obstacles for women in medicine: an overview,”medical education 35 (february 2001): 140, doi:10.1111/j.1365-2923.2001.00837.x. 6 liselotte n. dyrbye et al., “burnout and suicidal ideation among u.s. medical students,” annals of internal medicine 149, no. 5 (september 2008): 334, doi: 10.7326/0003-4819-149-5-200809020-00008. https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn8 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn9 https://michael-reaves-bkln.squarespace.com/newswire/2016/09/07/diagnosing-the-culture-of-medicine-gender-discrimination-disorder#_edn10 http://time.com/4337372/30-of-female-doctors-have-been-sexually-harassed/ http://time.com/4337372/30-of-female-doctors-have-been-sexually-harassed/ http://www.cfp.ca/content/57/9/983.full poleksic, gender discrimination disorder, voices in bioethics, vol. 2 (2016) 3 7 erica frank et al., “experiences of belittlement and harassment and their correlates among medical students in the united states: longitudinal survey,” bmj333, no. 7570 (september 2006): 683, doi: 10.1136/bmj.38924.722037.7c. 8 adrianne n. bruce et al., “perceptions of gender-based discrimination during surgical training and practice,” medical education online 20 (february 2015), doi: http://dx.doi.org/10.3402/meo.v20.25923. 9 ajay major, “to bully and be bullied: harassment and mistreatment in medical education,” virtual mentor16, no. 3 (march 2014): 157, http://journalofethics.ama-assn.org/2014/03/fred1-1403.html. 10 susan w. hinze, “‘am i being over-sensitive?’ women’s experience of sexual harassment during medical training,” health (london) 8, no. 1 (september 2004): 102, doi: 10.1177/1363459304038799. http://journalofethics.ama-assn.org/2014/03/fred1-1403.html cohen, the trials of patient o, voices in bioethics, vol. 3 (2017) * jennifer cohen is a current m.s. candidate in bioethics at columbia university. she holds a j.d. from st. john’s university school of law and a master of arts in religion from yale university divinity school. © 2017 jennifer cohen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the trials of patient o jennifer cohen* keywords: bioethics, aids, epidemiology, patient privacy, stigma introduction in 1987, harry reasoner of 60 minutes questioned dr. selma dritz about her search in the early 1980s for the origins of the deadly outbreak of aids in the united states. “it was the whodunit of the century, and i was born nosy,” she tells him. the title of the 60 minutes piece was “patient zero” who mr. reasoner explains “was a man – a central victim and victimizer” in the spread of aids. dr. dritz, who had been the head of infectious diseases in the san francisco branch of the centers for disease control and prevention (cdc), recalled warning patient zero of the danger he posed to others. in her retelling, mr. dugas callously rebuffed her concerns, showed little remorse for infecting others, and concluded their interaction with “screw you.” also interviewed was randy shilts whose book, and the band played on, identified patient zero as gaëtan dugas, a canadian flight attendant. mr. shilts explained that mr. dugas constituted what epidemiologists today call a superspreader – someone with unlimited ability to infect others and “speed this disease into every corner of america.” the narrative of a villainous foreigner maliciously spreading a deadly epidemic culminated in an infamous new york post headline condemning mr. dugas as “the man who gave us aids.” ____________________________________________________________ cohen, the trials of patient o, voices in bioethics, vol. 3 (2017) 2 analysis the story unraveled upon closer inspection. in 1984, the cdc had indeed identified a “patient o” who had sexual connections with other aids patients, but the “o” stood for “outside” california. nowhere in the study is “patient o” identified as “patient zero” -i.e., the person who introduced the virus in america. in 2007, an article in the proceedings of the national academy of sciences concluded that hiv traveled from africa to hait i and then on to the us sometime in 1969, many years before mr. dugas became infected. on october 26th of this year, the story was conclusively debunked in a study published in nature. the authors “recovered the hiv -1 genome from the individual known as ‘patient o’ and found neither biological nor historical evidence that he was the primary case in the us….” the mainstream media rediscovered the story with the new york times writing that “the alleged ‘patient zero’ of the american aids epidemic – a french canadian flight attendant named gaëtan dugas, who died of aids in 1984 – was exonerated last week.” dr. dritz’s description of the epidemic’s origins as a “whodunit,” as well as mr. reasoner’s characterization of mr. dugas as a “victimizer,” embody culpabl e language, reflecting the difficulties of balancing the need to identify “index cases” as they are known in epidemiology with the ethical considerations of patient privacy and justice. as discussed by ronald bayer and amy fairchild in the genesis of public health ethics, the aids epidemic triggered a rethinking of ethics in public health. hard fought battles for privacy and civil liberties had been won by the gay community, and the traditional epidemiological methods of mandatory case reporting by name, contact investigation and quarantine were perceived as threats to those gains. consequently, public health measures emphasized education to change cultural behavior, the protection of individual privacy, and a rejection of coercive measures in favor of voluntary testing and counselling of those infected and at risk. richard mckay, a co-author of the nature study, has questioned whether the notion of a “patient zero” is itself a fallacy that overshadows structural factors that contribute to the spread of disease such as cultural inequalities and barriers to health care and education. containing an epidemic is far more complex than hunting down the person who may have spread the disease initially. david heymann, an infectious disease epidemiologist at the londo n school of hygiene and tropical medicine, confirms that locating a patient zero is only useful if they are still alive and infecting others: “and more often than not, especially in large disease outbreaks, they’re not.” conclusion the modern healthcare response to epidemics aims to respectfully and ethically limit exposure and, when necessary, alter societal behaviors that may spread disease, but the gaëtan dugas case demonstrates that the media and the public may focus unduly on blaming the behavior of individuals. the overwhelming media attention on dr. craig spencer and nurse kaci hickox during the ebola crisis are more recent examples. many also believe that policymakers have over -reacted to the public’s fears of the individual, malicious aids infector: 32 states have criminalized the spread of hiv. the search and public identification of a “patient zero” risks stigmatizing and traumatizing individuals, and alienating those who may be infected from coming forward. the exoneration of patient o is a reminder that the management of an epidemic must be met with a determination to protect the privacy, liberty and just treatment of individual patients. references 1) dritz, selma. “patient zero.” interview with harry reasoner. 60 minutes. cbs. november 15, 1987. 2) rothman, kenneth j., et al. modern epidemiology, 3rd edition. (philadelphia: lippincott, williams & wilkins) 2008, 561. cohen, the trials of patient o, voices in bioethics, vol. 3 (2017) 3 3) shilts, randy. “patient zero.” interview with harry reasoner. 60 minutes. cbs. november 15, 1987. 4) mckay, ricard a., “patient zero”:the absence of a patient’s view of the early north american aids epidemic,” bull hist med. 2014 spring : 161-194. doi: 10.1353/bhm.2014.0005 5) auerbach, david m., et al., “cluster of cases of the acquired immune deficiency syndrome: patients linked by sexual contact.” the american journal of medicine 76, (march 1984) 487 92. 6) thomas, m. et al. “evolution the emergence of hiv/aids in the americas and beyond“ proc natl acad sci 2007 nov 20; 104(47): 18566–18570. published online 2007 oct 31. 7) worobey, michael, et al. “1970s and ‘patient o’ hiv-1 genomes illuminate early hiv/aids history in north america.” nature 539, 98-101. 26 october 2016. 8) mcneil, donald g., “h.i.v. arrived in the u.s. long before ‘patient zero’”. new york times, october 26, 2016. mr. mcneil wrote a second article addressing the ethical issues. “the ethics of hunting down ‘patient zero’” new york times, october 29, 2016. 9) bayer r1, fairchild al. “the genesis of public health ethics.” bioethics. 2004 nov;18(6):473 92.xi ibid, 478 10) bayer r1, fairchild al. “the genesis of public health ethics.” bioethics. 2004 nov;18(6):473-92.xi ibid, 478 11) cdc mmwr ebola transmission linked to a single traditional funeral ceremony april 17, 2015/64 (14); 386-388) 12)mohammadi, dara. “finding patient zero.” the pharmaceutical journal. 17 jan 2015, vol 294, no 7845, online doi: 10/1211/pj.2015.200067543. 13)"prosecutions for hiv exposure in the united states, 2008–2013". the center for hiv law & policy, positive justice project. retrieved. bechtel, hiv transmission, voices in bioethics, vol. 2 (2016) © 2016 sarah bechtel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are cre dited. the impact of cultural norms on hiv transmission in swaziland sarah bechtel keywords: global ethics, hiv introduction many countries in sub-saharan africa struggle with high rates of hiv incidence and, more pointedly, struggle to prevent hiv infection. this sub-saharan region of africa includes countries such as guinea, kenya, mozambique, somalia, and swaziland, all of which qualify as developing countries because of their minimal and arguably insufficient healthcare infrastructure, among other influencing factors.[1] hiv steadily prevails in these countries—and swaziland especially struggles with peak incidence of hiv. swaziland is a country located on the southeastern tip of africa; is landlocked by south africa and mozambique; and currently has the highest incidence of hiv worldwide. swaziland has “close to a third of the country’s adult population… infected with the hiv virus.”[2] this higher prevalence is widely attributed to swaziland’s cultural norms of polygamous and child-adult marriages.[3] many questions thus arise in regard to the possibility that swaziland’s peak hiv incidence rate stems directly from its cultural norms and tradition of polygamy, on the one hand, and childadult marriage, on the other. as a result, it is reasonable to argue that the ethical principle of beneficence should inform our approach to evaluating this situation justly while continuing to respect swaziland’s traditional customs. that is, given that hiv is a life-threatening disease and seems to propagate the adult population of swaziland through these norms, is it ethical to advocate for, and subsequently apply, changes to these cultural practices for the purpose of both saving lives and preventing hiv transmission in the first place? analysis swaziland’s cultural norms operate within a patriarchal status quo. swaziland’s king mswati iii openly admits the presence of legal polygamy.[4] in fact, king mswati is perfectly within his rights as monarch to “choose a new wife every year from among thousands of virgins.”[5] in this vein, swaziland hosts an annual reed dance festival in late summer that publicly celebrates a woman’s chastity and purity before marriage; an unwed pregnant mother or the man she slept with, for instance, can be fined a cow for disobeying this normative cultural standard.[6] this standard indicates cultural norms that also represent enforceable laws within the country. swaziland clearly seems to prefer female chastity until marriage—a status that suggests favoritism towards heteronormative relationships due to clear societal standards that clearly value a woman’s chastity, polygamous unions challenge the value of one woman by prioritizing the significance of one man. as a standard cultural practice, polygamy is unproblematic insofar as it does not promote disease. however, hiv infection is significantly higher among newly married adolescent girls since the men they marry tend to be older, hiv positive, and active participants in polygamous relationships. that is, polygamous marriages perpetuate sexual infection among people who were previously hiv negative.[7] consequently, swaziland’s https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn1 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn2 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn3 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn4 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn5 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn6 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn7 bechtel, hiv transmission, voices in bioethics, vol. 2 (2016) 2 cultural norms have significant potential to operate at odds with measures to lower hiv incidence. polygamous swazi unions are commonly acknowledged as a central factor driving swaziland’s considerable rate of hiv incidence. in 2012, swaziland’s government officials enacted a child protection and welfare act that criminalized child marriages and classified any sexual activity that occurred within these marriages as being equivalent to statutory rape with the intention of decreasing rates of hiv infection.[8] this official declaration recognizes that children—realistically, adolescent teenagers below the age of consent—should not be forced into a marriage that is potentially life-threatening as a result of consummating a marriage. therefore, swazi officials seem to acknowledge that allowing marriages with potentially hiv-positive men is inherently problematic, even though they clearly stay bound by traditional customs. the inclusion criteria for clinical trials in swaziland focus on pregnant women who are hiv positive and remain untreated, with no reference to whether they are in a non-polygamous marriage, or perhaps unwed. simply, the purpose of these clinical trials is to “understand how best to provide care and treatment services to human immunodeficiency virus (hiv)-positive pregnant women and their babies in swaziland,” and to “evaluate a new approach for preventing mother-to-child transmission (pmtct) where all hiv-positive pregnant women initiate lifelong triple antiretroviral (arv) therapy regardless of their disease stage.”[9] trial participants must either be (i) women eighteen years or older and pregnant, or (ii) the babies born to these women, who must also be concurrently enrolled in the study. these clinical trials are often funded by grants from american universities approved by swaziland’s ministry of health, which has been called in to evaluate specific aspects of hiv transmission. this is of seminal importance because, as recently as 2013, swaziland’s population growth rate was estimated to be 1.5 percent annually.[10] heavy prevalence of hiv in a country with minimal population growth limits the options for swaziland’s livelihood as a country. clinical trials are only the tip of the iceberg. with a sole focus on pregnant, positive women and their babies, these trials exclude testing possible treatments for women who are hiv positive but not pregnant. even so, when clinical trials seek to prevent and treat hiv in pregnant women, the potential arises for stigma and discrimination to occur between women who seek treatment and those who abstain—and who may, perhaps, be the other wives of the same husband. these clinical trials have the potential to greatly benefit swaziland by reducing the transmission of hiv from mother to child and allowing for the swaziland population to grow. however, they offer limited resources in terms of longer-term treatment for those who are hiv positive. treatment options also raise further ethical issues related to justice. given swaziland’s polygamous culture, hiv transmission is not limited to occurring solely between a mother and her child; polygamous men are also responsible for transmitting hiv. from a propatriarchal standpoint, it is reasonable to conclude that swazi men uphold the swazi tradition by seeking honor and status in alignment with their cultural norms. this perspective favors the preservation of the husband’s autonomy in his pursuit of polygamous relations and, by implication, the continued infection of others through intercourse—assuming that he is hiv positive. inherently, polygamy is not necessarily morally wrong; however, this social custom acquires risk when transmission of a life-threatening disease such as hiv persists. given the approximately 1:1 population growth ratio, this custom warrants reevaluation because it neglects to account for the wellbeing of the swazi people whose average life expectancy, coincidentally, is just more than fifty years.[11] conclusion many international researchers posit that judging other cultures for their traditional customs is equivalent to imposing other normative standards and cultural values on another society. however, swaziland’s problem with hiv and the fact that clinical trials targeting this issue exist—though, notably, are no longer recruiting participants—to examine its transmission indicates an overall desire to decrease the incidence of hiv in the population.[12] this earnestness suggests that swaziland’s cultural norms are shifting in favor of preventing https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn8 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn9 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn10 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn11 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_edn12 bechtel, hiv transmission, voices in bioethics, vol. 2 (2016) 3 hiv transmission in the future, and illustrates how the swazi people are now adapting to address these pressing healthcare issues. polygamy may very continue, but the swazi people must continue to find ways to minimize—and hopefully eradicate—transmission of hiv by promoting widespread use of condoms; using antiretroviral treatments; implementing countrywide hiv testing and treatment options for anyone, regardless of who is sexually active or gets married. references [1] least developed countries criteria, “lcd criteria,” un: development policy and analysis division, february 23, 2016. http://www.un.org/en/development/desa/policy/cdp/ldc/ldc_criteria.shtml. [2] hilary andersson, “sex-ban swazi king pays fine,” bbc news, november 12, 2001, http://news.bbc.co.uk/2/hi/africa/1651154.stm. [3] avert, “hiv and aids in swaziland,” february 23, 2016, http://www.avert.org/professionals/hivaround-world/sub-saharan-africa/swaziland. [4] king mswati iii, “the king of swaziland on polygamy,” multi media, february 23, 2016, https://www.youtube.com/watch?v=_e451kdfrqq. [5] andersson, “sex-ban swazi king pays fine” [6] mike unwin, swaziland (bradt travel guides ltd: london, 2012), 93. [7] global resource & information directory, “swaziland: legislation,” february 23, 2016, http://www.fosigrid.org/africa/swaziland#legislation. [8] ibid. [9] u.s. national institutes of health: clinical trials, “swaziland safe generations,” february 23, 2016, https://clinicaltrials.gov/ct2/show/nct01891799. [10] world bank, swaziland, february 23, 2016, http://data.worldbank.org/country/swaziland. [11] world life expectancy, swaziland, february 23, 2016, http://www.worldlifeexpectancy.com/swaziland-life-expectancy. [12] u.s. national institutes of health: clinical trials, “swaziland safe generations,” february 23, 2016, https://clinicaltrials.gov/ct2/show/nct01891799. https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref1 http://www.un.org/en/development/desa/policy/cdp/ldc/ldc_criteria.shtml https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref2 http://news.bbc.co.uk/2/hi/africa/1651154.stm https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref3 http://www.avert.org/professionals/hiv-around-world/sub-saharan-africa/swaziland http://www.avert.org/professionals/hiv-around-world/sub-saharan-africa/swaziland https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref4 https://www.youtube.com/watch?v=_e451kdfrqq https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref5 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref6 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref7 http://www.fosigrid.org/africa/swaziland#legislation https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref8 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref9 https://clinicaltrials.gov/ct2/show/nct01891799 https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref10 http://data.worldbank.org/country/swaziland https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref11 http://www.worldlifeexpectancy.com/swaziland-life-expectancy https://michael-reaves-bkln.squarespace.com/opeds/2016/05/26/the-impact-of-cultural-norms-on-hiv-transmission-in-swaziland#_ednref12 https://clinicaltrials.gov/ct2/show/nct01891799 glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) * shannon m. glick, ph.d. candidate, loyola university of chicago © 2023 shannon m. glick. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the ethical need for a fertility decision aid for transgender adults of reproductive age shannon m. glick* abstract current studies show that about half of transgender and gender-diverse (tgd) people wish to have children in the future. tgd patients who pursue gender-affirmation interventions must be aware of the impact that various treatments can have on fertility, as gender-affirming care through medical or surgical treatment can limit or alter reproductive potential. many medical professional societies encourage providers to educate and counsel patients about the consequences of treatment and viable options for fertility preservation (fp) as early as possible, though patients may not be aware of all the family formation methods available. there is a significant need for a tool that thoroughly details not only the various opportunities for parenthood but the perceived cost, rates of success, and risks associated with each option. a fertility decision-aid would allow for a more robust informed consent process and shared decision-making for all individuals pursuing gender-affirming care. keywords: transgender, fertility treatment, informed consent, decision-making, parenthood, fertility preservation introduction over 1.6 million adults and youth in the united states, or about 0.6 percent of those age 13 and over, identify as transgender, according to a report released by the williams institute in june 2022.1 current studies show that approximately half of transgender and gender-diverse (tgd) people wish to have children in the future, which aligns with the rate of cisgender individuals who desire parenthood in some form.2 studies on parenthood show improved quality of life and mental health in tgd adults and decreased incidence of suicide in tgd women.3 in one study, almost half of the tgd individuals who indicated an interest in parenthood said they wanted genetically related offspring. 4 however, medical or surgical therapies can limit reproductive potential.5 recent findings indicate that some tgd adults who underwent medical or surgical paths to affirmation regret decisions that may have led to their inability to have genetic children. perhaps they did not know it was an option, faced barriers to care, or were not interested at the glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) 2 time.6 many medical professional societies, including the world professional association for transgender health (wpath), the endocrine society, and the american college of obstetrics and gynecology, encourage providers to educate and counsel patients about the consequences of treatment and viable options for fertility preservation as early as possible. 7 this paper argues that tgd patients who pursue genderaffirmation interventions must be aware of the impact treatments can have on fertility and, ultimately, parenthood and that a design tool may help them understand the risks and make informed decisions. i. gender affirmation options some tgd individuals do not use medical or surgical therapies to feel affirmed in their identity. 8 nonmedical paths to affirmation include social and legal measures.9 these reversible paths do not impact the individual’s future fertility potential. tgd individuals can follow different paths of gender-affirming care through social, legal, medical, and surgical affirmation. 10 social affirmation can include using genderaffirming pronouns, names, and clothing.11 legal affirmation can include changing the gender and name on a birth certificate and other records in states where this is permissible.12 social and legal affirmations are reversible and do not impact fertility potential. medical affirmation involves the use of gender-affirming hormone therapy. feminizing or masculinizing hormone therapy allows for the development of secondary sex characteristics that more closely align with the individual's gender identity.13 no set regimen for treatment exists, as a patient’s goals will determine their individualized plan. 14 some standard feminizing agents include estrogen, androgen-reducing medications, and progestins, while the common masculinizing agent is testosterone.15 gender-affirming hormone therapy is not currently seen as a definitive cause of infertility, as it is possible to discontinue treatment and see a noted reversal of intended effects.16 research findings suggest that hormone therapy should stop for a minimum of three months to reverse any treatment effects.17 the only available data on long-term hormonal therapy use is inconsistent, based on observational studies with varying duration and doses. 18 individuals can stop gender-affirming hormone therapy, but its lasting impact on fertility is unknown.19 a tgd individual may choose to undergo surgical interventions that do not impact fertility. these interventions can masculinize or feminize body parts to allow a patient ’s physical appearance to align with their gender identity.20 this care could include breast augmentation for tgd women and adam’s apple reduction or breast reduction for tgd men. 21 other surgical interventions will impact tgd individuals’ fertility. genital surgery for a tgd woman can include the removal of the penis and scrotum (penectomy and orchiectomy) and the construction of a vagina and labia (vaginoplasty and valvuloplasty).22 a tgd man can have removal of the ovaries and uterus (oophorectomy and hysterectomy) and construction of a penis and scrotum (metoidioplasty, phalloplasty, and scrotoplasty).23 following these gender-affirming surgeries, individuals are infertile due to the removal of their reproductive organs.24 these procedures are irreversible and directly impact reproductive capacity in tgd individuals. ii. fertility counseling to explain paths to parenthood patients receiving gender-affirming care should have the opportunity to learn about the various ways to achieve parenthood, including fertility preservation. family formation methods include sexual intercourse, artificial insemination, surrogacy, and adoption or foster care.25 these methods apply to non-tgd people as well. patients may not be aware of the various means of family-building, so accurate and expansive fertility counseling is essential before initiating medical or surgical affirming care. the frequency with which tgd individuals receive fertility counseling and how thorough it is, is unclear. when surveyed about fertility glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) 3 preservation, healthcare providers reported a lack of confidence in discussing fertility preservation with patients due to gaps in their knowledge on best practices, success rates, and regret rates in patients who did not preserve fertility. they also had varied perceptions of their role in treating patients and whether they should discuss family planning.26 patients have reported receiving an overview of fertility options from their primary transgender-healthcare providers before being referred to reproductive specialists.27 while this is an essential step for patients seeking more information about their opportunities for parenthood, only 16 percent of society for assisted reproductive technology member clinics share information about options for transgender individuals on their websites.28 many organizations recommend discussing the risk of infertility. providers of transgender health care do not, and may not be trained to, provide adequate counsel to patients. patients also cannot give informed consent for fertility or gender-affirming care interventions without more information on the benefits and burdens of all available treatments. current literature demonstrates a need for a decision aid that thoroughly details not only the opportunities for parenthood but the perceived cost, rates of success, and risks associated with each option.29 this tool could foster a more informed dialogue between an individual and their care team. a fertility decision aid would also allow for a more robust informed consent process for all individuals pursuing gender-affirming care. regardless of the affirmation path chosen, a tgd individual should have early and frequent conversations with their care team regarding fertility. the world professional association for transgender health (wpath) asserts that healthcare professionals should discuss fertility preservation options before initiating gender-affirming hormone therapy or surgery. the american college of obstetrics and gynecology states that “fertility and parenting desires should be discussed early in the process of transition, before the initiation of hormone therapy or gender affirmation surgery.” 30 the endocrine society writes that “all individuals seeking gender-affirming medical treatment should receive information and counsel on options for fertility preservation prior to initiating puberty suppression in adolescents and prior to treating with hormonal therapy in both adolescents and adults."31 these conversations are essential even if the patient is not interested in parenthood at the time. wpath addresses the potential for regret, as cases of individuals who received hormone therapy and genital surgery and later desired genetically related children have been identified.32 tgd patients pursuing gender-affirming care should assess their individual fertility goals to better understand the many ways to build a family. surveys of tgd adults show that participants want to become parents in various ways. in one study, 31.3 percent of those surveyed wanted to become parents through adoption, 25 percent wanted children through sexual intercourse, 15.6 percent through surrogacy, 12.5 percent using donor sperm, 9.4 percent using a known sperm donor, and 6.3 percent through the foster care system.33 tgd women showed a significant interest in adoption (75 percent of participants), whereas more than half of tgd men wanted to become parents through sexual intercourse or pregnancy (58.3 percent). 34 these fertility goals should be acknowledged and discussed with the care team to guide decision-making about fertility preservation. iii. fertility preservation individuals who wish to share their genetic makeup with their child will usually need to speak with a reproductive specialist about fertility preservation options. they are the same as those for cisgender individuals using fertility services before cancer treatment or elective preservation.35 for tgd adults with ovaries, this includes freezing embryos (using donor or partner sperm) or ovarian tissue.36 while no longer viewed as an experimental treatment, professionals offer tissue freezing to few patients due to a lack of glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) 4 data on its safety and efficacy.37 for tgd adults with testicles, freezing sperm and preserving testicular tissue can preserve the ability to have biological children.38 fertility preservation numbers for tgd adults remain low. a study showed that 76.6 percent of tgd men and 76.1 percent of tgd women considered fertility preservation, but only 3.1 percent and 9.6 percent, respectively, initiated it.39 success rate, cost, need for travel, and elevated risk of gender dysphoria likely lead to lower use of fertility preservation.40 according to the american society for reproductive medicine, the average cost of an ivf cycle in the us is $12,400.41 intrauterine insemination can range in cost from a few hundred dollars to $2,000 per cycle.42 there are also associated costs to freeze and store sperm and eggs.43 insurance coverage and physical location impact the costs and how the patient bears the costs.44 for those who do not have sufficient or any insurance coverage, fertility preservation may not be feasible. of additional significance for this population, fertility preservation techniques can exacerbate gender dysphoria as the patient must produce gametes associated with the gender they do not recognize.45 for tgd women, masturbating in a clinical setting or sperm banking for sperm cryopreservation can cause severe distress. 46 furthermore, fertility preservation for tgd men can be challenging and invasive. a transvaginal ultrasound exam is a requirement for the cryopreservation of embryos and oocytes.47 this exam can cause significant distress as the procedure does not align with their male identity.48 controlled ovarian stimulation cycles require two weeks of daily gonadotropin injections, and the patient is given anesthesia for oocyte retrieval. 49 furthermore, tgd men undergoing fertility preservation must discontinue testosterone use, and menstruation can resume.50 iv. other paths to parenthood a. adoption tgd adults can also pursue parenthood through adoption systems, though foster care is a temporary option. while almost one-third of surveyed tgd adults consider adoption a means to parenthood, cost and fear of discrimination can prevent them from following through. 51 tgd individuals have expressed a reluctance to pursue adoption due to the fear of discrimination by adoption agencies, attorneys, or families.52 nineteen states in the us allow child welfare agencies to refuse to provide services to lgbtq+ families if it conflicts with the religious beliefs of the relevant people in the agency.53 nineteen states have no laws about discrimination during the adoption process based on sexual orientation or gender identity.54 only 29 states have statutory or regulatory protections against discrimination based on orientation and gender identity.55 b. surrogacy there are two types of surrogacies: traditional and gestational.56 in traditional surrogacy, professionals fertilize the surrogate’s egg by the sperm of an intended parent or a sperm donor through intrauterine insemination. in gestational surrogacy, the surrogate undergoes ivf to implant the fertilized embryo.57 egg donation can be used for gestational surrogacy if necessary. those considering surrogacy need to understand the specific laws in their state, as they can differ significantly.58 c. intercourse tgd individuals who have not undergone genital surgery can have intercourse with the intention of causing pregnancy. tgd men who have not had genital surgery can bear children. for those who have initiated hormonal therapy, limited data has been collected on the impact of gender-affirming hormone therapy on glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) 5 conception.59 tgd men have gotten pregnant after discontinuing testosterone use. 60 tgd women who have not had genital surgery can have intercourse with a person with ovaries and produce sperm to fertilize an egg. gender-affirming hormone therapy possibly affects sperm viability.61 v. a decision aid to support informed consent and shared decision making for individuals pursuing gender-affirming care, time is of the essence when considering fertility preservation. in one review, transgender health doctors reported that most patients did not want to postpone treatment for fertility preservation procedures, even if they wanted children; 62 any delay in treatment can be distressing for those with gender dysphoria.63 providers face several challenges when counseling patients about fertility. the wpath guidelines pose an ethical dilemma for transgender health providers as limited data offers guidance about discussing fertility risks and recommendations with patients.64 for tgd patients, limited and contradictory data about fertility outcomes before, during, and after gender affirmation exists, particularly for the lasting impact of genderaffirming hormone therapy.65 for tgd women who have taken estrogen and stopped to pursue fertility preservation, data on sperm quality is mixed.66 the data on when normal ovarian function resumes is variable for tgd men using testosterone who have stopped to pursue fertility preservation.67 much data comes from the oncofertility literature, which indicates that when providers use standardized counseling practices when discussing fertility with their patients, more patients undergo fertility preservation, and patient satisfaction increases.68 for individuals seeking gender-affirming care, there is a need for a decision aid that providers can utilize across multiple clinics and programs.69,70 patients must be aware of the benefits, risks, and alternatives of any intervention to provide truly informed consent. when discussing fertility for tgd patients, this includes which fertility options are available at each stage of transition and the potential for a live birth with each option.71 furthermore, a decision aid would allow for shared decision-making, where the patient is an active participant and co-designer of their treatment plan.72 shared decision-making acknowledges the healthcare provider’s beneficence, knowledge, and experience while equally valuing the right to patient autonomy and respecting the ability of the patient to inform the provider.73 a decision aid can help initiate the conversations between a patient and their provider that allow for a true partnership in decision-making. a recent study investigated the efficacy and impact of a web-based fertility decision aid targeted at tgd adolescents and young adults.74 this tool, titled aid for fertility-related medical decisions (affrmed), significantly increased fertility knowledge in both youth and their parents while improving youth’s perceived ability to make fertility decisions.75 youth participants and their parents found the tool “feasible, acceptable, and usable.”76 this initial study was small, with only eight adolescents or young adults and seven parents participating.77 at large, the effectiveness of the trial will be the next step in determining the legitimacy of the aid for clinical use.78 a similar decision-making tool designed for tgd adults would also be useful. the tool can present an average range of expected costs as much variability exists and costs change over time. this tool should also include general information on what is required to pursue each path to parenthood. for example, a patient undergoing fertility preservation needs to know what steps are necessary after the cryopreservation of gametes for live birth.79 glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) 6 conclusion individuals pursuing gender-affirming care must closely consider the impact of their medical and surgical care on their desire to become parents as early in their affirmation journey as possible. a decision aid can be helpful if it outlines the risks to fertility and options to preserve fertility, with the specific data necessary to make an informed choice. the tool should include the methods of fertility preservation, each step of the protocol and respective risks for each method, the expected timeline from initiation to completion, general success rates, options for remaining gamete disposition, and the average cost of treatment. this should include a list of steps to initiate the process for each method and any potential barriers or obstacles. for surrogacy, the tool should include the two types and the average cost. for intercourse, the aid should include information on risks for discontinuing gender-affirming hormone therapy and general success rates. clinics and providers could elect to tailor the decision aid for their population to include specific information about local laws and the availability of services. with a standardized fertility decision aid, tgd individuals can have a more thorough understanding of the opportunities and limitations placed on their reproductive capacity. healthcare providers can feel more confident that their patients have access to relevant information regarding family-building before initiating medical or surgical affirmation. this allows for a more substantial informed consent and shared decisionmaking process, regardless of the decision made. a trial-tested decision-making tool for tgd adolescents and young adults exists that can serve as a model for creating aid for tgd adults of all ages. a fertility decision aid designed explicitly for tgd adults of reproductive age would be invaluable to support patients and healthcare providers in transgender health. 1 herman, j.l., flores, a.r., o’neill, k.k. (2022). how many adults and youth identify as transgender in the united states? the williams institute, ucla school of law 2 moravek m. b. (2019). fertility preservation options for transgender and gender-nonconforming individuals. current opinion in obstetrics & gynecology, 31(3), 170–176. https://doi.org/10.1097/gco.0000000000000537 3 moravek (2019). 4 moravek (2019). 5 access to fertility services by transgender persons: an ethics committee opinion. (2015). access to fertility services by transgender persons: an ethics committee opinion. fertility and sterility, 104(5), 1111–1115. https://doi.org/10.1016/j.fertnstert.2015.08.021 6 harris, r. m., kolaitis, i. n., & frader, j. e.. (2020). ethical issues involving fertility preservation for transgender youth. journal of assisted reproduction and genetics, 37(10), 2453–2462. https://doi.org/10.1007/s10815-020-01873-9 7 bizic, m. r., jeftovic, m., pusica, s., stojanovic, b., duisin, d., vujovic, s., rakic, v., & djordjevic, m. l. 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(n.d.). is in vitro fertilization expensive? in vitro fertilization (ivf). retrieved november 28, 2022, from https://www.reproductivefacts.org/faqs/frequently-asked-questions-about-infertility/q06-is-in-vitrofertilization-expensive/ 42 american society of reproductive medicine. (n.d.). the difference between iui and ivf a patient education micro-video. reproductive facts. retrieved november 20, 2022, from https://www.reproductivefacts.org/resources/educationalvideos/videos/asrmsart-micro-videos/videos/the-difference-between-iui-and-ivf/ 43 family equality (2019). 44 sterling (2020). 45 bizic (2018). 46 bizic (2018). 47 choi (2022). 48 bizic (2018). 49 choi (2022). 50 choi (2022). 51 tornello (2017). 52 brown, c.. (2021). exploring trans people’s experiences of adoption and fostering in the united kingdom: a qualitative study. international journal of transgender health, 22(1-2), 89–100. https://doi.org/10.1080/26895269.2020.1867396 53 movement advancement project. "equality maps: foster and adoption laws." https://www.lgbtmap.org/equalitymaps/foster_and_adoption_laws. accessed 10/28/2022. 54 movement advancement project. “equality maps: foster and adoption laws” (2022). 55 movement advancement project. “equality maps: foster and adoption laws” (2022). 56 torres, g., shapiro, a., & mackey, t. k.. (2019). a review of surrogate motherhood regulation in south american countries: pointing to a need for an international legal framework. bmc pregnancy and childbirth, 19(1). https://doi.org/10.1186/s12884019-2182-1 57 family building through gestational surrogacy. committee opinion no. 660. american college of obstetricians and gynecologists. obstet gynecol 2016;127:e97–103. 58 family building through gestational surrogacy (2016). 59 light, a. d., obedin-maliver, j., sevelius, j. m., & kerns, j. l.. (2014). transgender men who experienced pregnancy after female-to-male gender transitioning. obstetrics & gynecology, 124(6), 1120–1127. https://doi.org/10.1097/aog.0000000000000540 60 obedin-maliver, j., & makadon, h. j.. (2016). transgender men and pregnancy. obstetric medicine, 9(1), 4–8. https://doi.org/10.1177/1753495x15612658 61 choi (2022). 62 bizic (2018). 63 finlayson (2016). https://www.lgbtmap.org/equality-maps/foster_and_adoption_laws https://www.lgbtmap.org/equality-maps/foster_and_adoption_laws glick, fertility decision aid for transgender adults, voices in bioethics, vol. 9 (2023) 9 64 moravek (2019). 65 mayhew, a. c., & gomez-lobo, v.. (2020). fertility options for the transgender and gender nonbinary patient. the journal of clinical endocrinology & metabolism, 105(10), 3335–3345. https://doi.org/10.1210/clinem/dgaa529 66 mayhew (2020). 67 mayhew (2020). 68 sterling (2020). 69 kolbuck, v. d., sajwani, a., kyweluk, m. a., finlayson, c., gordon, e. j., & chen, d.. (2020). formative development of a fertility decision aid for transgender adolescents and young adults: a multidisciplinary delphi consensus study. journal of assisted reproduction and genetics, 37(11), 2805–2816. https://doi.org/10.1007/s10815-020-01947-8 70 sterling (2020). 71 sterling (2020). 72 de snoo-trimp, j., de vries, a., molewijk, b., & hein, i.. (2022). how to deal with moral challenges around the decision-making competence in transgender adolescent care? development of an ethics support tool. bmc medical ethics, 23(1). https://doi.org/10.1186/s12910-022-00837-1 73 what does the evolution from informed consent to shared decision making teach us about authority in health care?. (2020). what does the evolution from informed consent to shared decision making teach us about authority in health care?. ama journal of ethics, 22(5), e423–429. https://doi.org/10.1001/amajethics.2020.423 74 chen, diane. (2021, june 3 2021, october 9). fertility decision-making in youth and young adults. identifier nct05175170. https://clinicaltrials.gov/ct2/show/nct05175170 75 chen, d., kolbuck, v. d., sajwani, a., shen, e., finlayson, c., & gordon, e. j.. (2022). 51. feasibility, acceptability, and preliminary efficacy of affrmed (aid for fertility-related medical decisions), a web-based fertility decision aid for transgender and non-binary youth and their parents. journal of adolescent health, 70(4), s27–s28. https://doi.org/10.1016/j.jadohealth.2022.01.164 76 chen (2022). 77 chen (2022). 78 chen (2022). 79 moravek (2019). https://clinicaltrials.gov/ct2/show/nct05175170 daws, philosophical pragmatism and abortion, voices in bioethics, vol. 6 (2020) © 2020 steven daws. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. philosophical pragmatism and abortion steven daws keywords: pragmatism, philosophy, abortion, bioethics introduction pragmatism as a philosophical tool has seen a surge in popularity over the last few decades in the united states[1][2] . the pragmatic approach focuses intensely on that which is immediately knowable, with empiricism and research at its core. rather than looking to universal laws or imperceptible knowledge, pragmatism instead concerns itself with the immediately relevant players, outcomes and circumstances. this offers a refreshing outlook compared to the abstract analyses and deductions from grand principles common in other approaches [4]. pragmatism rejects the notion of unwavering truth, alternatively viewing all knowledge as imperfect and amendable [3]. i will discuss the application of pragmatic bioethics to the question of the morality of abortion, specifically illustrating how three of its core concepts factor into the debate. analysis an important component of the pragmatic approach is to ensure that one’s working knowledge is the current knowledge. that is to say, pragmatism demands that the inputs for one’s moral accounting are grounded in the most contemporary conceptualizations. this is in accordance with pragmatism’s adherence to empirical research and the fluctuating status of understanding. because abortion is not a new issue, questions surrounding its practice and morality greatly predate their contemporary formulations. over those years, the relevant fields – embryology, social sciences, theology, etc. – have not been stagnant. considering the long-standing political nature of the abortion debate and its emotionally charged content, it seems like an issue at risk of historical entrenchment , with new discoveries being ignored in favor of repeating inculcated mantras. as an example, it is highly likely that an individual would find ultrasound images relevant in pondering whether or not a fetus at a certain stage of development constitutes a human life. the images would allow them to observe physical development and functional abilities, such as limb movement. it stands to reason that an individual pondering abortion in the years predating ultrasound technology may reach a different conclusion than someone might reach after the advent of ultrasound. this is the type of information that pragmatic bioethics holds paramount, and claims to be relevant to ethical reasoning [1]. in keeping with this commitment to modern understanding and research, pragmatic bioethics seeks to incorporate context and various perspectives, ultimately leading to a strong endorsement of democracy http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_1 http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_2 http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_4 http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_3 http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_1 daws, philosophical pragmatism and abortion, voices in bioethics, vol. 6 (2020) 2 [1,4]. when designing research, there is always the consideration of internal and external validity. democracy as a form of moral research has profound internal validity by including all the individuals involved in a situation, and also thereby eliminates the need for external validity. it goes straight to the source and essentially employs a fieldwork model of engagement as opposed to an armchair model of observation. pragmatic democracy is troublesome in the abortion debate because one highly relevant stakeholder (the fetus) cannot voice an opinion. overall, the interests of the potential offspring are left to speculation. this certainly constitutes a limitation of pragmatic bioethics on the matter of abortion, though the same is true for many ethical frameworks. however, there are plenty of other stakeholders, including the mother, father and community, that have relevant opinions and are able to express them. pragmatism dictates that consideration of these persons be included when an individual is deciding the morality of whether or not to bring a pregnancy to term. one of the more interesting stakeholders to which pragmatism gives a pulpit is society at large. the question of abortion is all too frequently and readily boiled down to a concern for either the mother or the child. because pragmatism does not operate in absolutes, the moral status of the fetus is not given priority as it otherwise often is. once life or potential life is viewed as having variable import, it is no longer viewed as unwaveringly paramount. this malleability allows the fetus’s moral status to be more readily weighed in conjunction with other considerations. similarly, the inconsistent moral standard applied to the fetus offers some absolution of the mother, in which her decision is no longer viewed as entangled in absolutisms. ultimately, the mother and child no longer take center stage, and the curtain is opened for other parties to have a larger role. pragmatic bioethics operates at ground level, and assesses real-world ramifications. while this discussion centers on the morality of abortion itself, this particular aspect of pragmatism would be especially relevant in the context of public policy. a pragmatic approach would take into account malthusian principles and population control, situating abortion in the scheme of healthcare costs and safety; consider trends in abortion selection that may ultimately be destructive, such as a disproportionate number of a certain sex being aborted; and evaluate the possible financial burdens of an offspring that may ultimately be dependent on social programs. while pragmatic bioethics may not prioritize such considerations in every case, they are certainly afforded a greater significance than in alternative philosophical approaches. conclusion overall, pragmatism offers an expansive view of abortion and its morality. it avoids dogmatism by approaching truth as ever-changing, embraces democracy to incorporate maximum context and perspectives, and remains practical in considering repercussions. through these means, it seems pragmatism has much to offer the abortion debate. [1] arras, john d. "pragmatism in bioethics: been there, done that." social philosophy and policy 19, no. 2 (2002): 29-58. [2] miller, franklin g., joseph j. fins, and matthew d. bacchetta. "clinical pragmatism: john dewey and clinical ethics." j. contemp. health l. & pol'y 13 (1996): 27. [3] sisti, dominic a., and david h. brendel. "philosophical pragmatism in psychiatric ethics." in the oxford handbook of psychiatric ethics. http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_1 http://www.voicesinbioethics.net/voices-in-bioethics/2020/4/13/philosophical-pragmatism-and-abortion#_msocom_4 daws, philosophical pragmatism and abortion, voices in bioethics, vol. 6 (2020) 3 [4] wolf, susan m. "shifting paradigms in bioethics and health law: the rise of a new pragmatism." am. jl & med. 20 (1994): 395. ravanpak, prescription drug monitoring, voices in bioethics, vol. 9 (2023) * ryan ravanpak, ph.d. mit department of philosophy and visiting scholar at phillips academy © 2023 ryan ravanpak. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. prescription drug monitoring: a perspective ryan ravanpak* keywords: prescription drug monitoring programs, database, addiction management, informed consent introduction ever received a prescription for xanax? you can bet that there was a record of it made in a digital database. prescription drug monitoring programs (pdmps) contain detailed information about which controlled medications physicians prescribe individuals, including where, when, how much, by whom, and more. the programs allow physicians to glimpse into the life of each patient that visits them — sometimes before a single word is exchanged between them. every state has a pdmp, and many states share the data they collect through it.1 lately, i have been concerned with the application of these databases in the context of addiction management. in the united states, overdose deaths in a twelve-month period leading to may 2020 involving fentanyl alone increased 38 percent over the same period the previous year.2 regrettably, i lost a partner to addiction. i have seen the difficulties those struggling with substance use go through — the shame, the guilt, and the roadblocks to positive change. but perhaps the most frustrating part has been the treatment they endure by others who brand them with a scarlet letter. unfortunately, this can sometimes include healthcare professionals. analysis my central concern revolves around the lack of an informed consent requirement before entering prescription data into the pdmp when the reason given for the prescription is addiction management. our community already stigmatizes those struggling with substance use disorder. the thought of having their prescriptions recorded rightly makes many of them feel uneasy. in the past, federal patient confidentiality guidelines prohibited recording narcotic prescription data in the pdmp in these contexts for this very reason.3 however, in 2020, this restriction was revised, paving the way for healthcare practitioners to have access to medication history. narcotics officers may also have access to the pdmp data and have raided dispensing practices. their access varies by state and may require a warrant or court order.4 ravanpak, prescription drug monitoring, voices in bioethics, vol. 9 (2023) 2 permitting access to sensitive prescription information can put patients in a position to be further alienated by their healthcare providers and it can impact access to healthcare. according to a recent study by the university of michigan, having an active opioid prescription in your medical history is enough to deter 40 percent of primary care practices from accepting you as a patient.5 additionally, if medical professionals are hesitant to see patients who have legitimate opioid prescriptions, it stands to reason that patients who have prescriptions primarily known for addiction management will not fare much better. studies suggest that those with prescription access cut off are twice as likely to turn to heroin.6 some die by overdose or suicide.7 to be fair, the current regulations do exhibit some regard for privacy. if patients receive medication through federal “part ii” programs, their consent is required to record the prescription in the pdmp.8 unfortunately, many prescriptions are dispensed by private healthcare providers or sent to local pharmacies. when this is so, the consent requirement does not apply, making the privacy provision extensionally short-sighted. i can understand why the healthcare and law enforcement communities would want easy access to prescription data. a central mission of the pdmp is to curb the diversion of controlled substances to nonprescription users and to help doctors better coordinate patient care. by curbing the diversion of opioid drugs specifically, it is thought that the rate of fatality related to opioid substances will also decline. if we monitor other opioid drugs like oxycodone so closely, we could monitor medications that manage addiction, such as suboxone. but the parallel between the two is not easily drawn. to be clear, addiction management medication like suboxone does not work on the opioid receptors to the same extent and in the same way that conventional opioids do.9 those that take suboxone for addiction frequently do not report feeling recreational effects. the medication has a ceiling effect where the receptors the substance targets become too saturated to allow for further effect, making abuse less likely. lastly, the medication tends to outcompete rival opioids from occupying those receptors of the brain. users often report that taking suboxone will inhibit them from feeling the effects of illicit opioids. characteristics like this make it harder to see why we should be as worried about the diversion of suboxone as diversion of other opioids like oxycontin. even when suboxone is diverted, studies suggest that it is diverted to those with opioid addiction who wish to manage their withdrawals – exactly those whom we would want suboxone to be reaching – rather than those who are looking to abuse the medication.10 in areas without major barriers to suboxone prescription, opioid death and addiction rates have fallen at a dramatic rate. in france, where there are no special waivers or provisions required for doctors to dispense suboxone, opioid overdose deaths have fallen by 79 percent since 1995.11 conclusion an informed consent requirement would allow those people trying to address their own drug misuse to maintain some privacy. as providing the data to practitioners has proven to disenfranchise some patients who have trouble finding care and could even expose them to law enforcement, it makes sense that some patients would not want to participate in pdmps. the ability to opt out and the requirement of informed consent to opt in would give patients more control over their data. there are good reasons, then, to amend regulations at state and federal levels to exclude addiction related medication from the pdmp without explicit and informed consent from the patient. ravanpak, prescription drug monitoring, voices in bioethics, vol. 9 (2023) 3 1 pdmp ttac. accessed may 2, 2023. “pdmp interstate partners.” pdmp assist. https://www.pdmpassist.org/policies/maps/pdmpinterstatepartners. 2 cdc. 2020. “overdose deaths accelerating during covid-19.” 3 asam. 2018. “public policy statement on prescription drug monitoring programs (pdmps)” 4 substance abuse and mental health services administration (samhsa), u.s. department of health and human services (hhs). 2020. “confidentiality of substance use disorder patient records.” see also: pdmp ttac. accessed may 2, 2023. “pdmps authorized and engaged in sending solicited and unsolicited reports to law enforcement entities”. pdmp assist. https://www.pdmpassist.org/pdf/law_enforcement_entity_table.pdf 5 lagisetty, et. al. 2019. “access to primary care clinics for patients with chronic pain receiving opioids” 6 binswanger, et. al. 2020. “the association between opioid discontinuation and heroin use: a nested case-control study” 7 oliva, et. al. 2020. “associations between stopping prescriptions for opioids, length of opioid treatment, and overdose or suicide deaths in us veterans: observational evaluation.” 8 federal guidelines: 42 cfr part ii. 2021. “part 2 confidentiality of substance use disorder patient records” 9 u.s. department of health and human services, substance abuse and mental health service administration center for substance abuse treatment. 2004. “tip 40.” 10 fiscella, et al. 2018. “buprenorphine deregulation and mainstreaming treatment for opioid use disorder.” 11 auriacombe, et al. 2004. “french field experience with buprenorphine.” mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) * bridget mckinney, doctorate in bioethics loyola university chicago © 2023 bridget mckinney. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. addressing the maternal mental health crisis through a novel tech-enabled peer-to-peer perinatal collaborative care model bridget mckinney* abstract suicide and overdose, associated with perinatal mental health conditions, are the leading causes of maternal mortality in the united states. experts in the field of perinatal mental health are using perinatal mood and anxiety disorders (pmad) as an umbrella term that includes many mental health conditions and bring to light the lack of screening and treatment for perinatal mental health in the united states. there is a growing need to equip obstetricians and gynecologist (ob-gyn) providers with better tools to screen, triage, and refer to mental health services that are equitable and immediately accessible to their patients. integrating a tech-enabled perinatal collaborative care model with peer-to-peer coaching as the driver of behavior change is a novel approach to addressing the maternal mental health crisis by improving outcomes, reducing disparities, and lowering costs. keywords: maternal mortality, psychiatric collaborative care model, obstetrics, mental health introduction over the past two decades, maternal mortality and other maternal health outcomes have worsened in the united states disproportionately to those in other developed countries.1 in 2021, 1,205 pregnant women died in the us, representing a 40 percent increase in maternal death from 2020 and the highest rise in rates since the 1960s.2 suicide and overdose associated with perinatal mental health conditions are the leading causes of maternal mortality. 3 mental health-related deaths are most likely to occur after six weeks postpartum. 4 despite the postpartum period representing a higher risk for mental health conditions, historically, only a single postpartum visit is performed between 4 and 6 weeks after delivery. 40 percent of women do not attend a postpartum visit.5 recent data from maternal mortality review committees reveal that 80 percent of maternal deaths are preventable. the maternal mental health crisis represents a unique ethical dilemma. for perinatal women, mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) 2 the current healthcare system is unjust. there is a growing need to equip obstetricians and gynecologists (ob-gyns) with the tools to screen, triage, and refer patients to mental health services that are equitable and immediately accessible to their patients. this paper will analyze the current state of perinatal mental healthcare in america. it will introduce the psychiatric collaborative care model and demonstrate its effectiveness. i highlight research performed using the psychiatric collaborative care model in obstetrics as well as barriers to real-world implementation. lastly, this paper will argue that the integration of a tech-enabled perinatal collaborative care model with peer-to-peer coaching as the driver of behavior change would improve outcomes, reduce disparities, and lower costs. i. scope of the problem prior to the covid-19 pandemic, the prevalence of postpartum depression ranged from 13.2 percent, to as high as 23.5 percent, of births in the us.6 the covid-19 pandemic has exacerbated this issue, with studies revealing up to 1 in 3 postpartum women experiencing postpartum depression. 7 although postpartum depression has been the focus of perinatal mental health conditions, it is just the tip of the iceberg. experts in the field of perinatal mental health are now using perinatal mood and anxiety disorders as an umbrella term that includes perinatal depression, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, bipolar disorder, and psychosis from the prenatal period through the first year postpartum. socio-economically disadvantaged women are at increased risk of experiencing perinatal mood and anxiety disorders and face greater barriers to high-quality mental health care.8 the american college of obstetricians and gynecologists (acog) recommends that physicians perform postpartum depression screenings during pregnancy. the health resources and services administration provides healthy start initiative grants to communities with high rates of adverse perinatal outcomes. yet, the healthcare effectiveness data and information set (hedis) reveals that screening in both pregnancy and the postpartum period occurs in fewer than 20 percent of patients. 9 furthermore, in the us, if screening does occur, only 22 percent of women who are deemed positive in their screening receive mental health care.10 the united states is currently experiencing a shortage of mental health providers that is expected to worsen in the upcoming years.11 nearly half of all americans currently live in a mental health professional desert.12 waitlists for therapists and psychiatrists average 48 days, and individuals report not seeking mental health care due to cost or lack of insurance coverage.13 given the significant mental health provider shortage, obstetric providers have a unique opportunity to care for the “whole patient” during and after pregnancy by addressing not only their physical health but also their mental health. approximately one-third of women consider their ob-gyn their primary care provider during and after pregnancy, and over 50 percent of ob-gyns perceive themselves as primary care providers for women, supporting primary, specialty, and preventive care.14 medicaid covers 42 percent of all births in the us, and more than half of all births in some states, thus ob-gyns provide a disproportionate amount of care for poor and minority women as compared to other specialties.15 yet, ob-gyn providers commonly feel hesitant to screen for depression due to the shortage of therapists and psychiatrists to address the mental health needs of their patients, particularly in the medicaid population.16 as a result, fewer than 10 percent of pregnant women with mental health conditions receive adequate treatment.17 a recent study of 288 obstetrics fellows revealed that 84 percent prescribed ssris to their patients; obstetricians are filling the mental health provider gap and taking ownership over their patients’ mental health.18 mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) 3 despite acog’s recommendations that obstetrics providers screen for and treat mental health conditions in the perinatal period, ob-gyns do not receive formal mental health training during residency or fellowship and do not typically use validated tools such as the diagnostic and statistical manual of mental disorders-forth edition (dsm-iv) for diagnosis of depression or prior to prescribing antidepressants. their lack of a standard reference can lead to misdiagnoses.19 in fact, 22 percent of women screened and found to have postpartum depression are later diagnosed with bipolar disorder.20 screening and treatment for perinatal mood and anxiety disorders are further impacted by patients’ lack of trust in healthcare providers. distrust between patients, particularly those receiving medicaid, and their ob-gyns in the us is high and strongly associated with worse self-reported health outcomes.21 notably, women with medicaid coverage reported being treated unfairly and with disrespect by providers because of their race and insurance status. they reported a loss of decision-making autonomy during labor and delivery and less postpartum emotional and practical support at home. 22 many women do not feel comfortable discussing mental disorders with a healthcare provider.23 connecting perinatal women to a person with shared lived experiences, known as peer-to-peer engagement or coaching, may be a simple solution. ii. collaborative care model the psychiatric collaborative care model (collaborative care), developed by the university of washington in 2002, is an integrated behavioral health approach designed to treat common mental health conditions such as depression and anxiety that require measurement-based follow-up due to their chronic nature.24 centers for medicare and medicaid services issued billing codes for the psychiatric collaborative care model in 2016. medicare adopted them in 2017, and they were widely operationalized in the primary care field.25 as of 2022, the collaborative care billing codes have been adopted by 19 state medicaid plans.26 the collaborative care model facilitates the integration of a behavioral health care manager, typically a licensed therapist or care worker, in the primary care setting. the behavioral health care manager can provide inperson or virtual care and facilitate mental health screenings, symptom monitoring, psychiatric consultations, and care coordination.27 a psychiatric consultant, typically a board-certified psychiatrist or psychiatric nurse practitioner, is an integrated behavioral health provider on the collaborative care team. psychiatric consultants do not see patients one on one. rather, they review complex or treatment-resistant cases and provide psychiatric management recommendations to the primary provider. thus, the primary care team is expanded by two members who provide behavioral health expertise to the primary care provider, who is ultimately the prescribing provider if any psychoactive medications are indicated.28 this model has been tested in over 90 randomized clinical trials evaluating efficacy for the treatment of depression and anxiety across multiple medical specialties.29 data from the primary care setting indicate that this integrated behavioral health approach is both successful and more cost-effective than usual care for patients with behavioral health conditions.30 studies show that the collaborative care model improves clinical outcomes and lowers costs, returning $6.50 for every dollar spent on treatment of depression. furthermore, the model is effective across diverse patient populations.31 iii. evidence for collaborative care in obstetrics the success of the collaborative care model for identifying anxiety and depression in the primary care setting and its potential for cost savings suggest that implementation of perinatal collaborative care for perinatal mood and anxiety disorders is a feasible approach.32 randomized clinical trials showed significant improvement in quality care, depression severity, and remission rates from before birth to 18 months mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) 4 postbaseline for socioeconomically disadvantaged women.33 in addition, collaborative care is associated with mitigating racial disparities in antenatal depression care; it may be an equity-promoting intervention for maternal health.34 the trials faced limitations, including the inability to establish causality, and the researchers recommended further research. although further research is warranted, the collaborative care model in obstetrics programs has indicated improved depression outcomes. iv. barriers to adoption of a collaborative care model in obstetrics despite promising results, implementation is limited, and collaborative care is billable under medicaid in only 19 states. 35 large health systems have difficulty operationalizing a collaborative care model in obstetrics due to implementation costs, mental health provider shortages, and administrative burdens. more evidence of financial benefits to obstetrics clinics, hospitals, and health systems is needed. additionally, obstetric practices must adapt to updated care plans, and obstetricians must be motivated to become involved in behavioral health issues and potentially broaden their scope of practice.36 as this is a major ask from practices and providers, there is a lack of robust evidence to show that a perinatal collaborative care model can be applied without the resources and infrastructure of a randomized trial. v. peer-to-peer engagement peer support in healthcare is growing. peer support is defined as help and support that people with lived experiences can give one another. 37 effective examples of peer support or engagement are found in addiction, mental health services, and the workforce. regarding addiction recovery support, a systematic review concluded that peer support interventions have a beneficial effect on participants and positively contribute to substance use outcomes.38 peer support is highly used in medicine and other professions when attending physicians or skilled professionals train new colleagues. the nursing profession uses peer support to help deliver quality care and reduce symptoms of burnout. 39 peer support has been well described in literature, and programs differ in their methodology and delivery. the feasibility and maintenance of peer support programs are possible through collaboration with all healthcare stakeholders. 40 understanding that shared experiences establish a foundation of trust may help obstetricians see peers as a way to bridge the gap. a peer coach may be valuable in the collaborative care model. vi. integrating peer-to-peer into the collaborative care model for obstetrics currently, a start-up based in boston and philadelphia, familywell, has piloted tech-enabled peer-to-peer engagement into a collaborative care model for obstetric patients. the company strives to solve the perinatal mental health crisis and close the health equity gap in the us by applying a text messaging platform to connect expecting and newly postpartum mothers with peer coaches. peer coaches are trained to support perinatal mothers, defined as third-trimester pregnancy through 12 months postpartum, by providing quality support based on the latest research. coaches have their own unique birth and postpartum stories, making them relatable and equipped to support mothers through the ups and downs of parenthood.41 increased education, screening, and treatment for perinatal mood and anxiety disorders co-occur as connections are being made through texting and virtual visits with coaches. on demand texting with coaches ensures no mother feels alone and that mothers have a safe space to ask questions and process emotions. if needed, enrolled moms can request longer virtual coaching sessions of 50 minutes with certified perinatal mental health coaches, who focus on current issues and how to move forward and feel better, accomplished through cognitive behavioral coaching techniques. 42 the platform schedules automated text messages containing educational content. individual care plans are developed in mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) 5 collaboration with an individual’s ob and include monthly mental health screenings during and postpregnancy. notably, at three-week postpartum, participants are sent the edinburg postnatal depression scale 3 (epds-3) questions via text messages.43 this screening is three weeks prior to the national six-weeks postpartum screening recommendation and focuses on antepartum anxiety, which represents a risk factor for depression.44 if an individual needs more mental health support compared to coaching, virtual therapy sessions are available through the platform, giving access to licensed therapist, specializing in perinatal mental health without extensive waitlist. therapists can diagnosis and provide medication management if needed. familywell ceo and founder, jessica gaulton, revealed that preliminary data collected during the first two months of the company’s launch, limited to the philadelphia, pa region and three clinics, indicated that 24 postpartum mothers consented to the program. a total of 3,000 texts were exchanged, and 44.2 percent of those texts came from participants to peer coaches.45 the platform expediates appropriate referrals, creates individualized maternal wellness treatment plans, and serves as a resource for navigating the medical system. vii. providing justice in the maternal healthcare system the well-being of mothers is a bellwether for the well-being of society; every injustice in our society shows up in maternal health.46 earlier, broader, and more frequent screening combined with direct mental health access is essential to address perinatal mood and anxiety disorders and ultimately the maternal mortality rate. integrating collaborative care with peer-to-peer coaching provides new mothers with direct support and follow-up care. this simple yet novel integration begins to close the gap by providing equitable care. the tech-based platform’s research and success highlight that a broader focus on screening is critical. limiting mental illness to depression fails to serve women adequately. expanding criteria to screen for indicators of future depression, such as anxiety, is a simple, proactive step. a relatable peer may be a critical factor in helping perinatal women feel comfortable openly discussing problems they are facing and beginning conversations not otherwise occurring in a perinatal or postpartum visit. companies like familywell can contribute to making collaborative care feasible in the ob-gyn setting. having an outside organization with peer-coaches building a foundation of trust and championing the collaborative care model reduces the burden for overworked obstetricians. furthermore, the tech-based platform can organize and facilitate interprofessional communications, which rarely take place in the current system.47 the texting and telehealth approach brings compassion, care, and more frequent contact directly to the patient, which is critical for socioeconomically disadvantaged women as they are the demographic not properly accessing care now. as the coaches and behavior care coordinator make the referrals for mental health services that align with a mother’s insurance coverage, they reduce stress for new mothers who might not know where to begin when navigating the mental health care system. additionally, obstetricians may feel more comfortable performing mental health screenings knowing their patients can access mental health care. conclusion the perinatal mental health crisis is significant. women are currently experiencing injustice in the healthcare system due to a lack of trust, screening, and effective, accessible care. the psychiatric collaborative care model has been proven effective in the primary care setting, and randomized clinical trials conclude it is also effective in obstetrics, but barriers exist. integrating peer-to-peer coaching through a tech-enabled platform into obstetrics collaborative care may eliminate barriers and build trust between mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) 6 patients and the healthcare system. more research is needed to show the efficacy of a tech-enabled model, and more research is critical to demonstrate that this model can be financially sustainable and revenuegenerating for hospitals and obstetrics departments. however, this simple novel step may begin to generate equitable care for women and potentially save lives. 1 collier, a. r. y., & molina, r. l. (2019). maternal mortality in the united states: updates on trends, causes, and solutions. neoreviews, 20(10), e561-e574. 2 hoyert, d. l. (2023). maternal mortality rates in the united states, 2021.health e-stats. national center for health statistics. centers for disease control. https://dx.doi.org/10.15620/cdc:124678 3 miller, e. s., grobman, w. a., ciolino, j. d., zumpf, k., sakowicz, a., gollan, j., & wisner, k. l. (2021). increased depression screening and treatment recommendations after implementation of a perinatal collaborative care program. psychiatric services, 72(11), 1268-1275. 4 trost, s. l., beauregard, j. l., smoots, a. n., ko, j. y., haight, s. c., moore simas, t. a., ... & goodman, d. (2021). preventing pregnancy-related mental health deaths: insights from 14 us maternal mortality review committees, 2008–17: study examines maternal mortality and mental health. health affairs, 40(10), 1551-1559. 5 blenning, c. e., & paladine, h. l. (2005). an approach to the postpartum office visit. american family physician, 72(12), 24912496; acog committee opinion no. 736: optimizing postpartum care. obstetrics and gynecology, 132(3), 784–785. https://doi.org/10.1097/aog.0000000000002849 6bauman, b. l., ko, j. y., cox, s., d'angelo mph, d. v., warner, l., folger, s., tevendale, h. d., coy, k. c., harrison, l., & barfield, w. d. (2020). vital signs: postpartum depressive symptoms and provider discussions about perinatal depression united states, 2018. mmwr. morbidity and mortality weekly report, 69(19), 575–581. https://doi.org/10.15585/mmwr.mm6919a2 7 shuman, c.j., peahl, a.f., pareddy, n. (2022) postpartum depression and associated risk factors during the covid-19 pandemic. bmc res notes 15, 102. https://doi.org/10.1186/s13104-022-05991-8 8 grote, n. k., katon, w. j., russo, j. e., lohr, m. j., curran, m., galvin, e., & carson, k. (2015). collaborative care for perinatal depression in socioeconomically disadvantaged women: a randomized trial. depression and anxiety, 32(11), 821-834. 9 hesi annual report. hesi. (2022, november). retrieved april 30, 2023, from special-report-nov-2022-results-for-measuresleveraging-electronic-clinical-data-for-hedis.pdf (ncqa.org) 10 byatt, n., levin, l. l., ziedonis, d., moore simas, t. a., & allison, j. (2015). enhancing participation in depression care in outpatient perinatal care settings: a systematic review. obstetrics and gynecology, 126(5), 1048–1058. https://doi.org/10.1097/aog.0000000000001067 11 satiani, a., niedermier, j., satiani, b., & svendsen, d. p. (2018). projected workforce of psychiatrists in the united states: a population analysis. psychiatric services (washington, d.c.), 69(6), 710–713. https://doi.org/10.1176/appi.ps.201700344 12 bureau of health workforce health resources and services administration (hrsa) u.s. department of health & human services. 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(2013). improving depression treatment for women: integrating a collaborative care depression intervention into ob-gyn care. contemporary clinical trials, 36(2), 362-370. 15 raney, l. (2020). cracking the codes: state medicaid approaches to reimbursing psychiatric collaborative care. oakland, california health care foundation. 16 hansen, m. e. d., tobón, a. l., haider, u. k., simas, t. a. m., newsome, m., finelli, j., ... & byatt, n. (2023). the role of perinatal psychiatry access programs in advancing mental health equity. general hospital psychiatry. 17 cox, e. q., sowa, n. a., meltzer-brody, s. e., & gaynes, b. n. (2016). the perinatal depression treatment cascade: baby steps toward improving outcomes. the journal of clinical psychiatry, 77(9), 20901. 18 taouk, l. h., matteson, k. a., stark, l. m., & schulkin, j. (2018). prenatal depression screening and antidepressant prescription: obstetrician-gynecologists' practices, opinions, and interpretation of evidence. archives of women's mental health, 21(1), 85–91. https://doi.org/10.1007/s00737-017-0760-7 19 garbarino, a. h., kohn, j. r., coverdale, j. h., & kilpatrick, c. c. (2019). current trends in psychiatric education among obstetrics and gynecology residency programs. academic psychiatry : the journal of the american association of directors of psychiatric residency training and the association for academic psychiatry, 43(3), 294–299. https://doi.org/10.1007/s40596-01901018-w ; 20 wisner, k. l., sit, d. k., mcshea, m. c., rizzo, d. m., zoretich, r. a., hughes, c. l.,& hanusa, b. h. (2013). onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. jama psychiatry, 70(5), 490-498 21 armstrong, k., rose, a., peters, n., long, j. a., mcmurphy, s., & shea, j. a. (2006). distrust of the health care system and selfreported health in the united states. journal of general internal medicine, 21(4), 292–297. https://doi.org/10.1111/j.15251497.2006.00396.x 22 declercq, e., & zephyrin, l. (2020). maternal mortality in the united states: a primer. commonwealth fund. https://www.commonwealthfund.org/publications/issue-brief-report/2020/dec/maternal-mortality-united-states-primer 23 scholle, s. h., & kelleher, k. (2003). preferences for depression advice among low-income women. maternal and child health journal, 7(2), 95–102. https://doi.org/10.1023/a:1023864810207https://doi.org/10.1023/a:1023864810207 24 aims center. (n.d.). collaborative care. https://aims.uw.edu/collaborative-care 25 press, m. j., howe, r., schoenbaum, m., cavanaugh, s., marshall, a., baldwin, l., & conway, p. h. (2017). medicare payment for behavioral health integration. n engl j med, 376(5), 405-407. 26 chang, d., morrison, d. j., bowen, d. j., harris, h. m., dusic, e. j., velasquez, m. b., & ratzliff, a. d. h. (2023). making it to sustainability: evaluating billing strategies for collaborative care. psychiatric services (washington, d.c.), appips20220596. advance online publication. https://doi.org/10.1176/appi.ps.20220596 27 miller, e. s., jensen, r., hoffman, m. c., osborne, l. m., mcevoy, k., grote, n., & moses-kolko, e. l. (2020). implementation of perinatal collaborative care: a health services approach to perinatal depression care. primary health care research & development, 21, e30. 28 raney, l. (2020). cracking the codes: state medicaid approaches to reimbursing psychiatric collaborative care. oakland, california health care foundation. 29 unützer, j., katon, w., callahan, c. m., williams, j. w., jr, hunkeler, e., harpole, l., hoffing, m., della penna, r. d., noël, p. h., lin, e. h., areán, p. a., hegel, m. t., tang, l., belin, t. r., oishi, s., langston, c., & impact investigators. improving moodpromoting access to collaborative treatment (2002). collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. jama, 288(22), 2836–2845. https://doi.org/10.1001/jama.288.22.2836 30 raney, l. (2020). https://doi.org/10.1023/a:1023864810207 https://doi.org/10.1001/jama.288.22.2836 mckinney, maternal health crisis, voices in bioethics, vol. 9 (2023) 8 31 unützer, j., harbin, h., schoenbaum, m., & druss, b. (2013). the collaborative care model: an approach for integrating physical and mental health care in medicaid health homes. health home information resource center, 1-13. 32 raney, l. (2020). cracking the codes: state medicaid approaches to reimbursing psychiatric collaborative care. oakland, california health care foundation. 33 grote, n. k., katon, w. j., russo, j. e., lohr, m. j., curran, m., galvin, e., & carson, k. (2015). collaborative care for perinatal depression in socioeconomically disadvantaged women: a randomized trial. depression and anxiety, 32(11), 821-834 34 miller, e. s., grobman, w. a., ciolino, j. d., zumpf, k., sakowicz, a., gollan, j., & wisner, k. l. (2021). increased depression screening and treatment recommendations after implementation of a perinatal collaborative care program. psychiatric services, 72(11), 1268-1275; snowber, k., ciolino, j. d., clark, c. t., grobman, w. a., & miller, e. s. (2022). associations between implementation of the collaborative care model and disparities in perinatal depression care. obstetrics & gynecology, 140(2), 204-211. 35 percent of people covered by medicaid/chip, 2022. (2022). medicaid state fact sheets. kff. retrieved may 1, 2023, from https://www.kff.org/interactive/medicaid-state-fact-sheets/ 36 miller, e. s., grobman, w. a., ciolino, j. d., zumpf, k., sakowicz, a., gollan, j., & wisner, k. l. (2021). increased depression screening and treatment recommendations after implementation of a perinatal collaborative care program. psychiatric services, 72(11), 1268-1275. 37 shalaby, r. a. h., & agyapong, v. i. (2020). peer support in mental health: literature review. jmir mental health, 7(6), e15572. 38 bassuk, e. l., hanson, j., greene, r. n., richard, m., & laudet, a. (2016). peer-delivered recovery support services for addictions in the united states: a systematic review. journal of substance abuse treatment, 63, 1-9. 39 eastburg, m. c., williamson, m., gorsuch, r., & ridley, c. (1994). social support, personality, and burnout in nurses. journal of applied social psychology, 24(14), 1233-1250. 41 familywell. (2023.). https://familywellhealth.com/ 42 patients, family well (2023). https://familywellhealth.com/patients 43 providers, family well (2023). https://familywellhealth.com/providers 44 patients, family well (2023). https://familywellhealth.com/patients 45 author interview with jessica gaulton, familywell. (2023) 46 maven (2022). “if moms are unwell, society is unwell.” recapping our q&a with dr. neel shah. maven. https://www.mavenclinic.com/post/if-moms-are-unwell-society-is-unwell-recapping-our-q-a-with-dr-neel-shah#! 47 klatter, c. k., van ravesteyn, l. m., & stekelenburg, j. (2022). is collaborative care a key component for treating pregnant women with psychiatric symptoms (and additional psychosocial problems)? a systematic review. archives of women's mental health, 25(6), 1029-1039. sathi, should homeless youth participate in research, voices in bioethics, vol. 4 (2018) © 2018 charlene sathi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and sour ce are credited. should homeless youth participate in research charlene sathi keywords: homeless youth, research ethics, inclusion introduction from taking the l to the g to the j, one of the most striking things about the vastly different people riding the new york city subway with you is the astoundingly large population of youth who are performing on the train for money. it seems that the most vulnerable in society are often easily coerced into doing things they generally would not dare to do if they had more economic resources. for instance, the homeless population, especially youth, sometimes sell sex in exchange for basic necessities such as food, shelter, and clothing.1 even further, homeless youth taking part in research often trade information to researchers in exchange for money, which in turn, may be used to pay for food, shelter and clothing. analysis how can we ensure that this vulnerable population is free from coercion whilst taking part in research? typically, research is conducted on homeless minors because they are a special population with unique health and social needs.1 research should continue to be conducted on homeless youth if they are above a threshold age, as determined by institutional review boards (irbs), and are able to freely consent to research without money being the primary incentive. indeed, there needs to be a consensus with irbs on strict guidelines for research incentives on homeless youth, or the research should not be conducted at all. consequently, there are two major ethical concerns that arise regarding research on homeless minors: first, their ability to consent to research, free from coercion; second, deciding on an appropriate compensation method for participating in the research.2 homeless youth make autonomous choices daily. they usually do not have a parental guardian to make these decisions for them. this raises the question of whether obtaining homeless youth’s consent is ethically justifiable, or if there should be more stringent guidelines. since homeless youth are considered a vulnerable group because of their ability to be coerced, stringent research guidelines should act in a protective manner and include an age restriction. in canada, for example, there is no specific age of consent for treatment as long as the individual is considered to possess capacity. criteria for capacity includes the ability for a person to understand the information provided and appreciate foreseeable consequences of consenting to treatment.3 there is a growing need for social and legal awareness of informed consent and the importance of autonomy in vulnerable populations. obtaining consent from autonomous homeless youth should be taken on a case-by-case basis where researchers prioritize assessing the youth’s ability to comprehend the research goals. sathi, should homeless youth participate in research, voices in bioethics, vol. 4 (2018) 2 according to irb guidelines, children are unable to provide legal consent until they reach 18 years old. adolescents between the age of 13-18 are able to participate in research with parental or guardian permission, or in complex cases, only sign an assent form.4 much of research conducted on homeless youth requires researchers to ask intimate and personal questions that have the ability to trigger past traumas and difficult emotional content.5 consequently, given that it should always be in a well-intentioned researcher’s best interests to avoid causing psychological harm to participants, homeless minors may not be able to fully consent to research if they lack the ability to assess the potential foreseeable risks from taking part in the research. there must be stricter guidelines in place for research that includes homeless youth. as long as homeless youth have the capacity to consent, research within the irb age threshold is acceptable. however, if they are unable to access future risks, then these youth must not be included in research. researchers must fully access whether homeless youth have the capacity to understand the risks involved in research participation. to establish research that is free from coercion, researchers must ask themselves: if there was no monetary incentive, would participants take part in this research for the good of promoting biomedical and social science research? much of the time, regardless of the population, the answer to that question is no. financial incentives are seen as a form of fairly reimbursing participants for their time and information. incentives are now so deeply embedded in recruiting research participants that it is difficult, and arguably unnecessary, to separate the two. young people themselves felt that $5$10 for taking part in a study “could be coercive and harmful to some homeless youth”.1 for homeless youth, research incentives are not solely a reimbursement for time, but should instead be considered as being used for daily living. there is also an issue of how much should be appropriately compensated. studies have shown that the amount paid varies tremendously on the type of research and who conducts it.6 one study, which documented research personnel’s experience of ethical issues surrounding homeless adolescents, found that those participating in mental health and substance use research were more likely to use gift cards as compensation, rather than those performing research on physical health.7 there was also a notable correlation that most of this research occurred in universities. homeless youth may be more likely to take part in research with higher risks when offered greater financial incentives. compared to filling out a few questionnaires, where only personal information may be at risk of being stolen, there are larger risks involved in research that requires a brain scan, which may expose participants to radiation or chemical exposure. to account for these risks, participants may receive different amounts of money; for example, a national institute of health (nih) study regarding pet imaging of dopamine, compensates participants up to $430 for their involvement in this study.7 the national commission for the protection of human subjects of biomedical and behavioral research (the national commission) published the belmont report, a helpful tool for considering research on vulnerable populations.8 the report defines respect for persons in research as “honoring the choices of subjects capable of exercising autonomy and protecting subjects incapable of making their own decisions. ethical human experimentation preserves respect for the subjects whose participation is essential to the humanitarian mission of biomedical and social science research”.9 additionally, the belmont report contains an obligation “to protect those with diminished autonomy, including those in need of extensive protection”.10 homeless minors are in need of protection because they possess a diminished level of autonomy due to difficult living circumstances and other mitigating life experiences that may be traumatizing. researchers, as well as healthcare workers, are held to a standard of providing care that does not discriminate on the basis of an individual’s race, lifestyle, socioeconomic status or any other attribute. they must provide services in which participants receive fair and equitable treatment. yet, how sathi, should homeless youth participate in research, voices in bioethics, vol. 4 (2018) 3 realistic is it for researchers to be treating homeless participants fairly when there is potential for an imbalance of power between this vulnerable population and researchers? adolescents are typically swayed by monetary incentives in their decision-making process, more so than adults11,12. for adolescents living in poverty who scramble to make ends meet, they are vulnerable to coercion -that is, to participate in research based solely on the draw of monetary incentives -more so than the average research participant. therefore, researchers must pay significant attention to underlying motives of why homeless youth are participating in their research. a possible objection to the need for strict irb guidelines for research on homeless youth may be that the information obtained from this unique population is significantly needed, since there are no alternative methods available. under the umbrella of this objection, guidelines should be less stringent; otherwise, useful data may be limited and it may produce results which are inconclusive. this objection argues that this valuable insight can help shape policy and government decisions which may have a lasting positive impact on the population as a whole. however, this line of reasoning should not be given weight because, while it supports research conducted for the larger benefit of society, it does not consider the potential harm to participants. throughout the 20th century, for instance, we have seen research conducted for the greater good of society while subsequently harming the participants. the tuskegee syphilis experiment and research performed by nazis in concentration camps are two notable examples of research attempts gone bad. in the tuskegee syphilis experiment, marginalized african-americans with syphilis were told they were receiving free treatment, but instead were receiving spinal taps, without any therapeutic benefits. additionally, when penicillin was widely available and deemed as an effective treatment for syphilis, participants were still not informed of their treatment options.13 the wide-range of unethical research performed in nazi concentration camps specifically included experiments of forcibly drowning prisoners to determine how long humans could survive underwater; they also injected healthy prisoners with festering tissues from unhealthy inmates to observe the pathological effects.14 though these examples are vastly different, each was highly unethical. both studies justified research without consideration of harm to individuals, but purely for the sake of a preconceived notion defining the greater good of society. conclusion when researching with homeless youth, it is necessary to ensure these young people are not being systematically manipulated. just as homeless minors sometimes engage in sex for survival, researchers must be wary of this group’s participation in research studies given their financial disposition. to ensure that researchers are held to this standard, objective guidelines need to be enforced by irbs. these guidelines should include a minimum age threshold for homeless youth to meet, as well as restrictions around monetary incentives for different levels of participation. most importantly, these guidelines will protect homeless youth from being coerced into participating in research to make money for their survival. in order to navigate around this issue of coercion, one solution would be to introduce more jobs for youth at homeless shelters. this will enable youth to make money, and avoid feeling the coercive pressure of having to sacrifice personal information for monetary compensation from research studies. youth, regardless of homeless status, are significant to our society, but they must not be manipulated or coerced for someone else’s benefit. 1 ensign, josephine, and seth ammerman. "ethical issues in research with homeless youths." journal of advanced nursing 62, no. 3 (2008): 365372. 2 grady, christine. "payment of clinical research subjects." the journal of clinical investigation 115, no. 7 (2005): 1681-1687. sathi, should homeless youth participate in research, voices in bioethics, vol. 4 (2018) 4 3 leo, raphael j. "competency and the capacity to make treatment decisions: a primer for primary care physicians." primary care companion to the journal of clinical psychiatry 1, no. 5 (1999): 131. 4 ucla. “guidance and procedures: child assent and permission by parents or guardians.” office of human research protection program. (2016) 5 ensign, josephine. "ethical issues in qualitative health research with homeless youths." journal of advanced nursing 43, no. 1 (2003): 43-50. 6 borzekowski, dina lg, vaughn i. rickert, lisa ipp, and j. dennis fortenberry. "at what price? the current state of subject payment in adolescent research." journal of adolescent health 33, no. 5 (2003): 378-384. 7 national institute of health clinical center. “pet imaging of dopamine in healthy study participants.” u.s. national library of medicine. accessed from clinicltrails.gov (2017). 8 department of health, education. "the belmont report. ethical principles and guidelines for the protection of human subjects of research." the journal of the american college of dentists 81, no. 3 (2014): 4. 9 dresser, rebecca. "mentally disabled research subjects." jama 276 (1996): 67-72. 10 quinn, camille r. "general considerations for research with vulnerable populations: ten lessons for success." health & justice 3, no. 1 (2015): 1. 11 beauchamp, tom l., bruce jennings, eleanor d. kinney, and robert j. levine. "pharmaceutical research involving the homeless." the journal of medicine and philosophy 27, no. 5 (2002): 547-564. 12 levine, robert j. "adolescents as research subjects without permission of their parents or guardians: ethical considerations. " journal of adolescent health 17, no. 5 (1995): 287-297. 13 heintzelman, carol a. "the tuskegee syphilis study and its implications for the 21st century." the new social worker 10, no. 4 (2003): 4-5. 14 roelcke, volker. "nazi medicine and research on human beings." the lancet 364 (2004): 6-7. introduction analysis conclusion goldberg, high price, voices in bioethics, vol. 1 (2014-15) © 2014 madeline goldberg. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. high price: a neuroscientist's journey of self-discovery that challenges everything you know about drugs and society madeline goldberg keywords: bioethics, neuroscience, drugs, addiction, book introduction drug addiction is a popular topic in the news today, but the portrayal of drug addiction is not as impartial as one would hope. carl hart, ph.d., an associate professor of psychology at columbia university, is on a mission to correct this bias in both pop-cultural depictions and government policies relating to drug use. first, dr. hart notes that drug addiction is not as prevalent as many believe. in fact, according to dr. hart, more than seventy-five percent of individuals who initially experiment with drugs, whether legal, illegal, or pharmaceutical, do not become addicted; in those individuals who become addicted, decisions to engage in drug use are often influenced by factors that transcend a physical addiction to drugs. one of these factors includes alternative opportunities in a drug user’s environment. to evaluate drug-seeking behavior, dr. hart has performed a number of experiments in his lab at columbia university. these experiments examine what motivates addicts to abstain from or use a drug. in one experiment, dr. hart, with the approval of an ethics committee, offers drug addicts two options: a dose of crack cocaine, or an “alternative reinforcer” such as monetary incentives or vouchers for merchandise. dr. hart found that many participants chose the alternative reinforcer over the drug. from this, dr. hart concludes that environmental factors influence addicts’ decisions to engage in drug use. ____________________________________________________________ goldberg, high price, voices in bioethics, vol. 1 (2014-15) 2 analysis contrary to what is commonly portrayed in the media and by anti-drug campaigns, drug addicts will not do everything and anything possible to gain access to a drug. instead, drug addicts make decisions based on many factors, one of which is the availability of alternative reinforcers. dr. hart’s study on human drug addicts confirms similar findings in animals. in one study, researchers discovered that rats raised in social isolation without environmental stimuli were more likely to press a lever for cocaine than rats raised in an enriched environment with socializing and exercise wheels for play. these studies support the view that drug use does not necessarily follow addiction; drug use is often influenced by factors such as impoverished environments and an absence of opportunities. conclusion dr. hart’s new book, high price: a neuroscientist’s journey of self-discovery that challenges everything you know about drugs and society, is a fascinating memoir that recounts dr. hart’s life, from growing up in a poor community in south florida to becoming the first tenured frican american professor in the sciences at columbia university. in his memoir, dr. hart clearly explains many issues that are prevalent in american society from the perspective of his own experiences and observations. these issues include discrepancies in prison sentences for drugs, such as crack and powder cocaine, as well as the negative impact of incarceration on juveniles. dr. hart explains how biased drug enforcement and disparities in prison sentencing unintentionally target racial minorities. in addition, dr. hart’s book includes references to scientific studies that are interwoven into his story. these scientific studies shed light on dr. hart’s experiences and add a level of analysis that allows the reader to appreciate his perspective. dr. hart’s forthright account of his life and beliefs makes high price a compelling and unusual story that challenges readers to reevaluate their assumptions and search for greater understanding of drug use and addiction. castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) * camille castelyn, ms candidate columbia university © 2020 camille castelyn. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. oversight of biohacking when the stakes are high: ethics police or fbi? camille castelyn* abstract biohackers should fall within the scope of research ethics boards, known as the “ethics police,” regardless of fbi involvement in reeling them in if they break the law. it may even be argued that the bioethical principles, often discussed in research ethics, may align with the goals of biohackers. both bioethicists and biohackers argue that equitable access and justice should be pursued, however, the means by which this is achieved differs greatly. bioethicist and journalist, alex pearlman, is leading a project to help biohackers setup their own norms. this paper argues that ethical conduct of biohackers falls within the broad scope of research ethics, with special consideration of practical implications and recommendations. biohacking refers to any form of optimizing or improving one’s body or mind and is part of synthetic biology and the diy (do-it-yourself) community. keywords: biohacking, research ethics, crispr, who, scientific centralization, open science introduction a gap exists in the scholarly field of research ethics in which the conduct of biohackers (often in their garages) is dismissed as a non-scientific phenomenon.1 bio-hacks like ex-nasa scientist josiah zayner’s attempts to make muscles grow bigger by using clustered regularly interspaced short palindromic repeats (crispr)-cas9 system to disrupt the myostatin gene, with himself as research subject, did not pass through any of the usual institutionalised ethical gatekeepers.2 some argue biohacking, which includes the unauthorized or unethical exploitation or altering of genetic material experimentally, is against the law and therefore has nothing to do with research ethics nor irbs.3 in 2009, the us federal bureau of investigation (fbi) joined forces with unusual allies:4 biohackers. the fbi did this by hosting them at the international genetically engineered machine competition (igem) with the goal of educating and building a network between the u.s. government and the biohacking community.5 biohackers should fall within the scope of research ethics boards, known as the “ethics police,”6 regardless of fbi involvement in reeling them in if they break the law. it may even be argued that the bioethical castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) 2 principles, often discussed in research ethics, may align with the goals of biohackers. both bioethicists and biohackers argue that equitable access and justice should be pursued, however, the means by which this is achieved differs greatly. bioethicist and journalist, alex pearlman, is leading a project to help biohackers setup their own norms.7 this paper argues that ethical conduct of biohackers falls within the broad scope of research ethics, with special consideration of practical implications and recommendations. biohacking refers to any form of optimising or improving one’s body or mind and is part of synthetic biology and the diy (do-it-yourself) community.8 the human augmentation market is estimated to grow to $2.3 billion by 2025.9 considering these numbers, biohacking is not an irritating fad, it is a distinct trend. social phenomena do not exist in isolation; they are influenced by cultural and political values.10 their conduct implies a general disregard for authoritative powers and a desperate attempt to democratize science11 and the clinical applications thereof, making it accessible for all. the conduct of biohackers should be considered scientific research. biohacking forms part of general scientific inquiry and consequently falls within the ethos of science.12 although biohackers generally operate in the privacy of their homes or online, many first gathered in 2003 for igem at massachusetts institute for technology.13 in 2011, 165 teams took part in the competition, and in 2012 a high school and entrepreneurship division were added.14 the projects ranged from “…rainbow pigmented bacteria and banana smelling bacteria to an arsenic biosensor.”15 today, communities such as biobricks offer online education and training, and genspace (nyc) offers a community biolab.16 ii. background: shifting paradigm scientific inquiry is indebted to greek philosophers such as socrates, plato and aristotle, who used reason rather than myths and stories to explain the world around them. today, the academic publishing industry is worth billions, driven by the exponential accumulation of data.17 research, includes all basic, applied, and demonstrated research.18 research records such as progress reports, journal articles, and laboratory records make up the facts resulting from scientific inquiry. during the development of science there was a shift from open science (consider the wright brothers who produced the first successful airplane), to a centralized institutionalization of science. furthermore, the foundations upon which ethical scientific research were built are a “…complex of values and norms which is held to be binding on the man of science.”19 the norms that guide research practices are communalism, universalism, disinterestedness and organized skepticism.20 stehr differentiates between social and cognitive norms of science, identifying a split between scientific ideas and scientific practice.21 these developments inevitably came with a strong drive toward monetization. consequently, both in biohacking and mainstream science, it would be prudent to keep in mind the possibility that objectivity of facts could be duly influenced. this is an evolving process by which science, society and economic factors determine research and its clinical application, i.e., what is eventually brought to market.22 the oversight of research and clinical application of crispr-cas9, the bacterial immune defense system23 which can be used to easily and cost-effectively edit any genome has been disparate and controversial. in 2015, one of the lead scientists in the discovery, jennifer doudna, called for a temporary moratorium on the use of crispr for clinical human gene editing until further research.24 it should have been understood that clinical application of crispr in germline cells, which are heritable changes in human sperm or egg cells, should not proceed anywhere in the world. yet, subsequent events suggest this was insufficient. in 2018, he jiankui, exploited this grey area when he edited heritable changes into human castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) 3 embryos, and two baby girls were born. he jiankui claimed that he had crispr edited these children’s genome by targeting the ccr5 gene to make them resistant to hiv, knowing their father was hiv positive. this, however, was a violation and ethical breach as there are much safer and more efficient ways to prevent acquiring hiv during the process of in vitro fertilization. even though somatic cell gene editing research as well as germline research is considered ethically acceptable, it is not acceptable to transplant any gene edited cells into a person’s uterus.25 in reaction, a well-established group of 18 scientists from seven countries called for a global moratorium against making genetically altered children.26 this example of one scientist’s exploitation of unclear oversight, resulting in the altering of the gene pool of humanity with crispr technology, is a reminder that the stakes are high. additionally, the national academy of medicine and national academy of sciences and the united kingdom’s royal society and others formed the 2019 international commission on the clinical use of human germline genome editing to set-up new, more stringent, and clearer recommendations, which may be binding in the future.27 the world health organization (who) also formed the who expert advisory committee on developing global standards for governance and oversight of human genome editing in 2019 to provide a comprehensive report that avoids ambiguity.28 it is anticipated that this report will be released in the summer of 2020. the constraints that govern mainstream institutions are mostly responsible for biohackers’ untraditional methods of conducting research. the strenuous process of passing through ethical gatekeepers enshrined by academic institutions29 also sparks biohacking. these rules and regulations can discourage scientific inquiry, slow down discoveries, and make it more difficult to bring much-needed solutions to those with diseases. by working against open science, too many rules are a constraint. yet without ethics oversight, biohacking would continue unchecked, possibly risking safety. the difference between research by professional scientists and biohackers is that biohackers can do things which are prohibited through mainstream science.30 experimentation without any oversight may lead to risks outweighing benefits. biohacking without respect to ethics is not aligned with the who’s guidelines of scientific integrity.31 some argue that wide acceptance of crispr-cas9 technology, could follow suit of the personal computer.32 people were skeptical about personal computers in their homes, and today everyone has a smart phone in their hand generally unregulated, used by the public as they see fit. iii. scope of research ethics the scope of research ethics spans an infinite and diverse field of inquiry.33 legally binding documents such as nuremberg code,34 declaration of helsinki35 and belmont report36 help govern inevitable research involving humans by requiring informed consent and irb/rec approval. the declaration of helsinki by world medical association37 states that “the primary purpose of medical research is to generate new knowledge, however that this may never take priority over the rights and interests of individual research subject.”38 medical research, involving human subjects “must conform to generally accepted scientific principles and be based on thorough knowledge of the scientific literature, other sources of relevant sources of information and adequate laboratory and as appropriate, animal experimentation.”39 “the design and performance of each research study involving human subjects must also be clearly described and justified in a research protocol.”40 biohackers usually do not have formally approved protocols and this lack of clarity is further highlighted when biohackers exercise their right to autonomy and self-informed consent by “enrolling” themselves as research participants in their own experiments, bypassing the role of irbs. irb’s main imperatives are to castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) 4 ensure scientific relevance, quality and integrity of the study, that the interests of all potentially affected parties are considered and that adequate risk-benefit assessments are done.41 these standards for the research ethics review system42 function within a systemized approach. this implies that all research with human participants is “presumptively subject to irb oversight” and also forms part of larger research participant protection programmes that ensure effective training and efficient functioning. under who’s43 systemized approach, biohacking forms part of the broad scope of research ethics and is within the ethos of a person of science’s norms.44 biohackers promote the norm of communalism as scientists rely on past science, basing their search for new discoveries on meaningful data.45 even unconventional research cannot be conducted without building on previous discoveries. biohackers are part of the broadly defined scientific community. an alternative suggestion is for biohackers to self-govern. some argue for the institutionalisation of biohackers, which may speak to the norm of universalism, on networks such as diybio.org, promoting selfgovernance of biohackers collectively. alex pearlman, a bioethicist and journalist, wants to help develop a set of norms distinct to biohackers. there is an urgency to establish a framework for systematically evaluating the risks and dangers of biological engineering.46 it can be argued that biohackers are not violating the bioethical principles as they are self-informed and autonomous. they are exercising their respect for their autonomous decisions, by choosing to elect themselves as the research participant, i.e., promoting the principle of distributive justice and beneficence. however, if they do germline editing, it holds risks and consequences for humanity that already are strongly governed by bioethical standards. biohackers should not be exempt from well-defined principles merely because they claim to operate based on other principles. within structural scientific communities, researchers cannot claim that autonomy allows them to violate helsinki standards. the field of research ethics should adapt to the paradigm shift of biohackers making important scientific discoveries. an attempt to engage instead of passing the buck to the fbi would lead to collaboration to develop ethical framework and give biohackers bright-line guidance. some might argue that the fbi’s oversight is sufficient as a policing power. however, the fbi chooses to involve itself in the actual act of biohacking by hosting igem. bringing biohacking into the scope of research ethics would address the ethical conduct of biohackers within research ethics, engaging the biohackers in the process of creating a systemic ethical framework. iv. practical considerations opposing critics might argue that to consider biohackers as part of the scope of research opens up an array of complexities. some assert that irb’s are already overworked and that there is no capacity for reasonable oversight of biohackers. however, the stakes are too high to not rise to the challenge of implementing a system of oversight. some also argue that, for now, biohackers are not conducting research of consequence. sloppy experiments done in kitchens do not amount to precise measurement of scientific outcomes. even if adequate empirical data could be collected it is likely that their research design would have a n=1 hypotheses, which is insignificant (p<0.05). yet, the chinese twins and other experiments show both an active field and the promise of new preventions and cures. as biohackers make more consequential discoveries, an organized ethical oversight is warranted. castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) 5 conclusion research ethics has not addressed the conundrum of ethical conduct of biohackers sufficiently. biohackers indicate a paradigm shift from a centralized power back to decentralisation with a strong focus on the democratization of science. while biohackers can lead to more accessible research and push science forward, the new paradigm calls for oversight in forming an ethical framework to which they must adhere. biohackers themselves should be invited to engage with the traditional scientific sphere to help frame the ethical guidelines and to represent their viewpoints and their scientific goals. better considerations should be made as to how research can be made more accessible for all. bioethicists and irb specialists can investigate how treatments for curative diseases can be brought to market in a more time efficient yet safe way. a balanced approach would hold biohackers accountable to ethical standards while addressing their concerns of scientific freedom and market-based accessibility to new discoveries. biohackers should be empowered to continue hacking in garages and basements with the hopes of a lucrative and scientifically valid discovery, albeit one that is ethically achieved. 1 gaymon bennet et al., “from synthetic biology to biohacking: are we prepared?,” nature biotechnology 27, no. 12 (december 2009): 1109–11. 2 george blazeski, “the need for government oversight over do-ityourself biohacking, the wild west of synthetic biology,” law school student scholarship, 2014, https://scholarship.shu.edu/student_scholarship/411. 3 howard wolinsky, “the fbi and biohackers: an unusual relationship,” embo reports 17, no. 6 (june 2016): 793–96, https://doi.org/10.15252/embr.201642483. 4 howard wolinsky, “the fbi and biohackers: an unusual relationship,” embo reports 17, no. 6 (june 2016): 793–96, https://doi.org/10.15252/embr.201642483. 5 blazeski, “the need for government oversight over do-ityourself biohacking, the wild west of synthetic biology.” 6 robert l klitzman, the ethics police, kindle (oxford: oxford university press, 2015). 7 delia paunescu, “can you be an ethical biohacker?” vox, october 15, 2019, https://www.vox.com/recode/2019/10/15/20915402/biohacking-josiah-zayner-crispr-ethics-gene-editing-reset-podcast. 8 blazeski, “the need for government oversight over do-ityourself biohacking, the wild west of synthetic biology”; anna wexler, “the social context of ‘do-it-yourself’ brain stimulation: neurohackers, biohackers, and lifehackers,” frontiers in human neuroscience 11 (may 10, 2017): 224, https://doi.org/10.3389/fnhum.2017.00224. 9 stefan nicola, “biohackers are implanting everything from magnets to sex toys,” bloomberg businessweek, october 19, 2018, https://www.bloomberg.com/news/articles/2018-10-19/biohackers-are-implanting-everything-from-magnets-to-sex-toys. 10 wexler, “the social context of ‘do-it-yourself’ brain stimulation.” 11 wexler. 12 robert k. merton, the sociology of science: theoretical and empirical incvestigations, 4. dr. (chicago: univ. of chicago pr, 1974). 13 blazeski, “the need for government oversight over do-ityourself biohacking, the wild west of synthetic biology.” castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) 6 14 blazeski, “the need for government oversight over do-ityourself biohacking, the wild west of synthetic biology.” 15 blazeski. 16 blazeski. 17 jason schmitt, “can’t disrupt this: elsevier and the 25.2 billion dollar a year academic publishing business,” medium, december 22, 2015, https://medium.com/@jasonschmitt/can-t-disrupt-this-elsevier-and-the-25-2-billion-dollar-a-yearacademic-publishing-business-aa3b9618d40a. 18 kenneth pimple, “six domains of research ethics a heuristic framework for the responsible conduct of research,” science and engineering ethics 8, no. 2 (2002), http://nordmansustainability.com/wpcontent/uploads/2013/01/six_domains_of_research_ethics.pdf. 19 nico stehr, “the ethos of science revisited social and cognitive norms,” sociological inquiry 48 (1978): 3–4. 20 alessandro delfanti, “hacking genomes. the ethics of open and rebel biology,” international review of information ethic 15, no. 52–57 (n.d.), https://s3.amazonaws.com/academia.edu.documents/6747790/015-delfanti.pdf?response-contentdisposition=inline%3b%20filename%3dhacking_genomes._the_ethics_of_open_and.pdf&x-amz-algorithm=aws4-hmacsha256&x-amz-credential=akiaiwowyygz2y53ul3a%2f20191119%2fus-east-1%2fs3%2faws4_request&x-amzdate=20191119t200519z&x-amz-expires=3600&x-amz-signedheaders=host&x-amzsignature=f4698da128020d859009dba7b7e3355912cb0b00b281107dbf6150dfb5548596. 21 stehr, “the ethos of science revisited social and cognitive norms.” 22delfanti, “hacking genomes. the ethics of open and rebel biology.” 23 broad institute, “crispr timeline,” n.d., https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crisprtimeline. 24 lucie wade, “ideologies of intellect a critical examination of the hype surrounding cognitive enhancement” (canada, mcgill university, 2011). 25 eric s. lander et al., “adopt a moratorium on heritable genome editing,” nature 567, no. 7747 (march 2019): 165–68, https://doi.org/10.1038/d41586-019-00726-5. 26 lander et al. 27 the royal society, “international commission on clinical use of human germline genome editing,” 2018, https://royalsociety.org/topics-policy/projects/genetic-technologies/international-commission/. 28 who, “who expert panel paves way for strong international governance on human genome editing,” march 19, 2019, https://www.who.int/news-room/detail/19-03-2019-who-expert-panel-paves-way-for-strong-international-governance-onhuman-genome-editing. 29 sarah zhang, “a biohacker regrets publicly injecting himself with crispr,” the atlantic, february 20, 2018, https://www.theatlantic.com/science/archive/2018/02/biohacking-stunts-crispr/553511/. 30 zhang. 31 who, “standards and operational guidance for ethics review of health-related research with human participants,” 2011, https://www.up.ac.za/media/shared/190/zp_files/who-research-ethics-committees_1.zp43599.pdf. 32 r. u. sirius and jay cornell, transcendence: the disinformation encyclopedia of transhumanism and the singularity (san francisco, ca: disinformation books, an imprint of red wheel/weiser, llc, 2015). 33 pimple, “six domains of research ethics a heuristic framework for the responsible conduct of research.” 34 “the nuremberg code,” n.d. castelyn, oversight of biohacking, voices in bioethics, vol. 6 (2020) 7 35 world medical association, “wma declaration of helsinki ethical principles for medical research involving human subjects,” 1964. 36 the national commission for the protection of human subjects of biomedical and behavioral research, “ethical principles and guidelines for the protection of human subjects of research commonly known as ‘the belmont report,’” 1979. 37 world medical association, “wma declaration of helsinki ethical principles for medical research involving human subjects.” 38 world medical association. 39 world medical association. 40 world medical association. 41 who, “standards and operational guidance for ethics review of health-related research with human participants.” 42 who. 43 who. 44 merton, the sociology of science. 45 merton. 46 bennet et al., “from synthetic biology to biohacking: are we prepared?” moscicki, working against biological explanations, voices in bioethics, vol. 6 (2020) © 2020 olivia moscicki. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. working against biological explanations of racial difference in the clinic and beyond olivia moscicki keywords: race, marginalized communities, healthcare and race, medicine and race, bioethics picture yourself as a well-intentioned physician who hopes to give your patients the best care possible. one afternoon in clinic, you see a black patient who is experiencing symptoms of heart failure. in medical school, you were taught that the best treatment for black patients with heart failure is bidil, the first drug marketed specifically for the needs of black patients, who supposedly benefit from the drug due to a genetic predisposition to salt retention and hypertension. you prescribe the patient bidil and wish them a good day. later that year, you see this patient again and are pleased to see that they are doing well. you’re delighted at the success of your care. not only did you seem to meet their medical needs, you were able to tailor their treatment according to what you understand to be their specific racial biology. you know that black individuals in the united states have long been medically underserved, and you are thrilled to be utilizing a drug reflective of their needs for once. however, there is of course more to the story of race and medicine. black communities have been definitively underserved by medicine and biomedical research, but these fields have also played far too large a role in the over-determination of race as a social category. undergirding hurtful sociopolitical discourse, scientific research and resultant clinical protocols have produced and reinforced racial difference so firmly as to locate it in the genetic code.1 while today’s predominant social paradigm is that racial categories have acquired meaning through political discourse and are thus socially constructed,2 with genetic classification reflecting this discourse rather than confirming its biological origins, some people, particularly within the fields of science and medicine, still operate under the assumption that race is indeed biologically inherent. and as biological identity has been further located in the genetic code over the last several decades, so have biological understandings of race. this is the position upon which products like bidil, which claim to address racial health disparities by biological means, rest. this position is dangerous. though these measures are temptingly defensible considering the medical underserving of black people, they actually neglect the history of scientific reification of socially created race categories, and thus misplace race and solutions to racial health disparities in biological rather than social approaches. moscicki, working against biological explanations, voices in bioethics, vol. 6 (2020) 2 unequivocally, the medical system’s underserving of the black community is a critical issue. it has included both a lack of access to medical care and exclusion from the benefits of biomedical research.3 these are the issues which bidil’s creators and supporters claim to address. though the drug was not originally intended for any particular racial group of patients, retroactive data analysis of a study showing unimpressive benefits to bidil was reexamined to reveal statistically notable benefits for black patients.4 eventually becoming the “only drug approved for a single ethnic group,” bidil was supported by the naacp5 and celebrated as a move towards better serving black patients and addressing health disparities.6 gary puckrein, executive director of the national minority health month foundation, argued in favor of bidil in health affairs. defending the merits of the drug, puckrein wrote, “race may be the coarsest of discriminators, but it now has proven life-saving potential for heart failure patients. the evidence that convinced the fda predicts a dramatic increase in black patients’ survival.”7 though puckrein’s defense of such an apparent improvement in the lives of black patients is understandable considering past neglect, race is indeed the “coarsest of discriminators,” and its use in this context has the potential to ultimately work against the interests of black patients by obscuring the social construction of racial categories. sociologist alondra nelson addresses the paradoxical danger of race-based medicines such as bidil when she asks “how did a civil rights tradition undergirded by claims about common humanity and shared inalienable rights become the banner under which social, political, and health industry leaders endorsed a drug predicated on african americans’ supposed essential biological difference?”8 advocacy for attention to racism must not be misconstrued as a call for attention to an imagined biological difference, and we must be particularly skeptical of such attention when it is attached to profit. this confusion in and of itself arises because scientists in medicine and other fields have long operated under the assumption that race is biological and have entrenched this framework more broadly via the authority afforded to their voices. one demonstrative historical example is found in political scientist melissa nobles’ historical examination of the u.s. census. around the turn of the twentieth century, people such as “racial theorist, medical doctor, scientist, and slaveholder josiah nott” influenced the racial categories of the u.s. census in order to prove their theories of black individuals’ “separate origins” and biological inferiority.9 as a result, scientists such as mr. nott shaped the racial discourse that oppresses still today. the legacy of this racially reinforcing research continues to play out in the manifestations of the well-intentioned 1993 nih revitalization act. in response to the historical exclusion of women and minorities from biomedical research, the measure required that federally funded clinical studies include minorityidentifying subjects. however, as author dorothy roberts warns, “while designed to correct historic neglect of people of color in biomedical research, requiring that biomedical researchers use race as a variable risks reinforcing the very biological definitions of race that have historically supported racial discrimination.”10 this obfuscation of the social construction of racial categories matters because such misunderstandings of the origins of race as biological could mean never addressing racial health disparities via the broader social subjugation that produces them. focused on inclusion of black individuals in the development and distribution of biological solutions like bidil, biomedical researchers and resultant clinical protocols may seem to be redressing past wrongs, but without a committed examination of the social histories that have created racial categories, reinforced these categories through science, and then used them to subjugate, these fields will continue to obscure the social and political conditions which are truly at the root of disparity. moscicki, working against biological explanations, voices in bioethics, vol. 6 (2020) 3 there is an ethical responsibility here, particularly for providers who do not have a lived experience of racism, to think deeply and act intentionally when it comes to race in the clinic and their research. how should providers understand race and racism in a clinical context? the conclusion is not that race is unreal or irrelevant. rather, it is an integral part of every single person’s experience on this planet. though race is socially constructed, it remains an experiential reality — and realities such as these insist on manifesting their power in the ills of the body. the ethical dilemma providers must confront is that of honoring the impact of racism on health and the body while simultaneously refusing to underwrite a belief in biological racial difference. at every turn, scientists must ask themselves, what do my actions imply about the origins of race? how will this ultimately impact the well-being of my patients, their families, and our society? 1 dorothy roberts, fatal invention: how science, politics, and big business re-create race in the twenty-first century (new press, 2012), 106. 2 sut jhally, race, the floating signifier featuring stuart hall (the media education foundation, 1997). 3 roberts, fatal invention, 107. 4 pamela sankar and jonathan kahn, “bidil: race medicine or race marketing?,” health affairs 24 (august 2006): w5. 5 “heart failure treatment for black patients, bidil, launched,” drug week, august 5, 2005. 6 alondra nelson, body and soul: the black panther party and the fight against medical discrimination (university of minnesota press, 2011), 185-6. 7 gary puckrein, “bidil: from another vantage point,” health affairs (november 2006), 372. 8 nelson, body and soul, 186. 9 melissa nobles, “history counts: a comparative analysis of racial/color categorization in us and brazilian censuses.,” american journal of public health 90, no. 11 (november 2000), 1740. 10 roberts, fatal invention, 105-6. esquenazi, memories shouldn’t last a megabyte, voices in bioethics, vol. 3 (2017) © 2017 shari esquenazi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. memories shouldn't last a megabyte shari esquenazi keywords: bioethics, eyewear, biotech, bioethical principles, memory introduction imagine a world where you can take a picture of anything you desire with just your eyes. you can keep these images stored forever on a wireless device, immediately and infinitely retrievable. sounds great, right? recent scientific advancements have made contact lenses that are embedded with small cameras a reality. such forthcoming technologies tend to bring an abundance of ethical considerations with them. google’s “glass” was the first step toward eyewear that can record photos and video. the tech giant applied for a patent for a contact lens camera in 2014. last year, sony filed a similar patent for a contact lensembedded camera. while these contacts have a variety of practical uses which both benefit individuals and the overall society, they are not without their faults. this technology would be undeniably valuable in innumerable situations. a witness to a crime could take a photo that defends the word of a victim, trimming down court cases and protecting innocent citizens in society. a surgeon who finds herself in a problematic operation could live stream the images to another specialist for advice on how to quickly and safely remedy the situation and save a life. while the technology has unparalleled benefits, there are ethical concerns that need to be deeply weighed before a person opts for such a capacity in day-to-day life. a brief bioethical analysis illustrates these concerns. ____________________________________________________________ esquenazi, memories shouldn’t last a megabyte, voices in bioethics, vol. 3 (2017) 2 analysis the existential and ethical theory of transhumanism is the belief that the human race can evolve beyond its current physical and mental limitations, particularly by means of science and technology.1 for those in favor of transhumanism, there is no difference between the technologies of antibiotics, anesthesia, global communication networks, and a contact lens camera. a technological advancement is a technological advancement, and to utilize one of the aforementioned technologies, but to castigate a contact lens enmeshed with a camera, is hypocritical. the goal is to be the “best” humans we can possibly be. i argue, however, that there is a difference between life-saving medications or a network that enables communication between loved ones across the world, and a technology that can potentially reduce an entire lifetime to a catalogue of images. beauchamp and childress outline two principles which are relevant here: beneficence and non-maleficence.2 these two are fairly self-explanatory: bring benefit, and do no harm. at first brush, these contact lenses appear to be bursting with benefits, with no evident downsides. if you can remember everything without the need to attach any emotion to it, the memory is stripped of what makes it so special. analogize it to “those people” at a concert who are glued to their phones, watching the show through a screen, rather than from their position in the front row. it seems a bit like a waste, does it not? this technology, while indisputably important, has the potential to take us further out of the moment than we already are. this is problematic in several circumstances as it has the potential to allow individuals to go into a sort of auto-pilot mode, ignoring present conversations because they can simply record it while their mind ponders another topic entirely. being human is meaningful because one day, we will die; our memories are special because we can only remember so much, and what we do retain holds particular significance to us, whether it is for a good or bad reason. we remember the most distinct moments in our lives because of the way they made us feel: human. the suggestion of this technology entering mainstream society opens up a pandora’s box of its own. would you want someone perusing through your life’s most private memories after you pass? moreover, how would you feel if your cherished memories were hacked and spread online during your lifetime? consent issues arise when we consider that this technology would allow an individual to film another in secrecy. pictures and video of unknowing sexual partners could be captured and distributed online. an individual who is confiding a secret in another may be risking confidentiality. how could this technology possibly be regulated or modified in order to prevent these occurrences? how would you feel if instead of truly being in the moment and committing the instance to memory, you simply snapped a picture, and one day, a technical glitch erased the memory which encoded the same butterflies you felt first time you held your soul mate’s hand on a roof under the stars? would it not be better to rely on our senses of sight, smell, touch, sound, and taste for the emotionally charged moments in our lives? what about the heavy heart that weighed your chest down with death of your childhood dog? what if you reduced the birth and upbringing of your children to photographs because your life becomes so busy and your seemingly infallible technology is always there to esquenazi, memories shouldn’t last a megabyte, voices in bioethics, vol. 3 (2017) 3 help you catalogue their childhood? there is no way that a photograph can capture the entire essence of how you felt during those times, and to rely on such a replication feels like bastardization. as technology progresses further, relying upon digital copies will likely come with less liability as advancements such as the “cloud” offer an alternative storage vessel. viruses and hacking approaches, however, advance on par with technology and so the risk is likely not to be fully mitigated. in addition, this technology is intimidating because of society’s preexisting reliance on our smart phones. a quick trip into a coffee shop will reveal social gatherings of friends and loved ones, and not uncommonly, one or more people will appear to be more interested in their phone than their company. the counter to this is that when our memories begin to fail, these images could persist, and so this technology would preserve the sentimental thoughts of patients with decreasing cognitive abilities. where do we draw the line, though? can we say that losing our memory is just an unfortunate part of life and chalk it up to being a human, or should we pull out all of the stops to preserve one part of our mortality by avoiding the other? sentimental concerns aside, there are also questions about equal access to the technology. the fourth of beauchamp and childress’ bioethical principles is justice, which beckons questions about fairness in distribution and what is deserved.3 would blind individuals be at a disadvantage? is there an economic factor at play, placing particular groups at a similar technological handicap? paralleling this technology to “smart drugs,” would students who do not have these contacts be at a detriment because they cannot possibly write or even type as fast as their professor is speaking? the possibility that the science behind the lenses may evolve to become a means of seeing the photos and films displayed within an individual’s field of vision poses an additional threat of enabling academic dishonesty. conclusion maybe it is possible to have both documented and intangible memories, but i believe that as this technology unveils itself, individuals need to make the decision for themselves of whether to become more dependent on technology, and whether such dependency is taking away from the true meaning of our existence as human beings. working backwards with regards to beauchamp and childress’ four bioethical principles, individuals have the right to self-governance.4 [4] personal autonomy entitles individuals to make their own decisions as to what happens to them. as with most things in life, balance is the key. 1 bostrom, nick. "transhumanist values." journal of philosophical research 30 (2005): 3-14. oxford university, 2005. web. 6 june 2016. 2 beauchamp, tom l., and james f. childress. principles of biomedical ethics. new york, ny: oxford up, 2001. print. 3 ibid, 241. 4 ibid, 99. janhonen, wisdom of the established pattern, voices in bioethics, vol. 9 (2023) * joel janhonen, ms king’s college london, phd candidate university of turku © 2023 joel janhonen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. wisdom of the established pattern joel janhonen* keywords: status quo bias, cognitive bias, adaptive value, reversal test, patterns, emotional dispositions introduction this short essay explores the plausible wisdom of status quo bias and questions the attempt by bostrom and ord to negate its influence. assuming that the standard role of reason in judgment-formation is only second to affect, i propose that attempts to study and counter cognitive biases should focus on the underlying emotional dispositions. with or without rational descriptions, such innate inclinations of our cognition likely contain some enduring adaptive value. cognitive biases are deviations from reason-based judgment-formation. they are largely due to conflicts between our subjective image of the world and objective reality. attaining an exhaustive comprehension of the complex interactions of natural and social worlds is impossible, so we have evolved to operate by relying on a built-in navigation system. most of our choices we do not base on precise rational modeling but on a far more ancient response mechanism. sense-making and decision making follow the order of their evolutionary emergence: intuition first, strategic reasoning second. according to jonathan haidt, even our moral reasoning mainly functions as a post-hoc confirmation of the preceding affective judgments.1 the constructed rationalizations are our attempt to understand and unravel the mystery of our intuition and its pragmatic insights. i. disposition to resist change dispositions are enduring patterns of mental processing. as our inherent qualities, they direct our reactions toward changes transpiring around us. rather than being an instance of dissonance within the cognitive system, influences like the status quo bias originate outside of it. therefore, shifting the emphasis from cognitive to affective level gives us a better starting point for evaluating the basis and merit of each identified deviation pattern. affective responses may appear irrational, yet these have in time become established for solid evolutionary reasons. this might not make them ethically or scientifically appropriate, but nonetheless, we should acknowledge the extensive contribution of these patterns to the success of our species. janhonen, wisdom of the established pattern, voices in bioethics, vol. 9 (2023) 2 in his well-known bioethical writing on repugnance, leon kass defended the value of disgust that is experienced over perceived violations against nature. 2 he argued that this emotional impulse is an expression of nature’s wisdom, a deeper understanding of the world that human reason is unable to fully articulate. from the evolutionary standpoint, the importance of such intrinsic dispositions and the resulting affective judgments are indeed easy to defend.3 humans can attain a significant fitness advantage through reliable collaboration, which requires people to operate according to shared rules. the experienced revulsion toward norm violators gave us a built-in advocate for doing the right thing – even in the absence of authorities. affect-based moral dispositions enacted a prosocial force over our ancestors, who later articulated and codified this acted-out morality. therefore, our emotional impulses can be rich in pragmatic ethical wisdom. the intuition to resist change has a similar evolutionary origin. in the absence of a sufficient understanding of the indirect and extended consequences of an alteration, it is generally more advantageous to preserve the status quo. the emotional tendency to experience unease when deviating from conventions can manifest itself in a variety of contexts from politics to healthcare. forms of affective sway over individual or societal attempts to be logical probably stem from the same roots as our moral sense. the resistance to violating the status quo is indeed often flavored with moral outrage toward the change. psychologically, maintaining the status quo requires less effort, intention, and awareness. 4 this clearly makes it our standard setting and a considerable cognitive bias. in a sense, this psychological distaste for novelty safeguards against divergent and untested solutions to recurring problems. in the language of kass, this predisposition is an expression of rarely articulated conventional wisdom.5 the likelihood of triggering a catastrophe is minimal when following a long-ago-established tradition or pattern of behavior. on the contrary, unprecedented actions always carry unforeseeable consequences. it is likely that many yet-unidentified tendencies have indispensably influenced human decision making. in aggregate, the impact of each established sway must have proven advantageous, even if outcomes in isolated instances would not invariably be optimal or even beneficial. such features of our cognitive processing can therefore contain adaptive value or natural wisdom, even if we have not identified them or defined their precise function. therefore, an inability to articulate a rationale for an omission that seeks to maintain the status quo should not be considered indisputable evidence of a misstep. ii. detecting and eliminating irrational stances in a paper that introduced the reversal test, bostrom and ord argued that it is improbable that the current state of affairs is the best possible one regarding any single parameter that could either be increased or decreased.6 they suggest this proposed improbability justifies shifting the burden of proof to those in favor of preserving the status quo. according to their example, if someone is opposed to increasing as well as decreasing the average human intelligence, they need a good reason for why the current level is optimal. this thinking suggests that the present state of nature is incidental and has no wisdom or justificatory standing. the authors acknowledged the counterargument based on evolutionary adaptation but questioned the present adaptive value of the evolved human traits and tendencies. the undeniable advantage of reasonbased decision making is its universal applicability, while intuitions are context specific. we did not evolve to perform in macroeconomics or quantum physics. reliance on anything except systematic and rational decision making is therefore inappropriate when studying them, even if we would generally recognize our janhonen, wisdom of the established pattern, voices in bioethics, vol. 9 (2023) 3 emotional responses to convey useful insights. have the instincts that were shaped by a now vanished world become a handicap for scientific and ethical inquiry within our ultra-modern circumstance? iii. enduring wisdom we can contend with this uncertainty over present adaptive value by either relying on the established patterns of judgment-formation before maladaptiveness is demonstrated or by insisting on fully rational conduct without any mental shortcuts or filtering of information. for me, it is not obvious where the onus to provide evidence on the enduring value of each deviation resides. humans themselves have not fundamentally changed, so many of our social instincts may hold and there is a plausible pragmatic wisdom in suspicion toward societal change. besides, human culture has built upon our evolved dispositions and adjusted them for new purposes. the value of an established deviation may remain unclear when an identified bias is interrogated only in relation to a specific parameter. variables of psychology, society, and nature are not independent but intricately interconnected. the wisdom of our intuition might not reveal itself case by case – rather it resides in its broad undefined influence over humanity. depending on the context, this influence should be protected against or granted an opportunity to protect us. conclusion reasons behind established conventions and practices may not become evident until some innovation alters the status quo. it may then be too late to prevent the unexpected downsides, downstream from the change. similarly, the pragmatic value of natural tendencies that have shaped and defined our mental patterns can remain concealed until a disruption. arguably, a stance or disposition contains wisdom if it accounts for the overarching pattern, even if its applicability in individual cases is questionable. therefore, the bias toward preserving the status quo is like a natural caution to favor slow change over rapid. the psychological preference for the established pattern introduces a little inertia to the ever-changing parameters of our world. rather than reasoning ourselves to a sensible midpoint between societal stagnation and upheaval, arriving there may partially depend on following our collective instinctive navigation system. 1 haidt, j. (2001). the emotional dog and its rational tail: a social intuitionist approach to moral judgment. psychological review, 108(4), 814–834. https://doi.org/10.1037/0033-295x.108.4.814 2 kass, l. (1998). the wisdom of repugnance: why we should ban the cloning of humans. val. u. l. rev. 32(2), 679–705. https://scholar.valpo.edu/vulr/vol32/iss2/12 3 mameli, m. (2013). meat made us moral: a hypothesis on the nature and evolution of moral judgment. biol philos 28, 903–931. https://doi.org/10.1007/s10539-013-9401-3 4 eidelman, s., & crandall, c., 'chapter 4 a psychological advantage for the status quo' (pp. 85–106), in jost, j., kay, a., and thorisdottir h. (eds), social and psychological bases of ideology and system justification (new york, 2009; online edn, oxford academic, 1 may 2009). https://doi.org/10.1093/acprof:oso/9780195320916.003.004 5 kass, l. (1998). the wisdom of repugnance: why we should ban the cloning of humans. val. u. l. rev. 32(2), 679–705. https://scholar.valpo.edu/vulr/vol32/iss2/12 6 bostrom, n., & ord, t. (2006). the reversal test: eliminating status quo bias in applied ethics. in ethics 116(4), 656–679. university of chicago press. https://doi.org/10.1086/505233 hawkins, it’s more than just bathrooms, voices in bioethics, vol. 2 (2016) © 2016 andrew hawkins. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. it’s more than just bathrooms: ethical considerations for prepubescent transgender children andrew hawkins keywords: bioethics, transgender, gender dysphoria introduction social media and television have brought newfound visibility to the distinctive issues faced by transgender youth. the tlc show “i am jazz” documents the life of jazz jennings, a transgender teenage girl living in south florida, who was diagnosed with gender dysphoria at the age of four—the youngest publically disclosed case of gender identity dysphoria (gid). 1 her parents have supported her gender transition by addressing her with female pronouns and changing her name, dressing her in female clothing and enrolling her in activities that supported her gender identity. jazz has received medical services that have enabled the development of alternative physical characteristics that include the use of pubertal endocrine blockers and cross-sex hormones. her story is a foray into the ethical considerations associated with treatment and gender reassignment of prepubescent transgender children. professional opinion in regard to hormonal treatments and gender reassignment surgery has changed drastically since the publication of the standards of care (soc) for transsexual people in 1980 by the world professional association for transgender health (wpath). 2 in particular, gender reassignment surgery for adults has been widely accepted and as of may 30, 2014 is an included service for medicare recipients.3 according to jack drescher and jack pula, this is largely due to the relative persistence of gid in adults once a diagnosis has been made.4 however, children who present with gid are not necessarily fixed in their gender identity. as noted in the latest standards of care, only 6 to 23 percent of boys and 12 to 27 percent of girls display persistence of gid into adulthood.5 this poses an issue for clinicians who must decide whether to initiate hormonal therapy before tanner stage ii, which can result in permanent differences in sexual development. analysis according to a longitudinal study involving 127 adolescents, the intensity and early appearance of gender dysphoria in childhood are predictors of its persistence following puberty.6 in the case of jazz jennings, she exhibited a strong belief that she was female and had these feelings early in childhood. jeanette jennings described jazz’s identification as a girl as “consistent, persistent, and insistent”; she “always loved dolls, dresses, sparkles, (and) everything feminine”.7 at the age of 11, she was prescribed gnrh agonist: hormone blockers, which stop the production of testosterone and prevent male puberty. the endocrine society recommends this intervention because delay of pubertal onset is fully reversible and allows the patient additional time to explore their gender.8 it also prevents physical changes (e.g. hawkins, it’s more than just bathrooms, voices in bioethics, vol. 2 (2016) 2 low voice, adam’s apple) that cannot be reversed and may increase gender dysphoria. for jazz it was a relief from the nightmares she experienced about “growing facial hair, her voice dropping and her body becoming more masculine”.1 the timeline that gid patients are allowed to decide their gender is necessarily short for medical and psychosocial reasons. suppression of puberty for an extended period of time has not been adequately studied and patients face risks such as reduced bone mineralization and unknown neuroanatomical changes.9 indeed, the food and drug administration has not approved the use of gnrh agonist for the treatment of transgender children.10 an additional factor is the emotional well-being of gender dysphoric youth who may face discrimination from their peers if they remain in a prepubescent state past the age of 16. in the case of jazz jennings, early initiation of cross-sex hormone therapy contributed to her emotional well-being; she felt truly “happy as a girl” after receiving treatment.1 her nightmares about growing facial hair, her voice dropping and her body becoming more masculine subsided. a study performed in the netherlands supports the initiation of gnrh agonist treatment as a means to reduce depressive symptoms and improve general mental health.11 de vries et al reported that all adolescents in the study decided to continue with cross-sex hormones after treatment with pubertal blocker. furthermore, a 22-year follow-up revealed no clinical signs of adverse effects on brain development.12 this data, however, is limited because it involved a small sample size of adolescents who had experienced lifelong gender dysphoria and strong support from their families during their social transition. in reality, the children and adolescents who are clinically evaluated by endocrinologists are a heterogeneous group, in which a majority experience shifts in their gender identity.13 since only children with lifelong gender dysphoria were selected, nearly 80% of the clinical population was excluded from the netherlands study. in addition, the observation that the gnrh-treated children had improved psychological stability is confounded by evidence that transgender children who receive social support have reduced rates of anxiety and depression.14 the endocrine society and wpath recommendations are therefore based upon sparse evidence. the ethical implications of either delaying social transition for children who’s gid persists or permitting early transition in children who desist is problematic. for the majority of adolescents who experience non-persistent gid, the transition back to their original gender is particularly arduous and may only be exacerbated by medically-induced physical changes from hormonal therapy.15 since most cases of gid are more malleable than jazz jenning’s, it is difficult for physicians to make treatment recommendations to patients and their families without further evidence to support the risk-benefit calculus of delaying gender reassignment. on the other hand, inappropriate delay of social and medical transition may be distressing for prepubescent children who express strong feelings of gender dysphoria. conclusion the story that jazz jennings has courageously shared with the public brings immediacy to these ethical questions, which require further research and deliberation. in a society that often pathologizes those who do not conform to the gender on their birth certificate, gender dysphoric children are often subject to social stigma that poses a threat to their mental and physical well-being.16 that is why it is so important that gender incongruent individuals receive healthcare from practitioners who are attentive to the intricacies of gender transition and have a proper evidence-base to best inform clinical judgment.17 1 tweedy, k. (2015). ‘i longed to be a girl from age three’: transgender teenager who was born a boy on her painful battle to be accepted… and her fears she will never find love. daily mail. http://www.dailymail.co.uk/femail/article-2966581/teenager-born-boy-wanted-girl-aged-three-revealsstruggles-finding-love.html http://www.dailymail.co.uk/femail/article-2966581/teenager-born-boy-wanted-girl-aged-three-reveals-struggles-finding-love.html http://www.dailymail.co.uk/femail/article-2966581/teenager-born-boy-wanted-girl-aged-three-reveals-struggles-finding-love.html hawkins, it’s more than just bathrooms, voices in bioethics, vol. 2 (2016) 3 2 berger, j., green, r., laub, d., reynolds, c. l., jrwalker, p. a., & wollman, l. (1977). standards of care: the hormonal and surgical sex reassignment of gender dysphoric persons. university of texas medical branch, janus information center, galveston, tx. 3 downs, m. (2014). gender reassignment surgery: medical, policy, and cost considerations. a report to the pension boards—united church of christ. lebanon, nh. 4 drescher, j., & pula, j. (2014). ethical issues raised by the treatment of gender‐variant prepubescent children. hastings center report, 44(s4), s17-s22. 5 meyer iii, w. j. (2009). world professional association for transgender health’s standards of care requirements of hormone therapy for adults with gender identity disorder. international journal of transgenderism, 11(2), 127132. 6 steensma, t. d., mcguire, j. k., kreukels, b. p., beekman, a. j., & cohen-kettenis, p. t. (2013). factors associated with desistence and persistence of childhood gender dysphoria: a quantitative follow-up study. journal of the american academy of child & adolescent psychiatry,52(6), 582-590. 7 mulkerrins, j. (2015). the teen trailblazer for transgender children: from the age of two, jazz jennings knew she was a girl born in a boy’s body. daily mail.http://www.dailymail.co.uk/home/you/article-3184776/transgenderjazz-jennings-knew-girl-born-boy-s-body.html#ixzz4f9prwbca 8 rosenthal, s. m. (2014). approach to the patient: transgender youth: endocrine considerations. the journal of clinical endocrinology & metabolism, 99(12), 4379-4389. 9 cohen-kettenis pt, delemarre-van de waal ha, gooren lj. the treatment of adolescent transsexuals: changing insights. j sex med. 2008;5:1892–1897. , google scholar crossref, medline – see more at: http://press.endocrine.org/doi/full/10.1210/jc.2014-1919#sthash.pvuz8zx9.dpuf 10 boghani, p. (2015). when transgender kids transition, medical risks are both known and unknown. frontline. http://www.pbs.org/wgbh/frontline/article/when-transgender-kids-transition-medical-risksare-both-known-and-unknown/ 11 de vries al, steensma td, doreleijers ta, cohen-kettenis pt. puberty suppression in adolescents with gender identity disorder: a prospective follow-up study. j sex med. 2011;8:2276–2283. , google scholar crossref, medline – see more at:http://press.endocrine.org/doi/full/10.1210/jc.2014-1919#sthash.yq50g8qn.dpuf 12 cohen-kettenis pt, schagen se, steensma td, de vries al, delemarre-van de waal ha. puberty suppression in a gender-dysphoric adolescent: a 22-year follow-up. arch sex behav. 2011;40:843–847. , google scholar crossref, medline – see more at:http://press.endocrine.org/doi/full/10.1210/jc.2014-1919#sthash.yq50g8qn.dpuf 13 drescher, j., & byne, w. (eds.). (2014). treating transgender children and adolescents: an interdisciplinary discussion. routledge. 14 olson, k. r., durwood, l., demeules, m., & mclaughlin, k. a. (2016). mental health of transgender children who are supported in their identities. pediatrics, peds-2015. 15 steensma, t. d., biemond, r., de boer, f., & cohen-kettenis, p. t. (2011). desisting and persisting gender dysphoria after childhood: a qualitative follow-up study. clinical child psychology and psychiatry, 1359104510378303. 16 russell, s. t., & fish, j. n. (2016). mental health in lesbian, gay, bisexual, and transgender (lgbt) youth. annual review of clinical psychology, 12, 465–487.http://doi.org/10.1146/annurev-clinpsy-021815-093153 http://www.dailymail.co.uk/home/you/article-3184776/transgender-jazz-jennings-knew-girl-born-boy-s-body.html#ixzz4f9prwbca http://www.dailymail.co.uk/home/you/article-3184776/transgender-jazz-jennings-knew-girl-born-boy-s-body.html#ixzz4f9prwbca http://press.endocrine.org/doi/full/10.1210/jc.2014-1919#sthash.pvuz8zx9.dpuf http://www.pbs.org/wgbh/frontline/article/when-transgender-kids-transition-medical-risks-are-both-known-and-unknown/ http://www.pbs.org/wgbh/frontline/article/when-transgender-kids-transition-medical-risks-are-both-known-and-unknown/ http://press.endocrine.org/doi/full/10.1210/jc.2014-1919#sthash.yq50g8qn.dpuf http://press.endocrine.org/doi/full/10.1210/jc.2014-1919#sthash.yq50g8qn.dpuf http://doi.org/10.1146/annurev-clinpsy-021815-093153 hawkins, it’s more than just bathrooms, voices in bioethics, vol. 2 (2016) 4 17 shumer, d. e., nokoff, n. j., & spack, n. p. (2016). advances in the care of transgender children and adolescents. advances in pediatrics. introduction analysis conclusion the story that jazz jennings has courageously shared with the public brings immediacy to these ethical questions, which require further research and deliberation. in a society that often pathologizes those who do not conform to the gender on their bir... menconi, orphan drug industry, voices in bioethics, vol. 5 (2019) * michael menconi is pursuing his ms in bioethics and mph at columbia university. © 2019 michael menconi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. is the orphan drug industry the proper scapegoat for unethical research funding? michael menconi* keywords: orphan drugs, cancer, bioethics, pharmaceutical industry introduction the mainstream media and general public have expressed frustration in recent months with the confluence of capitalism and the pharmaceutical research and development enterprise. outrage over arbitrary 1000 percent price hikes for lifesaving drugs like the epipen and widespread attribution of moral culpability for the opioid crisis have proven to be enormous outrage-generating controversies for big pharma. these headlines amass views, clicks, and social media activism on a massive scale—all portraying pharmaceutical companies as greedy and villainous adversaries. camouflaged beneath this understandable outrage lies yet another ethically problematic matter, albeit significantly more complicated—the use of federal research dollars, tax incentives, and policy loopholes to study and develop highly specialized “orphan drugs” that benefit a select few while commanding some of the highest prices ever recorded in the history of the pharmaceutical industry. analysis federal motivations for stimulating orphan drug development were “beneficent”—to co-opt a popular phrase prevalent in the contemporary bioethics vernacular. orphan drugs are specifically developed for rare diseases that affect less than 200,000 people. historically, most pharmaceutical companies avoided researching treatments for rare diseases as sales would be limited to the few patients with the disease, thus impeding profitability. today, most rare disease research uses federal research dollars in a variety of forms, and the fda closely coordinates with pharmaceutical companies through its office of orphan products development (oopd).1 in order to stimulate orphan drug research, the oopd offers tax incentives, special patent and marketing rights protections, and clinical research subsidies to pharmaceutical companies willing to undertake orphan drug projects. according to almost all conventional health policy metrics, the legislative instigator of these federal orphan drug policies—the orphan drug act of 1983—continues to successfully fulfill its mission. prior to 1983, only 10 orphan drugs were approved. today, the number exceeds 400.2 menconi, orphan drug industry, voices in bioethics, vol. 5 (2019) 2 to the superficial public eye, these figures are universally encouraging. effective treatments are efficiently developed for rare diseases that would otherwise be overlooked while patients reap the clinical rewards of cutting-edge scientific research. furthermore, one would expect that the millions in government subsidies and tax incentives approved by the fda for any given orphan drug project would allow drug companies to offer these lifesaving treatments at a minimal, affordable cost. soliris, a lifesaving orphan drug developed to treat the rare blood disorder paroxysmal nocturnal hemoglobinura (pnh), strongly rejects this assumption. while soliris is not a curative treatment, it inhibits the lethal physiological process that characterizes pnh— the rapid and uncontrolled death of red blood cells. consequently, pnh patients require the treatment for life at the hefty cost of $500,000 per year.3 alexion, the boutique pharmaceutical company that produced soliris, reported $6 billion in profits in just eight years, generated from both public and private health insurance reimbursements.4 although patients have not born the financial burden of this ultra-specialized treatment thus far, health economists concede these prices are unsustainable.5 the price of soliris is hardly an anomaly. as of 2016, the average orphan drug cost per patient exceeded $140,000 annually—over six times the cost of conventional pharmaceutical therapies.6 equally alarming is the absence of laws or policies that require orphan drug companies to publicly disclose their drug pricing strategies. persistent transparency requests from media and advocacy groups have failed to yield a response. this orphan drug monopoly—aided with federally established financial incentives and regulatory shortcuts—presents a plethora of bioethical concerns that are further exacerbated as drug prices continue to soar without regulation. intimate and liberally-regulated orphan drug trials are characterized by small sample sizes (often less than 1/3 of the average size of non-orphan trials), truncated study lengths, and diminished fda regulatory requirements and oversight.7 all of these attributes are cost-saving. when combined with government-supported financial incentives, serious doubts are raised about whether exorbitant orphan drug costs can be reasonably justified. given the comparably miniscule patient population that benefits from these therapies, the exponential rise of orphan drug prices, and the refusal of pharma companies to be transparent with corporate profits and pricing, a comprehensive bioethical critique of the orphan drug research industry is warranted. orphan drug research is blatantly unjust. suppose this research was completed in a financially responsible manner with drugs marketed at a reasonable, accessible price. would society approve of the allocation of millions in federal funds for a treatment that only benefits a few thousand people? the fda is inadequately equipped to shoulder these morally complex decisions. as public health experts and health economists recently opined in the orphanet journal of rare diseases, “the dearth of information on the overall costs of rare diseases prior to patients gaining access to orphan drugs makes it challenging to assess their costeffectiveness.”8 until further empirical research supports the efficacy of the current orphan drug research and development paradigm, claims that orphan drug research falls within the moral parameters of distributive justice will remain grossly unsupported. furthermore, uninsured patients are simply unable to afford lifesaving orphan drugs. orphan drugs cost patients on average 5.5 times more than non-orphan products.9 while a combination of private and public insurance programs largely cover orphan drugs for insured patients, this practice is approaching its unfortunate end. as the exponential increase in the number of available orphan drugs continues, public and private insurance companies will begin capping orphan drug reimbursement. due to the routine six-figure price tags, even a small percentage of the cost left for out-of-pocket pay would yield disastrous implications for drug accessibility. instantaneously, orphan drug acquisition would be exclusively correlated to menconi, orphan drug industry, voices in bioethics, vol. 5 (2019) 3 socioeconomic status. this would ensure the benefits of federally subsidized orphan drug research are only accessible to the wealthy, despite the fact drug production was partly financed by american taxpayers. these consequent inequalities are ethically impermissible. pharma industry loyalists continue to argue that orphan drug research and development costs are substantial enough to justify astronomical prices for final fda-approved products. however, the ubiquitous secrecy encompassing orphan drug price strategy suggests otherwise. researchers have estimated the r&d cost of an orphan drug is around the 27 percent of the r&d cost of conventional pharmaceutical therapies.10 [10]. pharma companies also insist that the number of potential patients – customers – is limited due to its sole application for rare diseases. this is perhaps big pharma’s most valid assertion. orphan drugs are specifically envisioned for rare disease, which by definition affects 200,000 patients or less. however, if 200,000 patients requiring soliris pay the drug’s price of $500,000 annually for a decade, the orphan drug will have generated $1 trillion in revenue. the earning potential for orphan drugs is difficult to overstate. it is also possible orphan drugs may hold therapeutic applications for diseases or ailments that are unrelated to the rare disease for which the drug was intended. although impossible to predict, the colorful history of pharmaceutical research reveals that unexpected applications of drugs are both plausible and impressively lucrative. conclusion evidently, the perennially impermeable ethos of scientific research—traditionally characterized by the noble pursuit of knowledge for society’s advancement—possesses newly exposed ethical vulnerabilities in the realm of orphan drug research. morally misguided and ill-regulated market forces currently dominating the orphan drug research industry are to blame. in a niche industry where a plethora of justice concerns endure, a comprehensive and transparent analysis of orphan drug economics must be completed prior to any further disbursement of federal research incentives. the contemporary reality of rapidly advancing medicine and biotechnology in the context of finite research dollars necessitates a prioritization of ethical responsibility. for the foreseeable future, the justice-informed course of action must embrace the reallocation of valuable research funding towards treatments that hold the prospect of benefiting expansive patient populations in lieu of micro-populations chosen for their collective potential as high-return investments. 1 national institutes of health. “faqs about rare diseases.” genetic and rare diseases information center. https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-diseases. 2 nih, genetic and rare diseases information center. 3 crowe, kelly. “how pharmaceutical company alexion set the price of the world’s most expensive drug.” cbc/radio-canada. june 25, 2015. https://www.cbc.ca/news/health/how-pharmaceutical-company-alexion-set-the-price-of-the-world-s-mostexpensive-drug-1.3125251. 4 kelly, cbc/radio-canada. 5 berdud, mikel, michael drummond, and adrian towse. “establishing a reasonable price for an orphan drug.” office of health economics, (july 2018). menconi, orphan drug industry, voices in bioethics, vol. 5 (2019) 4 6 evaluate ltd. “evaluatepharma® orphan drug report 2017” 4 (february 2017). http://info.evaluategroup.com/rs/607-ygs364/images/epod17.pdf. 7 evaluate ltd., orphan drug report 2017. 8 drummond, michael, and adrian towse. “is rate of return pricing a useful approach when value-based pricing is not appropriate?” the european journal of health economics, (february 15, 2019). https://doi.org/10.1007/s10198-019-01032-7. 9 drummond, the european journal of health economics. 10 rodriguez-monguio, r., t. spargo, and e. seoane-vazquez. “ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients’ health needs?” orphanet journal of rare diseases, no. 1 (december 2017). https://doi.org/10.1186/s13023-016-0551-7. rivera-agosto, global health policy, voices in bioethics, vol. 3 (2017) © 2017 jorge luis rivera-agosto. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. global health policy: trump and the reinstatement of the global gag rule jorge luis rivera-agosto keywords: global ethics, bioethics, abortion, reproductive ethics, gag rule on january 23, 2017, president trump signed a presidential memorandum reinstating the so-called mexico city policy. the memorandum conditions u.s. global health and family planning assistance to a strict rule that precludes foreign non-governmental organizations (also known as “ngos”) from promoting or performing abortion as a method of family planning. also known as the “global gag rule,” this policy represents a blow specifically to women’s health worldwide. thanks to this new action, it will become harder, like in past years when it was in effect, to have resources to support family planning and reproductive health services, such as “family counseling, contraceptive commodities, condoms, and reproductive cancer screenings.” even though the u.s. government won’t retract from the memoranda until this administration ceases, global efforts should be made to ameliorate the negative effects the new policy will cause. the mexico city policy was first enacted by president reagan in 1984 – and at the time, it represented an expansion of existing legislative restrictions of the use of u.s. funds for abortions internationally. it was then rescinded by president clinton in 1991; reinstated by president bush in 2001; rescinded by president obama in 2009; and reinstated and expanded by president trump in 2017. the policy requires foreign ngos “to certify that they will not perform or actively promote abortion as a method of family planning, using funds from any source (including non-u.s. funds), as a condition for receiving u.s. government global family planning assistance and any other u.s. global health assistance.” the reason given to enact such policy was that the u.s. did not consider abortion as an acceptable element of family planning; thus, it was no longer going to contribute to it – no other evidence nor reason were presented. the problem with this line of thinking was that it did not conform to declared national interests, u.s. foreign policy, foreign aid policy, nor foreign assistance programs. furthermore, the policy directly contravened (and continues to) the role and scope of the u.s. support for global health. in addition, the morally relevant issue at stake is the undermining of women’s rights and their health. when the mexico city policy is in place, it has been found that in sub-saharan african countries, the rate of abortion rates increases; precisely because foreign ngos that depend on u.s. funding, but declined it because of the policy, do not have the additional resources to provide family planning services such as contraception. also, they lack general essential services, that empower women and their families and produce better health outcomes, because they do not have the money – provided by u.s. aid – to provide such services. moreover, the mexico city policy erodes the fine work made by gender equality movements https://michael-reaves-bkln.squarespace.com/jorge-rivera-agosto rivera-agosto, global health policy, voices in bioethics, vol. 3 (2017) 2 and contravenes treaties ratified by the united states –such as the united nations charter, the universal declaration of human rights, and the international covenant on civil and political rights– because it takes away from women their right to choose, eliminates access to health care, and it directly impairs general wellbeing for all. finally, the new policy frustrates free speech and thwarts u.s. efforts to bring about democracy for developing countries; specifically, because the global gag rule takes money away from ngos that are mostly the contributors and the only viable openers of power restructuring and democratic participation in those countries. it can be argued in turn that the u.s. has the power to tie certain restrictions to the money it provides. but what this line of thought misses is that any good and workable framework to address issues of global health should undertake the essential health benefits to create a positive impact on well-being – because the underlying causes of poor health are directly dealt with. in that sense, abortion restrictions cannot be rationally achieved by restricting access to essential health benefits through money restrictions – for the effect on health care and well-being in general is disastrous for all, specially women in developing countries. the current administration won’t rescind of the mexico city policy any time soon. it is, therefore, the duty of other developed countries to help and provide the assistance that now lacks to women and their families in developing countries. some have taken the lead, namely the netherlands, creating international abortion funds that ameliorate the vacuum created by the new policy/ nonetheless more is needed, for the health of women and their families in developing countries is a morally relevant issue for all human beings and not just one country – it is part of our moral duty as people of this world. their health is our health – and their well-being is our well-being. references 1. the henry j. kaiser family foundation, the mexico city policy: an explainer, fact sheet, march 2017, p. 1. 2. the henry j. kaiser family foundation, supra (note i), p. 5. 3. policy statement of the united states of america at the united nations international conference on population (second session), mexico city, mexico, august 6-14, 1984. 4. the henry j. kaiser family foundation, the u.s. government engagement in global health: a primer, report, january 2017, p. 32; congressional research service, international family planning: the “mexico city” policy, april 2, 2001, rl30830, p. crs-3; gregory h. fox, american population policy abroad: the mexico city abortion funding restrictions, 18 n.y.u. j. int’l. l. & pol. 609 (1986). 5. bill clinton administration, subject: aid family planning grants/mexico city policy, memorandum for the acting administrator of the agency for international development, january 22, 1993. 6. george w. bush administration, subject: restoration of the mexico city policy, memorandum for the administrator of the united states agency for international development, march 28, 2001. 7. barack obama administration, mexico city policy and assistance for voluntary population planning, memorandum for the secretary of state, the administrator of the united states agency for international development, january 23, 2009. 8. white house, the mexico city policy, memorandum for the secretary of state, the secretary of health and human services, the administrator of the agency for international development, jan. 23, 2017. 9. the henry j. kaiser family foundation, supra (note i), p. 1. rivera-agosto, global health policy, voices in bioethics, vol. 3 (2017) 3 10. policy statement of the united states…, supra (note iii); see in general: lindsay b. gezinski, the global gag rule: impacts of conservative ideology on women’s health, 55 intl. social work 837 (2011). 11. nina j. crimm, the global gag rule: undermining national interests by doing unto foreign women and ngos what cannot be done at home, 40 cornell int’l. l.j. 587, 609-611 (2007). 12. the henry j. kaiser family foundation, supra (note iv), pp. 10-11 13. eran bendavid, patrick avila & grant miller, united states aid policy and induced abortion in sub-saharan africa, 89 bulletin of the world health organization 873 (2011); the henry j. kaiser family foundation, supra (note i), p. 5. 14. the henry j. kaiser family foundation, supra (note i), p. 5. 15. yvette aguilar, gagging on a bad rule: the mexico city policy and its effect on women in developing countries, 5 the scholar 37, 62-64 (2002); also, see in general sylvia a. law & lisa f. rackner, gender equality and the mexico city policy, 20 n.y.u. j. int’l. l. & pol. 193 (1987). 16. sylvia a. law & lisa f. rackner, supra (note xv); see in general: patty skuster, advocacy in whispers: the impact of the usaid global gag rule upon free speech and free association in the context of abortion law reform in three east african countries, 11 mich. j. gender & l. 97 (2004); allegra a. jones, the “mexico city policy” and its effects on hiv/aids services in sub-saharan africa, 24 b.c. third world l.j. 187 (2004); and melissa upreti, the impact of the “global gag rule” on women’s reproductive health worldwide, 24 women’ rts. l. rep. 191 (2003). 17. rachael e. seevers, the politics of gagging: the effects of the global gag rule on democratic participation and political advocacy in peru, 31 brook. j. int’l. l. 899, 915-927 (2006). 18. madison powers and ruth faden, social justice: the moral foundations of public health and health policy 81-82 (2006). 19. william h. frist, overcoming disparities in u.s. healthcare, 24(2) health affairs 445, 447 (2005). 20. lawrence o. gostin, meeting the survival needs of the world’s least healthy people: a proposed model for global health governance, 298 jama 225, 225-226 (2007). 21. id. 22. lawrence o. gostin, meeting basic survival needs of the world’s least healthy people: toward a framework convention on global health, 96 georgetown l. j. 331, 347-352 (2008). 23. james masters, netherlands moves on abortion funding after trump reinstates ‘gag rule’, cnn, january 26, 2017, accessed through http://www.cnn.com/2017/01/25/politics/netherlands-trump-global-gag-rule/. 24. madison powers and ruth faden, supra (note xviii), pp. 81-82. bolzon, when good doctors go bad, voices in bioethics, vol. 2 (2016) © 2016 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “when good doctors go bad:" paolo macchiarini and complications julia bolzon keywords: medical education, medicine, clinical ethics, medical profession introduction celebrity surgeon paolo macchiarini performed experimental transplant surgery on patients with missing or damaged windpipes using an artificial trachea made of a polymer scaffold and the patient’s own stem cells. in theory, the stem cells should grow to replace the missing tissue. however, of the eight surgeries he performed between 2011 and 2014, all but one of his patients died. the one who remained alive is still in intensive care. not only did macchiarini manipulate the results reported about the procedure’s success, he also lied to his patients about the procedure’s safety, and knowingly performed it on patients whose conditions were not lifethreatening. moreover, he executed much of this without his patient’s consent.1 analysis a few weeks before hearing about macchiarini, i read selections from atul gawande’s complications: a surgeon’s notes on an imperfect science for a bioethics class on the theme of ‘prudence and the concrete.’ complications is a doctor’s musings on the medical profession at large, what he finds is “a strange and in many ways disturbing business.”2 the medical field exudes competence, confidence, and technical mastery, but underneath it turns out to be “messy, uncertain, and also surprising.”3 in light of the report released surrounding macchiarini’s medical malpractice, gawande’s explorations of the perennial questions about medical decision-making, uncertainty, and trust are worth considering. as a student of philosophy and bioethics, with a keen interest in the treatment of the human person, i often wonder about the formation physicians receive, and how this affects their practice. how can physicians be better formed so as to make decisions that are humane, prudent, and just? gawande’s insights help address this question and more, by uncovering a fundamental aspect of medicine that is often overlooked: its inherently uncertain and risky nature. a. “education of a knife” the question of how surgeons “know” how to perform a surgery was something i had never considered, and the answers are naturally disconcerting. for his first-ever surgical procedure, gawande had watched the senior surgeon perform it twice, attending to every step. he knew what he had to do in theory, but the actual procedure “remained wholly mysterious” to him. the “idea of jabbing a needle bolzon, when good doctors go bad, voices in bioethics, vol. 2 (2016) 2 so deeply and blindly into someone’s chest” baffled him. 4 the difference between his and an experienced surgeon’s hands was not necessarily familiarity with the procedure, but the cumulative experience of ‘exposure to the knife.’ this includes the paradoxical combination of confidence and uncertainty that accompanies every surgery, giving the experienced surgeon “an air of mastery.”5 the reality of surgery is that “as in anything else, skill and confidence are learned through experience-haltingly and humiliatingly.”6 like other technical or “hands on” work, experience is necessary for proficiency and eventual mastery, but it can only be gained through practice. the one difference in medicine, gawande writes, is that doctors practice on people. with every surgery, there remains the element of the ‘unknown’--each body and each person being a unique case and bearing unique circumstances that make the procedure an inherently uncertain endeavor. 7 thus, medicine is continually faced with a conflict between the need to provide novice surgeons with experience and “the imperative to give patients the best possible care.” doctors carry “the moral burden of practicing on people,” which can often occur in clinics “populated by the poor, the uninsured, the drunk, and the demented.”8 gawande writes that this is the uncomfortable and often unspoken truth about surgical teaching. b. “when doctors make mistakes” it is uncomfortable to acknowledge with gawande that “all doctors make mistakes,” especially when it comes to ones that are life-threatening. the balance between being “aware of one’s limitations” and being “plagued by self-doubt” is a fine one. the doctor who experiences neither--who remains in denial about his limits and his fears--is dangerous. gawande, like others in his profession, grapples with how mistakes are dealt. he writes of the morbidity and mortality conference (m&m) happening weekly in most hospitals, commenting at length on its “paradoxical ethos.” the m&m exists to reinforce the idea that error is intolerable, while simultaneously acknowledging that mistakes are an inevitable part of medicine. mistakes happen, and they need to be addressed, learned from, and improved upon. the aim in surgery is always perfection, requiring a constant vigilance, “attention to the minutest details.”9 in addition to these technical feats, it is apparent that an air of trust, belief, and hope is also necessary. although gawande doesn’t use those exact words, he states: “i believe that with enough will and effort i can beat the odds. this isn’t just professional vanity. it’s a necessary part of good medicine.”10 c. “whose body is it, anyway?” making medical decisions about life-threatening or terminal conditions are inherently difficult. one must weigh the likelihood of survival, the challenges of recovery, and the quality of life after surgery with their current condition. how does a patient make a decision about seemingly impossible matters? and, as gawande asks, when a doctor sees a patient making a grave mistake, should they simply let it happen?11 medical decision making often forces the person to confront their deepest desires and fears: the ‘ultimate’ questions such as, ‘what do i fear most’ (pain, inability, death?) and ‘what makes life valuable to me?’ the “awkward truth” is that patients often either do not want, or do not know how, to handle the “freedom” of being able to make the final choice. gawande quotes carl schneider’s the practice of autonomy, who found that “the ill were often in a poor position to make good choices: they were frequently exhausted, irritable, shattered, or despondent.”12 our culture has decided that the patient be the ultimate arbiter, but gawande dives deep into this reality, uncovering the fact that “such a hard-and-fast rule seems ill-suited both to a caring relationship between doctor and patient and to the reality of medical care, where a hundred decisions have to be made quickly.”13 he suggests that we have gone wrong “in promoting patient autonomy as a kind of ultimate value in medicine rather than bolzon, when good doctors go bad, voices in bioethics, vol. 2 (2016) 3 recognizing it as one value among others.”14 schneider discovered that what patients want most from doctors isn’t autonomy per se, but competence and kindness. for gawande, this means also “taking on burdensome decisions when patients don’t want to make them, or guiding patients in the right direction when they do.”15 d. “the case of the red leg” “the core predicament of medicine--the thing that makes being a patient so wrenching, being a doctor so difficult … is uncertainty.” uncertainty is “medicine’s ground state.”16 the field is rife with “gray zones,” areas where “clear scientific evidence of what to do is missing and yet choices must be made.”17 gawande struggles with the gravity of the frequency with which doctors do wrong by their patients: failure to have done the right thing, or inaccuracy in diagnosis or treatment. and yet, decisionmaking cannot be done by a machine. there is no algorithm that calculates the cost-benefit analysis and comes up with the “right” answer. even if we attempted to make “decision analysis” trees, so as to “use explicit, logical, statistical thinking instead of just [one’s] gut,” there is no adequate way of giving a weight or percentage of desirability to all possible outcomes.18 and so how does one know what ought to be done in the face of uncertainty? he contemplates the often-baffling concept of intuition, of being able to know more than you can say or explain, and how that, too, is an inherent part of medicine.19 gawande writes that when there are no clear answers, decisions are made by feel: “you count on experience and judgment. and it is hard not to be troubled by this.”20 conclusion e. thoughts on medicine gawande summarizes how: “we look for medicine to be an orderly field of knowledge and procedure. but it is not. it is an imperfect science, an enterprise of constantly changing knowledge, uncertain information, fallible individuals, and at the same time lives on the line. there is science in what we do, yes, but also habit, intuition, and sometimes plain old guessing. the gap between what we know and what we aim for persists. and this gap complicates everything we do.”21 what then is certainty? can we ever have it? if serious decisions are ultimately made intuitively, and are laden with risk, it seems that we can never have it--either as a patient or as a physician. despite all the science, tests, drugs, procedures, and technology in medicine’s abilities, gawande is clear about how at the heart of it all is a human being, a doctor who has good days and bad days, with gaps in his knowledge and skills he can only build through experience. what then does our capacity to trust ultimately rest in? to trust is to have faith in something (or someone) solid or certain. but in what, when the outcomes are unknown? this concept is mysterious, because it is not exactly the competence of the doctor we can trust, but something even beyond them and their ability. gawande states that: “we are all, whatever we do, in the hands of flawed human beings.”22 when physicians like macchiarini fail their patients and the ethos of the practice so blatantly, it is cause to re-question not only what medicine is for, but also the way in which it is practiced. as a “fundamentally human endeavor,” medicine is rife with uncertainty, guesses, and mistakes. this is not something we can change. but precisely as a human endeavor, the formation of the mind and heart of the physician is paramount to the way in which they care for the person they are given. bolzon, when good doctors go bad, voices in bioethics, vol. 2 (2016) 4 1 vogel, gretchen. “karolinska institute has ‘lost confidence’ in paolo macchiarini, says won’t renew his contract.” science magazine. february 4, 2016. http://www.sciencemag.org/news/2016/02/karolinska-institute-has-lost-confidence-paolomacchiarini-says-it-wont-renew-his?utm_campaign=email-news-latest&et_rid=17669483&et_cid=256735 2 gawande, atul. complications: a surgeon’s notes on an imperfect science. metropolitan books, new york. 2002. p 4. 3 ibid, 4. 4 gawande, 15. 5 ibid, 16. 6 ibid, 18. 7 “surgical training is the recapitulation of [the] process … [of] floundering followed by fragments, followed by knowledge and occasionally a moment of elegance – over and over again, for ever harder tasks with ever greater risks,” gawande, 22. 8 ibid, 24. 9 ibid, 73. 10 ibid, 73. 11 ibid, 212. 12 ibid, 222. 13 gawande, 223. 14 ibid, 224. 15 ibid, 224. what is a “good” choice? how does the patient himself know what is best for him? who ultimately knows what is ‘best’ for the patient? medical decision-making is a fine and complicated balance between the doctor and his or her expertise with the needs of the patient. these needs, while particular to the patient and their situation, also run deeper to the under lying ‘human needs’ that exist at the base of everyone’s experience, needs such as belonging, being ‘heard,’ acceptance, etc. especially in the face of suffering, fear, or loneliness. how does the doctor balance the technical aspects of the decision w ith the human aspect – and how are the ‘real needs’ of the patient uncovered? 16 ibid, 229 17 ibid, 237. 18 ibid, 241. a trivial example i was reminded of is in the film interstellar, when cooper doesn’t agree with amelia’s decision to go to edmund’s planet–a decision she based on nothing other than her intuition-because it was an emotional and not logical one. 19 gawande cites the cognitive psychologist gary klein and the example of a fireman’s intuition, who was able to leave a burning house moments before the floor collapsed beneath them. “it is because intuition sometimes succeeds that we don’t know what to do with it. such successes are not quite the result of logical thinking. but they are not the result of mere luck, either, ” p 247. 20 ibid, 237. 21 ibid, 7. 22 ibid, 105. introduction celebrity surgeon paolo macchiarini performed experimental transplant surgery on patients with missing or damaged windpipes using an artificial trachea made of a polymer scaffold and the patient’s own stem cells. in theory, the stem cells should grow ... analysis conclusion woodward, responsibility in the age of precision medicine, voices in bioethics, vol. 3 (2017) * alexa is a fellow in the precision medicine: ethics, policy, and culture project funded by columbia university’s sustainable world initiative, cu's precision medicine initiative, and cu's center for the study of social difference. the article is her reflection on the ongoing discussion around the precision medicine initiative that has been the subject of recent political, social, and popular media attention. a recent presentation by sandra soo-jin lee, phd, from the center for biomedical ethics at stanford university spurred our multi-disciplinary discussion of some of the themes. © 2017 alexa woodward. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. responsibility in the age of precision genomics alexa woodward* keywords: precision medicine, genomics, genetics, privacy, stigma, bioethics what is normal, anyway? genetically speaking, that’s precisely the question that the obama administration’s precision medicine initiative (pmi) seeks to answer. in recruiting and collecting comprehensive genetic, medical, behavioral, and lifestyle data from one million americans, the scientific and medical communities will be better able to understand what constitutes normal genetic variation within the population, and in turn, what amount of variation causes or contributes to disease or disease risk.1 using this data, researchers could potentially create tailored approaches for intervention and treatment of an incredible range of diseases. the pmi has a secondary aim: to increase the representation of previously underrepresented populations in research – primarily african americans and hispanics/latinos. inclusion of these groups in research has been a challenge for decades, with lack of access, distrust in the medical and research systems, and institutionalized racism all playing exclusionary roles. more broadly, outside of the government initiative, the promise of precision medicine ultimately seeks to alleviate disparities by finding and addressing supposed genetic differences, and empowering people with information to take responsibility for their health. this empowerment, while perhaps well intentioned, can misplace the burden of genetic responsibility for various outcomes, fostering blame and stigma. furthermore, it may be used as an excuse to neglect social determinants of health. some social scientists now consider us to be in a “post-genomic” age, where promises of the genomic era have failed to materialize,2 gene-environment interactions remain undefined, and issues around the role of data on race and ancestry remain contested.3 research is already starting to move in the direction of epigenetics, the modulation of the three-dimensional structure of dna by molecular mechanisms a seemingly promising avenue for translation4 into both public health and individualized interventions. additionally, genetic risk is highly dependent on penetrance, which is expressed as the percentage of those woodward, responsibility in the age of precision medicine, voices in bioethics, vol. 3 (2017) 2 who have the gene who actually develop the disease. concerns over responsibility may heighten as we begin to better understand both the plasticity of the epigenome and the level of penetrance of various genetic mutations. a useful set of paradigms came up in our discussion of responsibility: either “[clinicians/researchers] change us,” “we change ourselves,” or “the government changes the environment.” each of these options places the responsibility in the hands of a different party. matters of personal health and reproductive decision-making prompt questions of personal responsibility. most western countries like the united states and united kingdom allow a high degree of reproductive liberty and parental autonomy; however, this could change in the context of the pmi and increased genetic information. although this may not change from a legal standpoint, existing attitudes towards people with identifiable and potentially harmful genetic mutations -which may pose harm to themselves or their future children -may exacerbate stigma towards difficult reproductive decisions. knowingly risking the transmission of harmful mutations to offspring, and when and if this should be considered irresponsible, remain to be addressed.5 there has already been a push for increased access to assisted reproductive technologies and for increased societal acceptance of adoption with a normalization of non-nuclear family structures.6 society is going to have to weigh the relative importance of “genetic prudence” against personal autonomy, both in the historical context of eugenics and the present context of biological citizenship and responsibility. genes and genetic data, along with topics such as neuroimaging and hiv, have often been viewed as “exceptional” in comparison to other medical challenges and information but the realm of such exceptionalism is limited. while each person is indeed genetically unique, such “exceptionalism” of individual genetic information is often invoked due to its potential for far-reaching impact and relevance for family members, both in a positive and negative sense. other medical information weight, blood panels, liver function tests don’t have such direct bearing on others. as precise as the pmi intends to be, impact extraneous to the individual is unavoidable, and fears of discrimination and stigma abound. multiple studies, as well as a recent meta-analysis published in the bmj, have found that genetic information does little, if anything to alter health related behavior.7 this has been similarly shown with regards to other medical information such as cholesterol levels or lung damage from smoking, but the supposed “exceptionalism” of genetic information seems to carry little weight in this realm. we are left to wonder: how will ideas around “empowerment” play out in landscape of sensationalism and address this indifference? the pmi aims for precision, down to the level of individual variation. but due to the inherent nature of genes and inheritance, precision, or at least “precision confidentiality” is hard to implement. regardless of how precise we are with our molecular techniques; unintended consequences will result. while seeking to be precise, the pmi may not really “hitting the nail on the head” in terms of causality and disease risk. we’ve all seen those bull’s-eye representations of precision and accuracy. imagine for a moment that the target is health disparities, and the rings represent different contributing factors. decades of research show that genetics isn’t at the center of what causes these disparities; rather, it is income, poverty, and health care access.8 why are we throwing all of our darts (or dollars) so precisely, but not accurately? medical research ought to ensure that taxpayer dollars being equitably distributed among the population. there has been a recent push for many of our bioethical frameworks to shift to a more communitarian, public health-oriented approach;9 but how to implement such a framework in the context of precision medicine and the pmi remains a salient question, given that public health is not precision-obsessed, but woodward, responsibility in the age of precision medicine, voices in bioethics, vol. 3 (2017) 3 rather looks to maximize outcomes. as the pmi moves forward under the new administration, bioethical scholarship and social science research remains imperative to answering these questions. 1 "fact sheet: president obama's precision medicine initiative." national archives and records administration. accessed april 21, 2017. https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precisionmedicine-initiative. 2 wade, nicholas. "a decade later, genetic map yields few new cures." the new york times. accessed april 20, 2017. http://www.nytimes.com/2010/06/13/health/research/13genome.html?pagewanted=all&_r=0. 3 shim, janet k., katherine weatherford darling, martine d. lappe, l. katherine thomson, sandra soo-jin lee, robert a. hiatt, and sara l. ackerman. "homogeneity and heterogeneity as situational properties: producing–and moving beyond?–race in post-genomic science." social studies of science (2014): 0306312714531522; darling, katherine weatherford, sara l. ackerman, robert h. hiatt, sandra soo-jin lee, and janet k. shim. "enacting the molecular imperative: how gene-environment interaction research links bodies and environments in the post-genomic age." social science & medicine 155 (2016): 51-60. 4 meloni, maurizio, and giuseppe testa. "scrutinizing the epigenetics revolution." biosocieties 9, no. 4 (2014): 431-456. 5 wasserman, david. "justice, procreation, and the costs of having and raising disabled children." in the oxford handbook of reproductive ethics, p. 464. oxford university press, 2016. 6 van den akker, o. b. a. "adoption in the age of reproductive technology." journal of reproductive and infant psychology 19, no. 2 (2001): 147-159. 7 hollands, gareth j., david p. french, simon j. griffin, a. toby prevost, stephen sutton, sarah king, and theresa m. marteau. "the impact of communicating genetic risks of disease on risk-reducing health behaviour: systematic review with metaanalysis." bmj 352 (2016): i1102. 8 adler, nancy e., m. maria glymour, and jonathan fielding. "addressing social determinants of health and health inequalities." jama 316, no. 16 (2016): 1641-1642. 9 dupras, charles, vardit ravitsky, and bryn williams‐jones. "epigenetics and the environment in bioethics." bioethics 28, no. 7 (2014): 327-334. https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative http://www.nytimes.com/2010/06/13/health/research/13genome.html?pagewanted=all&_r=0 bissassar, transnational stem cell tourism, voices in bioethics, vol. 3 (2017) © 2017 mahelia bissassar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. transnational stem cell tourism: an ethical analysis mahelia bissassar keywords: stem cells, medical tourism, transnational ethics, global health ethics transnational medical tourism is a growing sector of modern global health care, facilitated by globalism and connecting platforms like the internet, which provides opportunities for health care to those who can afford it. patients who can afford the steep price (and, very often, those who can't) partake in organ tourism as alternative means of seeking a needed organ, reproductive tourism as a method to treat infertility, in the form of egg donation and surrogacy, as well as stem cell tourism. during the past decade, stem cell research has skyrocketed spurring increased scientific excitement about what the future of stem cell research could hold for regenerative medicine and treatment of untreatable diseases. however, a developing market commercializing in an international setting without regulation and restriction has led to expensive pseudo medical treatments, for which there is no scientific rationale or evidence of efficacy or safety, that threaten the health of patients. several highly publicized cases including the death of a child in the german1 stem-cell clinic xcell center, as well as the highly publicized paralysis and cancer-like growth of american patient jim gass in stem-cell clinics in mexico, china, and argentina have prompted global outcry and a call for increased regulation and implantation of safety standards.2,3 the prevalence of stem-cell clinics that provide untested and potentially lethal medical interventions threatens the global health and financial security of patients. stem cell tourism, a growing industry largely advertised online, involves privately owned stem cell clinics, often managed by physicians, fraudulently advertising pseudoscientific stem-cell cures for a variety of untreatable conditions directly to health consumers. patients looking for stem-cell treatments travel from a diverse range of locations in north america, europe, the middle east and asia.4 the clinics they travel to are located around the world, the most popular ones in countries at the forefront of medical stem-cell innovation and in nations with lax stem-cell clinic laws. companies are located in united states, mexico, russia, germany, india, and china, among several other countries.5 they all rely on weak and subjective claims of improvement, selective anecdotes and testimonials, favorable media reports, untested scientific jargon, and links to unrelated studies to appeal to health consumers. 6 a further study on the data collected from clinics illustrates a therapeutic effect likely due only to a placebo effect.7 no clinical data or procedures have been released from these clinics, having the most dangerous implications. no data or procedures released means that efficacy cannot be measured, so hurtful experiences are not counted and actual therapeutically valuable data cannot be used or tested for efficacy against other studies of accepted treatment.8,9 these clinics cannot be held to clinical standards of safety or effectiveness and are not held responsible for futile treatment. this shoddy science threatens the future beneficiaries of such innovative clinical science and weakens proof that stem-cell clinics are anything but a farce. these clinics prey on the hopes and fears of their clients by appealing to a broad array of degenerative, chronic, and fatal diseases.10 unknown risks were withheld from patients, threatening not just their autonomy to make an informed decision about their own health but also violates the primary principle of medicine: to do no harm. embryonic and other stem cells have tumorigenic potential and have been proposed as a source of common origin for cancer.11 these clinics exist as an alternative to patients not eligible for clinical trials or otherwise averse to such trials in the us.12 patients go abroad in search of treatments unavailable at home, searching for a source of hope. patients suffering from serious or debilitating conditions, like alzheimer’s and multiple sclerosis, can’t be cured with modern medical treatments. their only treatment options include bissassar, transnational stem cell tourism, voices in bioethics, vol. 3 (2017) 2 palliative care, symptom management or drugs that temporarily slow the progress of the disease.13 these situations create similar circumstances of rashness that drive organ tourism and foment human rights violations.14 stem-cell companies provided misleading medical information to their consumers, projecting medical authority and expertise in order to frame their stem-cell therapies as new and innovative rather than unproven. 15 doing so is intentionally maleficent and puts patients in harm’s way. stem cell tourism brings unique intricate ethical concerns where generalized medical knowledge is at odds with patients’ immediate desire to survive, pushing patients to risky treatment many would not consider. this is not simply another case of buyer beware. the potential for serious harm to vulnerable patients is at stake.16 the stem cell tourism industry is a complex, extensive industry with multiple interlaced causes and contributions. one pronounced contributor is the patient frustration with the lack of treatment in their native country and their immediate healthcare needs. the overselling of stem cell treatments before they have been sufficiently validated and tested for safety has been attributed to the sensationalized attention given to stem cell research in popular media. stem cell research is portrayed as the next new big thing in medicine, in which the promising research potential is seen as rapidly translatable to cures. with some theatricals, stem cell clinics can extend the applicability of accepted clinical treatments to swindle customers.17 the perpetrators of the crime are the medical entrepreneurs and brokers who advertise and provide the treatments, but emphasis on communicating openly with patients to understand why patients go abroad for treatment rather than on persecuting brokers and dishonest clinicians carrying out procedures, may be a more effective way of battling unsafe stem cell tourism from the root. some researchers contribute the growth of stem cell tourism to american scientists and clinicians. they argue that scientists and clinicians underestimate the relevance of hope to patients making the decisions to travel abroad for dubious treatment, proposing that, even unfounded hope is better than no hope at all in the patient’s mind.18 it is imperative for discussion to reflect on why so little hope is found at home rather than just importance of allowing hope to flourish offshore.19 the paternalistic dismissive attitude of american physicians in the face of patients considering dangerous or futile stem-cell treatment in the hope of some improvement has been argued to push patients away from established medical professionals to dubious stem-cell clinics. the lack of health care at home has also been identified as a contributing factor. salter and colleagues insist that the matter at hand isn’t toning down the hype but rather domestically available health care supply.20 patients in need don’t care about expanding medical knowledge or the benefit of future suffering patients, they care about is getting better and surviving. demonizing stem cell tourism will never squelch this vital instinct.21 acceptable channels must be made available to seriously ill patients. constraints such as the proximity of death as well as the specific burdens of a particular disease condition contribute to the stress of the limits of local treatment to impress an immediacy pointing to external care.22 recognizing the role of health consumer choices in this emerging global market will be essential to discouraging risky and exploitative healthcare decisions. 1 mendick, r. and hall, a. (2011) europe’s largest stem cell clinic shut down after death of baby, the telegraph, 8 may. available at www. telegraph.co.uk/news/worldnews/europe/germany/8500233/europes-largest-stem-cell-clinic-shut-down-after-deathof-baby.html (accessed 1 may 2017) 2 berkowitz ,aaron l., miller, micheal b., mir saad a., daniel cagney daniel, chavakula vamsidhar, guleria indira, aizer ayal, ligon keith l., chi john h., n engl j med 2016; 375:196-198 3 kolata gina, (2016) a cautionary tale of ‘stem cell tourism’. the new york times, 22 june (accessed may 1, 2017) 4 lau d, ogbogu u, taylor b, stafinski t, menon d, caulfield t. stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. cell stem cell 2008; 3(6): 591–594. china stem cell news. http://www.stemcellschina.com 5 alsuntangled group. alsuntangled update 4: investigating the xcell-center. amyotroph lateral scler 2010; 11(3): 337–338 6 sipp, douglas. the unregulated commercialization of stem cell treatments: a global perspective. front. med. 2011, 5(4): 348– 355 7 see supra note 4. http://www.stemcellschina.com/ bissassar, transnational stem cell tourism, voices in bioethics, vol. 3 (2017) 3 8 sipp, douglas. the unregulated commercialization of stem cell treatments: a global perspective. front. med. 2011, 5(4): 348– 355 9 devereaux, mary and loring, jeanne f. (2010) growth of an industry: how u.s. scientists and clinicians have enabled stem cell tourism, the american journal of bioethics, 10:5, 45-46 10 ibid 11 see supra note 2. 12 hyun, insoo (2013) bioethics and the future of stem cell research, print cambridge university press, pg.186-204 13 see supra note 8. 14 shalev, carmel (2010) stem cell tourism—a challenge for trans-national governance, the american journal of bioethics, 10:5, 40-42 15 r. alta charo, alta r. on the road (to a cure?) — stem-cell tourism and lessons for gene editing, n engl j med 2016; 374:901-903 16 murdoch, c.e. and scott, c.t. (2010) stem cell tourism and the power of hope, american journal of bioethics, 10, 5, 16–23. 17 see supra note 15. 18 cohen, c.b. and cohen, p.j. (2010) international stem cell tourism and the need for effective regulation. part 2, developing sound oversight measures and effective patients support, kennedy institute of ethics journal, 20, 3, 207–30. 19 patra pk, sleeboom-faulkner m. bionetworking: between guidelines and practice in stem cell therapy enterprise in india. (2010) 7:2 scripted 295, http://www.law.ed.ac.uk/ahrc/script-ed/vol7-2/patra.asp 20 see supra note 12. 21 international society for stem cell research. 2008. guidelines for clinical translation of scs. available at: http://www.isscr.org/clinical trans/pdfs/isscrglclinicaltrans.pdf 22 olle lindvall and insoo hyun, medical innovation versus stem cell tourism, science 324, 1664 (2009) http://www.law.ed.ac.uk/ahrc/script-ed/vol7-2/patra.asp http://www.isscr.org/clinical%20trans/pdfs/isscrglclinicaltrans.pdf bolzon, wit, voices in bioethics, vol. 1 (2014-15) * julia bolzon is pursuing a master’s in philosophy, theology, and bioethics at the john paul ii institute for studies in marriage and family in washington, d.c. © 2015 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. wit julia bolzon* . keywords: bioethics, end-of-life care, philosophy, wit introduction i watched wit this past summer out of my interest in how film can be used to explore bioethical themes, and have not stopped thinking about it since. starring emma thompson as professor vivian bearing, who undergoes experimental treatment for stage four metastatic ovarian cancer, the 2001 film is based on the 1998 play by margaret edson.1 i discovered it in the anthologies bioethics at the movies(2009) and the picture of health: medical ethics and movies (2011), featured for its portrayal of the patient-physician relationship and the drama over the patient’s ‘do not resuscitate’ order. but the film is so much more than these isolated matters. it treats the profound human realities of suffering, pain, and death with sublimity; realities that—when not rejected or ignored—are where man begins to receive answers to his deepest existential questions. weaving vivian’s memories with her current reality in the hospital, wit depicts the existential phenomena that occur in times of medical crisis and at the frontier of death. such universal moments, when paid attention to, become pedagogic —teaching us something about what it means to be human. analysis a. dependency and need an overarching theme of the film is its portrayal of the human condition in a state of utter dependency and need. by chronicling vivian’s experimental treatment through first-person narrative, the film offers a window into the world of a patient suffering and dying of cancer a reality that remains unknown except through personal experience. vivian’s condition, however, is not limited to those who suffer with cancer, but instead becomes a lens through which the condition of the suffering patient can be explored and identified with. there are multiple moments where vivian’s mounting fears are too much for her to bear, and amidst her anxiety she reaches out for human presence by calling for her nurse, susie. like a child who is afraid of being left alone, vivian seeks reassurance that she is not going to be abandoned in her confrontation with death: “susie? … you’re still going to take care of me, aren’t you?” this is illustrative of the extent to which dying is deeply intertwined with the desire for presence – the longing for a ‘being-with’ – and also with the ability on the behalf of another to exhibit com-passion (to suffer with). as vivian descends into more frequent episodes of extreme pain, she appears to be almost alien – no longer looks ‘alive’ or human but instead writhes in pain – kept in isolation and effectively forced by her physician, dr. kelekian, to continue doing the full dose of treatment. the argument between dr. kelekian and susie over treating vivian’s pain reveals our varying attitudes to pain-relief in end-of-life care,2 but also offers a heightened example of what the patient in such a condition may need. kelekian and his resident jason are portrayed as indifferent to her pain, whereas susie is bolzon, wit, voices in bioethics, vol. 1 (2014-15) 2 keenly aware and concerned about how her pain is “killing her.” by not identifying with vivian’s pain, the doctors avoid both communicating with her and being in her presence as she undergoes her pain. the fear of being abandoned, which vivian experiences deeply, expresses a still-deeper desire that exists for a contact that is person-to-person: an experience of intimacy, belonging, or love that we can only have through the face of another, in the eyes of another, or in the arms of another.3 this desire is heightened in the moments of pain, suffering, and fear that accompany dying. b. the gift of the dying person wit is ultimately about a woman on her deathbed. yet the film’s unique treatment of the process of dying has much to offer bioethics—that is, how to respond to someone who is dying, and also what there is to receive from a dying person. in a work entitled the gift of the dying person, ruth ashfield notes that the dying person “is a visible reminder … [of] the deepest questions of meaning hidden in every moment of suffering,” which we often avoid or struggle to face.4 yet in paying attention to the dying, choosing to stay and suffer-with them, there is something to be learned, as demonstrated by susie. she does not remain unaffected by having to care for vivian, allowing herself to enter in to vivian’s life: first her life as a scholar ripped from her work and confined to treatment, and slowly into her suffering and pain, sharing moments with her, like their conversation over popsicles, or the moment of joy and laughter over ‘soporific.’ they are small, simple gestures; yet they speak volumes in terms of responding to vivian’s loneliness and craving for company. in front of the mystery of suffering, and the mystery of death, susie “accept[s] the opportunity to face the same deep questions of meaning … allowing [her] own need to search for the foundation of life to be reawakened.”5 in her conversation with jason over donne’s “salvation anxiety,” she wonders: “what happens in the end? … does [donne] ever get it? … do you ever get to solve the puzzle?” here we see her attempt to face the thick and weighty questions of life and death, and the meaning that they bear, especially in the presence of a dying patient. in contrast, jason’s response is to “forget all about that sentimental stuff,” because thinking about the meaning-of-life all the time would make you go nuts. but what does such an attitude towards death and pain result in when it comes to treating his patients; one that steps back and chooses “not to think about it” rather than entering into and suffering-with? unlike susie’s struggle to make sense of what happened to vivian, jason remains detached from what vivian undergoes, so much so that there is a distinct depersonalization during most of his visits with her. in jason we see the drive for ‘knowledge’—a wish that all patients would “go full throttle”—culminating in the horrific final scene where he attempts to resuscitate vivian’s dead body, in defiance of her code status. c. metaphysics, mystery, and art a final layer to the film’s pertinence to bioethics is the very way in which it portrays the realities of death and suffering: through art. the mysteries of suffering and death contain an essentially metaphysical nature, and as such, they are not realities that can be dissected, calculated, or solved. rather, one can explore their meaning through a medium that requires contemplation and imagination, as the film does through the motif of poetry. this is exemplified through having the protagonist be a scholar of john donne’s metaphysical poetry, who “explored mortality in greater depth than any other body of work in the english language.” through the use of symbolism, allegory, and poetry, wit conveys a certain reverence and awe towards the mystery of death: that it is not a problem to be conquered or eradicated (“acted out on a stage”), but embraced as a passage – albeit an inexplicable one into ‘life everlasting’.6 d. a fitting gesture and yet, what does one say to someone who is dying? what does one do? an aversion accompanies being at death’s bedside; “there is something intolerable about pain and suffering when we cannot cure the person. no one wants to be with people in pain, unless they can do something to alleviate the pain.”7 in the film’s penultimate scene, we are offered a thread of beauty and hope—a way of being with the dying that does not reduce or undermine their condition, but responds to it fittingly. after an entire eight months with no visitors, making her way down the wing is the elderly e.m. ashford, who sees vivian in her irreparable state. ashford coos over vivian like a mother soothing her crying baby, and in a gesture full of meaning and sympathy, she gently climbs into vivian’s bed and holds her, letting her cry onto her, simply repeating her name in an attempt to comfort. this is all one can offer, their mere presence, as a gesture of love.8 bolzon, wit, voices in bioethics, vol. 1 (2014-15) 3 conclusion at the end of life, we are brought back to simplicity, vulnerability, and a child-likeness that can only be responded to with tenderness. in some mysterious way, ashford’s reading of the runaway bunny captures vivian’s return to being like a child: vulnerable, dependent, and needy. this return to a child-like condition is alluded to halfway during her treatment, where vivian reminisces on the exact moment she knew words would be her life’s work. vivian is depicted as physically returning to being a child, in her hospital gown, bald-headed, huddling over the same book like when she was a little girl and struggling to read the words. this memory serves as harbinger of the return to our original condition of dependency at the end of life, a condition of being in relation to others that we never really exit from. as the final scene fades out with vivian’s voice reciting death, be not proud, the total effect of the film leaves an impression of the meaning of life and death, past and present that remains long after the final scene has ended. 1 many of the film’s artistic merits that i discuss are due to edson’s play. 2 jason is adamant that she’s “tough,” “she can take it,” and kelekian says that ordinarily, they would give the patient control of their pain management, but in vivian’s case no. margaret somerville explores attitudes to pain and pain-relief in her book death talk, revealing that there can exist a tone against pain-relief for various reasons – that patients are “complainers,” fear of their becoming “addicted” to morphine, or a general indifference to suffering. c.f. somerville, margaret. death talk: the case against euthanasia and physician-assisted suicide.mcgill-queen’s university press. 2001. 218-223. 3 a story i read recently depicts a patient dying of cancer in an isolation room, screaming of pain, whom the nurses avoided because there was nothing left for them to do, as much as they wanted to help. the visiting chaplain entered her room, got down on his knees, and started screaming with her, holding her hand: “she screamed, “oh god!” and he screamed, “oh god, help her! help her!” at least she knew that someone was praying with her. … at a certain point she changed from “why, oh why, god? oh, stop, stop!” into “i offer, i offer, i offer it!” in the last moments of her life, despair became hope.” see: lynch, jonah and michelle k. borras. technology and the new evangelization: criteria for discernment.2012.http://www.kofc.org/un/en/resources/cis/cis419.pdf 4 ashfield, ruth. the gift of the dying person.communio international catholic review. volume 39. fall 2012. 381. http://www.communio-icr.com/files/ashfield39-3.pdf 5 ibid, 393-94. 6 another example is how the presence of suffering is symbolized by the renaissance icon of the martyr st. sebastian: painfully depicting him tied to a post and shot full of arrows. sitting on vivian’s bedside, it is the only thing of colour in her hospital room, and we see it almost floating in the background as she first muses on her cancerous condition. it is actually a miniature version of the life-size one hanging on the wall of her mentor’s office, which we see fill the background when e.m. ashford is lecturing vivian on the meaning of death, be not proud. the repeated presence in the film is a reminder of the inherence of suffering to life. 7 quote from jean vanier, a man who devoted his life to being with the vulnerable, weak, and those who suffer in the form of physical disabilities. the full quote reads: “there is something intolerable about pain and suffering when we cannot cure the person. no one wants to be with people in pain, unless they can do something to alleviate the pain... when all is said and done, in l'arche there are no cures. what people need when all the therapy has been tried is a friend who is faithful, who stands by them, a loving milieu where they are respected as full human beings....” vanier, jean. letter to my brothers and sisters in l’arche, 1996. 8 “even when we feel that we can do absolutely nothing, we will still have to be prepared to stay. ‘watch with me’ means above all, just ‘be there.’ … there is a response to the “why?” of suffering, and it is a response not of words or explanations, but of presence” ashfield, 388. http://www.kofc.org/un/en/resources/cis/cis419.pdf http://www.communio-icr.com/files/ashfield39-3.pdf chase, ethics of ai, voices in bioethics, vol. 6 (2020) * alyse callaway chase, rn, msn, columbia school of nursing. © 2020 alyse callaway chase. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethics of a.i.: perpetuating racial inequalities in healthcare delivery and patient outcomes alyse callaway chase* abstract ai is increasingly being utilized in healthcare settings to improve patient outcomes by using big data to inform clinical decision making. like in many industries outside of healthcare, ai has the potential to revolutionize the current healthcare delivery system. the technological paradigm shift creates concerns with the gender and racial inequalities that these advancements may perpetuate. keywords: ai, racism, medical technology, bioethics, algorithm introduction disproportionately high rates of mortality and severe disease experienced by african americans during this covid-19 pandemic have been reported by the centers for disease control and prevention (cdc). initial characteristic data from 14 states identified 18 percent of overall covid-19 patients and 33 percent of all those hospitalized from march 1 to march 28 as black.1 however, this report is missing data from the majority of states. policymakers and medical experts have called for states and cities to provide greater transparency and more demographic data on patients’ racial and ethnic profiles.2 the covid-19 racial disparity highlights a growing problem: artificial intelligence (ai) may play a role in deepening racial health disparities in this country. ai is increasingly being utilized in healthcare settings to improve patient outcomes by using big data to inform clinical decision making. like in many industries outside of healthcare, ai has the potential to revolutionize the current healthcare delivery system. the technological paradigm shift creates concerns with the gender and racial inequalities that these advancements may perpetuate. specifically, i am troubled by the lack of oversight in formulating the algorithms used in ai and the sources and quality of the data sets. this essay focuses on the potential of ai to further entrench racial disparities in healthcare delivery and patient outcomes throughout healthcare institutions in this country. analysis racial biases have historically pervaded medical education and research institutions and are perpetuated by systemic racism. however, there is a shift toward improving “structural competency” to include social and chase, ethics of ai, voices in bioethics, vol. 6 (2020) 2 economic influences on healthcare decision making in an effort to broaden our approach to race and culture; this should be extended to the development of ai applications in healthcare. racial biases have impacted medical treatment and research as well as the code formulation for predictor algorithms already being used in health systems. understanding the biases that would skew ai, like narrow, unrepresentative data with a lack of female and minority research participants, should be important to all stakeholders. the significant consequences and risks of systemic racism in medicine are often overlooked. for example, most commercial spirometers, the tool used to assess lung capacity and diagnose respiratory diseases, have “race correction” built into their software. this demonstrates the fraught history of racism in healthcare and unconscious bias in modern healthcare delivery. thomas jefferson, in the slavery-based republic, was the first to speculate about racial differences in lung capacity. samuel cartwright, who in addition to being a physician, was a plantation owner and slaveholder, built his own spirometer with the support of thomas jefferson. benjamin gould, also supported by thomas jefferson, performed a large anthropometric survey during the civil war and dedicated an entire chapter to lung capacity of soldiers in the civil war based on their race. gould’s analysis took no other factors into consideration, but like cartwright found that “whites” had higher lung capacities than “full blacks.”3 fast forward to the late 20th century, to an asbestos lawsuit in baltimore in 1999. the attorney for the defendant, an asbestos manufacturer, requested that “race correction” be applied before compensation be sought for a black plaintiff. medical textbooks perpetuated this falsehood, citing an innate difference in lung capacity and function based on race. considering these examples of institutionalized racism in the history of healthcare it becomes clear that ai systems, i.e., algorithms are built on large quantities of data which inherently may contain less overt institutionalized racism and could therefore perpetuate racial bias. “objective” computational methods can easily provide a false sense of partiality for practice standards.4 an article by obermeyer et al. in science titled “dissecting racial bias in an algorithm used to manage the health of populations,” found that the algorithm for a widely used risk assessment tool was significantly racially biased. this commercial algorithm, though unnamed in the study, is used by many health systems throughout the united states. it identifies patients who have complex medical needs for “high-risk care management” programs. the ultimate goal is to allocate resources in a cost-effective manner. this algorithm is often deemed by health systems as “the cornerstone of population health management efforts…improving outcomes and satisfaction while reducing costs.” many health systems rely on it to identify individuals who will benefit most from additional medical resources.5 the researchers found that at a certain risk score, black patients are considerably sicker than white patients, and when correcting for this disparity, the number of black patients identified as needing extra care would increase from 17.7 percent to 46.5 percent. obermeyer and colleagues examined the inputs and outputs of the algorithm as well as the outcome data. they investigated how the algorithm was formed to ultimately reveal the mechanism that caused the racial disparity embedded in this risk assessment tool. the central flaw perpetuating racial disparities in this algorithm was found to be what is known in data science as the “problem formulation” (which in this case, equates healthcare costs to health care needs). black patients spend less on healthcare due to structural barriers, discrimination, and distrust, all of which are well-documented issues. therefore, the use of healthcare cost to predict healthcare needs in the algorithm perpetuates racial disparity. relying on the algorithm to determine necessary care leads to black patients receiving fewer services. the algorithm has a circular component: black people forgoing necessary care in the past is used to predict they need less care in the present or future. obermeyer et al. used different predictor variables which diminished the disparity. the unnamed manufacturer said it would chase, ethics of ai, voices in bioethics, vol. 6 (2020) 3 consider this finding in future rounds of algorithm development. this research shows that the use of ai presents serious ethical breaches. the research was made possible because researchers had access to how the algorithm was formed. the algorithm “black box” relies on quality representative data and accurate predictor variables.6 conclusion it is imperative that the quality of data is representative of the actual population and takes into account the multitude of factors that contribute to, and significantly impact, health outcomes. while we will need counter-bias algorithm tests to correct for subtle systemic discrimination, we also need greater emphasis and training on institutionalized racism in medicine. ai as a tool could deepen and perpetuate racial bias if racial historical contexts are not considered in the construction and testing of the algorithms.7 data sets must include minority and marginalized populations with attention to historical biases as well. lastly, a concerted effort must be made to increase the diversity of ai engineers so the tools being developed do not merely represent the backgrounds and needs of select groups. this new frontier of ai in health care demands even greater regulatory oversight and concerted efforts to address the issues of implicit biases. 1 garg, shikha, lindsay kim, michael whitaker, alissa o’halloran, charisse cummings, rachel holstein, mila prill, et al. hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019 — covid-net, 14 states, march 1–30, 2020. center for disease control and prevention (epublished: april 8 2020). 2 eligon, john, audra burch, dionne searcey, and richard oppel. "black americans face alarming rates of coronavirus infections in some states." new york times, april 7 2020. https://www.nytimes.com/2020/04/07/us/coronavirus-race.html. 3 lujan, heidi l., and stephen e. dicarlo. "science reflects history as society influences science: brief history of “race,” “race correction,” and the spirometer." advances in physiology education 42, no. 2 (2018): 163-65. https://doi.org/10.1152/advan.00196.2017. https://journals.physiology.org/doi/abs/10.1152/advan.00196.2017. 4 yu, kun-hsing, and isaac kohane. "framing the challenges of artificial intelligence in medicine." [in eng]. bmj qual saf 28, no. 3 (mar 2019): 238-41. https://doi.org/10.1136/bmjqs-2018-008551. 5 obermeyer, ziad, brian powers, christine vogeli, and sendhil mullainathan. "dissecting racial bias in an algorithm used to manage the health of populations." science 366, no. 6464 (2019): 447-53. https://doi.org/10.1126/science.aax2342. https://science.sciencemag.org/content/sci/366/6464/447.full.pdf. 6 obermeyer, ziad, brian powers, christine vogeli, and sendhil mullainathan. "dissecting racial bias in an algorithm used to manage the health of populations." science 366, no. 6464 (2019): 447-53. https://doi.org/10.1126/science.aax2342. https://science.sciencemag.org/content/sci/366/6464/447.full.pdf. 7 khullar, dhruv. "a.i. could worsen health disparities." new york times, jauary 3 2019. https://www.nytimes.com/2019/01/31/opinion/ai-bias-healthcare.html. https://www.nytimes.com/2020/04/07/us/coronavirus-race.html. https://doi.org/10.1152/advan.00196.2017. https://journals.physiology.org/doi/abs/10.1152/advan.00196.2017. https://doi.org/10.1136/bmjqs-2018-008551. https://doi.org/10.1126/science.aax2342. https://science.sciencemag.org/content/sci/366/6464/447.full.pdf. https://doi.org/10.1126/science.aax2342. https://science.sciencemag.org/content/sci/366/6464/447.full.pdf. https://www.nytimes.com/2019/01/31/opinion/ai-bias-healthcare.html. gumer, a new frontier in the fight against cancer, voices in bioethics, vol. 4 (2018) * jennifer mara gumer, ms, jd © 2018 jennifer mara gumer. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a new frontier in the fight against cancer (that is, for those who can afford it): the approval and cost of cart-t-cell therapies jennifer mara gumer keywords: cancer, gene therapy, car-t, kymriah,yescarta introduction the food and drug administration (fda) made history this fall with its approval of novartis’s kymriah and gilead’s yescarta—the first gene therapies to ever be approved in the united states.1,2 both treatments belong to a new class of cancer therapeutics called car t-cell treatments, which use patients’ own immune cells to fight cancer.1,2 these approvals may therefore mark the dawn of a new day for both gene therapy and the treatment of cancer. analysis the manufacture of car t-cell treatments begins with the collection of t-cells, a type of white bloods cells, from a patient.3 these cells are then genetically modified using a viral vector to express a protein known as chimeric antigen receptor (i.e., car). once injected back into the patient, car causes the t-cells to seek and destroy cancer cells, combating the disease with seemingly unprecedented efficiency.3 kymriah, for example, caused 83% of 63 juvenile clinical trial subjects with a certain type of leukemia to go into remission within three months of receiving treatment.[1] yescarta showed similar promise in clinical trials by sending 51% of the 100 adult subjects with b-cell lymphoma into complete remission.2 because these treatments must only be administered once, many see these drugs not as cancer treatments, but as cancer cures—a paradigmatic shift in the fight against cancer. both drugs, however, are not without their serious side effects. for instance, both treatments can induce cytokine release syndrome (crs), an immune system response to the presence of car t-cells that can cause high fever, flu-like symptoms, and potentially life-threatening neurological events.1,2 other serious side effects include: infection, hypotension, kidney damage, and hypoxia.1,2 given these significant risks, the fda approved both kymriah and yescarta pursuant to a risk evaluation mitigation strategy (rems), which, among other things, requires hospitals and clinics to obtain special certification in order to dispense these drugs.1,2 to become certified, personnel must undergo training to recognize and treat crs and hospitals and clinics must have the appropriate medications to treat crs on hand.1,2 furthermore, due to their associated risks, both treatments are approved only as a drug of last resort (i.e., after all other treatments have failed).1,2 by taking steps to reduce the risks associated with these uniquely effective treatments, the fda seems to have appropriately accounted for the bioethical principles of nonmaleficence and beneficence. however, given their exorbitant costs, these drugs do pose some concerns for the bioethical principle of justice. gumer, a new frontier in the fight against cancer, voices in bioethics, vol. 4 (2018) 2 kymriah is currently sold by novartis for $457,000, while yescarta is available for the slightly less eye-popping price of $373,000.4,5 moreover, because these drugs will be available only at certified institutions, many will have to incur travel costs to gain access to these treatments. the hefty costs associated with these drugs have further stoked the uproar against rising drug prices.4 specifically, some fear that, given the efficacy of these drugs, cancer will someday be a disease reserved only for the poor.4 such an outcome would for obvious reasons exacerbate the already problematic opportunity gaps that plague our country. manufacturers of these drugs, however, attempt to justify high prices by pointing to the fact that these drugs effectively constitute cancer cures.4,5 consequently, patients must only pay once for these drugs instead of multiple times over the course of several years as with traditional treatments. this justification, however, is made slightly less persuasive by the fact that these drugs are approved only as a last line of defense. as such, patients must endure costly treatment regimens before they’re asked to shell out almost half a million dollars for car t-cell therapies. novartis, however, has said that it will only charge patients who respond to kymriah within a month of receiving treatment; the company is currently working with the centers for medicare and medicaid services to design a payment plan to that effect.6 novartis has also stated that it “will offer an access program in the u.s. for eligible uninsured and underinsured patients” while “payers are developing their payment policies” for the drug.6 gilead has yet to make similar announcements regarding yescarta. debates regarding the costs of gene therapies are likely to heat up as more treatments of this kind are approved. other drug companies also developing gene therapies have already indicated that their products, if approved, will carry similarly high price tags.4 these companies, however, likewise justify the high costs. they claim that the prices are warranted given that these therapies: 1) can offer a cure for otherwise intractable conditions and 2) often target rare conditions and must therefore be priced highly in order to draw a profit.4 it is possible, however, that, as with any technology, the price of these treatments will drop over time. that may be particularly true if crispr-cas9, the most costeffective gene-editing technique discovered to-date, eventually replaces viral vectors as the primary means for creating gene therapies. also, insurers are discussing ways to devise alternative payment models for gene therapies such as paying for a treatment over time, the establishment of insurer risk pools, and the potential financing of one time payments.6 conclusion how all this will play out remains to be seen, but pharmaceutical companies and policymakers must take the appropriate steps to ensure that these promising new therapies don’t ultimately lead to the ghettoization of cancer and other genetic diseases. 1 fda news release, fda approval brings first gene therapy to the united states, (aug. 30, 2017), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm574058.htm. 2 fda news release, fda approves car-t cell therapy to treat adults with certain types of large b-cell lymphoma, (oct. 18, 2017), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm581216.htm. 3 national cancer institute, car t cells: engineering patient’s immune cells to treat their cancers, (aug. 31, 2017), https://www.cancer.gov/about-cancer/treatment/research/car-t-cells. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm574058.htm https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm581216.htm https://www.cancer.gov/about-cancer/treatment/research/car-t-cells gumer, a new frontier in the fight against cancer, voices in bioethics, vol. 4 (2018) 3 4 gina kolata, new gene-therapy treatments will carry whopping price tags, new york times (sept. 11, 2017), https://www.nytimes.com/2017/09/11/health/cost-gene-therapy-drugs.html. 5 toni clark and bill berkot, fda approves gilead cancer gene therapy; price set at $375,000, reuters (oct. 18, 2017), https://www.reuters.com/article/us-gilead-sciences-fda/fda-approves-gilead-cancer-gene-therapy-price-set-at373000-iduskbn1cn35h. 6 arlene weintrab, how to cover novartis’ $475k car-t drug kymirah? a’new payment model’ is the only way, express scripts says, (sept. 22, 2017), https://www.fiercepharma.com/financials/car-t-and-other-gene-therapies-need-new-payment-modelsays-express-scripts. https://www.nytimes.com/2017/09/11/health/cost-gene-therapy-drugs.html https://www.reuters.com/article/us-gilead-sciences-fda/fda-approves-gilead-cancer-gene-therapy-price-set-at-373000-iduskbn1cn35h https://www.reuters.com/article/us-gilead-sciences-fda/fda-approves-gilead-cancer-gene-therapy-price-set-at-373000-iduskbn1cn35h https://www.fiercepharma.com/financials/car-t-and-other-gene-therapies-need-new-payment-model-says-express-scripts https://www.fiercepharma.com/financials/car-t-and-other-gene-therapies-need-new-payment-model-says-express-scripts keywords: cancer, gene therapy, car-t, kymriah,yescarta introduction analysis conclusion weisberg, no animals were harmed, voices in bioethics, vol. 2 (2016) © 2016 edmund weisberg. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. no animals were harmed in the making of this veal edmund weisberg keywords: animal rights, food ethics, environmental ethics introduction i was raised on a conventional jewish-american meatand potato-based diet during my first two decades. in response to an emerging awareness of health risks related to my typical fare and exposure to alternative diets and, occasionally, the philosophies or dicta such as the feminism-rooted “the personal is political” supporting them, i embraced pescetarianism or pesce-vegetarianism/semi-vegetarianism in my twenties. in the ensuing years, as i’ve contemplated the implications for the broader food system and global environment of our food choices, i’m led to wonder whether more far-reaching and even universal changes in dietary practices are needed for the health and preservation of humanity, other species, and the planet. analysis a. something fishy here our tastes are affected by genetics, culture, and environment, which are all impacted by larger political forces. we may absorb these varied influences and arrive at a conscientious approach to reacting to, rejecting, or accepting the conventional dietary standards of our culture. but even after considerable or through incessant deliberation or debate over the merits of dietary components, one’s culinary choices may appear to be the result of somewhat muddled thinking. that is, although the human species is purportedly distinguished by our ability to reason, we show great capacity for irrationality and inconsistency. seventeenth century french philosopher rené descartes is perhaps best known for the dictum “cogito ergo sum” (“i think, therefore i am”). in other words, one might charge that my dietary patterns are more the result of rationalization than cogent rational decisions. i eat fish, but no beef, pork, poultry or any other flesh, as i do not want to contribute to the industrialized cruelty exhibited by modern factory farming. is my drawing the line speciesistic or hypocritical? is it even intelligible? one classic defense for eating fish but no other meat is that fish (and crustaceans) do not feel pain. it is an argument that once held sway with me. but as david de grazia has contended, this claim appears dubious, as fish and some invertebrates have been shown to react with aversion to painful stimuli. pete singer and tom regan’s arguments against the suffering of animals and in defense of animal rights are also compelling to me and strike me as applicable to all animals. james rachels is also quite convincing in his “the basic argument for vegetarianism” in finding the reasons cited to justify the harming of animals as insufficient. their cases are founded on the base brutality of modern factory farming practices. my decision to include fish in my diet, however, was arrived at more inductively, and intuitively, than deductively and was more of a reaction against the inhumanity and abominable restriction of liberty weisberg, no animals were harmed, voices in bioethics, vol. 2 (2016) 2 associated with factory farming and confined animal feeding operations (cafos). while the actual suffering of livestock animals greatly distresses me, it is the greater freedom of fish and awareness of the health benefits of consuming some fish that have most impelled my choice to continue eating nonmammalian creatures of the sea. nevertheless, i am concerned about the decline of certain fish species and prefer to eat fish that are sustainably harvested. b. where’s the beef? perhaps more important on a larger scale than what i’ve chosen to include in my diet is what i’ve excluded. i stopped eating beef, then pork and poultry, in my early twenties. while i do not shrilly react to friends and family who may eat cow meat in front of me, my sentiments are decidedly against the consumption of beef, in particular. i find the savage treatment of all livestock animals in factory farms to be abhorrent across the board, but the cattle and dairy industries deserve special mention because the impact of dairy farms and cafos that slaughter cows for beef are disproportionately contributing to the greatest existential threat to humanity and the planet—global climate change. in addition to the harsh and unnatural physical treatment that cows endure in both the dairy and cattle industries simply in terms of confinement and well-documented abuse, gross inefficiencies, inequities, and health-threatening practices are introduced into the life cycles of these animals that ultimately pose serious risks to human beings (carnivore or not, and well beyond creutzfeldt–jakob disease) and the planet. to produce one pound of beef, it takes anywhere from seven to sixteen pounds of grain, which would be better used to feed the nearly one billion hungry people on the planet. waste, if produced in the pasture, would recycle and fertilize the grasses. instead, the sheer volume of excrement produced in dairy and beef operations poses significant environmental pollution, including run-off into rivers used for drinking water. in terms of reducing greenhouse gas emissions that contribute to and accelerate global climate change, a 20 percent reduction in beef consumption alone has been estimated to be the equivalent of exchanging all cars and trucks for priuses (robbins 2012). roger scruton is no vegetarian. but he acknowledges the indignities and cruelties of what he terms “battery” farming of livestock and would like to see it end. his solution, though, is not to refrain from eating meat but to condone humane animal husbandry and smaller-scale family farm operations that allow for merciful stewardship of the animals until they are killed, humanely, for food and without the attendant terror recorded in undercover footage in documentary films such as food, inc. scruton would endorse, then, the “family owned, multi-generational, pasture-based, beyond organic, local-market farm” of joel and teresa salatin of virginia (polyface, inc.), and bill and nicolette niman (the niman ranch), as such humane practices are their stock in trade. becoming a “conscientious carnivore” is scruton’s suggestion, claiming that it is a duty of meat-eaters to “eat our friends,” or, in other words, to provide a humane alternative to the battery cages of factory farms. he theorizes that such practices, which folks should understand would cost more at first, could morph into a movement that would bring about the end of the factory farm. coff and the economist writers would certainly disagree (coff 2006; the economist 2006) taking a more cynical, jaded tack, they minimize the potential clout of consumers, contending that the shopping cart is no match for the ballot box. coff does concede that consumer activism can get corporate manufacturers to budge, though. john robbins notes several examples related to chocolate, with ben & jerry’s committing to using only fair trade certified cocoa, and the united kingdom’s cadbury dairy milk ensuring that all of its chocolate is fair trade certified (robbins 2012). but robbins suggests that a consumer movement that displaces cattle from confinement to pasture in the vast stretches of the american west would still confer substantial environmental burdens. he cites brazil and amazonian deforestation, eighty percent of which is ascribed to free-range, grass-fed cattle ranching. in addition, he notes that the remaining 20 percent of amazon deforestation is attributed to weisberg, no animals were harmed, voices in bioethics, vol. 2 (2016) 3 land use for soy farming not for human consumption but animal feed shipped to china (robbins 2012). c. got antibiotics? nevertheless, factory farming is a more insidious scourge. dairy cows are plied with genetically engineered growth hormones (banned in canada, much of the european union, australia, and new zealand) and antibiotics, and fed grains—often subsidized gmo corn—rather than the grasses on which they would normally graze (robbins 2012). their male offspring are often summarily killed or crated off to become veal. the steady diet of antibiotics for bovines—whether for dairy cows prone to udder infections due partly to induced overproduction as well as the use of bovine growth hormone itself or for beef cattle to help fight infections much more likely to occur because of cramped living quarters—more so than the overprescribed use in humans is responsible for drastically elevating the risk of engendering antibiotic-resistant bacteria. feeding corn to cows also acidifies the ph-neutral digestive tracts of the bovine, creating an environment much more like the acidic human digestive tract and inuring microbes (e.g., e. coli) previously adapted to ph-neutral environments to survive in acidic ones. the threat of antibiotic resistance is grave and imminent, according to the uk’s equivalent to the us surgeon general, dame sally davies, who exhorted in january 2013 that an “antibiotic apocalypse” is looming and it is on a par with the peril associated with global climate change (lallanilla 2013). this announcement came just six months after the world health organization (who) director-general margaret chan referred to a “global crisis in antibiotics” (culp-ressler 2013). d. bringing bees to their knees? antibiotics aren’t the only chemicals penetrating and endangering multiple parts of the food chain. colony collapse disorder (ccd) has been described over the last eight years as a mysterious dying off of pollinators, particularly honey bees, in the us and europe. this is a key thread in the intricate global food web because honey bees (and some other insects) pollinate the majority of the world’s agricultural crops (i.e., fruits, vegetables, nuts, and seeds). although it took a few years for investigators to identify the etiologic pathway of the bee die-off, it has recently been ascertained that the introduction of the now widely used class of pesticides known as neonicotinoids are largely responsible for ccd, in addition to the effects of climate change, food resource loss in over-farmed (likely monoculture) landscapes, and the dispersal or unintended introduction of foreign species and diseases (chamberlain 2013a). the somewhat encouraging news on this front is that the european union has enacted what is essentially a two-year moratorium on the use of neonicotinoids across the continent (chamberlain 2013b). it should be interesting to see if the former colonies across the pond respond in kind after data gathering is completed. bees, and other pollinators, are thought to be responsible for fertilizing about one-third of the world’s crops, representing $15 billion worth of crops in the us alone (natural resources defense council 2011). roughly half of my diet is composed of foods that may be traced to these vital pollinators. e. uncle sam knows best? the ancient greek philosopher socrates is known for, among much else, issuing the admonition “the unexamined life is not worth living.” it may not be worth living, but an unexamined life is far less exhausting. but, if one concludes through the course of examining one’s life and the countless ways in which one’s life is sustained that conscientious food consumption is imperative, such a course may feel eminently more rewarding, serving as an evolving guide through life’s various ethical and health choices. socrates, as recorded by plato, may have known best. but does the billion-dollar beef industry? after weisberg, no animals were harmed, voices in bioethics, vol. 2 (2016) 4 oprah winfrey won a high-profile lawsuit with big beef, which had a big beef with the billionaire and her guest, former cattle rancher howard lyman, the talk show host might not be so sure, though she felt that free speech prevailed. but the answer is a categorical ‘yes’ if we limit ourselves to maximizing profits, which is the primary intent of any industry. knowing best for human health and the health of the planet is a far different, even diametrically opposed, proposition. as several writers have diligently documented, the decline in the quality of life for beef cattle over the last half-century has resulted from deplorable conditions better characterized as cruel confinement or concentration rather than living. it is patently clear that factory farming isn’t the answer when the question pertains to humane treatment of animals and the provision of the best quality foods, let alone meats, to the public. judging from the obesity statistics alone, if one is to fleetingly blame the victim, the american public, by and large, has difficulty making healthy food decisions. the food industry plays the role of avaricious enabler, plying the public with the cheapest-to-manufacture victuals aided and abetted by government collusion and subsidization. grassroots movements oriented toward organic sustainable farming and healthy eating have made inroads, but not enough to stem the tide of several disturbing trends for public health and the health of the planet. on a small scale, sarah conley has weighed in on the potential role of coercive paternalism related to the use of certain known vices in the food industry. she applauds the intrusion of the new york city government in banning trans-fats and laments only that the policy isn’t more broadly applied. she is dubious about a food stamp soda ban though, primarily because she thinks it would be ineffective. further, on the broader notion of soda consumption, while she acknowledges the negative health effects of drinking soda, and that everyone would be better off drinking tap water, soda is sufficiently popular that banning it outright would also be ineffective. but she supports the idea of regulations to reduce portion sizes. would an even broader coercive paternalism be appropriate to mitigate the colossal twin menaces of global climate change and antibiotic resistance, both of which are intimately related to the destructive methods employed in the modern food industries? examples might include limiting meat portions, more stringent standards for raising livestock (e.g., further reductions in the use of antibiotics, which has gained some favor in the last two years), or even banning the use of animals entirely (which would obviously antagonize a huge swath of the population). at best, the us can be said to have a spotty record with paternalism. on the positive side of the ledger, there is social security and medicare/medicaid, signed by franklin roosevelt and lyndon johnson, respectively. but unelected gerald ford pardoned the disgraced richard nixon, speaker of the house thomas p. “tip” o’neill chose “for the good of the country” not to pursue impeachment hearings of ronald reagan over the iran/contra scandal (the illegal sale of arms to embargoed iran, the funds from which were funneled to support the nicaraguan contra insurgency), and barack obama, upon taking office, opted not to hold the previous presidential administration accountable for illegal wars and the curtailment of civil liberties (only to have his administration continue down that path itself). this is all to say that the us government has given precious little recent indication that it is truly inclined to act in the best interests of its citizens or citizens of the world. the folks who may be disposed to perform such genuine public service are few and far between in the government, individuals such as presidential contender senator bernie sanders (i-vt), former congressman and presidential candidate dennis kucinich (d-oh), a vegetarian who had the temerity to call for a department of peace, and, perhaps senator elizabeth warren (d-ma), who has shown herself to be a champion of the people on the financial front. but just two years ago, legislation signed on the environmental front reinforces the widespread belief that the legislative and executive branches of the federal government cater to industry. dubbed the “monsanto protection act” by critics, a provision or rider written into the consolidated and further continuing appropriations act of 2013 by senator roy blunt (r-mo), from monsanto’s home state, stipulated that the us department of agriculture issue temporary permits allowing the continued planting of genetically modified organisms even after a court ruling finding that the usda has made mistakes in its environmental impact review of the gmo in question. president obama signed the monsanto-backed legislation five days after the senate version passed, on march 26.1 weisberg, no animals were harmed, voices in bioethics, vol. 2 (2016) 5 in theory, a coercive paternalism, one that is altruistic in nature, could achieve more meaningful reform with much greater alacrity than grassroots movements, as encouraging as some of them are (e.g., the explosive growth of farmers’ markets, much greater acceptance of vegetarianism and veganism, community supported agriculture). that is, with benevolent, truly democratic rulers in place, a transitional scheme might be set up by which people are first informed of the profoundly detrimental role that the cattle industry plays in terms of contributing to and exacerbating global climate change, not to mention poor human and bovine health and in conditions far inferior to traditional small family farms. gradually, over the course of months, not years, the industry would be phased out, perhaps segueing first to a free range grass-fed rather than confined and grain-fed regimen. in practice, i cannot conceive of the us government biting off the hand that feeds it, namely billion-dollar corporations of many stripes. in fact, corporations pull government strings, lobbying successfully for what they want (and often involved in writing the legislation through intermediaries such as the american legislative exchange council), and then playing the public off as compatriots when even a whiff of paternalistic or “nanny state” policy can be detected from the beltway and enters what passes for public discourse in this era of budget-devastated, watered-down, celebrity-focused, crisis-chasing, attention-deficit, he said/she said journalism. conclusion f. no one is an island, but are we all on “survivor”? john donne, english writer, lawyer and cleric in the late 1500s and early 1600s, once wrote, in “meditation xvii,” that “no man is an island, entire of itself; every man is a piece of the continent, a part of the main.” indeed, human beings are highly social and interdependent, with our various needs manifestly writ large in our international system of ensuring that (most) people are fed on a daily basis. as with the rampant fallibility that marks our species, innumerable inequities and unintended consequences mar the delivery and consumption of food and, worse, characterize the critical implications of maintaining what has devolved into the status quo. we may be eating ourselves to a slow, hot death. choosing what to eat remains a personal, though often public, act. at its core, government should have as little stake in this decision as it does in whom individuals choose to marry. but our private acts can often have repercussions beyond our control, affecting other people in the process. the personal, particularly one’s palate and how to satisfy it, is deeply political. that is, our actions reveal our political biases or lack thereof, which also reflects where one stands on the political spectrum. even indifference says something. i am not close to figuring out all of the dynamic reverberating effects related to all food choices. but i know that these are fundamental decisions that we make. we all have to eat. the seminal greek physician hippocrates is credited with having said, “let food be thy medicine and medicine be thy food.” the majority of us do not treat food with such respect, unfortunately, with dire consequences for our own health, the many animals in the food chain, and the state of the earth. as for my relationship with food, i expect to strive to clean up any inconsistencies that crop up between my evolving thoughts and corresponding actions and to continue to seriously contemplate my food choices for my own health and that of my family, as well as the broader ramifications of such decisions for the planet. if a groundswell of people making concerted political choices in the supermarket, or better yet, farmers’ markets emerges, public and planetary health would likely benefit. in the meantime, activism—whether focused on factory farms throughout the us, the gmos of the borderless monsanto, or child slavery on cocoa farms in ghana and ivory coast—is an essential tool to better inform fellow citizens and a key adjuvant to the relative power of the wallet to force politicians to respond to the will and needs of the majority. weisberg, no animals were harmed, voices in bioethics, vol. 2 (2016) 6 1cardinale mc. “us activists outraged over so-called ‘monsanto protection act.’” inter press service, april 28, 2013. chamberlain j. “report: deadly human-made ‘cocktail’ threatening world’s pollinators.” common dreams, april 23, 2013. available at:http://www.commondreams.org/news/2013/04/23/report-deadly-human-made-cocktail-threatening-worldspollinators. chamberlain j. a win for the bees: eu votes to ban bee-harming pesticides. common dreams, april 29, 2013. available at:http://www.commondreams.org/news/2013/04/29/win-bees-eu-votes-ban-bee-harming-pesticides. coff c. the taste for ethics: an ethic of food consumption. springer: dordrecht, the netherlands, 2006. culp-ressler t. “medical experts warn the rise of resistant bacteria will cause ‘antibiotic apocalypse.’” think progress, january 24, 2013. “ethical food, good food? if you think you can make the planet better by clever shopping, think again. you might make it worse.” the economist, december 7, 2006. “food politics: voting with your trolley. can you really change the world just by buying certain foods?” the economist, december 7, 2006. lallanilla m. antibiotic-resistant disease crisis may bring ‘apocalyptic scenario,’ uk health officer says. huffington post, january 25, 2013. natural resources defense council. “why we need bees: nature’s tiny workers put food on our tables.” march 2011. robbins j. no happy cows: dispatches from the frontlines of the food revolution. conari press: san francisco, 2012. http://www.commondreams.org/news/2013/04/23/report-deadly-human-made-cocktail-threatening-worlds-pollinators http://www.commondreams.org/news/2013/04/23/report-deadly-human-made-cocktail-threatening-worlds-pollinators http://www.commondreams.org/news/2013/04/29/win-bees-eu-votes-ban-bee-harming-pesticides introduction analysis conclusion prabakar, medical ethics in india, voices in bioethics, vol. 8 (2022) © 2022 angel prabakar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the history of medical ethics in india: looking at the past as we try to change the future angel prabakar abstract india has had a solid standard for medical ethics since the birth of ayurvedic holistic science over 5000 years ago. the country’s views on healthcare policy, counsel on how to deal with patients, and what constitutes good behavior within the profession stem from ancient outlines for medical practice. these “codes of conduct” were heavily influenced by religious and spiritual practices, emphasizing the sanctity of life and transcending the needs of the body. with time, however, medical care evolved through shifting priorities in education and governmental pressures. these once-cherished “codes of conduct” were referred to less often, while malpractice issues have steadily increased. there is a need for an open discussion of why this spike in medical malpractice is happening in a country that used to condemn it and how improving ethics, limiting the role of profits, and returning traditional philosophies to the medical ethics curricula could help. keywords: medical ethics, india, education, malpractice, government, healthcare policy, bioethics introduction currently, india has the largest number of bioethics units of any country, reflecting the importance of ethical behavior in indian society. these centers do not affiliate with schools, yet they serve as spaces for bioethical discourse. the indian psychiatric society (ips) was the first to address escalating malpractice cases. other major medical organizations (e.g., the indian medical association and the medical council of india) followed, stressing the importance of standardized ethics. some have formed symposiums and organized conferences to address these concerns. 1 there have been several calls to revisit the classic “codes of conduct” and their focus on the spiritual concept of life-death-rebirth. toward this end, modern indian doctors were reminded that physicians existed not for fortune or status but for the welfare of their patients. these altruistic teachings came from the seminal ayurvedic texts, the cornerstone of india’s modern medicine. happiness for the “healer” was to come out of showing compassion for all living beings and prolonging the precious gift of life.2 in contrast, indian novelist, shashi prabakar, medical ethics in india, voices in bioethics, vol. 8 (2022) 2 tharoor, speaking on the current state of medical practice, recently remarked: “india is not an underdeveloped country, but a highly developed one in an advanced state of decay.”3 taking a closer look at what caused the core values of an ancient healthcare system to change so drastically involves evaluating how the indian medical education system evolved. this paper examines the development of medical principles, their influence across the subcontinent, commercialization, and the government’s role in india’s healthcare instability. this paper then lists some of the measures taken by bioethical units to counteract some of the issues brought on by corruption. i. western influence western influence on medical practices came when the french, portuguese, and british arrived in india. they almost completely reinvented india’s healthcare system. medical ethics based on the values of spirituality were almost completely stripped away and replaced by western concepts. 4 established traditional ethical standards were no longer taught, resulting in less deference to traditional moral beliefs. coupled with an increase in medical misconduct, the general population lost trust in their healthcare leaders.5 before the influence of western medicine, the carakha sumhita, a millennia-old sanskrit text detailing ayurveda, helped establish healthcare guidelines. a passage from the text sums up the ethics of that time: “he who practices medicine out of compassion for all creatures, rather than for gain or for gratification of the senses, surpasses all.”6 the carakha sumhita’s focus on medical ethics was ahead of its time, centuries before bioethics became a subject in its own right. healthcare was predicated on aphorisms that all medical students internalized rather than on business models, as in many developed nations. india’s caste system, established generations ago, permeated every aspect of south asian society except for when it came to medicine. healers tended to ignore the conventions of adhering to an individual’s caste. instead, they treated patients as if they were family and incorporated elements of spirituality when dealing with patients, making ethical misconduct a rare phenomenon. this was the case for almost two centuries.7 to become practicing physicians, doctors committed to a consecration ceremony to prove their good moral standing to the people they were to serve.8 their schooling prepared them for a profession designed to “give back,” not for monetary gain. the core values taught in medical school affect the mentality doctors carry with them. the lack of ethics training may have been at fault for the underlying corruption levels that now plague the healthcare space in india. there is a 110 percent increase in the rise of medical negligence cases in india every year.9 to pinpoint why this occurred, we must look at current medical training practices and how they influence doctors of our time period. after colonization, many established core values were stripped from the medical curriculum.10 in fact, by 1998, only one medical college in india, st. john’s in bangalore, even addressed medical ethics in its curriculum.11 graduates across the country were left ill-equipped to deal with the ethical issues that cropped up once they made it into the field. as a result, they were not prepared to think through consequences pertaining to patients and their families. some suggest that the curriculum changes were linked to rising malpractice cases. “when society at large is corrupt and unethical, how can you expect doctors to be honest?” 12 this topic arises regularly in bioethics discussions and the answer lies in education. reverting to a system of medicine that encourages students to recognize ethical consequences can solve many of the ethical problems in contemporary society. prabakar, medical ethics in india, voices in bioethics, vol. 8 (2022) 3 ii. privatization and tuition some argue that the global increase in capitalism caused the subcontinent’s ethical problems, that the indian medical education system began its descent into corruption and nepotism, and its loss in prestige, with the privatization of their colleges.13 in india, just over 50 percent of medical schools are public, and just under 50 percent are private. 14 through changing policies, private medical schools became increasingly for-profit like other businesses.15 despite having more medical schools than any other country, india has a shortage of doctors, primarily due to low enrollment rates and high university fees. while there are 202 medical schools in india, its large population means there are 5 million people per medical school.16 christian medical college, a top-ranked university in vellore, once had an acceptance rate of 0.25 percent, with only 100 seats for medical students.17 now its acceptance rate hovers around 5 percent. there has been minimal progress in making it easier to get a medical school acceptance; there is still a long way to go in equalizing access to education. india’s system for training doctors is now rife with corruption, with bribes accepted under the guise of “donations” and new curricula completely devoid of traditional indian training methods.18 nepotism in the industry has made qualifications even less significant. in 2010, 69 hospitals and medical colleges were reported for selling exam papers to students, and most employed staff lied about their clinical experience. 19 in a cheating scandal in 2013 involving several indian universities, students purchased falsified entrance exam results. not only are these students unqualified for the placements they secured, but legal action by the government did not materialize.20 dr. anand rai, a physician who had to go into protective hiding following death threats for being a whistleblower in the 2013 scandal subsequently remarked: “...the next generation of doctors is being taught to cheat and deceive before they even enter the classroom.”21 the effects of this scandal can be felt far beyond its borders india also happens to be the world’s largest exporter of doctors, with about 47,000 currently practicing in the united states.22 iii. hospital privatization with the privatization of major hospitals and the shift to a “united states” business focus, another serious problem emerged. in the recent past, patients hailing from rural villages and often living in poverty could access quality health care from public hospitals. they had access to highly trained doctors, and all costs were usually fully subsidized.23 this was in keeping with the old tradition that believed in aid no matter the circumstance. as the focus shifted towards maximizing profitability, these opportunities for poor patients vanished. chains of private hospitals are rapidly replacing public ones. their purchasing model is to consolidate through a centralized subsidiary.24 this usually results in significant savings. instead of passing on some savings to patients through reduced pricing, any savings are used to fulfill a key objective of privatized businesses: maximize profitability. the poor now contend with inflated prices and are being turned away from facilities that once treated them at no cost, all while levels of trust in the healthcare system have plummeted. this distrust can discourage people who cannot afford care from seeking medical aid when they need it. the healthcare system has devolved to the point whereby remaining public hospitals are overrun by huge numbers of patients unable to afford the hugely inflated prices at private institutions. this, coupled with healthcare workers that often have substandard training, has created deplorable public health conditions. prabakar, medical ethics in india, voices in bioethics, vol. 8 (2022) 4 iv. corruption this deplorable public health condition reflects a failing healthcare system. to make matters worse, hospitals hire unqualified graduates untrained in medical ethics to meet india's urgent need for large numbers of qualified doctors. many hospitals have even resorted to employing corrupt doctors to counteract the physician shortage. according to the indian medical association (ima), about 45 percent of those who practice medicine in india have no formal training.25 ima also reported that close to 700,000 doctors employed at some of the biggest hospitals, who are currently diagnosing, treating, and operating, have neither the training nor experience to do so. a large-scale forgery ring, broken up in 2011, revealed that buyers could pay as little as 100 us dollars for a medical degree from a non-existent college. this “cleared” them for practice.26 it has been estimated that over 50,000 fraudulent medical degrees have been purchased in the past decade. government level corruption is widespread, as one can gain placement into medical school, “graduate” with fake degrees, and sell fake practicing licenses. v. solutions these topics, raised by bioethics centers, are now being taken more seriously by healthcare professionals taking steps to address medical misconduct. as many as five million people in india die each year due to medical negligence.27 by requiring each physician to complete a new comprehensive acute critical care course (accc), specialists estimate that physicians can reduce the rate of malpractice deaths by as much as 50 percent in rural areas.28 this intensive two-year course contains detailed training methods built off of current knowledge and walks healthcare professionals through crucial steps designed to reduce errors. even small errors, such as a poorly inserted iv for fluid or a minor surgery mishap, can be life threatening. the course thoroughly covers these as mandated.29 the accc is unfortunately not a widely spread concept in a lot of rural areas. for now, while many major hospitals continue to ignore the high rates of avoidable deaths, implementation of the accc program seems slow. the current medical council of india needs to be more effective at addressing malpractice cases, as there are so many of them.30 one possible solution to the growth of unethical business practices in medicine is to offer physicians incentives to make ethically sound decisions. this can start by increasing the number of slots available for medical students at government-run medical schools. less student debt would lead more doctors away from overbilling their patients. this is a strategy currently being employed in the state of tamil nadu, where a centrally sponsored scheme has approved the induction of an additional 3,496 mbbs seats in government colleges.31 more students studying at subsidized costs with less competition lowers the inclination toward deceit and profiteering. another incentive for ethical practice can come from accountability and transparency. the background of every doctor operating should be public information, including the rate of successful surgeries versus unsuccessful ones resulting from personal negligence. this would encourage doctors to keep a clean record and, in turn, encourage hospitals to hire and train those who will preserve or improve their reputation. this information is kept in a medical record monitored in most parts of india through a traditional paper method.32 while eliminating paper in medical recording and reverting to digital use is the ultimate aim, it will take time to implement a system that takes into account e-signatures and verifiable witnesses. prabakar, medical ethics in india, voices in bioethics, vol. 8 (2022) 5 conclusion india’s history of leadership in medical ethics has undergone some major changes. a relatively recent privatization of the education system has caused a shift in values and decimated the medical industry on many levels. the moral principles of doctors have come into question. while industry and government leaders are trying to solve the multi-faceted issues facing the medical industry, it is obvious that this is an undertaking requiring inventive solutions. prioritizing ethics in medical education, de-privatizing medical schools and hospitals, offering affordable options, and limiting corruption would improve india’s ability to offer high-quality medical care. adding traditional indian medical ethics back into the curricula would foster a workforce dedicated to serving patients over profiteering. 1 deshpande, smitan. 2016. “the unesco movement for bioethics in medical education and the indian scenario.” indian journal of psychiatry 58 (4): 359. https://doi.org/10.4103/0019-5545.196722. 2 mukherjee, ambarish, mousumi banerjee, vivekananda mandal, amritesh c. shukla, and subhash c. mandal. 2014. “modernization of ayurveda: a brief overview of indian initiatives.” natural product communications 9 (2): 1934578x1400900. https://doi.org/10.1177/1934578x1400900239. 3 2020. eubios.info. 2020. https://www.eubios.info/ej102/ej102e.htm. 4 arnold, david, ed. 2000. “western medicine in an indian environment.” cambridge university press. cambridge: cambridge university press. 2000. https://www.cambridge.org/core/books/abs/science-technology-and-medicine-in-colonial-india/westernmedicine-in-an-indian-environment/28bab761be205b06d32bc3dc972e9384. 5 kulkarni, vani, veena kulkarni, and raghav gaiha. 2019. “trust in hospitals-evidence from india.” https://repository.upenn.edu/cgi/viewcontent.cgi?article=1026&context=psc_publications. 6 bhasin, dr sanjay k. 2005 “what ails medical profession.” www.academia.edu. accessed september 17, 2022. https://www.academia.edu/7631547/what_ails_medical_profession. 7 shapiro, natasha, and urmila patel. (2006) “asian indian culture: influences and implications for health care.” https://www.molinahealthcare.com/~/media/molina/publicwebsite/pdf/providers/fl/medicaid/resource_fl_asianindianculture_i nfluencesandimplicationsforhealthcare.pdf. 8 swihart, diana l, and romaine l martin. 2021. “cultural religious competence in clinical practice.” nih.gov. statpearls publishing. 2021. https://www.ncbi.nlm.nih.gov/books/nbk493216/. 9 “india’s mighty medical education mess.” 2022. education world. july 11, 2022. https://www.educationworld.in/indias-mightymedical-education-mess/. 10 pandya, sunil. 2020. “medical education in india: past, present, and future perspectives. in sun kim, ed. medical schools nova science publishers, inc. 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(2006). every country or state needs two medical schools. croatian medical journal, 47(4), 669–672. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2080437/ 17 miglani, andrew macaskill, steve stecklow, sanjeev. 2015. “why india’s medical schools are plagued with fraud.” mint. june 17, 2015. https://www.livemint.com/politics/bdgox3sapu3qbsrmjzuk9m/why-indias-medical-schools-are-plagued-withfraud.html. 18 clark, j. 2015. “indian medical education system is broken, reuters investigation finds.” bmj 350 (jun18 3): h3324–24. https://doi.org/10.1136/bmj.h3324. 19 reuters. 2015. “special report why india’s medical schools are plagued with fraud,” june 16, 2015, sec. special reports. https://www.reuters.com/article/uk-india-medicine-education-specialrepor/special-report-why-indias-medical-schools-areplagued-with-fraud-idinkbn0ow1n520150616. 20 andrew emett. (2015) “over two dozen witnesses and suspects mysteriously die in indian cheating scandal | nationofchange.” accessed september 19, 2022. https://www.nationofchange.org/2015/07/08/over-two-dozen-witnesses-andsuspects-mysteriously-die-in-indian-cheating-scandal/. 21 (reuters 2015) 22 clark, j. 2015. “indian medical education system is broken, reuters investigation finds.” bmj 350 (jun18 3): h3324–24. https://doi.org/10.1136/bmj.h3324. 23 barik, debasis, and amit thorat. 2015. “issues of unequal access to public health in india.” frontiers in public health 3 (october). https://doi.org/10.3389/fpubh.2015.00245. 24 “investment opportunities in india’s healthcare sector.” (2021) https://www.niti.gov.in/sites/default/files/202103/investmentopportunities_healthcaresector_0.pdf. 25 clark, j. 2015. “indian medical education system is broken, reuters investigation finds.” bmj 350 (jun18 3): h3324–24. https://doi.org/10.1136/bmj.h3324. 26 “are we importing fake doctors?” (2015) www.workerscompensation.com. accessed september 19, 2022. https://www.workerscompensation.com/news_read.php?id=21672&forgot=yes. 27 boston, 677 huntington avenue, and ma 02115 +1495‑1000. 2013. “millions harmed each year from unsafe medical care.” news. september 19, 2013. https://www.hsph.harvard.edu/news/press-releases/millions-harmed-each-year-from-unsafemedical-care/. 28 “specialised course for doctors can help cut the deaths due to medical errors; experts.” 2018. dailyrounds. october 29, 2018. https://www.dailyrounds.org/blog/specialised-course-for-doctors-can-help-cut-the-deaths-due-to-medical-errors-experts/. 29 sokhal, navdeep, akshay kumar, richa aggarwal, keshav goyal, kapil dev soni, rakesh garg, ashok deorari, and ajay sharma. 2021. “acute critical care course for interns to develop competence.” the national medical journal of india 34 (3): 167–70. https://doi.org/10.25259/nmji_103_19. 30 singhania, meghna a. 2020. “how much punishment?mci formulates sentencing guidelines for cases of medical negligence.” medicaldialogues.in. february 13, 2020. https://medicaldialogues.in/news/health/mci/how-much-punishment-mciformulates-sentencing-guidelines-for-cases-of-medical-negligence-62645. https://www.marketresearch.com/netscribes-india-pvt-ltd-v3676/private-medical-colleges-india-30399614/ https://www.npr.org/2019/08/04/745182272/when-students-in-india-cant-earn-college-admission-on-merit-they-buy-their-way-i https://www.npr.org/2019/08/04/745182272/when-students-in-india-cant-earn-college-admission-on-merit-they-buy-their-way-i https://doi.org/10.1136/bmj.h3324 https://www.reuters.com/article/uk-india-medicine-education-specialrepor/special-report-why-indias-medical-schools-are-plagued-with-fraud-idinkbn0ow1n520150616 https://www.reuters.com/article/uk-india-medicine-education-specialrepor/special-report-why-indias-medical-schools-are-plagued-with-fraud-idinkbn0ow1n520150616 https://www.nationofchange.org/2015/07/08/over-two-dozen-witnesses-and-suspects-mysteriously-die-in-indian-cheating-scandal/ https://www.nationofchange.org/2015/07/08/over-two-dozen-witnesses-and-suspects-mysteriously-die-in-indian-cheating-scandal/ https://doi.org/10.1136/bmj.h3324 https://doi.org/10.3389/fpubh.2015.00245 https://www.niti.gov.in/sites/default/files/2021-03/investmentopportunities_healthcaresector_0.pdf https://www.niti.gov.in/sites/default/files/2021-03/investmentopportunities_healthcaresector_0.pdf https://doi.org/10.1136/bmj.h3324 https://www.workerscompensation.com/news_read.php?id=21672&forgot=yes https://www.hsph.harvard.edu/news/press-releases/millions-harmed-each-year-from-unsafe-medical-care/ https://www.hsph.harvard.edu/news/press-releases/millions-harmed-each-year-from-unsafe-medical-care/ https://www.dailyrounds.org/blog/specialised-course-for-doctors-can-help-cut-the-deaths-due-to-medical-errors-experts/ https://doi.org/10.25259/nmji_103_19 https://medicaldialogues.in/news/health/mci/how-much-punishment-mci-formulates-sentencing-guidelines-for-cases-of-medical-negligence-62645 https://medicaldialogues.in/news/health/mci/how-much-punishment-mci-formulates-sentencing-guidelines-for-cases-of-medical-negligence-62645 prabakar, medical ethics in india, voices in bioethics, vol. 8 (2022) 7 31 “health ministry reports 30% increase in number of functional medical colleges in five years.” (2022) www.pharmabiz.com. accessed september 19, 2022. http://www.pharmabiz.com/newsdetails.aspx?aid=152299&sid=1. 32 honavar, santosh g. 2020. “electronic medical records – the good, the bad and the ugly.” indian journal of ophthalmology 68 (3): 417. https://doi.org/10.4103/ijo.ijo_278_20. http://www.pharmabiz.com/newsdetails.aspx?aid=152299&sid=1 https://doi.org/10.4103/ijo.ijo_278_20 nair, medical malpractice in south asia, voices in bioethics, vol. 3 (2017) © 2017 kasthuri nair. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. medical malpractice in south asia: approaching bioethics with a global lens kasthuri nair keywords: asian bioethics, global ethics, medical malpractice, global health “if it is given me to save a life, all thanks. but it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. above all, i must not play at god.” – hippocratic oath modern version ("evolution of medical ethics") “…thou shalt endeavour for the relief of patients with all thy heart and soul. thou shalt not desert or injure thy patient for the sake of thy life or thy living....” charaka saṃhitā (menon and haberman 1970, 295) as the fathers of early and modern medicine respectively, charaka and hippocrates symbolize a shift in the history of global medicine from asian, specifically south asian, to western thought. as divergent as their methods in medicine may be, it is clear from the oaths delineated above that charaka and hippocrates both believe that being a doctor is an awesome responsibility and should be treated as such. yet medical malpractice is a bioethical issue that is rampant worldwide; however, the manifestation and treatment of the issue varies from region to region. it can be assumed that these discrepancies arise from the differences in philosophies, spirituality and ethics that govern the east and west. in his publication titled “an introduction to medical malpractice in the united states,” dr. bal defines medical malpractice as “any act or omission by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient.”1 common medical malpractice claims in the united states include but are not limited to surgical errors, injury from anesthesia, injury during childbirth, failure to diagnose or misdiagnosis, and incorrect prescriptions. 2 on the other hand, examples of medical malpractice in south asia, more specifically india, include unjustifiable prescription of drugs, overtreatment, improper patient education and pandering to drug companies and diagnostic centers in exchange for extra commission.3 societies as early as babylon have warned health care professionals of their responsibility to their craft and their patient. according to the code of hammurabi, the punishment for medical malpractice is dismemberment.4 while doctors today do not physically lose their arms for medical negligence, they often face lawsuits that metaphorically cost them an arm and a leg. this is especially true of doctors who practice in the west. in the united states, approximately 1 in every 14 doctors is confronted with a malpractice lawsuit every year.5 medical malpractice lawsuits are not as common in india. in fact, in october of 2013 the indian supreme court issued a landmark ruling where they found a hospital and five doctors guilty of medical negligence.6 the plaintiff, dr. kunal saha, lost his 36-year-old wife in 1998 when a highly acclaimed doctor in kolkata overprescribed a depo medrol, a long acting steroid.7 dr. saha fought this case for the better part of a decade nair, medical malpractice in south asia, voices in bioethics, vol. 3 (2017) 2 and his win raised awareness of the medical corruption and negligence that is prevalent in south asia. the case of dr. saha proves that medical malpractice is approached differently in the eastern and western worlds. from a modern bioethical perspective, it seems criminal that the doctors in south asia are not held accountable for their misdeeds; however, before one criticizes the morality of the indian system it is important to note that modern bioethics is seen through a western lens not a global lens. this perspective does not pay homage to the philosophies, religions and cultures of the eastern world. for instance, there is little to no bioethical dialogue about ayurveda and homeopathy, both of which are ancient systems of medicine that is still used to this day.8 indubitably, it is imperative that modern bioethics is amended to include the traditions and values of societies outside of the western world. this new global standard of bioethics can be utilized to better understand medical malpractice in south asia. many south asian religions such as hinduism, jainism, buddhism, sikhism and islam are philosophical in nature. it is important to note that buddhism, jainism, and sikhism are closely related to hinduism and have many of the same philosophies. hindu philosophy consists of six divisions or schools of thought, which are the nyaya, the vaiseshika, the sankhya, the yoga, the mimamsa, and the vedanta.9 these schools are further divided into three groups. the purpose of these six schools of thought is to eliminate ignorance through knowledge so that an individual can attain freedom and bliss. hinduism places self-realization before all else.10 this internal journey utilizes education and allows an individual to achieve self-liberation so that they may be free from the constraints of self-importance and self-worth. in other words, the ultimate goal is to be freed of oneself. on the other hand, western philosophy argues that self-dedication is foremost. an individual should use education to achieve success and happiness for themselves in order to achieve bliss. the eastern philosophy adopts a more systemic approach whereas western philosophy adopts a more individualistic approach.11 south asian and western philosophy undoubtedly use education to achieve different means. using this knowledge, it becomes clearer why doctors are viewed differently in the different regions of the world. in the western world, doctors educate themselves so that they may create a better life for themselves. additionally, patients utilize the knowledge possessed by the doctors so that they may progress in life as well. when a doctor makes a mistake, it is not in the best interest of the patient and is considered a misuse of knowledge and so it is deemed acceptable for the patient to demand some type of compensation, usually monetary. on the other hand, in south asian society completing the education necessary for becoming a medical professional implies that an individual has forgone ignorance and self. these individuals have given themselves to a life of service. thus it seems wrong to question or accuse someone who in theory has pure intentions. the nature of western and south asian spirituality is also quite different. western religion tends to be a lot more resistant whereas south asian religions tend to be a lot more integrative.12 western religions involve conversion whereas most of the south asian religions, with the exception of islam, do not have a formal conversion ritual. in fact, hinduism is often referred to as a way of life. extrapolating from these practices, it makes sense that western societies often resort to coercion to get achieve what they want, whereas south asian societies refrain from doing so. other dissimilarities in spirituality include the fact that western religions view life as linear and south asian religions view life as cyclic.13 most western religions believe in the idea of heaven and hell, but one can also avoid going to hell through repentance. south asian religions believe in the idea of rebirth and any misdeeds committed in this life will be factored when deciding one’s next incarnation. a spiritual doctor practicing in western society might be afraid of ending up in purgatory, but in the event that they do commit a misdeed, they can confess and repent and avoid an unsavory fate. a doctor in south asia does not feel the same sense of finality. they will be in a cycle of rebirth until they finally attain enlightenment. the golden rule is the foremost rule in western society: do onto others as you would have others do onto you. once again there is this idea of individualism. people act in a certain way because they will eventually reap the benefits. in south asian society individuals act in a way that fulfills their social responsibility.14 everyone has a purpose within their family, their society, even within this universe. it is a culture of interdependence. within south asian society it is assumed that a doctor knows their responsibility and completes it to the best of their ability. nair, medical malpractice in south asia, voices in bioethics, vol. 3 (2017) 3 failure to adhere to the ethical codes in either of the societies can lead to very different punishments. western society prefers cerebral justice where an individual is held accountable by law and is punished accordingly. a doctor that is convicted of medical malpractice has broken a rule and the punishment is to monetary compensation for those they have wrong. south asian society believes that the punishment should be spiritual in nature. one who knowingly commits a wrongdoing must face their conscience.15 failure to do so prevents them from attaining self-liberation, freedom and eternal bliss. this internal punishment is considered to be worse than any material punishment. without a doubt, western and eastern traditions in philosophy, spirituality, and ethics are very disparate from one another. additionally, the treatment and response to bioethical issues, such as medical malpractice, varies from place to place. in south asia, people respect and revere doctors, but doctors are not held accountable for their actions. as a result, doctors are able to abuse their privilege. in the western world, doctors are not as respected and are always facing the threat of massive lawsuits. in order to address the flaws in both societies, a global code of bioethics must be created. this new code will integrate the traditions of the eastern and western world. if successful, the world of medicine would gain a global convention for morality that would make the profession honorable and rewarding for all, just as hippocrates and charaka hoped it would be. ____________________________________________________________ references 1 bal, sonny. "an introduction to medical malpractice in the united states." clinical orthopedics and related research467, no. 2 (february 2009): 339-47. doi:10.1007/s11999-008-0636-2. 2 vessels, ethan. "most common types of medical malpractice claims." fields, dehmlow & vessels. june 01, 2017. accessed july 15, 2017. https://fieldsdehmlow.com/most-common-types-of-medical-malpractice-claims/. 3 chatterjee, chirantan, and vasanthi srinivasan. "ethical issues in health care sector in india." iimb management review25 (2013): 49-62. http://www.sciencedirect.com/science/article/pii/s0970389612001231. 4 see supra note 4. 5 corapi, sarah. "could malpractice reform save the u.s. health care system?" pbs. january 31, 2014. accessed july 15, 2017. http://www.pbs.org/newshour/rundown/could-malpractice-reform-save-the-us-health-care-system/. 6 vaidyanathan, gayathri. "a landmark turn in india's medical negligence law." the new york times. october 31, 2013. accessed july 15, 2017. https://india.blogs.nytimes.com/2013/10/31/a-landmark-turn-in-indias-medical-negligence-law/. 7 ibid 8 chattopadhyay, subrata, and raymond de vries. "bioethical concerns are global, bioethics is western." eubios journal of asian and international bioethics18, no. 4 (july 1, 2008): 106-09. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2707840/. 9 das, subhamoy. "the darshanas: an introduction to hindu philosophy." thoughtco. february 24, 2017. accessed july 15, 2017. https://www.thoughtco.com/the-darshanas-an-introduction-to-hindu-philosophy-1770582. 10 ibid. 11 kotelnikov, vadim, and anastasia bibikova. "east vs. west." cultural intelligence. accessed july 15, 2017. http://www.1000ventures.com/business_guide/crosscuttings/cultures_east-west-phylosophy.html. 12 ibid. 13 ibid. 14 ibid. 15 ibid. mietla, rethinking rescue medicine, voices in bioethics, vol. 2 (2016) * kelsie mietla, md, resident, university of virginia. ms bioethics, columbia university. © 2016 mietla. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. rethinking rescue medicine: issues of justice and a preventive medicine role for ems kelsie mietla, md* keywords: bioethics, emtala, emergency medicine, ems introduction emergency medicine, both pre-hospital through emergency medical services (ems) and in the emergency department (ed), is focused on immediate response to a variety of different illnesses and injuries. through the emergency medical treatment and active labor act (emtala), all patients presenting to an ed are guaranteed to receive assessment and stabilizing treatment regardless of their ability to pay.1 thus, the ed often replaces the primary care doctor that many patients simply cannot afford. manageable illnesses, such as hypertension and diabetes, are left to progress untreated when patients cannot afford necessary health care services and medications. when the ed functions as the primary care doctor, it is often not in a manner that promotes overall beneficence and justice. the system is broken, and patients often come to the ed with end-stage diseases that could have been prevented. some argue that rescue resources should be withheld from patients who cannot benefit from them and that preventive medicine should be invested in further. this piece seeks to demonstrate the practical difficulties that arise in withholding care in all situations where it may be deemed futile while proposing that further emphasis should be placed on preventive medicine; ems resources can be utilized in this process. we shall begin with a consideration of when rescue medicine is necessary. nancy jecker is a professor of bioethics at the university of washington and specializes in ethics and healthcare. she argues for the rule of rescue (rr), where rescue medicine should be used only in situations where patients are expected to benefit: “we ought to attempt to rescue an individual when we are reasonably confident that our efforts can help, and when the individual’s death is imminent and our failure to act is reasonably expected to result in that person’s death.”2 the key point for jecker is the statement that efforts must help the individual. jecker develops this notion to argue that rescue medicine should not be offered when there is little prospect for benefit: clearly, if the prospect of benefit is extremely poor, so that the patient is doomed regardless of what we do, then rr does not apply and treatment should be withheld (or compassionately withdrawn if a rescue is already underway). similarly, if the quality of outcome to be achieved falls well below a threshold considered minimal, rr does not apply and treatment should not be attempted, even if resources are abundant.3 ____________________________________________________________ http://www.voicesinbioethics.net/opeds/2016/06/06/rethinking-rescue-medicine-issues-of-justice-and-a-preventive-medicine-role-for-emergency-medical-services#_edn1 http://www.voicesinbioethics.net/opeds/2016/06/06/rethinking-rescue-medicine-issues-of-justice-and-a-preventive-medicine-role-for-emergency-medical-services#_edn2 http://www.voicesinbioethics.net/opeds/2016/06/06/rethinking-rescue-medicine-issues-of-justice-and-a-preventive-medicine-role-for-emergency-medical-services#_edn3 mietla, rethinking rescue medicine, voices in bioethics, vol. 2 (2016) 2 analysis jecker argues that the resources dedicated to rescue medicine in cases with little hope for benefit (for example, resuscitating a patient in multi-organ failure) would be better withheld such that more resources can be dedicated to preventive medicine.4 in this case, justice to the community served outweighs the small chance of benefit to “doomed” patients. jecker also considers the notion of spatial distance, arguing that distance should play no role in determining who gets treatment: “fairness requires that we avoid discriminating between individuals on morally irrelevant grounds, and merely being located nearby does not seem to be a morally relevant ground.”5 however, distance often plays a distinct role in determining whether or not a rescue attempt is futile or offers little chance of benefit. while one group of patients in need of resuscitation consists of terminal patients similar to the example of the multi-organ failure patient, another group consists of patients who could benefit from resuscitation if it is provided in a timely fashion. ems provides rescue medicine to patients in both urban and rural settings. each setting provides its own unique set of challenges. for those who work in rural settings, a common challenge to rescue efforts is time. if a patient enters cardiopulmonary arrest and does not receive bystander cpr prior to the arrival of ems, passing time amounts to brain damage. thus, a patient less than five minutes away might be reasonably expected to benefit from resuscitation, whereas a patient twenty or thirty minutes away might be deemed a futile effort. it is unreasonable to place an ems agency every few miles to serve a handful of homes. yet, it is also unreasonable not to resuscitate those patients who are farther away from the agency. while many providers feel that these efforts are often futile and lead to false hope for family members, practicality disables us from withholding these efforts. first, a set time period would have to be determined for which these efforts are futile (likely based on a whole brain death criterion).6 second, bystanders would have to accurately measure the time elapsing between the onset of cardiopulmonary arrest and ems arrival. it is unlikely that bystanders would be able to accurately check for the absence of a carotid pulse and be able to accurately measure elapsing time during this chaotic circumstance. it is also incorrect to assume that a bystander would be present at the exact time of cardiopulmonary arrest. enacting such a policy would surely continue to result in some futile resuscitations, and, more dangerously, failure to resuscitate a patient who may benefit. the problem of futile rescue efforts may be alleviated in part by public education and preventive medicine efforts. ems agencies have been successfully involved in public education for injury prevention, but the role of ems in public education and prevention for medical ailments is much less common.7 in rural and impoverished areas, public education could enable patients to understand what a resuscitation effort in terminal illness actually entails for the patients and their loved ones versus when a resuscitation effort can truly make a difference. educating patients to discuss their wishes with their families and obtaining medical directives and orders, if necessary, can prevent some of the futile efforts that place burdens on both families and the system with no chance of benefit. community preventive medicine efforts should ensure that patients have access to and properly manage their medications, have follow-up visits with education on how to manage current ailments, live in environments that reduce the chance for falls, and have access to primary care physicians when needed. it must be realized that the overutilized ems systems and overflowing eds is a problem created by the view that rescue medicine is a right and primary care is not. the burden on these systems is created when patients need to be seen for ailments that either could be currently managed by a primary care physician or could have been prevented by prior access to a primary care physician: “in medical emergencies where simple measures could easily have prevented an emergency from occurring, the rr has run amuck. a broader view requires, for example, preventing a progressive disease that is left untreated from continuing on its present course and taking a predictable turn for the worse.”8 prevention entails essentially integrating the current primary care and emergency care systems to some extent. http://www.voicesinbioethics.net/opeds/2016/06/06/rethinking-rescue-medicine-issues-of-justice-and-a-preventive-medicine-role-for-emergency-medical-services#_edn6 http://www.voicesinbioethics.net/opeds/2016/06/06/rethinking-rescue-medicine-issues-of-justice-and-a-preventive-medicine-role-for-emergency-medical-services#_edn7 http://www.voicesinbioethics.net/opeds/2016/06/06/rethinking-rescue-medicine-issues-of-justice-and-a-preventive-medicine-role-for-emergency-medical-services#_edn8 mietla, rethinking rescue medicine, voices in bioethics, vol. 2 (2016) 3 conclusion primary care access and expansion are necessary steps that must be taken to reduce the load on eds and decrease hospitalizations for ailments that could have been prevented or managed through primary care. universal health care will grant financial access to patients who cannot currently afford primary care. the expansion of primary care will allow easier spatial access to those in rural areas and allow better access for patients who need to be seen promptly in urban areas. examples of how these improvements can reduce the load on unnecessary hospitalizations, which often involve ems, can be seen by looking at other healthcare systems. for example, france has a universal healthcare system that is similar to a single-payer system. it also has excellent coverage of medications and greater access to primary care, and even specialists, which greatly reduces the number of unnecessary hospitalizations: “the united states has exceedingly high rates of avoidable hospitalizations compared with britain, germany or france. comparing paris and manhattan, we have 2.5 times the rate of avoidable hospitalizations that they do in paris.”9 while the loss of physician autonomy is a general fear of universal health care, the french system is not government-run and provides better overall access and primary care for patients, and greater physician autonomy. while the transition to universal health care in the united states will likely come after much debate over the best way to achieve it, the lack of access and current abuse of our emergency medicine systems demonstrates a clear need. ems agencies can also play a major role in community preventive medicine efforts. by diverting some resources to preventive medicine efforts, many more expensive resources will decrease in need: emergency services personnel currently spend much of their time reacting to cases that fall between the cracks of today’s separate and isolated public safety, health care, and public health systems…although emergency response must remain our foundation, ems of tomorrow will be a community-based health management system that provides surveillance, identification, intervention, and evaluation of injury and disease.10 by decreasing the incidence of rescue efforts for those with preventable end-stage diseases, the rescue system can be better utilized to serve those with immediate injuries and illnesses that can benefit from rescue medicine. incorporating preventive medicine into rescue medicine can also save lives through less invasive and emergent measures with long-term benefits, instead of more emergent “life and death” measures without long-term benefits. such an effort would prevent the need for such extreme measures in the first place and prolong the lives of patients with manageable diseases. all things considered, rescue medicine seeks to keep the community it serves safe. however, it is important that such efforts maximize justice and benefits while minimizing risks. emergencies requiring a large amount of resources for little benefit to those with terminal or progressed illnesses limit justice for the community as a whole. more patients with manageable diseases will become patients with end-stage diseases, and this cycle will perpetuate until patients have access to the care and medications they need. with proper preventive medicine training, ems is uniquely equipped to integrate preventive medicine into rescue medicine and deliver it directly within the community. some preventive medicine providers, such as evolution health (a national home healthcare provider) and golder ranch fire district (which offers preventive care through additionally trained “community integrated paramedics”), have already had success in enacting community preventive health measures.11 this step, combined with improved access to primary care and medications, will expand justice, beneficence, and even autonomy as patients become better equipped to understand and manage their injuries and illnesses. 1 emtala was passed in 1986. 2 nancy s. jecker, “the problem with rescue medicine,” journal of medicine and philosophy 38, no. 1 (2013): 67. 3 jecker, “the problem,” 71. mietla, rethinking rescue medicine, voices in bioethics, vol. 2 (2016) 4 4 jecker, “the problem,” 75. 5 jecker, “the problem,” 70. 6 the whole brain death criterion is fulfilled when the entire brain, comprised of both the higher brain and the brainstem, has experienced an irreversible cessation of function. patients who meet this criterion are legally dead. 7 theodore r. delbridge et al., “ems agenda for the future: where we are … where we want to be,” annals of emergency medicine 31, no. 2 (1998): 258. 8 jecker, “the problem,” 79. 9 victor g. rodwin, “health care abroad: france,” interview by anne underwood and sarah arnquist, the new york times, september 11, 2009, http://prescriptions.blogs.nytimes.com/2009/09/11/health-care-abroad-france/?_r=0. 10 ricardo martinez, “new vision for the role of emergency medical services,” annals of emergency medicine 32, no. 5 (1998): 595. 11 joshua hurguy, “fire-based community paramedicine: golder ranch fire district’s community integrated healthcare program,” journal of emergency medical services, september 4, 2015, http://www.jems.com/articles/print/volume-40/issue9/features/fire-based-community-paramedicine-golder-ranch-fire-district-s-community-integrated-healthcare-program.html. puccio, who are we without trauma, voices in bioethics, vol. 6 (2020) © 2020 kaitlin puccio. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. who are we without trauma? kaitlin puccio keywords: brain stimulation technology, bioethics, identity introduction in using brain stimulation technology to suppress an individual’s fear response to a traumatic memory, we are effectively altering that individual’s identity. in this article, i argue that until we learn more, such technology should be available only to patients with objectively debilitating fear responses who give their informed consent. first, i provide an overview of how the technology works. second, i analyze the artificial, natural, and clinical changes in memory, and explores the ethical concerns associated with altering an individual’s identity. i conclude by asserting that the benefits of brain stimulation technology outweigh the concerns if the proper administrative procedure is followed. analysis researchers have developed a method of suppressing an individual’s fear response to a traumatic memory by weakening the synaptic connections between neurons that form the memory.1 by keeping the memory intact but extinguishing an overactive fear response, the individual maintains a complete narrative history, but is able to function normally without having overwhelming panic responses to triggers. in their experiments, researchers exposed mice to a high-pitched sound and a low-pitched sound, neither of which resulted in a fear response. then they administered a mild shock to the mice alongside the highpitched sound. when the mice were again exposed to the high-pitched sound with no accompanying shock, they exhibited freezing behavior—a fear response common in prey animals who “play dead” as a last-ditch attempt to escape a predator by whom they have been otherwise overcome. the researchers then “erased” the fear memory by weakening the synaptic connection between the sensory cue (high-pitched tone) and traumatic event (shock). fear responses have developed as a survival technique in response to dangerous situations. some fear responses, however, are debilitating. in humans, for example, a war veteran with ptsd may have an overactive fear response to the sound of a car backfiring, which may trigger memories of gunfire. brain stimulation technology in humans would weaken the connection between the nerve cells involved in forming this memory, resulting in a normalized response to the auditory signal. puccio, who are we without trauma, voices in bioethics, vol. 6 (2020) 2 brain stimulation technology used to suppress an individual’s fear response to a traumatic memory alters that individual’s identity. while the benefit of normalizing fear responses is clear, it must be weighed against the ethical concerns. first, our memories and experiences as a whole contribute to our identity, which constantly evolves as new experiences create new memories. it may be argued that a person’s true identity is how that person identified before the traumatic event came to pass. however, if we could select a point in time at which we could identify a person’s “true” identity, we might run the risk of pointing to a time before that individual was capable of forming memories. for example, if a two-year-old experiences an emotionally scarring event, she may be henceforth changed. assume that she is able to recall the traumatic event but has no memories of the rest of the first two years of her life. her “true” identity would lie at a point before the traumatic event. all of her experiences and memories from that point forward would, in essence, form a “false” identity. the question is whether her “true” identity indeed lies at a point before the traumatic event—where there are no memories, and where memories are part of forming an identity—or if the memory of the traumatic event is a necessary ingredient in formulating her true identity as she becomes capable of forming memories. a new question about identity arises with the possibility of brain stimulation technology being used in this way. after the synapse is weakened, does the individual indeed “go back” to the person she was before the traumatic event took place, or does she take on another, new identity? for example, say that before x went to war, at point a, he had normal fear responses to cars backfiring. after returning home from war, at point b, he suffered from ptsd and had an overactive fear response. after brain stimulation technology “erased” the traumatic memory, at point c he had a normal fear response once again. what brain stimulation technology does not do is erase x’s memory of going to war. so, the event at point b makes it impossible for point a and point c to be identical. x cannot “go back” to being x at point a when he is at point c. if the events at point b never happened, x could remain x at point a. at point c, he has not become x at point a, who would (as we know from the existence of point b) have ptsd from going to war. at point c he has become x at point c who does not have ptsd from going to war, necessarily making him different from x at point a. the artificial change imposed on x via brain stimulation interrupts the natural evolution of x as he moves along the points of his life. while this does not necessarily indicate that brain stimulation technology cannot be used, it does mean that individuals must understand that their identity will necessarily be altered by artificial means. patients with dementia are often considered in debates over whether changes in memory result in changes in identity. the change is not artificial or natural, but clinical. though this is a worthwhile question, the ethical issue that dementia raises with regards to brain stimulation technology involves memory enhancement rather than suppression. researchers have found a way to stimulate the hippocampus in rats so that they recall memories that they otherwise wouldn’t.2 patients with dementia would undoubtedly benefit from such technology if it became available to humans. though memory enhancement technology is not considered in this paper, the concept informs the ethical analysis of memory suppression technology as it applies to the loss of identity. in particular, where memory enhancement technology may result in the effective restoration of an individual’s identity, memory suppression technology may result in the diminution of an individual’s identity. if memory suppression technology were available, it would need to be regulated. those regulations would dictate the set of individuals to whom the technology is available. what is not traumatic to one person may indeed be traumatic to another, however, so determining the limits of what is a normal fear response and what is not may be a difficult task. further, the regulatory body would be faced with the question: if we have this technology, are we ethically compelled to use it to enhance healthy people, in furtherance of the ethical puccio, who are we without trauma, voices in bioethics, vol. 6 (2020) 3 principle of beneficence? that is, if any memory leads to any level of negative reaction in an individual, why not “erase” those memories and improve that person’s overall quality of life? the technology might even be used to prevent future trauma. while it may not seem traumatic if a student has an unpleasant but innocuous encounter with his classmate, erasing that memory may prevent him from bringing guns to school as a result of ruminating over that unpleasant encounter.3 this in turn may prevent the need to use this technology to erase school shooting memories. the agency tasked with regulating brain stimulation technology must, until we learn more, first allow it to be used only on those patients who inarguably suffer from a debilitating fear response. many of these patients will likely have gone through therapy, and it should be required that before this technology is used, therapists or clinicians discuss with patients the interrelation of memory and identity, and that patients give their informed consent. they key is that patients are thoroughly informed, because it may be just as traumatic for an individual to go through the process and come out with a new trauma because she feels she has lost her identity. the benefits of this technology outweigh the concerns if the proper procedure is followed. conclusion brain stimulation technology used to suppress an overactive fear response raises ethical issues. the method used effectively changes an individual’s identity while normalizing that individual’s fear response. it also raises the question of whether a regulatory agency that allows this technology to be administered to suppress fear reactions in those who have been traumatized must also administer the technology to enhance the mental health of those who have not been traumatized. as it stands, the technology presents us with a tremendous opportunity to normalize those who suffer from debilitatingly overactive fear responses. if those patients are made aware of the ethical and philosophical concerns, the technology should be available to them while we work through the remaining concerns. 1 university of california riverside, “how particular fear memories can be erased: findings have therapeutic implications in ptsd and phobias,” sciencedaily, august 2017. www.sciencedaily.com/releases/2017/08/170817131130.htm 2 “the disremembered,” aeon magazine, march 26, 2015. https://aeon.co/essays/if-your-memory-fails-are-you-still-the-sameperson 3 though there are additional underlying issues involved in such cases, the complexities will not be addressed here. yarmolinsky, ethical obligations, voices in bioethics, 2013 © 2013 rachel yarmolinsky. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethical obligations to psychopaths rachel yarmolinsky in their target article, what we owe the psychopath: a neuroethical analysis, gillet and huang make the case that psychopathy is caused by complex interactions which include genetic and environmental factors. however, their argument for the ethical treatment of psychopaths rests on psychopaths’ status as victims of abuse, and therefore that society has a moral obligation to psychopaths because of the presumably socially caused harm that underlies their illness. this argument is flawed. communities do have a moral obligation to psychopaths, simply because they are human beings, and in particular human beings with a defective brain (for whatever reason). we don’t need to cast aside the deficit model in order to find an ethical reason to treat psychopaths as human beings. neuroimaging is showing that indeed psychopaths do have different brains from non-psychopaths.[i] [ii] [iii] here, i critique the target article in light of current knowledge about the development of psychopaths. there are psychopaths who have not suffered abuse during development.[iv] are they somehow less worthy of understanding and treatment? the authors say that the psychopath seems ‘beyond empathy.’ the psychopath may not feel empathy, and we may have some difficulties feeling empathetic towards a psychopath because of their own lack. but as non-psychopaths we are capable of empathizing with a psychopath and capable of recognizing that we owe psychopaths no less than any other human beings are due. for a copy of the full article, please email ry2134@columbia.edu. http://www.tandfonline.com/doi/full/10.1080/21507740.2013.782920#.ukubcizvncp [i] kiehl, ka, et al (2001): limbic abnormalities in affective processing by criminal psychopaths as revealed by functional magnetic resonance imaging. biological psychiatry 50:677–684 p [ii] kiehl, ka (2006): a cognitive neuroscience perspective on psychopathy: evidence for paralimbic system dysfunction.psychiatry research 142:107–128 [iii] glenn, al, et al (2010): increased volume of the striatum in psychopathic individuals. biological psychiatry 67:52– 58 [iv] hare, robert (1993): without conscience. the guildford press, new york, ny https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__edn1 https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__edn2 https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__edn3 https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__edn4 mailto:ry2134@columbia.edu http://www.tandfonline.com/doi/full/10.1080/21507740.2013.782920#.ukubcizvncp https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__ednref1 https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__ednref2 https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__ednref3 https://mail.google.com/mail/u/0/?shva=1#141cbc3decc09bf5_141c82534a5b6d62__ednref4 ethical obligations to psychopaths ramji, compassion fatigue, voices in bioethics, vol. 6 (2020) *naila ramji, md, msc © 2020 naila ramji. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. compassion-fatigue and moral distress in health care during covid-19 naila ramji* keywords: ppe, covid-19, healthcare worker ethics introduction as a high-risk pregnancy fellow and obstetrician, i continue to be involved in caring for pregnant patients during this pandemic. more patients with covid-19 trickle into hospital icus and acute care units each day. north american health systems are increasingly strained, and we are preparing for them to potentially become overwhelmed. analysis despite the outward show of strength and confidence, and a desire to fulfill our duty of care for the public in a crisis, many individual health care providers are already struggling when we come home from the frontline. we hold it together for patients which, for me, are a lot of scared, pregnant women. we acknowledge their anxiety, provide reassurance, and empathize with their concerns about ever-increasing visitor restrictions. to contain transmission and preserve personal protective equipment (ppe), most hospitals in canada and the us currently allow a single support person once the woman is in labor, with no visitors permitted on antenatal and postpartum wards and no partners allowed in the operating room during cesarian sections. we remain professional, despite everyone being on edge. but we have witnessed patients stealing masks from our clinics and other parts of the hospital. other physicians, especially in communities that do not yet have a high number of covid-19-positive cases, are telling us off for wearing surgical masks (not even n95s) because it will “scare patients” and will deplete the ppe supply. but the evidence favors basic contact precautions for all patient encounters, regardless of symptoms, because of communitytransmission.1 then there are the larger ethical dilemmas that cause moral distress. notably, in obstetrics, we have limited evidence regarding whether the sars-cov-2 virus is aerosolized with maternal pushing efforts in the second stage of labor. aerosolization is more dangerous and infectious than transmission by contact or droplets because viral particles that hang in the air can infect anyone in the room (and therefore require a higher level of ppe, including n95 masks and protective eyewear, as opposed to regular surgical masks). ramji, compassion fatigue, voices in bioethics, vol. 6 (2020) 2 different societies and experts have been making conflicting recommendations, with some advising to err on the side of caution and ensure that all health care providers in the room caring for patients with covid-19 wear higher level ppe, including n95 masks.2 other societies and organizations, more concerned about equipment shortages advocate against liberal ppe use, citing insufficient evidence to make the same recommendation.3 these dichotomous decisions reflect variation in attitudes toward both risk and resource allocation. there is a palpable tension between the need to preserve ppe due to the global shortage and the need to protect our patients, families, and ourselves, so that we can ultimately serve more patients. sick and/or dead health care workers help no one, and preserving ppe is useless in their absence. as far as bioethical dilemmas go in this pandemic, this is the tip of iceberg. in labor and delivery, we have not yet had adverse outcomes due to delays in performing emergency c-sections so that we can properly don ppe (which takes an extra 3-4 minutes). we cannot simply skip this step because the risks of exposure to health care providers is significant, and if we have to put the woman to sleep under general anesthesia, placing a breathing tube in the patient’s throat is an aerosolizing procedure. no single patient’s individual emergency is worth risking the lives of many physicians, nurses, and allied health workers needed to care for the avalanche of patients expected from the community. in canada and most of the us, physicians have not yet had to decide who lives and who dies, though the popular press is covering some anticipated ethical dilemmas including allocation of limited ventilators and implications for cpr. we are anxious about having to face these moral quandaries in real life. by the time we leave the workplace, our empathy tanks are running on low. a stop for groceries will empty whatever is left, when we still cannot find toilet paper and observe shoppers wearing the same n95s that we are only allowed to wear in hospital if performing "aerosolizing procedures" like cpr and placing a breathing tube in someone’s throat. we arrive home, running on empty – bless our loved ones for putting up with us. the medical profession boasts a culture of martyrdom, placing duty of care above all else, especially in life-and-death emergencies. physicians enjoy saving lives and being heroes. our time is here, yet we are surprised by how scared we feel. fortunately, absence of fear is not a prerequisite to showing up and doing our jobs (that's courage, right?). we are used to pushing through our discomfort. but simply pushing through on an empty empathy tank serves nobody well. when we discover that other doctors are sick or stepping back, an inner meanness whispers “were they careless?" or "will i have more shifts?" though outwardly we try to be understanding. this is often followed by a deep sense of shame: “don’t you want to help as much as possible?!” what we often don’t realize is that those resentments are a direct consequence of not dealing with the uneasiness we feel amid the uncertainty. conclusion ultimately, like our surgical safety checklists adopted from the airline industry, we need to adopt the airplane safety principle, “secure your own oxygen mask, before assisting someone else.” the ppe issue is a literal manifestation of that principle. the empty empathy tanks we bring home every day are the less tangible ones. we need to find ways to acknowledge and address compassion-fatigue among health care workers, especially during this public health crisis. we are in this for the long haul. and health care professionals cannot fly without an abundance of fuel, not only in the form of physical supports, but also social and emotional ones. ramji, compassion fatigue, voices in bioethics, vol. 6 (2020) 3 1 bai y, yao l, wei t, et al. presumed asymptomatic carrier transmission of covid-19. jama 2020 feb 21. 2 society for maternal-fetal medicine and society for obstetric anesthesia and perinatology – labor and delivery covid-19 considerations. available online: https://s3.amazonaws.com/cdn.smfm.org/media/2277/smfmsoap_covid_ld_considerations_3-27-20_(final)_pdf.pdf 3 elwood c, boucoiran i, vanschalkwyk j, et al. updated sogc committee opinion –covid-19 in pregnancy. society of obstetricians and gynaecologists of canada. 2020 march 13. available online: https://sogc.org/en/content/featurednews/updated-sogc-committee-opinion__covid-19-in-pregnancy.aspx dale, utilitarianism in crisis, voices in bioethics, vol. 6 (2020) * samuel dale, student, university of toronto © 2020 samuel dale. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. utilitarianism in crisis samuel dale* abstract although utilitarianism is a useful ethical principle to employ when scarce life-sustaining resources must be responsibly allocated, it must be buttressed by the principles of deontology and autonomy to ensure proportionate, equitable decision making. keywords: utilitarianism, bioethics, covid-19, philosophy introduction the exigency and scarcity thrust on society by the emerging covid-19 pandemic have produced novel interactions and tensions within normative ethical theory. western ethics is occupied by the inherently incongruent frameworks of utilitarianism, deontology, and autonomy. the theoretical tension has manifested in our public health systems as healthcare providers struggle to fulfill their duty to provide the best possible care, and respect autonomy while saving the greatest number of patients; this crisis of praxis is further aggravated by the dearth of critical medical supplies like personal protective equipment (ppe) and ventilators. in times like these, utilitarianism often dominates the decision making of the government developing public health policy. while a maximizing principle may be ethically imperative in such circumstances, relying exclusively on consequentialist reasoning may produce unforeseen harms and moral failure if left unchecked by other ethical frameworks that maintain the dignity of human life, the equitable distribution of resources, and the autonomy of each patient.1 although utilitarianism is a useful ethical principle to employ when scarce life-sustaining resources must be responsibly allocated, it must be buttressed by the principles of deontology and autonomy to ensure proportionate, equitable decision making. ____________________________________________________________ dale, utilitarianism in crisis, voices in bioethics, vol. 6 (2020) 2 analysis despite the intrinsic tensions between utilitarianism, deontology, and autonomy, a multi-principled framework that dovetails each of these theories can mitigate some of the moral pitfalls of pure utilitarianism. kantian ethics focuses on the intentions behind actions and mandates the adherence to governing maxims, called “categorical imperatives.” according to immanuel kant,2 each human life is brimming with moral value and ought to be treated with dignity, and that one has a duty to treat others (patients, for example) as ends in themselves, not merely as means to an end (a number in a calculus, for example). utilitarianism, in contrast, ignores the intentions of actors and focuses instead on the outcomes of given actions or rules in order to maximize pleasure and minimize pain. moral good in the utilitarian framework is entirely contingent on whether the outcome of an action was maximally beneficial.3 to quantitatively conduct a utilitarian calculus, human lives must be considered homogenous and interchangeable, which contravenes kant’s “categorical imperative.” for example, during the summer of 1944, the nazis began terrorizing central london with v14 rockets. in order to protect westminster, the british government spread false intelligence to the enemy regarding the latitude of the blast site.5 consequently, the rockets attacking central london instead started bombarding south london, which was primarily populated by a working-class demographic.6 knowledge of the british plan was withheld from the residents of south london, who consequently endured the majority of the rocket attacks. utilitarianism in effect saved westminster, however, according to a kantian ethicist, it also implicated the british government in the deaths of south londoners who they used as means to an end rather than ends in themselves. a kantian living in central london at the time would likely have opted to shoulder the barrage if it rescued him from moral complicity in the nazi bombings. furthermore, the british government failed to fulfill its duty to protect its most vulnerable citizens. as complex and morally distressing as this decision was, the hindsight reveals that this utilitarian decision making was deeply disconnected from an adequate respect for human dignity constituting a moral failure. to build a corollary to the situation of scare medical resources, purely utilitarian decision making could result in similar, albeit less egregious, ethical transgressions during this pandemic. for example, one utilitarian framework may opt to maximize the number of lives saved by allocating ventilators only to those with the highest likelihood of therapeutic success.7 this decision may seem prima facie reasonable, but in practice it will result in moral injury to healthcare workers.8 doctors who had no say in the populationbased policy will be required to compromise their deontological integrity withholding scarce therapies from the most vulnerable patients who simultaneously have the lowest likelihood of therapeutic success. furthermore, this may violate a tenet of equity as those most vulnerable to covid-19, who are predominantly older,9 are discriminated against and barred access to the best possible care because of their identity. doctors forced to choose between their duty to individual patients and the greater good are subjected to a seemingly unavoidable moral dilemma that cannot be easily resolved. despite the moral shortcomings of utilitarianism, there is no ethical framework that rescues doctors from morally devastating decisions in times of crisis. a patient’s autonomy often yields to the principle of utilitarianism during crises like wars and pandemics because the dearth of medical and human resources precipitously lowers the ceiling of medical care. autonomy is a cornerstone of clinical ethics in western society that assigns tremendous moral weight to the individual and their wishes.10 utilitarianism, as a population principle, focuses purely on maximizing outcomes along a given parameter, which most likely will not align with each individual’s autonomous preferences. this reveals a structural problem with utilitarianism – it lacks a solid foundation for choosing which values to pursue in maximizing outcomes. there was a famous disagreement between the two fathers of utilitarianism on this issue: jeremy bentham insisted that pleasure and pain were the only relevant outcomes to maximize;11 but john stuart mill objected, noting that humans will often endure pain in order to achieve “higher pleasures” like parenthood, athletic achievement, and political power.12 dale, utilitarianism in crisis, voices in bioethics, vol. 6 (2020) 3 if we superimpose this disagreement onto a critical care situation and decide to follow bentham to maximize the number of lives saved with a finite number of ventilators, we may rob patients of the right to an autonomous decision that satisfies their “higher pleasures” at the expense of their own life. one notable example from recent memory is the italian priest, don giuseppe berardelli, who died of covid-19 after volunteering his ventilator so that a younger person struggling with the virus could live.13 one solution to this structural problem with utilitarianism that respects the autonomy of individuals is to focus on maximizing the satisfaction of individual preferences rather than the sum of their pleasure.14 conclusion although moral distress is an inevitable consequence of this pandemic, a multiprincipled ethical framework can lead to a more equitable and proportionate outcome than a purely utilitarian calculus. such a framework must be inclusive of the deontological nature of the doctor-patient relationship and the importance of respecting patient autonomy even in the midst of exigency and scarcity. 1 persad, govind, alan wertheimer, and ezekiel j. emanuel. "principles for allocation of scarce medical interventions." the lancet 373, no. 9661 (2009): 423-431. 2 kant, i. (1993). grounding for the metaphysics of morals (jw ellington, trans.). indianapolis, in: hackett.(original work published 1785).kant, immanuel. "grounding for the metaphysics of morals (jw ellington, trans.)." indianapolis, in: hackett.(original work published 1785) (1993). 3 smart, john jamieson carswell, and bernard williams. utilitarianism: for and against. cambridge university press, 1973. 4 the v1 rockets, originally named vergeltungswaffen (translated as “retaliation weapon”), were long-range missiles designed by the germans to traverse the english channel and detonate in central london. 5 crowdy, terry. deceiving hitler: double-cross and deception in world war ii. bloomsbury publishing, 2011. 6 ibid. 7 persad, wertheimer, and emanuel. "principles for allocation of scarce medical interventions." 8 zohny, hazem. “the moral cost of coronavirus.” journal of medical ethics blog, march 16, 2020. https://blogs.bmj.com/medicalethics/2020/03/16/the-moral-cost-of-coronavirus/. 9 https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html 10 beauchamp, tom l., and james f. childress. principles of biomedical ethics. oxford university press, usa, 2001. 11 bentham, jeremy, and john bowring. the works of jeremy bentham. vol. 7. w. tait, 1843. 12 mill, john stuart. utilitarianism. longmans, green and company, 1895. 13 wray, meaghan. “priest, 72, dies after giving up respirator to younger coronavirus patient in italy.” global news. global news, march 26, 2020. https://globalnews.ca/news/6723885/italian-priest-gives-up-ventilator/. 14 persad, wertheimer, and emanuel. "principles for allocation of scarce medical interventions." https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html eshikena, rise of the planet apes, voices in bioethics, (2013) © 2013 marilyn eshikena. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. rise of the planet apes marilyn eshikena keywords: film, animal ethics, autonomy, research, informed consent, pharmaceutical have you ever stared at your sad dog one evening and thought, “if only you could talk…”? well, apparently, alz-112 will do the trick! if you don’t believe me, then you need to watch rise of the planet of the apes. the scientific fiction movie, while showing the potential acting talent of apes, touches on ethical issues in the biopharmaceutical industry. will rodman, a research scientist for a biopharmaceutical company, genesis, spent five years of his life working passionately on a cure for alzheimer’s. his work birthed alz-112, which was tested on an ape captured in a dramatic manner. his experiment with this single subject yielded positive results and so began his eagerness for human trials. eventually, rodman’s ape, caesar, yells out “no!” the first ethical issue the movie raises is the protection of animals used in science research. the star ape that had shown a favorable response to the drug, went rogue. thus, all other apes involved in the experiment to be killed. this mirrors our real-world concern over the dispensability of animals to humans in research work. is it ethically justifiable to eradicate an entire herd of research animals without investigation just because one of them has become potentially dangerous? shouldn’t there be other ways to ease an aggressive animal that doesn’t involve a gun and bullets? the second ethical issue the movie raises is autonomy and informed consent in clinical trials. rodman, in his desperation to save his father from alzheimer’s, injected him with alz-112 while he was asleep. at this moment, his father had unknowingly entered into a one-man clinical trial for a drug that had not even gone through phase 1 safety testing. tied closely to this is the issue of surrogacy for subjects with diminished or no autonomy. in this case, rodman’s father had diminished autonomy because of his memory loss and vulnerable condition. normally, a caretaker or family member is expected to make this decision for such a patient and thus, will be responsible for protecting the patient from exploitation. what happens when a research subject is related to the researcher? who is then responsible for ensuring that there is no breach of autonomy? the third ethical issue the movie raises is conflict of interest (coi). while the movie highlights a pharmaceutical company’s primary concern for increased profit margins, questionable financial ties are not the only cois that affect research validity. ethical breaches like data manipulation may exist when a researcher is desperate to prove the validity of his work, especially if a loved one will benefit from its result. certainly, rise of the planet of the apes, does a good job of drawing awareness to modern bioethical questions. i recommend it to anyone interested in not only bioethical topics related to the pharmaceutical industry but also realistic science fiction. menconi, covid-19 ventilator allocation, voices in bioethics, vol. 6 (2020) *michael menconi is pursuing an ms and mph at columbia university. © 2020 michael menconi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. covid-19 ventilator allocation protocols are poised to disadvantage african americans michael menconi* keywords: covid-19, ventilator allocation, scarcity, bioethics, racial disparity introduction the social determinants of health—including race and socioeconomic status—continue to propagate health disparities at unprecedented levels. these negative health outcomes, including high prevalence of chronic diseases, are most pronounced in communities of color. since the first african slave arrived in virginia over four centuries ago, systemic racism, discrimination, and prejudice have permeated society to the point where african americans can expect to live, on average, five years fewer than their white counterparts. history demonstrates that these disparities are most pronounced during pandemics. during the height of the hiv epidemic in the united states, infection rates in black communities outpaced those in non-minority communities by a factor of ten.1 analysis unsurprisingly, data emerging from the ongoing coronavirus pandemic suggests these longstanding disparities persist. in michigan, african americans constitute only 14 percent of the state’s population but account for 40 percent2 of coronavirus-related deaths. such a grim empirical reality raises crucial ethical questions about fair, unbiased allocation of healthcare resources. specifically, ventilator allocation protocols—institutional policies intended to maximize the therapeutic value of scarce life-saving resources such as ventilators—require examination though a social justice lens. currently, there is no federal guidance on ventilator allocation protocols, and state-level guidance, where it exists, varies considerably.3 in the absence of universal, transparent policy, we must question how—and to what degree—race and ethnicity enter into the ventilator allocation process, a process that ultimately determines who lives and who dies. in response to concerns of potential bias in ventilator allocation, hospitals have touted the sequential organ failure assessment (sofa) scale as the gold standard of clinical objectivity. on its surface, the sofa scale menconi, covid-19 ventilator allocation, voices in bioethics, vol. 6 (2020) 2 represents a utilitarian exercise of triage—a practice first employed on 18th century battlefields. each patient is assigned a mortality risk score based on a set of clinical criteria, thus determining who is most likely to benefit from ventilation therapy. however, a closer analysis of the sofa scale reveals significant disadvantages for african american patients. the sofa scale measures six different clinical indicators, using basic blood-based lab tests to assess heart, lung, liver, kidney, and neurological function. african americans are about 30 percent more likely to suffer from chronic conditions including diabetes, obesity, and heart disease.4 all of these have been shown to exacerbate the symptomology of the novel coronavirus. in turn, patients with these conditions perform worse on the sofa and are therefore more likely to engender a higher mortality risk score. this all but ensures african americans will be excluded from ventilator therapy at disproportionately higher rates in the context of rationing. in the event two patients receive identical sofa scores, african americans continue to be disadvantaged. if two patients hold identical mortality risk scores and only one ventilator is available, priorities shift to maximizing the number of life-years saved.5 in this instance, clinicians will provide ventilation therapy to the patient poised to live the longest in the event of a full recovery, or at least a partial recovery that results in eventual withdrawal of the ventilator therapy. while this protocol will broadly favor younger patients, the unfortunate reality is that african americans are expected to lead the shortest lives of any ethnic group in the country. suppose an asian patient and a black patient of the same age hold identical sofa scores. determining who is likely to live the longest in the event of recovery (the number of life-years saved) is tragically simple. with black life expectancy at 75 and asian life expectancy at 87, there appears no room for interpretation—the black patient loses again. it is also plausible that hospitals lack ventilator allocation policies altogether. this circumstance is more likely in rural and underserved communities, where many hospitals operate independently of high-resource academic health systems. in this case, it’s business as usual—ventilators are distributed on a first-come, firstserve basis. decades of racial bias and discrimination within the us healthcare system have deeply damaged african american perception of the healthcare system, resulting in pervasive mistrust of the healthcare enterprise. this mistrust is justified—during non-crisis circumstances, black patients wait 20 minutes longer for care in clinics and emergency rooms. they are also allotted less face-to-face time with clinicians who, by a factor of ten to one, are unlikely to be persons of color.6 such systemic inequities result in african americans often delaying care until symptoms are severe—leading to devastating health outcomes.7 thus, the first-come first-serve model is poised to disproportionately benefit non-minority populations, as they are more likely to seek care upon early onset of symptoms, and, once in the clinic or emergency room, are less likely to wait for care. the unfortunate reality is that a lottery—a completely random process of ventilator allocation—may be the only fair solution in a society plagued by such pervasive health inequities. while this strategy has been previously employed in organ transplantation, it is fraught with ethical complications. first, lotteries engender a reckless disregard for resource optimization—an 85-year-old may be selected for ventilatory therapy over a 16-year-old, without any consideration of social or clinical factors. second, lotteries suffer from a crisis of transparency. in the absence of an established allocation procedure, it is impossible to prove to patients and/or families that the process was in fact random. for the african american community, it may be particularly difficult to accept a clinician’s assurance of a truly random process. the tuskegee syphilis study was terminated only fifty years ago following decades of deceit and exploitation of african american men in rural alabama. menconi, covid-19 ventilator allocation, voices in bioethics, vol. 6 (2020) 3 conclusion utilitarianism is often proclaimed as the predominant philosophical paradigm during public health crises. unfortunately, while government officials and healthcare administrators claim to prioritize the greatest benefit for the greatest number in their defense of clinically based ventilator allocation policies, attention to social justice remains woefully absent. current clinical and non-clinical frameworks of resource allocation do not account for the pervasive health disparities currently plaguing society, particularly those observed in underserved communities. regardless of how objective various triage frameworks claim to be, they fail to account for the pervasive social injustices that disproportionately burden black communities. until federal, state, and local governments and our communities begin to seriously address the social determinants of health, african americans will continue to unjustly bear the burden of resource rationing. the life-or-death context of ventilator allocation is no exception. 1 us centers for disease control and prevention. “health disparities in hiv/aids, viral hepatitis, sexually transmitted diseases, and tuberculosis in the united states.” (2007). https://www.cdc.gov/nchhstp/healthdisparities/docs/nchhstphealthdisparitiesreport1107.pdf. 2 state of michigan. “michigan coronavirus data.” (2020). https://www.michigan.gov/coronavirus/0,9753,7-406-98163_98173--,00.html. 3 new york state department of health and new york state task force on life and the law. “updated ventilator allocation guidelines.” (2020). https://www.health.ny.gov/press/releases/2015/2015-11-25_ventilator_allocation_guidelines.htm. 4 mckinsey & company. “covid-19: investing in black lives and livelihoods.” (2020). https://www.mckinsey.com/industries/public-sector/our-insights/covid-19-investing-in-black-lives-and-livelihoods. 5 truog, robert d., christine mitchell, and george q. daley. “the toughest triage — allocating ventilators in a pandemic.” new england journal of medicine 382, no. 21 (march 23, 2020): 1973–75. https://doi.org/10.1056/nejmp2005689. 6 johnson, carolyn. “racial inequality even affects how long we wait for the doctor.” the washington post. (october 15, 2015). https://www.washingtonpost.com/news/wonk/wp/2015/10/05/medicines-racial-divide-measured-in-minutes-spent-waitingto-see-a-doctor/. 7 chen, jie, arturo vargas-bustamante, karoline mortensen, and alexander n ortega. “racial and ethnic disparities in health care access and utilization under the affordable care act.” medical care 54, no. 2 (february 2016): 140–46. https://doi.org/10.1097/mlr.0000000000000467. https://www.cdc.gov/nchhstp/healthdisparities/docs/nchhstphealthdisparitiesreport1107.pdf https://www.michigan.gov/coronavirus/0,9753,7-406-98163_98173---,00.html https://www.michigan.gov/coronavirus/0,9753,7-406-98163_98173---,00.html https://www.health.ny.gov/press/releases/2015/2015-11-25_ventilator_allocation_guidelines.htm https://www.mckinsey.com/industries/public-sector/our-insights/covid-19-investing-in-black-lives-and-livelihoods https://doi.org/10.1056/nejmp2005689 https://www.washingtonpost.com/news/wonk/wp/2015/10/05/medicines-racial-divide-measured-in-minutes-spent-waiting-to-see-a-doctor/ https://www.washingtonpost.com/news/wonk/wp/2015/10/05/medicines-racial-divide-measured-in-minutes-spent-waiting-to-see-a-doctor/ https://doi.org/10.1097/mlr.0000000000000467 fleming, my sister’s keeper, voices in bioethics, vol. 3 (2017) © 2017 alex fleming. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. my sister’s keeper: an assessment of living organ donation among minors alex fleming* keywords: my sister’s keeper, organ transplant, bone marrow transplant, transplant ethics introduction the 2009 film my sister’s keeper, based on jodi picoult’s 2004 new york times bestselling novel which bears the same name, is among other things, a controversial story about a young girl (anna fitzgerald) who sues her own parents in order to obtain legal rights to the use of her body. for as long as she can remember, anna has unwillingly been providing blood and bone marrow to her older and critically ill sister, kate. as the story unfolds, tension within the family arises as the 13 year-old anna fitzgerald becomes fully aware of her reason for existence, so to speak, which is to prevent the death of her older sister by providing a regular supply of blood and bone marrow, which she has done regularly for several years. later on, as kate’s condition worsens and her renal function begins to fail, the parents naturally turn to anna to provide what could be a life-saving kidney transplant for her older sister. the climax of the story begins as anna confidently and heroically refuses. the story raises a slew of bioethical issues which are beyond the scope of this essay; however, the story sheds light on a topic worthy of discussion: living organ donation among minors. background & analysis as the supply of organs suitable for transplantation decreases and the demand for them increases, the question of living organ donation among those yet of age has become a question of greater concern, primarily among those who point to the various ethical implications which such a procedure creates. robert veatch refuses to pair the term organ ‘donor’ with that of a minor and claims that “young children can never be “donors.” they cannot give consent to have their organs used for transplant. the younger ones cannot even comprehend the idea of transplantation.”[i] on the flip side, it is of general agreement among many professionals both domestically and internationally “that consent from the minor’s parents or legal guardian is a necessary condition to allow the donation [of organs among living minors].”[ii] as this requirement seems only natural and obvious, informed consent for living organ donation among minors presents many ethical gray areas, and can easily become a form of abuse at the expense of the child or children in question. such was the case for anna fitzgerald, who was coerced into providing blood and bone marrow for her ailing sister after her parents had, on the surface, satisfied the criteria necessary for informed consent. the characters and the story which make up picoult’s book are all but fictional; however, provide us with a glimpse into real-life issues which are certainly not out of reach and are deserving of further examination. https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn1 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn2 fleming, my sister’s keeper, voices in bioethics, vol. 3 (2017) 2 the challenges in obtaining consent from minors for living organ donation are not the least bit insignificant, and point to numerous areas within the organ procurement process which may be in need of revision if the practice is to respect the whole person in his or her totality. such revisions are entirely possible; however, may require additional oversight and/or modifications in existing policy. concerns related to the informed consent process and donation itself ask whether minors are capable of being truly autonomous, and whether a parent’s approval is more often than not a conflict of interest in disguise. several professionals “question the capacity of minors to understand and balance the risks and benefits at stake and to make an autonomous decision.”[iii] further, many “highlight the risk of family pressure when the intended recipient is a close relative of the minor donor.”[iv] apart from the fictional events contained in my sister’s keeper, which clearly present examples of family pressure, there have been some famous real-life instances where a conflict of interest among family members may have been present during the debate on whether living organ donation should be permitted. this is what presumably occurred in the legal case strunk v. strunk, where the court claimed that it was in the best interests of jerry strunk, a 27 year-old incompetent man and ward of the state, that he should donate his kidney to his ailing older brother tommy, who suffered from kidney disease and was in need of a transplant. the court asserted that such a donation was necessary and “would not only be beneficial to tommy but also beneficial to jerry because jerry was greatly dependent upon tommy, emotionally and psychologically….”[v] this particular case does not involve children yet of age; however, brings to light an important issue within the organ procurement process as it involves vulnerable individuals incapable of giving true and informed consent. moreover, this point is especially important if one is comparing the decision-making capacity of a child with that of a mentally incompetent adult.[vi] further challenges pertaining to living organ donation among minors have to do with psychosocial risks and benefits. minors who donate major organs may experience a sense of “lower self-esteem, a sense of neglect, and lack of appreciation after the donation.”[vii] this is especially true among minors of the same family. the organ procurement and transplantation network (optn), which administers with the united network for organ sharing (unos), lists several policies pertaining to psychosocial evaluation requirements for living organ donors. the psychosocial evaluation requirements “apply to living kidney, liver, pancreas, lung and intestine donors.”[viii] some of the requirements, among others, involve evaluating potential mental health concerns, high-risk behaviors, possible therapeutic interventions, and a donor’s ability to make an informed decision and take on the stress and medical complications that donation may involve. beyond simply following policy, it is advisable that all involved in the organ procurement and donation process treat the donating child as holistically as possible, seeking insight into their personal values, wishes, history, and knowledge. for example, psychosocial red flags which could have precluded anna fitzgerald from donating one of her kidneys could have been her overall sense of detachment from the rest of her family. having been born in-vitro for the sole purpose of aiding her older sister, anna was left feeling as if she were not born out of true love, in comparison to her other siblings who were conceived via natural means and were apparently born for no other reason than for themselves alone. given these factors, for anna to donate her kidney may lead to stronger feelings of detachment and an even lower sense of selfworth, both having an impact on overall health. in order to ascertain whether living organ donation among minors is in fact prudent, professionals should feel encouraged to move beyond policy and try to understand the child in their whole essence, all while seeking to protect and affirm their inherent dignity. such an approach can lead to greater psychosocial benefits for the donor and an ultimately greater understanding of organ donation as gift, and may further strengthen family bonds and/or the relationship between donor and recipient. https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn3 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn4 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn5 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn6 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn7 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn8 fleming, my sister’s keeper, voices in bioethics, vol. 3 (2017) 3 as with any medical or surgical procedure, organ donation is not without its risk. medical complications during and after organ donation include but are not limited to: “pain, infection, blood loss, blood clots, allergic reactions to anesthesia, pneumonia, injury to surrounding tissue or other organs, and even death.”[ix] as a general rule in any medical or surgical intervention, a patient is not obligated to take on risks that he or she sees as disproportionate when compared to the intended or foreseen benefits. the united states conference of catholic bishops advise the following: “…no person should be obliged to submit to a health care procedure that the person has judged, with a free and informed conscience, not to provide a reasonable hope of benefit without imposing excessive risks and burdens of the patient or excessive expense to the family or community.”[x] this freedom from obligation becomes an even stickier situation when the decision to donate means possibly saving the life of a close relative (as was anna’s predicament), even when the risks involved in donation are minimal. robert veatch often equates organ donation, when it concerns minors, to participation in medical research and believes that children, moral agents like ourselves, “have very limited responsibility to contribute to the community... [and] have a greater obligation to their family members than they do to participate in minimal-risk medical research.”[xi] conclusion lastly, it should be noted that not all transplants involve major organs. sometimes children are faced with circumstances where there is not necessarily an organ to donate, and the donor and the recipient are the same person. in cases where a child is plagued with a musculoskeletal disease or has been involved in a tragic accident, an autotransplantation may be necessary. autotransplantation, also known as an autograft, occurs when “bone or tissue [is] transplanted from one part of a person's body to another part….”[xii] these sorts of procedures pose some minimal risk to the patient, including “theoretical risk for disease transmission….”[xiii] and should be given the same attention and scrutiny as organ transplantation procedures. in this case, in what is technically a living tissue transplantation, informed consent procedures still apply, and psychosocial factors are still relevant. revision to current optn/unos policy is advisable, and addition of these living tissue transplantation procedures is encouraged if the goal is to create policies which are as inclusive as possible and respect the inherent dignity of donors, recipients, and families. however, regardless of the organ or tissue being transplanted, or whether the donor and recipient are one and the same person, it is vital that the gift of donation be just that, a gift, and not an obligation which we owe by default to others or ourselves. [i] robert m. veatch, transplantation ethics, (washington, dc: georgetown university press, 2000), 236. [ii] kristof thys et al., “could minors be living kidney donors? a systematic review of guidelines, position papers and reports,” transplant international 26 (april 8, 2013): 955. [iii] ibid., 953. [iv] ibid. [v] jerry menikoff, law and bioethics: an introduction, (washington, dc: georgetown university press, 2001), 472. [vi] veatch, transplantation ethics, 236. robert veatch chooses to combine infants, children and mentally incompetent adults in the same category in regard to their ability to give consent to have their organs used for transplant. such a https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn9 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn10 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn11 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn12 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_edn13 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref1 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref2 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref3 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref4 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref5 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref6 fleming, my sister’s keeper, voices in bioethics, vol. 3 (2017) 4 sweeping categorization is indeed a stretch and prevents the inclusion of minors and older children who may be capable of understanding the full implications of organ donation. moreover, such a comparison undermines the principle of respect for the human person in that all mentally incompetent individuals are seen as incapable of making decisions for themselves. [vii] kristof thys et al., “could minors be living kidney donors? a systematic review of guidelines, position papers and reports,” transplant international 26 (april 8, 2013): 955. [viii] organ procurement and transplantation network, “policies,” u.s. department of health & human services, june 1, 2017, https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf [ix] american transplant foundation, “what to consider before donating,” http://www.americantransplantfoundation.org/about-transplant/living-donation/becoming-a-livingdonor/five-questions-to-ask-yourself/ [x] ethical and religious directives for catholic health care services: 5th ed., (washington, dc: u.s. conference of catholic bishops, 2009), n. 32. [xi] robert m. veatch, transplantation ethics, (washington, dc: georgetown university press, 2000), 195. [xii] american academy of orthopaedic surgeons, “bone and tissue transplantation,” http://orthoinfo.aaos.org/topic.cfm?topic=a00115 [xiii] ibid. https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref7 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref8 https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref9 http://www.americantransplantfoundation.org/about-transplant/living-donation/becoming-a-living-donor/five-questions-to-ask-yourself/ http://www.americantransplantfoundation.org/about-transplant/living-donation/becoming-a-living-donor/five-questions-to-ask-yourself/ https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref10 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref11 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref12 http://orthoinfo.aaos.org/topic.cfm?topic=a00115 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/7/10/my-sisters-keeper-an-assessment-of-living-organ-donation-among-minors#_ednref13 castelyn, environmental and economical ethics collide, voices in bioethics, vol. 6 (2020) *camille castelyn, ms candidate, columbia university © 2020 camille castelyn. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. environmental and economical ethics collide: business as usual after covid-19 or shifting towards a planetary health perspective? camille castelyn* keywords: environment, covid-19, planet, climate change, income inequality, poverty, carbon footprint introduction in january 2020, during china’s covid-19 outbreak, the nasa earth observatory captured aerial images indicating significantly lower emissions of nitrogen dioxide (no2), a major air pollutant, across china’s mainland.1 scientists across the globe have reported preliminary empirical data that amid shelter-in-place directives and the shutting down of large-scale economic activity, the environment is flourishing. abnormal sightings of wild animals roaming freely in deserted cities have been widely reported. for example, monkeys in lopburi, bangkok and leatherback turtles on deserted beaches in florida, us are thriving.2 this pandemic has given mother earth a chance to ‘breathe.’ environmentalists are asking how long the breather will last and whether it will sustain the earth for years to come, when business as usual returns bringing environmental challenges. analysis this pandemic has shaken up business as usual including major economic drivers of supply and demand. at the moment, the demand for oil is at an all-time low whereas personal protective equipment (ppe) markets are booming. the world has entered into a recession, with estimates of a us $2 trillion loss. approximately 11 million people are being pushed into poverty.3 people are functioning differently: there is a shift toward working remotely, micro gardening in urban settings, more mindful use of resources, and spending more time at home with friends and family. these trends may put less strain on people as well as on the environment. as people find a better work-life balance and commute less, the 77.5% of pollution caused by car and air travel, may be reduced.4 some scientists also argue that if the planet were healthier we would see fewer viruses take hold.5 castelyn, environmental and economical ethics collide, voices in bioethics, vol. 6 (2020) 2 although scientists estimate that the impact of covid-19 on the environment may be temporarily positive, long-lasting action and commitment are necessary to mitigate climate change. the sustainable development goals (sdgs) adopted by united nations member states in 2015 aim to achieve climate action, sustainable cities, and sustainable use of the earth and ocean’s resources by 2030. while there is a shortterm environmental benefit of lower emissions, the long-term goals may be set back due to the covid-19 pandemic.6 the sdgs include eliminating poverty, protecting the planet, and ensuring prosperity and peace for all people.7 the sdgs are a stark reminder that the pre-covid-19 world was far from perfect. most countries’ economies are driven by exponential capitalist growth in which the environment and people are exploited for the sake of profit. nearly half the world lives on less than $5.50 a day.8 44 percent of the world’s net worth belongs to 0.8 percent of the world’s individuals9. this crisis has exposed systemic flaws even more, as those who have lower socio-economic standing are disproportionately affected by this pandemic. they are more susceptible because they do not have access to basic sanitation and are often forced to live in places affected worse by climate change and pollution. in 2019 greta thunberg, the 15-year-old environmental activist, made the case that the economics to solve the current environmental constraints did not yet exist. in 2020, amid the pandemic, the united nations (un) reported that there is a need to rebuild economies differently.10 individuals and governments may be spurred to change their approach to climate action requiring a shift of societal norms to value the environment and people’s happiness more than profit growth. in amsterdam, donut economics will be used to help the economy recover.11 donut economics originated from kate raworth of oxford university’s environmental change institute’s book, ‘donut economics: seven ways to think like a 21st century economist.’ the inner ring of the donut refers to the minimum that people need to live a good life, which is based on the un’s sdgs (such as food, clean water, housing, sanitation, energy, education, healthcare, gender equality, income, and political voice). any person who does not have access to these minimum standards of living is described as living in the doughnut’s hole. the outer ring of the doughnut, where the sprinkles go, represents the ecological outer parameters, drawn up by earthsystem scientists. these outer parameters delineate the boundaries which humanity should not progress beyond if it is to avoid damage to the ozone layer, oceans, freshwater resources, and abundant biodiversity. in developing countries such as south africa, the opportunity to rebuild the economy by means of donut economics seems idealistic because a large percentage of the population lives inside the doughnut hole. the immediate challenges of debt, poverty, and food shortage brought about by the covid-19 lockdown are pressing.12 however, visionary leaders should take a long-term perspective as there is opportunity to do so now. for example, during this time president cyril ramaphosa aims to reduce the number of ‘people living inside the donut’s hole’ by improving housing infrastructure in rural areas. conclusion rebuilding a more ethical post-covid-19 world of both environmental and human flourishing13 will require a planetary health perspective.14 the lancet15 suggests that a planetary perspective must move beyond an emergency response toward resilience and prevention planning. in “happiness explained: what castelyn, environmental and economical ethics collide, voices in bioethics, vol. 6 (2020) 3 human flourishing is and what we can do to promote it,” paul aland explains that the principles of human flourishing are fairness, autonomy, community, and engagement. these principles may be the pillars for post-covid-19 environmental policies. amid the chaos and trauma of this pandemic, it is up to individuals, leaders, scientists, and bioethicists to take a breather to reflect. it is time to dare to imagine what human and environmental flourishing may look like in a more sustainable post-covid-19 world and start rebuilding it one step at a time. 1 “these satellite photos show how covid-19 lockdowns have impacted global emissions,” world economic forum, march 25, 2020, https://www.weforum.org/agenda/2020/03/emissions-impact-coronavirus-lockdowns-satellites/. 2 harry kretchmer, “these locked-down cities are being reclaimed by animals,” world economic forum, april 17, 2020, https://www.weforum.org/agenda/2020/04/covid-19-cities-lockdown-animals-goats-boar-monkeys-zoo/. deena robinson, “endangered sea turtles thriving amid covid-19 restrictions,” april 20, 2020, https://earth.org/endangered-sea-turtles-thrivingamid-covid-19-restrictions/. 3 world economic forum, “why we cannot lose sight of the sustainable development goals during coronavirus,” april 23, 2020, https://www.weforum.org/agenda/2020/04/coronavirus-pandemic-effect-sdg-un-progress/. 4 hiroko tabuchi, “‘worse than anyone expected’: air travel emissions vastly outpace predictions,” the new york times (online), september 19, 2019, https://www.nytimes.com/2019/09/19/climate/air-travel-emissions.html. 5 “first person: covid-19 is not a silver lining for the climate, says un environment chief,” united nations news, april 5, 2020, https://news.un.org/en/story/2020/04/1061082. 6 the world bank, “poverty,” april 16, 2020, https://www.worldbank.org/en/topic/poverty/overview. 7 united nations development programme, “what are the sustainable development goals?,” 2015, https://www.undp.org/content/undp/en/home/sustainable-development-goals.html. 8 the world bank, “nearly half the world lives on less than $5.50 a day,” october 17, 2018, https://www.worldbank.org/en/news/press-release/2018/10/17/nearly-half-the-world-lives-on-less-than-550-a-day. 9 james davies, rodrigo lluberas, and anthony shorrocks, “global wealth report 2018,” credit suisse research institute, 2018. 10 “first person: covid-19 is not a silver lining for the climate, says un environment chief,” united nations news, april 5, 2020, https://news.un.org/en/story/2020/04/1061082. 11 daniel boffey, “amsterdam to embrace ‘doughnut’ model to mend post-coronavirus economy,” april 8, 2020, https://www.theguardian.com/world/2020/apr/08/amsterdam-doughnut-model-mend-post-coronavirus-economy. 12 a van den heever et al., “south africa needs a post-lockdown strategy that emulates south korea,” the conversation, april 18, 2020, https://theconversation.com/south-africa-needs-a-post-lockdown-strategy-that-emulates-south-korea-136678. “‘people need to eat’: south africa eases coronavirus lockdown,” aljazeera, january 5, 2020, https://www.aljazeera.com/news/2020/05/eat-south-africa-eases-coronavirus-lockdown-200501072927207.html. 13 rose deller, “book review: happiness explained: what human flourishing is and how we can promote it by paul anand,” the london school of economics and political science, august 24, 2016, https://blogs.lse.ac.uk/lsereviewofbooks/2016/08/24/bookreview-happiness-explained-what-human-flourishing-is-and-how-we-can-promote-it-by-paul-anand/. 14 alistair brown and richard horton, “a planetary health perspective on covid-19: a call for papers,” the lancet 395 (april 4, 2020): 1099. 15 brown and horton. https://theconversation.com/south-africa-needs-a-post-lockdown-strategy-that-emulates-south-korea-136678 bolanos, orange is the new black, voices in bioethics, (vol.1) 2015 © 2015 eric bolanos. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. orange is the new black eric bolanos some of the issues raised in the show present interesting questions involving bioethics. corrections officers regard inmates differently than medical staff regard patients. there is little concern for the inmates’ autonomy in the series, and, i suspect, in real life. by definition, prison requires the loss of liberty, and unlike in a doctor-patient context, inmates realize that seeking the help of corrections officers will elicit further retribution by fellow inmates. while the warden is sympathetic towards piper, he repeatedly mentions that he will not be able to help her through her time in prison. this is a practical reality understood by both prison staff and the prisoners. this is not to diminish the job of corrections officers, but their time is spent differently than hospital staff. for instance, the warden is forced to view requests for seemingly innocuous items, such as a new freezer, with a great deal of suspicion. these are a very different set of concerns. orange is the new black is netflix’s new hour-long series set in a women’s prison that mixes elements of comedy and drama. the show is netflix’s fourth attempt at original programming, and while it appears to be a tv show, the only way to watch the show is by streaming the show through a netflix account. the show was created by weeds creator jenji kohan, and like weeds, orange is the new black tells a unique story from the perspective of an unconventional female protagonist. the series is based on piper kerman’s memoir documenting her time in a women’s minimum security prison in upstate connecticut. the female protagonist in the show is also named piper, and the show’s comedy and drama is based on her being forced to transition from her upper-middle class life with her fiancé, played by jason biggs, to life in prison. the show is often funny, and while the minimum security prison seems surprisingly dangerous, it is not as though the prison life is similar to that of hbo’s oz. many of piper’s fellow inmates have goofy nicknames and seem to be women who have encountered misfortune more than they are hardened criminals. the show features an unsavory guard who is shown smuggling contraband for the inmates. however, the warden is portrayed sympathetically, while a different guard is portrayed as being kind to the inmates. while the show is not particularly focused on the public policy issues that surround prisons, the major plotline in one episode follows the inmates attempt to capture a chicken, believed to carry drugs, in the prison yard; issues such as the smuggling of contraband and the ethics (or lack thereof) of prison staff often come up. still, many of the misdeeds on the show are committed by the prison guards. one guard is shown bringing contraband into the prison, while another is involved in a sexual relation with an inmate. given that these events occur in real life, these are not exactly revelations when portrayed on the show. what is interesting is that the show does not portray the love affair negatively, but simply portrays the guard and inmate as two people in love. this may be because the show does not have many ways to include a romance, but it is surprising to see such an ethically dubious act portrayed positively. these considerations are decidedly not the focus of the series, but are there to those who want to pay attention. overall, the series is well-written and the performance by taylor shilling in the main role is very strong. the show’s plot is decidedly different from standard tv fare, and the critical acclaim it has received is well justified. the show is definitely worth checking out, and i’ll continue to watch the second season. orange is the new black shakeri, adanty, and kugathasan, ethical framework governing water flouridation, voices in bioethics, vol. 6 (2020) *shakeri and adanty university of toronto, 27 king's college circle toronto, on m5s 1a1, canada; kugathasan, york university, 4700 keele st, toronto, on m3j 1p3, canada © 2020 ahmad shakeri, christopher adanty, and howsikan kugathasannina beguš. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. revisiting the ethical framework governing water fluoridation and food fortification ahmad shakeri, christopher adanty, howsikan kugathasan* keywords: food fortification, water fluoridation, consent, dietary intake, statins abstract food fortification and water fluoridation are two public health initiatives that involve the passive consumption of nutrients through food and water supplies. while ethical analyses of food fortification and water fluoridation have been done separately, none have been done together. this study does three things: first, we review the origin, reasoning, and mechanisms behind food fortification and water fluoridation. from there, we deduce the primary ethical dilemma that overshadows food fortification and water fluoridation they both require a form of deception and are consumed passively without the need for informed consent. finally, we look at various approaches ethicists have taken to understand the ethical issues surrounding the programs. two key ethical models appear in this discussion: the justificatory approach and the stewardship model. beyond these two frameworks, one ethical analysis deduces that water fluoridation is unethical based on the definition of consent from the nuremberg code. as recent scientific papers and the general public have started discussing and debating the passive consumption of various drugs via public water supplies, it is prudent that we revisit the ethics behind food fortification and water fluoridation programs; this will ultimately allow us to better navigate complex problems in nutritional ethics and passive delivery. introduction nutrition is one of the most important aspects of preventative health, and interventions such as food fortification and water fluoridation have been implemented widely to ensure that populations are meeting key micronutrient recommendations. food fortification is the idea of adding any one of a wide variety of micronutrients to staple foods to ensure that populations are meeting their micronutrient needs. food shakeri, adanty, and kugathasan, ethical framework governing water flouridation, voices in bioethics, vol. 6 (2020) 2 fortification started with the addition of iodine to salt after discovering the relationship between iodine deficiency and goiter [1]. other nutrients such as folate for the prevention of spinal bifida in newborns and vitamin d to prevent cancers, neurological, and cardiovascular diseases were later delivered to the public en masse via food fortification [2, 3]. i. analysis bioethics in healthcare typically governs the interaction and decision making between healthcare professionals and their patients. however, food fortification and water fluoridation seem out of scope compared to typical approaches, since there is no direct patient-clinician interaction and these interventions are delivered en masse to populations rather than individuals [3]. because of this, views on informed consent, deception, beneficence, and non-maleficence need to be adjusted for context. recent papers have looked at the feasibility of adding statins (drugs which inhibit the production of cholesterol in order to prevent heart disease [4]) to public water supplies. ginter et al. strongly suggested that statins should not be added to public water supplies as they will most likely cause detrimental health effects to those not suffering from high cholesterol or heart disease [5]. by contrast, the landmark jupiter trial (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin) found that statins administered to patients with normal or low cholesterol levels effectively reduced their chance of first heart attack or stroke [6]. outside of statins, leading bioethicist julian savulescu has argued that drugs for cognitive enhancement can be added to our water and food supplies [7]. both propositions, directly cite food fortification and water fluoridation programs as their predecessors, suggesting that adding statins and cognitive enhancers to water would be the “logical next step”. these propositions on statins or cognitive enhancement build upon the unstated premise that water fluoridation and food fortification are ethical. however, this assumption must be revisited by reviewing the ethical frameworks that justify food fortification and water fluoridation programs. in this paper, we will consider whether the similarities between food fortification and water fluoridation override their differences and thus what ethical conclusions can be cross-pollinated between the two interventions. from there, we will analyze the ethical frameworks that both support and reject such public health interventions. specifically, this paper will discuss the “known knowns” and the “known unknowns” concerning the ethics around water fluoridation and food fortification. “known knowns” – science of water fluoridation and food fortification food fortification can be generally defined as the practice of increasing the content of an essential micronutrient in a food with the aim of improving the nutritional quality of the food supply and provide a public health benefit with minimal risk to individual health [8]. unlike the somewhat simplistic process of adding sodium fluoride or fluorosilicate derivatives to public water supplies, food fortification encompasses the addition of a broad range of nutrients to various foods. a few prominent examples of such nutrient interventions include folate being added to flour, iodine being added to salt, and the fortification of vitamin d in milk. folate consumption was demonstrated to effectively prevent neural tube defects in unborn infants [9], iodine deficiency was demonstrated to cause goiter and hypothyroidism [10], while hypovitaminosis d was shown to cause osteoporosis amongst a vast range of other illnesses [11]. the diseases prevented by food fortification and water fluoridation should be taken into account when considering the necessity of these public health interventions. shakeri, adanty, and kugathasan, ethical framework governing water flouridation, voices in bioethics, vol. 6 (2020) 3 on the other hand, water fluoridation is the practice of adding fluoride chemicals (sodium fluoride or fluorosilicate derivatives) to public water supplies for the purpose of preventing tooth decay and cavities [12–14]. public water fluoridation first began in 1951 while food fortification began in 1992 with the addition of iodine, vitamin a, and iron [2, 15]. scientific evidence shows that water fluoridation prevents tooth decay by providing individuals with frequent and consistent contact with low levels of fluoride [16]. public water fluoridation programs have been shown to reduce tooth decay by 25% in children and adults [17–20]. the introduction of fluoride also prevents other oral health complications such as gum pain, gum disease, and oral abscesses [21]. a key difference between water fluoridation and food fortification is the policies regulating when and how these interventions are to take place. in the public health context, we shall assume that fluoride is added solely to water (we will consider alternatives later). water is unique in that it has other purposes for humans aside from consumption, such as for cleaning the body. for instance, in the united kingdom, water is not considered food until it emerges from the taps [22]. this loophole allows the addition of fluoride to water supplies early on in the processing stages to be exempt from the regulations for food fortification despite the obvious intent that the fluoride added to the water is meant for human consumption [22]. when considering the fortification of milk, salt and flour, only milk can be considered a food product in all its respective stages (from raw milk through to its final bottled form). flour is almost never consumed raw and its raw consumption as dough is strongly advised against by the food and drug administration due to risk of infection [23]. likewise, salt is almost never consumed in its pure form and instead is used as an additive to other dishes. in that sense, should folic acid addition to flour or iodization of salt be declassified as food fortification since they are not food in the most technical sense? taking such a view is disingenuous (as is the british water loophole) as it ignores the intent of adding nutrients to food precursors: so that they may be consumed in their final stages of processing (with food, the cooked dish). through this view, nutrients are added to the products with the intent of consumption. this intent should be the basis of ethical consideration, not the stage of nutrient delivery. “known unknowns” – ethical analysis of water fluoridation and food fortification to begin an ethical analysis of food fortification and water fluoridation, a thorough review of the similarities between the two processes brings several ethical questions/dilemmas to the fore. the key similarities between food fortification and water fluoridation can essentially be summarized in three general areas: intent, delivery, and consent (that is, the lack thereof). a. intent from the outset, both water fluoridation and food fortification have similar medical intents: to alleviate nutritional deficiencies and their resulting complications in the general public. in this sense, both water fluoridation and food fortification are prophylactic, intended to prevent disease as opposed to treating an already existing ailment. the principles of beneficence and stewardship (the duty of public health authorities to act for the welfare of persons and the population, especially vulnerable populations) support the argument that governments have a duty to actively protect and promote the health and well-being of the population. one can argue that governments have access to an easy to use, safe, efficient and costeffective means of reducing medical complications with water fluoridation and food fortification, and thus are effectively protecting the health of the populations. a question arises from the principle of beneficence regarding whether good intent can be applied to a broader range of drugs and diseases. such propositions of adding medications to water supplies are not farfetched as there have already been debates regarding the shakeri, adanty, and kugathasan, ethical framework governing water flouridation, voices in bioethics, vol. 6 (2020) 4 addition of cholesterol-reducing statins to public water supplies [24]. these propositions, especially the one by savulescu, build on the methods from food fortification and water fluoridation but shift the impetus from disease prevention to enhancement, posing new ethical challenges. b. delivery the modes of delivery for both water fluoridation and food fortification are highly similar. they involve the modification of products that are staple foods, and are therefore commonly ingested. the way fluoride is delivered makes consuming fluoridated water or micronutrient-fortified foods unlike taking fluoride or micronutrient supplements, in that consumption of the supplements implies the intent of the consumer to alleviate or prevent a particular micronutrient deficiency. however, consuming fluoridated water or folate-fortified flour products does not necessarily come with this same definite intent of disease prevention on the end of the consumer. equally, due to cost or unavailable alternatives, it may be difficult for individuals who do not wish to consume fortified foods or fluoridated water to purchase salt, flour, milk or water that do not contain these additives. in addition to this, the consumption of fortified foods and fluoridated water are personal and do not require the direct supervision or administration of a physician or other healthcare professional. this is contrary to vaccinations (another prophylactic public health intervention) which are delivered by a healthcare provider. this also poses additional ethical questions, namely those of whether beneficence supersedes consent and whether interventions that are intended to treat populations en masse need to follow the same guidelines that govern typical medical practice. c. consent the similarity in the consent procedure behind food fortification and water fluoridation is the most important area for ethical analysis. since a healthcare provider is not administering or prescribing fluoridated water or fortified food products, there is no room for an informed express consent procedure. what makes food fortification and water fluoridation more similar to one another and different from vaccinations and nutrient supplements is the fact that there is an implicit deception involved with the passive delivery of nutrients through food and water. that is, when an individual is consuming a fortified food or drinking fluoridated water, the sole and primary purpose of that act of consumption is not necessarily to replenish the nutrient which the food or water is fortified with. the passive consumption of nutrients is in fact the hallmark of these interventions as they do not require any lifestyle change to gain the benefits of consuming the nutrient. this, it can be argued, constitutes an infringement of individuals’ autonomy and their interest in self-determination. ii. ethical frameworks despite the different delivery mechanisms and ailments treated by food fortification and water fluoridation, the similarities regarding intent, passive delivery, and the lack of an informed consent procedure render the two types of public health interventions ethically similar. the corresponding ethical dilemmas and questions regarding intent, passive delivery and the lack of an informed consent necessitate a thorough analysis of the ethical frameworks used to evaluate food fortification and water fluoridation. two examples of ethical frameworks used to evaluate public health interventions are the justificatory approach of james childress and the stewardship model of the nuffield council on bioethics. shakeri, adanty, and kugathasan, ethical framework governing water flouridation, voices in bioethics, vol. 6 (2020) 5 the justificatory approach consists of the following tenets: effectiveness, proportionality, necessity, least infringement and public justification [25]. the stewardship model considers these principles: reduce the risk of ill health, address the health of children, reduce health inequalities, not intervene without the consent of those affected, minimize the interventions that affect important areas of personal life and not coerce ordinary adults to lead healthy lives [26]. mark lawrence applies the justificatory approach for all his food fortification case studies as does niyi awofeso to water fluoridation [27, 28]. jiang et al. and the nuffield council of bioethics use the stewardship model in their evaluation of water fluoridation in new zealand and the united kingdom respectively [22, 29]. table 1. description of the justificatory approach and stewardship model tenets. both of the frameworks have a number of key similarities. category justificatory approach tenet stewardship model tenet 1. intervention is effective in preventing disease effectiveness reduce the risk of ill health 2. intervention gains support from target population public justification no intervention without the consent of those effected 3. minimize the infringement on people’s rights least infringement not to coerce ordinary adults to lead healthy lives table 1 concisely displays how the tenets of both the justificatory approach and stewardship models overlap and agree. nonetheless, differences between the frameworks should not be overlooked, particularly the fact that the stewardship model places a particular interest in the health of children and focuses on health inequalities in the population. despite these differences, ethical analyses of food fortification and water fluoridation shows that similar, even identical frameworks lead to opposite ethical judgements. a distinct example of this is the consideration of coercion by jiang et al. and lawrence. jiang et al. argue that water fluoridation is inherently not coercive as it does not require any lifestyle change [29], while lawrence claims that mandatory folic acid fortification of flour is coercive as it indiscriminately raises folate levels for everyone [27]. this differing definition of the term “coercion”, shows that even within ethical frameworks, having a provision to minimize coercion is not sufficient without an agreed-upon definition of the term. the coercion argument against public water fluoridation is further supported by the availability and near universal, non-coercive use of fluoridated toothpaste. in addition, evidence within the past decade has shown that low chronic daily intake of fluoride is a health risk associated with dental fluorosis and unhealthy fluoride accumulation levels within the body [30]. the passive consumption and the implied deception associated with water fluoridation and food fortification is overlooked by both the justificatory approach and stewardship model. where this definition shakeri, adanty, and kugathasan, ethical framework governing water flouridation, voices in bioethics, vol. 6 (2020) 6 of deception directly relates to the ethics of food fortification and water fluoridation is in the fact that consumers are not necessarily fully aware of the entirety of their foods’ composition. while the fda in the united states does have labeling requirements for fortified foods and salt [31] and also recommends that individuals in a community should know about fluoride levels in their water [32], this does not necessarily override the claim of deception being present in these interventions. with fortified foods, the final consumer of the food is not necessarily the purchaser of the ingredients which the food is made with (as in the case of eating food prepared by someone else). in addition, the knowledge of additional nutrients in the ingredients is further dispersed from the final consumer, perpetuating the deception of fortified foods. douglas cross and robert carton take a more linear view on fluoridation [33]. their argument starts with the fact that the nuremberg code (and all successive ethics codes derived from it) prescribes: “research and routine medical procedures must be done with the voluntary cooperation of the subjects, who must be fully informed of the risks and benefits of the medical procedures in which they are involved”. from this, cross and carton establish that fluoride is a medicine according to definitions from european and american pharmaceutical codes (generally defining medical substances as products used for treating or preventing disease in humans or animals) and point out that fluoride is not governed by the nuremberg code, rendering it unethical. this argument does tap into the problem of deception in water fluoridation, as passive consumption prevents the consumer from being “fully informed of the [procedure’s] risks and benefits”. furthermore, this argument is easily transferrable to food fortification as adding nutrients to food does exhibit the qualities of a medicinal substance: nutrients such as folate and iodine have a preventive role in human illness (folate and iodine prevent neural tube defects and goiter respectively), and also do not fully adhere to the principle of informed consent. conclusion food fortification and water fluoridation interventions are very similar in that they do not involve a direct clinician-patient interaction and rely on the “patient’s” lack of knowledge and passive consumption of the target nutrient. the justificatory approach and the stewardship models both support from an ethical standpoint the processes of water fluoridation and food fortification. nevertheless, both ethical frameworks display shortfalls after careful analysis and considerations of other opinions critical of food fortification and water fluoridation. in light of recent public discourse surrounding the delivery of therapeutics to the public through passive consumption, it is important that we revisit and continue to analyze the ethical frameworks that govern the already widely accepted interventions of food fortification and water fluoridation. references 1. sirtori cr (2014) the pharmacology of statins. pharmacol. res. 88:3–11 2. bishai d, nalubola r (2002) the history of food fortification in the united states: its relevance for current fortification efforts in developing countries. econ dev cult change 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childress jf, faden rr, gaare rd, et al (2002) public health ethics: mapping the terrain. j law, med ethics 30:170–178. https://doi.org/10.1111/j.1748-720x.2002.tb00384.x 26. nuffield council on bioethics (2007) public health: ethical issues 27. lawrence m (mark a (2013) food fortification : the evidence, ethics, and politics of adding nutrients to food. oxford university press 28. peckham s, awofeso n (2014) water fluoridation: a critical review of the physiological effects of ingested fluoride as a public health intervention. scientificworldjournal 2014:293019. https://doi.org/10.1155/2014/293019 29. jiang y, foster page la, mcmillan j, et al (2014) is new zealand water fluoridation justified? n z med j 127:80–6 30. national research council (2006) fluoride in drinking water: a scientific review of epa’s standards. the national academies press, washington, dc 31. center for food safety and applied nutrition (2015) contains nonbinding recommendations 1 questions and answers on fda’s fortification policy guidance for industry 32. u.s. food & drug administration code of federal regulations title 21 food and drugs | fda. https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-anddrugs. accessed 26 jul 2019 33. cross dw, carton rj (2003) fluoridation: a violation of medical ethics and human rights. int j occup environ health 9:24–29. https://doi.org/10.1179/107735203800328830 anekwe, chronicling the tuskegee syphilis study through art, voices in bioethics, vol. 1 (2015) © 2014 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. chronicling the tuskegee syphilis study through art obiora anekwe i first heard about bioethics due to the tuskegee syphilis study, the forty-year clinical trial in which u.s. public health professionals neglected to treat hundreds of african american men who suffered from syphilis. in many ways, bioethics was my birth right. i was born in the john a. andrew memorial hospital in 1974 where the study had taken place. i have had a lifelong curiosity about the ethics of the tuskegee syphilis study and a desire to bring healing to communities such as tuskegee. i want to be able to help vulnerable populations, people who are sometimes voiceless and cannot speak for themselves. my new book, ancestral voices rising up: a collage series on the tuskegee syphilis study, translates the themes of the tuskegee syphilis study while simultaneously discussing ethics, philosophy, and bioethics in a way that everyone would understand. my book is the first published art collage series documenting this notorious study from the perspective of one who was born in the hospital where the study took place. the book highlights thirty art collages i created which historically and visually tell the story of tuskegee from multiple perspectives and insights. i began my art series with a collage about eunice rivers, the nurse who worked with the u.s. public health service to recruit black men into the study. although it was not my intention to complete a series of art pieces two years ago, i often felt the spiritual urging and insistence of countless ancestors affected by the study to tell their story through art. as i created each piece, i began to realize that i could actually educate a whole new generation by interpreting bioethics through a medium that is not often used enough as a vehicle for storytelling and ethical discussion. to my surprise, my pieces have been featured in well-respected research and medical journals such as academic medicine. i have often been told by others that they would not have known about the tuskegee syphilis study if it were not for my artistic renderings of this tragic american story. during the process of creating these works, i began to see the universal connectivity among similar unethical trials such as those conducted on mentally disabled children at the willowbrook facility in staten island and on holocaust victims at auschwitz. i integrated photographs from my travels to auschwitz and the african burial ground national monument in manhattan into my collages about tuskegee to document the commonality between human suffering and global injustice. in various other pieces, i also included photographs i took from the burial headstone sites of tuskegee syphilis study victims at the shiloh cemetery in notasulga, alabama. the integration of these photographs in my collages was significant because participants in the study were provided free burial headstones as a benefit of participating in the study. in fact, many men enrolled in the study due to the benefit of having their burial fees paid for by the u.s. federal government. in other collages, i depicted images of the black church because many african american men who participated in the tuskegee syphilis study where recruited through the black church congregation. these collective collages not only provide unknown historical facts about the study, but they also emphasize how racialized views about medicine persisted during the eugenics movement. these beliefs were shared by many black and white physicians alike and directly influenced the inception of studying syphilis in the black male body due to the unfounded medical belief that blacks were more resistant to syphilis than whites. although the intention of medical professionals was to study this premise until the death of human participants, victims of the study were unaware of the true goal of the study. rather, they were informed that they were actually being treated for syphilis when in reality they were not. anekwe, chronicling the tuskegee syphilis study through art, voices in bioethics, vol. 1 (2015) 2 it is my greatest desire as a bioethicist to translate the story of tuskegee to an audience that otherwise would not have known about it. but more importantly, my hope is that we can learn from the medical mistakes of the past in order to not repeat them again. chronicling the tuskegee syphilis study through art masters, politics of pain, voices in bioethics, vol. 3 (2017) © 2017 alix masters. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduc tion, provided the original author and source are credited. politics of pain: investigating the ethics of palliative care as a global human right alix masters abstract vietnam, a country with a culture strongly imbued with eastern buddhist values, has a long history of rejecting palliative care and pain medications in general. due to this, the world health organization’ declaration that palliative care is a universal human right could also be understood as a western organization blatantly ignoring buddhist cultural traditions. while the declaration of palliative care as a human right is important progress in many ways, it is also important that western medicine not impose our values globally without consideration for the complex histories and belief systems of diverse cultures. keywords: palliative care, pain management, bioethics, global ethics introduction within the last decade, strides have been made in the field of global health policy to extend the reaches of palliative care universally. in 2014, the world health organization formally declared palliative care a global human right.[1] this development in global health policy is a positive one when we consider the medical politics of pain relief across racial difference. both in the united states and abroad, there is a long medical history of discriminatory practices against certain groups of people with regard to pain management—including withholding necessary pain medication altogether. therefore, in many ways the declaration of palliative care as a human right is a necessary step in ensuring all peoples, regardless of identity, have their pain taken seriously by the medical establishment and have their comfort made a medical priority. when we consider how different cultures negotiate beliefs around death and pain relief, however, the issue of palliative care as a universal human right becomes more complex. for example, countries with strong histories of buddhist thought and culture have traditionally opposed the ideology of palliative care.[26] in buddhism, suffering is considered an inextricable part of life and masking this suffering through medical intervention is looked down upon.[2] for example, vietnam, a country with a culture strongly imbued with eastern buddhist values, has a long history of rejecting palliative care and pain medications in general.[26] due to this, the world health organization’ declaration that palliative care is a universal human right could also be understood as a western organization blatantly ignoring buddhist cultural traditions. while the declaration of palliative care as a human right is important progress in many ways, it is also masters, politics of pain, voices in bioethics, vol. 3 (2017) 2 important that western medicine not impose our values globally without consideration for the complex histories and belief systems of diverse cultures. analysis palliative care is defined as specialized medical care aimed at relieving the symptoms and stress of terminal illnesses. it is meant to increase the quality of life for someone suffering from a very serious illness without the prospect of recovery. palliative care often involves the administration of strong opioid medication to relieve severe pain associated with symptoms of advanced disease, as well as provide overall comfort to the patient. palliative care differs from hospice care in that palliative care can be provided along with treatment and does not have concrete time limitations. while hospice care is typically provided by a hospice nurse in the patient’s home or caretaking facility, usually for a patient very close to death, palliative care is provided by a physician typically in a hospital setting for patient who are not necessarily facing imminent death. in 1992, the medical law scholar, margaret somerville, argued relief from suffering is both the goal of palliative care and human rights, and therefore palliative care should be considered a human right.[3. since then, many international health institutions have made statements declaring palliative care as a human right.[4] in 2002, the cape town declaration of south africa declared palliative care, and its associated access to strong opioid pain killers, a universal human right for all its citizens. in 2005, the government of quebec released the montreal statement on the human right to essential medicines which made explicit arguments for the provision of palliative care as part of the international human right to health.[5] most notably, in 2006, pope benedict xvi made a statement emphasizing the importance of palliative care as “essential to preserving human dignity,” and also argued it be formally considered a universal human right.[6] then, in 2014, the world health organization finally made its resolution declaring palliative care as an essential part of healthcare and urging all countries to ensure access to pain medication and palliative care expertise for all citizens.[7] the declaration of palliative care as a human right is groundbreaking considering the history of medical discrimination in the realm of pain-relief. western medical practices have a long and sordid history of maintaining discriminatory and false beliefs about pain tolerances across different races. it is well documented that during the time of slavery in the united states there was a standard of belief that black patients had a much higher tolerance for pain than white patients.[8] as a result, black patients were often operated on without anesthesia even though anesthesia was commonly used on white patients. the rationale hinged on the fact that “unlike blacks, [whites] were unable to stand the pain involved” with surgery.[8] one particular documented case of patient anarcha, a black slave woman and a patient of dr. marion sims, states she endured over thirty experimental gynecological surgeries without anesthesia due to her “alleged superhuman threshold for pain.”[9] infamous slave doctor samuel cartwright of the university of louisiana coined the medical term “rascality,” which described the alleged phenomenon of black enslaved people seeming “to be insensible to pain when subjected to punishment.”[10] furthermore, white american neurologist silas weir mitchell, referred to foreign indigenous patients as “savages” who do “not feel pain as we do: nor as we examine the descending scale of life do animals seem to have the acuteness of pain-sense at which we have arrived.”[11] this logic greatly contributed to the rationale behind the tuskegee syphilis experiment of 1932-1972 during which black male syphilis patients were left untreated for their disease or their pain.[12] this racist history of the western medical establishment’s false ideas about pain difference across races is essential to consider when we discuss contemporary ideas about access to pain relief, and specifically, palliative care. it is especially important to consider this history as it is clear this scientifically false and racist belief system concerning pain continues even in today’s medical practices. increasing contemporary scientific data suggests that black patients continue to receive less pain treatment than their white counterparts. this can be seen in a study, published in 2007, which found american physicians were more likely to underestimate the pain intensity of black masters, politics of pain, voices in bioethics, vol. 3 (2017) 3 patients compared to white patients.[13] a recent study out of the university of virginia surveying medical students and residents found that “58 percent of the study’s general groups said they believed that ‘blacks’ skin is thicker than whites’.”[14] furthermore, the study showed that these same white medical students and residents were unaware of legitimate medical differences between races. for example, “only half of the residents knew that whites are less susceptible to heart disease than blacks.”[15] this phenomenon has become known as the “empathy gap”[16] and it is a global issue. for example, at the university of milano-bicocca in italy, it was found that when subjects “saw white people receiving painful stimulus, they responded more dramatically than they did for black people.”[17] due to these false racist beliefs imbedded in our medical history, black people are also less likely to receive prescriptions for pain killers. furthermore, a 2000 study out of emory university found that “74 percent of white patients with bone fractures received painkillers compared with 50 percent of black patients.”[18] an article published in 2015 found that black children with appendicitis received pain treatment less frequently than their white counterparts.[19] given these continued problems in medical prejudice, it is essential that palliative care, and relief from pain and suffering due to an illness, be considered a right and not a privilege. it is also imperative, however, to consider how other cultures view palliative care and pain relief in general and beyond our borders. for example, nations with strong traditions of buddhist religious practice historically eschew palliative care techniques. this stems from the fact that a fundamental doctrine of buddhist teaching is that life is suffering and that mindful acceptance of the suffering is imperative.[20] furthermore, mindfulness at the time of death is also a major tenet of buddhist belief.[20] therefore, pain medications are often rejected because they are considered to corrupt the mind and lead to haziness rather than alertness at the time of death. this complicates the idea of palliative care as a necessity for every human being because it ignores strongly held cultural beliefs that view the tenets of palliative care as inherently sacrilegious. in buddhism, pain can be lessened through mindful meditation alone, and therefore, pain killers are unnecessary. meditation is the only way to reach true comfort and make peace with pain. there is also an inextricable connection between the mind and the body and, therefore, to the cure the body, you must first cure the mind. while it is easy for western medicine to sneer at another culture’s belief in mediation in lieu of medical pain treatment as primitive, meditation has been found in many medical journals to ease chronic pain.[21] in fact, if we interrogate our own western history of the placebo effect, it is arguable we are engaging in hypocritical cultural condescension when we mock the idea of buddhist meditation as viable medical pain relief. the placebo effect, a well-documented phenomenon within western medical drug administration has been proven time and time again to show that simply the belief in a treatment can make someone’s condition improve, even when there is no active medication being offered. since this is a known phenomenon, upon which western scientific research is mostly based, it is hypocritical of western medical practitioners to mock or overly critique a belief-based approach to pain management in other cultures. vietnam is a country deeply influenced by traditional mahayana buddhist culture.[27] as such, vietnam has been one of the countries strongly opposed to palliative care techniques. in addition to buddhist culture, views on opioids in vietnam are particularly complex given widespread opiophobia, or fear of opiates. this phenomenon largely stems from the vietnam war and hiv epidemic, as well as the nation’s high rates of illegal heroin abuse. while vietnam has been an exporter of opium for many centuries, it was not until the vietnam war that injectable heroin became an epidemic in vietnam. since the latter half of the 20th century, heroin use has grown into a pervasive problem in vietnam, “with an estimated 20,000 addicts, it has the highest prevalence of injection drug abuse in southeast asia.”[22] injectable heroin is also the leading cause of hiv infection in vietnam with an approximate 60% of hiv cases reportedly due to infected needles.”[23] therefore, in vietnam, opioids are often closely associated with hiv infection, strengthening notions of widespread opiophobia. all of this coupled with the previously discussed overarching buddhist culture, this fear of opioids persists even in cases of legitimate medical necessity or pain relief. a study on opioid pain medication availability in vietnam states “we have found exaggerated fears that morphine and other opioid pain medicines will harm patients by causing respiratory depression or addiction, negative language about opioids in vietnamese laws and prime ministerial decrees, and masters, politics of pain, voices in bioethics, vol. 3 (2017) 4 highly restrictive opioid prescribing regulations issued by the ministry of health.”[24] it is no surprise, then, that vietnam’s consumption of medical morphine is miniscule. in fact, according to researchers at the pain & policy studies group at the university of wisconsin, vietnam ranks 122 out of 155 countries studied for their medical morphine use.[25] despite the clear schism between palliative care and buddhist faith, there are important connections between these belief systems that should be culturally explored. for example, both focus on accepting the inevitability of death. palliative care is considered radical in the medical community because it argues that dying is not a failure of medicine but rather an unavoidable part of life that should be embraced and handled with as much dignity as possible. similarly, buddhism also stresses the importance of accepting death, as accepting the inevitability of death of all creatures is what originally inspired the buddha to renounce the material world and devote himself to mindfulness and meditation. both palliative care and buddhism also share the goal of approaching death peacefully. it is simply in the methods that the tenets of palliative care and buddhist belief differ. while traditional western palliative care advocates for the use of pain relief medication to promote comfort and peace before death, buddhist teaching advocates for alert mindfulness and meditation and an embracing of pain. it is important to recognize our differences but also our shared values even across difference as a way to find common ground and hopefully promote cross-cultural understanding and respect. conclusion overall, the issue of naming palliative care as a human right has both positive and negative aspects that need to be considered in the field of ethics. on the one hand, taking into account the western medical world’s long and continued history of underestimating the pain of, and withholding pain treatment from, patients based on their race, the declaration of palliative care as a human right can be seen as a clear progressive step towards ethical justice. however, the western medical establishment must also take into account differing cultural ideas about death and pain relief before it declares what is best for all people. due to its buddhist culture and more recent history of heroin abuse stemming from the vietnam war, the vietnamese are logically wary of the methods of palliative care. it is important that this critique of palliative care be understood and respected by the western medical profession and world health organization. it is essential we preserve the bodily autonomy of vietnamese patients to refuse palliative care without judgement or condescension. rather than focusing on trying to convince cultures of western’s medicine’s superiority, we should be focusing our efforts in making palliative care economically and socially accessible to all who want it. [1] "un: who boosts hope on pain relief, palliative care." human rights watch. n.p., 16 sept. 2015. web. 06 july 2017. [2] masel, eva k. et al. "life is uncertain. death is certain. buddhism and palliative care." journal of pain and symptom management , volume 44 , issue 2 , 307 312 [3] khan, farzana. "palliative care is a human right." academia.edu share research. n.p., n.d. web. 06 july 2017. [4] khan, farzana. "palliative care is a human right." academia.edu share research. n.p., n.d. web. 06 july 2017. [5] khan, farzana. "palliative care is a human right." academia.edu share research. n.p., n.d. web. 06 july 2017. [6] khan, farzana. "palliative care is a human right." academia.edu share research. n.p.,n.d. web. 06 july 2017. [7] "un: who boosts hope on pain relief, palliative care." human rights watch. n.p., 16sept. 2015. web. 06 july 2017. masters, politics of pain, voices in bioethics, vol. 3 (2017) 5 [8] wall, l. l. "the medical ethics of dr j marion sims: a fresh look at the historical record." journal of medical ethics. bmj group, june 2006. web. 06 july 2017 [9] "meet the gynepunks pushing the boundaries of diy gynecology." motherboard. n.p., n.d. web. 06 july 2017. [10] "diseases and peculiarities of the negro race." pbs. public broadcasting service, n.d. web. 06 july 2017. [11] bourke, joanna. "pain sensitivity: an unnatural history from 1800 to 1965." the journal of medical humanities. springer us, 2014. web. 06 july 2017. [12] hoffmana1, kelly m., sophie trawaltera, and and jordan r. axta. "kelly m. hoffman." proceedings of the national academy of sciences. national acad sciences, n.d. web. 06 july 2017. [13] staton, l. j., m. panda, i. chen, i. genao, j. kurz, m. pasanen, et al. "when race matters: disagreement in pain perception between patients and their physicians in primary care." journal of the national medical association. u.s. national library of medicine, may 2007. web. 06 july 2017. [14] somashekhar, sandhya. "the disturbing reason some african american patients may be undertreated for pain." the washington post. [15] somashekhar, sandhya. "the disturbing reason some african american patients may be undertreated for pain." the washington post. wp company, 04 apr. 2016. web. 06 july 2017. [16] silverstein, jason. "i don't feel your pain." slate.com. n.p., 27 june 2013. web. [17] silverstein, jason. "i don't feel your pain." slate.com. n.p., 27 june 2013. web. [18] somashekhar, sandhya. "the disturbing reason some african american patients may be undertreated for pain." the washington post. wp company, 04 apr. 2016. web. 06 july 2017. [19] msce, monika k. goyal md. "racial disparities in pain management for appendicitis."jama pediatrics. american medical association, 01 nov. 2015. web. 06 july 2017. [20] "death and dying in tibetan buddhism." pbs. public broadcasting service, n.d. web. 06 july 2017. [21] bird, cindy. "buddhist meditations to ease chronic pain." the huffington post. thehuffingtonpost.com, 31 oct. 2012. web. 06 july 2017. [22] foreman, judy. the global pain crisis: what everyone needs to know. new york, ny: oxford up, 2017. print. /.latest_citation_text [23] foreman, judy. the global pain crisis: what everyone needs to know. new york, ny: oxford up, 2017. print. [24] krakauer, eric l. et al. "toward safe accessibility of opioid pain medicines in vietnam and other developing countries: a balanced policy method." journal of pain and symptom management, volume 49, issue 5, 916 – 922. [25] foreman, judy. the global pain crisis: what everyone needs to know. new york, ny: oxford up, 2017. print./.latest_citation_text [26]"journal of social work in end-of-life & palliative care." journal of social work in end-of-life & palliative care. n.p., n.d. web. 14 july 2017. [27] hinton, ladson, jane nhauyen tran, cindy tran, and devon hinton. "religious and spiritual dimensions of the vietnamese dementia caregiving experience." hallym international journal of aging : hija. u.s. national library of medicine, 01 jan. 2008. web. 14 july 2017. <https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2949976/>. menconi, want to survive the coronavirus pandemic? voices in bioethics, vol. 6 (2020) * michael menconi is pursuing his ms in bioethics and mph at columbia university. © 2020 michael menconi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. want to survive the coronavirus pandemic? invest in the social determinants of health michael menconi* keywords: medicaid, new york, bioethics, social determinants of health, dsrip introduction local, state, and federal governments are currently responding to the immediate healthcare infrastructure demands created by the covid-19 crisis. in new york city, these responses have included erecting makeshift field hospitals in central park, converting the javits convention center into a 1,000-bed field hospital, and sailing the 1,000-bed usns comfort to pier 88 in manhattan. such unprecedented efforts have required assistance from the new york army national guard, the united states army corps of engineers, and the u.s. navy. simultaneously, government-enacted social distancing measures have been implemented to “flatten the curve.” the predominant consensus among experts is that the combined strategies of widespread social distancing and isolation in conjunction with unprecedented health infrastructure expansion is the only way to avoid reaching a crisis point within the u.s. healthcare system—a disastrous scenario in which hospitals become unable to manage the exponential influx of patients. the situation is most dire in new york city, as the number of confirmed covid-19 cases approaches 165,000. analysis in the background, however, an obscure evidence-based healthcare delivery program designed to serve new york’s most vulnerable populations may be the most effective weapon in addressing resource shortfalls. in fact, this policy has the potential to mitigate the ongoing overflow of new york city’s emergency rooms, intensive care units, and inpatient units, potentially saving countless lives while simultaneously streamlining the massive public health response. this policy is known as the delivery system reform incentive payment program (dsrip), which derives from the current new york state medicaid expansion program. dsrip—a groundbreaking and award-winning medicaid redesign initiative—was implemented in 2015 after governor andrew cuomo signed a deal with the federal government that allowed $8 billion federal medicaid dollars to directly address the social https://www.npr.org/sections/coronavirus-live-updates/2020/03/30/823826987/hospital-ship-usns-comfort-arrives-in-new-york-to-ease-coronavirus-pressure https://www.npr.org/sections/coronavirus-live-updates/2020/03/30/823826987/hospital-ship-usns-comfort-arrives-in-new-york-to-ease-coronavirus-pressure https://www.governor.ny.gov/news/amid-ongoing-covid-19-pandemic-governor-cuomo-announces-regeneron-creating-500000-test-kits https://www.innovations.harvard.edu/medicaid-redesign-team https://www.health.ny.gov/health_care/medicaid/redesign/ menconi, want to survive the coronavirus pandemic? voices in bioethics, vol. 6 (2020) 2 determinants of health (sdh). one of the resulting initiatives, the supportive housing program, has served over 13,000 high-acuity medicaid patients to date. the most recent evaluation of the program demonstrated a 40 percent reduction in hospital days and a 26 percent reduction in emergency room visits. accomplishing this, however, was no simple feat. after patients are temporarily placed in supportive housing, they are assigned a primary care provider and then integrated into a network of social services that include food assistance (subsidies), mental health counseling, and a plethora of other services designed to treat social and clinical ailments simultaneously. many of the program’s beneficiaries suffer from multiple comorbidities including substance abuse and mental health disorders, as well as hiv/aids and other chronic conditions. in the event they contract covid-19, these individuals are at high risk of severe complications, including death. consequently, sdh-inspired initiatives like the supportive housing program not only protect vulnerable medicaid populations from institutional exposure to covid-19 by keeping thousands out of hospitals and clinics during the pandemic, such programs also alleviate strain on an already overwhelmed nyc healthcare infrastructure. with over 5 million medicaid enrollees in new york state—over 3 million of whom reside in one of the five boroughs of new york city—this level of reduction in healthcare service utilization has the potential to save countless lives during the onslaught of a global pandemic. if sdh-inspired programs were scaled to meet the entire new york state medicaid population, hospitals would be left infinitely more prepared to withstand the surge of emergency room visits and hospitalizations. recently, frontline clinicians have raised alarms about the suspicious decrease in heart attacks and strokes showing up in emergency rooms—many experts suggest this may be the unfortunate result of reluctance by the public to seek care in an overwhelmed healthcare system. such significant declines in healthcare utilization will also decrease personal protective equipment (ppe) use. this is critical in the context of the current national shortage. social scientists have long asserted that the key to ameliorating health inequities lies in addressing socioenvironmental factors such as housing insecurity, food insecurity, and inadequate healthcare access. these factors—dictated by race, ethnicity, and socioeconomic status— inevitably lead to health disparities evidenced by the disproportionate burden of chronic disease suffered by the medicaid population. as early as the mid-90’s, sociologists have postulated that access to flexible resources such as money, knowledge, and social capital dictate our health outcomes. this is known as the fundamental cause theory. we have long possessed the intellectual and conceptual tools necessary to identify factors that contribute to systemic health disparities. disparities continuously overburden the healthcare system. when new york city becomes an epicenter of a global pandemic, this burden thrusts the city’s healthcare infrastructure closer to its breaking point. dsrip remains one of the few available strategies capable of avoiding such catastrophe. tragically, barriers to the implementation of such socially conscious policies persist. most healthcare institutions operate with razor-thin margins. many fail to profit at all, only taking in enough revenue to pay their workforce. for example, the new york presbyterian hospital, one of the top-five academic hospitals in the country and one of the nation’s largest, reported only a 2.8% profit margin in 2018. while sdh-informed initiatives stemming from dsrip have proven cost effective in the long term, healthcare institutions are responsible for creating and implementing the infrastructure required of these programs, in addition to covering up-front costs. the most expensive and resourceintensive intervention in the dsrip program was the creation of health homes. these are not physical spaces like those employed in the aforementioned supportive housing program, but rather highly integrated resource networks that provide social services, housing and food services (subsidies), and healthcare management for high-risk members of the medicaid population. https://www.health.ny.gov/health_care/medicaid/redesign/supportive_housing/evaluation.htm https://www.health.ny.gov/health_care/medicaid/redesign/supportive_housing/evaluation.htm https://www.health.ny.gov/health_care/medicaid/redesign/2017/docs/mrt_evaluation.pdf https://www.health.ny.gov/health_care/medicaid/redesign/2017/docs/mrt_evaluation.pdf https://www.nytimes.com/2020/04/06/well/live/coronavirus-doctors-hospitals-emergency-care-heart-attack-stroke.html https://journals.sagepub.com/doi/10.1177/0022146510383498 https://www.ahd.com/free_profile.php?hcfa_id=470152be04c675460087661ddc61ef5a&ek=618fb60ee3d7cb296c2f64f9ce4e88e1 https://www.health.ny.gov/health_care/medicaid/program/medicaid_health_homes/ menconi, want to survive the coronavirus pandemic? voices in bioethics, vol. 6 (2020) 3 conclusion as long as the institutional cost savings of addressing social determinants of health are only realized longitudinally, revenue-conscious c-suite executives will continue to supplant humanity with corporate interests, thus avoiding implementing many of dsrip’s most efficacious interventions. both federal and state governments must bear some of the upfront cost of these programs by increasing the flow of medicaid dollars to dsrip, thus incentivizing healthcare institutions to provide the program’s infrastructure. the results, while not immediate, will indisputably improve health outcomes for new york city’s most vulnerable populations while simultaneously increasing preparedness for the next global public health crisis. anekwe, unheard voices, voices in bioethics, (vol.1) 2015 © 2015 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. unheard voices of willowbrook obiora anekwe during the celebration of rosh hashanah (jewish new year) on september 25th, 2014, i conducted a daylong research endeavor at the archives office of the college of staten island in staten island, new york. my goal was to gather research information to prepare for a special education course presentation about the willowbrook state school. ironically, the land that once occupied the residential facility of willowbrook state school now houses the buildings of the college of staten island. willowbrook state school was once a state-supported institution for children with intellectual disabilities located in the willowbrook neighborhood on staten island in new york city from 1947 until 1987. the school that had been designed for 4,000 patients eventually became a physical dumping ground for mentally disabled children, eventually servicing well over 6,000 patients. the facility was understaffed. patients were routinely locked in their rooms for extended lengths of time and forced to sleep on floors covered in their own excrement. many children within the facility were malnourished because they were underfed. when patients were not locked in their rooms, they frequently ran the hallways partially dressed or even naked. between 1963 and 1966, medical studies were conducted on children within the residential school, infecting them with hepatitis. in some cases, some patients were fed the fecal matter of other infected patients. throughout the first decade of willowbrook’s operation, outbreaks of hepatitis, primarily hepatitis a, were common at the school. these outbreaks led to a controversial and unethical medical study conducted between the mid-1950s up to the 1970s by medical researchers saul krugman and robert w. mccollum. these researchers conducted their experiments without the informed consent of patients or their guardians. throughout this experiment, the researchers monitored patients with hepatitis in order to measure the effects of gamma globulin in combating the disease. the college archives office location where i conducted my research was once the location of the main administration building for the willowbrook state school. even though i conducted most of my research that day in the archives office, my practical research of this significant subject matter began by photographing some of the former abandoned buildings of willowbrook. as i took photographs of my physical surroundings, i felt the universality of injustice conducted by humankind. whether it be medical or educational in nature, these lingering ties are atrocities that bind us. i thought about the tuskegee syphilis study, the jewish holocaust in europe, and other unreasonable tragedies that have harmed our global community. it was the spirit and nature of willowbrook that resounded in my collective consciousness. i felt as if i had been there in some other space or time. one particular abandoned building instantly grabbed my attention. i quickly decided to photograph this brick building on what seemed to be one of the rainiest days i had recently seen. this abandoned building apparently once housed one of willowbrook's facilities. its windows are now boarded up in dark brown wood. the dreariness of this day made the impact of taking photographs of the building even more dramatic and resonating. a few days after conducting research at the college of staten island, i began to reflect on ways in which i could tell the story of willowbrook. as i contemplated various ideas, i thought that a collage depicting the abandoned building would shed light on the disabled men, women, and children who once called willowbrook home. as depicted in image 1, the collage is a mixture of my building photograph and visual images i photographed at an exhibition about willowbrook (see image 2). in the artistic collage image entitled, unheard voices of willowbrook, i highlight how, in many instances, our most vulnerable black and latino children were unethically treated within anekwe, unheard voices, voices in bioethics, vol. 1 (2015) 2 the willowbrook facility. in the collage image, we can visually see this old abandoned building which may have medically treated and housed residents at willowbrook. at the left sided boarded window, i placed photographs of two older african american elders (male and female) who once lived at willowbrook. i blackened their faces in order to empathize the concept of confidentiality. through their hollowed and blackened eyes, i hear the tales of a thousand ancestral voices. but within the middle boarded window, i decided to leave two photographs of a young latino boy’s eyes visible in order to shed light on the lack of humanity shown toward young people. the right hand boarded window in the collage shows how young children were systematically impacted by unethical medical studies at willowbrook, i left the middle area of this right sided boarded window empty in order to symbolize the voided space of unheard voices of victims affected by willowbrook. now, as i think of willowbrook and all the countless mistakes that were made there, i am reminded that we, as educators and bioethicists, are called to serve those in greatest need, to right the wrongs of the past, and to go forth with the greatest promise of our calling. zimmerman, erosion and culture, voices in bioethics, vol. 9 (2023) * luke zimmerman, ba candidate davidson college © 2023 luke zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. erosion and culture: an examination of climate displacement in coastal louisiana luke zimmerman* keywords: erosion, environmental ethics, flooding, climate migration, displacement, climate disaster introduction on the louisiana coast, erosion and flooding threaten the survival of the indigenous villages of pointe-auchien and isle de jean charles. oil companies have submerged the bayou by cutting canals through the land, causing erosion, saltwater intrusion, and sea level rise. 1 additionally, the fuel these companies produce contributes to climate change, which causes an even greater rise in sea levels. the presence of the oil industry also hurts the shrimp and fish industries, which are critical to indigenous culture. eventually, climate change will make the louisiana coast uninhabitable.2 displacement has already begun on isle de jean charles: there were 78 homes on the island in 2002 but only 25 in 2012.3 some call it migration, which implies an intentional decision. displacement reflects the reality that these people are relocating as a last resort. displacement can also be more than just physical. people living in an environment that is “drastically altered and degraded” can experience the same stress and risks as those who are physically relocated.4 the coastal tribes (pointe-au-chien indian tribe and biloxi-chitimacha-choctaw indians) face an uphill battle in the effort to keep community members safe from flooding without sacrificing the culture that is so tied to this land. however, moving to a place free from climate disasters is not necessarily safer for the community if it destroys the culture; therefore, we need to redefine safety. in this paper, i will address the plans currently underway to solve these problems and explain the steps we need to take to keep these communities safe from flooding while preventing cultural loss. i. current perspectives there are disagreements among scholars and journalists on how to best approach climate displacement, the forced migration caused by climate change, in louisiana. jake bittle, author of the great displacement: climate change and the next american migration, thinks that displacement is inevitable and that we should not subsidize families living in risky places through affordable flood insurance. instead, the united states should focus on helping people relocate by making it easier for people in dangerous locations to find and pay for housing in safer places.5 while the cultural extinction of tribes on the louisiana coast devastates bittle, he accepts it. his proposed solutions focus more on protecting people from danger because he thinks zimmerman, erosion and culture, voices in bioethics, vol. 9 (2023) 2 cultural extinction will be hard to avoid. he sees a future in which coastal louisiana is unlivable and such environmental circumstances will force community members to disperse. others argue that affordable flood insurance near the coast is vital for families who decide to stay put and keep their community together as long as possible. high insurance prices would displace locals regardless of the success of restoration efforts.6 many residents agree. they take pride in being adaptable and overcoming challenges. resilience, the ability to respond to stress and maintain system identity and function, is important to the people living on the louisiana coast.7 after hurricane katrina, many households have kept only what they need in their home and are ready to rebuild and stay in place after a storm.8 however, environmental changes are becoming more rapid. storms and floods will become more frequent and severe until the coast is no longer livable. ii. approaches as solutions attempt to balance safety from floods with holding a culture together, it is crucial that indigenous community members are involved in decision making. when governments use cost-benefit analysis to decide on solutions and where to prioritize protection, they often neglect culture and underestimate the downsides of moving inland.9 working with native groups to understand their priorities is important. the united states has a history of forced relocation of indigenous groups. the 1830 indian removal act forced five native american tribes in the southeast to move to what is now oklahoma. isle de jean charles is the result of the biloxi-chitimacha-choctaw indians escaping that move. forced removals are a violation of human rights. indian removal in the 1800s involved death and cruelty, and it was difficult for communities to thrive in a new place after displacement. we need to ensure nothing resembling forced removal occurs again. migration must happen only if the indigenous communities feel it is best for them. as long as indigenous communities are empowered to choose their path, the government must play a pivotal role in aiding adaptation and relocation. we need a government agency dedicated to the issue of climate displacement.10 currently, most funding comes after a specific disaster such as a hurricane. there is less funding to help communities facing more gradual forms of climate change like rising sea levels and coastal erosion. the stafford disaster relief and emergency assistance act should give the federal emergency management agency (fema) a greater ability to deal with “slow, ongoing climate-induced environmental changes.”11 the legislation requires a presidential disaster declaration for federal funds to be used toward disaster recovery and hazard mitigation efforts.12 much more federal assistance is available for immediate threats than for communities suffering from slow changes. federal support should put as much effort towards assisting relocation as is put towards rebuilding. government-assisted relocation is not without precedent. franklin d. roosevelt created the resettlement administration, one of the public programs he enacted during the new deal in the 1930s, which relocated struggling families to neighborhoods planned by the federal government. agencies can apply the same principles to help families whose neighborhoods are being lost to rising sea levels. fema has started to include the possibility for community relocation in its plans, but the current process has flaws. in august of 2022, the federal government created a community-driven relocation subcommittee led by fema and the u.s. department of the interior. the goal of this subcommittee is to connect communities that want to relocate with the resources available to them. the program is voluntary and supports groups that want to move to a safer place or whose habitat has become unlivable. with that said, the government does not always meet the communities’ needs. the isle de jean charles resettlement zimmerman, erosion and culture, voices in bioethics, vol. 9 (2023) 3 project, for example, chose a new site that “lacked direct access to the water that had sustained the island tribe for generations.”13 when movement becomes necessary, preventing cultural extinction is difficult. additionally, some fear that the local government will allow the newly uninhabited land to be used for tourism.14 the government encouraging a native tribe to move out for the sake of increasing tourism on the coast would show a lack of integrity, but there is no problem if the move is voluntary and the government has no ulterior motives. the government needs to dedicate resources to helping tribal communities, either by helping them find a way to keep living in their current locations and adapt to the changing landscape or by helping them relocate to a new location. the state of louisiana is expecting isle de jean charles to be gone by 2050, and pointe-au-chien will be underwater not long after that.15 whatever these communities choose in the short term, they will eventually need to find a new place to live. the sooner they start planning for that transition, the smoother it will be. continuously rebuilding after storms puts a strain on our public resources. the more people that live in places susceptible to dangerous hurricanes, the less aid will be available to each family. however, the strain on the system is worth it because of the value of keeping a culture together. displacement is unavoidable in the long term. the end goal for these communities is to keep their culture alive as they transition to a new space, which is tough due to their connection to the land. certain overarching guidelines for climate relocation will give these tribes a better chance of both upholding culture and staying safe from coastal erosion. the fundamental principle is self-determination, meaning that the community can freely develop their culture and make their own decisions about internal governance. it is important that community members lead the relocation process. when they move, indigenous communities need the “right to safe and sanitary housing, potable water, education, and other basic amenities.”16 managing movement in a way that listens to the needs of indigenous groups will help minimize cultural loss, but the connection to the specific place makes migration a threat to the culture. many people living in native tribes on the louisiana coast have a strong attachment to their village, so resettlement will hurt the community. the tribes have spent years developing skills and knowledge specifically tied to the place they live, such as tailored fishing and shrimping practices.17 at some point, displacement will become obligatory, and they will lose some history and culture, but collaboration between the government and communities can lessen the downsides of relocation to safer land. as an alternative to community wide resettlement, the government could also help individual families looking to move to a safer place. for people to move to places less affected by climate change, affordable housing must be available. tax credits for people starting mortgages in new cities are one way to provide post-disaster aid. 18 more funding for housing vouchers would help people find places to rent in safe locations in louisiana or other states. expanding affordable housing in major cities would create an attractive option for people that need to leave the coast. this solution has drawbacks, as a city is a stark difference from a coastal town and could be a culture shock. however, it is still beneficial for coastal residents to have an affordable option if they decide or if environmental conditions force them to move. conclusion the government needs to assist households and indigenous communities with combating climate change in their chosen way. for now, the tribes of pointe-au-chien and isles de jean charles should choose if they want to adapt to living on the louisiana coast or move out. in the long term, displacement is inevitable. the government should support indigenous families in finding an affordable place to live somewhere with a temperate environment, protected from rising seas, and access to fresh water.19 any program, whether governmental or led by nonprofits, should help communities relocate in a way that allows them to continue zimmerman, erosion and culture, voices in bioethics, vol. 9 (2023) 4 traditional practices and keep their culture alive. also, making plans to adjust to climate change cannot make us forget about serious efforts to reduce emissions and find ways to sequester carbon from the atmosphere to reverse climate change. in sum, coastal erosion and cultural loss in louisiana is a “wicked problem,” a problem that is complex and has unclear solutions. 20 families that stay on the coast are vulnerable to floods and destruction, but relocating without losing culture is a nearly insurmountable task. the best way forward is to let the indigenous communities be the guiding voice. 1 patty ferguson-bohnee, “the impacts of coastal erosion on tribal cultural heritage,” forum journal 29, no. 4 (summer 2015): 60, muse.jhu.edu/article/587542. 2 anya groner, “when the place you live becomes unlivable,” the atlantic, october 13, 2021, https://www.theatlantic.com/culture/archive/2021/10/when-place-you-live-becomes-unlivable/620374/. 3 julie koppel maldonado et al., “the impact of climate change on tribal communities in the us: displacement, relocation, and human rights,” in climate change and indigenous peoples in the united states, ed. julie koppel maldonado, benedict colombi, and rajul pandya (switzerland: springer international publishing, 2014), 98. 4 julie koppel maldonado, “a multiple knowledge approach for adaptation to environmental change: lessons learned from coastal louisiana's tribal communities,” journal of political ecology 21, no. 1 (2014): 70, https://doi.org/10.2458/v21i1.21125. 5 jake bittle, the great displacement: climate change and the next american migration (new york: simon & schuster, 2023), 282. 6 kevin fox gotham, “coastal restoration as contested terrain: climate change and the political economy of risk reduction in louisiana,” sociological forum 31, no. s1 (september 2016): 800, https://doi.org/10.1111/socf.1227. 7 fikret berkes, “environmental governance for the anthropocene? social-ecological systems, resilience, and collaborative learning,” sustainability 9, no.7 (2017): 5, https://doi.org/10.3390/su9071232. 8 jessica r.z. simms, “‘why would i live anyplace else?’: resilience, sense of place, and possibilities of migration in coastal louisiana,” journal of coastal research 33, no. 2 (march 2017): 413, http://www.jstor.org/stable/44161446. 9 maldonado, “multiple knowledge approach,” 73. 10 maldonado et al., “displacement, relocation, and human rights,” 100. 11 maldonado et al., “displacement, relocation, and human rights,” 101. 12 robin bronen, “climate-induced community relocations: creating an adaptive governance framework based in human rights doctrine,” n.y.u. review of law and social change 35 (2011): 366. 13 bittle, great displacement, 133. 14 bittle, great displacement, 133. 15 maldonado et al., “displacement, relocation, and human rights,” 98. 16 maldonado et al., “displacement, relocation, and human rights,” 103. 17 simms, “‘why would i live anyplace else?’” 413. 18 bittle, great displacement, 280. 19 bittle, great displacement, 274. zimmerman, erosion and culture, voices in bioethics, vol. 9 (2023) 5 20 horst w. j. rittel et al., “dilemmas in a general theory of planning,” policy sciences 4 (1973): 155-169, https://doi.org/10.1007/bf01405730. van geem, app supports the compassionate use of cannabinoids for children , voices in bioethics, vol. 1 (2014-15) © 2015 kevin van geem. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. app supports the compassionate use of cannabinoids for children kevin van geem keywords: compassionate use, bioethics, ethics introduction on january 26th, 2015, the american academy of pediatrics (a.a.p.) released its first official position on marijuana usage since 2004, which will appear in print in march of this year1. the a.a.p. currently opposes the use of marijuana by children under the age of 21 yet “strongly supports the decriminalization of marijuana use.” 2more importantly “the a.a.p. recognizes that marijuana may currently be an option for cannabinoid administration for children with life-limiting or severely debilitating conditions and for whom current therapies are inadequate.” 2this is a stark departure from the 2004 a.a.p.’s firm opposition to the legalization of marijuana. the reason for this change in attitude can be attributed to the growing scientific literature on the benefits of marijuana–more specifically the active chemicals in marijuana, cannabinoids– for numerous diseases. research has indicated cannabinoids can be used to treat the muscle tightness associated with multiple sclerosis (m.s.), epilepsy, glaucoma, tics, tremors, and migraine.3 however, because the united states drug enforcement administration (d.e.a.) has classified marijuana as a schedule i drug, research with cannabinoids is extremely difficult. class i drugs are those “with no currently accepted medical use and a high potential for abuse” and include drugs like heroin, l.s.d. (acid), and m.d.m.a. (ecstasy).4however the growing literature about marijuana’s medicinal properties is proving this categorization to be erroneously applied to marijuana. for this reason, the a.a.p. is now advocating a recategorization of marijuana to a schedule ii drug that would allow for more research to be done as to its safety and efficacy. a major ethical issue arises in the consideration of giving children cannabinoids; is it morally acceptable to give a schedule i drug to children even if it may treat a life-limiting disease? analysis one element of this discussion should be to clarify what exact chemical would be given to children. the two most abundant chemicals present in marijuana are δ(9)-tetrahydrocannabinol (t.h.c.), a psychoactive cannabinoid, and cannabidiol (c.b.d.), which is not psychoactive, but does seem to have neuroprotective properties.3the drug to be provided in compassionate usage cases for pediatric patients would be c.b.d. this is a subtle but important distinction that has the potential to be ignored in discussions of the ethics of providing children with medical cannabinoids. psychoactivity aside, the medical usage of cannabinoids may cause significant mortality and morbidity. marijuana has been linked to atrial fibrillation, which in turn is associated with a 1.5-1.9 fold increase in risk of death as compared to individuals without atrial fibrillation.3and although it can be useful in treating debilitating seizure disorders such as dravet syndrome or lennox-gastaut syndrome (l.g.s.), marijuana usage has been linked to late onset epilepsy.5 these issues require more research to determine c.b.d.’s safety as well as efficacy. the moral acceptability of treating children with cannabinoids rests in a balance of whether the good to be gained through a reduction in symptoms outweighs the potential harm in giving children a schedule i drug. in pediatric epilepsy patients who cannot learn to walk, or talk due to the frequency and intensity of their seizures, and who are not responsive to currently available prescription medicines, marijuana may provide their best chance at limiting their seizures to the point of regaining some function. if for example a typical child van geem, app supports the compassionate use of cannabinoids for children, voices in bioethics, vol. 1 (2014-15) 2 suffering from l.g.s. has multiple seizures of different kinds in a day,6and they are best treated through the use of cannabinoids, the potential harms of increased cardiovascular events, or potential abuse would not outweigh the benefit of reduced seizures and increased function. conclusion ultimately the strongest argument for or against the use of c.b.d. to treat patients of all ages will come from scientific evidence, which will be more easily gained if marijuana can be re-categorized. because statistically powerful scientific evidence will be hard to come by if c.b.d. remains a schedule i drug, pediatricians who decide to prescribe compassionate use cannabinoids have an ethical duty–rooted in their commitment to evidence-based medicine, and a fiduciary duty to their patients–to publish the results of the compassionate use of c.b.d. as a case study in order to continue the evidence for or against c.b.d.r you. 1 american academy of pediatrics committee on substance abuse and committee on adolescence, “legalization of marijuana: potential impact on youth,” pediatrics, 113, no. 6 (june 2004): 1825-1826. 2 american academy of pediatrics committee on substance abuse and committee on adolescence, “legalization of marijuana: potential impact on youth update,” pediatrics, 135, no. 3 (march 2015). originally published online january 26, 2015; doi: 10.1542/peds.2014-4146. 3 selim r benbadis, juan sanchez-ramos, ali bozorg, melissa giarratano, kavita kalidas, lara katzin, derrick robertson, tuan vu, amanda smith, theresa zesiewicz, “medical marijuana in neurology,” expert review of neurotherapeutics, 14, no. 12 (december 2014): 1453-1465. 4 “drug scheduling,” united states drug enforcement administration, accessed january 31, 2015, http://www.dea.gov/druginfo/ds.shtml. 5 “atrial fibrillation,” medscape, last updated november 24, 2014, http://emedicine.medscape.com/article/151066-overview. 6 yannick fogoum fogang, massaman camara, paul chimi mbonda, , dènahin toffa, kamadore touré, “late onset epilepsy associated with marijuana abuse: a case report with mri findings,” the pan african medical journal 17, (march 2014): 158, doi: 10.11604/pamj.2014.17.158.2402. cheung, normalizing bribes as a solution to romania’s deteriorating health system, voices in bioethics, vol. 2 (2016) © 2016 allison cheung. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. normalizing bribes as a solution to romania’s deteriorating health system allison cheung keywords: romania, bribes, essay, contest introduction there is an old romanian folk tale about a young boy and a magical ox named tellerchen. the boy, abandoned by his cruel stepmother, is starving when he is found by a kind, rich man. the young boy works on the man’s farm for seven years, and when he is finally old enough to leave, the rich man gifts the boy with tellerchen, the magical ox, as a thank you for the years of hard work. tellerchen has the ability to produce just enough bread and wine from his horns to feed the boy. the boy returns home, hoping to regain the favor of his stepmother, but she is jealous of the boy’s good fortune and demands that the boy slaughter the ox. the boy is distraught, and that night, tries to set tellerchen free. however, tellerchen tells the boy to trust that it is okay have him slaughtered. the ox tells him to save only his horn after he is killed and to open the horn once he is far away. the boy reluctantly slaughters tellerchen the next day, saving only the horn before his stepmother banishes him from his home. the boy is starving without tellerchen and desperately wishes that he had not slaughtered his magical ox. however, the boy remembers to open tellerchen’s horn, and a herd of magical oxen appears, with powers even greater than tellerchen’s. the boy is saved from starvation, and he lives the rest of his days wealthy and prosperous. the moral of the story? a seemingly unthinkable action, which may appear to lead to negative consequences, can, with trust and faith, instead favor those brave enough to take the leap. and in no time and place is this more applicable than in romania’s current healthcare situation. romania’s health system is currently perched on a dangerous precipiceit faces a major dual dilemma of a “brain drain” of romanian physicians to other european countries, as well as negative health outcomes from the widespread practice of bribery in physicians and other healthcare practitioners. compared to their western counterparts, romanian physicians lack prestige, power, and profits, a dangerous lack of incentives for an already weak health system. analysis romania’s current healthcare problems has roots in the mid-20th century, during which both the west and the east experienced their own revolutions. in the west, a scientific revolution. in the east, especially across eastern europe, a communist one. though romania was only officially within communism’s chokehold for about forty years, the bruises from this indelible part of romania’s history are apparent even now, almost thirty years later. while mid-twentieth century physicians in western europe and the united states were blessed with a golden age, in which medicine was glamorized in popular media and shined with “miracle” breakthroughs, romanian physicians were suppressed under a communist rule that favored the common farmer and factory worker over the intellectual. and now, that historic disregard for physicians has translated into a weak foundation for healthcare in romania. as a result, its healthcare remains severely underfunded, and physicians are emigrating in search of better cheung, normalizing bribes as a solution to romania’s deteriorating health system, voices in bioethics, vol. 2 (2016) 2 status and higher wages. romanian-born and educated doctors are fleeing the nation as if escaping from a plague, and the impact of such is nearly as deadly. in 2011, there were 21,400 doctors in romania. as of november of 2013, there were 14,400.1 romania has lost nearly a third of its skilled physicians to the uk and other countries in the european union, and the number of romanian doctors emigrating to work abroad has rocketed since. this mass exodus of thousands of highly-skilled physicians is taking its toll on the country, in almost ridiculous statistics. for a population of 19 million, romania has only 48 radiotherapy physicians, despite high rates of cancer across the country, and only 54 geriatric physicians, despite the ageing population.2 in comparison to its central and eastern european peers, in bulgaria, hungary, and the czech republic, romania has the lowest life expectancy at birth, the highest infant mortality rate, and the highest incidence rates of aids, tuberculosis, and syphilis.3 the root of the problem is that romanian doctors are not being paid enough. romanian doctors earn a measly 400 euros a month, 4 which is hardly enough to support themselves, let alone a family. wages are an alarming eight to ten times higher abroad than in romania.5 thus, it is no surprise that romanian physicians are emigrating for better working conditions and higher financial benefits. however, an even more significant implication of romania’s inability to provide sufficient physician wages is the toxic bribery culture that has erupted within its health system. in 2014, romania was found to be the second most corrupt country in the european union, and within the health field, some physicians refuse to even treat patients without a bribe. 6 sadly, stories of impoverished romanians ignored in hospitals because they lack the money for a bribe, or a woman in labor being coerced into a bribe to just have her child birthed are common anecdotal woes. here as well, romania’s communist history has played a role in normalizing bribes. during the communist regime, it was common practice to use bribes to acquire scarce products, and as healthcare is now also becoming a scarce product, with the lack of doctors, so must bribery seem socially acceptable. with a measly 3.6% of romanian gdp allocated to healthcare, compared to 11% in both germany and france,7 the nation spends the least on healthcare compared to any other country in the european union.8 however, with the current state of the economy, it does not seem feasible for the government to subsidize physician wages. on the other hand, instead of seeking to extinguish bribes, romania should legalize bribes and build these “informal payments” into healthcare costs. it is time for romania to modify its socialized medical insurance by introducing a copayment system that will place some responsibility for payment on its citizens in a legitimatized fashion. romania’s current mandatory health insurance system has been chronically underfunded, and complete government support for all healthcare is unsustainable. many romanians are already paying for these higher healthcare costs through bribes, with about 25% of romanians reporting that a doctor or nurse had pressured them into paying a bribe for medical service. 9 legalizing these informal payments will give the romanian government the authority to standardize prices across hospitals and physicians, as well as more closely monitor payment practices to ensure equity amongst all patients. this proposal may seem like a radical step. however, a similar plan was enacted in 1997 in cambodia, a country that, like romania, has also had a communist past and a crippling bribery issue. a formal fee schedule was introduced, with the informal payments built into the cost of healthcare.10 and for critics wary of increasing the financial burden on patients, after just one year of reform, patients were actually paying less than they had paid before the reforms. in short, these informal payments were replaced by formal payments, and this change did not add much additional financial burden to cambodian patients because the government was able to standardize prices of these supplementary payments. when a similar program was introduced in albania in the early 2000s, some physicians even saw their incomes quadruple.11 not only will this plan provide better equity of care to all citizens, but physicians will also receive higher wages and will hopefully retain romanian physicians. in an effort to promote health equity, government funds can be used to give cash vouchers to the poorest in the nation so that they can afford these copayments. this will allow a better, more efficient use of government funds than the current health insurance system allows. conclusion romania needs a bold step like this to halt the deterioration of its health system. action is needed now to stop the bleeding out of physicians from romania before the country becomes too weakened. with over cheung, normalizing bribes as a solution to romania’s deteriorating health system, voices in bioethics, vol. 2 (2016) 3 19 million lives on the line, maybe it’s time for this small eastern european nation to take back control over its current trajectory and to remedy the consequences of its past. i’m sure that tellerchen would agree. 1 gillet, kit, and matthew taylor. "romanian health service in crisis as doctors leave for uk and other states." the guardian, february 2, 2014. 2 ibid. 3 world health organization. "highlights on health in romania." (1999). 4 lungescu, oana. "romanian healthcare on verge of collapse." bbc news europe, august 12, 2010. 5 toma, diana. "romania’s health service on brink of collapse." world socialist web site. last modified june 18, 2010. accessed june 29, 2016. https://www.wsws.org/en/articles/2010/06/roma-j18.html. 6 transparency international. corruption perceptions index 2014: results. corruption perceptions index. n.p.: n.p., 2014. 7 "health expenditure, total (% of gdp)." in the world bank. 2015. last modified 2015. accessed june 29, 2016. http://data.worldbank.org/indicator/sh.xpd.totl.zs. 8 lungescu, oana. "romanian healthcare on verge of collapse." bbc news europe, august 12, 2010. 9 european commission. corruption. special eurobarometer 397. n.p.: n.p., 2014. 10 vian, taryn. "corruption in the health sector: informal payments." lecture, boston university school of public health, boston, ma. 11 vian, taryn. "corruption in the health sector: informal payments." lecture, boston university school of public health, boston, ma. introduction analysis conclusion romania needs a bold step like this to halt the deterioration of its health system. action is needed now to stop the bleeding out of physicians from romania before the country becomes too weakened. with over 19 million lives on the line, maybe it’s ... tf_template_word_mac_2011 devlin, compensation in medical research, voices in bioethics, vol. 6 (2020) devlin, compensation in medical research, voices in bioethics, vol. 6 (2020) compensation in medical research: is money the problem? amie devlin* abstract the ethics of compensating research participants is perpetually debated, with opponents claiming that compensation is coercive. yet coercive financial arrangements are commonplace, such as in the labor market where employees perform tasks in exchange for money. this article compares research participation to another risky profession – firefighting by examining four key areas: risk level, motivations, worker protections, and societal benefits. while firefighting is heralded as a noble profession, compensation for participating in research is looked upon with scorn. to protect participant autonomy and avoid paternalism, participants must also make their own decisions, even if that decision is to participate in exchange for money. introduction when reviewing research protocols, institutional review board (irb) members determine whether an investigator has selected an appropriate level of compensation for study participants. one of the arguments against providing too high a level of compensation is that the promise of financial gain will entice a potential participant to make a different decision than what they would have made in the absence of compensation. perhaps the debate should not be whether money changes a person’s behavior, but whether it is unethical that money have that effect. as many scholars have pointed out,[endnoteref:1] we live in a world that is full of financial enticements. financial compensation is the basis of our labor market in which individuals perform tasks in exchange for money. just as in research, financial compensation in the labor market is used as motivation for a person to complete a task that they would be unlikely to do in the absence of compensation.[endnoteref:2] the purpose of this article is to critically compare medical research participation to another risky profession, firefighting, in four key areas: level of risk, motivations, worker protections, and societal benefits. [1: grant, ruth w., and jeremy sugarman. “ethics in human subjects research: do incentives matter?” journal of medicine and philosophy 29, no. 6 (december 1, 2004): 717–38. https://doi.org/10.1080/03605310490883046; emanuel, ezekiel j. “undue inducement: nonsense on stilts?” the american journal of bioethics 5, no. 5 (september 1, 2005): 9–13. https://doi.org/10.1080/15265160500244959. ] [2: largent, emily a., christine grady, franklin g. miller, and alan wertheimer. “money, coercion, and undue inducement: a survey of attitudes about payments to research participants.” irb 34, no. 1 (2012): 1–8. ] discussion i. level of risk while not all employment situations come with an assumption of risk, firefighting is one that is inherently risky. the risk is offset by a high level of societal benefit and financial reward, resulting in an overall positive risk-benefit ratio. in general, firefighters are held up as heroes and revered for their service. in many medical research studies, study participants assume a certain level of risk in turn for compensation. yet the attitude of reverence does not extend to paid research participants. when tragedy strikes in a clinical trial, rather than respectfully upholding those who were harmed as heroes, monetary compensation is scrutinized. following the tragic tgn1412 trial, ezekiel emanuel stated that “almost all press reports and commentaries have mentioned that the healthy research participants were paid £2000 for enrolling in a phase one trial of a new agent produced by a for-profit company, as if this necessarily signified the trial was ethically questionable.”[endnoteref:3] [3: emanuel, ezekiel j., and franklin g. miller. “money and distorted ethical judgments about research: ethical assessment of the tegenero tgn1412 trial.” the american journal of bioethics 7, no. 2 (march 2007): 76–81. https://doi.org/10.1080/15265160601111800. ] the discrepancy in responses following a tragedy illuminates the different ways in which the contributions of firefighters versus clinical research participants are viewed: fallen firefighters are upheld as heroes in the wake of tragedy whereas, clinical research participants are not. while the participants are not necessarily criticized, suggestions are made that the participants were recruited using unsavory methods. the structure that pays firefighters is not subject to similar scrutiny for enticing them to take risk. ii. motivations firefighters and clinical research participants have similar motivations for offering their service. while some firefighters assume the role because of a sense of altruism,[endnoteref:4] others choose to pursue firefighting as their profession. receipt of financial compensation for their services does not diminish the nobility of their action. among career firefighters, it is reasonable to assume that they may have made a different choice if there were no payment, yet rarely is a firefighter’s salary seen as coercive. [4: firmin, michael w, kristin dewitt, heidi gibbs ellis, lauren a smith, and nicole m tiffan. “a qualitative study of the motivations and affiliation dynamics involved with a firefighting career.” american journal of qualitative research 2, no. 2 (2018):60-74. ] similarly, research has shown that many research participants join clinical trials due to a sense of altruism,[endnoteref:5] yet many others do so for financial compensation. even among those primarily motivated by financial gain, many factors play into their decision.[endnoteref:6] both firefighters and clinical research participants accept financial compensation for their service, yet it is only research participant compensation that is viewed as coercive. [5: ferguson, pamela r. “clinical trials and healthy volunteers.” medical law review 16, no. 1 (march 1, 2008): 23–51. https://doi.org/10.1093/medlaw/fwm020. ] [6: stunkel, leanne, and christine grady. “more than the money: a review of the literature examining healthy volunteer motivations.” contemporary clinical trials 32, no. 3 (may 1, 2011): 342–52. https://doi.org/10.1016/j.cct.2010.12.003. ] iii. worker protections it is possible that financial compensation for firefighters is not questioned because their profession is vital. despite our best efforts, buildings will continue to catch fire and firefighters will put themselves in harm’s way to protect others. due to this inevitable risk, organizations such as the occupational safety and health administration (osha) have been established to ensure that the risks to firefighters are minimized as much as possible.[endnoteref:7] [7: occupational safety and health administrator. “fire service features of buildings and fire protection systems.” (2015). https://www.osha.gov/publications/osha3256.pdf. ] medical research similarly relies upon irbs to minimize risks, assess protocol safety, and protect participant rights. prior to any medical research being approved, the irb reviews the protocol to ensure that the benefits justify the risks and that all ethical guidelines are followed.[endnoteref:8] it would be preferable for neither firefighters nor research participants to be put at risk, yet fires will continue to occur and new drugs will continue to be clinically tested. [8: emanuel, ezekiel, emily abdoler, and leanne stunkel. "research ethics: how to treat people who participate in research". bethesda, md: national institutes of health clinical center department of bioethics (2016). https://doi.org/10.1037/14805-031. ] iv. societal benefits a common concern is that research participants are unlikely to receive the benefits of the drug post-approval.[endnoteref:9] there is no concern that firefighters’ services do not benefit the firefighter directly. both clinical trial participants and firefighters assume risk for the benefit of society as a whole, yet research is viewed with skepticism. there is no reason the assumption of risk should be evaluated by such different standards. [9: elliott, carl, and roberto abadie. “exploiting a research underclass in phase 1 clinical trials.” new england journal of medicine 358, no. 22 (may 29, 2008): 2316–17. https://doi.org/10.1056/nejmp0801872. ] while the principle of justice dictates that no one group should bear the burden of the risks,[endnoteref:10] this should not be interpreted to imply that a violation has occurred if the participant is unlikely to benefit directly.[endnoteref:11] in fact, one of the key distinctions between medical research and medical care is that the goal of research is to expand knowledge rather than provide direct benefit, a fallacy called the therapeutic misconception.[endnoteref:12] [10: institute of medicine (us) committee on ethical and legal issues relating to the inclusion of women in clinical studies, anna c. mastroianni, ruth faden, and daniel federman. justice in clinical studies: guiding principles. women and health research: ethical and legal issues of including women in clinical studies: volume i. national academies press (us), 1994. https://www.ncbi.nlm.nih.gov/books/nbk236544/. ] [11: elliott, pages 2316–17. ] [12: grieselhuber, nicole r., ira j. kodner, douglas brown, and jennifer yu. “confronting the therapeutic misconception.” surgery 162, no. 1 (july 2017): 183–87. https://doi.org/10.1016/j.surg.2017.01.031. ] there are systematic differences in the protections provided to traditional employees compared to research participants. for example, research participants in phase one trials are considered independent contractors and are exempt from the benefits provided to employees, such as workers compensation or disability and health insurance.[endnoteref:13] while this point is appreciated, this is more a critique of the gig economy[endnoteref:14] than of the ethical implications of compensation in clinical trials. [13: elliott, pages 2316–17. ] [14: kuhn, kristine m.“the rise of the ‘gig economy’ and implications for understanding work and workers ” industrial and organizational psychology; bowling green 9, no.1 (march 2016): 157-162. https://doi.org/10.1017/iop.2015.129. ] v. synthesis this comparison indicates that in society it is acceptable for individuals to assume risk in exchange for financial compensation. however, in clinical research this acceptance dissolves. while a literature review may reveal the reasons for unease surrounding financial compensation in medical research, it is more important to assess who is voicing this dissent. the debate over whether and how much research participants should be paid has been going on for decades.[endnoteref:15] much of this debate occurs at an academic level. ethicists and clinical researchers have debated what is most appropriate for the participants ad infinitum.[endnoteref:16] however, the research fails to elicit the attitudes of study participants and non-academics. among sparse literature, the focus has been on the general motivations of study participation,[endnoteref:17] with only sporadic studies featuring participants’ views on financial compensation.[endnoteref:18] [15: pandya, mansi, and chetna desai. “compensation in clinical research: the debate continues.” perspectives in clinical research 4, no. 1 (2013): 70–74. https://doi.org/10.4103/2229-3485.106394. ] [16: “financial compensation of oocyte donors: an ethics committee opinion.” fertility and sterility 106, no. 7 (december 1, 2016): e15–19. https://doi.org/10.1016/j.fertnstert.2016.09.040; dualé, christian, gaétan breysse, béatrice bories‐azeau, and catherine cornu. “french academic’s views on financial compensation of participants.” european journal of clinical investigation 46, no. 7 (2016): 619–26. https://doi.org/10.1111/eci.12638; largent, emily a., christine grady, franklin g. miller, and alan wertheimer pages 1–8. ] [17: stunkel, pages 342–52; friesen, lynn roosa, and karen b. williams. “attitudes and motivations regarding willingness to participate in dental clinical trials.” contemporary clinical trials communications 2 (april 15, 2016): 85–90. https://doi.org/10.1016/j.conctc.2015.12.011. ] [18: abadie, roberto, brandon brown, and celia b. fisher. “‘money helps’: people who inject drugs and their perceptions of financial compensation and its ethical implications.” ethics & behavior 29, no. 8 (november 17, 2019): 607–20. https://doi.org/10.1080/10508422.2018.1535976; karagic, merhunisa, justin chin, jun h. lin, nanette silverberg, and mary lee-wong. “a cross-sectional survey on patient perception of subject payment for research.” journal of hospital administration 9, no. 2 (april 15, 2020): 14. https://doi.org/10.5430/jha.v9n2p14. ] it is important to recognize that concerns surrounding financial compensation arise within the research and academic establishment not from participants themselves. this suggests that researchers hold the view that clinical research is inherently exploitative. the concern for exploitation arises despite preventive measures including a thorough review of protocols by the irb prior to implementation and the informed consent processes in which potential participants are provided all necessary information. while there exists the possibility that the informed consent process does not properly convey all relevant information or that the irb review is not sufficient, these are separate issues which do not directly apply to the question of financial coercion. conclusion clinical researchers should accept the autonomy of potential participants, leaving them free to make their own choices. just as firefighters are free to conduct a risk-benefit assessment to determine whether or not to engage in a risky profession, potential research participants should autonomously assess the risks and benefits of participation. to believe otherwise amounts to paternalistic, patronizing behavior. *amie devlin, mph, ma phd student, department of epidemiology and biostatistics urban health collaborative | drexel university © 2020 amie devlin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. misra, transitioning from who you were, voices in bioethics, vol. 2 (2016) © 2016 priya misra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. transitioning from who you were to who you must become: a necessary mental switch priya misra keywords: bioethics, medical school narrative, emergency medicine introduction during my first year of medical school, i applied to be on the committee of admissions, in which i would help interview new applicants for the school of medicine. during my interview the dean of admissions had asked us all a question that i had never considered before: how will you deal with the fact and pressure that you are holding an individual’s life decision in your hands? before that moment, i had never thought that by interviewing someone for medical school i would be altering their life. i was in my second semester of school and by then i was just simply going through the motions: studying, sleeping however much as possible, and trying to do the best i could in my classes. it was not until that point that i had considered the fact that after my first day of medical school, my life had been completely altered in ways that i had never imagined. applying to, and entering into medical school, is unlike anything else an individual will do in his or her life. it’s not just another step in your education; nor is it just a “career path." it is a truly life-altering decision. from the moment we enter school to the moment we become practicing physicians (and arguably even afterwards) our life is completely planned and structured. we are no longer the person we used to be, and we have little time to develop into the person we would like to become. the mental and emotional switch that must occur within ourselves in order to be successful physicians isolates us from those outside of medicine. we will see things and do things in our lives that very few in this world will ever have to do. under the hippocratic oath, we are obliged (even if against our moral will) to help those in need, whether or not they are our patients or if we are supposed to be working that hour; we are required to keep an open, and unbiased mind towards everyone we encounter. and, we are doctors from the moment we enter into school until the moment we retire. this is not a 9 am-5 pm, 5 day-a-week job. ____________________________________________________________ misra, transitioning from who you were, voices in bioethics, vol. 2 (2016) 2 analysis one of my clearest memories from orientation week was when our dean of students informed us all that as medical students, we no longer simply represent ourselves, but we are now “ambassadors for this school and for this field.” at the time it struck me as an odd thing to say to a group of students who were barely paying attention, and were just excited to be here. i was confused as to why all the faculty and staff we met constantly told us about the changes we would encounter as first years—this is just school and we’ve all been in school our entire lives thus far, so why or how is this any different? i was accepted into medical school for the student and person i am, so why would i have to change in order to fit this field? however, very quickly into the semester i realized the meaning of what they were saying. now that i was accepted into medical school, i came to understand the weight that the title “medical student” actually bears. as i met undergraduate students who were struggling to secure a seat in my position, family friends looked at me with a newfound sense of respect, and patients felt comfortable asking me questions despite my vast lack of knowledge. i soon realized that even if i didn’t feel any different, society saw me differently simply due to this new title. it was as if i needed to start acting the way a medical student was ‘supposed’ to act: hard working, mature, respectful, and responsible, even if i wasn’t on the hospital campus. it is as if i started to evaluate my actions through the question, “is that how i would want my doctor to act?” i know that some readers may think that’s a stretch and perhaps i am reading too much into it, but i feel as though not only the information we learn in school is relevant, but medical school itself is a learning experience. it presents us with emotionally trying experiences, stress beyond compare, and situations that will test our endurance and who we are at our core. i truly believe that the ways in which we handle such situations defines and refines who we will be as future physicians. for example, i try to handle every stressful situation as if it were me in an emergency room facing a patient who was beginning to code. what would i do? freaking out and hyperventilating is clearly not an option nor is doubting yourself and your knowledge going to help your patient. so, if i don’t want to handle those situations in such a manner, why should i handle stressful situations in school any differently? personally, i feel like one of the hardest things that we deal with as first year medical students is having to transition from who we are, or were, before school started to who we must become as future physicians. it is a necessary mental and emotional switch that must occur and unfortunately, not everyone is ready or even aware of it. we must understand that from now on, the way we act, feel, and handle stressful and emotional experiences must be in accordance with the kind of doctor we want to be. i know countless classmates who want to go into emergency medicine or oncology, but just shut down when faced with stress. before exams they are overcome with anxiety attacks, wonder if being a doctor is the right choice for them, and just completely shut down. such a manner of handling stress has always worked for them in the past, so why not continue to implement it? however, i feel that medical school is designed so that we can learn and develop proper coping mechanisms and healthy habits that will train us for similar situations in the future. believe me, the stress and emotions you face in your first year of medical school is not nearly what you will face as a doctor. if you don’t transition from who you were to who you must become, regarding such circumstances, it will only hurt your patients. but such a transition is not limited to just how we handle stress and emotions. it also relates to the mental switch that must occur when understanding why you are learning all of this material. i see so many students everyday arguing with professors about grades, trying to get those two extra points so that they can honor that course. it seems as though they have forgotten that this is no longer about being and doing your best to get the highest grades—now you have to actually learn and understand this material so that you can save peoples’ lives in the future. no one is going to care if you graduated the top of your class, if at the end of the day, you haven’t truly learned anything. i completely understand that the nature of “pre-med” necessitated such attitudes of getting the best grades, and doing whatever you can to be a competitive applicant; however, it is time to transition to the thought that you are finally in medical school; now you actually have to know this material for beyond the exam. misra, transitioning from who you were, voices in bioethics, vol. 2 (2016) 3 conclusion during hurricane sandy, i learned the meaning of yet another necessary transition: the transition to maturity and the responsibility of a medical student. many of the firstand second-year students took refuge in the school due to power outages and the weather. it is inevitable that conditions would get tight, restless and rowdy, with almost 40 of us sharing just a few classrooms and a lounge. however, when the power of the hospital and school finally went out, it was as if all of us had lost control. the generators kicked in, but it wasn’t enough light for any of us to get work done. most took that as an invitation to play games, and run around as if it was “cool” or “fun.” had they forgotten that just a few floors above us in the er patients were fighting for their lives? yes, generators kicked in for those on life support but generators can only last for so long and only supply so much to the hospital. what about those who had flooded the er with medical emergencies during the storm? or those who needed help but it never arrived in time? what about the nurses and staff upstairs who were probably overwhelmed and scared that their patients were all coding and there wasn’t enough manpower, or even power, to support them all? when the security guard came to ask us what we were doing in the building and why we were there, everyone kept saying “don’t worry, we’re medical students” as if the weight of those two words would be enough to reassure him that we belonged there. “medical students.” yes, we were. so why were we behaving like that? as medical students, during such a time we should be volunteering our services and help, not taking it as an open invitation to roam the empty dark halls of the school and spread chaos. doctors in the hospital always let us shadow them and handle patients ourselves, because they trust that as medical students, we are mature and responsible enough to understand the meaning and weight of our title; that we can understand that all of this that we’re going through is training us for our futures. as medical students, we have ourselves and our lifestyles under control and understand that we are now adults, responsible for human lives. it is necessary and vital that this mental and emotional switch occurs; it is a transition from who we used to be to who we must become in order to be successful physicians. this is not undergrad. this is not pre-med. this is a choice that we made, and every choice has consequences. it is time to understand that your training to become a doctor starts day one of medical school. the sooner we realize that, and all it encompasses, the better we can be. misra, momentary relief, voices in bioethics, vol. 1 (2014-15) © 2015 priya misra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. "momentary relief" & "a fool's guide to grief" priya misra as medical students we have the privilege and the burden of witnessing human suffering, death, healing, and humanity on a daily basis. regardless of our will and fortitude it is natural, and in some ways beneficial, that many of these experiences leak into our subconscious and infiltrate our emotions. our decision then becomes whether or not we recognize the distress amongst our emotions and embrace it in the hope of becoming grounded and empathetic physicians. personally, i believe that reflection is key in this journey to self-awareness and development. poetry and personal narrative are my own feeble attempts at untangling the confusion and emotional burden that stems from my experiences on the floors. if left unexamined those burdens threaten my growth as a physician. i can only hope that my writing will encourage my peers to embark on their own journeys of reflection, awareness, and humility. momentary relief winter seems endless. incurable. light is sparse, darkness abundant, and the disease as cold as the snow outside. warm humidified breath is replaced by icy harsh wind. it slaps your face like the prognosis that the tumor has resurfaced. still, melting snow gives rise to hope— resurrected from the depths of icy despair and slushy salt stained roads— hope that highlights happiness in blooming tulip buds, clear skies, and winter coats abandoned to the back of closets. and one day when you least expect it, a miraculous act of divine mercy, the sun too returns, ripping off your covers and kissing your wounds with its warm embrace. it comes with memories of open windows, hair blowing in the wind, songs of summer love and short skirts. spring is the food i take with my medication, it is the light at the end of my tunnel, reassurance that the end is near. a fool’s guide to grief i sit here contemplating death. and the foolish notion that i could possibly capture in one poem what thousands before me have tried to say. all that i know is fear: the frightening possibility that life only exists as a series of chemistries and hormones, now immobile. how can i stare him in the eyes and walk away unscathed each time? ingrained in my training is the theory that acceptance leads to apathy and so i’m left to dread its toll, the jaded nature it births through oblivion. misra, momentary relief, voices in bioethics, vol. 1 (2014-15) 2 what a grotesque thought to wish i could have experienced more loss, maybe it would prepare me for death’s arrival. bringing order to the inexplicable, maybe i could find the formula of how to grieve and grow. they say, “death is a part of life,” but i will never find comfort in this paradox that losing life is cornerstone to living. so i surrender myself to death, to my fear of the end, to my confusion on coping, to my failure at acceptance. ____________________________________________________________ lin, hurrican harvey, voices in bioethics, vol. 4 (2018) © 2018 john lin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hurricane harvey john lin keywords: hurricane harvey, marginalized communities, weather, inequality introduction harvey has been a nightmare for every houstonian, but some have faced more challenges than others. during the period before the hurricane struck, harris county and houston officials refused to order an evacuation, arguing that residents should stay put, even as cnn meteorologists forecasted more than 20 inches of rain for the first weekend, and the national weather service placed houston under a flash flood watch on the thursday before the storm struck [1]. despite knowing that the poorest residents of houston live in unelevated, flood-prone areas that could not handle the rain, city officials steadfastly refused to evacuate these neighborhoods, forcing residents to pray for search-andrescue operations. from the beginning, low-income houstonians of color have struggled to receive the same treatment provided to their wealthy counterparts. as houston continues its reconstruction efforts, the city must reduce the disparity between aid to privileged and marginalized communities. analysis this inequality predates hurricane harvey, especially in the texas medical center. during tropical storm allison in 2001, the entire medical center was flooded. decades of medical research at baylor college of medicine was wiped away as water entered the basement [2]. in the years since allison, almost every hospital that could afford renovations chose to improve their facilities. however, ben taub, which is run by a governmental entity named harris health system, was unable to obtain the funding needed to fix its flooding problem. in part because ben taub specializes in patients who cannot afford most treatments, harris health system has faced increasingly wide funding gaps, as the houston chronicle reported as far back as june 2015 [3]. the shortfall hurt their primary care clinics, health centers, and homeless outreach programs, ensuring that no building upgrades could be completed. during hurricane harvey, while almost every hospital in the texas medical center continued operations, largely unaffected by the rising waters, ben taub was forced to evacuate its patients [2,4]. the basements in all three of its buildings were flooded, displacing pharmacy and food services. compared with other houston health systems, ben taub’s continued shortage of funds because of its focus on low-income patients likely contributed to its failure at the hands of harvey. the working class houstonians who relied on ben taub were thus unable to receive care they needed during the hurricane. this issue was not limited to the texas medical center. according to a december 2017 report by the kaiser family foundation and episcopal health foundation, lower-income adults and people of color were statistically more likely to lack health insurance and to say that they are unsure about where to go for medical care [5]. considering that 1 in 6 storm victims said that a family member’s health condition was created or worsened by harvey, it is likely that many houstonians need to see a physician, but the wealthier ones will be more likely to actually have their medical condition treated [5]. lin, hurricane harvey, voices in bioethics, vol. 4 (2018) 2 over the same time period, vulnerable minority communities found their concerns ignored by the local government, resulting in considerable damage during hurricane harvey. in fact, according to the u.s. department of housing and urban development, the city of houston is in violation of the civil rights act [6]. one of the biggest problems with maps showing the relationship between ethnicity and location in houston is the east-west segregation of white, non-hispanic households from minority communities. but these divisions are not just racial; west houston–which is overwhelmingly white–also dominates houston properties’ list of the most expensive houston neighborhoods, comprising nineteen of the twenty areas listed [7]. this may seem coincidental, but the city council has perpetuated this division. over the past four years, 91 percent of buildings that they considered for tax credits were in majority-minority areas [6]. when the houston housing authority decided, for the first time in its history, to affirmatively invest in a majority white, low-poverty 2eighbourhood, the project was blocked by the city [7]. having different racial and ethnic groups neatly split by clear lines has allowed the city to provide better resources for predominantly white, non-hispanic groups and distribute hazardous materials almost entirely in minority neighborhoods. overwhelmingly non-white areas bear the vast majority of the city’s pollution: 84 percent of carcinogen emitters, 78 percent of closed landfills, and 88 percent of hazardous waste sites. this has had major effects on cancer rates in various houston racial communities [8]. according to a 2014 case study of south and southeast houston by the houston department of health and human services, compared to white women, african american women are more likely to develop more aggressive, more advanced-stage breast cancer earlier and die from breast cancer [9]. when harvey arrived, the impact became more severe. according to texas southern university sociologist robert bullard, the “father of environmental justice,” the petrochemical plants in neighborhoods of color spread toxic waste whenever the city floods [10]. data from air alliance houston shows that petrochemical plants will send over 1 million pounds of harmful pollution into the air because of harvey [11]. for low-income communities of color that already cannot afford the cleanup from the flooding, the long-term health issues that will arise as a result of harvey will ruin their lives. communities of color have already faced major difficulties in their attempts to receive aid when compared to predominantly white areas. the same study conducted by kaiser family foundation and episcopal health foundation found that while half of all storm victims believed they were not getting the help they need, this was true for sixty-six percent of black residents [12]. this disparity is shown through fema assistance numbers, too. while black, hispanic, and low-income respondents were more likely to have experienced property damage or income loss, they were less likely to receive aid [12]. only 13 percent of black houstonians had their fema applications approved, compared to 34 percent of white residents [12]. without this aid, medical bills become near impossible for most low-income people, many of whom were already uninsured before harvey. sixty percent of respondents say they have skipped or postponed needed treatment or medication, problems that will exacerbate treatable illnesses and chronic conditions like diabetes [12]. conclusion although the colossal volume of rainfall drenched every part of houston, the most impacted people were the most marginalized. harvey may not have specifically targeted the poor, but the poor have struggled the most to recover from it. because of racially and economically discriminatory policies by the city of houston, low-income communities of color were the least prepared for and most impacted by hurricane harvey. even as the cleanup effort continues, poor minorities face more hurdles than their wealthy, white counterparts. the local, state, and federal governments should ensure that their aid distribution policies are fair and non-discriminatory to ensure that all communities can effectively recover. lin, hurricane harvey, voices in bioethics, vol. 4 (2018) 3 references 1 andone, dakin. "why didn't houston evacuate?" cnn. august 29, 2017. accessed january 06, 2018. https://www.cnn.com/2017/08/27/us/houston-evacuation-hurricane-harvey/index.html 2 bentsen, ken. "bentsen: the texas medical center defeated harvey." houston chronicle. september 04, 2017. accessed january 06, 2018. https://www.houstonchronicle.com/opinion/outlook/article/bentsen-the-texas-medical-center-defeated-harvey-12172307.php 3 hawryluk, markian. "ben taub 'under assault' as funds from many sources cut, threatened." houston chronicle. june 05, 2015. accessed january 06, 2018. https://www.houstonchronicle.com/news/health/article/ben-taub-under-assault-as-funds-from-many-6310020.php 4 khazan, olga. "the houston hospital running out of food." the atlantic. august 28, 2017. accessed january 06, 2018. https://www.theatlantic.com/health/archive/2017/08/the-houston-hospital-running-out-of-food/538266/ 5 hamel, liz, bryan wu, mollyann brodie, shao-chee sim, and elena marks. an early assessment of hurricane harvey’s impact on vulnerable texans in the gulf coast region. report. episcopal health foundation. december 2017. accessed january 6, 2018. http://files.kff.org/attachment/report-an-early-assessment-of-hurricane-harveys-impact-on-vulnerable-texans-in-the-gulf 6 elliott, rebecca. "hud: city's subsidized housing procedures promote segregation, violate civil rights act." houston chronicle. january 13, 2017. accessed january 06, 2018. https://www.houstonchronicle.com/news/politics/houston/article/hud-city-s-subsidized-housing-procedures-promote-10857101.php 7 "2017's 20 most expensive neighborhoods in houston." houston properties. accessed january 06, 2018. https://www.houstonproperties.com/houston-neighborhoods/most-expensive-houston-neighborhoods 8 julian, elizabeth, ann lott, demetria mccain, and chrishelle palay. “why houston remains segregated.” houston chronicle. accessed january 06, 2018. https://www.houstonchronicle.com/local/gray-matters/article/why-houston-remains-segregated-10935311.php 9 community health profile. report. houston department of health and human services, city of houston. july 16, 2014. accessed january 06, 2018. http://www.houstontx.gov/health/chs/2014communityhealthprofile%20area%20a-nov%202014.pdf 10 kaufman, alexander c. "houston flooding always hits poor, non-white neighborhoods hardest." the huffington post. august 29, 2017. accessed january 06, 2018. https://www.huffingtonpost.com/entry/houston-harvey-environmental-justice_us_59a41c90e4b06d67e3390993 11 “shutdowns of petrochemical plants b/c of #harvey will send1m+ pounds of harmful pollution into air.” air alliance houston. august 28, 2017. accessed january 06, 2018. 12 hamel, liz, bryan wu, mollyann brodie, shao-chee sim, and elena marks. an early assessment of hurricane harvey’s impact on vulnerable texans in the gulf coast region. report. episcopal health foundation. december 2017. accessed january 6, 2018. http://files.kff.org/attachment/report-an-early-assessment-of-hurricane-harveys-impact-on-vulnerable-texans-in-the-gulf https://www.cnn.com/2017/08/27/us/houston-evacuation-hurricane-harvey/index.html https://www.houstonchronicle.com/opinion/outlook/article/bentsen-the-texas-medical-center-defeated-harvey-12172307.php https://www.houstonchronicle.com/news/health/article/ben-taub-under-assault-as-funds-from-many-6310020.php https://www.theatlantic.com/health/archive/2017/08/the-houston-hospital-running-out-of-food/538266/ http://files.kff.org/attachment/report-an-early-assessment-of-hurricane-harveys-impact-on-vulnerable-texans-in-the-gulf https://www.houstonchronicle.com/news/politics/houston/article/hud-city-s-subsidized-housing-procedures-promote-10857101.php https://www.houstonproperties.com/houston-neighborhoods/most-expensive-houston-neighborhoods https://www.houstonchronicle.com/local/gray-matters/article/why-houston-remains-segregated-10935311.php http://www.houstontx.gov/health/chs/2014communityhealthprofile%20area%20a-nov%202014.pdf https://www.huffingtonpost.com/entry/houston-harvey-environmental-justice_us_59a41c90e4b06d67e3390993 http://files.kff.org/attachment/report-an-early-assessment-of-hurricane-harveys-impact-on-vulnerable-texans-in-the-gulf introduction utomi, global health equity, voices in bioethics, vol. 6 (2020) © 2020 awele utomi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. global health equity: covid-19 highlights a need for ethical improvements awele utomi keywords: global ethics, covid-19, bioethics, pandemic ethics, scarcity, inequality during the covid-19 pandemic, one of the earliest positives some asserted was covid-19’s status as an “equal-opportunity killer.” the coronavirus does not distinguish between culture, race, class, or country and will infect everyone it can as opposed to diseases that typically infect the most vulnerable in our society. while the vulnerable population might be different based on geographical area, vulnerability typically intersects with socio-economic status and race. despite the fact that everyone can be affected by this virus, people who are already economically and socially disadvantaged will suffer the pandemic’s greatest burdens.1 in the 1918 pandemic, in both wealthy and developing countries, disadvantaged groups (lower social classes and oppressed groups) had substantially higher mortality rates than more privileged groups.2 even in the absence of vaccines and antiviral medications, a pandemic has the potential to produce profound inequalities in burdens, both within and across countries. 3 these burdens affect morbidity and mortality which are dependent on the socio-economic status of the individual or community. social justice is concerned with how features of the social structure result in systematic inequalities and disadvantages in well-being. while social justice theories and their practical implications differ, all agree that there are some basic obligations to minimize or prevent harm to others, especially when the others are vulnerable to harm or injuries and the cost of doing so is not unreasonable. the rationale for social distancing during this pandemic is the same: take reasonable precautions to protect the public and especially the vulnerable. the principle of justice demands that we ensure fair distribution, not only of social benefits and opportunities, but also of burdens and risks. although all countries must attend to the urgent concerns that affect their own citizens, none of us is exempt from moral obligations toward the world's vulnerable utomi, global health equity, voices in bioethics, vol. 6 (2020) 2 population.4 already, the pandemic and the response, be it containment, suppression, or social distancing, are exposing class divides among and within countries. the field of bioethics has not fully addressed global health equity or population health. as covid-19 spreads in countries with high population densities like india, social distancing is challenging to implement.5 we must be careful to ensure that responses account for local circumstances and cultural values to recognize differences between places and endeavor to protect the interests and rights of disadvantaged groups in this difficult period. the recent statistics in the us show that we are not doing a good job of protecting these groups. for instance, propublica reports that the pandemic is already disproportionately affecting people with intellectual disabilities, the black community, and people with english language barriers.6 in places like washington and alabama, pandemic preparedness plans discriminate against people with intellectual disabilities by designating them low priority when medical care is rationed. in wisconsin, chicago, and detroit, the mortality rate for black people far exceeds the percentage of black people there. while black people are at higher risk of preexisting health conditions, we can do more to ensure our planning guidelines involve representatives of marginalized groups. in addition, social distancing as a response policy does not effectively address the people who must work during this time, and these are more likely to be vulnerable populations. a report from the economic policy institute emphasizes, “only 9.2 percent of workers in the lowest quartile of the wage distribution can telework, compared with 61.5 percent of workers in the highest quartile.”7 the principles of beneficence and non-maleficence dictate that we must do the most good and avoid harm. in this case, the principles would require inclusion of disadvantaged groups in decisions as opposed to a one-size-fits-all response. engaging these groups is in everyone’s best interest as an effective response to a pandemic will require widespread cooperation throughout society with a range of government recommendations.3 disadvantaged groups have the best understanding of their own interests and priorities making them crucial in pandemic response policy. involving these groups would also engender their trust and cooperation as they historically have sound, deep-rooted reasons for distrusting their governments. secondly, more information and data need to be provided on these disparities including race-specific data on cases and deaths. knowing which communities are most impacted allows public health officials to tailor their approach and work on overcoming the distrust these groups have had for government. health officials in different countries can address inequities in health outcomes and testing that may emerge by focusing on marginalized communities as well. ultimately, covid-19 has shown that the field of bioethics should become more engaged in reducing global health inequities and that we must emphasize the importance of investing globally in emergency preparedness that will include protections for vulnerable groups during emergencies such as pandemics. 1 m.e. dyson, come hell or high water: hurricane katrina and the color of disaster (new york: basic books, 2006); d. atkins and e.m. moy, "left behind: the legacy of hurricane katrina," british medical journal 331 (2005): 916-18; a. rafi, s. doocy, and c. robinson, "tsunami mortality and displacement in aceh province, indonesia," disasters 30, no. 3 (2006): 340-50; m. fordham, "the intersection of gender and social class in disaster: balancing resilience and vulnerability," international journal of mass emergency disasters 17, no. 1 (1999): 15-37; y.j. chou et al., "who is at risk of death in an earthquake?" american journal of epidemiology 160, no. 7 (2004): 688-95; a. montazeri et al., "psychological distress among bam earthquake survivors in iran: a population-based study," bmc public health 5 (200) utomi, global health equity, voices in bioethics, vol. 6 (2020) 3 2 i.d. mills, "the 1918-1919 influenza pandemic: the indian experience," indian economic and social history review 23, no. 1 (1986): 1-40; h. phillips, black october: the impact of the spanish influenza epidemic of 1918 on south africa (pretoria, south africa: ctp book printers, 1990); e. sydenstricker, "the incidence of influenza among persons of different economic status during the epidemic of 1918," public health reports 46, no. 4 (193) 3 planning for an influenza pandemic: social justice and disadvantaged groups. author(s): lori uscher-pines, patrick s. duggan, joshua p. garron, ruth a. karron and ruth r. faden source: the hastings center report, vol. 37, no. 4 (jul. aug., 2007), pp. 32-39 published by: the hastings center stable url: https://www.jstor.org/stable/4625761 4 t. pogge, world poverty and human rights: cosmopolitan responsibilities and reforms (oxford, u.k.: polity press, 2002) vii, 284; t. pogge, "real world justice," journal of ethics 9, no. 1/2 (2005): 29-5 5https://www.usnews.com/news/best-countries/articles/2020-05-18/india-struggles-to-maintain-social-distancing-amidcoronavirus-pandemic 6 johnson, a, buford, t. (2020). early data shows african americans have contracted and died of coronavirus at an alarming rate. from https://www.propublica.org/article/early-data-shows-african-americans-have-contracted-and-died-of-coronavirusat-an-alarming-rate?utm_source=pardot&utm_medium=email&utm_campaign=majorinvestigations; silverman, a. (2020). people with intellectual disabilities may be denied lifesaving care under these plans as coronavirus spread. from https://www.propublica.org/article/people-with-intellectual-disabilities-may-be-denied-lifesaving-care-under-these-plans-ascoronavirus-spreads 7 gould, e, shierholz h (2020). not everybody can work from home. economic policy institute. https://www.epi.org/blog/blackand-hispanic-workers-are-much-less-likely-to-be-able-to-work-from-home/?referringsource=articleshare https://www.jstor.org/stable/4625761 https://www.usnews.com/news/best-countries/articles/2020-05-18/india-struggles-to-maintain-social-distancing-amid-coronavirus-pandemic https://www.usnews.com/news/best-countries/articles/2020-05-18/india-struggles-to-maintain-social-distancing-amid-coronavirus-pandemic https://www.propublica.org/article/early-data-shows-african-americans-have-contracted-and-died-of-coronavirus-at-an-alarming-rate?utm_source=pardot&utm_medium=email&utm_campaign=majorinvestigations https://www.propublica.org/article/early-data-shows-african-americans-have-contracted-and-died-of-coronavirus-at-an-alarming-rate?utm_source=pardot&utm_medium=email&utm_campaign=majorinvestigations https://www.propublica.org/article/people-with-intellectual-disabilities-may-be-denied-lifesaving-care-under-these-plans-as-coronavirus-spreads https://www.propublica.org/article/people-with-intellectual-disabilities-may-be-denied-lifesaving-care-under-these-plans-as-coronavirus-spreads https://www.epi.org/blog/black-and-hispanic-workers-are-much-less-likely-to-be-able-to-work-from-home/?referringsource=articleshare https://www.epi.org/blog/black-and-hispanic-workers-are-much-less-likely-to-be-able-to-work-from-home/?referringsource=articleshare anekwe, only don’t know, voices in bioethics, 2013 © 2013 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “only don’t know” – art exhibition obiora anekwe alix ankele began her professional career as a psychiatric social worker in new york city. but when she and her husband moved to kenya, where he worked in media, her exposure to batik art shifted her life. “art set my soul. it was a way of connecting through my heart”, recalls ankele. union theological seminary’s james memorial chapel will be the location of an exhibition of artist alix ankele’s monumental work on display from september 9-november 1, 2013. although ankele has been creating art for some time now, she began to make abstract art because it presented an intuitive process to painting rather than creating artwork from a structured conceptual mindset. her pieces are mostly large in scale, abstractly structured, and vividly colored in expression. the title of her recent art exhibition, “only don’t know”, refers to a korean zen master who promoted openmindedness without a sense of coming to our own prejudged conclusions. this sense of being is most pertinent to bioethics, which is based on a multidisciplinary approach that is based on seeing ethical realities as such rather than viewing them as we think they should be. ankele’s work stresses the interconnectedness of who we are and our inseparableness to our universe. one striking piece entitled, “cross of the moment” speaks to the words of one of the 20th century’s most morally conscious poets, w.h. auden: “we would rather be ruined than changed. we would rather die in our dread than climb the cross of the moment and let our illusions die.” auden’s nuances reflect how terminal illness can affect a patient’s innermost thoughts that are never mentioned. in her work, “easter morning”, we are called to ponder upon and keep open to a sense of a new beginning or fresh start. but ankele also challenges us to reflect upon collective and unconscious memory as observed in neuroscience and psychiatric medicine. freedom and emancipation is transparently interpreted in ankele’s 2013 piece, “todatsu”, reverberating one of bioethics most pertinent ethical principles-autonomy. after walking away from alix ankele’s multi-layered and highly global exhibition reflecting life, death, and new beginnings-all significant to human existencei felt spontaneously uplifted, vividly transformed, and rightfully moved. esquenazi, ethical assessment of fertility preservation, voices in bioethics, vol. 3 (2017) © 2017 shari esquenazi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an ethical assessment of fertility preservation in pediatric and adolescent patients shari esquenazi abstract defining universal guidelines for fertility preservation in pediatric and adolescent patient would be too restrictive and potentially biased. as is the case with most ethical quandaries, it is most appropriate to meet with patients and their families to have an honest, open discussion about the patient’s fears, wishes, and goals. the decision to pursue fertility preservation is not a simple one, nor are the impacts universal for every patient. a thorough ethics consultation can help to mitigate the decision-making process for the medical team, parents, and child and to come up with an ethical solution to such a complex situation. keywords: fertility issues, fertility preservation, pediatrics, adolescent patients, ethical assessment introduction pediatric cancer patients often undergo chemotherapy and radiation treatments which render their reproductive organs ineffective. oncofertility expands the options of a reproductive future in these patients, even when their cancer strikes before puberty. moreover, fertility preservation can be expanded to allow for a theoretically open future in postpubertal female patients with early signs of gynecological diseases such as endometriosis and polycystic ovary syndrome. while a child's caregiver may have the best intentions in mind, there are a handful of critical ethical considerations surrounding the idea of preserving fertility in such patients which ought to be thoroughly assessed before beginning any procedures. a. candidacy addressing each patient on a case-by-case basis is important, as no patient’s situation is the same. weighing factors, including age, gender, and the stage of disease/proposed treatments are all important when having a thorough ethical consultation and discussing the decision of adopting or rejecting a plan for fertility preservation. inherently, a patient’s age impacts whether their reproductive samples would still be viable by the point in life when they are hoping to start a family. samples can become fragile and null as time goes on. that is to say, the technology would be put to better use in a patient who is 17 as opposed to one who is 7 years old at the time of treatment. esquenazi, ethical assessment of fertility preservation, voices in bioethics, vol. 3 (2017) 2 gender also plays a role with regards to obtaining the sample. for males, obtaining a specimen in post-pubescent patients is simple enough for them to do on their own. if the patient is undergoing surgery and has not yet reached puberty, then a sample may be extracted at that point. for females, obtaining a sample is considered invasive -whether or not the patient has hit puberty. similarly, females carry a larger risk when it comes time to implant the tissue or eggs as they try to conceive. additional surgeries come with the increased risk of surgical site infections. for cancer patients, infections can escalate quickly and affect the efficacy of the individual’s treatment.1 lastly, the stage of the illness and the required treatment are of considerable importance. a patient who must undergo aggressive chemotherapy and radiation is believed to have long-term damage to their capacity for reproduction. looping back to the gender issue, this is likely to be a heavier influence for females as opposed to males. b. autonomy first and foremost, it is important to allow the patient to make their own treatment and fertility decisions, when applicable. when true patient autonomy is not possible, as is the case with younger patients, the child can be properly informed and involved in the discussion, providing assent for the proposed medical treatment when they agree with it.2 this gets a little hazy, however, when the patient is very young and cannot maturely grasp the concept of being infertile ten years later. young girls may be more inclined to be interested in fertility preservation as opposed to their male counterparts because of the social pressure for girls to become one day become mothers—a pressure that may stem even from their innocuous playtime activities. it is critical to thoroughly educate young patients on the fertility procedures, the longevity of the reproductive materials obtained, and the possibility that even with this technology, there is no guarantee of having a child of their own. asking for the child’s voice, respecting their opinion, and including them in the decision-making-process is a possibility when the proposed therapy is not mandatory, as would the treatment of the cancer or life-threatening illness. a child or adolescent patient may be too embarrassed to talk about reproduction with their parents or doctors. similarly, the patient may be completely resistant from any conversation about it due to their overwhelming diagnosis. forcing a child to endure additional procedures strips them of any autonomy that they may have in the situation. it is the role of clinicians to ensure that patients are not being coerced into undergoing additional, invasive, and painful procedures at the persuasion of their parents. children are highly impressionable, and the last people that they want to let down are their parents. on the other hand, parents may not always want fertility preservation for their children and there may be a disagreement between the two parties. for example, religious perspectives may influence a decline from parents. setting aside some time to meet with the family can help to establish an autonomous decision or agreement. c. beneficence albeit perhaps optimistic depending on the scenario, fertility preservation can “open doors” for patients who otherwise have had them shut in their faces. rather than promising the capacity to reproduce with this technology, it ought to be cautioned that it is more so the opportunity to try to reproduce. offering this potential service to patients and their families who have questioned what they will do when they try to start a family after aggressive chemotherapy and radiation treatment can be a large advantage, allowing them to focus instead on beating cancer or treating the underlying issue. d. non-maleficence this principle converges with the tenant of autonomy. without guiding a biased decision, it is important to make sure that the longevity, or the lack thereof, of the samples is made clear to the patient and his or her caregivers. is it realistic that the individual will use the samples before they begin to deteriorate and are no longer viable? is opting for preservation then a bad thing, as it will likely contribute to psychological pressure and mental turmoil several years later? esquenazi, ethical assessment of fertility preservation, voices in bioethics, vol. 3 (2017) 3 we certainly do not want to make a patient feel as though they have to rush through deeply personal experiences and decisions before a timer runs out, nor do we want them to feel as though they are forced into a commitment. alternatively, some cancers respond to the presence of estrogen by growing exponentially—a patient who has one of these tumors would clearly not be a good candidate for undergoing the ovarian stimulation necessary in order to obtain a sample.3 in an attempt to offer a patient the same reproductive abilities as their “healthy” peers, opting for preservation may require a delay of starting life-saving cancer treatment in order to harvest reproductive materials. for some patients more than others, time is of the essence, and any delay can be considered too critical of an impediment to treatment. this too is an example of a patient who may be precluded from utilizing fertility preservation tactics. the long-term effects of fertility preservation are unknown due to the newness of the technology. does introducing hormonal therapy for ovarian stimulation have any negative impacts on a patient who does not have an estrogen-sensitive cancer? is it possible that doing this will disrupt the patient’s hormones and result in a secondary (or more) medical conditions due to a hormonal imbalance? although impossible to predict, precautions need to be taken in order to prevent negatively impacting a patient’s endocrine system by flooding it with hormones which can adversely control their blood pressure and metabolism. some instances allow for preservation tactics to begin during and after treatment has already begun. is there enough research on the long-term effects of pregnancy and lactation in a woman who had cancer (and rigorous treatment) as a child? e. justice while there are often institutional, public, and private financial aid programs to assist families to completely cover or partially offset the financial burden of fertility preservation, not all who want the technology will be able to afford it. preservation fertilities are also not always child-friendly, nor willing to preserve materials of those beneath the age of 18. should we offer this technology to young patients with who are “too sick” with highly aggressive cancers and diseases, even in the face of statistics which illustrate poor outcomes? what if they go on to participate in novel clinical trials which yield remission or cures? what happens to the genetic, reproductive material in the event that the patient passes? what happens if the patient ends up getting cancer again and cannot make use of the materials—are they simply destroyed, or are they put to some scientific use? for non-cancer patients, we need to make sure that the trajectory of their illness is on par with undergoing fertility treatment. for example, offering preservation assistance to a high-school-aged student who has had one ovarian cyst is likely a misuse of the technology. this would be an instance of providing extraordinary measures in an inappropriate setting. conclusion defining universal guidelines for fertility preservation in pediatric and adolescent patient would be too restrictive and potentially biased. as is the case with most ethical quandaries, it is most appropriate to meet with patients and their families to have an honest, open discussion about the patient’s fears, wishes, and goals. the decision to pursue fertility preservation is not a simple one, nor are the impacts universal for every patient. a thorough ethics consultation can help to mitigate the decision-making process for the medical team, parents, and child and to come up with an ethical solution to such a complex situation. esquenazi, ethical assessment of fertility preservation, voices in bioethics, vol. 3 (2017) 4 1 loren aw, et al. fertility preservation for patients with cancer: american society of clinical oncology clinical practice guideline update. j clin oncol. 2013; 31: 2500-10 2 klass, perri. "when should children take part in medical decisions?" nytimes, september 20, 2016. accessed june 7, 2017. 3 fallat, mary. hutter, john. preservation of fertility in pediatric and adolescent patients with cancer pediatrics may 2008, 121 (5) e1461-e1469; doi: 10.1542/peds.2008-0593 chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) * jocelyn chase, md © 2018 jocelyn chase. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. healing generational trauma in aboriginal canadians jocelyn chase* abstract on january 19, 2015, makayla sault, an 11 year old aboriginal girl, died of leukemia.1 although her physicians gave her a 75% cure rate with treatment, she and her family refused chemotherapy in favor of pursuing alternative therapies. earlier in 2014, she completed 11 weeks of chemotherapy but decided to withdraw early. because untreated leukemia is a fatal diagnosis, the medical team tried to convince makayla and her family to proceed with the treatment and an ethics consult was obtained to support communication. discussions broke down however and makayla left hospital. many canadians were angered by what they perceived as the justice system failing to intervene to save makayla’s life. what is lacking in much of the discussion about cultural safety locally and internationally is meaningful data collection and research around how effective the above interventions are.27,28 key to the concept of cultural safety is that quality and safety are judged by aboriginal patients, not by health care providers or institutions keywords: cancer, case study, leukemia, chemotherapy, traditional medicine case introduction: makayla’s story on january 19, 2015, makayla sault, an 11 year old aboriginal girl, died of leukemia.1 although her physicians gave her a 75% cure rate with treatment, she and her family refused chemotherapy in favor of pursuing alternative therapies. earlier in 2014, she completed 11 weeks of chemotherapy but decided to withdraw early. makayla informed her doctors that, “i am writing this letter to tell you that this chemo is killing my body and i cannot take it anymore.” because untreated leukemia is a fatal diagnosis, the medical team tried to convince makayla and her family to proceed with the treatment and an ethics consult was obtained to support communication. discussions broke down however and makayla left hospital. her physicians pursued the matter further through the local children’s aid society, who declined to apprehend makayla and force her into treatment stating, "for us to take her away, to apprehend and place her in a home with strangers…when she's very, very ill — i can't see how that would be helpful".1 many canadians were angered by what they perceived as the justice system failing to intervene to save makayla’s life. did makayla die simply because she was aboriginal? others supported the sault’s decision to forgo western medical paternalism, in favor of traditional aboriginal medicine practices and a right to self-determination. regardless of one’s position, mikayla’s story resonates with the chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) 2 lived experience of many aboriginal canadians who suffer inferior health outcomes and face ongoing challenges reconciling their historical cultural narrative with that of the west. ii. discussion a. cultural safety as bioethical framework this paper will use a cultural safety framework as a bioethical tool to understand how western medical institutions and practitioners contribute to broken trust for aboriginal patients like makayla. cultural safety is a concept originating in new zealand for the maori people, and differs from other concepts like cultural humility, competency and awareness.2 cultural safety requires a thorough analysis of the social and historical contexts of health and health inequities. it does not focus on understanding “indigenous culture”, or specific belief systems. the cultural safety approach seeks to determine the roots of social injustice, and how imbalances in power, such as in the relationship between physician and patient, shape health care experiences. it demands that safety be evaluated and judged by those experiencing care, and not those providing it.3 through a cultural safety bioethical model, current and future strategies aimed at redressing health inequalities must first start with a self-reflective process on the part of the physician and health care organization. following this, careful educational, research and policy interventions can be constructed, in concert with aboriginal stakeholders. although deep consideration of solutions is necessary at all levels of the health care continuum, this paper will focus primarily on the individual interactions that aboriginal patients experience with health care providers and within health care institutions, and not specifically on governmental policy, judicial, and social reform. b. current inequities in social determinants of health and health care outcomes aboriginal canadians continue to experience ill health and inferior life expectancy compared to the rest of canadian society.4 for example, the lifespan of an inuit man in nunavik is 15.8 years less than the lifespan of a man in vancouver, british columbia.5 aboriginal individuals are much more likely to die young from violence or trauma, and are more likely to suffer from preventable conditions like diabetes, heart disease and tuberculosis.6 addictions and mental health disorders are highly prevalent in aboriginal communities.7 in contrast, canadians on the whole enjoy excellent health compared to the rest of the world and take pride in canada’s universal health care system and strong social safety net, founded on the principles of equality and justice. so why do health inequities continue to exist for aboriginals? disparities in basic social determinants of health, including lack of access to clean water, affordable and healthy food, and healthcare in the remote regions where aboriginals often reside explain much of their poor health.8 to illustrate, in july 2017 there were 92 advisories for unsafe drinking water in aboriginal communities.9 the canadian senate described current health conditions among aboriginal canadians as a “national disgrace”.10 certainly, recent governmental efforts through the truth and reconciliation committee (trc),11 aimed at closing socioeconomic disparities, as well as planned judicial reforms, will play a role in addressing wrongs, but this discussion is beyond the scope of this paper. instead, let us look to the past through a cultural safety lens to better understand the historical chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) 3 struggles that have set the stage for aboriginal canadians’ mistrust of western health care practitioners and institutions today. c. broken trust: colonial legacy of trauma the most damaging tool of colonialism, perpetrated by white settlers on canada’s original aboriginal inhabitants, is often considered to be the residential school system. more than 150,000 aboriginal children attended these church run schools between the years of 1870 and the 1990s when they were finally closed.12 taken by coercion or force from their homes, children were placed in these schools for the sole purpose of “aggressively civilizing” them, or to “kill the indian in the child.” severely underfunded and poorly staffed, these schools became synonymous with malnourishment and disease, with over 6000 children dying in care, and many more sent home to die. the trc, which conducted a detailed six-year review, found that physical, emotional and sexual abuse was rampant at the schools.11 further, the education provided at residential schools was substandard and many children barely attained basic literacy, furthering cycles of unemployment and poverty. because these children grew up outside of their traditional family structures, bands and nations, they lacked a basic understanding of community relations, parenting and household management. although these events reside in the past, it is crucial to understand that the legacy of trauma is in fact generational and continues to be vividly experienced by aboriginals today when they engage with the health care system. past suffering results in systemic harm to subsequent generations through a loss of language and culture, inferior educational attainment, and the disruption of family structures.13 children of attendees demonstrate worse health status than children of non-attendees. further, families in which multiple generations attended residential schools have greater distress, substance abuse and suicide than those in which only one generation attended.14 unfortunately, most practicing physicians and nurses have no formal education about the disastrous impact of residential schools on canadian aboriginals. medical schools do not include comprehensive teaching around traditional aboriginal values or sensitive communication. this profound lack of understanding allows ongoing biases and racism to run unchecked. rather than appreciating that present poor health conditions are influenced by social and historical events, many health care providers believe that aboriginals are simply doomed to cycles of addiction, poor health, suicide and early mortality because of personal choice or racial inferiority.15 institutional racism in western health care organizations engendered by these negative biases continues to perpetrate trauma upon aboriginal patients. many patients articulate feelings of fear, shame and judgement when admitted to hospital, to the point that they prefer to leave before treatment is complete, further worsening health outcomes.16 racist comments reported in the canadian media include physicians writing prescriptions with crossed out beer bottles, instead of legitimate medication or care plans.17,18 i have personally witnessed an older aboriginal woman admitted for severe medical issues being asked by a nurse, “so, did you fall down drunk?” further, the institutional nature of hospitals, where physicians and nurses typically hold great emotional and physical power over ill and infirm patients, can mirror past events experienced at residential schools. as a result, survivors of residential schools may experience triggering of post-traumatic memories following hospital admission.19 taking a historical view when interpreting present day health injustices is critical to progress cultural safety. unless health care providers understand the root causes of current health outcomes, their biases and racist beliefs will contribute to the cycle of trauma and injustice. the following chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) 4 bioethical analysis will clarify areas in which violations have occurred, while also striking a balance when advocating for solutions. health care providers and institutions must serve the unmet needs of vulnerable aboriginal patients, while also respecting their autonomy, diversity and resilience. iii. bioethics analysis: acknowledging vulnerability while promoting self-determination from a cultural safety perspective, all four foundational bioethics principles — personal autonomy, beneficence, justice, and non-maleficence — were violated in the process of colonization. autonomy was quashed, whereby those in power took an extremely paternalistic view of the aboriginal peoples, believing that “civilizing” them into euro-canadian culture was in their best interests. unfortunately this approach led to little or no benefits and many harms when we consider past and current health inequities. we continue to see infringement of autonomy and lack of respect for persons in the form of institutional racism in health care institutions today. from a justice perspective, the discussion can be framed as an issue of human rights, because it speaks to the degree of abuse perpetrated and the urgency with which a response is needed. clearly, the process of colonization, illustrated by the residential schools, deprived aboriginal canadians of basic human rights on a societal level. the right to life, thought, religion, free movement, as well as basic needs including clean water, adequate nutrition, safety, education and housing were all systemically denied. unfortunately, many of these gaps persist today. in 2015, a united nations report declared that canada’s tolerance of violence towards its aboriginal women and girls constituted a violation of human rights.9 all canadians, including health care providers and institutions, must recognize that human rights violations have occurred historically and continue to be perpetrated inside our own borders. human rights are not just theoretical constructs from the past, or issues that concern persons and aid organizations in the third world. work being done through the trc aims to address these social injustices through policy, but this is beyond the scope of this paper. on an individual level, aboriginal patients are often described as vulnerable by health care providers. vulnerability in health care can arise because of internal factors that affect ability to advocate for oneself, including physical illness, mental illness or substance abuse.20 external factors include epistemic power hierarchies, where physicians and nurses hold the power to provide or deny treatment to patients. acknowledging vulnerability is important because it calls attention to the need for special care and tailored resources to help aboriginal patients navigate the care environment with safety and quality. a. alternate voices and perspectives the bioethics concept of vulnerability is a nuanced one and must be handled with care. when we label a group as vulnerable, we risk being overly paternalistic and may excuse unjustifiable increases in social control.21 also, dwelling on vulnerability can perversely entrench the ideas it seeks to reverse, namely exclusion and stigmatization. lastly, aboriginal canadians are an extremely diverse group, and labeling or generalizing does disservice to individuals who have met adversity with resilience, or do not feel defined by the dominant cultural historical narrative. in any agenda meant to reduce vulnerability, input from the central stakeholder — in this case, aboriginal canadians — is necessary to chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) 5 ensure that solutions focus on unmet needs rather than further cementing misconceptions of internal deficiencies. canadian society as a whole is moving towards a better understanding of the challenges faced by aboriginals. however, racism and lack of education persists and is evidenced by attitudes that seek to deny aboriginals any special consideration or tailored aid strategies. some believe, as in discussions around the validity of international aid, that aid only prolongs dependency.22 this perspective belies the fact that aboriginals continue to face institutional racism and unfair social conditions. under these circumstances, largely created and propagated by the majority in power, we have an absolute ethical obligation to redress wrongs through research, education and policy change. iv. current and future directions: health care providers and institutions embracing cultural safety in many parts of the world with a colonial history, including australia, new zealand and canada, health care institutions are beginning to take steps to improve cultural safety.23 this starts with the creation of an education program, such as the san’yas indigenous cultural safety training program in british columbia, canada.24 these programs focus exclusively on the care of aboriginal patients, rather than cultural minorities in general, and aim to equip practitioners with the knowledge and communication skills needed to provide a safer health care experiences for their aboriginal patients. cultural safety training can be unexpectedly painful for health practitioners because it prompts self-reflection into one’s own biases and challenges conscious or subconscious racism. further, it forces the acknowledgement of one’s own elevated status and privilege, and how this power differential impacts the care of aboriginal people.3 health care institutions have also developed specialized roles, including aboriginal patient navigators (apn), to bridge the cultural trust gap between health providers and aboriginal patients.25 the involvement of these trained individuals, who are often aboriginal themselves, has been shown to decrease stress and anxiety for aboriginal patients in hospital, as well as improve their access to social supports. many health care institutions have also created “safe spaces” for patients of all faiths to practice and hold gatherings. these spaces have enabled aboriginal patients to hold traditional ceremonies, including smudging, allowing them to integrate aspects of traditional medicine while still receiving western treatments.26 what is lacking in much of the discussion about cultural safety locally and internationally is meaningful data collection and research around how effective the above interventions are.27,28 key to the concept of cultural safety is that quality and safety are judged by aboriginal patients, not by health care providers or institutions. the involvement of aboriginal people in the creation and evaluation of any program is essential to ensure that programs truly fill unmet needs. lastly, institutions have the potential to improve care for individual patients, but without a larger societal commitment to advance social justice for canadian aboriginals, beneficial change will be hampered. conclusion: resolution within team? we do not know the details of the interactions that led to a fracturing of trust between makayla’s family and the medical team. however, specific recommendations could be made for future such conflicts aiming to improve mutual understanding and respect. upon admission, the team could offer the services of an aboriginal patient navigator. if no apn role exists, the institution should urgently chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) 6 consider creating one. the team could benefit from specific training in cultural safety, and perhaps this should become a mandatory expectation for any front line health provider. a safe space could also be offered to makayla to facilitate integration of traditional medicine practices within the western institution. consideration could also be given to moving makayla to her home community, allowing her to continue her treatment in relative comfort. lastly, any such programs need to be evaluated by aboriginal patients and their families to ensure unmet needs are being served. references 1 "'chemo is killing my body:' first nations girl opts for traditional treatment,” cbc news, accessed sep 15, 2018, https://www.cbc.ca/news/indigenous/first-nations-girl-chooses-traditional-medicine-over-chemo-1.2644637. 2 papps, e. and i. ramsden. 1996. "cultural safety in nursing: the new zealand experience." international journal for quality in health care: journal of the international society for quality in health care 8 (5): 491-497. 3 government of canada, public services and procurement canada. "empathy, dignity, and respect: creating cultural safety for aboriginal people in urban health care,” last modified -07-01, accessed sep 15, 2018, http://publications.gc.ca/site/eng/445881/publication.html. 4 adelson, naomi. 2005. "the embodiment of inequity: health disparities in aboriginal canada." canadian journal of public health 96 suppl 2: 45. 5 unger, david. "the canadian bioethics companion." the canadian bioethics companion, accessed september 15, 2018, http://canadianbioethicscompanion.ca/the-canadian-bioethics-companion/. 6 cass, alan. 2004. "health outcomes in aboriginal populations." canadian medical association journal 171 (6): 597-598. doi:10.1503/cmaj.1041059. http://www.cmaj.ca/content/171/6/597.abstract. 7 rowan, margo, nancy poole, beverley shea, joseph p. gone, david mykota, marwa farag, carol hopkins, laura hall, christopher mushquash, and colleen dell. 2014. "cultural interventions to treat addictions in indigenous populations: findings from a scoping study." substance abuse treatment, prevention, and policy 9 (1): 34. doi:10.1186/1747-597x-9-34. https://doi.org/10.1186/1747-597x-934. 8 reading, c. l. and f. wien. 2009. health inequalities and the social determinants of aboriginal peoples’ health. prince george, canada: national collaborating center for aboriginal health. 9 "un human rights report shows that canada is failing indigenous peoples." amnesty international canada, accessed sep 15, 2018, https://www.amnesty.ca/news/public-statements/joint-press-release/un-human-rights-report-shows-that-canada-is-failing. 10 kirby, michael. 2002. the health of canadians – the federal role. interim report. volume five: principles and recommendations for reform part i. ottawa, canada: the standing senate committee on social affairs, science and technology. 11 truth and reconciliation commission of canada: calls to action. 2015. winnipeg, canada: truth and reconciliation commission of canada. 12 milloy, john. 1999. a national crime: the canadian government and the residential school system, 1879 to 1986. winnipeg, canada: university of manitoba press. 13 kaspar, violet. 2014. "the lifetime effect of residential school attendance on indigenous health status." american journal of public health 104 (11): 2184-2190. doi:10.2105/ajph.2013.301479. 14 hackett, christina, david feeny, and emile tompa. 2016. "canada's residential school system: measuring the intergenerational impact of familial attendance on health and mental health outcomes." journal of epidemiology and community health 70 (11): 1096-1105. doi:10.1136/jech-2016-207380. https://www.cbc.ca/news/indigenous/first-nations-girl-chooses-traditional-medicine-over-chemo-1.2644637 http://publications.gc.ca/site/eng/445881/publication.html http://canadianbioethicscompanion.ca/the-canadian-bioethics-companion/ http://www.cmaj.ca/content/171/6/597.abstract https://doi.org/10.1186/1747-597x-9-34 https://doi.org/10.1186/1747-597x-9-34 https://www.amnesty.ca/news/public-statements/joint-press-release/un-human-rights-report-shows-that-canada-is-failing chase, healing generational trauma in aboriginal canadians, voices in bioethics, vol. 4 (2018) 7 15 allan, b. and j. smylie. 2015. first peoples, second class treatment: the role of racism in the health and wellbeing of indigenous peoples in canada. toronto, canada. 16 browne, annette j., victoria l. smye, patricia rodney, sannie y. tang, bill mussell, and john o'neil. 2011. "access to primary care from the perspective of aboriginal patients at an urban emergency department." qualitative health research 21 (3): 333-348. doi:10.1177/1049732310385824. 17 "'unconscious, pro-white bias a major factor in poor aboriginal health care,” cbc news, accessed sep 15, 2018, https://www.cbc.ca/news/indigenous/racism-against-aboriginal-people-in-health-care-system-pervasive-study-1.2942644. 18 cunningham, james k., teshia a. solomon, and myra l. muramoto. 2016. "alcohol use among native americans compared to whites: examining the veracity of the 'native american elevated alcohol consumption' belief." drug and alcohol dependence 160: 65-75. doi:10.1016/j.drugalcdep.2015.12.015. 19 kurtz, donna l. m., jessie c. nyberg, susan van den tillaart, buffy mills, and the okanagan urban aboriginal health research collective. 2008. "silencing of voice: an act of structural violence urban aboriginal women speak out about their experiences with health care." international journal of indigenous health 4 (1): 53-63. doi:10.18357/ijih41200812315. https://journals.uvic.ca/index.php/ijih/article/view/12315. 20 clark, beth and nina preto. 2018. "exploring the concept of vulnerability in health care." cmaj: canadian medical association journal = journal de l'association medicale canadienne 190 (11): e309. doi:10.1503/cmaj.180242. 21 piggott, t. w. 2015. pursuing health: underserved populations in canada. ottawa, canada: canadian public health agency. 22 kopinak, j. k. 2013. humanitarian aid: are effectiveness and sustainability impossible dreams? | the journal of humanitarian assistance. http://sites.tufts.edu/jha/archives/1935. 23 schiffer, j. j. 2016. "why aboriginal peoples just can’t “get over it”: addressing and understanding intergenerational trauma." visions 11 (4): 7. 24 ward, cheryl, chelsey branch, and alycia fridkin. 2016. "what is indigenous cultural safety—and why should i care about it?" visions 11 (44): 29. 25 foreman, j. and s. stewart. 2011. an evaluation of the northern health aboriginal patient liaison program. prince george, canada: aboriginal health engagement. 26 "aboriginal health team calling back a different song," providence health care news, last modified june 25, http://phcnews.ca/news/aboriginal-health-team-calling-back-different-song. 27 paradies, yin, ricci harris, and ian anderson. 2008. the impact of racism on indigenous health in australia and aotearoa: towards a research agenda. casuarina, australia: cooperative research centre for aboriginal health. http://dro.deakin.edu.au/view/du:30058493. 28anderson, marcia, janet smylie, ian anderson, raven sinclair, and sue crengle. 2006. first nations, métis, and inuit health indicators in canada. a background paper for the project action oriented indicators of health and health systems development for indigenous people in australia, canada and new zealand. regina, canada: indigenous peoples’ health research centre. https://www.cbc.ca/news/indigenous/racism-against-aboriginal-people-in-health-care-system-pervasive-study-1.2942644 https://journals.uvic.ca/index.php/ijih/article/view/12315 http://sites.tufts.edu/jha/archives/1935 http://phcnews.ca/news/aboriginal-health-team-calling-back-different-song http://dro.deakin.edu.au/view/du:30058493 abstract case introduction: makayla’s story sexton, informed consent and food politics, voices in bioethics, 2013 © 2013 patrina sexton. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. informed consent and food politics patrina sexton “there is this deliberate veil that’s dropped between us and where our food is coming from. the industry doesn’t want you to know the truth about what you’re eating because if you knew, you might not want to eat it,” says narrator, eric schlosser, of 2008 film food inc.“this isn’t just about what we are eating. it’s about what we’re allowed to say, what we’re allowed to know.” while the film addresses a number of salient bioethical issues, the challenges raised in these opening lines point to an overarching domestic and global battle over what we know about the food sold, “donated,” and consumed around the world, and what rights we retain in making informed choices about those foods. insofar as we really do not know what we consume (unless we grow and prepare those foods ourselves or entrust that process to a neighbor whose practices are well described and relied upon for safety), we don’t really offer our informed consent to consume the foods currently sold in u.s. grocery stores and around the world. this is the innovative perspective on food ethics offered by columbia university’s school for international public affairs professor, dr. adela j. gondek. gondek, whose work focuses on ethics and corruption, has offered this unique model by which to assess food production as an ethical and – i add – a bioethical issue. she holds that the united states has had a long and integral history of consent as a practice critical to the democracy that governs the nation, which applies not only to political matters, but to medicine and to food. to the extent that we no longer see or participate in the picking of our fruits and vegetables, greens, sorting grains, harvesting nuts and seeds, and slaughtering and butchering animals to meet our nutritional needs, it is hard to know what actually occurs in the production of packaged goods consumed on a regular basis what’s more, the production practices, which include genetic engineering, high levels of exposure to antibiotics, and pesticide residues, appear to make food less safe and more risky. because we do not know, it is questionable that we actually provide valid informed consent to ingest what we ingest. parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) © 2020 ben parks. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. eighth and fourteenth amendment concerns with the bop guidelines for advance directives ben parks keywords: eighth amendment, fourteenth amendment, due process, dnr orders, advanced directives, bioethics, inmates’ rights absract the current guidelines set forth by the u.s. department of justice federal bureau of prisons (bop) for institutional supplements to advanced directives (ad’s) and do-not-attempt resuscitation orders (dnr’s) potentially violate the fourteenth and eighth amendment rights of inmates who do not wish to receive cardiopulmonary resuscitation (cpr). introduction the current guidelines set forth by the u.s. department of justice federal bureau of prisons (bop) for institutional supplements to advanced directives (ad’s) and do-not-attempt resuscitation orders (dnr’s) potentially violate the fourteenth and eighth amendment rights of inmates who do not wish to receive cardiopulmonary resuscitation (cpr). the bop’s guidelines state that an inmate may have an ad and dnr, and that, “the bureau’s withholding or withdrawal of resuscitative or life-support services pursuant to an advance directive or dnr order, is consistent with sound medical practice and is not associated with assisting suicide, voluntary euthanasia, or expediting the inmate’s death.”1 in an external medical care facility the bop follows the norms of the state and the facility providing care.2 so far so good; however, the bop states that an institutional supplement to an ad must: state that dnr orders will never be invoked while an inmate is housed at a general population institution. emergency resuscitative measures must always be performed on an inmate who suffers cardiopulmonary arrest at a general population institution.3 this stipulation is based on the government’s claim that, “the patient’s right to refuse medical treatment is not absolute and, in all cases, will be weighed against legitimate governmental interests, including the security and orderly operation of correctional institutions.”4 parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 2 however, if the only constraint on an inmate’s right to refuse care is a legitimate government interest, then there should be nothing standing in the way of generally respecting an inmate’s ad in a general population institution. there may be a legitimate government interest in not following through with an ad in cases of violence. yet, for an inmate who goes into cardiac arrest without violence it beggars belief to claim that there is a government interest in performing cpr. analysis the government’s claim becomes more incredulous when one considers the truth about cpr. fractures and injuries to the stomach, liver, spleen, and heart are common.5 one physician described a patient who received cpr as, “barely conscious, vomiting, with broken ribs and a bruised lung. her stomach was bloated and her chest was bleeding…when she died a few days later, i couldn’t help wondering if she really knew what she was getting herself into.”6 thus, when cpr fails, “it may mean that the patient dies in an undignified and traumatic manner.”7 moreover, cpr’s success rate outside of a hospital – such as in a prison – is abysmal: 10.2% of people who receive cpr outside of a hospital survive to hospital discharge with only 8.3% surviving with good or moderate cerebral performance.8 it is no surprise then that many people, including inmates, refuse cpr. based on the due process clause of the fourteenth amendment, patients’ right to refuse care was first declared in cruzan v. director, missouri department of health and then was echoed in the patient selfdetermination act.9 the due process clause states that no state may “deprive any person of life, liberty, or property, without due process of laws.” the supreme court ruled that the state of missouri violated the due process clause by refusing to allow the removal of cruzan’s life support, thus depriving her of her liberty to make decisions – in her case via surrogate – regarding her health care. of importance for our purposes is that the state of missouri’s interest in protecting life on its own was not deemed sufficient grounds for depriving cruzan of her right to refuse life sustaining treatment. the third circuit court ruled in white v. napoleon that this right extends to prisoners in a qualified sense. arguing by analogy from the way that the cases of “committed mental patients” are handled, the third circuit court stated that “convicted prisoners ... retain a limited right to refuse treatment and a related right to be informed of the proposed treatment and viable alternatives.” unlike the near unlimited right to refuse treatment enjoyed by patients who are not inmates, the “limited right to refuse treatment” that inmates have “must be circumscribed by legitimate countervailing state interests.” continuing their analogy to the care of psychiatric patients, the court reasoned that, “a prison may compel a prisoner to accept treatment when prison officials, in the exercise of professional judgment, deem it necessary to carry out valid medical or penological objectives.” however, just as the prisoner’s right to refuse treatment is not absolute neither is prison authortities’ right to compel treatment absolute. instead, their “judgment … will be presumed presumed valid unless it is shown to be such a substantial departure from accepted professional judgment, practice or standards as to demonstrate that the person responsible actually did not base the decision on such judgment.”10 in summary, a prisoner can refuse treatment when such a refusal is medically valid and does not interfere with the penological objectives of the institution, and the institution can compel treatment but the treatment must be in accordance with accepted professional judgment. after white, the supreme court held in washington v. harper that, “the due process clause [of the fourteenth amendment] permits the state to treat a prison inmate who has a serious mental illness with antipsychotic drugs against his will, if he is dangerous to himself or others and the treatment is in his medical parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 3 interest.”11 since white and washington, cases of involuntary treatment of prisoners have been decided based on the government’s interest in the orderly operation of correctional institutions.12 in order for the bop’s guidelines for ad’s to not be in violation of the fourteenth amendment, the bop would have to prove two things. one, that there are “legitimate governmental interests, including the security and orderly operation of correctional institutions,” for forcing cpr upon an inmate who does not want it.13 two, that there is a valid medical objective for performing cpr against the will of an inmate and that doing so does not constitute, “such a substantial departure from accepted professional judgment, practice or standards as to demonstrate that the person responsible actually did not base the decision on such judgment.”14 on the first point, the bop cannot claim a legitimate government interest for two reasons. one, in both cruzan and the psda, the government has shown that the government’s interest to preserve life is limited to some extent by patient autonomy even in the case of the removal of life-sustaining treatment. the government can offer no reason as to why they should suddenly have an interest in preserving life when a refusal of care comes from an inmate as opposed to a patient who is not incarcerated. therefore, the government cannot claim that it is forcing cpr on inmates out of the interest to preserve life because it has already determined that the interest to preserve life does not extend to undesired resuscitation. two, not attempting resuscitation and allowing an inmate to die can in no way seriously impede the orderly operation of a correctional institution. an inmate dying from cardiac arrest is different from a patient refusing vaccination, for the latter is refusing minimally invasive and highly effective care that also impacts the health of the staff and other inmates. additionally, an inmate dying from cardiac arrest cannot use his cardiac arrest to manipulate prison staff like a prisoner on a hunger strike. 15 moreover, there have been cases in which an inmate has been allowed to make refusals of treatment, such as refusing dialysis, that place a far greater burden on the prison and its staff than refusing cpr ever could.16 therefore, the bop cannot claim that an inmate’s ad can be overridden on the grounds of “legitimate government interest” because the government has sanctioned ad’s, and an inmate dying from cardiac arrest does not interfere with the orderly operation of a correctional institution. as for the second prong of a 14th amendment due process challenge, the guidelines fail the “accepted professional judgment” test put forth in white for two reasons. one, it is standard practice in the medical community to respect a patient’s ad, out of respect for both patient autonomy, federal law, and the low success rate of cpr. therefore, the bop guidelines themselves are “a substantial departure from accepted professional judgment, practice or standards as to demonstrate that the person responsible actually did not base the decision on such judgment.”17 two, the very nature of the guidelines prevents professional judgment from being exercised. as the supreme court ruled in chevron v. echazabel, a blanket policy did not allow for professional medical judgment to be made because the judgment could not be individualized.18 in order for a professional judgment to be made regarding whether or not an inmate’s ad should be respected, the individual inmate’s case must be examined to determine if forcing cpr would be medically indicated and if the inmate is seeking to undermine the orderly operation of the prison. the eighth amendment of the constitution which prohibits the use of cruel and unusual punishment is the basis for inmates’ right to health care. in estelle v. gamble, the supreme court held that the, “deliberate indifference by prison personnel to a prisoner's serious illness or injury constitutes cruel and unusual punishment contravening the eighth amendment.” chief justice marshall bases the extension of eighth amendment protection to include the provision of healthcare on “the evolving standards of decency that mark the progress of a maturing society” precedent that was set by trop v. dulles: parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 4 these elementary principles establish the government's obligation to provide medical care for those whom it is punishing by incarceration. an inmate must rely on prison authorities to treat his medical needs; if the authorities fail to do so, those needs will not be met. in the worst cases, such a failure may actually produce physical "torture or a lingering death," … the evils of most immediate concern to the drafters of the amendment. in less serious cases, denial of medical care may result in pain and suffering which no one suggests would serve any penological purpose … the infliction of such unnecessary suffering is inconsistent with contemporary standards of decency as manifested in modern legislation codifying the common law view that "it is but just that the public be required to care for the prisoner, who cannot, by reason of the deprivation of his liberty, care for himself." on these grounds, the “deliberate indifference to serious medical needs of prisoners” is a cause of action under 42 u.s. code §1983, and it does not matter if such indifference is, “manifested by prison doctors in their response to the prisoner's needs or by prison guards in intentionally denying or delaying access to medical care or intentionally interfering with the treatment once prescribed.”19 however, chief justice marshall in estelle notes that not every instance of malpractice violates the eighth amendment: in order to state a cognizable claim, a prisoner must allege acts or omissions sufficiently harmful to evidence deliberate indifference to serious medical needs. it is only such indifference that can offend "evolving standards of decency" in violation of the eighth amendment.20 thus, in order to demonstrate that there has been a violation of his rights, a prisoner must first show that the maltreatment was sufficiently harmful and “a culpable state of mind on the part of prison officials.”21 these are the objective and subjective components of an eighth amendment claim under estelle. in regards to the objective component, the violence of cpr described above is a source of “pain and suffering which no one suggests would serve any penological purpose.”22 furthermore, if “the evolving standards of decency that mark the progress of a maturing society” are taken into account, undesired cpr is cruel and unusual. for the standards of decency that mark the progress of a maturing medical society are such that not every patient should receive cpr, especially those who have a properly obtained dnr. as for the subjective component – establishing “deliberate indifference” – the bop’s policy that dnr’s will not be implemented in a correctional setting establishes that the provision of cpr against an inmate’s will is deliberate: it is not a matter of a prison guard not realizing an inmate has a dnr but a matter of official policy. that the policy is indifferent is evidenced by the lack of any consideration of the medical realities of cpr, its prohibiting true professional judgment, and its disregard for the medical decision making of inmates. additionally, the bop guidelines violate the eighth amendment by failing to provide inmates with adequate medical care. in order to provide adequate medical care to a patient, a physician must know when to treat and when not to treat. overtreatment, non-medically indicated treatment, and treatment against the patient’s wishes are not adequate care. moreover, refusals of treatment are necessary because what constitutes proper care is partly determined by the patient. in adopting a standard that equates medical care to medical treatment, the bop provides inadequate medical care that fails to meet the medical needs of inmates which, “may actually produce physical ‘torture or a lingering death.’”23 conclusion the current bop guidelines for ad’s expose the bureau to civil action under 42 u.s. code § 1983. they do so because they violate inmates’ fourteenth and eighth amendment rights. the guidelines violate the fourteenth amendment for two reasons. one, there is no legitimate governmental interest in forcing cpr parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 5 on inmates. two, the decision to force cpr on inmates is not based on professional judgment. the guidelines also violate the eighth amendment for three reasons. one, cpr can be the source of torture and a lingering death and forcing it on inmates against their will fails to meet the standards of an evolving society. two, by not considering the inmates’ wishes as a matter of official policy, the bop demonstrates deliberate indifference. three, the guidelines equate medical treatment with medical care and in so doing provide inadequate medical care. my suggestion for the bop is that it revise its guidelines for ad’s in correctional facilities to compel prison staff to respect inmates’ refusals of cpr in order to avoid potential future civil action for the violation of inmates’ civil rights. 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https://well.blogs.nytimes.com/2014/07/17/the-cpr-we-dont-see-on-tv/. parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 6 mycares. “cares summary report: demographic and survival characteristics of ohca.” accessed september 8, 2019. https://mycares.net/sitepages/uploads/2016/2015%20presumed%20cardiac%20national%20summary%20report.p df. olds, kelly roger w. byard, and neil e.i. langlois. “review: injuries associated with resuscitation – an overview.” journal of forensic and legal medicine 33 (july 2015): 39-43. accessed september 8, 2019. http://dx/doi.org/10.1016/j.jflm.2015.04.003. patient self-determination act of 1990. accessed september 8, 2019. https://www.congress.gov/bill/101stcongress/house-bill/4449 state ex. rel white v. narick 292 s.e.2d 54 (s.c. wv 1982). accessed september 8, 2019. http://law.justia.com/cases/west-virginia/supreme-court/1982/15442-4.html. stouffer v. reid (md ct. spec. app 2009). accessed september 8, 2019. http://caselaw.findlaw.com/md-court-ofspecial-appeals/1250955.html. trop v. dulles, 356 u.s. 86 (u.s.c. 1958). accessed september 8, 2019. https://www.law.cornell.edu/supremecourt/text/356/86. u.s. department of justice federal bureau of prisons. “patient care.” accessed september 8, 2019. https://www.bop.gov/policy/progstat/6031_004.pdf. van der bulck, j.j. “the impact of television fiction on public expectations of survival following inhospital cardiopulmonary resuscitation by medical professionals.” european journal of emergency medicine 9, no. 4 (december 2002): 325-329. accessed september 8, 2019. http://dx/doi.org/10.1097/01.emj.0000043720.82722.66. washington v. harper 494 u.s. 210 (u.s.c. 1990). accessed september 8, 2019. https://www.law.cornell.edu/supremecourt/text/494/210. white v. napoleon 897 f.2d 103. accessed september 8, 2019. http://openjurist.org/897/f2d/103/white-v-jnapoleon-l-white. willoughby, hannah and dylan harris. “resuscitation on television: realistic or ridiculous? a quantitative observational analysis of the portrayal of cardiopulmonary resuscitation in television medical drama.” resuscitation 80, no. 11 (november 2009): 1275 – 1279. accessed september 8, 2019. http://dx.doi.org/10.1016/j.resuscitation.2009.07.008. wilson v. seiter (u.s.c. 1991). accessed september 8, 2019. http://caselaw.findlaw.com/us-supremecourt/501/294.html. 1 u.s. department of justice federal bureau of prisons, “patient care,” accessed september 8, 2019, https://www.bop.gov/policy/progstat/6031_004.pdf, 33-34. https://doi.org/10.1097/01.emj.0000043720.82722.66 parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 7 2 u.s. department of justice federal bureau of prisons, “patient care,” 31-35. 3 ibid. 34. 4 ibid 5 kelly olds, roger w. byard, and neil e.i. langlois, “review: injuries associated with resuscitation – an overview,” journal of forensic and legal medicine 33 (july 2015): 39-43, accessed september 8, 2019, http://dx/doi.org/10.1016/j.jflm.2015.04.003 6 dhruv khullar, “the cpr we don’t see on tv,” the new york times, july 17, 2014, accessed september 8, 2019, https://well.blogs.nytimes.com/2014/07/17/the-cpr-we-dont-see-on-tv/ 7 general medical council, “end of life care: cardiopulmonary resuscitation,” accessed september 8, 2019, http://www.gmcuk.org/guidance/ethical_guidance/end_of_life_cpr_cardiopulmonary_resuscitation.asp 8 “cares summary report: demographic and survival characteristics of ohca,” mycares, accessed septemebr 9, 2019, https://mycares.net/sitepages/uploads/2016/2015%20presumed%20cardiac%20national%20summary%20report.pdf 9 cruzan by cruzan v. director, missouri department of health 497 u.s. 261, accessed september 8, 2019, https://www.law.cornell.edu/supremecourt/text/497/261 patient self-determination act of 1990, accessed september 8, 2019, https://www.congress.gov/bill/101st-congress/housebill/4449 10 white v. napoleon 897 f.2d 103, accessed september 8, 2019, http://openjurist.org/897/f2d/103/white-v-j-napoleon-l-white. 11 washington v. harper 494 u.s. 210 (u.s.c. 1990), accessed september 8, 2019, https://www.law.cornell.edu/supremecourt/text/494/210 12 e.g. stouffer v. reid (md ct. spec. app 2009), accessed september 8, 2019, http://caselaw.findlaw.com/md-court-of-specialappeals/1250955.html. 13 u.s. department of justice federal bureau of prisons, “patient care.” 14 white v. napoleon 15 state ex. rel white v. narick 292 s.e.2d 54 (s.c. wv 1982), accessed september 8, 2019, http://law.justia.com/cases/westvirginia/supreme-court/1982/15442-4.html. dept. of public welfare v. kallinger 134 pa.commw. 415 (1990), accessed september 8, 2019, http://www.leagle.com/decision/1990549134pacommw415_1490/dept.%20of%20public%20welfare%20v.%20kallinger. 16 stouffer v. reid 17 white v. napoleon 18 chevron v. echazabel, 536 u.s. 73 (u.s.c. 2002), accessed september 8, 2019, https://www.law.cornell.edu/supct/html/001406.zo.html. 19 estelle v. gamble, 429 u.s. 97 (u.s.c. 1976), accessed september 8, 2019, https://www.law.cornell.edu/supremecourt/text/429/97. 42 u.s. code § 1983, accessed september 8, 2019, https://www.law.cornell.edu/uscode/text/42/1983. 42 u.s. code § 1983 reads: every person who, under color of any statute, ordinance, regulation, custom, or usage, of any state or territory or the district of columbia, subjects, or causes to be subjected, any citizen of the united states or other person within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the constitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceeding for redress, except that in any action brought against a judicial officer for an act or omission taken in such officer’s judicial capacity, injunctive relief shall not be granted unless a declaratory decree was violated or declaratory relief was unavailable. http://www.gmc-uk.org/guidance/ethical_guidance/end_of_life_cpr_cardiopulmonary_resuscitation.asp http://www.gmc-uk.org/guidance/ethical_guidance/end_of_life_cpr_cardiopulmonary_resuscitation.asp https://www.law.cornell.edu/supremecourt/text/494/210 https://www.law.cornell.edu/supremecourt/text/429/97 parks, eighth and fourteenth amendment concerns, voices in bioethics, vol. 6 (2020) 8 20 ibid. 21 wilson v. seiter (u.s.c. 1991), accessed september 8, 2019, http://caselaw.findlaw.com/us-supremecourt/501/294.html. 22 estelle v. gamble 23 estelle v. gamble weisberg 12-14 voices towering.doc.docx winter 2015 towering hubris: fear and loathing in flaming san francisco edmund weisberg follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ the title and poster image of the towering inferno forewarn that something goes catastrophically wrong in the gleaming monument to human aspiration and engineering – the world’s new tallest building – featured in the film. flames engulf the fictional skyscraper overlooking san francisco bay and we learn through foreshadowing and exposition that human foibles are culpable for setting the stage for the conflagration. once the fire begins to rage unchecked, multiple close-ups of the burning building (while partygoers are trapped in the penthouse ballroom and firefighters wage a fierce battle to control the menace) convey the enormity of the growing disaster and the danger faced by all of the characters. but does the peril perish with the final flickering of the inferno’s embers? or does the flick imply that there is more to fear than fire itself? the film, released in 1974, follows builder james duncan (william holden) and architect doug roberts (paul newman) as they prepare to host a gala celebrating their completion of their 138-story glass colossus. early in the proceedings, a short circuit sets roberts on the path of discovering that his wiring specifications were not adhered to by duncan’s son-in-law, electrical subcontractor roger simmons (richard chamberlain). as roberts investigates how extensively simmons cut corners to keep from going over budget (at duncan’s behest), a malfunctioning circuit breaker on the 85th floor sparks flames that ultimately kill several people and besiege gala attendees on the 135th floor. attempts at rescue – through the buildings glass elevator, helicopters, and creating a virtual zipline using a rope shot to an adjacent building – are led by fire chief michael o’hallorhan (steve mcqueen) who bemoans the complications engendered by the height of the building and location of those trapped. the multiple-alarm blaze is ultimately brought under control after the deaths of over 200 people. if the movie had been made, as is, a mere 10 years later – set in one of the epicenters of a newly encroaching disease that would inflame the city and engulf most countries in a global epidemic – it might have insinuated a conservative, mainstream fear of aids, and by extension condemnation and trepidation regarding gay men, with san francisco standing in for homosexuals, one of the identified higher-risk populations for contracting aids in the early 1980s and very well represented in san francisco’s population. but absent such a time leap, does the towering inferno demonize at all and what does it say about human fear and anxiety? certainly, fire and fear spread throughout this cinematic cautionary tale. the fear, restrained at times, particularly among the stoic, virile heroes, is justifiable, not paranoid. characters have few means of escape and dread a fiery death. the fire, while provoking panic, is the unintended consequence of human short-sightedness, laziness, and arrogance. as depicted by richard chamberlain, simmons displays his villainy through his defensiveness and callous response to the unfolding disaster as much as his cost-cutting, slipshod job of wiring the heralded new building. his self-centered approach to saving only himself gives the viewer some measure of judgmental satisfaction when he plummets to his death. he may be a scapegoat, but human hubris doesn’t escape unscathed. in the penultimate words of the picture, fire chief o’hallorhan exhorts to roberts, “ya know, one of these days you’re gonna kill 10,000 in one of these fire traps, and i’m gonna keep eatin’ smoke and bringin’ out bodies until somebody asks us how to build ‘em.” this practical point reportedly had a genuine positive impact, influencing the tightening of various sprinkler code guidelines around the world. it also highlighted the human ego manifested in fashioning it as a good idea to erect such grandiose tributes to power. on the architectural level, humanity seems to have solved the inherent risks in creating even taller skyscrapers. but has our hubris been checked? the unintended consequence of antibiotic resistance suggests human overreach in combating a well-concealed foe. further, the increasing frequency of colossal natural events—tsunamis, hurricanes, tornadoes, earthquakes, floods, and droughts—arguably triggered and exacerbated by human-induced changes in the global environment indicate that we may yet face our comeuppance and that our persistent fear of death may be aggravated by our heedless activities that, ironically, may hasten its arrival. complicity in calamity is ascribed individually and globally in the towering inferno, though in a less prejudicial way than that expressed toward aids patients during much of the epidemic, or, in the celluloid world, the tom hanks character by his colleagues in philadelphia, who essentially believed that he got what he deserved. the towering inferno also offers a less salient metaphorical depiction of the threats to humanity than, say, the red menace (read: communism) of another steve mcqueen movie, the blob. but the shattered, charred glass of the towering inferno may reflect the anxiety attendant upon the potential for human pride and aggrandizement, on a large or even small scale, to run amok. perhaps it is contagion—ebola, parasitical aliens, zombies, fire, fear itself—that suggests real and imaginary, visible and invisible, threats to our survival that compound our lurking sense that sometimes humanity is its own worst enemy and that we can exacerbate any and all dangers. yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) * colburn yu, do candidate touro university california college of osteopathic medicine © 2023 colburn yu. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. policies affecting pregnant women with substance use disorder colburn yu* abstract the us government's approach to the war on drugs has created laws to deter people from using illicit drugs through negative punishment. these laws have not controlled illicit drug use, nor has it stopped the opioid pandemic from growing. instead, these laws have created a negative bias surrounding addiction and have negatively affected particularly vulnerable patient populations, including pregnant women with substance use disorder and newborns with neonatal abstinence syndrome. this article highlights some misconceptions and underscores the challenges they face as they navigate the justice and healthcare systems while also providing possible solutions to address their underlying addiction. keywords: reproductive ethics, substance use disorder, addiction, alcohol consumption, neonatal abstinence syndrome introduction pregnant women with substance use disorder require treatment that is arguably for the benefit of both the mother and the fetus. some suggest that addiction is a choice; therefore, those who misuse substances should not receive treatment. proponents of this argument emphasize social and environmental factors that lead to addiction but fail to appreciate how chronic substance use alters the brain’s chemistry and changes how it responds to stress, reward, self-control, and pain. the medical community has long recognized that substance use disorder is not simply a character flaw or social deviance, but a complex condition that requires adequate medical attention. unfortunately, the lasting consequences of the war on drugs have created a stigma around addiction medicine, leading to significant treatment barriers. there is still a pervasive societal bias toward punitive rather than rehabilitative approaches to addiction. for example, many women with substance use disorder lose custody of their baby or face criminal penalties, including fines and jail time.1 these punitive measures may cause patients yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 2 to lose trust in their physicians, ultimately leading to high-risk pregnancies without prenatal care, untreated substance misuse, and potential lifelong disabilities for their newborns.2 as a medical student, i have observed the importance of a rehabilitative approach to addiction medicine. incentivizing pregnant women with substance use disorder to safely address their chronic health issues is essential for minimizing negative short-term and long-term outcomes for women and their newborns. this approach requires an open mind and supportive perspective, recognizing that substance use disorder is truly a medical condition that requires just as much attention as any other medical diagnosis.3 background the war on drugs was a government-led initiative launched in 1970 by president richard m. nixon with the aim of curtailing illegal drug use, distribution, and trade by imposing harsher prison sentences and punishments. 4 however, it is worth noting that one can trace the roots of this initiative back further. in 1914, congress enacted the harrison narcotics tax act to target the recreational use of drugs such as morphine and opium.5 despite being in effect for over four decades, the war on drugs failed to achieve its intended goals. in 2011, the global commission on drug policy released a report that concluded that the initiative had been futile, as “arresting and incarcerating tens of millions of these people in recent decades has filled prisons and destroyed lives and families without reducing the availability of illicit drugs or the power of criminal organizations.” 6 one study published in the international journal of drug policy in the same year found that funding drug law enforcement paradoxically contributed to increasing gun violence and homicide rates.7 the commission recommended that drug policies focus on reducing harm caused by drug use rather than solely on reducing drug markets. recognizing that many drug policies were of political opinion, it called for drug policies that were grounded in scientific evidence, health, security, and human rights.8 unfortunately, policy makers did not heed these recommendations. in 2014, tennessee’s legislature passed a “fetal assault law,” which made it possible to prosecute pregnant women for drug use during pregnancy. if found guilty, pregnant women could face up to 15 years in prison and lose custody of their child. instead of deterring drug use, the law discouraged pregnant women with substance use disorder from seeking prenatal care. this law required medical professionals to report drug use to authorities, thereby compromising the confidentiality of the patient-physician relationship. some avoided arrest by delivering their babies in other states or at home, while others opted for abortions or attempted to go through an unsafe withdrawal prior to receiving medical care, sacrificing the mother's and fetus's wellbeing. the law had a sunset provision and expired in 2016. during the two years this law was in effect, officials arrested 124 women.9 the fear that this law instilled in pregnant women with substance use disorder can still be seen across the us today. many pregnant women with substance use disorders stated that they feared testing positive for drugs. due to mandatory reporting, they were not confident that physicians would protect them from the law.10 and if a woman tried to stop using drugs before seeking care to avoid detection, she often ended up delaying or avoiding care.11 the american college of obstetricians and gynecologists (acog) recognizes the fear those with substance use disorders face when seeking appropriate medical care and emphasizes that “obstetric–gynecologic care should not expose a woman to criminal or civil penalties, such as incarceration, involuntary commitment, loss of custody of her children, or loss of housing.”12 mandatory reporting strains the patient-physician relationship, driving a wedge between the doctor and patient. thus, laws intended to deter people from using substances through various punishments and incarceration may be doing more harm than good. yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 3 county hospitals that mainly serve lower socioeconomic patients encounter more patients without consistent health care access and those with substance use disorders.13 these hospitals are facing the consequences of the worsening opioid pandemic. at one county hospital where i recently worked, there has been a dramatic increase in newborns with neonatal abstinence syndrome born to mothers with untreated substance use disorders during pregnancy. infants exposed to drugs prenatally have an increased risk of complications, stillbirth, and life-altering developmental disabilities. at the hospital, i witnessed child protective services removing two newborns with neonatal abstinence syndrome from their mother’s custody. four similar cases had occurred in the preceding month. in the days leading up to their placement with a foster family, i saw both newborns go through an uncomfortable drug withdrawal. no baby should be welcomed into this world by suffering like that. yet i felt for the new mothers and realized that heart-wrenching custody loss is not the best approach. during this period, i saw a teenager brought to the pediatric floor due to worsening psychiatric symptoms. he was born with neonatal abstinence syndrome that neither the residential program nor his foster family could manage. his past psychiatric disorders included attention deficit disorder, conduct disorder, major depressive disorder, anxiety disorder, disruptive mood dysregulation disorder, intellectual developmental disorder, and more. during his hospitalization, he was so violent towards healthcare providers that security had to intervene. and his attitude toward his foster parents was so volatile that we were never sure if having them visit was comforting or agitating. throughout his hospital course, it was difficult for me to converse with him, and i left every interview with him feeling lost in terms of providing an adequate shortand long-term assessment of his psychological and medical requirements. what was clear, however, was that his intellectual and emotional levels did not match his age and that he was born into a society that was ill-equipped to accommodate his needs. just a few feet away from his room, behind the nurses’ station, were the two newborns feeling the same withdrawal symptoms that this teenager likely experienced in the first few hours of his life. i wondered how similar their paths would be and if they would exhibit similar developmental delays in a few years or if their circumstance may follow the cases hyped about in the media of the 1980s and 1990s regarding “crack babies.” many of these infants who experienced withdrawal symptoms eventually led normal lives.14 nonetheless, many studies have demonstrated that drug use during pregnancy can adversely impact fetal development. excessive alcohol consumption can result in fetal alcohol syndrome, characterized by growth deficiency, facial structure abnormalities, and a wide range of neurological deficiencies.15 smoking can impede the development of the lungs and brain and lead to preterm deliveries or sudden infant death syndrome. 16 stimulants like methamphetamine can also cause preterm delivery, delayed motor development, attention impairments, and a wide range of cognitive and behavioral issues.17 opioid use, such as oxycodone, morphine, fentanyl, and heroin, may result in neonatal opioid withdrawal syndrome, in which a newborn may exhibit tremors, irritability, sleeping problems, poor feeding, loose stools, and increased sweating within 72 hours of life.18 in 2014, the american association of pediatrics (aap) reported that one newborn was diagnosed with neonatal abstinence syndrome every 15 minutes, equating to approximately 32,000 newborns annually, a five-fold increase from 2004. 19 the aap found that the cost of neonatal abstinence syndrome covered by medicaid increased from $65.4 million to $462 million from 2004 to 2014. 20 in 2020, the cdc published a paper that showed an increase in hospital costs from $316 million in 2012 to $572.7 million in 2016.21 currently, the impact of the covid-19 pandemic on the prevalence of newborns with neonatal abstinence syndrome is unknown. i predict that the increase in opioid and polysubstance use during the pandemic will increase the number of newborns with neonatal abstinence syndrome, thereby significantly increasing the public burden and cost.22 yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 4 in the 1990s, concerns arose about the potentially irreparable damage caused by intrauterine exposure to cocaine on the development of infants, which led to the popularization of the term “crack babies.”23 although no strong longitudinal studies supported this claim at the time, it was not without merit. the maternal lifestyle study (nct00059540) was a prospective longitudinal observational study that compared the outcomes of newborns exposed to cocaine in-utero to those without.24 one of its studies revealed one month old newborns with cocaine exposure had “lower arousal, poorer quality of movements and self-regulation, higher excitability, more hypertonia, and more nonoptimal reflexes.” 25 another study showed that at one month old, heavy cocaine exposure affected neural transmission from the ear to the brain.26 long-term follow up from the study showed that at seven years old, children with high intrauterine cocaine exposure were more likely to have externalizing behavior problems such as aggressive behavior, temper tantrums, and destructive acts.27 while i have witnessed this behavior in the teenage patient during my pediatrics rotation, not all newborns with intrauterine drug exposure are inevitably bound to have psychiatric and behavioral issues later in life. npr recorded a podcast in 2010 highlighting a mother who used substances during pregnancy and, with early intervention, had positive outcomes. after being arrested 50 times within five years, she went through step: selftaught empowerment and pride, a public program that allowed her to complete her ged and provided guidance and encouragement for a more meaningful life during her time in jail. her daughter, who was exposed to cocaine before birth, had a normal childhood and ended up going to college.28 from a public health standpoint, more needs to be done to prevent the complications of substance misuse during pregnancy. some states consider substance misuse (and even prescribed use) during pregnancy child abuse. officials have prosecuted countless women across 45 states for exposing their unborn children to drugs.29 with opioid and polysubstance use on the rise, the efficacy of laws that result in punitive measures seems questionable.30 so far, laws are not associated with a decrease in the misuse of drugs during pregnancy. millions of dollars are being poured into managing neonatal abstinence syndrome, including prosecuting women and taking their children away. rather than policing and criminalizing substance use, pregnant women should get the appropriate care they need and deserve. i. misconception one: mothers with substance use disorder can get an abortion if an unplanned pregnancy occurs, one course of action could be to terminate the pregnancy. on the surface, this solution seems like a quick fix. however, the reality is that obtaining an abortion can be challenging due to two significant barriers: accessibility and mandated reporting. abortion laws vary by state, and in tennessee, for instance, abortions are banned after six weeks of gestation, typically when fetal heart rhythms are detected. an exception to this is in cases where the mother's life is at risk.31 unfortunately, many women with substance use disorders are from lower socioeconomic backgrounds and cannot access pregnancy tests, which could indicate they are pregnant before the six-week cutoff. if a tennessee woman with substance use disorder decides to seek an abortion after six weeks, she may need to travel to a neighboring state. however, this is not always a feasible option, as the surrounding states (wv, mo, ar, mi, al, and ga) also have restrictive laws that either prohibit abortions entirely or ban them after six weeks. moreover, she may be hesitant to visit an obstetrician for an abortion, as some states require physicians by law to report their patients' substance use during pregnancy. for example, virginia considers substance use during pregnancy child abuse and mandates that healthcare providers report it. this would ultimately limit her to north carolina if she wants to remain in a nearby state, but she must go before 20 weeks gestation.32 for someone who may or may not have access to reliable transportation, traveling to another state might be impossible. without resources or means, these restrictive laws have made it incredibly difficult to obtain the medical care they need. yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 5 ii. misconception two: mothers with sud are not fit to care for children if a woman cannot take care of herself, one might wonder how she can take care of another human being. mothers with substance use disorders often face many adversities, including lack of economic opportunity, trauma from abuse, history of poverty, and mental illness.33 fortunately, studies suggest keeping mother and baby together has many benefits. breastfeeding, for example, helps the baby develop a strong immune system while reducing the mother’s risk of cancer and high blood pressure. 34 additionally, newborns with neonatal abstinence syndrome who are breastfed by mothers receiving methadone or buprenorphine require less pharmacological treatment, have lower withdrawal scores, and experience shorter hospital stays. 35 opioid concentration in breastmilk is minimal and does not pose a risk to newborns.36 moreover, oxytocin, the hormone responsible for mother-baby bonding, is increased in breastfeeding mothers, reducing withdrawal symptoms and stress-induced reactivity and cravings while also increasing protective maternal instincts.37 removing an infant from their mother’s care immediately after birth would result in the loss of all these positive benefits for both the mother and her newborn. the newborns i observed during my pediatrics rotation probably could have benefited from breastfeeding rather than bottle feeding and being passed around from one nurse to the next. they probably would have cried less and suffered fewer withdrawal symptoms had they been given the opportunity to breastfeed. and even if the mothers were lethargic and unresponsive while going through withdrawal, it would still have been possible to breastfeed with proper support. unfortunately, many believe mothers with substance use disorder cannot adequately care for their children. this pervasive societal bias sets them up for failure from the beginning and greatly inhibits their willingness to change and mend their relationship with their providers. it is a healthcare provider’s duty to provide non-judgmental care that prioritizes the patient’s well-being. they must treat these mothers with the same empathy and respect as any other patient, even if they are experiencing withdrawal. iii. safe harbor and medication-assisted treatment addiction is like any other disease and society should regard treatment without stigma. there is no simple fix to this problem, given that it involves the political, legal, and healthcare systems. punitive policies push pregnant women away from receiving healthcare and prevent them from receiving beneficial interventions. states need to enact laws that protect these women from being reported to authorities. montana, for example, passed a law in 2019 that provides women with substance use disorders safe harbor from prosecution if they seek treatment for their condition. 38 medication-assisted treatment with methadone or buprenorphine is the first line treatment option and should be available to all pregnant women regardless of their ability to pay for medical care.39 to promote continuity of care, health officials could include financial incentives to motivate new mothers to go to follow-up appointments. for example, vouchers for groceries or enrollment in the special supplemental nutrition program for women, infants, and children (wic) may offset financial burdens and allow a mother to focus on taking care of her child and her recovery. iv. mandated substance abuse programs although the number of people sentenced to state prisons for drug related crimes has been declining, it is still alarming that there were 171,300 sentencings in 2019. 40 only 11 percent of the 65 percent of our nation’s inmates with substance use disorder receive treatment, implying that the other 89 percent were left without yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 6 much-needed support to overcome their addiction.41 it is erroneous to assume that their substance use disorder would disappear after a period without substance use while behind bars. after withdrawal, those struggling with substance use disorder may still have cravings and the likelihood of relapsing remains high without proper medical intervention. even if they are abstinent for some time during incarceration, the underlying problem persists, and the cycle inevitably continues upon release from custody. in line with the recommendations by global commission on drug policy and the lessons learned from the failed war on drugs, one proposed change in our criminal justice system would be to require enrollment and participation in assisted alcohol cessation programs before legal punishment. policy makers must place emphasis on the safety of the patient and baby rather than the cessation of substance use. this would incentivize people to actively seek medical care, restore the patient-physician relationship, and ensure that they take rehabilitation programs seriously. if the patient or baby is unsafe, a caregiver could intervene while the patient re-enrolls in the program. those currently serving sentences in prisons and jails can treat their substance use disorder through medication assisted treatment, cognitive behavioral therapy, and programs like self taught empowerment and pride (step). medication assisted treatment under the supervision of medical professionals can help inmates achieve and maintain sobriety in a healthy and safe way. furthermore, cognitive behavioral therapy can help to identify triggers and teach healthier coping mechanisms to prepare for stressors outside of jail. finally, multimodal empowerment programs can connect people to jobs, education, and support upon release. people often leave prisons and jail without a sense of purpose, which can lead to relapse and reincarceration. structured programs have been shown to decrease drug use and criminal behavior by helping reintegrate productive individuals into society.42 v. medical education: narcotic treatment programs and suboxone clinics another proactive approach could be to have medical residency programs register with the drug enforcement administration (dea) as narcotic treatment programs and incorporate suboxone clinics into their education and rotations. rather than family medicine, ob/gyn, or emergency medicine healthcare workers having to refer their patients to an addiction specialist, they could treat patients with methadone for maintenance or detoxification where they would deliver their baby. not only would this educate and prepare the future generation of physicians to handle the opioid crisis, but it would allow pregnant women to develop strong patient-physician relationships. conclusion society needs to change from the mindset of tackling a problem after it occurs to taking a proactive approach by addressing upstream factors, thereby preventing those problems from occurring in the first place. emphasizing public health measures and adequate medical care can prevent complications and developmental issues in newborns and pregnant women with substance use disorders. decriminalizing drug use and encouraging good health habits during pregnancy is essential, as is access to prenatal care, especially for lower socioeconomic patients. many of the current laws and regulations that policy makers initially created due to naïve political opinion and unfounded bias to serve the war on drugs need to be changed to provide these opportunities. to progress as a society, physicians and interprofessional teams must work together to truly understand the needs of patients with substance use disorders and provide support from prenatal to postnatal care. there should be advocation for legislative change, not by providing an opinion but by highlighting the facts and conclusions of scientific studies grounded in scientific evidence, health, security, and human rights. there can be no significant change if society continues to view those with substance use disorders as underserving of care. only when the yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 7 perspective shifts to compassion can these mothers and children receive adequate care that rehabilitates and supports their future and empowers them to raise their children. 1 nida. 2023, february 15. pregnant people with substance use disorders need treatment, not criminalization. https://nida.nih.gov/about-nida/noras-blog/2023/02/pregnant-people-substance-use-disorders-need-treatment-notcriminalization 2 substance use disorder hurts moms and babies. national partnership for women and families. june 2021 3 all stories have been fictionalized and anonymized. 4 a history of the drug war. drug policy alliance. https://drugpolicy.org/issues/brief-history-drug-war 5 the harrison narcotic act (1914) https://www.druglibrary.org/schaffer/library/studies/cu/cu8.html 6 the war on drugs. the global commission on drug policy. published june 2011. https://www.globalcommissionondrugs.org/reports/the-war-on-drugs 7 werb d, rowell g, guyatt g, kerr t, montaner j, wood e. effect of drug law enforcement on drug market violence: a systematic review. int j drug policy. 2011;22(2):87-94. doi:10.1016/j.drugpo.2011.02.002 8 global commission on drug policy, 2011 9 women na for p. tennessee’s fetal assault law: understanding its impact on marginalized women new york. pregnancy justice. published december 14, 2020. https://www.pregnancyjusticeus.org/tennessees-fetal-assault-law-understanding-itsimpact-on-marginalized-women/ 10 roberts scm, nuru-jeter a. women’s perspectives on screening for alcohol and drug use in prenatal care. womens health issues off publ jacobs inst womens health. 2010;20(3):193-200. doi:10.1016/j.whi.2010.02.003 11 klaman sl, isaacs k, leopold a, et al. treating women who are pregnant and parenting for opioid use disorder and the concurrent care of their infants and children: literature review to support national guidance. j addict med. 2017;11(3):178190. doi:10.1097/adm.0000000000000308 12 substance abuse reporting and pregnancy: the role of the obstetrician–gynecologist. https://www.acog.org/en/clinical/clinical-guidance/committee-opinion/articles/2011/01/substance-abuse-reporting-andpregnancy-the-role-of-the-obstetrician-gynecologist 13 r. ghertner, g lincoln the opioid crisis and economic opportunity: geographic and economic trends. aspe. office of assistant secretary for planning and evaluation. dhhs revised september 11, 2018 https://aspe.hhs.gov/reports/economic-opportunityopioid-crisis-geographic-economic-trends 14 midon, m. z., gerzon, l. r., & de almeida, c. s. (2021). crack and motor development of babies living in an assistance shelter. abcs health sciences, 46, e021215-e021215. and for example, see crack babies: twenty years later : npr https://www.npr.org/templates/story/story.php?storyid=126478643 15 williams jf, smith vc, the committee on substance abuse. fetal alcohol spectrum disorders. pediatrics. 2015;136(5):e20153113. doi:10.1542/peds.2015-3113 16 cdc tobacco free. smoking during pregnancy. centers for disease control and prevention. published april 11, 2022. https://www.cdc.gov/tobacco/basic_information/health_effects/pregnancy/index.htm 17 abuse ni on d. what are the risks of methamphetamine misuse during pregnancy? national institute on drug abuse. https://nida.nih.gov/publications/research-reports/methamphetamine/what-are-risks-methamphetamine-misuse-duringpregnancy https://drugpolicy.org/issues/brief-history-drug-war https://www.druglibrary.org/schaffer/library/studies/cu/cu8.html https://www.pregnancyjusticeus.org/tennessees-fetal-assault-law-understanding-its-impact-on-marginalized-women/ https://www.pregnancyjusticeus.org/tennessees-fetal-assault-law-understanding-its-impact-on-marginalized-women/ https://www.acog.org/en/clinical/clinical-guidance/committee-opinion/articles/2011/01/substance-abuse-reporting-and-pregnancy-the-role-of-the-obstetrician-gynecologist https://www.acog.org/en/clinical/clinical-guidance/committee-opinion/articles/2011/01/substance-abuse-reporting-and-pregnancy-the-role-of-the-obstetrician-gynecologist file:///c:/users/colbu/downloads/crack%20babies:%20twenty%20years%20later%20:%20npr https://www.npr.org/templates/story/story.php?storyid=126478643 https://www.cdc.gov/tobacco/basic_information/health_effects/pregnancy/index.htm https://nida.nih.gov/publications/research-reports/methamphetamine/what-are-risks-methamphetamine-misuse-during-pregnancy https://nida.nih.gov/publications/research-reports/methamphetamine/what-are-risks-methamphetamine-misuse-during-pregnancy yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 8 18 cdc. basics about opioid use during pregnancy | cdc. centers for disease control and prevention. published july 21, 2021. https://www.cdc.gov/pregnancy/opioids/basics.html 19 honein ma, boyle c, redfield rr. public health surveillance of prenatal opioid exposure in mothers and infants. pediatrics. 2019;143(3):e20183801. doi:10.1542/peds.2018-3801 20 winkelman tna, villapiano n, kozhimannil kb, davis mm, patrick sw. incidence and costs of neonatal abstinence syndrome among infants with medicaid: 2004–2014. pediatrics. 2018;141(4):e20173520. doi:10.1542/peds.2017-3520 21 strahan ae, guy gp jr, bohm m, frey m, ko jy. neonatal abstinence syndrome incidence and health care costs in the united states, 2016. jama pediatr. 2020;174(2):200-202. doi:10.1001/jamapediatrics.2019.4791 22 ghose r, forati am, mantsch jr. impact of the covid-19 pandemic on opioid overdose deaths: a spatiotemporal analysis. j urban health bull n y acad med. 2022;99(2):316-327. doi:10.1007/s11524-022-00610-0 23 mayes lc, granger rh, bornstein mh, zuckerman b. the problem of prenatal cocaine exposure: a rush to judgment. jama. 1992;267(3):406-408. doi:10.1001/jama.1992.03480030084043 24 nichd neonatal research network. the maternal lifestyle study. clinicaltrials.gov; 2016. https://clinicaltrials.gov/ct2/show/study/nct00059540 25 lester bm, tronick ez, lagasse l, et al. the maternal lifestyle study: effects of substance exposure during pregnancy on neurodevelopmental outcome in 1-month-old infants. pediatrics. 2002;110(6):1182-1192. doi:10.1542/peds.110.6.1182 26 lester bm, lagasse l, seifer r, et al. the maternal lifestyle study (mls): effects of prenatal cocaine and/or opiate exposure on auditory brain response at one month. j pediatr. 2003;142(3):279-285. doi:10.1067/mpd.2003.112 27 bada hs, bann cm, bauer cr, et al. preadolescent behavior problems after prenatal cocaine exposure: relationship between teacher and caretaker ratings (maternal lifestyle study). neurotoxicol teratol. 2011;33(1):78-87. doi:10.1016/j.ntt.2010.06.005 28 n, p, r. crack babies: twenty years later. npr. published may 3, 2010. https://www.npr.org/templates/story/story.php?storyid=126478643 29 miranda l, dixon v, september crp on, 30, 2015. how states handle drug use during pregnancy http://projects.propublica.org/graphics/maternity-drug-policies-by-state 30 ncdas: substance abuse and addiction statistics [2023]. ncdas. https://drugabusestatistics.org/ 31 (tenn. code ann. § 39-15-216). 32 institute g. interactive map: us abortion policies and access after roe. https://states.guttmacher.org/policies/ 33 whitesell m, bachand a, peel j, brown m. familial, social, and individual factors contributing to risk for adolescent substance use. j addict. 2013;2013:579310. doi:10.1155/2013/579310 34 cdc. five great benefits of breastfeeding. centers for disease control and prevention. published july 27, 2021. https://www.cdc.gov/nccdphp/dnpao/features/breastfeeding-benefits/index.html 35 welle-strand gk, skurtveit s, jansson lm, bakstad b, bjarkø l, ravndal e. breastfeeding reduces the need for withdrawal treatment in opioid-exposed infants. acta paediatr. 2013;102(11):1060-1066. doi:10.1111/apa.12378 36 ilett kf, hackett lp, gower s, doherty da, hamilton d, bartu ae. estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment. breastfeed med off j acad breastfeed med. 2012;7:269-274. doi:10.1089/bfm.2011.0096 37 pedersen ca, smedley kl, leserman j, et al. intranasal oxytocin blocks alcohol withdrawal in human subjects. alcohol clin exp res. 2013;37(3):484-489. doi:10.1111/j.1530-0277.2012.01958.x 38 montana sb0289. https://leg.mt.gov/bills/2019/billhtml/sb0289.htm https://www.cdc.gov/pregnancy/opioids/basics.html https://www.npr.org/templates/story/story.php?storyid=126478643 http://projects.propublica.org/graphics/maternity-drug-policies-by-state https://drugabusestatistics.org/ https://states.guttmacher.org/policies/ https://www.cdc.gov/nccdphp/dnpao/features/breastfeeding-benefits/index.html https://leg.mt.gov/bills/2019/billhtml/sb0289.htm yu, policies affecting pregnant women with substance use disorder, voices in bioethics, vol. 9 (2023) 9 39 mullins n, galvin sl, ramage m, gannon m, lorenz k, sager b, coulson cc. buprenorphine and naloxone versus buprenorphine for opioid use disorder in pregnancy: a cohort study. j addict med. 2020 may/jun;14(3):185-192. doi: 10.1097/adm.0000000000000562. pmid: 31567599. 40 drug related crime statistics [2023]: offenses involving drug use. ncdas. https://drugabusestatistics.org/drug-related-crimestatistics/ 41 association aph. online only: report finds most u.s. inmates suffer from substance abuse or addiction. nations health. 2010;40(3):e11-e11. 42 principles of drug addiction treatment: a research-based guide (third edition) | nida archives. published january 17, 2018. http://archives.nida.nih.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-edition https://drugabusestatistics.org/drug-related-crime-statistics/ https://drugabusestatistics.org/drug-related-crime-statistics/ strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) * gianna r. strand, ms in bioethics, columbia university, doctoral candidate in bioethics, loyola university chicago © 2023 gianna r. strand. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. contextual vulnerability should guide fair subject selection in xenotransplantation clinical trials gianna r. strand* abstract xenotransplant research offers hope to individuals waiting for vital organ transplants. nascent first-inhuman xenotransplantation research trials present unique ethical challenges which may translate into obligations for researchers and special considerations for institutional review boards (irbs). contextual vulnerability is an important consideration in reviewing proposed subject selection methods. some recipients are uniquely prone to receiving an unfair offer to enroll in an experimental clinical trial when excluded from allograft waitlists due to psychosocial or compliance evaluations. these exclusions represent an allocational injustice. enrolling research subjects subjectively excluded from allotransplantation into xenotransplant research is not a mechanism of fair access but rather an exploitation of an unjustly optionconstrained vulnerable group by the clinical transplant system. carefully considering contextual vulnerability can help researchers and irbs clarify eligibility criteria for xenograft clinical trials. a requirement for simultaneous allograft co-listing can safeguard the interests of vulnerable potential subjects. keywords: irb, xenotransplantation, clinical trials, research ethics, organ transplantation, allograft introduction in the united states, the supply of allogeneic, or human-derived, organs and tissues from living donors and cadavers available for transplant into critically ill individuals is inadequate.1 physicians refer only half of potentially eligible patients for transplant evaluation, and the clinical transplant team ultimately waitlists less than 30 percent.2 waitlists are lengthy for those who make it through the evaluation process, and many individuals die while waiting for a transplant.3 in contrast to allogeneic transplants, xenotransplantation, from the prefix, xenomeaning foreign, is the process of taking live organs or tissues from an animal for surgical placement into a human recipient. strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 2 xenografts are typically sourced from porcine animals (domestic pigs) or non-human primates (baboons) and range from simple tissues like corneas to complex vital organs like hearts, lungs, or kidneys. scientists have explored xenotransplantation methods for decades, but research with vital organ xenotransplants has been in largely haphazard and non-controlled studies, which demonstrated only short-duration survival for recipients.4 recent advances using gene modification and improved immunosuppression in single-patient attempts to transplant porcine organs into brain-dead human recipients have presented more realistic human-environment models; however, these modified xenografts have still functioned only for very short durations.5 the limited bioethics discourse on xenotransplantation centers primarily on the ethical use of high-order animals and the risks of zoonotic infectious disease spread.6 bioethics pays insufficient attention to the potential for exploitation of vulnerable individuals in need of a transplant amid growing interest in phase i clinical trials in living human subjects. clinician-investigators in contemporary literature repeatedly recommend that these trials enroll subjects who are medically eligible for, but effectively excluded or outright denied access to, an allograft. 7 the food & drug administration (fda) recommends xenotransplants be limited to subjects with serious or life-threatening diseases for whom adequately safe and effective alternative therapies are not available. 8 the ethically salient difference between the investigator and the regulatory recommendations is why alternatives are not available to potential subjects: because transplant centers have subjectively denied access or because there is a clinical contraindication that proves prohibitively risky. in a notable single-patient emergency use authorization, physicianinvestigators offered a genetically modified porcine heart to a living male recipient after denying him access to the waitlist for a human-donor heart, citing a history of non-compliance.9 this case suggests that a person denied access to a transplant waitlist due to subjective compliance criteria is an appropriate research subject. the physician-investigators failed to acknowledge how offering a xenotransplant to a contextually vulnerable subject is potentially unfair. contextual vulnerability is a specific feature of a research environment that increases a subject’s risk of harm. bioethics discourse must address this vulnerability within the transplant research environment. this paper describes the current transplant system’s use of subjective evaluation criteria, particularly psychosocial support and compliance. subjective evaluation criteria perpetuate discriminatory medical biases rather than advance the transplant system’s goal of additional life-years gained. researchers designing controlled human subject trials and institutional review boards (irbs) reviewing and approving proposed protocols must consider how disparate waitlisting practices unjustly preclude some patients from a fair opportunity to access an allograft and impacts their participation in research. it is unethical for physician-investigators to intentionally take advantage of this vulnerability, creating an exploitative and unethical transaction. 10 protocol inclusion criteria requiring proof of simultaneous allograft listing is a feasible procedural safeguard to protect research subjects’ interests. i. injustices in organ allocation solid organ allocation systems are varied but aim for equity and efficiency in granting individuals with similar claims a fair opportunity to access the scarce resource. allocation decisions attempt to maximize the common good of additional life-years gained.11 the federal oversight of allograft allocation in the us uses objective clinical metrics like blood type, immune compatibility, body size, and geographic distance to match organs to recipients to increase both graft and patient survival.12 transplant centers additionally use their own evaluations to waitlist patients. although variation exists between transplant center criteria across more objective measurements, such as lab values and concurrent diseases, significant strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 3 inconsistencies arise in how they incorporate subjective factors like compliance with medical recommendations, psychosocial support, and intellectual disability into the review process. 13 only 7 percent of renal transplant programs use formal criteria for subjective psychosocial assessments, while no pediatric solid organ transplant programs use formal, explicit, or uniform review to assess developmental delays and psychosocial support. 14 failing to establish uniform definitions and inconsistently applying evaluation criteria in the review of potential transplant candidates introduce bias into listing practices. 15 the center they present to and the variable evaluative criteria the center uses may discount an individual’s claim to a fair opportunity to access a scarce resource. labeling a patient non-compliant can preclude both a referral to and placement on a waitlist for potentially suitable recipients. compliance considerations presuppose that graft longevity will be jeopardized by an individual’s failure to adhere to preand post-transplant regimens. it is necessary to distinguish individuals who are intentionally non-adherent to treatment regimens and demonstrate willful disregard for medical recommendations from those who are involuntarily non-adherent due to barriers that limit full participation in care plans. the former would not be offered a spot on the waitlist for an allograft, nor would investigators offer them a spot in a xenotransplantation research study. significant and repeated refusals to participate in treatment plans would confound the ability of researchers to collect necessary data and perform the safety monitoring required by early-phase clinical trials. enrolling subjects who are medically eligible for a traditional transplant but denied access requires a population that is suitably compliant to participate in a clinical trial reliably and safely yet judged not worthy of receipt of a standard allograft during the evaluation process. the latter population is most disadvantaged by compliance judgments and unsubstantiated outcome predictions. multi-center research studies have found that moderate non-adherence to immunosuppression regimens is not directly associated with poor kidney transplant outcomes.16 nor are intellectual and developmental disabilities, conditions for which transplant centers may categorically refuse evaluation, clear indicators of an individual’s ability to comply with treatment regimens. 17 large cohort studies of both pediatric kidney and liver transplant recipients found no correlation between intellectual disability and graft or patient survival.18 rather, it is the perpetuation of medical biases and quality-of-life judgments that presumptively label specific populations poor transplant candidates or label their support systems insufficient, notwithstanding data demonstrating their ability to achieve successful transplant outcomes.19 variability in compliance assessments and psychosocial support criteria allows medical biases to persist and disproportionately impedes waitlist access to patients from underserved populations. 20 low-income medicaid patients are 2.6 times more likely to be labelled non-compliant as privately insured patients.21 additionally, the medical records of black patients are 2.5 times more likely to contain negative descriptors like non-compliant, non-adherent, aggressive, unpleasant, and hysterical than those of white patients.22 the higher prevalence of stigmatizing, compliance-based language in the medical records of minority, economically disadvantaged, and disabled persons decreases the likelihood that they will be recommended for a transplant, referred for an evaluation, placed on a waiting list, or ultimately receive a transplant.23 these populations are at heightened risk of being used in ethically inappropriate ways by xenograft research that capitalizes on this precluded access. ii. defining vulnerability subjective evaluation criteria in allograft waitlisting disproportionately impact some populations. this precluded access to waitlists increases their vulnerability to experience harm in experimental strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 4 xenotransplant research. fair subject selection requires the development of specific and appropriate inclusion and exclusion criteria designed to address and minimize known subject vulnerabilities. 24 this process begins with physician-investigators designing research trials and irb review of proposed trials in which some or all potential subjects are vulnerable.25 the literature has no consensus on defining vulnerability in the clinical or research setting.26 prominent guidelines such as the common rule and the declaration of helsinki focus on a categorical, consent-based approach to assessing vulnerability. the capacity to provide freely given consent is a necessary prerequisite for ethical human subject research. still, consent alone is insufficient to establish ethical permissibility or assure that a research transaction is fair.27 harm can occur even with informed consent if it results from coercion, undue influence, or exploitation.28 subjects have limited ability to avoid exploitation and act as an autonomous moral agents under such circumstances. categorical assessments label groups whose members share salient features, such as prisoners or children, as vulnerable. this shared characteristic may compromise their capacity for free consent and autonomous ability to protect their interests. although widely used, broad categorizations create monolithic views of populations but lack clarity as to why a particular feature makes one vulnerable or what a given characteristic decidedly renders one vulnerable to.29 individuals broadly vulnerable in society, such as the severely economically disadvantaged or incarcerated, are not necessarily vulnerable as research subjects in a given proposed trial.30 categorical vulnerability is insufficient to recognize that research-related harm is specific to a particular subject potentially participating in a given protocol at a definite time and place. iii. assessing for contextual vulnerability ensuring ethical consent, therefore, requires more than an accounting of capacity, competency, and freedom from coercion. this requires looking beyond voluntariness to ask whether the research offer is fair. contextual vulnerability recognizes and addresses how some subjects are at a heightened risk of being used in ethically inappropriate ways due to research-specific situations and environments.31 contextual vulnerability derives from a specific feature of the research environment that increases a subject’s risk of harm rather than an intrinsic categorical condition of that subject. accounting for contextual vulnerabilities is necessary because it is ethically unsound for a competent subject to give voluntary consent to an offer that is nonetheless unfair or exploitative.32 potential subjects excluded from accessing an allograft are contextually vulnerable in a research environment that may view their diminished range of choice as an opportunity for experimental research enrollment. proposals to exploit or take advantage of this vulnerability places these individuals at a heightened risk of researchrelated harm. iv. exploitative transactions in xenotransplant research in the landmark single-patient case in maryland, a genetically modified porcine heart was offered to the subject only because he was denied access to the allograft waitlist due to a history of noncompliance with a recommended medical regimen.33 physician-investigators did not define how they evaluated compliance, nor did they elaborate on how this claim demonstrated the subject’s clear and convincing contraindication to receive a conventional cardiac allograft. the subject was presented with a so-called hobson’s choice, in which there is the illusion of free choice but ultimately there is no real choice as only one outcome, the acceptance of the experimental xenograft, is permitted; access to other choices, such as pursuing standard of care waitlisting, have been removed. 34 this case set a precedent for researchers and irbs to view strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 5 individuals denied access to conventional allografts as an appropriate subject population without acknowledgment of how this transaction is consensually exploitative. consensual exploitation occurs when researchers intentionally and wrongfully take advantage of a subject’s vulnerability.35 in the cardiac xenotransplant case, the application of subjective evaluation criteria created a unique contextual vulnerability specific to transplant waitlist practices. investigators took advantage of the subject’s diminished ability to access the heart transplant waitlist to obtain consent for the xenotransplant procedure. researchers have no obligation to repair unjust conditions that they bear no responsibility for causing.36 the wrongfulness in this case is how subjective compliance-based waitlisting criteria precluded the subject from accessing the heart transplant waitlist and denied him fair consideration in accessing the standard clinical option. then, the transplantation team exploited this disadvantage they were morally responsible for creating. the subject agreed to the terms for an experimental and high-risk xenograft from a place of vulnerability due to the diminished range of choice specifically constructed by the policy and actions of the transplant center. the options offered by the physician-investigators to the patient were manipulated to promote the research system’s interests through the production of new scientific knowledge, not necessarily the subject’s conception of his own good.37 v. recommendation for simultaneous allograft listing ethical research design calls for assessments of which vulnerabilities and in which contexts researchers and irbs ought to offer additional safeguards. subjects should be clinically suitable to produce robust, reliable, and generalizable scientific knowledge and be presented with a fair research offer. researchers and irbs can achieve this through an inclusion criterion requiring that a subject has previously been placed on and maintains a spot on a waitlist for a conventional allograft. investigators and irbs must ensure that subjects are selected based on scientific rationale, not because they are easy to recruit due to a compromised or vulnerable position.38 evidence of simultaneous allograft listing would provide verification that a researcher expects a potential subject to survive the burdens of an experimental xenotransplant procedure. individuals of advanced age or with severe life-limiting comorbidities separate from their end-stage organ failure are less likely to survive after receiving an allograft or a research xenograft. these subjects would not produce valuable data in service to the study’s endpoints or knowledge generalizable to broader patient populations. requiring evidence of simultaneous allograft listing fulfills the ethical requirement that subjects who withdraw consent are not worse off than if they had not pursued research enrollment. 39 if a subject withdraws consent before receiving a xenograft, their continued place on a waitlist ensures that their fair opportunity claim to an allograft has been maintained. simultaneous allograft waitlisting excludes contextually vulnerable subjects clinically suitable to receive a graft but denied access to a waitlist. this inclusion criteria provides an additional safeguard against unfairly capitalizing on a subject’s marginalized status. requiring simultaneous allograft listing will narrow the potential subject population to those clinically suitable and well situated to receive a fair opportunity to enroll in research: individuals listed for an allograft but significantly unlikely to receive or to benefit from that allograft. this potential subject population includes individuals with broadly reactive antibodies who are unlikely to match to a donor organ and individuals with anatomical contraindications who face prohibitive risks with standard allografts or bridging therapies.40 this subject population aligns with the fda recommendation to enroll subjects for whom safe and effective alternatives are not available.41 strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 6 these individuals have not had their claim to a fair opportunity transgressed by a subjective evaluation process, nor has their interest in accessing a scarce resource been unjustly discounted. 42 neither the individual nor the transplant clinicians are responsible for creating a clinical or statistical disadvantage to receiving a standard allograft. an offer of research enrollment extended to this population has not been manipulated to favor one party over the other, but rather appropriately considers the interests of both parties.43 researchers have an interest in identifying subjects capable of producing scientifically valuable knowledge. potential subjects have an interest in exploring alternatives to the high morbidity of a traditional allograft. this subject population retains the autonomous choice to pursue a standard-of-care allograft or to enroll in xenograft research. having few treatment options available does not inexorably undermine the voluntariness of research consent or increase vulnerability.44 the consent transaction is not exploitative or unfair because the transplant system is not responsible for creating this diminished range of choice. simultaneous allograft listing represents an eligibility criterion that responds to and limits the products of subjective decisions from unjustly impacting trial enrollment. vi. counterargument: is something better than nothing? some may argue that for medically exigent individuals in need of a transplant, any option to participate in research is better than no option. autonomy and dignity, however, are not advanced when an inability to access the standard of care compels a subject’s decision to pursue experimental research. an offer of research enrollment that is unfair or exploitative remains unethical regardless of whether the subject stands to benefit. nor should benefit be expected in early-phase research. the goals of phase i research are primarily to collect short-term safety, toxicity, dosing, and pharmacologic data, not to provide efficacious treatment.45 expanding access to experimental research trials cannot be conflated with fair access to equitable health care. 46 broadened access alone does not produce a more ethical research environment. excluding contextually vulnerable subjects from research should not be the end goal, but rather a necessary interim to call attention to the need to redress biases and existing injustices in transplant access. research that targets a population’s vulnerability serves to enable the continuation of unjust systems. conclusion in summary, the urgent and significant clinical need for transplantable organs cannot undermine the requirements of ethical research design and conduct. fair subject selection is a requirement of ethical clinical research.47 potential subjects enrolled in upcoming xenograft research must be selected for their ability to answer the scientific objectives of a proposed study and must have the capacity to provide freely given informed consent within a fair research environment. denying access to allotransplants for subjective psychosocial or compliance-based claims creates contextual vulnerability specific to transplant research that perpetuates the unfairness of the organ allocation system. ethical research that produces valuable scientific knowledge cannot exploit the rights or interests of subjects in the process. a look beyond categorical vulnerability to contextual vulnerability highlights this currently overlooked area of exploitation. 1 “organ donation statistics,” health resources and services administration, accessed april 18, 2022, https://www.organdonor.gov/learn/organ-donation-statistics. 2 schold, j.d. et al., “barriers to evaluation and wait listing for kidney transplantation,” clinical journal of the american society of nephrology 6, no. 7 (2011): 1760-67. 3 abouna, g.m. “ethical issues in organ transplantation,” medical principles and practice 12, no. 1 (2003): 54-69. 4 anderson, m. “xenotransplantation: a bioethical evaluation,” journal of medical ethics 32, no. 4 (2006): 205-8. https://www/ strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 7 5 lambert, j. “what does the first successful test of a pig-to-human kidney transplant mean?,” sciencenews, october 22, 2021, https://www.sciencenews.org/article/xenotransplantation-pig-human-kidney-transplant.; koplon, s. “xenotransplantation: what it is, why it matters and where it is going,” uab news, february 17, 2022, https://www.uabmedicine.org/-/xenotransplantationwhat-it-is-why-it-matters-and-where-it-is-going. 6 anderson, supra; daar, a.s. “ethics of xenotransplantation: animal issues, consent, and likely transformation of transplant ethics,” world journal of surgery 21, no. 9 (1997): 975-82.; kim, m.k., et al., “the international xenotransplantation association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation,” xenotransplantation 21, no. 5 (2014): 420-30. 7 abouna, supra; pierson, r.n., et al., “pig-to-human heart transplantation: who goes first?,” american journal of transplantation 20, no. 10 (2020): 2669-74. 8 food and drug administration, source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans (silver spring, md, 2016), 43, https://www.fda.gov/media/102126/download. 9 wang, w., et al., “first pig-to-human heart transplantation,” innovation (camb) 3, no. 2 (2022): 100223. 10 carse, a.l. and little, m.o. “exploitation and the enterprise of medical research,” in exploitation and developing countries, ed. j. s. hawkins and e. j. emanuel (princeton, nj: princeton university press, 2008), 206-45. 11 halpern, s.d. and goldberg, d.“allocating organs to cognitively impaired patients,” new england journal of medicine 376, no. 4 (2017): 299-301. 12 “how we match organs,” united network for organ sharing, accessed april 18, 2022, https://unos.org/transplant/how-wematch-organs/. 13 uw medicine harborview medical center – uw medical center university of washington physicians, selection criteria: kidney transplant recipient (seattle, wa, 2019), 1-3, https://www.uwmedicine.org/sites/stevie/files/2020-11/uw-medicine-kidneyselection-criteria-uh2701.pdf; penn medicine, kidney transplant selection criteria (philadelphia, pa: hospital of the university of pennsylvania), 1-2. https://www.pennmedicine.org/media/documents/instructions/transplant/kidney_transplant_selection_criteria.ashx. 14 dudzinski, d.m. “shifting to other justice issues: examining listing practices,” american journal of bioethics 4, no. 4 (2004): 35-37.; richards, c.t., et al., “use of neurodevelopmental delay in pediatric solid organ transplant listing decisions: inconsistencies in standards across major pediatric transplant centers,” pediatric transplant 13, no. 7 (2009): 843-50. 15 dudzinski, supra. 16 israni, a.k., et al., “electronically measured adherence to immunosuppressive medications and kidney function after deceased donor kidney transplantation,” clinical transplantation 25, no. 2 (2011): 124-31. 17 national council on disability, organ transplant discrimination against people with disabilities (washington, dc, 2019), 25-35, https://ncd.gov/sites/default/files/ncd_organ_transplant_508.pdf.; halpern and goldberg, supra. 18 wightman, a., et al., “prevalence and outcomes of renal transplantation in children with intellectual disability,” pediatric transplantation 18, no. 7 (2014): 714-19.; wightman, a., et al., “prevalence and outcomes of liver transplantation in children with intellectual disability,” journal of pediatric gastroenterology and nutrition 62, no. 6 (2016): 808-12. 19 richards et al., supra; godown, j., et al., “heart transplantation in children with down syndrome,” journal of the american heart association 11, no. 10 (2022): e024883. 20 silverman, h. and odonkor, p.n. “reevaluating the ethical issues in porcine-to-human heart xenotransplantation,” hastings center report 52, no. 5 (2022): 32-42. 21 sun, m., et al., “negative patient descriptors: documenting racial bias in the electronic health record,” health affairs 41, no. 2 (2022): 203-11. 22 ibid. 23 dudzinski, supra; garg, p.p., et al., “reducing racial disparities in transplant activation: whom should we target?,” american journal of kidney diseases 37, no. 5 (2001): 921-31. 24 emanuel, e.j., et al., “what makes clinical research ethical?,” jama 283, no. 20 (2000): 2701-11. 25 45 c.f.r. 46.111(b). 26 hurst, s.a. “vulnerability in research and health care; describing the elephant in the room?,” bioethics 22, no. 4 (2008): 191202. 27 the nuremberg code, trials of war criminals before the nuremberg military tribunals under control council law 2, no. 10: 181-2 (washington, dc: u.s. government printing office, 1949); kipnis, k. “vulnerability in research subjects: a bioethical https://unos/ https://ncd.gov/sites/default/files/ncd_organ_transplant_508.pdf strand, xenotransplantation clinical trials, voices in bioethics, vol. 9 (2023) 8 taxonomy. ethical and policy issues in research involving human participants.,” in ethical and policy issues in research involving human participants, (bethesda, md: national bioethics advisory commission, august 2001), g1-g13. 28 dickert, n. and grady, c. “incentives for research participants,” in the oxford textbook of clinical research ethics, ed. e. j. emanuel et al. (oxford university press, 2008), 386-96. 29 gordon, b.g. “vulnerability in research: basic ethical concepts and general approach to review,” ochsner journal 20, no. 1 (2020): 34-38. 30 kipnis, supra. 31 hurst, supra. 32 lamkin, m. and elliott, c. “avoiding exploitation in phase i clinical trials: more than (un)just compensation,” journal of law, medicine & ethics 46, no. 1 (2018): 52-63.; jansen, l.a. “a closer look at the bad deal trial: beyond clinical equipoise,” hastings center report 35, no. 5 (2005): 29-36. 33 wang et al., supra; silverman and odonkor, supra. 34 silverman and odonkor, supra. 35 carse and little, supra. 36 wertheimer, a. “exploitation in clinical research,” in the oxford textbook of clinical research ethics, ed. e. j. emanuel et al. (oxford university press, 2008), 201-210. 37 brock, d.w. “philosophical justifications of informed consent in research,” in the oxford textbook of clinical research ethics, ed. e. j. emanuel et al. (oxford university press, 2008), 606-612. 38 council for international organizations of medical sciences, international ethical guidelines for health-related research involving humans (geneva: world health organization, 2016), https://cioms.ch/wp-content/uploads/2017/01/web-ciomsethicalguidelines.pdf. 39 ibid. 40 pierson et al., supra. 41 food and drug administration, supra. 42 hurst, supra. 43 kipnis, supra. 44 hawkins, j.s. and emanuel, e.j. “introduction: why exploitation?,” in exploitation and developing countries, ed. j. s. hawkins and e. j. emanuel (princeton, nj: princeton universiy pres, 2008), 1-20. 45 muglia, j.j. and digiovanna, j.j. “phase 1 clinical trials,” journal of cutaneous medicine and surgery 2, no. 4 (1998): 236-41. 46 dresser, r. “the role of patient advocates and public representatives in research,” in the oxford textbook of clinical research ethics, ed. e. j. emanuel et al. (oxford university press, 2008), 231-41. 47 mackay, d. and saylor, k.w. “four faces of fair subject selection,” the american journal of bioethics 20, no. 2 (2020): 5-19. winter 2015 aunt peggy carolyn riley chapman follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics we were driving back from maine on memorial day when my cell phone rang. it was my mother. peggy, her sister, had gone to the emergency room with shortness of breath and her local hospital had admitted her. i had just seen peggy a couple weeks before at my cousin’s daughter’s communion, and she had seemed fine. even though it wasn’t my daughter’s birthday party, peggy had remembered to bring her some fun little presents– decorations for her bike’s wheels and some beaded necklaces and bracelets. on tuesday, i took a one-hour drive up the new york state thruway to visit peggy in orange county. it was a hot, sunny day. i had music playing and the air conditioner running. the trees were so lush and green, in their prime, beckoning out over grassy fields. commuting for her job as a social worker, my aunt had taken the same trip thousands of times. on my drive up, i thought about a phone conversation i had with peggy over the winter. many years her senior, her husband was having health issues, and she was conflicted about leaving him when she had to go to work. she had sounded stressed out, and it was the first time in our relationship that the roles had shifted, where i found myself trying to support her, instead of the other way around. when i entered her room, it was clear peggy was uncomfortable. the doctors had found fluid around her lungs and inserted a tube to drain it (at bedside, no less). “here, just let me stick this tube into your side,” we tried to laugh. i told her how beautiful the drive up had been. from her hospital bed, she glanced out the window and nodded. peggy wondered whether a recent fall had hurt her lungs—she was significantly overweight—but she also mentioned having a cough that never went away. she was a biology major in college, and i had done graduate work in genetics. she had an unbelievable knowledge of medical issues that challenged my own. once we both acknowledged that we didn’t fully understand the cause of her symptoms, we changed the topic. i told her about my current worry—a big controversy at my son’s nursery school. “sounds like the wrong committee to be on,” she said, smiling. as i was leaving, i asked her if there was anything else i could do for her. she said the visit had been really nice. throughout the next week i got updates about peggy's status from my mother, but i didn’t get back to see her until almost two weeks later, a sunday which happened to be father’s day. she had been transferred to a larger hospital because she needed a special procedure that couldn't be performed at her local hospital. further complicating the situation was that her husband had since been hospitalized as well, but was at a different location. his grown children (from a prior marriage) were managing his care, but he was unable to support peggy himself. when my mother, sister, and i walked into the icu, we were happy and eager to see peggy, anticipating that the procedure would have improved her condition. the mood quickly turned serious. we needed to put on gloves as we were informed that peggy had contracted a mrsa infection. she, of course, laughed and smiled when we came in but we voices in bioethics immediately gathered that she was in a lot of pain. while we were taking a break in the waiting room, a nurse came to tell my mother that they needed to put peggy on a ventilator. a ventilator! we had no idea she was that sick. things unfolded rapidly. by monday, we learned she had cancer. by the end of the week, we learned it was at stage iv and was untreatable. peggy’s doctors and extended family struggled to figure out how much to tell her. during one visit that week, my sister and i asked peggy what we could do for her. she glanced around the room and looked up at us, with her eyebrows raised, trying to convey her meaning without being able to speak. the next day, we brought back cards, pictures, and silk flowers to decorate her room. we gave her a dry erase board so she could write messages to us. the following weekend, i was the first to arrive at the hospital, and was alone with her for a few moments. although peggy knew she had cancer, she did not know that the doctors felt it was untreatable and that her care was palliative at this point. she wrote me messages about her interactions with the doctor that morning-she was angry because he wasn’t sufficiently answering her questions. “the doctors don’t have all the answers,” i said to her softly. the following tuesday, the doctors gave peggy their prognosis. when she knew she was dying, she wrote notes to family and friends, and helped plan her own funeral. she wanted certain songs: “san francisco (be sure to wear flowers in your hair)” and “row, row, row your boat,” sung in rounds. she wanted origami butterflies. she wanted the service outside. thankfully, her husband’s health had improved, and the family was able to arrange for him to visit. on the dry erase board, she asked me if there was anything i wanted to tell her: she didn’t have much time left. i recalled that as a child, i had accidentally put pen marks all over the armrest in the back seat of her new yellow mustang. when she had dropped me back home, i was too mortified to say anything or to apologize. the next time i was in her car, the marks were gone. she never even asked me about it. i knew it was my last chance to say sorry, but i still couldn’t find the words. i didn’t want to make her feel bad that i remembered it. instead, i told her that she had a life well lived. she had loved all of us—her husband, her step-children, her grandchildren, her siblings and their spouses, her nieces and nephews, grandnieces, grandnephews and friends—for better, for worse, for richer, for poorer, in sickness and in health. she was non-judgmental in her love and so selfless. although the doctors told peggy that she would not last more than a couple of hours without the ventilator, she decided she did not want to continue on the machine. she wanted to be taken off on thursday night because she didn’t want to die on my son’s first birthday on friday. with her husband, family and friends surrounding her, she fought harder than they thought she would. she gasped for breath for more than twelve hours. only 55 years old, she died exactly one month after i had first visited her in the hospital on that sunny may day. peggy was gone. jackson, reelabilities, voices in bioethics, vol. 1 (2014-2015) © 2014 jhia jackson. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. reelabilities: heart-opening insights, mind-boggling questions jhia jackson film, quality of life, disability, differently abled quality of life is a standard phrase that can often be tossed into medical and bioethical discussions. when referring to a patient, this term sums up values such as respect for all persons, dignity, and serving the best interests of the patient. however, it can also be used to add validity to what would otherwise seem like an emotional response. “i wouldn’t want my child’s quality of life to be affected by...” “well what sort of quality of life would they have if...” “yes, but that’s not a good quality of life! they are missing out on...” “not everyone can handle that type of quality of life though...” phrases like the above are used to mask one key emotion: fear. fear of the unknown. uncertainty about our ability to thrive with a life we are unaccustomed to. anxiety over accepting an unexpected challenge. nonetheless, quality of life plays such an important part in our decision-making because all of our fears and concerns stem from a place of love. as potential parents are faced with the opportunity to screen embryos, mix and match selected dna, and generally have more influence on the genetic make-up of their child, the questions surrounding “quality of life” are beginning to manifest themselves in a whole new way. no longer are the outcomes shaped by what type of life they had been living, and what a person would want moving forward. reproductive technologies allow us to ask what we want for this potential person, and then make choices that will affect their entire lives. for those that have limited experiences interacting with people who are living with disabilities, answering quality of life questions may be negatively impacted by a lack of understanding. reelabilities: ny disabilities film festival promotes awareness and appreciation of the lives of people who have different disabilities. the films include showing the day-to-day lives, medical experiences, work experiences, and artistic expressions of people with a wide variety of diagnoses. a quick scan through the film descriptions shows unique themes that are often not discussed or easily found in the media: a successful matchmaker, a car manufacturing company with over 1200 developmentally disabled workers, views about the implications of genetic enhancement, and much more. the festival lasts from march 6-11 and is hosted by the jcc in manhattan with venues throughout the city. tickets, scheduling, and further information can be found by going to www.newyork.reelabilities.org. this is an excellent opportunity to watch great films, learn more about a variety of disabilities, and speak with others who have experiences within the disabled community. if you are unable to attend, even just browsing through the website may provide some more insight into answering questions surrounding quality of life. reelabilities: ny disabilities film festival march 6-11 www.newyork.reelabilties.org reelabilities national program, other cities http://www.newyork.reelabilities.org/ http://www.newyork.reelabilties.org/ jackson, reelabilities, voices in bioethics, vol. 1 (2015) 2 www.reelabilities.org http://www.reelabilities.org/ reelabilities: heart-opening insights, mind-boggling questions riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) * jacob riegler, md/mba candidate, university of central florida. ms candidate, alden march bioethics institute, albany medical college. © 2023 jacob riegler. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. comparative ethics of modern payment models: does the way we pay for care align with patient care ethics? jacob riegler* abstract payment models directly impact the way patients experience care. historically, payment model innovations have been examined mostly from economic, organizational, and public health lenses. financial incentives exist in all healthcare systems, whether a socialized, private or public insurance, or single payer system. this article examines the alignment of current predominant payment models of fee-for-service, capitation, and value-based payments with patient care ethics. the volume-based incentive of fee-for-service is misaligned with patient care, while capitation is a relatively neutral and highly modifiable model. value-based payments offer a unique benefit in improving patient agency and have a larger benefit of cost control. however, no model adequately addresses health disparities, and a larger consideration for justice is needed by payment model designers when considering incentives. in consideration of related values, bioethics must expand the discourse around patient care ethics to cover patient interactions with the health system and market forces outside the clinical context. keywords: incentive design, healthcare payment model, health disparities, fee-for-service, incentive introduction healthcare payment models have always been controversial. discussions about healthcare payment models broadly include economic, ethical, and medical realms. the “simple” act of one party paying for health care creates interactions between the payer, the provider, and the patient. payments are based on an agreed-upon price between the paying party and the provider. while in most industries, at the level of retail delivery, the direct customer pays for the item received, in healthcare, the system is more complex. riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 2 deciding what metrics to base healthcare prices on has become arduous. whether organizations should charge a patient for healthcare in nations where it is considered a human right is a subject of debate. this ethical debate over providing care is combined with the theoretical framework of how to price and pay for healthcare. this paper examines the ethics of various approaches to paying for care. outside of the controversial notion of patients financing their care, existing payment models always involve some entity other than the patient paying for the bulk of the care – whether in a socialized system, single payer, or public or private insurance system. in these systems, an implicit financial incentive to provide care based on payment criteria arises.1 depending on the nature of the payment, the financial incentive may align with, be neutral toward, or misalign with a patient’s best interest and goals of care. these payments create market forces in capitalistic or single payer healthcare models and drive organizational behavior in nationalized models. 2 we can see the organizational and marketplace adaptations to predominant volume-based payment models in the united states in the form of shorter visits, unnecessary care or increased volume of care, and medical determination of which care is provided based on coverage. fee-for-service has incentivized higher patient volume over quality time with patients, leading to 10to 25minute patient visits.3 payments based on any metric implicitly direct patient care by moving provider action toward the metric the payment is based on, regardless of intent or conscious effort.4 for example, when the paying body financially reward hospitals for shorter inpatient stays, then the average length of stay will decrease.5 payment for care has numerous, widespread effects on how patients experience care and even the quality of care they receive, creating ethical and economic issues. oddly, from a strictly financial perspective, patients are secondary consumers of their care in most healthcare systems. with this, providers have a financial responsibility to the paying body to act within the bounds of payment incentives (specifically, the paying body, such as an insurance company, is assured that the patient gets the care that is paid for based usually on pre-agreed terms) and an ethical and duty-based responsibility to the patient for patient care. as an example of misaligned interests, there is a clear financial incentive to deny prior authorization for a medication that is an expensive yet otherwise appropriate alternative for a patient’s condition. this could result in an equal treatment, perhaps a generic version even, or an alternative that the provider and patient would not have chosen otherwise. it could result in the patient being deprived of a choice. i. patient care ethics and payment using the four principles of bioethics, the tenets of ethics for patient care, the payment systems have clear effects on patient autonomy and agency, and may conflict with beneficence, non-maleficence, and justice. 6 the tension that providers experience in navigating payers while fulfilling their patient responsibility causes ethical dilemmas. volume-based reimbursement schemes prioritize efficiency, regardless of these major bioethical principles. to truly evaluate a payment model, we need not vaguely consider the supposed moral intentions of a model – we need to evaluate the theoretical incentive design as it pertains to the tenets of bioethics. i propose a novel model for viewing incentives with a bioethical framework. the motivation for viewing how the system design for payment models use incentives under a bioethical lens is summarized below. a. payments, by nature, create active and passive organizational incentives. b. incentives affect organizational and provider behavior, regardless of intent. riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 3 c. changed behavior in response to a financial incentive directly and implicitly impacts the tenets of bioethics. d. for payment models to be considered ethical, they must align organizational incentives with patient care goals and ethics. the argument that incentives should not exist in healthcare because they foster competition and, therefore, cause disparities is acknowledged.7 however, the argument against incentives ignores the reality of healthcare, especially in the united states, where the most progressive recommendations still retain a paying agency. therefore, the focus in this paper concerns the existing payment models. the alignment of predominant payment models—including fee-for-service, capitation or mixed models, and value-based payments —with patient care ethics is difficult. this paper argues that the value-based payment model is the most appropriately aligned model when considering health disparities, the rawlsian difference principle, and distributive justice. ii. payment models and patient care ethics alignment payment models are highly varied. as it currently stands, the most widely used model globally is fee-forservice, a volume-based model in which insurance companies pay physicians and organizations for performed actions based on evaluations such as relative value units. relative value units consider physician work, practice expense, service rendered, and professional liability.8 later models, like capitation, were enacted to control costs. simply put, purely capitated payments consist of flat-term payments for patient care that do not change based on services rendered. 9 within the past decade, value-based payments, which pay physicians based on patient value, as defined by outcomes divided by costs, became popular.10 there are other approaches to paying for patient care, such as health savings accounts or direct primary care (patients directly pay physicians without insurance).11 while these are assuredly interesting areas of study, the financial incentives mimic fee-for-service, in which physicians and organizations receive payments based on direct services rendered and will not be discussed further in this article. iii. fee-for-service fee-for-service is the main payment model worldwide.12 it has played a large role in shaping the structural nature of healthcare, particularly in the united states.13 fee-for-service, although declining, is still pervasive in the us health system and has created market forces that indirectly affect the geographic distribution of care, with an obvious volume-based market force.14 even with the advent of alternative payment models, fee-for-service remains the primary mode of physician compensation by percentage in primary care in the us.15 fee-for-service’s financial and organizational incentives are based on the number of patients seen and services rendered. the world health organization stated in its 2010 health system financing report that this model likely leads to care overprovision, inefficiency, and upwardly spiraling costs. 16 the pervasive volume-based incentive in fee-for-service misaligns with patient care goals as patient care is not its primary goal. this rudimentary payment system attempts to finance health care as if it were any other good or industry. but more care is not necessarily better care, and fee-for-service leads to higher patient bills, higher system costs, and largely inefficient and unnecessary treatment schemes.17 tummalapalli, et al. found that capitated models had lower visit frequency and fewer interventional actions with no difference in outcomes compared to fee-for-service models. care overprovision—in services rendered—and upwardly spiraling riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 4 costs are not in the best interest of patients, violating beneficence at the population level. the misalignment of incentives is at the root of the problem. as a rudimentary payment system, fee-for-service does not have patient care in mind, nor has beneficence as its goal. to evaluate fee-for-service from its own goals, the question here should not center around whether this model is in the best interest of patients. instead, it should focus on the principle of nonmaleficence. can we truly say that upwardly spiraling healthcare costs do not harm patients? in the us, fee-for-service has largely negative social effects on burdens in minority populations, enhancing disparity.18 the system is arguably unjust, violating the principle of justice. disadvantaged groups bear a disproportionally large brunt of the deleterious effects of fee-for-service. 19 with the wastefulness, the inefficiency, the failure to align with patient goals, and the injustice, it becomes clear that fee-for-service does not align with patient care ethics because of organizational and financial incentives. iv. capitation and mixed payment models pure capitation is a less common model than fee-for-service. the maximum effectiveness of this model is generally achieved with some combination of fee-for-service or value-based payment modifiers.20 both in principle and practice, capping payments for a term or service period inherently controls costs by setting a payment “cap.” from a theoretical perspective, the issue here is clear – there are minimal incentives in pure capitation to provide more care. in some cases, this can lead to care underprovision.21 this neglect is a problem: whether intended, there are generally fewer visits and interventional approaches to care in pure capitation models.22 some view the care under-provision as a disservice to patients. however, the true practice of capitation is rarely without some combined incentive model for organizations or physician salary. 23 adding fee-forservice incentives to capitation balances these issues while maintaining a discordant theoretical incentive compared to patient care. value-based modifiers add a more aligned incentive for reasons described in the following section. the overall nature of capitation is not inherently aligned or misaligned with patient care, given that it is a highly moldable model, and therefore is neutral regarding its alignment with patient care ethics. v. value-based payments since their inception, value-based payments have become a widespread and popular payment model internationally.24 the payment revolves around value, defined as patient outcomes divided by costs. the assumption in adopting such a model is that outcomes and costs can be readily measured, which is a challenge in implementing this model. however, aligning payments with patient value has spurred the adoption of more accurate cost accounting systems and the innovation of patient-reported outcome measures. while the full details of cost accounting are beyond the scope of this paper, robert kaplan is a proponent of using time-driven activity-based costing, an essential component in calculating value and an empirically more accurate accounting method than the other predominant forms in healthcare and feefor-service payments.25 while this is an accomplishment, perhaps the more ethically interesting innovation in value-based payments comes from measuring patient outcomes. these generally take form in two ways: objective measures and patient-reported measures. the objective measures include ideally controllable disease factors, such as hospital admissions or disease exacerbations in patients living with chronic obstructive pulmonary disease.26 such measures align payment incentives with quality and results, an important aspect riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 5 of patient care but not an absolute placeholder for ethical measures. one of the largest critiques of valuebased payments has always been that value cannot simply be measured with empirical data but must account for patient values. 27 the solution to such a critique is patient-reported outcome measures (proms), which factor patient values and lifestyle into the empirical payment calculation. 28 a study by groeneveld et al. showed that proms were useful in evaluating the progression of stroke patients at several different time intervals.29 bernstein showed that proms give insight into the sociodemographic factors a patient may be experiencing, which can guide targeted interventions.30 to providers, these may not sound like innovative clinical tools, but they resemble the everyday scoring systems and social work consultations seen in patient care. proms are an attempt to formally incorporate such items directly to payment. value-based payments directly incentivize innovation, use of accurate costs and the consideration of patient values. however, there are valid critiques. this payment model has the potential to prioritize care for those who are healthy and more likely to achieve favorable outcomes. adjustment for important social factors could worsen outcomes and undermine the model’s propensity to drive value for all patients.31 comparatively, value-based payments still incentivize a market force that is more in line with patient care ethics when contrasted with the other predominant forms of payment. this payment model has the theoretical advantage of spurring competitive forces to work toward a goal-like value while outcomes consider patient priorities and costs to be more accurate. from an ethical standpoint, the ideal value-based payment model addresses beneficence toward patients with some (but comparatively less) potential for harm and worsening of disparities. safeguards can protect patients in this realm. another main ethical advantage of value-based payments is that they add more patient marketplace agency by allowing patient desires and priorities to play a direct role in the payment process. this is a unique benefit that value-based payments have over fee-for-service and pure capitation, where the latter models are simply modicums for payment, not modicums for patient agency. based on these comparative ethics, the value-based payment models are the most aligned payment model with patient care ethics but require safeguards. vi. limitations of payment models in addressing disparities and distributive justice the aforementioned payment models continually miss opportunities to explicitly incentivize care for underserved and at-risk populations. studies have explicitly shown how fee-for-service can worsen care for minority groups. the greatest difference in care is seen in the chronically ill, the poor, and those with high burdens based on the social determinants of health.32 while value-based payments have been touted as a potential route to incentivize care for these populations, comparative studies show that those of lower socioeconomic status experienced no benefit when using a value-based modifier.33 other scholars have pointed out that these payment models are both slower to roll out in low-resource areas and are more likely to have the unintended consequence of leading to lower funding in these areas.34 therefore, the disparity may be a lack of access to the model rather than a reflection of its capabilities. these valid critiques of worsening health disparities under all existing payment models show that such models are not a silver bullet for the health system and that they do not address other crucial issues in medicine, like equity. however, this is not to say that payment models cannot address social disadvantages and disparities. value-based payments more ethically align payment-related incentives and spur more innovation. to this end, innovation must take place with consideration for distributive justice. the rawlsian difference principle, or the notion that any systemic approach must maximize the improvement of the least advantaged groups, is essential when discussing payment models. 35 as it currently stands, value-based payments may incentivize procedural justice or a more just and equitable process once patients are in the riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 6 healthcare system. yet, none of them ensure a just distribution of care to those of low socioeconomic status. future models must work towards incentivizing principles of distributive justice. while there have been many attempts to modify payments, those who design payment models clearly tend not to leverage financial benefits to help patients of low socioeconomic status. by leaving those least well-off in society out of the consideration, payment model designers contribute to systemic disparities, regardless of intent. all future designers of payment models must do more to improve incentive designs to work for these patients, not against them. vii. how should we ethically view incentive design? the public and those in charge of medical policy must realize the importance of market forces beyond efficiency. payment incentives should align with patient well-being, autonomy, access to care for underserved populations, and market efficiency. while some of these factors will be more pertinent than others depending on which health system is under discussion, we need ethical principles for patients on a system level that prioritize the patient's interaction with the health system outside of purely clinical scenarios. conclusion payment models remain a powerful tool for any health system that pays providers or organizations. the simple act of payment creates both direct and indirect financial incentives. these incentives create market forces that affect how patients experience their care, directly impacting autonomy, beneficence, nonmaleficence, and justice. as it currently stands, the predominant payment model of fee-for-service does not align with patient care ethics. while follow-up models to fee-for-service, such as capitation, aimed to simply control costs, neither explicitly intended to give patients marketplace agency or improve patient care ethics. the overall alignment of capitation and patient care ethics remained relatively neutral. newer innovations such as value-based payments have a much stronger stated purpose of aligning payment with positive outcomes and lower costs, where outcomes have patient-defined criteria and costs are more accurate. value-based payments create a comparatively more aligned model than fee-for-service or capitation. yet no payment model fully addresses the tenet of justice, and the rawlsian difference principle must be employed here to ensure that those of lowest socioeconomic status or the most disadvantaged are not worse off than before the implementation of a new payment model. as a system, healthcare should strive for the best possible outcomes for all patients, necessitating an integrated approach to social factors. 1 porter m. what is value in healthcare? n engl j med. 2010;363(26):2477-2482. 2 kontopantelis e, reeves d, valderas jm, campbell s, doran t. recorded quality of primary care for patients with diabetes in england before and after the introduction of a financial incentive scheme: a longitudinal observational study. bmj qual saf. 2013;22(1):53-64. doi:10.1136/bmjqs-2012-001033 3 linzer m, bitton a, tu sp, plews-ogan m, horowitz kr, schwartz md. the end of the 15–20 minute primary care visit. j gen intern med. 2015;30(11):1584-1586. doi:10.1007/s11606-015-3341-3 4 gupta r, gupta s. the effect of explicit financial incentives on physician behavior. arch intern med. 2002;162(5):612-613. doi:10.1001/archinte.162.5.612; rosenthal m. how will paying for performance affect patient care? ama ethics. 2006;8(3):162165. 5 wang y, ding y, park e, hunte g. do financial incentives change length-of-stay performance in emergency departments? a retrospective study of the pay-for-performance program in metro vancouver. acad emerg med. 2019;26(8):856-866. doi:10.1111/acem.13635 riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 7 6 beauchamp t, childress j. principles of biomedical ethics. 8th ed. oxford university press; 2019. 7 groenewoud as, westert gp, kremer jam. value based competition in health care’s ethical drawbacks and the need for a values-driven approach. bmc health serv res. 2019;19(1):1-6. doi:10.1186/s12913-019-4081-6 8 katz s, melmed g. how relative value units undervalue the cognitive physician visit: a focus on inflammatory bowel disease. gastroenterol hepatol (n y). 2016;12(4):240-244.; cattel d, eijkenaar f. value-based provider payment initiatives combining global payments with explicit quality incentives: a systematic review. medical care research and review. 2020;77(6):511-537. doi:10.1177/1077558719856775 9 tummalapalli sl, estrella mm, jannat-khah dp, keyhani s, ibrahim s. capitated versus fee-for-service reimbursement and quality of care for chronic disease: a us cross-sectional analysis. bmc health serv res. 2022;22(1):1-12. doi:10.1186/s12913-02107313-3; emanuel ej, mostashari f, navathe as. designing a successful primary care physician capitation model. jama journal of the american medical association. 2021;325(20):2043-2044. doi:10.1001/jama.2021.5133 10 porter m. 2477-2482. 11 kofman m. hsas: a great tax shelter for wealthy, healthy people but little help to the uninsured, underinsured, and people with medical needs. ama ethics. 2005;7(7):522-524.; eskew pm, klink k. direct primary care: practice distribution and cost across the nation. journal of the american board of family medicine. 2015;28(6):793-801. doi:10.3122/jabfm.2015.06.140337 12 cattel d, eijkenaar f. 511-537 13 linzer m, bitton a, tu sp, plews-ogan m, horowitz kr, schwartz md. 1584-1586. 14 lurie n. the role of market forces in us health care. new england journal of medicine. 2020;383(15):1401-1404. 15 reid ro, tom ak, ross rm, duffy el, damberg cl. physician compensation arrangements and financial performance incentives in us health systems. jama health forum. 2022;3(1):e214634. doi:10.1001/jamahealthforum.2021.4634 16 who. health system financing country profile. 2013. 17 tummalapalli sl, estrella mm, jannat-khah dp, keyhani s, ibrahim s. 1-12. 18 hudson d, sacks t, irani k, asher a. the price of the ticket: health costs of upward mobility among african americans. int j environ res public health. 2020;17(4):1-18. doi:10.3390/ijerph17041179 19 ibid. 20 tummalapalli sl, estrella mm, jannat-khah dp, keyhani s, ibrahim s. 1-12.; emanuel ej, mostashari f, navathe as. 2043-2044; brosig-koch j, hennig-schmidt h, kairies n, wiesen d. how to improve patient care? an analysis of capitation, fee-for-service, and mixed payment schemes for physicians. ruhr economic papers. published online 2013:1-36. doi:10.1080/00185860009596559 21 emanuel ej, mostashari f, navathe as. 2043-2044; brosig-koch j, hennig-schmidt h, kairies n, wiesen d. 1-36. 22 ibid. 23 emanuel ej, mostashari f, navathe as. 2043-2044.; reid ro, tom ak, ross rm, duffy el, damberg cl. e214634. 24 porter m. 2477-2482.; teisberg e, wallace s, o’hara s. defining and implementing value-based health care: a strategic framework. academic medicine. 2020;95(5):682-685. doi:10.1097/acm.0000000000003122 25 kaplan rs, anderson sr. time-driven activity-based costing robert s. kaplan and steven r. anderson november 2003. harv bus rev. 2003;82(november):131-138.; akhavan s, ward l, bozic kj. time-driven activity-based costing more accurately reflects costs in arthroplasty surgery. clin orthop relat res. 2016;474(1):8-15. doi:10.1007/s11999-015-4214-0 26 shah t, press vg, huisingh-scheetz m, white sr. copd readmissions: addressing copd in the era of value-based health care. chest. 2016;150(4):916-926. doi:10.1016/j.chest.2016.05.002 riegler, comparative ethics of modern payment models, voices in bioethics, vol. 9 (2023) 8 27 lynn j, mckethan a, jha ak. value-based payments require valuing what matters to patients. jama journal of the american medical association. 2015;314(14):1445-1446. doi:10.1001/jama.2015.8909 28 groeneveld if, goossens ph, van meijeren-pont w. value-based stroke rehabilitation: feasibility and results of patientreported outcome measures in the first year after stroke. journal of stroke and cerebrovascular diseases. 2019;28(2):499-512. doi:10.1016/j.jstrokecerebrovasdis.2018.10.033; bernstein dn, mayo k, baumhauer jf, dasilva c, fear k, houck jr. do patient sociodemographic factors impact the promis scores meeting the patient-acceptable symptom state at the initial point of care in orthopaedic foot and ankle patients? clin orthop relat res. 2019;477(11):2555-2565. doi:10.1097/corr.0000000000000866 29 groeneveld if, goossens ph, van meijeren-pont w, et al. 499-512. 30 bernstein dn, mayo k, baumhauer jf, dasilva c, fear k, houck jr. 2555-2565 31 tran l. social risk adjustment in health care performance measures. jama netw open. 2020;3(6). doi: doi:10.1001/jamanetworkopen.2020.8020 32 webster nj. medicare and racial disparities in health: fee-for-service versus managed care. vol 28. elsevier; 2010. doi:10.1108/s0275-4959(2010)0000028005 33 roberts et, zaslavsky am, mcwilliams jm. the value-based payment modifier: program outcomes and implications for disparities. ann intern med. 2018;168(4):255-265. doi:10.7326/m17-1740 34 bazzoli gj, thompson mp, waters tm. medicare payment penalties and safety net hospital profitability: minimal impact on these vulnerable hospitals. health serv res. 2018;53(5):3495-3506. doi:10.1111/1475-6773.12833 35 ekmekci pe, arda b. enhancing john rawls’s theory of justice to cover health and social determinants of health. acta bioeth. 2015;21(2):227-236. doi:10.4067/s1726-569x2015000200009 anekwe, the children’s learning center, voices in bioethics, vol. 4 (2014) © 2014 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the children’s learning center: educating students with cerebral palsy obiora anekwe your smallest decision can make the biggest difference in learning. recently, i became a member of the new york city teaching fellows program’s 25th cohort. my area of specialization is in special education. more than half of this year’s teaching fellows consist of prospective teachers in training in the field of special education, and during this summer, my fellow classmates and i participated in a site visit to the children’s learning center, the united cerebral palsy association of nassau county, inc. in roosevelt, new york. as stated on the agency’s website, the “united cerebral palsy association of nassau county, inc. (ucpn) is an independent, not-for-profit health agency serving over 1800 children and adults with cerebral palsy, developmental and other disabilities.” founded in 1948, the association operates a comprehensive treatment and rehabilitation center that has earned international recognition for innovative and high quality programs. in a tour of the school, i observed a montage of framed photographs featuring former heavyweight boxing champion muhammad ali, who once visited the school 15 years ago. ali was scheduled to visit for 30 minutes. instead, he decided to stay for 8 hours. his visit reminds us that the smallest decision affecting children often makes the biggest difference in a child’s education. i think that visually seeing throughout the school’s hallways framed photographs of ray charles and christopher reeves – icons who positively coped with their own physical limitations – helps these students with cerebral palsy know that they can also overcome any challenge. the majority of students who attend the school are non-residential. many of the toys and communicative devices have been adapted in order to meet their individual learning and social needs. most impressive is the fact that, although many students at the children’s learning center may have cognitive and/or physical needs, communication devices such as computers, toys, and machines are augmented to enhance effective and transferable learning. even the gymnasium was designed in order to adapt to the physical needs of students. the children’s learning center stresses the concept of learning by doing in addition to the belief that in every learning activity a goal exists. the best example i observed at the children’s learning center that greatly emphasized this learning strategy was art therapy. in essence, art therapy increased the self-confidence and efficacy of students because it centered on the practice of displaying their artwork throughout the art therapy classroom and hallways. as i reflect back on my site visit to the children’s learning center, i draw from the words of miyamoto musashi: “the journey of a thousand miles begins with one step. daws, procreative beneficence, voices in bioethics, vol. 3 (2017) © 2017 steven j. daws. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. procreative beneficence in the crispr world steven j. daws abstract no argument has been proffered for the moral obligation of prospective parents to act on the principle of procreative beneficence. it has only been argued that there is not just cause to specifically outlaw the principle’s application. the united states must act however, to mitigate risk and allow for parents to make an informed riskbenefit assessment if they elect to utilize crispr technology. while acting on the principle of procreative beneficence does not constitute child abuse per the legal ethics of intention, to not apply the principle to the selection of non-disease traits would not constitute child neglect, as it is likely the basic needs of the child are still being met. the united states must guarantee equal access to crispr and other gene editing technologies, thereby allowing for free selection on the part of parents, in which it is likely the heterogeneity of the united states population will be perpetuated. so long as these requirements are met, there is little risk of, or opportunity for, maleficence, so the united states should not act to ban procreative beneficence. keywords: crispr, gene editing, human genome, genomics introduction in his influential 2001 article, “procreative beneficence: why we should select the best children,” julian savulescu defends the idea that “couples (or single reproducers) should select the child, of the possible children they could have, who is expected to have the best life, or at least as good a life as the others, based on the relevant, available information.” however, savulescu might not have entirely foreseen the tremendous advancements in gene editing made in the years since the article’s publication. clustered relatively inter-spaced short palindromic repeat (crispr) technology is an increasingly promising field of research that has dramatically expanded our ability to alter the human genome. there has been discussion on the appropriate changes in public policy to ensure the ethical application of these developing technologies, including the permissibility of applying savulescu’s principle. despite the changes to the genetic selection paradigm as a result of crispr, passing laws to prevent the application of procreative beneficence would not be justified. savulescu’s discussion centers primarily on pre-implantation genetic diagnosis (pgd), and the subsequent selection of a particular embryo for implantation. in this context, the genetic content of the “possible” child is still confined almost entirely to the genetic contributions of the parental gametes. that is of course excepting mutation events and other sources of genetic variability. however, in most cases, the number of embryos that would need to be generated and undergo pgd to identify a single embryo with the complete desired genetic profile is unfeasible compared to what can be achieved through the utilization of modern genomic engineering. as the number of traits being screened for increases, and as the number of contributory loci increases, so decreases the likelihood of the optimal embryo being generated by random fertilization. the possible permutations eventually exceed the practical constraints of time and resources, which is why the application for procreative beneficence discussed by savulescu was primarily one of relative comparison – it was merely determining which of a select few embryos would likely enjoy the best life, and selecting that embryo for implantation. however, crispr technology has significantly altered these constraints, and subsequently, the vision. though at this point in time, the workflow for crispr editing does require cumbersome downstream selection, it remains vastly more efficient than alternative methods such as pgd.1 crispr holds the potential for the deletion, addition, mutation or inversion of any segment of genetic code.2 essentially, the genetic variability is no longer random and limited, but now, directed and infinite. in defense of procreative daws, procreative beneficence, voices in bioethics, vol. 3 (2017) 2 beneficence, savulescu refutes three common arguments against its application. despite developments in crispr technology, all three common arguments against procreative beneficence remain invalid, though the refutations have substantively changed. a. direct harm to child the first common concern is the risk of inadvertently selecting an embryo that ultimately has a worse life than an embryo that was not selected. in this situation, savulescu argues, harm has not been done to the selected embryo, as the alternative was non-existence. however, when crispr technology is employed, there are not multiple embryos – just one. the alternative is not non-existence, but rather an alternative existence, which could constitute either a worse or better life. in the case of crispr, the incorporation or deletion of genetic information could result in aberrant function, and have negative health consequences. however, these risks do not pose a philosophical objection to procreative beneficence as a principle, but merely advocate for proper risk-benefit considerations – as is the case with all technological advances. just because there is a risk of death and injury each time a human drives a motor vehicle, we do not categorically object to the concept of rapid transit. rather, we take immense precautions to mitigate risk and ensure safety. the same should be applied to crispr engineering. to that end, in recent years, there has been progress in improving the specificity of endonucleases to the extent that they can now discriminate between single nucleotide differences, thereby significantly reducing the potential for unintended outcomes.3 another form of potential harm to the child is as an unforeseen consequence of the addition or removal of a trait. it is important to recall that savulescu’s principle is one of expectation. the moral requirement is to choose the child “expected to have the best life.” while savulescu uses intelligence as a non-disease trait that most people believe to be conducive to an enjoyable life, very few people have not heard the phrase “ignorance is bliss.” even if there is a consensus that increased intelligence is expected to increase the quality of life, it is impossible to predict with certainty. suppose the augmented intelligence allows an individual to perceive a great injustice in the world – an injustice of which the individual would not have otherwise been cognizant. and suppose that injustice is so grave that the individual develops depression and ultimately commits suicide. while we may believe this scenario unlikely, few would argue that it is impossible. does this mean we should not proceed with the use of such technology? a principle based on expectation cannot be adequately addressed without discussing the ethics of intention. the question being considered is whether or not laws should be passed to prevent adherence to the principle of procreative beneficence in reproductive decision-making. in many domains of the american legal system, intent plays a significant role – consider manslaughter versus murder, or good samaritan laws. with regard to child abuse law, which is perhaps most appropriate when considering the potential damage done by parental decision making to an unborn child, the us department of health & human services, children’s bureau reports that in almost all states the harm to the child must be “nonaccidental.” 4 therefore, in the case of parental care, intention is considered relevant. while the hippocratic oath does indeed state to first do no harm, no medical procedure is without some degree of risk. in the case of genome editing, as long as the potential reward has been justified relative to the risk, the application of reproductive beneficence appears permissible to the extent that it should not be outlawed. b. psychological burden the second potential consequence addressed by savulescu is the psychological burden on the parent and child due to expectation. for the parent, should the child lead a tragic life by the parent’s measure, the parent could feel responsible. or perhaps, the parent could feel disappointment if the child does not develop as anticipated or intended. the child could experience pressure to be exceptional, or to meet specific expectations. or perhaps, the child could be impacted by an altered sense of free agency. savulescu argued that such psychological effects could be well managed with proper therapy. whether the applied technique is pgd or crispr, the role of the environment remains the genetic scapegoat. with regard to expectation, for traits that are indeed deterministic, there is no concern because the gene will certainly be expressed and the trait will indeed be manifest. for those traits that are multi-factorial, and for which the environment is demonstrated to play a role, that fact can be a refuge for the daws, procreative beneficence, voices in bioethics, vol. 3 (2017) 3 mind. both the child and the parent can place the child’s development externally, on environmental forces outside their control. however, should techniques for epigenetic modifications develop to eliminate the role of the environment in genetic expression, such developments would need to be considered. thus, the application of procreative beneficence poses no imminent threat to the psyche of the individual stakeholders. c. societal ramifications adopting a larger scope, some have suggested procreative beneficence would have a detrimental effect on society as a whole. savulescu argued that the risk of increased or maintained social inequality is not a valid objection, arguing that alternative avenues should be pursued to address such issues. with the aforementioned expansion of possible children, it seems unlikely that procreative beneficence would substantially alter societal equity, provided access is readily available to all strata of society. and it is worth mentioning that this is not entirely unrealistic considering the rapid decrease in cost observed for these technologies.5 if crispr engineering continues along its trajectory, every prospective parent could theoretically choose to create the exact same child. at which point, equality is a nonissue because every individual is quite literally identical. is it likely for society to progress towards that end? as members of a society, there are values shared in common by most individuals. however, overall, american society at present is largely heterogeneous. savulescu mentions that procreative beneficence will be weighed along with procreative autonomy. if the autonomy of the parents is respected, it is not likely all parents will select the same non-disease traits. it is more likely that the parents will project their biases and personal values onto their potential offspring during the selection process. for example, someone who feels that athletic prowess is essential to wellbeing will likely select a different body type than someone who places musical talent as paramount. hands suited to palming basketballs are not suited to manipulating violin strings. similarly, selfishness runs counter to altruism, independence to socialability, etc. and the notion of which of these values, at the expense of its counterpart, is conducive to well-being varies greatly over time and space. in some sense, this projection of parental values onto offspring already occurs, through environment manipulation. this process is usually termed “instilling” values, as parents attempt to encourage behaviors, while discouraging others. the inclusion of genomics into the equation merely constitutes an extension within the dna-environment interplay. to ban the selection of genetically based linguistic skills would be akin to banning a parent from reading to their child at night. it is also important to recognize that many traits only contribute positively to well-being insofar as their superiority relative to the general population. this is especially true in american society, which historically has emphasized competition to a certain extent, as well as a need for social mobility based on merit. an unfortunate reality of a society with finite resources is that often satisfaction of one’s desires requires that someone else’s not be satisfied. considering that crispr has opened the potential for equality of capability, should everyone pursue those traits, they are no longer conducive to well-being, and thusly no longer contribute to procreative beneficence. this runs parallel to savulescu’s discussion of sex selection in a society that discriminates against women. in that example, sex functioned as a trait homogeneous in nature, in that the status of “male” was uniform and treated uniformly by society. crispr has the potential to make other traits such as intelligence or height, equally uniform. it is worth noting that in some cases this also alleviates the aforementioned burden of expectation. if the expectation is one of superiority, provided equal access, that superiority is not realistic. conclusion no argument has been proffered for the moral obligation of prospective parents to act on the principle of procreative beneficence. it has only been argued that there is not just cause to specifically outlaw the principle’s application. the united states must act however, to mitigate risk and allow for parents to make an informed risk-benefit assessment if they elect to utilize crispr technology. while acting on the principle of procreative beneficence does not constitute child abuse per the legal ethics of intention, to not apply the principle to the selection of non-disease traits daws, procreative beneficence, voices in bioethics, vol. 3 (2017) 4 would not constitute child neglect, as it is likely the basic needs of the child are still being met. similarly, structures must be in place to allow for the counseling of both the child and parent throughout life, particularly to ensure all parties understand the intricacies of gene-environment interactions. additionally, the united states must guarantee equal access to crispr and other gene editing technologies, thereby allowing for free selection on the part of parents, in which it is likely the heterogeneity of the united states population will be perpetuated. so long as these requirements are met, there is little risk of, or opportunity for, maleficence, so the united states should not act to ban procreative beneficence. ______________________________ references 1 vasiliou, stella k., eleftherios p. diamandis, george m. church, henry t. greely, françoise baylis, charis thompson, and gerold schmitt-ulms. "crispr-cas9 system: opportunities and concerns." clinical chemistry 62, no. 10 (2016): 1304-1311. 2 didovyk, andriy, bartłomiej borek, lev tsimring, and jeff hasty. "transcriptional regulation with crispr-cas9: principles, advances, and applications." current opinion in biotechnology 40 (2016): 177-184. 3 ceasar, s. antony, vinothkumar rajan, sergey v. prykhozhij, jason n. berman, and s. ignacimuthu. "insert, remove or replace: a highly advanced genome editing system using crispr/cas9." biochimica et biophysica acta (bba)-molecular cell research 1863, no. 9 (2016): 2333-2344. 4 us department of health & human services. "definitions of child abuse and neglect." https://www.childwelfare.gov/pubpdfs/define.pdf. 5 jinek, martin, krzysztof chylinski, ines fonfara, michael hauer, jennifer a. doudna, and emmanuelle charpentier. "a programmable dual-rna–guided dna endonuclease in adaptive bacterial immunity." science 337, no. 6096 (2012): 816-821. kamb, the false choice between public health and civil liberties, voices in bioethics, vol. 6 (2020) ava kamb, candidate mph, columbia university © 2020 ava kamb. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the false choice between public health and civil liberties ava kamb* keywords: public health, civil liberties, protests, stay-at-home orders, bioethics introduction since the start of the covid-19 pandemic, the role of government in public health has come to the forefront of a national conversation. in the united states, social distancing measures such as mandatory stay-at-home orders and closures of schools and non-essential businesses have been implemented in nearly all 50 states. in response to the mandates, which have led to widespread unemployment and limitations on free movement, protests have been taking place in nearly half of the nation’s states. the protesters can be described as a coalition of social conservatives, fiscal conservatives, and civil libertarians unified by their desires “to get back to work and leave their homes.”1 this paper argues that public health mandates that are kept to the least restrictive means necessary can work with certain civil liberties to ensure public health: the two should not be seen as mutually exclusive. analysis among social, economic, and political concerns, one objection to stay-at-home orders is ideological: nationwide, orders are seen as a state overreach and infringement on certain civil liberties. in the words of a wisconsin supreme court justice, “isn’t it the very definition of tyranny for one person to order people to be imprisoned for going to work among other ordinarily lawful activities?”2 the shutdown of businesses has seriously affected the national economy, and with millions of americans held back from work and laid off from their jobs, the us unemployment rate has soared to levels unseen since the great depression.3 while the relationship between public health and economic activity is complex, these arguments in favor of civil liberties presume that freedom and public health cannot coexist during a crisis. the protests remain relatively small and spread out, and, according to a pew research center survey, the majority of americans on both sides of the political spectrum support the current social distancing restrictions.4 despite its current partisan amplification, the rhetorical strategy that positions public health kamb, the false choice between public health and civil liberties, voices in bioethics, vol. 6 (2020) 2 and civil liberties against one another is not new. many assume there are tradeoffs between public health and civil liberties and that to prioritize one is to sacrifice the other. public health is acceptable, the protestors seem to say, only until it clashes with civil liberties at which point it becomes an existential threat. to some, there is tension between protecting the health of a population and respecting the rights of the individual. the tension is between collectivism, or the prioritization of the wellbeing of the collective,5 and individualism, or the right of an individual to freely determine his or her own life. some of the core ethical challenges in public health arise when the two are at odds. in the influential 1905 court case jacobson v. massachusetts, the us supreme court upheld mandatory vaccination laws following an outbreak of smallpox. the ruling confirmed the police powers of the state to establish laws that guard the health and safety of the public like those that control the spread of deadly infectious disease.6 the court concluded that it is sometimes acceptable for the state to infringe upon the rights of the individual in order to protect the health of the collective. public health interventions that entail changes in civil liberties must be clearly shown to be both reasonable (given the situation) and necessary, and only implemented after less restrictive measures have failed. the aids epidemic in the 1980s added another dimension to the discussion around public health and civil liberties. some public health officials called for measures such as shutting down bathhouses7 and reporting the names of hiv-positive people to the government for surveillance purposes. however, others feared that coercive public health methods could backfire by driving people underground and eroding their trust in health systems. they recognized that privacy concerns, fear of discrimination, and laws prohibiting same-sex relations were hindering efforts to effectively combat the disease. in response, public health officials developed a new approach that better aligned civil liberties and public health through prioritizing hiv and aids education, building trust in marginalized communities, and encouraging voluntary condom usage. consequently, “a simple dictum emerged: no public health policy that violated the rights of individuals could be effective in controlling the spread of hiv. there was, therefore, no tension between public health and civil liberties. indeed, the protection of civil liberties was critical to the public health.”8 rather than presupposing that the health of the public and the rights of the individual conflict, the aids crisis revealed another possibility: to view public health and civil liberties not as antagonists, but as partners in protecting health. in the midst of the current covid-19 pandemic, it is possible that, like in the aids crisis, the debate presents a false choice between either public health or civil liberties. while there is a tension between the two, their opposition is not a foregone conclusion. failures in early detection and prevention, the disbandment of the white house pandemic preparedness team in 2018, and a lack of reliable testing kits contributed to the need for widespread stay-at-home orders that exacerbated the tension. a compromise solution could focus on educating the public on how covid-19 is transmitted, implementing voluntary public health interventions such as mask-wearing and social distancing that allow people to be in public safely, and providing sufficient safety net programs so that those who follow stay-at-home orders are not at risk of losing their paycheck. conclusion mischaracterizing public health as an enemy of civil liberties erodes confidence in the public health institutions that are themselves dependent on the trust of the public. in order to move forward, public health policies must use the least restrictive means necessary and support civil liberties. while the government may order mandatory measures if voluntary recommendations fail, the decision should be made transparently, with clear scientific evidence and public accountability to ensure that any trade-offs are kamb, the false choice between public health and civil liberties, voices in bioethics, vol. 6 (2020) 3 made openly with a process for appeal.9 protests could be avoided if less restrictive means (such as social distancing and mask requirements) were implemented early, which would allow businesses to remain open and workers to remain employed. this would align the goals of both public health and those dedicated to civil liberties. by thinking proactively about solutions that can simultaneously protect both public health and civil liberties, we will be better prepared the next time the country faces a crisis. 1 vogel, kenneth p., jim rutenberg, and lisa lerer. “the quiet hand of conservative groups in the anti-lockdown protests.” new york times, april 21, 2020. https://www.nytimes.com/2020/04/21/us/politics/coronavirus-protests-trump.html. 2 stern, mark joseph. “wisconsin’s supreme court is going to use fox news arguments to undo the state’s covid-19 restrictions.” slate, may 5, 2020. https://slate.com/news-and-politics/2020/05/wisconsin-supreme-court-lift-covid-restrictionsfox-news.html 3 long, heather and andrew van dam. “u.s. unemployment rate soars to 14.7 percent, the worst since the depression era.” washington post, may 8, 2020. https://www.washingtonpost.com/business/2020/05/08/april-2020-jobs-report/. 4 pew research center. “most americans say trump was too slow in initial response to coronavirus threat.” pew research center, april 16, 2020. https://www.people-press.org/2020/04/16/covid-19-and-the-countrys-trajectory/. 5 nuffield council on bioethics. “public health: ethical issues.” november 2007. http://nuffieldbioethics.org/project/publichealth/. 6 jacobson v. massachusetts, 197 u.s. 11 (1905). 7 culhane, john g. “sex, fear, and public health policy.” review of gay bathhouses and public health policy, edited by william j. woods and diane binson, yale journal of health policy, law, and ethics 5, no. 1 (2005): 327-340. 8 bayer, ronald and amy l. fairchild. “the genesis of public health ethics.” bioethics 18, no. 6 (2004): 473-492. 9 childress, james f. et al. “public health ethics: mapping the terrain.” journal of law, medicine & ethics 30 (2002): 170-178. https://www.nytimes.com/2020/04/21/us/politics/coronavirus-protests-trump.html https://slate.com/news-and-politics/2020/05/wisconsin-supreme-court-lift-covid-restrictions-fox-news.html https://slate.com/news-and-politics/2020/05/wisconsin-supreme-court-lift-covid-restrictions-fox-news.html https://www.washingtonpost.com/business/2020/05/08/april-2020-jobs-report/ https://www.people-press.org/2020/04/16/covid-19-and-the-countrys-trajectory/ http://nuffieldbioethics.org/project/public-health/ http://nuffieldbioethics.org/project/public-health/ cohen, walk in or get out, voices in bioethics, vol. 3 (2017) © 2017 jennifer cohen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. walk in or get out: overcoming distrust of medicine to improve outcomes jennifer cohen* keywords: immortal life of henrietta lacks, get out introduction popular culture has long provided an outlet for feelings of powerlessness toward medicine. 19th century novels frankenstein and the island of dr. moreau tapped into fears that medicine would cruelly pursue scientific knowledge at the expense of human life. two recent films, the immortal life of henrietta lacks and get out, examine the anxieties and mistrust that african americans, in particular, experience toward the medical community in the modern era. analysis henrietta lacks depicts a historical breach of ethics by researchers at johns hopkins university, whose work obscured the identity of ms. lacks’ “immortal” cell line and withheld attribution both to ms. lacks and her family for decades. in the film, this wrong exacerbates over time as the family struggles emotionally to understand the uses of their mother’s cells and to accept their mother’s consent was never considered necessary. indeed, the family believed that members of their community were routinely used for experimentation without their consent: they tell journalist rebecaa skloot that, as children, they were warned by their parents to get off the streets at night or “hopkins people” would snatch them up. in get out, a nightmarish surgical practice occurs in which a neurosurgeon and psychiatrist lure african americans to their home for use as receptacles for white brains in a bid for white immortality. both of these films explore the premise that african americans should be afraid medicine will treat them differently from white individuals. the ugly history of abuse toward african americans in the name of medical research was extensively documented in 2006 by the bioethicist harriet a. washington. her award winning book, medical apartheid: the dark history of medical experimentation on black americans from colonial times to the present, traces the extensive exploitation of african americans that occurred well before the well-known tuskegee syphilis experiments in alabama from 1932 to 1972.1 ms. washington details this shameful aspect of american medicine, which sweeps up notables such as thomas jefferson, who ordered the vaccination of hundreds of slaves with jenner’s new smallpox vaccine before injecting his own white family, to the 19th century gynecologist and president of the american medical association, h. marion sims who forcibly administered morphine to enslaved african american women after, but not prior to, painful surgical cohen, walk in or get out, voices in bioethics, vol. 3 (2017) 2 procedures.2 before ms. washington’s book, the history of research and clinical abuses of african americans was unapologetically ignored. but this is not dead history. ms. washington makes the compelling argument that, just as with the lacks family, the emotional damage of this history has created dangerous consequences for the african american communities, which are still pervasive today. distrust and suspicion toward medicine and clinicians may be contributing to devastating health disparities within the african american community. the centers for disease control and prevention report that from 2010 to 2014 african americans made up 45% of the total number of americans diagnosed with hiv with a death rate higher than any other group.3 african americans have higher rates of sexually transmitted diseases and account for 36% of tuberculosis cases.4 although life expectancy gaps between african americans and whites are narrowing, african americans die at higher rates than whites from most causes, including aids, heart disease, and cancer.5 can these health disparities be linked, in part, to a feeling of distrust african americans have toward medicine based on historical abuses? a 2006 study by clinicians at the university of illinois at chicago school of public health concluded that there exist significant differences between african americans and whites in their distrust of the motives of the medical profession, and many of these feelings of distrust can be traced to the historical treatment of african americans. one participant in the study reported that her knowledge of the tuskegee experiments led her to believe that “maybe sometimes you go instead of getting treated they just want to see what it’s going to do to you and they’ll try this and try that and they may give you a sugar pill.”6 the authors noted their “disturbing” and “disconcerting” findings that expectations of racism and experimentalism in routine medical care were reported in all focus groups and led many of the participants to distrust their physicians and decide not to seek care. conclusion medicine has a long way to go to rebuild trust with the african american community. additionally, larger studies should build on the chicago study to understand the feelings of distrust the african american community may have so that they may be directly addressed. this should represent a collaborative effort to acknowledge past mistakes and current distrust, while pledging to improve open communication. the fears of experimentation that lead patients to want to get out must be acknowledged and dealt with so that all patients feel more confident when they walk-in. 1 u.s. department of health and human services, centers for disease control and prevention, u.s. public health service syphilis study at tuskegee, last updated december 8, 2016, https://www.cdc.gov/tuskegee/timeline.htm# 2 washington, p. 65. 3 u.s. department of health and human services, centers for disease control and prevention, “ disparities in hiv/aids, viral hepatitis, stds and tb,” last updated june 2013, https://www.cdc.gov/nchhstp/healthdisparities/africanamericans.html 4 u.s. department of health and human services, centers for disease control and prevention, “tuberculosis in blacks,” last updated october 26, 2016, https://www.cdc.gov/tb/publications/factsheets/specpop/resources_tb_blacks.htm 5 washington, pp. 4-5. https://www.cdc.gov/tb/publications/factsheets/specpop/resources_tb_blacks.htm cohen, walk in or get out, voices in bioethics, vol. 3 (2017) 3 6 elizabeth a. jacobs, et al., “understanding african americans’ views of the trustworthiness of physicians,” j gen inter med 2006; 21:642-647, p.645. bellisomo, hearing loss, voices in bioethics, vol. 1 (2014-15) © 2015 randi bellisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hearing loss: an often-overlooked problem for hospice patients randi bellisomo keywords: hospice care, clinical ethics, ethics introduction among dying hospice patients, hearing problems are often overlooked, but should not be, experts say. families and physicians frequently mistake hearing loss for dementia among the elderly and terminally ill, said barbara weinstein, a professor of audiology at the city university of new york. analysis the institute of medicine’s recent report, dying in america, outlined core components of quality end of life care, many of which are tied to patients’ ability to listen and communicate: patient counseling, distress management, attention to social, cultural and religious needs and assessment of physical and emotional well-being. according to the centers for disease control and prevention, 80 percent of americans age 85 and older have hearing impairments. but medicare and the medicare hospice benefit do not cover hearing aids, which can cost between $1600 and $3500 each. hospices might be able to work “with resources in the community if there was a patient with a need for hearing aids,” said judi lund person, vice-president of regulatory affairs for the national hospice and palliative care organization. athens, ohio-based audiologist bethany gonczy started one such community program within her diles hearing center to loan hearing aids to hospice patients. she saw a need after treating cancer patients who lost hearing due to chemotherapy or pain regimens. “they can have relationships with their family,” gonczy said. “those relationships at the end of life are more important than ever. they are able to communicate with their kids and grandkids.” when a patient dies, the family returns the hearing aid for reuse. “for people we have helped, it has made a huge difference in their life,” she said. steven murphy, executive director of hearing charities of america, said too few community resources like gonczy’s exist. his organization maintains a list of philanthropic programs that help those who cannot afford hearing aids. in 2014, hearing charities backed the launch of the “new jersey hearing aid project,” which donated one hundred hearing aids in its first year. “the impact is significant,” murphy said. he would like physicians treating older patients to encourage screening earlier. if hearing loss is not recognized until the final stages of illness, it is often too late to receive help. “this problem will not be solved by any one organization,” he said. “it will require input by the government, the industry and other charities.” lise hamlin, the director of public policy for the hearing loss association of america, said the problem will linger as long as medicare coverage excludes hearing devices. she points out that federal employees may choose insurance plans with hearing coverage, and she said all americans should enjoy the same luxury. “we would like to see better solutions,” hamlin said. in the meantime, weinstein advises, bellisomo, hearing loss, voices in bioethics, vol. 1 (2014-15) 2 caregivers should frequently inquire if a patient hears what was said. most hard-of-hearing patients can be engaged in conversation with a personal sound amplifier and stereo headset that costs a little more than a hundred dollars, weinstein said. she advises doctors, particularly palliative care specialists, to keep such a device in their pocket.“a lot of people at the end of life have been marginalized” because they can’t hear, weinstein said. “they may appear confused or cognitively deprived, but it is because they have not been included in the conversation.” “it’s easier not to communicate with someone with hearing loss, especially at that stage,” said weinstein. “but it is not justifiable, especially when there are options.” eshikena, how to boycott animal testing, voices in bioethics, vol. 1 (2014-15) * marilyn eshikena, ms bioethics © 2014 eshikena. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. how to boycott animal testing marilyn eshikena* keywords: animal rights, in vitro testing, bioethics, ethics, drug development introduction animal rights extremism is no stranger to the news headlines, with involved individuals moving from attacking large corporations to intimidating individual researchers. according to the national association for biomedical research, “animal rights movement is a global movement that seeks to… stop the use of animals in research” among other things. well, science might just be getting closer to giving these animal rights extremists what they desire. ____________________________________________________________ eshikena, how to boycott animal testing, voices in bioethics, vol. 1 (2014-15) 2 analysis a study published in april 2014 in the american chemical society journal, reports the creation of a 3d model of the human airway that can be used for in vitro testing in the drug development process. this 3d model comprises a combination of airway epithelial cells, dendritic cells, and fibroblasts all cultured on a scaffolding involving electrospun porous fibres. thus, an improvement from the 2d model typically used for in vitro testing, this model allows for cell interaction that mimics that which takes place inside the human lung. conclusion the potential uses of this 3d lung model spans from academic to pharmaceutical research for the development of drugs. with this, it can be predicted that drug development costs will reduce, seeing as the need for animal models might be rendered obsolete. however, the replacement of animal testing by an in vitro 3d model is subject to fda approval after adequate evidence has been garnered. nonetheless, this has opened a new door to research while slowly closing the door of ethical dilemmas and negative public perception of research involving life organisms. one question that comes to mind, however, is that will it become eventually possible to eliminate the need for human subjects in research, especially in clinical trials? with the vast mountains that science and technology have managed to surmount, we just might be entering an era where these ethically controversial fields are able to resolve previous ethical dilemmas without instituting new ones. but as with every other hypothesis, only time will tell. wineke, actually helping some poor people, voices in bioethics, vol. 6 (2020) * jennifer wineke, md candidate, university of pennsylvania © 2020 jennifer wineke. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. achieving equity and agreement: the importance of inclusion of marginalized groups in hospital policy initiatives jennifer wineke* abstract as the ea and 80,000 hours movements have gained traction in recent years, critics have claimed that the movements’ focus on individual philanthropy detracts from the need for more systemic reform. in this paper, i will defend the fairness of that critique and discuss why a focus on individual contributions rather than systemic change can be harmful, particularly when one considers issues of sustainability and privilege. keywords: effective altruism, philanthropy, bioethics introduction effective altruism (ea) is a movement focused on doing the most good one can do. born out of utilitarianism, a philosophy that advocates for actions that produce the most good for the most people, the movement describes itself as seeking to answer a simple question: “how can we use our resources to help others the most?”1 effective altruists seek to answer this question systematically, by narrowing down the world’s most pressing problems, identifying organizations that are able to have the most impact in addressing those problems, and donating a portion of their income—many pledging as much as 10% of their lifetime earnings—to those organizations.2 in this way, the ea movement hopes to change the world by encouraging evidence-based, cost effective giving by individuals, while the affiliated organization 80,000 hours encourages people to choose careers that offer the highest social impact. as the ea and 80,000 hours movements have gained traction in recent years, critics have claimed that the movements’ focus on individual philanthropy detracts from the need for more systemic reform. in this paper, i will defend the fairness of that critique and discuss why a focus on individual contributions rather than systemic change can be harmful, particularly when one considers issues of sustainability and privilege. ____________________________________________________________ wineke, actually helping some poor people, voices in bioethics, vol. 6 (2020) 2 analysis in “stop the robot apocalypse,” amia srinivasan critiques the effective altruism movement on the basis that its effects are merely superficial: [it] does not address the deep sources of global misery – international trade and finance, debt, nationalism, imperialism, racial and gender-based subordination, war, environmental degradation, corruption, exploitation of labour – or the forces that ensure its reproduction. effective altruism doesn’t try to understand how power works, except to better align itself with it. in this sense it leaves everything just as it is.3 because the ea movement is based on the principle of using the tools of social and economic capital to help the world’s neediest—for example, using a princeton degree to get a job on wall street, then donating half of your income— it does not question the legitimacy of the foundation underlying that capital.4 an effective altruist seeks to effectively redistribute resources once they’ve come into possession by those in power, not to question how resources might be distributed more equally in the first place. the ea mission is not to “burn down the system,” so to speak, but to do as much good as can be done within the system we are currently in. but what if the current system is the root of the problem? in “against charity,” matthew snow explains why focusing on individual philanthropy is misguided: rather than asking how individual consumers can guarantee the basic sustenance of millions of people, we should be questioning an economic system that only halts misery and starvation if it is profitable. rather than solely creating an individualized “culture of giving,” we should be challenging capitalism’s institutionalized taking. we don’t have to accept capital’s terms for addressing its own problems or purported moral imperatives that presuppose them. we can overturn those terms completely.5 in snow’s view, the ea movement and true radical system reform are mutually exclusive, as effective altruism not only relies on the power structures already in place, but perpetuates them. to truly address problems like world poverty and starvation, we must reform the institutions that have led to those problems, or else long-term, sustainable solutions will remain out of reach. critiques like srinivasan and snow’s are based on the presupposition that radical systematic reform is within the realm of possibility. an effective altruist would argue that overturning the world’s power structures is simply not the most effective use of time— better to work within our current system to improve people’s lives than waste time and energy on radical reformation when the chances of success in that arena are remote at best. peter singer, the movement’s philosophical founder, has stated as much: “if there is little chance of achieving the kind of revolution you are seeking, then you need to look around for a strategy with better prospects of actually helping some poor people.”6 on the subject of capitalism, he is highly pragmatic: i'm waiting for someone to, first, describe a better system than capitalism, and second, set out a realistic path for getting from here to there. when that happens, it will be worth thinking harder about the ethical flaws in capitalism. until then…there is a huge amount we can all do, within the current economic system, to make the world a much better place.7 effective altruists might argue that the odds of instituting an alternative economic system or eradicating institutional racism, sexism, or imperialism are merely theoretical, while the benefits of donating your income to provide insecticide-treated malaria nets in sub-saharan africa are direct, supported by evidence, and can be seen virtually immediately. “effective altruists are usually not radicals or revolutionaries,” writes robert wiblin, research director for 80,000 hours, in a blog post entitled “effective altruists love systemic change.”8 “sometimes we view existing attempts at systemic change as more symbolic or idealistic than realistic, and so push back against them.” for example, wiblin has written about why advocating for gun control or open borders is not an effective use of wineke, actually helping some poor people, voices in bioethics, vol. 6 (2020) 3 time in the current us political climate. the ea movement is a scientific approach to maximizing the greatest good, which demands that goals be attainable and measurable. but this focus on measurable achievements necessarily prioritizes causes that can be effectively tracked by metrics. “the value of deworming might be measurable,” the atlantic’s derek thompson writes, “but what of the values of women’s rights, equality, or democracy?”9 the ea movement’s focus on quantifiable data points likely reflect the demographics of the movement itself. in an account of the 2015 effective altruism global conference, self-identified effective altruist dylan mathews described the ea movement as “very white, very male, and dominated by tech industry workers,” and “increasingly obsessed with ideas and data that reflect the class position and interests of the movement's members rather than a desire to help actual people.”10 while the ea movement’s overarching goal is certainly to help people, it is fair to question whether the strategies for doing so have been narrowed by its members’ socioeconomic backgrounds and resultingly myopic view of which issues should be considered the most pressing. one of the ea movement’s established priorities, for example, is addressing the threat to human extinction by advanced artificial intelligence; it is difficult to argue with the fact that the movement’s tech industry background influences that priority. similarly, it is easier to view existing attempts at systemic change as symbolic rather than realistic when you occupy a privileged place in a society whose power structures are organized in your favor. for people who are poor, marginalized, and affected daily by issues like gun control or us immigration law, the prospect of toppling existing oppressive systems might not be considered very radical or revolutionary at all. perhaps it might be fair to concede that one social movement cannot be everything the world needs—if effective altruism is lessening the world’s suffering, why fault it for its shortsightedness? could other movements work on the power structures behind the root causes of suffering with a focus on sustainable change, and in the meantime, ea will do its part to alleviate suffering through individual philanthropy? certainly it is difficult to condemn a movement that encourages the wealthy—which, as the 80,000 hours website points out, includes anyone earning a professional salary in the us—to share that wealth with those who need it.11 but it is hard to avoid the fact that those with the social and economic capital who are attracted to ea are precisely those who are in the unique position to challenge the power structures that have given them that capital in the first place. the world’s marginalized cannot be expected to shoulder the burden of systemic reform when they are working from a place of fewer resources and smaller platforms for change. while it is true that individual donations can help empower people to advocate for systematic change in their own interests—and in matthews’ words, ea is “not a replacement for movements through which marginalized peoples seek their own liberation”—the ea movement’s ability to attract wealthy people who have the privilege to be seen and heard, and who are willing to devote their life to an ethical movement, could enormously strengthen the efforts of those already fighting for radical systemic change across the globe. conclusion kerry vaughan, one of the organizers of the 2015 effective altruism global conference, declared that “effective altruism could be the last social movement we ever need."12 for those who are benefitting from the current power structures in place, that may ring true. but for those who don’t view radical systemic change as symbolic or idealistic, ignoring issues at the root of so much suffering in the world—economic inequality, institutionalized racism and sexism, imperialism, war—in favor of achievements that can be more accurately measured in disability-adjusted life years seems misguided at best and harmful at worst. the ea movement’s lack of focus on radical systemic change is a missed opportunity to address the foundations of inequity and work toward sustainable progress that might very well be more effective in the long run. wineke, actually helping some poor people, voices in bioethics, vol. 6 (2020) 4 1 the centre for effective altruism, “effective altruism.” https://www.effectivealtruism.org/. 2 the centre for effective altruism, “giving what we can.” https://www.givingwhatwecan.org/. 3 srinivasan, amia. "stop the robot apocalypse." rev. of doing good better: effective altruism and a radical new way to make a difference, by william macaskill. london review of books 37.18 (2015): 3-6. 13 dec. 2018. https://www.lrb.co.uk/v37/n18/amiasrinivasan/stop-the-robot-apocalypse/. 4 kristof, nicholas. “the trader who donates half his pay.” the new york times, 4 april 2015. https://www.nytimes.com/2015/04/05/opinion/sunday/nicholas-kristof-the-trader-who-donates-half-his-pay.html/. 5 snow, mathew. “against charity.” jacobin, 25 august 2015, https://www.jacobinmag.com/2015/08/peter-singer-charityeffective-altruism/. 6 singer, peter. the life you can save: how to do your part to end world poverty. random house, 2010. 7 singer, peter. “is capitalism unethical?” 2015. goodreads, https://www.goodreads.com/questions/389696-is-capitalismunethical/. 8 wiblin, robert. “effective altruists love systemic change.” 80,000 hours, 8 july 2015. https://80000hours.org/2015/07/effective-altruists-love-systemic-change/. 9 thompson, derek. “the greatest good.” the atlantic, 15 june 2015. https://www.theatlantic.com/business/archive/2015/06/what-is-the-greatest-good/395768/. 10 mathews, dylan. “i spent a weekend at google talking with nerds about charity. i came away…worried.” vox, 10 august 2015. https://www.vox.com/2015/8/10/9124145/effective-altruism-global-ai/. 11 wiblin, robert. “how accurately does anyone know the global distribution of income?” 80,000 hours, 6 april 2017. https://80000hours.org/2017/04/how-accurately-does-anyone-know-the-global-distribution-of-income/. 12 mathews, ““i spent a weekend at google.” staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) © 2014 voices in bioethics. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. in memoriam: bob whiteman introduction on february 20, 2014, the columbia university bioethics program lost a dear member of its community when bob whiteman passed away due to complications of a brief illness. thank you for you joining us this evening. it is my honor to welcome you – especially robert whiteman’s family and friends. we are here for two related reasons: to remember one of our alumni, bob, who very sadly died in february; and to celebrate his memory, passion and spirit. we are here, too, to hear from one of our distinguished colleagues about the area that bob was particularly interested in – clinical ethics. bob was a great man, and his sudden death left all of us here at columbia shocked, and in disbelief. he was a member of our first cohort of students, and was very instrumental in helping to shape our program. he came our masters of bioethics program already having degrees in divinity and law, and a wide range of life experiences, having served in the military, and practiced as a malpractice attorney for several years. most importantly, though, he brought passion to all that he did. from the outset, he brought fresh suggestions for how our masters of bioethics program could grow and develop, which we incorporated – in part with his help. in part, due to his output, we added new courses in topics such as neuroethics, clinical ethics, science for bioethicists, ethics and the pharmaceutical industry, and a clinical ethics practicum. bob embodied the best of bioethics, and the program embodies much of the spirit, and breadth of his interests in bringing together the law, theology and real dilemmas, small details and the “big picture”, the practical and the ideal, the earthy and the divine, he saw bioethics issues not just at the one-on-one level, but more broadly at the level of systems and organizations as well – though professional training and practice, and education of the public at-large. staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) 2 after he graduated, he remained an incredibly loyal friend and supporter of our program, not only staying close friends with members of his class, but volunteering to be a mentor to many students in subsequent years. when i wanted to start a new initiative to have our students to read each others’ papers to give each other feedback to submit them to scientific journals for publication, i asked him to head the group. and he readily agreed. when we had meetings for prospective students to tell them about our programs, i regularly asked him to speak and represent our alumni, and he invariably agreed. he continued to come to our events – and i know he would have been here this evening to hear our guest speaker. i was not alone in my admiration for him. bob will always have an important role in our program. we and future students in our program will be grateful forever be to him. i hope that the comments that appear as part of a permanent website tribute to bob on our voices in bioethics on-line journal, will continue to keep his vision and spirit alive and inspire others in the future. robert klitzman reflections from colleagues and friends although unable to attend bob's memorial service, my thoughts continue to be with his family. as shared with his sister during the earliest stage of their grief and disbelief, the memories i have of bob as a vital first-cohort columbia bioethics colleague are indelibly integrated into my experience with the program. whether our positions were in agreement or we respectfully agreed to disagree in ron bayer's early morning ph ethics lecture or during evening discussions surrounding philosophy and law with arthur and josie, bob could always be counted on to foster new insights. my most vivid recollection of bob however was not in the classroom per se; rather it was when bob was "on stage" and displayed his thespian talents in one of my vignette-plays. although many bioethicists and geneticists have ably portrayed the snarky nineteen-year character coincidentally called "bobby," bob truly captured the audience and ethical tension with the greatest panache thanks to his bellowing voice and dramatic flair! staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) 3 for me, bob will always remain larger than life. lynn bush i’ll never forget the first evening class of the first semester for the first cohort of bioethics students… i had moved to nyc only a week ago, i didn’t know anyone, and i was a little terrified of the walk i had ahead of me from morningside campus to my apartment on riverside and 153rd. i made my way down college walk, and there was bob, standing right by his car. he spotted me and waved me over, asked me where i was headed, and immediately offered me a ride. we had a wonderful conversation as he drove me home, and nyc didn’t feel as terrifying to me anymore. since that day, i considered bob to be a friend, a role model, and just simply a good person. i was thrilled to learn that we would be working together as teaching assistants during our second semester, and grateful to have him by my side. bob was one of those rare people who is fiercely intelligent and commanding, yet so incredibly thoughtful and gentle. he made the world a better place everywhere he went, and he will be greatly missed. bela fishbeyn bob was a student in my law and bioethics course in 2012. that was the first year i taught the course, so i was nervous. and it was more than a little intimidating to find that one of my students was himself a lawyer, with decades of experience in medical malpractice. but of course bob was generous with his expertise. he would hold back for a while so that other students could offer their thoughts and comments, and then he’d share his real-world experience with grace and humor. i was also lucky enough to get to know bob a little better because i ended up riding home with him almost every week after class. once bob realized we both lived in westchester, he told me that it made no sense for me to be schlepping back on the subway and train in the dark and the cold. so each week after class, he drove me to my door. i recall some great conversations on those smooth car rides up the hudson valley. we would discuss ideas and arguments from the class and from the intersection of law and bioethics generally. or bob would tell me about cases he had been involved with—difficult end of life decisions he had dealt with first hand. or we’d talk about a paper he was working on. he had a youthful interest in bioethics and in the problems that animate staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) 4 our field. i was so shocked and greatly saddened to learn of his death. he was full of energy and wit—as sharp as a tack—and was an absolute pleasure to work with. my heart goes out to his family at this sad time. josephine johnston bob's intelligence, compassion, and good humor added immeasurably to our bioethics classes. he had a unique gift for stimulating discussions and opening up spaces for reflection. he enriched our program not just by what he brought to it himself, but also by what he brought out in others. james colgrove bob was in the very first group of people entering our bioethics program here and he immediately helped to make my experience, and that of the others in the philosophy of bioethics class i was teaching that first semester, so much more rewarding. bob brought life and wit, experience and understanding to each monday evening’s discussions. as faculty, we had wondered how difficult it might be for our students to have good rapport with one another when they were at so many different places in their respective lives and careers. but bob was a key part of the answer to that question—he was a wonderful catalyst, greatly appreciated by everyone, so willing to engage people on the issues, always very knowledgably, always in a personable and affable way. when bob was almost finished with his own thesis, he generously continued to attend further sessions of the thesis workshop so he could offer his support to other students who were not as far along. indeed, well after he received his own degree, bob was a very valued and articulate presence at almost all of our information sessions for prospective new students. bob believed in the importance of bioethics and in the significance of our program here at columbia-and so he was willing to explain the program so clearly and to advocate for it so cogently. to me, bob was and is the spirit of what this program is, and ought to be, all about. i will always remember him in this way. arthur kuflik bob's positive influence cannot be overstated. he had a profound effect on my life, even though i only knew him for a short period of time. bob was one of the first people i met when i moved to new york from south carolina and he helped ease my worries about such a drastic lifestyle change. i met him at admitted students' night, which he was attending as an alumni. i was a nervous wreck at the event because i was still questioning staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) 5 whether or not i would be able to handle living in new york. bob welcomed me with open arms, literally and figuratively. he helped me realize that i was making the right decision. since that time, bob was always there for me, providing me with encouragement and comic relief every time we met. my life is better as a result of his being a part of it. i will always cherish the time that i knew him and attempt to live up to the jovial, witty, focused, intelligent, and talented example he set. i will miss you, bob. alanna walker dear bob, i am so thoroughly pleased to have met you and to have known you. upon arriving in new york and at columbia, i was a bit overwhelmed but your friendly guidance made the transition a pleasure. upon our first interaction, we sat next to each other at a dinner following a lecture on changing the face of palliative care. your jovial and insightful comments made the dire topic of the dinner feel empowering and full of possible triumphs for us. i have no doubt we have lost a great man in bioethics. i welcomed your invitations for trips up the hudson valley over autumn to see the leaves change and to scarsdale for wine tasting. i wish there were time for more. on our last meeting, i spoke to you seeking advice on how to enter the world of clinical bioethics. your knowledge and advice on entering a field still in its adolescence was invaluable and will continue to resonate with me. i thank you most sincerely for the pleasure of having made your acquaintance. i look to you as both a peer and a mentor. you are and will always be a role model. thank you for taking the time to welcome me and include me in your world, bob. staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) 6 sylvia english dear caren, i want to extend my deepest sympathy to you and your family at the passing of robert whiteman. robert was a real leader in the columbia university bioethics program. he pioneered a bioethics writing group and in that context, he very generously offered his time and energy to me in commenting on a piece i had written on research ethics for high school students. i was a new student at the time and his interest was especially significant to me. recently, i decided to submit the piece for publication and had retrieved what robert had written. his suggestion that i look at the style in which the articles are written for the particular journal has been very helpful. more important though, i think, was his encouragement to me about developing my work. he said, “i think you raise an excellent point about the importance of teaching science research students early about ethics so as to avoid scientific misconduct and some of its consequences and you support that with references.” my thoughts and prayers are with you and your family at this time of such a great loss. i will always remember robert and truly appreciate his good will, intelligence, and zest for life. donna light bob was assigned to be my mentor. we were both trained in the law so this made sense. being new to the program, i reached out to him for ideas on how to best navigate the full assortment of course options and strategies. what i liked about bob was that he had a calm presence that spoke volumes. he knew best the type of personality that would win over others and he had a gift for displaying that personality in a believable and likable way. although i did not have the pleasure of spending much time with bob, the few times we were able to speak proved to be a great help. i felt special that we could both share our ideas about the program. his foresight and contributions will truly be missed. jared silberman staff writers and faculty, bob whiteman in memoriam, voices in bioethics, vol. 1 (2014) 7 whiteman, robert g. "medical tourism and bariatric surgery." surgery for obesity and related diseases 7.5 (2011): 652-654. http://www.soard.org/article/s1550-7289%2811%2900493-x/fulltext this work is licensed under a creative commons attribution 4.0 international license. http://www.soard.org/article/s1550-7289%2811%2900493-x/fulltext https://creativecommons.org/licenses/by/4.0/ https://library.columbia.edu/ https://library.columbia.edu/ https://creativecommons.org/licenses/by/4.0/ foe, access to palliative care: a public health emergency, voices in bioethics, vol. 1 (2014-15) * gabriella foe, ms bioethics © 2014 foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use , distribution, and reproduction, provided the original author and source are credited. access to palliative care: a public health emergency gabriella foe* keywords: palliative care, public health, end of life care introduction increasingly, there has been a push for better access to palliative care. it could be the result of the baby boomer generation reaching the end-of-life stages, recent euthanasia legalization (for children in the netherlands, and for adults in quebec, canada), or for other reasons. regardless, medical associations and health organizations are asking for more funding from governments to make palliative care more accessible to those who are dying. in places where physician-assisted suicide and/or euthanasia have been legalized, it is important that dying patients do not feel pressured to choose to end their lives due to lack of access to palliative care. in places where such procedures are not legalized, it is ever more important to attend to and relieve the unnecessary pain experienced at the end of life. ____________________________________________________________ foe, access to palliative care: a public health emergency, voices in bioethics, vol. 1 (2014-15) 2 analysis according to bbc news, the lack of access to pain relief for those who are dying is a public health emergency: many in developing countries (without access to physician-assisted suicide or euthanasia) are “throwing themselves in front of trucks to escape pain.” while governments in developing countries are afraid to provide palliative care because they do not want their citizens addicted to morphine, the topic surrounding access to palliative care in canada revolves around the lack of national standard. funding for palliative care programs vary between canadian provinces. it seems that lack of government funding and distribution is partly due to ignorance and negative attitudes toward palliative care. these attitudes must be changed to develop an acceptable standard of care for pain management. the distinction between palliative care, physician-assisted suicide, and euthanasia seem to still be ambiguous for the public and some medical students or professionals; education materials to demystify misconceptions must be developed. medics in the developing world do not receive any palliative care training; medical students in 10 of 17 canadian medical schools receive less than 10 hours of training in pain management. this lack of training must be addressed if physicians are to provide acceptable care for pain management for those at the end of life. conclusion better attitudes toward and increased access to palliative care are required to ensure that the percentage of our population who are vulnerable are adequately cared for and shown respect and dignity at the end of their lives. this is also necessary to ensure that they do not feel pressured to forcibly end their lives, whether by committing suicide (i.e. throwing themselves in front of a bus) or through physician-assisted suicide or euthanasia. belisomo, death cafe, voices in bioethics, vol 1 (2014) 1 © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “death cafe”: end-of-life conversations and coffee now served worldwide randi belisomo keywords: clinical medicine, end-of-life, narrative introduction well-coiffed and clad in pink, lori is hoping to learn about legacy. what does it mean and how can she leave one? this grandmother of seven wants to be remembered well, and she intends to create some memories before it is too late. aida sips coffee between tears. her boyfriend died last weekone week shy of his 90th birthday. well past 80 herself, she is looking for answers about what to do with her money. should she spend it on herself or leave it to her children? she wants to ensure her lifesavings isn’t frittered on cigarettes and alcohol if she chooses to create a will. lenore says “devastation” is what brought her here. she has experienced plenty in recent years, including the suicide of a 15-year-old grandson. analysis “it was the death of the future,” lenore tells the other seven attending this afternoon “death cafe” at a senior center on chicago’s northwest side. this event is just one in a “death cafe” movement stretching far beyond this middle class enclave in the shadow of o’hare international airport; more than one thousand “death cafe” events have been facilitated across the u.s., europe, australia and asia since the first held three years ago this month in london. the objective of “death cafe,” always conducted over coffee and cake, is to “increase awareness of death with a view to helping people make the most of their finite lives.” dan bulf, the volunteer moderator of this event, promises his predominately female crowd that by the end of the session, they will experience a “deeper sense of connection." he asks everyone to be respectful and kind, emphasizing that “death cafe” is not intended to serve as grief support, counseling or as the determiner of right and wrong. “this is about your reality,” he tells the nodding seniors. bulf asks what a “good death” would look like. “amongst family.” “as little pain and suffering as possible." “leaving no mess behind.” belisomo, death cafe, voices in bioethics, vol 1 (2014) 2 © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “on my own terms.” “at peace with my decision.” “non-medicalized.” “with no long-term health problems.” bulf smiles warmly after each answer; after all, this isn’t about right or wrong. conversation flows about how to make such “good deaths” happen. some factors can be controlled; others cannot. “it really makes you aware of the reality we have to deal with eventually,” says 72-year-old dean afterwards. “it’s challenging. very challenging.” bulf agrees. making that challenge easier is exactly why he became a “death cafe” facilitator. “this is the first step in dealing with death,” bulf says. “this is an acknowledgement. then you are comfortable and can start planning.” lizzy miles hosted the first american “death cafe” in a suburban columbus, ohio panera bread in 2012. she has since held one each month since, drawing attendees from promotions on social media, community newspaper advertisements and postings in the eatery. as a hospice social worker, miles says she noticed very few broach the subject of deatheven when on its brink. “anywhere i went, if i told people i worked in hospice, they would tell me personal stories,” miles says. “so, i had the realization that people don’t talk, but some people want to.” ____________________________________________________________ conclusion in atlanta, at least 25 people each month are proving that to be accurate. “death cafe” attendees have ranged in age from 18-102, gathering in the visitor center at oakland cemetery. mark larocca-pitts, a former hospice chaplain, facilitates the two-hour events. “it’s a really real issue,” he says. “we have a saying that talking about sex won’t make you pregnant and talking about death won’t kill you.” megan mooney, who facilitates “death cafe” in st. joseph, missouri, says she believes its loose format is attractive to those who may be hesitant. “they can talk about whatever they want, there is nothing off-limits,” she says. meeting among similarly minded strangers may make this topic less touchy. belisomo, death cafe, voices in bioethics, vol 1 (2014) 3 © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “when they try to talk to their friends or families they get shut down or told they are morbid,” mooney says. “they really want to have an authentic conversation about death, but they have no one to have that conversation with. they can here.” winter 2015 texas house bill 2: discrimination toward abortion providers creates undue burdens for texas women rachel hill follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 1 in 1992, the united states supreme court, in planned parenthood of southeastern pennsylvania v. casey, upheld the ruling in roe v. wade, namely that women have a right “to choose to have an abortion before viability and to obtain it without undue interference from the state.”1 however, since this ruling, some states have imposed regulations that greatly limit this right by restricting access. texas is a recent example of this. two proposed restrictions in house bill 2 (hb 2), which will be discussed in detail below, will force all but eight clinics that are located in metropolitan areas to shut down. the u.s. supreme court put the proposed restrictions on hold in october 2014, allowing several clinics to remain open while the restrictions are being appealed in the u.s. court of appeals for the fifth circuit. if the restrictions are passed, however, those clinics will be forced to shut down and, as a result, many women in texas will be required to travel more than 100 miles in order to access a safe and legal abortion. much of the focus of these restrictions has been on women and rightly so. however, i want to turn the attention to physicians. the requirements exacerbate unfair treatment of abortion providers compared with other physicians. abortion providers face threats from the public—some of which turn into violent attacks—and they are often ostracized by their fellow medical practitioners. there are so few abortion providers to begin with and the proposed requirements limit these physicians’ opportunities to practice the branch of medicine of their choosing. although the hb 2 requirements may not result in an unconstitutional undue burden on physicians, the challenges created by the bill limit physicians’ abilities to provide abortions. as a result of these limits, hb 2 creates an unconstitutional undue burden for women seeking abortions by creating barriers directed at abortion providers and clinic staff who are willing and able to provide abortions. the first of the two controversial hb 2 requirements is the admitting privileges requirement: “a physician performing or inducing an abortion must, on the date the abortion is performed or induced, have active admitting privileges at a hospital that is located not further than 30 miles from the location at which the abortion is performed or induced.”2 the second requirement is the ambulatory surgical center requirement: “the minimum standards for an abortion facility must be equivalent to the minimum standards adopted under [texas health & safety code] […] for ambulatory surgical centres.”3 in order to meet these state-mandated obligations, some abortion clinics would have to spend more than $1 million in upgrades if they wish to remain open. the district court decided that the ambulatory surgical center requirement places an unconstitutional undue burden on women, and that the two requirements together place an undue burden on women in texas and especially in the rio grande valley where the nearest clinic is a couple hundred miles away.4 later, the u.s. court of appeals for the fifth circuit reversed the district court’s decision and argued, “the admitting privileges requirement is constitutional on its face.”5 while the regulations are being appealed, the supreme court granted a stay of injunction, allowing about twelve abortion clinics to reopen until a final decision regarding the regulations is made. the district court ruled that the purpose of the two regulations was to create a substantial obstacle for women seeking abortions in texas. while the defendants argued voices in bioethics 2 that the regulations were designed to make abortions safer and reduce risk, the court decided that this was not the case. an abortion, especially a first-term abortion, is a very safe procedure and is safer than many other routine surgical procedures. as stated in planned parenthood v. casey, “unnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right.”6 the undue burden in this case is imposed, not through restricting women’s access directly, but by restricting physicians’ freedom to perform abortions. the admitting privileges requirement has reduced the number of physicians who can perform abortions and the ambulatory surgical center requirement has reduced the number of clinics where abortions can be performed. the american medical association (ama) states, “[t]he principles of medical ethics of the ama do not prohibit a physician from performing an abortion in accordance with good medical practice and under circumstances that do not violate the law.”7 this means that physicians are not required to perform abortions, except in emergency situations, but can as long as the procedure is done safely and does not violate the law. the new texas regulations, however, are so restrictive that few abortion providers, limited to only four urban areas, can legally perform abortions. physicians do not have an absolute right to perform abortions as opposed to women who have an absolute right to have access to an abortion. physicians do face many challenges that other professionals face in terms of obtaining qualifications and finding work. abortion providers, however, face challenges that most other physicians do not. the restrictions imposed by these regulations exacerbate unfair treatment toward abortion providers and place further obstacles in their path in terms of providing the service they want and are qualified to provide. both abortion clinics and abortion providers are being treated differently from other medical clinics and physicians. for instance, “grandfathering of existing facilities and the granting of waivers from specific requirements is prohibited for abortion providers, although other types of ambulatory surgical facilities are frequently granted waivers or are grandfathered.”8 many abortion clinics cannot afford the necessary upgrades. furthermore, it is extremely expensive to open a brand new clinic that complies with the ambulatory surgical center requirements. being grandfathered in would be the only option available to abortion clinics that cannot afford the upgrade. however, unfair treatment of abortion clinics and providers is preventing those clinics from being grandfathered into the new system. as a result, many abortion clinics may be forced to close. admitting privileges are proving difficult or impossible for physicians both to obtain and, for those who have already been granted privileges, to keep. dr. sherwood lynn, an obstetrician-gynecologist who has performed abortions for decades, describes the process of obtaining admitting privileges and the difficulties abortion providers face. after sending in an application a physician must wait for the hospital to send them the required materials, “but if the address of the practice on the application is of an abortion provider or clinic, [the hospital] won’t send [them] the package of materials required. [they] simply can’t apply.”9 dr. lynn and several other physicians have surmised that hospitals are only withholding voices in bioethics 3 privileges from qualified physicians who perform abortions and that other physicians do not face this discriminatory treatment. hospitals have also revoked privileges granted to physicians after learning that the physicians perform abortions. for instance, in texas two doctors, “received notices […] informing them that their admitting privileges to the university general hospital of dallas have been revoked, with the hospital’s ceo claiming the hospital was unaware they were providing abortion care and that the hospital believed such care would damage its reputation.”10 what is curious about this revocation is that, “federal and state laws […] forbid hospitals from discriminating against doctors who perform abortions,” and yet hospitals are clearly doing just that.11 dr. pamela richter, another abortion provider in texas, had her temporary admitting privileges revoked with no explanation and because of this, the clinic where she performed abortions, reproductive services, can no longer provide abortions at all.12 as the hospital gave no reason for the revocation, it not clear dr. richter’s privileges were revoked because she performs abortions. dr. richter, however, has performed over 17,000 abortions and her privileges were revoked soon after hb 2 was introduced.13 according to the texas hospital association (tha), giving admitting privileges to doctors who do not work for the hospital is expensive and time-consuming but this does not account for the fact that hospitals are revoking previously granted privileges from physicians whom they learn are providing abortion services.14 as mentioned previously, the district court found that the admitting privileges requirement and the ambulatory surgical center requirement do not further ensure the health and safety of women undergoing an abortion. several physicians have testified to this fact. dr. lynn stated in an interview: the admitting privileges requirements are […] absolutely unnecessary. if you have a number of patients waiting for procedures, and something happens and a patient needs to be transferred to a hospital, you’re not going to leave everyone else and go to the hospital. that makes no sense. you’re going to refer that person to a gynecologist at the hospital. there is no safety issue involved here. if a patient shows up with an emergency, every hospital is required to admit that patient. they have to by law.15 it is rare that complications will arise from an abortion performed in a clinic. dr. richter, for example, has performed more than 17,000 abortions and not once had to send a patient to a hospital because of complications resulting from the procedure. according to dr. lynn even if abortion providers were granted privileges to hospitals, it is unlikely that they will exercise them. in essence, having admitting privileges at a hospital does nothing to further ensure the safety of an already safe procedure. the only result of the admitting privileges requirement is to limit certain physicians’ ability to perform legal abortions. not only do the hb 2 requirements fail to further ensure the health and safety of women, the hb 2 requirements may actually create more health risks to women who cannot access the eight remaining clinics. the first risk is that the remaining clinics would voices in bioethics 4 have an influx of patients that they may not be able to handle, forcing women to wait longer for an appointment. as stated by the district court, “[e]ven assuming every woman in texas who wants an abortion […] could travel to one of the four metropolitan areas where abortions will still be available, the cumulative results of hb 2 are that, at most, eight providers would have to handle the abortion demand of the entire state.”16 furthermore, “[t]hat the state suggests that these seven or eight providers could meet the demand of the entire state stretches credulity.”17 abortion is a time sensitive procedure. it is safest when performed early in a pregnancy. the increase in patients to these remaining clinics, assuming all women in texas can access them, will increase wait times and may force women to have abortions later in pregnancy. in the worst-case scenario, a woman would not see an abortion provider at all before viability. such instances may be rare, but they are possible. in such cases, women’s access to legal abortions becomes impossible and thereby violate the ruling in roe. clinics may be able to avoid the aforementioned problems if they hire more physicians. however, there are two barriers to hiring more physicians. first, as mentioned previously, admitting privileges to texas hospitals are difficult, if not impossible, for abortion providers to obtain. second, given the negative treatment of abortion providers by anti-abortion groups, many physicians are not willing to perform abortions. the harassment abortion providers face is unique to those physicians and many physicians will not perform abortions for that reason. in an article published in the austin chronicle, antiabortion activist abby johnson, “discusses how her group investigated appraisal district records to find the new location of where an austin abortion physician plans to work.”18 johnson states, “these abortionists are feeling the pressure from the pro-life movement in texas. i think they feel like they’re on the run. and that’s how we want to keep it.”19 if the hb 2 requirements are passed and there remain at most eight abortion providers in texas, these activists will concentrate on those clinics and, “the dangerous impact of their intimidation tactics will be exacerbated.”20 even if the number of physicians needed to meet the demand in texas can obtain admitting privileges and work at one of the remaining clinics, they may choose not to do such work because they are putting themselves at risk. the harm abortion providers face from such anti-abortion groups is not unique to texas. there are stories from all over the country and from other countries where abortion is legal of physicians receiving death threats. dr. george tiller, an abortion provider in kansas, was killed outside his church and had received numerous death threats prior to this. the hb 2 requirements are making it so that abortion providers either cannot provide their services any longer or will face increased threats and increased danger to themselves. physicians are allowed to conscientiously object to providing medical interventions in certain circumstances for moral and religious reasons. however, there are limits on this right. according to the american congress of obstetricians and gynecologists (acog), “[w]hen conscientious refusals conflict with moral obligations that are central to the ethical practice of medicine, ethical care requires that the physician provide care despite reservations or that there be resources in place to allow the patient to gain access to care in voices in bioethics 5 the presence of conscientious refusal.”21 i would argue fear for one’s safety in the face of immediate threats is perhaps a stronger ground on which to refuse to provide care than a personal belief that abortion is immoral or against one’s religion. acog also states, “[p]roviders with moral or religious objections should either practice in proximity to individuals who do not share their views or ensure that referral processes are in place so that patients have access to the service that the physician does not wish to provide.”22 this responsibility has been largely disputed by the medical community but in cases of rape, incest, and health risks to women, referrals must be made without exception. however, under the requirements of hb 2, working in proximity to an abortion provider may not be possible because they are so geographically limited. referrals are supposed to be made within reason (although what is considered within reason has not been officially defined). some areas of texas, such as the rio grande valley, are up to 200 miles away from the nearest clinic that would remain open if hb 2 is passed. referrals may simply not be feasible given the geographical distances and the decreasing number of available physicians. as mentioned above, there are two risks to the health and safety of women as a result of hb 2. the second of these is that if a woman cannot access one of the remaining clinics, she may seek out a more convenient but illegal and unsafe abortion, which is far more likely to result in a dangerous complication. dr. lynn states, “[b]ecause of the restrictions lawmakers impose, women will seek abortions illegally, and we’re going to see a rise in septic abortions.”23 some areas of texas might effectively revert back to a pre-roe era where abortions were performed in unsanitary conditions by unqualified people resulting in dangerous medical complications far more often than legal abortion procedures do now. physicians like dr. lynn who want to prevent this from happening generally cannot do so without facing legal sanction. physicians have a duty to provide safe medical care and if they cannot obtain admitting privileges, they cannot exercise this duty. acog released a statement expressing their objections to the new requirements. they state that hb 2 is, “plainly intended to restrict the reproductive rights of women in texas through a series of requirements that improperly regulate medical practice and interfere with the patient-physician relationship.”24 executive vice-president of acog, hal c. lawrence iii stated: the texas bills set a dangerous precedent of a legislature telling doctors how to practice medicine and how to care for individual patients. acog opposes legislative interference, and strongly believes that decisions about medical care must be based on scientific evidence and made by licensed medical professionals, not the state or federal government.25 abortion is one of only a few areas of medicine where the legislature imposes so many regulations restricting particular physicians’ ability to practice medicine. not only are abortions providers being regulated by the state, they are also facing clear discrimination from others within the medical community. the state is closing down clinics that do not voices in bioethics 6 meet the ambulatory surgical center requirements and hospitals are denying physicians admitting privileges because they perform abortions. in summary, abortion providers are being discriminated against both by the legislature and other members of the medical community. other physicians who do not perform abortions are not denied admitting privileges on discriminatory grounds. clinics that cannot afford upgrades to become an ambulatory surgical center are being grandfathered in, while abortion clinics are being forced to close down. ob-gyns who conscientiously object to performing abortions and who are not located in close proximity to at least one abortion provider cannot effectively fulfill their duty to refer patients. lastly, given the barriers these regulations will create, there will likely be a rise in complications resulting from abortions provided under grossly unsafe conditions. physicians, whose duty it is to provide safe and effective medical care, are being denied the right to exercise this duty. while this denial may not be unconstitutional, it is certainly unjust and discriminatory and creates obstacles that other physicians do not face. most importantly, these obstacles are creating an undue burden for women. the hb 2 requirements do not increase the health and safety of abortions; all they do is create substantial obstacles for women. in light of these observations, the requirements seem to me to be in clear violation of casey, in which it was decided that, “[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on that right.”26 these regulations do just what casey was meant to prohibit and this is accomplished through limiting physicians’ ability to practice safe abortions across the state of texas. therefore, the hb 2 requirements may not impose an undue burden on doctors but they do impose an undue burden on women. 1 planned parenthood of southeastern pennsylvania v. casey, pg. 2. 2 whole women’s health v. lakey, pg. 2. 3 ibid. 4 ibid., 4. 5 ibid., 2. 6 planned parenthood v. casey, pg. 16 7 ama code of medical ethics, “opinion 2.01 – abortion,” american medical association. 8 whole women’s health v. lakey, pg. 10. 9 dr. sherwood lynn, “a texas ob-gyn details the horrific consequences of abortion restrictions”, cosmopolitan. 10 feminist newswire, “texas hospitals revoke admitting privileges to abortion providers,” feminist majority foundation blog. 11 ibid. 12 ibid. 13 ibid. 14 glenn hegar, “texas hospital association’s statement of opposition to section 2 of the committee substitute for senate bill 5,” texas hospital association. 15 dr. lynn, “a texas ob-gyn.” voices in bioethics 7 16 whole women’s health v. lakey, pg. 10. 17 ibid. 18 mary tuma, “undercover audio reveals anti-abortion tactics: anti-abortion activists monitor and track providers, patients,” austin chronicle. 19 ibid. 20 ibid. 21 committee on ethics, “the limits of conscientious refusal in reproductive medicine,” the american congress of obstetricians and gynecologists. 22 ibid. 23 dr. lynn, “a texas ob-gyn.” 24 “ob-gyns denounce texas abortion legislation: senate bill 1 and house bill 2 set dangerous precedent,” the american congress of obstetricians and gynecologists. 25 ibid. 26 planned parenthood v. casey, pg. 16. erfan, bad blood, voices in bioethics, (2013) © 2013 asnan erfan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. bad blood: a cautionary tale asnan erfan keywords: hiv, blood donation, emergency, 1960s the human immunodeficiency virus (hiv) has disproportionately affected the gay community and victims of hemophilia, a rare bleeding disorder. for more than a decade in the 1960s, the food and drug administration (fda) turned the other cheek on drug regulation and allowed pharmaceutical industries to control manufacturing processes. this approach led to violations of safety standards, as pharmaceutical companies became increasingly concerned with enormous profits and less about oversight. when aids emerged in the 1980s, over 10,000 people with hemophilia were infected with hiv and hepatitis after receiving fda-approved medical treatment. this hemophilia treatment contained factor of active ingredients made from large pools of plasma of up to 60,000 donations, but only one hiv-infected donation was all it took to contaminate the entire supply. bad blood: a cautionary tale is a documentary highlighting the tragic historical facts of hiv detection in the u.s. blood supply and the aftermath of societal demands to correct the situation. the film portrays survivors and their family members showing that effects of deregulation are still felt by innocent members of our society. furthermore, it exposes evidence that pharmaceutical companies and government regulators were aware of the viral contamination and were slow to respond to emergency warnings from the center for disease control. the cautionary tale presents two bioethical issues: government’s awareness of contaminated blood donations and the pharmaceutical industry’s concern for prioritizing profit over safety. when the government chose to deregulate the pharmaceutical companies, it handed out thousands of death certificates. the film reveals the early years of blood processing as unsanitary, by depicting improper screening during donations from the homeless and sick. to make matters worse, the government and medical professionals were already aware hepatitis contaminated the factor. however, they continuously ignored it, believing the viral infections were mostly harmless and the societal benefit greatly outweighed the minimal risk. once these wrongdoings came to light, many companies responded by shipping the contaminated products out of the country, to continue making profits. although, we hope that with today’s standards government regulators do not repeat such oversight mistakes, many pharmaceutical companies are private enterprises. and thus, it is up to us, to push pharmaceutical manufacturers to listen to consumers and implement extensive safety measures when screening plasma products. although, there haven’t been any known cases of transmitted hiv or hepatitis for at least 20 years, fear of recurrence is well founded. the four personal stories at the center of the film are what really capture the viewer. each character’s struggle is depicted as a heartfelt journey described through interviews, narration, photographs, media coverage, and animations. you can feel the pain behind the idea of being infected with a deadly ailment by the very people you seek for help. holmquist, prescription opioids and heroin plague, voices in bioethics, vol. 1 (2014-15) © 2015 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. pharma, prescription opioids, and heroin plague—where we are now stephanie holmquist keywords: drugs, fda, heroin, pharmaceutical companies, prescription opioids introduction opioid drug manufacturers are largely responsible for the tsunami of prescription drug deaths and increase in heroin addiction of the last fifteen years. the sad story of the prescription opioid disaster is now well known. beginning in the 1990’s manufacturers of these drugs exploited legitimate medical concerns over the undertreatment of pain. marketing efforts disguised as physician education expanded the prescribed use of long acting forms of opioid pain relievers. without adequate evidence of their appropriateness1, opioids were promoted for use against headache, arthritis, and chronic back pain2. widespread addiction followed over-prescription and overuse. analysis a four-fold rise3 in deaths due to prescription opioids tracks the tripling of prescriptions for these drugs since the early 1990’s. prescription opioid availability also drives their illegal trafficking to recreational drug users. once dependent, they may continue to use the commercial drugs or move onto cheaper heroin. according to the cdc, the strongest risk factor for heroin addiction is “addiction to prescription opioid painkillers.”4 while prescription opioid deaths are leveling off, heroin use and related deaths are climbing, with fatalities up almost 300% since 20105. in tandem, worrying pockets of increased hepatitis c6 and hiv7 infection reflect needle sharing for both heroin and liquefied opioids. efforts to prevent infection are hampered by the congressional ban on federal funding8 of needle exchanges, a proven method for reducing transmission caused by sharing syringes. especially at risk are rural areas and small towns ill-prepared to quickly institute education and prevention strategies against hiv and hepatitis c.9 opioid manufacturers’ public relations campaigns portray them as working to prevent illegal access to opioids 10 and engineer abuse-proof drugs. but the disaster of dependent users, their damaged lives, and communities goes largely unacknowledged by these pharmaceutical companies. lawsuits filed by local governments in california and the city of chicago in 2014 against manufacturers opened with this sentence: “a pharmaceutical manufacturer should never place its desire for profits above the health and wellbeing of its customers.”11 it is easy to dismiss this idealistic formulation as irrelevant to a drug industry so regularly content to produce me-too drugs and expensive treatments of limited benefit to patients. but the behavior of drug manufacturers in creating the current opioid disaster has been so outrageous, it is beyond ignoring. the california and chicago governments sued to hold manufacturers of opioid drugs responsible for damage http://www.ncbi.nlm.nih.gov/pubmed/23983011 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6417a2.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a4.htm holmquist, prescription opioids and heroin plague, voices in bioethics, vol. 1 (2014-15) 2 caused by the widespread, deceptive marketing of these drugs.12 five firms were named in the chicago action, including purdue pharma, best known for oxycontin. (in 2007, purdue paid a $635 million dollar fine to settle both civil and criminal charges over its marketing of that drug.13) this week a chicago judge dismissed the four other manufacturers from that city’s lawsuit, but the city may re-file guided by the judge’s comments in his ruling.14 other actions are already under consideration by additional states and localities. like the tobacco companies, opioid manufacturers are facing a social accounting they never expected after knowingly using deceptive tactics to push a legal product. manufacturers have already been compelled to address some of the disasters they have created. these companies have been forced by the fda to offer drug reformulations that make them more difficult to abuse— for instance, by altering their composition so that crushing pills for snorting or dissolving for shooting up is difficult.15 of course drug reformulations preserve market share. oxycontin has been deemed so dangerous by the fda that it refused to approve a generic version.16 as a result, perdue’s own reworking of the drug is without generic competition that would cut costs for those patients with a real medical need for opioid pain relief. in addition, abuse resistance is important when effective, but does not equal lower risk of dependence for patients. opioid drug manufacturers trumpet their contributions to mitigating the hazards of prescription opioid over use. along with drug reformulations, they have supported state registries and databases to identify and prevent over-prescription. purdue makes much of its close relationship with law enforcement and joint efforts to combat criminal diversion of prescription opioids to the illegal market.17 but no manufacturer says anything about repairing the damage it has done to users and communities. the future-oriented perspective of drug companies is convenient for them. it externalizes the ongoing burden of addressing the prescription opioid and related heroin plague to communities, government and individuals. conclusion opioid manufacturers could act today to mitigate the harms they have caused, but they will not. they will discount responsibility, perhaps privately pointing out the legal and insurance disincentives to acknowledging a leading role in a public health disaster. they could support needle exchange programs and treatment efforts for opioid and heroin users incorporating newer treatment regimens using buprenorphine 18 alone and in combination with other drugs, but they will not. they could apologize both to patients who have become drug dependent and to pain sufferers whose legitimate access to drugs is compromised by restrictions designed to combat illegal use. they could simply align their marketing with the best available medical judgment on the appropriate use of these drugs, but they will not. so we will see continuing human suffering and death, while these opioid manufacturers parry regulations and legal actions that threaten their market and revenues. 1 https://www.aan.com/pressroom/home/pressrelease/1310 2 http://www.ncbi.nlm.nih.gov/pubmed/23983011 3 http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates 4 http://www.cdc.gov/vitalsigns/heroin/%202015 holmquist, prescription opioids and heroin plague, voices in bioethics, vol. 1 (2014-15) 3 5 http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates 6 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6417a2.htm 7 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a4.htm 8 http://www.nytimes.com/2015/05/17/us/surge-in-cases-of-hiv-tests-us-policy-on-needle-exchanges.html?_r=0 9 http://www.npr.org/sections/health-shots/2015/04/24/401968600/cdc-warns-of-more-hiv-hepatitis-c-outbreaks-in-drug-users 10 http://www.rxsafetymatters.org/law-enforcement-and-government/education-and-resources/ 11 http://www.nytimes.com/2014/08/25/us/chicago-and-2-california-counties-sue-drug-companies-over-painkillermarketing.html 12 http://www.nytimes.com/2014/08/25/us/chicago-and-2-california-counties-sue-drug-companies-over-painkillermarketing.html 13 http://money.cnn.com/2007/07/20/news/companies/purdue/index.htm 14 http://www.bloomberg.com/news/articles/2015-05-08/chicago-loses-bulk-of-claims-in-drug-company-suit-over-opiates 15 http://www.pharmacytimes.com/contributor/jeffrey-fudin/2015/01/abuse-deterrent-opioid-formulations-purposepracticality-and-paradigms 16 http://www.pharmacytimes.com/contributor/jeffrey-fudin/2015/01/abuse-deterrent-opioid-formulations-purposepracticality-and-paradigms 17 http://www.rxsafetymatters.org/law-enforcement-and-government/education-and-resources/ 18 http://www.drugabuse.gov/blending-initiative/buprenorphine-suite-blending-products bergstresser, the reason i jump, voices in bioethics, (vol.2) 2016 © 2016 sara bergstresser. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. "the reason i jump" by naoki higashida: a reconsideration of autism, empathy, and “mindblindness” sara bergstresser the field of bioethics has the potential to contribute to a better understanding of how the medical and social assumptions that accompany diagnostic categories impact the people who have been diagnosed. in particular, autism has recently been characterized as being defined by an inherent lack of empathy and as a state of “mindblindness,” or the failure to develop the “capacity to mindread in the normal way.”[1]naoki higashida’s book, the reason i jump, leads us to question the legitimacy of these assumptions as well as their impact on actual individuals in the world. in his introduction to the book, the novelist david mitchell asserts: “like all storytelling mammals, naoki is anticipating his audience's emotions and manipulating them. that is empathy. the conclusion is that both emotional poverty and an aversion to company are not symptoms of autism but consequences of autism, its harsh lockdown on self-expression and society's near-pristine ignorance about what's happening inside autistic heads.”[2] this book shines a light on the dehumanizing current behind the scientific discourse on autism by laying bare the sheer humanity of a single person's struggle to communicate with the world around him. naoki higashida is a japanese man who wrote this book when he was thirteen years old. because of his trouble with verbal and independent written communication, his writing began in a unique manner: higashida would form words by pointing to letters on an “alphabet grid,” and his mother would transcribe them. he later began to write directly on a computer. mitchell and his wife, k. a. yoshida, found the book to be a “revelatory godsend” because it helped them connect with their own son, also diagnosed with autism. the couple went on to translate it for an english-speaking audience.[3] the book is a combination of autobiography, short fiction, and a direct plea for understanding. higashida does not describe a condition of emotional apathy; rather, he outlines a state of disconnect with his own body and with the world beyond. that the people around him mistake this disconnect for a wish to be alone is a profound driver of his suffering and loneliness. this book paints a portrait of a social world that rejects the person with autism over and over again, then blames him or her for the resulting isolation: “one of the biggest misunderstandings you have about us is your belief that our feelings aren't as subtle and complex as yours ... but of course, we experience the same emotions that you do. and because people with autism aren't skillful talkers, we may in fact be even more sensitive than you are.”[4] the field of neuroscience has cast autism as a “puzzle” to be solved, which has often led to the reification of people with autism as puzzles themselves, rather than as people who deserve compassion and understanding. “so is there something wrong with the circuitry in our brains? life's been tough for people with autism, pretty much forever, yet nobody's really been able to identify the causes of autism.”[5] many individuals involved in self-advocacy object to the puzzle imagery due to its association with an undercurrent of unidirectional alienation and blame. for example, an entry entitled “i am not a puzzle,” on the aspergers and me blog, states: “i am puzzling, people don’t always understand me or the way that i think and process the world, therefore i am a puzzle. however, i find neurotypicals puzzling. i don’t always understand them or the way they think and process the world. does that mean that they are a puzzle as well? no, it means that i am deficient in some way, disabled by being on the spectrum and cut off from everyone else.”[6]perhaps bioethicists are in a position to help disentangle this persistent conflation of difference, disorder, and blame. http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn1 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn2 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn3 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn4 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn5 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn6 bergstresser, the reason i jump, voices in bioethics, vol. 2 (2016) 2 the question of difference is central to a number of fields including disability studies, which has a powerful tradition of challenging assumptions that being different is synonymous with being inferior. bioethics also has an investment in the careful consideration of difference, and this work will be bolstered by engagement with disability studies and other related fields. in addition, bioethics has tasked itself with identifying morally relevant areas of difference; this comes with a parallel responsibility to rigorously question taken-for-granted ascriptions of blame. in situations that involve resource allocation, for example, medicine and health systems still struggle with questions of difference, social justice, and fairness. bioethicists have the tools to identify and interrogate questions of difference, and i suggest that they also have the responsibility to identify and examine those avenues of blame through which stereotype, bias, and social stigma have masqueraded as morality. japanese social life is marked by complex interactions designed to smooth social relationships, including care, to avoid causing negative feelings or offense. as a product of the japanese social world, this book is filled with culturally appropriate affect: “the hardest ordeal for us is that we are causing grief for other people. we can put up with our own hardships okay, but the thought that our lives are the source of other people's unhappiness, that's plain unbearable.”[7]higashida describes the roots of his social isolation very deftly and without taking on an accusatory tone. indeed, i am not as emotionally skillful as he, and after reading the book, i have the urge to formulate accusations on his behalf. but instead of substituting my own harsher words, i have chosen a quote from the book's afterword: “i used to be afraid that as long as i had autism, i'd never be able to live properly as a human being. there were so many things i couldn't do like other people, and having to apologize day in, day out totally drained me of hope.”[8]perhaps we of the outside world are the ones who have been “mind-blind” all along. [1] simon baron-cohen, mindblindness: an essay on autism and theory of mind (mit press, 1997), 5. [2] naoki higashida, the reason i jump, trans. k. a. yoshida and david mitchell (random house, 2013), xv, emphasis in original. [3] a related interview with david mitchell by john stuart on the daily show is available here: http://www.thedailyshow.com/watch/tue-october-1-2013/david-mitchell [4] higashida, the reason i jump, 109. [5] ibid, 18. [6] anonymous, “i am not a puzzle,” aspergers and me blog, june 20, 2012, http://aspergersandmeblog.wordpress.com/2012/06/20/i-am-not-a-puzzle/. [7] higashida, the reason i jump, 43–44. [8] ibid, 137. http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn7 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_edn8 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref1 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref2 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref3 http://www.thedailyshow.com/watch/tue-october-1-2013/david-mitchell http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref4 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref5 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref6 http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d0719b8748e3aacbe04ffc/1473278363191/?format=original http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref7 http://www.voicesinbioethics.net/arts-media-in-bioethics/2016/04/04/the-reason-i-jump-by-naoki-higashida-a-reconsideration-of-autism-empathy-and-mind-blindness-3#_ednref8 "the reason i jump" by naoki higashida: a reconsideration of autism, empathy, and “mind-blindness” nwigwe, embryonic stem cell research, voices in bioethics, vol. 5 (2019) © 2019 lillian nwigwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. embryonic stem cell research: an ethical dilemma lillian nwigwe keywords: embryo, bioethics, reproductive ethics, stem cell research introduction in november 1998, two teams of u.s. scientists confirmed successful isolation and growth of stems cells obtained from human fetuses and embryos. since then, research that utilizes human embryonic cells has been a widely debated, controversial ethical issue. human embryonic cells possess the ability to become stem cells, which are used in medical research due to two significant features. first, they are unspecialized cells, meaning they can undergo cell division and renew themselves even with long periods of inactivity. secondly, stem cells are pluripotent, with the propensity to be induced to become specified tissue or any “organ-specific cells with special functions” depending on exposure to experimental or physiologic conditions, as well as undergo cell division and become cell tissue for different organs. the origin of stem cells themselves encapsulates the controversy: embryonic stem cells, originate from the inner cell mass of a blastocyst, a 5-day pre-implantation embryo. the principal argument for embryonic stem cell research is the potential benefit of using human embryonic cells to examine or treat diseases as opposed to somatic (adult) stem cells. thus, advocates believe embryonic stem cell research may aid in developing new, more efficient treatments for severe diseases and ease the pain and suffering of numerous people. however, those that are against embryonic stem cell research believe that the possibility of scientific benefits of research do not outweigh the immoral action of tampering with the natural progression of a fetal development and interfering with the human embryo’s right to live. in light of these two opposing views, should embryonic stem cells be used in research? it is not ethically permissible to destroy human embryonic life for medical progress. analysis a. personhood and the scientific questionability of embryonic stem cell research the ethics behind embryonic stem cell research are controversial because the criteria of ‘personhood’ is “notoriously unclear.” personhood is defined as the status of being a person, entitled to “moral rights and legal protections” that are higher than living things that are not classified as persons. thus, this issue touches on existential questions such as: when does life begin? and what is the moral status that an embryo possesses? there is a debate on when exactly life begins in embryonic development and when the individual nwigwe, embryonic stem cell research, voices in bioethics, vol. 5 (2019) 2 receives moral status. for example, some may ascribe life starting from the moment of fertilization, others may do so after implantation or the beginning of organ function. however, since the “zygote is genetically identical to the embryo,” which is also genetically identical to the fetus, and, by extension, identical to the baby, inquiring the beginning of personhood can lead to an occurrence of the sorites paradox, also acknowledged as “the paradox of the heap.” the paradox of the heap arises from vague predicates in philosophy. if there is a heap of sand and a grain is taken away from that heap one by one, at what point will it no longer be considered a heap – what classifies it as a heap? the definition of life is similarly arbitrary. when, in the development of a human being, is an embryo considered a person with moral standing? the complexity of the ethics of embryonic stem cell research, like the sorites paradox, demonstrates there is no single, correct way to approach a problem; thus, there may be multiple different solutions that are acceptable. whereas the definition of personhood cannot be completely resolved on a scientific basis, it serves a central role in the religious, political, and ethical differences within the field of embryonic stem cell research. some ethicists attempt to determine what or who is a person by “setting boundaries” (baldwin & capstick, 2007). utilizing a functionalist approach, supporters of embryonic stem cell research argue that to qualify as a person, the individual must possess several indicators of personhood, including capacity, self-awareness, a sense of time, curiosity, and neo-cortical function. proponents argue that a human embryo lacks these criteria, thereby is not considered a person and thus, does not have life and cannot have a moral status. supporters of stem cell research believe a fertilized egg is just a part of another person’s body until the cell mass can survive on its own as a viable human. they further support their argument by noting that stem cell research uses embryonic tissue before its implantation into the uterine wall. researchers invent the term “pre-embryo” to distinguish a pre-implantation state in which the developing cell mass does not have the full respects of an embryo in later stages of embryogenesis to further support embryonic stem cell research. based on this reductionist view of life and personhood, utilitarian advocates argue that the result of the destruction of human embryos to harvest stem cells does not extinguish a life. further, scientists state that any harm done is outweighed by the potential alleviation of the suffering enduring by tremendous numbers of people with varying diseases. this type of reasoning, known as bentham’s hedonic (moral) calculus, suggests that the potential good of treating or researching new cures for ailments such as alzheimer’s disease, parkinson’s disease, certain cancers, etc. outweighs any costs and alleviate the suffering of persons with those aliments. thus, the end goal of stem cell use justifies sacrificing human embryos to produce stem cells, even though expending life is tantamount to murder. opponents of embryonic stem cell research would equate the actions done to destroy the embryos as killing. killing, defined as depriving their victims of life, will therefore reduce their victims to mere means to their own ends. therefore, this argument touches on the question: if through the actions of embryotic stem cell research is “morally indistinguishable from murder?” (outka, 2013). the prohibition of murder extends to human fetuses and embryos considering they are potential human beings. and, because both are innocent, a fetus being aborted and an embryo being disaggregated are direct actions with the intention of killing. violating the prohibition of murder is considered an intolerable end. we should not justify this evil even if it achieves good. under the deontological approach, “whether a situation is good or bad depends on whether the action that brought it about was right or wrong,” hence the ends do not justify the means. therefore, under this feeble utilitarian approach, stem cell research proceeds at the expense of human life than at the expense of personhood. one can reject the asserted utilitarian approach to stem cell research as a reductionist view of life because the argument fails to raise ethical concerns regarding the destruction embryonic life for the possibility of developing treatments to end certain diseases. the utilitarian approach chooses potential benefits of stem nwigwe, embryonic stem cell research, voices in bioethics, vol. 5 (2019) 3 cell research over the physical lives of embryos without regard to the rights an embryo possesses. advocates of embryonic stem cell research claim this will cure diseases but there is a gap in literature that confirms how many diseases these cells can actually cure or treat, what diseases, and how many people will actually benefit. thus, killing human embryos for the potentiality of benefiting sick people is not ethically not ethically permissible. where the argument of personhood is concerned, the development from a fertilized egg (embryo) to a baby is a continuous process. any effort to determine when personhood begins is arbitrary. if a newborn baby is a human, then surely a fetus just before birth is a human; and, if we extend a few moments before that point, we would still have a human, and so on all the way back to the embryo and finally to the zygote. although an embryo does not possess the physiognomies of a person, it will nonetheless become a person and must be granted the respect and dignity of a person. thus, embryotic stem cell research violates the principle of “full human potential,” which states: “every human being […] deserves to be valued according to the full level of human development, not according to the level of development currently achieved.” as technology advances, viability outside the womb inches ever closer to the point of inception, making the efforts to identify where life begins after fertilization ineffectual. to complicate matters, as each technological innovation arrives, stem-cell scientists will have to re-define the start of life as many times as there are new technological developments, an exhausting and never-ending process that would ultimately lead us back to moment of fertilization. because an embryo possesses all the necessary genetic information to develop into a human being, we must categorically state that life begins at the moment of conception. there is a gap in literature that deters the formation of a clear, non-arbitrary indication of personhood between conception and adulthood. considering the lack of a general consensus of when personhood begins, an embryo should be referred to as a person and as morally equivalent to a fully developed human being. having concluded that a human embryo has the moral equivalent of a fully-fledged human being, this field of research clearly violates the amiable rights of personhood, and in doing so discriminates against pre-born persons. dr. eckman asserts that “every human being has a right to be protected from discrimination.” thus, every human, and by extension every embryo, has the right to life and should not be discriminated against for “developmental immaturity.” therefore, the field of embryonic stem cell research infringes upon the rights and moral status of human embryos. b. principle of beneficence in embryonic stem cell research the destruction of human embryos for research is not ethically permissible because the practice violates the principle of beneficence depicted in the belmont report, which outlines the basic ethical principles and guidelines owed to human subjects involved in research. stem cell researchers demonstrate a lack of respect for the autonomy and welfare of the human embryos sacrificed in stem cell research. while supporters of embryonic stem cell research under the utilitarian approach argue the potential benefits of the research, the utilitarian argument however violates the autonomy of the embryo and its human rights, as well as the autonomy of the embryo donors and those that are pro-life. though utilitarian supporters argue on the basis of rights, they exclusively refer to the rights of sick individuals. however, they categorically ignore the rights of embryos that they destroy to obtain potential disease curing stem cells. since an embryo is regarded as a human being with morally obligated rights, the principle of beneficence is violated, and the autonomy and welfare of the embryo is not respected due to the destruction of an embryo in stem cell research. killing embryos to obtain stem cells for research fails to treat embryos as ends in an of themselves. yet, every human ought to be regarded as autonomous with rights that are equal to every other human being. thus, the welfare of the embryo is sacrificed due to lack of consent from the subject. nwigwe, embryonic stem cell research, voices in bioethics, vol. 5 (2019) 4 the principle of beneficence is violated when protecting the reproductive interests of women in infertility treatment, who are dependent on the donations of embryos to end their infertility. due to embryonic stem cell research, these patients’ “prospects of reproductive success may be compromised” because there are fewer embryos accessible for reproductive purposes. the number of embryos necessary to become fully developed and undergo embryonic stem cell research will immensely surpass the number of available frozen embryos in fertility clinic, which also contributes to the lack of embryos available for women struggling with infertility. therefore, the basis of this research violates women’s reproductive autonomy, thus violating the principle of beneficence. it is also significant to consider the autonomy and welfare of the persons involved. the autonomous choice to donate embryos to research necessitates a fully informed, voluntary sanction of the patient(s), which poses difficulty due to the complexity of the human embryonic stem cell research. to use embryos in research, there must be a consensus of agreement from the mother and father whose egg and sperm produced the embryo. thus, there has to be a clear indication between the partners who has the authority or custody of the embryos, as well as any “third party donors” of gametes that could have been used to produce the embryo because these parties’ intentions for those gametes may solely have been for reproductive measures only. because the researchers holding “dispositional authority” over the embryos may exchange cell lines and its derivatives (i.e., genetic material and information) with other researchers, they may misalign interests with the persons whose gametes are encompassed within the embryo. this mismatch of intent raises complications in confidentiality and autonomy. lastly, more ethical complications arise in the research of embryonic stem cells because of the existence viable alternatives that to not destroy human embryos. embryonic stem cells themselves pose as a higher health risk than adult stem cells. embryonic stem cells have a higher risk of causing tumor development in the patient’s body once the cells are implanted due to their abilities to proliferate and differentiate. embryonic stem cells also have a high risk of immunorejection, where a patient’s immune system rejects the stem cells. since the embryonic stem cells are derived from embryos that underwent in vitro fertilization, when implanted in the body, the stem cell’s marker molecules will not be recognized by the patient’s body, resulting in the destruction of the stem cells as a defensive response to protect the body (cahill, 2002). with knowledge of embryonic stem cells having higher complications than the viable adult stem cells continued use of embryonic stem cells violates the principle of beneficence not only for the embryos but for the health and safety of the patients treated with stem cells. several adult stem cell lines (“undifferentiated cells found throughout the body”) exist and are widely used cell research. the use of adult stem cells represents research that does not treat human beings as means to themselves, thus, complying with the principle of beneficence. this preferable alternative considers the moral obligation to discover treatments, and cures for life threating diseases while avoiding embryo destruction. conclusion it is not ethically permissible to destroy human embryonic life for medical progress due to the violations of personhood and human research tenets outlined in the belmont report. it is significant to understand the ethical implications of this research in order to respect the autonomy, welfare, beneficence, and basic humanity afforded to all parties involved. although embryonic stem cell research can potentially provide new medical advancements to those in need, the harms outweigh the potential, yet ill-defined benefits. there are adult stem cell alternatives with equivalent viability that avoid sacrificing embryos. as society further progresses, humans must be cautious of compromising moral principles that human beings are naturally entitled to for scientific advancements. there are ethical boundaries that are crossed when natural nwigwe, embryonic stem cell research, voices in bioethics, vol. 5 (2019) 5 processes of life are altered or manipulated. though there are potential benefits to stem cell research, these actions are morally and ethically questionable. thus, it is significant to uphold ethical standards when practicing research to protect the value of human life. references shamblott, m. j., j. axelman, s. wang, e. m. bugg, j. w. littlefield, p. j. donovan, p. d. blumenthal, g. r. huggins, and j. d. gearhart. “derivation of pluripotent stem cells from cultured human primordial germ cells.” proceedings of the national academy of sciences 95, no. 23 (november 10, 1998): 13726–31. doi:10.1073/pnas.95.23.13726. national institutes of health, u.s. department of health and human services. “stem cell basics i.” stem cell information, 2016. https://stemcells.nih.gov/info/basics/1.htm. kitwood, thomas marris., clive baldwin, and andrea capstick. tom kitwood on dementia: a reader and critical commentary. maidenhead, berkshire: mcgraw-hill/open university press, 2007. university of michigan. “stem cell research: frequently asked questions,” 2013. http://www.stemcellresearch.umich.edu/overview/faq.html#section2. eurostemcell. “origins, ethics and embryos: the sources of human embryonic stem cells,” 2016. https://www.eurostemcell.org/origins-ethics-and-embryos-sources-human-embryonic-stem-cells. perry, david l. “some issues in contemporary neurological science and technology,” 2011. https://www.scu.edu/ethics/focus-areas/bioethics/resources/ethics-and-personhood/. swirsky, e. “week fourteen unit: minute paper 5 [blackboard assignment],” 2018. o’mathúna, dp. “personhood in bioethics and biomedical research.” research practitioner 7 (2006): 167–74. grobstein, c. “external human fertilization.” scientific american 240, no. 6 (june 1979): 57–67. mastin, l. “deontology,” 2009. https://www.philosophybasics.com/branch_deontology.html. spitzer, robert. “introduction and principles of ethics.” in ten universal principles: a brief philosophy of the life issues, xi– xii, 1-3, 20-29. san fransisco, ca: ignatius press, 2011. https://www.catholiceducation.org/en/religion-andphilosophy/philosophy/introduction-amp-principles-of-ethics.html. eckman, jim. “human embryonic stem cell research.” issues in perspective, 2011. https://graceuniversity.edu/iip/2011/05/14-2/.; eckman, jim. “the devaluing of life in america.” issues in perspective, 2015. https://graceuniversity.edu/iip/2015/09/the-devaluing-of-life-in-america/. https://stemcells.nih.gov/info/basics/1.htm http://www.stemcellresearch.umich.edu/overview/faq.html#section2 https://www.eurostemcell.org/origins-ethics-and-embryos-sources-human-embryonic-stem-cells https://www.scu.edu/ethics/focus-areas/bioethics/resources/ethics-and-personhood/ https://www.philosophybasics.com/branch_deontology.html https://www.catholiceducation.org/en/religion-and-philosophy/philosophy/introduction-amp-principles-of-ethics.html https://www.catholiceducation.org/en/religion-and-philosophy/philosophy/introduction-amp-principles-of-ethics.html https://graceuniversity.edu/iip/2011/05/14-2/ https://graceuniversity.edu/iip/2015/09/the-devaluing-of-life-in-america/ mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) © 2014 william mccabe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethical problems of gestational surrogacy in india william mccabe keywords: medical tourism, surrogacy, india cross border reproductive care, like medical tourism, is where potential parents travel from their home country to a country which will provide them with access to medical care, in this instance, gestational surrogacy. india has developed into a veritable mecca for cross border reproductive care, particularly gestational surrogacy. this paper will limit its discussion of cross border reproductive care to gestational surrogacy addressing the complex ethical issues it presents. in the first part of the paper i will provide background information regarding gestational surrogacy in india. the information covered will provide the reader with context for the argument that follows. the second part of the paper will discuss whether there is a positive right to procreative assistance for the commissioning mother. in the third part of the paper i will discuss the ethical issues confronting the potential surrogate mother. lastly, in the fourth part of the paper i will discuss the ethics of gestational surrogacy as they relate to the best interests of the child, and how the child’s interests may serve as a limiting step in going forward with gestational surrogacy. i will discuss how the ethical principles associated with each participant in the gestational surrogacy relationship will conflict and a balancing test is needed to determine whether gestational surrogacy is ethically supportable. surrogacy occurs when a woman agrees to gestate a baby for another couple or individual. gestational surrogacy occurs when a gestational carrier agrees to have an embryo implanted in her uterus conceived via in vitro fertilization, carries it to term, and delivers the baby. gestational surrogacy can be altruistic or commercial. where the commissioning party lacks ova, a third party may provide ova. the gestational carrier may not provide ova to prevent a claim to the child by the gestational carrier at the time of delivery. mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) 2 gestational surrogacy became popular in india due to advances in reproductive medicine, a large pool of impoverished women, and low cost compared to countries such as the united states, canada, and australia. reproductive tourism in india alone is "valued at more than $450 million a year" and was forecast by the indian council of medical research (icmr) to be a $ 6 billion a year market in 2008. according to kpmg's life sciences wing, the fertility industry in india is today worth rs 750 crores. surrogacy, which forms roughly seven per cent of that, stands at around rs 54 crores. as estimated by the confederation of indian industry (cii) india generates around $2.3 billion a year from fertility tourism. cii also reveals that nearly 10,000 foreign couples visit india for reproductive services and nearly 30 per cent are either single or homosexual.[i] reproductive medicine in general and surrogacy in particular raise the question whether there is a fundamental right to procreate. procreative rights have been defined as the right to initiate a pregnancy and bring children into the world, as distinguished from reproductive rights which concern the timing and manner in which one reproduces.[ii] the right to procreate involves a dual set of rights inquiries. these rights have been identified as negative (liberty) and positive (entitlement) rights claims.[iii] a negative right is a right of forbearance, such as the right to privacy which derives from the right to be let alone.[iv] negative rights include the right to bodily integrity, the right to not be touched in any manner without permission, and the right to choose one’s own beliefs and have been extended to preclude government interference as long as the scope of the exercise of one’s liberty does not infringe upon the liberty of others. positive rights have been defined as rights to assistance, resources and entitlement.[v] positive rights claims in gestational surrogacy are complicated because they implicate negative rights claims as a condition precedent. in order to exercise ones right to procreate people need to be free from interference described above in order to exercise their right to entitlement, in this discussion the right to travel to india to engage a gestational surrogate. the right to procreate has been deemed a fundamental right within the conception of the negative right or liberty to choose to bring a child into the world free of interference. the exercise of a liberty right is distinct from exercising a perceived right to assistance or entitlement. it is one issue to be free from encumbrances to reproduce via coitus, and another to seek the need of the medical profession, and surrogate to bring a child into the world. i argue procreative rights include the right to be left alone and maintain bodily integrity in choosing in a consensual manner to conceive a child but there is no fundamental right to seek out infertility treatment and gestational surrogacy. while there is a general right to receive assistance to in vitro fertilization there is no specific right held by anyone. this is consistent with the reasoning that the right of procreation is necessary for maintenance of the species, but does not apply to anyone specifically. in other words, the species will continue provided some but not all people reproduce. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn2 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn3 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn4 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn5 mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) 3 it may be argued that achieving parenthood via surrogacy respects the autonomy of the person seeking to become a parent, and helping them achieve that goal is beneficent. further, it may be argued as a matter of social justice people, because of their lack of access to the contents of conception, either due to medical infertility, sexuality, or being single should not be precluded from having a child. this is not a one sided analysis, however, because the rights of the surrogate and child require consideration. in india, gestational surrogacy is legal as it is in california, ukraine and czech republic. it is illegal in much of the united states, england, and australia, which recognizes only altruistic surrogacy. italy, france, sweden, norway, and germany do not recognize any manner of surrogacy agreements.[vi] the gestational surrogate pool in india is comprised of uneducated women from poor rural backgrounds.[vii] the decision to be a gestational surrogate is borne from the need to provide financial assistance to their families primarily, and secondarily as an act of altruism. surrogates are warehoused in communities created solely for surrogate mothers during their pregnancy. there is a social stigma associated with surrogacy in india so maintaining surrogates in a distinct community separate from indian society serves to protect the surrogate pool from public backlash. it has been reported these women bond and feel supported by each other during their time in these facilities. this is an incidental finding that can be expected when people share similar circumstances of physical and emotional isolation. often women agree to become surrogates because of coercion from middlemen who operate on the internet working in conjunction with infertility clinics. also, they may be compelled to become a surrogate by their husbands by their husbands or other male relatives. women’s independence in india is suspect in a large portion of the country. women are still subject to following the directives of their husbands. since surrogacy arrangements are either not recognized or illegal in several countries around the globe it is necessary to consider the country of origins laws regarding surrogacy. normally, a sovereign nation does not have to consider the laws of other nations regarding commerce within its borders. however, where the country is putting products into the stream of commerce, and in this case the product is a human infant, it is necessary to consider the laws of the country of origin for the commissioning party. the laws of the country of origin require consideration because the child may bear the burden of an illegal or unrecognized act which would leave them in limbo. the child produced as a result of the surrogacy agreement may be required to stay in india, either with the gestational carrier if she agrees, or be placed in an orphanage in india. the same may occur in the country of origin where children have been removed from their parents when it is believed their existence is the result of a gestational surrogacy. india does not want to bear the burden of increasing numbers of children, conceived via surrogacy, and not granted visas to return to their parents’ country of origin. the country of origin does not wish to bear the burden of raising a child whose existence is offensive to their laws, and may deny these children citizenship which occurred in france. france has banned surrogacy since 1991.[viii] the mennesson case arose in california when french consular officials in los angeles became suspicious the mennessons engaged a gestational surrogate while in the united states.[ix] the children conceived as a result of a gestational carrier https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn6 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn9 mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) 4 in california were denied french citizenship, and the parent’s were unable to adopt their children under french law. surrogacy is legal in california, as it is in india, so the case provides notice to policy makers in india too. if the children were not granted visas to return to france, then california may have borne the burden of rasing these children in the social welfare system. the same would be true for india, where it would be unlikely for a child conceived via surrogacy to remain with the gestational carrier. as discussed above gestational surrogacy bears substantial social stigma, and the child would not look like the gestational carrier. rather than deal with the social stigma the gestational carrier would leave the child in an orphanage. india and other countries may find laws similar to frances repugnant as violating human rights. unfortunately, they are laws promulgated by the legislature of a sovereign nation, and therefore require recognition. failure to draft policy in india considering the laws of the commissioning party’s country of origin theoretically could create a human rights crisis when infants are conceived, borne, and left to live in dire poverty because their parent(s) cannot return home with them. some may see the commissioning party’s circumvention of such laws worthy of praise as civil disobedience, but this view cannot be supported when a child may be banished to poverty because of their actions. does a right to procreate exist? yes, but only in its negative right, that is, a person’s right to be left alone. advances in science, such as assistive reproductive technology, may result in overall benefit to society, but do not confer a right to benefit from those advances on any individual. therefore, a party may seek to engage in assistive reproductive technology, such as in gestational surrogacy, but there is no right to it. this is consistent with the reasoning behind the right to an abortion in the united states. in the united states, a woman has a right to an abortion in accord with her right to privacy. the right to an abortion is a right of forbearance by the government in preventing her from seeking medical care. further, while a woman’s right to an abortion exists, there is no right of positive assistance by the government for the woman to obtain an abortion. when a party seeks to engage in assistive reproductive technology such as in vitro fertilization and gestational surrogacy we are confronted by a conflict in ethical principles. as i have argued, a party may seek out a gestational carrier, but has no fundamental right to one. since there is no fundamental right to gestational surrogacy, the autonomy of the commissioning party and the potential surrogate are in conflict. we respect the autonomy of the commissioning party to seek out a gestational surrogate to bear them a child. we do not respect their autonomous decision to engage a surrogate when their autonomy infringes upon the autonomy of the surrogate. the surrogate has a fundamental right to be left alone. when a fundamental right is infringed upon by another’s actions those actions must yield to the fundamental right. regarding surrogacy in india we need to determine whether surrogacy contracts respect the autonomy of the potential surrogate. when women agree to enter into surrogacy contracts they do so in order to benefit their families.[x] additionally, the informed consent process is limited or non-existent. potential surrogates are not informed of the potential risks related to the hormones they are required to take in connection with preparing their womb to receive the fertilized embryo. nor are they informed of the potential risks associated with pregnancy itself. while the financial windfall to the potential surrogate and her family may be seen as respecting her autonomy, i believe it is an undue inducement at best, and coercive at worst. further, it has been reported clinics in india pay the surrogate by trimester, and even withhold the funds after the child has https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn10 mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) 5 been delivered. the clinics justify this stating they are safeguarding the surrogate’s money from her husband who may go on a drinking binge or other men in her family who simply may take the money. another likely reason is the clinics keep the money for themselves.[xi] many women in india are still considered subordinate to men. the social context of a woman’s agreement to become a surrogate in india is also very important in assessing whether a women’s decision to become a surrogate in india is a true exercise of her autonomy or a result of her subordinate position as a woman in indian society. if all the factors discussed above are true woman entering into a surrogacy agreement are likely the result of undue influence of coercion. the above analysis leads me into a discussion into whether contract law can be equitably applied in surrogate contracts in india. contract law requires that for a contract to be valid there must be a “meeting of the minds.” in other words the parties to the contract must be on equal footing, and understand the terms of the contract in order for it to be valid. for the reasons stated above, generally the surrogate mother lacks the education to understand the complex terms of a contract. absent legal assistance there can be no meeting of the minds and the contract is void as unconscionable. the most unequal party in the surrogacy contract is the child resulting from it. it will be argued that the unconceived child has no rights to enter or refuse to enter a surrogacy contract. as a matter of social justice their potential existence must be considered when forming the contract. would a proxy for the child at the time of contract ameliorate this problem? it is unlikely, because the resulting child would be subject to the laws of the country of origin of the commissioning party. only, if the proxy acts in accord with the laws of the country of origin will these issues be resolved. namely, where the country of origin does not recognize surrogacy, or where it holds surrogacy illegal, the proxy must argue against conception. this would be an unusual argument to makeagainst life. does a potential child have the right to argue against life and remain a non-being? probably not but it presents us with a question as to whether using a rights approach is correct in this consideration. perhaps, a social justice approach best serves the needs of a potential child during a contract negotiation where the potential child is represented by a proxy. social justice demands the contracting parties to reasonably consider the potential outcomes of the contract. from a social justice perspective the contracting parties would have to agree the potential child receive reasonable assurances that he/she will be able to reside in the commissioning party’s country of origin; he/she will be considered the child of the commissioning party upon return home; that surrogacy is either legal or formally recognized in the country of origin; he/she will receive the benefit of reasonable parenting and medical care until the age of majority; should the commissioning party die prematurely monies exist for the support of the child and placement with a family member, preferably, is available; and should the commissioning party die while the potential child is in utero the gestational carrier will receive financial support for raising the child to the age of majority. therefore, the proxy would have to use a best interest of the child standard to ensure the most reasonable outcome for the potential child. many would disagree with this position for a couple of reasons. first, potential children typically have not rights. comparing a potential child’s rights to a commissioning party’s right to contract, the commissioning party’s right to contract carries the analysis. second, assuming arguendo that potential children have rights, these conditions present an unsurpassable barrier to forming a contract. i argue this is the high barrier that https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn11 mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) 6 must be set. the parties are not contracting to build widgets but human beings. laws regulating surrogacy contracts should be drafted using the enumerated social justice concerns as conditions to be met in the formation of a valid contract.. where states such as india permit parties to seek out assistive reproductive technology and surrogacy, the opportunity to do so is not a fundamental right and should be highly regulated to reflect this distinction. india is currently receiving substantial income from its assistive reproductive technology market, and as a result needs to step in and regulate this emerging market. they cannot equate bringing children into the world with other technology markets in the country. tight regulatory oversight, it is argued, will reduce profits. this may be true, and it should be supported by the government where the subject of the market is human life. the parties traveling to india are not exercising a fundamental right but seeking to act autonomously for their own end despite the adverse effects their autonomous actions may have on potential surrogates, and potential children. in conclusion, the right to procreate rests in the fundamental right to be left alone to choose whether to bring children into the world. the right to procreate does not consist of positive steps parties may take to have children when confronted by either infertility, or when they lack an aspect of the contents required for conception. the autonomous decision to seek out assistive reproductive technology and gestational surrogacy is unethical when it infringes upon a potential surrogates fundamental procreative right. the right to contract is a separate right distinct from the right to procreate. when a potential surrogate has not received or unable to understand the material information her autonomy is infringed upon. further, her autonomy is probably infringed upon simply as a result of her gender subordinating her to her male counterparts. the resulting contract is both unethical and void as a matter of law. there cannot be a “meeting of the minds.” the potential child which is the subject of the contract does not have rights as a matter of contract law. therefore, surrogacy contract negotiations should include a proxy for the potential child. this is consistent with a social justice approach because it seeks to prevent harm to the future child as well as indian society. it is incumbent upon india to ensure the well-being of the child resulting from the contract. india cannot to afford to bear the burden of raising children conceived by in vitro fertilization, and born as the result of a surrogacy contract. its profits would diminish if they had to bear the burden of raising children in state run facilities. they would also receive the brunt of international backlash if it is determined the surrogates themselves were manipulated into surrogacy, and the children born as a result were neglected, abused, or died. this is not a market where india should allow profits to drive the market. gestational surrogacy became popular in india due to advances in reproductive medicine, a large pool of impoverished women, and low cost. it remains largely unregulated, and as a result, large numbers of commissioning parties travel to india to take advantage of the open market. india has contemplated assistive reproduction technology legislation since 2008. its continued failure to pass legislation regulating the market demeans the sanctity of life by allowing the market to dictate that life may be created for the right price. mccabe, gestational surrogacy in india, voices in bioethics, vol. 1 (2014) 7 references [i] pushkar, p.; surrogacy in india: shedding its secrecy, new pro healthcare, nov. 2013 [ii] l. shanner; the right to procreate: when rights claims have gone wrong; 40 mcgill l.j. 823 1994-1995 [iii] id [iv] id at 2 pg 839 [v] id at 2 pg 840 [vi] saxena, p.; mishra, a.; malik, s.; surrogacy: ethical and legal issues; indian journal of community medicine, vol. 37, issue 4, october 2012 [vii] id [viii] i. glenn cohen, editor; the globalization of health care: legal and ethical issues; oxford university press, 2013, pps. 133-134 [ix] id [x] vora, k.; potential, risk, and return in transnational indian gestational surrogacy; k,icurrent anthropology, vol. 54, no. s7, potentiality and humanness: revisiting the anthropological object in contemporary biomedicine (october 2013), pp. s97-s106 [xi] id this work is licensed under a creative commons attribution 4.0 international license. how to cite mccabe, w. (2014). ethical problems of gestational surrogacy in india. voices in bioethics, 1. retrieved from https://journals.library.columbia.edu/index.php/bioethics/article/view/6471 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_ednref1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn2 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn3 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn4 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn5 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn6 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn9 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_edn10 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/ethical-problems-of-gestational-surrogacy-in-india#_ednref11 https://creativecommons.org/licenses/by/4.0/ https://library.columbia.edu/ https://library.columbia.edu/ https://creativecommons.org/licenses/by/4.0/ ringel, trap laws and their impact on women's health, voices in bioethics, vol. 1 (2014-15) * lillian ringel, ms bioethics © 2014 lillian ringel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. trap laws and their impact on women's health lillian ringel* keywords: trap, bioethics, ethics, abortion introduction eyal press, in the february 3, 2014 edition of the new yorker, wrote an expose on steven brigham, a physician and graduate of columbia university medical school, whose abortion clinics have been implicated in a string of patient injuries – both physical and psychological – and botched abortions. brigham has been and is now the subject of licensure status inquiries and/or revocation proceedings in new york, new jersey, pennsylvania, and maryland. brigham’s stated motive for opening up shoddy clinics was to provide an option for women (especially for minorities and the indigent) who would otherwise have had little to no resources to exercise their right to terminate. analysis women are subjected to an inconsistent patchwork of state laws and constant limitation by state legislatures creating trap (or, targeted regulation of abortion providers) laws. the diminishing availability of abortion in the united states has not only made safe, legal abortion ever more difficult to access (especially for those with limited or no means), but has left a dangerous, gaping hole where brigham – well-meaning or not – was able to establish his presence. trap laws limit abortions by unnecessarily regulating anything from where (e.g. the kind of building in which) abortions can be performed, to regulating the people who work in the office themselves (e.g. personnel regulations), to charging astronomically high fees to register a clinic within a state. these laws do little to veil their true purpose of making it nearly impossible for an abortion provider to do his or her job. conclusion the vacuum that patchwork state laws and trap laws create makes room for ill-qualified providers by ringel, trap laws and their impact on women's health, voices in bioethics, vol. 1 (2014-15) 2 discouraging other ob/gyns from incorporating abortion into their practices. whatever brigham’s motives, his clinics have harmed both women and families, and fuel anti-choice support for trap laws. back alley clinics add fuel to the fire for those who argue that government should enter women’s bodies. references eyal press, a botched operation, the new yorker (february 3, 2014), available at http://www.newyorker.com/reporting/2014/02/03/140203fa_fact_press http://www.newyorker.com/reporting/2014/02/03/140203fa_fact_press anekwe, emanuel and matisse, voices in bioethics, vol. 1 (2014-15) © 2015 obiora n. anekwe this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. emanuel and matisse: two distinct perspectives on aging obiora n. anekwe after reading ezekiel j. emanuel’s “why i hope to die at 75” in the atlantic (october 2014), i could not help but think about how the few and privileged have countless opportunities to fulfill their lifetime goals and aspirations, often left with a choice as to when and how they may end their life. emanuel is only able to feel that living too long is a loss or that by 75 his life will be complete because he has been lucky enough to be afforded a choice. for him it’s easy to see old age simply as a time where we are deprived of creativity and intelligence – to say that what comes after ultimately amounts to nothing is indicative of the assumption that everyone has access to the same resources and social capital. in reality, most people are left with little to no choice in rapidly navigating through their age in order to fulfill their destiny. although emanuel may feel that he would prefer to live until age 75, most people do not have the privilege to decide because of racial, wealth, gender, class, economic, educational, and religious inequalities. life simply gets in the way. they have families to feed and bills to pay. unfortunately for most, the achievements in which emanuel references in his own life’s journey are few and far between. it can take a lifetime to achieve a goal for people without access to opportunity, despite hard work and effort. emanuel’s perspective on aging is also troubling because life can and should be fulfilling at every stage. his perspective may be unfairly influenced by medicine’s several failures, failures he has witnessed firsthand in the hospital. however, after learning about the life and art of henri matisse i found a different perspective on aging. in matisse’s later life it’s easy to see that not all is right with emanuel’s stance. henri matisse is considered by many art critics as one of the greatest visual artists of his generation. he was an innovator, most famous for the “cut-outs” he created later in life that highlighted the array and spectrum of life’s ups and downs. matisse’s inspiration for these pieces came during the 1940s when his own life was turned upside down. he was diagnosed with abdominal cancer and then left wheelchairbound after his operation. he used this newfound physical challenge as a means to re-discover his love for cut-outs. as his surgery had left him debilitated, bound to his wheel chair and bed, painting and sculpture became more of a physical challenge. so, matisse, ever so the creative genius, sought to reinvent himself by turning to cut-outs. cut-outs are created by painting paper and cutting them into figurative forms before pasting or nailing the pieces on paper, canvas, or another palette. ultimately, cut-outs were a simple and sensible solution: sheets of paper paint-washed by assistants, large sturdy scissors, and plain tailor pins were far more manageable materials and tools. yet, what he managed to create was just as elaborate and beautiful as any of his prior work. for a man invigorated by the process of making art for art’s sake cut-outs became a kind of physical therapy as well as his trademark until his death at 84 in november of 1954. the exhibition henri matisse: the cut-outs, which ran at the modern museum of modern art from october 12, 2014 till february 10, 2015, reflected matisse’s renewed interest in form and color, but most http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d071228748e3aacbe045d0/1473278242030/?format=original http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d071228748e3aacbe045d0/1473278242030/?format=original anekwe, emanuel and matisse, voices in bioethics, vol. 1 (2014-15) 2 strikingly, his commitment to art during his years as a seasoned forerunner and elder in the modern art movement. most art critics believe matisse’s psychological relief at having survived mortal crises was the cause of the creative rush he went through in his later years. the legacy he left after passing continues to influence modern artists, its greatest takeaway that vigor and passion for art is ageless. what is meant by a fulfilling life? what does such a life consist of? does achievement have a time limit? i tend to see the life matisse lived as my plausible frame of reference. through his latest exhibition, matisse moves us to think and explore without limit, no matter our age or status. he directly challenges emanuel’s belief that past 75 we lose our chance at creativity and success. at the age of 40, my greatest desire is to light a flame of hope within myself so that my experiences, education, and talents can all be used in a meaningful way in order to transform society. it is my profound belief that we are never limited by who we are now or what others may perceive us to be. we are only limited by what we perceive of ourselves. for me, matisse will always represent timeless, unlimited creativity, and beauty. the dignity he displayed, even at his seasoned age as a master artist, has reminded me that our best is yet to be. ____________________________________________________________ klugman, et al., a survey of rural ethics teaching, voices in bioethics, vol. 1 (2014) © 2014 cr klugman, w.a. nelson, l.l. anderson-shaw, j.a. gelfond. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a survey of rural ethics teaching in north american allopathic and osteopathic medical schools cr klugman, w.a. nelson, l.l. anderson-shaw, j.a. gelfond keywords: rural ethics, teaching medical school introduction in 2010, the world health organization (who) released increasing access to health workers in remote and rural areas through improved retention: global policy recommendations, a report on strategies for increasing and retaining health care workers in rural regions. the report states that while 50 percent of the world’s population lives in rural areas, only 38% of the nursing and less than 25% of the physician workforce serves these regions. for the united states, the who states that 20% of the population lives in rural regions and only 9% of registered physicians practice in such areas. among the solutions the who offers is contextualizing medical education. in other words, medical students should be drawn from rural populations, trained through rural community experiences, and taught using rural health specific situations: “revise undergraduate and postgraduate curricula to include rural health topics so as to enhance the competencies of health professionals working in rural areas, thereby increase their job satisfaction and retention” (who 2010, 3; barrett, lipsky, and lutfiyya 2011). this, strategy suggests physician success and satisfaction in rural practice requires training using rural-specific cases, knowledge, and experience. in parallel to the need to increase rural clinical experience, there is a need to better understand the unique ethical issues that arise in the rural environment. a growing rural ethics literature points to an emerging awareness of klugman, et al., a survey of rural ethics teaching, voices in bioethics, vol. 1 (2014) 2 the special ethical considerations inherent to clinical practice in these closely-knit, tightly interdependent small communities, as well as the need to develop ethical resources for these providers. according to nelson, et. al. the “rural context significantly impacts the common health care ethical conflicts including confidentiality, boundary issues, shared decision-making, professional-patient relationship, and allocation of resources for a significant portion of our population” (nelson et al. 2006, 45). for example, there may be unique challenges to patient privacy when patients are also the physician’s neighbors, friends, children’s teachers, and relatives (klugman and dalinis 2008; nelson 2010; nelson 2010; nelson, greene, and west 2010; nelson and schmidek 2008). in the encyclopedia of bioethics, dan callahan wrote that bioethics has evolved into four areas of general inquiry including what he calls cultural bioethics, which, “refers to the effort systematically to relate bioethics to the historical, ideological, culture and social context in which it is expressed” (callahan 2004). john hardwig has also asserted that mainstream bioethics is focused on urban issues (hardwig 2006). in the last decade, a cultural bioethics subfield of “urban bioethics” has emerged that proposes “life-density, diversity, and disparity” create unique ethical challenges (fleischman, levin, and meekin 2001),(blustein and fleischman 2004). in recognizing that there exists an urban bioethics that focuses on problems of population density, then there must also exist a correlative cultural bioethics of rurality that reflects a low-density population, agricultural culture, and a lack of needed health care resources. “to date, there exists a limited focus on rural healthcare ethics shown by the scarcity of rural healthcare ethics literature, rural ethics committees, rural focused ethics training and research on rural ethics issues” (nelson et al. 2007). for instance, a national study noted that 40% of critical access hospitals do not have ethics committees to assist rural clinicians with ethics conflicts compared to almost 100% of hospitals with over 400 beds (fox, myers, and pearlman 2007; nelson et al. 2010). while nelson et. al. have made a call for increased training in ethical issues in rural contexts, there is no information available regarding whether physician education programs currently teach in this area (nelson et al. 2007). to empirically assess the prevalence of rural medical and ethics education for medical and osteopathic students, the researchers constructed a comprehensive survey. methods the rural medical ethics information survey employed yes/no, multiple choice, and fill-in-the-blank questions drawn from the literature and from recommendations by the rural health care ethics working group – a group of rural medical educators and ethicists. the university of texas health science center san antonio institutional review board determined the survey to be exempt in june 2010. in fall 2010, the researchers sent a recruitment email to all 133 u.s. member schools of the association of american medical colleges (aamc), and all 26 members of the american association of colleges of osteopathic medicine (aacom). the emails were directed to the senior medical/osteopathic education official at each institution, asking them to either complete a survey on surveymonkey or to forward the klugman, et al., a survey of rural ethics teaching, voices in bioethics, vol. 1 (2014) 3 survey link to someone within the organization who could appropriately respond (surveymonkey 2011). for schools that did not complete the survey, an email reminder was sent 3 weeks later. for schools that still did not complete the survey, a third email reminder was sent 4 weeks after that. the researchers asked whether the school had a required or elective rural experience and the form of that experience. the officials were also queried as to whether they offered training specifically in rural health care ethics. other information collected included demographics such as number of students in the student body, percentage of students originally from rural areas, the zip code of the school, and its self-identified distance from an urban center (i.e. the “rurality” of the location). the mainly descriptive statistical analysis was performed with exploratory tests of association. binary responses (yes/no items) were summarized by proportions, and their 95% confidence intervals (cis) were constructed with the exact binomial method. these cis can be constructed when there is no variation in the response (all yes or all no) and are conservative for small sample sizes especially in the finite population setting. the cis for differences in proportion were based upon asymptotic assumptions. non-responses were considered to be “no.” associations between binary and unordered categorical responses were tested using fisher’s exact method. associations with ordered categorical responses (distance to urban) were tested using a permutation-based method (h. and c. 1999). associations between binary outcomes and continuous variables (% rural residency) were tested using logistic regression. correlations between continuous variables were tested with the spearman rank correlation test. the level of significance was chosen to be p = .05 with 2-sided alternatives. we conducted the analysis with the r statistical software(r development core team 2006) and the “coin” r package (hothorn et al. 2008). the authors created the summary tables with sas software (sas institute inc 2008). results of the 159 schools surveyed, 124 completed the questionnaire (70.4% response rate). of those, 16 identified as osteopathic schools (do), 62 as allopathic (md) and 46 did not offer a disciplinary identity. the researchers asked schools to classify their geographic location. fifty-nine (47.6 %) indicated an urban location (0-5 miles from urban core), 3 (2.4 %) as suburban (6-20 miles from urban core), 3 (2.4 %) as exurban (21-50 miles from urban core), 8 (6.5 %) as rural (51 or more miles from urban core) and 51 (41.0 %) did not respond to this question. since 73 schools also reported their zip code, this information was used to identify the schools rural urban commuting area code (ruca) classification (united states department of agriculture economic research service 2005). of these 73 schools, the mean ruca code was 1.1 with a standard deviation of 0.5, meaning high-density development. klugman, et al., a survey of rural ethics teaching, voices in bioethics, vol. 1 (2014) 4 as table 1 demonstrates, the researchers asked schools if they require a rural experience of all students. thirty-two schools (29.4%) indicated that they had such a requirement. additionally, many schools offer rural education tracks that may be required only of a specific subset of students. some of these specialty tracks only accept students from rural areas while other tracks are intended for students who plan to practice in rural regions. six schools (12.5%) require a rural experience only for students in these specialty programs. sixty-two schools (61.4%) offer some form of an elective rural experience for their students. schools that had required a rural educational experience for all or some of their students often also offer a rural elective experience, thus the categories are not mutually exclusive. only 7 (21.9%) of the 32 schools that require a rural experience for all students also teach rural health care ethics. table 2 indicates that only 25 of the 32 schools with required rural experience answered this question. in the 6 schools with a rural specialty track, 4 (66.7%) teach rural health care ethics. in regards to the 64 schools with a rural elective, only 24 responded to the question, “does your elective program in rural medicine include rural-focused ethical issues?” eleven of those 24 (45.8%) indicated that they teach rural health care ethics. discussion less than 1/3 of schools require a rural experience of all students. of those, only 1 in 5 offer a rural ethics curriculum. of the 61.4% of schools that offer a rural elective, 17.7% of those offer training in rural ethics issues. however, in schools where a rural experience was required of a subset of students, 61.4% of those schools required rural health care ethics. thus, schools that require ethics experiences of a subset of students may be more likely to have rural ethics training because of their focused mission. or since these schools have a larger draw from rural areas, those students may demand the rural ethics focus in their training. in looking at the effect of geographic location on rural ethics teaching, the authors initially planned to rely on ruca codes, which are created by the federal government to map areas of urbanity and rurality. however, although 8 schools self-identified as rural (defined on the survey as more than 50 miles from an urban center), the median 1.1 ruca code for all schools shows that the self-report and the ruca codes did not always match. for example, the geisel medical school at dartmouth is located 125 miles from boston in a pastoral area of new hampshire. the population density for the town of hanover, nh is 1,792 people per square mile meaning that the ruca code is 1, or urban, while the average density for new hampshire is 146.8 (ruca codes 7 to 10). the presence of a medical school requires a certain density of people that may give the area an urban ruca code even though the setting is rural. therefore, ruca codes were not useful in looking at geographic location of a medical school and the researchers relied more on selfreports, a less objective measure. klugman, et al., a survey of rural ethics teaching, voices in bioethics, vol. 1 (2014) 5 the authors note several limitations and insights regarding this study. many schools skipped large sections of the survey. for instance, nearly 41% of all respondents did not indicate their zip code. the survey may have been too detailed, requiring too much time for a senior education officer to complete. additionally, few schools answered questions about hours of instruction, percent of students hailing from rural areas, and percent of graduates who go to residency in rural regions. those that did answer often indicated they were making guesses, raising questions of the validity of those responses and thus they were excluded from analysis. conclusion the survey results provide an enhanced understanding of the limited rural focused medical training programs in the united states. the survey results also indicate how rural ethics issues do not receive a great deal of attention in medical education. both of these may contribute to the minority of graduating students choosing to practice in rural settings. the authors believe that following the world health organization’s goal of increasing rural health care workforce requires medical training experiences in rural settings including attending to the ethical challenges faced by physicians practicing in such geographic locations and cultural spaces. drawing on callahan’s perception of the importance of cultural bioethics, rural bioethics should be part of rural practice experience and medical school curricula, to give students the information and skills needed in rural settings. barrett, f. a., m. s. lipsky, and m. n. lutfiyya. 2011. the impact of rural training experiences on medical students: a critical review. academic medicine : journal of the association of american medical colleges 86 (2):259-63. blustein, j., and a. r. fleischman. 2004. urban bioethics: adapting bioethics to the urban context. academic medicine : journal of the association of american medical colleges 79 (12):1198-202. callaghan, daniel. 2004. bioethics. in encyclopedia of bioethics, edited by s. g. post. new york: macmillan reference. fleischman, a. r., b. w. levin, and s. a. meekin. 2001. bioethics in the urban context. journal of urban health : bulletin of the new york academy of medicine 78 (1):2-6. fox, e., s. myers, and r. a. pearlman. 2007. ethics consultation in united states hospita ls: a national survey. the american journal of bioethics : ajob 7 (2):13-25. h., strasser, and weber c. 1999. on the asymptotic theory of permutation statistics. mathematical methods of statistics 8:220-250. hardwig, j. 2006. rural health care ethics: what assumptions and attitudes should drive the research? the american journal of bioethics : ajob 6 (2):53-4. hothorn, torsten, kurt hornik, mark a. van de wiel, and achim zeileis. 2008. implementing a class of permutation tests: the coin package. journal of statistical software 28 (8):1-23. klugman, craig m., and pamela m. dalinis, eds. 2008. ethical issues in rural health care. baltimore: the johns hopkins university press. klugman, et al., a survey of rural ethics teaching, voices in bioethics, vol. 1 (2014) 6 nelson, w. a. 2010. health care ethics and rural life. stigma, privacy, boundary conflicts raise concerns. health progress 91 (5):50-4. nelson, w. a., m. a. greene, and a. west. 2010. rural health care ethics: no longer the forgotten quarter of medical ethics. cambridge quarterly for healthcare ethics 19 (4):510-517. nelson, w. a., m. c. rosenberg, t. mackenzie, and w. b. weeks. 2010. the presence of ethics programs in critical access hospitals. health care ethics committee forum 22 (4):267-74. nelson, w. a., and j. m. schmidek. 2008. 'rural health care ethics. in the cambridge textbook of bioethics, edited by p. a. singer. cambridge, uk: cambridge university press. nelson, w., g. lushkov, a. pomerantz, and w. b. weeks. 2006. rural health care ethics : is there a literature? the american journal of bioethics : ajob 6 (2):44-50. nelson, w., a. pomerantz, k. howard, and a. bushy. 2007. a proposed rural healthcare ethics agenda. journal of medical ethics 33 (3):136-9. nelson, william a., ed. 2010. handbook for rural health care ethics: a practical guide for professional . hanover, nh: dartmouth college press. r: a language and environment for statistical computing. r foundation for statistical computing, vienna, austria. sas for windows 9.2. sas institute inc, cary, nc http://www.surveymonkey.com. surveymonkey, palo alto, ca. united states department of agriculture economic research service. 2011. measuring rurality: rural-urban commuting area codes. u.s. department of agriculture 2005 [cited december 7 2011]. available from http://www.ers.usda.gov/briefing/rurality/ruralurbancommutingareas/ who. 2010. increasing access to health workers in remote and rural areas through improved retention: global policy recommendations. geneva, switzerland: world health organization. this work is licensed under a creative commons attribution 4.0 international license. http://www.surveymonkey.com/ http://www.ers.usda.gov/briefing/rurality/ruralurbancommutingareas/ https://creativecommons.org/licenses/by/4.0/ https://library.columbia.edu/ https://library.columbia.edu/ https://creativecommons.org/licenses/by/4.0/ baruch, patient’s perspective, voices in bioethics, vol 1 (2014) © 2014 priya misra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. anatomy lab: it only takes 10 minutes priya misra keywords: clinical medicine, patient-physician relationship, narrative introduction anatomy lab is a rite of passage for first years in medical school; it’s like our hazing. everyone must go through it, and everyone must experience the awkward, uncomfortable feelings that inevitably accompany it. it’s weird though— people are always talking about lab and prepping us to face our emotions early, reassuring us that it is okay to be upset or walk out if you have to; but, at the same time, no one really wants to talk about it, or think about it at all. no one wanted to make a big deal out of it, but i think that inside we were all at least a little bit worried. i was afraid that i would be an emotional wreck—that i would have to leave because i couldn’t handle it. i claimed that i was afraid it would get in the way of my education if i acted like that, but in reality, i was just afraid of being embarrassed. i was scared that it would confirm my doubt that i did not belong in medical school. analysis like any other person my age, my way of dealing with anatomy lab was to just not think about it. when it happens, it happens, and if i didn’t think about it maybe i wouldn’t get upset. of course, being a neurotic, i was also concerned that this was my first step in the dreaded direction of becoming a jaded, apathetic physician. but i slowly realized that maybe this was just a very necessary defense mechanism that we use in order to keep a brave face and do what is expected of us in order to best serve our patients. i still remember the first day of anatomy lab. there we were, four extremely confused, unprepared, and shy medical students. none of us wanted to be the first one to open the bag. to this day, i’m not sure how or why, but all of a sudden, i just blurted out “okay, i’ll open it.” i unzipped the white body bag, and i still remember continually saying aloud, “okay, it’s okay, don’t worry,” as if i were reassuring my lab mates. but i knew i was saying it only for myself. i went to pull back the sheet that was covering the body, and i just froze. i yanked my hands back to my body, as if by reflex. it was as if i suddenly became conscious of what i was doing, and i truly did feel afraid. then we all pulled back the sheet and just tried to take it all in. the body was face down, and i remember one of my lab mates informing us all that she was a female. it really didn’t seem like a dead body at the time, or anytime thereafter. it just seemed lifeless, and that truly made all the difference for me. for example, a cup is not dead, it’s just lifeless, and for some reason that’s exactly how ester (what we named our body) seemed to me. parts of her were squished and deformed, and some parts were even stained odd bright colors. the skin didn’t exactly feel like skin; it just felt like really cold, thick, wet leather. honestly, i really appreciated that—it made it easier for me to take in everything that was happening and be okay with it all. we all just stood there confused, in shock. none of us wanted to make the first cut. then, i a ta came up to our table, and she was so matter misra, anatomy lab, voices in bioethics, vol 1 (2014) 2 . of fact as she explained how to properly skin a body so that most of the fat would come off with the skin and wouldn’t have to clean it off the muscles underneath. it sounds gross and extremely disturbing as i type that out now, but at the time it was just…i don’t know…work? it was what we were supposed to do, and there was no time to stop and analyze it all. we had to get it started and get it done, and we knew that the longer we stalled, the harder it would be. my lab mate emma had made the first cuts, and we were all a bit relieved that she had the courage to do so. then we just started cutting and peeling as if it were nothing. i still remember my anatomy professor telling us not to worry about being scared, that “within minutes—i assure you that within 10 minutes,” we would be accustomed to it all, and everything would be fine. i couldn’t believe that. how are you supposed to cut up a dead body and within minutes be okay? but that’s exactly what happened. we were just cutting as if we had done it hundreds of times. yes, we were confused, and we didn’t know what we were looking for, but as soon as we saw that first pink-red color of muscle, all of our fears and anxiety just went out the window. we were so excited, engrossed, and amazed by it all. it was exactly what we had seen in books, but now in real life, and i think that awe is what allowed us to justify what we had just done. still, i would get mentally freaked out before each “emotionally trying” lab: the day we flipped the body over for the first time; the day we had to take a chisel and hammer to the vertebrae and cut through the spinal cord; the day we skinned the face; the day we sawed the pelvis in half. i remember calling my mom before each one and telling her that i was afraid it would be too much for me. she would tell me not to worry and to think of it like it’s my job. but the funny thing is that even though i would get psyched out the night before and was afraid to do what was written in the lab manual, the moment i walked into the lab and started cutting, i was fine. it was over before i could even fathom what had just happened. it’s kind of like when you break up with someone you really loved. when you think ahead to the times you’re going to have to spend alone, you absolutely dread it; you ask yourself how you’re ever going to get through the day without him or her, how you’ll pass the time by yourself. but then you get distracted, or you stop thinking, and before you know it, an hour has passed, or the entire day is done. all of a sudden, you realize that you made it and you’re okay, and everything you were dreading never happened. sure, there are times when you get upset or things catch up to you, but that’s one more day you made it by yourself unscathed. for me, that’s how those ‘trying labs’ were: i psyched myself out beforehand and wondered how i would get through them, but then it all turned out okay and i was emotionally intact. as if i had worried for nothing. yet when i did get through it, i worried that i might be headed too far in the opposite direction. i didn’t want to be completely okay when cutting up a cadaver, not thinking twice about how disturbing it is. i remember a lab in which we had to skin the cadaver’s face; i was doing one side and someone else was doing the other. i was just going along my way, humming a song, in fact, and when one of my lab mates came up to me and asked, “don’t you feel sad that you’re skinning her face?” i didn’t. i didn’t feel happy, but i also didn’t feel sad or weird. i just felt…nothing. it didn’t really faze me, and that scared me when i thought about it later. what type of person had i become? i was able to skin a person’s face and be completely okay? i was worried that i had gone too far off the deep end. i remember talking to one of my mentors about this fear, and he said, “don’t worry. the fact that you’re already worried about this shows me that you care enough not to let it happen to you.” i hope that’s true, but part of me feels as though we have no choice but to say that to ourselves. we can’t always worry about the morality of cutting up cadavers without feeling remorse every time we do so; this is our job. if we want to help others, this is something we have to do. no, you should never take pleasure in it, but you can’t beat yourself up for finally finding some sort of mental peace that lets you be okay with everything that is happening around you. i hope that if you do dissect a cadaver that you are fascinated and that you do think it’s amazing to hold a human heart in your hand. to me, that misra, anatomy lab, voices in bioethics, vol 1 (2014) 3 . only confirms that you are meant for medicine. it is when that fascination exceeds its place that you should become concerned. still, as they say, admitting you have a problem is the first step toward solving it, so maybe my mentor was right: maybe just being aware of your emotions and being conscious of going too far is the first way to prevent yourself from turning out that way. ____________________________________________________________ conclusion i find consolation in the fact that i’m a bit nervous about entering the anatomy lab again next semester, when i go in to help the first years dissect their bodies. i’m worried that i’ll get scared again and freak out about staring death in the face, and that i won’t be able to dissect with as much confidence as i did before. sometimes the bodies don’t look as though they’re just sleeping peacefully. some of the faces can be misshapen, as though they’re experiencing extreme anguish. it makes me curious about what happened in the few minutes before they passed away: what would make their faces freeze like that? it shocks me that, after a whole semester of dissecting, i can still be nervous and frightened. but i guess that’s healthy. i guess that’s the one thing that separates me from the jaded and apathetic. anatomy lab truly opened my eyes to the truth that medical school is not like anything i have ever done or will ever do. it taught me that it’s okay to be scared, worried, or embarrassed. it’s a learning experience, and like everything else we will have to do, this is just one of those things that will teach us more about ourselves than perhaps we are willing to learn. even though your classmates may not admit it, they probably are scared and nervous about lab too. but it will turn out okay, and it will reassure you about your choices in life. it truly is an amazing experience, and if you conquer it with an open mind, you may experience something truly unique. jackson, physician-patient relationship, voices in bioethics, 2013 © 2013 jhia jackson. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. physician-patient relationship jhia jackson hannibal. just saying the name sends chills down the spine and piques the curiosity of the small part of you that asks “what if...” nbc’s thriller television series “hannibal” astonished viewers worldwide with its beautiful cinematography, captivating plots, and surprisingly relatable characters. as someone who can’t watch scary movies without closing my eyes and clutching my teddy bear, i was completely hooked on the show from episode 1. nbc was able to successfully develop a show that made gore look like art and serial killers look like masters of their craft. aside from each episode centering around a killer and their capture, the series itself focuses on the relationship between fbi special investigator will graham (played by hugh dancy) and forensic psychiatrist dr. hannibal lecter (played by mads mikkelsen.) graham seems to have a heightened sense of empathy, which helps him discover identifying characteristics of the serial killer by placing himself in the crime through both the victim’s and killer’s perspectives. his over-empathizing soon begins to negatively influence other areas of his life, thus leading him to seek help from a therapist. enter dr. hannibal lecter. their physician-patient relationship becomes complicated as graham begins to see hannibal as a co-worker, and hannibal confesses to viewing graham not only as his closest friend, but as the only person who can truly understand him. hannibal transitions from being able to objectively treat graham, to employing tactics of extreme beneficent deception, paternalism, and even experimentation. his reasoning for his unethical behavior includes professional curiosity, their friendship, and genuine care for graham’s safety. while one hopes that physician-patient relationships today are not as twisted and complicated as the one presented in the series, hannibal and graham’s interactions serve as an extreme example of questions physicians may ask themselves every day. how can i objectively treat someone that i know and care for? what are the limits of human experimentation? how much does the patient need to know and when do i tell them? season one features 13 episodes and first aired april 4, 2013. nbc has announced that season two will also feature 13 episodes and air sometime in early 2014. for more information, go to: www.nbc.com/hannibal http://www.nbc.com/hannibal physician-patient relationship augenstein, right to try, voices in bioethics, vol. 6 (2020) © 2020 jacqueline augenstein. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the right to try jacqueline augenstein abstract patients who request access to investigational drugs are terminally ill and consequently have an increased risk for serious adverse events. additionally, their terminal illness is a poor indicator for success with future treatment attempts. drug manufacturers are therefore often hesitant to grant these higherrisk patients access to their product, both inside and outside of their own tightly controlled clinical trial environments. through the rtt act, patients with life-threatening illnesses, who have exhausted approved treatment options and do not qualify for any available clinical trials, are able to seek access to investigational drugs without the fda’s approval and direct involvement. keywords: right to try, investigational drugs, experimental treatments, end of life, bioethics, access to care introduction the need for increased access to investigational drugs has consistently been supported by the public, in spite of the fact that the expanded access program (eap), which is regulated by the food and drug administration (fda), already exists.1 as a result, the right to try (rtt) act became a federal law on may 30, 2018. through the rtt act, patients with life-threatening illnesses, who have exhausted approved treatment options and do not qualify for any available clinical trials, are able to seek access to investigational drugs without the fda’s approval and direct involvement. eligible investigational drugs must have already completed a phase 1 clinical trial in order to ensure some, but nonetheless a bare minimum, level of safety.2 this law was enacted in an augenstein, right to try, voices in bioethics, vol. 6 (2020) 2 effort to increase terminally ill patients’ access to investigational drugs, which could possibly prolong their life that would otherwise surely end in the near future. analysis opponents of the rtt act favor the eap, which is the presumably safer route to gain access to investigational drugs because the fda provides direct regulatory oversight prior to and throughout the treatment process.3 the problem with the eap is that it involves an extensive pre-approval process.4 physicians are required to obtain informed consent from the patient, as well as approval from both an institutional review board (irb) and the drug’s manufacturer, prior to completing and submitting the eap application. once the eap application is received by the fda, it is almost always approved and the patient is granted access to the investigational drug through a clinical trial that is regulated by the fda.5 unfortunately, the pre-application process is tedious and time-consuming for physicians and these terminally ill patients are limited on time as it is. difficulties in obtaining access to investigational drugs are not solely a result of the fda’s pre-approval process. manufacturers of investigational drugs often deny these requests, and it is the manufacturer who ultimately determines whether or not a patient will be granted access to their product.6 patients who request access to investigational drugs are terminally ill and consequently have an increased risk for serious adverse events. additionally, their terminal illness is a poor indicator for success with future treatment attempts. drug manufacturers are therefore often hesitant to grant these higher-risk patients access to their product, both inside and outside of their own tightly controlled clinical trial environments. this is due to the fact that any adverse event associated with its use, which could be related to the drug or related to the patient’s condition, could negatively influence the fda’s decision to ultimately approve the drug. furthermore, the fda requires manufacturers to develop and continuously update expanded access protocols that require time and additional resources to produce.7 medium to smaller sized companies do not have the personnel nor the financial means to keep up with the requirements of the eap, and this limits their ability to provide access to their investigational drugs.8 the rtt act attempts to overcome these barriers to investigational drug access. in order to decrease the amount of time physicians spend on the pre-approval process, physicians are able to request and obtain investigational drugs directly from the manufacturer. the physician, rather than the fda, is responsible for monitoring and managing the patient’s clinical progression throughout the treatment process going forward. it addresses manufacturers’ concerns by prohibiting clinical outcomes and adverse events associated with drugs taken through the rtt pathway to be used to influence the fda’s review, and ultimately its approval, of the investigational drug. however, manufacturers are required to include a summary of severe adverse events experienced by these patients in the annual report they submit to the fda for review. lastly, drug manufacturers, physicians, and other involved parties are liberated of any liability claims associated with drugs administered through the rtt pathway, with the exception of instances where there is a clear act of misconduct or negligence involved.9 many people have voiced their concerns with the rtt pathway. they believe that in removing the fda’s role to provide regulatory oversight throughout the process, it also removes safety nets that are crucial for these augenstein, right to try, voices in bioethics, vol. 6 (2020) 3 vulnerable patients.10 the whole point of the issue at hand is that there is no safe and proven effective solution. the fact of the matter is that these patients are at death’s door and there is no hope in sight for they have exhausted every available treatment option approved by the fda. the rtt act was not developed to replace the eap. it was developed to provide an additional pathway that terminally ill patients can utilize to obtain access to potentially life-saving drugs. the drug’s manufacturer still has the option to provide access to their product through the eap.11 if the manufacturer is more inclined to grant access to its drug through the rtt pathway, then this opens a window of opportunity for patients who are faced with dire and limited circumstances. another concern people have with the rtt pathway is related to its lax requirements for obtaining informed consent.12 the eap requires physicians to obtain written consent from the patient, which is then reviewed by an irb to ensure that the patient is well informed and comprehends the risks associated with using the investigational drug. the rtt pathway only requires written consent from the patient and as previously mentioned, the physician is protected from liability claims if the information provided prior to obtaining written consent is incorrect or inconclusive. the reason physicians, and manufacturers for that matter, are absolved of liability in this situation is because there is limited information available about the safety and efficacy of these investigational drugs at that point in time. phase 1 clinical trials involve only a small number of patients and notable adverse events are often first discovered in later clinical trials that involve a larger number of patients.13 as a result of this, it is impossible to obtain a proper informed consent from patients prior to their use of investigational drugs through the rtt pathway. it is clear that investigational drugs taken through the eap are a safer bet, but the eap has been available for many years and people have consistently continued to support the need for increased access to investigational drugs.14 the rtt act is a new law that was enacted in order to help terminally ill patients overcome barriers that have prevented them from accessing investigational drugs in the past. however, because manufacturers are not required to report the total number of individual requests they receive, it is difficult to determine if the rtt act has effectively increased access to investigational drugs.15 this also makes it difficult to quantify the extent of the need for increased access among this population. drug manufacturers should be required to keep track of the total number of requests they receive for access to investigational drugs through both the eap and rtt pathways, which would provide pertinent insight regarding this matter. conclusion terminally ill patients do not seek access to investigational drugs because they think these drugs are a safe and effective treatment option. they seek access to investigational drugs because there is no other option left. claiming that the rtt act may do more harm than good is a moot point considering that the only alternative for these patients is dying. the rtt pathway is not perfect by any means, but it helps to preserve the autonomy of terminally ill patients by affording them the opportunity to decide whether or not they wish to take this extreme and unsafe risk. every dying patient has the right to choose how they spend their remaining days and if they choose to spend that time trialing an investigational drug on the off-chance that it leads them on a path to recovery, then this is something that i fully support. 1 jessica piel, “informed consent in right-to-try cases,” journal of the american academy of psychiatry and the law 44, no. 3 (september 1, 2016): 290-96. augenstein, right to try, voices in bioethics, vol. 6 (2020) 4 2 this and the preceding three sentences include information from susan thaul, right to try: access to investigational drugs, crs report no. r45414 (washington, dc: congressional research service, 2018), https://www.everycrsreport.com/reports/r45414.html. 3 jessica piel; susan thaul; beth roxland and elisa a. hurley, “taking a closer look at the new federal ‘right to try’ law,” ampersand (prim&r blog), august 21, 2018, https://blog.primr.org/right-to-try-law/; ellen v. sigal, “why right-to-try laws are dangerous,” the asco post, march 5, 2018, https://www.ascopost.com/issues/march-5-2018-special-report/why-right-to-trylaws-aredangerous/. 4 jessica piel; susan thaul; brian connelly, “right to try act: is it the answer for terminally ill patients?,” update magazine, october 2018, https://www.fdli.org/2018/10/right-to-try-act-is-it-the-answer-for-terminally-ill-patients/; leah lawrence, “the realities of ‘right to try,’” ash clinical news, october 1, 2018, https://www.ashclinicalnews.org/features/realities-right-try/. 5 this and the preceding sentence are from susan thaul. 6 susan thaul; u.s. food & drug administration, right to try, (silver spring, md: u.s. department of health and human services, 2020), https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try. 7 this and the preceding five sentences are from susan thaul. 8 susan thaul; brian connelly. 9 this entire paragraph includes information from susan thaul. 10 jessica piel; susan thaul; beth roxland and elisa a. hurley; ellen v. sigal; leah lawrence. 11 beth roxland and elisa a. hurley; brian connelly. 12 jessica piel; susan thaul; beth roxland and elisa a. hurley; ellen v. sigal; leah lawrence 13 this and the preceding three sentences are from susan thaul. 14 jessica piel. 15 susan thaul; ellen v. sigal. https://www.everycrsreport.com/reports/r45414.html https://www.fdli.org/2018/10/right-to-try-act-is-it-the-answer-for-terminally-ill-patients/ https://www.ashclinicalnews.org/features/realities-right-try/ https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try anekwe, rising up, voices in bioethics, vol. 1 (2014-2015) © 2014 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. rising up: hale woodruff’s murals from talladega college travel the country obiora anekwe hale aspacio woodruff (1900-1980) was a master of many arts, including printmaking, draftsmanship, and painting. i first heard of woodruff as a first-year college student at clark atlanta university, where he taught art and founded the atlanta university (now clark atlanta university) art department. one set of his murals titled, the art of the negro, is housed in the atrium of trevor arnett hall on the campus. as both a student of public health and visual artist, i was greatly influenced by his technique and skill as an artist and profoundly moved by his depiction of african american history. woodruff’s legacy as a prolific art professor and visual historian is being remembered through the restoration of his murals from talladega college through a nationally sponsored tour of rising up: hale woodruff’s murals at talladega college. i viewed his murals chronicling the history of talladega college, the amistad story, slavery, and other related themes at the 80wse galleries at new york university. to say seeing woodruff’s murals was an extraordinary moment would be an understatement. he not only traced the interpretive history of the amistad saga in his large scale murals —brightly colored, historically sound, and distinctly original—but he portrayed how african-americans lived after slavery: in physical conditions that undermined their health and dignity. several of woodruff’s smaller pieces illustrate his concern with poverty, especially housing conditions of poor black families depicted in scenes of outdoor bathroom facilities, shacks, and community wells. as the artist chronicled—and many public health historians have confirmed—the urban population increased dramatically during the early 1930s. fears within the white community of competition, decreased property values, and integrated schools further exacerbated the depredations of segregation.1 these smaller works, such as results of poor housing, are just as artistically revealing and educationally moving as his larger murals in the traveling exhibition. as woodruff noted in the september 21, 1942 issue of time magazine regarding his study of rural life in georgia, “we are interested in expressing the south as a field, as a territory, its peculiar rundown landscapes, its social and economic problems, and negro people.”2 although woodruff was one of the first academically trained african-american art professors to document the public housing conditions of black people in the south during the jim crow era, time magazine mistakenly coined his work in 1942 as “outhouse school of art.”3 but ralph mcgill, the anti-segregation columnist and later editor of the atlanta constitution, wrote a more accurate portrayal of woodruff's images of black urban life as art that speaks “out in rebuke. they are worth more, they say more than all the studies on economics and the need for slum clearance and for better housing.”4 the exhibition of woodruff’s historic murals and smaller works will continue to travel the country until 2015. the next viewing of his art will be held may 16 through september 14, 2014 at the new orleans museum of art. i encourage you to take time out and see this transformative exhibition of the murals and smaller works by artist hale a. woodruff. 1 hale woodruff bio, accessed november 8, 2013. http://moyepto.com/programs/gswa/artists/woodruff,%20hale/biography/hale%20woodruff%20bio.pdf 2 time magazine, september 21, 1942 3 time magazine, september 21, 1942 http://moyepto.com/programs/gswa/artists/woodruff,%20hale/biography/hale%20woodruff%20bio.pdf anekwe, rising up, voices in bioethics, vol. 1 (2015) 2 4 ralph mcgill, "quiet negro artist here hailed as one of modern masters," atlanta constitution, december 18, 1935; quoted in heydt, "rising up," p. 36. rising up: hale woodruff’s murals from talladega college travel the country ayeh, texas law obstructs pregnant mother’s right to die, voices in bioethics, vol. 1 (2014-15) * derek ayeh, ms bioethics © 2014 derek ayeh. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. texas law obstructs pregnant mother’s right to die derek ayeh* keywords: bioethics, ethics, abortion, texas introduction by now the legitimacy of do not resuscitate (dnr) orders are acknowledged by everyone – if a patient presents an advanced directive or their family members agree as to what the patient’s wishes were for endof-life care, then life-sustaining treatments can be withdrawn or withheld. however, a texas law is preventing a pregnant woman from exercising the choice to not be resuscitated. analysis the woman, marlise munoz, was found unconscious in late november and since then has not regained consciousness. however, the fetus she carries continues to have a beating heart and there is a texas state law that puts the rights of a fetus over the wishes of its mother. her husband, erik munoz, along with her parents all agreed that it would have been against marlise’s wishes to be kept on life support. already we can see how different this case is from the terri schiavo case between husband and parents. instead this case is between the marlise family and the john peter smith hospital in fort worth. it’s easy to see how this case could slip into questions of pro-life versus pro-choice. this issue pits the mother’s choices against the ‘best interests’ of the fetus (or at least, what certain groups interpret as the fetus’s best interests). however, a best interests stance is not straightforward in this case either. a few, including art caplan, have suggested that medicine currently does not understand the effect of life-support and oxygen deficiency on fetal development. the child can be born, but whether or not it will be born healthy or suffer complications due to the circumstances of birth is unknown. regardless, pro-life versus pro-choice is not the context that the munoz family wishes to interpret this problem in. they have stated that their only desire is to see marlise’s wishes fulfilled by having her taken off of life-support. they do not want their case to slide into the realm of abortion rights, though in a state like texas where the feud is heated that may be unavoidable. ayeh, texas law obstructs pregnant mother’s right to die, voices in bioethics, vol. 1 (2014-15) 2 conclusion with the munoz family now taking legal action against the hospital this case may be the one to set the precedent. there are other states that have laws similar to the one in texas and if the munoz family wins their case it could have an effect on state laws in the future. however, it is unlikely that this case will have any effect on the dispute over abortion rights, other than once again putting the topic of abortion on everyone’s mind. the lawsuit plans to utilize the texas health and safety code’s definition of death (irreversible cessation of circulatory and respiratory functions, which applies to marlise) to overturn the hospital’s decision to continue life-support. everything is being argued from the standpoint of end-of-life care and the munoz family is ultimately looking to respectfully bury marlise. regardless of how the case is construed as attention is drawn to it, a victory for the munoz family is a victory for dnr rights, not abortion. references husband wants pregnant wife off life support http://abcnews.go.com/health/husband-pregnant-wife-offlifesupport/story?id=21291086&singlepage=true family of pregnant texas woman sues hospital for keeping her on life support http://abcnews.go.com/health/family-pregnant-texas-woman-sues-hospitalkeepinglife/story?id=21531385 agredo, hands on the patient with eyes on the budget, voices in bioethics, vol. 1 (2014-15) * sebastian agredo, ms bioethics © 2014 agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hands on the patient with eyes on the budget sebastian agredo* keywords: medical services, social costs, bioethics, ethics introduction in 1993, marcia angell wrote an article highlighting the growing trend of doctors being asked to function as “double agents,” meaning physicians had to weigh their duty to patient care against the social costs of medical services.1 this situation of care rationing in the 1990s was a result of the rapidly rising costs of such medical services, and was propagated by the openended, fee-for-service nature of the country’s health care delivery system. it has been more than 20 years since the publication of angell’s article, but doctors are once again facing the ordeal of having to choose between what is best for their patients and what is most cost-efficient. ____________________________________________________________ agredo, hands on the patient with eyes on the budget, voices in bioethics, vol. 1 (2014-15) 2 analysis joining the fray are influential medical groups and associations, which recommend that costs become a part of the equation that guides physicians in making their conclusions regarding the best course of treatment. as was the case in the 1990s, the rising cost of health care is driving the push, and strengthening the claim made by many leaders in the medical field that doctors must be “good stewards of our health care resources as well as of the patient in our examination room.” medical societies such as the american society of clinical oncology, the american college of cardiology, and the american heart association are developing new guidelines to make their members more conscious of the economic significance of choosing certain drugs or technology. for example, the american society of clinical oncology is preparing a scorecard – expected to be ready this fall – that will rate drugs based on their cost, value, efficacy, and side effects. critics of such cost analyses argue that the practice leads to bedside rationing, and thus doctors face an inherent conflict when trying to be both “providers of patient care and financial overseers.” for these critics, the solution seems obvious: uphold the physician’s fiduciary duty to the patient. the patient is incapable of influencing or controlling the costs of expensive drugs or medical technology. therefore, why should the physician place the patient at an increased risk by cutting corners for the sake of the bottom line? this could especially pose a problem for medicare recipients, who make up a constituency that will continue to grow as baby-boomers continue to age, leaving policy makers with the difficult task of managing how to stretch limited government dollars. in critics’ minds, only by ensuring that patients receive the quality of care they deserve – regardless of cost – will the needs of the greater society be met, for stewardship of the patient first and foremost instills overall trust in the medical field. these are well-crafted an easily defensible arguments, especially with regard to the traditional, ethical role of the physician. however, they fall short in addressing the problem at hand. continuing as we have for the past couple of decades means that treatments costs will increase unimpeded, and with them, health care expenditures. where the door is open for change is at the policy level, represented by the various medical societies making the cost evaluations. by coupling with government agencies that have economic expertise in the health care arena, physician-policy makers can make economic decisions that bridge the gap between treatment efficacy and cost. by examining treatment methods and rating them according to their value, which can be quantified based on the cost per qualityadjusted lifeyear (qaly); medical societies are relieving the individual physicians of having to make the choice at the bedside. conclusion the important thing to note is that these guidelines will not govern the physician’s decisions, but rather guide. the value determinations of certain drugs and procedures can also have the effect of placing pressure on pharmaceutical or insurance companies to bring down the price of their products, expand coverage, or come to the table with policy makers and work out an agreement for cost-saving measures. this may be hopeful thinking, but it marks a step in realizing that medicine cannot go on ignoring the impact of cost on the system. agredo, hands on the patient with eyes on the budget, voices in bioethics, vol. 1 (2014-15) 3 references schwartz, jennifer a.t., pearson, steven d. “cost consideration in the clinical guidance documents of physician specialty societies in the united states.” jama internal medicine, 2013: 1091-1097. 1 angell, marcia. "the doctor as double agent." kennedy institute of ethics journal, 1993: 279-286. belisomo, the end-of-life lessons from casey kasem’s family feud, voices in bioethics, vol. 1 (2014-15) © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the end-of-life lessons from casey kasem’s family feud randi belisomo keywords: bioethics, end-of-life, ethics, family feud, lewy body disease introduction american music fans have lost an icon. in recent weeks, the dysfunction and drama of the last days of casey kasem, a radio personality who gained fame counting down the country’s top pop, pervaded national headlines. though family infighting among the famous was certain to capture the media’s interest, such conflict is sadly not unique in end-of-life cases such as his. those who followed this saga stand to learn a much-needed framework of multiparty communication from what went wrong here. ____________________________________________________________ analysis the case kasem, 82, suffered from lewy body disease, a progressive dementia. in 2007, he signed papers extending power of attorney for his health care to his daughter julie; the directive stated kasem’s desire for no “life-sustaining procedures.” however, julie, her sister kerri, and their brother contended that kasem’s wife since 1980, jean, prevented them from visiting their father. in may, kerri won court approval to see kasem. however, jean expressed displeasure to reporters, playing an audio recording of a groaning man she maintained was her crying husband. jean threw meat in the street, citing scripture as an ambulance took her husband away. “in the name of king david, i threw a piece of raw meat into the street in exchange for my husband to the wild rabid dogs.” the drama continued in the courtroom, where kerri won temporary conservatorship. but kerri was unable to execute such responsibility without knowing his whereabouts; according to kasem’s children, he was “isolated from his daughters, friends and other family” by his wife. a judge later decided kerri had the right to honor his directive to withhold food, hydration, and some medications, and she opted to transition him into hospice. kasem’s children released a statement, quoting his advance directive: belisomo, the end-of-life lessons from casey kasem’s family feud, voices in bioethics, vol. 1 (2014-15) 2 "if the extension of my life would result in a mere biological existence, devoid of cognitive function, with no reasonable hope for normal functioning, then i do not desire any form of life-sustaining procedures, including nutrition and hydration." jean opposed this decision and promised to pursue all legal options on her husband’s behalf. her attorney maintained that kasem was being “starved and cut off from medicine until he dies.” what went wrong family conflicts regarding end-of-life decision-making are common; as such situations would be stressful for any family. that stress was amplified, in this case, by the media spotlight. conflicts in such stressful times often arise because patients have not expressed their wishes and values regarding their health care, and patients also fail to appoint surrogate decision-makers.1 but in this case, the patient took proactive steps to ensure his care preferences would be clear. kasem appointed a surrogate and documented his wish for no life-sustaining measures. though he completed paperwork, it seems that what kasem did for a lifetime through our radios is what he failed to do within his own blended family: talk. the facts suggest the strained relationship between kasem’s wife and children was such for years, and this conflict was one he should have seen coming. without such conversations explaining his wishes and reasons behind them, kasem deferred conflict to a later day – and that day arrived. conflict was inherent upon completion of his advance directive, as kasem’s surrogate and main caregiver were different individuals. kasem was obligated to take that difference into account and ensure both parties understood the scope of their roles. “you want to communicate this information,” says nancy berlinger, a lead author of the hastings center guidelines.2 “it’s a problem when a person makes an advance directive, and the only person who understands its context is their lawyer.” not only would kasem’s surrogate be empowered with greater understanding of the values upon which his preferences rested, his family infrastructure would have likely been strengthened by such personal disclosures with all parties gathered. “if you really want to look at how to prevent situations like this, you need to have these conversations with not only surrogates, but with other loved ones,” says daniel johnson, the national clinical lead for palliative care with kaiser permanente’s care management institute. “when people take the time to have those informed discussions with family to ask the right questions to explore preferences with all important parties, you almost never see this.” kasem’s family would have received guidance about their roles from the patient himself, and perhaps they would also have understood exactly what he meant by his desire for no life-sustaining measures if “devoid of cognitive function.” while kasem’s daughter believed he was in such a state, his wife’s vow to pursue legal action suggested she understood his condition differently. “there may have been the assumption that this document would have magically taken care of everything,” says berlinger. conclusion unfortunately, end-of-life planning is often reduced to a “check-box” approach of medical options, with little understanding among patients and families as to what options actually denote. what does it mean to “lack cognitive function”? what is it to have a “mere biological existence”? more detail is required than loosely stated preferences, and the way to ascertain the meaning of those preferences is to have asked kasem directly. at their best, these conversations should expand beyond treatment preferences; discussions should explore considerations of real-life issues. examples of these belisomo, the end-of-life lessons from casey kasem’s family feud, voices in bioethics, vol. 1 (2014-15) 3 considerations are descriptions of what made kasem’s life “worth living” – quality of life discussions to unravel what he valued. was it the ability to communicate with loved ones? perhaps the capacity to hear the music he played for generations of young americans? the ability to maintain his own hygiene? we never knew, but his family should have. when we read cases like kasem’s, we are best served by allowing his tragedy to prompt our own end-of-life planning. complete your advance directive, and if you already have – locate it. discuss its contents with key loved ones, explain their roles, and let them know how they may best ensure your preferences are executed. we all can play disc jockey of our health care choices: don’t let your broadcast include dead air. references “casey kasem's daughter has the power, but will she use it?” by alan duke and ed payne http://www.cnn.com/2014/06/12/showbiz/casey-kasem/ “casey kasem's daughter granted visits amid concerns about care of ailing radio personality” by manuel valdes http://www.usnews.com/news/entertainment/articles/2014/05/30/casey-kasems-wife-ordered-to-appear-in-court “casey kasem hospitalized: wife throws raw meat at his daughter” http://www.tmz.com/2014/06/02/casey-kasem-wife-jean-fight-daughter-hospitalized/ “judge appoints casey kasem's daughter as temporary conservator” by jane caffrey http://www.cnn.com/2014/05/12/showbiz/casey-kasem-conservatorship/ “casey kasem's family feud: judge allows water, food infusions stopped” by alan duke http://www.cnn.com/2014/06/10/showbiz/casey-kasem-timeline/index.html?iref=allsearch 1 teno jm, licks s, lynn j, et. al. “do advance directives provide instructions that direct care? support investigators.” study to understand prognoses and preferences for outcomes and risks of treatment. journal of the american geriatrics society [1997, 45(4):508-512]. 2 berlinger, n., jennings, b., and wolf s.m. (2013) the hastings center guidelines for decisions on life-sustaining treatment and care near the end of life: revised and expanded second edition. oxford university press, 2013 http://www.cnn.com/2014/06/12/showbiz/casey-kasem/ http://www.usnews.com/news/entertainment/articles/2014/05/30/casey-kasems-wife-ordered-to-appear-in-court http://www.tmz.com/2014/06/02/casey-kasem-wife-jean-fight-daughter-hospitalized/ http://www.cnn.com/2014/05/12/showbiz/casey-kasem-conservatorship/ http://www.cnn.com/2014/06/10/showbiz/casey-kasem-timeline/index.html?iref=allsearch misra, relatability to those outside of medicine, voices in bioethics, vol. 2 (2016) © 2016 priya misra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. relatability to those outside of medicine: they just don’t understand priya misra keywords: bioethics, medical school narrative, narrative medicine ethics, clinical narratives introduction one of the first things i had noticed when medical school started was that i was no longer able to relate to friends who were working outside of the medical field as i used to. most people who are not going into, or aren’t already in, medicine do not want to hear about the gruesome things that we have to do in anatomy lab. yet for me, that was the most exciting part of my day. i was dying to tell my parents and sisters about how i held a human heart and how amazing our cadaver was; i wanted all my friends who ended up visiting me to come and see the anatomy lab. but once i realized that no one really wanted to hear about it, it seemed as though i didn’t have much to talk about anymore. i remember that my dad would call me every night and would always ask, “so, what’s new?” and i would never have anything to say. i studied, went to class, went to lab, and studied again; it seemed as though that was pretty much all i did everyday and there really wasn’t time for anything else to happen. i felt bad saying “nothing” or “the same as always” as a reply to him, but i really had no other choice. other times, when talking to my sisters, i would unknowingly end up telling them the same stories again and again. or, i would tell them how stressed i was about my exam, or even just a small assignment, and they would never understand why i would be so nervous. “it’s just a test,” they would say. “you’ve always done well in school, so don’t worry.” it was as if no one understood why i was so stressed or busy or scared. this wasn’t just “school” anymore; it was the beginning of the rest of my life. this was the first time i was learning vital information that would save people’s lives, and skills that would carry me through this insane lifestyle for the rest of my career. in college if i failed something, or didn’t completely understand the information being taught to me, most likely it would not affect me in any way other than a lower grade, but now i needed to truly learn this information and figure out how to conduct myself as a future physician. that is a lot of stress! ____________________________________________________________ analysis for me, medical school was unlike anything i had ever experienced before and i felt out of my element for misra, relatability to those outside of medicine, voices in bioethics, vol. 2 (2016) 2 a very long time. it seemed that even though i was studying constantly, i was always behind—just trying to catch up. most days i would stay in the library studying until midnight, and once the library closed my friends and i would find an open classroom and continue studying until two or three in the morning. then i would drive home and pass out as soon as my head hit the pillow, only to be back in class by 8:30 the next morning. i hardly had time to call my family, and would only find time to speak to them on walks from the library to the cafeteria, or during my drives to and from school. everyone in the laundromat knew me because i was the only girl who would read and study on her laptop while waiting for her clothes to be done. but regardless of all of that studying, it felt like as soon as i was caught up with anatomy i was behind in biochemistry, and seeing all of this information for the first time really didn’t help. compounded with all of the other issues i had to deal with outside of school, feeling like i didn’t have control of my academics just made everything worse. no one outside of my friends in class or in other medical schools could understand what i was going through. i don’t have a lot of experience in fields outside of medicine, nor have i had many jobs, but it seemed to me as though not a lot of people were accustomed to the intensive workload that we have. most jobs end at a certain time of the day and do not necessitate that you continue working at home, and so you end up having a bit of a break or a social life. however, especially during the first semester, that isn’t true for medical students; if anything, i would be happy on saturdays, not because it was the weekend, but because i didn’t have a class or lab and i had the whole day dedicated to studying instead. of course, once you find a balance and find out what works for you and what doesn’t, you do end up having more free time and can better balance your personal life with your academic one. but for me, that time was still very limited. and no one in my social network outside of medicine could understand why that was. no one could understand why i would get stressed before every exam, even though failing a class would mean repeating it despite all of the hard work i did to succeed. no one could understand why i was always so busy and couldn’t talk on the phone as much as i used to. even my family could never understand why i needed to study as much as i did. i felt isolated and soon realized how much value laid in my new-formed friendships at school—these were the handful of people who could understand me the most and relate to my struggles the easiest, even though our friendships were relatively new. as a future physician, i aspire to be the most understanding and patient person that i can be. i know that it will be an important quality to have later, and as a person who is going to devote her life to helping patients with their problems, i aim to be open and to be there for my friends no matter how big or small their problems may be. despite my efforts, i found myself getting extremely impatient with those who complained about what seemed to be minor issues. i would feel like snapping and saying, “how can you be sitting here talking about this boy who clearly isn’t worth your time, when there are people here dying with cancer or fighting for their lives as we speak?” i really hate to admit it but i felt like i was losing whatever mental filter i had left that stopped me from growing impatient or jaded. i tried to justify in my mind that it’s not fair for me to expect my friends to have the same perspective on life and its struggles as i do, because they are not in medicine. though we may see “bigger” problems in our work, that reality doesn’t belittle others’ issues. but, no matter what i may say or explain to myself, i know that even today it is hard for me to take others’ problems as seriously as i did before. it seems counterintuitive, seeing as how i am going to be a doctor and caring for others is my profession, but alas, it is what it is. as i slowly survived my first year of medical school, i realized that medical professionals are just a small group in society—a small, specialized, extremely different group of people who practice medicine as their profession and their lifestyle. we are united in the things we experience, the heartaches we bear, and the unique life that only we can understand. when i meet a family friend who is also in medicine, it only takes seconds before we begin the “doctor talk.” what other choice do we have? unlike other professions, medicine is truly our life and we are surrounded by it—literally all day. what else could we hold to as much importance as we do this? conclusion it truly is a culture. the culture of medicine: uniting those within it, severely isolating us from those who misra, relatability to those outside of medicine, voices in bioethics, vol. 2 (2016) 3 are not. i remember discussing these thoughts with my research preceptor during one of our meetings, and he gave me countless examples of people in his department who married one another and the relationships that formed and succeeded in his medical school class. he claimed that the reason so many people in medicine end up dating one another is because of the strong foundation that the common experience that medicine provides them. it’s as if you finally find someone who can understand what you go through. i reflected on how many relationships i had seen break apart between my classmates and their partners outside of medicine, and realized that the culture of medicine is one that unites those of us within it, while severely isolating us from those who are not. a few weeks after my first year ended, i attended a wedding and was talking to some family friends who were also there. one of their daughters is a doctor now and when she was asking me why i was moving out of my studio apartment into a house with some classmates, i explained to her how lonely it gets when you are at home alone studying all the time. i told her how many hours i spend in the library studying, instead of at home to be around people in my class, and how nice it would be to live with someone who can share in my experiences. i told her how overwhelming school was and how easy it is to get lost, especially as soon as you feel that you have gotten the hang of things. as i was pouring out my feelings about school to her, she just kept nodding and saying, “i know.” at the end of it all she said, “i know. i know just how you feel. i don’t know what else i can say except that i know exactly what you’re saying.” to her it may not have seemed like much, but to me it meant everything to find someone who could finally understand, and relate to, this new life of mine. kornyo, you are what you eat: when personal choices become public issue the case of sugar, voices in bioethics, vol. 1 (2014-15) * emmanuel a. kornyo, ms bioethics © 2014 emmanuel a. kornyo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. you are what you eat: when personal choices become public issue the case of sugar emmanuel a. kornyo* keywords: food politics, sugar consumption, autonomy introduction the aphorism “you are what you eat” or put more aptly “man is what he eats” succinctly encapsulates the theme for this week’s editorial.1 many new yorkers will remember when former mayor, michael bloomberg, found himself entangled in a swath of debate on the proposal to ban large size sodas, with an anticipatory good intent of reducing the menace of obesity and type 2 diabetes. in california, there has been a call for a “sugar tax” as a way of curbing the excessive consumption of sugar. as the debate continues to gather a new wave of momentum, it is expedient that we ponder over why the issue of excessive consumption of sugar be considered a serious health issue. this editorial reflects on these challenges through the nexus of ethics, among others. ____________________________________________________________ kornyo, you are what you eat: when personal choices become public issue the case of sugar, voices in bioethics, vol. 1 (2014-15) 2 analysis undoubtedly, added sugar continues to be an important source of calorie and a major component in our diets. sugar is found in many processed foods, medications, and drinks, either as a major component or as additives2. but over the years, scientists, especially from the medical community, have been sounding the alarm on the devastating ramifications of excessive sugar in our diets as one of the leading causes of type 2 diabetes and cardiovascular mortality. policy makers have also joined the chorus of groups to express tacit concerns about the effect of added sugar on the quality of life of individuals and the public. as it turned out, the consumption of sugar has become not just problems of the individuals per se, but has metamorphosed into a significant and seemingly epidemiological public health issue with ethical undercurrents worth debating. the average can of soda is estimated to contain between 7 to12 – teaspoon of sugar.3 while a healthy recommended beverage consumption is pegged at 64 calories per day, an average 12 ounce can of soda has 140 calories! five out of every ten people consume some sugary drink per day. 4 poor people are more than half as likely to derive their calories from sugary drinks or soda/juices. the high consumption rate is attributed to the fact that sugary drinks are cheap, accessible, and affordable. it is a cheap source of calories for many people. more so, “sugar” is sweet and naturally addictive to the palate. who does not like the taste of sugar? in a recent commentary on the menace of sugar consumption, a prominent scientist notes: “in sum, the study…contributes a range of new findings to the growing body of research on sugar as an independent risk factor in chronic disease. it underscores the likelihood that, at levels of consumption common …, added sugar is a significant risk factor for cvd [cardiovascular diseases], mortality above and beyond its role as empty calories leading to weight gain and obesity,” 5 this conclusion raises many ethical quandaries as well. when should individual autonomous rights to choose what to eat be regulated? in other words, should there be legislations limiting the size and the amount of calories in sodas, as suggested in new york, california, and other states? there is no doubt that everyone individual has an intrinsic responsibility to choose what, when, and how to eat and drink, devoid of any external regulation and ethical norms. but as the evidence continues to aggregate on the ramifications of excessive consumption of added sugar in our diets, the issue is now a public health problem. this is because scarce public resources are now being spent in ameliorating the problem. while individuals have the right to choose, it seems it may be a moral and a categorical obligation for stake holders on public health issues to chart a new frontier through appropriate legislations to solve the problem by reducing the size of sugary drinks, increasing costs of sugary drinks, and implementing active education of the public about the inherent dangers of added sugar in our diets and in most processed foods. some suggest that processed foods with excessive sugar calories should be properly labelled with some warning analogous to black box warnings on pharmaceuticals and tobacco products. the claim is that such information will help individuals to make informed decisions prior to eating any added sugary foods. conclusion some opponents assert that any intent to regulate, increase the costs, limit the size of added sugary drinks and processed foods interferes with individual liberties and the autonomy to make choices. furthermore, it is argued that such interferences may be synonymous to prohibitions that may not resolve the menace of excessive sugar consumption. in addition, in a free enterprise economy, is it ethical to suggest kornyo, you are what you eat: when personal choices become public issue the case of sugar, voices in bioethics, vol. 1 (2014-15) 3 to entrepreneurs and manufacturers as to what to do and the parameters with which to make their products? obviously these are seemingly cogent and justified points or counter arguments. but when there are competing rights between the individual and the public, sometimes individual liberties and choices may be construed to subsume in the larger public good. after all, as the court noted in jacobson v massachusetts: the liberty secured by the constitution . . . does not import an absolute right in each person to be . . . wholly freed from restraint. . . . on any other basis organized society could not exist with safety to its members. . . . he massachusetts constitution] laid down as a fundamental . . . social compact that the whole people covenants with each citizen, and each citizen with the whole people, that all shall be governed by certain laws for the ‘common good,’ and that government is instituted ‘for the protection, safety, prosperity and happiness of the people, and not for the profit, honor or private interests of any one man. as indicated in the introductory paragraph, there seem to be a truism in the assertion that we are what we eat. it is equally true that added sugar in our modern diet is flagrantly posing serious health issues with epidemiological proportions. added sugars as catalysts to type two diabetes and cardiovascular diseases/mortality are egregiously high. in view of the above evidence, it is the contention of this editorial that the time has come to re-debate the menace of the presence and the copious consumption of added sugar. it is diametrically a public health issue with ethical underpinnings worth legislating. any form of intervention to ameliorate the menace is in the interest of everyone. but charity begins at home. yes, sugar is sweet and satiates, but it also masquerades and causes many diseases as well. let the readers be the catalysts for this debate! 1 the quote is attributed to ludwig a. feuerbach 2 added sugar is to be distinguished from naturally occurring sugars in natural juices and other foods. 3 laura a. schmidt, phd. commentary in jama intern med. february 3, 2014. 4 ibid 5 ibid gibb, kansas state senate to declare surrogacy contracts against public policy, voices in bioethics, vol. 1 (2014-15) © 2014 tyler gibb. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. kansas state senate bill seeks to declare surrogacy contracts against public policy tyler gibb keywords: bioethics, ethics, surrogacy, public policy introduction the bioethics world has been abuzz lately over both the mcmath (13 year-old girl in california who suffered hemorrhaging after a tonsillectomy) and munoz (pregnant texas woman who developed aneurism) death by neurological criteria cases—and rightly so. the specter of judicial destabilization concerning the legal determination of death is likely to be one of the hot topics of 2014. but the judicial branch of the government is not alone in attempting to reopen issues once considered fairly well settled within the bioethics literature. analysis consider a newly introduced bill proposed in the kansas state senate. proposed by republican senator mary pilcher-cook, from johnson county, senate bill 302 (sb 302) in entitled “an act concerning surrogate parenting contracts.” sb 302 declares that “surrogate parenting contracts are hereby declared to be against public policy and such contracts shall be void and unenforceable.” not only will the contract be unenforceable, also the parties will be subject to criminal penalties. on monday, january 27, 2014, the senate public health and welfare committee heard testimony on the bill. the political and ideological lines were sharp. the bill’s sponsor argued that surrogacy potentially exploits poor women and encourages commodification of children. a pediatric nurse and president of the center for bioethics and culture, an advocacy group based in california, testified that surrogacy undermines the dignity of women, children and human reproduction. opponents of the bill, including parents of children born via surrogacy, argued that current kansas state laws adequately protect women against exploitation. a physician who specializes in infertility, dr. david grainger, argued that the law would have criminalized the birth of jesus christ, had it existed 2,000 years ago. reasonable people may disagree about the content, intent and potential impact of sb 302. this is not the first time the legitimacy of surrogate contracts has been challenged. the issue was first considered in the in re baby m case. that case involved enforceability a surrogacy contract. an infertile couple from new jersey, the sterns, entered into a surrogacy contract with mary beth whiteman, whom they located through an ad in a newspaper. whiteman’s own egg was used with stern’s sperm. this means that baby m was whiteman’s biological child, a traditional surrogacy. when the baby was born, whiteman decided to not give up the baby and the sterns filed suit to enforce the contract. the new jersey supreme court invalidated the contract as gibb, kansas state senate to declare surrogacy contracts against public policy, voices in bioethics, vol. 1 (2014-15) 2 violating public policy, but remanded the case to family court for determination of custody. eventually, the sterns were awarded custody and whitehead was allowed visitation. a similar case in california, calvert v. johnson, came to a different conclusion. the calverts were a married couple who were unable to have their own children. however, mrs. calvert and mr. calvert were capable of donating gametes, which were used to create a zygote. the zygote was implanted into ms. johnson for surrogacy. as was the case in the baby m case, after the baby was born, the woman who born the child refused to relinquish the baby. in that case, the court upheld the parental rights of the biological parents, not the gestational surrogate mother. conclusion more than the debate regarding public policy, careful bioethicists should be concerned about the use of vague or ambiguous language regarding surrogacy. as in the recent death by neurological criteria cases, the imprecise use of terms such as coma, life-support, and brain injury exacerbate conflict and confuse the facts— particularly in cases relying involving dynamic, evolving medical facts. in kansas, the failure to preserve precise definitions will muddy this debate as well. attempting to define surrogacy (the act which she finds worthy of laws to prohibit), pilcher-cook said it was “creating a child that you know is purposely not going to have either a biological mother, biological father or both.” the confusion here is palpable, were it not such an important issue for many infertile couples, it would be laughable. the advent of assisted reproductive technology has increased the permutations of parentage and surrogacy. distinctions are now made between traditional and gestational surrogacy, as well as between which parents or donors provide the gametes. the kansas senate bill, which is currently facing significant opposition, would criminalize all forms of surrogacy. if the kansas state legislature chooses to move forward with this law, it ought to provide some clarity and precision in the language, and then offer some reasonable justification. references kansas senate bill 302, available at: http://www.kslegislature.org/li/b2013_14/measures/sb302/ hanna, john (2014) kansas measure against surrogacy draws opposition, san francisco chronicle, january 27, available at: http://www.sfgate.com/news/article/kansas-measure-against-surrogacy-draws-opposition-5178143.php allen, anita l. (1988) privacy, surrogacy and the baby m case, georgetown law journal, 76, 1759-1792. bergstresser, mindscan, voices in bioethics, 2013 © 2013 sara bergstresser. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. mindscan: science fiction insights into the future of selfhood sara bergstresser science fiction is a ripe area for bioethical analysis. the consideration of how technology will impact lives in the future is of great concern to bioethicists, and the power of fiction can bring the energy of authentic human emotions and relationships to what might otherwise become a decontextualized endeavor. mindscan by robert j. sawyer (2005) is just the sort of book that can get us thinking in productive ways. the book is mainly set in canada in 2045. in this hypothetical future, there is a new technological possibility for extending life, though it is very expensive. a corporation named immortex has developed the mindscan process. a digital copy is made of the brain, and it is then transferred into an artificial body, which is designed to look like the original body at a selfidentified ideal age (with a few upgrades, such as removing bald spots and subtle enlargements to male genitalia). most individuals opting for this procedure are elderly and from the united states, where the regulatory climate is too conservative to support immortex or its process. of course, this procedure is also a commercial endeavor, and there are sales pitch seminars designed for the uncertain. the promise is not only a continuation of the authentic self, but also of the tantalizing possibility of eternal life: "our artificial brains congeal out of quantum fog, forming a nanogel that precisely duplicates the structure of the biological original. the new version is you your mind instantiated in an artificial brain made out of durable synthetics. it won't wear out. it won't suffer strokes or aneurysms. it won't develop dementia or senility. and... it won't die. the new you will live potentially forever" (20-1). at the center of the story is jake, a 44-year-old man with an incurable condition that may result in death at any time. this same condition is what left his father in a minimally conscious state for almost thirty years, and after waiting in vain the development of a cure, he has finally come to the conclusion that this new technology is his best option under the circumstances. of course, there is a catch. rather than actually transferred, consciousness is copied, leaving the original intact and needing a place to go. for this reason, the luxury retirement resort “high eden” has been created on the far side of the moon. the copy and the original can never meet, mainly to ensure the psychological health of the new version, and so the lunar trip is one way only. at the sales pitch, the original biological jake meets karen, an elderly woman who made her fortune writing children’s books. then, as the book proceeds after the split with two narratives of the two jakes, the second jake meets the second karen, now looking 30-years-old in her new artificial body. while bio-jake ascends to the moon, neo-jake attempts to adapt to his new body within his old life. of course, it is not as seamless as promised: his dog does not bergstresser, mindscan,, voices in bioethics, 2013 2 recognize him any more because he no longer smells right, and his mother and girlfriend are not quite comfortable with the new him. of course, we can not be surprised that surgery for the original jake’s incurable condition soon becomes available, leaving him facing forty more years in a home for the elderly. we also must expect that he wants to reclaim his life, whether it is forbidden or not. without giving away too much of the story, suffice it to say that he finds a way to return to earth. karen’s transformation is also an important component of this story. the new karen is rejected by her son. when she decides to continue her famous book series, he sues her in a court of law for copyright infringement. the resulting drama, questioning the legal validity of transferred selves and the continuities of selfhood, is a window into the philosophical arguments that are becoming immediately relevant to the world. a romance between new karen and old jake also poses interesting questions: does age difference mean as much when your body looks 30 and yet may be immortal? there are many questions that have extreme resonance for bioethics today and for the future. is the brain synonymous with mind? what about a soul? is continuous memory of selfhood the same as being the same self? one of immortex scientists points out an important scientific conundrum: “consider the fact that the atoms that make up your body are completely replaced every seven years: there’s not one bit of the you who was once a baby that still exists; it’s all been replaced. are you still you?” (25). while the exact details are still under debate, the fact remains: natural processes of material replacement are a reality. the body you had a child is now almost completely gone at a molecular level, yet you still remember your childhood. are you still you? mindscan: science fiction insights into the future of selfhood obiora anekwe, addressing forced duplicity, voices in bioethics, vol.1, 2014-2015 © 2014 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. addressing forced duplicity in black male identity and risky sexual behavior practices in tyler perry’s “the haves and the have nots” obiora anekwe keywords: movie, hiv/aids, african american, primary caregivers tyler perry has done it yet again. as writer, executive producer, and director of the own channel’s modern soap opera, the haves and the have nots, perry tactfully addresses the ethical challenge of forced duplicity in black male identity through the prism of risky sexual-behavior practices among african american homosexual men. for a number of years, many gay black men have been under societal pressure to conform and marry women. these practices eventually harm the entire family structure because many of these men live secret, closeted lives as homosexuals. in some cases, these men contract hiv/aids due to unsafe and risky sexual practices with other gay men, only to infect their wives or female partners. within the black community, this practice is known as “living on the down low.” although this ethical issue is seldom discussed in the african american community, especially within the traditional black church, unsafe and risky sexual practices by married homosexual men still unfortunately affect the entire black family, especially black women, who make up one of the leading groups of hiv/aids victims. in the season two episode (“again and again”), tyler perry highlights how “living on the down low” ultimately harms the medical good of society. the character, jeffrey, wants to live free from judgment for his decision to tell his parents that he is gay. his father, david, is very supportive of his lifestyle choice. jeffrey’s mother, veronica, on the other hand, is very judgmental and rejects his decision, only to forcibly blackmail him into living as a closeted homosexual young man. as a result, jeffrey goes through a crisis of black male identity because he tries to appease his mother by living as a heterosexual. in order to make jeffrey comply with her demands, his mother selects melissa, a beautiful african american young lady for him to date. although melissa is highly attractive, jeffrey initially resists her sexual advances after their first dinner date-only to have sexual intercourse with her later that evening. although he does not desire her sexually, jeffrey’s risky behavior of having unprotected sex with melissa contributes to the potentiality of acquiring hiv/aids. although the discussion of black male sexuality is a taboo subject within many black communities, it does not mean that the topic should not be discussed and confronted head on. as long as this troubling trajectory persists, a growing number of african american women with hiv/aids will continue to negatively impact their children’s upbringing. in the end analysis, children lose their primary caregivers because of this untimely disease. continuing educational health care initiatives through the black church is an effective means to help decrease the rate of african american women infected by hiv/aids because, in many cases, the makeup of this institution is mostly composed of black women. although some black churches have initiated hiv/aids programs in recent years since the escalated rise of hiv/aids cases, many black churches are resistant to facilitating public discussions or program initiatives on this significant public health problem. a much more concerted effort by the black clergy must play a significant role in promoting health care awareness surrounding hiv/aids prevention and educational awareness. because many facets of african american culture surround the black church, they are ethically bound and morally responsible for becoming change agents in the black community. the black church’s deliberate influence in hiv/aids awareness and prevention can make the most positive impact in health care advocacy. obiora anekwe, addressing forced duplicity, voices in bioethics, vol.1, ,2014-15 2 a false male identity based on stereotypical ideals of masculinity often poisons and deteriorates qualities of manhood that are otherwise valued. more salient values such as care, discipline, empathy, and responsibility are often replaced by a more abstract value system based on promiscuity, trickery, and thuggish mannerisms. oftentimes, contemporary society and the mass media feed into these false notions of black male identity through nonsensical and stereotypical portrayals of black men in popular music and television. these portrayals only promote externalized black male toughness based on mentally enslaved beliefs of low self-worth and value. tyler perry’s ingenious tackling of black male identity crafted in jeffrey’s storyline further shows that black men are complex and multilayered, full of contradictions like any other race of men. all in all, perry’s usage of hiv/aids awareness through a dramatic medium serves a multilayered purpose bringing to light the health care dangers of “living on the down low” while being cognizant of the fact that this practice ultimately harms black men, the black community, and those who they love the most. agredo, professional volunteers, voices in bioethics, vol. 1 (2014) © 2014 sebastian agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. professional volunteers: human guinea pigs in today’s clinical research sebastian agredo abstract pharmaceutical researchers are not only concerned about finding the most appropriate population of volunteers, they also need to do so as quickly as possible. the long-standing adage “time is money” is noticeably at play here. the more time the company takes to complete the enrollment of a sufficient number of subjects, the more time is taken away from the actual progression of the clinical trial. in order to achieve the best possible results in phase i, the drug’s developer relies on healthy volunteers, for it is a healthy population that is, “an indispensable requirement of the experimental design employed in the randomized clinical trials.” a healthy population helps to ensure that all participants start the trial in the same medical condition. keywords: research ethics, volunteers, research subjects, international medical research introduction in 1939, dr. william osler abbott used his opportunity with an audience at the charaka club in new york to recount the process for conducting necessary clinical research for his new gastroenterological technique for treating obstructions in the small intestine. the miller-abbott tube, as it is known, is a 10-foot long, double-lumen tube with a rubber balloon at the end which is blown up inside the intestine. after its development, abbott was immediately advised to test the new device in animals. however, he found this exercise to be a “waste of time” and instead focused his efforts on the “capture, selection, care and training of good healthy human guinea pigs”.[1] in doing so, abbott went against the better judgment of his colleagues, but he was also adhering to the tradition of experimental medicine set forth by claude bernard in the mid-19thcentury: “it is our duty and our right to perform an experiment on man whenever it can save his life, cure him or gain him some personal benefit”.[2] regardless of his determination, abbott’s contemporaries were skeptical of his ability to find healthy men and women eager to subject themselves to intubation, and rightly so. abbott’s research team made itself unpopular in the various hospital wards trying to find suitable agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 2 patients, and despite it being the height of the great depression, agencies, churches, and welfare organizations could not provide anyone keen on taking the $2 job as a human subject. even the destitute and desperate in philadelphia were unwilling to follow the doctor for a “short day’s work” at the hospital.[3] analysis it was not until abbott utilized a black janitor’s useful skill as a broker that willing research subjects began walking through his doors. within a short amount of time, the doctor was able to keep his “animals” in firm control. yet in 1935, abbott quickly learned an important lesson: human experimental subjects “are apt to be human”. his research subjects grew wiser and went on strike, demanding a raise right before an important exhibition at the american medical association; thus doing what no “dogs, cats, rats or rabbits that [he] had ever handled had done.”[4] abbott was only able to escape this minor crisis by imploring and securing the help of third-year medical students at the university of pennsylvania, offering them the same wage as his black professionals. needless to say, abbott’s once-reliable guinea pigs were fired, and he was forced to find a fresh source of willing subjects. he soon realized that the most effective way to find someone to work for him was to advertise to the masses in newspapers, and it was not long before his office was inundated with dozens of male and female volunteers ready to accept the task. abbott’s problems were solved, and as he states in his closing remarks to the charaka club, “the honorable and rapidly growing guild of tube swallowers [was] well established.”[5] it has been almost three-quarters of a century since those proceedings at the charaka club, but this anecdote serves as a backdrop to show how this specific characteristic of clinical research has not changed much in that time. it has merely been updated to fit the needs of modern-day dr. abbotts who take the form of pharmaceutical and research companies. phase i clinical trials have replaced abbott’s gastroenterological experiments, and they have exacerbated the phenomenon known as “guinea-pigging,” in which seemingly healthy volunteers offer themselves up as professional research subjects in exchange for monetary compensation. phase i clinical trials are a vital step in a drug’s progress from development to market. they are designed to test the safety of the drug, representing the first time that it is being exposed to human beings after having been evaluated in the laboratory and in animal subjects. whereas phase ii trials are used to measure the appropriate dosing requirements and “demonstrate therapeutic efficacy” and phase iii trials are larger scale comparisons of the drug’s efficacy against standard treatment, the purpose of phase i is to ascertain the possible side effects of the drug treatment.[6] in order to achieve the best possible results in phase i, the drug’s developer relies on healthy volunteers, for it is a healthy population that is, “an indispensable requirement of the experimental design employed in the randomized clinical trials.”[7] a healthy population helps to ensure that all participants start the trial in the same medical condition. should any physiological or psychological changes arise during the course of the trial, researchers are able to attribute these outcomes to, “the drug regimens to which the volunteers were exposed.”[8] to attain this kind of homogeneous population, clinical researchers screen potential candidates for existing medical conditions, making sure agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 3 to minimize the risk to volunteers by eliminating potential drug interactions. the ideal participants must be drug-free, non-smokers, who do not take any medications, and do not have any congenital conditions.[9] pharmaceutical researchers are not only concerned about finding the most appropriate population of volunteers, they also need to do so as quickly as possible. the long-standing adage “time is money” is noticeably at play here. the more time the company takes to complete the enrollment of a sufficient number of subjects, the more time is taken away from the actual progression of the clinical trial. this causes delays in subsequent phases, the drug’s fda approval, and its introduction to the lucrative pharmaceutical market. put one way, when a researcher was asked by the office of the inspector general of the department of health and human services about what sponsors were looking for when it comes to clinical trials, the researcher replied, “no. 1 – rapid enrollment; no. 2 – rapid enrollment; no. 3 – rapid enrollment.”[10] although speed is paramount, researchers cannot afford to rapidly enroll volunteers that do not meet the strict medical requirements, which would jeopardize the validity of the trial and put volunteers’ health at risk. the need to meet this overwhelming demand and expedite the process has caused a recent shift in the way phase i trials are conducted. whereas some pharmaceutical companies still prefer to run their own drug trials, many have found utility in outsourcing operations to universities and independent contractors known as contract research organizations (cros).[11] cros and other research institutions are incentivized to quickly attract a broad base of qualified research volunteers, for their recruitment and retention statistics are what make them stand out in the eyes of pharmaceutical companies. therefore, they not only offer competitive compensation – which can range from several hundred to several thousand dollars depending on the length of the trial – but some of the more lavish trial sites offer individual suites, internet access, pool tables, flat-screen televisions, and other desirable amenities.[12] although these facilities and financial benefits are a welcome improvement to the “prisonlike environments offered ten or more years ago”, this market-driven approach has effectively created a “new dynamic” in clinical research.[13],[14] essentially, the relationship between the researcher and the human subject has been relegated to that of a factory owner and a wage laborer. as carl elliott states, “the relationship…has become, more nakedly than ever, a business transaction.”[15] much like abbott’s “guild of tube swallowers,” there are those that seek to take advantage of the pharmaceutical industry’s never-ending need for healthy volunteers and reap the financial rewards. these individuals make up what has become a, “sub-population of normal volunteers…who participate in several studies, either simultaneously or over time.”[16] whereas clinical trial participants in the later phases are usually sick and might be motivated by altruism or the hope at receiving the therapeutic benefits of the tested drug, these professional guinea pigs cannot expect, “any therapeutic benefit to balance the risks they take.”[17] moreover, they do not hide behind the fact that money was the main incentive that attracted them to the clinical trial. a survey aimed at evaluating the, “weight of financial reward and other general details as seen by healthy volunteers who had already participated in clinical trials,” showed that 90% of “experienced volunteers” admitted that financial reward was the main reason to participate.[18]additionally, the survey revealed that 83.7% of respondents felt the compensation was adequate compensation considering the time spent and discomfort during the trial. agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 4 in light of these admissions, someone unaware of this growing trend in subculture might ask: who are these guinea pigs? are they not aware that they are responsible for the commodification of their bodies? roberto abadie’s ethnographic study of those who identify themselves as professional guinea pigs helps to answer these questions, providing insight into their lives. abadie’s study focused on 18 research subjects in philadelphia, which, along with houston, is considered a hotbed of clinical trials, offering plenty of “opportunities for aspiring human subjects.”[19] their ages ranged from 21 to 46, though most volunteers hovered around the midto late twenties. all but four of the volunteers were men; and all but one of them self-identified themselves as white or caucasian. the volunteers also covered a broad educational spectrum: one did not finish high school, four graduated high school, six completed some undergraduate study, six completed their undergraduate studies, and one was enrolled in a doctoral program. while three of the volunteers were homeowners, the rest lived in communal houses while paying rent. most did not have health insurance, with the exceptions of three volunteers who had employer-based hmo coverage. as was expected, when abadie asked about volunteers’ motives for entering clinical trials, all of the surveyed subjects declared that the trials were the ideal opportunity to “make easy money,” “quick money,” “a considerable amount of money in a relatively short time,” and a “huge sum.”[20] each of the professional guinea pigs studied by abadie understood their bodies to be commodities within the clinical trial context. they readily accepted the fact that pharmaceutical companies compensate them as “short-term agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 5 contractors,” for the “rent-use of the body and the inside operating fluids.”[21] they understood that their role as trial subjects comprises a kind of work inherently different from physical labor. one guinea pig described it as such: “it’s a weird kind of work in a ‘mild torture economy’ in which i am paid not to produce something, but to endure something.”[22] for this guinea pig, success in his line of work depended entirely on his ability to tolerate whatever physical or psychological pain came with the trial. this recognition on the part of such volunteers does a great deal to highlight the view held by industry--total denial that commodification takes place. using a series of “rhetorical moves” – much like the ones employed by the egg donation and ivf industry –pharmaceutical companies use the term “paid volunteers,” defined as those who, “receive financial compensation for time and travel expenses” to describe the guinea pigs.[23] this kind of language puts great stress and emphasis on the fact that the research subjects voluntarily enroll in the trials, which relieves pharmaceutical companies of any responsibility for the risks involved. however, this attitude disregards the reality that if not for the financial compensation, many, if not all, professional guinea pigs may not participate. they would, perhaps, seek out other ways to make “a quick buck.” between 1990 and 2001 there was a threefold increase in the number of enrolled research subjects.[24] by combining this fact with the awareness that abadie’s study only takes into account a small number of the self-identified professional guinea pigs, one can speculate that the prevalence of professional research subjects will continue to rise as the number of industry and government-funded clinical trials increase. such growth presents several ethical concerns that must be addressed for the sake of participant safety and the role of clinical research in medicine. in the case of clinical studies involving pharmaceutical drugs, subjects who participate in trials simultaneously or in quick succession endure increased safety and health risks. this is because, “multiplying the number of investigational drugs absorbed by a subject over a relatively short period of time can considerably increase the risk of severe adverse drug reaction.”[25] as mentioned above, financial compensation seems provide the greatest motivation for professional clinical trial participants. many willingly sign on to concurrent or successive studies because of increased financial benefit. such individuals may be ignorant of the risks inherent in that decision or choose to ignore the compounded risk altogether. a survey conducted in germany concluded that almost half of repeat volunteers who admitted to providing deceptive medical information to researchers, “did not see any risk associated with providing unreliable information.”[26] while study subjects may not see any risks in concealing the truth, the responsibility still lies with clinical researchers who must obtain appropriate information so to accurately discern candidate suitability for trials. the fact that financial motivation incentivizes deceit about medical histories, raises key ethical questions about informed consent and undue influence. the preeminent and guiding document with regard to ethical conduct in human subject research, the belmont report, clearly shows the incompatibility of the practice of guinea-pigging with clinical trials. the principle of respect for persons maintains that research subjects must be able to act autonomously, “capable agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 6 of deliberation about personal goals and acting under the direction of such deliberation.”[27] it is this principle that governs the process of informed consent, in which a capable research subject is free to choose what should happen to them. it could be argued that the professional subjects are not given all the necessary information to make an informed judgment regarding their willful participation in the clinical trial. those who choose to deceive research investigators may be doing so without the knowledge that participating in numerous drug trials carries significant health risks, and it is the duty of the researcher to ensure that the information is imparted to and comprehended by the subject. in addition, the subject’s consent to partake in the research study is only valid if, “voluntarily given…and free of…undue influence,” in which undue influence is constituted by offers of, “excessive, unwarranted, inappropriate or improper reward…in order to gain compliance.”[28] in abadie’s study, professional guinea pigs were well aware of the substantial risks involved – many having experienced them first-hand – but continued to enroll in multiple studies, spurred on by the promise of a big check at the end of the trial. many ethicists would argue that this alone suffices as undue influence--financial incentives hamper the ability to accurately weigh the risks and benefits associated with studies. thus, stricter safety guidelines must be enacted and enforced for the subjects’ safety. others would say that restricting their ability to freely choose participation in light of the information equals paternalism, violating the subjects’ rights to self-determination. finding a balance between protection and paternalism without compromising the subjects’ freedom of choice is a necessity moving forward. finally, it is evident that the principle of justice is at play in this case. the belmont report stipulates that the burdens and benefits of research must be justly distributed among members of society. it seems clear that those who offer themselves up as guinea pigs, “because of economic necessity may unduly bear the burden,” of clinical trials.[29] because many subjects are uninsured and poor, they participate in testing the safety of drugs that they could likely not afford once approved and released. guinea pig dependency on “contracts” with cros and pharmaceutical companies makes them easy, convenient targets for recruitment. and, although some professional guinea pigs welcome the extra opportunities, this should not be the case for all volunteer research subjects. given the current influence that pharmaceutical and research companies have on professional guinea pigs, one possible solution might be to eliminate payments to human research subjects. research could rely instead on altruistic reasons for participation. without undue influence preventing truly informed consent and enticing professional guinea pigs, the problem would be solved and the risks associated with repeat volunteering averted. however, this is a very idealistic approach. if clinical trial sponsors relied solely on altruism, “studies on healthy subjects would probably come to a halt.”[30] what drives the recruitment and retention of human subjects, especially guinea pigs, is the financial incentive. removing that from the equation would remove an integral component of the current infrastructure of phase i clinical trials. christine grady argues that denying research subjects money, “might have negative consequences because it could deny them a potential alternative income.” it is evident some professional guinea pigs depend on the earnings from trials to live a, “marginal lifestyle.”[31],[32]sheldon zink offers another rebuttal to the idea that halting payment would solve the issue. he points out that the, “healthcare system in the united states is a business based on payment for service and contracted agreements.” eliminating the opportunity for payment would potentially create a system of “real coercion for participation,” marked by drug manufacturers going to great lengths to ensure enrollment of human subjects in studies offering no individual benefit.[33] agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 7 the arguments above demonstrate that a focus on the payment of professional research subjects may be misguided, and misses the heart of the issue: existing guidelines are ill-equipped to deal with professional guinea pigs. the current regulatory framework has not been able to keep up with the “exponential growth in academic and commercial research activity,” and as a result, it has not been able to adequately address the rise of guineapigging.[34] the nih strongly advises volunteers to be honest and forthcoming with medical information, instructing them to “let the investigator know your participation in any other research studies – past, present, or planned.” yet it fails to identify the maximum number of trials in which a volunteer may participate per year.[35] furthermore, the fda’s guidelines for investigators state that, “trial subjects should not participate concurrently in more than one clinical trial…and should not be enrolled repetitively in clinical trials without time off treatment adequate to protect safety and exclude carryover effects.”[36] however, these guidelines do not provide specifics as to what is considered “adequate time of” or the “carryover effects.” by not providing enough elaboration and explanation to study investigators, the fda is putting the onus on researchers to judge what is appropriate. until federal guidelines are more straightforward in addressing the issue at hand, the current situation of professional guinea-pigging in clinical research will continue unimpeded. whereas the issue of “professional volunteerism” has received little attention in the united states, the united kingdom and france have enacted restrictions and established centralized registries to keep track of the increasing number of volunteer human subjects.[37] taking a similar approach, it seems only logical that responsible investigators maintain a database of volunteers at the institutional level. with these registries in place, investigators would be able to better communicate with each other regarding the participation of professional guinea pigs; and more importantly, they could “help prevent adverse events associated with a volunteer who is participating in simultaneous studies, or who has not allowed enough time to elapse between studies.”[38] analysis of the effectiveness of these institutional registries could provide insight into the proper implementation of a national registry of human subjects. these efforts are not meant to eliminate the freedom that guinea pigs enjoy in participating in clinical trials for the purpose of financial gain. they would, however, provide professional subjects with greater protections from unnecessary, increased risk. conclusion the future of clinical research and the safety of new drugs will continue to depend on the willingness of healthy volunteers to participate in clinical trials. it seems “inevitable that the job will fall to people who have no better options.”[39] without much official guidance or protection, professional guinea pigs have to rely on each other and watchdog or independent groups, such as citizens for responsible care and research (circare) and centerwatch, for reliable information regarding clinical trials and human subjects protection. further investigation into the unique social and economic needs of this sub-population of human research subjects, like the ethnographic study undertaken by roberto abadie, is an essential step in the construction of an ethical and practical framework aimed at improving the conditions of clinical research and ensuring the safety of trial participants. agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 8 photo by karlijn prot on unsplash reference notes [1]abbott, w. osler. “the problem of the professional guinea pig.” proceedings of the charaka club. new york, 1939. 249-60. [2]bernard, claude. “an introduction to the study of experimental medicine.” in medicine and western civilization, by david j. rothman, stephen marcus and stephanie kiceluk. new brunswick, nj: rutgers university press, 1995. [3] abbott, the problem of the professional guinea pig. [4] ibid. [5] ibid. [6]elliott, carl. white coat, black hat. boston, ma: beacon press, 2010. [7]abadie, roberto. professional guinea pigs: big pharma and the risky world of human subjects. durham, nc: duke university press, 2010. [8] ibid. https://unsplash.com/@karlijnfrederique?utm_source=unsplash&utm_medium=referral&utm_content=creditcopytext https://journals.library.columbia.edu/s/photos/guinea-pig?utm_source=unsplash&utm_medium=referral&utm_content=creditcopytext agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 9 [9] abadie, professional guinea pigs: big pharma and the risky world of human subjects. [10] elliott, white coat, black hat. [11] abadie, professional guinea pigs: big pharma and the risky world of human subjects. [12] ibid. [13] ibid. [14] elliott, white coat, black hat [15] ibid. [16] tishler, carl l., and suzanne bartholomae. “repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials?” perspectives in biology and medicine, 2003: 508-20. [17] elliott, white coat, black hat. [18] bigorra, j., and baños, j.e.. “weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials.” european journal of clinical pharmacology, 1990: 443-446. [19] abadie, professional guinea pigs: big pharma and the risky world of human subjects. agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 10 [20] ibid. [21] ibid. [22] ibid. [23] ibid. [24] lemonick, michael d., and andrew goldstein. “at your own risk.” time, april 22, 2002. [25] jaillon, p. “healthy volunteers data bank: where and how.” fundamental & clinical pharmacology, 1990: 177s-181s. [26] hermann, r. “adverse events and discomfort in studies on healthy subjects: the volunteer's perspective.” european journal of clinical pharmacology, 1997: 207-14. [27] the national commission for the protection of human subjects of biomedical and behavioral research. “the belmont report”. 1979. [28] ibid. [29] tishler and bartholomae, “repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials?”. agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 11 [30] elliott, white coat, black hat. [31] grady, christine. “payment of clinical research subjects.” the journal of clinical investigation, 2005: 168187. [32] abadie, professional guinea pigs: big pharma and the risky world of human subjects. [33] zink, sheldon. “maybe we should pay them more.” american journal of bioethics, 2001: 88-89. [34] national bioethics advisory commission (nbac). ethical and policy issues in research involving human participants. bethesda, md: nbac, 2001. [35] nih clinical center. program for healthy volunteers. n.d. http://clinicalcenter.nih.gov/participate/studies/healthy_vol_prg.shtml. [36] tishler and bartholomae, “repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials?”. [37] ibid. [38] ibid. [39] elliott, white coat, black hat. agredo, professional volunteers, voices in bioethics, vol. 1 (2014) 12 masters, ethics of brazilian abortion law, voices in bioethics, vol. 3 (2017) © 2017 alix masters. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduc tion, provided the original author and source are credited. the ethics of brazilian abortion law in the age of zika: a pro-choice, pro-disabled-rights perspective alix masters abstract as a woman who believes whole-heartedly in the human right to safe and legal access to abortion regardless of circumstance, it is rare i find myself balking at a movement to extend legal access to abortion. however, in the case of brazil’s zika epidemic, i am struck by an ethical dilemma. brazil, a historically pro-life country, is currently considering reforming their anti-abortion laws exclusively in cases of fetal defects caused by zika infection. i strongly believe reproductive rights are human rights, however, if the only exceptions made in allowing safe and legal access to abortion are in cases of a disabled fetus, we as ethicists must pause. the fact that in brazil, a country with a strong moral and legal belief in fetal personhood, lawmakers are willing to abandon this belief solely in cases of the physically and intellectually disabled presents dangerous infringements on disabled individuals’ rights. furthermore, advocating for legal abortion solely in the case of fetal disability is ethically wrong and has historically eugenic undertones. as a pro-choice individual, it is essential to consider the ethical concerns that exist even in movements advocating for anti-abortion law reform. keywords: public health, abortion law, zika virus, pro-choice introduction as a woman who believes whole-heartedly in the human right to safe and legal access to abortion regardless of circumstance, it is rare i find myself balking at a movement to extend legal access to abortion. however, in the case of brazil’s zika epidemic, i am struck by an ethical dilemma. brazil, a historically pro-life country, is currently considering reforming their anti-abortion laws exclusively in cases of fetal defects caused by zika infection.1 i strongly believe reproductive rights are human rights, however, if the only exceptions made in allowing safe and legal access to abortion are in cases of a disabled fetus, we as ethicists must pause. the fact that in brazil, a country with a strong moral and legal belief in fetal personhood, lawmakers are willing to abandon this belief solely in cases of the physically and intellectually disabled presents dangerous infringements on disabled individuals’ rights. furthermore, advocating for legal abortion solely in the case of fetal disability is ethically wrong and has historically eugenic undertones. as a pro-choice individual, it is essential to consider the ethical concerns that exist even in movements advocating for anti-abortion law reform. masters, ethics of brazilian abortion law, voices in bioethics, vol. 3 (2017) 2 analysis brazil, a predominately roman catholic country, has maintained historically restrictive abortion laws. it is a foundational belief of the catholic church that life begins at conception and therefore the termination of pregnancy is akin to murder. 2 thus, obtaining an illegal abortion is a crime punishable by up to three years imprisonment. 3 up until 2012, abortion was prohibited unless the pregnancy posed a significant risk to the woman’s life, or the pregnancy in question resulted from rape. however, in 2012 the supreme federal court of brazil ruled to legalize abortion in the case of fetal anencephaly.4 notably, the brazilian supreme court was able to make this decision by intentionally skirting the catholic belief in fetal personhood. since anencephaly leads to death immediately following birth, the court argued that in cases of anencephalic fetuses, abortion did not violate catholic beliefs since anencephalic infants were not living persons.5 in the current era of the zika epidemic, which has affected brazil significantly, brazilian lawmakers and advocates are fighting to amend these restrictive abortion laws. this is due to the fact that zika viral infection in pregnant women has been linked to fetal microcephaly and other significant birth defects characterized as congenital zika syndrome.6 as a result of these findings, advocates have argued to extend legal abortion status to pregnant women infected with zika as a legal way to terminate fetuses that will likely result in permanently disabled infants. it is important to note the differences between microcephaly -congenital zika syndrome -and the current exception to brazilian abortion law, anencephaly. infants born with anencephaly typically die within the first hours or day of birth, whereas in the case of microcephaly, diagnosed individuals can live up to 35 years and longer depending on the severity of the disease.7 therefore, the issue of personhood is not so easily skirted legally and morally in brazil. advocates for legal abortion in cases of zika infection argue that women should have the right to terminate a pregnancy that will likely result in an infant with severe birth deformities and disabilities. however, in a country that strongly adheres to the catholic belief that life begins at conception, it is imperative to consider what the ethical implications are on the rights of disabled individuals by making selective abortion law exceptions in cases of microcephaly. i recognize that raising any infant, but specifically a disabled infant is costly, both for the parents and for the state. additionally, reproductive freedoms are particularly limited to women of low socioeconomic standing. therefore, i do not mean to convey that abortion should not be allowed in cases of disability, or that abortion in cases of disability are always eugenic in nature. on the contrary, pregnant women should be able to weigh the pros and cons, economically and emotionally, before deciding to give birth to an infant. i also believe women should be allowed to abort a fetus under any circumstances without judgment. however, when the state makes exceptions exclusively in cases of disability, it poses numerous ethical concerns. there is a long and complicated global history between the movement for reproductive freedoms and disability rights movements. for example, in the united states, margaret sanger founded planned parenthood, an organization essential to providing safe and affordable reproductive healthcare, including abortions, on the principles of the eugenics movement.8 although it is likely sanger aligned herself with the mainstream eugenics movement of her time as a strategic way to broaden her message of a woman’s right to reproductive freedom, the unfortunate association remains historically documented. sanger is famously quoted as saying in 1921 that “the most urgent problem today is how to limit and discourage the over-fertility of the mentally and physically defective.”9 even feminists and strong reproductive rights supporters must recognize the eugenic potential of extending these rights only in specific circumstances. in a country like brazil, where life is believed to begin at conception and abortion is criminalized with little exception, it should raise ethical questions when exceptions are being made for disabled fetuses. additionally, these laws surrounding abortion present larger ethical issues that extend beyond reproductive rights. for example, if disabled fetuses are deemed specifically disposable simply for masters, ethics of brazilian abortion law, voices in bioethics, vol. 3 (2017) 3 their disability, what does this potentially suggest for the disabled community of brazil at large? this ethical framework could provide a precedent that works to justify the limitations of the rights of the disabled. all this being said, i do not believe reproductive rights and the rights of disabled individuals are inherently at odds with one another. on the contrary, i believe there are important connections between the limitation of women’s reproductive freedom and the oppression of disabled individuals, including intersecting class and race oppressions. perhaps the most famous example of this in the united states is the case of buck v. bell of 1927. under the mainstream eugenics movement, the u.s. supreme court ruled in favor of allowing forced sterilization of women who were deemed intellectually or physically unfit. in this case, disabled women’s bodies were forcibly sterilized without their consent by the state to promote a eugenic and able-ist agenda.10 similarly, there is a long history in brazil of sterilizing women with hiv often under dubious consent.11 although sterilization is a common form of birth control for brazilian women due to stringent anti-abortion laws, there are considerably higher rates of sterilization in populations of indigenous and brazilians of afro-descent, strongly suggesting racial prejudice in these practices.12 conclusion reproductive rights and disability rights are not inherently in conflict. however, when access to abortion is morally and legally restricted, as in brazil, making exceptions only in the case of disabled fetuses is ethically wrong. in a country where life is believed to begin at conception, abortion law exceptions in the case of zika strongly suggests and justifies the idea that disabled individuals are valued less by society. furthermore, it also perpetuates historical eugenic beliefs that have advocated for genocide. this is not to say i believe brazil should not work towards wide-ranging abortion law reform. on the contrary, i believe it is imperative that women in brazil and across the world are granted holistic and unrestricted reproductive freedoms to make their own choices regarding childbirth regardless of their circumstances. there is an ethical responsibility that women should be allowed safe, legal, and affordable abortions whenever needed and/or wanted including in cases of fetal disability if the pregnant woman so chooses. however, i do not believe that legal abortion should be exclusively granted solely in cases of fetal disability. granting legal abortion specifically in cases of fetal disability but not in other circumstances (besides rape and risk to maternal health) presents dangerous ethical implications that disabled populations are worth less than their fellow able-bodied citizens. ____________________________________________________________ references 1 boseley, sarah. "zika emergency pushes women to challenge brazil's abortion law." the guardian. guardian news and media, 19 july 2016. web. 03 july 2017. 2 catechism of the catholic church intratext. n.p., n.d. web. 03 july 2017. 3 human rights watch: women's human rights: abortion. n.p., n.d. web. 03 july 2017. 4 ray, audacia. "brazil: supreme court makes abortion legal in cases of anencephaly." international women's health coalition. n.p., 21 nov. 2013. web. 03 july 2017. 5 luna, naara. "anencephalic fetuses and research embryos: subjects of rights?" estudos feministas. revista estudos feministas, n.d. web. 03 july 2017. 6 "zika virus." centers for disease control and prevention. centers for disease control and prevention, 26 apr. 2017. web. 03 july 2017. 7 "microcephaly – life expectancy, pictures, definition, treatment." medical treasure. n.p., n.d. web. 03 july 2017 8 "margaret sanger, race and eugenics: a complicated history." time. time, n.d. web. 03 july 2017. masters, ethics of brazilian abortion law, voices in bioethics, vol. 3 (2017) 4 9 "the eugenic value of birth control propaganda." the public papers of margaret sanger: web edition. n.p., n.d. web. 03 july 2017. 10 buck v. bell, 274 u.s. 200 (1927) 11 "hiv-positive women in northeast brazil: tubal sterilization, medical recommendation and reproductive rights." taylor & francis. n.p., n.d. web. 03 july 2017. 12 sterilization in brazil. n.p., n.d. web. 03 july 2017. eshikena, taxpayers funding sex change, voices in bioethics, vol. 1 (2014-15) * marilyn eshikena, ms bioethics © 2014 eshikena. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. taxpayers funding sex change marilyn eshikena* keywords: taxpayers, sex change, bioethics, ethics, sex reassignment when convicted murderer robert kosilek sued the commissioner of the massachusetts department of corrections for refusing to provide major sex reassignment surgery to treat his severe gender identity disorder, candace ogonowski created the petition “stop the taxpayer funded sex change operation” on change.org. despite the petition and the defense arguments during kosilek’s trial this january, the u.s. circuit court of appeals ordered that the state is compelled to provide kosilek the sex change he desires. although the specifics of the kosilek case yielded talking points regarding justice in the realm of medical procedures for inmates, the government had refused medicaid payments for surgeries deemed medically unnecessary until now. the new ruling, removing sex reassignment surgeries from the list of medicaid ineligible procedures, came as a result of a 74 year-old man’s request for genital excavation in order to obtain the semblance of a vagina. although there is no general consensus among medical professionals regarding the necessity of sex reassignment surgery to treat gender identity disorder, this ruling may serve to validate this procedure. but as many frowned at the initial kosilek ruling, there are a number of taxpayers that will not find this development favorable. small, achieving equity and agreement, voices in bioethics, vol. 6 (2020) * pageen manolis small, ms, bsn © 2020 pageen manolis small. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distrib ution, and reproduction, provided the original author and source are credited. achieving equity and agreement: the importance of inclusion of marginalized groups in hospital policy initiatives pageen manolis small* abstract as a nurse and an ethicist who has been involved in many discussions within both my community and its local healthcare institutions, i recognize a distinct need for input from diverse healthcare workers and community members. keywords: covid-19, marginalized groups, hospital policy introduction as people adjust to the impacts of the covid-19 pandemic, many have expressed a myriad of diverse views regarding pandemic policies and who should be included in the decision-making process. the dispute may stem from lack of trust, inadequate communication, and lack of transparency. certain groups and individuals may be underrepresented in response planning. this is particularly relevant at the community level where individual institutions serve unique populations, multiple minority groups, and those with diverse needs. improving communication and increasing inclusion in decision-making discussions are necessary to develop management plans that are appropriate and acceptable for diverse, unique communities. as a nurse and an ethicist who has been involved in many discussions within both my community and its local healthcare institutions, i recognize a distinct need for input from diverse healthcare workers and community members. ____________________________________________________________ small, achieving equity and agreement, voices in bioethics, vol. 6 (2020) 2 analysis including more voices in the discussions would improve decision making and broaden agreement with pandemic management plans. some may initially think that adding more voices would exacerbate disagreements and would be prohibitive to operationalizing responses in two ways. first, the logistics of larger group meetings can be challenging, particularly when many are currently facing new burdens and changing roles. second, additional points of view add time to discussion and negotiation of decisions. this paper asserts the logistics and added time are worth the efforts. if we can promote inclusion and solicit buyin early in the process, more comprehensive and meaningful plans can be made that will prevent disagreements that call for revision or reconsideration after the policies are in place. individual hospitals, medical centers, and other healthcare facilities have an obligation to create plans that meet the specific and unique needs of their community. we are an individualistic society, and while the pandemic shifts us toward a more pluralistic public health foundation for decision making, members of our society still want to know that their individual needs will be met, particularly by their community healthcare providers. for example, members of disabled groups report a decrease in access to care during pandemic related restrictions1 and express concern that management plans may exacerbate discrimination against those with disabilities.2 members of certain racial and ethnic groups have already been and continue to be disproportionately impacted by covid-19.3 additionally, many community members who feel alienated by government processes are more vulnerable to the economic and social downsides of stay-at-home orders and restrictions,4 and in some cases, they face counter-protests from healthcare workers exacerbating the divide.5 transparency and representation in decision making foster trust. an organized opportunity to engage in discourse allows all to consider multiple points of view. a main tenet of an ethically appropriate response to a pandemic, broadly or at the hospital or community level, is a shift from prioritizing individualized care to public health needs.6 some individuals are being asked to sacrifice for the good of everyone. their less pressing medical needs may be temporarily put on hold while the crisis consumes more healthcare resources. as healthcare providers, our goal is to do “for” patients, rather than to do “to” patients. healthcare institutions should incorporate the perspectives, goals, and recommendations of multidisciplinary staff and community members and consider all potential hardships to create policies that encourage public health goals. in developing policies, organizations, hospital systems, and the government may overlook special considerations of marginalized communities if those communities are not brought into the discussion. hospitals must try to find a member or members of a marginalized group who can truly represent the group and its interests. it is both presumptive and discriminatory to suggest that a member of any one group is willing and able to speak for that entire group. the goal, creation of a diverse decision-making group, can be met by engaging diverse interprofessional staff, the institution’s diversity department, the institution’s patient advisory group, local social justice groups, and other community leaders to identify appropriate representatives of marginalized groups. hospital planning leaders should invite representatives to planning meetings and seek their input through forums and questionnaires that ensure their voices are heard and respected. one of the goals of ethical discussions is to create “moral spaces” where ethicists facilitate discussion and reflection and foster broader and deeper ethical discussions.7 to create an ideal moral space, the goal should be discussion rather than debate. people will not always agree with each other, but they can seek to understand each other opening the possibility of consensus in important policies. the goal of pandemic management discussions should be understanding others and coming together to meet the needs of the small, achieving equity and agreement, voices in bioethics, vol. 6 (2020) 3 public in an equitable and non-discriminatory way. all participants should be empowered to share their views and know that those views will be respected, they belong in the meeting, and can truly influence the outcome. institutions must include voices of marginalized groups in final decisions. this is particularly relevant at the community level where members of marginalized groups are our co-workers, family, friends, and neighbors. conclusion society’s response to the pandemic provides insights into inequity within our healthcare structure and highlights community concerns about public health responses. at the local level, there is an opportunity to shift toward more inclusive public health policies creating a more fair and well-accepted system and improving outcomes. by reaching out to the broader community as well as including diverse health professionals from within the hospital system, local healthcare facilities are well positioned to create meaningful change ensuring that marginalized groups drive the policies that affect them. 1 abigail abrams, “’this is really life or death.’ for people with disabilities, coronavirus is making it harder than ever to receive care,” time, april 24, 2020, retrieved from https://time.com/5826098/coronavirus-people-withdisabilities/ 2 stephanie collins and jane buchanan, “us disability groups push for equality in covid-19 response: successful challenge to discriminatory language in alabama’s emergency care plans,” human rights watch, april 22, 2020, retrieved from https://www.hrw.org/news/2020/04/22/us-disability-groups-push-equality-covid-19-response# 3 apm research lab staff, “the color of coronavirus: covid-19 deaths by race and ethnicity in the u.s.,” apm research lab, april 28, 2020, retrieved from https://www.apmresearchlab.org/covid/deaths-by-race; centers for disease control and prevention (cdc), “provisional death counts for coronavirus disease (covid-19): data updates by select demographic and geographic characteristics,” national center for health statistics, april 21, 2020, retrieved from https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/ 4 kirk siegler, “across america, frustrated protesters rally to reopen the economy,” npr, april 18, 2020, retrieved from https://www.npr.org/2020/04/18/837776218/across-america-frustrated-protesters-rally-to-reopen-theeconomy 5 liz neporent, “coronavirus social: healthcare stands up to covid-19 protesters,” medscape, april 21, 2020, retrieved from https://www.medscape.com/viewarticle/929082 6 douglas b. white, mitchell h. katz, john m. luce, and bernard lo, “who should receive life support during a public health emergency? using ethical principles to improve allocation decisions,” annals of internal medicine 150, no. 2 (2009): 132-138. doi:10.7326/0003-4819-150-2-200901200-00011 7 margaret urban walker, “keeping moral space open: new images of ethics consulting,” the hastings center report 23, no. 2 (mar-apr, 1993): 33-40, doi:10.2307/3562818; ann b. hamric and lucia d. wocial, “institutional ethics resources: creating moral spaces,” the hastings center report 46, no. s1 (2016): s22-s27, doi:10.1002/hast327 https://time.com/5826098/coronavirus-people-with-disabilities/ https://time.com/5826098/coronavirus-people-with-disabilities/ https://www.hrw.org/news/2020/04/22/us-disability-groups-push-equality-covid-19-response https://www.apmresearchlab.org/covid/deaths-by-race https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/ https://www.npr.org/2020/04/18/837776218/across-america-frustrated-protesters-rally-to-reopen-the-economy https://www.npr.org/2020/04/18/837776218/across-america-frustrated-protesters-rally-to-reopen-the-economy https://www.medscape.com/viewarticle/929082 holmquist, aids in new york, voices in bioethics, 2013 © 2013 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. aids in new york: the first five years stephanie holmquist it’s just a snapshot of a group of men, at a glance one can see it’s from 30 or so years ago. you might guess it’s a group of gay men, something about the mustaches, the clothes, the shirtless man in the foreground. none of them is yet fully middle aged. if you didn’t know otherwise, the smiles and camaraderie signal an evening ahead of dinner, wine, talk—an ordinary happy occasion. but then there are the name tags. the photo, from a conference of activists in denver in 1983, marks a turning point in the modern patient empowerment movement. this small group of men gave us the denver principles—the landmark response from the gay community to the crisis in medicine and medical ethics of the early 1980’s. they called themselves “people with aids,” neither victims nor patients, but whole persons who expected to be treated as such. national association of people with aids (napwa), the organizational home of the denver principles, dissolved this year. the ethos of the denver principles lives on for pwa and hiv and also in the general expectation of patient empowerment and dignity for all kinds of “people with…” and others facing medical challenges. aids in new york: the first five years winter 2015 starting the conversation randi belisomo follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 “you don’t seem to realize the fact that you’re white.” the voice on the line stung with derision, palpably piercing my senses more directly than the westward summer sun blanketing the balcony where i sat. i was home, near chicago’s loop, and that call to a colleague on the south side of town unsettled my surroundings that just moments ago were comfortable. i twitched with new uneasiness in my skin, fair but reddened by the season’s recreation. “is that really what you want me to know?” i asked timidly, the confident tone once transparent through the telephone had transformedcrumbled, perhapsto credulity. “yes, because they’re not going to like that message, especially coming from you,” she replied, unaware of the capacity her words had to wound. i had not given much consideration to race when embarking on the project at our conversation’s core, but my own race wasn’t something i took for granted. i looked out from a more privileged perspective upon a city cut into colored chunks, along racial lines. in my work as a journalista street reporteri had spent a decade knocking on doors, sitting in schools and attending meetings on chicago’s streets-straight lines of colorblack, brown or white. though residents may not have mixed with each other, they mixed with me-eager to share what mattered. i was equally eager, ready to record and replay it on the evening news. the difference between their race and mine didn’t keep them from wanting to be heard, and i thought this instinctively human desire could drive the project to success: promoting self-determination among chicago’s senior citizens when they neared the end of life. that’s the reason i called her: an african-american minister familiar with healthcare challenges within her congregation. she was dedicated to palliative chaplaincy and reinforced stereotypes my friends in medicine sometimes lamented. “my people,” she called them, “will always do everything.” not knowing what to say, i said nothing. perhaps i feared saying the wrong thing, knowing this conversation had taken a turn i didn’t know how to navigate tactfully. i could widen a divide already deep. while reasons behind the minister’s rationale were valid, i knew statistics and stories didn’t support her claim. most don’t want everything; what most want when they die is to be comfortable, pain-free and surrounded by those they love. voices in bioethics 3 “i’m sorry to hear that,” i responded, finally getting out words. her generalizations were not always the case, and when they werei surmised a dearth of information sometimes drove them. stereotypes ticked me off, while the notion they were “her people” put me off. it also got me off the phone. they were not her people, any more than those downtown were mine. neither were the puerto ricans a mile west those of my late husband; his death from colon cancer at 36 a few years prior drove my decision to enter end-of-life care education. the minister’s sentiments were difficult to shake as i opened the squeaky metal doors of the municipal building a week after that conversation. mary and i were there to have a conversation ourselves, one we hoped would go better. mary is white, too, with a freckled, ruddy irish face. however, as a medical oncologist, she had faced many patients who had given little thought to their end-of-life care. she knew the main reason why: most providers, like herself, gave little thought to giving patients the time and place for such considerations-when they were healthier and thinking more clearly than when she met them, on or close to the worst day of their lives. the day of diagnosis. because these conversations weren’t happening in her office, or those of her peers, she was heading out with me to have them where they could perhaps be better facilitated on neutral, neighborhood ground. without lab coats, stethoscopes and sterile scenery of exam rooms. without facing emergent crises. mary and i first collaborated months prior, believing our skills as physician and journalist could communicate clear messages of empowerment regarding end-of-life issues. from our vantage points as provider and caregiver, we saw realities representing data: care was not aligning with patient preferences. americans across the country and neighbors in chicago were not dying in the ways they wished. the issue is unique within healthcare because it is the opposite among patients. the universality of end-of-life experiences drove our urgency to encourage all to speak up and spell out the healthcare they want. beyond that squeaky door, a receptionist smiled beneath the sign: englewood senior center. voices in bioethics 4 “you’re the ladies in the photo,” she said, standing up, leading us to our podium. “what photo?” we asked simultaneously. “the photo on the flyer,” she exclaimed, pointing to the bulletin board-surprised we didn’t know how this worked. our nervous laughter lent evidence this visit was the first on our tour of 22 senior centers. the department on aging invited us to visit 60 and older patrons in every neighborhood, talking about end-of-life discussions, how to start them, and how to document preferences in advance directives. we called our presentation, “starting the conversation,” and the warmth of the receptionist in an englewood community i had only previously visited for crime-centric news coverage will be remembered. the institutional walls and linoleum floors seemed coated with kindness entirely unexpected. i dismissed the minister’s forewarnings and my recollections of trips to this block. inside the community room were two-dozen seniors on a tuesday morning, seeking refuge from loneliness in the company of peers. but they also waited to hear from two traveling from 60 blocks away. two much-younger ladies-ones they knew from the flyer happened to be white. i was anxious, but the turnout was a positive sign. we were there to help, and unlike prior visits to this area-i wasn’t looking for anything to take back up the dan ryan expressway to a downtown news studio. this trip would be for the seniors’ benefit. we were giving time, hoping only for attention in return. perhaps our talk wasn’t taboo. perhaps we were accepted. one hand was raised. nodding to a warm-up suited-woman, i said “hi.” “my kids won’t discuss it,” she projected mindfully, ensuring friends older and frailer could hear. “i don’t know what to do with them, but i know what they’ll do with me!” “what’s that?” mary smiled. voices in bioethics 5 “keep me around forever! but one day, i’ll be ready to go!” we were off-script, but it didn’t matter. three others nodded-hers was the reason they were here. one voice followed another, and then one more. they were ready to talk. some stories centered on health challenges of friends-intubated in intensive care units where they never wished to be. others discussed their own health scares and fears harbored about sharing care wishes. some questions we could answer: “how do i talk to my daughter?” “why hasn’t my doctor addressed this?” “will i be uncomfortable if i opt against artificial nutrition?” “how do i choose a decision-maker?” “what do i do with my advance directive?” others were harder: “what if i have no family to speak for me?” “what if i trust no one with my care?” it wasn’t hard to fill our one-hour slot, before the 11 a.m. zumba bell chimed. this crowd was active and healthy (two impressive indicators i noted) assuring them this was an ideal time to talk. tough decisions aren’t best made in times of stress or crisis. mary outlined options for consideration. this was the first time most had heard implications of intensive and non-intensive care. most medical talk was new to them; many technological measures were not ones their grandparents had the option of choosing. the seniors then heard from me. we had a conversation about conversation itself and how to discuss tough topics. reluctant adult children, i said, can often be persuaded to voices in bioethics 6 listen when conversations are framed differently. the seniors knew they were doing loved ones a favor in expressing preferences, but many loved ones wouldn’t hear it. instead, i explained, ask them to do a favor for you. ask them to give you the gift of time. deep down, the seniors knew this gift is theirs to give. deep down, i hoped to give the seniors gifts of clarity and confidence deserved after lifetimes well-lived. everyone left for zumba with an advance directive. if they did nothing else, we asked them to appoint a surrogate decision-maker. most asked for extras for family members and neighbors. a few called that night to ensure they completed the form correctly. with one center visited, mary and i had 21 to go. the seniors may have looked different, but the concerns were the same. “no one wants to talk about this!” “how do i have the final word?” “how do i make sure my daughter doesn’t pry me from bed and to the e.r. when i’m taking my last breath?” though thoughts were shared through smiles, concerns were serious. we took surveys at each stop and the responses reflected reason for worry. the majority of the seniors had never discussed end of life care with anyone, even though a similar majority said they thought about care they desired. most knew who would speak for them in a crisis, but most had never discussed this with that person. most had never heard of advance directives. one in ten had completed an advance directive, fewer than the national average. the disconnect between the end-of-life care most receive and the end of life care they desire led us to another disconnect in our citya knowledge gap. seniors weren’t preparing for end of life care. not because they didn’t want to plan. not because they didn’t want to discuss it. not because they wanted everything.they weren’t planning because no one had taken time to show them how and answer questions bothering them. questions they had, until then, were kept to themselves. many health care providers say the biggest challenge when patients don’t outline preferences is trying to guess for them, often picking between bad options. the patient, intubated or unconscious, has no say. voices in bioethics 7 one senior center at a time, mary and i are trying to give more seniors a say. we’re going back this fall, and with each visit, we hope we get better in helping the voiceless find a voice. no matter what divides us, those differences dissolve when discussing the basic desire to be heard. it seems like a fundamental right: when it comes to our own healthcare, we all should have the last word. i’m glad i didn’t allow the minister’s last words to determine our project’s fate. this city’s seniors? they are our people. listen to what they have to say. ducar, the boundaries of treating ebola, voices in bioethics, vol. 1 (2014-15) © 2014 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the boundaries of treating ebola dallas ducar ebola, experimental drug, cdc introduction on july 29th, 2014 the doctor who was leading the charge in sierra leone against ebola, sheik umar khan, was pronounced dead. the man who had dedicated his life to fighting the ebola outbreak had been fighting for his own life against the virus. just days earlier, two relief agencies – doctors without borders and the world health organization – were deciding on whether to give the doctor a drug which had never been tested on people. ____________________________________________________________ ducar, the boundaries of treating ebola, voices in bioethics, vol. 1 (2014-15) 2 analysis dr. khan would be the first person on the planet to receive this experimental drug for ebola, known as zmapp. according to the u.s. center for disease control (cdc), “it is too early to know whether zmapp is effective, since it is still in an experimental stage and has not yet been tested in humans for safety or effectiveness.”1 according to those who made the decision, the doctors feared fueling the suspicions of the already distrustful african populace, a move which could make treatment and containment for difficult. if dr. khan was to die when being treated with zmapp the public could become more doubtful of western relief groups. dr. khan’s virus levels were also reported to be extremely high and the doctors were thereby convinced that the drug would not be efficacious. however, doses of the drug have been given to two american aid workers along with a 75-year-old spanish priest who had been evacuated from liberia. mapp biopharmaceutical, the pharmaceutical corporation that developed the drug has claimed that after sending zmapp to west africa, there are now no remaining supplies of the drug. furthermore, according to recent estimates from u.s. officials there may only be a couple hundred doses available in the next few months. the question remains: who gets to use the experimental drugs it may seem political at first, as if the life of an african is less worthy than the life of a westerner. however, there already is a vivid history of controversy regarding drug testing in africa, and some workers worried that releasing the drug to west african civilians and workers would resemble recent unethical research trials. after a meningitis outbreak in 1996, pfizer settled charges which claimed the company failed to observe ethical standards in testing an experimental antibiotic. in the same vein, some may claim that zmapp and western nations have an ethical obligation to not administer the drug due to its experimental nature. others may claim ducar, the boundaries of treating ebola, voices in bioethics, vol. 1 (2014-15) 3 this is simply a public relations stunt in order to save face and ensure history does not repeat itself. perhaps the drug should go to healthcare workers instead, as they will adequately understand the risks and harms of taking an experimental drug. additionally, offering the drug to healthcare workers may give incentive to continue working in high risk areas, where they are needed most. while many are interested in who will get the experimental drug, perhaps the better question is the following: are western nations doing all they can to fight the outbreak? pushing economic and national interests to the side, one must examine the current ethical obligations affluent nations have towards the less affluent. in 2005 the world health organization created international health regulations developed in response to a sars outbreak.2 this effort has not been completed as of yet, mainly due to lack of priority and funding. creating an international fund to stem outbreak and create local disease-response centers (which the current ebola-stricken countries lack) would be a good start. furthermore, affluent governments should be investing additional aid to allow for more ability to curtail epidemics like ebola. pooling multinational resources and funds together will also allow for the ability to direct aid and focus it on where it is necessary. thus far, only doctors without borders and the world health organization have been aiding in the fight. both of these organizations are relief agencies, however much more could be done with multinational efforts from organizations such as the cdc, the european centre for disease prevention and control, the public health agency of canada, and many others from affluent nations. investing more money into drugs to fight these outbreaks will ensure healthcare workers are much more prepared. countries such as sierra leone, guinea, and liberia cannot be expected to manufacture and test these drugs when focusing many resources on prevention. this is not to say that these countries are not accountable as well, especially when one takes note of the fact that they continue to favor military spending over investing in public health infrastructure. nevertheless, the same could be said for a country like the united states, in regard to its internal ratio of military to public health spending, along with the external ratio. ducar, the boundaries of treating ebola, voices in bioethics, vol. 1 (2014-15) 4 while one can debate administering drugs such as zmapp and whether such action is prudent and just, one must also ask why this is the only current option. the outbreak has already killed over 1,000 people and is showing no signs of ceasing. if this outbreak was occurring in a western nation there would most likely be a much stronger impetus to contain and halt all infection. conclusion when examining bioethical issues and asking who deserves treatment, it is important to look to the root cause of the reasons as to why people are not receiving treatment. increased funding, coordinated multinational efforts, and investment into research can save the lives of many human lives. when fighting a deadly epidemic like this, it is important to know that disease knows no national boundaries, and neither should we. 1 prevention, c. (2014). questions and answers on experimental treatments and vaccines for ebola. ebola hemorrhagic fever. cdc. http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html 2 world health organization. (2008). international health regulations (2005). world health organization. eshikena, where do babies come from: another reproductive science progress, voices in bioethics, vol. 1 (2014-15) * marilyn eshikena, ms bioethics © 2014 marilyn eshikena. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. where do babies come from: another reproductive science progress marilyn eshikena* keywords: bioethics, ethics, reproductive technology, transplant, donor a relatively novel procedure has joined the frontiers in reproductive technology. as the world watches and waits for its absolute success, it serves as a source of hope for a group of women without the vessel for child conception. this procedure is known as womb transplantation and was successfully carried it in nine women in sweden, but it leads to important ethical dilemmas. the nine women, some born without uteri and others void of uteri as a result of hysterectomies, received donor wombs from close relatives. these transplanted wombs have been, at the moment, pronounced temporary. it is said that after two pregnancies, these uteri will be removed from the women, so that they can be weaned of anti-rejection medication. before this technology, these women would have to opt for adoption or surrogacy. however, in certain european countries like sweden, surrogacy is prohibited. thus, these women are left with limited possibilities to mother children. however, with womb transplantation, they have been given an opportunity to, not only have wombs, but to have full term pregnancies and birth healthy children. before 2014, attempts have been made to transplant uteri. the first attempt was in saudi arabia, in 2000. this transplanted womb lasted four months before it was rejected by the woman’s body. in 2011, turkish doctors performed a successful transplant. the patient’s pregnancy, however, did not reach its full term. hence, there is a possibility that one or all of these nine women will, in the near future, birth the first baby from a transplanted womb. this “new kind of surgery” has raised questions about the donor source. is it ethical to use living donors for a non-life saving therapy? it is even more questionable in this case because there are other options available to solve the problem of the targeted patients. british doctors, who seem to have taken into cognisance this ethical question, plan to carry out womb transplants with wombs from dead or dying donors. however, the first two unsuccessful transplants were done with wombs from these types of donors. should wombs from living donors prove more successful than those from dead donors, there is a possibility that more debates on the ethicality of this procedure will progress. belisomo, drug policy places new pressures on hospice, voices in bioethics, vol. 1 (2014-15) © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. drug policy places new pressures on hospice randi belisomo keywords: bioethics, ethics, drug policy, medicare, hospice introduction after outcry over a new rule intended to help avoid duplicate payments for medications of hospice beneficiaries, the centers for medicare and medicaid services met june 25th with representatives of thirty hospice organizations, who argue they now face financial burdens that are not theirs to bear. the rule took effect in may, requiring a prior authorization process for hospices and part d providers to determine responsibility of drug coverage. hospices must now cover medications unrelated to the hospice diagnosis. previously, part d providers covered drugs for hospice patients’ unrelated conditions, while hospices covered only those drugs for symptom management. the cms guidance, entitled “part d payment for drugs for beneficiaries enrolled in hospice,” resulted from a recommendation of the office of the inspector general. in 2012, the oig exercised oversight to examine medicare hospice patients whose drugs were sometimes paid for by part d rather than by the hospice. errors occurred in some instances, and part d plans had been used to pay for drugs that fell under the responsibility of hospices. more than 40 organizationsincluding the american medical association, the american society of clinical oncology, and the american geriatrics societyissued a letter to cms administrator marilyn tavenner on june 23rd, calling for the suspension of this policy. signatories expressed concerns that the rule places beneficiaries at the center of potential disagreements between hospice providers and part d plans– “requiring dying patients to navigate payer disputes.” it outlines a need for greater clarity in a policy “subject to differing interpretation, and already creating barriers for dying patients who are trying to access necessary medications.” the signatories cite reports of patients already paying out-of-pocket for medications, going without medications they need, or revoking the hospice benefit in order to access medicine through part d. though a spokesperson for the national hospice and palliative care organization says members are “pleased” cms heard concerns, there was “no indication” that any amendments to this new guidance would be made. ____________________________________________________________ analysis belisomo, drug policy places new pressures on hospice, voices in bioethics, vol. 1 (2014-15) 2 while cms quite validly seeks to ensure the appropriate entities pay for appropriate medications, there exists equally valid concern among providers that such a policy could impact access to quality end-of-life care. the impact is currently being felt financially and administratively, and the implications raise ethical concerns about the future of hospice access. financial: the operational strain the cms guidance places on hospices is tremendous, as providers are responsible for coverage of medical care, social services, nursing visits, chaplaincy, and other support in patient homes, for an average medicare reimbursement of 160 dollars daily. added bureaucracy and costs are not pressures hospices are structured to absorb, as typical margins are extraordinarily tight. angels grace hospice, which serves roughly 45 patients daily in chicago’s southwest suburbs, has experienced a 30 percent increase in drug costs during the past month. it is covering all drugs while the situation is assessed; a policy chief financial officer greg zrazik calls a “fairly liberal, compassionate approach.” since only a matter of weeks has passed since its effective date, an accurate financial strain has yet to be measured. “when you have a certain model in anticipation of cost structure and have the situation change, it requires some shifting and adapting and being creative,” zrazik says. “you’re going to see a more aggressive policy with new patients to assess all medications they are on and look to aggressively discontinue as many drugs as possible when they come on hospice.” such an uptick in drug costs threatens the existence of small to mid-sized hospices throughout the u.s. rural hospices, in particular, do not enjoy large patient censuses and are responsible for covering large geographic areas. such a substantial new line item is not one such providers can comfortably cover. dr. martha twaddle, medical director of barrington, illinois-based journeycare, says she is concerned about what some hospices may do to survive. “in the past, we may have allowed a patient to continue on a medication rather than engage in a negotiation. now, because of this financial pressure, some hospices will be forced to be more forthright in stopping medications not shown to be helpful,” twaddle says. financial pressures, however, may impact the supply of medications that are actually needed. “they may try to substitute less expensive medications that are not as effective, and you don’t want to be monkeying around when someone is dying,” she says. administrative: the interest of part d plans is not always best served by expediency. theresa forester, of the national organization for home care and hospice, says the opportunities for misunderstanding are numerousand of concern to patients and families. “there are incentives in the system that could lead part d plans to drag their heels in terms of coverage, because in some instances, someone else might pick up the tab,” forester says. “if there is a delay in payment, oftentimes family members will step up and pay out-of-pocket.” as patients and their families await resolutions in payer disputes, those families able to afford medication may feel urgency to cover drug costs themselves. those unable to afford the coverage may face unnecessary stress or pressure to purchase medications and worry about the bill later– in some instances, arriving after a loved one’s death. journeycare reports the average length of time for admissions visits has increased, and case managers and interdisciplinary teams must spend more time in homes sorting through medications and explaining to patients what medications may or may not be necessary. penny murphy, vice president of quality and compliance, says much work is being done to proactively communicate with part d plans. “i think the smaller programs have not had the resources to reach out and make those decisions,” murphy says. if patients are asked to stop medications they have been using for years – and aren’t receiving thorough explanations about the reasons why that drug for a thyroid condition may not be so important after a hospice belisomo, drug policy places new pressures on hospice, voices in bioethics, vol. 1 (2014-15) 3 enrollment – such administrative lack of capacity could cause undue stress or confusion. “why do we need to add more stress when people are in a time of tough decisions?” twaddle asks. “it’s just one more hoop to jump through.” access to care: while some smaller hospices, such as angels grace, report decisions to cover all medications in these first weeks of the new rule, it is uncertain how long such a policy can be maintained. if pressures result in financial failure, hospices in aforementioned rural areas may be forced to close, cutting off vital resources for terminally ill patients with fewer care options. hospices may also opt to turn down admissions from “complex patients” with multiple conditions the provider cannot afford to address. both long-term implications are dire, reducing patient choice and access. conclusion should hospices be forced to enact more stringent reviews of medication regimens upon admission? dr. robert arnold, of the university of pittsburgh center for bioethics and health law, says this policy puts providers in the position of “being the bad guy.” this practice would further common – and incorrect – beliefs about hospice services. “the problem, particularly for smaller hospices, is their complex patients with medications that are expensive,” arnold says. “the patients are scared about stopping them for symbolic value, which is psychologically difficult, or they feel better when they are on those medications.” such sentiments could stand in the way of a choice to opt for hospice support. arnold says this cms effort places problems within our larger health system on hospice providers. “it feels unfair, because they weren’t involved in starting these medicines.” "advocates blast 'prior authorization' for hospice drugs" by elise viebeck the hill, june 17, 2014 http://thehill.com/policy/healthcare/209657-advocates-blast-prior-authorization-forhospice-drugs "centers for medicare and medicaid services' policy hurts hospice patients" by callie jones journal-advocate, june 21, 2014 http://www.journal-advocate.com/sterling-local_news/ci_26006068/center-medicare-andmedicaid-services-policy-hurts-hospice-patients http://thehill.com/policy/healthcare/209657-advocates-blast-prior-authorization-for-hospice-drugs http://thehill.com/policy/healthcare/209657-advocates-blast-prior-authorization-for-hospice-drugs http://www.journal-advocate.com/sterling-local_news/ci_26006068/center-medicare-and-medicaid-services-policy-hurts-hospice-patients http://www.journal-advocate.com/sterling-local_news/ci_26006068/center-medicare-and-medicaid-services-policy-hurts-hospice-patients anekwe, celebrating the very special arts of new york city, voices in bioethics, 2013 © 2013 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. celebrating the very special arts of new york city public school students obiora anekwe the very special arts (vsa), new york city public schools in district 75 and marquis studios celebrated the mural and calendar project by presenting an exhibition of twenty-one murals by district 75 special needs students on tuesday, october 8th from 3:30 pm to 5:00 pm, columbia university, kolb annex, 40 haven avenue, washington heights, via subway: 1, a or c train to 168th street. this year’s theme is new york city: current and future. special needs students from district 75 created the murals, along with district art teachers and marquis studios teaching artists, which are featured in a calendar and will be on exhibit until november 8th. vsa founder ambassador jean kennedy smith will present awards to special needs students and art teachers recognizing their work in the project. the event, featuring live music, refreshments, and a hands-on art activity for parents and children, is free and open to the general public. ambassador kennedy smith, sister to john f. kennedy, robert f. kennedy and ted kennedy, founded very special arts 37 years ago as a part of the kennedy center’s effort to provide opportunities for children, youth, and adults living with disabilities to learn through and participate in the arts. marquis studios was named the new very special arts new york city (vsa-nyc) program affiliate in august of 2013. the studio is a 37-year old nonprofit organization providing arts-in-education services to new york city public schools. this year’s program will have remarks by mural and calendar project supporters: david marquis, executive director, vsa-nyc and marquis studios; dr. jeffrey lieberman, the lawrence c. kolb professor and chairman of psychiatry at the columbia university college of physicians and surgeons; dr. robert klitzman, professor of clinical psychiatry (in sociomedical sciences) and director of the bioethics program at columbia university; gary hecht, superintendent of special education, district 75, new york city; barbara joseph, deputy superintendent of special education, district 75, new york city; and mrs. lauren micheliniteacher, p255q@158q. the mural project is a model as to how art changes lives. “the student artists from special education district 75 schools who participated in the vsa new york city murals project and are represented in this exhibition are a testament to the fact that art is not a luxury. art is central to what makes us fully human. through art, these students have beautifully expressed their thoughts and captured the energy that is new york city,” notes ambassador kennedy smith. for more information on the event or to rsvp, contact vsainfo@kennedy-center.org mailto:vsainfo@kennedy-center.org yin, contraception and reproductive ethics, voices in bioethics, vol. 3 (2017) * sophia yin won the reproductive ethics category for our 2016 bioethics essay contest. © 2017 sophia yin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. contraception and reproductive ethics: constitutional right vs. right for the country sophia yin* keywords: bioethics, contraception, reproductive rights, women’s rights introduction though the male condom seems almost ubiquitous in current american society, female contraceptive methods constantly seem to be the subject of controversy. while debates in the twentieth century centered on the legalization of contraception, the discussion now is over who should be required to pay for contraception. this question of funding may seem less pressing than the question of legality, however, ability to pay is directly tied to access: women who cannot afford contraception cannot freely use it. though many supporters frame their case in terms of an infringement of women’s rights, this argument is inherently weak. women should have open access to contraception regardless of whether they have the right to it. the issue of women’s access to contraception is most often viewed through a legal lens, but it should be discussed in terms of its benefits to public health. analysis supporters of access to contraception argue that women have a right to contraception. this argument is based upon the rulings of griswold v. connecticut, 1 in which the supreme court ruled that states cannot outlaw the use of contraception by married couples because of “the zone of privacy created by several fundamental constitutional guarantees.” though the ruling did not directly state that women had a right to contraception, it did create a right to privacy in reproductive matters for married couples, which allowed them the freedom to decide, without state interference, whether they would like to use contraception. the supreme court extended the right to use contraception to unmarried couples in the 1972 ruling of eisenstadt v. baird.2 many women’s reproductive rights activists have cited these cases in debates, arguing that by forbidding interference with people’s abilities to obtain contraception, the supreme court essentially established a right to contraception. defining the argument for open access to contraception as one grounded in rights weakens and limits the argument. neither the right to contraception nor the right to privacy is specifically denoted in the constitution or the bill of rights. rather, the ruling is based upon the idea that “specific guarantees in the bill of rights have penumbras, formed by emanations from those guarantees that help give them life and substance.”3 the terms “penumbras” and “emanations” are not legal terms; rather, they were coined by justice douglas in the court’s opinion. therein lies the controversy: the right to privacy, which the nebulous right to contraception is based upon, is implied by the bill of rights rather than specifically listed in it. since the supreme court is the final interpreter of the constitution, the basis of the ruling does not diminish the validity of the ruling itself. however, the right to privacy does seem weaker in terms of legal basis when compared to other rights, especially those specifically enumerated in the bill of rights. the right that seems to conflict the most often with the right to privacy or the right to contraception is the right to freedom of religion. the conflict is founded in the fact that many major religions of the world oppose contraception. what happens when a woman’s access to contraception comes directly at odds with someone’s opposition to contraception on religious grounds? such a case occurred in burwell v. hobby lobby, inc. when the owners of hobby lobby, inc. and two other corporations argued that the contraceptive mandate in the patient protection and affordable care act violated their exercise of religious freedom as protected by the religious freedom and restoration act. the supreme court ruled that for-profit organizations could deny their employees coverage of contraceptives based on their owners’ religious yin, contraception and reproductive ethics, voices in bioethics, vol. 3 (2017) 2 beliefs.4 when the right to freedom of religion was at odds with access to contraception, the freedom of religion triumphed. the court ruled that not only do individuals have the freedom of religion, but also entire organizations can be considered worthy of this right. moreover, this ruling permits the access to contraception of large groups of women to be affected by the religious beliefs of one influential individual. the importance of protecting religious freedom is certainly a valid argument, but this supreme court decision does not seem to truly be about religious freedom. in burwell v. hobby lobby, inc., the court noted that its decision “concerns only the contraceptive mandate and should not be understood to hold that all insurance-coverage mandates, e.g., for vaccinations or blood transfusions must necessarily fall if they conflict with an employer’s religious beliefs.”5 required vaccinations and blood transfusions both contradict certain religious values. jehovah’s witnesses, for example, view blood transfusions as sinful.6 based on burwell v. hobby lobby, inc., an employer who is a jehovah’s witness would not be exempted from paying for insurance for blood transfusions, yet an employer who holds a religious belief that opposes contraception is exempt from paying for it. both cases discuss religious opposition to a medical treatment. why, then, is the supreme court arguing for protection of religious freedom only as it pertains to contraception? one explanation is that burwell v. hobby lobby, inc. is not truly about protecting religious freedom; rather it is simply a progression of the decades-long argument over control of women’s reproduction in which both sides have latched onto rights as a means to further their views. the birth control movement itself actually started as a movement for the right to free speech against the restrictions of the comstock act. after griswold v. connecticut, however, the basis of the argument changed to one based upon a right to privacy. the rapid shift demonstrates that perhaps the rights themselves were not the central focus of the arguments but rather tools to gain support for each side. the discussion of rights continues today, changing now to one about the right to freedom of religion. contraception needs to be discussed from a different perspective – to be rewritten as a health issue. with a topic as politically fraught as contraception, shifting the focus to health considerations allows people to distance themselves from political agendas and reconsider the issue of open access to contraception in a new light. debates over interactions between rights completely ignore another aspect of this issue: “is open access to contraception beneficial to society?” contraception is important not just because it is someone’s right; increased access to contraception promotes women’s health. contraception prevents unintended pregnancies. while condoms have a “typical use” failure rate of approximately 17%...the iud and implant have typical use failure rates of 1% or less…and oral contraceptives have typical use failure rates of 9%.7 the decrease in unintended pregnancies associated with increased use of contraception is particularly evident in the teenage population. in 2013, the “u.s. birth rate for teenagers aged 15–19 dropped 57% from its peak in 1991, paralleling a decline in the teen pregnancy rate.”8 using contraceptives also allows women to space out their births, improving the health of their infants. short interpregnancy intervals have been linked to “low birth weight, preterm birth, and small size for gestational age,” critical factors in infant health.9 providing women greater access to contraception improves women’s and infant health. arguing for open access to contraception through the perspective of public health also allows for a discussion about equity. much of the argument over funding and insurance coverage of contraception involves women who cannot afford contraception without financial help. women of lower socioeconomic status often rely on publicly funded contraceptive services. in 2006, more than nine million clients received contraceptive services that were publicly funded, helping women “avoid 1.94 million unintended pregnancies, including 810,000 abortions.” 10 without publicly funded efforts, “levels of unintended pregnancy and abortion would be nearly two-thirds higher among u.s. women overall and close to twice as high among poor women.”11 discussions around open access to contraception and public funding of the matter unfairly target women of lower socioeconomic status who have no other method of obtaining contraception. by discussing the matter through the public health lens, the inequity of the situation becomes apparent. conclusion women should have open access to contraception regardless of whether they have the right to it. arguing for open access through a discussion about rights is ineffective and often devolves into weighing the relative importance of rights. framing the debate in terms of public health allows for a much more productive discussion of women’s health. some may argue that this change causes the issue of morality to be overlooked, but the practice of reshaping political, social, or moral judgments as public health ones is not unprecedented. burwell v. hobby lobby, inc., for example, allowed religious freedom judgments to be made on provision of contraception but not on vaccinations and blood transfusions. in the cases of the vaccinations and transfusions, the supreme court made a value judgment by overriding religious beliefs against these medical practices in favor of promoting public health. if the argument over open access to contraception is redefined in a yin, contraception and reproductive ethics, voices in bioethics, vol. 3 (2017) 3 similar manner, the unproductive decades-long fight over which rights take precedence will be replaced by the enacting of measures that further the health of the nation. 1 griswold v. connecticut. 381 u.s. 479-486. supreme court of the united states. 1965. justia: u.s. supreme court. justia, 2015. web. 15 oct. 2015. 2 eisenstadt v. bard. 405 u.s. 438-440. supreme court of the united states. 1972. justia: u.s. supreme court. justia, 2015. web. 15 oct. 2015. 3 griswold v. conneticut. 381 u.s. 479-486. 4 burwell v. hobby lobby stores. 573 u.s. 354-356. supreme court of the united states. 2014. justia: u.s. supreme court. justia, 2015. web. 15 oct. 2015. 5 ibid., 354-356. 6 schaffer, amanda. "how jehovah's witnesses are changing medicine." the new yorker. condé nast, 12 aug. 2015. web. 10 nov. 2015. 7 guttmacher institute. testimony before the institute of medicine, committee on preventive services for women. guttmacher institute, 12 jan. 2011. web. 15 october 2015. 8 martinez, gladys m., and joyce c. abma. “sexual activity, contraceptive use, and childbearing of teenagers aged 15–19 in the united states.” rep. no. 209. washington d.c.: u.s. department of health and human services: center of disease control and prevention, 2015. print. 9 guttmacher institute. testimony before the institute of medicine, committee on preventive services for women. 10 ibid. 11 ibid. messina, monitoring human waste, voices in bioethics, vol. 6 (2020) © 2020 sarah messina. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are cre dited. monitoring human waste: a non-invasive early warning tool sarah messina keywords: wastewater monitoring, pandemic, covid-19, global ethics introduction the ability to respond quickly to potential viral epidemics like the covid-19 pandemic could be greatly improved by actively monitoring human waste to detect potential pathogens in a population. analyzing water at treatment facilities allows researchers to track infectious pathogens that are excreted in urine or feces. this type of monitoring would combat polarizing shame of individuals and whole countries. waste monitoring would also mitigate a lack of detection and reporting by disorganized governmental systems monitoring potential global pandemics. viral infections detected in sewage systems could be the key to monitoring and addressing potential global pandemics. each country’s contagion response system is likely never going to be streamlined and uniform, however, there is a chance that at least those viruses that can be detected in human waste can be detected early with this information. once the limitations and strengths of new technology are understood, the world health organization (who) could use the systems for monitoring purposes. relying on countries to act autonomously and self-report emerging viruses and infections has proven to be insufficient and has resulted in delayed detection. the risks are known; quick transmission with no intervention sacrifices many lives in the long run. with this information made available, response times could make a significant difference in how we work together as a global health community to prevent the next pandemic. analysis a non-invasive early warning tool to alert communities of new viral infections has the potential to enable rapid and coordinated responses to an outbreak. it could ultimately reduce high rates of morbidity and mortality. this new monitoring system would decrease the burden on healthcare systems, resulting in far fewer lives lost due to transmission from the lag in identifying novel viral respiratory diseases. dozens of researchers have begun analyzing wastewater to estimate the total number of infections. monitoring waste can be more effective initially than trying to test individuals. governments must offer individuals covid-19 testing in an organized and streamlined fashion for testing to be effective. the infrastructure of both impoverished countries and countries without a uniform system, such as the united states, can hinder this effort. monitoring waste might prove most effective in countries where populations vary in density. therefore, sewage systems in impoverished nations should be considered a health priority, not only for local health concerns, but global health concerns. this method may be used to detect a resurgence of the coronavirus in the most vulnerable populations. messina, monitoring human waste, voices in bioethics, vol. 6 (2020) 2 thus far, traces of the virus have been analyzed in sewage systems in the netherlands, the united states and sweden. 1 one treatment center can potentially have wastewater for more than 1 million people. monitoring wastewater is more effective than testing individuals. sars cov-2 has been isolated from feces and urine within just three days of infection. the median duration of the virus in stool was 22 days. 2 wastewater data could provide a better estimate for the actual number of those with the coronavirus than current testing measures. if appropriately implemented, this new system of monitoring could serve as a necessary roadmap for other global health systems. detection of the virus can be accomplished with nucleic acid-based polymerase chain reaction (pcr) assay which is also the current standard to confirm infection in covid-19 patients around the world.3 this could prove to be a fraction of the cost of traditional clinical testing measures and can be done using the same methods currently being used. factors such as the efficiency and condition of the sewage monitoring system may be considered by local healthcare authorities. depending on factors within the treatment facility, detection rates range widely. important factors include the temperature of the wastewater and the size of the sewage system. 1 in every 114 individuals infected with covid-19 can be detected in some sewage systems. at a low temperature, virus can be preserved and the wastewater could be tested. if 1 in 2 million people are infected, researchers can potentially detect the presence of a viral pathogen. although autonomy is an important part of the healthcare system, the preservation of autonomy in global pandemics is a health risk to us all. arguably, an individual or an entire country could be ostracized if others discover that anyone has contracted a novel virus and could potentially be spreading it. however, i would argue that with a standardized waste monitoring system, the individual is effectively removed from the situation and instead we can collectively coordinate. the testing will reveal which towns viruses have originated from and with swift action it can be contained. economically, countries would save money with this mass testing method instead of testing individuals. former epa scientist, christian daugthin, has urged researchers to develop waste-based epidemiology methods for future epidemics. ultimately, after sampling this method across many countries, test sites ought to be located in vulnerable countries that have dense populations. there is limited foreseeable risk in this testing at the current level of understanding of how this data will be collected and used. it would also be most beneficial for a global agency to monitor these countries to reduce the risk of missed identification due to unstable healthcare systems or government mismanagement. current limitations that must be resolved for this method to be effective include accurate and reliable quantification measures. researchers will need to find out how much viral rna is excreted in feces and extrapolate the number of infected individuals. additionally, the test needs to be able to detect the virus at low levels. sampling, preserving, and processing samples in current human testing conditions will remain a critical issue for detecting a virus with low concentrations in sewage. similar to the concerns associated with ebola, it is suspected that viral inactivation could be a problem due to the presence of bacteria. the virus could potentially undergo inactivation between 3 to 7 days. to address this concern, routine monitoring would have to be maintained. lastly, special attention must be afforded to the aerosol formation during wastewater treatment that poses a significant health risk to those monitoring and working in the sewage plant. protective measures for the employees working in wastewater treatment plants must be maintained along with adequate personal protective equipment. however, i would suspect that these measures are already in place considering the infrastructure for these systems already exists. furthermore, protective measures for workers in high risk environments like hospitals and other long-term care facilities, should be addressed as they are more likely to harbor viral pathogens. this is most evident in places like spain where 15 percent of cases of covid-19 represent individuals who work in healthcare. conclusion increased efforts to control pandemics are necessary with the next zoonotic virus potentially on the horizon. the consequences of this pandemic have yet to be fully realized. with population densities only increasing, greater surveillance is necessary. sacrificing personal privacy for the sake of global monitoring is messina, monitoring human waste, voices in bioethics, vol. 6 (2020) 3 not the only option. population epidemiology is possible in wastewater monitoring. the exploitation of vulnerable populations has historically occurred when greater risks are placed on the population, i.e., testing a new vaccine on a population of individuals in a disadvantaged group. in this case, i believe a wastewater monitoring system would give greater benefit and poses low risk. the disadvantaged groups represent those who are in the greatest need of early detection and swift action. the benefit of this system vastly outweighs the risks and those who are most at risk of devastation from the next viral contagion could be those who are first tested with the new application of the pcr technology. while testing vaccines and treatments in vulnerable populations can put people at heightened risk, testing a new contagion surveillance system could be a win for all involved. 1 orive, gorka, et al. early sars-cov-2 outbreak detection by sewage-based epidemiology. science of the total environment, elsevier, 8 may 2020, www.sciencedirect.com/science/article/pii/s0048969720328151. 2 barras, colin. monitor sewage to track spread of the coronavirus. new scientist (1971), published by new scientist limited., 2 may 2020, www.ncbi.nlm.nih.gov/pmc/articles/pmc7195334/. 3 yaniv, karin, et al. regressing sars-cov-2 sewage measurements onto covid-19 burden in the population: a proof-of-concept for quantitative environmental surveillance. medrxiv, cold spring harbor laboratory press, 1 jan. 2020, www.medrxiv.org/content/10.1101/2020.04.26.20073569v1. baruch, patient’s perspective, voices in bioethics, vol 1 (2014-2015) © 2014 sarah baruch. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. patient’s perspective sarah baruch keywords: clinical medicine, patient-physician relationship, narrative introduction first year students at the university of michigan medical school are sent in pairs to patients’ homes to help them appreciate the patient’s perspective. as we walked out of mrs. d’s apartment, my partner said, “go home and write your essay. get it over with so you don’t have to think about it over break.” although his advice was given with the best intentions, i couldn’t relate to it at all. it didn’t matter whether i would take the time to write an essay about mrs. d—our visit would not leave my mind. on a physical level, i lived four blocks away from her apartment. as i passed her building, i always glanced up at the 14th floor. i knew that she was there, often going days without seeing anybody. on an emotional level, though, i felt inextricably connected to her suffering. despite the fact that i give almost every waking hour of my days to becoming a physician, not a single moment passes when i do not struggle with the challenges of being a patient with an incurable condition. analysis on our first visit, mrs. d raved about her primary care physician. she described the physician as an equal partner— they faced each of her illnesses as a team. this time, however, her first words were, “have i told you about my terrible doctor?” i didn’t understand. how could a patient go from loving to hating a doctor over the course of a month? mrs. d explained that for 37 years she would send an email before every appointment, outlining her concerns, questions, and updates, so that during the appointment they could make the best use of their time. it was a single email correspondence that changed everything. the physician replied by asking mrs. d to stop sending emails to her personal address; she should leave messages with the receptionists instead. mrs. d was outraged; she felt betrayed and called the physician a horrible person. i couldn’t keep my thoughts to myself. i felt that i had a responsibility to defend the physician or attempt to fix the situation in some way. i asked mrs. d if it was possible that the doctor was just overwhelmed by patients’ emails. maybe, for her own health and life balance, the doctor was cutting back on personal correspondence with her patients. mrs. d refuted my suggestion, saying that good doctors should always be available to their patients. furthermore, mrs. d had no interest in sharing her personal questions with receptionists, who were likely to “misunderstand” them. since mrs. d had previously described the difficulty in finding good doctors, i suggested that she call the office and attempt to resolve this issue over the phone, through an honest conversation with her physician. mrs. d was uninterested; the damage had been done. baruch, patient’s perspective, voices in bioethics, vol 1 (2014-2015) is a good doctor one who dedicates 24 hours a day and 7 days a week to her patients? if that is what it means, i am sure to fail. while i aspire to do everything, i can for my future patients, i also have personal dreams and aspirations that are sure to take some of my time and focus away from medicine. a few days after the visit, i had muscle spasms in my back and urgently needed to see my doctor. as the pain continued to build up, i called his office every day but there were no openings for weeks. before leaving for a year of living abroad, my doctor had given me his personal email. i knew that if i emailed him, i would be seen right away. however, as i reflected on mrs. d’s experience, i felt conflicted. at what point are patients overstepping their boundaries? where will i draw the line with my patients? i sent the email and saw my doctor the next day, saving me weeks of agony. i apologized profusely to him, expressing my understanding that he deals with patients in pain every day and the guilt i feel knowing how much worse other patients’ conditions are. unlike mrs. d’s physician, my doctor was grateful that i had contacted him. maybe doctors are supposed to be superheroes, always available and ready to serve. or is it possible that the patient-physician relationship cannot be defined and only exists on a case-by-case basis? perhaps, like all relationships, there is a continuously changing dynamic, in which each party's needs and priorities are flexible depending on the situation. ____________________________________________________________ conclusion at the end of our conversation with mrs. d, we received some parting advice. “all old people should have a pet,” she told us. “i can go days without seeing anybody, so i talk to my cat.” she then glanced at the cat and said, “you look trusting, but you are fat.” she then looked at me with a smirk on her face and said, “at least she doesn’t mind what i say.” preston, us v. hendrickson, voices in bioethics, vol. 1 (2014-15) © 2014 joshua preston. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. us v. hendrickson: sentencing the addict’s brain joshua preston bioethics, addiction, us v. hendrickson introduction if there was any doubt whether bioethics scholarship was impacting the legal system, district judge mark w. bennett’s recent sentencing opinion in us v. hendrickson (2014) removed it. referencing society’s evolving view of addiction and disease, he noted that “advances in science continue to outpace advances in law” and that even though addiction is no longer regarded as a moral failing but rather an illness: the law still responds to drug abusers with punitive force, rather than preventative or therapeutic treatment. it is therefore unsurprising that, since 1980, the number of federal prisoners serving drug-related sentences has skyrocketed. analysis although the medical community recognizes that addiction affects a victim’s judgment and behavior, judge bennett wrote that, within the legal community, there is no consensus whether courts should treat it as a mitigating circumstance. instead, some judges insist it is mitigating only when it falls outside convention. rather than treat each individual’s illness according to their individual needs, the courts sympathize only with the most extreme instances. yet, because this evolving view of disease rightly equates physical as well as mental illness, this is akin to saving one’s sympathy for only the sickest cancer patients. next, acknowledging that those who violate the law must still face consequences, judge bennett in his opinion outlined what a neuroscientifically-informed sentence would look like. tasked with sentencing a twenty-three year old possessing stolen firearms, he did not overlook the defendant’s decade-long history of drug abuse and criminal history. in fact, he noted that the recommended sentencing guidelines suggest 37-46 months in prison. citing the supreme court’s opinion in roper v. simmons (2005) and several scholarly articles on addiction, brain development, and behavior, he concluded: just as there are fundamental differences between the juvenile and adult brain, so too are there fundamental differences between the addict and non-addict brain. because of these differences, addicts, like juveniles, tend to make “impetuous and ill-considered” decisions. thus, for the same reasons juveniles are generally less culpable, so too are addicts. preston, us v. hendrickson, voices in bioethics, vol. 1 (2014-15) 2 in other words, like a juvenile, the addict’s brain lacks the same capacity for decision-making that an otherwise “normal” brain may have. like any other mental illness, it can skew one’s ability for long-term planning, cost-benefit analysis, and understanding of punishment. so, with this in mind, judge bennett sentenced the defendant to 31 months in prison, which is six months less than the recommended guidelines. upon release, the defendant will be required to participate in three years of substance abuse treatment. conclusion although this sentence raises the question whether a different sentence – say, one with less prison time and more treatment – could be just as effective, it is a move in the right direction. it demonstrates that while it is a gradual process, the labors of medicine and neuroscience are being read not only by lawyers and legislators but also members of the court. hiller, celebrity medicine, voices in bioethics, vol. 2 (2016) © 2016 kaitlynd hiller. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. celebrity medicine: ben stiller’s prostate edition kaitlynd hiller keywords: prostate cancer, screening, preventative, patient decision-making process introduction during an interview in early october, ben stiller spoke publicly for the first time about his successful battle with prostate cancer, and how, if it were up to the american cancer society (acs), perhaps he wouldn’t have won. stiller also published a same-day article on medium1 that detailed the care he received and the factors that guided those decisions. although this public reveal is reminiscent of angelina jolie’s 2013 op-ed on genetic testing and prophylactic mastectomies, stiller’s is more controversial. not only did he pursue screening earlier than suggested and question the evidence-based national guidelines, he’s also gone on to advocate for a position that many public health experts today are trying to walk back on: that screening saves lives. analysis unlike jolie, stiller had no family history of the disease he received screening for. at the time he began having his psa levels routinely tested, stiller was 48 years old with no other known risk factors. the acs recommends starting the discussion of prostate screening with men like stiller (counted as “average risk”) at age 50.2 the american urological association’s guideline does not recommend annual screening in average risk men ages 40 to 55 years, and the us preventative services task force recommends against the use of the psa test in all asymptomatic, average risk populations.3 stiller credits his cancer-free status to his “thoughtful internist,” who began discussing psa testing multiple years ahead of what these guidelines suggest. ben puts it into perspective: “if [my doctor] had waited, as the american cancer society recommends, until i was 50, i would not have known i had a growing tumor until two years after i got treated. if he had followed the us preventive services task force guidelines, i would have never gotten tested at all, and not have known i had cancer until it was way too late to treat successfully.” because ben’s experience ended up being positive on the whole, it would seem as though his doctor’s decision was a good one. but the story is not that simple, and many worry that way in which stiller frames proactive screening as beneficial calls current guidelines into question, and downplays potential harms. screening was initially conceptualized as a way to detect cancer at an early, treatable stage, and thus save lives. in the past 20 years, however, a strong body of research has emerged which has challenged its effectiveness. out of some of the more prominent studies, the european randomized study of screening for prostate cancer (erspc) found an improvement in risk of disease-specific mortality. specifically, screening would have to diagnose 37 additional men in order to prevent 1 death from prostate cancer after 11 years of follow-up.4 by contrast, the prostate, lung, colorectal and ovarian (plco) screening trial found no diseasespecific mortality benefit to psa after 13 years of follow-up,5 and the latest cochrane review which conducted a meta-analysis of five randomized control trials found no difference in prostate cancer-specific mortality between the screened group and the control.6 part of what makes the evidence and debate on screening difficult to parse out is due to the harms that hiller, celebrity medicine, voices in bioethics, vol. 2 (2016) 2 can come of the screening itself. for men who have had three or four psa screens, the false positive rate is 1213%.7 these false positives can lead to not only emotional and psychological stress (men are more likely to commit suicide in the first year after prostate cancer diagnosis8), but also to physical harm of downstream, invasive testing that is needed to confirm screening results. impotence, incontinence, and sometimes even hospitalization and death can result from these invasive procedures aimed at diagnosing and treating a cancer that would otherwise remain clinically irrelevant had it never been found. however, stiller’s risk status, in conjunction with his bold assertion that “taking the psa test saved my life. literally,” doesn't take into account this threat of over-diagnosis and over-treatment. many health care professionals have spoken out about how misplaced his public statement is. vinay prasad, an oncologist and assistant professor of medicine at the oregon health and sciences university, commented: “[stiller’s] strong faith that the psa test “saved his life” is incompatible with a true understanding of over-diagnosis; no person whose cancer was found by psa screening can say ‘the test saved my life.’”9 yet even though stiller’s assertion is flawed, it is not uncommon. the public has been shown to have an inflated sense of the benefits of screening,10 and anecdotes such as the one stiller is promoting only serve to focus the public’s perception on the benefits that screening tests provide, while ignoring their limitations. due to the complexity of the research, evidence, and guidelines surrounding each test, the ideal patient decision-making process sometimes becomes less about what the patient knows and more about what the patient feels. psychological research shows that anecdotal stories can influence someone’s judgment and decision making more powerfully than reliable statistical data.11 the fact that ben stiller is a well-known celebrity gives him a broad platform to disseminate his powerful anecdote, no matter how logically unsound and misleading it might be. he does, however, provide one piece of undisputed good advice: that men should engage in shared decision-making with their doctor to decide what the right choice is for them. unfortunately, physicians suffer from statistical illiteracy almost as much as their patients, and their difficulty of conceptualizing data could (and does) lead to poor decisions and outcomes, especially in the case of screening.12 along with evidence-based guidelines compiled by experts in statistics, another tool to utilize is a pictorial, rather than numerical, method of presenting and digesting information (see figure 1). studies have shown that using visual aids increases one’s comprehension of statistics, counteracting the effect of anecdotal evidence.13 conclusion even while acknowledging that there is controversy surrounding the topic, stiller still presents a simplistic, opinionated, and privileged summary of preventative screening and clinical decision-making. while the intention beyond speaking out seemingly comes from a good place, many continue to question the ethicality of his actions. for numerous readers, his article will have been their first exposure to the labyrinth that is evidence, statistical reasoning, guidelines, and treatment. if they choose to pursue psa testing, there is a good chance it will end up harming them. it is up to health care practitioners to be prepared with the proper knowledge, empathy, and reasoning to properly engage with patients through the decisions to come. https://www.ncbi.nlm.nih.gov/pubmed/23440794 for further reading: saquib, n., saquib, j., and ioannidis, j.p.a. “does screening for disease save lives in asymptomatic adults? systematic review of meta-analyses and randomized trials.” international journal of epidemiology 44, no. 1 (2015): 264-277. hiller, celebrity medicine, voices in bioethics, vol. 2 (2016) 3 1 stiller, ben. “the prostate cancer test that saved my life.” medium. october 4, 2016. https://medium.com/cancer-moonshot/the-prostate-cancer-test-that-saved-my-life613feb3f7c00#.jxb3ag8cl. 2 “american cancer society recommendations for prostate cancer early detection.” american cancer society. last modified april 14, 2016. http://www.cancer.org/cancer/prostatecancer/moreinformation/prostatecancerearlydetection/prostatecancer-early-detection-acs-recommendations. 3 as stiller notes, the uspstf is currently in the process of updating their guidelines, which have now passed the five year mark. 4 hayes, j.h., and barry, m.j. “screening for prostate cancer with the prostate-specific antigen test.” jama 311, no. 11 (2014): 1143-1149. 5 hayes and barry (2014). 6 ilic, d., o'connor, d., green, s., and wilt, t.j. "screening for prostate cancer: an updated cochrane systematic review." bju international 107, no. 6 (2011): 882-891. 7 prasad, v., lenzer, j., and newman, dh. “why cancer screening has never been shown to “save lives”—and what we can do about it.” bmj 352 (2016): h6080. 8 fang, f., keating, n.l., mucci, l.a., adami, h., stampfer, m.j., valdimarsdópttir, u., and katja fall. "immediate risk of suicide and cardiovascular death after a prostate cancer diagnosis: cohort study in the united states." jnci: journal of the national cancer institute 102, no. 5 (2010): 307-314. 9 boyd, brian. “brian boyd: ben stiller did more harm than good by talking about his prostate cancer.” the irish times. october 18, 2016. http://www.irishtimes.com/opinion/brian-boyd-ben-stiller-did-more-harm-than-goodby-talking-about-his-prostate-cancer-1.2834477 10 prasad et. al (2016). 11 arkes, hal r., and wolfgang gaissmaier. "psychological research and the prostate-cancer screening controversy." psychological science 23, no. 6 (2012): 547-553. 12 gigerenzer, g., gaissmaier, w., kurz-milcke, e., schwarts, l.m., and woloshin, s. "helping doctors and patients make sense of health statistics." psychological science in the public interest 8, no. 2 (2007). 13 arkes and gaissmaier (2012). https://medium.com/cancer-moonshot/the-prostate-cancer-test-that-saved-my-life-613feb3f7c00%23.jxb3ag8cl https://medium.com/cancer-moonshot/the-prostate-cancer-test-that-saved-my-life-613feb3f7c00%23.jxb3ag8cl http://www.cancer.org/cancer/prostatecancer/moreinformation/prostatecancerearlydetection/prostate-cancer-early-detection-acs-recommendations http://www.cancer.org/cancer/prostatecancer/moreinformation/prostatecancerearlydetection/prostate-cancer-early-detection-acs-recommendations http://www.irishtimes.com/opinion/brian-boyd-ben-stiller-did-more-harm-than-good-by-talking-about-his-prostate-cancer-1.2834477 http://www.irishtimes.com/opinion/brian-boyd-ben-stiller-did-more-harm-than-good-by-talking-about-his-prostate-cancer-1.2834477 introduction analysis conclusion even while acknowledging that there is controversy surrounding the topic, stiller still presents a simplistic, opinionated, and privileged summary of preventative screening and clinical decision-making. while the intention beyond speaking out seemingl... https://www.ncbi.nlm.nih.gov/pubmed/23440794 for further reading: saquib, n., saquib, j., and ioannidis, j.p.a. “does screening for disease save lives in asymptomatic adults? systematic review of meta-analyses and randomized trials.” international journal of epidemiology 44, no. 1 (2015): 264-277. kasack, the case against pre-health volunteers in global health, voices in bioethics, vol 1 (2014) © 2014 lauren kascak. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the case against pre-health volunteers in global health lauren kascak keywords: clinical medicine, global health, health volunteers introduction this is advice given by the american physician-instructor of my monthlong global health internship in ghana. my two pre-med peers and i have just told him we are not comfortable participating in his experiment: leading our team of interns into a rural community, unannounced, to collect health data on children. where is the informed consent? do our subjects really have the ability to refuse to participate? would we have done something similar in any community in the united states? analysis i’m standing on the balcony of the hilltop hotel i’ve been living in for the past three weeks in the coastal area known as anamabo. i replay his words in my mind, staring down at a landscape of green palm trees and cinderblock houses beside the dusty teal ocean. confused about what good is being done to begin with, i am reminded of my first experience in ghana. the year before, i took part in a 10-day medical mission with this same global health ngo to deliver medical care to a developing community. the experience left me with serious questions about the nature of global health and the role of unskilled “medical volunteers” overseas — questions a 10-day trip could not answer, questions i had hoped a onemonth internship might help me address. but i have not found answers on this internship. i have instead traveled deeper down a rabbit hole that forces me to ask more questions and challenge the role of pre-health volunteers in global health altogether. my first trip to ghana 1. what do short-term medical missions teach pre-health students about global health? on the first day of my medical mission, i’m standing in the room used for water storage at a children’s school. a nurse hands me a speculum doused in lubricant and gestures toward the patient in front of me, an anxious woman lying— knees up—on the rough wooden teacher’s desk. “it’s your turn,” she says with a comfortable smirk. (see one, do one…) kascak, the case against pre-health volunteers, voices in bioethics, vol 1 (2014) 2 we don’t know the patient’s name. we don’t know her medical history. she is not briefed on the details of the exam. she has not given consent to be examined by an ill-trained volunteer. she is only told that she should have this exam by the ghanaian interpreter. my scrubs are clinging to the backs of my sweat-soaked knees. as a pre-medical student, i have played the role of a shadow behind dozens of physicians. throughout these many hours of observation, i have stood back, eager for the day i will be able to use the skills i will learn in medical school to attend to those who are suffering. but here i am, unexpectedly being asked to take on this role much sooner. “do i have to do this?” i think to myself. the nurse seems to read my mind as she nods and waits for me to insert the speculum into the patient’s body. i am told that “providing medical care to the poor requires improvisation.” is it true? don’t the poor deserve the best treatment? 2. what are the risks to the patient with this work? the next day i am assigned to work in the triage section of the clinic. here, patients flood in—mostly women and their children—to describe their symptoms of illness and have their vital signs taken by student volunteers. i hang my stethoscope around my neck with pride. i feel comfortable and confident. as an emt, i have been taught how to take patient vital signs and have taken hundreds of them. but the fellow student next to me is struggling. she wraps the thick blue velcro strap around the skinny arm of a woman who smiles gently, accentuating the wrinkles on her 89year-old face. erica inflates the blood pressure cuff four separate times before asking for assistance. as i hold the patient’s arm in my own, listening for her heartbeat, i overhear other students in the corner beside us: “i can’t get his blood pressure!” katie says to dave. “just write any number down, that’s what i’ve been doing!” but what if the doctors give anti-hypertensive drugs to healthy patients because dave wrote down too high a number? what then? 3. what do short-term medical missions teach pre-health students about patient care? my friend matt rushes in. “there’s a guy with polio in there! you all have to check it out!” he says. i walk to the doctor consultation station, past the adult patients who sit patiently on the red cement curb, still waiting to be seen. i am late to the gathering, but i do not see a male patient. i only see a herd of my peers, with their cameras framing their eyes and something below them. i realize their specimen is the man’s leg. i stand on the tiptoes of my left foot and then my right, trying to see something. is the man okay? a tiny space opens between two fellow students, and i meet the man’s gaze as he sits, powerlessly, in his chair. beside him, the doctor gazes passionately into his “tropical disease” handbook for beginners. the room echoes with loud voices i cannot understand. the voices, the camera flashes, the stench of body odor, and the stifling humidity swirl into a tunnel of discord. my colleagues snap and snap and snap photos. it is a photo-op: a safari of medical tourism, where the patients are the scenery. kascak, the case against pre-health volunteers, voices in bioethics, vol 1 (2014) 3 is the imagined distance between us and them only increased by medical missions, rather than decreased? are we dehumanizing those we seek to serve? 4. why did i come here? can i really save the world? the months leading up to the trip were filled with information sessions held by my university’s chapter of this global health ngo. during our meetings, we gathered and counted medications and supplies and had conversations about what to expect overseas although none of the brigade veterans had ever been to ghana. “this will be one of the most rewarding experiences of your life!” my biochemistry lab partner, shannon, said. the chapter president spoke proudly about how the organization is “sustainable, holistic, and ethical” and how we would “change peoples’ lives” through participating in this trip. one advertisement for the trip, on display in the student union, even read, “save children in africa this summer!” i looked through thousands of photographs of my peers who had been on trips, smiling with children of the developing communities they had worked in. i considered these photographs to be true representations of the positive impact they were having in these communities. no one challenged my decision to take part in a medical mission. rather, i was praised for my decision; my peers and family begged to see pictures and hear all of my stories when i came home. my first trip to ghana brought me a great sense of moral confusion. each day when i arrived at the community i found myself asking deeper and more difficult questions. the most important among those were: should pre-health volunteers be encouraged to go on short-term global health brigades? or is health volun-tourism simply a new form of colonialism? an attempt to answer my own questions desperate to find answers and reluctant to give up a passion to promote global health equity, i went back to work with this ngo in greater depth. like many others, it aims to empower both student volunteers and the community members these students work with, while improving access to healthcare and strengthening local systems. these are, of course, admirable intentions. it is without question that the majority of student volunteers feel empowered through these trips. most of my fellow interns had been on multiple brigades to central america; they were enthusiastic to work with different cultures and eager to have an impact. undoubtedly, these students had become activists for global health equity. furthermore, it is true that such organizations increase access to healthcare. the communities this organization works within, for example, host medical brigades every three months in partnership with a different american university chapter. however, through the research three of my peers and i conducted during this internship, i came to find that simple access does not guarantee high-quality care, nor does it lead directly to positive outcomes. 1. the challenges of global health cannot be overcome with a quick fix model kascak, the case against pre-health volunteers, voices in bioethics, vol 1 (2014) 4 while short-term medical missions inspire young adults to serve as advocates for global health equity, such trips can generate a flawed understanding of the ways in which the challenges of global health should be addressed. i often heard my peers describe their plans to go back to work with this organization as fully trained healthcare professionals on short-term missions in the future. although this desire is well intentioned, it suggests a belief that the multitude of problems that are blanketed by the term “global health” can be treated with a ‘quick fix’ model. on the one hand, students learn that causes (and preferred treatments) of illness are multifactorial and inextricably linked to an individual’s environment, socioeconomic status, and cultural views. yet simultaneously we experience a medical model in which hundreds of untrained foreign students pass through a community every year (many of whom have never set foot in that country at all). we are taught to believe that such a model is a respectable effort to promote and sustain the health of the world’s poorest citizens. the short-term nature of medical missions seems ideal for allowing student volunteers to feel inspired without seeing the challenges of global health work. we swoop in, taking in sights and sounds, snapping hundreds of selfies with local children, and participate in healthcare tasks we are ill-trained to complete. then, all too quickly, we swoop out, feeling self-satisfied with our efforts. such a model serves student volunteers while undermining the problems of the world’s poor, as well as the efforts of individuals who dedicate their lives to the work and advocate for a humbler and sustained, partnership approach to global health. such perspectives echo those of medical colonialists and imperialists alike, who believed that the issues of the developing world stemmed from its simplicity or primitiveness. they are also rife with a rescue mentality—that people in impoverished countries need (and want) to be saved. 2. putting patients and communities at risk wearing medical scrubs and stethoscopes around their necks, pre-health volunteers are passionate about working in impromptu clinics. yet the care that is carried out by these unskilled students is problematic at its best and life threatening at its worst. when i spent the day screening women for cervical cancer, i was lucky not to have made errors. i did an injustice to the women of the community i thought i was serving by virtue of reinforcing the facade that i (with my scrubs, stethoscope, and affiliation with the american doctors) was qualified to be examining patients and handle an emergency if one were to occur. when unskilled students take a patient’s vital signs, there is a risk that health abnormalities might be missed or falsely assigned to patients. these patients are given medication to treat both acute and chronic illness—medication that might be necessary for someone with a serious condition that goes unnoticed; medication that could be lifethreatening to individuals who do not have the indicated illness. furthermore, organizations, such as the one i worked with, can inadvertently establish parallel competing systems of healthcare between themselves and other ngos, as well as with the country’s existing health system. for example, in my internship research i learned that many patients avoid purchasing government-subsidized health insurance and using government health services because they depend on the free services of the american clinics. these individuals are not told that the organization plans to exit the community after an unknown period of time. ____________________________________________________________ kascak, the case against pre-health volunteers, voices in bioethics, vol 1 (2014) 5 conclusion rewriting the narrative of global patient care we need to reevaluate the standard of care for treating the world’s poor through global health initiatives. borrowing from ideas of liberation theology, paul farmer advocates for “a preferential option for the poor.” indeed, we owe a level of “perfection” to the communities we are so passionate about and eager to serve. we owe these individuals narrative and cultural humility: notions that may help challenge the way we speak about or for them. what’s more, we do not owe these individuals our service if we do not have a skill to offer them. would unskilled pre-health-oriented students continue to go on these trips if medical, nursing, therapy and other graduate admissions committees no longer condoned them or considered them to be valuable experiences? short-term global health brigades are harmful—to students, to patients, to communities, and, ultimately, to healthcare as a whole. it is a model that deserves to be challenged. it is a model that deserves to be changed. after all, not only do we owe the world’s poor our very best practices. we owe ourselves that as well. jackson, r*pe: still a four-letter word, voices in bioethics, vol. 1 (2014-15) * jhia louise jackson, ms bioethics © 2014 jhia louise jackson. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. r*pe: still a four-letter word jhia louise jackson* keywords: rape, bioethics, ethics, abortion, sexual assault introduction f*ck. sh*t. d*mn. most of us learned at an early age what the “forbidden” four-letter words were. we knew not to use them, especially around those with authority, and to be shocked and disgusted when we heard someone else use them. r*pe. rape. who knew that rape would still be a forbidden word in 2014? feminism is finally cool again, women are outperforming men in educational settings, and what falls within the parameters of an “acceptable” romantic relationship has generally increased since the 1950s. ____________________________________________________________ jackson, r*pe: still a four-letter word, voices in bioethics, vol. 1 (2014-15) 2 analysis so why do the most recent reports from the bureau of justice paint a picture that sounds painfully familiar in an otherwise progressive era: • between 2006 and 2010, an estimated average of 211,200 rape and sexual assault cases went unreported each year. • in that five-year period, 55% of male victims of violent crime did not file a report with the police. 49% of female victims did not file either. • 20% of females, compared with 8% of males, claimed they chose not to file a report for fear of reprisal or getting the offender in trouble. why all the silence? gender stereotyping cannot be the only cause, since research has shown that men are capable of becoming rape victims and women are capable of being the attackers. popular culture cannot be the only cause, since a plethora of crime shows, such as law & order and crime scene investigation, have featured victims of all ages, ethnicities, and genders becoming victims who seek police action that results in the attacker being caught and held accountable. it seems that fear of perception may be the answer. if bioethics is truly a field dedicated to the principles of justice, non-maleficence, autonomy, and beneficence, then rape, both its perception and prevalence, needs to become a topic of conversation. • how can we institute and enforce policies saying that abortion in the case of rape is acceptable, if we still have not agreed upon what rape is and is not? • how can patients who have been raped or sexually assaulted be treated, both physically and psychologically, if people feel unable to speak up? • if a potential victim does seek medical attention, how much care should there be and what kinds should be given? should a more paternalistic standard of care be given to college students, such as in the recently breaking florida state university case, who may feel unsure of what to do? should intimate partner violence assaults have a different standard of care from unknown attacker cases? • what steps can/should medical professionals take to ensure that victims are educated enough to recognize that they have been raped or sexually assaulted? should they limit their care to physical issues, or extend their care to include extensive psychiatric and police follow-up? further aggravating some of the more prevalent issues surrounding rape cases are the mixed messages that the internet allows quick access to. just as campuses nationwide are taking steps to prevent and spread awareness about forms of sexual assault, articles entitled “white house faking rape statistics” are being circulated and viewed. as non-profit organizations such as rainn (rape, abuse, & incest national network) are helping victims define what happened to them and do something about it, articles such as “the victims of false rape accusations” quote scholarly research that shows a 2%-8% rate of false rape reports, despite college students believing 50% of rape allegations are false. conclusion no one wins when a rape claim falls suspect due to petty factors such as stereotypes and other preconceived notions. everyone loses when stories circulate about rape claims truly being falsified, regardless of the reasons. we all suffer when the stigma of rape silences beneficial conversation. jackson, r*pe: still a four-letter word, voices in bioethics, vol. 1 (2014-15) 3 it’s 2014. let’s talk about rape. references bureau of justice statistics, “nearly 3.4 million violent crimes per year went unreported to police from 2006 to 2010.” published august 9, 2012. http://www.bjs.gov/content/pub/press/vnrp0610pr.cfm the new york times, “a star player accused, and a flawed rape investigation” by walt bogdanich. published april 16, 2014. http://www.nytimes.com/interactive/2014/04/16/sports/errors-in-inquiry-on-rape-allegations-againstfsu-jameis-winston.html?hp&hp&_r=0 worldnetdaily, “white house faking rape statistics?” by drew zahn. published january 25, 2014. http://www.wnd.com/2014/01/white-house-faking-rape-statistics/ rainn: rape, abuse, & incest national network, “types of sexual violence.” https://www.rainn.org/get-information/types-of-sexual-assault the dish: biased and balanced, “the victims of false rape accusations” by andrew sullivan. published february 28, 2014. http://dish.andrewsullivan.com/2014/02/28/the-victims-of-false-rape-accusations/ http://www.bjs.gov/content/pub/press/vnrp0610pr.cfm http://www.nytimes.com/interactive/2014/04/16/sports/errors-in-inquiry-on-rape-allegations-against-fsu-jameis-winston.html?hp&hp&_r=0 http://www.nytimes.com/interactive/2014/04/16/sports/errors-in-inquiry-on-rape-allegations-against-fsu-jameis-winston.html?hp&hp&_r=0 http://www.wnd.com/2014/01/white-house-faking-rape-statistics/ https://www.rainn.org/get-information/types-of-sexual-assault http://dish.andrewsullivan.com/2014/02/28/the-victims-of-false-rape-accusations/ ducar, suspending informed consent, voices in bioethics, vol. 1 (2014-15) © 2014 dallas m. ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. supsending informed consent dallas m. ducar keywords: bioethics, informed consent, ethics, advance directive introduction the notion of suspended human animation has long been a topic in science fiction. whether it is transporting human astronauts to far-off planets or freezing bodily processes for thousands of years, humans have been obsessed. our biological clocks are constantly ticking and remain a constant reminder of our own mortality. time is limited, and nowhere is this more evident than in the emergency room. in cases of traumatic injury, the more time the better. this is the current logic at upmc presbyterian hospital in pittsburgh. when the human body is at normal temperature, cells require oxygen for metabolic processes to continue normally. however, at lower temperatures, cells require less oxygen, as chemical reactions tend to come to a halt. according to those at upmc, if one can suspend the bodily processes of a patient while dying, there remains more time to fix structural problems and apply the appropriate treatment prior to death. ____________________________________________________________ ducar, suspending informed consent, voices in bioethics, vol. 1 (2014-15) 2 analysis the process itself involves replacing a patient’s blood with cooled saline solution to halt cellular activity. the procedure was originally demonstrated by alam et al., claiming no deficits in learning and memory.1 the experimenters induced a hemorrhage in a group of pigs; blood was then drained and replaced with saline or potassium at 10 °c. the animals were then treated, re-perfused, and tested, showing neurologic damage in only three animals. doctors at upmc intend to replicate this procedure to allow for more survival time for the patient. the doctors plan on performing this technique on 10 patients who meet the criteria for this procedure and match this group with 10 additional patients who also meet the criteria, but will not be selected. the research team plans to continue with this procedure until enough patients are treated and there exists enough data to analyze. notably, the protocol does not require informed consent according to the u.s. food and drug administration because patients will be in a life-threatening condition.2 the lack of informed consent required for participants in this study is suspect due to the limited knowledge of outcomes regarding the procedure. previous research for this procedure is dependent on the outcome of behavioral memory and learning functions in pigs. our knowledge of the potential neurological effects of this procedure is not based on any research regarding animals with more human-like intelligence, such as primates. moreover, the researchers did find neurological impairment in some of the animals tested, and this was only when testing for learning and memory. the research is unclear on how the procedure may have affected more long-term memories or cognitive functions such as language or facial recognition. learning and memory may not be affected; however most of this takes place in the hippocampus. this does not preclude the possibility of damage to the frontal lobe, resulting in cognitive defects. the full spectrum of possible risks has not been analyzed; thus, it is imprudent and possibly unethical for researchers to begin research on humans without further data from non-human primates. conclusion furthermore, less than 50 percent of severely or terminally ill patients, in general, have advance directives. 3, 4 it is likely that some of the patients admitted in this study will not have an advance directive. by including patients without advance directives, it is impossible to know how patients will react to involuntarily undergoing this procedure. it is quite possible that a patient will react adversely upon waking to a life where her quality of life has been significantly diminished. what if the patient has to spend his life on a feeding tube? or perhaps the patient experiences retrograde amnesia? why do we presuppose an overriding value on the patient’s life over their choice? the fda has sent an obvious message: that autonomy can be violated for those on the cusp of death. at the very least, this story elucidates society’s willingness to supersede our ethical principals at the risk of death. the risks of such an operation are unknown and further research is needed before beginning research on humans. ducar, suspending informed consent, voices in bioethics, vol. 1 (2014-15) 3 references 1 alam, h. b., bowyer, m. w., koustova, e., gushchin, v., anderson, d., stanton, k., ... & rhee, p. (2002). learning and memory is preserved after induced asanguineous hyperkalemic hypothermic arrest in a swine model of traumatic exsanguination. surgery, 132(2), 278-288. 2 code of federal regulations, [title 21, volume 1] part 50, protection of human subjects, subpart b--informed consent of human subjects sec. 50.24 exception from informed consent requirements for emergency research. 3 teno jm, licks s, lynn j, et al. do advance directives provide instructions that direct care? j am geriatr soc1997;45:508-12. 4 teno j, lynn j, wenger n, et al. advance directives for seriously-ill hospitalized patients: effectiveness with the patient selfdetermination act and the support intervention. j am geriatr soc 1997;45:500-7. gunshot victims suspended between life and death: http://www.newscientist.com/article/mg22129623.000-gunshot-victims-to-be-suspended-between-life-anddeath.html#.u4qw4fldx0q end of life preferences: http://www.ahrq.gov/research/findings/factsheets/aging/endliferia/index.html exceptions to informed consent: http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm249673.pdf http://www.newscientist.com/article/mg22129623.000-gunshot-victims-to-be-suspended-between-life-and-death.html#.u4qw4fldx0q http://www.newscientist.com/article/mg22129623.000-gunshot-victims-to-be-suspended-between-life-and-death.html#.u4qw4fldx0q http://www.ahrq.gov/research/findings/factsheets/aging/endliferia/index.html http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm249673.pdf ninia, hindsight is 20/20, voices in bioethics, vol. 6 (2020) james ninia, ms, columbia university © 2020 james ninia. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hindsight is 20/20: lessons from the covid–19 pandemic and the need for stronger, ethical disease surveillance james ninia* keywords: disease surveillance, global ethics, bioethics, world health organization introduction amid the covid–19 pandemic, it is disturbing to read that, in 2016, a united nations report assessed the ability of the international community to respond to communicable diseases as “woefully insufficient.”1 the global health crises task force, assembled in 2016 by then secretary-general ban kimoon, published a report entitled “protecting humanity from future health crises,” containing warnings that were prescient in light of recent events. the report called the 2013-16 west african ebola virus outbreak a “preventable tragedy” and criticized the international community for not addressing prior recommendations made to prevent such events in the wake of the 2009 h1n1 pandemic.2 the covid–19 pandemic should serve as a wake-up call – without bold action, future disease outbreaks could be just as devastating as the covid–19 pandemic or worse. analysis the un report cites mathematical modeling performed by the bill and melinda gates foundation which predicts that “a virulent strain of an airborne influenza virus could spread to all major global capitals within 60 days and kill more than 33 million people within 250 days” -a pandemic the likes of which the world hasn’t seen since the 1918 spanish flu. we are currently less than 250 days from the start of the covid–19 pandemic,3 and we are not on track to have a disaster on the scale that the gates foundation predicted possible.4 however, the numbers borne out by the gates foundation’s modeling are serious, and since most current estimates seem to point toward covid–19 being more fatal than the seasonal flu, they demand attention and action. while the un report contains twenty-seven different recommendations for action at national, regional, and global levels including more robust funding for the world health organization (who) and https://www.theguardian.com/society/2016/feb/08/millions-could-die-as-world-unprepared-for-pandemics-says-un https://www.theguardian.com/society/2016/feb/08/millions-could-die-as-world-unprepared-for-pandemics-says-un https://digitallibrary.un.org/record/822489?ln=en ninia, hindsight is 20/20, voices in bioethics, vol. 6 (2020) 2 addressing poverty, the need for improved disease surveillance is especially noteworthy. in a 2015 op-ed for the nejm, bill gates urges action on this exact front, writing, “routine surveillance systems should be designed in such a way that they can detect early signs of an outbreak beyond their sentinel sites and be quickly scaled up during epidemics. they should be linked with national public health laboratories to enable robust monitoring and response. and the data derived from such testing need to be made public immediately.”5 to make existing disease surveillance more effective, gates focuses in part on the need for improved data sharing among state actors. while who already has epidemic and pandemic alert and response (epr), a branch that deals with alert and response operations based on a few severe diseases (such as anthrax and the bubonic plague), who relies on individual countries to report outbreaks, which they may or may not do. reporting can be compromised by both the mixed quality of disease surveillance mechanisms within the country of origin, as was the case during the west african ebola crisis, or a government’s decision to treat information about new disease outbreaks to be a “state secret,” as some have alleged was the case with china’s initial handling of covid–19 compromise reporting.6 to help overcome the deficiencies of current disease surveillance mechanisms, the un panel recommended that countries set up a “one health” surveillance system, meaning integrating veterinary health data into disease surveillance programs.7 this makes sense given that the covid–19 pandemic is generally believed to have originated from animal hosts.8 additionally, the un panel called for all unusual health events to be reported to the who so that the international community could respond more promptly.9 the report also recommended that countries in the developing world strengthen both their laboratory capacities for more rapid diagnoses as well as their emergency health workforces. however, even resource-limited provinces in china tend to have robust laboratory infrastructure.10 the un’s 2016 report teaches us that some share of the deaths associated with the covid–19 pandemic were wholly preventable. by failing to implement the un’s recommendations made in the wake of the h1n1 and ebola pandemics, individual governments effectively allowed some share of the deaths associated with the covid–19 pandemic to occur. while the governments of the world are rightfully concerned with combatting the ongoing covid–19 pandemic now, the un’s 2016 recommendations demand a second look in the immediate future in order to prevent some share of deaths associated with the next infectious disease outbreak. the un report is correct in advocating for stronger disease surveillance mechanisms. international cooperation to the ends of implementing more robust disease surveillance appears to be a moral obligation such that some share of future deaths during the next major disease outbreak can be prevented. the implementation of any disease surveillance mechanisms or the modification of existing initiatives will raise certain ethical challenges. for example, disease surveillance data is often collected without the informed consent of affected individuals.11 while the waiving of an informed consent process paves the way for a more complete and robust dataset, it arguably constitutes a violation of an individual’s privacy or autonomy. additionally, while public dissemination of data obtained from disease surveillance is necessary to reap all the benefits associated with strong disease surveillance initiatives, certain published information could inadvertently lead to the stigmatization of a group and expose its members to discrimination.12 the implementation of stronger disease surveillance initiatives as well as the continuation of current ones should be balanced against these considerations. ideally, clear ethical guidelines agreed upon by experts and the international community should be developed. surveillance programs could potentially be seen as violating a nation’s sovereignty. currently, who requires that countries report outbreaks of many diseases including cholera, yellow fever, and typhus. https://www.nejm.org/doi/10.1056/nejmp1502918 https://www.nejm.org/doi/10.1056/nejmp1502918 https://www.axios.com/timeline-the-early-days-of-chinas-coronavirus-outbreak-and-cover-up-ee65211a-afb6-4641-97b8-353718a5faab.html https://www.axios.com/timeline-the-early-days-of-chinas-coronavirus-outbreak-and-cover-up-ee65211a-afb6-4641-97b8-353718a5faab.html https://link.springer.com/article/10.1186/s40779-020-00240-0 https://doi.org/10.1186/s12889-019-6777-2 https://www.ncbi.nlm.nih.gov/pubmed/14752148 https://cioms.ch/wp-content/uploads/2017/01/international_ethical_guidelines_lr.pdf ninia, hindsight is 20/20, voices in bioethics, vol. 6 (2020) 3 however, who depends upon individual nation states to report any outbreaks as well as to consent to the dissemination of that information.13 since governments have often been accused of covering up the severity of disease outbreaks, who may need to reexamine its enforcement of reporting requirements in order to implement stronger disease surveillance mechanisms for the prevention of future preventable deaths.14 the 2016 un panel broadened the reporting requirements by recommending that all unusual health events be reported to the who.15 nation states should be compelled to report such outbreaks. potential violations of national sovereignty seem to be a lesser evil than the prospect of preventable deaths due to communicable disease occurring on a global scale in the wake of any future pandemics. sovereignty should not extend to covering up disease outbreaks. conclusion the un’s 2016 report was correct to call for more robust disease surveillance at the international level. the implementation of “one health” surveillance mechanisms alongside calling for all unusual health events to be reported to who would be significant steps toward managing and preventing pandemics. however, disease surveillance mechanisms must be established and evaluated with ethical considerations in mind. ideally, clear ethical guidelines should be agreed upon at the international level. moreover, who’s policy of depending upon individual nation states to report disease outbreaks to the international community may demand a second look. some nation states are not proven to be responsible reporters of data. international cooperation to establish and strengthen disease surveillance mechanisms is necessary for the prevention of future pandemic events and to save lives. 1 sarah boseley. “millions could die as world unprepared for pandemics, says un.” the guardian. guardian news and media, february 8, 2016. https://www.theguardian.com/society/2016/feb/08/millions-could-die-as-world-unprepared-for-pandemicssays-un. 2 united nations, high-level panel on the global response to health crises, protecting humanity from future health crises : report of the high-level panel on the global response to health crises, a/70/723 (09 feb 2016), available from https://digitallibrary.un.org/record/822489 3 josephine ma. “china's first confirmed covid-19 case traced back to november 17.” south china morning post, march 13, 2020. https://www.scmp.com/news/china/society/article/3074991/coronavirus-chinas-first-confirmed-covid-19-case-tracedback. 4 rob picheta. “coronavirus global death toll passes 300,000 as countries wait in lockdown.” cnn. cable news network, may 14, 2020. https://www.cnn.com/2020/05/14/world/coronavirus-global-death-toll-300000-intl/index.html. 5 bill gates. “the next epidemic — lessons from ebola.” new england journal of medicine 372, no. 15 (april 9, 2015): 1381–84. https://doi.org/10.1056/nejmp1502918. 6 bethany allen-ebrahimian. “timeline: the early days of china's coronavirus outbreak and cover-up.” axios, march 18, 2020. https://www.axios.com/timeline-the-early-days-of-chinas-coronavirus-outbreak-and-cover-up-ee65211a-afb6-4641-97b8353718a5faab.html. 7 united nations, high-level panel on the global response to health crises, p. 37 https://www.who.int/csr/alertresponse/en/ https://foreignpolicy.com/2009/11/17/the-great-flu-cover-up/ https://digitallibrary.un.org/record/822489 https://doi.org/10.1056/nejmp1502918 https://www.axios.com/timeline-the-early-days-of-chinas-coronavirus-outbreak-and-cover-up-ee65211a-afb6-4641-97b8-353718a5faab.html https://www.axios.com/timeline-the-early-days-of-chinas-coronavirus-outbreak-and-cover-up-ee65211a-afb6-4641-97b8-353718a5faab.html ninia, hindsight is 20/20, voices in bioethics, vol. 6 (2020) 4 8 yan-rong guo, qing-dong cao, zhong-si hong, yuan-yang tan, shou-deng chen, hong-jun jin, kai-sen tan, de-yun wang, and yan yan. “the origin, transmission and clinical therapies on coronavirus disease 2019 (covid-19) outbreak – an update on the status.” military medical research 7, no. 1 (march 13, 2020). https://doi.org/10.1186/s40779-020-00240-0. 9 united nations, high-level panel on the global response to health crises, p. 12 10 bo liu, fang ma, jeanette j. rainey, xin liu, john klena, xiaoyu liu, biao kan, et al. “capacity assessment of the health laboratory system in two resource-limited provinces in china.” bmc public health 19, no. s3 (may 10, 2019). https://doi.org/10.1186/s12889-019-6777-2. 11 a. l. fairchild and ronald bayer. “public health: ethics and the conduct of public health surveillance.” science 303, no. 5658 (january 30, 2004): 631–32. https://doi.org/10.1126/science.1094038. 12 council for international organizations of medical sciences (cioms). international ethical guidelines for epidemiological studies. geneva: cioms, 2009. 13 who. “alert & response operations.” world health organization. world health organization, february 13, 2020. https://www.who.int/csr/alertresponse/en/. 14 alan i. sipress “the great flu cover-up.” foreign policy. foreign policy, november 17, 2009. https://foreignpolicy.com/2009/11/17/the-great-flu-cover-up/. 15 united nations, high-level panel on the global response to health crises, p. 12 https://doi.org/10.1186/s40779-020-00240-0 https://doi.org/10.1186/s12889-019-6777-2 https://doi.org/10.1126/science.1094038 https://www.who.int/csr/alertresponse/en/ https://foreignpolicy.com/2009/11/17/the-great-flu-cover-up/ belisomo, living donor fund, voices in bioethics, vol. 1 (2014-15) © 2015 author and author. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the american living organ donor fund: removing financial barriers to benevolent actions randi bellisomo keywords: organ donation, ethics, bioethics introduction an online fundraising campaign brought in three hundred dollars. friends from church pooled just a bit more than that for the cause. but the total was not enough to cover six weeks of 46 year-old stephanie washington’s expenses as she recovered at her sister’s home in hayward, california from kidney donation surgery to help her niece, a gunshot victim. “she knew that god would provide, but i knew that we had to put some plans in place,” said washington’s sister, faye herald, who didn’t anticipate the obstacles potential donors encounter. washington ran her own cleaning service, and if she didn’t go to workshe wouldn’t get paid. she provides for two children, a daughter at howard university and a 14 year-old son. money is tight, but she never considered not donating; if she did not, she feared her brother’s 24 year-old daughter would soon die. what she didn’t know when she first considered donating is what many americans don’t either: while a transplant recipients’ health insurance covers the medical expenses of donors, coverage does not include transportation, lodging, childcare or lost wages. the national organ transplant act of 1984 made it illegal to compensate organ donors. herald thought that some charitable assistance had to be available, and with some research, she discovered the newly established american living organ donor fund, founded late last year by bioethicist and health care attorney sigrid fry-revere to remove financial disincentives that accompany such a benevolent act. analysis “why should a living donor who is saving a life by giving part of their body go into debt or use up their savings?” fry-revere asked. she received a completed application from herald on behalf of her sister that included documentation that washington was self-employed, along with a client list and bank statements. fry-revere approved it, and one day after washington was discharged from a san francisco hospital following january 6th surgery, she received a check from the fund to cover two months of rent and household bills. “it’s such a blessing and relief,” washington said by phone from her sister’s home. “i can relax, and that’s one of the reasons my recovery is going so good. i don’t have to worry.” according to the american journal of nephrology, living donors incur an average of five thousand dollars in out-of-pocket expenses. sometimes, costs total as much as four times that. however, the census bureau reports that only eight percent of households can afford such a cost without dipping into savings or going into debt. twenty percent of american households have no discretionary funds.“this is awesome,” herald said about fry-revere’s new non-profit, funded initially by a successful kickstarter campaign. “she is doing a great thing.” fry-revere was once a potential donor herself. in 2010, she thought she had plans in place to donate bellisomo, living donor fund, voices in bioethics, vol. 1 (2014-15) 2 a kidney to a friend who experienced organ failure as a child due to a bout with strep throat and fever. his mother donated a kidney then; when it failed, he received a cadaveric kidney that lasted two decades. having two transplants already, chances were nil that he would receive another organ by waiting on the unos list. fry-revere believed that she was his solution, as she was medically compatible. she planned surgery during the christmas holidays, so that her husband and college-aged sons could take time away from work and school to help her recover at their ten-acre northern virginia farm. what she had not considered was the factor driving her current philanthropy: personal expenses. the university of michigan transplant center coordinator told her that an eight-week recovery plan was required; however, her caregivers could only be home for a month. unable to tend to daily tasks of property maintenance, she also would need to hire a farmhand. with the expense being unanticipated and unaffordable, she was quickly eliminated from the process. fry-revere’s friend died one year after her declined offer. “i was dumbfounded,” she said. “they would rather let him die than give me time to figure out how to take care of myself.” she has been lobbying congress to amend the national organ transplant act with more provisions and financial support for living donors. fry-revere said she believes funding donors’ out-of-pocket costs would save exponentially more money than continuing to cover long-term dialysis and other medical expenses for the thousands of patients awaiting a kidney. the most expensive patients, perhaps, could more easily receive organs from live donors; in turn, they would be removed from the unos waiting list. “here’s a real savings opportunity,” she said. “this is a win-win solution that saves money and saves lives”. in the meantime, her organization has the resources to assist 17 qualifying donors, and fry-revere is working to raise more. “there are probably potential donors who would be willing if they knew they would be getting some type of assistance,” washington said. conclusion living donors are desperately needed, as more than 120,000 americans are listed on the united network for organ sharing (unos) waiting list. those awaiting kidneys number 103,000; these patients are ones that could be helped through living donation. more than one million people have died as a result of end stage renal disease since 1980; fry-revere points out that this number is more than the approximate total of 623,000 military deaths in world wars i and ii, korea, vietnam, the persian gulf, afghanistan and iraq combined.“we are small peanuts right now,” fry-revere laughed. “it’s a drop in the bucket, but it helps our morale and helps educate people.” it wasn’t small peanuts for stephanie washington, or for her niece who is recovering well. for more information on the american living organ donor fund: http://www.helplivingdonorssavelives.org/ for more information about sigrid fry-revere’s related work: http://ethical-solutions.org/ http://www.helplivingdonorssavelives.org/ http://www.helplivingdonorssavelives.org/ http://www.helplivingdonorssavelives.org/ http://ethical-solutions.org/ http://ethical-solutions.org/ ayeh, is the war on electronic cigarettes legitimate?, voices in bioethics, vol. 1 (2014-15) * derek ayeh, ms bioethics © 2014 derek ayeh. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. is the war on electronic cigarettes legitimate? derek ayeh* keywords: vape, e-cigarettes, bioethics, ethics introduction with los angeles’ move to ban electronic cigarettes from public spaces they could soon be joining chicago, new york, and others who have restricted the use of this popular and controversial innovation. e-cigarettes have become a hot topic in the world of tobacco products now that they are becoming more widely used. advocates argue that e-cigarettes are safe because: they lack the tar and other dangerous chemicals found in regular cigarettes that make smoking dangerous and could help people with addictions to nicotine quit traditional tobacco products. because e-cigarettes are vaporizers, they do not produce smoke, which might mean that the dangers of any negative second-hand effects are null. however, there hasn’t been research on the effects of second-hand “vaping,” and it would be best that such studies be undertaken to ensure safety. analysis unfortunately, those lobbying against e-cigarettes aren’t solely concerned with the health risks of the devices. many are fearful of the possibility for e-cigarettes to become a gateway drug, or at least an innocent way for non-smokers to start before taking up normal cigarettes as well due to nicotine addiction. also, though e-cigarette marketers are not targeting younger audiences, their usage of words like “e-hookahs” or “vape pens” seem to be shedding a light on e-cigarettes that makes them sound harmless. this could further hook young people and critics are using the fear of creating new smokers to drive their war against e-cigarettes. some are fighting back by arguing that the question of whether e-cigarettes are acceptable is no longer based on empirical evidence. while more studies need to be done there is no reason to believe that e-cigarettes will function as a gateway drug, nor is there proof that ecigarette smokers will start using traditional tobacco products. instead, there is a claim, forwarded by will saletan and amanda marcotte of slate, that this war is really the result of cultural anxieties that we as a society have over smoking in general. ever since tobacco companies lied about the harmfulness of smoking in the past society has ostracized smokers ayeh, is the war on electronic cigarettes legitimate?, voices in bioethics, vol. 1 (2014-15) 2 in its attempts to get rid of smoking entirely. the distaste the u.s. has for smoking is within the public’s consciousness – it’s acceptable to disapprove of or condemn anyone who smokes. conclusion those who are battling against e-cigarette usage then are following in an old social construct that shames smokers. however, saletan and marcotte might say this construct is outdated and should not be used in discussions on the viability of e-cigarette usage. amy fairchild and james colgrove of the mailman school of public health at columbia university have also made comments concerning tolerating e-cigarettes. in their new york times article they said, “… there is a price to such rigidity. emotion should not rule out harm reduction, even if eradication of smoking is the ultimate goal.” they felt that public banning of vaping would not help reach that goal, but instead focused on fda regulation of e-cigarettes as the best possible course of action at this time. the wisest course then seems to be using the fda to regulate. they wouldn’t just serve the purpose of checking quality and safety to protect health concerns, but could be used to regulate advertising and marketing schemes to make sure that younger audiences are not targeted. perhaps through the fda more research could also be conducted to ensure the safety of e cigarette usage. references the moral panic over e-cigarettes intensifies http://www.slate.com/blogs/xx_factor/2014/03/05/e_cigarettes_are_all_the_rage_with_kids_these_days_what _else_to_do_but_panic.html e-cigarettes, by other names, lure young and worry experts http://www.nytimes.com/2014/03/05/business/e-cigarettes-under-aliases-elude-the-authorities.html?hp&_r=0 los angeles city council approves e-cigarette ban http://www.reuters.com/article/2014/03/04/us-usa-ecigarettes-california-idusbrea2324920140304 vapor war http://www.slate.com/articles/health_and_science/human_nature/2009/06/vapor_war.2.html the case for tolerating e-cigarettes http://www.nytimes.com/2013/12/09/opinion/the-case-for-tolerating-e-cigarettes.html?_r=1& stephanie holmquist, acupuncture journeys to the west, voices in bioethics, vol.1, 2014-2015 © 2014 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. acupuncture journeys to the west stephanie holmquist keywords: acupuncture, traditional medicine, bioethics, north america, acupuncture anaesthesia in 1972 as a propaganda statement. like other chinese social realist artworks, it was meant to convey a message about the chinese state and its people. in this case, the message was that china was fully modern, but modern with chinese characteristics. to contemporary eyes, the painting looks like an artifact from an era when the state exercised almost total control over visual culture. but acupuncture anaesthesia has a place in western medicine and bioethics. the early 1970s saw china beginning to recover from the cultural revolution, including a controlled reopening to the west. this was t he era of ping-pong diplomacy and nixon in china. at the same time, north american and european interest in alternative medicine grew alongside general skepticism toward authority, including medical authority. the painting marks a moment when acupuncture and other components of traditional chinese medicine (tcm) were embraced by many western patients and some physicians. despite its name, traditional chinese medicine is not traditional. it is a construct of the chinese state incorporating selected historical practices of chinese medicine and pharmacy into a modern framework. before and after the 1949 revolution, many chinese intellectuals argued that modernity required adopting western medicine in place of historical chinese medical practices. in the end, mao zedong himself rejected this argument, decreeing that a state interpretation of traditional medicine would be institutionalized and integrated into healthcare throughout china. today, tcm continues to evolve in china, taiwan, and in areas beyond its historical home, including in the united states. for the chinese regime of the 1970s, tcm was not just healthcare, but another chinese achievement to be displayed to foreign visitors, like model schools, farms, and factories. of all tcm therapies, acupuncture made the most spectacular impression on western visitors, especially as it was presented in acupuncture anaesthesia—a drug-free alternative or powerful adjunct to surgical anesthesia. since the 1970s, more americans have turned to complementary and alternative medicine (cam), including acupuncture. close to 40% of adults in the u.s. were using some form of cam in 2007 according to the national institutes of health.[1] colleges devoted to tcm and other cam modalities now train practitioners exclusively in those disciplines. in parallel, elements of cam have also been incorporated into conventional healthcare education—often labeled integrated medicine (im). the ethics of integrating alternative therapies into medical practice is complex; experts have yet to reach a consensus as to whether any of these practices have a place among mainstream medical treatments. acupuncture has been among the most scrutinized alternative therapies. even so, it falls into a gray zone—e.g., neither a quack remedy nor a well-understood medical therapy.[2] http://www.voicesinbioethics.net/arts-media-in-bioethics/2015/07/20/acupuncture-journeys-to-the-west#_edn1 http://www.voicesinbioethics.net/arts-media-in-bioethics/2015/07/20/acupuncture-journeys-to-the-west#_edn2 stephanie holmquist, acupuncture journeys west, voices in bioethics, vol.1, ,2014-15 2 high-quality research confirms that acupuncture may offer relief from chronic pain. however, its efficacy in treating digestive disorders, intractable headaches, infertility, and other conditions remains unsupported by evidence-based standards—but neither are many accepted therapies of conventional medicine. to further complicate matters, characterizing acupuncture as “merely” an effective placebo is no longer a clear scientific or ethical dismissal. it has been more than forty years since tang muli painted acupuncture anaesthesia. acupuncture and other tcm modalities are here to stay in american healthcare. their popularity is driven by patient demand and dissatisfaction with conventional therapies, as well as with the quality of patient-physician relationships. the 1970s western encounter with tcm evoked an expectation of panacea-like solutions easily transferable from one cultural context to another. acupuncture anaesthesia captures the dramatic quality of that encounter and a pivotal moment in the translation of tcm to the west. references [1]“the use of complementary and alternative medicine in the united states,” nih national center for complementary and integrative health. dhhs, https://nccih.nih.gov/research/statistics/2007/camsurvey_fs1.htm. [2]"acupuncture," nih national center or complementary and integrative health. dhhs, http://nccam.nih.gov/health/acupuncture. fig. 1 acupuncture anaesthesia, 1972 oil on canvas, 164 x 224 cm, chinese national art gallery, beijing, http://fotografie.hfg-karlsruhe.de/content/acupuncture-anaesthesia. http://www.voicesinbioethics.net/arts-media-in-bioethics/2015/07/20/acupuncture-journeys-to-the-west#_ednref1 https://nccih.nih.gov/research/statistics/2007/camsurvey_fs1.htm http://www.voicesinbioethics.net/arts-media-in-bioethics/2015/07/20/acupuncture-journeys-to-the-west#_ednref2 http://nccam.nih.gov/health/acupuncture anekwe, tyler perry’s have’s and have nots, voices in bioethics, (vol.1) 2015 © 2015 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. tyler perry’s have’s and have nots ethical obiora anekwe tyler perry has become an american entertainment icon. his golden touch as an actor, writer, producer, and director has reached arenas in stage, television, and film. perry continues to bring forth ethical and moral messages in the visual arts that are often overlooked or underestimated. it is no different with his first soap opera, the haves and the have nots, broadcast on the own channel. the racially diverse cast of characters portrays the lives of the rich (the cryer and harrington families) and the poor and destitute (the young family) in the southern city of savannah, georgia. but beyond the surface of class difference, these families share common bioethical themes and challenges such as cancer, substance abuse, homosexuality, suicide, prostitution, poverty, rape, perpetual crime, abortion, mental illness, and life support. one of the more salient themes of the show is the issue of life support and health care disparities based on class. katheryn cryer (the haves) befriends and confides in hanna, her maid (the have nots), during her treatment of cancer. katheryn and hanna share a bond as parents, but most significantly, as two cancer survivors. after hanna aids katheryn in her recovery efforts, katheryn promotes hanna as the head maid in the cryer household. hanna has a son, benny, who lives with her and diligently operates a tow truck company. while working late one night, benny is accidentally struck by a car driven by katheryn cryer’s son, wyatt, who was under the influence of heroin. wyatt not only harms benny, but subsequently kills a girl in the accident. as a result of this horrific turn of events, benny is in a coma with very little hope of recovery. his mother, hanna, constantly prays for her only son’s recovery; while wyatt, a young man of privilege, is being protected by his family’s wealth and power. to make matters worse, benny’s father, tony, who was not involved in his son’s life as a young man, legally seeks to remove his son off life support in order to acquire a much-needed kidney. this tale’s tragedy is found in the victim of the accident, benny. he cannot receive the treatment he deserves in a community hospital because he does not have health care insurance. the lack of access to medical resources is limited by benny’s status as a young person without medical capital. tyler perry creatively brought the issue of health care disparities to the forefront without preaching to the choir. his writing is so well crafted that you, as a viewer, are confronted with this issue without much notice. perry’s narrative from the haves and the have nots highlights how the passing of the affordable care act begins to bring justice and equality to health care. opposition to the act by those who seldom have read it in its entirety and oftentimes possess comprehensive health care insurance themselves simply brings to light subversive and undermining discriminatory practices against the poor and most vulnerable. as tyler perry’s television series demonstrates, the lack of comprehensive health insurance oftentimes results in the death of the poor. in this scenario, the poor and vulnerable are not the only victims. their families and even the larger society are harmed because of a lack of compassion for the helpless. rather than promoting further divide over disagreements about certain sections of the affordable care act, we, as a nation, should seek to make health care a nationalistic fundamental right that benefits all society. although the health care system in america seems fragile and even broken to some, it can be healed and repaired through a concerted effort of bipartisan political leadership and citizen support. tyler perry’s television series reminds us that we have what it takes to bridge the divide between the haves and the have nots if we are willing to work together for a common and necessary good tyler perry’s have’s and have nots ethical bergstresser, adrienne asch, voices in bioethics, vol. 1 (2014) © 2014 sarah bergstresser. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. adrienne asch: a career at the intersection of bioethics and disability studies sarah bergstresser keywords: adrienne asch the first time i heard adrienne asch speak, she had assumed her role as a respected and influential member of the disability studies field. later, as a student of bioethics, i discovered that she was also a respected and influential bioethicist. who was this scholar with such expertise in two fields, and why did her contribution to each field have to be discovered separately? asch passed away in november of 2013. widely missed and memorialized in these two fields, i realized that there must be a third form of recognition for her pioneering work at the intersection of disability studies and bioethics. asch was born in new york in 1946. born premature, she developed retinopathy from too much oxygen in her incubator, thus losing her vision (roberts 2013). asch’s own difficulty in finding employment after graduating from swarthmore college with a bachelor’s degree in philosophy made her keenly aware of disability as a civil rights issue (fox 2013). she went on to study social work and social psychology at columbia university and in 2005, she was recruited to direct the center for ethics at yeshiva university in new york. a great deal of her work crossed disciplinary boundaries; bridging bioethics, disability studies, feminist studies, public health, and human rights. her most influential work opposed genetic testing and abortion to select against children predicted to have disabilities. asch was known for her straightforward and often blunt nature, but what struck me most was her profound intellectual patience with other people and their entrenched assumptions. on more than one occasion, i attended lectures and meetings on the topic of reproduction in bioethics or health policy contexts, at which asch was present. sometimes, at these events, the discussion would turn to a consideration of what to do in case a fetal genetic test predicted disability (a narrative still broadly overshadowed by suggestions of burden and tragedy). she would listen to the conversation unfold. after a while, she would interject, reminding everyone that speaking of disability as tragedy bergstresser, adrienne asch, voices in bioethics, vol. 1 (2014) 2 reflects mistaken assumptions about the value and quality of human life and the reality of human families. how many times must she have repeated this type of statement? i can only imagine how frustrating it must be to have spent a career battling such tenacious social attitudes about disability and the imaginary ideal of the “perfect” child. underlying her persistence was a commitment to say what needed to be said, time after time. i have a profound respect for asch and the dedication and passion that she brought to the world. the pieces that follow were written by three individuals who knew her both professionally and personally. i think that, by seeing her through the eyes of friends and colleagues, we can begin to fully appreciate the great and lasting impact that asch has had in bioethics and beyond. references: fox, margalit. "adrienne asch, bioethicist and pioneer in disability studies, dies at 67." the new york times, november 23, 2013. http://www.nytimes.com/2013/11/23/nyregion/adrienne-asch-bioethicist-and-pioneer-indisability-studies-dies-at-67.html roberts, dorothy. "adrienne asch (1946-2013)." nature 504, no. 7480 (2013): 377-377. corinne kirchner, phd, columbia mailman school of public health adrienne asch’s recent death was premature in ways not yet fully acknowledged in the wide public recognition of the great loss it will have for our society. this brief article will focus on one sphere of intellectual creativity that engaged asch for much of her professional development. (i did not write “professional career” because it is so artificial to separate activities that constituted asch’s life in general from the more formal category we call “career”). i refer to her efforts to knead together the fields of disability studies and of bioethics, for the expansive effects their blending would have on the thousands of individuals involved. it was a persistent frustration to asch that many of her admirers classified her first and foremost as a pioneering voice in clarifying disability rights and tended to overlook or diminish her identity as a bioethicist. they often http://www.nytimes.com/2013/11/23/nyregion/adrienne-asch-bioethicist-and-pioneer-in-disability-studies-dies-at-67.html http://www.nytimes.com/2013/11/23/nyregion/adrienne-asch-bioethicist-and-pioneer-in-disability-studies-dies-at-67.html bergstresser, adrienne asch, voices in bioethics, vol. 1 (2014) 3 based their prioritization on her lifelong blindness, thereby seeming to overlook her training and production in the philosophical analytic basis for work in bioethics. as asch’s professional colleague and friend, i, too, was somewhat misinformed about the significance of this particular interdisciplinary effort. i did not understand the difficulty in promoting this combination of intellectual foci. to me, and presumably many others in disability studies, it seemed a logical linkage, and therefore an easy task. to me, it seemed that both fields expressed preeminent concern with social justice which had engaged asch from her earliest professional entrée. thus, i thought that promoting those two fields to work together would be a natural development. but no! as asch spelled out in her early writing on the topic, there was a serious barrier between the two fields. as her chapter in the influential handbook of disability studies (albrecht et al., 2001), explained bioethics assumed the traditional and still lingering “medical model” view of disability. that view has been countered with the “social model,” an alternative analysis of disability with multidimensional consequences. those who take the medical perspective tend to view the wide ranging social consequences as a direct result of physiological difference, rather than as separatelygenerated sociocultural practices that can be addressed in their own terms to eliminate or minimize functional limitations and related attitudes of pity and rejection. to those observers, among them many bioethicists of the 1970s and beyond, disability was a ‘tragedy’, necessitating reduced quality of life and hence exclusion from typical pleasures of valued community roles. writers on the critical life-and-death and health resource allocation issues central to bioethics, generally applied paternalistic, overly protective attitudes in making their judgments about by whom and how decision-making should proceed for the benefit of people with disabilities, including those with cognitive impairments. thanks in part to asch’s prolixity in writing and lecturing about the intersections of bioethics and disability studies, and also to the many other leading thinkers whose writings she stimulated or partnered with over the last decade and more, much progress was made toward the initial vision of a robust interdisciplinarity. as recently as the past spring, a lengthy entry in the stanford online encyclopedia of philosophy (the sep) coauthored by asch, wasserman, blustein, and putnam on “disability and justice”, reveals that much of the original problematic view of disability continues to undermine bioethicists’ ability to accord full acceptance to people with disabilities. however, that gap is likely to persist. as long as disability entails, both of the two types of injustice recognized by philosophers of justice – 1) physiological impairments, and 2) related disadvantageous societal outcomes – the challenge exists for analysts to identify the precise nature of the societal problem along with realistic aims and means for solutions. in other words, the challenge for bioethics is to reach and study consensus on how justice for all members of society can be achieved or at least maximized, taking into adequate account that not all members have the same bodily capacities, i.e. the facts of the distribution of disabilities. comparing the 2001 and the 2013 chapters reveals that asch had moved spectacularly into the complexities of relevant philosophical scholarly treatises on social justice. her closing comment as of 2013 called for even more work bergstresser, adrienne asch, voices in bioethics, vol. 1 (2014) 4 by the philosophers. as in all her intellectual and personal ventures, she maintained clarity of focus throughout the period on disability as a cultural phenomenon, which offers variegated opportunities and difficulties for individuals to manage creatively. sadly, and ironically, the two fields whose linkage she tackled may come closest together in recognizing the vital loss of asch’s intellectual, moral, and emotional leadership. references: asch, adrienne, (2001) “disability, bioethics and human rights,” chapter 11 in albrecht, gary, seelman, katherine, bury, michael (eds.) handbook of disability studies, thousand oaks, ca.: sage publications. wasserman, david, asch, adrienne, blustein, jeffrey, putnam, daniel, (summer 2013) “disability and justice” in zalta, edward n. (ed.) the stanford encyclopedia of philosophy url¸http://plato.stanford.edu/atchives)/sum2013/entries/disability-justice/ visited 1/2/14. rachel adams, columbia university at a workshop a few years ago, adrienne asch asked me to accompany her when we moved from one room to another. as i took her arm, tentatively attempting to steer her in the right direction, she barked, “don’t clutch at me!” making no effort to hide her irritation, she repositioned my hand where she wanted it. that may have been the first time asch snapped at me; it would certainly happen again. anyone who knew asch is aware that she could be prickly, irascible, and blunt. she did not suffer fools gladly, and would tell you in no uncertain terms when she thought you were wrong. asch was also kind, generous, and brilliant. she took life experiences, like our clumsy encounter at the workshop, as opportunities for reflection, thinking deeply about the ignorance, fear, and misunderstanding that continue to inform prevailing attitudes toward bodily difference, as well as the possibilities of transforming beliefs, customs, and policies to make the world a better place for people with disabilities. she loved to meet people, to collaborate, and to debate. i was especially struck by how she made herself available to graduate students and younger http://plato.stanford.edu/atchives%29/sum2013/entries/disability-justice/ bergstresser, adrienne asch, voices in bioethics, vol. 1 (2014) 5 scholars. she was a generous advisor and mentor, but she was also open to learning from new ideas and perspectives. every so often i could expect an email from adrienne with the name and address of a colleague she thought would share my interests. i treasure those contacts and mourn the lost possibility of future connections. when i learned that my second child had down syndrome, asch’s writing about genetics, prenatal testing, and reproductive ethics became an invaluable source of wisdom. in the months after my son’s birth, i was dismayed by the information about prenatal testing and genetic disability in the advice manuals i had accumulated during my pregnancy. so much was underdeveloped, inaccurate, and biased. these books seemed to assume a genetically perfect fetus, giving minimal or no information at all about the meaning of a positive diagnosis (one that disclosed a genetic disability). i have always believed strongly in women’s reproductive freedom, including the right to abort a pregnancy for any reason. in becoming an advocate for my son, i realized i had to think further about the status of a disabled fetus in an otherwise wanted pregnancy. i still believed women should have control over their own bodies, but i wondered how free they were in the context of so much misinformation and prejudice? how refreshing to find adrienne’s co-authored chapter in the our bodies ourselves pregnancy and birth book. there, she managed to distill the complex ideas about reproductive ethics developed in her academic work into language that would be accessible to many different kinds of readers. unlike the standard pregnancy guides, which tend to say nothing about what happens after a positive diagnosis, this chapter addressed the option of abortion frankly, including the personal story of a woman who chose to end her pregnancy after discovering the fetus had down syndrome. even more remarkably, it addressed the option of continuing a pregnancy with a disabled fetus. it featured a second personal story written by the mother of an eight-year-old girl with down syndrome. while giving plenty of information about possible developmental and medical complications, the chapter also insisted that a diagnosis of down syndrome or another genetic disability would be only one aspect of a child’s identity. here was a chapter that walked a fine line between respect for the woman’s right to make choices about her own body and the person the disabled fetus might become. i take this chapter as a model of asch’s accomplishment. while fiercely independent, asch also frequently asked for help. many who knew asch had the occasion to guide her from once place to another. as thinkers, we are also privileged to have had the opportunity to be guided by her passionate convictions, fierce loyalties, and strong ethical sensibility. susie a. han, deputy director and principal policy analyst, new york state task force on life and the law i met adrienne asch through her participation as a member of the new york state task force on life and the law. the task force functions as new york state's bioethics commission, charged with developing public policy on bergstresser, adrienne asch, voices in bioethics, vol. 1 (2014) 6 issues arising at the intersection of medicine, law, and ethics. asch was appointed to the task force by governor spitzer in 2007, and since i became a staff member in 2009, i had the pleasure of getting to know her both professionally and personally. as a member of the task force, asch offered strong and thoughtful opinions, which were shaped by her personal experiences and prolific academic career in bioethics as well as feminist and disability rights studies. asch recognized the importance of diverse perspectives, and despite her strongly held beliefs, she worked with others to reach a compromise and/or consensus. if she expressed a dissenting opinion, she expressed them in a thoughtful, reasoned manner that made those in the majority reconsider their position. she reminded us that the responsibility of changing society’s perception on various "vulnerable" (a word she hated!) populations should not be the sole burden of these individuals. instead, all members of a civil society need to be more inclusive and embrace those with disabilities to further the goals of respect, social justice, and equality for all. asch was particularly attuned to terminology; she understood how terms used to describe people and groups influence social attitudes and help to shape policy. she consistently affirmed in her academic work and at the task force that the term “disability” was simply a label that should not diminish expectations for one’s capabilities or future. yet, as accomplished as she was, asch never claimed to be a role model for those with disabilities, she simply wanted to be known as a bioethicist and feminist. although i worked with asch for several years, it wasn't until this past year that i got to know her outside of the task force. as many people have noted, asch was feisty, blunt, and fiercely independent. she once told me that some found her personality to be off-putting, demonstrating a great deal of self-awareness. asch actively chose to express who she was without allowing external factors to force her to change. these same qualities made her a good friend and confidante. one could not mince words with adrienne; she kept you honest with yourself and in return she was honest with you. adrienne did not believe in sugarcoating the details, and she got straight to the point and one had to keep up. she may have been tricky to get to know initially, but she was a loyal and protective friend to me, and as i have learned, to many others as well. asch treasured her friends, and she was definitely someone you wanted in your corner. asch’s passing is a great loss for many, both professionally and personally. the task force and i will miss her greatly, and her opinions and perspective will continue to resonate in bioethics. https://library.columbia.edu/ https://library.columbia.edu/ goldberg, studies reveal rx for doctors: a daily dose of meditation, voices in bioethics, vol. 1 (2014-15) © 2014 madeline goldberg. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. studies reveal rx for doctors: a daily dose of meditation madeline goldberg keywords: bioethics, ethics, lifestyle, compassion, meditation introduction one personal quality that many patients seek in their physicians is compassion. in addition, medical schools are beginning to search for premedical students that possess compassionate qualities. premedical students and physicians alike might wonder how they can increase their compassion. it seems that the answer may arise from an age-old tradition—meditation. meditation has been around for thousands of years, and has been shown to lead to several benefits including increased well-being, reduced stress, and positive emotions. in addition, recent studies have found that mediation can benefit others through the promotion of altruistic behavior. researchers in boston have found that both mindfulness meditation and compassion meditation, over the course of eight weeks, can increase the likelihood that a person will give up his or her seat to relieve the suffering of another. analysis in the new york times article “morality of meditation,” david desteno, a psychology professor at northeastern university, explains the study’s findings. desteno and colleagues recruited 39 participants from the boston area to participate in an eight-week meditation course. among the 39 recruits, 20 participants (the meditators) were assigned to weekly meditation classes. nineteen participants (the nonmeditators) were informed that they were placed on a waiting list for the meditation study. after eight weeks, both the meditators and the nonmeditators (the waiting list controls) were brought to the lab to participate in an experiment, which they believed was about memory, attention, and cognitive functioning. the actual experiment occurred in the waiting room. when the participant entered the waiting room, only one chair was available out of three. members of the research team occupied the remaining two chairs, pretending to be participants. a third researcher on crutches then enters the room, also pretending to goldberg, studies reveal rx for doctors: a daily dose of meditation, voices in bioethics, vol. 1 (2014-15) 2 be a participant. the experiment examined whether the true participant would altruistically offer his or her seat to the “hurt participant” on crutches. the researchers found that only 16 percent of the nonmeditators offered their seats, but 50 percent of the meditators behaved altruistically. this three-fold increase in altruistic behavior in the meditation group was additionally impressive since the seated research team was instructed to ignore the “hurt participant” on crutches. this created a situation where the true participant would be less likely to act compassionately, a phenomenon known as the bystander effect. in another study, helen weng and colleagues were interested in examining the neural relationship between mental training and altruism. the researchers recruited participants to a two-week mental training functional magnetic resonance imaging (fmri) study at wisconsin-madison university. in this study, participants listened to 30-minute audio recordings that taught them skills in either compassion meditation or reappraisal training. compassion meditation involves envisioning the suffering of others and repeating phrases such as, “may you be free from this suffering. may you have joy and happiness.” reappraisal training is used in cognitive behavioral therapy, and it is a technique that involves the reassessment of troubling past events, which continue to cause a person to feel distress and negative emotions. in this study, participants’ neural responses to images of suffering were recorded in an fmri scanner at both the beginning and end of the experiment (after two weeks). the fmri scanner measures the oxygenated blood flow in participants’ brains over time. after the final scan, participants completed another study, which they believed was unrelated to the meditation study. this study utilized an online economic redistribution game. in this online game, participants interacted with what they believed were live users, but were actually computer-generated interactions. the participants had the opportunity to redistribute wealth between a dictator with $10 and a recipient with $0. the participant had $5 and could choose to redistribute wealth in the game at a small personal cost. researchers found that the participants who were trained in compassion mediation were significantly more likely to redistribute wealth. in addition, the researchers examined the fmri images to see if altruistic behavior correlated with activation of emotional and regulatory regions in the brain. weng found that increased altruistic behavior in the compassion meditation group correlated with increased activation of: the inferior parietal cortex (ipc); the dorsolateral prefrontal cortex (dlpfc); and the dlpfc and nucleus accumbens (nacc) connectivity. the ipc is believed to contain mirror neurons, which allow us to simulate the behaviors and emotional states of others. it is suggested that the increased activation in the dlpfc modulates the distress that results from perceiving suffering; this occurs by up-regulating positive emotions through the dlpfc’s connection with the nacc. the nacc has been linked to charity and positive assessments of negative stimuli. conclusion if you are interested in boosting your compassionate side, there are many options. you can download free meditation apps, or even listen to the audio recordings that were used in weng’s research at http://www.investigatinghealthyminds.org/compassion.html. one free guided meditation app for the iphone, which i would recommend, is called headspace. happy meditating! goldberg, studies reveal rx for doctors: a daily dose of meditation, voices in bioethics, vol. 1 (2014-15) 3 references “the morality of meditation” by david desteno july 5, 2013. the new york times http://www.nytimes.com/2013/07/07/opinion/sunday/the-morality-of-meditation.html?_r=0 desteno et al., “meditation increases compassionate responses to suffering,” psychological science 24, (2013): 2125-2127. doi:10.1177/0956797613485603 weng et al., “compassion training alters altruism and neural responses to suffering,” psychological science 24, (2013): 1171-1180. doi: 10.1177/0956797612469537 http://www.nytimes.com/2013/07/07/opinion/sunday/the-morality-of-meditation.html?_r=0 holmquist, spotlight on fiction, voices in bioethics, 2013 © 2013 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. spotlight on fiction: the tenth of december stephanie holmquist in his most recent collection of short stories, the tenth of december, george saunders parodies the nullity of consumer culture and the bottomless anxieties of ordinary joes and joesephines caught living through the collapse of the middle class. his style is dark, twistedly funny and microscopically observed. in the story “escape from spiderhead,” we get a saunderian glimpse into a near future of life style enhancement by cognitive pharmaceutical tweaks. we don’t see the new consumers of these wonder drugs. saunders instead imagines for us hapless human subjects undergoing trials of new compounds like verbaluce—a pharmaceutical enhancer of lucidity and verbal expression. our protagonist tests out a new drug that intensifies the appreciation of nature. under its influence, the garden looks “nice” and then: “he added some verbaluce™ to the drip, and soon i was saying the same things, but saying them better… it was as if i could suddenly discern, in a contemporary vignette, the ancient corollary through which plato and his ancient contemporaries might have strolled, to wit, i was sensing the eternal in the ephemeral.” turn off the verbaluce drip and the garden is again “nice”, not a greek pastoral brought to life. turn off the love drug and your new soul mate is once again “nothing special.” all is not enhancement in this brave new lab. “darkenfloxx” is your blackest depression raised to the tenth power. a little “docilryde” will make human subjects obey every order—but frustratingly requires special authorization from senior management. it’s just the trick when your subject is refusing to “darkenfloxx” another subject for yet more data collection. “escape from spiderhead” represents a world of criminals trading out prison time to serve as research subjects in a dystopian pharma-industrial complex. saunders gives us a rat’s-eye of view their servitude. they are means used to an end— the design of synthetic emotions and a chemical push against limits of free will. kornyo, patent protection, voices in bioethics, vol. 1 (2014) * emmanuel kornyo © 2014 emmanuel kornyo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. patent protection and the global access to essential pharmaceuticals during patent infringements under trips emmanuel kornyo* abstract this paper examines the arguments for sustaining international patents and explanations for patent infringements, especially when there are serious medical needs of pandemic and global proportions within the context of trips and ethical principles. keywords: patents, innovation, bioethics, intellectual property introduction patents are negative legal rights that act as stop signs to prevent non-innovators from making, using, or selling inventions without expressed permission from inventors. infringements on patents are serious violations from the legal and ethical perspectives. it is therefore not surprising, that there were mixed feelings when the supreme court of india rejected novartis’s patent protection claim against the indian pharmaceutical production of the generic version of gleevec. in the wake of the hiv/aids pandemic, brazil, south africa, and thailand defiantly broke international protocols on patent protection and manufactured patented medicines for their citizens at relatively affordable prices.[i] it is important to note here that these countries are all signatories to the world trade organizations’ (wtos) agreement on trade related aspects of intellectual property rights (trips).[ii] this leads one to question why these countries infringed on such laws that they have made a commitment to keep. should there be legal consequences for stark violations of these laws? are these actions ethical? to what extent should there be a sense of accountability in these matters? https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn1 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn2 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 2 this paper examines the arguments for sustaining international patents and explanations for patent infringements, especially when there are serious medical needs of pandemic and global proportions within the context of trips and ethical principles. scope the first part of the paper will examine some treatises or applicable laws on international patents. the second part will analyze reasons why certain patents may be infringed especially in the context of south africa, and i will then conclude with some ethical arguments for making essential medicines accessible within the framework of patent laws. background in the wake of the global hiv/aids pandemic, the governments of thailand, south africa, and brazil issued compulsory licenses for the importation and manufacture of the generic versions of some essential antiretroviral medicines in line with the world trade organization’s trips article 31, which inter alia grants exemptions for infringements when there are health emergencies. while these decisions were accepted internationally as bold and novel, patent holders challenged the legality of infringing upon such patents. furthermore, patent holders argued tacitly that the reasons given for patent infringements were not health emergencies per se, challenging thailand’s issuance of compulsory license for the generic versions of plavix – used for treating patients with heart diseases – as a violation of wto international laws. on the other hand, many have suggested that infringements of patents should be construed or judged on a case by case basis. but is it true that international laws such as wto’s trips prohibit such infringements? or do these laws/agreement actually support such actions? are these international norms inadequate? if so, why, and further, how could these be resolved? why is the south african (sa) case significant in 1996? what impact could it have on the world? in perspective, the south africa case is significant for many reasons and i intend to contextualize it. it is instructive to note that demographically, sa had a total population of 40.5 million people; 50 percent were black, 13.6 percent were white, 8 percent mixed race and 2.06 percent indians. unemployment was at 31 percent with a per capita income of $2,700, compared to $37,500 in the united states. at the peak of the hiv/aids pandemic in 1996, about 20 percent of all adults were living with the disease in sa alone. it was obvious that the cost of treatment for hiv/aids – pegged at $12, 000 per year at the time – far exceeded any financial capacity of the victims. the proportions were higher in places like johannesburg and some mining cities. furthermore, only 20 percent of the population was covered by adequate private health insurance while the rest relied on a public health system fraught by "irrational use of resources, poor working conditions, and inadequate infrastructure."[iii] https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn3 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 3 faced with this existential public health pandemic and national emergency, the south african government made reforms to their health sector and passed the medicines act amendments of 1997 and in particular granted certain legal powers to the minister of health such as: (b) prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the council in the prescribed manner, may be imported; and (c) prescribe the registration procedure for, as well as the use of, the medicine referred… the rationale among other things was ostensibly to provide affordable antiretroviral medicines for the victims of the hiv/aids pandemic. the promulgation of these laws and the subsequent issuances of licenses were received with mixed feelings evidenced in many protests and legal actions. many legal scholars believe the bone of contention was the insertion of section 15cinto the south african medicines and related substances control act (mrsca). the pharmaceutical manufacturers association of south africa (pma) filed a complaint with the public protector of south africa (a neutral investigative body with limited power) alleging that some officials of the ministry of health of sa created distorted and offensive statements, thus creating "a perception in the minds of the general public that medicines in south africa are unreasonably expensive and moreover that the blame for such expensive medicines lies with the manufacturing and primary importing companies”.[iv] in february 1998, the pharmaceutical companies filed a lawsuit before the high court of south africa contesting the legality of mrsca and patent infringements.[v] but was this lawsuit justified? which laws and legal precedents serve as the prima facie case for this lawsuit? how does sa counter this lawsuit? in attempt to answer these questions, the next sections will examine a medley of these applicable and relevant laws. relevant laws and precedents in february 1998, pharmaceutical companies filed a lawsuit before the high court of south africa alleging that sa was violating international laws such as article 27 of trips, as well articles 25, 44, and 231 of the sa constitution which prohibits the use of patents without permission and compensation. the lawsuits in part states: 2.4 it is discriminatory in respect of the enjoyment of patent rights in the pharmaceutical field which discrimination is in conflict with the provisions of article 27 of the trade relates aspects of intellectual property rights agreement [hereinafter referred to as the "trips agreement"], an international agreement binding the republic and to which parliament has given effect by the promulgation of the intellectual property laws amendment act, no. 38 of 1997, and consequently such provision is in conflict with section 44(4) of the constitution read with sections 231(2) and 231(3) of the constitution;[vi] https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn4 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn5 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn6 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 4 each party to the lawsuit made references to international laws/agreements on patents as well as the sa patents act 57 of 1978. the first law in contention was the wto trips agreement which was promulgated in the uruguay round of the general agreement on tariffs and trade(gatt) in 1994. gatt formed the basis for the formation of the world trade organization in 1995 which conferred intellectual protection to members of the organization, including patents rights. the wto therefore enforces all intellectual property laws under the trips. according to section 28 of trips, “a patent shall confer on its owner the following exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product”.[vii] while trips de facto stipulates protection of all intellectual property, laws including patents on pharmaceuticals, articles 8, 30 and 31 respectively grants certain exemptions.[viii] sa countered these allegations by first responding that mrsca was promulgated to grant powers to the minister of health in order to circumvent patents in consonant with article 31 of trips. this was because, before the promulgation of mrsca, sa had limited legal powers to issue compulsory licenses under the patents act of 1978. but faced with such national pandemics, the sa government promulgated its new laws to ensure that victims of the hiv/aids would have access to affordable medicine which they asserted was consistent with international laws. it is important to note that the general public interest exemptions were stipulated in article 8 (1) of trips which categorically requires members to “adopt measures necessary to protect public health…and to promote the public interest in sectors of vital importance”. in addition article 30 indicates that “members may provide limited exceptions to the exclusive rights conferred by a patent” cognizant of the interests of third parties. and perhaps most significantly, article 31 of trips grants the use of patents by legitimate authorities without the authorization of patent holders in the case of national emergencies (such as the hiv/aids pandemic).[ix] in brief, both parties agreed on the substantive fact that there was a dire medical need, but the main issue was whether the insertion of section 15c to the mrsca contravened trips as evident in the lawsuit. however, on april 19, 2001, 39 members of the pharmaceutical trans-national corporations (tncs), dropped the lawsuit against the south african government. the european union and wto supported the sa position, and later, sa pledged to comply with trips agreements.[x] in summary, the sa government successfully contested its case within the scope of international laws such as trips because hiv/aids was indeed a health emergency covered under the agreement. also, the promulgation of mrsca, in particular section 15c, circumvented patent laws within the scope of the constitution. it was therefore not surprising that south africa (and allied southern african countries) became the architects in drafting the agenda leading up to the declaration on the trips agreement and public health (the doha declaration), which reaffirmed patent protection as well as the public health challenges facing developing nations. both the united states and canada also expressed their willingness to use the doha declaration to override bayer’s patent to manufacture ciprofloxacine (cipro) in case of a hypothetical outbreak of anthrax which could constitute a case of national emergency. the sa legal case therefore has become significant in clarifying and reaffirming wto trips. there are many ethical principles gleaned from the legal precedents above, and i intend to focus on some of these issues in the next section. https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn7 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn8 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn9 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn10 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 5 utilitarian perspective one of the major contentions in patent infringements is that they serve to provide immediate, affordable, and accessible pharmaceuticals for more people in health emergencies such as pandemics. this line of thinking and justifications seemingly aligns with the ethical principle of utilitarianism. jeremy bentham posited an important question as to whether something is utilitarian by asking “what is the use of it? the theory or the principle of utility suggests that when one is confronted with moral choices or liberties, one has to choose an action that leads to the highest or maximal amount of pleasure or good for a greater number of people while concurrently minimizing any harm as much as possible. for utilitarians, an action is ethical if it is “useful”; hence the principle of utility. but utilitarianism is both quantitative and qualitative. bentham further noted that an action is ethical if it maximizes the greatest amount (qualitative) of pleasure and minimizes pain by testing these actions against the “pleasure-pain calculus”. mill added a quantitative component to bentham’s theory by suggesting that an action is ethical if it brings about the greatest amount of pleasure for the greatest number of people. in brief the end justifies the means.[xi] juxtaposing these strands of views on utilitarianism, it could be inferred that patent infringement is justified because it brings about a greater good for a greater number of people especially in the wake of the hiv/aids pandemic. this may be accentuated by the fact that ordinarily, most patients in south africa and brazil could not have afforded the pricy anti-retroviral drug. by breaking the patents, these two countries were able to provide enough and affordable medications to their patients. had the patents not been infringed, most probably, very few people could have afforded the anti-retroviral drug to the exclusion of the majority. furthermore, by infringing on the patents, many lives were saved and thus quantitatively, the anti-retroviral drug was made available to many people and maximizing a useful purpose. less “harm” was caused as many people (presumably) benefited from breaking the patents. furthermore, physical pain in the form of diseases were minimized and curtailed while optimizing some pleasure or happiness by improving the lives of the patients and their families. economically, these nations have saved substantial amounts of their budgets on health care and could use these resources in other sectors of their local economies. moreover, by producing these medications locally, they have also created some jobs for the local population. in brief, patent infringement under the aegis of the principle of utility may be deemed justified. counter arguments one of the major arguments against utilitarianism is that it is too reductionist with the tendency to cause the lake-wobegon effect. that is, it has the proclivity of reducing ethical choices to mere “pleasure” and “pain”. overtly emphasizing the maximization of pleasure does not address the specific circumstances in each ethical decision. it dehumanizes morality. in the case of patent infringements, the principle of utility does not take into account the inventors and the companies who owned these patents and have invested substantial amount of time and resources in research and development. most of them chose to work hard and endured https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn11 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 6 lots of “pain” in order to obtain these patents. the question herein is, should society inflict pain on them by depriving them of their happiness as well? would these inventors and investors be willing to sacrifice their resources in inventing other novel technologies and pharmaceuticals for the common good if their inventions are not incentivized? in brief, justifying the breaking of patents under the expediency of the principle of utilitarianism is fundamentally flawed and has the inherent tendency to truncate innovations and deny patents owners their rights.[xii] the second counter argument to the principle of utilitarianism is deontology. deontologists such as kant suggest that morality should be based on the set of universal normative principles that impose a categorical imperative on moral agents.[xiii] in evaluating a course of ethical action, one has to adhere to universal principle akin to a call to duty such that anyone, anytime, and anywhere may make the same ethical decision. as kant summarizes: when i think of a categorical imperative i know at once what it contains. for, since the imperative contains, beyond the law, only the necessity that the maxim be in conformity with this law, while the law contains no condition to which it would be limited, nothing is left with which the maxim of action is to conform but the universality of a law as such ... there is, therefore, only a single categorical imperative and it is this: act only in accordance with thatmaxim through which you can at the same time will that it become a universal law.[xiv] in addition, the principle of deontology imposes an obligation on all people to never use another human being as a means to attain an end. in other words, the end does not justify the means. hence, in dire humanitarian crises such as the hiv case, by breaking the patent, the government of these countries “used” the intellectual property of these patents to attain their own local or national needs. one cannot use the larger interest of the population to the exclusion of the investors or patent holders who have rights as well.[xv] in brief, patent infringements under the aegis of a national health emergency may be justified depending on what ethical principle one uses. but each position also has some weaknesses that need to be addressed from the ethical perspectives. breaking a patent will obviously infringe upon the rights of patent holders even in such emergencies. the question then arises as to how to find some common grounds such that the larger humanitarian health needs are met while the individual and equally important rights of inventors are protected. but is that possible? this then begs the question of justice which will be the focus of the next section.[xvi] [xvii] justice[xviii] some proponents of patent infringements in humanitarian health crises contest that justice demands expeditious availability and accessibility of essential medical interventions to serve vulnerable populations. justice as fairness means that legitimate governments have fiduciary responsibilities towards ensuring that the most vulnerable such as the victim of the hiv/aids pandemic have essential and life sustaining drugs even if it means temporarily interfering with rules governing patents. after all, no human life is replaceable; hence https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn12 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn13 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn14 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn15 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn16 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn17 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn18 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 7 every measure to preserve life must and ought to be taken.[xix] it is important to note at this juncture that according to the universal declaration of human rights, “everyone has the right to life, liberty and security of person”.[xx] everyone is guaranteed an equal protection of “life” which implicitly includes access to health care even in humanitarian crises such as an pandemic or the flu. furthermore, the wto trips (article 31) anticipated such emergencies and therefore stated among other things “…in situations of national emergency or other circumstances of extreme urgency, the right holder[of a patent] shall, nevertheless, be notified as soon as reasonably practicable”. clearly, breaking patents has saved many lives; if countries in such health emergencies had not taken any action, the harm would have been egregiously high.[xxi] another justified reason for patent infringements within the law may be construed around the cost for generics and in particular biologics. currently, the pricing of biologics are very high and patents on biologics entail twelve years of exclusivity. for instant, cerezyme is estimated to cost more than $ 150,000 per year per patient. this and the cost of many other biologics prompt many in the international community to suggest that breaking the patent to make biosimilars under the aegis of justice may be deemed ethical. counter arguments[xxii] patent infringement is a transgression of the rights of patent owners. in other words, patent owners and inventors have “equal” protections under the law, which includes according them justice for the use of their intellectual property. equal protection under the auspices of justice as fairness means that society must ensure adequate compensation to patent owners as well. but in most of the cases, such as in south africa, brazil, and thailand, patent owners have not been compensated even though their patents and innovations have been used in making pharmaceuticals and therapies to save lives. essentially, they have been deprived of their legal rights to their ingenuity and inventions. it is ironic that violators of patents make a claim to justice and yet refused to accord the inventors their concurrent claim for a just use of their intellectual property. one wonders if this is actually fair. it is important to distinguish “actual demonstrable existential” and “good” reasons for breaking patents. in the case of the hiv/aids pandemic, it clearly posed existential threat to both patients and the global health at large. breaking a patent may be justified in this circumstance. however, we see in the case in thailand, that their “good” reason was only to advance their own parochial economic need rather than existential public health crises. such (mis)conduct cannot be justified under the expediency of justice.[xxiii] non-maleficence& beneficence one of the justified ethical reasons for patent infringements is the ethical principle of beneficence and, implicitly, non-maleficence. [xxiv] first is the issue of cost. as noted in my exposition so far, many of the pharmaceuticals made in developed countries are very expensive with many years of patent exclusivities without the generic versions. consequently, without even a national emergency, there is always the temptation of breaking some of these patents for the benefit of the local population. this is evident in the https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn19 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn20 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn21 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn22 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn23 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn24 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 8 case of thailand and india, where pharmaceutical companies question the very logic of patenting if patented drugs are not generally and reasonably affordable. this is why some of these patents have been broken with impunity. in the case of the hiv/aids pandemic, it was demonstrably evident that many patients could not afford $12,000 per year, especially in developing countries with abysmally low wages of $1 or less per day. without breaking a patent, it is hard to see how these essential lifesaving drugs could have been afforded and accessed by those in dire need. in an ethical conundrum, risk ought to be shared to the extent that the most vulnerable are insulated.[xxv] breaking a patent and making these drugs available should be weighed against the risks of losing these patients. the risks of not breaking a patent in a hypothetical case of anthrax could be higher and possibly catastrophic. this then leads to the third element, ‘benefit’. who are the beneficiaries in such national emergencies? are they the most vulnerable? who determines and defines vulnerability? for the most part, countries like sa that have broken patents have seemingly justified their actions by arguing that their most “vulnerable” people were victims of hiv/aids. in addition, breaking a patent means that the cost of the generic versions would be reasonably low and therefore beneficial to all patients. counter arguments it may be argued that the world risks losing innovators if they should opt out from patenting their innovations and keep them private as trade secrets. if this occurs, it means that the larger society may not have access to valuable knowledge and these could be costly in the wake of humanitarian health crises. for instance, if scientist x decides to hide an essential therapeutic formulation that could potentially save many lives, it means that during a potential humanitarian crises, the larger society could pay dearly for it. in view of this, some have proposed that innovators should be “reasonably and properly” compensated after their patents are broken. another counter argument is that patent infringement to develop generics does not and will not necessarily benefit the general public. a classic example is the case of thailand, which has broken many patents for nonemergencies such as in the case of plavix. the thai government issued compulsory licenses for the importation of these pharmaceuticals from india, as well as for the production of the generic versions locally by invoking the trips agreement (article 31). obviously, heart diseases are not diseases of national emergencies of epidemic proportions, but the thai government broke the rules with impunity. this is why, it has been suggested that breaking patents or allowing local governments to issue compulsory licenses on patents could be a bad precedent. another counter argument is on counterfeits and issues of safety. breaking of patents means most patent owners might not be able to monitor counterfeits on the open market. in addition, most developing countries might not have the facilities to safely produce these pharmaceuticals compared to the patent holders, and could potentially compromise the safety of patients as well. https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn25 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 9 the ethical argument of beneficence is important because it seeks to balance risk allocations, costs, and benefits to the most vulnerable in society among others. circumventing patent protection in order to provide lifesaving therapies could be justified especially as in the case of the hiv/aids case in south africa. as the us and canada have both indicated, they will break patents on cipro in emergencies in order to save lives. some perspectives and conclusion inventors are granted certain exclusive protections by national and international laws such as the us patent laws as well as wto’s trips.[xxvi] nonetheless, the trips grants some exemptions for circumventing patents in the case of national emergencies such as epidemics. in the wake of the hiv/aids pandemic, trips laws became a bone of contention between international pharmaceutical companies such as glaxosmithkline and the government of south africa, resulting in a subsequent lawsuit. even though the lawsuit was later withdrawn, the case became a litmus test for breaking international laws on patents, as well as charting the path for the declaration on the trips agreement and public health (the doha declaration). this paper has argued that patent infringement is legal within the context of international laws. in addition, this piece has analyzed patent circumventions through many ethical principles such as utilitarianism, the question of justice, and beneficence with allusion to non-maleficence. this analysis makes the case that it is possible to set aside stringent patent laws in the wake of emergencies. but it is important to ensure that inventors are properly compensated when such emergencies subside. if possible, tariffs could be imposed on all pharmaceuticals and given to wto trips oversight committee so that in the case of such emergencies, patent holders could still recoup some of the costs of research and development. in the case of exclusivities of twelve years on biologics, this paper contends that it may be prudent to reduce in order to prevent the likelihood of patent infringements under trips. furthermore, patents should be protected but each attempted infringement should be analyzed based on specific needs, and infringers (as in the case of non-emergency situations) should be sanctioned under the laws. in brief, the case of the hiv/aids pandemic throughout the world and especially in sa reverberated with a sense of urgency and emergency. i believe the actions of patent infringement within the context of section 15c of mrsca and the patent provisions of wto was justified as millions of lives were saved. scientific innovations and the law are geared toward improving the lives of every human being and the world – this is the human factor. and the human factor is the humane factor. references [i] william w. fisher iii et al the south africa aids controversy: a case study in patent law and policy in the harvard law school. the law and business of patents (february 10, 2005) https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_edn26 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref1 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 10 [ii] wto intellectual property overview of trips agreement [iii] south african department of health, national drug policy for south africa 3 (1996). [iv] see public protector of the republic of south africa, report on the propriety of the conduct of members of the ministry and department of health relating to statements in connection with the prices of medicines and utilisation of generic medicines in south africa, special report no. 6 (1997) [v] see notice of motion in the high court of south africa (transvaal provincial division), case no. 4183/98 [vi] notice of motion in the high court of south africa (transvaal provincial division), case no. 4183/98 [vii] see www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm [viii] see naomi a. bass, note, implications of the trips agreement for developing countries: pharmaceutical patent laws in brazil and south africa in the 21st century in geo. wash. int'l l. rev. 191, 210 vol 34 (2002). also marjorie cohn, the world trade [viii]organization: elevating property interests above human rights, in ga. j. int'l & comp. l. 427, 435-37 vol. 29 (2001). [ix] it is important to point out that here that the trips agreements especially on circumventing patents in the wake of national emergencies were reaffirmed in the doha declarations [x] rachel swarns, drug makers drop south africa suit over aids medicine in the new york times (new york april 20, 2001)p. a1 [xi] jeremy bentham, an introduction to the principles of morals and legislation [xii] william w. fisher et al. see also lissett ferreira access to affordable hiv/aids drugs: the human rights obligations of multinational pharmaceutical corporations in fordham law review volume 71(2002) [xiii] immanuel kant kant's grounding for the metaphysics of morals (1985) [xiv] kant groundwork 4:420-1 [xv]tom beauchamp et al. principles of biomedical ethics (oxford university press: london, 2009). see marjorie cohn, the world trade organization: elevating property interests above human rights, 29 ga. j. int'l & comp. l. 427, 435-37 (2001) [xvi] beauchamp et al. 197 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref2 https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0cb4qfjaa&url=http%3a%2f%2fwww.wto.org%2fenglish%2ftratop_e%2ftrips_e%2fintel2_e.htm&ei=_kypvkmzdcs1yasr9idqbq&usg=afqjcnfszxmos7a8fdlgrvg33rn65bt_7q&bvm=bv.74649129,d.aww https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref3 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref4 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref5 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref6 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref7 http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref8 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref9 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref10 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref11 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref12 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref13 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref14 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref15 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref16 kornyo, patent protection, voices in bioethics, vol. 1 (2014) 11 [xvii] ibid. see also theodore c. bailey, note, innovation and access: the role of compulsory licensing in the development and distribution of hiv/aids drugs, 2001 u. i11. j.l. tech. & pol'y 193, 202-04.36 [xviii] beauchamp et al p197. also norman daniels justice, health, and healthcare in american journal of bioethics, (december 7, 2010) p2-16. john rawls, a theory of justice, (harvard university press, massachusetts; 1971) p6 [xix] ibid [xx] article 3 of the universal declaration of rights [xxi] theodore bailey. 202-04 [xxii] beauchamp. p197-198 [xxiii] ibid [xxiv] ibid [xxv] ibid [xxvi] u.s. patent laws, regulations, policies & procedures https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref17 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref18 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref19 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref20 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref21 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref22 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref23 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref24 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref25 https://michael-reaves-bkln.squarespace.com/features/2014/09/11/patent-protection-and-the-global-access-to-essential-pharmaceuticals-during-patent-infringements-under-trips#_ednref26 https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0cdiqfjaa&url=http%3a%2f%2fwww.uspto.gov%2fpatents%2flaw%2f&ei=74n1u4huj4mpsat8xigocq&usg=afqjcnhau1gvjk7ohtjxxxyh0iiw9-2y_g holmquist, coverage watch: elisabeth rosenthal, the new york times, voices in bioethics, vol. 1 (2014-15) © 2015 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. coverage watch: elisabeth rosenthal, the new york times stephanie holmquist bioethics, elisabeth rosenthal you may not have noticed her byline, but chances are you’ve read, and groaned over, elizabeth rosenthal’s reporting on healthcare costs for the new york times. in her “paying till it hurts” series, rosenthal reports on our national whack-a-mole game of controlling healthcare costs. since 2013, her steady stream of memorable stories has explained how the two block, $900 ambulance ride became routine and why an insured surgical patient can be blindsided by an extra $117,000 cost, despite his best efforts to stay within his policy’s restrictions. readers may come to her stories for their human interest, but will stay for rosenthal’s lucid unraveling of the complexities and absurdities of medical care pricing. rosenthal’s reporting is a counterpoint to the familiar narrative that expenditures in the last six months needlessly drive up healthcare costs. she focuses instead on the mechanics of routine costs increases for patients of all ages as the other big healthcare cost story. her work illustrates that small medical advances can yield big upticks in out-of-pocket expenses and how doctors and healthcare systems push back against insurer driven cost controls. in her continuing reporting, rosenthal creates an ever richer picture of the obstacles to managing medical costs for individuals, insurers and government. the times page devoted to her series includes rosenthal's stories, graphics and a link to a related facebook page. don’t miss at least scanning the series page, and don’t be surprised if you find yourself reading one story after the other. http://www.nytimes.com/interactive/2014/health/paying-till-it-hurts.html niburski, ice cold, voices in bioethics, vol. 1 (2014) © 2014 kacper niburski. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ice cold: analysis of the dachau experiments kacper niburski keywords: research ethics introduction while abhorrent by any standard, the nazi medical experimentation has become a core illustration of unethically collected data currently being used in scientific research.1-4 due to the extremes achieved – nearto sub-zero temperatures in investigating hypothermia and its effect on the body – some medical and scientific researchers have claimed it imperative to use the records in order to help individuals in the future.5 this justification is not limited to otherwise unachievable scientific boundaries either; there are calls that the data is just data, the seemingly cold, impersonal collection of numbers and words, while others have oppositely stated that its use not only serves as a reminder of the suffering and injustice endured by those victims, but a way to do good from evil. but this reasoning is wrong. any loss of knowledge is miniscule compared to the loss in the medical profession if such data is used. by understanding the function of a physician through a kantian perspective on the hippocratic oath, determining the fundamental scientific failures in the dachau hypothermia experiments, and realizing the moral transgressions under a principlistic paradigm, one can contextualize these bioethical fallacies and work towards creating a morally responsible research framework. analysis the oath and its implications the hippocratic oath serves as prima facie foundation of physician’s morals. as among the first deontological treatises, the oath expands on a physician’s relation to a patient. rather than serve a mere mechanical role, niburski, ice cold, voices in bioethics, vol. 1 (2014) 2 the physician, “will use treatment to help the sick according to [their] ability and judgment, but never with a view to injury and wrong-doing.”6 thus while there is an immediacy to patients as a function of their career, to be a physician is not limited to that function. instead a physician must transcend this direct professionalism by entirely supporting the beneficial healthcare of a person, whomever they may be. yet what constitutes healing instead of harming, helping instead of hurting, and doing good instead of bad? while no answers are directly provided, the oath places stress on a physician’s disposition to differentiate between right and wrong. 6 but with different cultural backgrounds, societal expectations, and a whole gamut of other variables that a physician must tightrope in their daily life, physicians may differ in their comprehension of good. what is perceived to be beneficent care by one person’s standards may be considered horrendous by another – a gap which the oath does not elaborate on. a kantian consideration can null this ambiguity. by providing an a priori principle that is applicable to all physicians in all circumstances at all times, a kantian reading can define the rough guidelines of a physician’s obligation to a patient. in accordance with kant’s first formulation, doctors should, “act only in accordance with that maxim through which you can at the same time will that it become a universal law.”7 doctors who stand firm to this maxim cannot see patients as a means to an end, but rather as an end in themselves.8 whether through research, clinical studies, or direct surgical care, patients are the reason for the profession, not the consequential baggage from it. this does not mean that the sick are merely subjective ends, however. rather in the construction of a binding categorical imperative, those that are ill are objective ends with no other alternative than care. one cannot probe or prod unless ensuring it is for the well being of the patient. thus a true physician acts as though they were treating themselves and operating in a way that would be universally advantageous to all. they consider the individual, even, and perhaps especially, if their research is pertinent to a larger whole. there is no other option. for in following these kantian dimensions, doctors act wholly human, and in doing so they see the humanity of others reflected in themselves. the nazi political machine the nazi experiments, from chemical castration to phosgene gassing, poison this egalitarian interpretation of the hippocratic oath. key to nazi germany was the conception of an unquestioning and unwavering political machine. all individuals were subjected to the eugenically informed policies as a means to “strengthen a biological group on the basis of ostensible hereditary worth despite evolutionary claims.”9 in fact, hitler was resolute that in order for “the state to act as the guardian of a millennial future…it must put the most modern medical means in the service of this knowledge.”9 a physician’s care was not immune to these intrusions; it instead became the pivot of nazi biocracy. through endless appeals to supposedly airtight biology, the romanticism of severe biomedical aspirations, and the unyielding power that doctors were granted in the political sphere, physicians became the veins and arteries niburski, ice cold, voices in bioethics, vol. 1 (2014) 3 of the nazi lifeblood.10 approximately 11% of the physician population joined the s.s. compared to 1% of the general german population. rudolf ramm of the medical faculty of the university of berlin went so far to propose that, “each doctor was to be no longer merely a caretaker of the sick but was to become a ‘cultivator of genes’ and a ‘ biological solider’”.9 this politically charged personage changed the role of the doctor. from caregiver to care-insurer, physicians acted as both vanguards and mediums for the legitimization of the nazi medical ethos. under these eugenic boundaries, no longer was there just a consideration of single individuals; instead a whole population was under a physician’s purview. the function of the physician as implicated in a kantian reading of the hippocratic oath was thus eschewed.9,10in the aftermath, doctors became blind biological barbarians with moral vulnerabilities exposed, moral philosophies skewed, and whose concern was the health of a subjectively chosen population – the volk – rather than a person and their particular sickness. dachau hypothermia experiments this dichotomy in the conceptualization of a nazi doctor from the one deduced here is important to note, particularly in understanding the ethics behind the research data complied by the nazi doctors. if physicians are bound to the hippocratic oath as it was defined in kantian terms, then the doctors and medicinal researchers of the nazi era were anything but physicians. they failed to ensure that the care they provided was care they themselves would want to undergo. claims of utilizing the most up-to-date science – eugenics – are beside the point. not because they do not necessarily apply, but because their basis in scientific reasoning is, and was, hackneyed, the progression of racially corrupted thoughts and no more.10 thus in furthering the analysis of the ethics behind the data collected by these doctors in-name-only, one must understand that what was on display in nazi germany was how a profession can fail so completely. it was from this broken philosophy that the dachau hypothermia experiments were born. due to the limited knowledge of the physiological effects of the cold and the frequency at which german pilots often succumbed to it, a national interest into the mechanism of, as well as ways to avoid death from, hypothermia became prevalent.1,2 to satisfy this need, concentration camp prisoners from a wide variety of backgrounds, age groups, and physical conditions were submerged in tubs of freezing temperatures. many variables were tested.4,5 rectal, skin, and gastric temperatures were recorded; blood sugar, concentration of chloride, sedimentation rate, red cell count, plasma proteins, among other blood incidences, were charted; even urinalysis, including the nonprotein nitrogen, viscosity, albumin, sodium, was utilized in the experiments. additionally, different types of warming methods were developed, from body-to-body contact, warm baths, and candle burning, all of which had varied conclusions. niburski, ice cold, voices in bioethics, vol. 1 (2014) 4 ethics in war while these multitudes of experimental conditions suggest the making of a sound scientific study, the goals of the inquiry must be understood. in dachau, the experiments were not simply done to satiate experimental curiosity. it was not a progression of knowledge, a dismantling of earlier theories, or an honest, careful probing at the universe. instead it was a politically clouded agenda honed in the time of war and littered with theories of racial superiority and inferiority. this purpose, then, could have skewed results for a fixed objective with military weight was the end goal, as opposed to an open interpretation and possibility of alternate hypotheses in a dataset. this potential for slipshod stringency of the results is only furthered by the suspension of ethics in wartime. while it is easy to decry the nazi regime for their obvious moral decrepitude, the utility of any data, even if unethically determined, can be viewed in simple terms: will it help win the war; or alternatively stated, if these ends are not pursued, even if they may be malicious, will the war be lost? to answer the moral dilemma presented, one must refer back to the depiction of the oath. only a physician who acts in accordance with it can be rightfully called as such. this means that respect for the patient’s autonomy is guaranteed. otherwise, the use of a patient in medicinal studies can be seen as nothing more than a banal conclusion in a longwinded study. a non-deontological reading reduces them from human beings who were experimented on to punctuation or a mere footnote of cold insignificance. thus a physician can never under any circumstance – even if war – perform such inhumane actions. while unsettling because it may mean the loss of a war, and thus, the loss of even more lives, including the physicians themselves, this is the physician’s moral obligation. consider a secondary thought experiment: chemical warfare. military doctors may be interested of the effects of a new, improvised chemical weapon supposedly owned by terrorists. in this inquisitiveness, they may decide that live populations need to be tested upon. foregoing ethic boards – or perhaps even convincing them of the very real problem, very likely result of an attack – they test it on prisoners serving life sentences. “it is a requirement in order to save troops,” the researchers say. while the nazis and this hypothetical example differ in their definition of a prisoner, the effect is the same: both abuse the physician’s role to the patient. that is, to help, heal, and ensure that autonomy is respected, beneficence – as couched by boetzkes and waluchow (2000) – is ensured, and non-maleficence is carried throughout an experiment’s design and implementation. to input any findings that deny these considerations, even if they will save lives, is damage too severe. the loss of a war is small by comparison. other paradigms niburski, ice cold, voices in bioethics, vol. 1 (2014) 5 but other models, particularly the utilitarian, offer unique insights by creating obligations based solely on judgments of value; 8 that is, one’s actions are morally permitted if and only if they achieve some greater usefulness. only by the balancing such utility over disutility, often defined in happiness over sadness, and therefore generating the greatest good for the greatest number, can morality be guaranteed. in this consideration, then, the utilitarian reading of the hippocratic oath would state that such research, whether in dachau or the hypothetical example, would be ethically sound insofar as it ensures that a war is won and more lives are saved. unfortunately, problems arise in exactly what utilitarianism prescribes: the consequentialist perspective demands the individuals be killed for another’s benefit. though it is true that people will die regardless of the outcome in the hypothetical, this prescription of weighing the good of others against someone else seems questionably valuable, not to mention too flexible to individual interpretation. in fact, the utilitarian perspective was the justification behind the nazification of medicine in the first place.11 stated simply: the volk were the future of germany, and the suffering of the jews and other minority populations were a necessary evil. to heal the volk, massacre and experimentation was required. anything else was worse than death itself. therefore such reasoning leads to a slippery slope where select populations with power, in this case the military mass of germany, define what is ethically good and sound.12 the failure of dachau yet what if the survivors of dachau, some of those involved in the very experiments themselves, claim that the data should be used as not only a way to commemorate the suffering, but also offer some trace of benefit in an otherwise bleak event? different complications result in this novel consideration for it is not a continuation of some past injustice, but an allowance of it by the group directly affected. consent is therefore obtained, and surely to abuse this agreement is to abuse the abused once again.13 otherwise stated: unlike the nazi’s who tried to bury their findings in shame, such allowance does not allow the discoveries to buried again. appealing as these considerations may be, the credibility of the data collected must be assessed. in dachau, the consensus is varied. berger (1990) maintains the entire experiment, from design to the data to the principle researcher himself, were of little use.4 he noted that the report is riddled with inconsistencies, falsification, and suggestions of fabrication. others, such as ivy (1950), have disagreed, claiming that some aspects “were obviously good… and worthwhile.”14 niburski, ice cold, voices in bioethics, vol. 1 (2014) 6 regardless of what either say, however, the integrity of science, and medicine by extension, is shot in stating that the conclusions hold any clout. forget that the patients involved are unrepresentative of the larger german population; that is, they were emaciated, used against their will, and were broken, battered, and mistreated if they did not follow orders.1-5 instead what is central to scientific inquiry – more than the collection, analysis, and presentation of some form of data – is reproducibility.13 by their very nature, the dachau experimentations are irreproducible. the claims cannot be challenged, only postulated upon; the results cannot be replicated, only assumed to be true within degrees of error. thus, they lack the scientific rigor that is otherwise necessary to be truly defined as science. the broader scientific implications moreover, a truly comprehensive study is only benefited, not deterred, by ethical treatment.8 a balanced research relationship encourages disclosure, trust, and awareness of findings and their implications. denying this denies the justice in recognizing a patient’s vulnerability, the holistic approach to inquiry with its multifaceted concerns, from a person’s personal background, medical history, beliefs, and opinions, and the two-fold narrative of healthcare. with an ethical model, those experimented on can comment on unique aspects of a study and physicians and researchers alike can mend the design as is required and suggested to produce the best results. however, what if the nazi doctors discovered a cure to cancer? on intuition alone, there seems no harm in allowing the dissemination of this knowledge; in fact, it seems by not bringing this knowledge to the fore, more harm will result. however what is clearly evident that no physician, as it was defined, is justified in reducing subjects to their ends, whatever they may be. doing so encourages further unethical experimentation that rides a slippery slope to scientific martyrdom. and selecting martyrs is not science’s business. neither is it the physician’s. more importantly is that such unethical experimentation may be supplemented by ethical treatment. take dachau again. similar findings were discovered in animal studies, and these may be extrapolated to human cases.2 and if this is not a possibility, then the alternative is much less dark: informed consent may be given by the patients and this allows a more fruitful discovery to occur. in this way, there are always better, more reasonable means to the spirit of invention. that is science’s testament. it is what the scientific methodology ultimately strives for: putting humanity in the inhumane. to do otherwise, and to participate in unethical medicinal practice, is to deny the very construction of science and medicine. conclusion niburski, ice cold, voices in bioethics, vol. 1 (2014) 7 unethical practice and research of medicine should never be pursued for its own end. the loss of autonomy, the warping of a physician’s both moral and vocational duty, the disregard of trusting relationships, the reduction of patients from research subjects to research objects, and the skewing of beneficence necessary to achieve the supposed end is not worth the result, no matter how lucrative and beneficial it may seem. the kantian philosophy, as well as the framework of principlism, cries for research of a higher moral standard. because while under the utilitarian lens of science all types of research can be used to rationalize saving lives, what must not be asked is what is the end result, but instead, what is the cost to get there – whether that be to the physician, the patient, and humanity as a whole. references 1. dyal, e. nazi medical experimentation: should the data obtained be used? southern illinois university theses, 2000. 2. pozos, r. nazi hypothermia research: should the data be used? military medical ethics, 2, 1991. 3. caplan, a. when evil intrudes. the hastings center report, 22, 1992. 4. berger, r. the dachau hypothermia experiments. the new england journal of medicine, 322, 1990. 5. post, s. the echo of nuremberg: nazi data and ethics. journal of medical ethics, 17, 1991. 6. hippocrates. trans: jones, w. h. s. oath. cambridge: harvard university press. 1923. print. 7. kant, i. trans: wood, allen. groundwork of the metaphysics of morals. boston: yale university press. 2002. print. 8. introduction; readings in health care ethics. elisabeth boetzkes and wilfrid j. waluchow eds. broadview press 2000. 9. lifton, r. the nazi doctors: medical killing and the psychology of genocide. united states: basic books. 2000. print. 10. colaianni, a. a long shadow: nazi doctors, moral vulnerability, and contemporary medical culture. journal of medical ethics, 38, 2012. 11. dixon b. citations of shame. new scientist. 1985; 105: 31. 12. nichols, s. mallon, r. moral dilemmas and moral rules. cognition, 100, 2006. 13. rob, a. eisenhauer, l. wynaden, d. ethics in qualitative research. journal of nursing scholarship, 33, 2000. 14. mitscherlich a, mielke f. doctors of infamy: the story of the nazi medical crimes. new york: henry schuman; 1949. ringel, injectable contraceptive introduced in burkina faso, voices in bioethics, vol. 1 (2014-15) © 2014 lillian ringel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. injectable contraceptive introduced in burkina faso lillian ringel bioethics, reproductive ethics, burkina faso burkina faso’s health ministry has begun its initiative to have contraception available to 25% of married women by 2015. depo-provera, the injectable contraceptive, has been introduced as a “uniject” capsule under the name, “sayana press.” containing one dose of the contraceptive, the uniject capsule is a simple device that administers a long-acting drug (it has to be administered every 13 weeks). the hope is that women in burkina faso will eventually be able to administer the medication themselves. this is important for many reasons but mainly because, as married women, they may not want their husbands to know they are using birth control. sayana press has been approved as depo-provera in the united states since 2004. agredo, polst: making sure patients get what they want, voices in bioethics, vol. 1 (2014-15) * sebastian agredo, ms bioethics © 2014 agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and rep roduction, provided the original author and source are credited. polst: making sure patients get what they want sebastian agredo* keywords: polst, bioethics, ethics, life-sustaining treatment introduction in stark contrast to the legislative developments in the louisiana capitol, a bill is awaiting illinois governor pat quinn’s signature that would expand a health care paradigm being hailed as the “best kind of end-of-life care that has come along.” the bill is an effort to improve upon an already successful medical order called physician orders for life-sustaining treatment (polst). specifically, it is an attempt to bridge the noticeable gap that exists between the number of patients who would rather die at home and the actual one-third of patients who have that wish realized. the polst paradigm was developed in order to improve the quality of care afforded to seriously ill patients by giving them the opportunity to direct the path that their care will take at the end of life. it is a legal document that specifies what care will be carried out in an emergency medical situation, and it is filled out by the patient, in consultation with their physician, and signed both by the patient and the physician. it is generally only appropriate for patients suffering from an advanced stage of terminal illness or whose prognosis indicates that they have approximately one year left to live, for the patient’s current health status points to the need for standing medical orders. the key component of the paradigm is thoughtful conversations between health care providers, patients, and their families and friends to determine what life-sustaining treatments fall in line with their personal values, beliefs, and goals. although one might confuse polst with an advance directive, which is designed to help healthy people make their end-of-life decisions known to loved ones in the event of serious illness or injury, polst is actually a complementary tool. signing such an order is highly encouraged for the target patient population due to clinical experience and research demonstrating that advance directives are not sufficient by themselves in ensuring that patients’ preferences in health care are respected and honored. the most recent high-profile case of casey kasem provides a striking example. a significant advantage in having polst is that the order is completely portable, becoming a part of the patient’s medical record, thus reducing the risk of unwanted or ineffective care. however, it must be noted that polst does not replace an advance directive, as it does not substitute for naming a health care agent or durable power of attorney for health care. ____________________________________________________________ agredo, polst: making sure patients get what they want, voices in bioethics, vol. 1 (2014-15) 2 analysis polst has already been available in illinois for over a year, and its use throughout the country has been steadily increasing over the past twenty years, beginning with its introduction in oregon in 1991. today, almost all states employ polst, with the forms varying in their language and structure from state to state. a recent study conducted in oregon also found that polst is successful, finding that the end-of-life preferences for patients only seeking comfort care were honored and only 6 percent of such patients died in the hospital. 1 conversely, 34 percent of patients without a polst order died in the hospital. yet, polst is not just about limiting the kind of life-sustaining measures that should be implemented; it can also be used to ensure that a patient’s wish for aggressive care is also fulfilled. so long as the patient and the physician engage i n a dynamic conversation wherein the patient is adequately presented with the diagnosis, prognosis, treatment alternatives, and the burdens and benefits associated with life-sustaining treatment, then the patient’s informed decision must be respected regardless of the preferred course of treatment. as mentioned above, the bill presented to gov. pat quinn is an expansion of the already existing polst form in illinois. it includes the opportunity to discuss additional treatment options that were not present in the previous form, such as iv solutions, feeding tubes, pain medications, and hospice. it allows for physician’s assistants, nurses, and senior medical residents to sign the polst, in addition to physicians, which accurately reflects the fact that these health care providers are often the ones most likely to have the time to talk and discuss varying options with patients. it also provides three general options for their end -of-life care: • comfort measures avoiding transfers to hospitals; • limited interventions of basic medical treatments and transfers to hospitals if indicated but avoiding intensive care; • and full treatment including a transfer to a hospital or intensive care unit. critics of the bill and polst itself have voiced issues concerning the validi ty and relevance of seriously ill patients’ advance choices, especially when taking into consideration the possibility of patients changing their minds. furthermore, opponents often cite the inherent power imbalance that exists between patients and their physicians, stating that polst is not “protective enough” and is “more about withholding treatment” than patient autonomy. conclusion these concerns are not unique to polst, as similar arguments have been made in regards to advance directives. this is why continuous conversation must take place between health care providers and their patients and their families. a form is just a filled out piece of paper. it carries no weight if the necessary concentration is not given to (1) the prerequisite conversation and (2) the professional duty placed upon health care providers to honor the requests that come out of that conversation. only then can the filled out piece of paper become actionable, hopefully resulting in the kind of delicate care that seriously ill illinois patients deserve. agredo, polst: making sure patients get what they want, voices in bioethics, vol. 1 (2014-15) 3 1 fromme, e. k., zive, d., schmidt, t. a., cook, j. n. b. and tolle, s. w. “association between physician orders for lifesustaining treatment for scope of treatment and in-hospital death in oregon”. journal of the american geriatrics society. doi: 10.1111/jgs.12889 stripling, a question of mercy, voices in bioethics, vol. 1 (2015) © 2015 stripling. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a question of mercy: contrasting current and past perspectives on physicianassisted suicide mahala yates stripling, ph.d. keywords: right to die, assisted suicide the right-to-die debate was cast into the spotlight on november 1, 2014, when brittany maynard, a beautiful young california woman, took her own life by a doctorprescribed lethal dose. maynard, in her october 7, 2014, cnn article, “my right to death with dignity at 29,” describes what led up to this decision. 2 married just over a year, she and her husband were trying for a family. however, after months of suffering from debilitating headaches, she learned on new year’s day that she had brain cancer. “our lives devolved into hospital stays, doctor consultations, and medical research,” she states in her article. nine days after the diagnosis, she had a disfiguring partial craniotomy and partial resection of her temporal lobe to stop the growth of the tumor. when her aggressive tumor came back three months later, she was given a prognosis of six months to live. she opted out of full brain radiation that would leave her scalp covered with first-degree burns. “my quality of life, as i knew it, would be gone,” she admits in the cnn article. she ruled out hospice care because medication would not relieve her pain or forestall personality changes, including verbal, cognitive, and motor loss. withholding treatment or removing life support—decisions made in america every day—were not an option for her. whatever life she had left in her strong young body was mitigated by a deteriorating brain. she did not want for herself or her friends and family that dire reality in the few remaining months. choosing to live her brief life as fully as she could, without the fear of intolerable pain, she uprooted her family, moving from california to oregon, where the death with dignity act was passed in 1997. 3 the act allows terminally-ill oregonians to end their lives through the voluntary self-administration of lethal medication expressly prescribed by a physician for that purpose. the harrowing burden facing death, for this woman and her family, besides finding a new home and a physician willing to prescribe a lethal medication, was compounded by the need to establish residency. she had to get a new driver’s license and change her voter registration. she met the strict patient eligibility criteria of being at least 18, mentally competent, and with a terminal illness, defined as less than six months to live, confirmed by two independent physicians.4 two oral requests were made with a 15-day waiting period in between, and she made a written request that was witnessed. a prescription for the lethal dose she needed was written no less than 48 hours after the receipt of the written request, and she had to prove that she could self-administer the medications (i.e., have the mental and physical capacity to take the medications on her own). brittany filled the prescription but did not take it immediately: “i am not suicidal. i do not want to die. but i am dying. and i want to die on my own terms,” she affirms in the cnn article. she chose how and when to die. after finishing her bucket list, including seeing the grand canyon and celebrating her husband’s birthday, her condition worsened. she laid in her upstairs bedroom surrounded by her husband, dan, mother, deborah, and stepfather, gary, and died peacefully, rather than in a cold hospital room in intolerable emotional and physical pain during a time dominated by fear and uncertainty. stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 2 her situation brought national attention in people magazine as well on her own facebook page on november 1st: “goodbye to all my dear friends and family that i love. today is the day i have chosen to pass away with dignity in the face of my terminal illness, this terrible brain cancer that has taken so much from me . . . but would have taken so much more.” and so, in dying, brittany maynard revitalized the right-to-die debate. in sharp contrast to her story, and seven years before oregon’s first death with dignity law in 1997, three men conspired in secrecy in a seventh floor new haven apartment. richard selzer, who had left an active surgeon’s life in 1985 to write full-time, was drawn into a prickly situation, as he relates it: “a man i know here at yale, a poet, called up and asked if i would see these two gentlemen. one had fullblown aids and the other was a faculty member here. the sick man wanted me to end his life. i talked to them, and i of course said, ‘no. i’m not practicing medicine anymore.’ he implored me to go and visit them. i did, and i became involved in their plight.” in diary entries from january 14 through february 15, 1990, selzer recorded each visit to the apartment, a ten-minute walk from his house. the doorman, a former patient, greeted him warmly and lifted his shirt to show the doctor how well his gallbladder incision had healed. the action unfolding in real time is set out in selzer’s subsequent publication, “a question of mercy,” and in it he describes the dramatis personae. first, there is the “almost too handsome” lionel, a man in his late 30s who is an ordained minister. second, his lover of six years, ramon, also in his 30s, is a short, delicate man “with a neat lawn of a beard,” who was a public health physician specializing in “women’s problems, birth control, family planning, and (aids).”5 acquired immune deficiency syndrome, or aids, was first identified as a disease in 1981.since aids had an unknown etiology, if ramon had known about his infection while he was on the job, he had to conceal it or be fired. locally, the doctors at yale-new haven hospital double-gloved when treating an aids-infected patient; nationally, almost everyone was afraid to be near someone with the disease, believing that contracting it was a death sentence. christian conservatives cultivated fear, saying aids was a punishment from god for deviant sexual acts. so being outed at this time was tantamount to receiving both a social and physical death. selzer was unknowingly in the cross-fire of the two national debates relating to aids and physician-assisted suicide (pas), long advocated by michigan pathologist jack kevorkian, who first publically assisted in the suicide of an alzheimer-stricken woman on june 4, 1990.6 even with so much uncertainty about the nature of aids and the public controversy surrounding pas, selzer, right then and there in that room, was the compassionate former doctor who understood that the man’s suffering was “worthy of job”7. plain to see was ramon’s fatigue, depression, and fulminating kaposi’s sarcoma in the left naso-orbital region, the pain of which was exacerbated due to his pride in his appearance. soon he would be blind. the foul odor in the room was evidence of his intractable incontinence. the doctor took him into the bedroom where he examined ramon’s ulcerated hemorrhoids more closely: “his anus is a great circular ulceration, raw and oozing blood. his buttocks are smeared with pus and liquid stool.” lionel tenderly bathed and dressed him in a fresh diaper. “even though i have been summoned here,” the doctor thought, “i feel very much the intruder upon their privacy.”8 and yet he was convinced that this man wanted to retain his dignity in death. lionel had undoubtedly read selzer’s confessional story, “mercy” (1980), which emboldened him to contact selzer ten years later.9 the story describes a doctor whose 42year-old patient had the unrelenting pain of end-stage pancreatic cancer. “i won’t let you suffer,” the doctor said. the man, his wife, and mother wanted the doctor to administer a fatal dose of morphine to end his life. when that did not work, the doctor could not take that extra step by putting three minutes of pressure on his patient’s windpipe. now selzer, given another opportunity to end the suffering of a human being, was again reluctant. but he thought, “if i would do it for myself, why not for another?” ramon, lionel, and selzer were joined by a fourth person, melanie, a supportive friend sworn to secrecy. stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 3 feeling like conspiratorial criminals, they were all aware of the sense of impending doom that filled the air. they must tell noone. and yet they all wondered how they would handle the gravity of it. ramon was suffering and wanted to die. lionel, although a minister, had never seen death before. his religous beliefs of the afterlife were unspoken, but he feared the premature death of his friend and lover. the compassionate selzer, caught up in the drive for ramon’s assisted suicide, faced a dilemma. he was in the midst of opposing ethics in an existential crisis. he was trained as a doctor in the hippocratic oath—"i will not administer poison to anyone where asked," and i will "be of benefit, or at least do no harm."10 being sworn to preserve human life, he now found himself in an action to alleviate prolonged suffering by taking one. the silence in the hall outside the apartment was in marked contrast to the noisy horn-tooting cars of yale students on the street below as the plan took shape. ramon, who was columbian, expected to receive a sufficient supply of barbiturates from a columbian doctor he knew. selzer instructed ramon on how the pills should be taken at intervals with sips of water, being careful not to get too full too early or he would not have the capacity to absorb the lethal dose. he should also add a codicil to his will, which lionel was the sole beneficiary of, that his mortal remains should be cremated. the blood work at autopsy would reveal the overdose. selzer had a prescient dream that things went terribly wrong, and he was arrested for murder. that fitful urgency caused him to test ramon’s and lionel’s resolve once again. he hoped they would allow ramon to die naturally of thirst. it also concerned selzer that lionel was too sensitive to bear any of ramon’s suffering and that he would not be able to tell any necessary lie. they both relied more heavily on selzer who had grown weak in the knees. the reality hit that a compulsory autopsy would confirm ramon’s use of barbiturates and someone seeing selzer enter the building would suggest his complicity. so lionel let selzer back out, unbeknownst to ramon. three weeks later, on the appointed day, lionel and melanie, whose absences would make them above suspicion, took the train to new york for the night, while at 6 p.m. in new haven ramon began to take his pills. the man, alone in the apartment, was so weak that he could not take the final lethal dose. he did not know that selzer, afraid of being charged with murder, would not be there to help him by injecting the morphine. that act of omission—something that would not have happened if pas were legal and ramon had met the medical criteria, caused the attempt to be botched. lionel returned to the apartment to find ramon unconscious but alive. he called an ambulance. “what else could i do?” asked lionel. placed in the hospital icu, ramon was put on a respirator and had his stomach washed out. as related in “a question of mercy,” selzer went to see him. “ramon!” i call out. he opens his eyes and looks up, on his face a look that i can only interpret as reproach or disappointment. he knows that i was not there. lionel the honest has told him. “do you want to be treated for the pneumonia?” i ask. he cannot speak for the tube in his trachea, but he nods. “do you want to live?” ramon nods again. “do you still want to die?” ramon shakes his head no.11 standing on the dark threshold of death, life became more precious to ramon. but twelve days later he died in the hospital. in the close-knit community of yale elites, everyone seemed to know about it. whether or not selzer’s desire to help was brave or foolish, dying and death was not a new arena for him, but public exposure regarding the hot issues of aids and pas was. 12 ten months after the incident, selzer says a reporter at the new york times, who had heard about it, asked him to write a piece on physician-assisted suicide, a topic that was increasingly in the media due to jack kevorkian. he replied, “no, that’s not my subject.” he had repressed this experience because it was so negative. he then reconsidered and went back to his notebook and typed out the entries as he had written them in longhand. in his haste, he did not change the names and location enough to offer anonymity. he met lionel at the library and asked him to read the manuscript before he sent it to the times. “he did so in my stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 4 presence,” selzer says, “and said that of course i should publish it--that it would be pro bono publico. and so, with lionel’s blessing, i allowed the times to publish the story.” selzer is no stranger to controversy but he could not have anticipated what lay ahead. his true and unflinching account of attempted physician-assisted suicide, titled “a question of mercy,” was published on september 22, 1991. the hot national issue had considerable letter-to-the-editor follow-up. although selzer had changed the names, all of the characters lived in new haven, and “the survivor told everybody,” selzer says. “so everyone at yale, where i live, knew who i was and who they were. it was common knowledge. it was extremely uncomfortable for me.” when the diary account appeared, “lionel had a change of mind, and bruited about yale that i had unfairly used his tragedy for my own purposes,” says selzer. there was to be a meeting to discuss this, but lionel canceled, and they never spoke again. selzer does not know of any personal or professional ramifications felt by lionel as the surviving partner, except that he left yale for another university. it did not end there. at a reading of selzer’s work sponsored by the program for humanities in medicine, “everyone knew that he was going to talk about it,” says howard spiro, the program director, “and there was a lot of animus about dick that he unwittingly identified one of the men as a gay man and outed somebody who did not want to be.” some of the other program organizers wanted to call the event off, but spiro, instead, moved the program from the smaller beaumont room to the hope building, a place that could be easily defended by the provost’s security. based on the buzz in the community, spiro worried that a crowd of enraged people would tear his friend richard selzer into pieces. “it was sort of like the day the black panthers came to march on the new haven green,” recalls spiro, “and the fbi and the national guard came out. we expected armageddon but nothing happened. it was a similar attitude—in a smaller way—but i don’t think there were even a lot of heated questions from the audience.”13 but anger spread like a tsunami throughout selzer’s community. he was a wellknown surgeon who had operated on many of them, and now they wondered if he had lost his empathy for patients in favor of being a vampire artist needing to feed. broader questions arose having to do with whether or not lionel, who was not selzer’s patient, should be concerned about being “exposed.” selzer felt the consequences of his actions. new haveners, who thought that selzer had prized being published over maintaining confidentiality, shunned him. 14 long-time acquaintances, who would normally greet him with, “hi doc,” offer a smile and friendly wave when meeting him on the street, crossed to the other side. selzer, who ostensibly had the thick-skin of a surgeon, was underneath a sensitive soul who avoided the spotlight. this painful scrutiny, on top of being adversely affected emotionally and psychologically by the pas attempt, matched the suffering of the other survivors in the days following it. “a question of mercy,” which describes a volatile situation and its aftermath, ends with everyone involved in this failed plan sucked into a quicksand of their own making. it is a cautionary tale that asks, whether pas is legal or illegal, could you, as a family member, friend, or health care professional, help someone die and live with the consequences of your actions? the medical climate has changed a great deal since the complicated and muddled situation described in richard selzer’s “a question of mercy.” for those who meet the criteria, the right to die is simply about free will and choice, if you reside where it is legal. in the 24 years that separates the two cases, a great cloak of conspiracy shrouded the events of ramon’s last days, but the national media broadcasted brittany’s story. the cause of death on her certificate was not suicide or euthanasia but “brain tumor.” oregon, washington, and vermont have legalized assisted suicide through the legislature or popular referendum. in bernalillo county, new mexico, and in montana it is legal through court decisions; and new jersey’s house has passed legislation legalizing assisted suicide. bills in connecticut and california are under review with their state legislatures who are now debating the issue.15 stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 5 the profound impact of widelylegalized pas is that it alters the very foundation of the doctor-patient relationship. a terminal patient’s right to alleviate suffering by choosing death, called autonomy, creates a tension when doctors are trained to see human life as an inherently valuable. while in a gallup poll conducted may 8-11, 2014, before maynard's story went public, nearly seven in 10 americans said they believed physicians should be able to "legally end a patient's life by some painless means,” the american medical association and the american geriatrics society oppose assisted death. 16 will the groundswell of popular opinion and the consequential state-wide movements to legalize physician-assisted suicide cause them to reformulate their current ethics? among the arguments against pas, the most zealous come from people who uphold the religious tradition of the sanctity of human life. in fact, controversy erupted when pope francis and the vatican denounced the right-to-die movement as showing a “false sense of compassion” and a sin against god, who determines when we die.17 the vatican’s top bioethicists took it further, calling brittany maynard’s actions “reprehensible.” brittany maynard’s mother immediately responded in a letter written to compassion and choices, a no-cost end-of-life resource center for the terminally ill. she rejected this religious doctrine of god’s perfect timing for eternal life versus her daughter’s earthly relief. believing that god should never have entered this conversation, she said: “my 29-year-old daughter’s choice to die gently rather than suffer physical and mental degradation and intense pain does not deserve to be labelled as reprehensible by strangers a continent away who do not know her or the particulars of her situation."18 still others see brittany maynard’s precedent as being on a slippery slope. the downside includes, a physician who might inadequately treat pain or make a mistake in diagnosis or prognosis; because aid-in dying is less expensive than end of life care, its availability could affect decision making at the insurance, doctor, and patient levels, and vulnerable populations who become a burden to families may be coerced into it; and, not the least of which is, as more doctors use pas in their practices, the way it will change the integrity of the doctor-patient relationship and how the public views the profession. 19 whatever else happens in our lives, our final journey may become a spiritual quest, and some may find meaning in their own suffering; however, not all will. there are the faithful who adhere to ancient beliefs of life’s end; removing god from this equation does not unravel society’s morality is another viewpoint. modern medicine has opened the door for everyone to reconsider that a terminal illness can have a more peaceful end. once more, pertinent literature on the topic of pas, such as richard selzer’s “a question of mercy,” offers historical, cultural, and spiritual perspectives for bioethicists considering contemporary problems. 20 in the end, one of brittany maynard’s last wishes has been fulfilled: her final illness shines a light on the death with dignity movement, impacting public opinion and the passage of laws in the near future. pdf available: mahala stripling, "question of mercy," voices in bioethics (2015). references: 1 this is partly excerpted from chapter 12,”a deep black hole,” of the forthcoming mister stitches: the life and arts of richard selzer, m.d. all selzer quotations, unless otherwise noted, come from interviews with author. 2 “my right to death with dignity at 29.” cnn.com october 7, 2014. updated november 2 , 2014. http://www.cnn.com/2014/10/07/opinion/maynard-assisted-suicide-cancer-dignity/ . 3 on october 27, 1997, oregon enacted the death with dignity act. it requires the oregon health authority to collect information about the patients and physicians who participate in the act and to publish an annual statistical report. providers may decline to prescribe medication under the1997 death with dignity act. http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070a28748e3aacbe03306/1473278114656/mahala-stripling-question-of-mercy.pdf?format=original stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 6 http://public.health.oregon.gov/providerpartnerresources/evaluationresearch/deathwithdignityact/page s/index.aspx 4 “the oregon death with dignity act: a guidebook for health care professionals.” http://www.ohsu.edu/xd/education/continuing-education/center-for-ethics/ethics outreach/upload/oregon-death-with-dignity-act-guidebook.pdf 5 selzer, richard. “a question of mercy.” the exact location of the soul. new york: picador, 2001: 13 6 jack kevorkian (1928-2011), called “doctor death,” championed a terminally ill patient’s right to die via pas, saying: “dying is not a crime.” between 1990 and 1998 he helped 130 people take their final action, such a pushing a button on a machine that released drugs, resulting in their deaths. things heated up in 1999 with his direct role in voluntary euthanasia, a second-degree murder offence sending him to jail for eight years of a 10-25 sentence. in 2010 cnn’s anderson cooper asked kevorkian, “you are saying doctors play god all the time?” kevorkian’s reply: “of course. anytime you interfere with a natural process, you are playing god.” anderson cooper 360 (cnn). april 16, 2010. kevorkian, jack. prescription medicide: the goodness of a planned death. new york, prometheus books, 1991. job’s faith in god by causing him to lose his family, wealth, and health, including having excruciating sores all he book of job. satan tests over his body reminiscent of ramon’s. although cursing the day he was born, the blameless job remains devout. "naked i came out of my mother's womb, and naked shall i return: the lord has given, and the lord has taken away; blessed be the name of the lord." job 1:21. a story about human suffering and god’s sovereignty, job is rewarded for his loyalty when god restores to him his health, happiness, and prosperity. 7 “a question of mercy”, 134. references to the old testament in the bible are often seen in selzer’s work. here he refers to the intense emotional and physical pain felt by job, as told in t 8 “a question of mercy”, 137. writings about them must be devoid of patient identifiers or they must have permission from the patient involved in the writing. in today’s reality, blogs or twitter feeds that release information instantaneously are a real concern. http://www.hhs.gov/ocr/privacy/hipaa/administrative/statute/hipaastatutepdf.pdf 9 selzer, richard, “mercy.” letters to a young doctor. new york: simon & schuster, 1982: 70-4. it is ethical for a doctor to alleviate the suffering of a patient even if it hastens death as an unwanted side effect, but this scenario approached the level of active euthanasia. 10 internet encyclopedia of philosophy. http://www.iep.utm.edu/hippocra/ 11 “a question of mercy”, 146. 12 selzer renews his narcotic license every year. “it is within the law to do so, although i have never used it to procure drugs for the purpose of physician-assisted suicide. i am a proponent of pas as a choice to relieve suffering under the strictest controls. i have advised very ill and symptomatic pre-terminal patients on a couple of occasions on how to end their own lives, but i have never taken an active role à la dr. kevorkian, nor have i been present at the time of death. with more liberal laws, i doubt not that i would be among those who would ease the hopelessly ill out of their agonies.” and, he may need it someday “to kill myself easily,” he adds, “should the occasion arise.” 13 sprio interview with author 9 may 2001. 14 since hippocrates patients’ stories have been used to teach, first in the closed society of medicine but now they entertain and instruct the general public. like selzer, william carlos williams felt sandbagged when new masses asked for a contribution, and he sent them one he had simply filed away. “the five dollar stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 7 guy,” published in 1926, was about a woman friend who was propositioned by the owner of a local oil company. williams did not change the names or location, and new masses did not vet it for possible libelous material. they were sued for $15,000—in 1926 three years of williams’ salary— but settled for $5,000 and a promise never to print the story again. mariani, paul. william carlos william: a new world naked. new york: norton & co., 1981: 254-5 15 “physician-assisted fast facts.” november 26, 2014. includes timeline. http://www.cnn.com/2014/11/26/us/physician-assisted-suicide-fast-facts/ in the netherlands, belgium, and luxembourg doctors, under strict conditions, can euthanize patients whose medical conditions have been judged hopeless and who are in great pain. in canada, in a unanimous decision, the supreme court ruled in february 2015 that doctors can help the gravely ill end their lives but the decision does not immediately allow physicians to assists patients in their deaths. existing legislation and regulations will remain in place for one year to allow the federal government, which enforces criminal law, and provinces, which administer health care, to adopt new measures. 16 swift, art. “brittany maynard’s story and americans’ views on assisted suicide.” http://www.gallup.com/opinion/queue/179159/brittany-maynard-story-americans-views-assisted suicide.aspx 17 “pope francis: assisted suicide is a ‘false sense of compassion.’” christian science monitor: nov. 15, 2014. http://www.csmonitor.com/world/latest-news-wires/2014/1115/pope-francis-assisted-suicide-is-a false-sense-of-compassion https://www.compassionandchoices.org/2014/11/18/brittany-maynards-mother-responds-to-vatican other-critics-of-her-daughters-end-of-life-choice/ 18 “brittany maynard’s mother responds to vatican, other critics of her daughter’s end-of-life choice.” november 18, 2014. 19 these and other arguments are made in “what are the arguments against physician aid-in dying (pad)?” “physician aid-in dying.” ethics in medicine, university of washington school of medicine. revised april 2013 by helene starks, phd, denise dudzinski, phd, and nichole white, m.d. http://depts.washington.edu/bioethx/topics/pad.html david rabe, who adapted selzer’s essay, “a question of mercy,” into a play premiered in new haven at the longwharf theater in 1998, took a position on pas, saying he fears pas becoming legal through “authorities”— rather than being helped by a personal physician—and that’s when “anything that becomes bureaucratic ultimately is corrupt. i just see an endless area of danger with insurance companies or families who want to get rid of someone. that is my fear about legalizing it.” quoted in “life to stage,” an interview by frank rizzzo in the hartford courant 2-15-98: g4. *a talkback panel following the premiere was led by roland clement representing the new haven chapter of the hemlock society. speakers included several doctors, a rabbi, a chaplain, a psychotherapist, a bereavement specialist, a lawyer, the director of pastoral care at a ct hospice, and the director of education for the aids project in new haven. 20 with writing medical narratives now an industry, doctor-writers must add enough unique expression to a patient’s case history to make it their own. lapses in confidentiality cause harm to patients in the admittedly cannibalistic act of writing. when selzer published “a question of mercy” in the times in 1991, the health insurance portability and accountability act of 1996 (hipaa), setting out patient privacy standards, had not been enacted. today doctor-writers must take care in divulging information about their patients. stripling, a question of mercy, voices in bioethics, vol. 1 (2015) 8 dias, ethics of public health messaging abroad, voices in bioethics, vol. 2 (2016) © 2016 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethics of public health messaging abroad: are the recent zika-related recommendations of various health agencies unjustified paternalism or sound public health guidance? matt dias keywords: zika, public health, global ethics introduction the role of public health agencies is to facilitate approaches to health planning by supporting health promotion, prevention, and preparedness activities. and in theory, good public health messaging supports these aims. yet in recent months, various governmental health agencies around the globe have faced sharp criticisms in response to certain recommendations they have issued regarding pregnancy risks and newborn health outcomes. specifically, in several caribbean, central american, and south american countries where the zika virus is on the uptick, governmental health authorities have suggested that women take steps to avoid pregnancy for at least several months or until the virus wanes, whichever comes first.[1] analysis the criticisms, which rely on arguments relating to sociopolitical, cultural, and historical issues, suggest that the agencies in question are out of touch with social currents and accordingly that their recommendations are unrealistic to follow. the critics—who range from women’s and human rights activists to public intellectuals and media contributors—allege that the recommendations are naïve, unrealistic, and unjustified, and that the advice transcends the scope of public health imperatives.[2] however, such criticisms are misguided because of two specific reasons. these critics (i) misunderstand the purpose and responsibilities of public health agencies and (ii) sidestep important ethical and scientific dimensions of the health risks at hand. to this end, the respective governments’ advice is justified (e.g., effective paternalism), and the dissemination of such content accords with the methods and ethics of public health messaging as well as with the mission of the public health field. in just half a year, the mosquito-borne zika virus has transformed from a geographically isolated concern to a menacing global adversary. though several outbreaks have occurred within the last decade, the spring– fall 2015 emergence of the virus in brazil became the first time in history that the infection was associated with serious neurological and immunological complications in newborns—including microcephaly (a congenital brain deformity) and guillain-barre syndrome (a potentially crippling autoimmune disease). international concerns about infant health have since increased, especially after researchers in brazil detected https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn1 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn2 dias, ethics of public health messaging abroad, voices in bioethics, vol. 2 (2016) 2 signs of the virus in the amniotic fluid of pregnant women whose fetuses were diagnosed with microcephaly via ultrasound.[3] today, concerns are pronounced where zika outbreaks have already occurred: jamaica, colombia, brazil, ecuador, and el salvador. in response to these very real concerns, the governments of these nations have taken swift action in sounding warning alarms—as a rational strategy to promote newborn health and vitality, and to prevent neurodevelopmental disorders that may last a lifetime and thus render a poor quality of life.[4] in jamaica, for instance, authorities are urging women to delay becoming pregnant for the next six to twelve months.[5] and in el salvador, the country at the heart of these criticisms, the public health ministry advised women to put off pregnancy for the next two years—until 2018—or until zika wanes. the country’s vice minister of health, dr. eduardo espinoza, justified the nation’s guidelines by referencing the duty to public health: “we see ourselves obligated to make this recommendation to partners trying to get pregnant.”[6] el salvador—which has, purportedly, nearly one hundred pregnant women infected with zika—has been a subject of heightened criticism.[7] in that country, abortion is illegal with zero exceptions, sexual education is limited, and contraception is widely unaffordable and inaccessible. moreover, in el salvador, up to 90 percent of pregnancies are unplanned. to both of these points, un commissioner for human rights zeid ra’ad al hussein recently advised that the advice “to delay getting pregnant ignores the reality that many women and girls simply cannot exercise control over whether or when or under what circumstances they become pregnant.” furthermore, dr. guillermo antonio ortiz, a salvadoran obstetrician, said, “it isn’t fair to say ‘don’t get pregnant’ when there is no sexual education program in schools.”[8] undoubtedly, there is merit to these criticisms. it is true that the infrastructure of el salvador’s sex education is nowhere near comprehensive, so the actualization of the government’s advice may not receive the widespread attainability that the agency hopes for. given various social and cultural constraints (e.g., the inaccessibility of birth control; religious, social, and political pressures and expectations surrounding sex practices), many women may perceive the recommendation to be impractical. by the same token, however, many of the arguments are misguided, especially those characterizing the guidelines as being enforceable. for instance, in a new york times column, dr. howard markel of the university of michigan is quoted as likening el salvador’s guidelines to “verboten” governmental action.[9] not only is this comparison misguided, but it is simply wrong. the public health ministry of el salvador—and of the other countries—is in no sense forbidding pregnancy or sexual practices. in this sense, such critics ought to be reminded that none of these recommendations carries legal authority. by definition, recommendations are guidelines, and individuals are entitled to accept or reject the suggested course of action. it is true that the recommendation is paternalistic. yet many sensible public health laws and recommendations must be paternalistic or else, prevention might not occur. indeed, public health is an inherently paternalistic profession, and effective public health guidelines sometimes must intentionally encourage the avoidance of an activity as a means of promoting health and implementing disease prevention strategies. importantly, paternalism is not necessarily value-laden: as philosopher thomas pogge has argued, paternalism can be an effective and accepted method of an institution insofar as certain criteria are met.[10] this truth also undermines the argument that the government’s recommendation is not grounded in reality: not issuing a recommendation that expounds upon the potential outcomes of zika-induced pregnancy would fail to meet the ethical imperatives of the field of public health.[11] scientifically speaking, the statistics are striking, and reasonably insightful regarding the degree of pregnancy risk and potential health outcomes of newborns. in el salvador, more than 2,400 cases of zika were reported in the first three weeks of january alone.[12] to this end, it would be ethically untenable for that government not to disclose its data and caution its citizens about the potential dangers of becoming pregnant during this zika outbreak—or at least until the virus is somehow contained or treated. in light of these considerations, it is evident that these countries’ recommendations are scientifically https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn3 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn4 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn5 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn6 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn7 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn8 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn9 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn10 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn11 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_edn12 dias, ethics of public health messaging abroad, voices in bioethics, vol. 2 (2016) 3 supported. but several follow-up questions remain. for one, were these agencies justified in advising women on behaviors relating to their reproductive/sexual practices in the first place? many of the voiced criticisms are indicative of a misunderstanding of the purpose of public health agencies. not only do these criticisms sidestep the scientific realities of the issues at hand, but also they ignore important moral and ethical dimensions of public health imperatives, including the timely dissemination of necessary facts and recommendations as a means of informing and safeguarding the public. these recommendations fall within the agency’s ethical obligation to educate and caution the public on the ramifications of zika-exposed pregnancy, and not issuing the recommendation would be ethically untenable. secondly, one might ask: are the agencies in question doing enough? if many of the individuals in the affected nations do not even receive sexual education, how effective will a simple recommendation really be, and how does the government measure this efficacy? while there are not yet concrete or official answers to these questions, one preliminary suggestion is for these public health agencies to provide women and their families with reasonable access to ongoing (i) counseling services, as a means of preventing an unintended or unwanted pregnancy, and (ii) education workshops concerning the spread of zika—including best practices for prevention and scientific information about the virus itself. conclusion in the final analysis, while the public health agencies in question may be temporarily recommending abstinence, they are not prescribing it as a normative way of life. rather, it is a temporary preventive measure proposed in response to a severe threat whose comprehensive ramifications remain unknown and largely undefined (even domestically, the cdc recently commented that current knowledge of zika is “evolving” and that preventive and precautionary measures should be taken to the fullest extent possible). so, communicating statistics and warnings about pregnancy in the wake of an infectious outbreak undoubtedly falls within the purview of its responsibilities. to this end, the public health messaging of these agencies is valid, and the recommendations of governmental health authorities should not necessarily be held accountable to social norms or cultural expectations. rather, the recommendations are an appropriate public health suggestion aimed at disability prevention, rooted in science, and issued in accordance with the aims of the profession. [1] the zika virus is a mosquito-transmitted infection related to dengue, yellow fever, and west nile virus. although it was discovered in the zika forest in uganda in 1947 and is common in asia and africa, it did not begin spreading widely in the western hemisphere until spring 2015, when the first outbreak occurred in brazil. see donald g. mcneil jr., catherine saint louis, and nicholas st. fleur, “short answers to hard questions about zika virus,” the new york times, february 12, 2016, http://www.nytimes.com/interactive/2016/health/what-is-zika-virus.html. [2] anastasia moloney, “advice to delay pregnancy due to zika virus is naïve, activists say,” reuters, january 22, 2016, http://www.reuters.com/article/us-americas-health-zika-iduskcn0v100h. [3] rae ellen bichell, “zika virus: what happened when,” npr, february 10, 2016, http://www.npr.org/sections/health-shots/2016/02/10/466127813/zika-virus-what-happened-when. https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref1 http://www.nytimes.com/interactive/2016/health/what-is-zika-virus.html https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref2 http://www.reuters.com/article/us-americas-health-zika-iduskcn0v100h https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref3 http://www.npr.org/sections/health-shots/2016/02/10/466127813/zika-virus-what-happened-when dias, ethics of public health messaging abroad, voices in bioethics, vol. 2 (2016) 4 [4] john bonifield, “facing zika fears: raising kids with microcephaly,” cnn, february 23, 2016, http://www.cnn.com/2016/02/23/health/zika-microcephaly-moms/. [5] edwin mora, “zika in jamaica: warnings of ‘pandemonium’ as women take ‘laissez faire’ approach to pregnancy,” breitbart, february 1, 2016, http://www.breitbart.com/national-security/2016/02/01/zikajamaican-women-ignore-advice-to-delay-pregnancy/. [6] andre puglie, “el salvador fears zika virus, discourages pregnancies before 2018,” latin post, january 26, 2016, http://www.latinpost.com/articles/111600/20160126/zika-virus-el-salvador-discouragespregnancies-before-2018.htm. [7] “casi un centenar de embarazadas con sospecha de zika,” el salvador website, january 20, 2016, http://www.elsalvador.com/articulo/nacional/casi-centenar-embarazadas-con-sospecha-zika-99257. [8] see pew research center, “worldwide abortion policies,” october 5, 2015, http://www.pewresearch.org/interactives/global-abortion/, jonathan katz, “the dilemma of zika: pregnancy warnings rise in a region lacking contraception,” stat news, february 1, 2016, http://www.statnews.com/2016/02/01/zika-pregnancy-warnings-latin-america/, and alex zielinski, “un demands zika-infected countries give women access to abortion and birth control,” think progress, february 5, 2016, http://thinkprogress.org/health/2016/02/05/3746661/un-birth-control-zika/. [9] azam ahmed, “el salvador’s advice on zika virus: don’t have babies,” the new york times, january 26, 2016, http://mobile.nytimes.com/2016/01/26/world/americas/el-salvadors-advice-on-zika-dont-havebabies.html. [10] for the four criteria, see thomas pogge’s personal website, on “paternalism,” at: http://thomaspogge.com/paternalism/. [11] kathy bougher, “government recommendations on zika virus not grounded in reality, say el salvador locals,” reproductive & sexual health and justice reality check, january 28, 2016, http://rhrealitycheck.org/article/2016/01/28/government-recommendations-zika-virus-groundedreality-say-el-salvador-locals/. [12] joshua partlow and sarah esther maslin, “the country with the world’s worst homicide rate now grapples with zika,” the washington post, january 30, 2016, https://www.washingtonpost.com/world/the_americas/the-country-with-the-worlds-worst-homiciderate-now-grapples-with-zika/2016/01/30/02f4ac1a-c446-11e5-b933-31c93021392a_story.html. https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref4 http://www.cnn.com/2016/02/23/health/zika-microcephaly-moms/ https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref5 http://www.breitbart.com/national-security/2016/02/01/zika-jamaican-women-ignore-advice-to-delay-pregnancy/ http://www.breitbart.com/national-security/2016/02/01/zika-jamaican-women-ignore-advice-to-delay-pregnancy/ https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref6 http://www.latinpost.com/articles/111600/20160126/zika-virus-el-salvador-discourages-pregnancies-before-2018.htm http://www.latinpost.com/articles/111600/20160126/zika-virus-el-salvador-discourages-pregnancies-before-2018.htm https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref7 http://www.elsalvador.com/articulo/nacional/casi-centenar-embarazadas-con-sospecha-zika-99257 https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref8 http://www.pewresearch.org/interactives/global-abortion/ http://www.statnews.com/2016/02/01/zika-pregnancy-warnings-latin-america/ http://thinkprogress.org/health/2016/02/05/3746661/un-birth-control-zika/ https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref9 http://mobile.nytimes.com/2016/01/26/world/americas/el-salvadors-advice-on-zika-dont-have-babies.html http://mobile.nytimes.com/2016/01/26/world/americas/el-salvadors-advice-on-zika-dont-have-babies.html https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref10 http://thomaspogge.com/paternalism/ https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref11 http://rhrealitycheck.org/article/2016/01/28/government-recommendations-zika-virus-grounded-reality-say-el-salvador-locals/ http://rhrealitycheck.org/article/2016/01/28/government-recommendations-zika-virus-grounded-reality-say-el-salvador-locals/ https://michael-reaves-bkln.squarespace.com/opeds/2016/03/22/ethics-of-public-health-messaging-abroad-are-the-recent-zika-related-recommendations-of-various-health-agencies-unjustified-paternalism-or-sound-public-health-guidance#_ednref12 https://www.washingtonpost.com/world/the_americas/the-country-with-the-worlds-worst-homicide-rate-now-grapples-with-zika/2016/01/30/02f4ac1a-c446-11e5-b933-31c93021392a_story.html https://www.washingtonpost.com/world/the_americas/the-country-with-the-worlds-worst-homicide-rate-now-grapples-with-zika/2016/01/30/02f4ac1a-c446-11e5-b933-31c93021392a_story.html belisomo, undisclosed surgical incentives, voices in bioethics, vol. 1 (2014) © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. undisclosed surgical incentives compromise informed consent randi belisomo keywords: research ethics, informed consent, pharmaceutical ethics, big pharma introduction rigorous oversight has achieved great success in ensuring fully informed consent from patients when choosing to take prescription drugs. as concerns about the influence of pharmaceutical gifts on physicians have increased, state legislatures have adopted statutes intended to reduce the influence of such gifts; “sunshine laws” require pharmaceutical companies to disclose gifts to doctors. the department of health and human services office of the inspector general has issued industry guidance that delineates marketing that is not permissible.[1] the patient protection and affordable care act requires drug companies to disclose payments made to physicians for consulting, speaking and travel.[2] full disclosure and transparent reporting enable patients to discern financial motive or any other incentive a physician may have in prescribing drugs, but when patients seek a new procedure or innovative surgery, achieving informed consent is challenging without a regulating body’s control. background informed consent constitutes a process in which a fully informed patient can take part in decisions about his or her health care.[3] informed consent is based on the principle that people are the best guardians of their own interests. elements of informed consent include disclosure, cognition and a process of consent, refusal or choice. this belisomo, undisclosed surgical incentives, voices in bioethics, vol. 1 (2014) 2 paper shall focus on the current gap in disclosure requirements in doctor-patient dialogue regarding surgeries or other procedures and the impacts of that gap. while state and federal oversight have enhanced informed consent among patients in regards to pharmaceuticals, safeguarding informed consent is more challenging when providing care dependent on the skill of a surgeon or when seeking a new procedure without the control of a regulating body. this difficulty can be remedied through increased oversight, with the burden upon both the physician and health care facility to pursue objective evidence of benefit and risks and then disclose such data to the patient. cytoreductive surgery with hyperthermic chemotherapy (hipec) hipec is a complex surgical procedure now offered to patients with advanced cancers of the gastrointestinal tract without definitive evidence of benefit. hipec involves surgical removal of all visible metastatic cancer within the abdominal cavity and the instillation of heated chemotherapy in the cavity to penetrate the surfaces; the goal is to eradicate all metastatic disease.[4] hipec was popularized by paul sugarbaker, md, to treat the rare condition of pseudomyxoma peritonei, a complication of appendix cancer. appendix cancer affects 1,500 americans annually, while pseudomyxoma peritonei occurs in one to two per million per year.[5] the success of hipec to eradicate disease in this rare condition led to the extrapolation of the approach to other cancers of the gastrointestinal tract that have spread within the abdominal cavity, mainly colon cancer. due to the complexities of randomized studies of surgical procedures, scant evidence exists showing hipec works for metastatic colon cancer. one randomized study showed that patients undergoing hipec lived an average of 22.4 months post-surgery, while those who pursued traditional chemotherapy lived only 12.6 months.[6] however, the study’s flaws were rampant. those who pursued chemotherapy alone received a now outdated regimen; average current survival for chemotherapy alone is more than 22 months.[7] second, the extent of disease was known only in those patients who underwent surgery; a wide variation in survival existed dependent on those with small volume as compared to large volume disease (29 months and 5 months, respectively). the extent of disease for the control group, those receiving chemotherapy alone, is not known. third, 8 percent of surgical patients died in the post-operative period. belisomo, undisclosed surgical incentives, voices in bioethics, vol. 1 (2014) 3 a recent retrospective review of the experience at the roswell park cancer institute, in buffalo, new york, over an eight-year period supports a benefit of hipec for colon cancer with intra-abdominal spread.[8] of 38 patients treated in this manner, the five-year overall survival rate was 38 percent. using standard chemotherapy regimens for advanced colon cancer during this time period, the expected five-year survival rate would be less than 10 percent. the limitations of this study are its retrospective and nonrandomized design. it is important to note that in this series, the five-year overall survival rate for appendix cancer treated with hipec, its original intent, was greater than 66 percent. despite scant evidence of efficacy, patients—anecdotally younger, healthier and wealthier—seek out this treatment, and the number of physicians offering it has increased. david ryan, md, a gastrointestinal oncologist at massachusetts general hospital, has noted that hipec’s use has been growing due to the inability of surgeons to make a living performing it only on appendix cancer patients, its original intent.[9] because such an innovative surgery involves a departure from standard practice, greater caution and regulation is needed for a number of reasons. when that innovation is in the surgeon’s self interest, the surgeon’s judgment about the patient’s best interest may be clouded. surgeons may hold an economic interest in promoting the procedure, they may fear being left behind the curve of medical advancement, or they may be influenced by a desire for rewards.[10] lessons learned by the late 1980s, nearly every american academic medical center had established bone marrow transplantation programs for the treatment of breast cancer after several small, uncontrolled phase 1 and 2 studies suggested that high-dose chemotherapy with autologous bone marrow transplantation resulted in better outcomes than would have been expected with standard chemotherapy alone. a single randomized study, in 1995, supported this hypothesis.[11] as a result of this single study, an estimated 30,000 breast cancer patients in the u.s. received bone marrow transplants between 1985 and 1998. despite scant data, the presumption of benefit was widespread.[12] belisomo, undisclosed surgical incentives, voices in bioethics, vol. 1 (2014) 4 in an attempt to ensure objective evidence of efficacy, multiple academic institutions pursued rigorous randomized clinical trials comparing high-dose chemotherapy with autologous bone marrow transplant to standard chemotherapy for all stages of breast cancer. in 1999, results of five randomized trials were presented at the american society of clinical oncology meeting, only one of which supported the therapy’s use. that study was conducted by the same investigators who presented the first data in 1995. an on-site investigation and review of records of the institution revealed scientific misconduct, including no signed informed consent and no institutional review board approval. the results of both studies were retracted.[13] medical centers moved to shutter their programs.[14] the same conflicts at play in the decision to perform hipec are evidenced in this historical lesson. academic medical centers opened programs as others did, maintaining competitiveness in the fast-moving field of cancer care. doctors performed transplants on little data; if they did not, these women—often desperate—would go elsewhere in search of a doctor willing to perform the procedure. there was little regulation over tens of thousands of treatments that were later deemed to have no proven benefit. conclusion belisomo, undisclosed surgical incentives, voices in bioethics, vol. 1 (2014) 5 conflicting values and interests among physicians and patients are inescapable. when disclosure is required in cases in which an outside commercial entity may profit, such as pharmaceutical companies, patients are made better aware of any reason outside of his or her best medical interest for which he or she may be prescribed a drug. in the absence of a regulatory body, patients are at risk of incomplete disclosure. such incomplete disclosure impedes informed consent in these medical instances of pursuing surgeries or other procedures. outside interests, such as prestige sought by a physician, financial gain, or support of a burgeoning academic program may induce medical providers to encourage or perform a surgery or procedure absent data regarding efficacy. patients may be unaware of the need of the physician or hospital to justify the expense of these programs, such as those currently opening for hipec treatment, or those that performed bone marrow transplants on breast cancer patients. in such cases in which statutory framework is nonexistent and in which no federal agency governs medical care with clear rules, it is the responsibility of physicians to both ensure that true informed consent is secured and expose their motivation, in the absence of objective data, to this vulnerable population. reference notes 1. d. grande, “limiting the influence of pharmaceutical industry gifts on physicians: self regulation or government intervention?,” journal of general internal medicine, 2010, 25:79-83. 2. p.c. hebert, n. macdonald, k. flegel et al., “competing interests and undergraduate medical education: time for transparency,” canadian medical association journal, 2010, 182:1279. 3. s.n. whitney, a.l. mcguire, l.b. mccullough, “a typology of shared decision making, informed consent, and simple consent,” annals of internal medicine, 2004, 140:54-9. 4. d. bartlett, “hipec: the complexities of clinical trials,” annals of surgical oncology, 2008, 15:1277-79. 5. p.h. sugarbaker, “new standard of care for appendiceal epithelial neoplasms and pseudomyxoma peritonei syndrome?,” lancet oncology, 2006, 7:69-76. 6. v.j. verwaal, s. van ruth, e. de bree, et al., “randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer,” journal of clinical oncology, 2003, 21:3737-43. 7. e. jullumstrø, a. wibe, s. lydersen, et al., “colon cancer incidence, presentation, treatment and ou tcomes over 25 years,” colorectal disease, 2011, 13:512-8. 8. m. halslinger, v. faancescutti, k. attwood, et al., “a contemporary analysis of morbidity and outcomes in cytoreduction/hyperthermic intraperitoneal chemoperfusion,” cancer medicine, 2013, 2:334-342. 9. d. ryan, “cytoreductive surgery and hyperthermic intraperitonal chemotherapy: history repeating itself or a new standard?,” american society of clinical oncology, 2011, 127-8. belisomo, undisclosed surgical incentives, voices in bioethics, vol. 1 (2014) 6 10. d. meyerson, “innovative surgery and the precautionary principle” journal of medicine and philosophy, originally published online oct. 24, 2013. 11. w.r. bezwoda, l. seymour, r.d. dansey, “high-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial,” journal of clinical oncology, 1995, 13:2483-2489. 12. r.a. rettiq, p.d. jacobson,, c.m. farquhar, et al., in false hope: bone marrow transplantation for breast cancer (new york: oxford university press, 2007), p. 1-355. 13. “special departments: retraction,” journal of clinical oncology, 2001, 19:2973. 14. h.g. welch, j. mogielnicki, “presumed benefit: lessons from the american experience with marrow transplantation for breast cancer,” british medical journal, 2002, 324:1088-92 agredo, miso on the market in south texas, voices in bioethics, vol. 1 (2014-15) * sebastian agredo is an alumnus of the columbia master's in bioethics program. he also serves as the managing editor for voices in bioethics. © 2014 agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and rep roduction, provided the original author and source are credited. miso on the market in south texas sebastian agredo* keywords: miso, bioethics, ethics, trap, abortion introduction as was reported in a february 20, 2014 post on the voices in bioethics newswire, the rise in implementation of targeted regulation of abortion providers (also known as trap laws) has diminished the availability of abortive services in several states, resulting in a detrimental impact on women’s health. over 200 abortion restrictions have been enacted throughout the country since 2011,1 leading to the closure of more than 73 abortion clinics.2 it is not surprising then that this trend has left women with little recourse when it comes to taking charge of their own reproductive health decisions. and nowhere is this becoming more evident than in south texas, where women have begun to avoid medical clinics altogether and are now turning to a “revolutionary” abortion pill known as misoprostol. miso, at it is commonly called, works by inducing a miscarriage during the early stages of pregnancy, and it has long been considered a “lifeline” by latin american women living in countries where abortions are outlawed. ____________________________________________________________ agredo, miso on the market in south texas, voices in bioethics, vol. 1 (2014-15) 2 analysis a piece written by erica hellerstein and published on june 27th in the atlantic details how misoprostol went from being an over-the-counter ulcer medication sold in brazilian pharmacies to being the “magic personal solution to a dreaded problem that dared not be discussed.” beginning in 1986, brazilian women sought a safe alternative to the grisly procedures and complications of underground abortions, which were a byproduct of its criminality and religious admonition. upon realizing the desired effects of miso on pregnancies, the word spread throughout latin america, and doctors were noticing a dramatic decline in the number of women coming into hospitals suffering from the horrific medical effects of botched, sloppy abortions. with heavy restrictions being placed on the drug since the discovery of its popularity in the early 1990s, miso has become prevalent in the black market trade and is often sold for up to $60 a pill. the fact that miso can be attributed to nearly half of brazil’s one million annual abortions goes to show that women in latin america have welcomed it as a safer option. this brings us to the situation in texas, where the restrictions of house bill 2 –signed this past october –have shut down 12 of the state’s 40 abortion providers, leaving many lowincome, uninsured women without access to abortive services. this is most notably the case in the rio grande valley, where both of the county’s clinics were forced to close due to the legislation. taking their place are local flea markets and vendors who secretly sell miso on account of it only being available with a prescription in the united states. the drug supply is usually smuggled in from mexico, where miso is sold over-the-counter as an ulcer medication, and women will continue to look for it in the black market along the border, hellerstein’s article indicates, as long as the clinics remain closed. in an effort to meet their anti-abortion agenda, lawmakers have essentially propagated the perfect conditions for a black market: one that should not exist in a country where the law protects a woman’s right to abortive services. lawmakers justify the passage of trap laws by assuring their constituents that the laws are meant to protect the welfare and health of women. yet, the laws seem to be having the direct opposite effect by forcing women on the lower end of the socio-economic spectrum –those who cannot make the 150-mile trip to the closest open clinic –to turn to dangerous alternatives. although misoprostol can be 8085 percent effective at inducing the desired miscarriage, vendors and consumers are rarely informed of the necessary dosage, which leads to improper use and negative outcomes. furthermore, recent crackdowns in south texas have left vendors hesitant about selling the drug. if women are desperate enough and cannot find the drug, then the only other options are to self-induce abortion or to travel across the border into mexico and get clandestine abortions, both of which are unhygienic and unsafe. yet another twist in the situation is the unescapable fact that many women in south texas are undocumented, and in order to reach the nearest abortion provider they would have to pass an immigration checkpoint. this only adds to their desperation and urgent need for misoprostol. conclusion it should also be noted that another strict provision of house bill 2 has yet to go into effect. this portion requires that all abortion providers conform to the standards set for ambulatory surgical centers— a requirement that is expected to be too costly for many providers and will leave the whole state of texas with a total of six abortion providers. one can only assume that this development will lead down two roads: either women will be forced to look underground or in neighboring mexico for abortions, or misoprostol will take root and thrive in the flea markets of south texas. if the former is true, then health care providers in emergency rooms will be inundated with cases of gruesome complications due to unsafe abortions, and the health of thousands of women will be put in jeopardy at the expense of political gains. if the latter is true, then the phenomenon of “do-it-yourself” abortions agredo, miso on the market in south texas, voices in bioethics, vol. 1 (2014-15) 3 prevalent in latin america will cross the border and create a state of affairs that texas will be ill-equipped to handle. 1 elizabeth nash et al. “laws affecting reproductive health and rights: 2013 state policy review”. guttmacher institute: 2013. 2 esme e. deprez, “the vanishing abortion clinic”. bloomberg businessweek, november 27, 2013. goldberg, the new don't ask, don't tell, voices in bioethics, vol. 1 (2014-15) © 2014 madeline goldberg. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the new don’t ask, don’t tell madeline goldberg keywords: bioethics, ethics, transgender, army introduction in the wake of the “don’t ask, don’t tell” laws that were passed by congress and later repealed, a new story is emerging of unjust discrimination against transgender troops. unlike canada, australia, england and israel, the united states bans transgender individuals from serving in the u.s. army. this ban is found in department of defense regulations, which suggest that transgender individuals are medically unfit to serve in the u.s. army. recently, a san francisco think tank published a report that criticizes the military’s transgender ban and calls for president barack obama to bypass congress and lift the ban through an executive order. for more information on the think tank report see: transgender military service repot http://www.palmcenter.org/files/transgender%20military%20service%20report.pdf panel urges end to us ban on transgender troops http://www.wdam.com/story/24963555/panel-urges-end-to-us-ban-on-transgender-troop ____________________________________________________________ http://www.palmcenter.org/files/transgender%20military%20service%20report.pdf http://www.wdam.com/story/24963555/panel-urges-end-to-us-ban-on-transgender-troop goldberg, the new don't ask, don't tell, voices in bioethics, vol. 1 (2014-15) 2 references further reading on transgender health issues: about a boy. transgender surgery at sixteen. http://www.newyorker.com/reporting/2013/03/18/130318fa_fact_talbot?currentpage=all college health plans respond as transgender students gain visibility http://www.nytimes.com/2013/02/13/education/12sexchange.html?_r=0 winkel, a matter of personal responsibility, voices in bioethics, vol. 1 (2014-15) © 2015 maia winkel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a matter of personal responsibility maia winkel ebola, bioethics, cdc introduction how much screening is too much screening – and how much is too little? with the recent outbreak of the ebola in west africa – where the virulent virus first ravaged guinea, and is now also leaving its mark on liberia and sierra leone – we are universally experiencing the worst ebola epidemic to date. in an effort to reduce and contain the spread of this fatal virus, the world health organization (who) strongly recommended that the governments in these three grief-stricken countries mandate airport screening for all passengers entering and leaving the country for fever and other ebola-like symptoms.1 analysis identifying infected people – though they may be in the 1-21 day incubation period – before they are able to unknowingly spread it to others through bodily fluids has become a top public health priority in the past few weeks, which has been escalated recently as the number of cases has grown exponentially. with the vast majority of instances of the disease and deaths occurring in west africa, and with the presence of an ebola patient now in the united states, special attention must be given to the ease with which this agent can spread via international travel. as of october 2nd, the centers for disease control (cdc), world health organization (who), and the respective ministries of health in guinea, liberia, and sierra leone, have listed the total case count at 7,157; the total death count at 3,330; and the total number of laboratory-confirmed cases at 3,953.2 these are numbers reflective of a catastrophic disease plaguing western africa; they also highlight what could follow elsewhere if we fail to act promptly and judiciously. we must be prudent about making a dual effort to alleviate the symptoms and cure those who are infected and ill, as well as dedicating a more organized effort towards containing and preventing the spread of the virus. in light of this epidemic, though i am aware of the frustration passengers may experience when their freedom of privacy is compromised, i propose that an extra, more intrusive standard of screening be used. considering how contagious and lethal the ebola virus is, in addition to the current procedural manner of screening at-risk passengers to determine whether or not passengers are febrile, i strongly propose that airport screening personnel take and analyze saliva swabs from these passengers at the time they pass through the screening process, as a more reliable, valid, specific, and sensitive diagnostic screening measure – rather than simply relying on unverified, self-proclaimed declarations about possible contact with diagnosed patients winkel, a matter of personal responsibility, voices in bioethics, vol. 1 (2014-15) 2 and travel through afflicted areas. while an elevated temperature could be a reliable, valid and sensitive indication of illness or infection, it is certainly unspecific. it’s a condition found in any number of illnesses and conditions, including for instance, the common cold. adding data obtained from saliva swaps would make the procedure scientifically robust in a relatively non-intrusive way and in a short period of time, thus helping titrate suspected carriers, confirmed infected and others. doing so will help contain the pathogen – before passengers present with symptoms – and prevent its spread, all while raising awareness of the pathology and stage of illness in the carrier and/or already ill passenger. this would, in turn, allow for more rapid treatment of an infected individual. conclusion obtaining more concrete and useful data than passenger responses – which are likely to be colored by various factors – could help determine whether a passenger is carrying the ebola virus and showing ebola-like symptoms, carrying the virus but not presenting with symptoms, not infected with ebola but appearing to be sick and febrile, or neither infected nor unwell (i.e., true positives, false negatives, false positives, and true negatives).3 until we raise our standards for rapidly determining whether or not passengers are suffering from the ebola disease or have recently been infected with the ebola virus, certain personal liberties may have be relinquished. this epidemic has reached our shores and constitutes an emergency. as such, constitutional protections and civil rights, such as the right to privacy, equal protection, the right to refuse to make selfincriminating statements, and the right to be protected from searches without a warrant may have to be weighed and perhaps temporarily limited against the urgent need to prevent and control a potential global public health catastrophe. 1 http://time.com/3137031/who-ebola-exit-screenings/ 2 http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html 3 http://www.reuters.com/article/2014/10/03/us-health-ebola-screening-iduskcn0hs09j20141003 http://time.com/3137031/who-ebola-exit-screenings/ http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html http://www.reuters.com/article/2014/10/03/us-health-ebola-screening-iduskcn0hs09j20141003 winter 2015 2 + a checklist: the formula for compassion khushboo jhala follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ with my cleanly pressed short white coat, a pen planted neatly in the top left pocket above my official “medical student” id, and a fresh notepad firmly grasped between my hands, i knocked on the door. i heard the soft-spoken words, “come in,” and entered with the intention of seeing a 22-year-old female patient who, according to her chart, was hospitalized because of an anticoagulant medication overdose. she was a new admittant at the end of the day, right at 5 pm. my purpose as a third year medical student was to obtain a thorough medical history and formulate a plan of action to keep her stabilized after the overdose. as i pulled up a chair next to her hospital bed, i leaned forward and made a point to have good eye contact. i took note of her vitals and began to ask the standard questions of why she was on anticoagulant medications, what were her previous diagnoses, and why she took more than prescribed. it was already 5:45, and as i hurriedly began wrapping up the interview, i was reminded of one more thing on my mental checklist, “oh, don’t forget to be culturally competent and verbally compassionate.” i awkwardly asked a few questions from the list of kleinman questions that i was familiar with from my first two years of medical school. like many other medical schools, my institution emphasizes compassion. the theme is woven into all of our activities, from basic science courses to community volunteering. a class entitled “on doctoring” focuses on the application of skills and tools necessary for fostering compassionate and competent physicians. one of the first tools in our toolbox was a script of questions called kleinman questions. developed by dr. arthur klienman, a psychiatrist and professor of medical anthropology at harvard university, the eight questions provide a framework in which the medical provider can better explore how a patient’s culture, thoughts, and beliefs affect their understanding of their illness. these questions empower patients as active participants in the medical decision making process. examples of the questions include: “what do you fear most about your illness?” and “what are the biggest problems that your illness has caused for you?” the kleinman questions script is not the only checklist that has been created for physicians to follow in order to be more compassionate. interested in the idea of how best to teach compassion, i undertook a research endeavor as part of the schwartz fellowship sponsored by the schwartz center for compassionate healthcare. upon researching the topic, my mentor and i came upon the work of dr. helen reiss, a psychiatrist and director of the empathy and relational science program at harvard university, who developed the acronym “empathy” based on scientific translational research. in the video, introduction to e.m.p.a.t.h.y, reiss explains that, “how physicians choose to communicate can influence their patient’s neurological and physiological states.”1 the acronym empathy helps providers with compassionate communication. in the model, e is for eye contact, m is for muscles of facial expression, p is for posture, a is for affect (expressed emotions), t is for tone of voice, h is for hearing the whole person without judging and y is for your response, as people mirror each other’s feelings. what, then, is the impact of teaching nonverbal and verbal compassionate gestures to a group of medical students? a survey asking how patient interactions have gone through implementation of these techniques to our first and second year class painted the picture of an awkwardly scripted patient interview, with robotic gestures and phrases, leading to segmented interactions. simultaneously, a survey of patients’ opinions on the matter indicated that many disliked the idea that a standard template could be used to understand their individual and unique values, goals, ideas, and concerns. while one would hope that being compassionate would come effortlessly to all physicians, the scenario at the beginning presented an example of how sometimes interactions may not go so smoothly. first, while i wanted very much to be present and empathetic with my patient, she was a new admittant at the tail end of a day in which i had skipped lunch to address other patients’ concerns; the churning of my empty stomach contributed to my distraction and hurriedness. second, at a glance of her chart, i had close to no similarities that would allow me to connect with her, be it demographic, medical, personal, or any other. for many, it is difficult to pull empathy out of a hat when there is little common ground in the first place. i imagine that the initial interaction felt distant and uncomfortable to her, as she was already in a vulnerable position. despite this rough beginning, we both went through the motions of asking and answering questions. when i asked her what bothered her the most about her disease as part of my checklist, rather than telling me about medical issues, she described to me about how she felt like a burden to her already financially struggling parents. when she told me that she had never had a boyfriend, i “sustained eye contact” instead of looking at my notes. while looking at her, i could see the fear she felt of never being loved by anyone because of her disease. these were concerns that many of us have faced: the general distress of letting others down, the longing to be loved. within a matter of minutes, i became more present and the interaction seemed to flow more naturally. when i left the room, i entered the information in her chart while eating a granola bar. i brought her back a glass of water and magazine before i left for the day since she had told me that the television in her room did not work. in my view, there was absolutely nothing spectacularly compassionate about that interaction. so when i found out that she later said that the magazine was one of the most comforting and compassionate things anyone had done for her during her stay in the hospital, i was surprised. her comment made me re-examine what compassion meant, and what it was that i saw in my own personal physician care that led me to think that doctors were compassionate individuals. compassion does not come in magnificent gestures. it comes in little gestures, like bringing someone a magazine or a glass of water. how, then, does a checklist translate to compassion in the way just described? i cannot speak for how the patient felt about the kleinman questions or how my gestures were perceived. perhaps she did not feel empowered at all by the questions, and was not particularly affected by my posture. what i do know, however, is that by understanding her narrative, i was reminded that we are both human; that while i was hungry, she was scared, and that we both needed each other’s support and cooperation to make this a meaningful interaction. i did not think twice about giving her the magazine because the natural extension of that interaction was walking out of the room and thinking, “what would comfort me if i were in her position?” and that while i could not change her financial situation or the reality of her disease, “what could i do right now?” i have come to the conclusion that checklists do not foster compassion. sitting with the right posture, making the right eye contact, and asking the right questions does not in and of itself make a physician sympathetic or empathetic. rather, it is the absorption of what you observe while leaning forward and sustaining eye contact, and the listening of and responding to the answers of the questions on the checklists, that allow for meaningful relationships. while most often these things come naturally to physicians, in times of being rushed, tired, hungry, or wrapped up in the bustle of work, the checklists serve as solid reminders to be the type of doctor that each of us came into medicine to be: considerate and kind individuals. to patients, then: thank you for bearing with us through our occasional robotic routine. sometimes, compassion takes 2 + a checklist. 1 helen reiss, introduction to e.m.p.a.t.h.y. retrieved from http://empathetics.com/wordpress/wp-content/uploads/2012/06/web_intro_r1.mp4 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) © 2014 sebastian agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. should the united states sign off on presumed consent? sebastian agredo keywords: presumed consent, bioethics starting in december 2015, wales will be the first nation in the united kingdom to break away from convention and join the twenty-four european countries that have adopted presumed consent legislation to address the stagnant transplant rate and shortage of human organs. hailed by many ministers in the national assembly for wales as the “most significant piece of legislation” since the united kingdom was granted full lawmaking powers in 2011, the law hopes to alleviate the transplant list and save the lives of those who would normally die from waiting. [1] as is the case worldwide, there is a remarkable deficiency in donor organs, which fails to meet the demand for organ transplantation. in the united kingdom, the active transplant waiting list has increased approximately eight percent each year, with the aging population and rising incidence of type-2 diabetes likely to worsen the strain on the transplantation system.[2],3 support for the legislation has stemmed from the rising donation rates of other european countries, especially spain, which has the highest rate of donors per million population (pmp) in the world, attributing this trend to the adoption of presumed consent legislation. with wales being the latest country to go down the road of presumed consent, the question will inevitably rise: should the united states take a more critical look at its current system of explicit consent and “required referral” for organ donation? in light of all the available empirical data, should the united states follow suit of its european counterparts and adopt presumed consent? what are the ethical concerns regarding such a proposal; and how does the nation’s previous attitudes toward presumed consent shape the conversation? opt-out vs. opt-in presumed consent for organ donation is the systematic framework in which a deceased person’s consent to be an organ donor is assumed. those wishing not to be donors must express their objection in a national registry or a family member must object to organ donation after the person’s death. thus, presumed consent differentiates itself by being an “opt-out” system, whereas the majority of the world’s organ donation systems https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn2 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 2 are “opt-in”, requiring an individual to register their intent as organ donors. advocates of presumed consent often point to the successes of european nations such as spain, belgium, and austria, highlighting how their donation rates significantly increased after the implementation of presumed consent. while spain’s donation rate of 34.8 pmp is certainly remarkable on a global scale, 2,[3] it is necessary to undertake a systematic review of the empirical data in order to arrive at any assertive conclusion as to presumed consent’s potential for use in the united states. in addition to the umbrella terms “presumed consent” or “opt-out” system, legislation can vary between countries, leading to the use of additional terms such as “hard” and “soft” to characterize the degree of emphasis placed on the views of the decedent’s relatives.2 for instance, in spain physicians must take active steps to make sure that the decedent’s family does not object to the procurement of their organs. therefore, the presumed consent law in spain is “soft.” this is in direct contrast with the case in austria where procurement will proceed under all circumstances, barring evidence of the decedent’s objection before death. the law in this case is relatively “hard” because the family is not consulted by doctors about their own objections to organ extraction. irrespective of the “soft” or “hard” terminology, both forms of presumed consent have seemingly proven to be significant factors influencing the organ donation rate. before the enactment of the legislation, the austrian donation rate was 4.6 pmp. within four years the rate increased to 10.1 pmp, and five years later the rate was 27.2 pmp. three years after the adoption of presumed consent legislation, belgium saw a rate increase from 18.9 to 41.3 pmp; and singapore also saw an extraordinary increase from 4.7 to 31.3 pmp over a three-year period. in 1989, spain’s donation rate was similar to that of the united kingdom – 14 pmp – and over the past twenty years the rate has climbed to its current levels. to further contrast the united kingdom and spain, the rate of families refusing to give consent to organ removal has dropped to 15 percent in spain, while the refusal rate in the united kingdom still sits at approximately 40 percent, which is an attributing factor to the lagging donation rate overall. [4],[5] learning from the spanish experience have these notable increases in the rate of deceased organ donation simply resulted from the implementation of a presumed consent law? or are there other factors that are hiding behind the numbers? the facts tend to favor towards the latter. for example, the jump from 10.1 to 27.2 donors pmp found in austria is not only because of the presumed consent law. rather, the five years that reflect this increase was a time of focused improvement upon the country’s transplantation infrastructure, which included the training of full-time transplant coordinators.2,[6] in addition, spain’s rate increase was only measured a full ten years after the spanish government passed the presumed consent legislation. from 1979 to 1989, the donation and refusal rate did not change much relative to the other european nations.2,4 it was in 1989 that spain comprehensively reformed its organ procurement system, which included a number of innovations. in spain, the defining characteristic of the innovations is the placement of transplant coordinators at every procurement hospital—these coordinators have a unique educational profile that helps them quickly identify potential donors. many coordinators are intensive care physicians that play increasingly active roles in the organ procurement process, such as approaching the potential donor’s family and checking for potential donors in and out of the intensive care unit on a daily basis. because transplant coordinators are not members https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn3 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn4 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn5 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn6 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 3 of the transplant team, but rather part of the in-house hospital staff, they can be placed throughout the country and especially in hospitals that have lower rates of deceased organ donation.4moreover, the coordinators are trained and organized by a central agency, the organización nacional de transplantes, which provides regular courses on the organ procurement process. this model has led to more than 11,000 medical professionals being trained as coordinators since 1991. 4 thus, it was not the new presumed consent law by itself that triggered the rise and steady maintenance of a high donation rate but a widespread overhaul of how potential donors were identified in the places they are most likely to be found: the intensive care unit. the systematic review of various studies conducted by rithalia et al. also indicates that a number of other factors have a positive impact on the donation rate. the most obvious component of an increased donation rate is the availability of potential donors. without a sizeable and renewable pool of donors from which to procure organs, the donation rate will remain stagnant and will fail to respond as the need increases. interestingly, three studies conducted in organization for economic cooperation and development (oecd) countries considered the mortality rate from road traffic accidents and showed a significant correlation with donation rate.2 additional studies illustrated that wealth and healthcare expenditures, measured in gross domestic product (gdp) per capita and health expenditure per capita, were strong predictors of high donation rates. 2 a review of european countries by gimbel et al. also discovered that the percentage of the population enrolled in third-tier education, used to assess the influence of social demographics on donation rates, had a significant positive association.[7]finally, there was an overall favorable relationship between the percent of the population that identified themselves as roman catholic and the donation rate.7,[8] this result is consistent with the popular suggestion that catholicism tends to have more encouraging attitudes toward organ donation, recognizing it as a “service of life.”2 these statistics and correlations drive home the sentiment that presumed consent in and of itself cannot account for the rise in donation rates in european countries. nor is the adoption of a presumed consent law a guarantee that the country will achieve high donation numbers.[9] this is further exhibited in greece, where despite “presumed consent” legislation the donation rate remains at 6.9 pmp; thus supporting the argument that economic and social factors have influential roles to play.[10] conclusions such as these certainly make the case that presumed consent is not the sole predictor for improving the donation rate. evaluating, understanding, and reforming the underlying economic and social circumstances hold great promise in changing the trend of organ donation. what presumed consent could provide, however, is a framework for expanding the availability of potential donors.[11] with a national survey finding a disparity between the number of americans willing to donate organs and the number who are currently registered as donors,[12] the discussion concerning the adoption of presumed consent takes on a more significant role and scholars have urged for this change.[13],[14],[15] in the united states, the donation rate is 26.1 pmp,[16],[17] placing it fourth worldwide.9 yet, the waiting list for organ transplants has exceeded 122,000 and is anticipated to grow roughly 10 percent each year, which results in thousands of people dying while waiting for an organ.[18]this is all despite the fact that more than 28,000 transplants are performed each year in the united states, more than any other country.16 these facts are what drive the debate in the direction of presumed consent, for if the country is to save as many people as possible who are currently waiting on the transplant list, then legislators believe that presumed consent holds the key to reforming the decades-old “opt-in,” explicit consent model. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn9 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn10 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn11 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn12 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn13 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn14 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn15 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn16 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn17 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn18 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 4 philosophical arguments promoters shape their arguments around the need to fundamentally change the american assumption that “absent specific notification to the contrary, decedents are best protected if we act as though they had autonomously willed that their organs not be donated for transplantation.”14 this is precisely the principle governing explicit consent for organ donation, in which a person during their lifetime, or a family member after their death, must clearly express the will to donate the organs. cohen argues that this ideology should be reformed and replaced with the notion that the best way to protect the autonomous wishes of the deceased would be to assume that they would have willed for their organs to be used for “beneficial medical uses.” furthermore, he espouses the “hard” form of presumed consent, stating that no permission should be sought from anyone in the absence of express refusal from the deceased. the basis for cohen’s reasoning lies in his appeal to the moral argument: it is morally just—not only for the decedent, but also for the members of society who need organs—to remove the organs from the majority of individuals who would have wanted to donate their organs but left behind no indication of that wish. it is therefore morally unjust to violate their wishes and bury them with all their organs intact inside their bodies. cohen characterizes this as a breach of autonomy; a breach that only a presumed consent policy would rectify, resulting in an increase in the number of decedents whose wishes are respected. veatch and pitt counter cohen’s claims by asserting that presumed consent is morally unacceptable because it results in the violation of a person’s fundamental right to be able to autonomously choose what happens to his or her body after death.[19] whereas cohen’s majority would have wished to have their organs removed, veatch and pitt’s minority prefer not to have their organs removed after death. if presumed consent were instated, then it would be easy to assume that many in the minority would fail to properly indicate their desire not to donate, much like the many in the majority who fail to properly indicate their desire to donate. what would result are instances in which individuals who wished to be buried with all their organs inside their body would have their organs removed. veatch and pitt posit this as a far more egregious violation of autonomy than the one found in cohen’s argument. the current system of explicit consent, therefore, is in a better position to protect autonomy and respect the wishes of those who do not wish to donate. michael gill attempts to reconcile the two sides of this debate, ultimately reaching the conclusion that presumed consent provides the most morally acceptable solution. he starts by acknowledging that mistakes will be made in either consent scheme. regardless of how well explicit consent is instituted, there will be cases where those who wished to donate their organs will be buried with their organs intact. similarly, regardless of how well presumed consent is instituted, there will be cases where those who did not wish to donate are buried with their organs removed. gill emphasizes the moral duty to respect a person’s wishes concerning his or her body, but asserts that violating this duty by either mistakenly removing or not removing organs is equal. both of these mistakes fail to bring about the “state of affairs the individual desired.” with the moral gravity of these mistakes being equal in gill’s view, the moral question then becomes: which consent scheme minimizes the moral harms and maximizes the moral benefits? it becomes easy to see from this line of thinking that the ethical fortitude sides with presumed consent, which is prone to make fewer mistakes than explicit consent. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn19 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 5 how does the united states fit in? although gill’s conclusion would certainly appease those fighting for the implementation of presumed consent, his notion is meant for a country with a stronger communitarian ethic; one in which the tenets of utilitarian moralism outweigh those of individual autonomy. such a policy, however, goes “against the grain of american individualism.”13 as orentlicher states, the united states has actually tried presumed consent on a limited basis for the past forty years, and it failed because it went either too far or not far enough. in allowing family members to overrule the presumption that the decedent would have preferred donation, presumed consent did not go far enough. this deference to the family in regard to organ donation never allowed presumed consent to surpass the real reason why decedents do not become organ donors, namely the refusal of family members to give consent.13 this is akin to the kind of “soft” presumed consent found in spain. spain places great importance upon the fact that death is not an isolated event involving the deceased, but instead engages the whole family. spain realizes that any organ procurement system relies on the trust that exists between the patient’s family and the physicians or transplant coordinators. undermining that trust would completely damage the entire organ donation process. this serves to highlight spain’s accomplishment in keeping the refusal rate so low at 15 percent; which is achieved mainly through its extensive training of transplant coordinators, lack of donor registry , and enhanced capacity to identify potential donors.4 in essence, the spanish model succeeds without much need for presumed consent. according to orentlicher, presumed consent in the united states went too far in regard to the fact that public officials attempted to bypass family members in an effort to avoid the possibility of family refusal. such attempts only exacerbated concerns and fears that physicians would harvest organs from those who would not have wished for their removal. starting in the late 1960s, state legislatures passed measures that authorized the removal of corneas, pituitary glands, and sometimes even hearts, lungs, kidneys, and livers if the decedent’s body came under the custody of a medical examiner or coroner. the lawmakers’ reasoning was rather simple – since the body of these individuals would already be subjected to a major intrusion in the form of an autopsy, then removal of an organ for the benefit of living persons was acceptable. this practice was supported and reinforced by the 1987 uniform anatomical gift act, but has since been discarded since the document’s 2006 revision and adoption by a vast majority of states.13 therefore, the largest hurdle for presumed consent to conquer is that of public perception and attitudes against it. because the registration process varies from state to state, many state legislatures have tried to bring up the issue of presumed consent, proposing opt-out systems. these have never gotten very far due to concerns about individual rights—another testament to the importance of autonomy, which is present in american minds. for example, colorado tried to pass an opt-out law in 2011, but the lawmaker who introduced the bill was forced to pull it due to negative reactions from the public.10 there has been abundant skepticism about the possibility of presumed consent as a solution to close the organ gap that exists in the united states.11,[20] researchers have concluded that despite the substantive differences in the laws themselves, presumed consent, in countries like spain, does not differ dramatically from the application of explicit consent in the united states. in both the united states and spain, primacy is given to respecting the wishes of the individual and the family. if anything, the experience in spain has shown that https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn20 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 6 what can truly improve the donation rate is diligent attention to the infrastructure of the organ transplantation system, using it to quickly and efficiently identify patients in the intensive care unit who are potential donors and taking the necessary steps to ensure that the organs are procured ethically and respectfully once death occurs. with respect to the procurement system currently in place in the united states, legislation was introduced by the surgeon general that legally requires all hospitals to identify and refer potential donors to an organ donor organization.3 potential donors are identified using clinical markers that are present in patients likely to be diagnosed as brain dead, and organ donor organizations are well-staffed with an extensive network of trained organ coordinators. alternatives to presumed consent comparatively, the transplantation environment of spain and the united states is very similar. what is lacking, then, in the united states is not the adoption of presumed consent, but a method of improving the family refusal rate. this can be achieved through public policy that aims to increase the likelihood that individuals will document their wishes. family members who are aware and confident in the decedent’s wish to donate his or her organs after death are more likely to respect these wishes and consent to organ procurement upon request. orentlicher suggests that if everyone willing to donate were to officially register, then organ donation rates could increase by as much as 50 percent.13 efforts such as the hero act in new jersey have taken the initiative by mandating that new jersey public schools provide information about organ and tissue donation and that material be included in the state’s core curriculum content standards for comprehensive health and physical education for grades 9–12.[21] the goal is to ensure that all residents have the “fundamental responsibility to choose whether to help save another’s life.” overcoming high refusal rates can also be done by combating the misconceptions that seem to be at the root of the refusals,13 such as the notion that organ donation violates certain religious ideals or that donation would affect the body’s appearance at an open casket funeral. motivated physicians dedicated to the cause of organ donation have been the key for success in spain,4and as such, physicians in the united states must develop the skills to delicately approach families. gortmaker has found that this is best realized when the discussion about the patient’s death is separated from the discussion about organ donation, when organ procurement professionals join with hospital staff in the donation discussion, and when the request for donation takes place in a quiet, private setting.[22] procurement professionals have also begun utilizing a “presumptive approach” when discussing organ donation with families, which is an approach that takes on a more value-positive tone and strives to encourage the family to consent to donation.[23] application of strategies such as these may see refusal rate in the united states drop significantly, altering the transplantation landscape in ways that presumed consent legislation simply could not. in all, the talk about presumed consent seems to have taken a back seat since its abandonment in the latest version of the uniform anatomical gift act and public sentiment has proven to be a difficult obstacle to clear in recent years. although it may always seem like an attractive solution to an issue that is at the forefront of medicine, the data illustrates that presumed consent is not what the united states is clamoring for. it begs for a solution that makes use of the current organ procurement infrastructure, expands the base of information available to potential donor registrants, and continues to build upon the trust between families and hospitals. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn21 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn22 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_edn23 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 7 references [1] bbc news wales. “organ donation: presumed consent to start in december 2015.” september 10, 2013. [2] amber rithalia, catriona mcdaid, sara suekarran, lindsey myers, and amanda sowden. “impact of presumed consent for organ donation on donation rates: a systematic review.” british medical journal, 2009. [3] simon bramhall. “presumed consent for organ donation: a case against.” annals of the royal college of surgeons of england, 2011: 268-272. [4] john fabre, paul murphy, and rafael matesanz. “presumed consent is unnecessary.” british medical journal, 2010: 922924. [5] european union directorate-general for health and consumers. “key facts and figures on eu organ donation and transplantation.” 2010. [6] m.f.x. gnant, p. wamser, p. goetzinger, t. sautner, r steininger, and f. muehlbacher. “the impact of the presumed consent law and a decentralized organ procurement system on organ donation: quadruplication in the number of organ donors.” transplantation proceedings, 1991: 2685-2686. [7] gimbel, rw, ma strosberg, se lehrman, gefenas e, and f taft. “presumed consent and other predictors of cadaveric organ donation in europe.” progress in transplantation, 2003: 17-23. [8] neto, giacomo balbinotto, ana katerina campelo, and everton nunes da silva. “impact of presumed consent law on organ donation: an empirical analysis from quantile regression for longitudinal data.” latin american and caribbean law and economics association annual papers, 2007. [9] remco coppen, roland friele, richard marquet, sjef gevers. “opting-out systems: no guarantee for higher donation rates.” transplant international, 2005: 1275-1279. [10] sydney lupkin. organ donation rates: how the us stacks up. june 18, 2013. http://abcnews.go.com/health/organ-donation-rates-us-stacks/story?id=19437070# (accessed may 5, 2014) [11] alberto abadie and sebastien gay. the impact of presumed consent legislation on cadaveric organ donation: a cross country study. working paper, cambridge, ma: national bureau of economics research, 2004. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref2 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref3 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref4 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref5 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref6 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref9 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref10 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref11 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 8 [12] astellas pharma us, inc. survey finds disconnect between number of americans willing to donate organs and number currently registered as donors. april 15, 2013. http://newsroom.astellas.us/news-releases (accessed may 3, 2014). [13] david orentlicher. “presumed consent to organ donation: its rise and fall in the united states .” rutgers law review, 2009: 295-331. [14] carl cohen. “the case for presumed case to transplant human organs after death.” transplantation proceedings, 1992: 2168-2172. [15] gill, michael b. “presumed consent, autonomy, and organ donation.” journal of medicine and philosophy, 2004: 3759. [16] donate life california. presumed consent: an attractive concept with unattractive results. may 8, 2014. http://donatelifecalifornia.org/education/faqs/presumed-consent/ (accessed may 8, 2014). [17] howard m. nathan, suzanne l. conrad, philip j. held, keith p. mccullough, richard e. pietroski, laura a. siminoff, akinlou ojo. “organ donation in the united states.” american journal of transplantation, 2003: 29-40. [18] u.s. department of health and human services. organdonor.gov. may 8, 2014. http://www.organdonor.gov/index.html (accessed may 8, 2014). [19] rm veatch and jb pitt. “the myth of presumed consent: ethical problems in new organ procurement strategies.” transplant proceedings, 1995: 1888-1892. [20] bj boyarksy, ec hall, na deshpande, rl ros, ra montgomery, dm steinwachs, dl segev. “potential limitations of presumed consent legislation.” transplantation, 2012: 136-140. [21] new jersey driver education. for organ/tissue donation. http://www.njdrivereducation.com/organ-donation (accessed may 7, 2014). [22] steven l. gortmaker. "improving the request process to increase family consent for organ donation." journal of transplant coordination, 1998. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref12 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref13 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref14 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref15 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref16 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref17 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref18 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref19 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref20 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref21 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref22 agredo, should the united states sign off on presumed consent, voices in bioethics, vol. 1 (2014) 9 [23] robert truog. "consent for organ donation balancing ethical obligations." new england journal of medicine, 2008: 1210-1211. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/should-the-united-states-sign-off-on-presumed-consent#_ednref23 belisomo, cms amends prior authorization drug policy, voices in bioethics, vol. 1 (2014-15) © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. facing pressure from hospices, cms amends prior authorization drug policy randi belisomo cms, hospices, policy revision introduction under pressure from hospices nationwide experiencing financial and administrative strain, the centers for medicare and medicaid services has revised its own guidance that was intended to help avoid duplicate payments for prescription drugs. this change comes two months after the cms rule’s effective date; months in which, providers say, access to end-of-life care was jeopardized. ____________________________________________________________ belisomo, cms amends prior authorization drug policy, voices in bioethics, vol. 1 (2014-15) 2 i. policy revision in may, cms began to require a prior authorization process for hospices and medicare part d providers in order to determine responsibility of drug coverage. hospices were charged with covering medications not related to the hospice, or terminal, diagnosis. previously, hospices paid only for drugs needed for symptom management, and part d policies covered medications for hospice patients’ unrelated conditions. “based on discussions with stakeholders, we are adjusting our rules so that beneficiaries enrolled in hospice will continue to have access to their medications while balancing recommendations by the inspector general meant to safeguard the medicare program,” said raymond thorn of the cms office of communications. the office of the inspector general had recommended the policy’s implementation to minimize mistakes in which part d plans covered hospice drugs. however, the more than 40 healthcare organizations and hundreds of hospice providers that have lobbied against the rule in recent weeks maintain it unduly burdened beneficiaries, requiring dying patients to navigate payer disputes. “cms listened when they convened all the various stakeholders, and heard a unified message focused on protecting beneficiaries from an onerous and insensitive prior authorization process,” said jonathan keyserling, senior vice president of the national hospice and palliative care organization. “the announcement of significant modifications in the previous guidance will greatly relieve the stress that patients and families, as well as providers, were experiencing under the prior flawed process.” under the revised policy, cms expects part d sponsors to use hospice prior authorization only on four drug categories typically covered under the hospice benefit – analgesics, anti-nauseants, laxatives, and anti-anxiety medications. “barriers to access should be minimized,” thorn said, as the number of these claims is expected to be minimal. ii. implications providers say the original guidance lengthened admission processes and they maintain it often deterred patients from hospice support if medications taken for decades, psychiatric drugs for example, would not be covered upon enrollment. “we had changed our admission documentation, and we were starting to have those conversations with new admissions,” said greg zrazik, chief financial officer of angels grace hospice in chicago’s southwest suburbs. “we have been looking at the drugs, trying to determine what we felt we would pay for, what would be paid for by part d and aggressively looking at things they could consider stopping or could pay for themselves.” angels grace has experienced a 30 percent uptick in drug costs since the rule took effect. serving 45 patients a day, the hospice experienced a “huge burden” that threatened its financial future – average daily medicare hospice reimbursement is $160. “this puts things back to if hospices are doing the right thing, we would certainly recommend a patient come off of drugs that aren’t appropriate,” zrazik said. “but we don’t have to be aggressive, or make patients make difficult decisions.” hospices may realize instant efficiency as a result of this revision, providers say. belisomo, cms amends prior authorization drug policy, voices in bioethics, vol. 1 (2014-15) 3 “we don’t have to be focused so much on the rigmarole of all the paperwork, and instead we can think more about what the patient and family needs and spend time with them,” said martha twaddle, medical director of journeycare, a hospice serving 500 patients daily across northern illinois. “time and personnel are the most important resources a hospice has,” said twaddle, “and the extra work the guidance required was threatening the long-term sustainability of quality bedside care. conclusion the tone of the cms guidance and the agency’s willingness to reverse course are encouraging to end-oflife care providers. “if we are going to do good care for americans, we have to be working together, changing models of delivery, and be willing to change ourselves,” twaddle said. “this is a fabulous sign.” zimmerman, economics and the value of human life, voices in bioethics, vol. 6 (2020) *anne zimmerman, jd, ms bioethics candidate, 2020 © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. economics and the value of human life: the priority narrative in public health ignores secondary health effects influenced by the economy anne zimmerman* keywords: public health, health and economics, social determinants, bioethics, introduction covid-19 politics have centered around a priority narrative: in the short-term all must sacrifice to save some lives. based on the set priority, public health experts and the media portrayed those questioning social distancing, business closures, and stay-at-home orders as indifferent or even hostile toward the lives of the elderly or vulnerable. yet the public health policies came with a well-documented economic cost. economists readily discuss the economic consequences in macroeconomic terms like lost gdp, unemployment figures, and business closures. personal economic stories of unemployment and financial losses are emerging. job loss is associated with physical conditions including hypertension and other physical vestiges of emotional stress. the priority narrative should have accounted for a mitigating factor: health problems due to secondary health effects of public health policies. saving lives from covid-19 is crucial -limiting incidental physical and economic damage would prevent a pyrrhic victory and present a unifying message. analysis the priority narrative, prevalent in march and april, assigned everyone the same priority: saving lives in the short term. for the wealthy and upper middle class, the goal was easy altruism. savings accounts were plentiful. in some cases, vacation homes replaced city apartments and the shift to earning high incomes from home was smooth. a focus on mental health and on being one’s best quarantine self (daily yoga and meditation, being patient parents, and eating health foods) was trending on social media. for others, the secondary health effects that stem from economic problems may last longer than the economic problems themselves. a lack of income and savings increases reliance on low-priced, low-quality foods. a lack of access to medical care for the uninsured and underinsured leaves some avoiding necessary care for ongoing medical conditions. the poor and struggling middle class held mixed views of the priority zimmerman, economics and the value of human life, voices in bioethics, vol. 6 (2020) 2 narrative. their health and livelihood were at stake, so they evaluated stay-at-home orders in personal economic terms. they weighed health risks and economic risks, although little choice existed for essential workers unable to work from home. the rural population tended to protest stay-at-home orders for ideological reasons like civil liberties and the urban poor and middle class living in close quarters were more supportive. many essential workers needing to use public transportation recognized that encountering fewer people would be safer. rural work in crowded meat-packing plants also proved unsafe. those protesting stay-at-home orders touted civil liberties and economic freedom, a priority that conflicted with the public health priority narrative. in some states, the economic priority narrative was mainstream, especially in states that embraced ideological objections to restrictions imposed to prevent transmission. florida, where the economic priority narrative shaped public policy, is seeing a rapid increase in cases of covid-19 and related deaths. those prioritizing their own ability to earn money are accepting the risk of covid-19. (vice news did a great story about destin, florida.) many government officials struggled to follow public health advice while under local pressure from business owners and workers. while public health experts rightly do not weigh money against human life, initial measures should have weighed secondary health problems caused by economic strife against covid-19 risk. it was predicted some would suffer emotionally; a higher suicide incidence is suspected. in areas where food pantries had lines around the block, public health officials should have begun crunching numbers on health detriments caused by a long-term lack of fresh foods, an inability to pay bills, and possible housing insecurity. time was the balancing factor. learning more about covid-19 transmission and risk helped the economic narrative and acted as a check on the priority narrative. masks and social distancing became viable options to a complete shutdown. while the shutdown was necessary and should have taken place sooner and lasted longer in certain areas, the dialogue that focused on one priority should change for future pandemic preparation. a public health narrative that suggests everyone take an equal hit for the sake of the vulnerable and that measures health problems and deaths not just from covid-19 but from depression, lack of resources, and diseases of stress and poverty would be more convincing and unifying. the comorbidities i addressed at the very beginning of the pandemic are leading causes of death in the us. if public health experts want a unifying role, they should create a system that ensures there will not be an increase in chronic health conditions while guaranteeing that economic burdens will be shared. if public policy improved conditions based on the social determinants of health, it would create a level playing field. the following policies have the potential to minimize hardship: • subsidizing employers so that employees remain employed. many us employers fired people to allow them to collect unemployment. • ensuring gig economy workers have insurance. instacart and shipt are doing very well in part because people turned to them to earn money—their shoppers, like uber drivers, should receive insurance benefits from their employers. in our healthcare system, absent a health insurance mandate, definitions of employee must be broad and enforced. • encouraging actual health—this includes prohibiting lobbyists from influencing government health recommendations (food pyramids) and eliminating subsidies for the least healthy foods like corn for corn syrup; creating a food cost structure that reflects cost of production and subsidizes only the most healthy foods; and, publicizing the ability of food and lifestyle choices to improve health very quickly. conclusion socioeconomic status, education, physical environment, and social supports all influence health. poverty, poor living conditions, air pollution, and a lack of lead-free clean water cost lives. the health effects of financial hardship are exacerbated by the government’s failure to address the social determinants of health. the priority narrative of saving lives of those currently vulnerable to covid-19 may have more acceptance if we recognize that saving the lives of the constantly vulnerable matters too. foe, are you and your significant other compatible?, voices in bioethics, vol. 1 (2014-15) * gabriella foe, ms bioethics © 2014 gabriella foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. are you and your significant other compatible? gabriella foe* keywords: bioethics, ethics, genetics, genes, heritability introduction compatibility is of great importance when it comes to relationships. after all, every match-making website asks many questions, from personality types to habits to pet peeves, in order to determine whether or not two people will be a good match. but there is another type of compatibility criteria that is becoming increasingly important: your genetic material. theperfect46 is a genetics company that claims to determine whether you are with “the one,” according to your genes. they focus on ensuring that your offspring will be free from known genetically heritable diseases. ____________________________________________________________ foe, are you and your significant other compatible?, voices in bioethics, vol. 1 (2014-15) 2 analysis does this sound plausible? very much so—but not yet. theperfect46.com is not a real company’s web-page, but a site to promote the film the perfect 46. this film raises many relevant ethical issues that our society will have to face in the near future. how much responsibility, if at all, do we owe the future generation to ensure that they are free of known genetically heritable diseases? is this another form of eugenics? are we playing god? how much should we consider genetic compatibility when choosing our significant other? is there a duty to consider it at all? conclusion these are all important questions that our society will have to answer as genetic technology rapidly advances to do what was thought to be impossible not too long ago. where is the boundary? how should it be determined? this film has been released in the united kingdom and parts of united states. it will be shown in new york city on may 19, 2014 at the soho international film festival. check it out and let us know your thoughts and opinions! references manaster, joanne, “the perfect 46: the future is near,” scientific american, http://blogs.scientificamerican.com/psi-vid/2014/04/21/the-perfect-46-the-future-is-near/ the perfect 46, http://theperfect46.com/index.html soho international film festival, “2014 calendar of events,” http://www.sohofilmfest.com/2014_season.php http://blogs.scientificamerican.com/psi-vid/2014/04/21/the-perfect-46-the-future-is-near/ http://theperfect46.com/index.html http://www.sohofilmfest.com/2014_season.php belisomo, respecting choices, voices in bioethics, vol. 1 (2014-15) © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. respecting choices: financial facts and figures randi belisomo abstract respecting choices, an advance care planning program developed in lacrosse, wisconsin’s gundersen health system and highlighted in a previous column, engages patients in informed discussions about end-oflife decision-making. its aim is the establishment of effective systems that allow individuals to consider future medical situations and have their personal values and goals respected if they may one day be unable to speak for themselves. bioethics, end-of-life, decision-making introduction respecting choices, an advance care planning program developed in lacrosse, wisconsin’s gundersen health system and highlighted in a previous column, engages patients in informed discussions about end-oflife decision-making. its aim is the establishment of effective systems that allow individuals to consider future medical situations and have their personal values and goals respected if they may one day be unable to speak for themselves. however, the program’s association with a lower utilization of acute care services is drawing the attention of healthcare administrators and policymakers at multiple levels, and the culture of silence regarding the costs of end-of-life care seems to be changing. programs such as this one are proving that the identification, documentation and honoring of patient preferences at the end-of-life results in both reduced spending and use of resources within health institutions. patients are receiving the care they request, and health systems are cutting costs. ____________________________________________________________ belisomo, respecting choices, voices in bioethics, vol. 1 (2014-15) 2 ii. financial facts and figures health spending at the end-of-life has been cited as wasteful, exorbitant, and often unwanted by the patient receiving the care. in keeping patient preferences at the center of all decision-making, the cost savings of respecting choices are telling, and its designer, bud hammes, calls it “a blessing and unexpected event.” according to dartmouth atlas, gundersen’s average reimbursement per patient in the last 24 months of life was $18,359 – a figure nearly $7,500 less than the u.s. hospital average of $25,860. hospital days per patient in the last two years of life averaged 13.5 days; that number is half the u.s. average of 23.5 days. evidence reveals that when asked, most do not wish to spend their last days and weeks receiving highintensity care. when end-of-life preferences are known and subsequently respected, unwanted tests, treatments and hospital days are reduced. expensive resources with no benefit are avoided, and overall costs decline. these costs matter now more than ever, hammes says, citing the current shift from a fee-for-service healthcare payment system as a reason interest in respecting choices implementation is growing. “now, organizations are being held more accountable for quality of service,” hammes says. “if they can provide high quality care providing fewer services, there’s clear incentive. the respecting choices model fits with this new payment system perfectly.” that win-win has made respecting choices the recent focus of national media attention, as the model is sprouting across the country and globe. internationally, hammes has been behind program development in australia, singapore and germany. closer to home, kaiser permanente is implementing respecting choices system-wide, and medical societies in wisconsin and minnesota have spearheaded state-wide projects. in early september, respecting choices facilitator training begins in richmond, virginia. pilot sites in three health systems there are slated to open in early 2015, which is when the south carolina medical association plans to roll out a preliminary phase of respecting choices in six hospital systems. iii. local programs: financing and implementation as fees to implement respecting choices range from $190,000 to $500,000 – a figure tied to size and speed of start-up – those establishing such advance care planning programs are not seeking immediate payoff. “healthcare is a business, and it has to look at the cost of doing things – training staff, redesigning systems, facilitation of the conversation – all of that has cost,” hammes says. “so you have to look at what is the value of this work.” the answer to that, he says, is clear. “the primary purpose is not to save money, but to prepare families to make critical decisions. in doing so, we improve care.” those currently seeking to do just that offer possible funding models for others considering implementation. a. minnesota when twin cities medical society members voted to implement respecting choices in 2008, they were seeking a project to make their own; the desire to improve end-of-life care resonated throughout the belisomo, respecting choices, voices in bioethics, vol. 1 (2014-15) 3 organization and the community surrounding it. “this is universal, and everybody has dealt with a good death and a bad death,” says sue schettle, ceo of the twin cities medical society. “the notion of patient-centered care and shared decision-making is wonderful, and everyone knows we can be doing a better job at this.” the society’s foundation and four influential ceos in minneapolis-st. paul contributed $25,000 each, and “honoring choices minnesota” launched with $125,000 in the bank. hammes and gundersen colleagues flew in and got to work. as hospital-based pilot sites opened at a rate of about six a year, a fundraising dinner in 2009 secured $150,000 more. facilitators are now in place in community centers, senior service organizations, and health clinics. “it’s sort of gone viral,” schettle says. the initiative has since partnered with public television and planned a three-year public engagement strategy. additionally, about a dozen more funders were identified, including private insurance companies. about 1700 advance care planning facilitators have been trained so far, and roughly 35 percent of residents report having an advance directive – a figure above the national average. “all health systems in town knew we could do end-of-life care better,” schettle says. ”the competitive nature of health systems can be put aside on this issue, and we can do it better. we’re in it for the long haul.” b. wisconsin though the respecting choices model was developed more than two decades ago in southwest wisconsin, it was minnesotan success that drew the attention of healthcare leaders in madison. the 12,000-member wisconsin medical society launched “honoring choices wisconsin” in the fall of 2012, training 60 facilitators from primary care clinics across six health systems in the milwaukee-madison corridor. “getting health systems to collaborate was not too difficult,” says john maycroft, director of policy development and initiatives. “what is difficult is helping organizations set up systems and workflows to make sure these conversations are routinely offered, scheduled, had, documented and entered in the medical record. you have to have full support to make sure everything works.” maycroft is measuring the number of conversations offered, how many patients agree, how many conversations take place and the number of advance directives completed. so far, about three thousand facilitated dialogues have occurred as a result of “honoring choices wisconsin.” private insurers provide a substantial portion of the initiative’s $350,000 annual budget. humana, united healthcare, unity health insurance and wps health insurance are among those supporting the effort. “honoring choices wisconsin” employs three full-time staff: a program lead, a program coordinator, and a community outreach coordinator. community groups, clergy and senior service organizations will be key in the initiative’s continued success. “we found an incredible amount of pent-up energy, because people have come out of the woodwork to help,” maycroft says. “we thought we could do it, and we were willing to work really hard to make it happen. so far, it looks darn good.” c. virginia the richmond academy of medicine has contributed the first $100,000 into a trust for this fall’s respecting choices facilitator training, beginning within three health systems on september 8th. each participating organization is contributing the same amount for program development. when academy members initially voted to lead such a project, neither financial costs nor incentives were broached, says executive director deb belisomo, respecting choices, voices in bioethics, vol. 1 (2014-15) 4 love. “they wanted to do the best thing possible for the patient and family,” she says. such support had been brewing within the 2,300-member academy for two years, since a physician member addressed colleagues with concerns about late hospice referrals. as the conversation continued, love says members “were not just talking about physicians needing education to do earlier referrals, they were talking about a community education project.” the academy then convened a community meeting, inviting hammes to speak to more than one hundred end-of-life care “stakeholders” in the state capital. when the respecting choices model was received enthusiastically, the academy gathered a fifteen-person advisory board of nurses, social workers, chaplains, lawyers, and physicians. support was unanimous, and agreement upon such a centralized approach to advance care planning was reached among three typically competitive health systems. thirty employees in all will initially receive facilitator training, establishing three pilot sites within each of the three health systems they represent. advance care planning sessions will be offered to patients starting in january, 2015. six months later, a second series of pilots are slated to open. by the end of next year, love says efforts will have shifted from the hospital and into richmond’s diverse communities. “we want to train an army of facilitators that are respected in their spheres of influence to carry this message forward,” she says. whiteman, for everything a season, voices in bioethics, vol. 1 (2014) © 2014 bob whiteman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. for everything a season bob whiteman robert g. whiteman ("bob") was a graduate of the columbia university bioethics program and this featured article is in memory of him, commemorating his enthusiasm and dedication to the program. “no man is an island entire of itself…any man's death diminishes me, because i am involved in mankind. and therefore never send to know for whom the bell tolls; it tolls for thee.”[a] across the span of history, death has always been imbued with cultural importance. we are all grounded in the deep individual desire to retain control over our lives and bodies. why should we be any less desirous of maintaining a dignified control over that time when we are to depart our lives? as dworkin suggests: “death has dominion because it is not only the start of nothing but the end of everything, and how we think and talk about dying—the emphasis we put on dying with ‘dignity’— shows how important it is that life ends appropriately, that death keeps faith with the way we want to have lived.”1 the ineluctable truth that “there is a time to be born and a time to die”[b] has presented challenges to medical science to push back the moment of death for millennia. not much more than a generation ago, the principle tool of life extension was the respirator which more often than not lost out to the processes of disease and organ failure. today, the ability to sustain biological life beyond useful or even cognitive purpose raises questions about when enough is enough—is medical science prolonging the process of living or prolonging the process of dying? this creates a legal and ethical question of what happens when a physician believes that continuing a current treatment will neither cure nor benefit the patient and wishes to discontinue such treatment but the patient or the family members disagree with the physician’s determination and proposed course of action.2 the concept of “futility” arose as an attempt to resolve or to avoid disputes like this and reflects a perceived need by doctors to limit patient or family autonomy and justify a decision withdraw or not initiate life-sustaining medical treatment (lsmt).3 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftn1 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_1 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftn2 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_2 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_3 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 2 medical futility the central issue in most futility cases is not whether it is possible to extend the patient’s life but whether the life should be extended. such disputes involve “moral conflicts concerning our most deeply held beliefs about the value of life, about which there inevitably are diverse and incommensurable views within a pluralistic society.”4the dispute over the legal duties owed to patients requesting lsmt judged futile by doctors has proven intractable and reached a bioethical stalemate because no consensus has emerged regarding what constitutes “futile” medical treatment.5 while there have been many attempts to define medical futility as a form of professional, scientific assessment, none have been universally accepted as an objective test and “futility still remains inherently and unavoidably subjective.”6 historically, the concept of medical futility is present in hippocratic writings, which suggested three major goals for medicine: cure, relief of suffering, and refusing to treat those who are overmastered by their diseases. however, the extraordinary advances in medicine over the last several decades particularly the development of cardiopulmonary resuscitation, which ultimately caused death to be redefined, both patients and physicians could legitimately question what it meant to be “overmastered” by illness.7 what is futile care? this is a highly complex and emotionally charged question with no easy or always satisfying answer. in fact some intensive care unit (icu) workers believe the term futile care “should be expunged” from their vocabulary because “(a) that the term is not an objective determination, (b) that it depends on the goals that an intervention is meant to achieve, and (c) that applying it to a given patient runs the risk of creating a self-fulfilling prophecy.”8 the american medical association (ama) through its council on ethical and judicial affairs9 has weighed in on this difficult issue and suggested that a patient's care is futile when nothing further can be done medically to cure the patient; the patient is going through the dying process. when this occurs, the ama code requires physicians to act in accordance with their own value judgments and to not "prolong the dying process without benefit to the patient or to others with legitimate interests." the ama code also states that "patients should not be given treatments simply because they demand them."9 taking the bull by the horns https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_4 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_5 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_6 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_7 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_8 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_9 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_9 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 3 virtually every state has attempted to deal legislatively with the dilemma of futile or medically inappropriate treatment10 but only texas has developed a statutory procedure that attempts to bring the medical futility process to a finite conclusion.2 for over a decade, by virtue of the texas advance directives act (tada)11 doctors in texas have had the statutory authority, essentially 10 days after the concurrence by a hospital ethics committee, to discontinue lsmt of a patient even over the patient’s or surrogate’s objection. judicial intervention is not authorized to review the decisions of the physician or ethics committee which appear to be unreviewable and is limited to granting an extension of time in which to find another facility to treat the patient. if the procedure has been properly followed, the physicians and the ethics committee are granted complete criminal, civil and administrative immunity.12 the texas advance directive act of 199911 the tada combines several prior laws dealing with end-of-life decisions into a single statute and makes numerous changes including provisions for a living will and definitions of terminal and irreversible illness.13 most importantly, the law establishes a legally sanctioned extrajudicial process for resolving disputes about end-of-life decisions. this mechanism for dispute resolution may be used in response to a surrogate, living will, or medical power of attorney request to either “do everything” or “stop all treatment” if the physician feels ethically unable to agree to either request. as explained by dr. robert fine[c] of baylor, the co-author of the statute, “a ‘medical futility’ conflict is a situation in which the physician is asked to ‘do everything’ but feels that withdrawal of treatment is most appropriate; a ‘right to die’ conflict is a situation in which the physician is asked to stop all treatment but feels that it should be maintained.”7 as dr. fine has explained, in practice, tada comes into play “only when (1) the patient is declared terminally or irreversibly ill, (2) the patient is unable to make his or her wishes known, (3) the surrogate is demanding treatment that the responsible physician believes is medically inappropriate, and (4) the responsible physician asks that the process be invoked.” he also observes that while physicians are not obligated to follow this process, if they don’t, they would lose immunity for the decision to withdraw disputed treatment.14 although the tada is lengthy and deals with a variety of end-of-life issues, the key (and most controversial) section has to do with the procedure for resolving cases of medical futility.15 the key provisions of this section are:16 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_10 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_2 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_11 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_12 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_11 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_13 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftn3 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_7 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_14 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_15 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_16 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 4 1. the physician’s refusal to comply with the patient’s or surrogate’s request for treatment must be reviewed by a hospital-appointed medical or ethics committee of which the attending physician is not a member and during the pendency of the process, the disputed treatment must continue. 2. the family must be given 48 hours’ notice and be invited to participate in the committee consultation process. 3. the ethics consultation committee must provide a written report detailing its findings to the family and must include this report in the medical record. 4. if the ethics consultation process fails to resolve the dispute, the hospital, working with the family, must make reasonable efforts to transfer the patient’s care to another physician or institution willing to provide the treatment requested by the family. 5. if after 10 days from the time the family receives the ethics consultation committee report no such provider can be found, the physician and hospital are no longer obligated to provide life sustaining treatment. 6. the patient or surrogate may request court intervention but only to attempt to obtain a court-ordered time extension of the 10 day period which can only be granted if the court finds that the extension would provide a reasonable likelihood of finding another treatment provider in the additional time. 7. if the family does not seek a time extension or the court does not grant one, life sustaining treatment may be withdrawn by the treatment team with immunity from civil and criminal prosecution. it should be noted that while the tada provides a mechanism by which futile medical treatment may be withdrawn, this is not mandatory but permissive and that palliative or comfort care should be continued.14 positive results and strengths https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_14 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 5 one of the most positive aspects of the tada, is that it recognizes and attempts to resolve the conflicts that can arise between the competing autonomies of the patient and the physician. it provides a mechanism by which the physician’s individual integrity is protected against having to render treatment which she believes is medically inappropriate or morally unacceptable by requiring transfer to another caregiver while at the same time avoiding a unilateral decision by the physician on withdrawing disputed care.17 rather than trying to specifically define the elusive “medical futility”, the law fosters a process-based approach, as suggested by the ama guidelines, by which each case is individually evaluated first by the physician and then by the ethics committee. as a practical matter, if the committee agrees with the physician’s assessment and no other caregiver can be found to render the treatment in question, this collective agreement in essence has established a “community standard” of medical futility18 as well as providing physicians the “safe haven” of immunity from civil or criminal entanglements for doing that which they deem to be medically and ethically correct. the process seems to have provided an additional, perhaps initially unintended, benefit to the patients’ families of providing a mechanism by which they do not have to bear the emotional burden (and potential guilt) of authorizing the death of a loved one even though it may in fact what they believe should occur. as dr. fine has reported concerning his own experience with the tada: “we have had many conversations with families who said in essence, ‘if you are asking us to agree with the recommendation to remove life support from our loved one, we cannot. however, we do not wish to fight the recommendation in court, and if the law says it is ok to stop life support, then that is what should happen’.”7 it may also have given a level of comfort to physicians by defining a process and granting immunity from actions that had previously been accomplished in the shadows and which have now become more explicit and increased by 67%.7 in a survey of 197 returned surveys from members of the texas hospital association (tha) in 2007, smith et al reported that of those cases that utilized the tada process, most of the cases were resolved before the 10-day waiting period because “patients died, patients or representatives agreed to forgo the treatment in question, or patients were transferred” and that cessation of requested life-sustaining treatment occurred in only a small number of cases.10 criticisms, concerns and ethical issues https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_17 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_18 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_7 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_7 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_10 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 6 as law professor thomas mayo[d], of smu the other co-author of the statute notes, “two of the most persistent and insightful critics” are dr. robert truog and professor thaddeus mason pope whose essential objection is that the tada “is procedurally deficient because of the absence of minimal due-process safeguards against biased, substantively flawed, or otherwise inappropriate decision-making by treating physicians.”19 they argue that because there is no provision for judicial review of a decision by a hospital ethics committee which they imply is biased because it is staffed by “insiders” and therefore not independent, it fails to meet basic standards of procedural fairness.19 this concern about the composition of the ethics review committee and the procedural process is shared by pope some of whose concerns were that decisions on life-sustaining treatment were being made “outside the shadow of the court system” by an in-house committee whose decision was “final and unreviewable.”20 in a lengthy legal treatise on the tada[e], o’callaghan concluded that the statute would be found to be unconstitutional on the grounds of a denial of 14th amendment due process protections because: “(1) the statute’s failure to set forth a standard limiting the doctor’s discretion with regard to the denial of lsmt authorizes arbitrary deprivations of the patient’s liberty and life guarantees; (2) the hospital’s ethics committee is not a neutral, unbiased adjudicator of the dispute; and (3) the balance of interests indicates that the patient is due formal procedural protections in the adjudication of this dispute.21 it should be noted that to date, no decision has declared the tada to be unconstitutional. in response to the basic objections raised, professor mayo has argued that “the due-process criticism starts off right but ends up seriously wrong.”19 he noted that it was a conscious judgment of the statute advisory panel to provide for “an intramural ethics committee review of ‘futility disputes’” because: 1) members of the ethics committee bring an expertise to the issues that trial judges generally don’t have; 2) ethics committee members may not include physicians with subject patient care responsibility and there is no reason to assume that such a committee would simply be a “rubber stamp” of the attending’s decision “short of a deep seated distrust of hospital workers and volunteers”; and 3) while judges may be experts at legal due process, there is nothing to suggest that they “should be the gold standard for decision-making in end-of-life disputes.”19 professor mayo argued further that although nothing in the principally disputed section (§166.046) specifically provided for judicial review, neither does it preclude it and in the advisory panel’s discussion of the tada, it was understood that judicial review would be available through the usual leagal routes in texas and the panel even considered making the procedure explicit in the statute but rejected that option as unnecessarily redundant.19 finally, he argued that notwithstanding any perceived limitation on the courts power to intervene or extend time periods, texas courts clearly have the inherent power to intervene and preserve the status quo and would be “highly unlikely” to “allow a patient to die in a contested case” pending their evaluation of the merits and jurisdiction and that most courts when presented with a dispute under the tada, have not hesitated to issue a temporary injunction until the issues-including the existence of a cause of action and subject-matter jurisdiction could be sorted out.19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftn4 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_20 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftn5 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_21 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 7 point-counterpoint-rebuttal in a summary of the main procedural and ethical disagreements surrounding the tada, a spirited “pointcounterpoint” debate in the literature occurred in 2009 between dr. fine, the proponent of the tada and dr. robert truog a noted bioethicist from harvard who was critical of some of its provisions. dr. truog had expressed his concerns two years previously by observing that what made the tada effective was also what created its greatest problem because: “it relies on a due-process approach that is more illusory than real and that risks becoming a rubber-stamp mechanism for systematically overriding families’ requests that seem unreasonable to the clinicians involved.”16 dr. fine in his point14, argued that the tada “effectively and ethically resolves disputes about medical futility” and that although the statute tada does not include the words “medical futility” it “does recognize the concept with the term medically inappropriate treatment.” he noted that attempts to resolve “futility conflicts” should start with the “foundational rule of good communication” and that “palliative care and clinical ethics consultants may be helpful.” he referenced a report made to the texas legislature in 2005 from multiple hospital ethics committees concerning the involvement if the tada which found that: “of 2,922 ethics consults, including an estimated 974 futility consults, only 65 10-day letters were issued. of those 65 cases, 11 patients were transferred within 10 days, 22 patients died during the 10-day period, 27 patients had the disputed treatment withdrawn, and 5 patients had treatment extended and/or were transferred later.”14 dr. truog in his counterpoint22 continued to raise concerns about the procedure and argued that the tada “is ethically flawed...medical futility disputes must be resolved by a fair process.” he felt that “the most fundamental flaw with tada is that it specifically excludes the involvement of the courts, ceding all of the authority to the hospital ethics committee or medical review committees.” he continued his procedural objections by arguing that an aggrieved family had “no options for appealing the decision of the ethics committee” and the court’s power was limited to “granting an extension of time for the family to locate an alternative care provider” but “only if there is a reasonable likelihood that such a provider can be found, which is often unlikely.” he agreed that keeping cases out of court was “a distinct advantage” but suggested that the ethics committee composition was flawed because it “fails to bring the diversity of the community into the deliberative process.” as a result of what he apparently believed was an ethics committee bias, he found it to be “no surprise, then, that in 47 futility cases described in one report from texas, the ethics committee agreed with the clinicians > 90% of the time.” in addition, dr. truog felt that there was a socioeconomic bias present because the tada was invoked most often in urban hospitals so that “the law may therefore be disproportionately applied to people who have been denied, or at least believe they have been denied, beneficial medical treatments that are available to others. these families may believe that, once again, they are being deprived of treatment that is not only beneficial, but indeed life sustaining.” dr. truog then suggested that the fair thing to do would be to “level the playing field” by taking the decisional authority out of the hands of the hospital ethics committee and placing it into the hands of the judicial system. he concluded his arguments by suggesting that “tada essentially accepts a tradeoff between a solution that effectively resolves a relatively small number of hard cases in exchange for a process that summarily dismisses some of the most fundamental protections that our society has entrusted to the legal system. in my view, such a compromise does not reflect either our constitutional principles or our ethical ideals”22 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_16 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_14 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_14 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_22 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_22 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 8 dr. fine in his rebuttal23 observed that the major argument raised against the tada was that it “excludes the involvement of the courts and may be unconstitutional.” he specifically disputed that assertion and argued that “the law does not exclude the courts, but directs the court to review matters it is most qualified to judge: compliance with procedure, not medical decision making.” as concerns the constitutional argument, he pointed out that in a recent tada case, gonzalez, the court-appointed guardian of the infant patient argued that the tada did not violate either the state or federal constitution and that “no court has declared tada unconstitutional after 10 years of use.” he also pointed out that dr. truog’s assertion that “judges provide more diversity and less potential bias than ethics committees” seems to overlook the fact that “judges secure their position either through political appointment or election” and that a judge “no matter how wise, cannot match the collective wisdom or diversity of an ethics committee and does not have expertise in medical decisions.” he also challenges the socioeconomic bias assertion of dr. truog by suggesting that no evidence to support the claim was presented and challenged the accuracy of the conclusion suggested by dr. truog’s 47 case examples [that the ethics committee agreed with the clinicians > 90% of the time] by noting that 37 of the 47 futility cases were resolved by ethics consultations prior to resorting to the full dispute process and that of the remaining 10 cases which were heard by the ethics committee, the committee agreed with the physician in 6 cases and not in the other 4 so that this “60/40 split is hardly bias!”23 some proposed amendments to the tada professor mayo, in response to the concerns and criticisms surrounding the statute, proposed a number of modifications to the law in an effort to assuage its critics and keep its essential purpose intact:19 judicial reviewif it were necessary to preserve the essential structure of the law…from a finding of unconstitutionality, the availability of judicial review could be made more explicit. as a starting point, "reasonable medical judgment" could be added…[to provide] a basis for substantive review of the medical decision-making involved in the case. limit the scope of the immunity available -if there is doubt about the availability of judicial review …the broad immunity …is one of the principal reasons for that doubt. the immunity from criminal liability should be preserved, as should the immunity from disciplinary action byappropriate licensing boards, but the immunity from civil liability could be limited to monetary damages, making it clear that injunctive relief would still be available as a remedy. https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_23 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_23 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 9 limit the scope-. the law should be limited to apply only when the patient lacks decision making capacity. …in addition, [the law] should be limited to disputes over treatment decisions for "qualified patients"--that is, to patients who have been certified to have a terminal or irreversible condition. require a prior informal dispute-resolution-style ethics consultation. many texas hospitals seem to have gravitated toward a two-step process, even though it is not required bythe statute. it should be required of all hospitals, however, as a "best practice" that would give all parties a chance to find an acceptable middle ground without going directly to the formal statutory process. extend the time deadlines-the time limits could easily be extended to provide a minimum number of weekdays' (rather than calendar days') notice before the review consult occurs (five) or during which the attempt to transfer shall take place (ten). at a minimum, the law should encourage facilities to be flexible in applying the time requirements… in order to meet the reasonable needs of families and to avoid treating minimum time requirements as setting upper limits. require hospitals to offer another informal dispute-resolution style ethics consult after the expiration of the ten-day waiting periodthe ten-day waiting period may develop potentially significant information, even if no transfer has been arranged. the patient's condition may have changed, or it may have stayed the same. treatment alternatives may have been tried with various outcomes. and the fact that no provider has been found who is willing to accept the transfer is a significant fact in itself. any or all of this new information might contribute to an agreed-upon resolution of the end-of-life treatment dispute. afollow-up ethics consultation should be considered a "best practice" unless it is rejected by the surrogate decision maker.19 conclusions perhaps technology has gone too far. we've overcome the natural order of life by overriding the natural processes of death possibly beyond that which was reasonable. there was a general sense in medicine to do everything one could to preserve life in the hopes that some heroic intervention might restore a loved one to us against the odds of nature. now it seems that perhaps all that science can do has become more than nature was meant to bear. it is clear that while the tada is not perfect, “it does provide a mechanism for dealing with irreconcilable conflicts between physicians and patients and/or their surrogates regarding end of life care.”2 even its most persistent https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_2 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 10 critic, dr. troug recognizes its value in addressing “both the financial implications of providing allegedly inappropriate care and the concerns of clinicians who must endure the moral burdens and burnout associated with being compelled to provide treatments they believe are ethically wrong.”26 as professor mayo has written, “unilateral withdrawal of life-sustaining treatment should not be done casually and should never be a first resort to settle end-of-life treatment disputes. proper regard for the values of the patient and the choices of the surrogate decision maker should ordinarily counsel a slow process that ends in unilateral action only as a last resort.” 19 in the most recent session of the texas legislature, there was an attempt to amend the tada by the “patient and family treatment choice rights act of 2011” whose proposed amendments are aimed at ensuring that “when an attending physician is unwilling to respect a patient's advance directive or a patient's or family's decision to choose the treatment necessary to prevent the patient's death, life-sustaining medical treatment will be provided until the patient can be transferred to a health care provider willing to honor the directive or treatment decision.” 27 in other words, the 10 day rule would be removed and lsmt could not be withdrawn by the physician over objection. as of this writing, the bill has been “left pending in the subcommittee.” 28 the medical decisions “to withdraw or withhold intensive care treatment are complex and value laden.”3 in view of the changing face of medical intervention possibilities, precise guidance as to when this can be done has been elusive and perhaps that is as it should be. it has been ethical at least since the ama guidelines of 1999 for physicians to decline to provide lsmt when by the exercise of their own professional judgment, they believe such treatment is either medically inappropriate or futile for the overall benefit of their patient. in that sense it almost seems that the tada simply confirms what is already permitted and its real benefit is the “safe harbor” immunity it provides to physicians from legal entanglements for exercising their professional judgments for their patients’ best interests. ultimately, there’s no escaping that human judgment must be used to evaluate whether any patient’s condition is terminal and whether further medical intervention is futile by simply prolonging the dying process. while i would agree that the best person for the role of ensuring that proper legal due process is a judge, trained and experienced in the operation of the law, it seems just as clear that the best arbiter of the status and effects of a medical condition are the trained experts in that field—the physicians themselves. https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_26 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_19 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_27 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_28 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_enref_3 whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 11 reference notes 1. dworkin r. life's dominion: an argument about abortion, euthanasia, and individual freedom. new york: vintage books; 1994. 2. dahm ll. medical futility and the texas medical futility statute: a model to follow or one to avoid. the health lawyer. 2007;20(6):25. 3. wilkinson d, savulescu j. knowing when to stop: futility in the intensive care unit. current opinion in anaesthesiology. 2011;24(2):160. 4. white db, pope tm. the courts, futility, and the ends of medicine. jama: the journal of the american medical association. january 11, 2012 2012;307(2):151-152. 5. o'callaghan n. when atlas shrugs: may the state wash its hands of those in need of life-sustaining medical treatment. health matrix. 2009;18:291. 6. stewart cl. a defence of the requirement to seek consent to withhold and withdraw futile treatments. medical journal of australia. 2012;196(6):406. 7. fine rl, mayo tw. resolution of futility by due process: early experience with the texas advance directives act. annals of internal medicine. 2003;138(9):743-746. 8. silverman rb. continuation of extracorporeal membrane oxygenation support after multiple failed lung transplantations. icu director. march 1, 2012 2012;3(2):91-96. whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 12 9. ama. medical futility in end-of-life care: report of the council on ethical and judicial affairs. jama. 1999;281(10):937-941. 10. smith ml, gremillion g, slomka j, warneke cl. texas hospitals' experience with the texas advance directives act*. critical care medicine. 2007;35(5):1271. 11. texas health and safety code, § §166.001-166.166(2007). 12. burge cr. texas advance directives act versus" state-created danger" theory: a prima facie analysis. am. j. trial advoc. 2009;32:557-611. 13. fine rl. medical futility and the texas advance directives act of 1999. proceedings (baylor university. medical center). 2000;13(2):144. 14. fine rl. point: the texas advance directives act effectively and ethically resolves disputes about medical futility. chest. 2009;136(4):963-967. 15. texas health and safety code, § 166.046(e)(2007). 16. truog rd. tackling medical futility in texas. new england journal of medicine. 2007;357(1):1-3. 17. zientek d. the texas advance directives act of 1999: an exercise in futility? 2005. 18. jacobs hc. the texas advance directives act--is it a good model? seminars in perinatology. 2009;33(6):384-390. whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 13 19. mayo tw. the baby doe rules and texas’ 'futility law' in the nicu. georgia state university law review. 2008-2009;25(4). 20. pope t. the patient and family treatment choice rights act of 2011, hb 3520: written testimony to the human services committee of the texas house of representatives on april 12, 2011. 2011. 21. o'callaghan n. dying for due process: the unconstitutional medical futility provision of the texas advance directives act. baylor law review. 2008;60:527. 22. truog rd. counterpoint: the texas advance directives act is ethically flawed. chest. 2009;136(4):968971. 23. fine rl. rebuttal from dr. fine. chest. october 1, 2009 2009;136(4):971-972. 24. heitman e, gremillion v. ethics committees under texas law: effects of the texas advance directives act. hec forum. 2001;13(1):82-104. 25. sauler m, siegel md. the past, present, and future of advance directives as a guide to end-of-life decision making. chest. 2012;141(1):9-10. 26. truog rd. patients and doctors—the evolution of a relationship. new england journal of medicine. 2012;366(7):581-585. 27. the patient and family treatment choice rights act of 2011, h.b. 3520. whiteman, for everything a season, voices in bioethics, vol. 1 (2014) 14 28. texas legislature online. 2012. http://www.legis.state.tx.us/billlookup/history.aspx?legsess=82r&bill=hb3520. accessed may 3, 2012. [a] john donne meditation xvii. [b] ecclesiastes3:1 [c] director of the office of clinical ethics and palliative care for baylor health care system, chairperson of the institutional ethics committee at baylor university medical center, and director of the palliative care consultation service at baylor university medical center. [d] associate professor, smu law school, adjunct associate professor of internal medicine at the university of texas southwestern medical school. [e]for an extensive legal treatise on the claim that the statute is unconstitutional, see o'callaghan, n. (2008). dying for due process: the unconstitutional medical futility provision of the texas advance directives act. baylor law review, 60, 527; and o'callaghan, n. (2009). when atlas shrugs: may the state wash its hands of those in need of lifesustaining medical treatment. health matrix, 18, 291. http://www.legis.state.tx.us/billlookup/history.aspx?legsess=82r&bill=hb3520 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftnref1 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftnref2 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftnref3 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftnref4 https://michael-reaves-bkln.squarespace.com/features/2014/04/09/for-everything-a-season#_ftnref5 https://library.columbia.edu/ https://library.columbia.edu/ fleming, medical futility, voices in bioethics, vol. 3 (2017) © 2017 alex fleming. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduc tion, provided the original author and source are credited. medical futility & parental “rights”: a glimpse into the charlie gard case alex fleming keywords: medical futility, bioethics, charlie gard introduction decisions regarding withholding and withdrawing care raise some of the most difficult, yet classic, bioethical questions. the current events related to charlie gard, an infant and native of the united kingdom, born with a rare and devastating disease known simply as mitochondrial depletion syndrome, provide perfect examples of such difficult and classic questions. charlie gard’s predicament has gained international attention, as “european courts have ruled that he should be taken off life support, as there are no effective treatments for his condition.”[i] meanwhile, the parents of charlie have insisted on experimental treatment in hopes of saving their son, and at the very least, have sought permission to take their child home to die if all else fails. european courts and physicians from great ormond street hospital, where charlie currently is located, have outwardly rejected such ideas on the basis “that the therapy would not help him and it was in his best interest to prevent further suffering by withdrawing life support.”[ii] analysis several aspects of charlie gard’s case show similarities with previous cases involving infants and what physician’s refer to as ‘futile care.’ however, charlie’s case stands out from the others and presents an impasse so large that it breaks all common conceptions of such care, particularly those cases which involve an infant’s parents. wesley smith states: “this is where charlie gard’s case is breaking new and even more authoritarian ground. not only are doctors and judges forcing charlie off life-support; they are also declaring that their ethics rule over charlie’s life, even if the parentschris and connie gardfind alternative care.”[iii] https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn1 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn2 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn3 fleming, medical futility, voices in bioethics, vol. 3 (2017) 2 the concept of medical futility has long been engrained into our health care system and has proven to have serious effects on the physician-patient, or parent, relationship. moreover, what makes the topic of medical futility so interesting is its capability of easily overriding the long-accepted notion of parental authority, even when it has been shown that the parents are fit to make health care decisions for their child and are invested whole-heartedly in their child’s care. medical futility or futile care does not refer simply to cases in which patients are faced with circumstances or treatment options which present no hope or benefit to them. for a patient’s circumstances or treatment options to be considered futile involves very ambiguous and amorphous language, and is often tinged with personal value judgements and biases entirely dissociated from the patient and their loved ones. in cases involving patients whose care is deemed futile or useless, health care providers and policy-makers, while seeking to do what is in the ‘best interests’ of the patient, can easily become prey to the temptation of substituting their own personal opinions for how they themselves would wish to be treated if placed in the patient’s shoes. tom beauchamp and james childress state: “the most appropriate standard in cases of…seriously ill newborns, is that of best interests, as judged by the best estimate of what reasonable persons would consider the highest net benefit among the available options”[iv] these sorts of judgements are all but natural; however, can be misplaced if one is attempting to define the quality of another person’s life, even if that person is an infant and has a minimal grasp of the world around him. physicians are perhaps the best determinants of such judgments when a patient’s condition seems so stark as to allow him or her to be taken off of life support; however, physicians are still advised to act first in consultation with a child’s parents when the patient is too young and unable to speak for himself. for to refuse to do otherwise might be seen as “an act of bioethical aggression that will extend futile-care controversies, creating a duty to die at the time and place of doctors’ choosing.”[v] it is certainly understandable for a physician, an individual totally invested in the life of another, to feel quite strongly in regard to the welfare of his or her patient. some physicians may feel as if continued treatment, after a determination of medical futility, would be in direct violation of the ancient maxim to ‘do no harm,’ and may be seen by others as a useless prolongation of suffering. however, “compared with the situation of the parents, these burdens seem insignificant, are short term, and most likely do not evoke such profound emotions.”[vi] an unbiased, cooperative, and informed approach on the part of the physician is advisable during such circumstances involving terminally ill infants and their emotionally torn parents. inherent dangers when applying the best interest standard to cases where a determination of medical futility has been made have to do with an examination of benefits and burdens, and are focused, perhaps too narrowly, on the extent of the one’s suffering. the best interest standard, commonly applied to cases where there appears to be little hope of benefit for the patient, “asks the decision-makers to weigh the “net benefit” for each possible option and subtract the “net burdens” of those options.”[vii] this utilitarian way of thinking seeks to maximize what is ‘good’ and minimize pain and suffering. this method, if seeking only to eliminate one’s suffering, can prove disastrous for patients and infants alike, for “the ability to feel pleasure and avoid pain… [is] a difficult condition to assess in the neonate.”[viii] an examination of benefits and burdens which is concerned with the infant in his or her physical, familial, and spiritual totality, with a focus on the family unit, is preferred in cases where a physician has deemed a infant’s case as futile. alongside assessing the benefits and burdens of withholding and/or withdrawing treatment, or that of any proposed intervention, involves first and foremost the principle of informed consent. in cases dealing with infants, informed consent from the patient is not possible. in these cases, informed consent by proxy must suffice. in most cases, the proxy will be the infant’s parents. many, including law and policy-makers, have challenged the notion of proxy consent when it has to do with young children. the common belief is that “the child’s parents or guardians have the authority or “right” to give consent by proxy.”[ix] this belief is generally not contested by the courts, for example, unless it is obvious that the parents or guardian(s) are unfit to take care of or make health-care decisions for the child. in relation to charlie gard, this does not seem to be of any concern. https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn4 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn5 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn6 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn7 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn8 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn9 fleming, medical futility, voices in bioethics, vol. 3 (2017) 3 when entrusting the care of a child to a team of physicians, parents enter into what edmund pellegrino calls “a covenant of trust, a special kind of promise to serve those who require her expertise.”[x] this relationship of trust between physicians and parents, which is meant to transcend mere contractual relations, involves mutual cooperation and the sharing of values, opinions, and alternatives in regard to care, up to and including experimental treatment. therefore, it is advised that “practitioners should seek the informed permission of parents before medical interventions….”[xi] so called medical interventions would include both the withholding and withdrawal of treatment, and might include forms of both ordinary and extraordinary care. in cases where extraordinary care is employed, the choice to do so is by no means obligatory; however, given the circumstances of the individual case, the parents or guardian(s) should have the freedom to consider the option of such care if they have been proven fit to do so. as should be the scenario in any infant case, physicians and those involved in the determination of care are advised to consult with the parents or guardians early and often, in order to devise a plan for future care as well as analyze the benefits and burdens of proposed treatment(s). benefits consist of any treatment or intervention which will provide either obvious improvement or hope of such improvement to the patient’s medical condition. parents are never obligated to consent to any intervention which has been deemed extraordinary, or in this case, experimental; however, the parents are free to make this choice if they wish. on the flip side, burdens are concerned with those treatments or interventions which obviously or will presumably cause needless harm or added suffering. it happens that “the notion of burden is to be understood as applying not only to the patient but to others, such as family, hospital, and civic community, and could include those such as third-party payers.”[xii] conclusion in any case, it is critical that physicians and parents come as close to an agreement with regard to a plan for care, and that that plan be “always balanced against the intrinsic value of human life. one must not overstate the burdens of treatment, just as much as one must avoid an irrational belief in the benefit of a medical intervention.”[xiii] in regard to baby charlie, what we have witnessed is a failure in the balancing act between the physicians involved in charlie’s care toward his parents. with charlie’s current condition looking very dismal, his trajectory of care remains to be seen. [i] roni c. rabin, “new york hospital offers to treat british baby with rare disease,” new york times, july 6, 2017, https://mobile.nytimes.com/2017/07/06/health/uk-infant-charlie-gard-ny-hospital.html. [ii] lindsey bever, “charlie gard not allowed to receive vatican’s care, hospital spokesman says,” the washington post, july 5, 2017, https://www.washingtonpost.com/news/worldviews/wp/2017/07/05/charlie-gard-not-allowed-to-receivevaticans-care-hospital-spokesman-says/?utm_term=.a4a669089d7d. [iii] wesley j. smith, “whose baby is charlie gard, anyway?” first things, july 4, 2017, https://www.firstthings.com/webexclusives/2017/07/whose-baby-is-charlie-gard-anyway. [iv] tom l. beauchamp and james f. childress, principles of biomedical ethics, 7th ed. (new york, ny: oxford university press, 2013), 174. [v] wesley j. smith, “whose baby is charlie gard, anyway?” first things, july 4, 2017, https://www.firstthings.com/webexclusives/2017/07/whose-baby-is-charlie-gard-anyway. [vi] john a. robertson, “examination of arguments in favor of withholding ordinary medical care from defective infants,” in intervention & reflection: basic issues in bioethics, eds. ronald munson and ian lague (boston, ma: cengage learning, 2016), 553. https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn10 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn11 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn12 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_edn13 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_ednref1 https://mobile.nytimes.com/2017/07/06/health/uk-infant-charlie-gard-ny-hospital.html https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_ednref2 https://www.washingtonpost.com/news/worldviews/wp/2017/07/05/charlie-gard-not-allowed-to-receive-vaticans-care-hospital-spokesman-says/?utm_term=.a4a669089d7d https://www.washingtonpost.com/news/worldviews/wp/2017/07/05/charlie-gard-not-allowed-to-receive-vaticans-care-hospital-spokesman-says/?utm_term=.a4a669089d7d https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_ednref3 https://www.firstthings.com/web-exclusives/2017/07/whose-baby-is-charlie-gard-anyway https://www.firstthings.com/web-exclusives/2017/07/whose-baby-is-charlie-gard-anyway https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_ednref4 https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_ednref5 https://www.firstthings.com/web-exclusives/2017/07/whose-baby-is-charlie-gard-anyway https://www.firstthings.com/web-exclusives/2017/07/whose-baby-is-charlie-gard-anyway https://michael-reaves-bkln.squarespace.com/voices-in-bioethics/2017/9/14/medical-futility-parental-rights-a-glimpse-into-the-charlie-gard-case#_ednref6 fleming, medical futility, voices in bioethics, vol. 3 (2017) 4 [vii] andrew c. beckstrom and david e. woodrum, “witholding and withdrawing life-sustaining intervention from neonates,” in clinical ethics in pediatrics: a case-based textbook, eds. douglas s. diekema, mark r. mercurio and mary b. adam (cambridge, uk: cambridge university press, 2011), 85. [viii] ibid. [ix] carl h. coleman et al., the ethics and regulation of research with human subjects (newark, nj: matthew bender & company, inc., a member of the lexisnexis group), 536. [x] edmund d. pellegrino, “professionalism, profession, and the virtues of the good physician,” the mount sinai journal of medicine 69.6 (november 2002): 382. [xi] carl h. coleman et al., the ethics and regulation of research with human subjects (newark, nj: matthew bender & company, inc., a member of the lexisnexis group), 536. [xii] albert s. moraczewski and greg f. burke, “medical facts and ethical decision making: assessing benefits and burdens,” in catholic health care ethics: a manual for practitioners, 2nd ed., eds. edward j. furton, peter j. cataldo and albert s. moraczewski (philadelphia, pa: the national catholic bioethics center, 2009), 201. [xiii] ibid. ____________________________________________________________ belisomo, role of graphics memoir in decision making, voices in bioethics, vol. 1 (2014) © 2014 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “can’t we talk about something more pleasant”: the role of graphic memoir in medical decisionmaking randi belisomo keywords: graphic medicine, medical narratives, storytelling introduction end of life issues don’t always have to be so difficult to discuss, especially upon reading new yorker cartoonist roz chast’s new memoir, “can’t we talk about something more pleasant.” now spending its eighth week at the top of the new york times best seller list in the category of graphic books, it’s funny and unflinching words and images provide intimate perspective into chast’s experience caring for stubborn, quirky, and “codependent” parents in brooklyn. it was a neighborhood chast loathed, and she avoided it entirely for the eleven years prior to navigating the complexities of assisted living, nursing homes, and hospice care for her mother and father, elizabeth and george. their illnesses and frailties compounded rapidly after years in which their decline “was blessedly gradual.” analysis chast savvily hires an elder attorney, one whom her mother believes to ask too many “personal questions!” they assign health care proxies in a delightfully illustrated conversation in which elizabeth expresses her fears – emphasized by chast in all capital letters – of being a “pulsating piece of protoplasm!” assisted living is an idea the two initially resist, referencing the actions of the “mellmans’ daughter.” before they died, the mellmans signed over financial authority to their daughter; they were sent to a “home,” and the daughter bought a “drawerful of cashmere sweaters.” this is not a scenario the frugal couple wants to repeat after decades of scrimping and preserving practically every possession in a packed apartment of knick knacks, petroleum jelly, pencils, schick shavers and jar lids – all photographed for inclusion in the pictorially-driven narrative. elizabeth fears both doctors (believed to have a “god complex”) and the thought of hospitals. “that’s where you go to die,” she says; elizabeth wryly describes herself as a “jewish christian scientist.” hospitals, however, cannot be avoided. george breaks a hip, and elizabeth’s diverticulitis is a chronic struggle. while addressing hospitalizations and moves along the care continuum, chast tackles the many non-medical aspects of caregiving. she keeps notebooks with social security numbers, phone numbers, elder care information, bank records, and lists of medications. “if you can pass the job on to someone else, i’d recommend it,” she writes. “if not, you have my total sympathy.” it is a tedious and time-consuming task with which many readers can easily relate. bellisomo, role of graphics memoir in decision making, voices in bioethics, vol. 1 (2014) when the time comes for assisted living, chast pokes fun of the euphemistic facility names: “sunset gardens,” “endof-the-trail acres,” “final bridge resting home.” elizabeth and george would not return to the apartment they rented for decades. for george, the following stop is a nursing home. there, the linoleum floors and institutional colored paint are depicted starkly – without the sconces, sofas, and oriental rugs of the prior assisted living facility. though chast knows his health is failing quickly, her mother wants only “positive thinking.” chast agrees with george’s physician that he would be best served by hospice care, but elizabeth insists soup will do the trick. after george’s death, elizabeth adjusts to being alonewith the exception of a hired caregiver that costs chast a bundle. that expense is on top of the more than seven thousand-dollar monthly facility fee, and chast is blunt about both her financial worries and the guilt accompanying them. in fact, a hospice nurse encourages chast to share these concerns with her mother. days before elizabeth’s death, chast approaches her bedside to say “you are running out of money.” chast draws bedside images of her mother in these final days, thirteen most realistic sketches included in the narrative – contrasting with her colorful cartoons. neither her storytelling techniques nor the tale’s content shy from numerous issues with which adult children struggle as their parents age. her dry wit, realism, and willingness to shatter taboos accompanying such an “unpleasant” topic make this memoir a must-read for those facing similar circumstances. conclusion graphic medicine chast’s memoir is the latest in recent spate of graphic books targeting tough topics at the end of life, and their illustrative format may extend greater ease to those struggling with how best to approach such issues and plan for the future care of loved ones. sarah levitt’s “tangles,” brian fies’ “mom’s cancer,” joyce farmer’s “special exits” and aneurin wright’s “things to do in a retirement home trailer park when you’re 29 and unemployed” are among those addressing serious illness and death in what is being called a “new golden age of comics” by penn state university humanities and medicine professor michael green. the internal medicine specialist teaches fourth-year medical students graphic storytelling and medical narratives, and green says comics like chast’s are perfect for providing multiple perspectives on such a multi-faceted topic such as end-of-life care. “comics play an important role in popular culture in general, and they are a great medium for telling stories and for learning things about people they might otherwise not learn,” green says. green serves on the editorial board of graphicmedicine.org, a platform for comics that advance health care discourse. the site is intended for providers, artists, and patients seeking peeks into what the experience of an illness may be like. bellisomo, role of graphics memoir in decision making, voices in bioethics, vol. 1 (2014) “because they not only use the words but the images too, the images to a great job at showing what it feels like to be in a situation,” green says. “a lot of emotional context gets conveyed through comics that can be moving to people.” m.k. czerwiec, also known as “comic nurse,” contributes to the site as well, adding her own work produced in her role as artist-in-residence at northwestern university’s feinberg school of medicine. czerwiec had no formal artistic training prior to the initial sketches she made during nursing training among aids patients. feeling helpless, she decided to draw and color. “i stumbled into doing it as i was trying to cope with keeping myself alive and aware during that crisis by drawing a picture, writing a few words and putting a box around it,” czerwiec says. “i started really confused and unclear, but there is something about the box-by-box process that was about knowing through drawing. there’s something about space with the comics and boxes. somehow, it’s more comfortable.” in increasing numbers, others agree. czerwiec attended the first comics and medicine conference in london four years ago, when attendance was roughly 60. this year’s conference in baltimore drew 235. though neither czerwiec nor green know what the role of comics in clinical settings may one day be, they say books like chast’s are enhancing knowledge and dialogue among patients and caregivers. chast, green says, “does a fantastic job exploring some of the ambivalences, challenges and mixed feelings one has around these issues.” czerwiec says the memoir normalizes a topic that sadly, isn’t so in american discourse. “when you’re going through something like that, it’s great to know you’re not alone and to be able to laugh at it.” li and napiorkowska, rethinking figurative language, voices in bioethics, vol. 6 (2020) * brian li with marta napiorkowska, phd, the lawrenceville school. © 2020 brian li and marta napiorkowska author and author. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, dist ribution, and reproduction, provided the original author and source are credited. rethinking figurative language in the rhetoric of healthcare allocation brian li and marta napiorkowska, phd abstract despite its illuminative properties, figurative language can distort our views, bringing more emotion and prejudgment than fact. when dealing with the morality of allocation, physicians should be cautious of the judgments inherent in their words. the excessive use of figurative language in the rhetoric of allocation may be inappropriate; instead, physicians should use patient-focused and factual language that can account for the unique moral quandaries posed by each scenario they encounter. keywords: bioethics, figurative language, physician patient relationship introduction our words not only reveal our values but also inform them. figurative language supplies an aesthetic aspect to the rhetoric that influences allocation during times of scarcity, such as the covid-19 pandemic. despite its illuminative properties, figurative language can distort our views, bringing more emotion and prejudgment than fact. when dealing with the morality of allocation, physicians should be cautious of the judgments inherent in their words. the excessive use of figurative language in the rhetoric of allocation may be inappropriate; instead, physicians should use patient-focused and factual language that can account for the unique moral quandaries posed by each scenario they encounter. analysis orwell suggests that the “slovenliness of our language makes it easier for us to have foolish thoughts.”1 engelhardt states that it is physicians, not gods, who create the moral fabric of allocation with their words.2 figurative language is ingrained in our communication, guiding how we view our world. some physicians might call a person a “vegetable” or invite residents to examine “the kidney failure down the hall.” in the former example, “vegetable” makes the abstractness of a disorder of consciousness into a potentially derogatory colloquialism. “vegetable” is often synonymous with the clinical term “persistent vegetative state,” but it might li and napiorkowska, rethinking figurative language, voices in bioethics, vol. 6 (2020) 2 hold the implication that the patient more closely resembles a head of lettuce than a full human. such a term might seem benign to some seasoned physicians, but it is nonetheless problematic, as when confronting scarcity, physicians might ignore the needs of a patient in a persistent vegetative state if they are labelled as a “vegetable.” in the latter example, synecdoche, a form of figurative language which defines an object by a part, reduces a patient to their underlying pathology, a kidney failure in this case. lakoff and johnson pioneered the thesis that figurative language, particularly metaphor, defines our thinking, and, since figurative language shapes how abstractions are matched to our understanding, it produces ethical insights which we apply to our lives.3 figurative language influences how physicians view their work and respond to ethical dilemmas. words describing the physician as “employee” and the patient as “warrior” relegate the physician to a corporate object or the patient to a pawn in the war against disease.4“evangelist” physicians do not subscribe to the idea of corporatist healthcare and assert they are working for the good of their patients.5 physicians then find themselves in difficult situations in which they are forced to decide which values they should emphasize, leading to different medical decisions. figurative language often sparks behaviors or medical decisions which might occasionally benefit the patient but more often harm them.6 for example, doctors who see themselves as “warriors” may work hard to treat a patient, but an overzealous “warrior” might be prone to overusing resuscitation, pharmaceuticals, or other interventions. figurative language also dehumanizes patients through objectification. physicians might use similes to describe patients as dependent or passive (e.g., patients are “infant-like” in their behavior), thus eliminating their agency, which can lead to ignoring the possibility that they are capable of informed consent.7 discussions surrounding allocation become impersonal, as patients no longer retain their personhood and instead become inanimate biomasses. sound decision-making cannot be nurtured in an environment that fails to respect the full humanity of patients.8 as a consequence, figurative language makes it more difficult to objectively discern whether a patient needs a surrogate decision maker or is capable of advocating on their own behalf. figurative language is also reductionist, normative, and lacking in nuance, distorting the realities of a moral problem. it is often based on hypothetical situations rather than those normally encountered in actual hospital settings. if figurative language is grounded in a concrete source field, it would be tempting to think that these reductions are also absolute truths. childress introduces the example of allocation in a nicu. there might be an urge to apply comparisons to socio-utilitarian “rationalization” or “emergency” triage, but childress observes that nicus rarely encounter an absolute scarcity, eliminating the need to use the idea of “triaging.” it is also impossible to apply arguments of social utility to newborns.9 while there may be instructive value in figurative language, the lack of similarities between different situations should preclude its broad use.10 physicians’ rhetoric must then confront the unique difficulties posed by each situation and prioritize the patient. this responsiveness does not call for a constant reinvention of standards and practices. rather, it calls for a more careful interpretation of how frameworks are applied and discussed. physicians are capable of exercising good judgment without turning to rhetoric and abstractions.11 figurative language affects the ethical discourse of public health as well. the comparison of allocation to “rationalization” or “rationing” demonstrates the influence of language on decision making. these words give public health an element of consumerism and reduce people to mere clients. this framework holds that resources must be allocated “rationally,” prioritizing considerations that often conflict with the well-being of the patient. for example, a physician might not be willing to render treatment because of the patient’s inability to pay, for doing so would place an undue burden on the payer system.12 in other words, “rationalization” is a transactional paradigm that views the patient primarily as a consumer. resources become a small lifeboat available to those who can pay, survive, or produce some other benefit to society, with the premise that healthcare is highly limited in capacity, demanding that some be thrown overboard. this model assumes the inevitability of scarcity and has become the accepted paradigm under which many bioethicists operate.13 it removes the physician from the decision-making process, as the decision is based on public health criteria including a balance sheet or numerical calculus.14 li and napiorkowska, rethinking figurative language, voices in bioethics, vol. 6 (2020) 3 the flaws of figurative language invite a reevaluation and reshaping of its use. physicians should not use figurative language to disguise or mute the consequences of allocation. straightforward terminology and language are a better standard in medicine. figurative language that suggests the inevitability of allocation approaches it with moral distance, creating allocation schemes that fail to prioritize the person. concrete language that directly links physicians’ moral decision making to patient outcomes under allocation can encourage more thorough contemplation. there is also no room for the thoughtless use of figurative language. utterance, meaning, and intentions are all painfully intertwined with one another, and it is difficult to pick the three apart. because our language is loaded with examples that compromise patient-centered decision making, physicians must carefully examine their rhetoric and the assumptions they harbor. finally, physicians must adopt a person-centered language. patients are individuals deserving of moral respect, which includes due consideration in allocation and clear communication. physicians must use language that can candidly communicate the realities of allocation to patients, as it will encourage physicians to think more scrupulously and act more compassionately. small acts, such as using a patient’s name, may seem like token measures, but when taken together, could have immense effects on fostering humanism in healthcare. conclusion the use of figurative language raises further questions about power relations in medicine when deciding which figurative language is acceptable and which is not. contemporary healthcare practice is a complex interplay between a variety of interests, but if medicine is the humanistic institution that it strives to be, it is the patient that should remain at the heart, and the language utilized by physicians in ethical discussions must reflect this. while we cannot extricate ourselves from our attachment to figurative language, we can find ways in which we can use it more responsibly and curtail its negative influence. we can speak more deliberately, act more responsively, and focus more on the patient. this entails a recognition of the shortcomings of figurative language in allocation, and that which fails to acknowledge the complexities of allocation should be disposed of, as orwell suggests, in the “dustbin where it belongs.”15 1 george orwell, “politics and the english language,” n.d., 1–16. 2 h. tristram engelhardt, “allocating scarce medical resources and the availability of organ transplantation,” new england journal of medicine 311, no. 1 (july 5, 1984): 66–71, https://doi.org/10.1056/nejm198407053110135. 3 george lakoff and mark johnson, “conceptual metaphor in everyday language,” the journal of philosophy 77, no. 8 (1980): 453–86, https://doi.org/10.2307/2025464. 4 douglas s. diekema, “metaphors, medicine, and morals,” soundings: an interdisciplinary journal 72, no. 1 (1989): 17–24. 5 rashi fein, “what is wrong with the language of medicine?,” the new england journal of medicine, 1982, https://doi.org/10.1056/nejm198204083061409. 6 james f. childress and ruth g. bernheim, “a framework for public health ethics,” in essentials of public health ethics (jones & bartlett learning, 2013), 1–19. 7 james f. childress and mark siegler, “metaphors and models of doctor-patient relationships: their implications for autonomy,” theoretical medicine 5, no. 1 (february 1, 1984): 17–30, https://doi.org/10.1007/bf00489243; thomas s. szasz and marc h. hollender, “a contribution to the philosophy of medicine: the basic models of the doctor-patient relationship,” a.m.a. archives of internal medicine 97, no. 5 (may 1, 1956): 585–92, https://doi.org/10.1001/archinte.1956.00250230079008. 8 fein. 9 childress, “triage in neonatal intensive care.” 10 courtney s. campbell, “metaphors we ration by: an interpretation of practical moral reasoning,” soundings: an interdisciplinary journal 96, no. 3 (2013): 254–79, https://doi.org/10.5325/soundings.96.3.0254. 11 leon r. kass, “ethical dilemmas in the care of the iii: i. what is the physician’s service?,” jama 244, no. 16 (october 17, 1980): 1811–16, https://doi.org/10.1001/jama.1980.03310160027019. 12 saul weiner, “‘i can’t afford that!,’” journal of general internal medicine 16, no. 6 (june 2001): 412–18, https://doi.org/10.1046/j.15251497.2001.016006412.x. 13 ibid. 14 frank braio, “understanding triage: three sorts and cases,” accessed july 16, 2019, https://www.qcc.cuny.edu/socialsciences/ppecorino/deathanddying_text/braio_triage.htm. 15 orwell. https://www.zotero.org/google-docs/?ohzpms https://www.zotero.org/google-docs/?x8hrcv https://www.zotero.org/google-docs/?x8hrcv https://www.zotero.org/google-docs/?x8hrcv https://www.zotero.org/google-docs/?x8hrcv https://www.zotero.org/google-docs/?rpscsk https://www.zotero.org/google-docs/?rpscsk https://www.zotero.org/google-docs/?rpscsk https://www.zotero.org/google-docs/?rpscsk https://www.zotero.org/google-docs/?hft3fw https://www.zotero.org/google-docs/?hft3fw https://www.zotero.org/google-docs/?hft3fw https://www.zotero.org/google-docs/?41g2pd https://www.zotero.org/google-docs/?41g2pd https://www.zotero.org/google-docs/?41g2pd https://www.zotero.org/google-docs/?41g2pd https://www.zotero.org/google-docs/?wmyl8y https://www.zotero.org/google-docs/?wmyl8y https://www.zotero.org/google-docs/?wmyl8y https://www.zotero.org/google-docs/?wmyl8y https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?etl1n1 https://www.zotero.org/google-docs/?sasqrz https://www.zotero.org/google-docs/?wvsflj https://www.zotero.org/google-docs/?wvsflj https://www.zotero.org/google-docs/?wvsflj https://www.zotero.org/google-docs/?wvsflj https://www.zotero.org/google-docs/?pxxrxn https://www.zotero.org/google-docs/?pxxrxn https://www.zotero.org/google-docs/?pxxrxn https://www.zotero.org/google-docs/?pxxrxn https://www.zotero.org/google-docs/?7ut5kf https://www.zotero.org/google-docs/?7ut5kf https://www.zotero.org/google-docs/?7ut5kf https://www.zotero.org/google-docs/?7ut5kf ducar, the right to refuse treatment, voices in bioethics, vol. 1 (2014-15) © 2015 author and author. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credi ted. cassandra’s choice: the right to refuse treatment dallas ducar keywords: refuse treatment, rights, ethics introduction cassandra, a teen patient from connecticut, was diagnosed with hodgkin lymphoma in september 2014. after being diagnosed, she and her mother missed several appointments, motivating providers at connecticut children's medical center to notify the state department of children and families.the child welfare agency investigated cassandra’s situation and a trial court soon granted temporary custody over her wellbeing.cassandra will turn 18 in september of next year and therefore, in the eyes of the court, is still considered a minor and unable to make her own medical decisions. the case went to the connecticut supreme court and the court concluded that cassandra was not mature enough to make her own medical decisions.however, cassandra and her mother both are continuing to rebuke the treatment, calling the chemotherapy treatment “poison” being injected against the patients will. cassandra’s mother, jackie, claimed that she was not being negligent and instead seeking alternative treatments to chemotherapy. according to clinicians at connecticut children’s medical center, chemotherapy would allow an 85 percent chance of survival for cassandra, while withholding it would result in her dying within two years.cassandra had previously been described in november as “very bright” by court documents, with a lucid understanding of her condition. however, she is now confined within a room at connecticut children’s medical center where she is now mid-treatment. analysis in most cases, adults have the option to reject a medical treatment despite how successful it may prove in saving the patient’s life. the patient’s wishes are generally treated with utmost respect, and if the patient is too young, the patient’s legal guardian may represent the patient’s wishes. in this case, legal guardianship was transferred to the state department of children and families. while cassandra is not considered mature enough to make a choice regarding her own medical decision in this case, she is able to make others due to connecticut law. in connecticut, a 17 year old is allowed to obtain contraception, seek psychiatric care, and undergo an abortion, all without parental consent. this begs the question, what does it mean to truly be mature enough to make rational decisions regarding one’s own care? the court was specifically reviewing this case under the “mature minor doctrine,” already recognized by many other states. in these cases the court allows for hearings wherein minors who are 16 and 17 can prove they are mature enough to make medical decisions. the court denied that there was substantial evidence to prove cassandra’s maturity. ducar, the right to refuse treatment, voices in bioethics, vol. 1 (2014-15) 2 according to the assistant attorney general, cassandra exhibited “magical thinking” and she was not taking her case as seriously as she should. when a patient does not make the choice society believes she should be making, when is it permissible for society to override the choice? there are more outcomes to consider besides cassandra’s chance of survival. with chemotherapy, cassandra will most likely also experience appetite changes, bleeding problems, malaise, memory changes, hair loss, nausea, sexual changes, and a weakened immune system. this change in cassandra’s lifestyle represents a liminal stage in her life, faced with forced treatment, her identity and relationship with others will change. the treatment will change her. quality of life will be drastically reduced and this is not easy to accept for anyone in this case. for cassandra, her quality of life is more important than overall health. the clinicians at connecticut children’s should respect her wishes; while it may not be easy, it is the right thing to do. law may dictate that she is not mature enough, however, she is still a human with wishes, hopes, and desires. if cassandra does not want the “poison” injected into her body, the clinician should honor these wishes, and be there to hold her hand. conclusion legally, cassandra may become an adult overnight, but psychologically she has faced circumstances many adults never have to confront until much later. cassandra is faced with the prospects of depravity, disability, and death, she wants to live according to her wishes.does the state and the hospital truly have the right to dictate what will happen to her body more so than she does? is mortality all that should be considered in this case?healing is not a zero-sum game, it is a deeply meaningful process that requires the patient to approve of the treatment, trust the healer, and accept what may come. ducar, the ethics of introspection, voices in bioethics, vol. 2 (2016) © 2016 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the ethics of introspection: reducing healthcare costs and inspiring wellbeing with ancient philosophy dallas ducar keywords: philosophy, introspection with u.s. healthcare costs rising and threatening to bankrupt the nation, many critics have turned a critical eye to the healthcare system. according to the world health organization (who), in 2013, the u.s. spent more on healthcare per capita ($9,146), and more on health care as percentage of its gdp (17.1%), than any other nation.[1] moreover, in the past ten years healthcare costs have nearly doubled from $1.2 trillion to $2.3 trillion.[2] critics of these rising costs cite wasteful procedures, excessive testing, fear of malpractice law suits, and administrative costs as among many of the reasons healthcare costs have increased. higher incidence of comorbid disease offers a likely explanation for this escalation. specifically, patients struggling with a ‘physical disorder’ and a diagnosis of depression, anxiety, or other mental illnesses, generally have higher disease burdens; more additive function impairment; incur higher medical costs; and demonstrate lower rates of selfcare and adherence.[3] if it is clear that patient care is more expensive and less effective when the patient is also diagnosed with a mental illness, what are we doing about it? current standard of care seeks to bandage symptoms. mental illnesses tend to get chalked up to ‘brain chemistry imbalances’ despite the fact that there is little evidence for this hypothesis. with over 100 known neurotransmitter systems in the human brain, it is no longer plausible that a single medication can fundamentally alter neurotransmission and therefore result in wellbeing.[4] unfortunately, the current medical model does not focus on wellbeing, but instead, stabilization. effectively, the goal of stabilization is to minimize relapse and reduce recurrence of symptoms. the standard of care in most acute psychiatric wards and psychiatric hospitals set the bar at “returning to baseline functioning” rather than “striving for wellbeing.”[5] this standard has not always been the case. ancient moral philosophy, for example, recommended how one ought to live. the stoics and epicureans of ancient greece, saw meaning-making as essential to living – philosophy not as an abstract esoteric concept, but instead as a way of life. recent work by psychologists reflects this mindset on the basis of human morality, rooted in evolution, beginning with an assumption that morality is a shared set of intuitions regarding what is right or wrong. similar to ancient stoic and epicurean beliefs, modern science reveals a world where our virtues, character, and reflection matter. unlike current conceptions of philosophy -lofty, intellectual notions that are divorced from daily living -deep, critical thought is inherently practical because it focuses the mind. to live philosophically entails applying mindful practices to everyday tasks – even when planning a shopping list or coordinating and resolving conflict within a team. mindfulness of this sort takes the onus for promoting self-care and flourishing moment by moment, instead of debating over rule-based systems that may lose focus when applied to daily living. https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn1 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn2 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn3 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn4 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn5 ducar, the ethics of introspection, voices in bioethics, vol. 2 (2016) 2 implementing wellbeing generally depends on introspection, which has been demonstrated to be fundamental to change.[6] current leaders focus intensely on introspection. the 14th dalai lama has acknowledged this, “true change is within; leave the outside as it is.”[7] commonly used clinical theories promote the necessity of contemplation prior to acting.[8] before deciding to change or to not change, one must first turn their own perception inward. cognitive behavioral therapy, one of the most popular reflective therapies, is rooted in this ancient stoic tradition. moreover, mindfulness based therapy, another popular model, draws many of its theories from eastern traditions such as buddhism. similarly, most current therapies advocate identifying thoughts, specifically when one is stressed, and subjecting them to rational inquiry. when faced with distress, the first step is to notice the thoughts, and then act to reduce the stress. importantly, many of these techniques have been shown to be instrumental in preventing psychiatric illness.[9] if we know of models that can help to prevent illness, why do so few people practice them? one commonly cited reason for inability to introspect is overwhelming stress.[10] if we assume that the u.s. is a “stressed out nation,” is there time for reflection? most americans suffer from high stress, with 44 percent reporting that their stress levels have increased over the past five years.[6] moreover, self-care is usually not valued as a priority: only 40 percent of americans rate their mental health as very good or excellent.[6] one commonly cited problem is lack of willpower, however 70 percent believe that willpower is something they can learn or improve.[11] if stress was an infectious virus, the united states would be in the midst of an epidemic. indeed, the effects of stress, similar to a disease, are deeply biological. recent developments in psychoneuroimmunology have demonstrated a clear link between mental and physical health. notably, decreased stress is correlated with a decrease in gi problems and autoimmune disorders along with faster recovery times and less hospital readmissions, among many other results.[12] we know that too much stress can cause inflammation, which can lead to life-limiting illness and perhaps dissuade the individual from actively trying to improve and regain mental health. we know that most americans are stressed; we know that most americans want to feel well; and we know that we can become healthier by engaging in reflective thought. to do this, we must take time for ourselves and for others, truly engage in philosophy as it was millennia ago, as a way of life. this is not to say that reflection is the cure all, but rather, a starting point for meaningful self-care. what does this examined life look like? it meets each and every day with the courage to be skeptical, to search for meaning, and to care deeply for others. the ancient stoics saw it as a duty to be reflective; the epicureans believed it was the path to happiness. wherever introspection may lead, it is a necessary condition to determine one’s own way of being. modern psychiatry tends to pathologize, worrying about what is wrong rather than what is right with the individual. identifying when one flourishes is the starting point for change. simply taking a moment to pause, reflect, and identify meaning in one’s life allows for the possibility of preventing future mental illness. reflection, therefore, is not an ethical imperative for clinicians, but all levels of society. just as handwashing was revolutionary in terms of disease prevention and led to new standards of hygiene, mental hygiene has the capability to be equally as powerful. reflection has been shown to improve wellbeing and reduce healthcare utilization and costs. specifically, mindfulness-based stress reduction has been shown to be effective on both fronts.[13] this process is not an otherworldly esoteric process, but a very real and imperative action. one has the capability to engage in therapeutic processes that can reduce the incidence and prevalence of mental and physical illness. lower incidence of illness has the very real impact of reducing healthcare costs – entirely prudent and necessary in the current economic climate. now is the time to encourage reflection, not just for the sake of economic gains, but to foster human flourishing. https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn6 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn7 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn8 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn9 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn10 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn6 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn6 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn11 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_edn12 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[2] national center for health statistics. health, united states: 2013. hyattsville, md. (2014). available at http://www.cdc.gov/nchs/data/hus/hus13.pdf [3] katon, w., & ciechanowski, p. (2002). impact of major depression on chronic medical illness. journal of psychosomatic research, 53(4), 859-863. [4] kandel, e., schwartz, j. & jessell, t. (2000). principles of neural science. new york: mcgraw-hill, health professions division. [5] weiden, p., & daniel, d. g. (2005). the standard of care in treating psychiatric disorders. johns hopkins university school of medicine advanced studies in medicine, 5, s216-s239. [6] bohner, g., and nina d. (2011). attitudes and attitude change, annual review of psychology, 62: 391– 417. [7] lama, d. (2012). how to practice: the way to a meaningful life. random house. [8] prochaska, j. o., & velicer, w. f. (1997). the transtheoretical model of health behavior change. american journal of health promotion, 12(1), 38-48. [9] teasdale, j. d., segal, z. v., williams, j. m. g., ridgeway, v. a., soulsby, j. m., & lau, m. a. (2000). prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. journal of consulting and clinical psychology, 68(4), 615. [10] siegel, d. j. (2015). the developing mind: how relationships and the brain interact to shape who we are. guilford publications. [11] american psychological association. (2011). stressed in america. monitor on psychology. retrieved from http://www. apa. org/monitor/2011/01/stressedamerica. aspx on, 5(1), 2013. [12] pace, t. w., & heim, c. m. (2011). a short review on the psychoneuroimmunology of posttraumatic stress disorder: from risk factors to medical comorbidities. brain, behavior, and immunity, 25(1), 6-13. [13] roth, b., & stanley, t. w. (2002). mindfulness-based stress reduction and healthcare utilization in the inner city: preliminary findings. alternative therapies in health and medicine, 8(1), 60. https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref1 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref2 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref3 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref4 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref5 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref6 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref7 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref8 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref9 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref10 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref11 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref12 https://michael-reaves-bkln.squarespace.com/features/2016/02/15/the-ethics-of-introspection-reducing-healthcare-costs-and-inspiring-wellbeing-with-ancient-philosophy#_ednref13 bove, the united states should consider compulsory sars-cov-2 vaccinations, voices in bioethics, vol. 6 (2020) * margaret bove, candidate for ms bioethics, columbia university © 2020 margaret bove. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the united states should consider compulsory sars-cov-2 vaccinations margaret bove* abstract several laboratories across a multitude of countries have begun to develop a vaccine1 for sars-cov-2 with anticipated public arrival as early as late 2020. however, a vaccine is not effective at the population level if only a few decide to receive it. herd immunity (or “herd protection”) is the phenomenon that occurs when a sufficient proportion of a population is immune to a virus (through natural exposure or vaccination). keywords: covid-19, vaccine, mandatory vaccination introduction as we face this unprecedented epidemic, researchers are racing to develop a cure and find ways to prevent more infections in the future. yet, with so much uncertainty about the future of this virus (i.e. will we experience another influx of cases? will it disappear over the summer and return come autumn?), the current absence of an effective therapy,2 and limited research on natural immunity to the disease through direct exposure,3 it seems the only certainty is that a vaccine could be a solution. several laboratories across a multitude of countries have begun to develop a vaccine4 for sars-cov-2 with anticipated public arrival as early as late 2020. however, a vaccine is not effective at the population level if only a few decide to receive it. herd immunity (or “herd protection”) is the phenomenon that occurs when a sufficient proportion of a population is immune to a virus (through natural exposure or vaccination). this decreases the amount and/or duration of pathogen shedding, thereby reducing the spread of a pathogen to susceptible individuals.5 herd immunity is obtained most easily and safely through widespread vaccination, and it is essential to protecting the most vulnerable. this includes individuals of lower socioeconomic status who are more likely to have high-risk comorbidities, the immunocompromised, the elderly, and those with disabilities. the question then arises: should we consider mandating compulsory vaccinations for sars-cov-2? is this the only way to ensure the virus does not return (at least not in a way that will overwhelm our medical system and disproportionately harm the most vulnerable)? ____________________________________________________________ bove, the united states should consider compulsory sars-cov-2 vaccinations, voices in bioethics, vol. 6 (2020) 2 analysis the prospect of compulsory vaccinations has an arduous history in the united states dating back to the 1905 court case jacobson v. massachusetts when, in the face of the smallpox epidemic, henning jacobson refused vaccination, arguing that the law requiring all adults vaccinate or pay a fine was an infringement on his autonomy and “an assault on his person”6 (he was fined five dollars after the court ruled that no person was ever forced into compliance).7 in the modern era, the conversation has largely shifted its focus toward childhood vaccinations. a combination of poorly conducted research,8 sensational media coverage, safety concerns, desire for additional education, and philosophical opinions about “natural” immunity have all been cited as reasons that people refuse to vaccinate.9 as a result, many parents have claimed exemptions to vaccinations, and consequently, outbreaks of preventable diseases such as measles have struck several communities across the country.10 now, this is not to say that these fears are entirely unwarranted. although most adverse reactions to vaccinations are quite mild, there are some known, extremely rare potential side effects to some common childhood vaccinations.11 these, however, are frequently mitigated through proper medical screening and exemption. furthermore, rigorous research on the efficacy and safety of the sars-cov-2 vaccine prior to fda approval will help to prevent our most vulnerable populations from experiencing adverse effects. government control over vaccine research and use of the national vaccine injury compensation program (vicp)12 can ensure potential adverse outcomes are limited and properly addressed. furthermore, educational resources and proper use of the media can help establish trust in concerned populations. the greater philosophical discussion of the value of personal autonomy in the u.s., however, is much more complicated. the case for autonomy may be summarized as the right to choose for oneself. culturally and constitutionally, it is considered to be a fundamental right in the u.s., and supreme court cases have ruled in favor of autonomy and the right to bodily integrity time and time again, as demonstrated in roe v. wade (1973)13 and griswold v. connecticut (1965).14 there is a basic philosophy of autonomy: any person with capacity and competence has the right to choose what they deem to be in their own best interests, and a right to protect their body from unwanted intrusion or harm. a competent patient cannot be forced to undergo surgery, nor can they be held against their will in the emergency room, nor forced to receive a blood transfusion if they are a jehovah’s witness. there is, however, a second part to this philosophy: an autonomous decision may not pose significant risk or harm to another person. consequently, the case for personal autonomy and bodily integrity in the context of highly infectious diseases is weak. unlike many other personal medical decisions (e.g. discontinuing treatment for a terminal cancer, signing a dnr order, or refusing a transplant), refusing to vaccinate is not a decision that affects the patient independently. instead, it poses a threat to any community member who is unable to vaccinate for legitimate medical purposes. moreover, i argue that a mandatory vaccination program does not significantly inhibit the autonomy of any normally healthy person (where the risk of harm from vaccination is incredibly low), but rather it acts to protect those who are not already in good health (where the risk of infection is significantly high). a compulsory vaccination program would serve as a viable public health effort to protect the most vulnerable groups. in the case of covid-19, this includes those who are immunocompromised, diabetic, elderly, obese, or with chronic heart or lung disease.15 vaccination should therefore be considered a moral responsibility of the healthy. in essence, the argument for autonomy simply does not carry enough significance when weighed against community-level beneficence. bove, the united states should consider compulsory sars-cov-2 vaccinations, voices in bioethics, vol. 6 (2020) 3 this novel coronavirus also raises an entirely new dilemma not often faced with other infectious diseases – scarcity of resources. for those who become extremely ill, treating this disease requires invasive, expensive, and scarce medical resources. many of the patients admitted to the hospital are placed on ventilators and their healthcare providers require copious amounts of personal protective equipment. as many states reach their projected peak of new cases, many hospitals continue to teeter on the edge of maximum capacity. hospital ethics committees face the real possibility of deciding to withdraw or withhold care to preserve resources for those with a higher chance of survival.16 this has raised alarms for disability rights groups,17 as should a purely utilitarian approach be applied to resource allocation, people with many cognitive and physical disabilities may be denied treatment despite the fact that it violates the american with disabilities act.18 as we look toward the future of this pandemic, it is unclear if hospitals will face another spike of cases come autumn that will, once again, stretch resources and place many lives at risk. i argue that we have a moral duty to do what we can to prevent this ethical quandary from occurring as part of an effort to protect those with high-risk comorbidities and disabilities. these individuals deserve equal moral value under the utilitarian practices that guide triage decisions. this is most easily realized through a compulsory vaccination program for sars-cov-2. there is a caveat, however. should a mandatory vaccination program be implemented, cost should not represent a limitation. this virus already disproportionately affects those of lower socioeconomic status.19 populations already at increased risk of contracting the virus should not be denied access to the vaccine due to cost. if vaccination becomes mandatory, these populations should not incur the burden of cost. for such a system to be considered just, the u.s. government must be willing to cover the cost of sars-cov-2 vaccination for everyone. conclusion we cannot be certain what the next several months will look like. this novel coronavirus may fade over the summer, or it may return in the fall, and we may experience another spike in cases. nevertheless, in the absence of effective therapeutic measures, and assuming a vaccine becomes available, the risk of repeating our current situation is too high and we must consider mandatory vaccination as a real possibility. personal liberty does not give one the right to endanger another person, and people have an individual right to be protected from others who may place them in danger. even a culture that prides itself on individual choice and personal liberty should be willing to see the crucial need for such measures. it is thought that younger generations are unwilling to trust vaccines because they have not experienced outbreaks such as smallpox or polio, and therefore do not believe vaccines are an effective or necessary tool in preventing disease. perhaps this pandemic will be the experience that motivates them to reconsider and reappreciate the role of vaccination in our lives. with that in mind, we can begin to ask again, is the ongoing pandemic the catalyst we needed for compulsory vaccinations to enter the forefront of health policy discourse? bove, the united states should consider compulsory sars-cov-2 vaccinations, voices in bioethics, vol. 6 (2020) 4 1 jeff craven. “covid-19 vaccine tracker.” regulatory affairs professionals society (raps). regulatory focus, april 10, 2020. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker. 2 “therapeutic options for covid-19 patients.” centers for disease control and prevention. centers for disease control and prevention, march 21, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html. 3 apoorva mandavilli. “can you become immune to the coronavirus?” the new york times, march 25, 2020. https://www.nytimes.com/2020/03/25/health/coronavirus-immunity-antibodies.html?auth=link-dismiss-google1tap. 4 jeff craven. “covid-19 vaccine tracker.” regulatory affairs professionals society (raps). regulatory focus, april 10, 2020. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker. 5 fe andre, r booy, hl bock, j clemens, sk datta, tj john, bw lee, et al. “vaccination greatly reduces disease, disability, death, and inequity worldwide.” bulletin of the world health organization 86, no. 2 (february 2008): 81-160 6 da salmon, sp teret, cr macintyre, d salisbury, ma burgess, and na halsey. “compulsory vaccination and conscientious or philosophical exemptions: past, present, and future.” lancet 367, no. 9508 (4 february 2006): 436-42 7 wendy k mariner, george j annas, and leonard h glantz. “jacobson v massachusetts: it's not your great-great-grandfather's public health law.” american journal of public health 95, no. 4 (april 2005): 581–90. https://doi.org/10.2105/ajph.2004.055160. 8 aj wakefield, sh murch, a anthony, j linnell, dm casson, m malik, m berelowitz, et al. “retracted: ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.” the lancet 351, no. 9103 (february 28, 1998): 637–41. https://doi.org/10.1016/s0140-6736(97)11096-0. 9 chephra mckee and kristin bohannon. “exploring the reasons behind parental refusal of vaccines” the journal of pediatric pharmacology and therapeutics 21, no. 2, (mar-april 2016): 104-109 10 “measles cases and outbreaks.” centers for disease control and prevention. centers for disease control and prevention, april 6, 2020. https://www.cdc.gov/measles/cases-outbreaks.html. 11 “vaccines: vac-gen/side effects.” centers for disease control and prevention. centers for disease control and prevention, april 2, 2020. https://www.cdc.gov/vaccines/vac-gen/side-effects.htm. 12 “national vaccine injury compensation program.” official web site of the u.s. health resources & services administration, january 7, 2020. https://www.hrsa.gov/vaccine-compensation/index.html. 13 roe v. wade, 410 u.s. 113 (1973) 14 griswold v. connecticut, 381 u.s. 479 (1965) 15 shikha garg, lindsay kim, michael whitaker, alissa o’halloran, charisse cummings, rachel holstein, mila prill, et al. “hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019 – covid-net, 14 states, march 1-30, 2020” mmwr morb mortal wkly rep 69, (april 8, 2020). https://dx.doi.org/10.15585/mmwr.mm6915e3 16 mike baker, and sheri fink. “at the top of the covid-19 curve, how do hospitals decide who gets treatment?” the new york times, march 31, 2020. https://www.nytimes.com/2020/03/31/us/coronavirus-covid-triage-rationing-ventilators.html. 17 “protect rights of people with disabilities during covid-19.” human rights watch, march 26, 2020. https://www.hrw.org/news/2020/03/26/protect-rights-people-disabilities-during-covid-19. 18 amy osteen. “preventing discrimination in the treatment of covid-19 patients: the illegality of medical rationing on the basis of disability.” disability rights education & defense fund, april 2, 2020. https://dredf.org/the-illegality-of-medicalrationing-on-the-basis-of-disability/. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker https://doi.org/10.2105/ajph.2004.055160 https://doi.org/10.1016/s0140-6736(97)11096-0 https://www.cdc.gov/measles/cases-outbreaks.html https://www.cdc.gov/vaccines/vac-gen/side-effects.htm https://www.hrsa.gov/vaccine-compensation/index.html https://dx.doi.org/10.15585/mmwr.mm6915e3 https://dredf.org/the-illegality-of-medical-rationing-on-the-basis-of-disability/ https://dredf.org/the-illegality-of-medical-rationing-on-the-basis-of-disability/ bove, the united states should consider compulsory sars-cov-2 vaccinations, voices in bioethics, vol. 6 (2020) 5 19 max fisher, and emma bubola. “as coronavirus deepens inequality, inequality worsens its spread.” the new york times, march 15, 2020. belisomo, media landscape opens opportunity, voices in bioethics, vol. 1 (2014-15) © 2015 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. media landscape opens opportunity for earlier, better end of life care: asco’s inaugural palliative care symposium randi belisomo p.a.u.s.e., r.e.m.a.p., bioethics introduction the prevalence of end of life decisions in current media and literature provides an opening for physicians to prompt conversations about the subject with patients, said anthony back, a seattle cancer care alliance medical oncologist, in remarks to the palliative care oncology symposium in boston. before beginning such difficult dialogue, however, he offered frameworks to facilitate end of life conversations both early and later on in a patient’s disease trajectory. analysis the symposium was the first such hosted by the american society of clinical oncology to promote discussion and integration of palliative care—a medical specialty designed to address physical, emotional and psychological symptoms of disease. the meeting drew an international audience of medical, radiation and surgical oncologists along with nurses, social workers and physician assistants. “this is a window of opportunity to get in the public dialogue in a really public way,” back said during a session addressing the skills required for optimum end of life care. back pointed to the new york times’ widely-circulated coverage of joseph andrey and his daughter’s struggle to honor his wish to die at home. back also outlined social efforts underway nationwide as a result of a project that began in his home of seattle, death over dinner, along the success of physician atul gawande’s new book, being mortal. “this reflects the work done over the last 20 years that set the stage for this discussion,” back said. “being mortal wouldn’t be on the new york times’ best-seller list if not for the work you are doing.” he emphasized, however, that work remains to help physicians charged with navigating patients through the complex medical decisions they may face as they approach the end of their lives. “the task for physicians is the question of ‘how do we get to telling patients that we will give them an extra layer of support to talking about the really tough stuff?’” back said. communication, he warned, is a learned expertise that must include frank, explicit discussion about what may happen when curative treatment options are no longer available. “we have to role model the developmental pathway to wanting to do this, to learning to do this, to becoming a ninja,” back said to laughter and applause. physicians miss opportunities to educate patients about what may be ahead in one of three ways, he said: belisomo, media landscape opens opportunity, voices in bioethics, vol. 1 (2014-15) 2 1) in thinking “bad stuff won’t be quite so bad” if you don’t talk about it, 2) by delaying discussion about “bad stuff until you absolutely have to,” or 3) in thinking that “cutting to the chase” will save time and decrease patient distress. those approaches are faulty, back warned, and asked the audience to consider how they may move such conversations “upstream” in ways that will not “completely freak everyone out.” for end of life dialogues occurring early on in a patient’s illness—the optimal time for such conversation— back offered the framework p.a.u.s.e: a. p.a.u.s.e. for early end of life dialogue • pause: as “time” is often cited by physicians as a barrier to facilitating what can be a lengthy and complex discussion, they should stop to consider that this conversation may be more important than one about further treatment options. • ask permission: physicians should ask for permission to have this conversation and explain its importance. “could we take a moment?” or “this will help me guide you,” are two conversationstarters that prove empowering to the patient. • suggest a surrogate: patients who do wish to engage in advance care planning are often thwarted by confusion about proxy selection. physicians should ask simply, “who is the person who knows you the best?” • expect emotion: the many emotions that accompany such conversations often add to the time required to facilitate dialogue, further necessitating the need for physicians to “pause.” doctors must empathize and realize the topic is a tough one for everyone in the room. for end of life discussions taking place later in a patient’s disease course, back offered the framework r.e.m.a.p: b. r.e.m.a.p. for late end of life dialogue • reframe: physicians are obligated to communicate that the “status quo” is no longer working. however, they often face tough follow ups: “there’s another chemotherapy after this one, right?” “i only want to talk about positive things,” or “i want to be aggressive.” • expect emotion: in response to these follow ups, there is even greater urgency to empathize with patients from the start. • map: the conversation should turn to what a patient finds most important and to his or her goals. physicians should explore patients’ interests, ask to see photographs and inquire about special family occasions or milestones. • align: physicians should ask about a patient’s values and the beliefs guiding any particular goal. • plan: the final step for physicians taking part in late end of life dialogues is to match any particular treatment to a patient’s stated values. conclusion back acknowledged that the execution of a “p.a.u.s.e.” or “r.e.m.a.p.” conversation is often met with resistance. “patients often say ‘it doesn’t feel like time to give up,”” back said. “assure them that ‘i’m not giving up on you.’” introduction a. p.a.u.s.e. for early end of life dialogue b. r.e.m.a.p. for late end of life dialogue conclusion holmquist, the challenges of preventive screenings, voices in bioethics, vol. 1 (2014-15) * stephanie holmquist, ms bioethics © 2014 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the challenges of preventive screenings stephanie holmquist* keywords: bioethics, ethics, preventative screening, diseases introduction implementing preventive care and screening test strategies to reduce disease and illness continues to prove challenging. assessing the efficacy of screening and preventive interventions requires ongoing monitoring and consistent revision of standards of care to incorporate new information. some items recently in the news echo the continuing difficulties of crafting preventive strategies to deliver real benefits. analysis preventive care ought to reduce the incidence of disease. however, prevention efforts may pose unanticipated risks. reporting in the current issue of infection control and hospital epidemiology, u.s. investigators asked, “are well-child visits a risk factor for subsequent influenza-like illness visits?” 1 the answer appears to be yes. while the goal of well child visits is health maintenance, this study’s authors identified pediatric waiting rooms as a potent source of infection for children and their parents. based in data from 1998-2006, conservative estimates are that wellness visits may be responsible for as many as 700,000 excess cases of influenza in the u.s. each year. the authors suggest two strategies for reducing the numbers of incidental flu infections from well child visits—adherence to standard infection control policies in waiting rooms and scheduling well-child visits outside of peak influenza seasons. when and if mammography’s benefits outweigh the risks of over-diagnosis and treatment of breast cancer continues to be in dispute. publishing in the february 11th issues of the british medical journal, canadian researchers concluded that screening women under 60 produces no benefit when compared to breast self-exam plus an annual physician exam. the authors are reporting further findings of a contentious study, now in its 25th year.2 this canadian research adds to uncertainties for women and their physicians. in 2009, the independent u. s. preventive services task force (u.s.p.s.t.f) recommended against routine screening for women under 50 and only bi-annual screens for older women. 3pushback from physician and breast cancer advocacy groups to the u.s.p.s.t.f. recommendations is echoed by immediate challenges to the new canadian report. 3, 4 holmquist, the challenges of preventive screenings, voices in bioethics, vol. 1 (2014-15) 2 conclusion on the prostate cancer front, screening for prevention may soon take a step forward. as in breast cancer, overdiagnosis and treatment of non-aggressive prostate cancers diminishes quality of life. faced with elevated psa scores, physicians and patients have had few tools to guide decisions on opting for “watchful waiting” or choosing surgical and other interventions—and their risks. new research suggests genetic assessment of the risk of aggressive prostate cancer may be available soon for improved clinical guidance. reporting in the british journal of cancer on february 20th, researchers identified 13 mutations predisposing their carriers to invasive forms of prostate cancer.5 among the genes tested for were variants of brca1 and brca2, familiar as risk factors in some heritable breast cancers. genetic testing combined with psa screening should allow for more accurate risk assessment timely treatment for some men at higher risk. 1 simmering, j. e. are well-child visits a risk factor for subsequent influenza-like illness visits? infection control and hospital epidemiology 35, 251-256, doi:10.1086/675281 (2014). 2 miller, a. b. et al. twenty five year follow-up for breast cancer incidence and mortality of the canadian national breast screening study: randomised screening trial. bmj 348, doi:10.1136/bmj.g366 (2014). 3 force, u. s. p. s. t. screening for breast cancer: u.s. preventive services task force recommendation statement. annals of internal medicine 151, 716-726, w-236, doi:10.7326/0003-4819-151-10-200911170-00008 (2009). 4 woolf, s. h. the 2009 breast cancer screening recommendations of the us preventive services task force. jama 303, 162-163, doi:10.1001/jama.2009.1989 (2010). 5 leongamornlert, d. et al. frequent germline deleterious mutations in dna repair genes in familial prostate cancer cases are associated with advanced disease. br j cancer, doi:10.1038/bjc.2014.30 (2014). stephanie holmquist, boxing and neuroethics, voices in bioethics, vol.1, 2014-2015 © 2014 stephanie homquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. boxing and neuroethics stephanie holmquist keywords: neuroethics, contact sports, brain injury, football muhammad ali has parkinson’s disease. ken norton barely speaks and moves slowly using a walker. these giants of the “the sweet science of bruising” are the most prominent victims of the sport, but an estimated 20 -50% of former professional fighters suffer or will from boxing related brain injuries. over the last two decades, evidence has accumulated that blows suffered in the ring lead to these sad outcomes. a successful career is no protection from a life altering brain injury syndrome, generally labeled chronic traumatic brain injury (ctbi). since the 1980s, the ama and other medical organizations worldwide have called for bans on boxing, to little avail. so, as brains continue to be battered, it’s time to revisit the issue. partisans will argue that bo xing is being unfairly singled out. they are partially correct—singled out, yes, but not unfairly. success in the ring is giving and taking brain-endangering hits. in contrast, the goals of football and hockey do not depend on inflicting blows to the brain, although contact sports should and are being pressured to make their games more brain safe. physicians must act against a practice which damages its participants so profoundly. if boxing can be made much safer, as has been suggested, let’s welcome that change. but if not, it should, like bullfighting, go from culturally lauded to disreputable. boxing can be pressured to reform or retreat in two ways. first, researchers of ctbi should highlight their work in the popular media. for example, the cleveland clinic’s lou ruvo center studies fighters for early signs of brain injury and possible prevention. their research is an example of an ethically correct and compassionate stance towards these athletes. second, and more radically, physicians need to refuse some services to youth and professional boxing. pediatricians and specialists in adolescent medicine should respect and promote the american association of pediatrics (aap) 2011 statement opposing youth boxing. this means more than speaking frankly to parents about risks, as the aap suggests. it also means refusing to serve where boxing takes place and declining to certify that children can safely box when permissions are required. these last two steps were neglected by the aap, which called on doctors to provide “appropriate medical care…for children and adolescents who…participate in boxing." office and ed care must remain available to young boxers. but no stronger statement on boxing’s undue risk to children could be made than for the physicians to remove themselves from the ring. if the result is that youth boxing stalls, so be it. similarly, doctors don’t belong ringside at professional fights or at pre and post-bout exams, as many states require. just as physicians are ethically excused from engaging in capital punishment by lethal injection, it is intolerable that physicians lend themselves to this program of gladiatorial self -destruction. physicians who do so should be censured and labeled enablers of disease. ducar, trading autonomy for therapy, voices in bioethics, vol. 1 (2014-15) © 2014 ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. trading autonomy for therapy dallas m. ducar keywords: autonomy, therapy, mental health, bioethics, ethics introduction the city board of supervisors of san francisco county is considering implementing a law which would mandate “assisted outpatient therapy,” known to many as involuntary treatment of mental health patients on an outpatient basis.1 this law would specifically target those who have refused aid from san francisco county. the law was originally passed by the california state legislature in 2002, however, for it to be authorized the city’s county board of supervisors must first authorize it locally and pass a resolution. ____________________________________________________________ ducar, trading autonomy for therapy, voices in bioethics, vol. 1 (2014-15) 2 analysis while 44 u.s states have authorized similar laws, only two counties within california have passed a resolution on laura’s law. san francisco county had already denied passage of the law once after public health officials claimed that compelled medication was necessary for laura’s law to have its intended effect. the law specifically attempts to break the cycle of patients wandering from the streets and then to the hospital or jail, and back again. advocates for the law claim that it will save the city money in the long-run, and ensure more mental health patients are receiving the aid they require. however, in 2001 the rand corporation reviewed the effectiveness of involuntary outpatient treatment and concluded that they could not assertively declare whether the treatment is effective or not.2 still, advocates of the law claim that it has the possibility to preclude further calamities, such as the killing of laura wilcox, for whom the law is named after, or additional mass shootings. but how effective will a treatment be when the patient is opposed to the clinician? mental health treatment depends on a fiduciary relationship between clinician and patient, one that is unlikely to form when the patient is forced into treatment. leaving efficacy off the table, deeper ethical issues are at stake here. while many groups throughout the county have been included in the discussion regarding laura’s law, one group omitted has been the mental health patients themselves. perhaps the county should be going to the potential patients directly and encourage discussion regarding laura’s law. moreover, all of us should consider one question, “is it morally reprehensible to compel people to be treated against their will?” mental health patients have commonly been treated as second-class citizens, with little say in the workings of their own community. moreover, patients with severe conditions have often been equated with violent offenders. the macarthur community violence study, an in-depth analysis of the prevalence of the risk of violence among newly released mental health patients, concluded: “the prevalence of violence among people who have been discharged from a hospital and who do not have symptoms of substance abuse is about the same as the prevalence of violence among other people living in their communities who do not have symptoms of substance abuse.”3 why then are mental health patients equated so closely by society to violent offenders? contemporary research that has drawn other conclusions and proposals such as laura’s law may possibly increase stigma surrounding mental health diagnoses and treatment. conclusion before continuing with the possibility of involuntary treatment, governments should consider the ethical ramifications of treating a patient without consent. in 2011 the county launched community independence placement project (cipp), which started as a program wherein patients could be referred for treatment and ducar, trading autonomy for therapy, voices in bioethics, vol. 1 (2014-15) 3 would have to voluntarily agree to participate. cipp administrators have noted that many who have voluntarily signed up for cipp have gone on to lead healthy, independent lives. perhaps treating patients cannot and should not be resolved by violating autonomy. at the very least, this law highlights the government’s utilitarian position, that violating autonomy is permissible when in the best interest of the whole. more preventative measures should be taken to ensure patients are never in need of such severe treatment. furthermore, it is highly likely that better outcomes will follow suit when working compassionately with patients and ensuring a trusting relationship is developed, rather than involuntary treatment. instead of resorting to brute force tactics, societies, such as san francisco county, should include current and prospective patients, in dialogue, instead of omitting them entirely from the decision-making process. 1 http://www.sfbos.org/index.aspx?page=16358 2 ridgely, m. s., borum, r., & petrila, j. (2001). the effectiveness of involuntary outpatient treatment: empirical evidence and the experience of eight states. rand. 3 steadman, h., mulvey, e., monahan, j., robbins, p., appelbaum, p., grisso, t., roth, l., & silver, e. (1998). violence by people discharged from acute psychiatric inpatient facilities and by others in the same neighborhoods. archives of general psychiatry, 55, 393-401. http://www.sfbos.org/index.aspx?page=16358 howard, ethicizing the ebola epidemic, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethicizing the ebola epidemic louisa howard ebola, bioethics, epidemic introduction it is the topic of almost every healthcare, political, and legal news article—ebola. last month, the world health organization stated that the 2014 outbreak, which originated in western africa, has killed more than 1,000 people. this year’s epidemic marks the largest and most dangerous ebola outbreak ever documented. as the number of cases grows, another significant topic has surfaced—the ethical implications surrounding this public health nightmare. analysis although no current vaccine or treatment has been identified to cure this deadly disease, scientists are working relentlessly to find an effective treatment and a few experimental vaccines are already available in limited quantities. the possibility of an experimental cure poses many ethical questions, including allocation. however, before the ethical issue of drug or vaccine allocation can even be considered, another ethical dilemma must be addressed—is it ethical for experimental drugs and or vaccines to be distributed before proper research has deemed them safe? conventionally, for drugs to be used in clinical care, they must be researched for many years and tested in vitro, on animals, and in systemized clinical trials before distributed to and implemented in the wider community. yet, with the onset of a public health emergency, like the current ebola crisis, the regular protocol for proper testing must be reevaluated. global ethics comes into play as healthcare workers engaged in containing the spread of this fatal disease must weigh the risks of using experimental therapies whose effects are still unclear. in medical ethics, the fundamental code doctors must follow is “do no harm.” nevertheless, regarding a disease like ebola, with an approximate 90% mortality rate in some areas, the harm is already being done. the likelihood of survival is so slim that experimental therapies might be the only way to save a dying patient. in medical emergencies, such as this, i believe there should be guidelines allowing for exceptions to general rules regarding experimental testing. the fda already has a reserve procedure allowing doctors to apply investigational drugs in cases for which there is no other alternative. although disagreements inevitably arise over what constitutes an emergency, i think in this current situation the only option is to make exceptions. moreover, as mentioned above, if experimental drugs or vaccines were to be allowed, and informed howard, ethicizing the ebola epidemic, voices in bioethics, vol. 1 (2014-15) 2 consent was obtained, the issue of allocation poses many more ethical questions, starting with—who should be treated first? in august, two american workers providing aid relief in africa who contracted the virus were given an experimental drug, zmapp. these patients were two of only three infected individuals with access to the drug. both of the patients survived, and are doing well now. although it has not been proven whether or not the drug played a part in curing the patients, this circumstance provokes the question of whether it was fair that these two individuals were administered the drug while hundreds of others, including doctors aiding in the cause, have no access to any experimental therapies. ethics inevitably comes into play with regard to equality in distribution based on fundamental factors including race, religion and ethnicity. conclusion for now, while scientists work to discover a safe and effective treatment regimen, the most ethical thing health care providers can do is to provide basic care to those in need. at this point, the primary goal is to try and contain the disease. as demonstrated from the rapid spread of other diseases in our modern world, public health crises affect us globally. even if there are drugs to help prevent or cure the virus, public health infrastructure is the fundamental key to prevent medical mayhem. ethical issues will continue to arise and be debated, but what cannot be argued or ignored is the need for global cooperation to ensure that all nations can provide proper healthcare to their citizens and that each and every nation is armed with the necessary resources to prevent the further spread of this violent virus. foe, on the case of child euthanasia, voices in bioethics, vol. 1 (2014-15) * gabriella foe, ms bioethics © 2014 gabriella foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. on the case of child euthanasia gabriella foe* keywords: bioethics, ethics, children, euthanasia introduction opponents of legalizing physician assisted suicide (“pas”) argue that legalization would create a slippery slope leading to the legalization of euthanasia (also known as “mercy killing”). some believe that if pas and euthanasia are legalized, then some who are vulnerable will feel coerced to end their lives: they may feel that they are burdening their family and relatives by staying alive, and that they have a duty to die. while the united states has continued to debate the legalization of pas and euthanasia, parts of europe have practiced both for some time. analysis even many of those who support pas have qualms against euthanasia because of the idea that doctors should not kill their patients. but euthanasia has been legalized in parts of europe. in belgium, for instance, where physicians have legally performed euthanasia on adults since 2002, they are now trying to take it a step further: belgium is considering the legalization of euthanasia for children. this would mean that if a child is considered competent to make the decision, then they could be euthanized if they wish. to be sure, this brings up a number of arguments against it and, in my opinion, strengthens the slippery slope argument that is often used by those opposing the legalization of pas and euthanasia. a few points of controversy for this child euthanasia bill follow: 1) at what point does a child become competent? it is unclear whether or not competency should have an age attached to it. the netherlands already allows euthanasia for children over the age of 12, but this proposed bill in belgium would not have any age restrictions. 2) how can we be sure that the child is acting voluntarily? for a child to even ask for euthanasia, the idea must have been planted on his/her mind by either his/her parents and/or medical staff. some might say that this, in itself, is undue influence since the child may start to think and believe that he or she is a burden and no longer wanted, and thus have a duty to ask for euthanasia. some will say that it is part of informed consent that the choice of euthanasia is told to the child. foe, on the case of child euthanasia, voices in bioethics, vol. 1 (2014-15) 2 3) would the parents also have to consent to their child being euthanized? if we follow the logic that this child is considered competent, is presented with all possible choices, and chooses euthanasia, then it should follow that no parental consent is necessary. but most of us would likely think this is absurd. however, if parental consent is required, then how can we say that we are respecting the child’s autonomy as a competent person with the ability to make his or her own choices? conclusion there are surely many additional points of debate in this issue, especially when taking into consideration various religious and cultural groups. if we think about normal, daily lives of parents and children, we would think it absurd if parents grant the wishes of their children just because they continually ask for it (especially if parents believe that what they are asking for is not good for them). the rationale behind this would be that children do not yet know what is and is not right or good for them. the continual request for euthanasia would be a criterion to be fulfilled if this bill is passed. many considerations based on values and morality must be taken into account; the controversy within the adult, global community with regards to euthanasia suggests that we do not agree on what the right thing to do is. so how can we burden a child to make such a decision? references euronews. “belgium: child euthanasia bill passes latest hurdle.” 15 january 2014. http://www.euronews.com/2014/01/15/belgium-child-euthanasia-bill-passes-latest-hurdle/ pressly, linda. “belgium divided on euthanasia for children.” bbc news magazine. 8 january 2014. http://www.bbc.co.uk/news/magazine-25651758 russel, paul. “insane conversations: talking to children about euthanasia.” mercatornet: navigating modern complexities. 31 january 2014. http://www.newsxs.com/en/go/15389539/mercatornet/ http://www.euronews.com/2014/01/15/belgium-child-euthanasia-bill-passes-latest-hurdle/ http://www.bbc.co.uk/news/magazine-25651758 http://www.newsxs.com/en/go/15389539/mercatornet/ ducar, using prudence when prescribing, voices in bioethics, vol. 1 (2014-15) © 2014 dallas m. ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. using prudence when prescribing dallas m. ducar bioethics, prescription, cdc introduction over the last decade, the number of americans who took a single prescription drug increased by 10 percent, while the use of multiple prescription drugs increased by 20 percent. according to the centers for disease control and prevention (cdc) almost half of the united states population uses prescription drugs. the most commonly prescribed drugs were those used to manage high blood pressure and heart disease for patients 60 and older. additionally, the most commonly prescribed drugs for ages 20-59 were antidepressants.1 ____________________________________________________________ ducar, using prudence when prescribing, voices in bioethics, vol. 1 (2014-15) 2 analysis the increase in prescription drug use comes at a high price. in the past decade, the national pharmaceutical bill has more than doubled to a hefty $234 billion dollars. this cost is expected to increase with the rise in population, increase in acute and chronic conditions, and the growing cost of new pharmaceuticals. when examining the increasing cost, one must ask, “is this worth it?” this question is not meant demean the efficacy of pharmaceutical intervention, but rather, to examine whether clinicians are being prudent in their decisions regarding patient care. the mental health field is one area where this question should be posed. medical expenditure panel surveys conducted by the federal agency for healthcare research and quality found that more than 57 percent of patients now receive medication without psychotherapy. additionally, the portion of patients that received both psycho-therapeutic and pharmacological therapy has dropped from 40 to 32 percent.2 this statistic conflicts with the current research in the field. it has been shown that medication and psychotherapy have comparable short-term benefits, and certain psychotherapies have outperformed current medications. as antidepressants are one of the most prescribed medications nationally, it is vital to scrutinize whether they are necessary as a method of treatment. current meta-analyses of the efficacy of psychotherapy (particularly cognitive behavioral therapy) versus medications conclude that the longer-term effects outperformed newer antidepressants. 3 the combined effects of psychotherapy and medications indicate faster recovery rates, decreased rate of relapse, improved compliance and satisfaction, and lower long-term health costs.4 extended conversations and therapeutic interventions may necessitate spending more time with patients, resulting in clinicians being able to see fewer patients overall. psychiatrists and general physicians generally complain of too little time and too many patients. while less time with patients may result in more care for the overall patient population, the quality of care must be taken into account. efficacy must not be substituted for efficiency. in terms of mental healthcare, behavioral intervention may offer a decreased rate of relapse5 and lower long-term health and social service costs6 which has the potential to cease a patient’s need for chronic medication. the point is not that behavioral interventions will significantly impacts all patients, however it may be in the patient’s best interest to attempt behavioral health interventions before pursuing medication. furthermore, this approach does not necessarily preclude pharmacological interventions, but rather encourages consideration of behavioral intervention for all clinicians prior to any other approaches. behavioral interventions can be prescribed in other areas aside from the mental health field. implementing proper interventions that focus on nutrition and exercise can also help to trim down the patient’s medical bill. the reasoning here is the same, to discourage “giving fish, and instead teaching one how to fish.” the clinician has a fiduciary relationship to the patient, one that relies on trust and confidence. the clinician’s focus should not be solely on what will be efficacious in the short-term, but also the long-term effects chronic medication may have on the patient. clinicians should not put their patients on an antidepressant when behavioral therapy may be just as, or more, efficacious, and result in less longitudinal cost. every clinician has a responsibility to determine and use the most effective interventions for their patients, basing their judgment on that patient’s individual case. a clinician must also consider alternative prescriptions to medications. modern healthcare emphasizes the role of healthcare workers to fix a problem rather than prevent a problem. preventative care has been shown to be extremely efficacious in improving public health and thereby reducing the need for bandaging issues ducar, using prudence when prescribing, voices in bioethics, vol. 1 (2014-15) 3 rather than averting them. prescriptions could be written for thirty minutes of cardiovascular exercise a day, or even two additional servings of fruits and vegetables a day. organizations such as health leads connect low-income patients with basic health-related resources. clinicians participating with health leads can prescribe food, fuel assistance, housing and more.7 some may decry this approach as paternalism and assert that a clinician should not have such authority over the patient’s life. this approach does not mandate that the patient must agree to all behavioral interventions, but instead simply encourages the patient to do so. autonomy is not restricted as the mechanism of prescription leaves the final choice (to obtain and use medications) up to the patient. conclusion with the rise in prescription drug use, it is imperative for clinicians to consider viable alternatives, which may be more efficacious and less costly. this process starts with spending additional time with the patient, getting to know their lifestyle, where they come from, and how they feel about their own condition. the extra time the clinician spends with the patient may make a difference for a lifetime. 1 http://www.cdc.gov/nchs/data/databriefs/db42.htm#frequently 2 http://www.apa.org/monitor/2011/09/psychotherapy.aspx 3 spielmans gi et al, j nerv ment dis 2011;199:142–149 4 http://www.psychiatrictimes.com/articles/combining-drug-therapy-and-psychotherapy-depression 5 teasdale, j. d., segal, z. v., williams, j. m. g., ridgeway, v. a., soulsby, j. m., & lau, m. a. (2000). prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. journal of consulting and clinical psychology, 68(4), 615. 6 browne, g., steiner, m., roberts, j., gafni, a., byrne, c., dunn, e., ... & kraemer, j. (2002). sertraline and/or interpersonal psychotherapy for patients with dysthymic disorder in primary care: 6-month comparison with longitudinal 2-year follow-up of effectiveness and costs. journal of affective disorders, 68(2), 317-330. 7 https://healthleadsusa.org/ http://www.cdc.gov/nchs/data/databriefs/db42.htm#frequently http://www.apa.org/monitor/2011/09/psychotherapy.aspx ayeh, pregnancy, brain death, and a proposed louisiana bill, voices in bioethics, vol. 1 (2014-15) * derek ayeh is an alumnus of the columbia master's in bioethics program. © 2014 derek ayeh. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. pregnancy, brain death, and a proposed louisiana bill derek ayeh* keywords: pregnancy, brain death, louisiana, bioethics, ethics introduction since the moment house bill 1274 hit louisiana governor bobby jindal’s desk, it has been the subject of much debate. the bill says that if a woman is at least 20 weeks pregnant she must be kept on mechanical life support unless she has a will specifically stating that she would want support removed if she is pregnant. some have already started drawing parallels between the issues that this new bill creates and the marlise munoz case from texas, settled not so long ago (see sources below). it seems that the law is being used as a tool to infringe on the rights that women have to bodily integrity. it sounds as if pregnant women are only being allowed to make autonomous decisions far before such an incident occurs. but what if a woman in critical condition requests that support is ended at the bedside? what if her husband or parents claim that her wishes would have been to end care, similar to what happened in the munoz case? at the moment bill 1274 stands as an unethical limitation on the rights of louisiana women to make health care decisions about their bodies, decisions that in any other situation they wouldn't need a written will to make. ____________________________________________________________ ayeh, pregnancy, brain death, and a proposed louisiana bill, voices in bioethics, vol. 1 (2014-15) 2 analysis of course this proposed bill is suggesting that pregnancy is a unique case where a woman’s bodily autonomy is justly limited. state representative austin badon was quoted saying, “do we really want to pull the plug of that healthy baby,” during debates involving the bill. he and other supporters are focused on maternal-fetal conflict – what are the rights of the fetus and when do those rights equal or trump the rights of its mother? they hope to resolve this issue in at least one case: a mother’s right to die is undermined when the fetus reaches a gestational age of 20 weeks. however, choosing to prioritize fetal life at the 20-week mark seems ill-advised considering the medical uncertainty surrounding delivering preterm infants. critics of the bill are comparing it to using women as incubators because the fetus can be kept in the womb until it reaches a more acceptable gestational age. however, there is limited data concerning whether the atmosphere of the womb in a mother in critical condition or brain dead should actually support a fetus, or whether it carries its own risks in the long run. in cases like the marlise munoz’s other factors like oxygen deprivation could lead to severe fetal malformations. should hospitals allocate so many resources to preserving brain dead pregnant mothers, and for how long should they be preserved? what about the burdens of care the state would then be placing on both the hospital staff and the family of the deceased mother? even with all the life support that a hospital can muster there is no way to keep a mother’s body from eventually deteriorating. that point will differ in each case but premature births will be the inevitable end point. a fetus at 20 weeks is still three weeks away from being considered viable for birth (currently 23 weeks is the lowest standard of fetal viability). this is hugely important considering that survival rates for infants born preterm increase drastically with each additional week of gestational age (30% at 23 wks, 52% at 24 wks, 76% at 25wks according to a study by the national institute of child health and human development). gestational age also comes with an error margin of +/5 days. it’s the physician’s best estimate, not a finely calculated answer. with survival depending on the difference of 1-2 weeks a five-day discrepancy only further builds the case against the louisiana bill. even successful deliveries at 23-25 weeks come with their own set of consequences. studies show that the chances of moderate to severe disability stay at about 50% regardless of where the fetus is in the 23-25 week range. these fetuses can be affected by blindness, deafness, or cerebral palsy and many will be affected by more than one. additionally, many fetuses will experience neonatal morbidities such as respiratory distress syndrome (causing respiratory failure or apnea), various chronic lung diseases, growth failures, and various other health issues. someone should tell representative badon that there is nothing healthy about these births. conclusion to end i want to turn back to the munoz case again. what brought her case to the public’s attention was the plight of her family. it was unfortunate enough that they lost marlise, forcing them to wait to bury her, and refusing her last wishes just added salt to the wound. the proposed bill is only good for making other families shoulder similar burdens. is it acceptable for louisiana lawmakers to create such a blanket law for personal situations? let’s hope governor jindal stops the bill before it becomes a problem. kearns, revisiting nurse rivers, voices in bioethics, vol 1 (2013) © 2013 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. revisiting nurse rivers lisa kearns keywords: narrative medicine, tuskegee study, race introduction the tuskegee syphilis study’s most enduring figure is also one of its most intriguing. nurse eunice rivers was instrumental to the study for both procuring its members and then keeping them involved in it. straddling as she did the professional medical world and the world of the study’s subjects, she was the ideal link between the disparate spheres.1 over the years, historians who have studied rivers have found her to be a complex character: a black woman who betrayed her race even as she sought to improve the black subjects’ well-being; a nurse who betrayed her profession by dooming those she was charged with caring for. through modern eyes, she becomes more victim than betrayer: a victim of her gender, powerless to speak up in a man’s world, or a victim of race herself, powerless in a world controlled by whites. 2 susan smith, in “neither victim nor villain,” analyzes the tuskegee study from the perspective of rivers as a black professional, in the historical context of her gender and race. 3 another, equally compelling way to look at rivers is also within a historical context, again as a medical professional, but this time as one attempting to practice that profession during an economically devastated and racially repressive period of american history. the poverty and unemployment prevalent in the rural south of the 1920s and 1930s is the background against which rivers ought to be evaluated. and although social conditions don’t provide excuses for her involvement in the infamous study, they do offer a context in which to try to make sense of her participation. analysis the economic boom before the crash of 1929 didn’t skip the south, but its effects there were much different than in other parts of the country. by 1920, for the first time in united states history, most americans lived in cities, and by 1940 an additional 6 million farmers had left the fields for urban areas, among them cotton growers from the south.4 for rural america, then, the boom before the bust meant a population drain, and in the decade following world war i the south was the most rural region in the country.5 as wartime demand for agricultural products (chiefly cotton) gave way after armistice day to material surpluses and over farmed land, farmers migrated in droves to urban centers. left behind were those who either could not or would not follow suit. yet, david kennedy notes, “the urbanization of early twentieth-century america can be exaggerated. more than one in five working americans still toiled on the land in the 1920s.” at the same time, “a stubborn agricultural depression, the product of war and technological change, badly exacerbated the problems of the countryside.” in 1930 four-fifths of all blacks remained in the south.6 president herbert hoover decided to address the social problems of the time by gathering the brightest minds in the country (a month before the market crash of october 29, 1929) and asking them to amass nationwide data and analysis that would be, according to hoover, “the basis for the formulation of large national policies looking to the next phase in the nation’s development.” 7 the report was delivered in 1933: the exhaustive recent social trends, which provided data on everything from the nation’s mineral resources to the impact of new technology on work and home life. writes kennedy, “from its turgid prose and endless tables emerged a vivid portrait of a people in kearns, revisiting nurse rivers, voices in bioethics, vol 1 (2013) 2 © 2013 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the throes of sweeping social, economic, and political change, even before they were engulfed by the still more wrenching changes of the depression era.”8 that turgid prose also revealed a stark conclusion: if residents of the rural south were suffering during that era, black residents were suffering significantly worse. earlier immigration restrictions (via literacy tests, for example) culminated in a 1921 quota law, followed by an even more stringent one in 1924 and then another in 1929. 9 the resulting reduced immigrant workforce created employment opportunities for blacks in towns and cities, furthering emptying rural farms of tenant farmers and sharecroppers; a devastating boll weevil infestation in southeast cotton fields spurred even more relocation as crops failed.10 those who stayed in the countryside lived in deplorable conditions. by as late as 1940, homes for both black and white tenant farmers were valued at around $250. few houses had running water; fewer still had flush toilets.11 black farmers also faced a credit system that was particularly unfavorable to them. the usurious interest rates they were charged (15 percent to 35 percent) drastically ate into already meager profits. “this crop mortgage system is weak to begin with and its abuses make it even more burdensome,” recent social trends reported. “with these handicaps the returns from farming are small… after this small product has been divided between tenant, the landlord and the furnisher of credit, the shares are inadequate to support a good standard of living.”12 it was in this bleak social and economic landscape that rivers found herself when she was starting her career. and if she hadn’t noticed it from the confines of the nursing program at the tuskegee institute, she witnessed it firsthand after her 1922 graduation in her first job, with the movable school. tuskegee institute founder booker t. washington wanted to teach agricultural techniques to black farmers in the last decade of the 19th century. that idea led to the establishment of an agricultural extension department at tuskegee and ultimately the movable school,13 so named because it brought a learning center to people (first by a mule-drawn wagon and later via truck). the original “farmers’ college on wheels” initially educated farmers on new technology and methods to help improve crop and livestock yields. in 1918, federal funding allowed the hiring of home economics instructors, who taught women canning, cooking, and cleaning,14 and later public health professionals came on board to teach basic hygiene and sanitation skills.15 in 1923, rivers joined the school as a public health nurse. in addition to basic hygiene, she taught women and midwives safe birthing methods, childcare, and how to tend to the sick, and provided men information on “social hygiene,” euphemism for sexually transmitted diseases.16 the movable school ventured to the farthest rural corners of alabama, including macon county, the pool from which prospective subjects for the tuskegee study would be drawn. for rivers, the movable school was more than just an opportunity to advance the tuskegee institute’s philosophy of service to the indigent; it was a job at a time when jobs were scarce, and it was a good one at that. landing it was an achievement in itself. black nurses had fewer employment opportunities than white nurses did, and southern black nurses lucky enough to find work were paid lower salaries for performing the same duties as their white counterparts. in alabama, for example, white nurses were paid $110 a month by the board of health, while black nurses received $65.17 the openly racist attitudes of even those in the profession compounded the economic inequalities. darlene clark hine writes of margaret bruesche, a white nursing teacher in fairfield, alabama, who felt that “the negro woman has no place as a graduate nurse.” they weren’t smart or well educated, “they are not conscientious, and their sense of responsibility is very weak.” (at least bruesche was ostensibly assessing professional skills. a white nursing superintendent at atlanta’s grady hospital at the time felt black nurses hadn’t “any morals… they are such liars…and will cut up each other’s clothes for spite.”)18 rivers remained with the movable school for nine years, until the depression forced financial cutbacks that led to the elimination of her position, leaving her to choose between unemployment and a night nursing supervisor position at the john a. andrew memorial hospital at the tuskegee institute. she chose the latter. she hated working the night shift, and less than a year later, as she was preparing to migrate north herself, she heard about a job with the united states public health service, working on a study of the effects of untreated syphilis on black men.19 it was an assistant’s position, paying a thenattractive $1,800 a year.20 river’s years with the movable school in and around macon county, and her concurrent work for the bureau of vital statistics for the alabama health department compiling birth and death records in the same area, were on-the-job preparation for the tuskegee position. her experience and performance were impressive enough that dr. eugene dibble, medical director of the tuskegee institute and head of the andrew hospital, recommended rivers, who had been one of the institute’s star nursing school pupils, for the opening. she was hired kearns, revisiting nurse rivers, voices in bioethics, vol 1 (2013) 3 © 2013 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. for the study in 1932 to monitor the participation of its black subjects.21 with 21st-century eyes it might be difficult to see how a black woman would be willing to participate in something called “the tuskegee study of untreated syphilis in the negro male.” but in light of the prevailing economic conditions in the rural south early in the previous century, it is not so hard to discern reasons why. syphilis was rampant and posed a serious health threat, and treatments available then were harsh. (“i saw so many reactions with these medications,” rivers said in an interview).22 the natural progression of the disease was to be studied in hopes of determining better treatments.23 by taking the job with the u.s. public health service, rivers would be working to help the people she knew to be in desperate need of medical attention. also, in the beginning decades of the 1900s, it was presumed that the course of the disease progressed differently through blacks than it did through whites—the tuskegee study would complement the oslo study of untreated syphilis in whites.24 “this is the way i saw it: that they were studying the negro just like they were studying the white man, see, making a comparison,” rivers said later.25 yet given the scarcity of good jobs for black women, in the rural south in particular, a perhaps more compelling reason for rivers to join the study is simply that it offered employment—and a chance to get off the odious night shift. (“i was so glad to go off night duty that i would have done anything,” rivers said).26 that the position was one in the career for which rivers had trained was a bonus. nursing positions were not easy to come by, and the depression was forcing state public health departments to cut funds.27 the unemployment rate for the country was approaching 25 percent.28 rivers was an ideal candidate for the job. she had been an exemplary student at tuskegee. she’d done administrative work for the bureau of vital statistics, and nursing school had trained her to examine patients. the movable school had taught her public outreach and the interpersonal skills of a public health nurse; her personality and tact were remarkable. 29 in fact, dr. dibble cited her effectiveness as a public health worker when he suggested her for the tuskegee position.30 the relationships she established with the people in macon county from her movable school days would be the key to her success in the tuskegee job. other syphilis studies were being conducted at the time, and a lack of patient compliance with treatment protocols was an ongoing, pervasive challenge. a birmingham, alabama, doctor who had worked with public health syphilis programs noted that failing to keep up with treatment until cure was an issue for both blacks and whites, and that developing a way to keep patients compliant would be essential to any program’s success.31 as it turned out, rivers excelled at making sure that patients enrolled in the study stuck with it. the study was originally designed to last six to eight months, but of course it went on far longer, and by the time the decision was made to leave the termination date open-ended, rivers was a firmly entrenched tuskegee team member. after all, notes susan smith, “rivers considered her participation in the study merely a continuation of her previous public health work.”32 over the course of the study she had become more than just an assistant; she was, if not in title, the de facto chief liaison between the doctors and the subjects. dr. raymond vonderlehr, director of the public health service’s venereal disease division and the head of the study from its inception till 1943, acknowledged river’s skills in ensuring the ongoing compliance of the subjects.33 if river’s complicity in withholding treatment in the original study can be understood within the economic and employment contexts of the time, can it also explain why a caring, dedicated nurse would continue to risk the lives of her patients—patients she had known and followed for 15 years—after an accepted treatment for syphilis became available, in the mid-1940s? yes, but this time rivers needn’t be regarded as someone lucky enough to have a job but rather as a dedicated tuskegee team member. if she was an entrenched member of the tuskegee team when the decision was made to continue the study indefinitely, by the time penicillin was widely available she would have been a full-fledged “company woman.” others in the study came and went over the years, but rivers steadfastly remained. (she was replaced by elizabeth kennebrew in 1965 but continued to help public health service physicians when they were in town and remained in contact with the men).34 rivers was a loyal employee who identified more with the researchers—the company—than she did with the subjects. born and raised in rural georgia,35 she may have come from the subjects’ world, but even at the beginning of the study she didn’t live in it anymore. ten years out of nursing school, she was working steadily, both for tuskegee and in her midwife-training capacity.36 she was a working professional. smith refers to “rivers and other black professionals,” and suggests that this professionalism may have kearns, revisiting nurse rivers, voices in bioethics, vol 1 (2013) 4 © 2013 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “blinded them to the high price paid by poor, rural black men in the study.”37 to the scientific assistant part of rivers, the poor, rural black men were subjects; to the nurse part of her they were patients. but more important, they were her job. she was working for an organization whose purpose was to gather data on untreated syphilis in black men; thus, it would have been more surprising if treatment had been provided. as some journalists realized at the time, given the study’s design, withholding penicillin was a foregone conclusion. penicillin was withheld because all treatment was withheld.38 darlene clark hine suggests that “[years] of conditioning and living in the south made it virtually impossible for rivers to have rebelled against a white, male government doctor, the ultimate authority figure in her world.”39 looking at rivers as a loyal employee accounts for her subservience to the white government-official doctors in charge in a different way: they were her bosses, and as a good employee she did what the bosses told her to do. telling moments from two interviews with rivers suggest she strongly identified with the tuskegee study team. she rarely spoke of her role in the scandal,40 and so publicly expressed few regrets. however, in a 1977 conversation with helen dibble and daniel williams, she allowed one: that the results of the study’s labor may have been lost. “[t]his was the thing that was so disturbing to me was that somehow all of the records of this study and the health department have been destroyed,” she told them.41 another moment came in an interview with james jones several years after a $10 million class-action lawsuit against the u.s. government was settled with the living participants of the study, in 1974.42 jones and rivers were driving through macon county when rivers saw a former study participant in a field and went out to say hello. when the man asked her why she had stopped coming by to see him, she told him, “you don’t get the money and nurse rivers too.”43 ____________________________________________________________ conclusion considering rivers in the specific socioeconomic context in which she lived is one more way to make sense of her ongoing participation in what is now known as a deadly racist medical experiment perpetrated against rivers’s own friends and patients. by first seeing her as fortunate to have secured a position with the study and then as a loyal team member later on, she escapes the harsher accusations of race traitor and coward; more important, it is consistent with her remaining in history the dedicated, caring nurse she professed to be. “really and truly,” said nurse rivers, “when we were working with those people…that was the joy of my life.”44 today she might simply be called a cog in the machine, but half a century ago she was someone lucky to be working in her chosen profession when nearly a quarter of the country was not working at all, someone who did not have the luxury of resigning in protest. 1 james h. jones, bad blood: the tuskegee syphilis experiment—a tragedy of race and medicine (new york: the free press, 1981), p. 6 2 susan m. reverby, examining tuskegee: the infamous syphilis study and its legacy (chapel hill: the university of north carolina press, 2009), p. 168 3 susan l. smith, “neither victim nor villain: eunice rivers and public health work,” tuskegee’s truths, ed. susan m. reverby (chapel hill: the university of north carolina press), p. 349 4 david m. kennedy, freedom from fear: part i: the american people in the great depression (new york: oxford university press, 1999), p. 16 5 ibid., p. 18 6 ibid., p. 16–17 7 ibid., p. 11–12 kearns, revisiting nurse rivers, voices in bioethics, vol 1 (2013) 5 © 2013 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. 8 ibid., p. 12 9 recent social trends in the united states: report of the president’s research committee on social trends (new york: mcgrawhill book company, inc., 1933), p. 557 10 ibid., p. 566 11 wayne flynt, “poverty in alabama” (encyclopedia of alabama, http:encyclopediaoflabama.org, november 2007) 12 recent social trends, p. 570 13 felix james, “the tuskegee institute movable school, 1906–1923,” agricultural history, july 1971: vol.45, no. 3, p. 202 14ibid., p. 206 15 ibid., p. 208 16 reverby, examining tuskegee, p. 170 17 darlene clark hine, black women in white: racial conflict and cooperation in the nursing profession 1890–1950 (bloomington: indiana university press, 1989), p. 92 18 ibid., p. 101 19 reverby, examining tuskegee, p. 170 20 jones, bad blood, p. 102 21 ibid., p. 6 22 laurie interview; eunice rivers, stanley h. schuman, lloyd simpson, and sidney olansky, “the twenty years of follow-up experience in a long-range medical study, public health reports 68 (1953): 394, cited in jones, bad blood, p. 163 23 “the u.s. public health service syphilis study at tuskegee” (centers for disease control and prevention, www.cdc.gov/tuskegee) 24 smith, “neither victim nor villain,” p. 354 25 laurie interview, p. 167 26 ibid., p. 11 27 ibid 28 robert vangiezen, albert e. schwenk, “compensation from before world war i through the great depression,” compensation and working conditions, fall 2001 (bureau of labor statistics, www.bls.gov/opub/cwc/cm20030124ar03p1.htm, posted jan. 30, 2003) 29 clark hine, black women in white, p. 155 30 jones, bad blood, p. 111 31 ibid., p. 46 32 smith, “neither victim nor villain,” p. 358 33 jones, bad blood, p. 116 34 reverby, examining tuskegee, p. 172 35 ibid., p. 169 36 ibid., p. 172 37 smith, “neither victim nor villain,” p. 360 38 jones, bad blood, p. 9 39 clark hine, black women in white, p. 156 40 reverby, examining tuskegee, p. 168 41 helen dibble, daniel williams, “an interview with nurse rivers,” tuskegee’s truths, ed. reverby, p. 327 42 the u.s. public health service syphilis study at tuskegee: the tuskegee timeline” (centers for disease control and prevention, www.cdc.gov/tuskegee) 43 james h. jones to susan m. reverby, personal communication, july 7, 2004, cited in reverby, examining tuskegee, p. 183 44 jones, bad blood, p. 161 http://www.bls.gov/opub/cwc/cm20030124ar03p1.htm http://www.cdc.gov/tuskegee 1 non-covid-19 patients left out in the cold –inevitable outcome of pandemic ethics? dear editor in chief of voices in bioethics, please receive this submission for your consideration as an op-ed. this piece has not been published elsewhere. nor is there any conflict of interest. i am a ms in bioethics program student (cc4419). thank-you in advance for your time. kind regards, camillecastelyn@gmail.com; +27795065117 mailto:camillecastelyn@gmail.com 2 non-covid-19 patients left out in the cold – inevitable outcome of pandemic ethics? 1. introduction countries across the globe including the united states (us) and south africa have recently reported a surge of non-covid-19 related deaths.1 as there is limited accurate and reliable data of this new problem emerging during the covid-19 pandemic,2 the full extent of the problem is unknown. the lack of data makes it difficult to understand the gravity of the situation and to address it. medical professionals are asking why these noncovid related cases did not present at hospitals. aside from each country’s unique demographics influencing the ability to treat pre-existing chronic diseases alongside covid-19, resource allocation may lie at the heart of the problem.3 the world health organization’s4 declaration that covid-19 was a pandemic on march 12 2020 placed the fight against covid-19 front and center in most countries across the world. italy was one of the first countries to be hit hardest, as localized lockdowns expanded to a countrywide lockdown in a desperate attempt to stop the outbreak. in the us, the first case was confirmed on january 21 2020.5 presidential actions lagged in decisiveness6 leading to disproportionate loss of life7 and diminishing hopes of containing the outbreak. in south africa, swift action included a lockdown long before community spread was confirmed, 8 which slowed the initial spread of the virus. this swift response may be attributed to the fresh memories of malaria and hiv, which remain a threat. a proactive lockdown like this does come at a price. buying time for emergency departments (eds) and medical professionals to prepare9 meant slowing the economy to a halt. in different countries across the world, healthcare was accessible to varying degrees prior to the pandemic. in south africa, the healthcare system is severely strained10 in comparison to nations like the us. a non-covid-19 patient’s ability to access healthcare during this time has been limited. for example, routine child vaccinations have been disrupted,11 critical delivery of anti-retroviral drugs for hiv treatment has been disrupted, nonelective surgeries have been suspended, cancer patients have been receiving limited treatment,12 and mothers have had limited labor and delivery care.13 while these disruptions occur in other nations as well, countries 3 with more robust healthcare systems may be able to bear the brunt of this burden more successfully than nations like south africa. these disruptions are not trivial and add pressure on healthcare systems in both the short and long run. 2. status quo of resource allocation re-evaluated the status quo of resource allocation both within and outside a clinical setting in this pandemic prioritizes covid-19 tacitly and overtly. if two patients of equal need and prognosis arrive at an ed, it is more likely that the patient with covid-19 symptoms will be treated first, or at the very least be transferred to a separate room or hospital section. furthermore, non-covid-19 patients have avoided eds due to fear of contracting covid-19.14 up until now, most people would argue that this is a necessary sacrifice to mitigate the impact of covid-19. however, increased deaths of non-covid-19 patients have brought a re-evaluation of the current status quo. this re-evaluation is further complicated by a global shortage of medical staff and medical equipment (including ppe and ventilators). many ethical frameworks and guidelines have been issued to help navigate these uncharted waters of pandemic ethics in the 21st century.15 all of these frameworks inevitably have underlying value judgements and prevalent ethical principles that guide resource allocation. these principles can be divided into four categories – maximizing total benefits, treating people equally, promoting and rewarding social usefulness, and favoring those that are worst off.16 prioritizing covid-19 patients in a pandemic maximizes total benefits for all in a pandemic situation.17 however, this approach has also led to people dying at home from conditions that could have been effectively treated in a hospital setting. maximizing total benefits is a utilitarian approach. however, the tension between providing the best possible care and respecting an individual’s autonomy, while also saving the greatest number of lives, has once again been re-evaluated.18 often, pandemic ethics single out one principle, such as utilitarianism; however, this has proven to be detrimental. consequently, there is a shift toward utilizing multi-principle allocation systems. 4 in the past, a multi-principle allocation system as described by persad et al., has ensured distributive justice when applied to scarce medical interventions on allocation of organs and vaccines.19 in these instances, choosing only one of the principles, such as youngest first or favoring those with the best prognosis or those who are worst-off, may favor a certain group of people at the cost of another. this is inefficient if we consider the concept of distributive justice as first described by john rawls.20 rawls described the veil of ignorance, where in order for one to gauge whether decisions are adequate, one must conduct a thought experiment from behind the veil of ignorance. for example, if you choose to prioritize those who are youngest first, without knowing whether the person standing behind the veil is young or old, your decision should be fair to whoever is behind the veil. amid covid-19, a multi-principle approach would address the moral complexities of these perplexing decisions better than a one principled approach such as maximizing the most lives. it would take into account numerous principles even though they may seem to be in tension with one another. this would include socioeconomic factors as well, while aiming to treat people equitably and also taking into account those who are worst off. opposing critics might argue that saving the most lives, with specific reference to triage protocols, is the only way to enable healthcare workers to make fast and efficient decisions in hospital settings. these approaches do have their rightful place in resource allocation. however, this article makes a plea toward the complexities of pandemic ethics that should be factored in. 3. drawing on past experiences south africa and other african countries have experienced other severe infectious disease outbreaks such as aids and ebola, an extremely valuable occurrence that should be drawn upon.21 for example, allocating scarce resources amid outbreaks of ebola trained medical professionals to act efficiently and intuitively. ebola and hiv also sparked innovation and identification of creative uses for available resources. south africa has been grappling with the hiv crisis for 20 years. it has vast experience in tracking and studying viruses. furthermore, a lot of specialized research has been done for the past 15 years to study people’s 5 immune responses to hiv.22 technologies are being repurposed to investigate what immune responses can be expected from patients infected with sars-cov-2.23 south africa is also well suited for vaccine trials as it has been a major contributor of sites for internationally funded clinical trials. consequently, a landmark covid-19 treatment trial has already been lined up. 24 in west africa, surveillance techniques that were developed for the 2014-2015 ebola outbreak, which infected 28,000 people and killed 11,000 people in guinea, liberia, and sierra leone, are now being deployed in the fight against covid-19.25 26 across the continent, lessons learned include the critical importance of adequate respect for culture, appropriate community engagement and education, vigilance in reports of symptoms, and leveraging past research and laboratory capacities for testing and clinical vaccine trials. 4. limitation to this approach and proposed interventions already strained healthcare systems may risk great losses in regarding the overall health of the population if the limited care that has been offered before this pandemic is jeopardized. for example, the disruption of anti-retroviral treatments has serious consequences for the patients due to the high mutation rate of hiv, which makes the treatment plan time sensitive. other examples include many homeless people who are on methadone treatment, who at the moment are still receiving mobile delivery of their treatments. if there were complications in delivering these medications, we could see many people with extreme symptoms of withdrawal and great setbacks for people wanting to ‘come clean.’ cancer patients also report that they find themselves having to decide whether they are willing to risk contracting covid-19 when going in for routine treatments or skipping treatments now and risking cancer later. interventions, including telemedicine, should be prioritized. although there may also be unique challenges of exposure to healthcare professionals upon home visits, these risks must be evaluated and mitigated to ensure continuation of care. some hospitals in the us are currently evaluating the impact and effectiveness of current telemedicine approaches. midwives and other healthcare workers should also be trained adequately and 6 dispersed to deliver care at home. furthermore, this challenging time may also serve as an impetus for all stakeholders to prioritize improving healthcare delivery for all, albeit through seemingly unrelated victories, such as adequately communicating and educating local communities on basic healthcare or delivering basic sanitary services like running water and improved infrastructure. 5. conclusion the very nature of pandemic ethics provides unforeseen challenges such as the one that has been described here. a multi-principle approach, which also draws on past experiences, will empower all global stakeholders (governments, leaders, patients and medical professionals alike) to make choices that enable equitable resource allocation. 1 krumholz, harlan. 2020. “where have all the heart attacks gone?,” april 6, 2020. https://www.nytimes.com/2020/04/06/well/live/coronavirus-doctors-hospitals-emergency-care-heart-attack stroke.html?algo=identity&fellback=false&imp_id=450663239&imp_id=67343380&action=click&module=science%20%2 0technology&pgtype=homepage. walsh, james d. 2020. “the mystery of ‘excess fatality.’” intelligencer, april. https://nymag.com/intelligencer/2020/04/coronavirus-is-only-part-of-the-excess-fatality-mystery.html. 2 gillum, jack, lisa song, and jeff kao. 2020. “there’s been a spike in people dying at home in several cities. that suggests coronavirus deaths are higher than reported.” propublica, april 14, 2020. https://www.propublica.org/article/theresbeen-a-spike-in-people-dying-at-home-in-several-cities-that-suggests-coronavirus-deaths-are-higher-than-reported. 3 bettina taylor, jeannette parkes, and johannes j fagan, “how should health resource allocation be applied during the covid-19 pandemic in south africa?,” south african medical journal (online), may 20, 2020, https://doi.org/. https://doi.org/10.7196/samj.2020. v110i7.14916. 4 world health organization. 2020. “rolling updates on coronavirus disease (covid-19),” april 28, 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen. 5 centers for disease control and prevention. 2020. “coronavirus disease 2019: cas in us,” february 5, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. 6 larry buchanan, rebecca kk lai, and allison mccann, “u.s. lags in coronavirus testing after slow response to outbreak,” the new york times (online), march 17, 2020, https://www.nytimes.com/interactive/2020/03/17/us/coronavirus-testingdata.html. 7 john eligon et al., “black americans face alarming rates of coronavirus infection in some states,” the new york times (online), april 14, 2020, https://www.nytimes.com/2020/04/07/us/coronavirus-race.html. 8 cyril ramaphosa, “message by president cyril ramaphosa on covid-19 pandemic 30 march,” march 30, 2020, http://www.thepresidency.gov.za/speeches/message-president-cyril-ramaphosa-covid-19-pandemic; cyril ramaphosa, “message by president cyril ramaphosa on covid-19 pandemic 9 april,” april 9, 2020, http://www.thepresidency.gov.za/speeches/message-president-cyril-ramaphosa-covid-19-pandemic-0. 9 road accident fatalities over the easter weekend decreased from 128 people in 2019 to 28 in 2020 (saleka 2020). emergency departments (ed) were also eerily quiet decreasing from 34 000 cases per week to 12 000 cases per week. bbc. 2020. “south africa coronavirus lockdown: is the alcohol ban working?,” april 22, 2020. saleka, ntwaagae. 2020. “28 died in accidents during the easter weekend, while 719 arrested for traffic violations.” news24, april 17, 2020. https://www.news24.com/southafrica/news/28-died-in-accidents-during-the-easter-weekend-while-719-arrested-fortraffic-violations-20200417. 10 n aikman, “the crisis within the south african healthcare system: a multifactorial disorder,” south african journal of bioethics and law 12, no. 2 (n.d.): 52–56. 11 unicef. 2020. “covid-19 putting routine childhood immunization in danger: un health agency.” united nations news, april. https://news.un.org/en/story/2020/04/1062712. 12 vanderpuye, verna, moawia mohammed, ali elhassan, and hannah simmonds. 2020. “preparedness for covid-19 in the oncology community in africa,” april. https://doi.org/10.1016/ s1470-2045(20)30220-5. 13 menconi, michael. 2020. “ny hospitals issue problematic ban on birthing support persons from labor & delivery units.” voices in bioethics, march. http://www.voicesinbioethics.net/voices-in-bioethics/2020/3/28/ny-hospitals-issueproblematic-ban-on-birthing-support-persons-from-labor-amp-delivery-units. https://www.nytimes.com/2020/04/06/well/live/coronavirus-doctors-hospitals-emergency-care-heart-attack 7 14 krumholz, harlan. 2020. “where have all the heart attacks gone?,” april 6, 2020. https://www.nytimes.com/2020/04/06/well/live/coronavirus-doctors-hospitals-emergency-care-heart-attack stroke.html?algo=identity&fellback=false&imp_id=450663239&imp_id=67343380&action=click&module=science%20%2 0technology&pgtype=homepage. 15 the south african medical association. 2020. “sars-cov-2 (covid-19) guidance for managing ethical issues (living document).” the south african medical association. wisner, benjamin, john adams, and world health organization, eds. 2002. “environmental health in emergencies and disasters: a practical guide.” world health organization. https://apps.who.int/iris/bitstream/handle/10665/42561/9241545410_eng.pdf?sequence=1. nuffield council on bioethics. 2020. “rapid policy briefing: ethical considerations in responding to the covid-19 pandemic.” rapid policy. london: nuffield council on bioethics. https://www.nuffieldbioethics.org/assets/pdfs/ethical-considerations-inresponding-to-the-covid-19-pandemic.pdf. berlinger, nancy, matthew wynia, tia powell, micah hester, aimee milliken, rachel fabi, felicia cohn, et al. 2020. “ethical framework for health care institutions responding to novel coronavirus sars-cov-2 (covid-19) guidelines for institutional ethics services responding to covid-19 managing uncertainty, safeguarding communities, guiding practice.” the hastings center. thehastingscenter.org/ethicalframeworkcovid19. 16 persad, g, alan wertheimer, and ezekiel j emanuel. 2009. “principles for allocation of scarce medical interventions.” lancet 373: 423–31. 17 ibid. 18 dale, samuel. 2020. “utilitarianism in crisis.” voices in bioethics, august. http://www.voicesinbioethics.net/voices-inbioethics/2020/5/8/utilitarianism-in-crisis. 19 g persad, alan wertheimer, and ezekiel j emanuel, “principles for allocation of scarce medical interventions,” lancet 373 (2009): 423–31. 20 john rawls, a theory of justice (oxford: oxford university press, 1999). 21 mm kavanagh et al., “access to lifesaving medical resources for african countries: covid-19 testing and response, ethics, and politics,” the lancet, july 5, 2020, https://doi.org/10.1016/ s0140-6736(20)31093-x. 22 sarah wild, “how hiv expertise is helping south africa tackle coronavirus,” the world economic forum, september 4, 2020, https://www.weforum.org/agenda/2020/04/south-africa-hiv-coronavirus-covid19-pandemic-health-virus. 23 wild. 24 wild. 25 29/05/2020 20:08:00 26 medecins sans frontiers, “crisis update may 2020,” medecins sans frontiers, may 18, 2020, https://www.msf.org/drcebola-outbreak-crisis-update. https://www.nytimes.com/2020/04/06/well/live/coronavirus-doctors-hospitals-emergency-care-heart-attack https://apps.who.int/iris/bitstream/handle/10665/42561/9241545410_eng.pdf?sequence=1 https://www.nuffieldbioethics.org/assets/pdfs/ethical-considerations-in-responding-to-the-covid-19-pandemic.pdf https://www.nuffieldbioethics.org/assets/pdfs/ethical-considerations-in-responding-to-the-covid-19-pandemic.pdf foe, genomic microsurgery: the good and the bad, voices in bioethics, vol. 1 (2014-15) * gabriella foe, ms bioethics © 2014 gabriella foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. genomic microsurgery: the good and the bad gabriella foe* keywords: bioethics, ethics, genetics, genomic microsurgery introduction genomic microsurgery is a type of genetic modification whereby dna segments are inserted, removed, or replaced in order to obtain desired phenotypes. it has only recently been developed but already brings with it possibilities to customize one’s genome to eliminate diseases or obtain certain traits. ____________________________________________________________ foe, genomic microsurgery: the good and the bad, voices in bioethics, vol. 1 (2014-15) 2 analysis crispr, or “clustered regularly interspaced short palindromic repeats,” are found in bacteria and known to help bacteria fight off viruses. crispr contains dna sequences of viruses which have infected the bacteria or its ancestors, each separated by a short repeat. using crispr, the bacteria can recognize a viral gene and destroy it. when a novel virus invades, the new viral dna sequence will be added to the end of the chain. crispr is known to work in human cells even though we do not have crispr-based immune system. before the crispr gene is incorporated into the human genome through genomic microsurgery, there are ethical questions which must be considered. the benefits of incorporating crispr into the human genome can be significant, one of which would be the potential to replace vaccines. however, there are unknown side effects (caused by introducing crispr into the human genome) that may significantly harm individuals. furthermore, genomic microsurgery does not yet have adequate specificity, scientists are still trying to make these ‘edits’ more specific, and the effectiveness of incorporating any gene into the human genome is unknown. how confident should scientists be of this technique before they start human experimentation or marketing to the public? conclusion aside from its potential benefits, the topic of gene editing raises fear of people wanting designer babies. parents would be able to use it to edit the dna of their embryos once it is available to the public. but each time the topic of gene alteration has come up in discussion, professionals in the field of genetics have stressed the fact that each individual—without exception—carry a number of lethal mutations. no one has a perfect genome; this may say something about our evolution and the ability of someone with the perfect genome to survive. so while scientists are still learning more about genomic microsurgery, it is essential to develop ethical guidelines and regulations to ensure that it will not be abused by the human desire to create the perfect, dream-child. references pollack, andrew, “a powerful new way to edit dna,” the new york times. march 3, 2014. http://www.nytimes.com/2014/03/04/health/a-powerful-new-way-to-editdna.html?src=twr&smid=tw-nytimes&_r=1 reardon, sara, “gene-editing method tackles hiv in first clinical test,” nature. march 5, 2014. http://www.nature.com/news/gene-editing-method-tackles-hiv-in-first-clinical-test1.14813?wt.mc_id=twt_naturen http://www.nytimes.com/2014/03/04/health/a-powerful-new-way-to-edit-dna.html?src=twr&smid=tw-nytimes&_r=1 http://www.nytimes.com/2014/03/04/health/a-powerful-new-way-to-edit-dna.html?src=twr&smid=tw-nytimes&_r=1 http://www.nature.com/news/gene-editing-method-tackles-hiv-in-first-clinical-test-1.14813?wt.mc_id=twt_naturen http://www.nature.com/news/gene-editing-method-tackles-hiv-in-first-clinical-test-1.14813?wt.mc_id=twt_naturen van geem, hiv screening guidelines still not implemented, voices in bioethics, vol. 1 (2014-15) © 2015 kevin van geem. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. kaiser study finds cdc hiv screening guidelines are still not implemented 8 years later kevin van geem hiv, cdc, screening introduction according to the centers for disease control and prevention (cdc) roughly 50,000 people become infected with the human immunodeficiency virus (hiv) every year in the united states. about 29,000 of those are men who have sex with men (msm). 1 despite this fact, a recent study by the kaiser family foundation found that 56% of gay and bisexual men surveyed have never had discussions about testing for hiv with their doctors, and 27% had never been tested at all.2 analysis in 2006 the cdc published guidelines for hiv testing that recommended opt-out hiv testing for everyone aged 13-64 years, in all health-care settings.3 opt-out testing allows patients to decline testing, yet assumes consent. this would effectively make hiv testing a routine part of health care much like screening for other treatable diseases. the cdc published these guideline to increase uptake in screening, and because the method of only offering screening to at-risk populations was not practical, nor was it effective.3 the problems surrounding hiv testing stem from the early association and stigmatization of the virus with gay sexual activities, intravenous drug users, and immigrant populations. because there was no effective treatment available until 1987, and because of uncertainty about transmission, the fear of acquired immunodeficiency syndrome (aids) in the 1980s caused people afflicted with the disease to be fired from their jobs, evicted from their homes, and ostracized by their communities.4 this intense stigma of people with hiv caused public health officials and legislators to approach hiv testing with increased sensitivity. as a result aids control efforts were unique, and unlike any other public health measures in the past. for example in new york state, the hiv testing laws allowed for anonymous testing (making surveillance of case incidence impossible), and also made it illegal to compel anyone to get tested, including individuals convicted of assault or battery where victims were exposed to blood or semen.5 although much has changed in the way of stigma towards homosexuals since the late 1980s and early 1990s the most common approach to dealing with aids has not changed much in 25 years6 as exemplified by the kaiser survey findings. the results of the survey indicate that screening is not offered as an opt-out test within routine care as per the cdc guidelines. even more problematic, is that screening is not being offered to the majority of men in van geem, hiv screening guidelines still not implemented, voices in bioethics, vol. 1 (2014-15) 2 high-risk groups (i.e., msm). this fact is troubling for numerous reasons, primary of which is that asymptomatic individuals can still spread the virus through fluid exchange. symptoms may not appear for many years after infection. conclusion in a new york times blog, jen kates, kaiser’s director of global health and hiv policy stated, “in general, providers are uncomfortable talking about sex.” [2] if health-care settings implement the cdc guidelines, discomfort would be much less of an issue and hiv testing would become a routine test within the standard of care. in effect, this would de-stigmatize the test itself, the disease, and at-risk populations. 1 centers for disease control and prevention. “hiv in the united states: at a glance.” last updated december 3, 2013, http://www.cdc.gov/hiv/statistics/basics/ataglance.html 2 “more than half of gay and bisexual men say a doctor has never suggested hiv testing,” new york times: the upshot blog, september 25, 2014. accessed: september 29, 2014, http://nyti.ms/1sutaif 3 centers for disease control and prevention. “revised recommendations for hiv testing of adults, adolescents, and pregnant women in health-care settings.” last reviewed september 12, 2006, http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm 4 shilts r. and the band played on: politics people, and the aids epidemic. new york: st. martin’s press, 1987. 5 new york state public health law article 27-f § 2781-2782. 6 frieden tr, das-douglas m, et al. “applying public health principles to the hiv epidemic.” the new england journal of medicine 353 (2005): 2397-2402. http://www.cdc.gov/hiv/statistics/basics/ataglance.html http://nyti.ms/1sutaif http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm winkel, children without childhood, voices in bioethics, vol. 1 (2014) © 2014 maia winkel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. children without childhood: robbed innocence and its implications for violence maia winkel* keywords: childhood, pediatrics, violence, africa, child soldiers background afghanistan, chad, south sudan, myanmar, somalia, the democratic republic of congo, yemen, and sudan these are eight countries in which armed forces – be it in a national capacity or in de facto rebel militia regularly and mercilessly exploit hundreds of thousands of children.[i] a quick internet search for images of child soldiers turns up thousands of pictures of hardened children with vacant stares holding machine guns; something alarming but not unexpected, in the thousands of photographs that appear, not a single child smiles. these are children because of their chronological ages ranging from as young as five years old to seventeen not because of how they behave, what they do, how they think. with their childhoods quickly ripped away, these individuals are often given guns and ordered to kill or to die; ruthless violence becomes endemic to their lives. with a current estimated count of 250,000 child soldiers (possibly as high as 300,000), something must be done to preserve these children’s innocence, as well as to prevent future aggression and hostility that this indoctrination is engendering.[ii][iii] so, who is to blame for this ongoing crisis? the governments, the children, or the rebel leaders who put youths to use for their own cause? in 2007, the united nations children’s fund (unicef), published the paris principles, wherein “the principles recognise that, in situations of armed conflict, states and armed groups are https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn2 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn3 winkel, children without childhood, voices in bioethics, vol. 1 (2014) 2 the primary actors responsible for the protection of civilians in their effective control and that if they are unable or unwilling to meet all of their humanitarian responsibilities directly they are charged with enabling the provision of humanitarian action by impartial actors.” [iv] while blameworthiness and responsibility are major components of exploiting youth as child soldiers and accountability must be expected of those responsible, the immediate focus should not be only on blaming the responsible parties, but rather, that there should be a global aim of addressing the more pressing issues of prevention of violence, rehabilitation from the damage caused by severe indoctrination, and reintegration into a non-violent world. to understand the degree to which child soldiers are exploited, we must first clarify the roles into which these children are generally forced. according to the paris principles, a child “associated with armed forces or armed groups,” is defined as “any person below 18 years of age who is or who has been recruited or used by an armed force or armed group in any capacity, including but not limited to children, boys and girls, used as fighters, cooks, porters, messengers, spies or for sexual purposes. it does not only refer to a child who is taking or has taken a direct part in hostilities.” [v] therefore, the at-risk group is clearly much larger than that comprised by the sadly iconic gun-toting children; as such, “child soldier” describes a number of functions that these children are expected to perform, many of which inappropriate for people of any age, but especially for young children, and which are carried out regardless of the children’s lack of maturity and inability to understand and give consent. to realize the gravity of ethical corruption regarding this human rights violation, we must first discuss several motives for why young children are regularly kidnapped and coerced by armed forces into becoming child soldiers. firstly, it does not require much effort to steal these children away from their families. entire communities are constantly terrorized with individual and collective punishment – with frequent murderous raids, kidnappings, mass rape, wanton destruction, and threats of violent annihilation if they fail to surrender a given number of children to these forces. at the various, early stages of development during which these children are captured, they still rely on authority figures to understand the ways of the world; therefore, they can be easily influenced. often under the effects of drugs forced upon them by their captors, these children can undergo frightful transformations with regards to moral understanding, appropriate social behavior, and sense of self, in relation to others. the physical, emotional, and psychological malleability and susceptibility to indoctrination and the subsequent harmful consequences are often sufficient to desensitize these child soldiers to the atrocities they witness and commit. furthermore, young children do not have the capacity to understand the gravity and finality of death, the mental and emotional capacity to comprehend the meaning of their actions whether self-intended or when ordered to do so or the willpower to resist the authority that coerces them into committing such despicable and vile actions.[vi] moving forward in response to this widespread, terrible crisis, on march 6, 2014, the united nations publicly announced its most recent goal: “to end the recruitment and use of children in government forces in conflict by 2016. secretary-general ban ki-moon stressed that children should be armed with pens and textbooks, not guns.” [vii] the secretary-general’s annual report on children and armed conflict, named eight countries in https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn4 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn5 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn6 http://www.un.org/sg/ https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn7 winkel, children without childhood, voices in bioethics, vol. 1 (2014) 3 which armed forces recruit and use children as soldiers. as previously noted, they are: afghanistan, chad, south sudan, myanmar, somalia, democratic republic of congo, yemen, and sudan. [viii] as of june 2013, the first six nation states listed had agreed to collaborate with the united nations to reduce the recruitment and exploitation of children as soldiers. [ix] discussions with the governments of yemen and sudan have already occurred and, according to the united nations, the two are expected to sign action plans, as well. however, the fact that authorities in these countries have been complicit in the commission of grave crimes against their own children, in addition to having poorly functioning democratic institutions devoted to safeguarding human rights, makes their public pronouncements questionable. worse still, the ostensible cooperation with the united nations has been consistently used as a foil against exposure and criticism. revisiting an earlier question, when government security forces recruit and employ child soldiers for use in armed conflict, upon whose shoulders does the responsibility lie to rescue and protect these broken youths? i agree with the spirit of the paris principles that stipulate that in situations of armed conflict it is primarily the responsibility of the states and armed groups to provide the public with humanitarian protection and aid. however, it is certainly unrealistic to expect the violators to become human rights enforcers. therefore, when child soldiers comprise a significant component of armed forces, who then is to be held responsible for the action of these young killers and what can be done when innocent children become mechanical murderers? to what degree, if at all, should child soldiers be held accountable for their actions? here, we must consider the mental state and capacity of child soldiers – in both an emotional and psychological sense. in evaluating issues of moral responsibility, we cannot ignore the context in which the child soldiers operate; we must take into account what exactly is at stake, how the children interpret and internalize violent experiences that surround them, how cognitively aware these children are of their actions and the ensuing consequences, what their state of cognizance is (i.e., drugged, drunk, brainwashed), and how much physical and psychological trauma can be endured before an individual’s moral sense and personal dignity collapse. with their lives torn asunder, these children are robbed of their innocence and of their trust in humanity; what remains is a generation of deeply scarred minds and souls. as hundreds of thousands of child soldiers are currently being used, there are crucial issues that demand our immediate attention: protecting children by preventing future exploitation, rehabilitating the psychologically, physically, and emotionally damaged children, and reintegrating the youth into protective, rehabilitative, and healthy societies. there must be a collective, universal effort to end this exploitation of children and save them from witnessing and taking part in human rights atrocities. although the attitude is commendable, i am wary that the action plans between countries with child soldiers and the united nations represent noncommittal efforts on both sides. i am not advocating for foreign invasion into these countries, however appeals of nonmaleficence and justice to these national forces will only fall on deaf ears. i worry that this trusting reliance on this illusion of cooperation will inevitably lead to the betrayal and abandonment of the victims, the damaged children; particularly since child soldiers are often ostracized from their families and home communities as a result of the atrocities they are forced to commit. in hopes of rehabilitating rescued child soldiers reversing as much emotional and mental damage as possible we need to collectively engage in a prolonged, involved educational and therapeutic intervention; ideally, these efforts would involve support from people within the communities most affected by this crisis, so as to restore a sense of worth to these children. when approaching this difficult task of rehabilitation, a key concept https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_edn9 winkel, children without childhood, voices in bioethics, vol. 1 (2014) 4 that must be honestly confronted is that what has happened cannot be undone. this sensitive issue must be addressed in a supportive environment in which the youths should neither be punished for their previous actions nor be exonerated. instead, we should help them to understand the significance of their actions, explaining how they may not have had the discretion to refuse to participate in acts of brutality. realizing the devastating effects of the conditions into which child soldiers are forced, i believe these children should be rescued, protected, and rehabilitated. in our most vulnerable, exposed state, we cannot always be accountable for our actions. for these often kidnapped children, the integrity of the self, willpower, and sense of agency are compromised; instead, these internal structures have been distorted and overwhelmed by violent ideology and action. i do not believe their actions can truly be classified as decisions because exploited and abused child soldiers have limited capacity with respect to making informed decisions. it is crucial to bear in mind that they do not have the intellectual and emotional maturity to comprehend the meaning of their newly assigned identities and ascribed roles. furthermore, the range of severe emotional and psychological trauma that these youths experience often serves to blind them from the horrors of violence, their actions, and the human rights violations they regularly commit. they behave in the manner in which they have been treated and taught, where violence is an acceptable, standard part of everyday life. only once the world succeeds in eradicating child exploitation in situations of armed conflict and rehabilitating and reintegrating rescued child soldiers challenging goals, at the very least should we turn our focus to assigning blame and retribution. references [i] war child. http://www.warchild.org.uk/issues/child-soldiers [ii] ibid. [iii] amnesty international. “hidden scandal, secret shame: torture and ill-treatment of children.” published december 8, 2000. index number: act 40/038/2000. http://www.amnesty.org/en/library/info/act40/038/2000/en [iv] the united nations children’s fund (unicef), the paris principles: principles and guidelines on children associated with armed forces or armed groups. published 2007, section 1.6 http://www.unicef.org/emerg/files/parisprinciples310107english.pdf [v] ibid, section 2.1. [vi] child soldiers international. http://child-soldiers.org/ https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref2 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref3 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref4 http://www.unicef.org/emerg/files/parisprinciples310107english.pdf https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref5 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref6 winkel, children without childhood, voices in bioethics, vol. 1 (2014) 5 [vii] the united nations office of the special representative for children and armed conflict. “un unveils global campaign to end use of child soldiers in government forces by 2016.” published march 6, 2014. http://childrenandarmedconflict.un.org/12078/ [viii] the united nations general assembly security council, children and armed conflict: report of the secretary-general, 2012. [ix] supra, war child. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/children-without-childhood-robbed-innocence-and-its-implications-for-violence#_ednref9 howard, the modern family fiasco, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the modern family fiasco louisa howard keywords: bioethics, conception, art, ethics, sperm donor introduction for the majority of couples, conception is a process involving the woman’s own eggs and the sperm of her male partner. this makes parental identity, for the most part, straightforward—the woman is the child’s rightful mother and the biological father is the child’s rightful father. however, assisted reproductive technology (art) has brought new definitions to the term parenthood. the legal sanction of parenthood now extends beyond individuals who pass along their dna or choose to adopt children—sperm donors, egg donors, and gestational carriers now vie for the title of parental ownership. ____________________________________________________________ howard, the modern family fiasco, voices in bioethics, vol. 1 (2014-15) 2 analysis with the rapid rise in art, the traditional framework of rightful parentage must be reevaluated, especially when considering sperm donors. the laws on this issue vary across states, and in some states, laws regarding donor sperm are still unclear. traditionally, a donor of genetic material is not legally considered to be the parent of the child. specifically in california, the family code does not consider a sperm donor to serve as the parent if he is not married to the woman conceiving. only if a written agreement exists before the conception of the child can the donor be deemed the legal parent. however, the judicial system is beginning to reconsider who might be the “intended” parents of a child. case by case, the courts often evaluate the adult who has served as a parent to the child and decide whether or not the individual can be considered the legal guardian. the topic of sperm donation becomes most ethically entangled when discussing nonanonymous sperm donors. a recent case in california sheds light on the intricacies involved in using a non-anonymous donor and his legal rights to the conceived child. achieving national publicity, this case helped to ignite the introduction of a new bill into california legislation, known as the modern family act. the non-anonymous sperm donor has been struggling to obtain parental right to his biological child, while the mother continues to uphold a strict restraining order and denial of any paternal relationship. the former couple did not form an agreement before the child’s conception and broke up permanently shortly after the birth. although the son shares a middle name with the father’s familial lineage, and spent a significant amount of time with his biological father during infancy, the mother’s lawyer insists on referring to the father as simply the sperm donor. anonymous donors make up the vast majority of the more than 30,000 estimated births annually resulting from donated sperm. the california cryobank, which is the nation’s largest sperm bank, administers less than 10 non-anonymous samples a month out of 2,000 total. 1 although this is not a large number, the frequency of issues that occur from such donations prove that states would greatly benefit from clear-cut regulations. the aforementioned example, along with many other similar non-anonymous sperm donor cases, raises the question of original intention. issues with same-sex couples create their own confusion; however, the situation can grow even more complicated when the biological parents were originally in a relationship together, could not conceive naturally, sought art services, and then later permanently split apart. situations like this beg the question: what type of relationship did the biological father originally intend to have with the future child when he offered his genetic material? disagreements and legal battles could be more easily prevented if patients who used a fertility center were required to make these life-altering decisions about their future child before seeking physician assistance. another way to look at these circumstances would be to consider what it would have been like if the pair could have conceived naturally. if this were possible, then the father would have undoubtedly been both biologically and legally the parent. is it fair that just because the child was conceived through in-vitro fertilization that the mother can use this condition as leverage to label her former partner as a mere sperm donor? moreover, it is important to consider the well-being of the child. one would think that denying the child of a fatherson relationship gravely affects their upbringing. conclusion fortunately, if california’s new law passes, it will require donors to enter into a formal, written agreement before donating semen for artificial insemination or in-vitro fertilization. along with many other implementations, some more controversial than others, the modern family act would demand that all parties sign a statement of parental intention before any medical procedure can take place. this would eliminate many of the ambiguities infiltrating the tangled web of assisted reproductive medicine and would prevent the hundreds of cases that have already howard, the modern family fiasco, voices in bioethics, vol. 1 (2014-15) 3 surfaced in courts across the country due to disagreements over child custody. as the modern world reveals, people create their families in different ways. this act would allow people the freedom to safely enter into agreements. california has recognized a need for clarity and regulation within the assisted reproductive realm, and one hopes that they will set a precedent for other states as well. 1 “does sperm donor mean dad?” by brooks barnes new york times. ringel, ridding ourselves of noxious “death panel” discourse, voices in bioethics, vol. 1 (2014-15) * 2014 lillian ringel, ms in bioethics. © 2014 lillian ringel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ridding ourselves of noxious “death panel” discourse lillian ringel* keywords: bioethics, ethics, death panel, medicare, end-of-life introduction on friday, april 11, 2014, senator tom coburn (r-ok), along with co-sponsors senators chris coons (d-de) and richard blumenthal (d-ct), introduced the “medicare choices empowerment and protection act" (s. 2240), which would pay eligible medicare beneficiaries if they create an advance directive: $75 if they create an a.d. online, and $50 if they create an a.d. manually. the bill would also create a system to store the advance directives to make them easily accessible for health care proxies, health care providers, and beneficiaries. beneficiaries would be able to register their advance directives during their initial enrollment in medicare part c (medicare advantage). ____________________________________________________________ ringel, ridding ourselves of noxious “death panel” discourse, voices in bioethics, vol. 1 (2014-15) 2 analysis in a press release, sen. coburn said the following: "advance directives are a valuable, voluntary tool that offers patients the ability to protect patients’ future health care preferences or to specify someone to act on their behalf. this bill would encourage their adoption by medicare beneficiaries and is intended to start a discussion about how best to move this policy forward. we welcome constructive comments from stakeholders to improve this plan and to better encourage the voluntary adoption of advance directives by medicare beneficiaries that can be accessible in real-time by their physicians and hospitals." sen. coons also added: "every american deserves the opportunity to live his or her final days with dignity," senator coons said. "too many americans leave their end-of-life care to chance or to the preferences of distraught family members. this bill will help more americans ensure they are the ones making the choices about their end-of-life care, reducing confusion and empowering more americans to spend their final days and hours on their own terms." conclusion though advance directives are not a panacea for end-of-life decision-making, efforts to encourage advance directives recognizes, at the very least, the importance of end-of-life contemplation. references "government would pay seniors to create advanced directives under senate bill" by tim mullaney http://www.mcknights.com/government-would-pay-seniors-to-create-advanced-directives-undersenate-bill/article/342803/ "senator advances bill to pay medicare beneficiaries to register advance directives" by craig klugman http://www.bioethics.net/2014/04/senator-advances-bill-to-pay-medicare-beneficiaries-to-registeradvance-directives/ http://www.mcknights.com/government-would-pay-seniors-to-create-advanced-directives-under-senate-bill/article/342803/ http://www.mcknights.com/government-would-pay-seniors-to-create-advanced-directives-under-senate-bill/article/342803/ http://www.bioethics.net/2014/04/senator-advances-bill-to-pay-medicare-beneficiaries-to-register-advance-directives/ http://www.bioethics.net/2014/04/senator-advances-bill-to-pay-medicare-beneficiaries-to-register-advance-directives/ preston, bioethical expertise and government, voices in bioethics, vol. 1 (2014-15) © 2014 joshua preston. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. bioethical expertise and government joshua preston bioethics, government introduction in a new paper published by dr. annabelle littoz-monnet, an associate professor of political science at the graduate institute of international and development studies in geneva, she asks whether government bioethics experts bolster or inhibit democratic control of policy. to answer this, she cites the european group on ethics in science and new technologies’ (ege) role in the european union’s early-2000s debate on whether to fund human embryotic stem cell research. drawing upon news articles, reports, and personal interviews, dr. littoz-monnet observes that when the debate reached a stalemate, the european commission (the eu’s executive body) sought out the ege’s recommendations. what followed was the use of the ege as a means for “control[ling] the policy process despite the presence of a salient and publicly debated conflict (17, italics in original). analysis although the case study is itself interesting, the value of dr. littoz-monnet’s paper lies in her broader conclusions. in particular, there has been an effort to elevate ethical expertise to the same domain as scientific expertise. such conflation is problematic, though, as one field is inherently normative where the other is descriptive. doing this gives decision-makers – in this case those within a governmental institution – “a crucial means of orienting political action while keeping the appearance of the rational, apolitical character of their actions” (4). to put it differently, by appealing to a committee’s bioethical expertise the same way one would appeal to, say, a climate panel, one obscures the definition of “expertise” and denies the role of ideology in bioethics. far from being neutral, governmental institutions “have an incentive to preserve the erosion of the technocratic domain, and ethics experts … provide them with a crucial governance tool,” one that “engender[s] consent and legitimacy for the development of biotechnologies” (17). by claiming to be apolitical, objective, and holding the moral high-ground, one sets the perimeters of debate and the window of acceptable actions. for a nondemocratic institution to do this stifles what could be legitimate, democratic discourse and hides “whose ethics and whose values prevail in … politics” (17). in this way, even though governmental bioethics committees have social, philosophical value, they are, like any committee, instruments. this can lead to some disheartening predictions. preston, bioethical expertise and government, voices in bioethics, vol. 1 (2014-15) 2 because controversial bioethics issues stem from conflicting hard values and interests between both individuals and institutions, one may expect bioethical expertise to be appealed to in those instances where deliberation most jeopardizes these interests. in contrast: one would expect ethical expertise to not be mobilized when value-based issues are not the object of a publicly debated controversy (either when a broadly accepted normative framework is in place or when no stakeholder considers the issue at stake to be threatening its position or values) (6). this strategic use of expertise means that challenges to the established consensus are likely to go unheard and unaddressed. as long as there are “certain ethical positions [held] as apolitical ‘truths’ that do not need to be questioned and submitted to contested, democratic decision making,” this will be a stumbling block for reformers (17). bioethics committees can guide the flow but not redirect the torrents – even if they are manmade and heading right toward the city. even though dr. littoz-monnet’s paper focuses on the european system, which is institutionally and demographically dissimilar from that of the united states, her warnings are universal. as the university of pennsylvania neuroethicist dr. jonathan d. moreno notes in progress in bioethics: science, policy, and politics, much changed with the collapse of “the great bioethics compromise.” by this dr. moreno means the “academic politeness within the small fraternity of bioethicists” in the 1980s and 1990s (xviii). as it dissolved, so too did the ideological détente in bioethics. president george w. bush’s council on bioethics was especially guilty of this as his appointments included such “experts” as a conservative newspaper columnist and several young scholars from conservative think tanks. of the latter, dr. moreno writes, it was a community of political philosophers who “came to washington with more than just an ideology … they came with an agenda” (xviii). coincidentally, this shift in the united states coincided with the debate over stem cell research in the european union. conclusion it should be added that this is not an attack on bioethics as a field of study for it is undeniable that any community with scientific aspirations must continue to develop its moral compass. still, this does not mean philosophy happens in a vacuum. the moral component at the heart of the major bioethical issues of the 21st century – from health care to human cloning – makes them inherently contentious as it is these values that most often define us. therefore, it should be unsurprising that some would seek to establish the borders of debate and thus the range of acceptable values. when the stakes are so high, this, which plays out in all policy, is as exclusionary as it is natural. yet, as they say, nature is what we’re here to rise above. sultan, reckoning two societies, voices in bioethics, (2013) © 2013 brandon sultan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. reckoning two societies: a proposal to provide compensation for harm done to animal research subjects brandon sultan keywords: animal research, research ethics, harm in recent years, federally funded institutions have been criticized and scrutinized for their treatment of animal research subjects. many critics advocate for severe restrictions or a ban of animal-based research in these institutions. peter singer and tom reagan argue against animal-based research from opposite ends of the rights-based spectrum. in this paper, i choose not to explore whether singer’s or reagan’s points are valid or appropriate. instead i propose a new perspective on the morality of animal-based research. i developed the two societies principle in the wake of the singer and reagan debate. it contains components of principlism, the modern ethical lens of bioethics. the two societies principle separates the animal society from human society. human rights and values trump animal rights and values, i argue, and use the two societies principle to support an addition to the current three r’s of animal-based research restoration. restoration entails providing some form of compensation to the environment and animal society for animals killed or severely harmed during research. in the end, i hope to show that animal-based research in federally funded institutions should be allowed to continue, without strong restrictions, because the scientific benefits of the research outweigh any perceived “bad science.” instead, there should be appropriate guidelines to the treatment of animals in these institutions. i will demonstrate that although singer and reagan bring up valid points in their arguments, ultimately the two societies principle better settles ethical concerns about animal-based research in federally funded institutions. sultan, reckoning two societies, voices in bioethics, (2013) 2 philosophical argument against animal-based research peter singer and tom reagan have led the rights-based movement against animal research. singer believes that our current policies exhibit “speciesism,” a form of discrimination against animals that is similar to racist policies and slavery. reagan argues that animals should not be used in research because doing so treats them as means to ends, violating their basic moral rights. peter singer singer’s reasoning against animal research employs analytical ethics, a mode of philosophical understanding and analysis based on universality and logical consistency. singer believes in a universal standard whereby what is true for humans is true for other beings with similar circumstances and/or characteristics, such as animals.1[1] in animal liberation, he offers a utilitarian ideal that humans and animals should be treated equally. the driving point behind this is that animals are sentient beings; their reactions to pain are equivalent to humans’ and they are morally equal. humans feel pain and strive to avoid it; animals do the same. therefore, according to singer, practices that involve inflicting pain on animals in an effort to minimize pain on humans create an ethical imbalance.2 tom reagan reagan asserts that animals have moral rights. he states that humans have no right or ability to place an intrinsic value on the life of an animal.3 thus, animals have inherent values, and humans should not interfere with these, especially because we do not know their values. this implies that humans are not able to place greater value on a human life than on an animal life. reagan develops the “subject of life” criterion, according to which each sentient creature is equally important, regardless of its value to others. he uses this to debunk arguments that humans are more valuable to the world and reject claims that humanity’s well-being justifies research. instead, reagan believes that the implied moral rights of animals, which are equivalent to humans’, should guide decisions on the morality of research on animals.4 regan and singer attempt to debunk the notion that a human life is more valuable than an animal’s, and that research on animals is justified because it improves human life. they emphasize the importance of equal treatment for animals because they believe it prevents a slippery-slope analysis of valuing life. singer draws an analogy to the arguments against research on mentally disabled people. if humans are more valuable than animals based on consciousness and self-awareness, then experimenting on less competent or disabled humans can be justified. but it is not ethically justifiable, because a mentally disabled individual has the same interest in not being experimented on as https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn1 https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_ftn1 https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn2 https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn3 https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn4 sultan, reckoning two societies, voices in bioethics, (2013) 3 does a great pianist. reagan’s and singer’s arguments together create the utilitarian argument that if you can kill animals for the good of mankind, then you can kill humans for the good of mankind. according to reagan’s utilitarian argument, killing an older woman who is very wealthy and donating her money to charity is as morally justifiable as killing a mouse for research. both reagan and singer are cautious in their overall valuation of animal life. singer importantly notes that killing a rat is not the same as killing an adult human with complete self-awareness. he acknowledges that some organisms’ lives have more value, and that humans have more value than mice when a human life is in direct conflict with a mouse’s; a situation that doesn’t happen in a research setting.5 reagan limits the justifications for research on animals because the positive utility in killing an animal or experimenting on it is probable and not definitive. experimenting on mice or primates does not guarantee a cure to the pain and suffering of humans from cancer, for example. singer notes that there is a tradeoff in research, if painlessly killing an animal would lead to a cure for all cancers, there could be grounds for justification. understanding research ethics the basic ethical principles that govern research arose in the aftermath of tragedies involving human subjects. incidents such as the tuskegee syphilis study and nazi experimentation on humans led to the nuremberg code, the belmont report, and the formation of irbs. principlism is the dominant ethical lens of bioethics, and research ethics embodies—and is constrained by—it. the principlist systems is based on four moral principles: autonomy, which allows for free will and self-determination; beneficence, the obligation to do good; nonmaleficence, the obligation to do no harm; and justice, equal distribution of goods and services or risks and benefits. traditionally principlism has been applied to humans. arguing that animals have moral rights establishes that it applies to animals as well, and, thus, previous animal research qualifications, such as minimizing harm, have been transformed into issues concerning animals’ inability to grant consent or the need to refrain from harming animals. extending principlism to animals will drastically limit animal-based research or end it altogether. reckoning with research limitations some of the most influential and useful research has come from research practices that were unethical. the nazi experimentation and pellagra and polio vaccine experimentation are but a few research events that drastically changed medicine and science. these experiments would not be allowed under today’s standards. i do not condone these actions, but they do highlight the fact that great discoveries of great medical benefit have resulted from not only unethical research but unrestricted research. today’s human-based research standards are necessary and appropriate, of course, but they can restrict researchers’ ability to test some hypotheses that could eventually lead to results that would benefit humans. although there is a core of harm and the potential for unethical practice when testing on https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn5 sultan, reckoning two societies, voices in bioethics, (2013) 4 animals, the results have largely been positive. testing on high-functioning and low-functioning animals has enabled the great minds in science and medicine to explore cures for some of the deadliest diseases afflicting the human population. the two societies although singer’s and reagan’s rights-based arguments are persuasive, the debate on whether to use animals should transcend a rights-based justification. instead, human society should implement a cost-benefit analysis of each research situation and make its best efforts to limit the harm that is done to the “animal society.” animal society includes all animals, whether they are born in captivity or in the wild. while human-based research is governed by principlism, the animal-based research debate must be viewed through a different lens. i call this lens the two societies principle, and through it one can see a human society and an animal society. two societies is a utilitarian system dedicated to the promotion of the greatest good for each society. it acknowledges the speciesist argument—that humans have a greater right to life and liberty than animals—and maintains that animal-based research ethics are governed by beneficence and non-maleficence. the two societies principle argues that the greatest benefit to the human society is to provide the most effective and efficient research at the least cost to humans. our current system reflects this: we have limited research that can be conducted on humans and have expanded research that can be conducted on animals. we have acknowledged that the mentally ill, prisoners, foster children, and others, who were once discriminated against and underrepresented in our society, have the same interests and rights as other humans. this human rights success far outweighs any restriction of medical or scientific research. harm to the animal society might come from killing animals born in nature or draining resources from animal habitats. these harms are often justified by an advanced darwinian argument of survival of the fittest: developing land and killing animals for food are necessary for human survival. in the two societies principle, animal-based research is justified because it does not directly harm the “natural” animal society and because animal-based research is linked to human survival through medical innovation. (i use “natural” animal society to refer to those animals that are born and remain in the wild.) natural animal society is not directly harmed because animals in that society are not experimented on; only animals born in captivity will be research subjects, and thus no harm to the natural animal society will occur. experimentation is what might yield harm. neither animals’ autonomy nor distributive justice is essential to ethical governance according to the two societies principle. this is the case because the rights of humans outweigh the rights of animals. even singer and reagan acknowledge that a human life can trump an animal life. limiting or banning animal research can have a detrimental impact on humans. research that is restricted might forestall potentially lifesaving innovations. the iacucc, sultan, reckoning two societies, voices in bioethics, (2013) 5 institutional animal care and use committee, requires that all research done on animals must significantly improve their or humans’ lives.6 that is, the rights of animals are limited in this case because human rights trump animal rights. these premises are essential to the two societies principle. the principle of non-maleficence in the two societies system is employed on a macro level. for instance, what is good for the animal society as a whole outweighs what is good for an individual animal. within the animal society are animals born in nature and in captivity. animals born in nature have a stronger rights claim than animals born in captivity. many of the primates, rats, and birds used in research are bred for experimentation, while animals born in nature have a natural liberty interest; the “purpose” of their birth is to be a part of nature. scientific and medical research do not directly harm the natural animal society when research is done with animals bred for research. the principle of beneficence in the two societies principle focuses on doing good for the animals harmed from testing. while testing on animals does not pose harm to the natural animal society, there is still a level of harm inflicted on the animal society because animals born in captivity are harmed. in addition to previous measures to reduce harm on animals tested, the two societies principle advocates for a form of compensation to be provided to the animal society for the harm done by the research. this leads to the policy proposal of restoration. the addition of restoration to the three rs the three rs of animal research refers to reduction, refinement and replacement. reduction means limiting inefficient use of animals in research (often by using the minimum possible number of animals in research). refinement is the goal of minimizing pain and stress to animals. this comes from techniques such as providing appropriate living conditions and ensuring that proper handling methods are employed as parts of a reasonable quality of life. replacement is the use of alternative methods and might entail the use of less sentient beings, not using animals at all, or avoiding repeating certain experiments.7 restoration the two societies principle includes a fourth r: restoration, which requires compensation be provided to the natural environment for every animal either killed or severely harmed from research. the exact definition of “severely harmed” and establishing a specific level of compensation are not necessary for a preliminary understanding of the idea. when an animal is harmed in an experiment, the greatest compensation that animal society can receive is restoration for its natural habitat or other efforts to preserve the lives of those born in the nature. this helps to offset harm on the individual level by providing a benefit on the macro level. cash donations could be used to help preserve animal habitats. when high-functioning animals such as primates are harmed, the level of compensation would be greater than when lower-functioning animals such as rats suffer. if rare animals are harmed, the compensation would go to either a federal fund or nonprofit agency dedicated to preserving lives of the animal. for common animals such as rats, compensation would also go to funds that promote preservation of habitat and animal lives, but not specifically those of rats. https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn6 https://michael-reaves-bkln.squarespace.com/features/2013/10/15/compensation-animal-subjects#_edn7 sultan, reckoning two societies, voices in bioethics, (2013) 6 restoration would increase the cost of animal research, which would in turn help ensure that only well-funded and scientifically necessary research is conducted. this macro view is essential to shaping arguments for animal-based research. medical and scientific research are as much about saving individual lives as they are about preserving the quality of life and survival chances of the species. a restoration policy would increase the cost of animal-based research, which would leave the remaining three rs to focus on safer practices and alternatives to animal-based research. 1 richard p. vance "an introduction to the philosophical pressuppositions of the animal liberation/rights movement." in jama 268.13 (1992). 2 ibid 3 ibid 4 ibid 5 ibid 6 “ overview of animal care and use at ucsc,” university of californa santa cruz, accessed october 2nd, 2013, http://officeofresearch.ucsc.edu/orca/iacuc/ 7 alan goldberg "the three rs and biomedical research" (science volume 272.5267,1996) p1403 http://officeofresearch.ucsc.edu/orca/iacuc/ sultan, a pre-med student’s, voices in bioethics, vol 1 (2014) © 2014 brandon sultan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a pre-med student’s reflection witnessing an internist brandon sultan keywords: clinical medicine, patient-physician relationship, narrative introduction as i sat in the back pew, i suddenly heard the door gently creak open. i turned and saw a man creeping through the wrinkled oak door. his dark withered face was barely visible as he delicately leaned over his walker. what could be seen of his face bared no remnants of a smile. each step from his suede shoes slowly slushed together as he walked past. he sat down and then slouched over with his arms crossed over the back of the pew in front of him. as he starred down at the floor, the priestess approached him from the front and subtlety placed her hand on his shoulder. analysis standing tall over the man, the priestess began to speak, “hola carlos, dime, how is everything.” the old man leaned back and shrugged his hands to his side and replied, “i have pain madre, me duele mucho.” “where is this pain?” asked the priestess. the old man clutched his hands on his legs and said, “madre, i must tell you, my legs hurt, and my neck is very difficult to move.” the priestess nodded her head and replied, “i can imagine this pain to be very difficult to deal with.” staring down at the ground the old man replied, “as you say madre, as you say.” “when i have seen you here before you have told me you have pains. where else does it hurt?” asked the priestess. “madre mia, me duele, me duele.” complained the old man the priestess quickly replied, “i can’t help you unless i know where your pain is.” sultan, a pre-med student’s reflection, voices in bioethics, vol 1 (2014) 2 “madre, i don’t know, this pain is different, all of it hurts” he responded. the priestess starred at him and gently responded, “carlos i cannot help you, or prescribe you medication or therapy if i don’t know where and importantly why it hurts.” the old man turned to the priestess and opened his hands in front of her, and pleaded “you, you know, doctora, you know, you know why i have this pain. digame, digame doctora.” the old man then leaned over and placed his right hand over his forehead and his elbow on his knee. the priestess paused for a moment and began to lean on the pew. she looked at carlos and smiled as she said, “well, have you been outside, have you been active, who have you been spending time with?” “no madre, i just sit in my apartment most of the time.” he replied the priestess looked at him, twiddled her fingers on the back of the pew and said “carlos i don’t think that is good, dime algo, share a story with me, what did you do for fun last week carlos?” “as you say madre, as you say. occasionally, once in a while i sit in front of the apartment building.” the old man paused and looked up at the priestess for a moment and began to laugh as he turned away. conclusion the doctor sat down next to him. and before she could speak the cackling old man said, “you know madre, when i sit outside, once in a while some of the pretty young women say hi to me.” the priestess paused for moment, as she turned facing the old man, she smirked and responded: “well look at you carlos.” after pausing for a moment, she said, “you must enjoy the company. how was your thanksgiving, did your family come and visit?” the old man continued to look away as he replied, “no madre all my family is far away in santa domingo.” the priestess looked at him and nodded her head and she said, “that is never easy, you must miss not being able to see them.” in a soft and waning voice, the old man replied “si, si doctora.” the man looked up at the priestess and said “you know madre, i have to tell you, mi mujer, my wife, she died around this time a few years ago. i miss her, i miss her. it is very sad, very sad.” sultan, a pre-med student’s reflection, voices in bioethics, vol 1 (2014) 3 the priestess nodded her head and put her hand on the old man’s shoulder and before she could say a word the old man replied, “it hurts, it hurts” “dime mas, tell me more” replied the priestess. the old man smiled and grabbed her hand, kissed it and gently responded “as you say madre, you know me well doctora.” caryn_no men allowed.docx winter 2015 no men allowed caryn rubanovich follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 1 i stood in the very back of the nurses’ station in the ob-gyn ward of the hospital, looking out at the scene of nurses, fellows, and doctors gathering around a single four by three foot whiteboard. this whiteboard, the very center of everyone’s attention, was divided into neatly drawn cells each filled with words, phrases, numbers, and symbols. the towering attending stood beside me. he was calm and collected and he scanned the room with his gaze, taking a mental note of the space. he was the one i was shadowing that day. after a few more moments, the room had become filled with the ward’s mostly female medical staff. a few male clinicians filed in and sat down, sprinkled amongst their colleagues. as soon as the attending made eye contact with a nurse in the front of the room, she stood up, commanding the room’s attention. in what seemed to be a daily procedure, the nurse gave an overview of each of the patients written on the whiteboard. each patient was endowed her own row of cells that separated her information from the others. amongst the drawn cells, her medically relevant information and data were divided into a few categories: gestation/partition, medications, medical history, age, etc. the final column was titled “other.” the nurse systematically went down the list of patients, from top to bottom, one by one, using the information in the cells to guide her explanations. other than the occasional question from a staff member, or additional remark, most individuals in the room remained silent. the process was fairly quick and efficient. as the only non-medically trained individual in the room, i tried my best to listen for any words or phrases i might recognize, and i did my best to make sense of the medical jargon. whenever i was lost in translation, i looked back to the “other” information, a kind of home base for me. i found comfort in the “layperson’s” terms—“spanish-speaking,” “penicillin allergy,” etc— seeing as those were the ones comprehended more fully. eventually, the nurse at the front stopped on the final patient. as she spoke, my eyes automatically darted towards the “other” cell on the far right-hand corner: “from somalia,” “female circumcision,” and “no men allowed.” intrigued, i waited to hear the nurse go into explanation about this information, but to my disappointment, she skipped over it, not mentioning any of the phrases. with the conclusion of the nurse’s lecture, the staff shuffled out, returning to their respective posts and designated areas. the attending walked over and entered a glass room, conjoined to the nurses’ station, and motioned me in to follow. a fellow and a couple of other doctors—all male—filed into the same room. switching over to their medical language once again, they hurriedly discussed other patients in the brief moments they had before their day really started. i stood on the side watching them interact. nevertheless, i became increasingly more confused by something that was not making sense to me. after a few minutes, the fellow and other doctors exited out of the room, and the attending stayed behind. alone now, i mustered up the courage to ask him a question. voices in bioethics 2 “so, you know the last patient on the whiteboard…the one where it was written “from somalia,” “female circumcision,” “no men allowed”? “yes.” “i can’t help but notice that you and the other doctors who are working right now are all…men. what happens if there is an emergency and the patient needs help? it says ‘no men allowed.’” his answer, more or less: too bad, we go in. his answer was simple, confident, and matter-of-fact. yet, i didn’t feel any relief from hearing it. i wasn’t sure i agreed with the answer, but i feared making myself look like a fool by asking any follow-up questions. instead, i remained silent, letting the moment pass. “well let’s go see our first patient.” and i followed him out. my ethical questions the attending doctor and i never ended up seeing that patient, the one whose “other” notes puzzled me. nor, to my knowledge, was she ever involved in an emergency that day. nevertheless, i could not stop thinking about her. i was left wondering many questions: --what are the ethical obligations of a hospital, medical institution, clinic, or practice to provide and ensure access for patients, upon request, to physicians and other medical professionals with a certain gender or sex? --what are the boundaries for patients authorizing who can and cannot enter their hospital rooms? --if an emergency did occur and one of the male physicians in this situation entered the room against the patient or family’s wishes, would the physician be at fault or be seen as having committed an ethical breach? or would he be cleared and be viewed instead as a hero, having saved the life of a woman and her baby? --conversely, how might the physician be seen if he did not enter the room? potential areas to explore it is easy to fall into a trap of “black-and-white,” dichotomous thinking when considering matters of ethics—“was the physician wrong or right?” “should the patient just change his or her mind?” etc. but, perhaps we need not limit ourselves this way. communication makes for good caretaking. in an optimal situation, a clinician would be able to talk to a patient about her views or concerns, but in this specific voices in bioethics 3 circumstance, communicating directly with the patient was off-limits. scenarios like this, although initially frustrating, call for creative, out-of-the-box thinking. fortunately, narrative medicine and social justice work can help us cultivate and exercise alternative approaches towards collaborative solutions for ethical dilemmas. for example: 1. could there have been a female ob-gyn on call in case an emergency situation occurred? 2. if there was an emergency, and depending on the specific emergency, could a female medical professional, such as a nurse, have gone in and communicated with one of the male physicians via phone, skype, video, etc? one could argue that in order to best treat the patient, the doctors should get to the bottom of why she didn’t want men treating her and understand her viewpoint. it would obviously be nice for this to happen, but it’s not realistic. we can’t always understand others’ views or opinions, despite our best intentions. but that doesn’t mean we shouldn’t respect their personhood and decision-making. do you have to get to the bottom of something or truly understand a viewpoint in order to honor another’s decisions and give them the comprehensive care that they desire? i would say no, you don’t, the same way that clinicians who are personally pro-life can still help their clients seek resources and care for abortions even if they don’t understand their viewpoints. clearly, the attending, and the patient and her family, approached the patient’s care with various beliefs. it can be worthwhile to argue and debate different sides, trying to figure out who was “more correct,” but for clinicians, this shouldn’t be the main focus, and certainly not in an urgent situation when the stakes are high. instead, it is more fruitful to have backup plans in place, and be ready to respond to any kind of emergency or curveball. conclusion i recognize that there may not be simple answers to ethical questions that could satisfy all parties; nevertheless, i believe it is vital to pose them for consideration. furthermore, it is critical to utilize creative, out-of-the-box thinking to create a space where we can consider alternate pathways, and at the same time, respect one another’s viewpoints. it is in contemplating ethical dilemmas, such as the one described above, that we continue asking the challenging and unequivocally necessary questions of a healthcare and medical system that (one hopes) is drawing closer to becoming more self-aware and conscientious. preston, neutral on “neurolaw,” voices in bioethics, vol. 1 (2014-15) © 2015 joshua preston. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the general public is neutral on “neurolaw" joshua preston keywords: neutrality, nuerolaw, ethics introduction over the last ten years, much has been written about the intersection of neuroscience and law and how it may lead us to re-conceptualize punishment and blame. so for all its promises and controversies, it is interesting that a new study suggests people are “generally neutral in [their] support for neuroscience-based legal reforms” (shen & gromet 2015 86). this support, though, is not static, and depending on the frame, wavers along partisan lines. analysis noting that “political science perspectives have been noticeably absent” in the “neurolaw” literature (87), the authors set out to study how different framings influence public approval. incorporating their survey into a national omnibus poll (n = 1,010), they offered subjects one of three frames: the first characterized neurolaw as a means for enhancing punishment, the second as a means for diminishing it. (the third was a control). these first two they called prosecution and defense frames, respectively: [prosecution] “thinking about how prosecutors may use neuroscientific evidence to show that criminal defendants deserve lengthy prison sentences, do you disapprove or approve of legal reforms based on advances in neuroscience” (92)? [defense] “thinking about how defense lawyers may use neuroscientific evidence to show that criminal defendants deserve reduced sentences, do you disapprove or approve of legal reforms based on advances in neuroscience” (92)? what shen and gromet found is that while the general attitude toward neurolaw is neutral, “republicans’ approval of [it] decreases when neuroscience is seen as primarily serving to reduce offender culpability, whereas democrats’ approval is unaffected by how neurolaw is framed” (86). for scholars and activists this means “the interaction of partisanship and framing can influence approval of neurolaw, particularly with regard to the use of brain science to help defendants receive less severe punishment” (95). this study is not without its weaknesses (some of which they discuss), but most problematic for me is that the poll was conducted in may 2011 – four years ago. since then there have been a handful of popular science books, documentaries, and focusing events (e.g. the mental health of mass shooters), each of which have likely had some effect on public opinion. my intuition is that, today, the public is less neutral than this study suggests; http://ann.sagepub.com/content/658/1/86 preston, neutral on “neurolaw,” voices in bioethics, vol. 1 (2014-15) 2 but if the authors are correct, still, we cannot presume this neutrality will last forever. within a few years’ time neurolaw may be as politically polarizing as climate change or the teaching of evolution in public schools. and as with those, the framing that prevails will dictate the policies that follow. ducar, when the disabled become isolated: the story of snowflake, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. when the disabled become isolated: the story of snowflake dallas ducar bioethics, snowflake, mcs introduction on the outskirts of a small town called snowflake, just 150 miles northeast of phoenix, arizona lies a small community suffering from a disease known as multiple chemical sensitivity (mcs). those with mcs suffer from migraines, fatigue, rashes, and other incapacitating symptoms which they believe to be due to chemical sensitivities. perfumes, detergent, smoke, and many other artificial chemicals are thought to be the cause of such sensitivities. analysis people with mcs arrive from around the nation, generally due to overexposure to multiple chemicals, pollen, or other environmental pollutants. many who have chemical sensitivities also have electromagnetic sensitivities and have fled from what is known as “electropollution.”1 the population of this community attempts to build with “safe” materials such as ceramic tiles rather than carpeting, which can capture certain odors. the electrical sensitivity has causes some members of the community to build their houses without installing electricity. however, many remain worried as a new resident or company could build with “unsafe” materials, which may force many to leave the place they call home, once more. the residents of snowflake have generally suffered from more than mcs. the needs of many of the residents are strict, they require very certain “safe” products and generally cannot enter into larger communities. therefore, most of the people with mcs are unable to work and many of their spouses end up leaving. however, this community of three dozen households is a promised land for many of the arrivals. many claim to have been suffering for years and are simply looking for refuge. there are reports of many others who call weekly, asking for availabilities, generally met with disappointment and grief. the problem is that most scientific studies have been unable to show any strong connection between exposure to these chemicals and the symptoms being reported. moreover, the american medical association does not recognize the mcs as chemically-caused. blinded clinical trials have shown those with mcs react as often and as strongly to placebos.2 fundamentally, many doctors still disagree about the exact etiology, claiming that the symptoms may be physiological, psychological, or both. regardless of the etiology, these are human beings claiming to have severe, disabling symptoms which result in a complete uprooting of their lifestyle. ducar, when the disabled become isolated: the story of snowflake, voices in bioethics, vol. 1 (2014-15) 2 the unrecognition of mcs by the larger community poses a more general question. some residents do not do not receive disability benefits as mcs is not fully recognized. is it just for the state to not offer assistance to the sufferers of mcs? even for the doctors who doubt the etiology of mcs, shouldn’t more research be invested to ensure these people are helped? this is most likely the first time you have heard about mcs. however, mcs is a name all too familiar to the residents of snowflake, arizona. who will speak out for this small town when a new gas station decides to move in? who tells the new family building with “unsafe” materials that they cannot move to snowflake? it is quite possible that without proper representation, the residents of snowflake are inadvertently isolating themselves. however, mcs is unique as it inhibits sufferers from entering any large area where public policy decisions would be made in the first place. mcs can result in isolation, thereby resulting in less advocacy for those afflicted. when considering the rights of those afflicted with mcs it is also important to understand what the government may owe to these people. when considering whether to recognize a paraplegic as qualifying for disability benefits, one does not look primarily to the cause, so why is this the case for sufferers of mcs? conclusion while some may not take their disability seriously, they do. cases such as this create impetus to ask what classifies as a disability, why it is a disability, and what should be done, if anything, to change this mentality. the residents of snowflake are real people with real voices. even if the pain may be psychologically induced, does this make the suffering and disability any less real? 1 http://www.eiwellspring.org/arizona/snowflakecommunity.htm 2 j. das-munshi, g. j. rubin, s. wessely, multiple chemical sensitivities: a systematic review of provocation studies, journal of allergy and clinical immunology, 118, pp.1257-1264 (2006) winter 2015 the daughter linda e. clarke follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics her favorite shoes of her father’s are his brown wingtip shoes, and they are the last ones she polishes every sunday night when she polishes all of his shoes for the work week ahead. they are chestnut brown with thick soles lifted slightly at the toe, one with a hole in the middle that has been repaired. she caresses the heavy toe each time she rubs it with shoe polish and brings it to a dull shine with the brush. one day she is home sick and stays up in her bed, listening to the sounds of the house around her. in the morning her brother slams the door on his way out to school. she hears her mother turn on the radio, then talk on the phone, followed by the faint whining of the vacuum cleaner, and so on throughout the day. when her brother thumps into the house at the end of the school day, she knows it’s almost five o’clock and that means her father will be home from work soon. outside her window she sees the light in the sky is fading; he’s on his way. she hopes he knows that she has been home sick all day as she prepares for his arrival. feeling her cheeks and forehead, she is relieved that they are still warm to the touch. she snuggles into the blankets and waits. the sky is pitch-dark when she hears the crunch of the car tires in the driveway. she pictures her father coming into the front hall; she hears him downstairs calling hi to everyone and mom comes to kiss him hello and to hang up his coat. she listens hard for the sound of their voices, speaking, she imagines, in hushed and urgent tones. “how are the kids?” he would ask, and mom would shake her head and tell him that the daughter has been sick all day and is upstairs in bed. “i’d better go see how she’s doing,” she imagines him saying. and, right on cue, she hears his footsteps in the hall. he stands in the doorway, backlit by the hall light. she can see his silhouette and relishes the concern that she knows is on his face. she struggles to look sick and valiant all at the same time. “hi, sweetie,” he says, coming into the room and looking down at her. “mom says you aren’t feeling very well.” she nods at him and mumbles hi. he comes over and sits beside her on the bed; he smells of cigarettes and wrigley’s spearmint gum. he reaches over and brushes her hair from her eyes, feeling her forehead. “hmmm, still a little warm,” he says. “is there anything you want?” she shakes her head. he leans over and kisses her cheek, then stands up to leave. “if you want anything you just call, we’ll be right downstairs.” she smiles. she had been waiting for that visit all day. ***** voices in bioethics twenty-five years later, the daughter is driving through friday afternoon traffic. she is late to pick her father up from the hospital to bring him home for the weekend. he’ll be worried and upset that she isn’t there yet; since the accident he is impatient and becomes furious when routine is disrupted. it’s almost six o’clock when she pulls into the parking lot, more than an hour late. the wide door to the hospital sighs open when she steps on the grey mat. inside, the smells of old food and cleanser meet her; at this hour most patients would be eating dinner in their rooms. she turns left to the bank of elevators. entering one, she pushes the button for the fourth floor, it deposits her directly across from the nurses’ station. she sees that one of dad’s nurses is leaning against the desk, facing the elevator. the woman’s dark eyes widen and flash when she sees the daughter, her round face turns a deep red. she is carrying a denim jacket. she steps up to the daughter, blocking her passage. “you’re late! you’re very late! my shift is over and i have to talk to you and you are late!” the nurse spits the words at her. the daughter stares down at the slight woman, she feels enormous. “what? what has happened?” the words are thick on her tongue. “you!” the nurse jabs the air between them with her finger. “you must talk to your father. you must tell him to behave himself. if he doesn’t behave we will have to tie him up!” the nurse puts an emphasis on the word “up” and she gestures with a finger, swooping upwards. “we will have to tie him up.” she breathes heavily. the daughter stares at her. how can she say this? this nurse doesn’t even know her father. she doesn’t know that he is funny or that he is wonderfully curious. she doesn’t know how proud he is to be the first university graduate in his family. this nurse knows nothing about how he loves his wife or about his stubbornness. the air around them hums and the daughter shakes her head. “no.” her words feel hot. “no. no. you will never do that.” she walks around the woman and strides down the hall to her father’s room. dad is sitting on his bed, ready to go; his black overnight bag is by the door. he’s still handsome, the soft yellow of his cardigan showing the red in his cheeks and the new grey in his thick black hair. his mouth is set in a thin, sharp line. he’s been staring at the doorway. trying to smile, the daughter enters the room, “sorry i’m late, dad, but the traffic was awful.” voices in bioethics with his hand he brushes away her excuses, sweeps away her smile. he struggles to stand up, grabbing her arm for balance and pushing it away the minute he is on his feet. she notices a bruise on his right hand, at the wrist it is purpled. for the space of just a breath, she wishes she hadn’t noticed it. he heads towards the door taking steady, careful steps. “let’s go. now.” his voice is brittle. the daughter touches her father’s arm, “dad, wait a minute. we’ve got to talk. ” she sits on the bed and motions to the grey chair for him to sit down. “please.” he shakes his head, “no, no, don’t want to talk.” he slams his mouth closed. “i know,” she says, “but i need to know what happened. how did you get that bruise? what happened, dad? please tell me.” he stands for the measure of three breaths. she watches him as he turns back into the room and sits down. she notices how carefully he holds his wrist close to his body, how that hand is trembling. he starts to tell the story. “yesterday was a very slow day,” he starts. “very, very slow.” he pauses, breathes deeply, rubs his bruised hand. he hunts for the words; they don’t come so easily since the accident. “i am so goddamned tired of all the time waiting, waiting, waiting.” he shakes his head. “such a waste of time.” the daughter nods. he continues, “two o’clock is my appointment for learning to walk. my appointment to get stronger.” “your physiotherapy appointment, dad.” big words elude him. he nods. “but no one came. almost 2:30 and no one. so, i started to walk there by myself.” “oh, dad,” she says. he’s just learning to walk again and he isn’t supposed to walk alone. he shrugs, “i had to try it. at least i had to try it.” she nods. “i was doing okay. no one saw me. it was slow but i was almost all the way to the, the, elevator.” he says the word carefully. voices in bioethics “what happened then, dad?” “one of them nurses called my name. i tried to walk faster but it made me fall.” he lifts his right arm and shows her the bruise, tries to push his sweater sleeve up. “i fell.” “don’t worry about it dad. i can see it’s bad.” she helps him pull the sweater sleeve down. he is watching her closely, trying to smile at her. “the nurses are angry at you now, eh?” she asks. he shrugs, “yes, i think so.” he doesn’t look a bit sorry. the daughter nods, tries not to think of her father lying in the hallway. he leans over to squeeze her hand. his touch is warm. she smiles at him. “i really don’t want you to get hurt, dad. you’ve got to be careful.” he nods. outside his window, the night has painted the sky a starless black. she helps him up and reaches for his overnight bag. hill, commentary to "ethicizing the ebola epidemic", voices in bioethics, vol. 1 (2014-15) © 2015 rachel hill. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduc tion, provided the original author and source are credited. commentary to "ethicizing the ebola epidemic" rachel hill commentary, ebola, bioethics introduction the author introduces two key issues of the ebola epidemic very clearly. however, the author could elaborate further on the objections to using experimental drugs. the author does a very good job of enumerating the reasons for using these drugs (that there is no alternative and that harm is already being done to those infected). in terms of reasons against using the drugs, the author only writes that there are regulations in place that are usually followed. several supporting facts are given to suggest different regulations should be put in place for a crisis like ebola. ebola is a deadly disease with no cure. at present, all we have are these experimental drugs. ordinarily, such drugs would not be given without extensive testing. however, in this case, there is no time for that to be done. people who contract ebola have no other alternatives, so an unapproved experimental treatment is better than nothing at all. it is important to weigh the risks and benefits. ____________________________________________________________ hill, commentary to "ethicizing the ebola epidemic", voices in bioethics, vol. 1 (2014-15) 2 analysis some may argue that the risks of using an experimental drug may be too great and that we should wait to administer any experimental drug until it has been proven safe. we do not know what the long-term side effects may be. while that argument may be appropriate for other situations, in the case of ebola epidemic, i do not think it applies. as i have said, and as the author has said, there is no cure or other treatment available for ebola. people who contract it will likely die of the disease and these experimental treatments are their only option. in this case, the benefits outweigh the risks. conclusion as the author mentions, access to these drugs is very problematic. however, they do not elaborate enough on both sides of the issue. there are reasons supporting and reasons against giving health care workers experimental treatments first and i think including them would have added to the depth of the argument presented here. agredo, envisioning a health system without necessary informed consent, voices in bioethics, vol. 1 (2014-15) * sebastian agredo, ms bioethics © 2014 sebastian agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited . envisioning a health system without necessary informed consent sebastian agredo* keywords: ethics, bioethics, informed consent, healthcare introduction ever since the publication of the belmont report and the adoption of the declaration of helsinki by the medical community, the cornerstone of ethical human experimentation has been the obtaining of informed consent from the research subject. the emphasis on this necessary, primary step in conducting safe research on human subjects has placed a great duty on the shoulders of clinical researchers—making sure that the subject is aware of and comprehends the various benefits, risks, and procedures involved in the study. putting the onus of subject safety on the shoulders of researchers and overseers has been an ongoing effort to prevent the kind of unethical activity that has tainted the history of medical research. analysis however, according to a commentary published in the latest issue of the new england journal of medicine and written by a trio of renowned leaders in bioethics, full informed consent should not be ethically necessary for all kinds of health research. in the piece, tom l. beauchamp, nancy kass, and ruth faden make the argument that acquiring informed consent from a patient can be burdensome and time-consuming in some cases, resulting in a situation that is potentially more harmful than beneficial. “learning healthcare systems” and randomized comparative effectiveness research (cer) are two such cases that the authors address in their commentary. as described by the institute of medicine (iom), learning healthcare systems are dynamic systems in which the effectiveness and quality of future clinical care is reliant upon the results of continuous research in clinical practice. cer involves the assignment of patients into random treatment groups for the sake of testing and comparing widely accepted and safe interventions. it is within these learning systems that cer could be improved by simplifying the consent process or foregoing informed consent entirely. the authors note that this is not possible within the current healthcare system, which lacks the sufficient safeguards to make such an approach ethically acceptable. what is missing from today’s system in their eyes is adequate “patient engagement,” in which patients are represented on the ethics committees that approve clinical research. patients and their advocates are in the best position to recognize when a research study will benefit them or future patients, and the focus on incorporating patient engagement in the approval stage would signal a significant step forward in giving them an increased role in the development of clinical care. agredo, envisioning a health system without necessary informed consent, voices in bioethics, vol. 1 (2014-15) 2 conclusion what drove this push toward patient engagement is the sentiment shared by the authors that: “current consent and oversight practices too often overprotect patients from research that has little impact on what matters to patients, while in other cases oversight practices underprotect patients from medical errors and inappropriate medical management.” therefore, research proposals that pose no negative effects to the clinical outcomes that matter to patients would not be required to obtain informed consent, but researchers would instead have to provide a “public notification” to the patient community. studies resulting in minor but still meaningful effects would be conveyed via oral consent procedure, with the patient having the option to decline participation; studies with possible negative effects would require written, informed consent. the authors provide two examples of research that would fall under the consent-exempt and oral consent categories. first, comparing the effectiveness of using email or text messages as medication reminders to patients; and second, comparing two commonly used medications for hypertension, with physicians being able to make alterations to the medication at any time. iom has made a concerted effort and called on healthcare leaders to begin the transformation of their health systems into learning healthcare systems, capable of taking what is learned through clinical research and incorporating it into the improvement of efficiency and quality. this will require a clear integration of the ethical oversight that is predominant in the field of clinical research and the ethical discretion involved in clinical practice. beauchamp, kass, and faden’s commentary seems to find a significant way of blending the two frameworks cohesively so that ethical consideration is still given to research endeavors, while streamlining what can be a convoluted consent process. informed consent, comparative effectiveness, and learning healthcare – new england journal of medicine http://www.nejm.org/doi/full/10.1056/nejmhle1313674 ethical oversight of learning healthcare systems – the hastings center report http://www.thehastingscenter.org/learninghealthcaresystems/ institute of medicine consensus study: the learning healthcare system in america http://www.iom.edu/activities/quality/learninghealthcare.aspx winter 2015 u.s. bioethics, moral absolutism, and apolitical humanitarianism james ahn follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 introduction dr. renee c. fox states that united states bioethics is morally absolute, lacking diversity in our policies and laws. however, three major on-going bioethical debates in the u.s., abortion, brain death, and organ transplants, reflect that us bioethics is a transient ongoing, internal debate. additionally, dr. james orbinski believes in the dualism concept where humanitarianism must remain apolitical while only being aware of the political consequences that it could have. however, politics lead to changes in policy and law, which directly alters the very parameters by which people can live their lives. moral absolutism abortion may be legal, but its nuances are still not in consensus. the u.s. is generally divided into two perspectives: pro-choice and pro-life. on one hand, the u.s. cherishes autonomy, so we want to protect the interest of women’s liberty to choose. on the other hand, the state has a compelling interest to preserve the life of a child. this issue is further divided regarding human life and personhood. when does a fetus become a human? is it a person with tangible rights recognized by policies and laws? the ethics behind abortion is not absolute, especially with conflicting evidence and new discoveries being made in the neurological field. there are many differing views on when death actually occurs. brain death is also not absolute. does it occur on the last breath? inability to breathe on one’s own? heartbeat? functioning lungs? higher brain capacity? there is no consensus and while our laws acknowledge brain death, most individual states have differing enforcement policies. we simply cannot agree on an absolute definition of brain death, nor agree on the ethical justifications supporting one view over the other. furthermore, due to the concern of prematurely killing someone, we are constantly questioning ourselves to make sure that the dignity, autonomy, and personal wishes of patients are respected and honored. organ transplant has its complexities and many people have differing viewpoints, especially regarding distributive justice. should there be different standards for prisoners? how do we assess who is in the most need? again, there is no absolute answer. dr. john harris proposes a lottery system where all individuals needing an organ transplant are given a number and those numbers are drawn out of lottery. some argue that dr. harris’ method is morally fair since the transplants are left up to chance without relying on subjective standards. on the other hand, the lottery system ignores the fact that some patients are in need of organ transplants more so than others. there is no absolute answers and we are constantly reassessing our laws and policies, evaluating effectiveness and conducting research. our legislative histories are filled with constant self-questioning, debates, and assessments on the fairest and most cost-effective way of distributing a scarce resource. even the debate surrounding fairness is not absolute and is heavily debated in universities, among legislators and hospital ethics boards. voices in bioethics 3 apolitical humanitarianism in order for humanitarianism to effectuate change, it cannot remain separate from politics. dr. orbinski provides examples of how a doctor cannot stop genocide, ethnic cleansing or make peace. he argues that these are political responsibilities, not humanitarian imperatives. however, remaining apolitical while being aware of the political consequences is irresponsible. for example, maternal mortality is a serious issue in south africa. in order to decrease maternal mortality, such as increasing the standard of care in hospitals, increasing access to pre-natal care, and providing legal protections provided by the right to health, there needs to be data provided to the legislature and policy-makers to help them understand and pin-point exactly what the problems are and how to address them to develop the appropriate laws and policies. the people in the best position to provide such data are the medical professionals since they treat the mothers directly and can attest to what is lacking. a medical professional can treat patients all day and night, but if the environment (i.e. political, cultural, and physical) causes the patient to keep coming back and the main source of the medical problem is not addressed, what good are the humanitarian efforts in the long-run? there is no sustainability and only the symptoms are being treated at best. should the doctor just consider the medical conditions while ignoring the environmental structures causing the illnesses and injuries in the first place? medical professionals should not treat patients strictly with bandages and a scalpel. otherwise, it is too robotic and ignores the intrinsic values that make up human-beings. does this mean the medical professional should become a politician or lobbyist? not necessarily, but it does mean they should at least respond to their awareness of political consequences. if excessive hemorrhaging is a problem during birth, the medical professional can treat that symptom, but s/he can also address with the legislature the fact that there are no geographically close hospitals from various villages, no ambulatory system or vehicles, and a lack of sanitary equipment and access to proper medical equipment so that policies and laws can address these root issues. professor lawrence gostin, a public health lawyer and policy-maker, made an observation regarding a problem he saw in the public health field, which i think applies here. he stated that sometimes professionals become too compartmentalized and they become too narrowly focused on their work and fail to see anything else outside their “tunnel vision”, or respective fields do their own specific work without much collaboration with other fields, therefore stunting progress. while medical professionals do not necessarily have to become political, they can still communicate with other professionals (i.e. human-rights attorneys) about their observations and what they can do collaboratively to not only address the medical needs of these people, but aid in changing the laws and policies as well. of course, this will take time, but i think a more unified front between international humanitarian doctors and humanrights attorneys would be extremely effective. it has been my observation, however, that this collaboration either does not exist or is very faint. kearns, apology laws, voices in bioethics, vol. 1 (2014) © 2014 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. apology laws and the doctor-patient relationship lisa kearns keywords: medical error, bioethics introduction in 2000, the institute of medicine (iom) published “to err is human: building a safer health system,” a report on the woeful state of patient safety in american hospitals.1 this alarming study not only forced the medical establishment to acknowledge the extent and consequences of human error; it spurred states to look for ways to better protect their citizens from medical mistakes. one intriguing suggestion was to allow healthcare providers to own up to those mistakes. conflict resolution scholars, hospital administrators, and state governments (everyone who had an interest in improving the iom statistics) agreed that if errors could be discussed in the open, they could be freely and thoroughly analyzed. such transparency might expose the reasons for the mistakes, which could lead to prevention strategies. traditionally, medical error is dealt with in the courts, and the threat of litigation serves as a deterrent to doctors. the new, post–iom report suggestion also involved the legal system, but in this case it didn’t include the courts hearing malpractice cases but rather state legislatures granting immunity to certain expressions of apology by statute. this new approach was implemented in 2003, when colorado enacted the country’s first “apology inadmissibility law.” other states soon followed suit. kearns, apology laws, voices in bioethics, vol. 1 (2014) 2 the new laws were designed to reduce medical error and malpractice litigation, but bioethicists hailed them too. bioethicists hoped that the apology laws, even in the wake of adverse outcomes, could serve to maintain the continuity of care that is part of humane medical attention. an atmosphere in which physicians could openly admit mistakes, express condolences, and perhaps discuss reparations without fear of being sued would mean patients or their families wouldn’t have to go to court to discover what had gone wrong with their loved ones’ medical treatments. the doctor could preserve his own dignity and autonomy as well, by honoring his professional and ethical mandates to act in his patient’s best interests. bioethicists saw in state apology laws a chance to prevent the devolution of the relationship of doctor-patient into that of defendant-plaintiff. yet despite state efforts to protect doctors, the moral promise of the apology laws was never fulfilled. to the contrary, as a review of the laws reveals, the doctor-patient relationship couldn’t be a concern of the apology statutes because of the way the statutes were crafted in the first place. “a pivotal development in american legal and medical practices may have occurred quietly in colorado last year,” wrote jonathan cohen, a law professor and dispute resolution scholar, in spring of 2004. “it took the form of a change in colorado’s evidence code.”2 cohen was writing about crs §13-25-135: colorado law governing apology for unanticipated outcome in medical-legal proce[e]ding,3 the country’s first “apology inadmissibility law.” (six states already had statutes on the books exempting expressions of benevolence or sympathy from admissibility as evidence— massachusetts was the first, in 1986—but colorado’s law was the first to specifically exempt physicians’ admissions of fault.4) the practice caught on, and, by mid-2013, 37 states and the district of columbia had enacted some form of apology inadmissibility law.5 although all of them provide protection for simple expressions of sympathy, most of the statutes specify to whom the expressions can be made. in addition to defining what is inadmissible as evidence, the laws dictate what the apologies or benevolent gestures can “relate to.” for instance, 14 states protect expressions of sympathy only if they spring from cases in which there’s been an “unanticipated outcome” during medical care. five kearns, apology laws, voices in bioethics, vol. 1 (2014) 3 states allow expressions of sympathy only if an adverse outcome is the result of an accident. hawaii protects expressions of sympathy when the sympathizer is a participant in the event that elicited the expression, and iowa exempts statements of condolence or compassion for cases in which the adverse outcome results from a breach in the “applicable standard of care.” a few statutes impose interesting additional qualifications. west virginia’s inadmissibility law is restricted to “civil action, including arbitration, mediation, or alternative dispute resolution proceeding” (emphasis provided). texas’s law requires that expressions of compassion or commiseration “emanat[e] from humane impulses…or a general sense of benevolence” but adds that a “communication including an excited utterance as defined by rule 803(2) of the texas rules of evidence, which also includes a statement or statements concerning negligible or culpable conduct pertaining to an accident or event, is admissible to prove liability of the communicator.” the breadth and variety of restrictions and qualifications to the laws reflect the diligence that went into drafting them. yet for bioethicists who had hoped that apology laws would benefit the doctor-patient relationship by kearns, apology laws, voices in bioethics, vol. 1 (2014) 4 removing the threat of litigation, the upshot of the laws has been disappointing. they remain focused on reducing the exposure of states and their medical institutions to civil action and potential penalties; instead of including the doctorpatient relationship within the scope of the legislation, the laws have achieved the opposite. bioethicists interested in the ethical implications of apology laws will be alarmed to learn that fewer than a quarter of the statutes allow physicians to take responsibility for their actions: for an apology to be sincere, after all, it must include both the transgressor’s acknowledgement of wrongdoing and an expression of remorse. without an admission of fault or other recognition of responsibility for error, an apology is incomplete—it’s more like a politician’s acknowledgment that “mistakes were made.” critics of apology laws have noticed that the apologies protected by the statutes are neither sincere nor complete. ethicist and lawyer lee taft wrote “apology within a dialectic” in reply to an empirical study of the role of apology in legal settlements.7 he takes issue with the notion of legislating apology at all, precisely because the laws can lead to incomplete, insincere expressions. he believes utility to be the real motivation behind the inadmissibility laws, and thus they’re liable to discount the crucial, moral component of a sincere apology. even if apology laws are proven to reduce malpractice cases, taft maintains, and even if they improve patient safety, they would still fail to “adequately address the moral harm of legislative protection for apology.”8 put another way, the “efficacy of apology is not dependent on its admissibility [in court].”9 rebecca dresser agrees, writing in “the limits of apology laws” that inadmissibility statutes “will achieve a positive ethical outcome only if they are accompanied by full disclosure and fair compensation.”10 apologies that don’t include admissions of fault are also one-sided. by failing to own up to his role in causing harm, the transgressor fails to acknowledge the victim’s moral status in the equation. without that acknowledgement, the harmed party is little more than the passive recipient of legally approved remorse. on the american medical association’s (ama) chart of state inadmissibility laws, patients or their families are there to receive legislated expressions; they play no active role in the process.11 nancy berlinger is thinking in this vein in “avoiding cheap grace: medical harm, patient safety, and the culture(s) of forgiveness.” she writes that, in partial apologies, the injured party is “pushed out of the frame, while the person who has made the error is forgiven without any assurance that the relational actions traditionally described as confession and repentance have taken or will take place.”12 for berlinger, a partial apology is one in which forgiveness is not sought by the transgressor but is instead bestowed upon himself by himself. this conception is notable for its absence of moral consideration of the injured party. on more practical grounds, writes law professor anna mastroianni and colleagues in their survey of the impact of apology laws on malpractice litigation, “lawsuits that protect only expressions of sympathy and explanation may make for awkward communications, as it may be difficult to explain an error without discussing the different but closely related issues of responsibility and fault.”13 kearns, apology laws, voices in bioethics, vol. 1 (2014) 5 to the bioethicist, then, the more than 75 percent of apology inadmissibility laws currently on the books are not about apology at all, but rather a circumscribed notion of it. if most apology inadmissibility laws aren’t really about apology, then they must be about something else. one reasonable candidate would be the continued protection from civil action for adverse medical outcomes that result from physician error. so even though the apology legislation movement gained momentum after the iom report, the way the laws have been written indicates that the move to shield expressions of physician mea culpas was never sparked by concern for patient safety to begin with. instead, the laws seem to exist to better protect medical providers from legal exposure at very little expense. (as cohen notes, the cost of enacting laws that protect healthcare providers’ expressions of sympathy is pretty much “nothing.”14) taft agrees that apology laws are more about lawsuits and less about encouraging an honest dialogue between doctor and patient. he takes issue especially with the idea that an adversarial legal system can be retrofitted to both reduce malpractice suits and accommodate a moral relationship like that of doctor and patient, writing that the “risk of subversion arises whenever we transcribe moral processes into systems that are primarily adversarial.…15 this harm rises dramatically when one extracts components of moral processes and inserts them into utilitarian schemas”16— such as those designed to improve patient outcomes and reduce instances of malpractice suits. flauren fagadau bender, an attorney specializing in health law, advises physicians who are thinking about extending apologies to patients to check with an attorney first.17 that is, before a doctor decides to act in accordance with a law that was created expressly to encourage him to act without fear of being sued, he first should run his decision by legal. the undercurrent of the ethical objections to inadmissibility laws is the simple fact that when a physician inadvertently injures a patient, he harms someone with whom he has created a uniquely intimate relationship. the physically and emotionally vulnerable patient entrusts her well-being to her doctor. if he harms her, and chooses to override his humane (and human) impulse to apologize in favor of checking first to see if such an apology comports with his institution’s legal protocol under state law, he withdraws from his relationship with her; he has turned his attention to his own needs rather than his patient’s. his concern now is with his new role as potential respondent to litigation. with this shift in priority, the doctor has effectively abandoned his patient. • of course, state lawmakers never claimed to be trying to inject a dose of morality and humanity into the world of malpractice litigation when they drafted the apology statutes. the ama calls them apology inadmissibility laws, after kearns, apology laws, voices in bioethics, vol. 1 (2014) 6 all, and its state-by-state overview is titled a “summary of state legislation.” three states and the district of columbia are quite up-front about their purpose in enacting apology laws when they restrict the domain of expressions to cases in which civil action has already been undertaken. also, given the size and complexity of the u.s. medical system, it isn’t surprising that a solution to the problem of fatal medical error would include bottom-line considerations. early last year, journalist steven brill provided an exhaustive investigation into how big medicine operates in the u.s.18 anyone reading his descriptions of the often inscrutable world of the business side of medicine would easily understand why such ethical considerations as the doctor-patient relationship would play second fiddle to financial concerns in any attempt to improve the system. add in the cost of malpractice insurance and lawsuits, and hospital administrators and state legislators would be deemed fiscally irresponsible if they undertook any kind of medical system overhaul without keeping the costs of malpractice litigation firmly in mind. still, the laws arose against the backdrop of the iom report’s dismaying statistics on patient mortality. they were seen as a potential solution to medical error, and because medical error necessarily entails a doctor to commit the error and a patient to be harmed by it, ethicists had good reason to believe the laws might include an ethical component—that the apologies covered by the statutes would be real ones offered sincerely and openly by remorseful doctors to their suffering patients. when cohen wrote about that first apology law in colorado, he welcomed it as an opportunity to “promote an open, trusting and care-giving relationship following medical error.”19 similarly, dresser thought the statutes had the potential to “advance other ethical objectives,” such as enabling doctors to “tell the truth and promote patients’ best interests.”20 yet even if the intent of the laws was always to reduce the number and impact of malpractice claims, that doesn’t mean that lawmakers and hospitals are justified in letting the doctor-patient relationship go by the wayside. without doctors and patients, the medical enterprise wouldn’t exist. their relationship is the foundation of both medicine and bioethics. a solution to the problem of patient safety, then, will necessarily have to be an ethical one. the legacy of the apology inadmissibility law movement has turned out to be a raft of statutes that suggest new ways of protecting the medical establishment from its own mistakes. the unintended consequences of these seemingly well-intended laws are doctors who can’t apologize for harming their patients even if they want to and injured patients who’ve been abandoned by their caregivers. reference notes 1. to err is human: building a safer health system, ed. l. kohn, j. corrigan, 
m. donaldson (washington: national academy press, 2000), p. 26. kearns, apology laws, voices in bioethics, vol. 1 (2014) 7 2. j. cohen, “toward candor after medical error: the first apology law,” harvard health policy review 5, no. 1 (spring 2004), p. 21. 3. crs §13-25-135: colorado law governing apology for unanticipated outcome
in medical-legal proceeding. 4. j. cohen, “toward candor after medical error: the first apology law,” p. 21 –22. 5. “apology inadmissibility laws: summary of state legislation,” american medical associat ion advocacy resource center (2012). 6. ibid. 7. j. robbennolt, “apologies and legal settlement: an empirical examination,” michigan law review 102, no. 3 (dec. 2003), p. 460–516. 8. l. taft, “apology within a moral dialectic: a reply to professor ro bbennolt,” michigan law review 103, no. 5 (mar. 2005), p. 1011. 9. ibid. 10. r. dresser, “the limits of apology laws,” hastings center report 38, no. 3 (2008), p. 7. 11. “apology inadmissibility laws: summary of state legislation.” 12. n. berlinger, “avoiding cheap grace: medical harm, patient safety, and the culture(s) of forgiveness,” hastings center report 33, no. 6 (2003), p. 34. 13. a. mastroianni, m. mello, s. sommer, m. hardy, t. gallagher, “the flaws in state ‘apology’ and ‘disclosure’ laws dilute their intended impact on malpractice suits,” health affairs 29, no. 9 (2010), p. 1611. 14. j. cohen, “toward candor after medical error: the first apology law,” p. 24. 15. l. taft, “apology within a moral dialectic: a reply to professor robbennolt,” p. 1016. 16. ibid., p. 1014. 17. f. fagadau bender, “‘i’m sorry’ laws and medical liability,” american medical association journal of ethics 9, no. 4 (2007), p. 302. 18. s. brill, “bitter pill: why medical bills are killing us,” time 181, no. 8 (mar. 4, 2013). 19. j. cohen, “toward candor after medical error: the first apology law,” p. 22. 20. r. dresser, “the limits of apology laws,” p. 6. hanrahan and lebel, unanticipated findings, voices in bioethics, vol. 1 (2014) © 2014 brian james hanrahan and robert roger lebel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. reporting unwelcome unanticipated findings of diagnostic genomic studies brian james hanrahan robert roger lebel keywords: genomics, genetics, unanticipated findings, autonomy the introduction of comparative genomic hybridization has revolutionized clinical genetics. it is used as a routine approach to the workup of developmental delays and multiple malformations.1-3 by subdividing chromosomes into their submicroscopic components, clinicians can detect minute losses or duplications of stretches of genetic material. the evolving technology has brought a new level of detail with single nucleotide polymorphism (snp) array. snp arrays enhance diagnostic success due to its ability to uncover small regions of loss of heterozygosity (loh), which are significant in the diagnosis of autosomal recessive diseases. however, snp arrays also have the ability to expose large and/or numerous regions of loh. these larger regions of loh are presumed to have been inherited from two parents who share alleles derived from a recent common ancestor (consanguinity). the american college of medical genetics and genomics (acmg) recognizes that there is insufficient research to make evidence based recommendations regarding the disclosure of results unrelated to the primary goal of the genetic testing.4 recently, the acmg presented a list of genetic diseases that should be disclosed to the patient when encountered as an incidental finding4, but the acmg has yet to present recommendations for disclosing previously unknown consanguinity. to explore the ethical considerations surrounding consanguinity uncovered by snp array we offer a hypothetical case and provide a formal ethical analysis. case report courtney is a healthy 36-year-old woman who comes to a clinic with her husband larry for evaluation of a new pregnancy. the ultrasound reveals a fetus, appropriately sized for 18 weeks gestation with multiple anomalies hanrahan and lebel, unanticipated findings, voices in bioethics, vol. 1 (2014) 2 including encephalocele, omphalocele, and polydactyly. the differential diagnosis includes a chromosomal abnormality and meckel-gruber syndrome, a rare autosomal recessive disease. indicated by maternal age and ultrasound findings, an amniocentesis is performed. karyotype analysis reveals a normal chromosomal configuration at the microscopic level of analysis, but snp array is pursued. results show a high degree of loh (11%) consistent with a parental half-sibling relationship. one of the regions displaying a high degree of loh is a portion of the long arm of chromosome 17, the region which includes the gene associated with meckelgruber syndrome type 1. courtney, an only child, was born in seattle, washington. courtney’s parents attended medical school in chicago. during that time her parents experienced fertility problems and consulted a specialist to achieve conception. larry is also an only child born in chicago to two faculty members at a public high school. larry earned his bachelor’s degree in miami, fl, and courtney obtained hers at ucla; they met while studying law at boston college. upon further questioning it is discovered that larry’s parents also experienced infertility. unknown to both larry and courtney, their mothers received semen from the same donor: a graduate student working on his phd in genetics at northwestern. analysis principlism has been enshrined in the medical ethics literature for the past thirty years as the preferred basis for ethical analysis, in part, because it purports to allow for critical ethical analysis that is not founded on any religious tradition. it enjoins us to honor patient autonomy, seek justice, and act with beneficence and nonmaleficence.5 these four principles should be honored to their full extents, with the relative value of each dependent on the context of the ethical dilemma in question. ideally, there should be a balance between the four principles with no one principle ranking higher than the others. that being said, western medicine places a priority on patient autonomy over the other principles.6 autonomy has played a major role in shaping the practice of clinical genetics, laws surrounding genetic privacy, and genetic counseling. this principle focuses attention on the importance of allowing patients to make their own decisions regarding their medical care. in order to make autonomous decisions about their reproductive future, parents have the right to comprehensive knowledge and understanding of the health risks facing their future offspring. it is estimated that each human is heterozygous for several genes that would be lethal in the homozygous state.7 since there is a risk that consanguineous parents share several deleterious alleles in the heterozygous state, any future child could be at a 25% risk for more than one disorder. given this increased risk, consanguineous unions have a lower level of genetic fitness in relation to the general population. this is manifested by increased rates of recessively inherited diseases, congenital malformations, intellectual disability, and childhood morbidity and mortality.8 hanrahan and lebel, unanticipated findings, voices in bioethics, vol. 1 (2014) 3 in order to identify the most appropriate options regarding their reproductive future, parents must have full access to information about their offspring’s potential conditions.9 failure to inform the couple of the negative biological effects of consanguinity on health will render the couple’s future reproductive decisions nonautonomous, for they will be ill-informed. now that courtney and larry’s fetus is known to have loh in the region that includes a gene which could explain the malformations discovered by ultrasound, they can have mutation analysis to document this. they can also be advised of 25% recurrence risk in any future pregnancy. the question, however, is whether they should be informed that they are closely related to each other and have a significant chance of other shared recessive alleles. when considering this case it is important to determine whether exposing incidental information to courtney and larry is justifiable. there have been three lawsuits against physicians in the united states regarding failure to warn family members about hereditary disease risks.10-12 the most recent of the three cases is molloy v meier. in 2003, kimberly molloy filed a lawsuit with the minnesota supreme court against physicians who failed to diagnose her daughter with fragile x syndrome, an x-linked cause of intellectual disability. the plaintiff claimed that the physicians who cared for her child were negligent because they failed to inform kimberly molloy of the risk of intellectual disability in future offspring. the court held that the “physician’s duty regarding genetic testing and diagnosis extends beyond the patient to the biological parents who foreseeably may be harmed by a breach of that duty.”12 in the case of courtney and larry, it would be unjust to reveal only diagnostic information regarding the diagnosis of meckel-gruber syndrome in the fetus without also discussing the broader reproductive health risks implied by the high loh reflecting close consanguinity. this finding must be considered “actionable” because the patient can use it to guide health decisions. “actionable” is defined as some action that may be taken by a physician to prevent a genetic-related disease or disorder from occurring, or to alter its natural progression in some way. providing courtney and larry with all known necessary information on reproductive health will allow them to pursue other reproductive options with less risks. the principles of non-maleficence and beneficence will be discussed jointly because they are best understood as the minimization of burdens and the maximization of benefits. the outcomes from uncovering consanguinity can be either beneficial or harmful depending largely on the circumstances of the scenario. uncovering unknown genetic information has the potential to negatively impact self-esteem and selfperception.13 in a study that reviewed families with tay-sachs disease, 25% of carriers and 6% of carriers’ spouses felt that knowing their own or their spouse’s carrier status would have affected their marriage decisions.14 people who become aware of their genetic hereditary diseases have an increased risk of mental health issues, and are more likely to experience a significant decline in satisfaction with their relationships.15 we suspect that knowing of consanguineous relationships after the fact would cause many people to forego further pregnancies. discovering unintentional consanguinity in the already highly-charged circumstances of a pregnancy or child in distress has the potential to create an even greater psychological challenge to those involved. psychosocial stressors such as denial, worries of divorce, and other major lifestyle changes can also produce detrimental repercussions to the family dynamic. hanrahan and lebel, unanticipated findings, voices in bioethics, vol. 1 (2014) 4 some physicians may feel more comfortable in choosing not to disclose consanguinity for it will avoid the negative repercussions from exposing such information. however by doing so, important information regarding the health of future children would be withheld and entailing deception. we do not believe that the clinician is at liberty to provide such selective and incomplete disclosure. informing a couple of their relatedness provides an opportunity to pursue other safer options for expanding their family. any short-term gain of tranquility associated with nondisclosure of reproductive risks would not honor the duty to act beneficently. conclusions clinicians who provide snp array testing should discuss with precision the potential implications of loh so that those signing the consent form have no ambiguity. the case of courtney and larry illustrates one of several plausible scenarios that can result from discovery of pronounced loh. other possible cases include adoption, incest, infidelity, and intentional concealment due to social stigma or legal implications. physicians need to be prepared to discuss the risk of uncovering high loh even though the probability of consanguinity is low. the consent form should include an explanation that disclosure will include all elements of the test results that are thought to have clinical significance, including consanguinity. the advantages and disadvantages of genetic testing vary significantly from one patient to the next. it is essential to disclose both the positive and negative repercussions of snp array testing so that involved parties can make fully informed decisions. we find no merit in the clinician assuming responsibility for deciding what information should or should not be disclosed on the basis of it being uncomfortable to discuss. full disclosure is necessary to enhance patient autonomy by providing the patient with information to make an informed decision to “accept these conditions, find another physician or forego testing.”16 in the clinical encounter, embarrassment, surprise, anger, and fear are all undesirable but normal reactions which physicians and counselors must be prepared to address. more explicit and detailed communication will ensure that these emotions will be limited in any clinical encounter. we do not propose that all incidental findings should be disclosed to patients, however we believe that consanguinity is actionable in reducing reproductive risks and should be disclosed for that reason. genetic counselors must be prepared to provide supportive counseling for patients with incidental findings on snp array testing, just as they do for other currently available testing methods. there may be patients who need counseling beyond what is offered in the genetics counseling office, which will require a referral to professionals skilled in psychological counseling. as developments in genetic testing become more advanced, it is necessary to keep these ethical considerations regarding the reporting of incidental findings in mind. practitioners must bear in mind the potential findings of genetic tests such as snp array, and be prepared to discuss such findings, despite the potential discomfort and stressors imposed on the parties involved. hanrahan and lebel, unanticipated findings, voices in bioethics, vol. 1 (2014) 5 references 1. manning, m., and l. hudgins. "array-based technology and recommendations for utilization in medical genetics practice for detection of chromosomal abnormalities." [in eng]. genet med 12, no. 11 (nov 2010): 742-5. 2. miller, d. t., m. p. adam, s. aradhya, l. g. biesecker, a. r. brothman, n. p. carter, d. m. church, et al. "consensus statement: chromosomal microarray is a first-tier clinical diagnostic test for individuals with developmental disabilities or congenital anomalies." [in eng]. am j hum genet 86, no. 5 (may 14 2010): 749-64. 3. hoffmann, t. j., m. n. kvale, s. e. hesselson, y. zhan, c. aquino, y. cao, s. cawley, et al. "next generation genome-wide association tool: design and coverage of a high-throughput european-optimized snp array." [in eng]. genomics 98, no. 2 (aug 2011): 79-89. 4. green, r. c., j. s. berg, w. w. grody, s. s. kalia, b. r. korf, c. l. martin, a. l. mcguire, et al."acmg recommendations for reporting of incidental findings in clinical exome and genome sequencing." [in eng]. genet med 15, no. 7 (jul 2013): 56574. 5. beauchamp, tom l., and james f. childress. principles of biomedical ethics. 7th ed. new york: oxford university press, 2013. 6. chieng, w. s., n. chan, and s. c. lee. "non-directive genetic counselling respect for autonomy or unprofessional practice?" [in eng]. ann acad med singapore 40, no. 1 (jan 2011): 36-42. 7. morton, n. e., j. f. crow, and h. j. muller. "an estimate of the mutational damage in man from data on consanguineous marriages." [in eng]. proc natl acad sci u s a 42, no. 11 (nov 1956): 855-63. 8. vogel, friedrich, and arno g. motulsky. human genetics : problems and approaches. 2nd, completely rev. ed. berlin ; new york: springer-verlag, 1986. 9. tadmouri, g. o., p. nair, t. obeid, m. t. al ali, n. al khaja, and h. a. hamamy. "consanguinity and reproductive health among arabs." [in eng]. reprod health 6 (2009): 17. 10. pate v. threlkel, 661 west's southern reporter 278-82 (1995). 11. safer v. estate of pack, 677 atlantic reporter 1188-93 (1996). hanrahan and lebel, unanticipated findings, voices in bioethics, vol. 1 (2014) 6 12. molloy v. meier, 660 west's north western reporter 444-58 (2003). 13. carter, m. a. "ethical aspects of genetic testing." [in eng]. biol res nurs 3, no. 1 (jul 2001): 24-32. 14. childs, b., l. gordis, m. m. kaback, and h. h. kazazian, jr. "tay-sachs screening: social and psychological impact." [in eng]. am j hum genet 28, no. 6 (nov 1976): 550-8. 15. andrews, l., and e. s. zuiker. "ethical, legal, and social issues in genetic testing for complex genetic diseases." [in eng]. valparaiso univ law rev 37, no. 3 (summer 2003): 793-829. 16. lacroix, m., g. nycum, b. godard, and b. m. knoppers. "should physicians warn patients' relatives of genetic risks?" [in eng]. cmaj 178, no. 5 (feb 26 2008): 593-5. kornyo, genetically modified organisms, voices in bioethics, vol. 1 (2015) © 2015 emmanuel kornyo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. genetically modified organisms (gmos) – part i emmanuel a. kornyo keywords: gmo introduction the phenomena and practice of improving crop and animal species seem germane to humanity across every known documented civilization. some of these methods include cross and selective hybridization, grafting among others. genetically modified organisms (gmos) are unique in that certain desirable genes or protein sequences are deleted, inserted or reengineered from the same or different species into a new organism.1 it is estimated that nearly 90% of all soybeans, corn, and cotton cultivated in the united states are genetically modified.2 the introduction of gmos) continues to generate global debate. for instance, the introduction of gmos in the united states was fraught with many debates much as it is even now in canada and europe.3 opponents have often contested that gmos may affect naturally occurring organisms, become resistant to antibiotics and potentially affect the environment and even humans. some have raised questions on bioequivalence and safety of gmos to non-gmos. it is thus not surprising that the introduction of gmos continue to generate unprecedented controversies with scientific, ethical, and even legal dimensions.4 recently, the parliament of ghana debated and passed the “plant breeders bill act 2013” which ostensibly authorized the center for scientific and industrial research (csir) to conduct field trials for three gmos.5 these gmos are cowpea, rice, and sweet potatoes. the rationale for genetically modifying these organisms is to address specific needs, including food security, nutritional enrichments, and protection of the environment.6 as anticipated, this generated substantial public outcry throughout ghana and beyond. what is behind this global ambivalence toward the acceptability of gmos? are these scientifically, legally, and ethically justified? scope this paper will examine the debates and the challenges on gmos in general with cryptic references to the plant breeders bill as a case study. i will examine some of these challenges through the acuity of some ethical concepts, such as the uncertainty theory in resolving disagreements, beneficence/non-maleficence, and justice. i will also attempt to propose some policy, legal, and ethical solutions. the debate on genetically modified organisms (gmos) as indicated above, gmos comprise an insertion of a particular gene of interest into living organisms or the deletion of a gene due to some desirable traits.7 sometimes, a particular gene or protein sequence deemed obnoxious may be spliced or eviscerated from the host genome so as to attain the expression of certain characteristic or traits.8 genetic modifications of organisms have a wide scope of applications especially in bioengineering of plants and animals for therapeutic, commercial, and other novel purposes such as pest and weed control.9 some of these gmos are bt-corn, atlantic salmon, and bt-cowpea.10 the introduction of new genes into different organisms has degenerated into contentious debates. indeed, http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d071448748e3aacbe046b9/1473278276647/?format=original kornyo, genetically modified organisms, voices in bioethics, vol. 1 (2015) 2 the hysteria of a new or “foreign gene” in a new host’s genome makes it unfathomable to many people and also raises serious questions. but are these technologies safe? what is the threshold in defining these products as safe? questions on the possibility of transgenic introgressions into wild varieties of certain organisms such as corn or soybean have been justifiably raised even though no conclusive scientific data has substantively proven it nor disputed the assertions to date.11 furthermore, one of the major socio-economic aspects of the debate is that small scale farmers may perpetually rely on the big corporations for gmo seeds, which culminates in a high cost in production. it seems society has trust in biotechnology products in general, but it is particularly ambivalent about gmos. some religions, especially of the abrahamic traditions, have some dietary obligations enjoined on them. some of these include the prohibition from eating pork. what arises is the question of whether or not a gene from a pig used to engineer a product such as a vegetable would constitute a transgression of these religious tenets? this is an important question in the debate prompting many to favor a complete labeling of gmo products.12 but does a particular gene in a genome define an entire organism? in view of these challenges, i will examine these questions with some ethical concepts. what about the socio-political context? it should be noted that, whereas in the us, most initiatives on introducing gmos have been orchestrated by private companies such as monsanto while in developing countries such as ghana, the government has remained quiet on the introduction of gmos. some ethical challenges and analysis one of the major challenges on the debate on gmos is that there are many uncertainties or “disagreements”.13 this is further exacerbated by the pervasive phenomena of conceptual, factual, and evidential disagreements on gmos.14 the question that emerges herein is: what are the best and most certain ethical frameworks to use in analyzing the debate on gmos, especially as there are many uncertainties and unanswered questions? does any single ethical theory suffice in responding to the debates? if so, which one? what makes the debate on gmos seemingly divisive both within the scientific community and the general public as a whole? indeed as beauchamp noted “neither [one] morality nor ethical theory has the resources to provide a single solution to every moral problem.”15 consequently, in this section, i will analyze these challenges through the nexus of the ethical framework of dealing with disagreements. 16 first of all, there are conceptual uncertainties or moral disagreements among scientists and even ethicists about gmos.17 some proponents postulate the argument that biotechnological innovations and the introduction of gmos are good and novel human inventions in advancing the common good. aligned with this is the idea that humanity has always improved living organisms in the past through methods such as grafting and domestication of wild crops and animals. therefore, the introduction of gmos is consistent with an intrinsic disposition of humans to improve naturally occurring living organisms. gmos, such as the case of genetically modified cowpeas in ghana, is to insure food security and enhance nutritional needs of people, and thus ameliorate the problem caused by the fact that nearly 30-70% of non-gmo cowpeas were lost during propagation and harvesting. hence, the notion and the conception of resolving a seemingly significant natural problem should be accepted under the expediency of its novelty, rather than the presumption that gmos are inherently bad.18 on the other hand, some have countered the above argument, suggesting that unlike other forms of biotechnological innovations such as crop and animal breeding, in gmos, genes from unrelated species are introduced for specific purposes that may not be natural to the host organism(s).19 there is no certitude and data to substantiate the case that these new genes are substantively safe especially in the long term.20 should the introduction of gmos be halted until questions of uncertainty are addressed albeit resolved?21 this then leads us to the issue of disagreement based on insufficient information and evidence.22 the debate on gmos is further compounded and enveloped with apparently insufficient information. proponents of this view asserted that there are unreliable and insufficient data to make the case for gmos. furthermore, there seem to be many disagreements among scientists about some data on gmos. 23 for example, some data suggests that gmos are perilously invasive and may have altered other living organisms kornyo, genetically modified organisms, voices in bioethics, vol. 1 (2015) 3 within an ecosystem, including humans.24 currently, the fda has endorsed the production and the release of gmos while the european food and safety authority (efsa) has adopted a precautionary principle and banned gmos in europe. 25 the crust of the issue is that these are two credible scientific organizations mandated to ensure food and drug safety but both have stark disagreements on the information on gmos. both the fda and efsa seem to agree on the lack of scientific certitude and insufficient biodata on the safety of gmos.26 to buttress this argument, proponents agree with the who statement that gmos “...are not likely to present risks for human health”.27 furthermore, the world trade organization’s (wto) sanitary and phytosanitary agreement (sps) article 5.7 inter alia indicates that: “....in cases where relevant scientific evidence is insufficient, a member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other members. in such circumstances, members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time”. 28 given the apparent insufficiencies of the information on gmos, it begs the questions as to whether ethicists have any formidable grounds to assume a particular position to be accurate or good! the third component to the uncertainty theory is based on the premise of factual disagreements. there is no doubt that there are many biodata on gmos evidenced in the many scientific publications and peer reviewed information about scientific “facts” on the pros and cons of gmos.29 on the contrary, some scientists have also demonstrated seemingly convincing biodata challenging and raising the question of safety of gmos, allergenic reactions and eco-safety. for example, a seminal study conducted on the effect of gmo bt-corn on larvae and concluded that material from the bacterium bacillus thuringiensis (bt ) are generally thought to have “although plants transformed with genetic negligible impact on non-target organisms, bt corn plants might represent a risk because most hybrids express the bt toxin in pollen, and corn pollen is dispersed over at least 60 metres by wind.”30 on the contrary, six teams of scientists also demonstrated and concluded that the gmo corn did not pose any such risks!31 these two conclusions have tangentially demonstrated factual disagreements about the safety of gmos. in the ghanaian context, many opponents to the introduction of gmos made cryptic references to this theory by suggesting that there are disagreements among scientists on the facts on gmos hence it should not be introduced. but do gmos actually cause harm or good? what is the factual evidence to substantiate these claims? in an attempt to respond to questions on uncertainty, i propose the ethical theory of beneficence among others. the right to food security and socio-economic justice one of the seemingly cogent arguments is that gmos will lead to food security, especially in the context of developing countries such as ghana. proponents have suggested that nearly 30-70% of all cowpeas were destroyed by the pod borer insect-maruca vitrata. this has caused substantial economic loss for producers and the general public. the new genetically engineered variety, bt-cowpea presumptively has the potential for resistance to the pod borer, thus potentially saving millions of dollars in expenses on pest control. as the lead investigator, atokple noted, "pod borer infestation is a major constraint to cowpea production in africa”.32 in addition, the proposed gmo sweet potatoes are purported to be nutritionally enriched with essential amino acids to curb the incidence of malnutrition. thus the introduction of these crops will lead to greater nutritional value, bioefficiency and economic gains that will be of immense “benefit” to consumers. these benefits also include food security and sustainable production as producers may spend less maintaining their fields in terms of pest control.33 another benefit is the environment. bt-cowpea could lead to less application and release of obnoxious agrochemicals into the micro and macro ecosystems. this means, less damage to the ecology such as reducing water pollution and less harm to other microorganisms on the fields where these crops are cultivated. kornyo, genetically modified organisms, voices in bioethics, vol. 1 (2015) 4 furthermore, the gmo rice is purported to have been specifically engineered to optimize nitrogen intake to solve the challenges of hydromorphic fields caused by seasonal and excessive irrigations. but conspicuously missing from the debate are the possibilities of transgenic introgression into wild varieties of these crops or similar crops that could potentially cause serious environmental problems such as super weeds.34 gene transgressions could be fatal if these “new genes” enter the food chain.35 on the contrary, it has been suggested that there are many “uncertainties” on the biosafety of these crops. furthermore, the possibility of gmos causing harm such as allergenic reactions is factually demonstrable. for example, in brazil, a genetically engineered soybean enriched with methionine-rich 2s albumin from the nut bertholletia excelsa caused allergenic reactions during initial trials prior to being released.36 because of this and others, some have called for field trials and human biosafety testing spanning a longer period of time in ensuring eco-safety and consistent with the ethical dictum non primum non nocere (above all cause no harm). furthermore, there is the perceptual argument of gene linkage into the environments and crop mingling with non-gmos, thus causing unintended harm.37 a preliminary conclusion from the beneficence argument is that the “benefits” as presented based on current biodata on gmos (especially regarding the bt-cowpea, sweet potatoes, and rice) seems to outweigh any “risks” or harm. nonetheless, the potential for harm remains unpredictable.38 conclusion despite these challenges, consumers still make decisions and choices about gmos. two questions emerge: why choose or not to choose gmos? an affirmation of the former implies accepting some of the potential risks in gmos products. while an affirmation of the latter question might appear benign and precautionary, it nonetheless carries unintended consequences as well. thus choosing gmos or not implies some preponderance ethical calculi of risks. as a sequel to this piece, we will explore some other ethical perspectives such as the principle of double effect in response to these nagging questions with dexterity!39 pdf available: emmanuel kornyo, "gmos part i," voices in bioethics (2015). references: 1 estibaliz sansinenea (editor) bacillus thuringiensis biotechnology (springer; new york; 2012); 41-85 2 mellman group, survey on labeling gmos, 2012 (mellman survey results just label it) 3 chris a. wozniak et al. regulation of agricultural biotechnology: the united states and canada (springer; new york; 2013) 4 mascia pn et al. safe and acceptable strategies for producing foreign molecules in plants in curr opin plant biol. (april, 2004) (2):189-95 5 plant breeders bill peace fm 6 ibid 7 it can also be a deletions or a complete repacking of a specific gene of interest 8 ronald j. herring opposition to transgenic technologies: ideology, interests and collective action frames in naturereviewsgenetics9,(june2008) 458-463 9 maria navajas et al. genes in new environments: genetics and evolution in biological control in nature reviews genetics 4, 889-899; gerald nelson. genetically modified organisms in agriculture: economics and http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070a28748e3aacbe03301/1473278114575/emmanuel-kornyo-gmos-part-i.pdf?format=original kornyo, genetically modified organisms, voices in bioethics, vol. 1 (2015) 5 politics. (academic press: waltham, ms: march 2001) 10 estibaliz sansinenea. bacillus thuringiensis biotechnology; roy macarthur et al model for tuning gmo detection in seed and grain in nature biotechnology 25, 169 170 (2007) 11 neal stewart et al. transgene introgression from genetically modified crops to their wild relatives in nature review-genetic volume 4, october, 2003; alexander haslberger gmo contamination of seeds nature biotechnology 19, (july 2001) 613-613 12 jagadeesan premanandh global consensus – need of the hour for genetically modified organisms (gmo) labeling in journal of commercial biotechnology vol. 17 (2011): 37–44 13tom beauchamp et al. principles of biomedical ethics (oxford university press; london, 2009) p24. some call this the ideological part of the debate. 14 ibid 15 beauchamp. principles of biomedical ethics 16 ibid 17 ibid 18 this argument carries the potency of the principles of utility. 19 it should be noted here that some genes are also deleted in some gmos. 20 i decline to call this the safety arguments because most of these are generally “conceptual”! doebley, j. molecular evidence for gene flow among zea species in bioscience 40, 443–448 (1990) 21 d. k. agorsor et al. ghana’s gmo debates: beyond the sticking points. www.ghanaweb.com february 2014 22 beauchamp, p24 23 muir, w., & howard, r. possible ecological risks of transgenic organism release when transgenes affect mating success: sexual selection and the trojan gene hypothesis. proceedings of the national academy of sciences 96, (1999) 13853–13856 24 ibid. paul pechan et al. genes on the menu: facts for knowledge-based decisions (springer press; new york: 2004)and chris a. wozniaketal. regulation of agricultural biotechnology: the united states and canada 25 dorothy du. socioeconomic and ethical consideration be incorporated into the regulation of genetically modified crops? in harvard journal of law and technology volume 26, number 1, fall 2012; demont, m., et al. gm crops in europe: how much value and for whom? eurochoices 6, 46–53 (2007). according to dana, the precautionary principle is defined as “a decision making heruristic that ‘counsels serious contemplation of regulatory risk in the face of evidence of health and environmental risk, even before the magnitude of risk is necessarily known or harm manifested. see david a. dana, a behavioral defense of the precautionary principle, 97 nw. u.l. rev, 1315, (2003) 26 see also the cartagena protocol on biosafety http://www.biodiv.org/biosafety 27who report modern food biotechnology, human health and development (2005) p24 (2006:)1–7 28 wto sanitary and phytosanitary agreement article 5.7 see www.wto.org/sps 29 covello, v.t. and j.r. fiksel (eds), the suitability and applicability of risk assessment methods kornyo, genetically modified organisms, voices in bioethics, vol. 1 (2015) 6 for environmental applications of biotechnology (national science foundation, washington dc;1985) 30 john e. losey et al. transgenic pollen harms monarch larvae in nature vol. 399, 214 (1999) 31 sears, m., et al. impact of bt corn on monarch butterfly populations: a risk assessment. proceedings of the national academy of sciences 98, (2001): 11937–11942. see also theresa phillips, genetically modified organisms (gmos): transgenic crops and recombinant dna technology in nature education 1 (1) 32 adelaide arthur. ghana to begin gmo testing cowpea improvement (october, 2012) 33 suzie key et al genetically modified plants and human health in journal of royal society of medicine ( june 1, 2008)101(6): 290–298 34 gurr sj et al. engineering plants with increased disease resistance: what are we going to express? in trends in biotechnology (2005) 23:275–82 35 ibid. see also latham jr et al the mutational consequences of plant transformation in j biomed biotech (2006): 1-7 36 julie a. nordlee et al identification of a brazil-nut allergen in transgenic soybeans in new england journal of medicine vol 334, (march 1996) 688-692 37 ibid. see also marion nestle, ph.d allergies to transgenic foods —questions of policy in new england journal of medicine vol. 334 (march 1996) 726-728 38 bawa a. et al. genetically modified foods: safety, risks and public concerns—a review in journal of food science and technology vol.50, issue 6 (dec.2013): 1035-104; see also health impact of biotechnology, report of a who (world health organization) working group, dublin, 9-12 nov. 1982, who, copenhagen, 1984; swiss biotech, no. 5, pp. 25-26 (1984) 39 the doctrine of double effect: philosophers debate a controversial moral principle, notre dame, in: university of notre dame press. mcintyre, alison (2001) coulter, a homegrown solution, voices in bioethics, vol. 1 (2014-15) © 2015 andrew coulter. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a homegrown solution: plant-based diets and urban bioethics andrew coulter keywords: vegetarianism, health, lifestyle change, sustainability introduction as a nation, we are in an urban health care crisis: our most vulnerable citizens face a lack of access to care, inequality in quality of care, and often do not have the means—monetary, temporal, or educational—to fully follow the care plans of their physicians. chronic disease runs rampant and uncontrolled throughout the poorest areas of our major cities. patients are routinely prescribed lifestyle modifications that are too elaborate or difficult to maintain over time, leading to higher rates of complications from chronic disease and, ultimately, a higher mortality rate. each month researchers debate the merits of different antihypertensive regimens and the newest diabetes medication, but we lag behind sorely in a comprehensive, sustainable lifestyle change that can help to alleviate many of the diseases affecting the urban poor. in response to these challenges, i ask for the medical establishment to consider prescribing a diet with a higher ratio of unprocessed plant-based foods (like fresh fruits and vegetables, legumes, and seeds), for the benefit of the patient, through improved health; the community, through decreased economic cost to society; and the planet, by encouraging environmental sustainability. analysis as a dietary system, vegetarianism has increased in prevalence and popularity over the last few decades in america. simply put, vegetarian diets are broadly defined by abstaining from dietary intake of meat and foods which result in the death of the animal. however, the system has numerous variations, ranging from limited consumption of milk and eggs (which do not result in the death of the animal) to others that completely avoid any animal derived products, known as veganism (and to be clear, any reference to vegetarianism refers to this spectrum of diets, not only those who don’t eat animal products which result in the death of the animal). research on vegetarianism points towards health benefits to those who follow it — there are notable decreases in mortality among vegetarians when compared to meat eaters, and consumption of a diet with a higher ratio of unprocessed plant-based foods has shown decreases in coronary artery disease and hypertension.1234 furthermore, the vegetarian/plant-based diet avoids costly sources of protein, like seafood and meat, in favor of more reasonably priced proteins, like beans, making it more affordable for the average consumer. patients are often instructed to “eat more lean meats,” like chicken or fish, but these products are relatively expensive and require time for preparation. too often it seems the magnitude of the lifestyle interventions we recommend are poorly designed when keeping an impoverished urban population in mind: a group that simply does not have the resources, be it time or money, to implement these changes. economically, a diet coulter, a homegrown solution, voices in bioethics, vol. 1 (2014-15) 2 higher in plant-based foods is sustainable at the macro and micro level. pound for pound, beans and lentils, though not as protein dense, are more affordable than chicken or beef, and can require significantly less preparation from store to plate. many herbs and vegetables, like tomatoes and green beans, can be grown at home, and can even be adapted to grow in urban environments. at the macro level, ending global hunger with a diet including american rates of meat consumption would require more land for livestock than we have available. moving towards a more plant-based diet frees up land for production of grains and other crops that could be more easily mobilized to feed those in need. furthermore, the environmental impact of meat consumption is staggering relative to the modest amount of resulting product. we have seen a higher rate of atmospheric greenhouse gases proportional to increases in global meat production – as much as 14.5% of human-caused emissions come from livestock.5 indeed, livestock production accounts for 70% of freshwater use and 93% of its depletion.6 currently in california, a severe drought has led to governmental restrictions on residential water consumption— those in relative affluence will have the means to mitigate and side-step the inconveniences, but those in poverty are forced to live with the burden of a decreased water supply. the health benefits of a diet with a higher amount of plant-based foods for the individual have been mentioned earlier, but i’d like to focus on the benefit of plantbased nutrition from the perspective of the community and the ethical tenet of justice. protein, as an essential nutrient, should be accessible to the majority of the population. beans, legumes, and nuts are more accessible sources of protein at a population level, and are less environmentally taxing. physicians and healthcare professionals should encourage patients to include a greater amount of plant-based foods in their diet, while decreasing meat consumption. the usda has made great strides in encouraging plant-based protein sources in their 2010 dietary guidelines via myplate.gov, offering portion sizes/equivalents for plant-based proteins, as well as having a portion of the site dedicated to vegetarian diets.7 the website has a series of printable guides, which healthcare providers could offer to their patients to simplify making these choices. this shift in dietary policy would not be easy to complete, but with advocates from healthcare backgrounds engaging the community and pushing for change i believe this is a feasible goal. by suggesting that patients consume plantbased proteins rather than meat ones, we can ensure that those with less access to meat have a similarly healthy and equivalent alternative. physicians and other healthcare professionals should serve as community advocates and encourage their local representatives to support urban farming projects. the cultivation of high-protein plant products is a simpler operation to initiate in an urban environment; it’s easier to develop a community garden than a community cow pasture. urban farming of fruits and vegetables is a rising practice in many cities throughout the united states, with successes in multiple sites and many benefits on top of provision of fresh food for the community. engaging the community to implement an urban farming program can create a sustainable source of the foods necessary for a diet with more unprocessed plant-based foods, while also improving community health. in some cases, it may also be possible to use a larger scale urban farm, possibly in an industrial area or similar location, as a source of jobs. the intervention is scalable based on need, from a simple home garden or a community plot to a large-scale farm if the space is available. we could expect to see several direct benefits from greater numbers of community/urban farming projects. there would be a decrease in urban blight through development of empty lots and repurposing of abandoned dwellings, an increase in the availability of fresh food in neighborhoods that otherwise lack access to healthy and affordable food, and urban communities would experience a sense of agency in their health. last, i’d encourage members of the healthcare community to implement these changes in their home institutions. improving the health of patients and community through sustainable food and decreased meat consumption are not foreign concepts among health systems. for example, kaiser permanente offers a regular farmer’s market held on its hospital campus, allowing patients to take the medical dietary advice offered and put it into practice.8 they also have made efforts to increase the amount of their food spending on sustainable agriculture, supporting good nutrition and local economies. a pilot study of four san francisco hospitals looked for the effects of decreased meat procurement and increased usage of sustainable meat. researchers found coulter, a homegrown solution, voices in bioethics, vol. 1 (2014-15) 3 reductions in costs and greenhouse gas emissions over the study period.9 overall, healthcare professionals at any level within an organization can encourage healthier diets with fresh foods and a higher ratio of plantbased foods in communities that lack access. while i fully advocate for these reforms, how we implement these changes is just as important as the changes themselves. for example, this system is not meant to be a two-tiered dietary system based on socioeconomic status, where the underprivileged are encouraged to avoid meat while still promoting it for those with the means to purchase it. obviously, that would be a gross violation of the justice principle. nor do i intend it as a blanket policy; all dietary recommendations should take the health of the patient into perspective first and foremost. i intend this to be a solution applicable and scalable to all populations, but i believe the most significant benefits would be observed among poor urban populations. conclusion my hope is that in the coming years physicians will see the positive effects of prescribing a diet with a higher ratio of fresh, plant-based foods, and offer it as a more sustainable and affordable lifestyle intervention for patients, especially in urban communities. it is a substantial shift in our current thinking and policy that would certainly require a significant amount of support to implement, but the payoff for individuals, the community, and the environment would be well-worth the effort. 1 halton tl, willett wc, liu s, et al. “low-carbohydrate-diet score and the risk of coronary heart disease in women.” n engl j med. vol. 355, no. 19 (2006):1991-2002 2 trichopoulou a, orfanos p, norat t, et al. “modified mediterranean diet and survival: epic-elderly prospective cohort study.”bmj : british medical journal 300 no. 7498 (2005):991. doi:10.1136/bmj.38415.644155.8f. 3 fraser ge, shavlik dj. “ten years of life: is it a matter of choice?”arch intern med. vol 161 no 13 (2001):1645-1652. doi:10.1001/archinte.161.13.1645. 4 li d. "effect of the vegetarian diet on non-communicable diseases". j. sci. food agric. vol 94 no. 2 (2014): 169– 73. doi:1002/jsfa.6362.pmid23965907. 5 gerber, p. j., h. steinfeld, b. henderson, et al. “tackling climate change through livestock a global assessmaent of emissions and mitigation opportunities.” food and agriculture organization of the united nations, rome. (2013) 115 pp. 6 turner, k., georgiou, s, clark, r. et al. economic valuation of water resources in agriculture, from the sectoral to a functional perspective of natural resource management. fao paper reports no. 27, (2004) rome, fao.choosemyplate.gov. (n.d.). retrieved june 8, 2015, from http://www.choosemyplate.gov/ 7 sustainable food. (n.d.). retrieved may 2, 2015, from http://share.kaiserpermanente.org/article/environmental-stewardshipsustainable-food/ 8 lagasse, l., & neff, r. (2010, april 20). a pilot evaluation of implementation in four san francisco bay area hospitals. retreived may 2, 2015, from https://noharm-uscanada.org/sites/default/files/documents-files/459/balanced_menus_pilot_eval.pdf https://en.wikipedia.org/wiki/digital_object_identifier https://dx.doi.org/10.1002%2fjsfa.6362 https://en.wikipedia.org/wiki/pubmed_identifier https://www.ncbi.nlm.nih.gov/pubmed/23965907 http://www.choosemyplate.gov/ http://share.kaiserpermanente.org/article/environmental-stewardship-sustainable-food/ http://share.kaiserpermanente.org/article/environmental-stewardship-sustainable-food/ https://noharm-uscanada.org/sites/default/files/documents-files/459/balanced_menus_pilot_eval.pdf maia winkel, who’s to blame, voices in bioethics, vol.1, 2014-2015 © 2014 maia winkel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. who’s to blame? maia winkel keywords: hiv/aids, sociopolitical, as journalist gregory gilderman bluntly put it, “russia is dying.” according to the centers for disease control and prevention (cdc), russian federal aids center, and the joint united nations programme on hiv/aids (unaids), the hiv/aids and injection drug use epidemics in russia are spiraling out of control. in a country of approximately 143 million people, over 1 million are hiv-positive and over 2 million are injection drug users, primarily addicted to heroin. as a point of comparison, between 2002–2012 new hiv cases in south africa decreased by 38 percent (although south africa still has the highest prevalence of hiv/aids transmission), while new cases in russia increased by a shocking 41 percent, during that same period. this current situation is unacceptable, particularly given the allocation of resources toward hosting the 2014 olympic winter games. in russia, injection drug users (idus) and their partners, as well as sex workers, have the highest prevalence of hiv/aids. following the collapse of the soviet union in 1991, and the ensuing socio -geographical fragmentation that resulted from it, russia and the former eastern bloc countries have experienced a marked increase in drug trafficking and drug use, which have been steadily rising since then. this can be attributed to several factors, including economic stagnation, a high unemployment rate, and a steady supply of cheap, easily obtainable intravenous drugs (mostly opium-derived); it has become easy for its disoriented, dislocated population to acquire these drugs, using them as a temporary escape from the anxieties provoked by the soci o-political upheaval. this issue should not—at least at this critical time—be viewed through a moral lens; instead, russia’s values crisis should be approached as a sociopolitical failure which has resulted in a public health pandemic. in 2013 alone, approximately 54,000 new cases of hiv were reported in russia; of these, injecting drug users represent an alarming 57.9 percent. one of the barriers to addressing this epidemic has been the limited government funding for education regarding sex and drugs. this has only exacerbated the epidemic and interfered with prevention of hiv/aids. although russia allocated federal funding to hiv/aids treatment in 2006 (and those resources have since been bolstered by private donations) the fact remains that service delivery is sporadic, at best. this stems, in part, from logistical difficulties associated with importing and distributing medications. despite the obvious problem, the russian government has refused to recognize the magnitude of this problem, and has failed to permit or provide funding for interventions that are widely and successfully implemented in other parts of the world, as a means of coping with these serious health issues. maia winkel, who’s to blame, , voices in bioethics, vol.1, ,2014-15 2 in spite of substantial evidence demonstrating the effectiveness of medication-assisted therapies, the kremlin insists on funding abstinence-based drug treatment, a method called “narcology,” as the preferred and only officially sanctioned “cure” for drug addiction. for example, the russian healthcare department, which has provided state-sponsored healthcare since 1996, supports a “cold-turkey” approach to treating severe alcoholism and drug addictions. furthermore, russia prohibits treatment of drug addiction with methadone, a synthetic opioid used in opioid-substitution therapy—continuing to uphold a 1998 law banning narcotics and psychotropic substances. despite some controversy, methadone has been consistently shown to be beneficial in treating opioid addiction. rather than consider the medical and social benefits of trea ting hundreds of thousands of idus with methadone or any other medical opioid substitute, the russian government takes a legalistic, as well as moralistic stance. ultimately, this results in a lack of much-needed medical services. this unfortunate approach has serious implications, not only from a health-related perspective, but from a humanitarian one, as well. in addition, russia does not provide funding to develop and foster other harm reduction programs, such as syringe exchange programs (seps). instead, not-for-profit, international medical and public health focused nongovernmental organizations (ngos), such as médecins sans frontières, have attempted to fill the void, endeavoring to provide healthcare, as well as education and services to the russian people. furthermore, in early 2012, the putin administration blocked access to the website of the andrey rylkov foundation for health and social justice, a public health organization that advocated for methadone use to treat drug addictions. this move came after years in which the russian government exhibited systemic reluctance to allocate funds for hiv/aids and drug addiction research, prevention, and outreach. consequently, the kremlin’s opposition to methadone use matches its active repression of diss ent towards these policies. in recent years, russia has been under increasing scrutiny by the international medical and public health communities. the country’s ethnodemographic problems are a reflection of the russian government’s complete failure to provide adequate healthcare services that adequately attend to the hiv/aids and intravenous drug epidemics. given the scope of the problem, russia has an obligation to its people to utilize an empirically grounded and deontological approach in addressing this dual epidemic. sochi: a just reward? an important question worth asking is, why the international olympic committee (ioc)—and the rest of the world by participation—has supported russia’s hosting of the 2014 winter olympic games when this country has consistently acted in resolute defiance of human rights, the responsibility to provide its people with adequate healthcare services, and the rights to free speech and to live without persecution? as a developed country, russia behaves like a developing country struggling to afford its people basic medical and human rights—yet it manages to spend $48 billion on the most expensive olympics in history. the international olympic committee is the body responsible for choosing the city where the olympic games are held, an honorary position for which applicant cities must meet certain basic conditions in order to qualify. the applicant city must prove that it is capable of hosting the olympic competitions (i.e., that is has available space and can provide the requisite accommodations, transportation, security). it is essential, and quite interesting, to note that the requirement that the host city and country demonstrate justice, equality, and respect to its citizens—a basic value at the core of the olympic games–does not seem to be a consideration when making the choice. maia winkel, who’s to blame, , voices in bioethics, vol.1, ,2014-15 3 despite the frightening increase in new cases of hiv/aids each year, the russian government prefers to focus its attention on cultivating an image of opulence, success, and prosperity, rather than on its dire healthcare situation. nearly 1 percent of the population is infected with hiv/aids, though it seems the government is unconcerned by such statistics, which show to what degree its healthcare system is in a state of utter disrepair. it is ethically disconcerting and worrisome to see how the world turns a blind, ambivalent eye to these horrors in order to be able to watch and celebrate the games. just like most everyone out there, i relish the experience of watching the olympics. nevertheless, there is a certain bitterness in watching the games this year, knowing that they are taking place in an authoritarian, homophobic country with seemingly little concern for its current public health tragedy. our participation in this year’s glitzy, over -the-top expensive olympic games brought into bold relief a silent fault line in our presumed principled stance about a public health concern of universal proportions. it is both fascinating and highly troublesome to see how people all over the world choose to forget the ethical principles they claim to uphold. a most revealing and unflattering observation about the olympic games lies in our willingness to ignore host countries’ abuses, for the privilege and pleasure of watching the games. shouldn’t our choices and behaviors reflect what we believe and guide us to fight for those principles we wish to uphold? should we not refuse to support a country which disregards these principles? la rochefoucauld said, “hypocrisy is the tribute that vice pays to virtue.” do we believe in what we say or in what we do? the evidence supports the former. unless we want to betray our democratic values, our self -serving, selective application of principles (i.e., only when it does not inconvenience us) should be exposed, ac knowledged, and debated. it should not be overshadowed by the immediate gratification afforded us by the excitement elicited by the greatest winter sporting event in the last four years. i wonder why has russia, and before it china—another notorious abuser of human rights with a poor record of public health politics—been given the international honor of hosting the 2014 winter olympics? are we not, then, all responsible as well? van geem, gentle cesareans, voices in bioethics, vol. 1 (2014-15) © 2015 kevin van geem. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. gentle cesareans: the humane future of surgical delivery kevin van geem keywords: bioethics, c-sections, clinical ethics, ethics introduction in 2013 nearly 1 in 3 american babies were born via cesarean delivery.1 in the united states these deliveries are very clinical, with the primary concern being the medical safety and well-being of both mother and child. while this is a very important concern for surgeons (and patients), there is an often-overlooked interest in the emotional quality of a delivery. after an average of 39 weeks of gestation, the moment of birth is one of relief and excitement, yet women who undergo conventional c-sections can go hours without holding or seeing their newborn child. in order to address this issue a growing trend of “family-centered cesareans”–also referred to as “gentle” or “natural” cesareans–has gained favor in great britain. analysis the differences between family-centered c-sections and conventional c-sections is that mothers and fathers are given the option to watch the surgery and the delivery of their child, and in an additional effort to approximate a vaginal birth, as soon as the baby is delivered it is placed on the mother’s chest for skin-to-skin contact (which has been shown to provide a clinical benefit for newborns)2,3 over the past two years interest in gentle cesareans has increased in the united states, with stories about them featured on cbs and npr’s morning edition. 4 , 5 despite this growing awareness of the humane modification to cesarean surgery, it is not widely available. while it is offered at boston’s brigham and women’s hospital6 most hospitals and surgeons are reluctant to allow for gentle c-sections because there is only a small medical literature about the safety of allowing skin-to-skin contact directly following cesarean sections. this reasoning5,7,8,9,10 makes sense both ethically and legally for experimental surgeries, but for a tweak on an established intervention, with a clear benefit to both mother and newborn, this reasoning seems overly cautious, and based less in a concern of non-maleficence, and more out of avoiding litigation. it is morally problematic to withhold an intervention that could be beneficial to both mother and child during delivery for fear of legal recourse. what is clear is that the gentle c-section could offer a benefit to mother and child, yet what is unclear is if it is more beneficial or less safe than the conventional c-section, therefore studies must be undertaken to show its safety and efficacy, and to help alleviate concerns that providing gentle cesareans could lead to litigation. van geem, gentle cesareans, voices in bioethics, vol. 1 (2014-15) 2 1 joyce a. martin, brady e. hamilton, michelle j.k. osterman, sally c. curtin, t.j. mathews, “births: final data for 2013” national vital statistics reports 64, no. 1 (2015): 1-13. 2 ann-sofi matthiesen, ann-marie widström, mario lepage, louise dumas, ksenia bystrova, barbara wellesnyström, “influence of skin-to-skin contact and roomin-in on early mother-infant interaction: a randomized controlled trial,” clinical nursing research 22, no. 3 (2013): 310-336. 3 elizabeth moore, “early skin-to-skin contact for mothers and their healthy newborn infants,” journal of obstetric, gynecologic, & neonatal nursing 42, no. s1 (2013): s86. 4 “dr. max gomez: the ‘gentle’ c-section” cbs new york. accessed march 19, 2015. http://newyork.cbslocal.com/video/11112856-dr-max-gomez-the-gentle-c-section/ 5 jennifer schmidt, “the gentle cesarean: more like a birth than an operation.” national public radio. last modified march 18, 2015, 6 brigham and women’s hospital bulletin, “the gentle cesarean: a new option for moms-to-be at bwh.” accessed march 19, 2015, http://www.brighamandwomens.org/about_bwh/publicaffairs/news/publications/displaybulletin.aspx?articleid=5 992. 7 concepción de alba-romero, isavel camaño-gutiérrez, paloma lópez-hernández, javier de castro-fernández, patricia barber-casado, maria luisa salcedo-vázquez, dolores sánchez-lópez, pilar cantero-arribas, maria teresa moral-pumarega, carmen rosa pallálla-alonso, “postcesarean section skin-to-skin contact of mother and child” journal of human lactation 30, no. 3 (2014): 283-286. 8 sylvia gouchon, dario gregori, amabile picotto, paola di giulio, “skin-to-skin contact after cesarean delivery: an experimental study” nursing research 59, no. 2 (2010): 78-84. 9 jane s. grassley, judith jones, “implementing skin-to-skin contact in the operating room following cesarean birth” worldviews on evidence-based nursing 11, no. 6 (2014): 414-416. http://www.brighamandwomens.org/about_bwh/publicaffairs/news/publications/displaybulletin.aspx?articleid=5992 http://www.brighamandwomens.org/about_bwh/publicaffairs/news/publications/displaybulletin.aspx?articleid=5992 http://www.brighamandwomens.org/about_bwh/publicaffairs/news/publications/displaybulletin.aspx?articleid=5992 bellisomo, remove financial disincentives to organ donation, voices in bioethics, vol. 1 (2014-15) © 2015 randi bellisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a call to remove financial disincentives to organ donation randi bellisomo keywords: organ donation, financial, ethics introduction taking the financial burden off the shoulders of donors and families is not only more fair, but it might also lead to more organs for transplant, according to representatives of the american society of transplantation and the american society of transplant surgeons—and they urge americans to find ethical ways to get rid of financial “disincentives” to organ donation. in addition to the removal of financial barriers, they would also like to see careful consideration and testing of potential financial incentives for organ donation. but any changes in current practice must be able to pass tests of both efficacy and ethics, says the 38-member incentives workshop group in a paper in the american journal of transplantation. analysis “every person in the chain of an organ donation, except one, profits,” said daniel salomon, the paper’s author and medical director of the kidney and pancreas transplant program at scripps health in san diego. according to the american journal of nephrology, living donors incur out-of-pocket expenses averaging $5,000. while a recipient’s insurance covers a donor’s medical expenses, transportation, lodging, childcare, and lost wages are not included. families of deceased donors, according to the paper, may face higher hospital and funeral costs resulting from donation. “donor costs should be incorporated into the cost of the transplant,” said tom mone, ceo of onelegacy, the nation’s largest organ procurement organization. “the donor should bear no economic detriment.” paper authors maintain that upfront cost coverage would result in drastic and long-term savings among insurers. “from every single patient that stays on dialysis, the payer is losing $60,000 a year if they are not transplanted,” salomon said. according to the u.s. organ procurement and transplantation network, more than 123,000 americans await organ transplants. roughly 4,000 die each year. however, living kidney donation numbers peaked in 2004 at 6,991, according to united network for organ sharing data. the number of living kidney donors has declined every year since; in 2014, they numbered 5,817. though 120 million are registered to be deceased donors, successful organ recovery typically depends on brain death, often resulting from an accident or trauma. because such a circumstance drastically narrows this pool, salomon said “moving the dial” with regard to living organ donors is an urgent strategy. while agreement exists that financial barriers prevent too many potential donors from surgery, incentives represent murky territory. the 1984 national organ transplant act made donor compensation illegal; bellisomo, remove financial disincentives to organ donation, voices in bioethics, vol. 1 (2014-15) 2 however, paper authors write that other incentives may be effective without interfering with inherent altruism. for families of deceased donors, the provision of funeral costs was among considerations. for living donors, incentives are tricky. “we have a responsibility to living donors,” salomon said. “but, we basically take their kidney and say goodbye.” he maintains that donors should receive lifetime health coverage, while other working group members have suggested coverage for a certain time. still, for others, such offers go too far. “it is so ethically charged,” said elisa gordon, a northwestern university medical anthropologist and working group member. “we don’t know if that would result in exploitation or undue inducement.” any harm attributable to living donation, including lost wages, should be mitigated, said mildred solomon, ceo of the hastings center, a bioethics institute. disincentives could include medical costs related to donation well after surgery, she said, but lifetime care constitutes a “perverse incentive” in the u.s. “we are the only developed country in the world that doesn’t see health care as a universal right,” solomon said. “what a statement it would be about our society if people decided to give an organ so they could get health insurance.” working group members say a balance should be struck between burdensome donation costs and compensation, and this balance can be identified in the careful consideration of other incentives—but not cash. “the conversations have been too polarized,” said university of nebraska medical center transplant surgeon alan langnas, a paper co-author. “when you have those two arguments, nothing happens.” salomon said he anticipates dialogue with the centers for medicare and medicaid services, private insurers, and former donors who have experienced roadblocks. “we need to initiate discussions with a broad group of stakeholders in this country, starting with the patients, families and payers,” salomon said. agredo, alternative to withdrawal of anh for pvs/mcs patients, voices in bioethics, vol. 1 (2014-15) * sebastian agredo, ms bioethics © 2014 sebastian agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. research study: many uk families hope for alternative to withdrawal of anh for pvs/mcs patients (review of research) sebastian agredo* keywords: bioethics, ethics, mcs, pvs, euthanasia introduction an article recently published in the journal of medical ethics and open to the public is calling necessary attention to the clinical approach of treating patients in permanent vegetative state (pvs) and minimally conscious state (mcs) in the united kingdom.1 the administration of artificial nutrition and hydration (anh) is a central element of caring for patients with severe brain injury, for it allows physicians to keep the patient alive while exploring other treatment options. unfortunately, it is most often the case that these other options are unsuccessful in improving the patient’s condition, and after a period of 12 months, it is very unlikely that the patient will ever regain full consciousness. for many families, this exhaustion of viable alternatives means that the next step is to ensure that the patient is able to die peacefully and mercifully. analysis as it stands in the uk, the only legal method of ensuring death for the patient is through the withdrawal of anh. additionally, what distinguishes the situation in the uk from that in the united states is that – under british law – the withdrawal of this life-sustaining treatment must be approved by the courts, and relatives of the patient – unless specified in an advanced directive – “do not have a deciding voice on this (or any other) treatment decision for an incapacitated adult family member”2. therefore, it is up to the attending physicians to make the clinical decisions based on the best interest of the patient, taking into account what the patient would have wanted. this leaves the patient’s family without much recourse other than to accept withdrawal of anh as the only solution, and watch as their loved one suffers a long, slow death. agredo, alternative to withdrawal of anh for pvs/mcs patients, voices in bioethics, vol. 1 (2014-15) 2 this is where the research study by professors celia and jenny kitzinger has the most to offer. whereas previous scholarship on the issue in the uk have centered on the philosophical, medical, and legal ethicality of withdrawing anh from pvs/mcs patients, this study centers on the perspectives of the families who have experienced this first-hand. by interviewing 51 individuals, the researchers were able to see that many yearned for a less distressing and more “merciful way of allowing people to die”3. many interviewees could not bear the thought of seeing their family members essentially starve to death as the anh was withdrawn, thinking that such treatment could only be described as “barbaric”, “cruel”, and “unacceptable” 4 . the prevailing opinion among most of the interviewees was that a kinder and more compassionate way of seeing their loved ones die would be through terminal sedation or some kind of lethal injection. it is important to note that euthanasia and assisted suicide are illegal under british law, punishable with a maximum penalty of up to life imprisonment, 5 and it is easy to see how the use of a lethal injection to deliberately end the patient’s life can be construed as active euthanasia. thus, it would have to overcome the legislative hurdle of becoming legal in order to be considered a viable option for the patients and their families. conclusion terminal sedation, on the other hand, takes on a different role. when coupled with the termination of medical treatment, terminal sedation is widely accepted as a moral action, for it does no more than to ease the symptoms and suffering associated with the patient’s illness. terminal sedation is not meant to end a person’s life or hasten their death; it is meant to ease the process of dying. in the case of the pvs/mcs patient, the sedation would ensure unconsciousness so that anh can be withdrawn, and the patient can die peacefully. this may comfort and relieve the fears of the family members of a pvs/mcs patient, but it does not negate the fact that withdrawal of anh would still be a necessary step to cause the patient’s death. consequently, family members will still have to consider the withdrawal of anh in order for terminal sedation to be utilized in the dying process; and this is something that the research data show many families are unwilling to do. the authors hope that this article, in sharing the lived and real experiences of families who have gone through the ordeal of having a family member in a vegetative or minimally conscious state, will contribute to the philosophical debate surrounding the withdrawal of anh and the full ethical consideration of other methods of bringing about the death of pvs/mcs patients. references full article in the journal of medical ethics http://jme.bmj.com/content/early/2014/01/03/medethics-2013-101799.short?g=w_jme_ahead_tab 1 kitzinger c, kitzinger j. withdrawing artificial nutrition and hydration from minimally conscious and vegetative patients: family perspectives. j med ethics. published online first: 15 jan 2014. http://jme.bmj.com/content/early/2014/01/03/medethics-2013-101799.short?g=w_jme_ahead_tab 2 ibid. http://jme.bmj.com/content/early/2014/01/03/medethics-2013-101799.short?g=w_jme_ahead_tab agredo, alternative to withdrawal of anh for pvs/mcs patients, voices in bioethics, vol. 1 (2014-15) 3 3 ibid. 4 ibid. 5 national health services. euthanasia and assisted suicide. retrieved from nhs choices: http://www.nhs.uk/conditions/euthanasiaandassistedsuicide/pages/introduction.aspx http://www.nhs.uk/conditions/euthanasiaandassistedsuicide/pages/introduction.aspx ingram, justification for stem cell research, voices in bioethics, vol. 6 (2020) © 2020 elizabeth ingram. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. justification for stem cell research considering embryos have some moral status elizabeth ingram keywords: moral status, early embryo, bioethics, stem cell research introduction our ethical commitments and moral values are evolving rapidly in response to advancements in technology. embryonic stem cell research (escr) has the potential to create breakthrough treatments for incurable human diseases but only by a process that destroys human embryos. the arguments regarding whether the destruction of embryos in escr is justified rely on establishing the moral status of human embryos. most arguments conclude either that human embryos have moral status equal to that of developed humans and escr is morally impermissible, or that human embryos have no moral status even as organisms distinct from humans. alternatively, lawrence j. nelson argues embryos have some moral status that grants them the right to be respected in escr and other research during which they might be harmed or destroyed. this essay argues in favor of nelson's position supporting embryos having a moral status that does not condemn escr. i. background: positions of an embryo's moral status lawrence j. nelson argues that human embryos have some moral status and conditionally supports escr. 1 they assert that human embryos have moral status because they are alive, they have a special relationship with the humans that constitute them (donors), and they are valued by sincere moral authorities. they also argue that, like all living things, embryos have some inherent good. 2 embryos have distinct characteristics from humans precluding moral status equal to humans. nelson reasons embryo destruction or harm is permissible only if they are respected as organisms with some moral status and used as needed for substantial reasons, for example, advancing our understanding of, and creating effective treatment for, untreatable diseases to improve human quality of life. ii. counterarguments a. embryos and humans have equal moral status precluding escr positions against escr generally argue human embryos have equal moral status to humans which automatically condemns escr as a process that violates human rights. according to deontological ethics, granting embryos equal moral status to humans also grants embryos should never be used as a means to some end as they are in escr.3 however, the utilitarian approach argues that while embryos may have moral status equal to humans, the potential good of escr outweighs the harm of using and sacrificing those embryos. this argument benefits from the less identifiable potential of escr versus the easily identified harm. also, some ingram, justification for stem cell research, voices in bioethics, vol. 6 (2020) 2 are concerned the use of embryos in escr may lead to the devaluing or demoralization of human life. accepting the utilitarian view leads to the slippery slope argument where justifying harming embryos for research if it has potentially good outcomes could also justify research that harms humans. if the moral status of humans and embryos were equal, escr also violates the kantian imperative to treat humans as ends in themselves rather than using them as a means to an end. therefore, escr is unethical despite the potentially good outcomes. b. embryos have no moral status making escr permissible those arguing that embryos have no moral status generally base their arguments on the distinguishing characteristics between developed humans and human embryos. differences include possession of cortical function and consciousness, having an interest in being protected from harm, and having autonomy.4 having personal interests is important because those interests are what is protected when preserving human rights, and rights are derived from moral status. 5 furthermore, consciousness is necessary for having personal interests to be protected and for beings to perceive physical or emotional harm, and thus be harmed and protected from it. c. distinguishing characteristics do not preclude moral status dr. geoffrey chu, a proponent of equal moral status, criticizes these distinctions and how they are used to justify escr. they identify problems with arguments denying embryos have any moral status but does not sufficiently argue for embryos having equal moral status to humans. 6 first, chu criticizes the use of distinguishing characteristics between humans and embryos to determine moral status. some research facilities find escr to be morally permissible for a periodof up to fourteen days, because they determine7 rights attach after this period, which chu explains is another unfortunate arbitrary definition of who is human. chu admits distinctions such as cortical function and self-awareness are useful descriptions but argues they do not explain how human embryos are not persons or otherwise lacking equal moral status to developed humans. for example, cortical function cannot define moral worth because severely intellectually impaired humans lack cortical function, but they are not considered to have less moral worth than humans without impairment. similarly, comatose patients lack brain function like human embryos, but comatose patients have the same moral status as those who are awake. chu also notes it is simply inaccurate to equivocate living embryos to dead cadavers. by explaining how some characteristics used to distinguish human embryos to developed humans are arbitrary, chu concludes these arbitrary characterizations lead to inappropriate judgments about moral status. second, chu argues creating and using embryos for escr without consent of the embryos is unethical. some embryos are created for escr directly and some are created during in vitro fertilization (ivf) for the purpose of implantation. creating embryos for ivf is controversial because more embryos are produced than will be implanted, and non-implanted embryos can be donated to escr or discarded. if the reason that overproduction of embryos in ivf is unethical is that the excess embryos are wasted, escr is a worthy use.8 although there are no ethical or legal rights assigned to embryos, many argue embryos deserve rights because they have the potential to develop into humans. iii. analysis: supporting nelson's contention that embryos have some moral status a. nelson: embryos have some moral status the appropriate uses of a human embryo, according to nelson, include pursuing research which harms human embryos only when it is intended to improve human life, such as research aimed at understanding and treating diseases. because their position does not rely on removing all moral status from embryos, it has a sufficient justification for morally permitted escr. by acknowledging embryos have some moral status and that humans have a higher status, nelson recognizes an ethical boundary which permits the use and destruction of embryos for research without supporting the use or destruction of humans for research or other ingram, justification for stem cell research, voices in bioethics, vol. 6 (2020) 3 purposes with some potential good. also, acknowledging embryos have some moral status unequal to humans prevents the use of embryos for research from violating kant's humanity imperative, as neither humans nor beings with equal moral status to humans are being used as a means to some end. b. distinguishing characteristics are useful in determining moral status while distinctions such as brain activity, personhood, or personal interests do not justify an organism’s moral status, they are useful for recognizing an organism’s rights in different circumstances. 9 we usually have the right to be autonomous, but when we lose the capacity to be autonomous, we rely on those assigned to make our decisions without our moral status changing10 these distinguishing characteristics are not useful for determining moral status, but nelson uses morally relevant characteristics which justify why embryos have some moral status. c. response to arguments that embryos have potential to become humans nelson acknowledges embryos only have the potential to become fully developed humans with equal moral status if they are implanted in a womb where they are intended to develop. embryos used in escr do not have the potential to develop into born persons because they are not to be implanted.11 roy perrett adds "the fact that persons have certain rights does not by itself entail that potential persons have those rights too. on the contrary, it is often the case that a potential x does not have the rights of an actual x: prince charles is presently a potential king, but this does not now give him the rights of an actual king."12 perrett concludes, "there is no reason to suppose it is intrinsically wrong to kill a potential person,"13 and the argument from potentiality does not justify embryos having equal rights to humans. iv. why escr should be pursued: asc and ipsc are not replacements one suggested alternative to escr is using adult stem cells (asc) which occur naturally in developed humans. while asc can differentiate as needed, as embryonic stem cells (esc) do, without the ethical issues of esc, asc do not multiply as readily as esc. because asc do not grow easily outside of the body, they have limited therapeutic use and cannot replace escr. the other suggested alternative is induced pluripotent stem cells (ipsc) which are reprogrammed adult cells. to be pluripotent means that cells, like esc, can be manipulated to multiply into any kind of cell making them very useful for treatment of an array of cellular loss diseases.14 however, the process for ipsc through nuclear reprogramming is not efficient or effective enough to be a replacement for escr. additionally, escr promises breakthroughs in how we understand human biology and diseases which asc and ipsc cannot offer. v. escr is a valuable tool that respects the partial moral status of embryos embryos have some moral status ensuring them the right to be respected as a living organism with morally relevant connections to the humans that constitute them with moral worth recognized by moral authorities. the partial moral status allows conditional use of embryos for substantial reasons like research. using nelson’s philosophical reasoning acknowledging embryos as organisms distinct from humans and not potential humans, the problems of violating kant's imperative against using humans as means to an end and the possible slippery slope of permitting destructive research on embryos leading to permitting harmful or destructive research on humans are avoided. some distinguishing characteristics are morally relevant and help identify embryos as having some moral status and some moral rights, albeit not equal to humans. although it remains controversial, escr should be pursued as long as there is no sufficient alternative that matches the potential for understanding human biology and treating human disease. ingram, justification for stem cell research, voices in bioethics, vol. 6 (2020) 4 1 nelson, lawrence j. "a brief case for the moral permissibility of stem cell research." markkula center for applied ethics (santa clara university, 2000). 2 nelson, "a brief case for the moral permissibility of stem cell research." 3 kant, immanuel, groundwork of the metaphysic of morals. translated and analysed by herbert james paton (harper & row, 1964), 96 429. 4 steinbock, bonnie. “chapter 18: moral status, moral value, and human embryos: implications for stem cell research.” in the oxford handbook of bioethics (oxford university press , 2007), 416–40. 5 steinbock, bonnie. “chapter 18: moral status, moral value, and human embryos: implications for stem cell research.” in the oxford handbook of bioethics (oxford university press , 2007), 428. 6 chu, geoffrey. "embryonic stem‐cell research and the moral status of embryos." internal medicine journal 33, no. 11 (2003): 530-531. 7 chu, geoffrey. "embryonic stem‐cell research and the moral status of embryos." internal medicine journal 33, no. 11 (2003): 530-531. 8 steinbock, bonnie. "what does “respect for embryos” mean in the context of stem cell research?." women's health issues 10, no. 3 (2000): 127-130. 9 banja, john. "personhood: elusive but not illusory." the american journal of bioethics 7, no. 1 (2007): 60-62. 10 varelius, jukka. "the value of autonomy in medical ethics." medicine, health care and philosophy 9, no. 3 (2006): 377-388. 11 nelson, "a brief case for the moral permissibility of stem cell research." 12 perrett, roy w. "taking life and the argument from potentiality." midwest studies in philosophy 24, no. 1 (2000): 186-197. 13 perrett, "taking life and the argument from potentiality." ingram, justification for stem cell research, voices in bioethics, vol. 6 (2020) 5 14 wilson, kitchener d., and joseph c. wu. "induced pluripotent stem cells." jama 313, no. 16 (2015): 1613-1614. niburski, hope in a freezer, voices in bioethics, vol. 1 (2014-15) © 2015 kacper niburski. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hope in a freezer: the 21st century pandora’s box kacper niburski pregnancy, conception, bioethics introduction pregnancy has become a disease. saying as much is hard to stomach, harder even to conceive. but in the current climate of political wrangling over birth control and further contraception,1 in the restrictive aerospace of reproductive technologies,2 and in a workplace that maintains imbalances in gender inequities,3 such a conclusion seems unquestionable, if not altogether tame. analysis consider egg freezing. originally developed for the storage of oocytes under the duress of certain ovarian cancers, 4 the procedure has transfigured into a newfangled panacea against the tantrum tornados that motherhood can birth. companies like apple and facebook, as well as numerous other unofficial law and banking practices, have offered these children-vs-career quashing services as part of their employment packages.56 but in a company such as facebook that employs 70% males7 and whose board of director is comprised of only two females out of nine, the unquestionable question creeps to the surface: who defines these needs, how are they tested, and how do they relate to the institution’s culture, end outcomes, and the women who work there, who don’t, and who want to? answering these questions is necessary, particularly when it comes to weighing otherwise shaky, still largely experimental procedures such as egg freezing. doing so also realizes that decisions aren’t made in a vacuum; social, political, and environmental factors affect a women’s choice in pursuing such an alternative. caveats are required, then. first such large corporations may be waltzing along with the north american pattern of starting families later, generally around age 30.8 as trailblazing early adopters, apple and facebook may be both redefining the functionality and narrative of traditional families. if women are postponing childrearing (the rate that woman are having a child in their thirties has quadrupled since 1970) 9, and if fecundity decreases as the biological window closes (a woman’s fertility drops from 86% at age twenty, 52% at thirty-five, and36% at forty)10, the harvesting of healthy, fertile eggs that can be used later may be seen as a godsend against biological mishaps. moreover, lives can be built around such policies. by deferring maternity, women can disrupt hypercompetitive professionalism. rather than rearing their children, they have the time to pursue a candideesque cultivation of their own garden. financial stability can be ensured. a devoted partner can be discovered. niburski, hope in a freezer, voices in bioethics, vol. 1 (2014-15) 2 and by encouraging such employment bundles that may go so far to entice generations of younger females, women can not only smash the glass ceiling, but stand on the roof above it. yet with glass on the floor, ethical considerations can – and do – bleed into the cracks. marketed in a plutocratic lens, egg freezing is being couched as treatment. systems do not need to change; women do. such a myopic perspective views pregnancy as a condition requiring a cure rather than a modification of workplace behaviours. for example: instead of foregoing motherhood and being blind to the asymmetrical penalty of fatherhood, substantive perks can be offered like on-site childcare or paid maternity leave. notably, facebook offers paid maternity leave, subsidized daycare, and nursing rooms in addition to the new reproductive technologies.11 but this marginal gain in a hodgepodge of services is scarcely something praiseworthy. hope is not found in a freezer. coercion is. consider the options: the generous wealth of possibilities, including egg freezing, or raising a family during one’s peak professional wherewithal. a woman who does not choose the former could be viewed as less serious about their employment. fewer opportunities could result. stigma may promulgate. and emotional pressures may influence the family dynamics at home, further worsening the already battered environment. still, the reverse option is not necessarily better. if a woman has children later in life – a 40 year old using her 20 year old eggs for example – they will still face all the challenges maternity brings with it (which says nothing of the difficulty of an older woman trying to bounce back from pregnancy compared to someone younger). all that will be different is their experience, standing, relationships, and pay grade. the overall climate wouldn’t have revolutionized. rest would still be required. careers would still halt. nothing, it seems, would have changed dramatically except for the passage of time. but as it passes and as the age piles on atop of it, the little hope of a quieter, more stable life as a result of egg freezing becomes a pandora’s box. at best, it is parochial; at worst, catastrophically misleading. the current state of research is hardly comprehensive. lifting the experimental label in 2012, the american society of reproductive medicine cited that “data on the safety, efficacy, cost-effectiveness and emotional risks of elective oocyte cryopreservation are insufficient to recommend elective oocyte cryopreservation.” 12 the lack of any guarantee – whether in the long term effects of preservation or in the failure rate (flash freezing methods known as vitrification have a 77 percent failure rate among women age 30, and 91 percent at age 40)12 – skews the consent that can be developed between physician and patient. a physician cannot inform the patient about the certainties of the procedure because they are not known. while such unknowns are stark enough, it is also worth mentioning that the power dynamics have changed altogether. it is not a physician who is suggesting a procedure, but a woman asking for the medicalization of their body. this warps any form of consent given. a physician is not providing what could be the best alternative; it is the woman who has already surmised the conclusion based on social conditions beyond the doctor’s direct control. of course, other considerations precipitate: the divide between women of different cultures, races, and social status may be exacerbated by those who can afford the procedures;13 the exercising of a woman’s autonomy in a sphere where she is choosing between the best of numerous bad options; the corporate culture that is influencing a decision as though it were isolated from all others, rather than one element of a greater system. conclusion forgetting all these disparate yet connected fragments is to forget a women’s relation to them. a woman, like a man, is not just an employee. yet by offering egg freezing as the pinnacle of corporate benefits, liberation niburski, hope in a freezer, voices in bioethics, vol. 1 (2014-15) 3 is chained to medicalization, not with possible labour strategies that integrate the intricacies of men and women alike. ethical concerns suggest that this technology-centric mentality is short-sighted and leads to further questions. problems create problems, and egg freezing simply delays trying to find an answer. 1 vogue, a. hobby lobby wins contraceptive ruling in supreme court. abc news. <http://abcnews.go.com/politics/hobby-lobbywins-contraceptive-ruling-supreme-court/story?id=24364311> 2 raymond, j. women as wombs: reproductive technologies and the battle over women’s freedom. harper san francisco. 1993. 3 acker, j. inequality regimes: gender, class, and race in organizations. gender and society. 2006. 20, 441-464. 4 wang, c et al. optimized protocol for cryopreservation of human eggs improves developmental competence and implantation of resulting embryos. journal of ovarian research. 2013. 6, 15-21. 5 vincent, j. apple and facebook offer egg-freezing services to hang on to talented female employees. the independent. <http://www.independent.co.uk/life-style/gadgets-and-tech/facebook-and-apple-offer-eggfreezing-services-tohang-on-to-talented-female-employees-9795580.html> 6 tran, m. apple and facebook offer to freeze eggs for female employees. the guardian. <http://www.theguardian.com/technology/2014/oct/15/apple-facebook-offer-freeze-eggs-female-employees> 7 hawver, m. apple big on hiring white men, not so much women or minorities. tech times. <http://www.techtimes.com/articles/12934/20140813/apple-white-mans-employer-tech-titan.htm> 8 bingham, j. average age of women giving birth now nearly thirty. the telegraph. <http://www.telegraph.co.uk/women/mothertongue/10380260/average-age-of-women-giving-birth-now-nearly-30.html> 9 mohapatra, s. using egg freezing to extend the biological clock: fertility insurance or false hope. harvard law and policy review. 2013. 8, 380-410. 10 bailey, r. the ethics of egg freezing: what’s wrong with women resetting their biological clocks. reason.com. <http://reason.com/archives/2012/05/22/the-ethics-of-freezing-eggs> 11 shontell, a. biological moms get preferential treatment over parents who adopt at companies like yahoo and google. business insider. <http://www.businessinsider.com/maternity-paternity-leave-policies-at-google-facebook-yahoo-twitter-microsoft-20138> 12 zoll, m. will egg freezing liberate women. mercatornet. < http://www.mercatornet.com/articles/view/will_egg_freezing_liberate_women> 13 black, d et al. gender wage disparities among the highly educated. the journal of human resources. 2008. 43, 630-659. introduction analysis conclusion sultan, rationing care of illegal immigrants, voices in bioethics, vol. 1 (2014) © 2014 brandon sultan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the domestic and international ethical debate on rationing care of illegal immigrants brandon sultan introduction: the millions of illegal immigrants in the united states have created a significant burden on the country’s healthcare system. the passage of the affordable care act will lead to a significant reduction in uncompensated care this year, which will force hospitals to ration, and perhaps ultimately limit or stop, care of illegal immigrants.[1] this issue is even greater on a global scale. as medical tourism in europe increases, healthcare costs in europe will increase as well. european countries may have to follow in the footsteps of the u.s. and limit treatment for illegal immigrants. thus, debate about whether to limit illegal immigrant healthcare services in the u.s. may serve as a model for future debate and policy in europe. regulations on hospitals: the emergency medical treatment and active labor act (emtala) requires hospitals that receive medicaid funding to provide any patient with emergency medical care. it does not matter whether a patient is uninsured, in the country illegally, or unable to pay for carehospitals have to treat them.[2] under emtala hospitals are required to provide two types of services. the first is a free medical screening examination to determine the type of care needed. then, based on the evaluation, the second is treatment to stabilize patients with an emergency condition. heart attacks, severe bleeding, and asthma attacks are examples of services mandated under emtala. life-preserving treatment that is not urgent, such as chemotherapy, is not covered. traditionally, uninsured or undocumented individuals have received additional services from hospitals. low-cost clinical care is an example of non-urgent medical care that hospitals sometimes provide if patients are uninsured and can’t pay. the costs incurred by the hospital traditionally have been offset by disproportionate share hospital funds (dsh) and, to a lesser extent, donations from charities and non-profits. dsh funds are federal funds given to hospitals to support uncompensated care. however, many times dsh funds are not sufficient, and hospitals will close their emergency rooms partially or completely if they accumulate too much uncompensated care debt.[3] https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn1 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn2 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn3 sultan, rationing care of illegal immigrants, voices in bioethics, vol. 1 (2014) 2 under the affordable care act (aca), u.s. citizens must purchase health insurance or pay a penalty. the resulting increased pool of insured patients and money received from penalties of uninsured legal residents, as well as certain non dsh related aca funding will result in us citizens and legal residents receiving more comprehensive medical services than they did previously when emtala was the law of the land. however, the individual mandate and additional care provided will not be applicable to illegal immigrants. moreover, under the affordable care act, 75 percent of dsh funding is being cut, leading to an even greater financial burden on hospitals to treat illegal immigrants.[4] with many hospitals in financial trouble, they will likely cut uncompensated non-emergency medical services. more importantly, many believe that hospitals will start refusing to treat costly emergency medical procedures for illegal immigrants and instead opt to pay a potential fine. the result will be a significant and dangerous gap in healthcare coverage for illegal immigrants, which raises many ethical issues. some scholars and legislators have argued that healthcare is a social good every human being is entitled to. therefore a just government should provide healthcare even for illegal immigrants to ensure a baseline level of health.[5] [6] the u.s. healthcare system’s treatment of illegal immigrants as a global ethics issue: the medical treatment of illegal immigrants is a global ethics issue for two reasons. first, illegal immigrants who come to the u.s. are citizens of other countries engaging in a type of medical tourism, thus deflecting healthcare costs from their country to the u.s. this limits the ability of this country to help its own legal residents. second, any action the u.s. and its hospitals take to deal with medical tourism and uncompensated care will be a model for how other countries and hospitals handle the issue. in the past 40 years, the u.s. has had a significant influx of illegal immigrants from developing countries, more than many of its european contemporaries. many of these immigrants are of a lower-socioeconomic status and create a large financial burden on the country’s healthcare system. recently, the numbers of immigrants illegally entering european countries have risen; as the health disparities gap between developing and non-developing countries increases, medical tourism of illegal immigrants will only increase in europe. traditionally, in countries such as england, which have publicly funded health insurance systems, international patients are covered at minimal or no cost to the patient. uncompensated cost has not been a huge issue in the past. however, as the financial burden begins to increase, european nations will need to start making policy decisions about whether to provide uncompensated care to international patients who are in their country illegally. because this has been a long-term problem in the united states, it is reasonable to expect that the future policies taken by european countries will mimic those of the united states. therefore, the lessons learned from the ethical argument in the united states about coverage of illegal immigrants will lay the groundwork for how dozens of other countries treat illegal immigrants. the four principles of bioethics: https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn4 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn5 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn6 sultan, rationing care of illegal immigrants, voices in bioethics, vol. 1 (2014) 3 james childress and thomas beauchamp were immensely influential in forming the structure of american bioethics. in their book principles of biomedical ethics they detail the four pillars of bioethics: beneficence, nonmaleficence, justice, and autonomy. the principle of autonomy dictates that individuals should be able to make voluntary and informed healthcare decisions. nonmaleficence means that no unnecessary harm should be done to the patient; the cause of harm can result from action or inaction. beneficence requires healthcare providers to do “good” in society. justice sets out standards for fairness in the treatment and care of patients and research subjects. these principles lay the foundation for evaluating the ethics of treating illegal immigrants.[7] the plight of patient x: the financial restraints on hospitals in the wake of the aca will lead to difficult and possibly unethical decisions for hospitals. a potential dilemma could go as follows: dsh restrictions have been implemented. person x is an illegal immigrant who came to this country in 2007. he is an agricultural laborer with a wife and three kids at home. while driving his truck, he is hit by another car, causing severe and acute brain trauma, in addition to other serious injuries. the ambulance takes person x, who is now patient x, to the emergency room of the local community hospital. hospital y is in a poor rural area of arizona. the hospital, already poorly funded and in financial trouble, is struggling even more after the large cuts in dsh funding. while diagnosing patient x, doctor z realizes that if he survives, there’s the possibility he will either be in a persistent vegetative state or need months of recovery; however, an almost full recovery is also a possibility. after speaking to the family of the patient, the doctor learns that the family cannot pay for x’s care, and that they are illegally in this country. the cost of care for patient x will be tens of thousands, if not hundreds of thousands, of dollars. under pressure from hospital administration, a decision is made later that day to not treat patient x, and he dies. in this case, under the aca, the doctor and the hospital are not legally liable. however, under emtala the hospital would have been fined, and be at risk of losing medicaid funding.[8] the ethical dilemma of denying care to illegal immigrants: unethical behavior by the government in the case of patient x, there are two ethical questions. first, are the policies taken by the u.s. to limit illegal immigrant healthcare ethical, and are the actions taken by the individual hospital ethical? if an individual like patient x is denied care, has there been a violation of autonomy? some may argue that autonomy has been violated since the decision to accept or refuse care was taken out of the patient’s and/or family’s hands. if a patient is incapacitated at admission, the family members usually become the healthcare decision-makers. in patient x’s case, following the principle of autonomy would mean giving family members a say in whether he should receive treatment or not. https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn7 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftn8 sultan, rationing care of illegal immigrants, voices in bioethics, vol. 1 (2014) 4 when person x came to the country in 2007, he was most likely under the impression that if he were severely hurt, he could receive emergency medical care. many immigrants come to this country to engage in dangerous work, and many may be aware of the safety net of emergency medical services that traditionally have been available to them. the aca has reduced dsh funding, limiting treatment options for illegal immigrants. since these reductions have not been highly publicized, most people (especially illegal immigrants) would not have been fully informed of the consequences of their decision to continue residing in the u.s. if more illegal immigrants knew that care might not be provided in an emergency, they might choose to leave the country, fearing they might not be treated. patient x and his family, for example, were not fully informed on how patient x would be treated by the hospital in an emergency. therefore the hospital’s actions violated patient x’s autonomy, because neither he nor his family chose to forgo treatment. the united states’ actions led to the ethical violation of patient autonomy because it created financial restrictions that don’t allow certain patients to receive care. the government’s restrictions on dsh funding also create a situation in which individuals are harmed, a violation of the principles of non-maleficence and beneficenceon both policy and hospital levels. traditionally the majority of funding for uncompensated care have gone to illegal immigrants but the aca’s large reduction in dsh funding clearly results in harm of illegal immigrants because no additional funding will be provided for their care. the aca did not override emtala; it is still law, and it mandates the legal duty to treat all patients in an emergency situation. doctors have a professional obligation to treat a patient in need of care (beneficence). no matter what the law says, doctors have an ethical obligation to treat a patient. the aca violates the principles of non-maleficence and beneficence because it results in harm of patients and potentially inhibits physicians from providing care for their patients. the hospitals and physicians are forced to act unethically due to financial restraints. the government’s actions also violate the justice principle because the outcome of the aca funding cuts and hospitals’ reduction in care result in an unfair distribution of goods in society. a merit-based analysis would show that many illegal immigrants have the same right to healthcare services as many americans. both illegal immigrants and some uninsured citizens of the u.s. pay sales tax: both parties pay equally into the system. paying taxes is a strong component of the social contract that justifies providing healthcare to those who pay. thus, just based on taxes, both parties should receive equal treatment. however, under the aca regulations, the u.s. citizen would receive care and the illegal immigrant may not. furthermore, the principle of justice requires that every patient who enters into a hospital should be treated equally, regardless of ability to pay. the hospital did not act according to this principle in the case of patient x. reconciling the principles sultan, rationing care of illegal immigrants, voices in bioethics, vol. 1 (2014) 5 at first glance, although the government’s restrictions and the hospital’s actions seem to clearly represent a violation of all four bioethical principles, many will argue differently. the mode of analysis used above represents a limited scope and understanding of the principles. these principles are often understood and analyzed in the clinical context of the doctor-patient relationship; in this context, the physician should treat the patient in a way that benefits and doesn’t harm him. at that same time, the patient should have the capacity to make decisions, and this care should be provided fairly to all individuals in similar situations. the prima facie duties of these four moral principles create obligations that cannot always be fulfilled. physicians have to constantly balance these duties to try to achieve the most ethical and medically appropriate outcome. this requires that some interests be weighted more heavily than others. this weighing of interests also occurs on a larger scale in all countries. the moral codes are often viewed in isolation within the doctor-patient relationship, instead of on a larger scale of aggregate healthcare distribution. bioethics, medical ethics, and public health ethics are not limited to just doctors treating patients; the interests of society, not just the individual, must be considered as well. for example, in many countries, healthcare is rationed. this is because, with limited resources, they need to prioritize costs in hopes of treating more patients, more effectively. this similar mode of analysis can apply to the hospitals acting within aca restrictions. the ethical justification for the government’s and hospital’s actions the expenses of large-scale illegal immigrant medical tourism can limit the capacity for other members of a community to be treated, which causes an ethical violation on a larger scale. if patient x and all illegal immigrants receive emergency medical care, hospitals could go bankrupt and be forced to close emergency rooms. if a hospital and a physician treat patient x knowing of the potential financial risk to the hospital, then they are acting in a manner that will result in greater harm for the whole community. this represents a violation of non-maleficence, because the hospital acted in a way that would harm the hospital, which leads to the harm of patients. the hospital violates beneficence because it has not allowed its physicians to fulfill their ethical obligations. thus, if the hospital does not treat patient x, it may harm one individual, but, on a larger scale, it can potentially save the lives of many other patients. in the case of justice, treating illegal immigrants may represent a fair distribution of goods. patient x’s treatment could lead to less care for legal residents either because care is stopped or patients will need to travel farther and thus may forgo care. these legal residents are acknowledged by the country as members of the population and pay federal and state taxes. paying taxes, as well as legal residency are some of the core factors that established a social contract. in return the country has a duty to provide services to the residents who fund it. hospitals receive significant federal funding and fall under the ethical obligation to fulfill the social contract. even though some illegal immigrants sultan, rationing care of illegal immigrants, voices in bioethics, vol. 1 (2014) 6 pay taxes, their status as members of the social contract in the u.s. is blurred because they are residing illegally. if treating illegal residents results in limiting care of legal residents, the country and the hospitals within it must ethically prioritize its legal residents first or else it violates the social contract. in the specific case of patient x, he had a poor prognosis. providing him services would have also rendered the hospital potentially incapable of helping patients with better prognoses. conclusion: the dsh funding restrictions that the aca will place on the united states hospitals will be devastating. hospitals will have to choose between which illegal immigrants to treat. in the next few years a similar debate will arise in europe. publicly funded systems will not be able to afford the high cost of medical tourism for illegal immigrants. these countries will be forced to ration care, and illegal immigrants are a population whose care may be rationed first. not providing care for these illegal immigrants presents ethical questions about the role of the government, hospitals, and the illegal immigrants themselves. there are ethical justifications for and against limiting care. the best possible course of action is ethically unclear, and, unfortunately, whichever course is taken will lead to rationing of care for certain individuals. references [1] diamond, michelle nicole. "legal triage for healthcare reform: the conflict between the aca and emtala." columbia human rights law review 43.215: 254. [2] diamond, michelle nicole. "legal triage for healthcare reform: the conflict between the aca and emtala." columbia human rights law review 43.215: 254. [3] diamond, michelle nicole. "legal triage for healthcare reform: the conflict between the aca and emtala." columbia human rights law review 43.215: 254. [4] diamond, michelle nicole. "legal triage for healthcare reform: the conflict between the aca and emtala." columbia human rights law review 43.215: 254. [5] childress, james. "a right to healthcare?" the journal of medicine and philosophy 4.2 (1979): 132-47. [6] daniels, norman. "rights to health care and distributive justice: programmatic worries." the journal of medicine and philosophy 4.2 (1979): 174-91. [7] mccormick, thomas r. "ethics in medicine." principles of bioethics. university of washington school of medicine. [8] "emergency medical treatment and active labor act (emtala)." ascension health. accessed february 9, 2014. http://www.ascensionhealth.org/index.php?option=com_content&view=article&id=146&itemid=172. https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref1 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref2 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref3 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref4 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref5 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref6 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref7 https://michael-reaves-bkln.squarespace.com/features/2014/04/01/the-domestic-and-international-ethical-debate-on-rationing-care-of-illegal-immigrants#_ftnref8 https://library.columbia.edu/ https://library.columbia.edu/ aurora and jones, a new year, a new perspective, voices in bioethics, vol. 2 (2016) © 2016 pranav aurora and tristan jones. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are cre dited. a new year, a new perspective: reframing the national dialogue on gun control and gun violence research pranav aurora and tristan jones* keywords: gun control, second amendment, gun rights, public safety, ethics introduction the new year is a symbol of both continuity and rebirth. a new year serves as an important mile-marker, reminding us of our progress over the previous year and empowering us to carry on into the next one. a new year also offers a clean slate to start anew, providing an opportunity to reflect on how we can better ourselves and strive to achieve new feats. as we begin 2016, it is our hope that this new year can be a symbol for not only our individual growth, but also for growth in our national dialogue on gun violence. gun violence, which includes both homicide and suicide, is an epidemic in the united states. gun violence claims the lives of more than 30,000 americans each year. [3] since 1968, more americans have been killed by guns than in all us wars combined from the american revolution through the current global war on terrorism.[4] deaths from gun violence far outnumber deaths by terrorism in the us and overseas.[5] american children are fourteen times more likely to die from firearm-related injuries on average than children in other developed nations.[6] in addition, with the frequency of deadly mass shootings in recent years,[7] the bbc commented on the horrific attack in san bernardino, california, as “just another day in the united states of america. another day of gunfire, panic and fear.”[8] the toll of gun violence is unconscionable because it can be prevented, but there is very little that we can actually do about it because of a decades-long moratorium on federal funding for gun violence research. in december 2015, gun violence research became a heated topic of debate in congressional negotiations for this year’s federal budget and even raised the possibility of another “government shutdown.”[9] however, the rhetoric that this research threatens our second amendment right continues to persist after the federal spending bill once again passed without any appropriations for gun violence research.[10] in this article, it is not our intention to dwell on traditional arguments and gridlock surrounding the moral standing of the right to bear arms. instead, we seek to move the dialogue forward by arguing that if a society has the liberty to bear arms, then that society has a moral obligation to do all that it can to mitigate the harms that result from that freedom. in doing so, we aim to elucidate why federal funding for gun violence research is in the best interest of both gun owners and non-owners and why it is fundamental to making progress on one of the greatest ills in our society. ii. history of federal moratorium on gun violence research historical support for undermining gun violence research is rooted in a misperception that such research is https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn3 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn4 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn5 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn6 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn7 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn8 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn9 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn10 aurora and jones, a new year, a new perspective, voices in bioethics, vol. 2 (2016) 2 no different from gun control advocacy.[11] the moratorium on gun violence research was ratified by congress in 1996, just years after a study funded by the centers for disease control and prevention (cdc) concluded that the ownership of guns in the home increased the risk for homicide by a family member or intimate acquaintance.[12] championed by representative jay dickey (r-ak), congress re-appropriated the $2.6 million spent the previous year on gun violence research for research unrelated to guns. in addition, congress included legislative language that stated, “none of the funds made available for injury prevention and control at the centers for disease control and prevention may be used to advocate or promote gun control.”[13] while not an explicit ban on research, arthur kellerman, author of the controversial 1993 study, has stated that, “precisely what was or was not permitted under the clause was unclear. but no federal employee was willing to risk his or her career or the agency's funding to find out. extramural support for firearm injury prevention research quickly dried up.”[14] more recently, in 2011, congress applied similar language to the national institutes of health (nih) after a study sponsored by the nih concluded that individuals in possession of a firearm were more likely to be shot in an assault than those who were not.[15] congressional efforts to stifle gun violence research have succeeded. research to prevent firearm-related injury and death amounts to less than $5 million annually, primarily coming from non-federal sources.[16] since 1996, cdc spending on gun violence research has fallen 96 percent to just $100,000 of its nearly $6 billion budget.[17] in addition, this past year the nih funded only two studies specifically focused on gun safety, totaling less than $1 million of its more than $30 billion budget.[18] meanwhile, gun violence is estimated to cost our nation at least $229 billion in healthcare costs and lost productivity every year.[19] the imperative to develop a new perspective on this long-standing issue could not be greater. iii. reframing the national dialogue on gun violence traditional ethical arguments on gun violence have centered on whether or not private ownership of firearms is a fundamental right. fundamental rights are liberties that protect “fundamental interests” necessary for human flourishing and living a good life.[20] support for the fundamental nature of the right to bear arms follows the rationale that we have a fundamental interest in self-defense and that guns are the best means to protect this interest.[21] conversely, others argue that unrestricted access to guns is not necessary for self-defense. [22] the non-fundamental interpretation of the right to bear arms ranges in support for moderate regulation on gun ownership to the abolishment of firearms entirely.[20] however, framing the dialogue based on the moral standing of gun ownership is intensely polarizing and damaging to efforts to mitigate firearm-related injuries and deaths. consequently, non-violent gun owners and non-owners remain staunchly divided on the issue of gun ownership at the expense of discussing the greater issue of gun violence. surveys show that an overwhelming majority of americans, including gun owners, support stronger gun safety measures.[23],[24] colleen barry, author of survey studies after the deadly shooting in newtown, connecticut, has commented: all too often, pollsters ask americans whether they support more or less gun control, or frame gun policies as controls on gun ownership generally rather than as measures to keep guns from criminals or other high-risk group. when you drill down to specific policies, you see that americans are very much in support of commonsense regulations to keep their families and communities safe from gun violence.[25] the sentiment for common-sense regulation of firearms was echoed recently by justice antonin scalia, an unwavering proponent of constitutional liberties, when the supreme court declined to hear an appeal by gun owners of an illinois ban on semi-automatic assault rifles and high capacity ammunition magazines.[26] both the ethical debate and broader national dialogue should no longer dwell on the morality of gun ownership, but rather focus on the duties and obligations that come with such liberty. reframing the conversation in this context can dismiss the polarizing language of “gun control” and motivate commonground policies on reducing gun violence. furthermore, reframing the dialogue in this light can change the 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https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn21 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn22 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn20 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn23 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn24 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn25 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn26 aurora and jones, a new year, a new perspective, voices in bioethics, vol. 2 (2016) 3 perception of gun violence research. instead of conflating research with advocacy, gun violence research may be viewed as one of the most effective tools for learning how to find the right balance between liberty and safety. iii. the importance of research for protecting the second amendment and public safety a compelling example for how gun violence research may protect the second amendment while mitigating harm lies in the progress of automobile safety. guns and motor vehicles are the second and third largest contributors to years of potential life lost, respectively.[27] in 2015, the national highway traffic safety administration, a federal agency devoted to motor vehicle safety, was appropriated $830 million, which starkly contrasts with the $5 million to prevent firearm-related injury and death.[28] the similarity in gun and automobile deaths but disparity in research funding highlights the myopia of the federal ban on gun violence research. research to promote automobile safety has shown to be effective at reducing harm without diminishing access to the technology. in the early 1970s, about 25 americans per 100,000 died in motor vehicle accidents annually. today the rate is 10, a 60 percent reduction.[29] yet over the same time period, us vehicles per capita have increased by over 50 percent.[30] a wide variety of factors have led to improvements in safety, from safer roadways and automobiles to campaigns to stamp out drunk driving, but these interventions would not have been possible without research to understand the nature and causes of motor vehicle deaths. for instance, early investigations into the benefits of seatbelts encouraged car manufacturers to begin including them in standard models, and eventually compelled governments to mandate seatbelt usage.[31] the many decades of research, safer technology and laws, and fewer motor vehicle fatalities without a concomitant fall in car ownership offers a lesson. a similar scenario could be envisioned for firearms, where improving safety does not threaten access or ownership. jay dickey, author of the 1996 amendment effectively halting federal gun violence research, has since regretted that such research has not continued and publicly stated that, “if we had somehow gotten the research going, we could have somehow found a solution to the gun violence without there being any restrictions on the second amendment … we could have used that all these years to develop the equivalent of that little small fence”—referring to the highway safety barriers that are credited with saving many lives.[16] it is not known whether an equivalent technological improvement exists that might reduce gun violence, but the tragedy is that there is no political will to try to find one. other firearms research has been shown to increase safety without any attempt to restrict access to guns. in particular, social campaigns that treat gun violence like a disease have proven effective. dr. gary slutkin, a world health organization epidemiologist, has noted that the same characteristics observed in a cholera outbreak are seen with gun violence. the single best determinant for whether or not someone will commit a violent act is whether or not they have been exposed to violence before.[32] slutkin’s organization, cure violence, aims to control gun violence in the same way he would control cholera: blocking person-to-person transmission. his team of “interrupters” uses conflict mediation after a shooting to prevent further violence.[33] when cure violence and other organizations employed these strategies from baltimore to chicago and baghdad to cape town, they noticed a significant reduction in violence.[34], [35] put simply, the intervention works and the spread of gun violence can be addressed like an epidemic. compellingly for gun owners, the organization never attempts to restrict access to guns or remove guns from the population. as news of mass shootings continues to occupy the airwaves and americans continue to perceive a rise in gun crime, the pressure for lawmakers to limit access to firearms will only increase. while this may be an effective solution for reducing violence, any such attempt would meet fierce resistance from gun advocates. https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn27 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn28 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn29 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn30 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn31 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn16 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn32 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn33 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn34 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn35 aurora and jones, a new year, a new perspective, voices in bioethics, vol. 2 (2016) 4 it seems this political impasse can be solved, or at least bypassed, by agreeing to fund federal research on firearm-related injuries and deaths. if gun owners and advocates continue to protest any infringement on the second amendment, surely better gun safety research is in their best interest. otherwise, the political winds may change. without any knowledge of how to make guns safer, the public and the government may fall back to the conclusion that guns must be banned, and every gun owner’s worst fear will be realized. research on gun violence would be no guarantee for improved safety, but it would be irresponsible not to try. iv. taking action the lack of funding for gun violence research is beginning to enter the national spotlight. the new york times and washington post have stepped up coverage of the issue.[36], [37] the institute of medicine continues to call for research on gun violence, gun safety technology, and the effects of violence in media.[38] the message is clear. there are many strategies that reduce the toll that guns have on our society without restricting access. many more might be discovered if federal research funding is directed toward reducing gun violence. because gun violence threatens the public’s health and welfare, the nih and cdc are particularly well positioned to research effective interventions. it is time for the federal ban on these two agencies’ gun violence research to be lifted. we urge you to take action and join in this effort by signing a petition to end the moratorium on gun violence research. as of thursday, january 28th, just weeks into the new year, more than 3,600 shootings, 900 deaths, and 1800 injuries from firearms have been reported in the united states.[39] let us change this before one of us or our loved ones becomes another victim of this tragic epidemic. references [1] voices in bioethics staff writer [2] medical student at the university of chicago pritzker school of medicine [3] web-based injury statistics query and reporting system (wisqars™). u.s. center for disease control and prevention. retrieved from: http://www.cdc.gov/injury/wisqars/ [4] jacobson, l. (18 jan. 2013). “pbs commentator mark shields says more killed by guns since ’68 than in all u.s. wars.” politifact. [5] jones, j. & bower, e. (30 dec. 2015). “american deaths in terrorism vs. gun violence in one graph.” cnn. [6] kristof, n. (26 aug. 2015). “kristof: lessons from the virginia shooting.” the new york times. [7] cnn library (03 dec. 2015). “30 deadliest mass shootings in u.s. history fast facts.” cnn. [8] cook, j. (03 dec. 2015). “california shooting: ‘another day of gunfire, panic and fear’.” bbc. [9] johnson, s. (10 dec. 2015). “pelosi stops short of threatening shutdown over ban on federally funded gun research.” modern healthcare. [10] ferris, s. (16 dec. 2015). “house dems lose fight to nix gun research ban in budget.” the hill. [11] cox, c. (09 dec. 2015). “why we can’t trust the cdc with gun research.” politico. https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn36 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn37 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn38 https://www.change.org/p/congress-stop-blocking-gun-violence-research https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_edn39 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref1 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref2 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref3 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref4 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref5 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref6 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref7 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref8 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref9 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref10 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref11 aurora and jones, a new year, a new perspective, voices in bioethics, vol. 2 (2016) 5 [12] kellerman, a. et al. (1993). gun ownership as a risk factor for homicide in the home. new england journal of medicine, 329(15). 1084-91. pmid: 8371731 [13] omnibus consolidated appropriations act, 1997. retrieved from: https://www.gpo.gov/fdsys/pkg/plaw-104publ208/pdf/plaw-104publ208.pdf [14] kellerman, a. & rivara, f. (2013). silencing the science on gun research. journal of the american medical association, 309(6). 549-50. pmid: 23262635 [15] branas, c. et al. (2009). investigating the link between gun possession and gun assault. american journal of public health, 99(11). 2034-2040. doi: 10.2105/ajph.2008.143099 [16] stobbe, m. (11 oct. 2015). “basic gun violence research is seriously underfunded.” the huffington post. [17] mayors against illegal guns. (2013). access denied: how the gun lobby is depriving police, policy makers, and the public of the data we need to prevent gun violence. retrieved from: http://everytownresearch.org/documents/2015/04/access-denied.pdf [18] stein, s. (06 oct. 2015). “the congressman who restricted gun violence research has regrets.” the huffington post. [19] follman, m, lurie, j., lee, j. & west, j. (may 2015). “what does gun violence really cost?” mother jones. [20] rights. stanford encyclopedia of philosophy. retrieved from: http://plato.stanford.edu/entries/rights/ [21] wheeler iii, s. (1997). self-defense: rights and coerced risk-acceptance. public affairs quarterly, 11(4), 431-443. [22] lafollette, h. (2000). gun control. ethics, 110(2). doi: 10.1086/233269 [23] barry, c., mcginty, e. & webster, d. (2013). after newtown—public opinion on gun policy and mental illness. new england journal of medicine, 368(12). 1077-81. doi: 10.1056/nejmp1300512 [24] barry, c., mcginty, vernick, j. & webster, d. (2015). two years after newtown—public opinion on gun policy revisited. preventive medicine, 79. 55-8. doi: 10.1016/j.ypmed.2015.05.007 [25] johns hopkins center for gun policy and research. (03 jun. 2015). “large majority of americans – including gun owners – support stronger gun safety policies.” johns hopkins bloomberg school of public health. [26] ropeik, d. (09 dec. 2015). “the secret weapon gun control advocates should use: antonin scalia.” the huffington post. [27] parsons, c. & johnson, a. (2014). young guns: how gun violence is devastating the millennial generation. center of american progress. [28] nhtsa budget information. national highway traffic safety administration. retrieved from: http://www.nhtsa.gov/laws+&+regulations/nhtsa+budget+information [29] fatality analysis reporting system (fars) encyclopedia. national highway traffic safety administration. retrieved from: http://www-fars.nhtsa.dot.gov/main/index.aspx [30] fact #617: april 5, 2010 changes in vehicles per capita around the world. office of energy efficiency https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref12 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref13 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref14 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref15 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref16 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref17 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref18 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref19 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref20 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref21 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref22 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref23 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref24 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref25 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref26 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref27 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref28 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref29 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref30 aurora and jones, a new year, a new perspective, voices in bioethics, vol. 2 (2016) 6 & renewable energy. retrieved from: http://energy.gov/eere/vehicles/fact-617-april-5-2010-changesvehicles-capita-around-world [31] cohen, a. & einav, l. (2001). the effects of mandatory seat belt laws on driving behavior and traffic fatalities. the center for law, economics, and business, harvard law school. retrieved from: http://www.law.harvard.edu/programs/olin_center/papers/pdf/341.pdf [32] slutkin, g. (apr. 2013). “let’s treat violence like a contagious disease.” tedmed 2013. retrieved from: https://www.ted.com/talks/gary_slutkin_let_s_treat_violence_like_a_contagious_disease?language=en [33] the cure violence health model. cure violence. retrieved from: http://cureviolence.org/themodel/essential-elements/ [34] webster, d., whitehill, j., vernick, j. & parker, e. (2012). evaluation of baltimore’s safe streets program: effects on attitudes, participants’ experiences, and gun violence. johns hopkins bloomberg school of public health. [35] cure violence results from around the world. cure violence. retrieved from: http://cureviolence.org/results/recent-successes/ [36] dennis, b. 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[39] gun violence archive 2016. gun violence archive. retrieved from: http://www.gunviolencearchive.org/ https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref31 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref32 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref33 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref34 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref35 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref36 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref37 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref38 https://michael-reaves-bkln.squarespace.com/opeds/2016/01/29/a-new-year-a-new-perspective-reframing-the-national-dialogue-on-gun-control-and-gun-violence-research#_ednref39 foe, end-of-life discussion, voices in bioethics, vol. 1 (2014-15) * gabriella foe, ms bioethics © 2014 foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use , distribution, and reproduction, provided the original author and source are credited. end-of-life discussion: what are the roles of physicians, governments, and patients? gabriella foe* keywords: bioethics, end-of-life, right to choose, ethics, euthanasia, assisted suicide introduction the discussion around end-of-life issues largely centers on the right of the patient to choose (to refuse life sustaining treatment, or, in some cases, to end his or her life through physician assisted suicide or euthanasia where it has been legalized) or to preserve life through invasive treatment. patients and physicians may have their own opinions on the matter, but their decisions are limited by the government and the law. the british medical journal (bmj) recently argued for the legalization of assisted suicide because the ability of a patient to choice is paramount; the editors stated that this was “a matter for parliament, not doctors to decide.” but do doctors have a say at all, considering they will be the ones who will have to perform the act and take responsibility for their actions? the british medical association, royal college of physicians and royal college of gps all oppose assisted suicide and polls show that most doctors share the same view, daily mail reports. ____________________________________________________________ foe, end-of-life discussion, voices in bioethics, vol. 1 (2014-15) 2 analysis while we worry whether patients will be coerced into choosing physician assisted suicide or euthanasia where it has been legalized, we rarely discuss the moral distress that physicians may feel when they are required to actively assist patients in dying. it is true that patients may have a right to exercise choice regarding their own lives, but should it not be limited by the right that physicians have to refuse to participate when it is morally distressing to them? if assisted suicide is legalized in the uk, all physicians will be trained to assist patients in dying. conclusion there is danger in going too far with the notion of patient autonomy. this is not only true for one end of the spectrum—when patients ask for assistance in dying—but also for the other extreme—when patients or their families ask for life sustaining treatment that serve only to delay death. it seems that as we start to request certain procedures on the grounds of patient autonomy, physicians and health care providers will be viewed as service providers. as a result, healthcare may begin to be reduced to mere business transaction. gabriella foe, one step closer to gattaca, voices in bioethics, 2013 © 2013 gabriella foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. one step closer to gattaca? gabriella foe keywords: gene, society, child, dna, genetic screening, mit what if you could know the complete genetic make-up of your child before he or she is born? with the ability to sequence prenatal dna, this is no longer a “what if” question. in the m.i.t technology review, antonio regalado reported that “sequencing the dna in the blood of a pregnant woman could reveal the full genetic code of the fetus.” but this innovation poses some ethical concerns. does our genetic make-up define us? there is risk of discrimination towards the fetus. this latest technology will shed li ght on whether the infant will be born with birth defects or other disabilities, be at risk of certain diseases later in life, and have certain physical characteristics. regalado reports that at present, about 65% of us women choose abortion after finding out that their child will be born with down syndrome. it is possible that the availability of this service will cause some form of eugenics, where a woman will carry her baby to term only if the baby has desirable characteristics. what criteria would a baby have to fulfill in order to be accepted into our society? the thought that we would stifle any child’s potential to do great self and social good simply because of his or her genetic make-up is frightening. this is true especially when we consider how many diseases are determined by factors other than our genes, or how many come into effect later in life, after humans are known to be “most productive” and contribute to society. another question to consider is whether we adequately understand the information from our genes. parts of our genes are known to have direct link to genetic disorders, others are still being debated. some diseases are actionable, others are not. depending on what diseases would be revealed after screening, families might incur additional unforeseen burdens. is there a benefit of sequencing prenatal dna from the fetus’ point of view? regaldo argues that “while adults can decide whether to undergo genome sequencing, an unborn child can’t consent to knowing its genes”, and the consequence of this procedure could adversely affect the child’s entire life. common congenital diseases (such as cystic fibrosis and beta-thalassemia) are caused when a child inherits two defective versions of a gene, one from each parent. in cases like this, it w ould be better if both parental dna were sequenced to determine the probability of the disease affecting the child. the burden of dealing with that probability should be something parents are willing to take when having a child, but, at times, this does not seem to be the case. the issue at hand seems to be the amount of control parents should have over the genetic outcome of their children. is this similar to our attitudes toward ordering a certain marketing product, expecting it to come in perfect condition and working order? gabriella foe, one step closer to gattaca,, voices in bioethics, 2013 2 “prenatal dna sequencing” by antonio regalado april 23, 2013. m.i.t. technology review. http://www.technologyreview.com/featuredstory/513691/prenatal-dna-sequencing/ http://www.technologyreview.com/featuredstory/513691/prenatal-dna-sequencing/ ducar, the social responsibility of a social network, voices in bioethics, vol. 1 (2014-15) © 2014 dallas m. ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the social responsibility of a social network dallas m. ducar facebook, social network, social responsibility you may have participated in a published research study without even knowing it. in 2012, facebook ran an experiment on almost 700,000 users wherein their emotions were manipulated without the participants knowing they enrolled in the study. after the paper was published, many users inquired as to when they gave consent to participate in the study. facebook, like many other online companies, obtains legal consent through their terms of service. according to facebook’s data use policy, “we may use the information we receive about you ... for internal operations, including troubleshooting, data analysis, testing, research, and service improvement.” therefore, any of the participants involved in this study legally consented to having their data used for research purposes. but was this consent informed? the federal policy for the protection of human subjects, also known as the common rule requires informed consent to involve an explanation of the research and any procedures that may be experimental, foreseeable risks, contact information for debriefing and possible injury, and a statement, which explicitly states that participation is voluntary. facebook’s data use policy is far from the common rule. however, the common rule only applies to federally funded research, which should make facebook exempt. however, facebook was not the only institution responsible for this study. jamie guillory from the university of california, san francisco (ucsf) and jeffery hancock from cornell university were both co-authors on the study. both ucsf and cornell receive federal funding and therefore the study requires informed consent, voluntary participation, and debriefing. participants were not debriefed by the researchers and instead, facebook news feeds were simply returned to their original algorithms. it is possible that some participants could have been exposed to potential harms in this study. the potential risks were unknown and the researchers have no knowledge as to whether individuals were harmed. moreover, the impact of potential harms remains unknown and it may be possible that these harms are still ongoing. the lack of debriefing on behalf of the researchers may have exposed participants to continuing damages. it would have been more prudent for the researchers to inform participants of their involvement after the study was concluded, yet this was never done. ducar, the social responsibility of a social network, voices in bioethics, vol. 1 (2014-15) 2 one may call into question the level of harm involved in this study, could it really have caused long-lasting damage? it is important not to exaggerate the harm committed, but rather to elucidate that damage that could have been inflicted. the level of risk is not what is at stake here, but rather that the researchers exposed individuals to risk without informed consent. this was an experimental study, not an observational study, as it manipulated the newsfeeds (and as a result, emotions) of the unwitting participants. the common rule allows for the waiver of informed consent for research that poses “minimal risk” to participants. however, it seems that this study could not have been carried out without a waiver of informed consent. the researchers may argue that asking for informed consent before the study would have muddled with the results. another option could then be to ask users to opt-in to the possibility of being included in a research study once every couple months. users could receive compensation, such as removal of advertisements or more customizable features, for agreeing to participate in the research. whatever the solution may be, this study clearly highlights the privilege and power facebook and other similar companies have. with such influence, it is necessary to investigate what responsibility, if any, the technology sector has to society. large corporations such as walmart have been criticized for lack of corporate social responsibility; perhaps it is time to turn the lens towards silicon valley as well. the standards of social responsibility must be raised for companies like facebook that affect our daily lives. dallas ducar, the sin and guilt of inaction, voices in bioethics, vol.1, 2014-2015 © 2014 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the sin and guilt of inaction dallas ducar keywords: individual, society, bioethics, utalitarianism there is significant tension between the value of the individual and society within clinical research. while various deontological theories have argued for the necessity of informed consent, these theories have been repudiated by consequentialism. it is my position that neither deontological nor consequentialist theories are entirely erroneous. while investigating both sides, i will highlight the necessary requirements for ethical research as i examine the claims put forth by deontological and consequentialist theorists. i will first critique the arguments of two deontologists, alan donagan and hans jonas and then offer an argument for the necessity of informed consent, while borrowing from leon eisenberg and rule utilitarian theory. both donagan and jonas argue for the necessity of informed consent. they defend the inviolability of individual agency and claim that any research done without consent, regardless of the outcome, would be coercive or deceptive. however, the authors disagree about the requirements for informed consent. donagan argues that informed consent is sufficient, while jonas pushes further. jonas emphasizes the participants’ ‘thinghood’ (i.e., an existence that is separate from the intended purpose) and claims that consent is not sufficient for ethical research; voluntary willingness is required.[1] before analyzing jonas’s claim that voluntary willingness is required for ethical research, i will first examine the issue of informed consent. informed consent requires both that instructive and accessible information is provided to participants and that they comprehend it. informed consent is necessary for medical research for reasons highlighted by donagan.[2] first and foremost, the physicianpatient relationship rests upon informed consent. without transparency, there can be minimal trust. if informed consent is mandated, then the fundamental rights of the patient are secured along with trust. additionally, the patient is assured the opportunity to decline to participate in an informed manner, rather than relying on a possibly biased researcher. according to donagan, comprehension, assessment, and written consent must be obtained to guarantee that ethical informed consent has been secured for clinical research. the field of bioethics was born of scandal and tragedy. early clinical trials required minimal to no consent; when there was consent, it was often uninformed. trials such as those in tuskegee, which were conducted without any informed consent, engendered an ethos of mistrust in the american research community. although many regulations such as the nuremburg code were drafted after this, regulation overall remained sparse. in 1966, henry k. beecher wrote about the lack of informed consent in clinical trials and noted 22 examples of unethical practice out of a sampling of 100. throughout the latter half of the 20th century, concern was directed at the amount and quality of information being supplied for those consenting in trials. research conducted abroad in developing nations was heavily scrutinized and many proposed that consent being attained from participants was uninformed. critics claimed that the lack of knowledge regarding western clinical trials and the duty the researcher had to the study (over the individual’s healthcare) consequently misled participants about what type of care they were receiving. while some critics desired increased regulation, others demanded recruitment from highly able and educated populations. while informed consent is necessary for ethical research, recruitment of highly able and educated volunteers may prove to be a significant hindrance to it. jonas argues that when a researcher recruits participants for a study, he should search for subjects with whom a “maximum of identification, understanding and spontaneity can be expected.”[3] in typical deontological fashion, jonas argues for the supremacy of the will and claims that a motivated and educated volunteer will ensure that his service is not https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn1 https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn2 https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn3 dallas ducar , the sin and guilt of inaction, voices in bioethics, vol.1,2014-15 2 only permitted, but willed. jonas calls this method of recruitment the “descending order of preference” and notes that it is an “inversion of normal market behavior.”[4] yet it is hardly believable that researchers would seek out the less-available and morevaluable participants, especially when funding is low. jonas’s only reply to cases involving recruitment from the less-valuable and highly available populations is that the researcher must “sin and fall into guilt.” granting that jonas’s method of recruitment is correct, and setting aside initial pragmatic concerns about his model, there are still concerns about the idiosyncratic selection of participants and the effectiveness of research. as louis lasagna writes, in an experiment in which postpartum patients, experiencing pain, were approached for a study, 80 percent to 85 percent of the patients refused to participate despite a minimal risk of harm.[5] utilizing jonas’s volunteer-based requirements for informed consent could cause patient populations to be highly idiosyncratic, possibly damaging results. if a researcher is drawing his pool of participants from the most valuable and scarcest, then the sampling of the population would most likely be of a certain demographic, thereby skewing results. although the efficacy of an intervention may be shown to be high in the test group, translating these results from a specific population to a worldwide demographic will most likely be difficult, and the intervention will have a decreased probability of effectiveness. in addition to potentially biasing results, jonas’s descending order of preference could create problems for research in developing nations. if only the scarce and valuable participants are allowed to participate, then participant pools will consist primarily of participants in developed nations. a variant of the rrv-tv vaccine was recently tested in the united states and demonstrated 49 percent to 68 percent efficacy in preventing diarrhea and 90 percent efficacy in preventing severe cases of diarrhea. however, it was quickly taken off the market, as it was shown to lead to intussusception.[6] in some developing nations, one in 200 children die annually from rotavirus.[7] does one halt all randomized controlled trials of the vaccine if it is effective for those developed nations but risks intussusception? in cases similar to the rrv-tv vaccine case, the risk-benefit ratio may be seen as unethical in a developed nation while less dubious in a developing nation. if the risk-benefit ratio is deemed too harmful, then the research may never be performed, and many may die without the hope of research. jonas’s order of preference would not only create discrepancies in effectiveness of research (due to creating a biased sample); it would also limit the potential benefits of research. flaws are present not only in jonas’s framework but in donagan’s as well. donagan argues for the necessity of informed consent, but his methodology assumes a deontological moral theory, which i do not believe is necessary. donagan provides no compelling reason why we should use a deontological theory, instead of consequentialism. the same protection of patient rights can be guaranteed using alternative theoretical approaches. employing rule-utilitarian theory, a form of consequentialism, one can come to the conclusion that informed consent is necessary. supporters of rule-utilitarian individualism claim that research participants are the best judges of their own selves and interest. evidence for this is provided by john stuart mill, who writes, “over himself, over his own body and mind, the individual is sovereign.”[8] adapting this version of rule-utilitarianism ensures the most beneficial consequences for the greatest number of people, while respecting the individual. individual-centered rule-utilitarianism maximizes the summum bonum, the highest good. with individual-centered rule-utilitarianism, society can be at ease, patients can be protected from abuse, and the individual’s choice remains paramount. my position is in line with this rule-utilitarian theory. according to contemporary principalist concerns in bioethics, one must respect the individual while also promoting beneficent consequences. adopting this position orients one to help the greatest number of people while still respecting the autonomy of the participant. the consent process can be undergone in a variety of ways, but the experimenter must ensure that it is instructive, accessible, and comprehensible. the rule-utilitarian framework allows clinical trials such as those in the aforementioned rrv-tv case to proceed in populations where interventions are desperately needed and clinical care is dangerously low. the consequences of this rule-utilitarian framework are that research is https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn4 https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn5 https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn6 https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn7 https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn8 dallas ducar , the sin and guilt of inaction, voices in bioethics, vol.1,2014-15 3 devoted to populations in dire need without risk of coercion or compulsion. the goal of research is to yield new, generalizable knowledge. with a rule-utilitarian framework, results can benefit indigent populations while ensuring that tragedies such as tuskegee never occur again. this rule-utilitarian framework has the capability to help millions of disadvantaged humans. jonas’s model, on the other hand, cannot work in an international context. drawing from solely educated and volunteer-based populations limits the amount of research, and thereby meaningful knowledge, that can be produced. the consequences of jonas’s model would be research confined specifically to smaller, more affluent populations. restricting research to these populations could easily cause mor e research to be focused on chronic conditions found in developed nations rather than lifesaving treatments in developing nations. the rule-utilitarian framework avoids this misstep and favors helping those who need it the most, while still ensuring that each autonomous agent is consenting and is informed. upon adopting this rule-utilitarian theory, deontologists such as jonas may still be wary of recruitment. jonas claims that if a researcher recruits from the less-valuable and highly available populations, then that researcher must grapple with sin and guilt. jonas may believe that researchers may sin and fall into guilt during recruitment, yet it is more likely that sin and guilt will be created through inaction. inaction is a form of action; this is especially true when the resources to maximize health benefits and research are available. eisenberg makes a strong case for directing medical research resources to the needs of the developing world, where infant mortality may reach 20 percent and life expectancy is limited to 30 years.[9] it is clear that there is a moral justification for developed nations to focus on research that will prevent such horrific disease and death. contagion knows no political bounds and neither should advances in medical research. jonas constrains his view to what a society can and cannot afford; however, once we expand our view to encompass the global community, it becomes clear that we cannot afford such death and disease. if there were a deadly ailment afflicting large populations of children in a developed neighborhood, research would begin immediately to eliminate the disease. why hesitate when funding research that is beyond our local neighborhoods, in more remote, less developed nations? i see no moral difference, only a spatial difference. despite distance, if it is possible to dedicate research to share in the freedom from death and pain, then it is justified that we do so. if one is more concerned with recruitment of lives than saving them, then perhaps this person too wil l experience graver sin and fall deeper into guilt. instead of standing idly in the face of death, we can choose to act, while still protecting the individual. 1. jonas, hans, “philosophical reflections on experimenting with human subjects,” daedalus 98, no. 2 (1969): 219-247. 2. donagan, alan. “informed consent to experimentation.” ethical issues in modern medicine. mountain view: mayfield publishing co 525 (1995): 531. 3. crouch, robert a., john d. arras, jonathan d. moreno, and christine grady, ethical and regulatory aspects of clinical research: readings and commentary. (baltimore, md: johns hopkins university press, 2003), 159. 4. ibid, 160. 5. lasagna, louis, “some ethical problems in clinical investigation,” human aspects of biomedical innovation, eds. e. mendehlsohn, jp swazey and i. taviss,(cambridge, ma.: harvard university press, 1971), 105, 48. 6. emanuel, ezekiel j., david wendler, and christine grady. “what makes clinical research ethical?.” jama: the journal of the american medical association 283, no. 20 (2000): 2701-2711. 7. ibid, 2709. 8. mill, john stuart, on liberty, (broadview press, 1999), 135. 9. eisenberg, leon, “the social imperatives of medical research,” science 198, no. 4322 (1977): 1109. https://michael-reaves-bkln.squarespace.com/opeds/2014/03/26/sin-guilt-inaction#_ftn9 hiller, confidentiality and cost, voices in bioethics, vol. 1 (2014-15) © 2015 kaitlynd heller. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. confidentiality and cost: barriers to adolescent contraception kaitlynd hiller bioethics, pregnancy, contraception introduction in late september, the american academy of pediatrics published an article updating their 2007 recommendations regarding adolescent contraception. the article calls on pediatricians to educate adolescents who choose to engage in sexual activity on a wide variety of contraceptive options (emphasizing abstinence), and highlights long-acting reversible contraceptives (larc) as the first line of contraceptives for teenagers.1 this recommendation comes after the 2012 publication from the american college of obstetricians and gynecologists heralding larc methods to be the easiest, safest, and most effective way to prevent unwanted pregnancy. analysis approximately 50% (or 3 million) pregnancies are unintended in the united states each year,2 which can result in serious physical and mental health challenges, especially for adolescents. sexually active teens are more than twice as likely to experience unintended pregnancy than other women.3 targeted research regarding how teenagers use contraception has helped to shed light on the possible reasons for highunintended pregnancy rates, as well as what methods are more effective than others for preventing this. the most prevalent form of contraception used by youth is the male condom. this is due to the relative ease of access and use, with no prescription required and a low up-front cost. when used perfectly the failure rate of a male condom is 2%, however in actual practice this increases to 18%. combined oral contraceptives (cocs) are the most common hormone-based contraceptive method used by teens, with a typical use failure rate of 9%. although the article stressed the use of condoms for every sexual encounter to reduce the spread of sexually transmitted disease, the american academy of pediatrics (aap) recommends neither barrier contraception nor cocs as the first line birth control method for adolescents. instead, they urge pediatricians to counsel adolescents about birth control starting with the most efficient contraceptives—larc methods—first, in the hopes that more teens will opt for this type of contraception. there are three larc methods which are available in the us. two types of intra-uterine devices (iuds), and one progestin implant. matchstick-sized subdermal progestin implants are the most effective, with a failure rate of less than 1% and lasting up to 3 years. iuds inserted into the uterus can act through chemical or hormonal means to prevent pregnancy and can last 3-10 years, depending on the type selected. in all studies, larc methods outperform other types of contraception. since the administration of such methods is done by a physician, the perfect usage and typical usage failure rates are the same: around 0.2% for iuds and 0.05% for progesterone implants. these methods require minimal compliance, making them the easiest and most reliable for teens to use. although abstinence is to be encouraged as the best form of birth control and sti protection, the aap also acknowledges that pediatricians should not rely on it as adherence rates are low. the same applies to condoms as birth control, for their regular usage is known to drop off over time due hiller, confidentiality and cost, voices in bioethics, vol. 1 (2014-15) 2 to low compliance. however, their use is still stressed in order to protect from stis. so if the top-tier effectiveness of larc methods has been known for some time, why is their use not more prevalent among women in the us? there are some barriers to teens choosing and receiving larc methods that have been discussed in research (recent history of unsafe iuds, lack of education on options, etc.),4 however the greatest ones that have emerged are cost and confidentiality. the aap the importance of pediatricians to be sensitive to the confidentiality of teens seeking counsel for contraception, as they may face negative stigmatization from their family, friends, or community. and since different states have different laws surrounding the rights of minors to confidentiality, physicians also need to be aware of how to address the situation of sexual history taking and contraceptive choice. currently, 21 states and the district of columbia allow all minors to consent to contraceptive services while 25 states permit minors to consent in special circumstances (including married minors and those already pregnant). 4 states have no explicit policy on minors consent to contraceptives as of yet.5 iuds and implants are more cost-effective than other methods in the long run, but they do incur a large out-of-pocket amount up front for the device and implantation. if adolescents don’t have the monetary resources they may have to go through their parents’ insurance—losing confidentiality in their care. the contraceptive choice project gave a picture of what it might look like to have those barriers removed when their study offered free contraception to 9,245 adolescents and women in the st. louis region. after educating them on all fda-approved options and highlighting the safety and effectiveness of larc methods, each woman chose which method she would like to receive, being free to switch methods at any time during the study. the project found that when cost as a barrier was removed, the pregnancy rate in those aged 1519 dropped significantly,6 adding tangible evidence to support the institute of medicine’s recommendation that a fuller range of contraception methods and counseling be provided at no cost under the affordable care act. indeed, under this law many private insurance plans are beginning to provide birth control without co-pays or deductibles, making it more affordable to gain access to a wide range of contraceptive methods.7 if a minor is not covered under private insurance, teens may seek services through federally funded family planning centers such as title x without parental consent.8 conclusion taking steps to ensure that teens can gain access to the most effective contraceptive methods freely and without stigma is imperative. the aap article echoes this in their recommendations for pediatricians to be aware of state or federally subsidized programs that provide confidential and free or affordable reproductive health and contraceptive services. with the comparative effectiveness of larc being known for adolescents, it is more ethical for healthcare providers to make sure that individuals are aware of the best contraceptive options available, rather than relying on traditional methods (abstinence, condoms, cocs) which are known to have higher failure rates. unintended pregnancy can negatively affect individuals as well as society at large, and if pediatricians adhere to the aap’s policy statement there could be real strides taken to minimize those instances. 1 committee on adolescence. “contraception for adolescents. pediatrics. 2014; 134(4): e1244-e1256. hiller, confidentiality and cost, voices in bioethics, vol. 1 (2014-15) 3 2 brooke winner, et al., “effectiveness of long-acting reversible contraception,” new england journal of medicine 366 (2012). page numbers? 3 “unintended pregnancy in the united states,” guttmacher institute, accessed october 14, 2014, http://www.guttmacher.org/pubs/fb-unintended-pregnancy-us.html#10. 4 amy k. whitaker, et al., “adolescent and young adult women’s knowledge of and attitudes toward the intrauterine device.” contraception 78:3 (2008). 5 “state policies in brief (minors’ access to contraceptive services),” guttmacher institute, accessed october 1, 2014, http://www.guttmacher.org/sections/by-type.php?type=spib 6 jeffrey f. peipert, et al., “preventing unintended pregnancies by providing no-cost contraception.” obstetrics & gynecology 120:6 (2012). 7 “the affordable care act,” planned parenthood, accessed september 26, 2014, http://www.plannedparenthood.org/about-us/newsroom/the-affordable-care-act 8 “title x family planning,” us department of health and human services, accessed september 30, 2014, http://www.hhs.gov/opa/title-x-family-planning/ http://www.guttmacher.org/sections/by-type.php?type=spib dias, dignity after death, voices in bioethics, vol. 1 (2014-15) © 2015 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. dignity after death & protecting the sanctity of human remains matt dias keywords: ethics, philosophy, morality, bioethics introduction moral and philosophical conceptions of dignity hold that a human being is entitled to receive ethical treatment, and to be respected and valued in all phases of life and even through death. notwithstanding this truism, a single, agreed-upon definition of human dignity in the scientific and legal contexts is difficult to achieve due to societal complexities and traditions associated with various cultures and practices. many scholars and healthcare professionals support the notion that all individuals have a right to die with dignity— and that all people should be allowed to die comfortably and naturally and, to the extent possible and in compliance with applicable laws, have their final wishes honored and protected. but1 it is less evident whether and to what extent the concept of dignity should be applied or extended to the remains of deceased individuals and even their next of kin. in recent history, several notable events have called into question the treatment of human remains. a review of these circumstances bears scrutiny on the dilemma, signaling that dignity—and perhaps even a strengthened legal protection of some kind—should extend to the remains of the deceased.2 analysis in the united states, some laws do recognize and protect the interests or dignity of the deceased. for instance, physicians are required to obtain consent from the deceased’s next of kin before using a cadaver to instruct medical students, though whether to notify the next of kin first has been a topic of ethical and legal debate.3 on the federal level, the native american graves protection and repatriation act of 1990 (i) requires federal agencies to return native american human remains to lineal descendants and culturally affiliated indian tribes and (ii) provides greater protection for native american burial sites as well as more careful control over the removal of native american human remains.4 furthermore, a number of statutes exist to penalize the desecration of grave sites, but criminal tampering with human remains—e.g., grave robbing and defilement of interment spaces—remains fairly common. just this month, a casket with human remains was dumped onto a street in brooklyn, new york; and several vaults were vandalized in a historic cemetery in new orleans.5 according to the international cemetery, cremation, and funeral association, no cemeteries are immune to vandalism and serious acts of desecration, since many states have virtually no statutory provisions addressing cemetery vandalism or desecration. m6ost states do, however, have regulations that explicitly prohibit the unlawful disturbance, removal, or sale of human remains—but what happens when the sanctity dias, dignity after death, voices in bioethics, vol. 1 (2014-15) 2 of human remains is potentially compromised beyond this criminal context? are the current laws sufficient in protecting the dignity of the deceased? a controversy of this nature surfaced in 1995, when european anatomist gunther von hagens premiered body worlds—the original exhibitions of real human bodies. in body worlds, von hagens gathered and plastinated real human bodies to make them more malleable and prevent their decay. some of the bodies’ inner organs were exposed and then positioned in playful, lifelike poses. while supporters of the exhibit recognized its potential educational value—including the moral and ontological standing of plastinates—critics vocalized that the display fell short of respecting the dignity of human remains. for instance, bioethicist lawrence burns noted that “some aspects of the exhibit violate[d] human dignity,” and medical ethicist carol taylor remarked, “my major objection stems from the belief that there’s an innate dignity to humans that extends to our bodies.”7 other criticisms indicated that the bodies were denied a proper burial and did not give consent to be on public display.8 the exhibit has toured europe, africa, asia, and even america—though it did not enter the united states until 2004, after an ethics advisory committee of the california science center addressed the exhibit’s ethical issues and mandated that domestic displays require consent of the bodies.9 more recently—this month—a cemetery in sacramento, california, informed a woman that her son’s buried remains must be moved to another location. in 2014, april robinson’s son, maurice, passed away, and his cremated remains were buried near a small tree at st. mary’s catholic cemetery & mausoleum. even though it has been a year since the burial, cemetery officials just realized that they assigned maurice to the wrong location and indicated that the remains must be dug up and relocated, since another family owns the plot. trying to protect her son’s remains, robinson believes that maurice’s burial plot is sacred and should not be touched. while it is uncertain when st. mary’s plans to move maurice’s remains, robinson plans to take legal action to prevent the move from occurring.10 though california health & safety code (7052(a)) provides that the unlawful disinterment of human remains is a felony, there are no existing provisions addressing cemeterial mistakes that potentially endanger the sanctity of human remains.11 conclusion theories of human dignity ought to consider the value and inviolability of a human being after personhood. without these proper considerations, ethical treatment of the deceased may be jeopardized. additionally, stories like the robinsons’, coupled with the trajectory of case law, should help to promote further dialogue and protections concerning the treatment of human remains. 1 guo, qiaohong and cynthia s. jacelon, “an integrative review of dignity in end-of-life care.” palliative medicine 28, no. 7 (2014): 931–940. doi: 10.1177/0269216314528399. 2 a distinction between skeletal/corporeal and ash residue/cremated human remains is recognized but not discussed for the purpose of this article 3 moore, gregory. “ethics seminars: the practice of medical procedures on newly dead patients—is consent warranted?” academic emergency medicine 8, no. 4 (2001): 389–92. 4 mcmanamon, francis. “the native american graves protection and repatriation act (nagpra).” national parks service archeology program, 2000, www.nps.gov/archeology/tools/laws/nagpra.htm. http://www.nps.gov/archeology/tools/laws/nagpra.htm dias, dignity after death, voices in bioethics, vol. 1 (2014-15) 3 5 see sheldon dutes, “decades-old casket dug up, mysteriously dumped on brooklyn street with human bones inside: officials,” nbc new york, may 6, 2015, www.nbcnewyork.com/news/local/mystery-casket-dump-streetbrooklyn-police-investigation-bushwick-evergreens-302774351.html and matt sledge, “vaults broken into, remains exposed at resting ground of historic benevolent society,” the new orleans advocate, may 12, 2015, www.theneworleansadvocate.com/news/12322058-123/vandals-strike-lafayette-cemetery-no. 6 “desecration of a cemetery: model guidelines for state laws and regulations.” international cemetery, cremation, and funeral association (iccfa), 1998, www.iccfa.com/government-legal/modelguidelines/desecration-cemetery. 7 see catherine myser, “taking public education seriously: body worlds, the science museum, and democratizing bioethics education” and lucia m. tanassi, “responsibility and provenance of human remains” in the american journal of bioethics 7, no. 4 (2007): 34–38, doi: 10.1080/15265160701220766; lawrence burns, “gunther von hagen’s body worlds: selling beautiful education” in the american journal of bioethics 7, no. 4 (2007): 12–23; and “exploitation, art or science? popular ‘corpse exhibits’ cause controversy,” associated press/nbc health news, may 9, 2005, www.nbcnews.com/id/7723133/ns/health-health_care/t/exploitationart-orscience/#.vvxxplvik 8 y. michael brailan, “bodyworlds and the ethics of using human remains: a preliminary discussion.” bioethics 20, no. 5 (2006): 233–247. doi: 10.1111/j.1467-8519.2006.00500 9 “body worlds: an anatomical exhibition of real human bodies: summary of ethical review, 2004/2005.” california science center, 2005, www.bodyworlds.com/downloads/englisch/media/press%20kit/bw_la_summaryofethicalreview.pdf. 10 maher, jeff. “cemetery to move sacramento murder victim’s remains.” news10 sacramento, may 13, 2015, http://www.news10.net/story/news/local/sacramento/2015/05/13/cemetery-to-move-sacramento-murdervictims-remains/27220861/. 11 california health and safety code section 7050.5-7055. http://www.leginfo.ca.gov/cgibin/displaycode?section=hsc&group=07001-08000&file=7050.5-7055. http://www.nbcnewyork.com/news/local/mystery-casket-dump-street-brooklyn-police-investigation-bushwick-evergreens-302774351.html http://www.nbcnewyork.com/news/local/mystery-casket-dump-street-brooklyn-police-investigation-bushwick-evergreens-302774351.html http://www.theneworleansadvocate.com/news/12322058-123/vandals-strike-lafayette-cemetery-no http://www.theneworleansadvocate.com/news/12322058-123/vandals-strike-lafayette-cemetery-no http://www.iccfa.com/government-legal/model-guidelines/desecration-cemetery http://www.iccfa.com/government-legal/model-guidelines/desecration-cemetery http://www.nbcnews.com/id/7723133/ns/health-health_care/t/exploitationart-or-science/#.vvxxplviko http://www.nbcnews.com/id/7723133/ns/health-health_care/t/exploitationart-or-science/#.vvxxplviko http://www.bodyworlds.com/downloads/englisch/media/press%20kit/bw_la_summaryofethicalreview.pdf http://www.bodyworlds.com/downloads/englisch/media/press%20kit/bw_la_summaryofethicalreview.pdf http://www.news10.net/story/news/local/sacramento/2015/05/13/cemetery-to-move-sacramento-murder-victims-remains/27220861/ http://www.news10.net/story/news/local/sacramento/2015/05/13/cemetery-to-move-sacramento-murder-victims-remains/27220861/ http://www.news10.net/story/news/local/sacramento/2015/05/13/cemetery-to-move-sacramento-murder-victims-remains/27220861/ http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=07001-08000&file=7050.5-7055 http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=07001-08000&file=7050.5-7055 gabriella foe, biobanks and informed consent, voices in bioethics, vol.1, 2014-2015 © 2014 gabriella foe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. biobanks and informed consent gabriella foe keywords: science experiments, biobanks, blanket consent, open consent, research introduction biobanks have added complexity to the idea of informed consent, which is an important ethical component in research involving human subjects. the idea behind informed consent is that each potential participant needs to voluntarily determine whether or not to take on the risks of research in order to take part in producing the benefits. the problem arises because researchers wish to obtain consent for future unknown investigative uses of biological materials. some have argued that any such blanket consent is not truly informed. proponents of the typical informed consent document argue on the grounds of autonomy. those trying to propose the use of broader consent procedures argue from a point of view focused more on public health. this paper will explain that it is unnecessary to place biobank research within the scope of public health to ensure a desired amount of public participation; in fact, this line of argument should be discouraged. the public is willing to participate contribute to biobanks as long as they trust researchers; thus, three ways to increase trust will be proposed, along with consent procedures that will suit both the public and researchers. analysis how biobanks complicate informed consent most scientific experiments do not directly benefit participants. through informed consent documents, potential participants must weigh altruistic motives against risks of participation. biobanks have caused research in genomics to proceed with great speed and, as a result, there is hope for personalized medicine sometime in the near future.1 to work towards personalized medicine, researchers need to create gene maps.2 using genetic data along with phenotypic characteristics, environmental factors, and other determinants, researchers hope to understand the causal factors of diseases and work to prevent disease manifestation. since possible future biobank research is continually evolving and cannot be specified, researchers have questioned whether traditional informed consent can apply to this research field.3-5 biobank research takes place at the population level. and although the ultimate goal of biobank research is personalized medicine, solving public health issues is its immediate concern.13 biobank research is designed to explore the connection between genes and diseases, allowing for health services to improve. to increase the statistical power of research, it is important to include a great number of samples. thus, chances of obtaining better data increase when more participants are willing to donate genetic samples. however, study results may show why certain groups of people are more susceptible to certain diseases than others, which can lead to stigmatization and act as a deterrent to participation. some argue that informed consent regarding future use of genetic samples cannot be truly given, while others believe that disclosing current known information is adequate. failing to consent for future research and having to re-consent each time will hinder research progress by limiting the samples that researchers can use—some participants will be unable to be contacted and others will not respond. in addition, the cost and frequency of reconsenting make it unfeasible. prospective participants have also said that it would be burdensome to receive a gabriella foe, informed consent and biobanks, voices in bioethics, vol.1,2014-15 2 notice for each future study asking them to re-consent.6 for these reasons, biobanks have considered opt-out systems and different levels of opt-in procedures.2,3,7 with an opt-in procedure, the three levels include specific consent, broad or categorical consent, and blanket or open consent. different types of consent opt-out procedures have been criticized because participants are often unaware that they have been automatically included in a study. an example of an opt-out biobank research project that raised controversies is the decode project in iceland, where the government allowed decode to access the nation’s health records, with an opt-out option.8 an opt-in procedure: provides participants with more information about the study; is seen to give participants a more active control in decision-making; and is preferred. however, the opt-in system is a barrier to research progress since it will take more time for researchers to obtain the same number of samples as with an opt-out procedure. researchers recognize that challenges in acquiring the desired amount of participation will affect the statistical significance of research results.9 as a result of these concerns, researchers have proposed alternate types of opt-in consent with biobank research. specific consent is the prototypical informed consent used in other fields of research. it includes the purpose of the research, risks and benefits, procedures, and other categories that inform the potential participant of exactly how their genetic samples will be used. broad or categorical consent does not mention specific studies; rather, it allows participants to choose the different fields of studies toward which they would like their samples to contribute (e.g. diabetic research, cancer research). participants determine their participation by checking boxes beside different categories. blanket or open consent asks participants for permission to use their samples in various types of research, as the researcher sees fit. open consent gives participants the smallest amount of control over how their genetic material is used. contributing to scientific progress informed consent aims to give individuals control over what is done to their genetic material: it allows them the right to self-determination.3,10,11however, if research is to benefit society and allow scientific progress, the control that participants desire must be balanced with society’s interests; namely, that researchers need to make significant conclusions.5,12 the public cannot erect too many barriers to research and at the same time expect science to make significant progress. members of society are open to making contributions toward research. for instance, when individuals are asked the reason they contribute to biobanks, most refer to altruistic motives and a desire to benefit to the common good.3,13,14 participants recognize that they are not likely to gain any direct benefit from biobank research, but they hope that future generations will benefit. a number of studies have shown that participants who are parents and/or older in age are more likely to contribute to biobank research and prefer open consent.14,15 the public realizes that knowledge in medicine today is a result of past research contributions. thus, it can be said that through participation, individuals affirm the importance of belonging to society, and realize the necessity of mutual dependence. in order to promote the interests of the individual, the interests of society must also be promoted. improved social conditions will allow everyone to exercise a higher degree of personal autonomy. when potential participants are asked which type of consent they believe should be used in biobank research, those participating in phone surveys and focus group discussions have various opinions.6, 9, 15 most are willing to gabriella foe, informed consent and biobanks, voices in bioethics, vol.1,2014-15 3 give either broad or blanket consent.16 what matters is not the amount of information they are given but the degree of trust they have that researchers will not misuse their samples. thus, in biobank research, the idea of reconsenting will be to ensure that participants agree with the purpose of the research, instead of protecting individuals against coercion.17,18 autonomy versus solidarity researchers are working on ways to increase the number of people who are willing to contribute to biobanks by addressing public concerns, and some have tried to appeal through solidarity. while the principle of autonomy exercised through informed consent is important to the public, it is also known that solidarity motivates individuals to participate in biobank research.17 hansson refers to this as the patient-donor perspective versus the patientbeneficiary perspective.19 when the two conflict, it is logical to think that appealing to autonomy will put up a barrier to research, while appealing to solidarity will promote research. appealing mainly to solidarity entails justifying the good of biobank research from a public health perspective. furthermore, appealing to solidarity compels people to contribute to biobanks using arguments similar to those used to increase vaccination rates— which some researchers have tried to do.2,13,20 to determine the most appropriate type of consent, it must first be decided whether the public interest in scientific progress can trump the individual interest of maintaining control over the use of genetic material. since medical care today is the result of past research, there has been debate on whether individuals have a right not to participate in research: “there is a question mark over the morality of benefiting from research in general while refusing to take part in it.”19following from this, some say there may be a duty to participate in biobank research, and this duty can certainly be required by a governing body if it is determined to be a compelling public health interest. 13,20 another question which must be answered is how to determine ownership of biological material. four possibilities of ownership have been proposed: unowned, owned by humanity, owned by the person from whom it was taken, or owned by the researcher or company who transformed it into a useful commodity.19,21the legal system has held that biological material is unowned until someone makes it useful, after which it is owned by the researcher who transforms it into a useful commodity (moore v. regents of the university of california). an example would be the development of hela cells from henrietta lacks and the patenting of spleen cell lines obtained from john moore. although arguing from the public health perspective is compelling and could achieve researchers’ goals, it is unnecessary. researchers and the public are on the same side; arguing from a public health perspective will create a gap and put them on different sides. what is required are ways to produce a better relationship and increase trust between the two parties, since it is essential for the success of biobank research. the amount of trust the public places in researchers varies depending on social context and historical events that have revealed past unethical research. presently, at least part of society has remained skeptical towards science, while at the same time wanting to contribute to the greater good done through scientific research. this is one of the underlying reasons so many are willing to contribute to biobanks but want great control over what is done with their genetic material: to ensure that researchers do not intentionally harm them. it is important for the public to perceive that research institutions and researchers see their participation and contribution as a gift, and acknowledge the responsibility that it entails. many studies have reported that developing a course of action to actively promote a better relationship and build trust is of importance.1-6,9-12,14,15,18-29 before participating, participants would need reasons for trusting researchers. they would like to know that researchers will not perform research that will cause stigmatization of specific populations. in addition, they would like researchers to ensure that data are protected so that the risk of informational harm is decreased, and they would like researchers to be transparent to the public. three ways to increase trust gabriella foe, informed consent and biobanks, voices in bioethics, vol.1,2014-15 4 although most of the research about public perspective on biobanks has involved the caucasian majority population , a study found that minority groups tend to favor specific consent more.6this may be due to a lack of trust in researchers after hearing about or participating in unethical studies in the past, or because minority groups are at greater risk of stigmatization.23,30 to improve relations and increase trust, researchers should work together with small ethnic and population groups to see whether their proposed research is acceptable. the tri-council policy statement, the ethical code of conduct that is adhered to in canada, requires that researchers consult leaders of aboriginal communities or other minority groups to obtain community consent before asking for individual consent.31 other reports have also suggested this.22,32 the leader of the community will be involved in ensuring that the purpose of the research is in line with cultural beliefs, and before publication, the community leader will also read and approve the final document. adopting extra measures such as this will allow researchers to understand their culture and norms, improving the relationship between researchers and minority groups, thus fostering trust. since the genetic profile of a person may reveal individual health status and predisposition to disease, the public is afraid that by making it available to researchers, the information may fall into the wrong hands.1,22some have voiced concerns that insurance companies will gain access to genetic data, and others are worried that the information will become commodified and commercialized.1,21 since individuals voluntarily give researchers access to this information, they expect that it will be used to better society in the future, and not for commercial purposes. using materials for commercial purposes is seen as unfair because researchers will be profiting from data that was not rightly theirs, nor was given to them (i.e. it was “stolen”). therefore, as the means to ensure greater privacy of these data become available, it is only fitting for researchers to warrant that they do everything possible to ensure they are safe. from the participants’ view, researchers have been entrusted with a precious gift, so they should take great care of it and make certain that they use it responsibly. the public values transparency in research. when researchers are transparent regarding experimental procedures and how results are obtained and reported, the public can be ensured that researchers are using this “gift” responsibly and are not exploiting them.14,22 using databases, such as clinicaltrials.gov, and giving general updates online through other websites would not only improve the relationship between the public and researchers, but also ensure that the public has access to more primary scientific results.29 working with the public building a better relationship between researchers and the general public will ensure that more trust is given to researchers. if researchers are to work with the public, then public perspectives and preferences must be taken into account when it is feasible. by working together, participants will feel more comfortable approving of broad or blanket consent for biobank research. several studies have found that a great number of potential participants find it a burden to be continually contacted to participate in research when they have given previous consent on a related topic. they would rather give blanket consent provided that they trust the researchers.3,6,15 thus, an increase in trust will be beneficial to both parties. however, some would still want to maintain a certain level of control to ensure their samples do not contribute toward studies with a purpose that conflicts with their beliefs or morals.6,27 so, using blanket or open consent would not show the greatest respect for everyone’s autonomy. some have argued that having to check off numerous boxes is time-consuming when people want to get out of the doctor’s office or hospital.9,15 therefore, participants can be given the option to sign for blanket consent and the opportunity to opt-out of categories which gabriella foe, informed consent and biobanks, voices in bioethics, vol.1,2014-15 5 they may oppose. but these categories would not be listed; instead, it would be up to participants to mention it on the form. an alternative but similar idea would be to sign for blanket consent, and check if a participant would like to be re-contacted for future research with a chance to opt-out. this is less of a barrier than re-contacting for optin consent since researchers would be able to use samples unless they receive correspondence from participants. this option would also ensure that there is an on-going communication between researchers and participants, which some prefer.15 the latter procedure would put more burden on researchers than the former. however, if we hold that individuals may change their participation status, it is important to give them the means to do so. conclusion typical informed consent used in other types of research cannot be adequately applied to biobank research. as a result, researchers have proposed alternate types of consent documents that would balance the participants’ interest in upholding their autonomy with the researchers’ need to conduct research without too many barriers. different types of consent procedures include opt-in consent—ranging from specific consent to blanket consent— and opt-out consent. because the typical type of informed consent document has been critiqued as not meeting the standard, arguments have shifted to justify obtaining broader consent. this has largely been done by the appeal to the public’s altruistic motivation of donating to biobanks. when using public health arguments, researchers can justify the infringement on participants’ right to autonomy for greater social good. however, this is unnecessary since the public understands the advantages of broader consent from the researchers’ perspective, and some are already willing to hop on board. others who prefer more specific consent to maintain control over how their genetic samples are used say that it is due to their lack of trust in researchers. nevertheless, they are conflicted because they confess that continual re-consent procedures are burdensome. therefore, researchers do not need to go so far as to put biobank research in the field of public health to ensure that an adequate number of participants donate their samples. people want to participate in a way that will allow research to progress as researchers wish, but need to know that they can trust them. to build a better relationship and continue to improve trust, three things can be done: work with minority groups so results of the research will not stigmatize them, ensure that maximal protection of privacy will be given for the samples, and increase transparency in the research procedures. we can come to a result that will satisfy both parties by working together with the public. it is unnecessary to introduce public health’s ethos of the duty to participate in research for the greater good of society. this altruistic motive is already instilled in the public; stressing this duty will create a gap between researcher and the public. when approaching research from a public health perspective (for example, by stressing on the duty to participate to benefit society), we increase the authority of the researcher and diminish the importance of the public, ultimately creating a tension that will not promote trust between science and the public. gabriella foe, 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t., respecting donors to biobank research. hastings center report, 2013. 43(1): p. 41-47. 19. hansson, s.o.v.e., the ethics of biobanks. cambridge quarterly of healthcare ethics, 2004. 13(4): p. 319-26. 20. bialobrzeski, a., j. ried, and p. dabrock, differentiating and evaluating common good and public good: making implicit assumptions explicit in the contexts of consent and duty to participate. public health genomics, 2012. 15(5): p. 285-292. 21. ursin, l., privacy and property in the biobank context. hec forum, 2010. 22: p. 211-224. 22. artizzu, f., the informed consent aftermath of the genetic revolution. an italian example of implementation. medicine health care and philosophy, 2008. 11(2): p. 181-190. 23. botkin, j.r., ethics cases: informed consent for biobank-dependent research. american medical association journal o ethics, 2012. 14(8): p. 610-615. 24. andreas brekke, o. and t. sirnes, population biobanks: the ethical gravity of informed consent. biosocieties, 2006. 1(4): p. 385-398. 25. brothers, k.b., d.r. morrison, and e.w. clayton, two large-scale surveys on community attitudes toward an opt-out biobank. american journal of medical genetics part a, 2011. 155(12): p. 2982-2990. 26. cervo, s., et al., an effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank. bmc medical ethics, 2013. 14(1): p. 30. 27. gottweis, h., h. chen, and j. starkbaum, biobanks and the phantom public. human genetics, 2011. 130(3): p. 433-440. 28. gottweis, h., biobank governance in the post-genomic age.personalized medicine, 2010. 7(2): p. 187-195. 29. saha, k. and j.b. hurlbut, treat donors as partners in biobank research. nature, 2011. 478: p. 312-313. gabriella foe, informed consent and biobanks, voices in bioethics, vol.1,2014-15 8 30. elger, b.s. and a.l. caplan, consent and anonymization in research involving biobanks.european molecular biology organization reports, 2006. 7(7): p. 661-666. 31. ethics, g.o.c.p.o.r., tri-council policy statement: ethical conduct for research involving humans. 2010. 32. knoppers, b.m., biobanking: international norms. the journal of law, medicine & ethics, 2005. 33(1): p. 714. cooper, nightmare of medical tourism, voices in bioethics, (2013) © 2013 rachel cooper. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. caveat emptor does not cut it: the regulatory and philosophical nightmare of medical tourism rachel cooper keywords: medical tourism, healthcare rationing, policy introduction we live in the era of facebook, fitbit, and skype. as such, it would be unreasonable to expect that the healthcare industry would not see the same kind of globalization as do our social spheres and consumer activities. indeed, the explosion of information technology, the ease of transcontinental travel, and the emergence of a more globally aware citizenry allows for scientific collaboration that has had many positive effects on global health. however, the economic and structural disparities between systems of healthcare delivery in the industrialized world and parts of the developing world have created a monster in the form of an international medical tourism industry that endangers the health and safety of citizens of the host country as well as visiting patients. not only does the practice of medical tourism pose a practical danger to those in direct contact with the industry, but it brings up troubling philosophical problems centering on national responsibility and the commodification of healthcare, among other important issues. in the united states, the driving force behind international medical tourism is the exorbitant cost of healthcare, particularly for the uninsured but also for the underinsured and those who experience catastrophic medical expenses from chronic illness or sudden health crises. not only have individuals begun to look outside the u.s. for surgical procedures and other expensive therapies, but employers have begun to toy with the idea of outsourcing the medical care of the employees they insure in order to cut costs. analysis in other industrialized nations, the issues that underpin international medical tourism are related to healthcare rationing and reflect different shortcomings in the delivery of healthcare in those nations, such as the united kingdom and canada, that have single-payer systems. yet the regulatory and philosophical implications for both patients and hosts of international healthcare are largely the same. the challenge of regulating international trade in medical care is obvious and becomes particularly acute when there are insurers and employers involved. complicating matters further, medical care that takes place outside the country of origin of the patient is often brokered by “medical concierge services,” which, though quick to claim indemnity from any harm arising from substandard or inappropriate medical care, cannot be divorced from responsibility for the health outcomes of their clients. agreements hashed out between concierge services and patients specify that any remedy for harm stemming from their medical care must be pursued within the confines of the law of the host country, but the practical implications of this are troublesome. how can a foreign patient—often without either linguistic or cultural competency in the host country—be expected to navigate the complexity of a foreign legal system, particularly one that may be far less developed than (or at least largely incongruent with the values of) his home country? furthermore, if insurance companies and employers are involved with such care, who pays for an adverse result or determines responsibility for harm that may befall the patient? under which countries’ laws? if a patient travel to cooper, nightmare of medical tourism, voices in bioethics, (2013) 2 singapore for sexual reassignment surgery or a cardiac valve repair, returns to the states and suffers complications, who pays for the restoration of her health? beyond legal standards and judicial remedies for harm to patients seeking care on the international market, there is the question of what ethical standards and norms apply to such patients. what effect does it have on american patients, for example, to receive care within a system that does not emphasize autonomy and informed consent the way they are used to? why should foreign physicians care about the cultural mores of their patients’ country of origin? can they (or should they) be expected to grasp cultural differences between american, canadian, and british patients? the medical concierge might respond, “well, buyer beware!” this is unreasonable: it is nearly impossible for any patient to accurately assess the various options, risks and benefits that go with a particular medical treatment, much less the patient who is attempting to do so on the international market. and the crass invocation of the doctrine of caveat emptor betrays a view of healthcare as a commodity that is naive and inappropriate. paramount in my mind, however, are the practical implications for the care of the citizens of developing nations that host international patients and the broader philosophical issue of what the goals of the medical profession as a whole and each country’s individual healthcare system should be. while i understand the argument that international medical tourism creates great economic gains for developing nations, which can then be channeled toward the care of their citizenry as a whole, there is much reason to doubt that this “trickle-down” model of economics provides real benefits for underserved, whether in healthcare or other arenas. what is more likely is that, while lucrative international “medi-cities” may keep bright doctors in their home countries, it is also likely to lure them away from the institutions that serve the lion’s share of their countrymen. with the concentration of talented native doctors in private hospitals that serve citizens of the developed world, the population at large is left to obtain care at institutions that suffer “brain drain” from the flight of talented local staff to more prestigious, often “brand name,” institutions that give them more western-like salaries while allowing them to practice in their countries of origin. conclusion the very fact that citizens of the wealthiest nations in the world are forced to go abroad for life -saving care speaks to an abdication of national responsibility on the part of their home countries. the provision of health care is one of the principal responsibilities of any nation and it is unacceptable that a nation with the strength and wealth of the united states would take advantage of the weaker political and economic situations of developing nations in order to shirk its responsibility to its fellow citizens. if we take care of our countrymen and take pride in an equitable system of healthcare delivery, there will be no need to shrug our shoulders and say “buyer beware” to the patient who heads to the philippines for heart surgery. introduction analysis conclusion preston, gillian bennett & physician-assisted suicide, voices in bioethics, vol. 1 (2014-15) © 2015 joshua preston. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. gillian bennett & physician-assisted suicide joshua preston death with dignity, gillian bennett, newswire, pas, physician-assisted suicide introduction “i want out before the day when i can no longer assess my situation,” wrote gillian bennett, a vancouver woman, in an open letter to be published after her death. “[i] will be physically alive but there will be no one inside.” addressing the dementia she had been living with for three years: “[m]uch faster now, i am turning into a vegetable … dementia gives no quarter and admits no bargaining.” so, dragging a mattress to her favorite spot, on august 18, 2014, bennett, age 83, self-administered a lethal dose of barbiturates and passed with her husband holding her hand. analysis in canada, physician-assisted suicide (pas) is illegal, leaving individuals with degenerative illnesses to make these decisions on their one without the resources available to most hospitals. as bennett observed, if she wished to resist becoming a vegetable, this was her only option – she had to act before the day when she could “no longer assess my situation.” though using language common in the “death with dignity” debate, in her letter she notes there was another influence on her decision. this one was more utilitarian than personal: as we – the elderly – undergo manifold operations and become gaga while taking up a hospital bed, our grandchildren’s schooling, their educational, athletic, and cultural opportunities will squeeze up. media attention to bennett’s story has been positive, with many agreeing that pas laws ought to be revisited. still, it is not without its detractors. some have expressed skepticism toward bennett’s utilitarian argument while others are critical of rhetoric that implies “sticking it out” to be undignified. currently, only quebec has passed right-to-die legislation, but this is expected to be challenged by the federal government – this is in light of the fact that the canadian medical association has softened its stand on pas. what is certain is that bennett has raised questions too often secluded to the bioethics classroom. while all end-of-life decisions should be left in the hands of the patient, bennett’s consideration of societal costs is a unique approach to an otherwise personal issue. in an era when life expectancy exceeds what it was when canada’s health care system was created (the same applies to social security in the united states), how many years are we entitled to? at what point, in the artificial prolonging of human life, does one weigh quality of life against cost? is quality of life even the best measurement? far from being personal, as long as the costs are incurred by the whole society, all of society has a vested interest in its outcomes – and because these are choices everyone must make, ideally, these will be both fair and just. it is unclear what effect this story will have on the united states. compared to canada, the u.s. has a preston, gillian bennett & physician-assisted suicide, voices in bioethics, vol. 1 (2014-15) 2 different relationship to healthcare and medical rights. this is highlighted by the fact that, in recent memory, even conservative legislation like the affordable care act inspired fears of “death panels.” since the supreme court ruled in washington v. glucksberg (1997) and vacco v. quill (1997) that there is no constitutional “right to die,” pas laws must be decided on the state-level. even though a 2013 gallup poll found that 70% of americans support pas, only five states allow it (table 1). table 1 in finding data on who uses this service, only those states that went through the democratic process – by either ballot initiative or the legislature – produce annual reports monitoring it. in those where it was legalized through the courts, it is not so much that the state condones pas as much as they are unable to prosecute physicians. each follows similar regulations – for example, patients must (1) be capable of making decisions, (2) diagnosed with a terminal illness, and (3) have less than six months to live. when/if the data is collected for montana and new mexico, it will likely confirm doctors’ anecdotes, which is that it is selected by only a few who are eligible. conclusion again, it is uncertain what gillian bennett’s legacy will be in both canada and the united states, but as a focusing event, her story raises questions that everyone – and every society – must address. the very fact that it has done that much is as much a legacy as anyone can hope to leave. it was right of her to title her letter, “goodbye & good luck!” – because we need it. ducar, shrinking responsibility, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. shrinking responsibility: providing mental health treatment in a profit driven system dallas ducar keywords: court of law, justice, mental health introduction what does it mean to be mentally ill? we generally define mental illness as a condition which affects one’s psyche so intensely that it impairs function. specifically, many claim that a mental state becomes disorderly when it becomes maladaptive to one’s environment. analysis the late oliver sacks wrote about an island wherein the majority of the people are color-blind. on this island, the activities and norms reflect the needs of the majority. in this case, the people of this island are most active during the du and dawn as both those times provide the best vision. in this case, non-color-blindness has become maladaptive as the social practices revolve around color-blindness. in this case, illness has become normative, that is to say, the definition of an illness is determined by the interpretation of a change from the norm. in the case of mental illness, the normative factor is usually more difficult to identify. some may argue that social perceptions are directly influencing the perception of the illness, however the illness still exists. for example, one schizophrenic may be considered a shaman; however he still exhibits the signs and symptoms of schizophrenia and has simply not been detected within his culture. this argument becomes less obvious when we look to cases of joan of arc who claimed she heard voices of god, or claire of assisi who spent the last 27 years of her life in bed, too weak to move, and venerated as a saint. the point is not to say that mental illness is not real, but rather to highlight the very real fact that it is a normative endeavor. the implications of the normative basis of the definitions of mental illness are resounding when one analyzes the connection between the practitioners and both political and corporate agencies. texas is just one example of many states where a corporation is contracted by the government to jail juvenile offenders, including those whom are deemed mentally unwell. moreover, if the level of care needed ducar, shrinking responsibility, voices in bioethics, vol. 1 (2014-15) 2 increases, more compensation is also required per prisoner. the sentencing system in texas works by assigning an indeterminate term to offenders with release only possible when a vague set of treatment programs have been fulfilled. assessing whether a prisoner is ready for release is usually up to a mental health clinician, or team. the legal precedent to allow mental health clinicians to testify in the courtroom about the presence of mental illness is due to the 1962 u.s. court of appeals decision jenkins v. u.s. since then, the use of mental health clinicians within the judicial system has skyrocketed. a study in virginia discovered that mental health experts will side with the prosecution 80 percent of the time.1 not only do these mental health clinicians have the capability to diagnose and justify detention of offenders, but also retain the offenders within privately contracted prisons. this level of responsibility becomes more dubious when it is in the best interest of the corporation to keep profitable offenders for as long as possible. when the dsm-5 was released discussions ensued about the power it held as a definitive mental health manual, especially in the court room. hypersexuality, binge eating, paraphalic coercive disorder, and other dubious disorders were almost available for use in trial at this time, allowing for a greater range of civil commitment. ultimately, this becomes quite dangerous when the institutions’ interests encourage detainment. when we rely on the government to certify practitioners and definitions, diagnoses, and prescriptions become beholden to political and corporate agencies, there is an inexorable drift towards treatment as punishment. currently, 7 million americans are under law-enforcement supervision and the demand for mental health services has never been greater. however, the goals of mental healthcare have been abandoned in favor of lucrative contracts and corporate models. this compromise fails to reduce recidivism, fails to alleviate incarceration rates, and fails to promote public safety. conclusion if we fail to acknowledge that the definitions for what constitutes as a mental illness are normative, we fail to accept the tenuousness of our own conclusions as a society and truly fail those who suffer. 1 murrie, d. c., boccaccini, m. t., guarnera, l. a., & rufino, k. a. (2013). are forensic experts biased by the side that retained them?. psychological science, 0956797613481812. hamm, autonomy, justice, voices in bioethics, (2013) © 2013 deborah hamm. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. autonomy, justice, and injustice with indian gestational surrogacy deborah hamm keywords: autonomy, doctor, role, justice, gestational, surrogacy, reproduction bioethics developed in the united states within the context of rapidly advancing medical technology that presented new ethical challenges. in varying combinations, the four bioethical principles of autonomy, justice, beneficence, and non-maleficence have been collectively used to meet these challenges. as healthcare technology and research have grown into corporate interests for international export and development, bioethics has been exported along with it. however, the exportation of western bioethics to developing countries has precipitated controversy regarding the universality of these principles and raised concern about ethical imperialism. autonomy, the principle that guides the protection of individuals across cultures, serves a pivotal role in protecting research subjects, while issues of justice are more readily activated within contexts of healthcare delivery. advances in assisted reproductive technology (art) have already outpaced the ability of bioethicists to meet the ethical challenges within the culture that developed it, the backdrop for international discourse. art is largely unregulated within the u.s. and variably regulated within europe. in the u.s., where individuals have more freedom and greater autonomy, art flags the issue of justice, related to inaccessibility due to expense. gestational surrogacy, a form of art in which a woman’s uterus is used to carry the embryo of another couple’s baby to term, poses unique challenges in regard to autonomy, justice, and the balance between them. the procreative right and interest of a couple to have a baby are balanced against the autonomous right of a surrogate to contract free of coercion, with protection against harm. in the u.s., contract pregnancy is legally protected in only a few states. it is banned in some countries and remains unregulated in india, where it is has grown with lightning speed into big business, expected to yield billion-dollar profits within the coming years. the cost of contract surrogacy in the u.s. ranges between $40,000 and $150,000, in contrast to india where it is typically lower, between $12,000 and $25,000, including travel expenses, with the surrogates receiving between $2,000 and $6,000 of this amount. because india is an englishspeaking country with cheap labor, well-trained doctors, and advanced healthcare systems in urban settings, it is ideal for medical tourism and has developed the infrastructure to support it. historically, women’s rights and reproductive rights have developed in tandem, and india is a country with civil liberties, democratic traditions, and feminist movements. however, despite its pro-natal culture with liberal contraception and abortion rights, india has an enduring history of preferential male sex selection and discrimination against women, notably women of color, stratified within a rigid caste system. most indian women live in poverty, earn less than half of what men earn, have little or no access to medical care, and suffer the highest incidence of anemia in the world. presumably this is due to gender-based discrimination in food, nutrition, and healthcare. the center for reproductive rights’ (crr) and the national human rights commission (nhrc) report alarming statistics regarding indian maternal health linked to poverty, education, and social status. less than half of indian women have a skilled attendant when giving birth, with less than 40 percent of births occurring in hospital settings. maternal morbidity and mortality cluster near the highest levels in the world.1 how does one understand the phenomenal success of outsourcing contract surrogacy to a country where women’s maternal health is so marginal? hamm, autonomy,justice, voices in bioethics, (2013) 2 western attitudes toward indian gestational surrogacy, including those of feminists, tend to fall within two camps: those who view it as autonomous decision-making that leads to mutually beneficial outcomes, and those who view it as coercive, colonial exploitation of women in developing countries who need rescuing. both perspectives fall short of the complex reality of these arrangements, which have the paradoxical potential for simultaneously oppressing and liberating indian woman. when the pristine lens of autonomy is superimposed over the decision-making process, one can readily conclude that indian women are making autonomous choices that generally improve their lives. a new, ethnographic literature is emerging about indian surrogacy that culturally embeds these arrangements within life narratives. common unifying motivational themes are identifiable and include financial empowerment, access to healthcare, and improvement in the lives of family members, particularly children. within nine months, a surrogate can earn wages that could take 10 to 15 years to earn in the only other jobs available to them. many of the surrogates interviewed reported plans to use surrogacy pay for caring for their own children, including paying for education, medical care, and even dowries. a brief description of dr. nayna patel’s akanshka fertility clinic in anand, gujarat, is illuminating. dr. patel accepts impoverished, (usually) illiterate women from the surrounding villages into her clinic, where they live together in a dormitory-style setting under her watchful care, which includes good nutrition, rest, monitoring, and even supplemental education. to be accepted, a woman must have already delivered a child of her own, indicating that she has experienced a successful pregnancy and understands the risks undertaken. she must also be making an autonomous choice. dr. patel claims to be able to detect and avoid accepting women who are being coerced into surrogacy by husbands or relatives. dr. patel additionally prides herself on facilitating women’s empowerment by helping them protect their finances. “for example, if she wants to buy a house, we’ll hold her money for her until she’s ready. or if she wants to put it in an account for her children, we’ll go with her to the bank to set up the account in her name.” sofia vohra, a surrogate who works as a glass crusher for $25 per month and is married to a “lazy drunk,” was interviewed about her surrogacy experience. “it’s exhausting being pregnant again.” then, in case her complaints are misunderstood, she quickly adds, “this is not exploitation. crushing glass for 15 hours a day is exploitation.”2 narrow focus on the principle of autonomy can easily obscure the deep injustice behind indian gestational surrogacy, which when revealed exposes an illusory aspect of so-called autonomous decision-making. closer scrutiny and deeper analysis of ethnographic narratives reveal that many indian women are choosing surrogacy as a basic survival strategy for obtaining access to food, shelter, clean water, and healthcare. this is not a moral choice; rather, it corresponds to what is philosophically understood as a forcing offer.3 a comparable western analogy is when circumstances force a mother with a sick child to choose between a high-risk job that offers health insurance and a low-risk job that offers no insurance. neither choice is desirable, but the mother can “autonomously” choose. context critically shapes the ethical issue, shifting it from autonomy toward justice, with emphasis on the impingement of the structure of choice on the freedom of choice. this leads to a greater appreciation of the injustice underlying gestational surrogacy in india. beyond reframing choice as a survival strategy for obtaining basic needs, this sheds light on what it means to be human. the language used to invite women into surrogacy arrangements routinely casts women as little more than a function for delivering a baby, with all interventions (nutrition, monitoring, housing, health, etc.) focused on the baby’s worth, with little value accorded to the woman apart from this function. if women miscarry, they are not paid. virtually all deliveries are via c-section, which exposes women to higher surgical risk and complications. all medical care ceases at the point of delivery, with no follow up for complications that may occur. death can happen. for example, easwari, a second wife who was pressed into surrogacy in order to earn extra money for her family, died following delivery of a healthy baby. the ishwarya fertility clinic was reportedly unprepared to handle her postoperative hemorrhaging and she died en route to a nearby hospital, after her husband complied with instructions to independently secure transportation for her. a requested official investigation was reported as “perfunctory.”4 although surrogacy offers an option for women of darker color and lower caste a capitalist mechanism for climbing the economic ladder, its offering is limited. despite having no genetic relation to a fetus, hamm, autonomy,justice, voices in bioethics, (2013) 3 women of darker color and lower caste have less negotiating power and are paid less than lighter skinned and higher caste women, implying that darker skinned women have inferior wombs.5surrogacy work remains stigmatized in india, and life in a dormitory, potentially oppressive, offers women protective shelter from disapproving communities and villages. ultimately, a woman’s ability to obtain basic goods only within the context of carrying a baby for someone else, with little or no access to this for her own children, reveals troubling meaning about social worth. the purpose of this essay is not to argue for or against indian gestational surrogacy; nor do i want to diminish the importance of autonomy in ethical deliberation regarding these arrangements. the tone of this essay surely reveals my bias toward understanding gestational surrogacy as a vehicle through which marginalized indian women can empower themselves, but with risks that mandate protective regulatory measures and underlying injustice that requires serious attention. rather, my purpose is to highlight the necessity of looking beyond autonomy into issues of justice, and to use the lens of justice to reflect back on autonomy in order to better understand the degrees of freedom that constrain or enhance autonomous decision-making. i also believe that ethnographic analysis can anchor moral understanding within cultural contexts, yielding a deeper and more accurate picture of ethical complexity, without weakening the principles of autonomy and justice, or moral integrity. finally, such analyses can better clarify analogous concerns within u.s. culture that escape detection or resist acknowledgment and discussion. 1bailey, a,"reconceiving surrogacy: toward a reproductive justice account of indian surrogacy," hypatia 26, no.4 (2011): 26. 2haworth, a, "surrogate mothers: womb for rent," marie claire 5, (2010). 3ezorsky, g, freedom in the workplace? (ithaca: cornell university press 2007). 4carney, s, "cash on delivery," mother jones 35, no.6 (2010). 5bailey, et al. anekwe, global colorism, voices in bioethics, vol. 1 (2014) © 2014 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. global colorism: an ethical issue and challenge in bioethics obiora anekwe keywords: colorism, discrimination, african ancestry, divisions within race global colorism is seldom discussed in the field of bioethics, but it affects almost every facet of medical practice. the ethical challenge of colorism has global implications that are psychologically, physiologically, sociologically, and medically related. one impacts the other, sometimes without much notice. my goal for this paper is to bring issues related to colorism to light in order to begin the process of holistic healing for people of color who are often the most vulnerable in health care and medicine. secondly, i hope that this discussion of global colorism will bring forth a greater realization that more research needs to be conducted on the various impacts of colorism in medical practice. what is colorism? according to baruti (2000), colorism is a global prejudice that people of african ancestry have toward each other and seemingly use against or to the advantage of themselves and others with relatively similar complexion. herring (2004) also defines colorism as “discriminatory treatment of individuals falling within the same ‘racial’ group on the basis of skin color” (p. 21). in order to provide a more expansive definition of global colorism, i would like to emphasize in this paper that global colorism may also be promoted and practiced by the oppressed (in this case, people of color) and the oppressor (post-colonialist caucasians). as such, the term racism, for the purpose of this paper, is referred to as discriminatory power dynamics externally expressed by post-colonialists of european descent through conscious decision-making practices based on the skin tone and complexion of oppressed people of color. anekwe, global colorism, voices in bioethics, vol. 1 (2014) 2 the history of skin color the various skin colors of humans that currently exist evolved over the past 60,000 years as humans dispersed out of equatorial africa and adapted to new environments (jablonski, 2012). specifically, scientific records confirm that all humanity originates from the khuiland great lakes region in northeast africa before 7 million years ago (bynum, brown, king, & moore, 2005). subsequent migrations occurred east to ethiopia, north to egypt and eurasia, south to south africa, west to chad, west africa, and north africa (2005). thousands of years later, humans migrated out of africa onto every continent on the planet (2005). because ecosystems in africa changed beginning 2 to 1.5 million years ago, weather conditions became highly seasonal. these unpredictable changes produced transitions from forest to woodland and woodland to grassland (jablonski, 2012). as a result, plants and animals either evolved to cope with these changes in their environments or they became extinct (jablonski, 2012). as the late archaeologist j. desmond clark cited, human populations followed the seasonal migrations of the herds they depended on (2012). this action drew some populations of people northward and eastward out of africa into asia. by 1.8 million years ago, these people were living in central and eastern asia (2012). as indicated in image 1, this facebook advanced image shows the interconnection of the human race on earth throughout thousands of evolutionary years. note that the divided regions of the earth can fix approximately as a whole like a puzzle if these regions are digitally put back together. this phenomenon can be explained because the earth once was one collective body of land that eventually divided into various regions or continents because of environmental climate changes. anekwe, global colorism, voices in bioethics, vol. 1 (2014) 3 thus, it is reasonable to conclude that skin color in humans evolved over many centuries to suit the environments where people eventually settled (jablonski, 2012). as jablonski (2012) notes: the first hominid dispersal out of the tropics of africa required changes in bodies, behavior, and culture to adapt to new environments and respond to new threats. the intensity and yearly pattern of sunshine in tropical africa is, and was, very different from that of most of asia and europe. research estimates that it took 10,000 to 20,000 years for human populations to achieve the optimal level of pigmentation for the regional areas they settled (jablonski, 2012). it is significant to note that people living in africa have high levels of mixed ancestry and display more genetic diversity than all the rest of people in the world combined. this type of diversity is most visible through skin pigmentation (see images 2 and 3). nevertheless, this variation in skin pigmentation within africa is reflective of natural selection, migration, and the creation of new pigmentation mutations (2012). anekwe, global colorism, voices in bioethics, vol. 1 (2014) 4 the origins of colorism colorism mostly originates from the mental and physical enslavement of black people in the western hemisphere. for example, in 1712, willie lynch gave a speech in virginia to teach his proven and effective http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070828748e3aacbe02aa3/1473278082195/global-colorism-2-e1410284205241.jpg?format=original http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070828748e3aacbe02aa5/1473278082438/global-colorism-3.jpg?format=original anekwe, global colorism, voices in bioethics, vol. 1 (2014) 5 methods of enslaving black people in the americas. he was the british slave owner in the west indies for which the term lynching is derived from when people were hanged on trees by a mob of people. in willie lynch letters: the making of a slave, lynch (1712) revealed that segregating the black race according to color served as the most effective means by which slave owners could control and manipulate their black slaves. in order to become an effective slave owner, willie lynch (1712) argued that “you must use the dark skin slaves vs. the light skin slaves, and the light skin slaves vs. the dark skin slaves….they must love, respect and trust only us…the slaves themselves will remain perpetually distrustful of each other” (p. 1). early in the colonization of north america, slave owners began to do as lynch directed. they separated the light-skinned, mixed race (mulatto) slaves and housed them in the master’s house. these slaves worked in the home of their slave master because, oftentimes, they were the biracial children of their slave master (ulen, 2013). on the other hand, darker-skinned black slaves worked in the outdoor fields and lived in the external living quarters (shanties) near the big house or slave master’s home (ulen, 2013). this system of color segregation helped establish and promote what we now know as colorism within the international black community. as willie lynch’s message of dividing and conquering black enslaved people spread throughout north america, it also gained acceptance as an effective means to guarantee the enslavement of other colonized people around the world. colorism and racialized discrimination of african people were two dominant factors involved in justifying institutionalized slavery in the americas. it essentially was a savvy political move to maintain the transatlantic slave trade (jablonski, 2012). in the u.s. war of independence, the enslavement of blacks was one of the most significant factors in fighting for and defending american freedom (2012). needless to say, there is an inextricable relationship between slavery, slaveholding, and the founding of the united states of america (2012). the strategically planned dehumanization of africans began when colonialists first associated blackness as evil and negative through a series of brutal and negative imagery and mythical language. for example, colonialists often used scripture in the bible as a justification of slavery. in the account of cain’s exile, scripture was inaccurately interpreted to infer that the black descendants of cain were cursed, when, in fact, the mark of cain conferred god’s protection and involved a curse on any person who harmed cain in his exile (jablonski, 2012). it was only later when christian colonialists purposefully misinterpreted the mark itself as a sign of punishment, shame, and corruption that black people were a cursed race (2012). race constructs: sociological, rather than scientific in a lecture at harvard university, nell irvin painter (2012), author of the history of white people (2010), pointed out that “race is an idea, not a fact.” trautmann (2004) rightly asserts that “race is socially constructed, that it is not objective but conventional, and that, therefore, it has contingent, historical character that is not perduring but governed by forced in play at a given time ” (p. 214). therefore, there is no scientific evidence anekwe, global colorism, voices in bioethics, vol. 1 (2014) 6 to allude to the belief that race is a scientific quality. race is an abstract and flexible notion. it is sociologically, rather than biologically, based. the meaning of race has also translated into interpreting physical characteristics (painter, 2012). we mostly view beauty, especially light skin complexion, as personal characteristics in which we deem as attractive and worthy of deserved attention (2012). the age-old question of whether race determines genetic differences has been debated for decades. in 2000, the human genome project concluded that there is virtually no genetic difference between people of different skin colors (rogers, 2010). in fact, scientists have discovered that all humans share 99.99 percent of the same genetic code, no matter the race of the person (rogers, 2010). geneticist j. craig venter concluded that this fact proves that race is definitely a “social concept, not a scientific one” (2010, p. 1). nell irvin painter notes that the concept of whiteness originates from ancient rome, where slaves were ironically, mostly white. the elevation of some ethnic populations such as germans as “whiter” than other groups originates from scientists who measured human skulls and set abstract criteria for beauty in people (2010). colorism around the world brown-glaude (2007) notes that in european-colonized countries like jamaica and tanzania, there are perceptions that light-skinned people in the middle and upper classes typically fair better during tough economic times than darker-skinned people. in fact, these groups have even thrived during economic hardships (lewis, harris, camp, kalala, jones, ellick, huff, & younge, 2013). therefore, this occurrence actually translates into real economic, social, and health care advantages. in indian society, for instance, colorism affects just about every social, political, and health-related stratosphere (see image 4). the caste system in india is a unique form of social division in society. for instance, the aryan race (composed mostly of the upper class in india) was historically largely equated with the european/caucasian race. they were considered as warriors who were physically sturdy and handsome due to their lighter skin, blue eyes, and sharp nose. the aryans were mostly the european invaders of india whose descendants now occupy the upper class. in contrast, the indigenous darker-skinned people of india were described as ugly because of their dark skin, as extensively documented in the canonical text of the hindus. many of these religious writings expound on the racial distinction between lighter-skinned aryans, who migrated into india from the north, and dark-skinned indigenous indians of the south (glenn, 2009). thapar (2008) argues that the term “aryan” refers to a specific term of language and a sign of social superiority that has been misused to refer to race. these views have been evident in reinforced ideals of social darwinism and biological determinism. anekwe, global colorism, voices in bioethics, vol. 1 (2014) 7 one of the negative side effects of colonialism in india and the americas was a divide and conquer social order based on such external attributes as skin color, hair texture, and facial structure (khan, 2009). this well-devised form of racial categorization was established in order to maintain social order. in trinidad, for instance, racebased, unscientific social orders were promoted in order to maintain social, legal, and moral order (2009). most caribbean nations such as trinidad held a nationalistic and scientific belief that race was both biologically and socially heritable (2009). although these belief systems still exist today, some scholars contend that such localized coloristic stratifications existed well before european colonialism (2009). as john rogers points out, “ideas of difference with a quasi-biological character were already prevalent before the beginning of british rule, and many of the symbols and labels propagated in the name of racial ideology were drawn from earlier periods” (khan, 2009, p. 103). it is interesting to note that after colonialism, there has been an increased presence in afro-trinidadian traditional heritage such as calypso and steelpan music, the orisha religion, and carnival celebrations (see images 5 and 6). as one can observe in images 5 and 6, celebrations such as carnival highlight the diversity of skin color and the influence of the yoruba religion on caribbean culture. http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070828748e3aacbe02aa7/1473278082682/global-colorism-4.jpg?format=original anekwe, global colorism, voices in bioethics, vol. 1 (2014) 8 http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070828748e3aacbe02aa9/1473278082928/global-colorism-5.jpg?format=original anekwe, global colorism, voices in bioethics, vol. 1 (2014) 9 http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070808748e3aacbe02a93/1473278080114/global-colorism-6.jpg?format=original anekwe, global colorism, voices in bioethics, vol. 1 (2014) 10 skin tone bias and colorism in egg donations for assisted reproduction the practice of skin tone bias and colorism has impacted the practice of donating eggs for assisted reproduction. in an effort to preserve skin tone, some egg donor recipients base their selection on the skin color of egg donors. skin tone is one of the many categories in which some egg donor databases use to characterize and differentiate donors (thompson, 2009). for instance, a source of skin tone signaling in structuring commercial u.s. egg donation is through donor photographs and biographical detail (2009). in most cases involving sperm donation, photographs of a donor as a child are common visual representations (2009). in contrast, adult rather than baby photographs of egg donors are often provided to potential donor recipients. these examples highlight how potential donor recipients are able to unscientifically determine the potential skin color of their future child. this practice, of course, is not guaranteed to produce babies with lighter-skin, but it does establish a framework in which donor recipients may produce lighter-skinned babies. therefore, a consideration of skin tone in egg donation illustrates the process of racializing biology for the sake of lightskinned preservation (thompson, 2009). further research in bioethics needs to be conducted in order to explore this vital and significant issue in global and medical colorism. the physical, sociological, and psychological impact of colorism psychiatry serves as an ample foundation to discuss global colorism because what we think about ourselves often affects what we eventually do. a critique of mental behavior can ultimately help explain the practice of internalized skin discrimination within certain groups of colored people. according to psychiatrist frantz fanon (1952), darker-skinned people who have been oppressed as a result of colonialism tend to later take on the psychological, spiritual, and physical attributes of their oppressors. for instance, the practice of lightening one’s skin is a physical expression by the oppressed (black people) to assimilate and become as their oppressors (fanon, 1952). they find little to no value in their own cultural expressions of selfhood, but rather depend on the spiritual, physical and psychological characteristics (language, religion, dress, etc.) of their oppressors in order to define and validate their human existence (1952). in fact, one can argue that the reason why people of color were and continue to be oppressed by the dominant power structure is because of the collective human ego’s desire to dominate and control the most vulnerable by any means necessary, even to the extent of promoting non-scientific beliefs about inferiority based on skin color. noted psychiatrists such as frantz fanon and frances cress welsing explain that colorism in medical practice is inherently based on self-hatred and low self-esteem rooted in colonialism and white supremacy. in many ways, the practice of colorism is a form of self-hatred that ultimately causes greater harm to the oppressed, not the oppressor. for instance, rather than ridding oneself of his or her dark melanated skin through the act of skin bleaching, greater physical and psychological harm is caused to those who are the most vulnerable in health care. but on the other hand, one can also argue that because of the salient effects of global colorism, anekwe, global colorism, voices in bioethics, vol. 1 (2014) 11 it impacts all humans interactions through medical challenges such as negative mental health and psychological implications of low self-esteem found among some dark-skinned women. colorism systematically seems to affect many areas of medicine and health care practice. for instance, if a person with highly melanated skin has internalized a belief system that says that he/she is inferior based on the darkness of skin color, then he/she is more likely to rid him/herself of this physical attribute by eliminating it in order to psychologically feel better about one’s own human existence. unfortunately, colorism even affects how research is framed, what is studied, who is studied, who is selected as research subjects, and how they are selected. medical historian harriet a. washington (2007) most vividly documents this belief in her book, medical apartheid, which is considered one of the most comprehensive historical critiques about unethical medical practices conducted on black people in america. harvard trained sociologist w.e.b. dubois was one of the first scholars to address the psychological conflict that people of color have to encounter in their attempts to assimilate to the dominant white social group (myrdal, 1944). he often referred to this particular phenomenon as a “double consciousness,” indicating that it was a response to cultural domination in a color-ranking society (lewis, et al, 2013). dubois (1903) noted in his breakthrough book, the souls of black folk, that “the problem of the twentieth century is the problem of the color-line,—the relation of the darker to the lighter races of men in asia and africa, in america and the islands of the sea” (p. 1). this problem has persisted even throughout the 21st century. unbeknownst to many, colorism has unfortunately been a determining factor in unethical, discriminatory practices in scientific inquiry. it has negatively affected people of color and affected the way in which science is practiced. but most significantly, it has affected the perspective to which darker-skinned people have viewed themselves, which is often manifested in internalized communal practices such as colorism within the black and brown communities of color throughout the world. psychiatrist frances cress welsing’s theory of color confrontation helps to explain the negative practices of colorism and the strategic suppression of highly melanated people around the world. her theory is based on the research analysis of race theorist neely fuller, jr., who argued that racism is a system woven into the very fabric of american society (welsing, 2013). fuller concluded that racism and white supremacy are articulated and practiced in every social system (welsing, 2013), including for our discussion, science and medicine. welsing (2013) argues that white supremacy and racism are systems built on the global view of the white minority class that highly melanated people around the globe must be suppressed and even eliminated in order to maintain white domination. in essence, we can see how such a system is actualized through decade’s old race-based medical practices. racism, as welsing (2013) contends, is woven into the very fabric of human society, especially within american society, which was distinctly built upon through the physical and now mental subjugation of people of a darker hue. she concludes her analysis by arguing that black suppression by the white race is a practiced form of psychological projection of white fear and inferiority (welsing, 2013). in other words, the white population’s anekwe, global colorism, voices in bioethics, vol. 1 (2014) 12 internalized inferiority complex and global fear of population extinction has been historically masked through vicious and violent acts of racism, white supremacy, human enslavement, and territorial colonization. historically, a miseducation about skin color has persisted over the centuries. in fact, the enslavement of darkskinned people was systematically justified because slave owners promoted the non-scientific concept that blacks were genetically inferior and less human than white people. although geneticists have consistently demonstrated that race is biologically unsubstantiated, this belief unfortunately still exists among some scholars (funderburg, 2013). in fact, it was german scientist johann friedrich blumenbach who established racial categories according to skin color in the late 18th century (2013). this form of color classification was eventually used as a mechanism to divide and conquer the hearts and minds of melanated people in order to continue the slave trade and justify the suppression of the darker race throughout the world. studies related to colorism skin color affects life outcomes in physical health, mental health, and interpersonal relationships (luisa et al., 2006; eric et al., 2002; & wade & sara, 2005). wilder and cain (2011) argue that colorism is perpetuated more frequently by women. it has caused a significant negative psychological impact during the childhood and adolescence of females (wilder & cain, 2011). stephens and few (2007) have also examined skin color in relation to adolescent perceptions of sexual attractiveness in women via music videos and found that african american boys believed that light skin is the most significant factor in beauty ideal. de casanova (2004) conducted a colorism and self-esteem study on ecuadorian latina adolescent girls and discovered that ecuadorian girls describe beauty ideal as “tall, thin, long yellow hair, and light eyes” (p. 296). colorism seems to affect every aspect of our social existence, from employment hiring practices to prison sentencing. for example, in the united states, south africa, the caribbean, india, the philippines, korea, latin america, and mexico, skin color is a major factor in determining one’s social stratification and its outcomes, whether in education, employment opportunities, income, and health status (jablonski, 2012). it has had a negative psychological and physical impact on mainstream america’s perceptions of personhood to such an extent that skin color is more significant than more tangible human qualities. for example, a johns hopkins university study in 2011 of u.s. census data concluded that mixed-race people are socially placed below whites, but ahead of blacks (smith, 2011). moreover, a recent villanova university study in 2011 reveals that dark-skinned black women are given longer prison sentences than their lighter-skinned counterparts. the study, which sampled of over 12,000 black women imprisoned in north carolina between 1995 and 2009, showed that light-skinned women are sentenced to 12 percent less time behind bars than their darker skinned counterparts. the results also showed that having light skin reduces the actual time served by 11 percent (smith, 2011). http://www.sentencingproject.org/detail/news.cfm?news_id=1136 anekwe, global colorism, voices in bioethics, vol. 1 (2014) 13 a university of georgia study in 2006 revealed that employers prefer light-skinned black men to dark-skinned men, regardless of their qualifications (banerji, 2006). these results hint to the very fact that the majority of white mainstream america believes that blacks with lighter-skin have greater similarities than differences to white americans as compared to their darker-skinned counterparts. according to harrison, these similarities make white people feel more comfortable around light-skinned blacks, which translate into positive hiring practices as compared to darker-skinned blacks (smith, 2011). as harrison pointed out, skin tone differences are responsible for increasingly different perceptions within standard racially defined groups, like blacks (banerji, 2006). he highlights that other world cultures such as hindus in india as well as some cultures of asians and hispanics are more aware of this color bias (banerji, 2006). many of these color biases and perceptions are also applicable to medicine, because doctors and researchers may tend to treat their lighter-skinned patients and research subjects with more respect and human dignity than their darker-skinned counterparts. as our society becomes more global, we must be cognizant of how our own biases affect decision-making in areas such as medicine and health care. more socio-medical research needs to be conducted on the medical treatment and research selection of black patients and research subjects based on their skin color range (light to dark skin color) by doctors and researchers. these data results could help shed light on racial bias in the recruitment and selection of human subjects in clinical trials. recommendations and conclusion in my conclusion, i offer some relevant recommendations that may decrease the unethical practice of colorism in health care and medicine. first, as bioethicists, we must promote a genuine understanding about the origins of skin color and the reasons for skin color variation. the lack of understanding one’s racial origins, in essence, leads one to make uninformed decisions and internalize false beliefs about one’s own human value. the strategic promotion of self-esteem, self-efficacy, and positive body imagery can essentially lead to changes in one’s psychological consciousness and behavior. the arts can also serve as a means to help eliminate colorism in the study of human science. earlier this semester, i visited the metropolitan museum of art in new york city in order to conduct research on european artists’ depictions of melanated people in africa during the rise of european colonialism. in a marble and bronze sculpture entitled, la capresse des colonies(1861), charles henri joseph cordier (1827-1905) portrayed his highly melanated female subject during his travels in france’s north african colonies as exotic and beautiful, not in an exaggerated stereotypical form as most european colonial artists often documented in their works. the sculpture depicts the beauty of a tribeswoman who was a member of the highly melanated ethnic groups of africa and madagascar, the cafres. cordier’s admiration for the beauty of highly melanated people was unique and unusual during a period in world history when europeans routinely portrayed africans with dark skin as savages. to date, archeologists in northern spain and throughout the latin american world are still http://www.post-gazette.com/pg/06360/748295-51.stm http://thegrio.com/2013/09/25/black-men-take-to-bikes/#s:allen-hill-taking-a-break-from-a-weekend-ride anekwe, global colorism, voices in bioethics, vol. 1 (2014) 14 discovering monumental works by european, moorish, and other craftsmen that highlight the strength, beauty, admiration, and grand genius of highly melanated people. as more of these accurate depictions of highly melanated people are revealed, negative perceptions of blackness will hopefully be reduced. because of my own great admiration for cordier’s sculpture, i created a collage rendering based on his portrayal of la capresse des colonies (see image 7). i believe that my own modern collage rendering of cordier’s sculpture will also help counter modern colorism. anekwe, global colorism, voices in bioethics, vol. 1 (2014) 15 http://static1.squarespace.com/static/5792a137ff7c5081cb88ace7/57d06fdd8748e3aacbe022cd/57d070818748e3aacbe02a9f/1473278081705/global-colorism-7.jpg?format=original anekwe, global colorism, voices in bioethics, vol. 1 (2014) 16 colorism can be counteracted through psychosocial therapy in order to change the way in which one believes negative ideas about dark skin color. by analyzing the centralized root cause of colorism, there is a greater likelihood of holistic healing for all those affected by unjust discriminatory practices. advocacy groups must also promote equality and the development of programs that counter colorism and promote the diversity of skin color (lewis, et al., 2013). and lastly, there needs to be a conscious willingness to conduct research on skin color discrimination (colorism) in the medical treatment, practice, and clinical trial recruitment/selection of patients and research subjects by doctors and researchers. the purpose of such research will help uncover hidden race perceptions by medical professionals that can be resolved through continuing education. all in all, i believe that if racialized medical perceptions based on skin tone are reduced, perhaps the true intent of healing can be practiced in health care and medicine. references banerji, s. (2006, august 31). study: darker-skinned blacks hit more job obstacles. diverse issues in higher education. retrieved from http://diverseeducation.com/article/6306/ baruti, m.k.b. (2000). negroes and other essays. akoben house. brown-glaude, w. (2007). the fact of blackness? the bleached body in contemporary jamaica. small axe, 24 (3), 34-51. bynum, e.b.; brown, a.c.; king, r.d.; & moore, t.o. (eds.). (2005). why darkness matters: the power of melanin in the brain. chicago, illinois: african american images. de casanova, e.m. (2004). no ugly women: concepts of race and beauty among adolescent women in ecuador. gender and society, 18 (3), 287-308. dubois, w.e.b. (1903). the souls of black folk. chicago: a.c. mcclurg & company. eric, u.; nilanjana, d.; angelica, e.; anthony, g.g.; & jane, s. (2002). subgroup prejudice based on skin color among hispanics in the united states and latin america. social cognition, 20 (3), 198. fanon, f. (1952). black skin, white masks. new york: grove press. funderburg, l. (2013, october). changing face of america. national geographic, 82-84. glenn, e.n. (ed.). (2009). shades of difference: why skin color matters. stanford, california: stanford university press. herring, c. (2004). skin deep: race and complexion in the ‘color blind’ era. in herring, c.; keith, v.m.; & horton, h.d. (eds.). (2004). skin/deep: how race and complexion matter in the ‘color-blind’ era, urbana: university of illinois press. jablonski, n.g. (2012). living color: the biological and social meaning of skin color. berkeley: university of california press. khan, a. (2009). caucasian, coolie, black, or white? color and race in the indo-caribbean diaspora. in glenn, e.n. (ed.). (2009). shades of difference: why skin color matters. stanford, california: stanford university press. lewis, k.m.; harris, s.; camp, c.; kalala, w.; jones,w.; ellick, k.l.; huff, j.; & younge, s. (2013). the historical and cultural influences of skin bleaching in tanzania. in hall, r.e.(ed.) (2013). the melanin millennium: skin color as 21st century http://diverseeducation.com/article/6306/ anekwe, global colorism, voices in bioethics, vol. 1 (2014) 17 international discourse. new york: springer. luisa, n.b.; catarina, i.k.; david, r.w.; ana, v.d.r..; & penny, g.l. (2006). self-reported health, perceived racial discrimination, and skin color in african americans in the cardia study. social science & medicine, 63 (6), 1415. lynch, w. (1712). willie lynch letters: the making of a slave. myrdal, g. (1944). an american dilemma. new york: harper & row. painter, n.i. (2012, november 26). lecture on, the history of white people. harvard university bookstore. retrieved from youtube. rogers, t. (2010). “the history of white people”: what it means to be white. salon media group. retrieved from http://www.salon.com/2010/03/23/history_of_white_people_nell_irvin_painter/ smith, j.s. (2011, december 21). americans rank mixed race people ahead of blacks socially. the gio: an online magazine. stephens, d.p. & few, a.l. (2007). the effects of images of african american women in hip hop on early adolescents’ attitudes toward physical attractiveness and interpersonal relationships. sex roles, 56 (3-4), 251-264. doi: 10.1007/s11199-006-9145-5. thapar, r. (2008). the aryan: recasting constructs. gurgaon: three essays collective. thompson, c. (2009). skin tone and the persistence of biological race in egg donation for assisted reproduction. in glenn, e.n. (ed.). (2009). shades of difference: why skin color matters. stanford, california: stanford university press. trautmann, t. (2004). aryans and british india. new delhi: yoda press. ulen, e.n. (2013). dark-skinned vs. light-skinned: 500 years of self-hatred. dvd video. wade, t.j. & sara, b. (2005). the differential effect of skin color on attractiveness, personality evaluations, and perceived life success of african americans. journal of black psychology, 32(3), 215. washington, h. a. (2007). medical apartheid: the dark history of medical experimentation on black americans from colonial times to the present. new york: doubleday. welsing, f.c. (2013b). public lecture on, surviving racism in the 21st century. youtube channel. wilder, j. & cain, c. (2011). teaching and learning color consciousness in black families: exploring family processes and women’s experiences with colorism. journal of family issues, 32(5), 577-604.doi: 10.1177/0192513x10390858. http://www.salon.com/2010/03/23/history_of_white_people_nell_irvin_painter/ howard, reevaluating current hiv laws, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. reevaluating current hiv laws: a call to action louisa howard keywords: hiv, law and ethics, ethics introduction the us is one of approximately 60 countries that has enacted laws making it a crime to expose others to hiv, to engage in certain sexual acts without the disclosure of one’s hiv status, as well to intentionally transmit hiv to another person.1 thirty-three us states have laws criminalizing hiv transmission or exposure, while 38 can use general crime laws to prosecute hiv transmission or exposure. twenty-four states require that hivpositive people reveal their status to their sexual partners and 14 of those 24 states require that hiv-positive people reveal their status to any needle sharing partners.2 since 2008, the us alone has had more than 200 hiv-related prosecutions. while some of these prosecutions were warranted, hiv-infected individuals have been imprisoned for exploits as trivial as spitting or biting, acts known to carry no risk of transmission. many of these laws were created over 20 years ago, when much less was known about the virus, and may have been seen as prudent at the time. however today, hiv can be very well controlled with proper testing and treatment, rendering many of these laws obsolete and discriminatory. analysis jeff s. crowley, program director of the national hiv/aids initiative at the o’neill institute for national and global health law, has spent much of his career shedding light on issues surrounding hiv and the law. i had the pleasure of attending his stimulating talk at the conference on retroviruses and opportunistic infections (croi).3 amid the myriad of cutting-edge hiv research presentations, crowley enlightened attendees with an informative presentation focusing on the need to reframe current conversation about hiv criminal laws in order to protect and promote public health. since the birth of the hiv epidemic in the 1980’s, the ethical concerns surrounding this disease have always been muddled with misunderstanding and misinterpretation. it seems that in the last decade hiv, and its ensuing bioethical baggage, has taken a backseat to other demanding problems facing our healthcare industry. nevertheless, crowley reminded his audience that the criminalization of hiv remains a barrier to further progress in ending this global epidemic. the cdc’s website contains a thorough and updated list of known risks and their potential rate of hiv transmission. a person who is on therapy, with complete viral suppression, carries an insignificant risk of transmitting to another person. even for those not on treatments, the risk for needle-sharing during injection drug use is 63/10,000 exposures, while receptive anal intercourse is 138/10,000, a mere .014% risk of infection.4in his talk, crowley noted that although the cdc reports spitting and biting as posing a “negligible” risk of transmission, this type of wording does not always hold up in a courtroom where vague phrasing can be misinterpreted and used against a person in trial. still, each case carries its own nuisances. proving if a disclosure was made, the person who rightfully transmitted the disease, and whether or not a condom had been used can be very difficult in a court of law. howard, reevaluating current hiv laws, voices in bioethics, vol. 1 (2014-15) 2 however, what can be certain is that many of the laws previously enacted must be revisited. most do not reflect the current hard scientific facts about hiv transmission risk. additionally, as crowley pointed out, there is no evidence proving these laws deter risky behavior. currently, these laws simply cause worry, confusion, and send an “inaccurate message”1 that the best prevention strategy is to avoid sexual partners with hiv. outdated and inaccurate laws continue to fuel stigma, isolating the hiv positive population and discouraging many from seeking the care of health professionals. the individuals most at risk for transmitting hiv are more often the ones who do not know of their own positive hiv status. with laws still in place that continue to stigmatize hiv, these individuals are less likely to get tested, due to fear of legal prosecution. nevertheless, it is crucial to differentiate between intentional and malicious cases of hiv transmission—which should undoubtedly be prosecuted—and less harmful cases such as nondisclosure. furthermore, existing criminal assault laws cover these “purposeful intent” cases and do not require additional hiv-specific laws to properly convict a criminal. this past summer, iowa paved the way for change, becoming the first state in the country to reform its existing hiv criminalization law. one of the most strict in the country, this law subjected people living with hiv/aids to up to 25 years in prison as well as inclusion on the state’s sexual offender registry if no proof of disclosure to a sexual partner existed—regardless of whether safe sex had been practiced.5 it is the hope that the other states with hiv criminalization laws will follow suit and revisit laws that contain statutes which no longer reflect contemporary scientific research. while iowa’s unprecedented repeal demonstrates a sign of progress, crowley reminded all croi attendees that there is still much to be done, and change is not solely in the hands of lawyers, lobbyists and politicians. crowley addressed all healthcare personnel in saying as patient providers, we have a unique capacity to shape popular opinion and serve as patient advocates. it is vital that healthcare providers learn about hiv laws and educate patients, as well as find opportunities to present objective scientific evidence to prosecutors about hiv transmission risk. new initiatives, such as developing tools for judges to learn more about hiv, can further educate all parties involved so we can begin to seal the rift between public health and law. 1 global commission on hiv and the law: risks, rights & health, july 2012. http://www.hivlawcommission.org/index.php/report 2 mcdonald, helen, “five things you should know about the u.s.’s criminalization of hiv” http://www.hivlawandpolicy.org/news/five-things-you-should-know-about-us’s-criminalization-hiv. 3 crowley, jeff s. "“criminalizing hiv: recent experience in the united states and africa to update laws and policies to promote the public health." conference on retroviruses and opportunistic infections. seattle, washington. 25 feb. 2015. lecture. 4 http://www.cdc.gov/hiv/policies/law/risk.html 5 philpott-jones, sean, “living with hiv/aids should not be a crime,” https://thebioethicsprogram.wordpress.com/2014/06/06/living-with-hivaids-should-not-be-a-crime/. http://www.hivlawandpolicy.org/news/five-things-you-should-know-about-us's-criminalization-hiv http://www.hivlawandpolicy.org/news/five-things-you-should-know-about-us's-criminalization-hiv lee, reconciling surrogacy adversaries through the embryo, voices in bioethics, vol. 1 (2014-15) © 2015 katarina lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. reconciling surrogacy adversaries through the embryo katarina lee keywords: autonomy, fertility, human embryos, informed consent, surrogacy, surrogacy laws introduction surrogacy is constantly in the news, with the supreme court’s decision in obergefell,1 the recent conviction of an owner of an american surrogacy company,2 and the recent birth of lucy liu’s son via a gestational surrogate.3 like many bioethical issues, surrogacy divides individuals into three distinct groups: (a) those who believe surrogacy is ethically permissible, (b) those who believe surrogacy is ethically impermissible, and (c) those who are apathetic—meaning they would not engage in surrogacy, but either have no opinion or hold the conviction that individuals should be able to make autonomous choices. in my piece last month, i discussed why surrogacy is a legally problematic enterprise; this month i will present the ethical problems of surrogacy. much of the literature elucidating the surrogacy debate is prejudiced, incomplete, highly repetitive, and too politically polarizing. instead of focusing on the typical ethical arguments surrounding surrogacy, commentators need to start looking at surrogacy in the realm of both the physical and mental health of the intended child. analysis those who oppose surrogacy typically present the following arguments: • surrogacy exploits and commodifies women.4 1. surrogacy is especially exploitative in foreign countries in which there is less regulation, language barriers, and typically little or no legal representation.5 2. domestically, intended parents “prey” on women who are young and desperate for cash.6 • surrogacy exploits and commodifies children (a.k.a. “baby selling”).7 • surrogacy is ethically impermissible because it alters nature. • surrogacy is ethically impermissible because fertility specialists are “playing god.”8 https://michael-reaves-bkln.squarespace.com/blog/2015/08/26/shifting-surrogacy-laws-and-legal-parenthood lee, reconciling surrogacy adversaries through the embryo, voices in bioethics, vol. 1 (2014-15) 2 • the exchange of money and other means of compensation create a myopic lens that prevents surrogates from informed consent. • through gestating a child, a surrogate bonds with the child and therefore has an important connection to that child. this bond should not be severed.9 those who support surrogacy typically present the following arguments: • individuals should have the “right” to a family.10 1. surrogacy provides an opportunity for individuals struggling with fertility to have the opportunity to be a parent. 2. surrogacy provides same-sex individuals and couples (particularly male homosexuals) the opportunity to have a family.11 • individuals should have the “right” to make individual choices.12 • surrogacy, especially for surrogates in lesser socioeconomic situations, provides an opportunity for women to sustain themselves and their families.13 • the medical risks to surrogate pregnancies are minimally greater than typical pregnancies. • surrogacy laws regulate the practice; therefore, there is minimal risk of exploitation.14 • regarding altruistic surrogacy: other “donations” such as kidneys are permissible, so how is surrogacy any different? the problem with these arguments is that no one is going to capitulate. for example, the argument that surrogacy is impermissible because of its manipulation of nature or “playing god” will never reconcile with the conviction that individuals should be able to make choices for themselves. similarly, those who believe that monetary exchange provides a good financial opportunity to surrogates are never going to reach the same conclusion of those who oppose surrogacy based on the “baby selling” argument. as a result, the debate surrounding surrogacy involves ethicists, politicians, journalists, and advocates talking past each other ad nauseam. a possible bridge between opponents and supporters of surrogacy is that most individuals will agree that if there are negative health repercussions to surrogates then surrogacy may be impermissible. those who oppose surrogacy argue that women should be prohibited from consenting to surrogacy, as it increases a woman’s physical and mental health risks.15 surrogacy supporters argue that women should be able to make autonomous informed choices and that the medical risks are not too severe as to prohibit the practice. where this argument breaks down for those who support autonomous choices is that the intended child cannot consent. arguably, the most important party in third party reproduction cannot consent to its creation. for those who oppose surrogacy (especially from a pro-life ethic), it is almost impossible to argue that an embryo is better off not born than born, nor is it feasible to argue that there are ideal situations in which children should be procreated. what is possible to argue is that individuals have a duty not to create situations that may harm the physical and mental health of an intended child. those who disagree with this premise will typically argue that a living person’s ability to choose how he/she wants to procreate supersedes the interest of the embryos; that the embryos are this person’s property and/or genetic material and therefore the intended parent can beget these children in whatever way he/she deems permissible. what opponents fail to account for is that having a child through surrogacy increases the health risks to that child. first, we have seen increasing rates of negative health effects to children created through ivf16 and second, we have noticed cell transfer between surrogates and the children they gestate.17 moreover, https://michael-reaves-bkln.squarespace.com/newswire/2015/09/30/reconciling-surrogacy-adversaries-through-the-embryo#_edn9 lee, reconciling surrogacy adversaries through the embryo, voices in bioethics, vol. 1 (2014-15) 3 studies suggest there are possible negative psychological impacts on children born through surrogacy.18 the potential impacts of these concerns will only become apparent with time. conclusion those who disagree with this may also argue that embryos are not persons and therefore do not have the right to consent; moreover, abortion is legal. first, even if one wishes to argue that embryos are not persons, at the very least, embryos are intended persons. the parties involved in third-party reproduction hope that an embryo will implant and that the intended child will result. second, abortion is primarily legal because it allows women the ability to make autonomous choices regarding their bodies. embryos in third-party reproduction are created outside of a woman’s body and then placed in a woman’s body. they are a completely separate entity in which a woman’s autonomous choice is not relevant. therefore, instead of individuals arguing over the problems associated with the surrogate and the intended parents, it is more fruitful if we start examining the impact of third-party reproduction on children. 1 http://www.latimes.com/opinion/op-ed/la-oe-nejaime-gay-marriage-decision-does-not-solve-everything-20150628-story.html 2 http://mynewsla.com/crime/2015/09/28/glendora-surrogacy-agency-owner-gets-prison-for-cheating-would-be-parents/ 3 http://www.inquisitr.com/2451158/lucy-liu-role-model-for-non-traditional-families-and-gestational-surrogacy/ 4 http://www.nytimes.com/roomfordebate/2014/09/22/hiring-a-woman-for-her-womb/paid-surrogacy-is-exploitative 5 http://www.nytimes.com/roomfordebate/2014/09/22/hiring-a-woman-for-her-womb/the-role-of-international-law-forsurrogacy-must-be-expanded 6 https://erlc.com/article/issue-analysis-surrogacy 7 http://www.lifenews.com/2015/04/01/surrogacy-firms-are-selling-extra-babies-on-the-black-market-to-the-highest-bidder/ 8 http://www.cnn.com/2013/03/04/health/surrogacy-kelley-legal-battle/ 9 http://www.thepublicdiscourse.com/2015/05/15037/ 10 https://www.psychologytoday.com/blog/genetic-crossroads/201507/is-family-equality-right-surrogacy 11 http://www.thepublicdiscourse.com/2015/07/15362/ 12 https://web.stanford.edu/group/womenscourage/surrogacy/moralethical.html; https://www.washingtonpost.com/opinions/surrogacy-should-be-regulated-not-banned/2013/05/29/2198c134-c7db-11e29cd9-3b9a22a4000a_story.html 13 http://theweek.com/articles/544253/how-made-60000-surrogate-mother 14 http://www.psmag.com/politics-and-law/the-messy-complicated-nature-of-assisted-reproductive-technology 15 http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/surrogacy_the_issues?open https://web.stanford.edu/group/womenscourage/surrogacy/moralethical.html lee, reconciling surrogacy adversaries through the embryo, voices in bioethics, vol. 1 (2014-15) 4 16 http://www.dailymail.co.uk/health/article-180379/child-health-problems-linked-ivf.html; http://www.cbcnetwork.org/pdfs/what’s%20wrong%20with%20third%20party%20assisted%20reproduction%20center%20for%20bioethics%2 0and%20culture.pdf 17 http://philpapers.org/rec/fismct 18 http://www.dailymail.co.uk/health/article-2344362/surrogate-born-children-likely-suffer-depression-carried-real-mother.html; http://ncbcenter.org/document.doc?id=897 http://www.dailymail.co.uk/health/article-180379/child-health-problems-linked-ivf.html http://www.dailymail.co.uk/health/article-2344362/surrogate-born-children-likely-suffer-depression-carried-real-mother.html kaikini, the necessity of understanding disasters in the language of suffering, voices in bioethics, vol. 6 (2020) * srajana kaikini, phd, philosophy. assistant professor of philosophy, krea university, india © 2020 srajana kaikini. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the necessity of understanding disasters in the language of suffering srajana kaikini* abstract the categorization of disasters as natural or manmade does little for our understanding of the moral stakes of institutions and collectives involved in the aftermath of disasters. this paper presents a brief account of how disasters can be understood philosophically taking cues from studies in sociology. having articulated the gap in conceptualizing disasters, the paper argues that an interpretation of disasters as “events of social suffering,” will help foreground the complex moral and phenomenological nature of such events to prompt a more ethical response from institutions and collectives. keywords: suffering, philosophy, natural disaster, metaphysics, social suffering, ethical disaster management introduction context: a series of unfolding tragedies the categorization of disasters as natural or manmade does little for our understanding of the moral stakes of individuals, institutions, and collectives in disasters. there is a greater possibility of understanding the complex moral nature of disastrous events when they are classified as events of “social suffering.” this reframing enables us to necessarily relate to these disasters by way of a consciously chosen ethical positioning. when disasters are understood in the language of suffering, there is hope that such an ontological rephrasing can inspire institutions to respond with ethically sensible measures that safeguard the dignity of the lives at stake at the individual and collective levels. the mismanagement of the covid-19 pandemic across nation states resulted in several tragic collateral disasters. disasters are often seen as law and order enforcement projects in which institutions deal with what agamben calls “bare lives.”1 such a view led india to use a top-down disaster management response to kaikini, the necessity of understanding disasters in the language of suffering, voices in bioethics, vol. 6 (2020) 2 the pandemic with implementation of curfews and lockdowns reflecting an authoritarian attitude towards a complex human condition.2 analysis thinking about disasters historically, compared to social scientists and sociologists, philosophers have given relatively little thought to the understanding of “natural” disasters and the social experiences related to them.3 describing disasters as sudden and unexpected occurrences, often beyond immediate human control, encourages people to think about disasters only from the interest of how to act when disaster strikes. disasters, conventionally defined as “events” that begin and end, require an ethical response not just in terms of short-term action but also in terms of long-term existence. covid-19 is a disaster predicted to linger and therefore calls for long-term social action. one way of defining disasters is through identifying their cause as either “natural or the result of accidental or deliberate human action.”4 zack’s definition of disaster calls for a need for action toward recovery in disaster zones. such an application-based ethical approach to disaster is necessary in order for us to act when in a disaster. however, a large number of people must simply be with such an event, i.e., remain aware or engage with the event. they may be distantly located and engaging with it predominantly through media. they may be unable to help based on the expertise necessary. in order to make sense of the ethical obligations in relation to a disaster, we need a metaphysical framework of disasters, one which helps us understand our relation to an event where we are not in a position to act or help. while it is important to understand a disaster that requires action, it is equally significant to understand that many people must relate to a disaster while unable or ill-equipped to take action. in either scenario, the moral response must first and foremost allow people to be able to be with the disaster and relate to it. a disaster could also be defined socio-politically as “an event that destroys or disables the institutions required for moral agency and effective citizenship.”5 such a definition gives significance to both the loss of the dignity of life and the loss of physical life. seen this way, disasters become moments of crisis for humanity where the status quo of a contemporary human condition is disturbed or forced to change. the disconnect between the crisis and people’s ability to relate to it increases when ongoing disasters become historical events relegated to the past in memoirs and museums. responding becomes an integral ethical concept to articulate whenever we are recollecting, representing, or mediating these experiences. a critique of the classification of disasters will help us understand why most of us fail to grasp our moral response to disasters. natural or unnatural disasters? scientific research categorizes disasters as natural or unnatural. recently, researchers in disaster studies questioned the use of the phrase “natural disasters.” chmutina and von meding argue that the widespread use of “natural disaster,” especially by the scientific community, depoliticizes the event such that it dispenses with questions of moral responsibility and fails to address a moral backdrop under which many people are unnecessarily vulnerable to the natural event.6 this argument gained particular prominence in recent times under the trending social media hashtag #nonaturaldisasters. human vulnerability and fallibility are recognized as key components to the experience of any disaster. kaikini, the necessity of understanding disasters in the language of suffering, voices in bioethics, vol. 6 (2020) 3 amidst glaring inconsistencies in the ways in which research is done on disasters with minimal representation from the affected community, there is an urgent need for moral codes of conduct while researching disasters.7 the terminologies, technologies, and methodologies employed in engaging with disasters risk a split between those involved directly and those aware of (those who are with) the disaster. this split affords certain members of society the possibility of being apathetic to the conditions on the ground contributing to the resultant collateral humanitarian crisis, for instance, the tragedy of the migrant workers across india as a result of blind enforcements of the covid-19-related lockdowns.8 the moral responsibility of the bystanders should be to coexist with the disaster in a way that fosters support of the vulnerable rather than disconnected apathy. convenient naturalization9 of disasters to suit the needs of information transaction greatly affects the way in which we relate to these events. our intuitive ethical experience and, subsequently, our ethical response is determined by how ‘naturalized’ the event is in the understanding of those who are with the event but neither close enough to be personally hurt or personally able to actively help. labeling the event natural creates the feeling that people do not need to experience the disaster as their own morally. regardless of our sense of an event’s causes as natural or unnatural, what remains universal is the occurrence of suffering. suffering, either from being in a disaster or being with a disaster, resists easy resolution. instead, it makes us aware of the need to articulate an ethics of being in and being with. social suffering, the individual and the collective many philosophies think about suffering from the perspective of emancipation or liberation from it. malpas and lickis define suffering as a “state of severe distress associated with events that threaten the intactness of the person [as a person].”10 when a large-scale disaster occurs, and the events appear to threaten the “intactness” of an entire group or collective of persons, suffering undergoes a shift in its locus: the suffering is not of any one person but belongs to an entire “social” or a community. trauma the psychological suffering individuated in persons – takes on the form of “social suffering.” suffering, always understood with the constitutive individual as its locus, needs to also be understood as occurring within social groups or the “social self.”11 to address the phenomenology of disasters, pierre bourdieu, arthur kleinman, veena das, and margaret lock, looked at the concept of social suffering in these two ways: individually located and socially located. when public sites like housing projects, schools, or parks become places of confrontations and conflicts (often with tragic consequences), the society or collective suffers. often, individuals do not choose the people they are with. bourdieu observes that sociologists often fail to understand such situations of conflict in their rush to respond.12 bourdieu’s idea of social suffering is rooted in the individual who then becomes part of a group in the context of conflicts. within this individual-centric framework, he articulates the tension between the individual and social suffering as a “positional suffering” that often becomes dispensable in light of so-called “real” suffering related to material poverty. the focus on “real” suffering creates hierarchies of suffering between la grande misere and the many kinds of ordinary suffering or la petite misere.13 this production of the various orders of suffering either end up magnifying, valorizing, or reifying some types of suffering while weakening the value and validity of others. however, some kinds of social suffering also have a non-quantifiable nature – this suffering pervades across space and time and permeates the consciousness of collectives sometimes across generations. labeling disasters natural interferes with the process of a social response. for kleinman, das, and lock, social suffering results from the entangled relationship among politics, economics, and institutional power and the manner in which this power influences a social response to a kaikini, the necessity of understanding disasters in the language of suffering, voices in bioethics, vol. 6 (2020) 4 given problem.14 pressing the need to look at well-being not as a “social indicator” but as a “social process,” they observe how the cultural responses to social violence often “transform the local idioms of victims into universal professional languages of complaint and restitution – and thereby remake both representations and experiences of suffering.”15 there is a certain flattening of experience that takes place by what they term “historically shaped rationalities and technologies.” the violence of response is partially due to the ways in which the pragmatically organized world fractures the experiential phenomenon of suffering into measurable units.16 noting ways in which human suffering can be singular and collective, local and global at the same time, they propose the notion of “social suffering” as a concept that can encourage a collective social response. they argue for strengthening the ethical relationship between experiences of collective suffering and the seemingly unrelated individual. theories that are preoccupied with the incommunicability of pain fail to articulate and mediate collective experiences of suffering. theories that solely focus on knowledge and do not engage with experience, often fail to help make ethical sense of suffering. in the worst case, this results in apathy by those who are unaffected. alternatively, the framework of social suffering offers a way to ethically situate ourselves in relation to events. conclusion disasters as social suffering an ethical reframing the language of suffering enables us to begin to articulate the experiences of disasters and their memories metaphysically. the categorization of disasters as natural or manmade has done little to address the moral response of the collective to disasters and has led to apathy by those less personally impacted. it is only when disaster is understood through the concept of social suffering, rather than as natural or not, that we find some grounds to relate ethically to it. disasters that are understood as events of social suffering inspire a necessary collective ethical response, limiting apathy. institutions and the state should incorporate an understanding of suffering into the state’s code of conduct that reflects covid-19’s collateral implications due to a current framework that leaves society vulnerable to suffering. then, there can be some hope that those responding by taking action as well as those who exist with the disaster and its suffering can morally be with the disaster. a failure to bring the ethical language of collective suffering to public policy will continue to manifest as an endless series of unfortunate events. 1 agamben, giorgio. 2002. remnants of auschwitz: the witness and the archive. (homo sacer). new york: zone books. 2 ministry of home affairs. 2005. “disaster management act 2005.” government of india.https://indiacode.nic.in/handle/123456789/2045?view_type=browse&sam_handle=123456789/1362 accessed may 13, 2020. 3 see sandin, per. 2018. “conceptualizations of disasters in philosophy.” in o’mathúna d., dranseika v., gordijn b. eds. disasters: core concepts and ethical theories. advancing global bioethics, vol 11. springer, for a brief overview of some analytic philosophers on disasters. 4 zack, naomi. 2009. ethics for disaster. lanham: rowman & littlefield publishers. https://indiacode.nic.in/handle/123456789/2045?view_type=browse&sam_handle=123456789/1362 kaikini, the necessity of understanding disasters in the language of suffering, voices in bioethics, vol. 6 (2020) 5 5 voice, paul. 2016. “what do liberal democratic states owe the victim of disasters? a rawlsian account.” journal of applied philosophy. 33. no. 4: 396–410. 6 chmutina, k., von meding, j. a. 2019. “dilemma of language: “natural disasters” in academic literature.” international journal of disaster risk science. 10. 283–292. https://doi.org/10.1007/s13753-01900232-2 7 gaillard, j.c and peek, lori. 2019. “disaster-zone research needs a code of conduct.” nature. https://www.nature.com/articles/d41586-019-03534-z 8 guru, gopal. 2020. “a tragic travelogue.” economic and political weekly. 55, no. 19. https://www.epw.in/journal/2020/19/editors-desk/tragic-travelogue.html 9 guru and sarukkai give a detailed philosophical account of how the natural and social sciences employ this process of naturalization to suit their purpose of study in order to create their own objects. see guru, gopal and sarukkai, sundar. 2019. experience, caste and the everyday social. new delhi: oxford university press. 10 malpas, jeff and lickis, norelle. eds. 2007. perspectives on human suffering. springer. 11 guru, gopal and sarukkai, sundar. 2019. experience, caste and the everyday social. new delhi: oxford university press. 12 bourdieu, pierre et. al. 1999. the weight of the world: social suffering in contemporary society, trans. by fergusson, priscilla. stanford university press. california. 13 ibid. 14 kleinman, arthur, das, veena. and lock, margaret. 1997. social suffering. university of california press. berkeley. 15 ibid. 16 ibid. https://www.nature.com/articles/d41586-019-03534-z https://www.epw.in/journal/2020/19/editors-desk/tragic-travelogue.html dias, newborn screening laws, voices in bioethics, vol. 1 (2014-15) © 2015 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. balancing human subjects protection with public health benefits in newborn screening laws matt dias keywords: screening newborns, early detection introduction for more than fifty years, screening united states newborns has been a federal public health mandate designed to test infants within forty-eight hours of birth for a set of genetic diseases or conditions that are treatable—such as cystic fibrosis, sickle cell disease, and congenital adrenal hyperplasia. since the 1960s, newborn babies have been screened by newborn dried bloodspot screening (“ndbs”), an assay developed by microbiologist robert guthrie, which involves pricking the heel of a newborn and placing several bloodspots on a collection card made of special filter paper.1 the bloodspot card is then sent to a state laboratory for testing, usually within forty-eight hours of collection. if the newborn’s screening suggests a disorder, a lab technician immediately contacts the healthcare provider to coordinate clinical care. early detection and treatment is critical because it helps prevent lifelong disabilities or death.2 analysis since their inception, the state screening programs have allowed for the release of bloodspots for public health research. until recently, in all but a few states, 3 parental consent to use ndbs samples has been presumed, unless parents actively opt out. research projects involving the use of residual bloodspots require review by institutional review boards—a body of scientific and legal experts charged with protecting the privacy rights of the persons from whom the samples came. to ensure the privacy and identity of the newborn samples, the genomic data is protected. only public health related projects that are approved may go forward, and those that do must adhere to the approved research protocol.4 a recently enacted5 newborn screening law, the newborn screening saves lives reauthorization act of 2014 (“nsslra”), reauthorizes $20 million to continue funding for the state-based newborn screening programs described above. however, the law is deeply troubling to the biomedical research community and public health officials due to one of its provisions, which changes the scope of human subjects protection in connection with ndbs.6 section 12 of the nsslra (the “provision”) (i) reclassifies newborn dried bloodspot screening (ndbs) as research on human subjects, thereby requiring state health departments to obtain parental informed consent for deidentified newborn screening samples7 and (ii) eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried bloodspots.8 in a recent jama viewpoint, biomedical researchers and policy experts from the national institutes of dias, newborn screening laws, voices in bioethics, vol. 1 (2014-15) 2 health and the national human genome research institute warn that the provision on parental research consent can damage public health investigations. as such, these experts believe that more discussion is necessary before modifying the consent policies. they assert that requiring parental consent could reduce the number of samples available for research and therefore adversely impact newborn screening participation rates. this could produce long-term consequences, such as a dearth of biomedical research relating to certain rare diseases, such as leukemia, thereby disadvantaging affected populations. 9 given the potential of screening samples to benefit public health research—the cdc has even stated that ndbs “is one of the nation’s most successful public health programs”—it is unsurprising that the nsslra provision has alarmed public health officials.10 while it is true that the provision may hamper important research outcomes, it remains important not to lose sight of autonomy, a core principle of research ethics. as the experts note, “the issue over whether and how to obtain parental consent for health research on residual dried bloodspots represents a tension between respecting individual liberties and ensuring public health,” acknowledging the possibility for technicians to reidentify the samples. ultimately, the viewpoint concludes that “the importance of biomedical research for public health purposes is too great…to risk seriously adversely affecting the number of samples available for research.”11 all things considered, since research using bloodspots has been a tremendous public health success and is likely to increase, it may be worth considering a bifurcation of consent processes (e.g., making screening optout and research opt-in), thereby providing comprehensive information to parents in order for them to make a considered decision. another proposal that has gained traction among some bioethicists is to educate parents earlier—e.g., well before the pre-partum period.12 conclusion at this point, there remains considerable cross-state variability in the administration of newborn screening. while there have been some recent efforts to standardize state screening processes, such as the advisory committee on heritable disorders in newborns and children,13 newborn screening laws, including nsslra, must work toward developing a regulatory framework that is more palatable to both public health officials and concerned parents. 1 bridget kuehn, “after 50 years, newborn screening continues to yield public health gains,” jama 309, no. 12 (2013): 1215– 1217, doi: 10.1001/jama.2013.2087. 2 alan hinman, marie mann, and rani singh, “newborn dried bloodspot screening: mapping the clinical and public health components and activities,” genetics in medicine 11 (2009): 418–424, doi: 10.1097/gim.0b013e31819f1b33. 3 parents have sued health departments in minnesota and texas for retaining newborns’ bloodspots for research without consent. see “researchers spot reason for concern in newborn screening amendment,” genome web, june 17, 2015, https://www.genomeweb.com/scan/researchers-spot-reason-concern-newborn-screening-amendment and elizabeth cohen, “the government has your baby’s dna,” cnn news, february 4, 2010, http://www.cnn.com/2010/health/02/04/baby.dna.government/. 4 “frequently asked questions about newborn sequencing,” national human genome research institute, april 28, 2015, https://www.genome.gov/27556918. https://www.genomeweb.com/scan/researchers-spot-reason-concern-newborn-screening-amendment http://www.cnn.com/2010/health/02/04/baby.dna.government/ https://www.genome.gov/27556918 dias, newborn screening laws, voices in bioethics, vol. 1 (2014-15) 3 5 nsslr was signed into law in december 2014 and went into effect in march 2015. 6 the provision deviates from the current regulatory definition (45 c.f.r. §46.102(f)), which specifically defines human subject research as involving identifiable private information. the provision is in effect for up to two years after the 2014 law’s enactment, or until an updated common rule is released. for the common rule generally, see http://www.hhs.gov/ohrp/humansubjects/commonrule/. 7 per 45 cfr 46, the common rule defines human subjects research as activities in which (i) the research investigator receives samples through direct interaction with living individuals or (ii) the samples are linked to individually identifiable private information. since dried bloodspots are deidentified before researchers access them, research on dried bloodspots was interpreted not to be human subjects research—until the 2014 law. see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. 8 newborn screening saves lives reauthorization act of 2014, hr 1281, 113th congress, 2nd session, december 17, 2014, https://www.congress.gov/bill/113th-congress/house-bill/1281. 9 michelle bayefsky, katherine saylor, and benjamin berkman, “parental consent for the use of residual newborn screening bloodspots: respecting individual liberty vs. ensuring public health,” jama, june 8, 2015, doi: 10.1001/jama.2015.6175. 10 “newborn screening laboratory bulletin,” centers for disease control and prevention, february 21, 2014, http://www.cdc.gov/nbslabbulletin/bulletin.html. 11 see michelle bayefsky, katherine saylor, and benjamin berkman, “parental consent for the use of residual newborn screening bloodspots: respecting individual liberty vs. ensuring public health” and jeannie baumann, “newborn screening law could hamper important research, nih staff say in jama,” bloomberg bna medical research law & policy report, june 17, 2015. 12 mary carmichael, “newborn screening: a spot of trouble,” nature 475 (2011): 156–158, doi: 10.1038/475156a. 13 this committee was established under the public health service act in may 2015. the committee recommends that every newborn screening program include a uniform screening panel that screens for 32 core disorders and 26 secondary disorders (us dhhs, 2015). see u.s. department of health and human services, advisory committee on heritable disorders in newborns and children, http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/index.html. http://www.hhs.gov/ohrp/humansubjects/commonrule/ http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html https://www.congress.gov/bill/113th-congress/house-bill/1281 http://www.cdc.gov/nbslabbulletin/bulletin.html http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/index.html preston, neuro-interventions and the law, voices in bioethics, vol. 1 (2014-15) © 2015 joshua preston. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the atlanta neuroethics consortium: neuro-interventions and the law joshua preston bioethics, neuroethics, anec recently, i attended the atlanta neuroethics consortium’s (anec) conference on neuro-interventions and the law: regulating human mental capacity (september 12-14). hosted by professor dr. nicole vincent, it was my first foray into the “neurolaw” world. most of the attendees and keynote speakers were pulled from the macarthur foundation’s law and neuroscience research network, and because of this, i was impressed by the cross-disciplinary representation. the conference included experts in the biological sciences and psychiatry as well as legal scholars and practicing judges. additionally, i must add, it was free, which is the best price. the opening keynote from vincent laid out the major topics that would be explored over the next three days. in it she outlined her taxonomy of the relationship between responsibility and mental capacity (i.e., how does an individual’s cognitive abilities affect our expectations of them?). each panel addressed a different component of this taxonomy and the following breakout sessions further expanded upon it. the panels followed an interesting format in that each member was asked the same question and then proceeded to answer it from the vantage point of their own discipline. i am summarizing only three of the four panels (the last of which was on “neuroenhancement”), and as is apparent, more questions were asked than answered. sometimes, though, the mere recognition that questions exist is itself a valuable outcome. an edited volume of conference papers will be submitted to oxford university press to be considered for a part of its neuroscience, law, and philosophy series. additionally, video recordings of the conference will be posted online soon. if you are interested in learning more, i suggest reaching out to vincent through her personal website. panel 1: “should a neurointervention be a condition of release from prison for sex offenders?” most of the discussion focused on chemical castration and its ambiguous effects on recidivism. in some states, it is offered as a condition of early-release and several panel-members were skeptical about the illusion of “choice” it presented. is it really a “choice” if the alternative is draconian? justice david e. nahmias of the georgia supreme court raised an interesting point: the moral discomfort with most neurointerventions stems from its intrusiveness and unintended side-effects. yet, the legal system already mandates non-intrusive neurointerventions such as anger-management classes and addiction treatment. in fact, as the brain is constantly rewiring itself in response to its circumstances, it is impossible to do otherwise. what if the same effect could be achieved with a medical procedure? should the individual’s consent matter (they have no choice to attend anger-management classes)? http://global.oup.com/academic/content/series/o/oxford-series-in-neuroscience-law-and-philosophy-osnlp/?cc=us&lang=en& http://nicolevincent.net/ preston, neuro-interventions and the law, voices in bioethics, vol. 1 (2014-15) 2 panel 2: “can neurointervention restore an insane inmate’s competency for execution and, if so, should it?” by raising an issue that, in my opinion, will be irrelevant when capital punishment is banned, this question forces one to address the philosophical questions on its peripheries. this was the most lively panel, i thought, and included a brilliant line-up: vincent, stephen j. morse, francis shen, and andre m. davis, a senior judge on the us court of appeals (fourth circuit). each was assertive in their opposition to capital punishment, but the conversation hovered around why we punish. how does an inmate’s incompetency tangle what, in lesser circumstances, seems straightforward? by treating an individual’s illness merely to kill them, it is unclear how the intervention deters others and, because the inmate dies, how it rehabilitates. it seems solely to satisfy retributive desire. after all, it is only possible to give someone their “just deserts” if they are able to comprehend and appreciate the punishment directed toward them. as morse said, if the individual is not competent, “you’re giving [the death penalty] to the wrong person and not the person convicted.” for example, no longer are you executing someone who in a calm, collected manner planned a heinous crime; instead, you are punishing someone who may have no grasp of where they are and why. in the worst cases, you may as well be executing a dog. panel 3: “what standards apply to dangerous, pre-trial detainees when it comes to involuntary neurointervention?” this panel focused on the case of jared lee loughner, the arizona shooter who targeted u.s. rep. gabrielle giffords. following the 2011 shooting, loughner was forcibly medicated with antipsychotics to restore his competency for trial. this set off a year-long legal battle that resulted in the courts ruling it was necessary to ensure his as well as others’ safety. as an extension of the previous panel, this raises questions relevant to the insanity defense: if someone is delusional when they commit a crime, what is the point in punishing the saner version of himself? is it fair to blame someone when they are suffering from undue influence -not a gun against their back but an illness that affects their very perceptual reality? during the discussion, vincent raised a valuable point, “who is competent to participate in a trial?” currently, we put an emphasis on eye-witness testimony, but contrary to our instincts, it is pretty unreliable. and what about those we expect to have insight into their own motivations (introspection illusion)? “maybe what we’re coming to,” added vincent, “is the conclusion that there’s something uncomfortable about the idea of retribution.” i think so, and rather than satiating the desire of vengeance, the goal of the legal system must always be the prevention of crime and the reintegration of individuals into society. http://agora.stanford.edu/sjls/issue%20one/fisher&tversky.htm http://en.wikipedia.org/wiki/introspection_illusion reaves, self-tracking pills, voices in bioethics, vol. 1 (2014-15) © 2015 michael reaves. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. self-tracking pills: medical adherence in the twenty-first century michael reaves keywords: medical adherence, self-tracking pills introduction what if your prescription pill contained a microchip inside of it? yes, a microchip inside of a pill. a piece of silicon, magnesium, and copper no more than one millimeter wide. a combination that creates an electrical circuit when exposed to stomach acid. within minutes of reacting to gastric acid, the microchip relays electric pulses to a stick-on patch attached to the patient's navel. the patch wirelessly syncs to the patient's mobile device and the data is automatically transmitted to the physician. in essence, a doctor can now track a patient's medical adherence electronically. analysis self-tracking pills will no doubt improve the ability of medical professionals to monitor patients and their prescription use, an effort that has failed in recent history. in the united states, 50 percent of all prescriptions are not taken as prescribed by the physician.1 nonadherence has been a problem in primary and secondary healthcare; individuals with chronic issues such as diabetes or high cholesterol are at a higher risk of developing serious health complications if they take prescriptions irregularly. furthermore, some populations with mental illness are more likely to hurt themselves or others if they do not abide by their prescription regimen.2 proteus digital health, the developer of the self-tracking pill and patch, has set its sights on combating medical nonadherence with the release of proteus discover, which gained patent approval in 2012.3 proteus insists that using this new technology will cut costs and reduce waste in the healthcare industry. a doctor who knows whether his or her patient is taking the correct dosage will be able to diagnose and treat that patient more efficiently. improving tracking efforts will allow preventative and secondary care to become more seamless for both the patient and physician. reaves, self-tracking pills, voices in bioethics, vol. 1 (2014-15) 2 not futuristic enough for you? try pill #2. the us patent and trademark office is reviewing a new patent submitted by inventor and chairman of new york college, donald spector. so what is different about spector's magic pill? similarly sized micro-tracers are placed inside of the pill. however, when digested, these tracers transmit the exact blood concentration of a particular drug in the patient's system directly to nearby supercomputers. no intermediary device or patch is required with spector's pill, unlike that of proteus discover. the exact science behind these microprocessors and how they transmit the data on the digestion of drugs has not yet been released to the public, as it is still pending approval in 2016.4 spector has also filed patents to monitor the state of individuals via a biological sensor attached to the wrist. in this way, a remote receiver can track the health status of an individual and send alerts to various entities in the case of an emergency.5 the most prolific living inventor you have never heard of, spector holds patents in hundreds of products in areas ranging from toys and crafts to telecommunications and healthcare science. he has resources at his disposal as well, filing inventions under new york college's intellectual property (ip) policy. spector believes that the introduction of this technology will greatly reduce both death attributed to nonadherence as well as instances of violence in susceptible populations. as he stated shortly after the newtown tragedy of 2012, "everyone mourns in their own way; for me, i find hope in trying to change the future and prevent these kinds of tragedies. the massive problems of our society in medicine, economics, and energy are not going to be solved by politicians; they will ultimately be solved by science."6 however, how the public and politicians receive this health advance will determine the scope of its impact. will pill-tracking become a staple in primary and secondary care, or is something about these technologies ethically troubling? medical paternalism is one concern that appears to stand out. technology such as this can be implemented into state monitoring programs to ensure medical adherence. some bioethicists, such as arthur caplan of nyu, believe there are valid concerns regarding the use of systems like proteus or spector's super pills. in an interview with abc in 2013 that covered the filing of spector's patent, caplan presented a slippery-slope argument for why acceptance of the practice may lead to ethical violations. 7 using this technology for conditions like heart disease and diabetes are incredibly valuable, but what about other conditions in which the patient and the public will benefit? what are the limits? caplan contends that this technology may be used to target individuals with a criminal past, a history of violence, or who are mentally ill. these practices, he contends, may lead to an encroachment on the civil liberties of privacy and confidentiality. keeping tabs on ex-convicts or those with a mental illness may be beneficial to society, but enforcing an individual to take a pill seems to go against the traditional concept of patient autonomy. furthermore, invasion of privacy may discourage patients from being compliant in their medical care and may encourage distrust between a patient and medical professional. while caplan’s points are well taken, there are legal protections guarding citizens that assuage many of his concerns. a majority of patients who will end up taking advantage of this technological advance will do so voluntarily after giving informed consent. additionally, it would require a court order to force any patient who is non-adherent to follow a prescription regimen. public opinion may be swayed on this topic when instances of violence take place in society. for example, the public is likely to favor legislation requiring those who exhibit signs of violence to adhere to their prescription regimen after a tragedy or mass shooting. conclusion donald spector believes that his patents will be utilized to the extent that public policy allows. it is not up to him, he believes, to decide the limits of his innovations. as he notes, "who the supercomputer delivers that information to is more going to be the result of legislation rather than the invention."8 as these advances in healthcare science become more prevalent, public perception and reception, along with the help of those trained in medical ethics, will decide the limits of these technologies. reaves, self-tracking pills, voices in bioethics, vol. 1 (2014-15) 3 1 brown, marie t., and jennifer k. bussell. "medication adherence: who cares?" mayo clinic proceedings vol. 86 (4): 304–314 (april 2011). mayo foundation for medical education and research. doi: http://dx.doi.org/10.4065/mcp.2010.0575. 2 fazel, seena, johan zetterqvist, henrik larsson, niklas långström, and paul lichtenstein. "antipsychotics, mood stabilizers, and risk of violent crime." the lancet 384.9949 (2014): 1206–214. 3 body-associated receiver and method. proteus biomedical, inc., assignee. united states patent #8114021. february 14, 2012. http://patents.justia.com/patent/8114021 4 stuart, hunter. "pill-tracking device could monitor whether you're taking your medication." the huffington post. http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html 5 "sensor with remote communications capability." us patent application for patent application (application #20130241728, issued september 19, 2013). http://patents.justia.com/patent/8823512 6 "following newtown tragedy, inventor takes aim at controlling violence from mental illness." december 20, 2012. prnewswire. http://www.prnewswire.com/news-releases/following-newtown-tragedy-inventor-takes-aim-at-controllingviolence-from-mental-illness-184252131.html 7 lupkin, sydney. "invention would track meds in mentally ill patients, but is it ethical?" abc news. abc news network, january 21, 2013. http://abcnews.go.com/blogs/health/2013/01/21/invention-would-track-meds-in-mentally -ill-patients-but-is-itethical/ 8 stuart, hunter. "pill-tracking device could monitor whether you're taking your medication." the huffington post. http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html http://patents.justia.com/patent/8114021 http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html http://patents.justia.com/patent/8823512 http://www.prnewswire.com/news-releases/following-newtown-tragedy-inventor-takes-aim-at-controlling-violence-from-mental-illness-184252131.html http://www.prnewswire.com/news-releases/following-newtown-tragedy-inventor-takes-aim-at-controlling-violence-from-mental-illness-184252131.html http://abcnews.go.com/blogs/health/2013/01/21/invention-would-track-meds-in-mentally%20-ill-patients-but-is-it-ethical/ http://abcnews.go.com/blogs/health/2013/01/21/invention-would-track-meds-in-mentally%20-ill-patients-but-is-it-ethical/ http://www.huffingtonpost.com/2013/01/24/pill-tracking-device_n_2535466.html winter 2015 hipaa insanity david hoffman follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 thanks to an article in the new york times on the hipaa privacy rule, i favor a new definition of “insanity.” i used to think of insanity as repeating the same behavior and expecting a different outcome. it is a timeless and classic definition but lacks the medical relevance and topical urgency of my new favorite definition in the electronic age. it is brought to us by the new york times’ article posted on august 9, 2014, entitled “baby pictures at the doctor’s? cute, sure, but illegal.” insanity can now be defined as applying an ethically grounded federal regulation in such a way that leaves well-intentioned clinicians unable to experience an essential joy of their profession. what is insane about this article is its complete and utter mangling of both the intent and the actual language of the rules regarding medical record privacy that we all have come to know as hipaa. the fatal flaw in the argument put forward by the author and the “authorities” that she cites is the notion that any information whatsoever given to a doctor by someone who is or has been a patient is covered under the rules that we call hipaa. the practice of parents sending in pictures of their children for posting on the walls of their obstetrician’s or pediatrician’s offices is a proud and joyous one, which was neither intended to be infringed upon, nor actually, legally, infringed upon by the adoption of the hipaa privacy regulations. the reason for this legal conclusion is threefold. first, a photograph taken by a parent outside the context of medical treatment is by definition not health information. it is both axiomatic and obvious that anything which is not health information cannot be protected health information. second, even if the photograph is of a patient, if the photograph is not identifiable as that of a particular patient, as is typically the case with baby pictures, it is not individually identifiable. the hipaa regulations contain extensive descriptions of permissible de-identified pieces of protected health information. however, the regulations are clear that the information, in this case a photograph, has to be protected health information in the first place, in order to necessitate de-identification and conform with hipaa standards. the third and most important reason that this practice is not prohibited by the hipaa regulations is whether that photograph might be health information in a different context that has no relation to medical treatment. if that is the case, then it is certainly not the health information of that clinician. patients have an unrestricted right to do whatever they want with their health information, including posting it to the internet, or even on a highway billboard, if they want. in certain situations information supplied by a patient when it is received by a clinician for clinical purposes, and incorporated into the patient’s medical record can become protected health information. when that information is supplied for the purpose of, and used for the purpose of diagnosing, treating or preventing illness in individual concerning whom the doctor has receives the information, it becomes protected. for example, if the picture was supplied by a parent, but maintained by the doctor for the purpose of monitoring the progression of a skin disease, that would constitute conversion of the document to protected health information. but if a patient, perhaps one with a longstanding relationship with his or her doctor, were to supply a recommendation for an italian restaurant; that information would never become protected health information simply because it is not health information. the same can be said of baby pictures offered for public posting by glowing new parents. voices in bioethics 3 there are some notable exceptions to the general rule for information that can be considered protected health information. an important example, one which directly relates to the initial hysteria over posting patients’ names outside their doors, is being able to identify a particular patient based on which physicians’ specialty necessarily reveals the patient’s diagnosis. for example, if a patient is admitted to the hospital on a general medical surgical floor it is common practice for that patient’s name to be posted on the door, in order for clinicians to properly identify which patient is intended to receive which treatment. that is not a hipaa violation. but if that patient were to be admitted to a surgical floor specifically designated for treatment of patients with hiv, then posting that patient’s name would disclose the patient’s hiv diagnosis. while it is not specifically addressed in the hipaa privacy regulations, posting the names of individuals particularly those with distinctive names or those residing in a small town with very limited choice of health care institutions might constitute a hipaa violation. it is therefore an appropriate exercise of medical judgment by clinicians treating hiv patients not to post patient names in a publicly visible location specifically designated for treatment of individuals with that diagnosis. the concern that drove congress to first propose the adoption of a medical record privacy rule has been characterized, as a conversation between a doctor and the ceo of a medical device supply company on the proverbial golf course. as the story goes, the ceo says to his physician friend, “boy do i waste money on all the advertising i do for my business. i would really like to be able get my hands on a list of patients who have diabetes so i don’t have to advertise in the newspaper to thousands of people who will never be customers for my diabetic testing supply business because they don‘t have diabetes. but where could i find such a list?” the physician responds, “oh, i have lists of patients of mine who are diabetic and i can’t see any reason in the world why i shouldn’t be able to give them to you.” the obvious sequela of such golf-course-dialogue is the creation of a booming market for such lists. in fact the practice of sharing patient information for commercial marketing purposes is well established and for a time was considered an entirely legitimate and beneficial form of medical commerce. with the adoption of the hipaa privacy regulations those practices became unlawful and doctors became well informed of their obligation to maintain the privacy of patient medical information. this is referred to under the hipaa regulations as protected health information (phi), absent the explicit written consent and authorization of the patient to the release of that phi for specific and appropriate purposes. the insanity that is the purported or alleged prohibition on posting photographs of babies born to particular obstetrical practices arises from the same lack of common sense and regulatory insight that produced the early restriction, on putting the name of a patient on the door to his or her hospital room. an interesting case that falls along the middle of the spectrum of permissible and impermissible identification of patients and their conditions arises when patients are admitted for treatment at hospitals that specialize in the treatment of one broad category of disease. the paradigm example of this phenomenon is of course the prevalence of voices in bioethics 4 hospitals that are dedicated solely to the treatment of cancer. it is worth noting that at most, if not all specialized cancer treatment hospitals, patients’ names are posted on the door to enable clinicians to identify the appropriate individual to receive a particular treatment. the distinction between the appropriateness of name posting for cancer patients and the appropriateness of naming posting for hiv patients derives from the social stigma attached to one diagnosis versus the other. the point that this distinction illustrates is that hipaa and its privacy regulations, as specific and detailed as they are, cannot provide clear guidance as to how they should be implemented in each and every clinical situation. however it is clear that hipaa is only intended to provide protection of patients’ privacy with regard to protected health information, which must always be actual health information. in context of the preceding hipaa evaluation, baby pictures sent to show a physician their happy thriving patients are fine. ducar, the need for dialogue before editing human embryos, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the need for dialogue before editing human embryos dallas ducar keywords: gene editing, ethics, research ethics introduction an ethical line may have recently been crossed, stirring up long-lasting debates on the ethics of manipulating the human genome. the research under scrutiny was conducted in guangzhou, china by a gene-function researcher at sun yat-sen university, junjiu huang and his team of researchers. the group utilized a well-known technique known as crispr/cas9. the method utilizes an assemblage of molecules that researchers can target at stretches of dna and slice and replace the strands. analysis researchers are now able to synthesize molecules that can bond themselves to specific locations on dna strands within any individual cell. the location can then be sliced out utilizing enzymes, and researchers can supply a differing version of the dna to incorporate itself where the original strand was. overall the researchers had injected 86 embryos, 71 survived long enough to study. however, researchers using crispr/cas9 were only able to splice dna from a very small number of embryos, and a much smaller percentage was able to take up the new dna segment. in the end, the study was stopped because the authors thought the process was too immature. recently researchers from various countries have called for a moratorium on human embryo modification. if this procedure had been successful, it would enable new genes to manifest within the cells while the embryo is developing. this technique is so powerful that it has been suggested for use in personalized medicine, novel drugs, and human genome modification. editing human embryos is contentious because, in theory, any changes made to the genetic line can be passed along to successive generations. however, the jury is still out on whether huang and his research team’s experiments count as germline modification because the embryos were fertilized with two sperm cells. in these cases the embryos start dividing normally, however the atypical assortment of genes halts the developmental process before it goes too far. one issue associated with this process is that it results in mosaics, a combination of edited and unedited cells. the problem with this is that if a clinician desires to know if the patient is disease-free, the clinician must sample a cell to come to a diagnosis. a cell from a mosaic has the probability of being either edited or unedited, which may result in an incorrect conclusion. a second issue that arises from editing the germline results from the molecules binding with an unanticipated portion of the dna. if the dna is synthesized at an incorrect area it would fail to ameliorate the disease and could possibly create a novel disease of its own. moreover, increasing the dose of nuclease ducar, the need for dialogue before editing human embryos, voices in bioethics, vol. 1 (2014-15) 2 used would also increase the probability that more slices would be made elsewhere in the genome. overall, the process could result in more harm than benefit. perhaps most importantly, genome editing within human embryos using these current methods could result in long-term unpredictable effects on subsequent generations. before proceeding with such work, researchers must first be able to demonstrate safe outcomes and reproducible data over many generations. currently, it is unclear what risks are present in such a procedure and in many cases the risks are impossible to know until after birth. regarding research, those who wish to investigate genetically engineered cells in human populations must ensure informed consent. in these cases, it is unclear what information would be essential and accessible to inform prospective parents of the very real risks this may pose towards their children, and successive generations. conclusion it is quite clear that while the implications of such research remains unknown, there is a global imperative to engage in dialogue regarding humanity’s role in genetic engineering. now that humans are capable of editing the human germ line, researchers, policy-makers, and scientists must engage in substantial dialogue. guidelines and regulations must be established regarding how to continue immediately, and whether it is morally acceptable to research within germline engineering. the results of this one experiment do not imply that all others who utilize this method will also end poorly. genetic engineering attempts have become increasingly successful in the past ten years and the crisp/cas9 may demonstrate a similar trajectory. simply because we can do this does not mean we should. before continuing, we need generations of replicable data and to be able to demonstrate safe outcomes for all those involved. curtis, research in developing countries, voices in bioethics, (2013) © 2013 henry curtis. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. an advocacy of a modified double standard for research in developing countries henry curtis keywords: international research, efficacy, research ethics advances in medical technology and treatment procedures have brought about a need for international research. new medications are being developed that are designed specifically for developing areas across the world. these treatments are less costly, easier to use, they represent a massive shift in the focus and goals of pharmaceutical companies. however, this trend has also led to a change in how research is conducted. with treatments directed towards individuals in developing nations, research must occur in these regions in order to determine efficacy for the intended population. to perform this research, some investigators decide to use placebo trials despite the availability of better treatments with which to compare the trial medication. they justify this by claiming that the better treatments can be quite costly and are widely available only in developed nations. the standard of care in the developing nation where research is being conducted is quite different from the researcher’s native country and it does not mandate that certain expensive options be used. this presents us with an interesting ethical dilemma. which ethical standard of care ought to be followed when conducting international research? the standard of care delineates how the research is conducted, the level of compensation provided for subjects, and what ancillary care is provided to said subjects amongst other factors. there are two options available. the first is a single standard based upon the best possible treatment options available, echoing the standards of research used in developed nations, implying that researchers cannot use placebos unless absolutely necessary and ancillary care that would be provided in a study in a developed nation would be provided in this case. a contrasting standard allows researchers to tailor their practices to the location in which their research is conducted. if an alternative medication is not widely available to test against, placebo trials are used and ancillary care is provided based upon what the standard of care is in the nation where the study is occurring. so which should researchers default to? do they have an obligation to provide the best possible alternatives or are placebos acceptable curtis, research in developing countries, voices in bioethics, (2013) 2 for foreign research? does the ancillary care provided have to be the best option available? the answers to these questions are not explicit in the current debate . in fact, the best solution for international research is a blend of the two models that prevents researchers from conducting studies based upon the lowest common ethical denominator and does not require the provision of treatment only available to the wealthiest individuals. in order to understand this mixed approach, let us first examine both standards. the desire for a single standard rose from the need to protect subjects of research in developing nations. the lowest common denominator argument1 illustrates this point perfectly. researchers often find that the legal standards required to perform research are often less strict in developing nations. studies that would get denied instantly by an institutional review board in a developed nation are accepted and sometimes encouraged in the developing world. because of these lower standards, researchers would act to the lowest common ethical denominator. instead of acting as they would in a study based in their home country, researchers can maintain minimal standards for their experiments. they do so by denying ancillary care and conducting placebo trials since the comparative treatment options that would be mandated in developed nations are not available in less developed areas. they do enough to minimize the harm caused to their subjects, but nothing more. however, ruth macklin argues that if we have any belief in the concept of beneficence, researchers need to do more: if the principle of beneficence has any relevance to the conduct of research, it requires researchers to maximize benefit in as well as to minimize harms. since the research subjects themselves are surely among those who should be counted in seeking to maximize benefits, it follows that providing a higher standard of care during the research, when that is feasible, is ethically preferable to providing the minimal standard dictated by background conditions in the country or region.2 essentially, researchers cannot simply minimize harm to the subjects they are experimenting on and call it a day. since the goal of research is to create a treatment that would maximize benefits, that maximization ought to apply in the research process as well as in the results. despite dr. macklin’s argument, the single standard approach does have its drawbacks. the primary issue is the problem of undue inducement. the research pool for a study is considered less valid if the subjects are unduly induced into entering the experiment. essentially, researchers cannot give participants an offer they cannot refuse in order to increase the number of enrollees. undue inducement presents us with two unique dilemmas. first, it entices people to enter into a study that they would not participate in normally. for example, if a researcher paid a high level of compensation for a study performed in a lower income area, people would be clamoring to enter. however, they would be participating for reasons other than the point of the research, tainting the results. this issue would be magnified if researchers entered a developing nation promising ancillary care that individuals would never be able to afford or receive otherwise (for example, prescription medications or therapies that require specific infrastructure or have an excessive cost). this undue inducement of participants makes the outcome of the study questionable at best. this is also ethically problematic because people could be forced into participating in research in order to receive healthcare that they would not get otherwise. although it is not outright coercion, undue inducement still persuades individuals to be subject to potentially dangerous research for dubious reasons. this element of undue inducement violates two of the primary tenets of principlism. first, it violates autonomy because the individual has their choice removed from them via the level of ancillary care provided. they are presented with an offer they cannot refuse. https://mail-attachment.googleusercontent.com/attachment/u/0/?ui=2&ik=df30678cb2&view=att&th=141a0312b87975c1&attid=0.1&disp=vah&realattid=f_hmikb4hz1&safe=1&zw&saduie=ag9b_p-a6jyjrf7pw_xvwndr02xq&sadet=1381462931986&sads=jy4szktjv9ibtkz_evieentqvfs#0.1_footnote1 https://mail-attachment.googleusercontent.com/attachment/u/0/?ui=2&ik=df30678cb2&view=att&th=141a0312b87975c1&attid=0.1&disp=vah&realattid=f_hmikb4hz1&safe=1&zw&saduie=ag9b_p-a6jyjrf7pw_xvwndr02xq&sadet=1381462931986&sads=jy4szktjv9ibtkz_evieentqvfs#0.1_footnote2 curtis, research in developing countries, voices in bioethics, (2013) 3 excessive ancillary care pushes individuals into the study instead of having them enter as willing participants. second, undue inducement harms justice because an individual is exposed to risks that they would not normally have to face. inducement makes individuals agree to do things they would not do otherwise. participation in a trial under these circumstances is unjust. while the four principles can never be perfectly met and are sometimes at odds with each other, we cannot ignore the problem that undue inducement presents. the second dilemma presented is a more logistical one. since individuals in developing areas will be clamoring to enter the study because of the benefits provided, they may falsify medical information in order to gain entry. in developing countries, records are often poorly kept, so what the individual tells the researcher about their medical history is all that the investigators will get. over-the-top ancillary care will make people lie about pre-existing conditions in order to become research subjects. this has two implications. first, the data collected becomes questionable at best. a pre-existing condition could interfere with the results of the study, possibly pushing researchers towards a false conclusion. second, the trial medication could have adverse effects on the individual because of their undisclosed health issues. if the subject lies to the investigator about conditions that would conflict with the study, they cannot be informed about potential risks specific to their case. the double standard follows a more pragmatic approach. researchers argue that since they are conducting research in a different nation, they should follow the ethical guidelines of wherever the study is taking place. as mentioned previously, this leads to placebo experiments and the inadequate provision or the outright denial of ancillary care. those who conduct experiments in developing nations claim that since the best or most advanced treatment in the world is not available in the country where they are conducting research, they are not obligated to provide them. additionally, some claim that it is feasibly difficult to actually operate or distribute the best available option. some medications are just too expensive for a researcher to provide without increasing the cost of the study too greatly. however, is the increased cost of using the best treatment instead of a placebo enough to outweigh maximizing the benefits for the research population? most would argue no. at the point at which researchers are using disadvantaged subjects to test a medication that will create a profit for the sponsoring organization, the participants ought to be due something a bit better than a placebo. on top of this, the double standard bites into macklin’s lowest common denominator argument. when it comes to the lives of individuals, there is no reason to operate at the lowest ethical standard. since participants in research are subject to potentially dangerous experimental medication, they deserve better than the easiest standard that researchers could manage to meet. so who is right? which standard ought to be applied? in my estimation, the correct answer is both. to be more specific, i believe in a modified double standard. by providing the best possible treatments and meeting the standard of care in developed nations, researchers are forced into a difficult burden of paying for and providing medication that is only readily available in wealthy areas and unduly inducing individuals into participating, which could taint the value of their research. however, researchers have a greater obligation to their subjects than to provide absolutely nothing. therefore, i believe that researchers should provide ancillary care that is not overly difficult to provide such as medications that are available to the average citizen in their home country that might not be for individuals in developing nations. also, researchers should not be able to use the lower standard of developing nations in order to skirt around basic procedural practices such as maintaining a clean and safe testing environment or keeping adequate records and results. doing so maximizes the benefits of research participants to a point that triggers much less undue inducement than the single standard would. curtis, research in developing countries, voices in bioethics, (2013) 4 there are two arguments that could possibly be used to counter the modified double standard. first, some individuals claim that undue inducement will occur anyway. even the medication being tested is more than individuals in developing areas would be able to receive on a regular basis, meaning that they could be induced to participate in the study regardless of any ancillary care. however, this is a burden that all studies carry. no matter what, there will be an element of inducement. nevertheless, researchers ought to attempt to minimize undue inducement as much as possible. the less that undue inducement occurs, the less likely the subject pool will be tainted by those who participate for faulty reasons. the level of inducement provided by the research itself pales in comparison to what providing the same level of healthcare that developed nations receive would cause. even though some inducement is inevitable, the modified double standard reduces it as much as possible in order to preserve the quality of results. a second argument that could be used against the modified double standard is that researchers have a greater obligation to provide justice and equity than to preserve the subject pool. as stated before, individuals participating in risky experiments ought to be due more than just a placebo and some tylenol. instead, the just thing to do would be to provide the best available treatments instead of a placebo and to give ancillary care comparable to what would be offered in a study conducted in a developed nation. however, one cannot ignore the harm that undue inducement causes. if providing a level of ancillary care unlike anything research participants could ever get on their own nullifies the results of the experiment, then the individuals involved in the study subjected themselves to potentially dangerous research for nothing. one must consider the scope and future results of research before making claims about justice. if providing a lesser level of ancillary care means the results of research are preserved and can go on to help future generations of individuals in developing nations, then it is more just. at the end of the day, it is clear that participants in international research are due more than the lowest common ethical denominator concerning standard of care. however, we cannot harm the results of research by forcing researchers to provide the best available treatments and care in the world. therefore, researchers ought to use the modified double standard proposed earlier. it avoids the pitfalls commonly associated with the traditional double standard while placing realistic burdens on researchers to provide care for subjects as much as possible. because it preserves the outcome of research while still providing participants in experiments clear benefits, the modified double standard is the best compromise to use in international studies in developing nations. photo by andrew stutesman on unsplash reference notes 1 ruth macklin, double standards in medical research in developing countries, (cambridge: cambridge university press, 2004), 59. 2 ibid https://unsplash.com/@drewmark?utm_source=unsplash&utm_medium=referral&utm_content=creditcopytext https://journals.library.columbia.edu/s/photos/map?utm_source=unsplash&utm_medium=referral&utm_content=creditcopytext donna hanrahan, concussions in sport, voices in bioethics, 2013 © 2013 donna hanrahan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. concussions in sport: nfl carrying the ball toward change in brain injury policy donna hanrahan keywords: sport, concussions, concussions have long been the dominant subject of concern in the sports world and are a serious concern in public health. this august, the national football league (nfl) settled a lawsuit brought by more than 4,500 players and their families. the plaintiffs accused the league of concealing information about the dangers of repeated hits to the head, including minor traumatic brain injury (mtbi), concussions, and most significantly, chronic traumatic encephalopathy (cte), a degenerative brain condition similar to alzheimer’s disease. the $765 million settlement will be available to all retired players with neurological problems, not just the plaintiffs. this settlement marks an important shift in policy not only for the nfl, but also for other contact sports at all levels of play. as a part of the settlement, a $10 million research fund will be established. the league will continue to modify its medical protocols for concussions and change its rules to make the game safer in light of new scientific research. one of the most promising sectors of research is the use of advanced information technology to develop safer helmets and high-tech sensors to detect injury. however, it remains to be seen whether these advancements will significantly reduce incidence or severity of concussions on the field. until relatively recently, the nfl has remained on the sidelines when i t comes to brain injuries and their associated long-term neurodegenerative pathologies. in fact, the plaintiffs maintain that the nfl failed to properly warn players about how concussions could affect their brain functions after they retired until 2010. further, they attest that the league did so despite available scientific evidence about the risks, thus failing to regulate the sport in a manner that would prevent brain injuries in accordance with this knowledge. the nfl denied knowingly misleading players about head injuries, maintaining that its concussion policies relied on the best science available at the time. with millions of children and adolescents playing football in the united states alone each year, now is the time to push new policies over the goal line to avoid further concussion-related brain injuries like cte. further ethical and legal analysis of the nfl concussion litigation is necessary to determine its effect on the development of policies to ensure safer conditions for players. "n.f.l. agrees to settle concussion suit for $765 million" by ken belson, august 29, 2013. the new york timeshttp://www.nytimes.com/2013/08/30/sports/football/judge -announces-settlement-in-nfl-concussionsuit.html?smid=tw-share&_r=1&&pagewanted=all http://www.nytimes.com/2013/08/30/sports/football/judge-announces-settlement-in-nfl-concussion-suit.html?smid=tw-share&_r=1&&pagewanted=all http://www.nytimes.com/2013/08/30/sports/football/judge-announces-settlement-in-nfl-concussion-suit.html?smid=tw-share&_r=1&&pagewanted=all hill, the texas ruling and undue burdens, voices in bioethics, vol. 1 (2014-15) © 2015 rachel hill. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the texas ruling and undue burdens rachel hill texas, supreme court, abortion introduction on october 29, 2013, texas house bill 2 (hb2) went into effect, greatly changing women’s access to an abortion in the state. this bill requires that physicians performing clinic-based abortions obtain admitting privileges at a hospital within 30 miles of the clinic. a few months later, on january 1, 2014, the texas health and safety code was amended to include the requirement that all abortion clinics must meet the standards of an ambulatory surgical centre. these requirements will result in heavy burdens for women seeking an abortion. many clinics cannot afford the upgrade and are being forced to close down. analysis on august 29, 2014, a federal district court for the western district of texas ruling to overturned the two proposed requirements. the court deemed them unconstitutional violations of a woman’s right to obtain an abortion recognizing that their purpose was to create obstacles for women. the ruling was appealed and the federal appeals court allowed for the new regulations, forcing all but eight clinics in texas to close their doors. before the enactment of hb2, there were approximately 40 abortion clinics serving texas’ population of about 26 million. the new regulations would force all except eight clinics to close down. the remaining clinics are located in four cities (houston, austin, san antonio, and dallas) forcing many women to travel hundreds of miles to access them. for some, it is more feasible to leave texas to go to an abortion clinic outside the state. even if every woman seeking an abortion was able to travel to one of the remaining clinics, the clinics could not meet the demand. both of these requirements, the ambulatory surgical requirement and the admitting privileges requirement, constitute an undue burden for women. but what about the physicians? these requirements also place an undue burden on physicians who want to perform abortions. for affected physicians, it is difficult or impossible to obtain admitting privileges at a nearby hospital. many hospitals are denying these privileges to physicians because the hospitals have no interest in participating in performing abortions and gain nothing by allowing it. if the majority of abortion clinics are forced to close down, physicians who want to perform abortions would have to relocate to one of the four cities mentioned previously, or even leave the state. women seeking an abortion have to travel to the clinic once or twice. physicians would have to relocate permanently. conclusion hill, the texas ruling and undue burdens, voices in bioethics, vol. 1 (2014-15) 2 much of the focus of these rulings has been on women’s rights and what constitutes an undue burden for women. in addition to this, physician’s rights should also be considered. there have been several cases of doctors facing harassment and even death threats for performing abortions. fear of such treatment has led to many doctors to decline to perform abortions. doctors do not have an obligation to perform abortions, but it is within their rights as physicians to do so. however, given this harsh treatment by anti-abortion groups, not a lot of doctors are willing. the new regulations will leave open clinics in four cities in texas making it more difficult for those few doctors who want to perform abortions to do so. the new regulations impose undue burdens on women and doctors alike. on tuesday, october 14, the supreme court struck down the new requirements allowing thirteen clinics in texas to reopen. introduction conclusion van geem, ebola patients and the ethics of unilateral dnr orders, voices in bioethics, vol. 1 (2014-15) © 2015 kevin van geem. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ebola patients and the ethics of unilateral do-not-resuscitate orders kevin van geem dnr, ebola, bioethics introduction the bioethicist joseph fins, m.d. recently called for unilateral do-not-resuscitate (dnr) orders for all patients suffering from ebola virus infection. 1 if dr. fins’ suggestion is adopted it will mark the first time unilateral dnr orders will be made based solely on infection status, and not on individual prognosis. his thoughtful argument is based in the principle of non-maleficence and the concept of futility. despite this dr. fins fails to adequately address the popular misconceptions of dnr orders as “giving up” and letting patients die.234 as a result, dr. fins’ well-reasoned call for unilateral dnr orders may inflict unintended harms to patients suffering from ebola hemorrhagic fever. the course of action that strikes an appropriate balance between ethical action and practicality should be a clear, in-depth conversation with patients and their loved ones about the limitations of ebola critical care in the event of cardiopulmonary arrest, the initiation of preventative intubation or extracorporeal membrane oxygenation (ecmo) before a patient arrests, and the provision of limited cardiopulmonary resuscitation in the event of arrest. analysis while dr. fins argues for unilateral dnr orders for all ebola patients from an ethical standpoint, a dnr may be justified based solely on healthcare workers’ inability to provide cardiopulmonary resuscitation (cpr) for ebola patients. cpr requires a team of physicians, nurses, and a respiratory therapist. in the event of a “code blue” (i.e., patient’s cardiopulmonary arrest), any physicians, nurses, and respiratory therapists not involved in the patient’s routine care, but necessary for cpr would need to put on their required personal protective equipment (ppe) before helping the patient. depending on the protocol, 10 to 28 steps are required to properly put on ppe.5,6,7,8 in an emergency (e.g., cardiopulmonary arrest), these steps will either take too long for healthcare providers to successfully attend to the patient, or the healthcare providers may accidently skip, or err on any given step, exposing them to risk of infection. the most likely scenario would be a combination of the two where the patient receives unsuccessful cpr–due to a delay in receiving resuscitative efforts–and one or more healthcare workers are needlessly exposed to the ebola virus. the only way to overcome this barrier to providing cpr would be to have a 24/7 on call cpr staff already suited in ppe; this would effectively render them unable to attend to any other patients shifting the healthcare worker to ebola patient ratio to around a dozen to one. practical concerns aside, a unilateral dnr for ebola patients can be ethically justified–just as dr. fins argues–on grounds of non-maleficence.1 ebola virus infections cause massive internal bleeding, which means that at least some patients experiencing cardiopulmonary arrest will most likely be in extremis due to exsanguination (i.e., bleeding out). the chest compressions involved in cpr would most likely worsen the patient’s blood loss, in effect hastening death. furthermore, cpr for such a patient will most likely be futile, van geem, ebola patients and the ethics of unilateral dnr orders, voices in bioethics, vol. 1 (2014-15) 2 due to their disease process and compounded by the time it takes for healthcare workers to properly don their ppe. patients who arrest in hospitals have a 6.5-15% chance of survival.9 these data do not take underlying disease process into account, which has a great effect on survival rates.10 as was previously outlined, the time between arrest and cpr will be greatly protracted in the ebola patient due to the lengthy process of donning ppe, which will make any resuscitative efforts much less effective then if they were started immediately. despite these practical and ethical justifications for the unilateral dnr for ebola patients, dr. fins fails to acknowledge that many people, physicians included, do not have an accurate understanding of dnr orders.4,9,11,12a popular misconception of the dnr order treats it synonymously with “giving up.” however the more accurate understanding of a dnr–and how dr. fins views it in relation to ebola patients–is described by the american medical association (ama) as an order preventing the initiation of cpr, exclusive of another treatment.10 a review of cpr on television found that resuscitative efforts in popular media rarely fail. 9 this feeds an unrealistic public perception of dnr orders as a withdrawal of care. asking the public to understand a dnr order based on the futility of cpr is extraordinarily difficult if most people expect cpr to revive a majority of patients suffering cardiopulmonary arrest. the potential for misunderstanding a unilateral dnr order is great, and could potentially undermine many patient-physician relationships, regardless of disease. although considerations of public perception are important, a widespread misconception of dnr orders among the lay public is much less problematic than misconceptions within hospital staff. some studies have indicated that the ama’s definition of dnr orders is not fully understood or implemented by healthcare providers. 11,12 the implications of these findings indicate that the mere appearance of a dnr in a patient’s chart affects the non-cpr treatments they will receive, potentially resulting in less than optimal care. if a unilateral dnr is enacted for all ebola patients, any physicians without a proper understanding of dnr orders may treat ebola patients less aggressively than they would patients requesting full resuscitative efforts. while this potential exists already, the individualized nature of ordering a dnr requires a discussion between physicians and patients regarding the patients’ end-of-life goals of care, including but not limited to cpr and a dnr orders. however, a unilateral dnr order removes the impetus for such a discussion to occur. in effect the unilateral dnr could cause, at least theoretically, the death of patients suffering from ebola infection who might otherwise have otherwise recovered, solely because of physician misunderstanding. this is ethically unacceptable. conclusion rather than call for the highly controversial unilateral dnr as dr. fins has done, a more nuanced approach would be equally effective at maintaining healthcare worker safety and would be less ethically problematic. upon admission, the attending physician should have a conversation with the patient, and their loved ones, as to the realities of providing cpr to patients with ebola hemorrhagic fever. they should explore the patient’s goals of care, and whether or not the patient wants cpr or a dnr order. in the event that a patient requests “everything be done” (i.e., perform aggressive cpr), the physician and the icu team should explore “preemptive” cpr-like options (i.e., aggressive, non-futile life-sustaining medical treatments like intubation or ecmo) prior to an arrest, as well as less aggressive, yet still effective, cpr efforts (i.e., withholding chest compressions, only the attending physician and the nurses perform cpr, epinephrine injections, monitor electrolytes) after an arrest. most importantly, healthcare providers must ensure that their patients don’t feel abandoned, or feel like their physicians will give up on them because they are unfortunate enough to have contracted the ebola hemorrhagic fever. 1 fins joseph. “responding to ebola: questions about resuscitation.” the hastings center: bioethics forum. last modified october 10, 2014. http://www.thehastingscenter.org/bioethicsforum http://www.thehastingscenter.org/bioethicsforum van geem, ebola patients and the ethics of unilateral dnr orders, voices in bioethics, vol. 1 (2014-15) 3 2 bishop jeffrey, brothers kyle, perry joshua, ahmad ayesha. “reviving the conversation around cpr/dnr.” the american journal of bioethics 10 no. 1 (2010): 61-67. 3 burns jeffrey, edwards jeffrey, johnson judith, cassem ned, truog robert. “do-not-resuscitate order after 25 years.” critical care medicine 31 no. 5 (2003):1543-1550. 4 clark jonna, dudzinski denise. “the false dichotomy: do ‘everything’ or give up.” the american journal of bioethics 11 no. 11 (2011): 26-27. 5 centers for disease control and prevention. “guidance on personal protective equipment to be used by healthcare workers during management of patients with ebola virus disease in u.s. hospitals, including procedures for putting on (donning) and removing (doffing).” centers for disease control and prevention web site. last modified october 20, 2014. http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html 6 sterk esther, ed. “filovirus haemorrhagic fever guideline, 2008.” medicines sans frontieres 2008. 7 university of nebraska medical center. “donning biological ppe – ebola patients.” university of nebraska medical center. accessed november 7, 2004. http://app1.unmc.edu/nursing/heroes/ppe_posters_vhf.cfm 8 world health organization. “steps to put on personal protective equipment (ppe).” world health organization. last modified august 2014. http://www.who.int/csr/resources/publications/ebola/filovirus_infection_control/en/ 9 diem susan, lantos john, tulsky james. “cardiopulmonary resuscitation on television.” the new england journal of medicine 334 no. 24 (1996): 1578-1582. 10 council on ethical and judicial affairs american medical association. “guidelines for the appropriate use of do-not-resuscitate orders.” journal of the american medical association 265 no.14 (1991): 1868–1871. 11 beach mary catherine, morrison r. sean. “the effect of do-not-resuscitate orders on physician decision-making.” journal of the american geriatrics society 50 no.12 (2002): 2057-2061. 12 cohen rubin i, lisker gita n, eichorn ann, multz alan s, silver alan. “the impact of do-not-resuscitate order on triage decisions to a medical intensive care unit.” journal of critical care 24 no.2 (2009): 311-315. http://app1.unmc.edu/nursing/heroes/ppe_posters_vhf.cfm http://www.who.int/csr/resources/publications/ebola/filovirus_infection_control/en/ http://www.who.int/csr/resources/publications/ebola/filovirus_infection_control/en/ introduction analysis conclusion dias, the commodification of breast milk, voices in bioethics, vol. 1 (2014-15) © 2015 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the commodification of breast milk: recent issues, ethical concerns, and a call for regulation matt dias keywords: bioethics, ethics, low-income, justice, breast milk introduction in recent months, a controversy surrounding the commodification of breast milk has resurfaced, indicating that the currently uncontrolled market may need regulation.1 in autumn 2014, a corporation called medolac laboratories sought to purchase breast milk from low-income african american mothers in detroit. 2 unfamiliar with the benefits that breast milk could provide their infants, some mothers were led to believe that they must either give the milk to their children or pump milk for money.3 while medolac pledged to “increase breastfeeding and economic empowerment in urban areas” and promote “wealth creation among intercity mothers,” community activists, including the nonprofit black mothers’ breastfeeding association (bmbfa), alleged that medolac was (i) targeting breast milk providers based on race and income levels and (ii) exploiting a group of women whose breastfeeding rates are significantly below the national average. 4 in partnership with community members and local lawmakers, bmbfa launched a public accountability campaign, which effectively ended medolac’s recruiting attempts in january 2015.5 analysis the commodification of breast milk has been trending in popular culture and online. a recent storyline in showtime’s shameless portrays a lucrative breast milk sweatshop that operates in the attic of a fictional chicago bar, and online community forums entice stay-at-home moms to “turn their extra milk into extra cash” at up to $23,000 per year.6 indeed, the digital age has made breast milk more accessible; however, online sales are unregulated and do not necessarily screen milk for contamination or tampering, which is often unbeknownst to buyers.7 in fact, recent studies have uncovered dangerous levels of salmonella, staph, and strep in unscreened breast milk that was sold in several leading online marketplaces, as well as instances of intentional tampering—including the addition of illicit drugs, cow’s milk, or water. 8 undeniably, casual exchanges or sales of breast milk can be precarious, since there is no way for consumers to verify the quality and safety of unscreened milk. a scenario of this nature materialized in february, when a nursing woman sold her breast milk to the highest bidders on craigslist.9 while this person sells to mothers incapable of nursing, she apparently also sells to bodybuilders who believe that the properties of breast milk will optimize their energy levels. 10 she advertises “i do not drink, or do drugs, and i take a multivitamin daily,” yet the milk she sells is not tested for disease, in contrast to donor milk at licensed milk banks.11 the consumption of unscreened milk could pose serious health risks for infants and adults alike, thus leading to a high risk of disease transmission.12 dias, the commodification of breast milk, voices in bioethics, vol. 1 (2014-15) 2 conclusion recent issues plaguing unregulated sales of breast milk should serve as a call to action for healthcare professionals and policymakers. while licensed donor-based breast milk banks comply with fda and state regulations regarding tissue banking, the absence of federal or state regulations specific to breast milk sales is alarming.13 thus, policymakers should take swift action to safeguard the secure collection, processing, and shipping of human milk.14 furthermore, healthcare professionals should be urged to inform nursing mothers of the benefits that breast milk can provide to help ensure that they will not be exploited in the production of their breast milk. though the cost-effective attributes of the online breast milk market may appeal to mothers who produce excess breast milk or who experience difficulty with breastfeeding, relying on a medium of exchange with no regulatory standards presents more risks than benefits. in the meantime, those in need of breast milk should heed safer alternatives to the current online market, such as licensed breast milk banks, until regulations are developed to ensure the integrity of the breast milk trade. 1in this article, the “commodification of breast milk” and breast milk “market” or “trade” refer to the trading, buying, and selling of breast milk, especially through online platforms. 2 medolac laboratories partnered with mothers milk cooperative for this milk banking enterprise. see wdiv local 4/click on detroit news, “company offering to buy breast milk creates controversy,” january 13, 2015, accessed march 20, 2015, http://www.clickondetroit.com/news/company-offering-to-buy-breast-milk-createscontroversy/30684026 and pr newswire, “medolac laboratories and mothers milk cooperative announce agreement,” october 17, 2013, accessed march 14, 2015, http://www.prnewswire.com/news-releases/medolaclaboratories-and-mothers-milk-cooperative-announce-agreement-228218701.html. 3 robin erb, “detroit moms protest breast milk banking effort,” january 14, 2015, accessed march 15, 2015, http://freep.com/story/news/health/2015/01/13/breast-milk-bank-protest-detroit/21702019/). 4 medolac stated that paying intercity women for excess milk will create a financial incentive to continue nursing, and provide much-needed money to nursing moms and milk to newborn babies, while community activists retorted that women will be coerced into diverting milk that would otherwise feed their own babies. see kimberly seals allers, “inviting african-american mothers to sell their breast milk, and profiting,” the new york times online, december 3, 2014, accessed march 16, 2015, http://parenting.blogs.nytimes.com/2014/12/03/invitingafrican-american-mothers-to-sell-their-breast-milk-and-profiting/?_r=0 and “the surgeon general’s call to action to support breastfeeding,” 2011, accessed march 14, 2015, http://www.surgeongeneral.gov/library/calls/breastfeeding/calltoactiontosupportbreastfeeding.pdf 5black mothers’ breastfeeding association, “open letter to medolac laboratories from detroit mothers,” january 12, 2015, accessed march 17, 2015, http://blackmothersbreastfeeding.org/2015/01/open-letter-to-medolaclaboratories-from-detroit-mothers/. 6 see laura agadoni, “got breast milk? how some moms earn $60 a day selling ‘liquid gold,’” august 28, 2014, accessed march 20, 2015, http://www.thepennyhoarder.com/sell-breast-milk/ and the penny hoarder twitter account, august 29, 2014, https://twitter.com/thepennyhoarder/status/505379458359255040. 7 web platforms such as onlythebreast.com connect lactating women who want to sell/donate their milk with prospective buyers. onlythebreast.com founder glenn snow has stated that the company does “not mind men seeking milk for health or wellness needs.” see hannah ongley, “move over, coconut water: breast milk is this dias, the commodification of breast milk, voices in bioethics, vol. 1 (2014-15) 3 season’s hottest health drink,” styleite.com, may 28, 2014, accessed march 22, 2015, http://www.styleite.com/news/move-over-coconut-water-breast-milk-is-this-seasons-hottest-health-drink/. 8 see nicholas bakalar, “breast milk donated or sold online is often tainted, study says,” the new york times online, october 21, 2013, accessed march 29, 2015, http://www.nytimes.com/2013/10/21/health/breast-milkdonated-or-sold-online-is-often-tainted-study-says.html; sarah keim et al., “microbial contamination of human milk purchased via the internet,” pediatrics 132, no. 5 (2013), accessed march 30, 2015, http://pediatrics.aappublications.org/content/early/2013/10/16/peds.2013-1687.full.pdf+html; and sarah keim et al., “breast milk sharing via the internet: the practice and health and safety considerations,” maternal and child health journal 18, no. 6 (2014): 1471–9, doi:10.1007/s10995-013-1387-6. 9 advertisement was posted in spite of craigslist’s terms that expressly prohibit the sale of “body parts/fluids.” see https://www.craigslist.org/about/prohibited. 10while participants in online milk marketplaces are typically confined to mothers, nontraditional consumers have become apparent, raising eyebrows in the medical community. see chavie lieber, “meet the men who drink breast milk,” new york magazine, may 28, 2014, accessed march 22, 2015, http://nymag.com/thecut/2014/05/meet-the-men-who-drink-breast-milk.html. 11 “roseville mom sells breast milk online for bodybuilders,” february 18, 2015, accessed march 16, 2015, 12 there are serious known risks of consuming unscreened breast milk, including exposure to hepatitis, hiv/aids, and syphilis. see keim et al., “breast milk sharing via the internet: the practice and health and safety considerations,” 1471–9. the donation of breast milk is not regulated by the government as are donations of other bodily fluids, such as blood or semen, which is one reason that the breast milk trade has significantly grown. see judy dutton, “liquid gold: the booming market for human breast milk,” wired online, accessed march 20, 2015, http://www.wired.com/2011/05/ff_milk/. 13 the fda has not issued any formal regulations concerning breast milk sales or suppliers, and only a handful of states regulate donor-based milk banks. according to the human milk banking association of north america (hmbana), nonprofit milk banks serve cities across the united states. existing hmbana standards and fda regulations regarding tissue banking requirements help ensure safe donor milk and support breastfeeding. see https://www.hmbana.org/; phoebe ramsey, “the breast milk market and the need for clearer rules,” october 23, 2013, accessed march 23, 2015, http://www.oneillinstituteblog.org/breast-milk-market-need-clearer-rules/; and pauline sakamoto, hmbana advisory committee meeting presentation, http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee /ucm235619.pdf. 14 sarah steele, jeanine martyn, and jens foell, “risks of the unregulated market in human breast milk,” the bmj 350 (2015): h1485, doi:http://dx.doi.org/10.1136/bmj.h1485. winter 2015 personal responsibility for health: is it enough? zelig weinstein follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 the phone rings. it is 2:30 a.m. saturday morning. the call is from the hospital. a 59-year-old was brought to the er with acute onset of severe headache soon followed by collapse. routine ct and ct angiography demonstrate a subarachnoid bleed with no obvious aneurysm. catheter angiography with possible coiling of an aneurysm is requested. after a brief conversation with the on-call radiology resident i head to the hospital. this is the third early morning emergency procedure that i have had this week. i may be tired, but my brain is working. i get to the hospital and meet the patient, who is semiconscious, and the family. he is a morbidly obese longtime smoker with a history of poorly controlled hypertension and a recent history of a “mild” heart attack. he has been prescribed multiple medications and many times has been told to exercise and stop smoking. he is poorly compliant with his diet, exercise regimen, and managing his multiple medications. he continues to smoke at least one pack of unfiltered cigarettes a day. i explain the procedure, its possible complications, and the chances of increased morbidity from the procedure secondary to the patient’s significant medical problems. this is the kind of case i dread – a sure-fire incarnation of murphy’s law. this patient is not atypical. he is not an old man. he could be considered a “victim” of “selfinflicted” medical conditions. overall, it is estimated that at least 40 percent of all deaths in the united states are from “self-inflicted” medical conditions. the overwhelming number of deaths from cardiovascular and cerebrovascular disease, two of the three leading causes of death in the u.s., is considered to be “self-inflicted.” in 2008 about 35 percent of all deaths in high-income countries worldwide were due to ischemic heart disease, cerebrovascular disease, chronic obstructive pulmonary disease (copd), diabetes and hypertensive heart disease. in lowand middle-income countries the two leading causes of death were ischemic heart disease and cerebrovascular disease. cigarette smoking is linked to at least 20 percent of deaths in the united states and 10 percent of deaths globally. by the year 2030 the world health organization (who) estimates that globally at least 16 percent of deaths will be linked to smoking. 1 it has been estimated that, on average, adult cigarette smokers die 14 years earlier than nonsmokers. 2 worldwide obesity has more than doubled since 1980. in 2008, 1.5 billion adults, 20 and over, were overweight. more than 500 million—10 percent of the world’s population—were obese (bmi> 30). in 2010 there were at least 43 million children younger than five years old who were obese. in the united states and canada these numbers are far worse. close to 35 percent of the adult u.s. population and 25 percent of the canadian adult population are obese. the obesity level is less than 20 percent in only one state, colorado,. in the united states, the rate of obesity has almost doubled since 1995. 3 twenty years ago the obesity level did not exceed 15 percent in any state in the united states. 4 the who estimates that overweight and obesity are the fifth leading risk for death globally. at least 44 percent of the diabetes burden, 23 percent of the ischemic heart disease burden and between 7 percent and 41 percent of certain cancer burdens are attributable to overweight and obesity. 5 this paints a gloomy picture. it seems incontrovertible that we humans are killing ourselves with indulgences that many cannot deny themselves. http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn1 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn2 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn3 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn4 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn5 voices in bioethics 3 despite this gloomy picture there are glimmers of hope. though smoking is on the rise in the developing world, it is falling in developed nations. by 1997 less than 25 percent of american adults smoked, representing a nearly 50 percent drop in the rate of smoking from the mid-1960s to the mid-1990s. this decrease resulted from many factors. when it comes to personal health, there seems to be a disconnect between what people profess they want and what people do. people say they want to be healthy but people’s behavior contradicts that which they profess. there seems to be little attempt at implementing measures that would lead to a healthier lifestyle. after the passage of president obama’s health care bill, the comment, “i’m tired of paying for everyone else’s stupidity,” was posted on the internet. it would be no surprise if this feeling were found to be common among healthy people. after all, if i can exercise, if i can eat a healthy diet, if i stopped smoking, if i have adopted a healthy lifestyle, why can’t every one do the same? why do i have to pay for everyone’s stupidity? the reality is that “no matter what, we pay for others’ bad habits. the majority of americans say it is fair to ask people with unhealthy lifestyles to pay more for health insurance.” many believe in the concept of “personal responsibility,” which was clearly enunciated by president obama when he said, “we’ve got to have the american people doing something about their own care.” 6 with the worldwide crisis in healthcare, with health care costs escalating at unsustainable rates, there are widespread calls for “personal responsibility” for healthcare. the theme of the 4 th international jerusalem conference on health policy held in december 2009 in israel was: “improving health and healthcare: who is responsible? who is accountable?” there were numerous presentations at this four-day conference with the talks published in three conference books totaling 498 pages (available on-line for free downloading). the concept of personal healthcare is that if we follow healthy lifestyles (exercising, maintaining a healthy weight, not smoking) and are good patients (keeping our appointments, heeding our physicians’ advice, and using a hospital emergency department only for emergencies), we will be rewarded by feeling better and spending less money.” there are many initiatives that have been introduced to promote personal responsibility for health. one of the major goals of the federal government’s “roadmap to medicaid reform” is to promote personal responsibility. 7 throughout our history, there has been a “dominant cultural preference for notions of personal responsibility…consonant with jeffersonian democracy’s emphasis on voluntarism, decentralization, and only limited obligation to the common good.” minkler 8 stresses that by emphasizing personal responsibility, we are blaming the victim—what has been referred to by crawford 9 as the “victim-blaming ideology,” which “ignores what is known about human behavior and minimizes the importance of evidence about the environmental assault on health.” http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn6 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn7 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn8 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn9 voices in bioethics 4 is it practical to expect people to have personal responsibility, and accountability for their health? emanuel, in a trenchant analysis of the “difficulties in making accountability practical,” discusses the “facts of human nature.” he feels that these facts reflect some “deep-seated evolutionary and other trends that are built into our psychology.” he outlines six points to prove that “it’s impossible to get organizations and individuals to be accountable” (emphasis added). included in these points are:  people want power, authority, and control. people do not want to be held accountable because accountability is a challenge to their authority and power. accountability is not a good thing when it applies to us.  as an exercise of our power, we hold other people accountable. we are very supportive when it comes to holding other people accountable.  we don’t want to be accountable for situations over which we have little or no control.  “human beings are fundamentally conservative.” we do not like change; we resist change. we like and have adapted to our environment. we will resist change unless forced to change. 10 (the strongest human urge is not for food or for shelter or for sex. the strongest human urge is to be an immovable boulder, to stay where and how we are.) kawachi outlines three myths about lagging u.s. health performance that have “attained the status of shibboleths.” these myths include the ideas that our poor health performance reflects the inherited differences in health stock of our population, comes from poor people behaving badly, and is due to the lack of universal healthcare in the united states. 11 kawachi carefully debunks these myths and poses an important question: “if bad genes and bad behaviors can’t explain america’s dismal state of health, then what can?” he proceeds to outline the social determinants of health, determinants that over many years have been shown to be necessary for the overall good health of the population. these social determinants that are most important are: safe neighborhoods, productive employment, freedom from discrimination and full participation in communal life. “peoples access to health-promoting social conditions is played out through politics.” it is politics that determines who gets what, how much, and when. he quotes rudolph virchow, who asserted, “medicine is a social science, and politics is nothing else but medicine on a grand scale.” prosperity alone will not guarantee health. the deleterious effects of economic inequality, and not just the inequality confined to the “officially poor,” exert an independent, detrimental influence on population health. “as private wealth becomes more concentrated, the quality of public life suffers.” there is a striking association between the degree of household income inequality and mortality rates. the more unequal the distribution of income, the more unhealthy people tend to be.” 12 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn10 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn11 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn12 voices in bioethics 5 the “sensitivity of health to the social environment and to…the social determinants of health” was detailed in a who publication. the authors agree that while “exhortation to individual behavior change” is a well-recognized approach to promote health, evidence suggests that there are limitations to this approach. the overarching theme for advancing health is the absolute need for a more just and caring society with much depending on understanding the interaction between material disadvantage and its social meanings. 13 the problems of, and the reasons for poor health are complex. there are no simple solutions. playing the blame game is morally and ethically wrong. “regardless of any social decision as to the limits and scope of individual responsibility for health, the moral framework for discussing the issue is equality…to reach a consensus, discourse should be according to the common basis of all theories of justice-aristotle’s formal principle of justice: ‘equals must be treated equally and un-equals must be treated unequally, in proportion to the relevant inequality.’” when using this framework, golan concludes that even conditions that were avoidable and were caused by the patient, conditions that were the fault of the patient, cannot be considered relevant inequalities that exclude the patient from care. 14 we must heed these wise words. references 1 the world health organization. www.who.int/research/en. 2 cdc fact sheet. www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/. 3 cdc morbidity and mortality weekly report. august 26, 2011. volume 60(33); 1135. 4 levi j. the huffington post. february 29, 2012. 5 who, media centre. obesity and overweight, fact sheet. updated march 2011. 6 jauhar s. no matter what, we pay for other’s bad habits. new york times. march 29, 2010. 7 steinbrook r. perspective: imposing personal responsibility for health. 2006. nejm; 355:753-756. 8 minkler m. personal responsibility for health? a review of the arguments and the evidence at century’s end. 1999. health education & behavior; 26(1): 121-140. 9 crawford r. you are dangerous to your health. 1977. int j health serv; 4:671. http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn13 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftn14 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref1 http://www.who.int/research/en http://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/ http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref3 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref4 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref5 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref6 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref7 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref8 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref9 voices in bioethics 6 10 emanuel e. difficulties in making accountability practical. 2009. in conference book part 1: the 4 th international jerusalem conference on health policy. pages 51-61. 11 kawachi, i. why the united states is not number one in health. in healthy, wealthy and fair: health care for a good society, eds. brown, l.d., jacobs, l., morone, j. new york: oxford university press, 2005. pages 222-230. 12 kawachi i, ibid. 13 wilkerson r and marmot m, editors. social determinants of health: the solid facts, 2 nd ed. copenhagen: who regional office for europe, 2003. 14 golan o. the right to treatment for self-inflicted conditions. 2010 j medical ethics; 36:683-686. http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref10 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref11 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref12 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref13 http://cubioethics.ning.com/group/global-bioethics/forum/topics/personal-responsibility-for-health-is-it-enough#_ftnref14 goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) © 2014 madeline goldberg. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. brain imaging and diagnosis: ethical implications in disorders of consciousness madeline goldberg keywords: brain imaging, bioethics introduction current theories of the mind hold that it is physical in nature; however, much debate exists about whether the mind can be interpreted with brain imaging research. the purpose of this paper is to provide a review of theories of the mind and how they relate to current debates on disorders of consciousness, and to explore the ethical implications of medical diagnoses and misdiagnoses. questions concerning the nature of the mind and consciousness have been raised since ancient times, and scientists are now turning to cognitive neuroscience for answers. empirical research and brain imaging studies provide information to interpret states of consciousness, particularly in patients who have suffered brain injuries. research about the nature of the mind and consciousness is important because it may affect ethical, legal, and medical decisionmaking. in 2005 a 15-year legal battle between the family and husband of terri schiavo, a woman diagnosed to be in a persistent vegetative state (pvs), came to an end. the conclusion: the courts ruled that the feeding tube keeping schiavo alive should be removed.[i] the schiavo case gained notoriety as the ethical, scientific, and legal arguments goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 2 surrounding the case were broadcast, in great detail, by media outlets. this case highlights conflicting opinions of whether terri was conscious or could ever hope to regain consciousness. michael schiavo, terri’s husband, believed medical prognoses stating that terri had no hope of ever recovering consciousness; terri’s parents thought otherwise. terri was diagnosed as being in a persistent vegetative state when, after awaking from a coma, she showed no signs of awareness of herself or her environment although she maintained sleep and wake cycles and some involuntary reflexes.[ii] despite evidence from brain imaging tests, which found that terri suffered from severe brain damage and a lack of activity in her cerebral cortex, terri’s parents maintained that she should be kept alive since they interpreted terri’s unconscious reflex behaviors as meaningful and intended actions. the schiavo case shows that the nature of consciousness is of practical concern today and has far-reaching implications. in this paper, i will briefly describe several theories of the mind, how they have evolved with respect to scientific discoveries, and how these theories can be applied to current research on consciousness within vegetative state (vs) and minimally conscious state (mcs) patients. brief overview of the mind-body problem dualist theories of the mind claim that the mind is separate from the body and is nonphysical in nature.[iii] today, many people, especially those in the scientific community, support a physical theory of the mind, which holds that the mind is physical in nature; however there is still conflict within the physicalist community. physicalists disagree on whether the mind is identical to brain states, as identity theorists hold, or whether the mind is the functioning of brain states, as functionalists believe. debates surrounding these two theories, identity theory and functionalism, express differing opinions on whether the mind can exist in non-carbon-based matter, such as computers. functionalists believe that the brain can be recreated in other substances, and identity theorists believe that the mind, being a collection of brain states, cannot. functionalism versus identity theory turing test goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 3 alan turing, a functionalist, proposed the turing test, also known as the imitation game, in 1950.[iv] the turing test is a hypothetical test to determine whether computers possess intelligence. to summarize this test: a human and a computer communicate with a second human through written language, as opposed to verbal language. if the human observer cannot differentiate between the human and the computer based on the responses, then the computer has passed the turing test—it has fooled a human into believing that the computer is another human. in this hypothetical situation, turing operationally defines human intelligence as passing a turing test. the turing test has relevance for diagnosing brain-damaged individuals. humans signal understanding to other humans through behavioral responses, such as head nodding, or verbal responses. brain-damaged individuals may be incapable of such behaviors. when a person suffers brain damage and cannot communicate through overt behavior, it is still possible to determine if understanding exists within this person by comparing her brain scans to those of healthy individuals. the turing test has inspired many debates and criticisms, including philosopher john searle’s “chinese room” thought experiment. chinese room overview searle, as an identity theorist, believes that the mind is defined as brain states and processes. as such, a mind cannot exist in matter that is different from the carbon-based matter of our brains. the turing test can never prove intelligence or understanding in a computer because a computer is not made of the same matter as our brains. in the chinese room thought experiment, a native english speaker is placed in a room and, through a hole in the wall, is presented with a piece of paper depicting chinese symbols.[v] the english speaker does not speak chinese, but he consults a rulebook that tells him which chinese symbols should be used to reply to the chinese symbols received. because the english speaker provides the correct response to the chinese symbols, a native chinese speaker, standing on the other side of the wall, assumes that the person responding understands chinese. we, as observers, know that the native english speaker does not understand chinese. searle uses this thought experiment to show that the intelligence attributed to a computer that passes the turing test does not reflect true understanding; instead, the computer is merely creating responses through formal symbol manipulation according to specified rules. chinese room conclusions searle’s thought experiment demonstrates the difficulty in proving that computers may possess human intelligence. nonetheless, the doubt that searle casts upon computer intelligence may be overshadowed by searle’s biases. he does not apply the same standard to interpreting human understanding that he does to computers. with humans, we assess understanding in another person, not by proving it, but by perceiving a behavioral or verbal response. this is because we, as observers, do not have access to another person’s inner thoughts. thus, turing might goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 4 reply to searle by pointing out that searle’s doubts about whether computers that pass a turing test possess true understanding also apply to human understanding. in essence, turing would claim that searle should apply the same standard measure of understanding to computers as he does to humans. is brain activation enough to prove consciousness in vs patients? connections between the turing test and current fmri studies the ability to measure understanding by observing inner mental processes in an individual, instead of behavior, might sound far-fetched. in recent years, however, technology has advanced to the point where scientists are finding that some vs patients may understand commands and can respond through brain activation, as measured by functional magnetic resonance imaging (fmri). john stins discusses how current studies on vs patients are like modern-day turing tests and believes that criticisms of these studies are similar to those raised against searle’s chinese room thought experiment.[vi] the turing test, which tested for intelligence or understanding in computers, is comparable to testing for consciousness in vs patients for three reasons: (1) both the turing test and fmri studies of vs patients apply external stimuli to an object under observation (computer or vs patient); the external stimuli consists of questions for the computer and verbal commands for the vs patient. (2) both the computer and the vs patient respond to the stimuli (input); the computer responds by answering questions and the vs patient responds through brain activation. (3) the output that the computer and vs patient produce is analyzed by an external observer, or experimenter, for conscious intelligence; for the computer to have intelligence it must respond in a way that is indistinguishable from a human’s response, and for the vs patient to demonstrate conscious intelligence, her brain activation, recorded through fmri, must be indistinguishable from the brain activation of healthy individuals. so, if a vs patient responds to external stimuli in such a way that her brain scans are the same as the brain scans of a healthy individual, then she passes a modern-day turing test for conscious understanding. goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 5 brain activation suggests consciousness in vs patients adrian owen and his colleagues have conducted fmri research on vs patients.[vii] they wondered whether fmri studies are capable of identifying pockets of consciousness in vs patients. if this is the case, then vs patients might be capable of communicating their thoughts via neural brain activation instead of motor activation, which, by definition, vs patients cannot control. vs patients are diagnosed as being in a vegetative state when, after awaking from a coma (“an unarousable unresponsiveness state”), they do not show any signs of conscious intelligence. vs patients are not aware of their environment or themselves, nor do they show observable voluntary reactions to stimuli presented to them. although vs patients do not display an external awareness of their environment, owen theorizes that they may still possess some residual cognitive abilities, which could only be discovered through brain imaging studies. misdiagnoses of disorders of consciousness are relatively high; some studies report up to 43 percent of patients are misdiagnosed. owen believes that fmri studies could possibly provide a supplementary method to measure cognitive functions.[viii] several disorders of consciousness may be misdiagnosed as vs; these include the minimally conscious state (mcs) a disorder of consciousness in which a small amount of awareness of self or environment is displayed in a patient, or locked-in syndrome (lis) in which patients’ bodies are paralyzed but they may retain sufficient control over eye movements that enables communication through blinking. summary of owen’s study method in a 2006 study, owen used fmri to measure brain activation in vs patients.[ix] studies using fmri allow researchers to observe the oxygenated blood flow over time in a patient’s brain. with this information, researchers hope to determine whether patients are participating in conscious processing, which activates the brain for a significant amount of time, or unconscious processing, which activates the brain for a short amount of time. in owen’s study, two experiments were conducted on a 23-year-old woman who was diagnosed as being in a vegetative state. goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 6 in the first experiment, researchers used fmri scans to measure the patient’s response to verbal sentences and to “acoustically matched noise sequences.” they found that there was activation in the patient’s middle and superior temporal gyri when the patient was listening to verbal speech. further, when this activation was compared to the activation in a healthy individual’s brain, there was no significant difference in the brain scans. in addition, the patient showed increased activation when ambiguous sentences were presented, which suggests that the patient was processing the meaning of the speech, although researchers were unsure if this was a conscious or unconscious process. in order to determine if this patient could consciously respond to external stimuli, a second experiment was conducted. fmri images of the patient’s brain were recorded after the patient was told to imagine either playing tennis or walking through her house. researchers used both spatial navigation tasks (walking through the house) and motor imagery tasks (playing tennis) because these tasks have been found to produce the most robust activation in the brain compared to other mental imagery tasks.[x] results indicate that the activated areas of the patient’s brain were the same areas that were activated when a healthy individual engaged in the mental imagery tasks. so, when the patient was asked to imagine playing tennis, her supplementary motor area (sma) was activated, and when the patient was asked to imagine walking through her house, the parahippocampal gyrus (ppa), the posterior parietal lobe (ppc), and the lateral premotor cortex (pmc) were activated. researchers found that activation of these brain regions persisted for 30 seconds and until the patient was instructed to rest. owen concluded from this experiment that the patient possessed some awareness of her surroundings; she was able to respond to external stimuli through brain activation that was indistinguishable from how a healthy individual responds.[xi] criticisms of study daniel greenberg claims that owen’s study did not address viable alternative explanations in its interpretation of the fmri brain scans.[xii] greenberg suggests that the fmri activation could have reflected the patient’s automatic and unconscious reactions to the external stimuli. that is, instead of the patient consciously imagining playing tennis, she might merely have been reacting to the last word said to her (in this case, “tennis”). greenberg recommends that owen conduct further experiments with sentences such as “sharleen was playing tennis?” to see if the same brain areas are activated. if the patient understands that this alternative sentence is not a command to imagine playing tennis, then her supplementary motor area would not necessarily show activity. if it did, then one might conclude that the patient is unconsciously reacting to the word “tennis.” also, sentences like “imagine visiting the rooms in your home after playing tennis” should be presented to the patient to determine whether she understands the instructions or if she is just responding to the last word. if, in the previous example, areas of the patient’s brain related to imagining spatial navigation become activated, then, greenberg maintains, researchers can attribute understanding and intention to the patient. goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 7 in addition to greenberg’s criticism, parashkev nachev and masud husain claim that in order for owen to attribute consciousness to the patient, owen must ensure that the same activation in the brain that was observed with the stimuli would not occur without the stimuli.[xiii] further, they criticize owen’s conclusions because they are based on a comparison of brain activation when subjects were resting to brain activation when subjects were responding to mental imagery instructions. nachev and husain recommend instead that owen compares brain activation when opposing verbal instructions are provided. for instance, researchers should compare the difference between patients’ responses to “imagine playing tennis” and “do not imagine playing tennis.” nachev and husain also believe that one cannot attribute conscious decisions to brain activation alone because brain activation can also occur when a person is not conscious. this line of reasoning is similar to criticisms of the chinese room argument because nachev and husain do not believe that indistinguishable brain scans (between a brain dead and conscious patient) are sufficient to assign understanding to a person. similarly, searle believes that indistinguishable responses between a computer and a person do not prove a computer’s understanding in the turing test. response to criticisms in his first response to these criticisms, owen claims that the patient would not have automatically been responding to words such as “tennis” and “house” because the brain activation lasted for 30 seconds and occurred in areas of the brain associated with mental imagery.[xiv] past studies have found that brain activation is usually transient for unconscious, automatic processing. further, the areas of the brain that were activated were areas involved in mental imagery tasks, not areas involved in word comprehension. owen also believes that nachev and husain’s claim that activation must be proven to be absent without the stimuli would be impossible to test because it would require an infinite number of fmri scans. owen addresses greenberg’s criticisms by suggesting that future research should compare brain activation in healthy individuals and brain-damaged individuals when both non-instructive sentences are presented, including words such as “tennis” and “house,” and instructive sentences are used, such as “imagine playing tennis” or “imagine walking through a house.” conclusion although there is much debate about the interpretations of fmri studies of vs patients, the evidence for a small amount of consciousness in certain vs patients is compelling. future studies will be needed to conduct additional research on such issues in order to conclusively determine which interpretations of consciousness in brain-damaged patients are correct. with more research and improved technologies, answers about the nature of the mind and consciousness may be found. goldberg, brain imaging and diagnosis, voices in bioethics, vol. 1 (2014) 8 references [i] timothy quill, “terri schiavo – a tragedy compounded,” the new england journal of medicine 352, (2005): 1630-1633. retrieved from http://content.nejm.org/cgi/content/full/352/16/1630 [ii] ibid. [iii] jay friedenberg and gordon silverman, “the philosophical approach: enduring questions,” cognitive science: an introduction to the study of the mind (newbury park, ca: sage publications, 2006), 29-64. [iv] robert french, “the turing test: the first fifty years,” trends in cognitive sciences 4, (2000): 115-121. retrieved from http://www.u-bourgogne.fr/lead/people/french/tics_turing.pdf [v] ibid. [vi] john stins, “establishing consciousness in non-communicative patients: a modern-day version of the turing test,” consciousness and cognition 18, (2009):187-192. doi:10.1016/j.concog.2007.12.005 [vii] adrian owen, martin coleman, melanie boly, matthew davis, steven laureys, and john pickard, “detecting awareness in the vegetative state,” science 313, (2006): 1402. doi:10.1126/science.1130197 [viii] adrian owen, martin coleman, melanie boly, matt hew davis, steven laureys, dietsje jolles, john pickard, “response to comments on ‘detecting awareness in the vegetative state,’” science 315, (2007):1221c. doi:10.1126/science.1135583 [ix] owen et al., science, 1402. [x] melanie boly, martin coleman, matthew davis, adam hampshire, daniel bor, gustave moonen, pierre maquet, john pickard, steven laureys adrian owen, “when thoughts become action: an fmri paradigm to study volitional brain activity in non-communicative brain injured patients,” neuroimage 36, (2007): 979-992. doi:10.1016/j.neuroimage.2007.02047 [xi] owen et al., science, 1402. [xii] daniel greenberg, “comment on “detecting awareness in the vegetative state.” science 315, (2007):1221b. doi:10.1126/science.1135284 [xiii] parashkev nachev and masud husain, “comment on ‘detecting awareness in the vegetative state,’” science 315, (2007): 1221c. doi:10.1126/science.1135096 [xiv] owen et al., science, 1221c. louisa howard, respectful destruction, voices in bioethics, vol.1, 2014-2015 © 2014 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. respectful destruction: on the moral permissibility of embryonic research louisa howard keywords: embryo, morality, ivf, fetus, fertility cryogenically frozen embryos present a major problem for virtually all fertility centers across the globe. as procedures for ivf, including egg retrieval and inter -cytoplasmic-sperm-insemination (icsi), have become more precise, predictable, and promising, the production of excess viable embryos now leaves couples with the decision to freeze or discard the surplus. in most cases, couples choose to freeze the extra embryos—a choice that subsequently gives rise to a multitude of ethical issues. in this paper, i will focus specifically on options for the large number of embryos frozen to date. the four main options for frozen embryos include: disposal, indefinite freezing, research, and embryo adoption. the philosophical issue at the heart of this debate centers on the moral status of embryos. the choice a couple will make with regard to the future of the embryos is fundamentally tied to their distinct view of this entity’s moral status. the pro-life model maintains that biologically, an embryo is no different than a fetus or fully-fledged human being. if one considers an embryo as a person with rights, then donating each frozen embryo to an infertile couple becomes the only acceptable option. most people grant embryos at least some meaning beyond a cluster of disposable cells, while others hesitate with regard to embryo adoption, a logistical nightmare that often leads to disagreement and ultimate failure. indefinite freezing is a costly enterprise, offering only a temporary solution. with this in mind, the only viable alternative is to donate leftover embryos for research, a highly controversial topic that has yet to be fully resolved in public policy. based on this pro-choice framework, the assumption that an embryo lacks moral status (personhood) is not sufficient in determining what to do with frozen embryos, and another categoryis necessary to further explain our moral judgments. regardless of moral status, there should be sincere moral deliberation about an embryo’s treatment, prompting the question of how one spells out notions of respect. ascribing embryos a strictly symbolic valuegrants them the respect they deserve. however, even if one takes into account symbolic value, using frozen embryos for pertinent research is still morally permissible—proving it is in fact possible to “respect what we destroy.” it is fundamental to first clarify the moral status of embryos before establishing the moral permissibility of intentional destruction. providing this working hypothesis will allow for a clearer understanding of why the morality of research is not wholly determined by an embryo’s moral status. the interest view, developed by bioethicist bonnie steinbock, stresses that the most important characteristic for moral status is sentience — the ability to feel pain. while it is not quite clear why certain aspects of the personhood view, including the ability to reason or use language, pertain to moral status, the moral significance of sentience is straightforward. the singular fact that a being has the capability to suffer provides a strong reason to treat it with respect. a sentient being has stake in its life since what is done to it matters directly to that being. broadly speaking, the notion of sentience describes a capacity for having experiences of any kind, an essential requirement, specifically, for having interests. from the moral point of view, lacking sentience makes it impossible for one to have interests of one’s own. without sentience, it is not possible to take the interests of a being into considerati on with regard to moral louisa howard, respectful destruction, voices in bioethics, vol.1,2014-15 2 status. following this view, since embryos lack any experiences, desires, or interests that would give them a stake in something, they therefore lack moral status. although the interest view can be used to define the moral status of embryos, this definition alone cannot adequately direct us when deciding what ought to be done with frozen embryos. as steinbock rightly recognizes, treating an embryo as mere bodily tissue would make many people “profoundly uncomfortable.” a com promise position is in order, between the individuals who view embryos as human subjects with full rights, and others who cast off embryos as disposable waste. this compromise entails creating a new category that can sufficiently convey our moral feelings toward embryos, since it is possible that non-sentient embryos can still rightfully embody a type of moral value (there are still reasons for protecting a being based on our own interests or its own intrinsic value). however, the question remains—what degree of value should be granted to these embryos and how can this value still support the use of embryos for research? i suggest a way to grant embryos significant respect is through appreciating strictly their symbolic value. as steinbock emphasizes, embryos deserve respect because they are an emergent human life, a symbol of human existence. as “a source of awe,” with the potential to one day develop into a full human being, an embryo represents something innately valuable. embryos are a symbol of the mysteries of biology, an emblem of successful fertilization between egg and sperm. granting an embryo symbolic value allows for it to be properly respected although it is not a moral subject with interests of its own. philosopher joel feinberg reminds us that it is important we do not respect symbols too much, for then we begin to respect them at the “expense of the very values they symbolize,” becoming tangled in the moral web of “sentimentality and squeamishness.” sentimental actions can often lead to unwarr anted responses, thereby creating a kind of “hypocritical inconsistency.” while on one hand an embryo can evoke sentiment through its symbolic representation of human life, if the sentiment toward embryos becomes too strong, one can lose sight of the ultimate goal of embryonic research—to extend the gift of human life. the vast benefits of using frozen embryos for research provide a strong argument to outweigh any concern that a practice like this weakens sentiments, thereby degrading human character. when determining what to do with embryos, i insist it is best to leave sentiments aside and focus strictly on their symbolic nature. a conflict arises surrounding the fate of unused and costly frozen embryos, the potential for scientific advances through embryonic research, and the symbolic commitments we owe to embryos. robertson suggests that a key distinction between persons with interests and mere symbols is that the latter do not make moral claims on the individual. a symbolic meaning can be so variable and personal that subordinating a symbol to research, in this case an embryo, does not seem to violate any moral duties. we all acknowledge the need to find a common ground between “prohibition on destruction and a moral license to kill.” when determining how one can respect what is ultimately destroyed, the native american’s view toward animals provides an interesting illustration. while ultimately sacrificed, wild animals are highly revered by native americans, serving as living symbols of the natural world. indians honor what they destroy through never putting any piece to waste, using every part of the animal for various purposes, even the bones. while i am not suggesting a researcher perform a ritual after the use of each embryo, i believe it to be important that the destruction and disposal in some way reflect the significance of the entity being destroyed. a similar example involves the use of human cadavers for educational and scientific purposes. the significance of a cadaver derives from the very nature of what it symbolizes— a deceased human being. but as feinberg urges, louisa howard, respectful destruction, voices in bioethics, vol.1,2014-15 3 this symbolism must be balanced against the benefit of medical knowledge and the possibility that a multitude of illnesses and deaths might be prevented through the study of the dead. the use of dead bodies, feinberg contends, will not lead to an overall decline in symbolic meaning since the medical practice will not be performed “crudely, indiscreetly, or disrespectfully.” embryonic research should be approached similarly , the work performed by professionals who execute with nothing less than the utmost respect for the human life embryos symbolize. in order to properly respect embryos for their symbolic value, regulations must be developed for research. above all, the research conducted using spare embryos can be neither “frivolous nor trivial.” using embryos for something mundane, for instance, in shampoo testing, would not grant embryos the respect they deserve. however, respect for embryos does not rule out significant research that leads to the cure of debilitating diseases, potentially saving many lives through scientific advances. embryonic stem cells hold great promise in research due to their ability to develop into a variety of tissue types and multiply once cultured in the lab. another essential restriction requiring careful consideration involves the issue of commodification. the buying and selling of embryos for research could very well lead down a slippery slope that would degrade the moral value of embryos, unavoidably displaying contempt rather than respect for these symbols of human life. embryos given for research must be obtained through altruistic donation, and never viewed as property. donating to research must reflect a carefully considered choice—not an alternative based on mere monetary incentive. in my opinion, the use of embryos for scientific advancement grants them indisputably more respect than simply disposing them in a fertility center’s waste bin. daniel callahan grapples with the concept of ultimately destroying something one claims to respect. he questions whether granting an embryo this “profound respect” is an act of “profound wisdom” or merely “profound self-deception.” in his opinion, this is an “odd form of esteem” for someth ing that is damaged and destroyed during the research process. he fears that validating research while concurrently claiming to respect embryos simply gives license to do anything with a clear conscience. callahan demands that only research within moral limits should be granted respect. however, if the research is performed within the restrictions mentioned, i believe that it indeed lies within moral limits, and can retain moral justifiability. callahan insists that embryonic research is a classic example of the ends justifying the means. however, i believe that this statement depends on the moral validity of the end in question. if the end might result in the potential to cure many diseases, then using previously frozen embryos as a means to achieve this end remains perfectly justifiable. callahan claims that the only way to make a just claim for embryo research would be through “stripping pre implantation embryos of any value at all,” a statement i believe leaves these embryos very little moral defense. respect for the symbolic value of an embryo can coincide with the employment of these unused embryos for pertinent, and hopefully, life-altering research. rather than requiring a tradeoff between respect and research, i maintain that if one views an embryo to have strictly symbolic value and certain restrictions are carefully crafted and implemented, then respect and research can harmoniously coexist. donna hanrahan, leveraging law as the principal, voices in bioethics, vol.1, 2014-2015 © 2014 donna hanrahan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. leveraging law as the principal instrument of public health policy: lessons learned through michael bloomberg’s mayorship in new york city donna hanrahan keywords: public health, new york city, introduction michael bloomberg has been touted as the nation’s first “public health” mayor. mayor bloomberg’s final term as new york city’s mayor has now come to a close, and it is important to reflect on the accomplishments and challenges he has faced in leveraging law as a tool to promote public health efforts. in a 2006 address, bloomberg boldly stated that law is the principal instrument of public health policy. throughout his time in office, bloomberg has been forthright about taking legal measures to improve public health in the city. his initiatives include banning trans fat, forbidding smoking in restaurants, and putting a cap on soda sizes. bloomberg has received both praise for his work in public health and condemnation for his policies that may place restrictions on individual liberty and create a “nanny state.” some argue that legal coercive measures should be substituted for lesser restrictive alternatives, such as persuasion through public information campaigns. critics, like richard epstein, see modern public health law as over ly inclusive, intrusive, and unduly infringing on individual freedom.[1] while less intrusive measures are certainly preferred as the first line of defense in public health, coercive measures such as laws are necessary to ensure the health and safety of the population. as thomas friedan posits, “when government fails to protect and improve people’s health, society suffers.”[2] accordingly, governments are faced with the challenge of taking the most effective, yet least restrictive, means to maximize health benefit, even if it means taking coercive measures at the expense of individual liberty. analysis salus populi suprema lex: the well-being of the public is the supreme law democratically elected governments have legal authority to protect the public’s health.[3] it has been long established through jacobson v massachusetts that the state has the police power authority to create legislation to protect the health, safety, and general welfare of the population.[4] while public health action is sometimes characterized as inappropriately intrusive, the population’s reliance on the state for protection implies an ethical obligation for the government to exercise its authority to ensure health and safety. individual liberty must be subordinated to protect the common public health good. accordingly, the state is justified to use public force to achieve this end.[5] be that as it may, regulation of individual behavior through laws and other coercive measures is often met with opposition. under the millian harm principle, which holds that “the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others,” donna hanrahan, leveraging law as the principal, voices in bioethics, vol.1, ,2014-15 2 intervention and regulation on individual behavior is justified so long as it prevents harm and risk to others.[6] liberalism, a dominant philosophy in the united states, centers on the values of freedom, self -determination, personal responsibility, and limited government. champions of autonomy would argue that competent individuals should be free from controlling interferences. any infringement on liberty, privacy, individual choice, and economic freedom can be seen as a violation of rights. similarly, kantian philosophers would argue that an individual cannot be used to further another’s objectives without regard to his own goals, or in other words, a man should not be used as a means to an end. accordingly, interventions that intrude on individual freedom and do not offer any direct benefit to the individual can be viewed as unethical, regardless of the beneficent intent. regardless of these ethical concerns, public health laws are still created and generally accepted with the understanding that people enter into a social contract and willingly forgo some self-interest in exchange for protection, or otherwise face a tragedy of the commons.[7] the tragedy of the commons is a dilemma that arises when multiple individuals, each acting independently and rationally according to their own self-interest, ultimately deplete a shared limited resource even when it is clear that it is not in anyone's long -term interest for this to happen.[8] one case that illustrates public health efforts to avoid the “tragedy of the commons” is the case of mandatory vaccination laws and herd immunity. herd immunity occurs when a significant portion of a community is immunized against a contagious disease, thereby protecting most members of the community against that disease because there is little opportunity for an outbreak. once a certain proportion of the community is immunized, those who are not eligible for certain vaccines, including infants, pregnant women, and immunocompromised adults, have some protection because the spread of contagious disease is contained. this is also known as community immunity. while opinions vary about whether different health behaviors should be regulated, one need only look at the success of the new york city series of anti-smoking laws to understand the success of law-based public health campaigns. while these laws were first seen as an infringement on individual liberty and potentially detrimental to business, they gained wide public acceptance throughout the years as they proved to be efficient, costeffective, and life saving. persuasive and coercive measures in public health all public health measures aiming to affect individual behavior lie on the spectrum between persuasion and coercion. law is essentially an act of coercion, as laws limit, by threat or penalty, individual choice through eliminating, restricting, or burdening an option, thereby diminishing autonomy.[9] on the other hand, acts of persuasion, such as public information campaigns, are intended to change individual action through appeals to reason.[10] critics like epstein argue in favor of a narrower conception of public health and limiting the scope of coercive government intervention.[11] persuasive measures, such as educational public health campaigns, are certainly less restrictive than laws. however, it is important to consider whether these campaigns are as efficacious or cost-effective. while intervention through public health communications is effective in raising awareness of health risks and promoting the adoption of recommended treatment regimens, interventions alone often do not have enough clout to change health behavior on a mass scale.[12] furthermore, education-based campaigns in public health are not without ethical concerns. such campaigns are often sullied by issues of manipulation, stigma, responsibility, and stereotyping, thereby compromising individual autonomy in persuasive health measures.[13] donna hanrahan, leveraging law as the principal, voices in bioethics, vol.1, ,2014-15 3 while persuasion is preferable over coercion from a bioethics and human rights perspective, it is not without ethical concerns. persuasive public health campaigns may contain elements of manipulation or nonargumentative influence through reason countering or reason bypassing, causing the campaigns to have undue influence on autonomy. reason-countering nonargumentative influence occurs when methods of manipulation change one’s affective state, including playing on social pressures and personal desires. similarly, reason-bypassing nonargumentative influence occurs when a person's reasoning capacities or awareness through framing (setting up an environment a certain way) is primed using subconscious cues.[14] beyond the ethical concerns that accompany persuasive public health campaigns, it is said that persuasion alone through educational public health campaigns is not enough for effective change in health behavior on a mass scale. as willard gaylen and bruce jennings posit, “coercion is usually quicker and surer than education.”[15] in other words, law is more effective and efficient in achieving public health goals than public health campaigns. risk proportionality, least restrictive means, and public trust the state’s fundamental authority to protect the population’s safety and welfare is limited by the individual’s legally protected rights to autonomy, privacy, liberty, and property. to intrude on individual liberties, the s tate must first demonstrate a rational and legitimate interest in intervention. accordingly, one must assess the nature, duration, probability, and severity of the risk at hand. for example, in the case of bioterrorism, there is uncertain risk but potentially high magnitude of harm.[16] in cases where public health risks may be unknown, responses must be swift and bold. in such cases, it is best to adhere to the precautionary principle. in the absence of certainty, coercive action is acceptable to protect the public, so long as the action is proportional to the suspected risk of harm. according to the principle of proportionality, the least restrictive means should be exercised so as not to unduly compromise the rights and liberties of an individual. while persuasive measures, such as public health campaigns, are certainly less restrictive, it is difficult to demonstrate efficacy or cost -effectiveness compared to coercive measures. many would argue that if a persuasive measure is proven to be equally effective and costefficient as a coercive measure, it should be taken over a coercive measure. similarly, the principle of proportionality purports that in nonemergency cases, measures should be made voluntary before legal mandates or sanctions are issued. this theory rests on the concept that if a government requires citizens to sacrifice their own liberties for the good of others, then the government has a reciprocal obligation to provide a safe, habitable environment. moreover, it is essential that public heal th policies are applied across society equally, in a nondiscriminative fashion.[17] this is essential for maintaining public trust and cooperation.[18] with only 40 percent of americans reporting trust in public health officials, this will be no easy task.[19] at minimum, authorities should clearly communicate measures and their justifications in a timely fashion and allow for a process of appeal.[20] low levels of trust translate into low rates of public cooperation, which may make a community more vulnerable to harm during states of public health emergencies. these concerns call for public discourse on coercive measures by the majority affected so that the laws are mutually agreed upon within the community. conclusion achieving a just balance between maintaining individual liberties and ensuring health and safety of the population is an enduring problem for public health authorities. champions of autonomy see public health law donna hanrahan, leveraging law as the principal, voices in bioethics, vol.1, ,2014-15 4 as an unwarranted violation of one’s autonomy and personal liberties. on the other hand, utilitarian thinkers consider law as a way to ensure the health and welfare of the community. as public health threats become increasingly complex, it is important to ensure that new laws keep pace with ethical principles. trade-offs must be made to ensure that collective benefits of population health warrant infringement on individual rights, while balancing competing ethical, health, economic, and political concerns. as new york city says goodbye to mayor bloomberg, we reflect on the progress made in public health policy during his tenure as mayor. much has changed in the field of public health in the last decade, but it stands that fair and effective law remains the cornerstone of successful public health policy. references: [1] richard allen epstein, “let the shoemaker stick to his last: a defense of the "old" public health,” perspectives in biology and medicine 46 (2003): s138-s159. [2] thomas frieden, “government's role in protecting health and safety,” n engl j med. 368 (2013): 1857-1859. [3] lawrence gostin, “jacobson v massachusetts at 100 years: police power and civil liberties in tension,” am j public health 95, no. 4 (2005): 576–581. [4] jacobson v. massachusetts, 197 u.s. 11 (1905). [5] epstein, perspectives, s138-s159. [6] gostin, public health law: power, duty, restraint (2009). [7] gaylen and jennings, “the perversion of autonomy, revised and expanded edition: the perversion of autonomy: coercion and constraints in a liberal society,” (2003). [8] garrett hardin, “tragedy of the commons,” science 162, no. 3859 (1968):1243-1248. [9] gaylen and jennings, “the perversion.” [10] ruth faden, “ethical issues in government sponsored public health campaigns.” [11] blumenthal-barby, “between reason and coercion: ethically permissible influence in health care and health policy contexts,” kennedy institute of ethics journal, 22, no. 4 (2012): 345–366. by the johns hopkins university press. donna hanrahan, leveraging law as the principal, voices in bioethics, vol.1, ,2014-15 5 [12] gaylen and jennings, “the perversion.” [13] epstein, perspectives, s138-s159. [14] nurit guttman, “guilt, fear, stigma and knowledge gaps: ethical issue s in public health communication interventions,” bioethics 18, no 6 (2004): 531-52. [15] ruth faden, “ethical issues,” 27-37. [16] lawrence gostin, “jacobson,” 576–581. [17] lawrence gostin, “ethical and legal challenges posed by severe acute respirator y syndrome,” jama 290, no. 24 (2003): 3229-37. [18] rj. blendon, “attitudes toward the use of quarantine in a public health emergency in four countries,” health affairs 25, no. 2 (2006): 15-25. [19] ibid. [20] lawrence gostin, “ethical,” 3229-37. belisomo, skype spiritual support, voices in bioethics, vol. 1 (2014-15) © 2015 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. spiritual support on skype for the seriously ill randi belisomo keywords: end of life care, hospice, religion, telechaplaincy introduction newly diagnosed and seriously ill patients who need spiritual support, but are unable to travel for it, can now access free counseling via skype or phone from chaplains working with chaplainsonhand.org, chaplaincareforveterans.org and cantbelieveihavecancer.org. analysis the three websites also offer resources to assess spiritual distress, aids in defining personal spirituality and guides to end of life decisions. “when people are faced with a crisis, somewhere in their minds and in their hearts, they ask questions about why this is happening to them,” said rev. eric hall, presiden t of the healthcare chaplaincy network (hccn), the new york-based nonprofit which launched the services in the past year. “we face our own frailty, and people want an answer and to be able to talk it out.” the initiative reflects a growing prevalence in tele-health, increased outpatient care delivery and shorter hospital stays, hall says. he calls this service one step among many that the field of chaplaincy must take to keep up with current modes in providing care. response has reflected demand. cantbelieveihavecancer.org attracted 200,000 unique visitors in its first four months online. chaplains of diverse affiliations across the country respond to requests for support within 24 hours. “people are isolated and alone so much of the time, and spiritual care is something that has often been dismissed and ignored,” said rev. amy strano, hccn’s director of programs and services. in the project’s early months, loneliness has been most frequently cited as the factor driving requests for spiritual care. guilt and questions about suffering have also been common. “after patients are no longer in the hospital, many find themselves without the spiritual support they had while hospitalized,” said lisa anderson-shaw, the university of illinois hospital and health system’s director of clinical ethics and a contributing author to handbook for rural health care ethics: a practical guide for professionals. “many rural areas may not have a church," she said. "or, the closest church may be many miles away, making homebound persons unable to find the spiritual care they wish to have. privacy may also be a concern for patients and families who live in small, rural communities and wish to keep health information more private.” according to the pew research center, one-fifth of the u.s. public now identifies as religiously unaffiliated. the hccn maintains that this statistic supports the need for this service, as chaplains are trained to guide patients through existential questions about belisomo, skype spiritual support, voices in bioethics, vol. 1 (2014-15) 2 meaning, pain, isolation and relationships either within or outside of theological frameworks. “back in the day, everyone belonged to a local congregation, and the pastor, the rabbi, or the imam came to the house,” said rev. george handzo, hccn’s director of health services, research and quality. “that day is gone. our services are aimed at those that for whatever reason are thankfully not dying in hospitals. who reaches out to them? you can’t just send a chaplain up and down halls like we used to.” chaplains in the halls of health institutions are increasingly rare. according to the institute of medicine, only two-thirds of u.s. hospitals have chaplains. however, ". “this provides more people access and resources to end of life questions, faith questions and prayer,” said eric price, spiritual care manager at ann and robert h. lurie children’s hospital of chicago, who is not affiliated with the tele-chaplaincy service. “however, many hospitals may see this as a more valuable alternative than live face-to-face contact, because it is cheaper than a chaplain. at its best, it will offer another tool for the staff chaplain. at its worst, it may replace the profession.” the hccn funded the initiative’s roll out and is now seeking grant support and hospital partnerships for fiscal sustainability. conclusion strano acknowledges the limits of tele-chaplaincy, describing it as a “spiritual first-aid” capable of connecting patients with local resources for further support. “something is better than nothing,” she said. *first published at reuters health ducar, remembering john arras, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. remembering john arras dallas ducar keywords: john arras, philosopher, ethics john arras, a down-to-earth, outspoken, and kind-hearted philosopher, died after having a stroke on monday march 9th, in galveston, texas at the age of 69.professor arras lived in charlottesville, virginia where he taught courses in bioethics such as research ethics, reproductive ethics, and a newly minted neuroethics course. he was a founding member of the ethics advisory board of the centers for disease control and served on the presidential commission for the study of bioethical issues. his research interests included prenatal screening for newborns, rationing medical care, assisted reproductive technology, physician assisted suicide, and more. he authored and edited numerous articles and books including the routledge companion to bioethics, ethical and regulatory aspects of human subjects research, ethical issues in modern medicine (in its eighth edition) and bringing the hospital home. he also has two books in press, emergency ethics: public health preparedness and response, and the ways we reason now: skeptical reflections on method in bioethics, which arras has described as “long-gestating.” john arras was born on august 25th, 1945 in san mateo, california. he graduated from the university of san francisco after majoring in french and philosophy and earned his doctorate in philosophy from northwestern university. he married liz emrey and served in the peace corps in sierra leone. he returned stateside and taught at albert einstein college of medicine-montefiore medical center and barnard college. following this, he moved to the university of virginia in 1995 where he directed the undergraduate bioethics major. while at the university of virginia, he impacted and molded many with his wry wit and genuine compassion. he was a vibrant, deeply moral, profane professor with a sidesplitting sense of humor. according to tom murray, president emeritus of the hastings center, “he had a sense of humor unsurpassed in bioethics. he was fall-of-your-chair funny.” yet professor arras also had his serious moments. never afraid to stand his ground, he was always ready for a well-tuned argument. if one had a persuasive point, he would bite back, with no time for bullshit. without being harsh he would engage, perseverance and wit would win the day, and if you held your own, remuneration would come in the form of a loyal, sharp, and creative friend, who would always take your words seriously. professor arras had a genuine commitment to justice in his writings, as well as in his actions. he was deeply entrenched in the university’s moral and academic ethos. whether he was counseling a student during his office hours, helping to promote a bioethics event, or attending a rally, he was sincerely and wholly involved. moreover, he was always willing to pull out the stops for any student. being a teacher was one aspect of his life that mattered most to him. as arras said in the spring 2014 university of virginia magazine: “i see myself as being in the business of helping students become who they are going to become. i love being around young people, prodding them, arguing with them. there is a socratic element to it, an intense connection between the teacher and student. it’s a kind of secular blessedness, to love what you do over ducar, remembering john arras, voices in bioethics, vol. 1 (2014-15) 2 a very long stretch of time. that’s as good as it gets.” first and foremost, john arras was a teacher. he was never afraid to ask the difficult questions and inspired many to reflect on life and the choices each of us make each and every day. perhaps most importantly, he always reminded everyone around him never to take things too seriously. a true mensch--he will truly be missed. aurora, compassionate use, voices in bioethics, vol. 1 (2014-15) © 2015 pranav aurora. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. compassionate use: where we are now and how johnson & johnson is changing the game pranav aurora keywords: ethics, bioethics, compassionate use, experimental treatments introduction earlier this month, johnson & johnson (j&j) announced that it will create an independent panel to review compassionate use requests and determine how the company should respond.1this announcement, which comes after high-profile social media campaigns and the growing popularity of the “right to try” state laws, may have provided a path forward to enable the dying to pursue potentially promising, experimental treatments. according to dr. caplan, whom j&j has appointed to lead this panel, “it used to be you would call your local news and try to beg them to cover you. now you build this giant twitter thing and you make the media come to you.”1 these new platforms to pressure drug companies may finally be the catalyst to change the way they respond to patients’ request for experimental medicines. analysis the issue of compassionate use has come a long way since the aids epidemic of the 1980s, when the food and drug administration (fda) set up a process, called expanded access, to help patients obtain the experimental antiretroviral drug, azt (azidothymidine).2 since its inception, the program has been a pathway for patients who have exhausted all treatment options to access investigational therapies outside of formal clinical trials. but the program has been quite controversial. in may 2006, the abigail alliance won an appeal suing the fda on the grounds that patients have a constitutional right to access experimental medicines without permission from the fda.3 the case was resolved when the supreme court declined to hear it, stating that patients do not have a right to obtain "a potentially toxic drug with no proven therapeutic benefit.”4 since the ruling, there have been a number of other efforts to sidestep fda approval in the pursuit of investigational drugs.5,6 none have been more successful than the “right to try” measures proposed by the goldwater institute, which empowers states to allow terminally ill patients to access experimental therapies without fda approval.7 supporters argue that fda involvement introduces unnecessary obstacles that overly complicate the process and discourage patients and physicians from applying. the popularity of this proposal aurora, compassionate use, voices in bioethics, vol. 1 (2014-15) 2 is evidenced by the more than 20 states that have introduced “right to try” bills since 2014.8 however, critics of the bills have emphasized that drug companies, as opposed to the fda, are the major roadblock to drug access under compassionate use.1 the fda cannot compel a company to give a desired drug, but has worked to decrease barriers for those seeking compassionate use. in 2014, the fda approved 99.5% of nearly 1900 expanded access requests,9 and this year is taking steps to streamline the application process by making its website more user-friendly and introducing a simplified request form.10 according to patti zettler, a former fda associate chief counsel and current fellow at the stanford law school center for law and the biosciences, “the fda is not the obstacle to access. these laws aren’t doing anything to address understandable obstacles that companies face when a drug is requested.”11 this shortcoming is exemplified by a recent social media firestorm that resulted in the ousting of chimerix’s former ceo, ken moch.12 in 2014, chimerix garnered national attention after denying josh hardy, a 7-year-old boy, access to brincidofovir (cmx001), an investigational antiviral drug that his doctors believed could cure his life-threatening infection. josh’s family launched an aggressive social media campaign that bombarded the small drug manufacturer. however, chimerix’s decision is not out of the ordinary. small companies like chimerix often lack the resources to balance the demands of lengthy and expensive clinical trials with the demands of patients fighting for compassionate use. josh would eventually receive the treatment through a small 20-patient clinical trial, but many others in his situation are not so lucky. “right to try” laws fail to address this reality. in the words of dr. caplan, they are “pathetically inadequate.”13 fda is no longer the problem, but it is not a simple matter for drug companies to handle compassionate use requests. according to ken moch, “we need guiding principles, but we don’t have them. the laws don’t address this. so companies are left as the ultimate arbiters.”12 conclusion j&j’s announcement of an independent panel may be a promising move toward better handling expanded access requests. according to dr. caplan, “if we could structure this right, this would be a chance to not just complain about what’s wrong, but maybe to suggest a way forward.”1 the panel will consist of clinicians, ethicists, and patient advocates. it will be funded by j&j, but the company will have no influence on the panel’s decisions. however, the creation of this panel begs the question: how will these requests be evaluated? so far, this critical question has yet to be answered. nonetheless, the move by the large pharmaceutical company may entirely change the way compassionate use is handled in the united states. while it is difficult to tell if this will be for the better, it is a refreshing idea in the ongoing struggle of improving access to experimental therapies for the terminally ill. to get it right, we need to continue the dialogue and debate. 1 http://www.nytimes.com/2015/05/07/business/company-creates-bioethics-panel-on-trial-drugs.html?_r=0 2 http://www.nytimes.com/2015/05/07/business/company-creates-bioethics-panel-on-trial-drugs.html?_r=0 3 http://www.utimes.pitt.edu/?p=8605 4 http://www.scotusblog.com/archives/07-444_ob.pdf aurora, compassionate use, voices in bioethics, vol. 1 (2014-15) 3 5 http://www.abigail-alliance.org/bill___access_act___s1956is_1_.pdf 6 http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/03/rep-watson-introduces-the-compassionateaccess-act-of-2010.html 7 https://goldwater-media.s3.amazonaws.com/cms_page_media/2015/1/28/right%20to%20try.pdf 8 http://www.raps.org/regulatory-focus/news/right-to-try/ 9http://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/dru gandbiologicapprovalreports/indactivityreports/ucm430188.pdf 10 http://blogs.fda.gov/fdavoice/index.php/tag/individual-patient-expanded-access-applications-form-fda-3926/ 11 http://blogs.wsj.com/pharmalot/2015/03/27/more-states-pass-right-to-try-laws-but-will-these-make-adifference/ 12 http://www.forbes.com/sites/davidkroll/2014/04/10/chimerix-ceo-out-in-wake-of-josh-hardy-compassionateuse-media-frenzy/ 13 http://www.nbcnews.com/health/health-news/bioethicist-right-try-law-more-cruel-compassionate-n108686 kearns, in defense of the nanny state, voices in bioethics, (2013) © 2013 lisa kearns. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. in defense of the nanny state lisa kearns keywords: nanny-state, soda ban, new york introduction new york city mayor michael bloomberg, in a september 2006 speech, endorsed the forceful application of the law as the principal instrument of public health policy. since then, new yorkers have felt the effects of that stance through regulations on everything from smoking to trans-fats, as well as in his efforts to limit the serving size of sugary drinks, known popularly as the “soda ban.” with the city set to elect its first new mayor in 11 years, it’s time to urge new york’s next chief executive to take up the mantle of “public health autocrat,” as the washington post once called bloomberg. it is easy to see why public health ethicists would encourage forceful regulation in health matters. but why on earth would a bioethicist endorse rules that infringe on consumer autonomy, such as by dictating how much soda someone can buy at one time? to answer this question, consider why people might be inclined to, say, purchase a 44-ounce soda at a movie theater. even with calorie counts posted above their heads —another bloomberg innovation—moviegoers often still choose to drink unhealthy quantities of empty calories (560 of them in the larger servings). why would they knowingly act against their best interests, in this case by potentially compromising their health? one reasonable answer is that something or someone has tinkered with their rational decision -making processes. analysis if critics of the junk food industry are to be believed—and they offer plenty of compelling evidence to do so— the “someone” doing the tinkering is the soda industry. the tinkering itself is the manipulation of consumers through incessant marketing and the exploitation of cognitive biases to which all humans are subject. the “present bias,” for example, keeps us focused on what’s in front of us—a big, sweet, refreshing soda, sold at a bargain price—and downplays in our mind’s future ill effects of the choice, such as weight gain and poor health. a quick peek at principles of biomedical ethics will remind bioethicists that choices manipulated are not choices given freely, and that freedom from controlling interference is crucial to any theory of autonomy. thus, if “nanny -state” regulations, as critics have labeled bloomberg’s aggressive public-health regulatory schemes, blunt the effects of this industry manipulation, logically bioethicists should not only defend the regulations but also encourage these efforts to restore citizens’ free choice, a hallmark of autonomy. democratic mayoral candidate bill de blasio supported bloomberg’s failed soda ban but since then has not said publicly if he will pursue similar legislation. joe lhota, the republican candidate (who was trailing de blasio by 50 percentage points a month before the election), will not pursue bloomberg-type legislation; he has said that he prefers instead to educate new yorkers about the dangers of overconsumption of soda and junk food, and leave the decision kearns, in defense of the nanny state, voices in bioethics, (2013) 2 of whether to indulge in them to consumers. lhota might be overestimating the power of education alone. bloomberg himself argued in that 2006 speech that information campaigns are “insufficient to the enormous tasks” involved in implementing public health policy, which is why he believes the full force of law to be necessary. conclusion trying to revive bloomberg’s soda ban legislation might be legally unfeasible. a new york state judge already struck down the original proposed amendment to the city’s health code on several fr onts, and a state appellate court later affirmed that decision. but that doesn’t mean the next mayor shouldn’t strive to defend citizens’ autonomy from attempts by corporations, advertisers, and other market “persuaders” to short-circuit rational decision-making in pursuit of profit. de blasio’s success, in this predominantly democratic town, has come in large part from promises to narrow the income gap that widened so dramatically under bloomberg’s watch. this, along with his earlier support of the failed serving-size legislation, is reason to be optimistic that he will continue nanny -state legislation for public health issues. bioethicists should cheer. introduction analysis conclusion weigand and weigand, losses in times of a pandemic , voices in bioethics, vol. 6 (2020) *bárbara bowoniuk wiegand ms bioethics (puc-pr brazil), lawyer and teacher *solange do carmo bowoniuk wiegand ms bioethics (puc-pr brazil), psychologist and teacher © 2020 bárbara bowoniuk wiegand and solange do carmo bowoniuk wiegand. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduc tion, provided the original author and source are credited. losses in times of a pandemic: bioethical perceptions about mourning caused by covid-19 in brazil bárbara bowoniuk wiegand* solange do carmo bowoniuk wiegand* keywords: brazil, end-of-life care, palliative care, mournig, covid-19, discussing death introduction as of june 22, 2020, brazil had 1,106,470 confirmed cases of covid-19, in addition to 571,649 recovered cases. furthermore, 51,271 deaths were caused by the coronavirus in the country.1 brazilians are dealing with a mourning routine due to fear of the disease and the readjustment of life or death itself. according to a survey commissioned by the union of cemeteries and private crematories of brazil,2 “talking about death is taboo for more than 73% of brazilians.” in this regard we argue that dialogues on bereavement are needed, especially in a country where citizens do not like to talk about death and are not prepared to face it. the aim of this paper is to discuss types of mourning caused by covid-19 in the lives of brazilians from three perspectives: health professionals; infected patients and their families; and other non-infected individuals in society. i. health professionals caring was not always a priority in medical schools in brazil which train doctors to treat or cure reflecting their hippocratic oath. this understanding has been gradually changing, especially with clinical bioethics. the paternalistic physician, which decides on the treatments for the patient, is left aside, giving the patient autonomy over their medical decisions. according to the national academy of palliative care (ancp, brazil), there were nearly 190 palliative care services across the country in 2019. "t[t]here are financing sources, greater availability of morphine, training centers and more palliative services available to the population."4 in weigand and weigand, losses in times of a pandemic, voices in bioethics, vol. 6 (2020) 2 addition, doctors are valuing care at the end of life. the increased life expectancy in brazilians and aging of the population will be better addressed by doctors. in this context, the concepts from the principlist bioethics of beauchamp and childress3 are verified daily in health centers and hospitals across the country. issues related to autonomy, non-maleficence, beneficence, and justice, accepted principles of bioethics, seem to come out of books and acquire new shapes in face of health professionals’ exhaustion, resource scarcity, and hospital bed shortages caused by covid -19. public health in brazil suffers due to lack of resources, diversion of funds, overcrowding, outdated infrastructure, and low quality technology, among other aspects.5 according to a survey carried out by the paulista medical association, nearly 50 percent of physicians stated that there is a lack of n95 or pff2 masks suitable for blocking the coronavirus; they also suggested a lack of other facial protections (38.5 percent), glasses (26 percent), aprons (31 percent), and surgical masks (36.5 percent).6 accordingly, we argue that the pandemic accentuates already known problems and ends up creating new concerns. since the coronavirus pandemic is worsening, brazilian hotels are housing doctors and nurses who prefer not to have contact with family members to spare them from contagion. hotels charge a small daily rate to maintain costs. thus, owners can “keep the hotel running without [the need to] waive or reduce salaries of its employees.”.7 health professionals are experiencing latent mourning in brazil. those providing palliative care are essential in this pandemic moment. taking care of those who care and recognizing the efforts of health professionals is also a way to alleviate suffering, by supporting professionals and those who suffer a loss. the city hall of curitiba (brazil), for example, “decreed official mourning for the death of nursing technician valdirene aparecida ferreira dos santos, 40, victim of covid-19, who died while performing her duty.”8 more than healing and being healed, the act of protecting is increasingly necessary. palliative care since ancient times brings with it a mantle of protection providing “a form of care, aiming to alleviate pain and suffering, whether they are of physical, psychological, social or spiritual origin.”9 ii. infected patients and their families the vulnerability of elderly patients and / or those who have underlying diseases, such as diabetes, heart disease, and obesity may be accentuated , putting them in a risk group for covid-19. according to protection bioethics, a latin american school of thought in bioethics led by fermin roland schramm and miguel motow, these patients should be considered vulnerable, since “they are not able to protect themselves or do not have any protection.”10 besides the condition of heightened vulnerability, brazilian patients face the lack of communication with family members, as visits to hospitals are not allowed. in addition, "relatives of people with suspicion or confirmation of the disease need to deal with the lack of information about patients admitted to health facilities in the state."11 the communication is currently made with a single family member responsible for the patient, with daily bulletins, to allow the reception of family members by the health teams. in cases of death, families are called to the hospital and receive the news in person.12 there is also another challenge in the brazilian reality: the distress of family members of infected patients who do not know if they also have the coronavirus due to the lack of mass testing in the country. in brazil, the recommendation of the states, together with the health commission, is that, given the scarcity of tests, “they should be directed to patients under covid-19 suspicion with more severe health conditions.”13 this new reality also causes mourning feelings due to treatment uncertainties and the disease itself. weigand and weigand, losses in times of a pandemic, voices in bioethics, vol. 6 (2020) 3 brazilian families are also facing changes in the way of dealing with the deaths of relatives. funeral homes had to adapt to the changes imposed by the new disease. an example is what is being done in natal (brazil), where funeral homes now offer virtual funerals to families, to avoid displacement and agglomerations.14 in addition, families need to face the difficulties in freeing bodies in the health system, coffins must be sealed, and goodbyes are short or nonexistent. there is difficulty in locating deceased ones since the number of bodies allocated in cold chambers is greater than the capacity. there are reports of family members who cannot find the bodies of their deceased relatives, while in other places the families receive incorrect death certificates with the names of strangers on them.15 thus, in the brazil, there are extreme situations for both patients and family members, and it is not possible to predict how long this context of uncertainty will last. iii. other non-infected individuals in society considering the general population, we can highlight the abrupt change in routine caused by the pandemic. suddenly, bereavement permeates brazilian society, whether due to the limited mobility suggested by the health authorities, the deprivation of freedom and farewell, the collective loss of thousands of citizens, or the suffering related to news of bed shortages in hostpitals.16 there is also the possibility of additional mourning, pointed out by the brazilian doctor ana claudia quintana arantes, related to the losses that still occur during pandemic “due to the lack of awareness” about the severity of the disease.17. the brazilian scenario indicates a concern with the mental health of citizens in times of pandemic, which points to a “hidden epidemic.” 18 other brazilian tragedies marked our era and have repercussions in our thoughts. however, the concern with the mental health of brazilians stands out due to the economic crisis that reached the country with covid-19. therefore, "it will be necessary to reinvent and adjust expectations to ensure both economy and mental health balance."18 unfortunately, uninfected brazilians are spectators of a pandemic that continues to create victims, including patients, their families, and even health professionals. the current bleak scenario allows important reflections on the reality of public health and social relations in brazil, with the expectation of contributing to and improving of public policies. conclusion death during pandemic times is lonely and mourning is composed of new aspects. we argue that death in brazil in the time of covid-19 is lonely for everyone involved in this process: families are deprived of contact; patients find themselves alone in bed; health professionals, now exhausted by the imposed care, are often isolated from their own family members. brazilian society, at home, practicing isolation, and readjusting the routine as much as possible also goes through a social mourning. but at the same time, the isolation allowed the mourners to have a new perspective. isolation has made people think about their finitude and the end of their lives. discussions about palliative care and bioethics are more present in the routine of brazilian residents and doctors are beginning to address the importance of end-of-life care. all individuals are more vulnerable: patients, families, healthcare providers, and the general public.covid for these reasons, the bioethical perceptions about the mourning weigand and weigand, losses in times of a pandemic, voices in bioethics, vol. 6 (2020) 4 caused by covid-19 in brazil allow a look at the present with a view to the future and the new possibilities in health and in relation to social life. 1. brasil, ministério da saúde. painel coronavírus. [internet]. may 31, 2020, https://covid.saude.gov.br/. 2. coelho, tatiana. brasileiro não gosta de falar sobre morte e não se prepara para o momento, revela pesquisa. [internet] june 06, 2020, https://g1.globo.com/bemestar/noticia/2018/09/26/brasileiro-naogosta-de-falar-sobre-morte-e-nao-se-prepara-para-o-momento-revela-pesquisa.ghtml. 3. santos, andré filipe junqueira dos; santos, esther angélica luiz ferreira e guirro, úrsula bueno do prado. atlas dos cuidados paliativos no brasil 2019. organização messa, luciana; coordenação piovezan, stefhanie. 1. ed. são paulo: ancp, 2020. [internet] june 06, 2020, https://paliativo.org.br/wpcontent/uploads/2020/05/atlas_2019_final_compressed.pdf. 4. beauchamp, tom l. making principlism practical: a commentary on gordon, rauprich, and vollmann. bioethics. [internet]. 25(6):301-3. may 02, 2020, http://onlinelibrary.wiley.com/doi/10.1111/j.14678519.2011.01908.x/pdf. 5. brasil, ceen – centro de estudos. os 6 maiores desafios que a saúde pública do brasil vem enfrentando. [internet]. may 31, 2020, https://www.ceen.com.br/os-6-maiores-desafios-que-a-saudepublica-do-brasil-vem-enfrentando/. 6. bocchini, bruno. coronavírus: pesquisa mostra que 50% dos médicos acusam falta de epi. [internet] june 06, 2020, https://agenciabrasil.ebc.com.br/geral/noticia/2020-04/coronavirus-pesquisa-mostra-que50-dos-medicos-acusam-falta-de-epi. 7. knoploch, carol. coronavírus: profissionais de saúde se 'isolam' da própria família para minimizar riscos de contágio [internet] june 06, 2020, https://oglobo.globo.com/sociedade/coronavirus-servico/coronavirusprofissionais-de-saude-se-isolam-da-propria-familia-para-minimizar-riscos-de-contagio-24323533 8. jornal “bem paraná”. prefeitura de curitiba decreta luto oficial por morte de técnica de enfermagem [internet] june 04, 2020, https://www.bemparana.com.br/noticia/prefeitura-de-curitiba-decreta-luto-oficialpor-morte-de-tecnica-de-enfermagem#.xtv6jdpkjiu. 9. brasil, academia nacional de cuidados paliativos. o que são cuidados paliativos. [internet]. may 14, 2020, https://paliativo.org.br/cuidados-paliativos/o-que-sao/. 10. schramm fermin roland. a bioética de proteção: uma ferramenta para a avaliação das práticas sanitárias? ciênc. saúde coletiva [internet]. 22 (5): 1531-1538. may 31, 2020, http://www.scielo.br/scielo.php?script=sci_arttext&pid=s1413-81232017002501531&lng=en. 11. rainheri, amanda. familiares de pacientes internados por coronavírus reclamam de falta de informação. [internet] june 06, 2020, https://jc.ne10.uol.com.br/pernambuco/2020/04/5607514-familiaresde-pacientes-internados-por-coronavirus-reclamam-de-falta-de-informacao.html 12. brasil, governo do estado da bahia. desafios da comunicação entre equipe assistencial e família durante a pandemia de covid-19. may 30, 2020, http://www.saude.ba.gov.br/2020/05/27/desafios-dacomunicacao-entre-equipe-assistencial-e-familia-durante-a-pandemia-de-covid-19/. 13. mota, camilla veras. coronavírus: a angústia das famílias que não sabem se foram infectadas. [internet]. may 31, 2020, https://noticias.uol.com.br/ultimas-noticias/bbc/2020/03/26/coronavirusangustia-das-familias-que-nao-sabem-se-foram-infectadas.htm. weigand and weigand, losses in times of a pandemic, voices in bioethics, vol. 6 (2020) 5 14. brasil, tribuna do norte. funerárias se adequam às novas regras impostas pelo covid-19. [internet]. may 02, 2020, http://www.tribunadonorte.com.br/noticia/funera-rias-se-adequam-a-s-novas-regrasimpostas-pelo-covid-19/478907. 15. coutinho, rogério. famílias de pacientes mortos com coronavírus têm dificuldade para localizar corpos em hospitais do rj. may 31, 2020, https://g1.globo.com/rj/rio-dejaneiro/noticia/2020/04/15/familias-de-pacientes-mortos-com-coronavirus-tem-dificuldade-para-localizarcorpos-em-hospitais-do-rj.ghtml. 16. rossi, marina. [internet]. “vamos ter um luto pela falta de consciência. muitos vão se arrepender de não ter ficado em casa”. may 21, 2020, https://brasil.elpais.com/politica/2020-04-20/ana-claudia-quintanaarantes-havera-um-arrependimento-coletivo-tambem.html. 17. bezerra, anselmo e outros. fatores associados ao comportamento da população durante o isolamento social na pandemia de covid-19. [internet]. may 02, 2020, http://www.cienciaesaudecoletiva.com.br/novidades/fatores-associados-ao-comportamento-da-populacaodurante-o-isolamento-social-na-pandemia-de-covid19/105). 18. biernath, andré. a epidemia oculta: saúde mental na era da covid-19. [internet]. june 02, 2020, https://saude.abril.com.br/mente-saudavel/a-epidemia-oculta-saude-mental-na-era-da-covid-19/. sylvia english, of free trade agreements, voices in bioethics, vol.1, 2014-2015 © 2014 sylvia english. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. of free trade agreements, pharmaceuticals and global ethics sylvia english keywords: supply chain, business, policy, free trade agreement, global the trans-pacific partnership (tpp) is a proposed multilateral free trade agreement between 12 countries; australia, brunei darussalam, canada, chile, japan, malaysia, mexico, new zealand, peru, singapore, usa and vietnam. the tpp arose out of the asia-pacific economic cooperation (apec),and an agreement known as the p4 between brunei, chile, singapore, and new zealand, a conference with the aim of free and open trade in the asiapacific region. a final round of negotiations was completed in 2013, with some details being closely guarded, and others leaked thanks to whistle-blower edward snowden. of particular interest for bioethics is how the tpp will handle patent law, intellectual property and pharmaceutical regulation. focusing on two countries (usa and new zealand) within the proposed agreement, we can see how varied regulation can have a dramatic impact on cost and thus access to medications. in 1993 new zealand created a price regulatory body, the pharmaceutical management agency (pharmac), which manages government spending on medicine inside a universal healthcare system. p harmac was largely created in response to the astronomical increase in the cost of medicines over the late 1980s and early 1990s. in the first year of implementation, the group achieved savings of $3.1 million and halved the growth in pharmaceutical expenditure to 5 percent per annum. by 2001, cumulative savings passed $1 billion. recent figures show $937 million saving in the years 2009-10 alone, when compared to a 1999 baseline. generally, the pharmac system functions well. however, patient dissatisfaction can arise when a relatively rare disease is potentially alleviated with high cost medications. strict pharmac decision criteria are based on nine principles, which encompass population health needs, clinical benefits, direct patient costs and costeffectiveness of pharmaceutical action over other health interventions. if the potential cost outweighs the benefit, pharmac will not fund access to medication. pharmac essentially controls what medications and medical devices enter the country and manages pharmaceutical funding for district health boards (dhbs). the creation of pricing referencing and regulation was not without opposition even in a country with firmly established socialized (universal coverage provided by the government, funded by the taxpayer ) healthcare like new zealand. early critiques of pharmac favored similar arguments as those commonly proposed by fiscally libertarian sides in the us against universal healthcare. a situation where a patient is denied drug access by government regulation due to cost is almost inconceivable in america. generally in the us, if you can pay for it, you can have it. this ethos stems from an emphasis on individual freedoms propagated through the free market. the us federal system is designed for less government intervention, and favors a free market economy. attempts to curtail the dramatic rise in the cost of pharmaceuticals have met with cries of ‘health care rationing’, and claims of devaluing the patent and intellectual property laws that aim to encourage innovation and discovery. the high cost of pharmaceuticals has also been defended on the basis of the high cost of bringing a single drug to market, with one influential (but controversial) study citing a figure of $1.3 billion. as such, regulation of the u s sylvia english, of free trade agreements, voices in bioethics, vol.1,2014-15 2 pharmaceutical industry comes from within medicine itself; individuals, hospitals or pharmacies, and insurance company funding. a prime example of this self-regulation in recent years is the decision of memorial sloane kettering cancer center to not list a new colon cancer medication, called zaltrap, due to the high cost and clinical similarity to a lower priced alternative. this type of decision (whilst similar to the formal processes carried out by pharmac in new zealand) is not beholden to any formal regulatory body in the us. this gives individuals more autonomy over the medications available in the country, though at a higher cost because of lack of regulation. however, aside from the ‘slim’ 25 million people in the us without health insurance coverage, most patients do not directly incur the cost of their own healthcare as costs are deferred to third parties such as medicaid or insurance companies. between the us and new zealand, we have two very different ideologies behind two vastly divergent approaches to managing pharmaceuticals. how will this translate into a functional agreement when tpp negotiations come to a close? we should clearly elucidate the ethical issues that are continually emerging due to the tpp. we are faced with meeting compromise between two seemingly ideologically conflicting pharmaceutical systems. the political environment has more power than philosophical reasoning in both these countries democratic systems. the goals of medicine and principles of ethics cannot be held paramount in this situation because interests outside of healthcare hold equal weight. in itself, this presents a uniquely global ethical dilemma. in bioethics, (rightly or wrongly) we utilize the four principles of autonomy, justice, beneficence and non-malfeasance to inform our judgments. within a multi-state free trade agreement such as the tpp there are other values of equal weight, such as wto goals of trade liberalization and longevity of economic policy. the us business coalition for tpp has been formed to represent the interest of major segments of the us economy. pharmaceutical interests in the coalition include the big names like pfizer, glaxosmithkline, and advamed, as well as the society of chemical manufacturers and affiliates (socma). how big should the voice of these interests be? should it overshadow that of pharmac’s desire to regulate pharmaceutical use in new zealand? in working toward a comfortable solution for both the us and new zealand in the pharmaceutical component of tpp, key policy aims for each country have emerged. new zealand aims to expand its export of agricultural goods to strengthen its vital economic interestdairy. according to a january 2013 congressional research service (crs) report, the us has previously shielded its dairy market from new zealand. much has been made of the us potentially removing restrictions and allowing new zealand market access. negotiation speculation in the crs report indicates new zealand may lessen regulation carried out by pharmac in return for access to the us dairy market. the impacts of economic globalization on healthcare are not clearly understood, and whilst we roughly estimate these impacts in dramatically different countries, these are hard to determine with less developmental gaps. what is certain is that in this increasingly global community, trade agreements will become pertinent to the access and supply of not only pharmaceuticals, but to healthcare overall. this can be advantageous or detrimental depending on how an agreement is constructed and what end of it you reside on. sylvia english, of free trade agreements, voices in bioethics, vol.1,2014-15 3 just exactly when the agreement might be formally agreed upon depends significantly on whether or not it is ‘fast tracked’ (trade promotion authorityformerly known as fast-trackis a congressional trade agreement negotiation system.) to avoid potentially debilitating alteration by the us congress. the ability of us congress to make adjustments has seen wariness on the part of other participatory countries that are trying to seek assurances this process will be averted via the fast-track method. according to us president barack obama, “the tpp will boost our economies, lowering barriers to trade and investment, increasing exports, and creating more jobs for our people.” however, the divisive political climate of the us government may make it difficult for the proposal to enter fast track status. this will mean it may be off the table until after tpa has passed, or the political environment somewhat stabilizes. the tpp provides an excellent opportunity for international collaboration on pharmaceuticals and healthcare issues. both the us and new zealand have systems that can improve in some aspects. for the us, calls for formal limited ama or other industry regulation might be the only politically palatable possibility. similarly in new zealand, some limited increase in price competition would result in benefits to patient consumers without infringing on the current regulatory body. what will be most interesting to follow in this emerging issue are just how flexible principles in each country and industry will be, and what is worth compromising for. 1 www.pharmac.health.nz 2www.usnzcouncil.org/tpp/ 3http://www.mfat.govt.nz/trade-and-economic-relations/2-trade-relationships-and-agreements/transpacific/index.php http://www.pharmac.health.nz/ http://www.usnzcouncil.org/tpp/ http://www.mfat.govt.nz/trade-and-economic-relations/2-trade-relationships-and-agreements/trans-pacific/index.php http://www.mfat.govt.nz/trade-and-economic-relations/2-trade-relationships-and-agreements/trans-pacific/index.php eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) © 2014 marilyn eshikena. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. prescription to over-the-counter switch: a case study in oral contraceptives marilyn eshikena keywords: prescription, oral contraceptives, reproductive ethics introduction nearly 55 years after the fda approved the pill,[i] as it is commonly known, controversies continue to accompany its journey to become an integral part of reproductive choice. today, a large majority of the countries have access to oral contraceptives as a method of birth control. birth control pills are the most common form of contraception in africa, europe, and oceania, and are the most commonly used reversible contraception in the americas.[ii] however, there still exists a disparity between countries in the ease of access to these contraceptives. while about 33 countries have oral contraceptive pills as prescription medication, a majority of the countries of the world have oral contraceptive pills with an over-the-counter (otc) designation. it appears that most of the countries with otc oral contraceptives are less developed countries. it thus seems that this otc designation is due to the fact that these countries need to encourage family planning and to make birth control methods readily available. if this is an advantage of otc contraceptive pills, then why do these oral contraceptive pills remain available only by prescription in many developed countries? to answer this question, it is necessary to explore the rationale behind maintaining a medication in prescription status, and the criteria that need to be fulfilled for a medication to become designated as otc. before the united states food, drug, and cosmetic act (fdca), any drug had the potential to be marketed legally without a prescription. however, according to the fdca, the food and drug administration (fda) has to make individual decisions regarding what drugs can be sold and purchased otc. according to the fdca, a drug ought to be designated a prescription medication if: • it is a habit forming drug; • it has potential harmful effects or toxicities that make it unsafe for use except under professional supervision; and https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn1 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn2 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 2 • its approved new drug application (nda), specifically limits it to prescription status. therefore, based on the above, for a drug to be considered for an rx-to-otc switch, it should: • have benefits that outweigh the risks; • have low potential for abuse or misuse; • be able to be used by consumers for self-diagnosed conditions; and • not rely on health practitioner supervision for its safe and effective use[iii]. according to the state food and drug administration (sfda) in china, a prescription drug qualifies for over the counter evaluation if: • “its formulation or active pharmaceutical ingredient [is] approved by sfda and [is] widely applied in patients over a long period of time; • there is sufficient research on its formulation or active pharmaceutical ingredient with precise results and satisfactory safety data; • there are statutory quality specifications for its formulation or active pharmaceutical ingredient and a proven quality profile thereof; • the method of use, dosage, and treatment course are precise and the efficacy can be ascertained; • the indication is listed in sfda’s approved scope of otc indications, typically common diseases or symptoms, recurring diseases or chronic diseases; https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn3 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 3 • the instructions for clinical application are clear if intended for pediatric diseases or pregnant women; and • the route of administration, dosage form, dosage, specification, timing of administration, storage, packaging, label, and insert sheets are suitable for self-medication.”[iv] although the guidelines provided by the chinese sfda are more detailed than those of the u.s. fda, it is clear that both serve the function of ensuring that otc medications are generally safe for self-administration. if this is the case, then it would appear that oral contraceptive pills have been deemed safe for this purpose by china’s sfda. hence, their sale as otc drugs. however, the u.s. fda has yet to approve these same oral contraceptive pills as otc drugs. the issue raised here, in comparing these two systems with fairly comparable pharmaceutical regulatory authorities, raises questions about the variations in different global pharmaceutical regulatory bodies’ perception of safety however, this issue will not be addressed in-depth in this paper. as alluded to in the portions of acts outlined above, other decisive factors comprise the general theme of drug safety, one of which is the ability of an otc drug to be self-administered effectively without a health professional’s intervention. therefore, even if a drug ticks all the boxes and there is no consensus as to whether such a drug can be trusted entirely in the hands of patients, then that drug is likely to face difficulties in transitioning from prescription to otc. before further addressing this point and how it applies to oral contraceptive pills, i would like to highlight the implications that an rx-to-otc switch has on the key players in the drug manufacturing, marketing, and utilization sector, and how these implications factor into an ethical discussion regarding otc designation for oral contraceptive pills. effect of rx-to-otc switch on physicians and pharmacists after vaginal antifungal products made the move from prescription to over-the-counter (rx-to-otc), a study showed that there was a large decline in patient visits for physician consultation[v]. it can be assumed, that an rx-to-otc switch for oral contraceptives may cause the same type of decline. the fear, then, that has been expressed by some physicians opposed to this switch, is that women will be less likely to comply with routine gynecologist visits[vi]. conversely, pharmacists will become more involved in dealing with patient issues regarding oral contraceptive use. this is because pharmacists will serve as the only professional link between a patient and her contraceptive pills, and so any question she has will need to be handled by the pharmacist. in addition, in countries that require some form of screening before patients are able to purchase otc oral contraceptives, pharmacists typically carry out this screening. therefore, an rx-to-otc switch for oral https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn4 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn5 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn6 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 4 contraceptives could occur simultaneously with a shift in professional advice and assistance from physicians to pharmacists. effect of rx-to-otc switch on patient consumers a national survey carried out in the united states found that a new patient, on average, waits two weeks before being able to secure an appointment with an obstetrics-gynecologist[vii]. women are more likely to miss oral contraceptive pills because of this difficulty in setting up an appointment, and the time and money it takes to set up a gynecology visit[viii]. these are some of the barriers that women face in reaching prescription-only oral contraceptives. it has also been shown that more women would prefer that they did not need to see a physician before having access to these contraceptive pills. in addition, it would appear that women from lowincome areas, who would have difficulties in raising children, face the most restriction to acquiring oral contraceptive pills[ix]. these pieces of evidence support the fact that an rx-to-otc switch for oral contraceptive pills will benefit patients by increasing ease of access, thereby preventing unwanted pregnancies. effect of rx-to-otc switch on manufacturers an rx-to-otc switch can be lucrative to brand name drug manufacturers, especially after patent expiration[x]. if more patients gain convenient access to the medication under discussion, and if previous non-users become users as a result of this otc switch, then brand name manufacturers benefit more in terms of sales. in a study done on an allergen, zyrtec, it was found that post-otc switch, 84% of sales were derived from the otc products, even though only 27% of prescription patients moved to zyrtec otc. what this showed is that the majority of the sales were from new users that were new allergy patients or that had not purchased any product to treat their conditions in the past two years[xi]. although the monetary benefit to drug manufacturers is worth discussing, it should not take center stage when considering the ethics of an rx-to-otc switch for any medication, especially oral contraceptives. ethical discussion justice in oral contraceptive prescription/over-the-counter disparity on the face of this discuss lies a glaring justice issue that is worth taking into consideration. at the beginning of this paper, i gave a brief summary of the percentage of countries that have oral contraceptive pills as otc, against those that still require patients to obtain physician prescriptions. as shown in the map (see appendix), there are a number of neighboring countries across continents that differ vastly in the otc/rx status of oral contraceptives. for example, in africa, while patients in zimbabwe require a physician prescription to purchase oral contraceptives, patients that share a border in zambia are able to purchase oral contraceptives over the counter. the same is true in the united states versus mexico, where patients in mexico have otc access to oral contraceptives, and patients in the united states are not afforded this option. in a 2010 study[xii] following https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn9 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn10 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn11 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn12 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 5 the choices that women make who live on the us-mexico border, it was found that women that purchased prescription-only oral contraceptive pills were younger, more likely to be single, have fewer children, have higher levels of education, and speak english more fluently than spanish. in addition, women that purchased prescription-only oral contraceptive pills cited inconvenience as a disadvantage to their preferred practice, while otc pill purchasers cited the fear of getting stopped by the us customs on getting to the border, as disadvantageous to their own preferred practice. these results show that patients have a desire to be able to procure oral contraceptives without the inconvenience of frequenting health care providers prior to do so. these results also show that there is a population of women that is not being catered to adequately with the current prescription-only status of oral contraceptives in the united states. these women are in a low socioeconomic and educational class, and so even though there are advantages to prescription-only contraceptives, these women make the difficult choice to go to mexico for their oral contraceptives. unfortunately, it is unclear that crossing the border to mexico is safe and/or reliable in terms of clear labeling and drug quality. as the fda does not approve or monitor the manufacturing and labeling practices of drugs made and used in mexico, the practice opens this population of women up to the dangers associated with purchasing their oral contraceptives across the border. contraindications to oral contraceptive use that can be harmful to patients one important argument against the rx-to-otc switch for oral contraceptive pills is how to address safety for use in patients with contraindications. for example, combined oral contraceptive use has been shown to increase thromboembolism, especially in women with thromboembolic risk factors[xiii]. however, oral contraceptives, should they gain worldwide otc status, will not be the first otc drug to pose some risk to a group of its users. a good example of a generally accepted otc medication that falls in this category is non-steroidal anti-inflammatory drugs (nsaid). the fda estimates that about 2-4% of nsaid users, yearly, will either develop gastrointestinal bleeding, symptomatic ulcers, or intestinal perforations[xiv]. in addition, based on study analyses8 it appears that the percentage of women that use or desire oral contraceptive pills with medical contraindications do no exceed this percentage reported for nsaid user complications. finally, studies have shown that oral contraceptives are safer for a woman’s health than pregnancy and delivery8. prescription otc violates a patient’s right to self-administration there is a notion that prescription medication, in general, constitutes benevolent paternalism in medical practice[xv]. it is understandable that patients, without medical knowledge, might be unable to self-diagnose and self-prescribe appropriate medication. this is because the large majority of patients are not even aware that certain drugs exist on the market and can be used for treating their ailment. however, if a patient has been diagnosed by a medical professional, and a particular medication has been suggested for use by this https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn13 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn14 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn15 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 6 medical professional, a legitimate question arises as to why formal permission, in the form of a prescription, is needed before that patient can gain access to the needed medication. one might argue that prescription-medications are needed to reduce the risks posed to the general patient population in terms of adverse reactions brought about by drug-drug interactions, or by pre-existing contraindications. another argument in support of prescription medications is the fact that certain approved substances have been shown to have addictive qualities, and so close monitoring by medical professionals ensures that these drugs are not misused. however, even with the existing norm of prescription medications, certain drugs are still subject to abuse and misuse. in addition, in terms of safety of the medication, no drug can be entirely safe for every member of the population. even acetaminophen is responsible for up to 400 deaths in the united states, every year9. in the case of oral contraceptives, on the other hand, there is no fear of their addictive properties. there has not been any incident reported of these hormone-laden pills causing addiction in the five decades they have been on the market. also, in the discussion of the need for these oral contraceptives to remain prescription medications, alluding to problematic patient self-diagnosis is a red herring. unlike most prescription medications, and even over-the-counter drugs, oral contraceptives are not used to cure illness or mitigate disease symptoms. these pills are used as preventives for unwanted pregnancies. if a woman is denied access to this form of birth control because her physician has not given her permission to use this method, does this not fall under a form of medical paternalism? as stated previously, physicians not in favor of the otc switch for oral contraceptive pills have cited compliance with routine medical checks, such as pap smears, as a reason for why oral contraceptive pills should continue to be available only by physician prescription[xvi]. this reason is glaringly a breach of patient autonomy. patient compliance with other routine medical checks should not be a bait that they women have no choice but to swallow in order to make sound reproductive choices. conclusion in this paper, i have considered the current discussions of the prescription-to-over the counter switch for oral contraceptive pills, especially in the united states. in doing so, i have discussed the effects that general prescription-to-otc switches have been historically shown to have on patients, physicians, and the drug manufacturing industry. one issue that i did not address in this paper is the part that insurance companies can play in these rx-to-otc switches. currently, in the u.s., insurance companies do not cover otc medication costs. it seems unfair that there are countries in the world where patients have unhindered access to oral contraceptives, while there are countries where patients still have to go through the burden of seeking out physician prescription before they can benefit from them. time spent booking appointments and limited access to healthcare facilities cause problems in terms of patients becoming complacent in keeping up with https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_edn16 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 7 this routine practice of seeking prescription before going to the pharmacy. when this happens, we stand the risk of allowing more women to be subject to unwanted pregnancies, circumstantial abortions, and/or health complications that arise due to pregnancies and deliveries. oral contraceptives’ safety and effectiveness, and their selective global otc status, should cause every country to make this otc switch. this will not only increase access to the medication, it will also ensure that women, especially women residing on borders between countries that differ in the status of these pills, are being catered to in terms of ensuring that the labels on the medication that they purchase are detailed and can be followed easily by these patients. while more data is needed that shows the safety of use in the different contraindications, public health initiatives can aid in helping women have the ability to self-screen for contraindications. in addition, it could be more acceptable for oral contraceptive pills to have a “behind-thecounter” status than for it to remain completely prescription-only. this ensures that the patient is adequately screened for contraindications, has access to professional advice if needed, while still being able to access the medication quickly. finally, there ought to be more studies that compare patient use, incidence of complications from oral contraceptive use, and patient attitudes towards oral contraceptives in countries where these pills are currently prescription-only, countries where the pills are informally available over-the-counter, and in countries where they are formally available behind-the-counter. this will eliminate speculations and nonempirically driven inferences made in the discussion of rx-to-otc switch for oral contraceptive pills. references [i] nikolchev a (2010). a brief history of the birth control pill. pbs. http://www.pbs.org/wnet/need-to-know/health/a-briefhistory-of-the-birth-control-pill/480/. last accessed 05/08/2014. [ii] grindlay k, burns b & grossman d (2013). prescription requirements and over-the-counter access to oral contraceptives: a global review. contraception 88(1): 91 – 96. [iii] howard d.l, wall j & strickland j.l. (2012). physician attitudes toward over the counter availability for oral contraceptives. maternal and child health journal. [iv] wang k. (2012). chinese fda released guidelines for rx-otc switch. http://www.mondaq.com/x/209864/healthcare/chinese+fda+released+guidelines+for+rxotc+switch. last accessed 05/08/2014. [v] gurwitz j.h, mclaughlin t.j & leslie s.f. (1995). the effect of an rx-to-otc switch on medication prescribing patterns and utilization of physician services: the case of vaginal antifungal products. health services research 30: 5. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref1 http://www.pbs.org/wnet/need-to-know/health/a-brief-history-of-the-birth-control-pill/480/ http://www.pbs.org/wnet/need-to-know/health/a-brief-history-of-the-birth-control-pill/480/ https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref2 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref3 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref4 http://www.mondaq.com/x/209864/healthcare/chinese+fda+released+guidelines+for+rxotc+switch https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref5 eshikena, prescription to over-the-counter, voices in bioethics, vol. 1 (2014) 8 [vi] howard d.l, wall j & strickland j.l. (2012). physician attitudes toward over the counter availability for oral contraceptives. maternal and child health journal. [vii] landau c.s, tapias m.p & mcghee b.t. (2006). birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. contraception 74(6): 463 – 470. [viii] smith j.d & oakley d. (2005). why do women miss oral contraceptive pills? an analysis of women’s self-described reasons for missed pills. journal of midwifery & women’s health 50(5): 380 – 385. [ix] landau c.s, tapias m.p & mcghee b.t. (2006). birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. contraception 74(6): 463 – 470. [x] pharmaceutical industry whitepaper. why rx to otc switch is a viable off-patent strategy. http://www.ozpharmagroup.com/_data/docs/whitepaper_otc%20switch%20as%20patent%20extension_final %202.pdf. last accessed 05/08/2014. [xi] pharmaceutical industry whitepaper. why rx to otc switch is a viable off-patent strategy. http://www.ozpharmagroup.com/_data/docs/whitepaper_otc%20switch%20as%20patent%20extension_final %202.pdf. last accessed 05/08/2014. [xii] potter j.e, white k, hopkins k, amastae j & grossman d. (2010). clinic versus over-the-counter access to oral contraception: choices women make along the us-mexico border. ame j pub health. 100(6): 1130 – 6. [xiii] tepper n.k, paulen m.e, marchbanks p.a & curtis k.m. (2010). safety of contraceptive use among women with peripartum cardiomyopathy: a systematic review. contraception 82(1): 95 – 101. [xiv] xu h, eisenberg d.l, madden t, secura g.m & peipert j.f. (2014). medical contraindications in women seeking combined hormonal contraception. am j obstet gynecol 210.e 1 – 5. [xv] flannigan j. (2012). three arguments against prescription requirements. j med ethics 2011. [xvi] howard d.l, wall j & strickland j.l. (2012). physician attitudes toward over the counter availability for oral contraceptives. maternal and child health journal. https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref6 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref7 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref8 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref9 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref10 http://www.ozpharmagroup.com/_data/docs/whitepaper_otc%20switch%20as%20patent%20extension_final%202.pdf http://www.ozpharmagroup.com/_data/docs/whitepaper_otc%20switch%20as%20patent%20extension_final%202.pdf https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref11 http://www.ozpharmagroup.com/_data/docs/whitepaper_otc%20switch%20as%20patent%20extension_final%202.pdf http://www.ozpharmagroup.com/_data/docs/whitepaper_otc%20switch%20as%20patent%20extension_final%202.pdf https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref12 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref13 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref14 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref15 https://michael-reaves-bkln.squarespace.com/features/2014/09/09/prescription-to-over-the-counter-switch-a-case-study-in-oral-contraceptives#_ednref16 pirzada, non-human primates in research, voices in bioethics, vol. 8 (2022) * nefes pirzada, candidate, ms, columbia university © 2022 nefes pirzada. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the ethical dilemma of non-human primate use in biomedical research nefes pirzada* keywords: non-human primates, research ethics, animal autonomy, regulations, policies, iacuc, irb introduction when people think of biomedical research, they often envision rats kept in cages with scientists in white coats and blue gloves checking on them, taking notes, and injecting them with substances. the images make some people uncomfortable, evoking a twinge of guilt as they think of the rats suffering. however, the idea that the sacrifice of a few mice saves thousands of human lives may outweigh their guilty conscience. based on arguments for and against non-human primate (nhp) use in research, this paper concludes that nhp use is scientifically necessary but would be more ethically sound if novel policies and regulations were added to existing measures. i. arguments that the use of nhps is ethically unjustified on one end of the spectrum, bioethicist peter singer argues that animals, including rats, should not be used in biomedical research at all.1 he states that the use of animals is an indicator of speciesism.2 like racism, speciesism condemns exploiting a group, here, animals. singer also challenges differentiating humans and animals based on sentience. he claims that if sentience, autonomy, and self-consciousness provided the basis to deprive animals of the same rights and privileges as humans, then humans who lack such traits would, theoretically, not be entitled to the rights and privileges that other humans have.3 lastly, singer argues that using animals in experimentation forces researchers to acknowledge similarities between animals and humans.4 if a human were to be largely stressed by an experiment, it may be safe to assume that animals, such as rats, would be as well. beyond singer, other authors suggest that it may be ethically impermissible to use nhps as animal models in biomedical research. they emphasize nhps’ phylogenetic similarities to humans and their need for more pirzada, non-human primates in research, voices in bioethics, vol. 8 (2022) 2 complex social, behavioral, and psychological care in a laboratory environment.5 it is difficult to meet these needs, as researchers do not have the resources or the time to devote to consistently fulfilling them.6 in addition, nhp use in the us compromises the integrity of the animal model itself. most nhps are imported from asia, africa, and south america as7 there are relatively few captive breeding sites in the us.8 these journeys are long and tedious, causing considerable stress on the animal.9 housing conditions, weaning, and quarantine practices further jeopardize animal welfare.10 climate change, new patterns in light-dark cycles, and different diets can alter the physical and social integrity of the nhp.11 some argue that nhps should not be used in research due to their long lifespan. nhps can be used for multiple experiments throughout their lifespan. 12 this can be physically and emotionally taxing on the animals, who would spend years in captivity.13 subjecting nhps to multiple experiments inflicting varying levels of harm can be seen as a form of abuse. forcing these highly social and complex animals to live in captivity their whole life, often in inadequate living environments that do not satisfy their complex needs, can result in immense suffering. as anti-vivisection and animal welfare organizations argue, the close phylogenetic similarity of nhps to humans highlights that they suffer in similar ways to humans.14 nhps respond to pain, and they reflect upon pain as well. 15 painful memories endure after experimentation, magnifying the suffering of the animal.16 nhps also exhibit a level of sentience comparable to humans. this challenges cohen’s belief that animals have no rights since nhps theoretically exercise and respond to moral claims to a certain degree.17 nhps demonstrate reflective self-awareness, a rudimentary theory of mind, linguistic abilities, and deep emotional attachments.18 given their cognitive complexity and sociality, some would argue that the benefits to the nhp should also be taken into account. nhp use in research rarely, if ever, benefits the nhp. for an animal that expresses a level of sentience, nft use violates the research principles of autonomy and beneficence. ii. arguments favoring ethical use on the other end of the spectrum, bioethicist carl cohen argues that animals have no rights and research should freely use them.19 cohen claims that animals are incapable of exercising, or responding to, moral claims.20 thus, they cannot engage in free moral judgment. he notes that humans kill millions of animals daily for consumption, despite scientific advancements that have made animal consumption largely unnecessary. thus, humans kill and consume animals purely for taste and pleasure in the modern day. cohen questions why it would be ethically permissible to recreationally kill animals without benefit but impermissible to use animals to serve medical science and human advancement.21 if the rats in cages were to be altered and a dog was in the place of the rat, more would object to cohen’s utilitarian idea. as dogs are social beings that form bonds with humans, their suffering to save human lives evokes different emotional reactions and is ethically problematic. the closer the bond between an animal and humans, the more unethical their research use seems to be. the ethical implications of animal use reach a pinnacle when the previous example uses a monkey. nhps are the closest phylogenetic relatives of humans.22 nhps exhibit high levels of intelligence, reflective self-awareness, self-recognition, linguistic abilities, and distinct personalities. 23 similar to humans, nhps create social mechanisms in which they transmit learned behaviors and customs. 24 nhps have proven valuable in the advancement of science and medicine. approximately 100,000 to 200,000 nhp’s are used annually for research worldwide.25 the use of nhps has been rising due to increasing research on monoclonal antibodies, in which nhp’s are the only animal that can be used for preclinical safety studies.26 pirzada, non-human primates in research, voices in bioethics, vol. 8 (2022) 3 iii. the middle of the spectrum: permissible use this paper argues that using nhps as animal models in biomedical research is ethically permissible. nhps are very phylogenetically similar to humans, making them the ideal models to represent humans in biomedicine.27 the weatherall report, published in 2006, argues that the use of nhps in research is “not only morally accepted, but morally required.”28 however, the report specifies that this argument is credible only if there are no more effective ways of pursuing the research in question.29 the report outlines a utilitarian approach to the need for nhps in research.30 the report claims that, while nhps are harmed in research, the harm is necessary to prevent harm to humans. 31 while relatively few nhps are used in research, the number of humans that benefit from the harm decreases the net harm under a utilitarian approach.32 given an nhp’s long lifespan and ability to learn social tasks,33 an nhp may be used for one study in which it learns a specific skill, then used in subsequent studies that require demonstration of the skill,34 resulting in the sacrifice of fewer animals for medical research. the similarity of nhps to humans both socially and cognitively may increase better animal welfare practices in the laboratory and a net reduction in harm to animal models in general. for example, positive reinforcement rather than physical restraint can be used with nhps, encouraging researchers to treat nhps with more respect than other animals.35 exposure to signs of suffering may lead researchers to adopt research practices that are more humane and minimize the harm to animals.36 to be ethical, scientists must consider the importance of the research and the inability to use other animals. if the research can be performed another way, the use of nhps would not be morally justified. despite the ethical dilemmas, utilitarianism is the best approach to animal research. nhps’ expressing a cognitive and emotional complexity does not outweigh the benefit to humans as animal models in research. as with the rules surrounding human research subjects, research using nhps requires protection of the research subjects and requires attention to the scientific benefits. current policies guided by russell and burch’s “3 r’s principle” reduce the harm to nhps.37 the principle states that in research, there should be a “replacement of animals with non-animal methods;” “reduction of the number of animals used to obtain information of a given amount and precision;” and “refinement of scientific procedures and husbandry to minimize suffering and improve animal welfare.”38 a stringent set of rules and regulations govern nhp use.39 the 2000 chimpanzee health improvement, maintenance, and protection act legally prohibits the euthanasia of chimpanzees used in biomedical research. 40 the act mandates the creation of sanctuaries where chimpanzees can be retired and cared for until their death.41 institutional animal care and use committees (iacucs) regulate the use of nhps and serve as ethical regulatory committees similar to institutional review boards (irb) overseeing human subjects research. 42 iacucs prohibit academic or commercial research on nhps unless researchers are appropriately trained, procedures for independent oversight are established, use of the specific species is justified, and the data’s significance is established.43 the united kingdom american society for the prevention of cruelty to animals (aspca) has stated that nft use can occur only if other species are unsuitable for reaching scientific gains.44 45 iv. recommendations while the above policies build a strong foundation to ensure that the research setting ethically respects nphs, more can be done. limiting continuous research on one nft and limiting the number of studies an nhp can participate in would protect the nft and could consider the level of harm an nhp is exposed to per study. to meet the complex needs of nfts, animal research labs should be created for nhp use only and should include comprehensive care and specialized captivity practices. 46 a ranking system for labs pirzada, non-human primates in research, voices in bioethics, vol. 8 (2022) 4 could help distinguish which labs have enough protective measures and a complex environment to be entitled to engage in nhp research. similar to biosafety levels (bsl) from one to four for research labs, with each level requiring unique sets of protective measures, animal research labs should be created for nhp use that requires the implementation of specific captivity practices. conclusion nhps have contributed greatly to the scientific community and the advancement of modern medicine. as emotionally and cognitively sophisticated beings, they need special protections in research contexts. as utilitarianism calls for their continued use to save human lives, improving their care in captivity is important to ethical research practices. policies similar to those regulating human subjects in research should be implemented to protect them. this paper, therefore, sought to offer novel solutions, such as creating a ranking system for animal research laboratories and limiting the number of studies in which an animal can be used. 1 singer, peter. “equality for animals?” in practical ethics. cambridge university press, 2011. 2 singer, “equality for animals?” 3 singer, “equality for animals?” 4 singer, “equality for animals?” 5 prescott, mark j. "ethics of primate use." advances in science and research 5, no. 1 (2010): 11-22. https://doi.org/10.5194/asr5-11-2010 6 tardif, suzette d., kristine coleman, theodore r. hobbs, and corrine lutz. "iacuc review of nonhuman primate research." ilar journal 54, no. 2 (2013): 234-245. https://doi.org/10.1093/ilar/ilt040 7 prescott, mark j. "ethics of primate use." advances in science and research 5, no. 1 (2010): 11-22. https://doi.org/10.5194/asr5-11-2010 8 prescott, “ethics of primate use.” 11-22 9 prescott, “ethics of primate use.” 11-22 10 prescott, “ethics of primate use.” 11-22 11 carlsson, hans‐erik, steven j. schapiro, idle farah, and jann hau. "use of primates in research: a global overview." american journal of primatology: official journal of the american society of primatologists 63, no. 4 (2004): 225-237. https://doi.org/10.1002/ajp.20054 12 prescott, “ethics of primate use.” 11-22 13 prescott, “ethics of primate use.” 11-22 14 prescott, “ethics of primate use.” 11-22 15 prescott, “ethics of primate use.” 11-22 16 prescott, “ethics of primate use.” 11-22 17 cohen, carl. "the case for the use of animals in biomedical research." (1986). https://www.wellbeingintlstudiesrepository.org/cgi/viewcontent.cgi?article=1001&context=moreaexp 18 prescott, mark j. "ethics of primate use." advances in science and research 5, no. 1 (2010): 11-22. https://doi.org/10.5194/asr5-11-2010 19 cohen, carl. "the case for the use of animals in biomedical research." (1986). https://www.wellbeingintlstudiesrepository.org/cgi/viewcontent.cgi?article=1001&context=moreaexp 20 cohen, “the case for the use of animals in biomedical research.” 21 cohen, “the case for the use of animals in biomedical research.” 22 tardif, suzette d., kristine coleman, theodore r. hobbs, and corrine lutz. "iacuc review of nonhuman primate research." ilar journal 54, no. 2 (2013): 234-245. https://doi.org/10.1093/ilar/ilt040 23 prescott, mark j. "ethics of primate use." advances in science and research 5, no. 1 (2010): 11-22. https://doi.org/10.5194/asr5-11-2010 24 prescott, “ethics of primate use.” 11-22 27 tardif, suzette d., kristine coleman, theodore r. hobbs, and corrine lutz. "iacuc review of nonhuman primate research." ilar journal 54, no. 2 (2013): 234-245. https://doi.org/10.1093/ilar/ilt040 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.1093/ilar/ilt040 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.1002/ajp.20054 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.1093/ilar/ilt040 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.1093/ilar/ilt040 pirzada, non-human primates in research, voices in bioethics, vol. 8 (2022) 5 28 gardar, “the ethical justification for the use of non-human primates in research.” 328-331 29 gardar, “the ethical justification for the use of non-human primates in research.” 328-331 30 gardar, “the ethical justification for the use of non-human primates in research.” 328-331 31 gardar, “the ethical justification for the use of non-human primates in research.” 328-331 32 gardar, “the ethical justification for the use of non-human primates in research.” 328-331 33 tardif, suzette d., kristine coleman, theodore r. hobbs, and corrine lutz. "iacuc review of nonhuman primate research." ilar journal 54, no. 2 (2013): 234-245. https://doi.org/10.1093/ilar/ilt040 34 tardif et al., “iacuc review of nonhuman primate research.” 234-235 35 olsson, i. anna s., and peter sandøe. "“what’s wrong with my monkey?” ethical perspectives on germline transgenesis in marmosets." transgenic research 19, no. 2 (2010): 181-186. https://doi.org/10.1007/s11248-009-9316-6 36 olsson et al., “what’s wrong with my monkey?” 37 prescott, “ethics of primate use.” 11-22 38 prescott, “ethics of primate use.” 11-22 39 phillips, kimberley a., karen l. bales, john p. capitanio, alan conley, paul w. czoty, bert a. ‘t hart, william d. hopkins et al. "why primate models matter." american journal of primatology76, no. 9 (2014): 801-827. https://doi.org/10.1002/ajp.22281 40 carlsson, hans‐erik, steven j. schapiro, idle farah, and jann hau. "use of primates in research: a global overview." american journal of primatology: official journal of the american society of primatologists 63, no. 4 (2004): 225-237. https://doi.org/10.1002/ajp.20054 41 prescott, mark j. "ethics of primate use." advances in science and research 5, no. 1 (2010): 11-22. https://doi.org/10.5194/asr5-11-2010 42 tardif, suzette d., kristine coleman, theodore r. hobbs, and corrine lutz. "iacuc review of nonhuman primate research." ilar journal 54, no. 2 (2013): 234-245. https://doi.org/10.1093/ilar/ilt040 43 phillips, kimberley a., karen l. bales, john p. capitanio, alan conley, paul w. czoty, bert a. ‘t hart, william d. hopkins et al. "why primate models matter." american journal of primatology76, no. 9 (2014): 801-827. https://doi.org/10.1002/ajp.22281 44 prescott, mark j. "ethics of primate use." advances in science and research 5, no. 1 (2010): 11-22. https://doi.org/10.5194/asr5-11-2010 45 article 7 of directive 86/609/eec in the european commission on the protection of animals used for experimental and other scientific purposes states that “in a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress, or lasting harm, and which are most likely to provide satisfactory results, shall be selected.” 46 tardif, suzette d., kristine coleman, theodore r. hobbs, and corrine lutz. "iacuc review of nonhuman primate research." ilar journal 54, no. 2 (2013): 234-245. https://doi.org/10.1093/ilar/ilt040 https://doi.org/10.1093/ilar/ilt040 https://doi.org/10.1002/ajp.22281 https://doi.org/10.1002/ajp.20054 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.1093/ilar/ilt040 https://doi.org/10.1002/ajp.22281 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.5194/asr-5-11-2010 https://doi.org/10.1093/ilar/ilt040 howard, support controversy, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the support controversy continues louisa howard keywords: informed consent, research ethics introduction no doubt, the bioethics community recalls when in the spring of 2013, the office for human research protections (ohrp) sent a detailed letter to the principal investigator of the support study admonishing the study team for its failure to provide adequate information about the study’s risks in the consent forms.1 pandemonium ensued throughout the medical community as varying opinions formed regarding ohrp’s assessment of the study. a few families of support participants sued on the platform that their premature infants were harmed as a result of the study. some years and hundreds of debates later, a federal judge threw out the suit this august, asserting that the families could not exclusively prove that the research study caused injury to participants.2 analysis the support study, which took place between 2004 and 2009, included at least 22 academic institutions nationally and was approved by approximately 23 institutional review boards. the study sought to determine the optimal oxygen saturation to provide premature infants in the neonatal icu (nicu). in the past, neonatologists have met difficulty in determining an effective level of oxygen saturation. though it was originally thought that higher levels of oxygen would improve an infant’s outcome, studies in the 1950’s demonstrated increased cases of retinopathy of prematurity (rop) (a condition often leading to blindness), with the administration of higher oxygen saturation. on the other hand, oxygen restriction can impair neurodevelopment or even result in death. when the study began, the standard of care encompassed oxygen levels anywhere between 85-95%, with specific calibrations based on each child’s individual circumstances. thus the study, designed to determine how best to reduce rop without producing other negative effects, addressed a crucial research question. the clinical trial assigned 1,300 infants born between 24-27 weeks to two different oxygen ranges— the low range (85-90%) and the high range (90-95%). it is important to note that the entire oxygen range remained within the standard of care, defining this as a comparative effectiveness trial. published by the new england journal of medicine (nejm) in 2010, the study revealed that babies in the low-oxygen group suffered statistically higher rates of death and those in the high-oxygen group developed significantly more cases of howard, support controversy, voices in bioethics, vol. 1 (2014-15) 2 rop.3 following the nejm scientific publication, an ohrp official wrote the support study’s principal investigator, maintaining that the study violated “regulatory requirements of informed consent.” ohrp, an agency that ensures the rights of participants in government-financed research, determined that the study failed to define the “reasonably foreseeable risks of blindness, neurological damage, and death.”1 the ohrp describes in its very detailed letter that the study did not thoroughly convey the risks in assigning patients to either arm. the ohrp disclosed that while the “intended benefits” section boldly highlights a decreased chance of rop for the lower level cohort, the consent’s risk paragraph lacked the inclusion of any information about intended risks. the consent stated that since all treatments proposed were within the standard of care, no “predictable increase of risk for [a parent’s] baby” existed.1 in allocating participants to two extreme ranges within the standard of care, the researchers purposefully increased the probability of detectable differences between the groups. in the opinion of ohrp, infants assigned to the upper range would therefore receive, on average, a higher level of oxygen than standard care and the lower-oxygen cohort, the opposite. understandably, the ohrp’s letter created quite an upheaval in the research community. a few weeks following the letter’s public release, the editor in chief of nejm, dr. jeffrey drazen, and other nejm affiliates authored an editorial condemning the ohrp’s decision to “retrospectively” criticize the study in light of new knowledge gained from the published research.4 drazen et al affirmed that the increased risk of death proved a significant and unexpected finding of the study; if it had been known before the study began, standard clinical care would not have encompassed the lower oxygen range, and therefore, it would have been unethical to pursue the study. they claimed it was not a failure on the part of investigators to obtain informed consent from parents of participating infants. drazen et al maintained this situation “casted a pall” over the conduct of clinical research, creating a greater barrier to the pursuit of answering important questions in daily practice.4 others in the research community also stressed the distinction between risks associated with a study intervention, which must be disclosed in the informed consent document, and risks inherent to the illness being studied. although the resultant trial focused specifically on harm done to the infants and not on the inadequacy of consent forms, the judge remarked, "correlation does not equal causation.”2 while the trial may have increased the babies’ risk, the judge argued that their prematurity already placed them at very high susceptibility for injury. following the recent court ruling, drazen et al published a second article in praise of the verdict, calling it a “ victory for newborns, their parents, and all who spend their professional lives gathering the data we use in everyday practice of medicine.”5 while some view this ruling as a positive for the research community, others point out that the trial did not address the key issue, that of informed consent. bioethicists ruth macklin and lois shepherd found validity in the ohrp’s original claims.6 macklin and shepherd believe not one of the consent forms conveyed previous knowledge about the relationship between oxygen-level targets and mortality or that changing the oxygen ranges at which infants are maintained might affect whether an infant experiences a higher risk of death. since the nicu already has a national registry of premature infants, a study with minimal additional risk could hypothetically be conducted through non-interventional collection of data. however, as macklin and shepherd maintain, the study clearly involved obvious risks, especially considering the low likelihood that infants outside the study would have been intentionally maintained in either the lower or higher oxygen targeted range. furthermore, a similar study performed in the same time frame in new zealand (boost), included the increased risk of rop for the higher-level cohort and death/neurological damage for the lower range cohort. in my opinion, the fact that another country found it necessary to include these risks should further confirm that the u.s consent forms were inadequate. howard, support controversy, voices in bioethics, vol. 1 (2014-15) 3 conclusion as both a clinical research assistant at the nih and a patient participant in trials myself, i can recognize all sides to this controversy. research remains the keystone of medical progress, and we would be doing our world a disservice without performing trials like support. on the other hand, transparency and ensuring patient safety remain essential components of research. i think francis collins and other nih officials said it best when they released an editorial following the controversy, underlining the need for further discussion on how risks should be conveyed in the informed-consent process. collins et al reminded us that the public debate surrounding the support study has “set the stage” for a fundamental “national dialogue.”7we must bring together research, advocacy and ethics communities in a quest to determine how best to not only respect and protect participants in research studies conducted within the standard of care, but also to define “reasonably foreseeable risks” in this setting.7 regardless of whether one agrees or disagrees with aspects of the debates surrounding support, this situation has created an optimistic opportunity to better understand scientific and ethical issues that must be addressed when designing future studies. 1 http://www.hhs.gov/ohrp/detrm_letrs/yr13/mar13a.pdf 2 u.s. district court for the northern district of alabama southern division, looney v. moore. case no.: 2:13-cv-00733-kob (n.d. ala. aug. 13, 2015). 3 support study group of the eunice kennedy shriver nichd neonatal research network. target ranges of oxygen saturation in extremely preterm infants. n engl j med 2010;362:1959-1969 4 drazen jm, solomon cg, greene mf. informed consent and support. n engl j med 2013;368:1929-1931 5 drazen jm, solomon cg, greene mf, support for support. n engl j med september 2015. online. 6 macklin r, shepherd l, dreger a, et al. the ohrp and support — another view. n engl j med 2013;369:e3-e3 7 kathy l. hudson, ph.d., alan e. guttmacher, m.d., and francis s. collins, m.d., ph.d., n engl j med 2013; 368:2349-2351 chokshi, the burden of deciding for others, voices in bioethics, vol. 6 (2020) * krishna chokshi, md, mt. sinai hospital © krishna chokshi 2020. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the burden of deciding for others: caring for unrepresented patients with covid-19 krishna chokshi* keywords: covid, palliative care, end-of-life, bioethics, advance directive, narrative “is there anyone — family or friends — who would help make medical decisions for you in case you could not?” i asked, sounding muffled through my constrictive n95 mask and face shield. my patient, an 82 yearold-woman with dementia who was admitted with severe covid-19 pneumonia, slowly shook her head no. my patient was unrepresented – meaning she lacked the capacity to make her own medical decisions, had not previously expressed wishes about treatment, and did not have a decision-making surrogate.1 the covid-19 pandemic has highlighted the impact of structural inequities and social determinants on health outcomes.2 these disparities become especially significant among unrepresented patients, who are more likely to be people of color, homeless, socially isolated elderly, or those afflicted with mental illness. 3 as a result, unrepresented patients are particularly vulnerable which raises numerous ethical considerations for clinicians and healthcare systems. although nearly 50 percent of hospitalists or intensivists report seeing at least one unrepresented patient per month, the challenges of caring for these covid-19 patients has not been sufficiently explored.4 in the context of the coronavirus pandemic, collaborating with patients to make medical decisions has presented challenges. only one third of adults have documented advance directives, meaning that many covid-19 patients were likely unprepared to even think about advance care planning.5 additionally, nearly one third of hospitalized covid-19 patients have demonstrated confusion due to brain disease at the time of admission.6 many others did not have family members present due to strict visitation policies. there has not been much data on healthcare outcomes of unrepresented patients during the pandemic, but, given the demographics of this group, they would likely be disproportionally affected by covid-19. for instance, people of color are three times more likely to be infected with covid-19 and six times more likely to die from it.7 the mortality rate for homeless people with covid-19 in new york city is estimated to be nearly 80 percent greater than the rate for domiciled new yorkers.8 with these statistics, it is no surprise that the chokshi, the burden of deciding for others, voices in bioethics, vol. 6 (2020) 2 unrepresented are more likely to require intensive care unit (icu) care. one study estimated the number of unrepresented patients in the icu may be as high as 16 percent of all critically ill patients.9 to make matters worse, the number of unrepresented patients is expected to increase by 2030.10 as their wishes are unknown, these unrepresented patients are at risk for both undertreatment and overtreatment. 11 unrepresented patients are also less likely to be enrolled in hospice, even when curative options are exhausted.12 though the best interest standard has determined the basis for decision making for patients in this group, the “best” treatment strategy for severe covid-19 infection remains difficult to elucidate.13 during the covid-19 pandemic, physicians face challenges to make a myriad of important medical decisions for their patients based on limited medical evidence and a rapidly expanding body of research, some of which has been unreliable or inaccurate. 14 making these decisions for unrepresented patients heightens these challenges, especially when considering treatments with limited supporting data or facing patients’ deaths without any proven treatments to offer. in spring 2019, when the pandemic began, clinicians struggled to decide if medications such as corticosteroids or hydroxychloroquine, seemingly innocuous but without much supporting data, would do more harm than good. though there are now nearly 200 phase iii trials, unrepresented patients belong to marginalized groups that are regularly excluded from clinical trials.15 since many investigational covid-19 therapies have undetermined benefits, physicians may struggle with the moral dilemma of either excluding unrepresented patients from potentially beneficial therapies or exposing them to greater harm. also, some studies do not allow the enrollment of incapacitated patients without surrogates, which further limits the patients’ access to emergency treatment options that are readily available to patients with surrogates.16 i was recently involved in the care of an elderly covid-19 patient who i learned was a holocaust survivor. like the estimated 3 percent of older adults in nursing homes, this patient was incapacitated and had no surrogate or appointed guardian.17 he presented to the emergency room with respiratory failure and was immediately intubated. several hours later, a decade-old medical order for life-sustaining treatment (molst) was discovered. the molst indicated the patient would have wanted a critical care trial without permanently relying on machines to sustain his life. the medical team struggled to discern what a duty to provide a trial of care means for someone who is expected to die regardless. a few days later, the patient died while still on a ventilator. in addition to medical uncertainty, the isolation of hospitalized patients has been a well-recognized source of moral distress for clinicians, which is amplified in the care of unrepresented patients.18 in some ways, covid19 has made the hospital experience equally isolating for all patients. the majority of hospitalized elderly patients with covid-19 died without family present and, due to acute illness, they were unable to express their wishes in their last days.19 amid such isolation, we have been buoyed by the many moving stories of togetherness and connection. i have seen elderly couples with covid-19 sharing the same hospital room, and i have been moved by patients’ sentimental facetime calls to family. however, it is far more distressing to see patients without any such connections enduring these challenges alone. for hospitalized and unrepresented patients, healthcare workers are the ones offering human connection. as physicians, to be worthy of our patients’ trust, we have pledged to make the most medically and ethically sound decisions for our patients. we also feel a deep sense of connection to our patients’ suffering, as moments of clinical or moral uncertainty can leave indelible marks on our minds.20 while medical decisions should be objective, the human dimension in deciding for and with patients cannot be underestimated. many clinical decisions also become personal ones. this personal element to decision-making – the part that relies chokshi, the burden of deciding for others, voices in bioethics, vol. 6 (2020) 3 on a patient’s values, hopes, and relationships – is inaccessible to unrepresented patients. as clinicians, we can be left wondering if we are genuinely doing what is best for our most vulnerable patients. we wonder whether we are doing too much or too little. even after the pandemic is over, part of the emotional burden healthcare professionals will carry will be the psychological impact of making difficult decisions for others, especially for those who could not advocate for themselves and had no one to advocate on their behalf. in a world where having someone to love is exalted, we will remember that those who are alone are not any less worthy of our care. 1 andrew courtwright and emily rubin, “who should decide for the unrepresented?: who should decide for the unrepresented?,” bioethics 30, no. 3 (march 2016): 173–80, https://doi.org/10.1111/bioe.12185. 2 a. anyane‐yeboa, t. sato, and a. sakuraba, “racial disparities in covid‐19 deaths reveal harsh truths about structural inequality in america,” journal of internal medicine 288, no. 4 (october 2020): 479–80, https://doi.org/10.1111/joim.13117. 3 stephanie a. chamberlain et al., “characteristics and unmet care needs of unbefriended residents in long-term care: a qualitative interview study,” aging & mental health 24, no. 4 (april 2, 2020): 659–67, https://doi.org/10.1080/13607863.2019.1566812. 4 godfrey, david, “health care decision-making during a crisis when nothing is in writing,” national academy of elder law attorneys journal 15 (spring 2019): 1–16. 5 colette a. mcafee et al., “covid-19 brings a new urgency for advance care planning: implications of death education,” death studies, september 17, 2020, 1–6, https://doi.org/10.1080/07481187.2020.1821262. 6 eric m. liotta et al., “frequent neurologic manifestations and encephalopathy‐associated morbidity in covid‐19 patients,” annals of clinical and translational neurology, october 5, 2020, acn3.51210, https://doi.org/10.1002/acn3.51210. 7 clyde w. yancy, “covid-19 and african americans,” jama 323, no. 19 (may 19, 2020): 1891, https://doi.org/10.1001/jama.2020.6548. 8 “age-adjusted mortality rate for sheltered homeless new yorkers coalition for the homeless,” accessed october 15, 2020, https://www.coalitionforthehomeless.org/age-adjusted-mortality-rate-for-sheltered-homeless-new-yorkers/. 9 mark d. siegel, “alone at life’s end: trying to protect the autonomy of patients without surrogates or decision-making capacity*:,” critical care medicine 34, no. 8 (august 2006): 2238–39, https://doi.org/10.1097/01.ccm.0000229637.22252.8c. 10 naomi karp and erica wood, incapacitated and alone: health care decision-making for the unbefriended elderly (washington, dc: american bar association, commission on law and aging, 2003). 11 thaddeus m. pope et al., “making medical treatment decisions for unrepresented patients in the icu. an official american thoracic society/american geriatrics society policy statement,” american journal of respiratory and critical care medicine 201, no. 10 (may 15, 2020): 1182–92, https://doi.org/10.1164/rccm.202003-0512st. 12 andem effiong and stephanie harman, “patients who lack capacity and lack surrogates: can they enroll in hospice?,” journal of pain and symptom management 48, no. 4 (october 2014): 745-750.e1, https://doi.org/10.1016/j.jpainsymman.2013.12.244. 13 courtwright and rubin, “who should decide for the unrepresented?” 14 shivakumar narayanan, joel v. chua, and emily heil, “covid-19: pitfalls in offering research participation as therapy in clinical settings,” journal of general internal medicine, september 3, 2020, s11606-020-06158–6, https://doi.org/10.1007/s11606-02006158-6. 15 narayanan, chua, and heil. 16 victoria shepherd, “advances and challenges in conducting ethical trials involving populations lacking capacity to consent: a decade in review,” contemporary clinical trials 95 (august 2020): 106054, https://doi.org/10.1016/j.cct.2020.106054. 17 karp and wood, incapacitated and alone. 18 meera pahuja and devon wojcikewych, “systems barriers to assessment and treatment of covid-19 positive patients at the end of life,” journal of palliative medicine, may 7, 2020, jpm.2020.0190, https://doi.org/10.1089/jpm.2020.0190. 19 peter strang et al., “dying from covid-19: loneliness, end-of-life discussions, and support for patients and their families in nursing homes and hospitals. a national register study,” journal of pain and symptom management 60, no. 4 (october 2020): e2–13, https://doi.org/10.1016/j.jpainsymman.2020.07.020. 20 georgina morley et al., “addressing caregiver moral distress during the covid-19 pandemic,” cleveland clinic journal of medicine, june 9, 2020, ccjom;ccjm.87a.ccc047v1, https://doi.org/10.3949/ccjm.87a.ccc047. bhatt, three is a crowd, voices in bioethics, vol. 6 (2020) *rohin bhatt is a candidate, gujarat national law university, india © 2020 rohin bhatt. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. three is not a crowd: a case for granting parental rights to mitochondrial dna providers rohin bhatt* keywords: mitochondria, dna, adoption, donor, parenthood, ivf introduction parenthood claims based on mitochondrial dna are justified biologically and could arise from people using mitochondrial dna as part of an in vitro procedure to create children genetically related to two mothers. this paper explores parental rights issues in three parent babies arguing the rights of anyone contributing only mitochondrial dna should be similar to that of a gamete provider: contractual when no parenting is intended and subject to parenthood claims in the case of lesbian mothers giving two parents equal child-rearing rights when both contribute dna. this could avoid a need for adoption procedures when one partner’s pregnancy results in the birth of a baby that is the genetic child of both. like egg or sperm donations, when the provider plans to raise the child, parenting rights attach partly based on genetics. when the donor is not part of the childraising circle, the donor normally waives parenting rights and is relieved of parenting obligations. mitochondria are cell organelles present in the cytoplasm responsible for producing the energy cells need to carry out their normal activities. mitochondria possess their own dna, distinct from ours, containing about 37 genes. this accounts for less than 0.1 percent of the total dna present in our bodies. nevertheless, mitochondrial dna is crucial: without it, mitochondria could not function.1 background mitochondrial dna is inherited from the maternal germline. that is, it is passed down from a mother to her children. mutations in this dna can lead to a variety of diseases, some of which result in poor growth, fatigue, and other serious symptoms.2 in february 2016, the united kingdom became the first country to legalize a technique to replace mutated mitochondrial dna with unmutated dna via mitochondrial dna donors. this represented a major first step towards eradicating mitochondrial dna diseases.3 multiple scientists from around the world have called for legalization of the technique in their home countries. however, they have cautioned that the technique must be properly regulated.4 mitochondrial dna transfer is done through two complex microsurgical techniques. the first is called spindle transfer (st), and the second pronuclear transfer (pnt).5 in the first technique, mitochondrial dna is replaced prior to fertilization of the female egg, while in the second technique, replacement is carried out at the zygote stage. while st has been successfully carried out in humans, at present, pnt has been performed only in laboratory animals.6 bhatt, three is not a crowd, voices in bioethics, vol. 6 (2020) 2 st has received more research attention because it is a more manageable technique for clinics as working with only the egg, rather than the zygote, is less logistically challenging.7 in addition, some people accord zygotes different moral status than eggs, further complicating their use for mitochondrial dna therapy. it is appropriate to talk about a “three-parent child,” as three people will have contributed genetic material: the father, the gestating mother, and the mitochondrial dna donor.8 i argue that the mitochondrial dna provider who is raising the child or a donor who has not contractually waived rights has a rightful genetic claim to be recognized as a parent. analysis origins of the claim of parental rights during the english parliament’s early debates on the origins of parental rights of mitochondrial dna providers, jacob rees-mogg, m.p., made the following remarks on march 12, 2014 in a westminster hall debate: “...the embryo has three parents: the spindle mother, the egg donor mother and the father. genetic parenthood is complete in the case of the father but fragmented in the case of the two mothers.”9 the processes or the effects of donation were not discussed thoroughly.10 the government claimed that the status of the mitochondrial dna donor was somewhere between that of an organ donor and a gamete donor.11 the donor status does not cover the circumstance of the donor actively partaking in raising the child. semantic problems and the downplayed role of mitochondrial dna because mitochondrial dna donors donate an egg, they must undergo pre-donation screening and navigate the complicated donation and post-donation process. for example, they might need to substantially modify their family and work routines in order to receive hormone therapy.12 according to the ethics committee of the american society for reproductive medicine, donors spend approximately 56 hours on counselling, screening, egg removal, and hormone therapy.13 furthermore, the process of egg donation is not risk-free. in undergoing hormone therapy, donors put themselves at risk of cramps, ovarian hyperstimulation syndrome (ohss) and other side effects.14 the use of terminology that undervalues the role of the provider has led to systematic erasure of the importance of the donor and the work that is involved with the donation. even the term “mitochondrial dna donor” suggests that these women give only mitochondrial dna, when in fact these women essentially donate an egg. referring to them as “mitochondrial dna donors” is dismissive of the inordinate amount of time, dedication, and inconvenience they face. their efforts and dedication are significantly downplayed by the use of terms like “only 13 genes” and “just mitochondria,” and by framing the debate in terms of organ or tissue donation where anonymity is the norm.15 this contributes to the lack of importance and “renders them invisible.”16 the report by the nuffield council on bioethics on the ethical review of the prevention of mitochondrial dna disorders has also been subject to criticism; some scholars allege that it neglects the social and ethical dimensions of the donation from the perspective of the egg donors and those who plan to raise the resulting child.17 mitochondrial dna providers who plan to parent the child do everything that egg providers do when using reproductive technology to become a parent but are still refused parental rights. given that gamete providers who raise the resulting children have parental rights under certain circumstances (men whose sperm are used for in vitro to produce a child they plan to jointly raise),18 mitochondrial dna providers should have comparable legal rights. bhatt, three is not a crowd, voices in bioethics, vol. 6 (2020) 3 the genetic case for lesbian parenthood in other circumstances, mitochondrial dna donors would generally contractually waive the right to parenthood as would any gamete donor. as with fathers, a marital presumption does exist in many states in the us and two mothers can be named on birth certificates. yet, because the presumption in some states is negated if the father is not the sperm provider, the role of mitochondrial dna would be especially important in the us. so far, the technique has been used for only therapeutic reasons (disease avoidance in offs pring) and carried out only with the advice of a doctor. the technique should be allowed for non -therapeutic reasons like enabling lesbian mothers to have a biological connection to their child. some courts have rejected the parental and visitation rights of same-sex couples on the grounds that they are not genetically related to the child.19 a lesbian mother who provides her mitochondrial dna parental rights should be recognized as a legal parent. not allowing lesbian couples to use the technology would be, as griffith puts it, “an example of how science and regulation seek to expand models of traditional relatedness in a way that does not challenge the (bionormative) existing order.” 20 the non-therapeutic uses have come under fire by bioethicists who consider them eugenic.21 there is forceful opposition to the idea of lesbian parents having a child that is genetically related to both of them because, as baylis puts it, “ [i] want to live in a world where bioethics is not busy fiddling while rome burns – occupying itself with inconsequential matters such as the desire for genetically-related children when there are so many more urgent problems in the world.”22 others argue valuing biological relationships devalues adoption and that mitochondrial dna use is experimental and unjustified.23 i argue that parenthood has traditionally been determined by a parent’s genetic likeness to the child and there is nothing wrong in a parent wanting to be genetically related to their children. in fact, t he historical concept of kinship in family law is dependent on having biological offspring. 24 i argue that giving birth to biological children is perhaps the most basic of the procreative rights. cavaliere, et al., who support access to mitochondrial replacement therapy for lesbian mothers, argue that any liberal society that only provides heterosexual couples with a means to meet their reproductive needs has a skewed view of equality. they further assert that homosexual couples have already limited reproductive autonomy that deprives them of their reproductive freedom.25 ensuring lesbian mothers have access to mitochondrial replacement therapy will ensure that the rights of both mothers are equal and that the rights of the mother who gives the nuclear dna do not supersede the rights of the other mother on mere account of genetic similarity.26 conclusion the role of mitochondrial dna providers could be equivalent to that of a parent. in those cases, they should have parental rights. the role that mitochondrial dna providers play in the lives of three-parent children should be rethought; they must be recognized as legal mothers absent donation contracts to the contrary. in the case of lesbian mothers, giving legal recognition of parenthood to mitochondrial dna providers is crucial for ensuring that the rights of both mothers are equal and that resultant children feel equally connected to both their parents. creating genetically related offspring is a worthy rationale for access to the technology. bhatt, three is not a crowd, voices in bioethics, vol. 6 (2020) 4 1 border, peter, and barber, sarah. 2020. "mitochondrial donation". house of commons library. https://commonslibrary.parliament.uk/research-briefings/sn06833/. 2 " mitochondrial genetic disorders | genetic and rare diseases information center (gard) – an ncats program ". 2020. rarediseases.info.nih.gov. https://rarediseases.info.nih.gov/diseases/7048/mitochondrial-genetic-disorders. 3 "world’s first ‘three-parent’ babies could be born in the uk". 2014. the guardian. https://www.theguardian.com/science/2014/dec/17/three-parent-babies-uk-mitochondrial-transfer-dna-ivf ; callaway, ewen. 2015. "world hails uk vote on three-person embryos". nature 518 (7538): 145-146. doi:10.1038/518145a. 4 "parliament should approve regulations for mitochondrial donation | letter from professor john carroll and 39 0thers". 2015. the guardian. https://www.theguardian.com/science/2015/jan/30/parliament-should-approveregulations-for-mitochondrial-donation. 5 amato, paula, tachibana, masahito, sparman, michelle, and mitalipov, shoukhrat. 2014. "three-parent in vitro fertilization: gene replacement for the prevention of inherited mitochondrial diseases". fertility and sterility 101 (1): 31-35. doi:10.1016/j.fertnstert.2013.11.030. 6 mitalipov, shoukhrat, and wolf, don p.. 2014, "clinical and ethical implications of mitochondrial gene transfer". trends in endocrinology & metabolism 25 (1): 5-7. doi:10.1016/j.tem.2013.09.001. 7 cyranoski, david, and hayden, erika check. 2013. "stem-cell cloner acknowledges errors in groundbreaking paper". nature. doi:10.1038/nature.2013.13060. 8 baylis, the ethics of creating children with three genetic parents. 9 united kingdom, westmminster hall debates, hansard 2014a, col 164wh. https://hansard.parliament.uk/commons/2014-03-12/debates/14031278000002/mitochondrialtransfer(threeparentchildren). 10 haimes, erica, and taylor, ken. 2015. "rendered invisible? the absent presence of egg providers in u.k. debates on the acceptability of research and therapy for mitochondrial disease". monash bioethics review 33 (4): 360378. doi:10.1007/s40592-015-0046-7. 11 public health directorate, health science and bioethics division. draft regulations to permit the use of new treatment techniques to prevent the transmission of a serious mitochondrial disease from mother to child. 2014. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/332881/co nsultation_response.pdf. 12 haimes and taylor, rendered invisible 13 baylis, françoise. “the ethics of creating children with three genetic parents.” reproductive biomedicine online 26, no. 6 (2013): 531–34. https://doi.org/10.1016/j.rbmo.2013.03.006. 14 "ihr.com risks and side effects of donating eggs". 2020. ihr.com. http://www.ihr.com/infertility/eggdonation/for-egg-donors/egg-donor-risks-side-effects.html. 15 e, oliver, moreno g, and grinyo, jm. 2019. "anonymity of organ donors under discussion". giornale italiano di nefrologia: organo ufficiale della societa italiana di nefrologia 36 (6). https://pubmed.ncbi.nlm.nih.gov/31830397/.; haimes and taylor, rendered invisible. 16 haimes and taylor, rendered invisible. 17 haimes and taylor, rendered invisible. 18 jhordan c v. mary k., 179 cal. app 3d, 386, 397, 1986. 19 kazmeirazak v. query 736 so. 2d 106 (fla. dist.ct app 1999) https://commonslibrary.parliament.uk/research-briefings/sn06833/ https://www.theguardian.com/science/2014/dec/17/three-parent-babies-uk-mitochondrial-transfer-dna-ivf https://hansard.parliament.uk/commons/2014-03-12/debates/14031278000002/mitochondrialtransfer(three-parentchildren) https://hansard.parliament.uk/commons/2014-03-12/debates/14031278000002/mitochondrialtransfer(three-parentchildren) bhatt, three is not a crowd, voices in bioethics, vol. 6 (2020) 5 20 griffiths, danielle. 2016. "the (re) production of the genetically related body in law, technology and culture: mitochondria replacement therapy". health care analysis 24 (3): 196-209. doi:10.1007/s10728-016-0329-z. 21 cavaliere, giulia, and palacios-gonzález, césar. 2018. "lesbian motherhood and mitochondrial replacement techniques: reproductive freedom and genetic kinship". journal of medical ethics 44 (12): 835-842. doi:10.1136/medethics-2017-104450. 22 baylis, françoise. 2018. "‘no’ to lesbian motherhood using human nuclear genome transfer". journal of medical ethics 44 (12): 865-867. doi:10.1136/medethics-2018-104860. 23 leah lowthorp, “3-person ivf and lesbian motherhood: a flawed argument for reproductive equality,” center for genetics and society, april 9, 2018. https://www.geneticsandsociety.org/biopolitical-times/3-person-ivf-and-lesbian-motherhood-flawed-argumentreproductive-equality 24 mccandless, s., & sheldon, s. (2014). genetically challenged: the determination of legal parenthood in assisted reproduction. 25 cavaliere and palacios, lesbian motherhood and mitochondrial replacement techniques 26 jones v. barlow, 154 p.3d 808, 819 (utah 2007) introduction background conclusion ducar, mandatory vaccines, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. mandatory vaccines will not ease fears: the need for dialogue dallas ducar keywords: vaccination, vaccination requirements introduction a bill that would make vaccinations a requirement for every child enrolling in public or private schools passed the california legislature. the bill, known as sb 277, will soon be resting on democratic gov. jerry brown's desk, awaiting his signature. under the proposal, any child enrolling in public or private schools, and day care, would be required to have verification of certain vaccinations. importantly, parents of these children would no longer be able to cite personal or religious beliefs to decline immunizations. the only case in which any california parents would be able to decline vaccinations for their children is if their child had specific medical problems, like an immune system deficiency. analysis the bill was originally started with a petition by the krawitt family in a chronically under-vaccinated marin county school district. the krawitt's son, rhett, has been advised not to be vaccinated due to the state of his immune system. their son is a 7-year-old leukemia survivor who is currently recovering from chemotherapy and, therefore, his health depends on whether enough people within the surrounding community are immunized. this concept, known as herd immunity, not only protects the child, but also safeguards those who are not vaccinated by slowing the spread of the disease. some people, such as the krawitt family, claim that other parents who refuse vaccination are putting their own immunocompromised children at risk. the bill is sponsored by democratic sens. richard pan of sacramento and ben allen of santa monica. santa monica is a hotbed for vaccine debate. an early childhood center in santa monica is reported to have a personal belief exemption rate of over 65 percent. this means that this community, along with others in the united states, has lower vaccination rates than countries suffering from extreme poverty and civil war. the “personal belief exemption” laws differ from “religious exemptions.” parents with religious exemptions tend to remain stalwart in their original argument when presented with arguments, citing their religious convictions. this delineation is important because states that only allow religious exemptions have 2.5 times less the vaccine refusal rates than those with religious and philosophical exemptions. parents that oppose vaccines for personal belief exemptions do not cite religious convictions; however they ducar, mandatory vaccines, voices in bioethics, vol. 1 (2014-15) 2 can become less likely to vaccinate even after being presented with clear evidence in favor of vaccinations from their clinicians.1 this form of rationalization is a form of confirmation bias, when one thinks they are reasoning when they are actually rationalizing. in the case of this study, parents thought they were being good scientists when they were actually being lawyers, using new arguments to defend their views. moreover, academic assessments of religious beliefs have found no evidence of organized religions prohibiting vaccines. most of those who declined vaccines on religious reasons did so for motives that were not rooted in the teachings of their own religion.2 the bottom line: a well-informed scientific public service announcement (psa) will not change the hearts and minds of any person who is against vaccinating their child. so what does one do when scientific arguments no longer work? the majority of voters and representatives in california have taken the heavy-handed, no argument approach. a mandatory vaccine requirement will surely increase the rate of vaccinations. states such as mississippi have the highest vaccination rates which are correlated with the fact that the state does not allow any vaccine exemptions beyond medical exemptions. but simply because a policy is effective in achieving its outcomes, does it mean it is the right policy to implement? as i wrote in a previous article, championing morals alongside science may help the pro-vaccination movement.3 values and beliefs shape people's lives in very fundamental ways and the scientific community cannot hope to change the minds of others without addressing core values. similarly, in related national dialogue, proponents of gun-control continue to use statistics and recent evidence to marshal support for their own position. however, proponents of gun-control may be more likely to win hearts and minds when adopting a strategy similar to their opponents. speaking about shared values such as “fostering life” or “liberty” can encourage a constructive debate. by bringing shared values to the foreground, advocates of gun-control can discuss which position “engenders an ethos of life” or encourages “liberty the flourishing of other human beings.” in the same light, a similar position can be taken by those in favor of vaccination if they admit that both morals and science can stand toe to toe. supporting this form of discourse does not mean that these scientific issues should be argued with oppositional political rhetoric, but instead, constructive value-based dialogue. the real crisis is not “antivaxxers” or “pro-vaxxers”, it is our inability to have a conversation as a nation. we should strike to the root of the crisis and start conversations about our common values. many californians are cheering the legislative agreement on sb 277 on a 46-30 vote. however, does this division really represent the best outcome? perhaps california's new law will be statistically effective, but it will also place a band-aid on a deeply divided issue. the state will still have concerned parents that either do not understand the science behind vaccines, or are rationalizing their views due to deeper reasons. this conversation starts with a clinician, not simply discussing the facts of the matter but the worries and desires that the parent has. perhaps the parent may have a deeper distrust of authority or a desire for the child to flourish, all great places to initiate dialogue. on a local, and national level, groups can also begin to change the conversation to a desire for a “culture of life” or “liberty for human flourishing.” while the california bill may be passed, it still has yet to be signed. moreover, even if the bill is signed, many concerned human beings will still remain. https://michael-reaves-bkln.squarespace.com/blog/2015/03/04/measles-and-morals-values-must-take-center-stage-with-science ducar, mandatory vaccines, voices in bioethics, vol. 1 (2014-15) 3 it is easy to villainize the other, to conflate their view with their humanity. however, if we desire to have any real, constructive dialogue, we must remember that we all belong to the same human race. we all have hopes, dreams, fears, and morals. the growing lack of immunizations is surely a public health risk, but isolating oppositionists will not gain any ground in winning hearts and minds. we must instead acknowledge our connectedness rather than risk polarization if we truly wish for our values to be conveyed. conclusion if more people decide not to vaccinate their children in california, the public health risk may turn into a national security concern. if any such concern lies ahead, it is imperative for a national dialogue to become collaborative rather than competitive. discussing virtues that underpin our society and humanity may not change hearts and minds completely, but they will bring us closer to a common ground. 1 nyhan, brendan, jason reifler, sean richey, and gary l. freed. "effective messages in vaccine promotion: a randomized trial." pediatrics 133, no. 4 (2014): e835-e842. 2 grabenstein, j. d. (2013). what the world's religions teach, applied to vaccines and immune globulins. vaccine, 31(16), 20112023. 3 ducar, d., (2015). measles and morals: values must take center-stage with science http://voicesinbioethics.org/2015/03/04/measles-and-morals-values-must-take-center-stage-with-science/ lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) © 2022 shannon lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. hold my hand: how abortion doulas improve abortion care shannon lee keywords: abortion, doulas, training, prevention, volunteer, autonomy, beneficience introduction patients seeking abortion services in the united states face several problems, including factual inaccuracies about the procedure, the stigma surrounding the procedure, and barriers to quality care across the country. the problems surrounding abortion pose a threat to patient autonomy and beneficence —ethical principles that are usually upheld in medicine. abortion doulas can enhance patient autonomy, improve the quality of medical care, help women talk through their emotions or the associated stigma, and provide other benefits that can address the problems surrounding abortion. their role ranges from discussing emotional decisions and answering patient questions before the procedure, to simply holding their hand in the recovery room. in this paper, i propose that the use of abortion doulas may help address some of the problems surrounding abortion by mitigating factual inaccuracies, stigma, and barriers to quality care. i. background abortion doulas were started by the doula project in new york city.1 they initially worked with new york city public hospitals and eventually expanded to working with planned parenthood clinics, as well as other care providers.2 over recent years, abortion doulas have been offered in more states such as california, arizon a, and new hampshire. abortion doulas can work independently, in a collective, or in an abortion clinic. 3 more often, they work in a collective where they are trained and employed in clinics that are partnered with the organization. many abortion doulas started working on a volunteer basis. now, many are funded by donations, which allow their services to be free for patients.4 when abortion doulas work independently, their rates are based on the specific services that they provide.5 patients can seek out abortion doulas through multiple avenues. they can seek out doulas that work independently, work in an abortion clinic, or through doula organizations, such as the doula project or the san francisco doula group. ii. doulas the role of a doula has existed since ancient times. the word “doula” comes from the greek language and translates to “a woman who serves”.6 in 1969, dr. dana raphael originated the use of the word “doula” in the us to describe a person who guides mothers through childbirth and assists them postpartum, specifically helping them breastfeed.7 dr. raphael encouraged emotionally supporting new mothers through creating the new professional role of a doula.8 lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) 2 currently, doulas are trained in helping women emotionally and physically during pregnancy, childbirth, and postpartum. doulas do not provide medical care, but they provide services such as birthing education, massage, assistance with breastfeeding, and educating mothers about the delivery process, such as knowing wha t to expect and what can go wrong. research has demonstrated the effectiveness and benefits of doulas. for example, one meta-analysis compared women who received doula support during childbirth to women who did not. the study showed that doula-supported women had shorter labors, decreased complications with delivery, and rated childbirth as less painful than women without doula support. 9 psychosocial benefits such as reduced anxiety, decreased symptoms of depression, and positive feelings associated with childbirth were significant for the doulasupported group.10 in the last couple of decades, doulas have become increasingly popular. more recently, doulas have started a movement labeled “full spectrum doula,” in which the role of a doula in supporting wome n has expanded beyond birth to include abortion and adoption.11 iii. ethical considerations factual inaccuracies complete and accurate medical information is fundamental to informed consent and autonomous decision making. inaccurate medical information about abortion is very common and can come from multiple sources. currently, there are 29 states that have policies restricting abortion that are not based on scientific evidence.12 while both state policies and national media may convey false information to the public about abortion, perhaps what is most surprising is when these inaccuracies are presented to patients by physicians or medical facilities. in most states, policies mandate that any medical facility providing abortions develop and p resent written material to patients that is intended to educate the patient about the abortion procedure.13 however, in some states, laws have been passed that mandate the inclusion of misinformation in these materials.14 healthcare providers try to mitigate the harm of this inaccurate information by prefacing it with qualifiers, disclaimers, and apologies. 15 however, they are still not able to completely avoid harm from the outdated and misleading information, which also often intends to dissuade patients from receiving an abortion. 16 the most common factual inaccuracies include stating that an abortion leads to an increased risk of breast cancer, that the fetus can feel pain as early as 12 weeks old, and that psychological effects of the procedure can lead to suicide and “post abortion traumatic stress syndrome.”17 all these statements are false and not supported by scientific evidence; in fact, psychologists and the diagnostic and statistical manual of mental disorders (dsm-v) do not recognize a post-traumatic stress syndrome associated with abortion. 18 furthermore, another common inaccuracy in almost 20 states includes materials with contact information to “crisis pregnancy centers” that provide false information with the intent to deter women from having an abortion.19 even once piece of inaccurate information can impede a patient’s ability to make an informed, autonomous decision. when these false facts are given to patients from the hands of trusted medical professionals, it has a more influential impact than when portrayed in media and advertisements. trust is a core value in the medical profession that determines the patient-physician relationship, and a part of this trust is communicating accurate and up-to-date information; if this trust did not exist in medicine, how would any patient make an informed decision? where would they turn to for guidance and advice?20 challenges to informed consent and autonomy exist throughout medicine, as consent forms are complicated and filled with medical vocabulary t hat is often hard to understand. signatures are sometimes scribbled onto forms before a procedure with minimal discussions to assess the patient’s understanding of the many risks and benefits. however, abortions have an additional layer of complexity regarding informed consent due to the religious and moral implications of choosing an abortion, while other common medical procedures, such as an appendectomy, do not carry the same implications. for example, a patient consenting to general surgery would probably not wonder if their physician’s advice against the surgery is due to his or her own moral values, or what the moral weight of the surgery will have on their conscious afterwards. informed consent, regardless of procedure, should prioritize informed decision-making with evidencebased medicine without moral overtones. when inaccurate, biased, and false information is given to patients from medical institutions, it not only threatens the trust between patients and medical staff, but also prevents women from making an informed decision about their reproductive health. lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) 3 if abortion doulas can be a source of correct, up-to-date medical information, then women can make informed decisions based on thorough and accurate facts that allow them to exercise autonomy. abortion doulas are well situated to correct the factual inaccuracies patients face for several reasons. first, abortion doulas are trained through a curated program with partnered medical facilities. 21 in other words, abortion doulas are thoroughly trained in patient-centered care that facilitates continuous patient support, which ranges from emotional support to providing accurate medical information when addressing patient concerns. second, they have the time before the procedure to meet with the patient and discuss pre-abortion care topics such as providing information, addressing concerns, and preparing the patient for potential stigmatization. 22 simultaneously, the doula can evaluate for any risk factors that may indicate negative emotions after the abortion, such as lack of social support, self-esteem, psychological stability, or multiple abortions.23 third, abortion doulas can provide post-abortion care counseling. while the doulas also have limited time with patients after the procedure, they would have more time than other healthcare professionals, such as nurses, to make sure the patient understands the medication regime while also offering psychological counseling for the patient on grief, guilt, and forgiveness.24 with doulas providing technical post-procedure information, this allows them to answer any more questions that the patient may have about misleading, biased, out-of-date, or false information. therefore, doulas can enhance patient autonomy by giving more accurate information. iv. stigma another critical problem facing patients who seek abortions is the stigma surrounding the procedure itself. an abortion requires many decisions to be made: do you want to be sedated or awake for the procedure? if you are awake, do you want someone to hold your hand or someone to talk to? do you want to have privacy after the procedure? in fact, the first decision to be made is whether to have the abortion at all. for some women, that decision is immediate, quick, and assured. for others, the decision can be morally conflicting, such as due to religious reasons, society’s stigma, or other reasons. the moral conflict a woman faces when deciding on an abortion is determined by how much moral weight they apply to a fetus or embryo.25 an abortion can make a woman feel as though they are a bad person or doing something morally wrong, especially if they place more weight on the moral status, or viability, of the fetus or embryo.26 regardless of why a woman feels conflicted, the bottom line is that these feelings exist, which can affect their decision-making abilities during the actual process. our society stigmatizes women for having an abortion, it is our “modern-day scarlet letter.”27 this stigma is under-researched but often theorized to be based on gender-biased roles of women in society.28 women who receive an abortion are labeled as “irresponsible” for having an unwanted pregnancy, or “selfish” and “unmotherly” for not wanting children. therefore, women avoid judgement and prefer privacy during their abortion—but are these choices made because that is truly what a woman desires, or are they making these choices to avoid stigma? and, if they are making these choices to avoid stigma, how does it affect their autonomy as a decision-maker for their own healthcare choices? there is a difference between secrecy and privacy: women may want to keep their abortion decision private, like any other medical decision or health information. 29 however, some women make the decision in secret to avoid judgment and stigmatization. there is evidence that stigma plays a role in every decision of the abortion process. for example, one study explores the reasons why some women prefer to be awake versus asleep during the procedure. women who choose to be asleep want to be less emotionally present for the fear of “seeing something” during the procedure. on the other hand, women who choose to be awake want to feel present, safe, and receive support during the process.30 the study also found that most women rated an abortion procedure a “good experience” if care was provided in a discreet and private manner.31 by preferring anesthesia and privacy, many women try to avoid dealing with the stigma and judgement from others. the stigma also prevents women from seeking or receiving social support.32 while some women may make these choices because it is what they truly want, others might choose these options to avoid others witnessing their decision and from being stigmatized as a woman who “got an abortion.” lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) 4 although abortion doulas cannot completely abolish the overarching societal stigma, they can help in several different ways on an individualistic level. abortion doulas may fit the role of personalizing each experience to fit patients’ specific preferences. doulas have the time and appropriate training to understand and discuss the emotional burdens that come along with the social stigma that surrounds abortions.33 they have the training to explore the patient’s reasons for their decisions and can make sure they are comfortable with them. they do so in a non-judgmental way and strive to act as an advocate for the patient.34 by listening to women and validating their decisions, women may not feel as many negative emotions surrounding the stigma or feel empowered that they made the right decision for themselves, regardless of social labels. this validation and empowerment gives women more agency in their own healthcare decisions while also providing emotional support in a situation that requires many difficult choices. abortion doulas would become a support system for women, thereby promoting feminist ethics by normalizing emotions in a morally charged decision. they also promote the principal of beneficence by helping patients address any conflict between societal stigma and the woman’s own beliefs and morals. v. barriers to quality care access to abortion is limited: only 62 percent of american women live in counties with an abortion provider.35 many insurance companies do not cover abortions and clinics are often busy with limited availability, staff, and resources. additionally, many women would need time off from work, childcare, transportation, and other resources to make it to any medical appointments—abortion care is not an exception. currently, there are no professional programs for abortion providers to offer post-abortion counseling.36 additionally, in busy clinics, hospitals, or non-profit organizations such as planned parenthood, physicians attempt to provide as many abortions as possible to as many patients, leaving little time for post-abortion care. provider burn-out is a major problem throughout healthcare, which has become more pronounced throughout the covid-19 pandemic. many providers, nurses, and other hospital staff are overworked and underpaid while hospitals themselves are overcrowded and underfunded. moreover, abortion providers may be especially vulnerable to burn-out as they tend to both their patient’s medical and emotional needs during a procedure that has both physical pain and a plethora of emotion surrounding it.37 with an increase in patient number due to decreased availability of services and a physician’s responsibility to tend to the patient’s emotional well-being and physical pain, this increases the risk of provider burn-out, which in turn, can affect the quality of medical care given to women receiving abortions.38 abortion doulas can fill the role of providing post-abortion care and help alleviate provider burn-out in many ways. first, as mentioned previously, they have the time before the procedure to meet with the patient and discuss pre-abortion care topics, provide information, and answer questions.39 secondly, abortion doulas can provide patients with the post-abortion care counseling that many physicians and nurses are not able to provide. this role has multiple effects. while post-abortion counseling can help address factual inaccuracies through answering questions, it can also allow doulas to make sure the patient understands the medication regime and how to deal with the pain that follows the procedure. 40 with doulas providing technical post-procedure information, this relieves understaffed nurses of some of their many tasks and responsibilities in the postabortion recovery room; this will likely decrease the number of women who come back to the clinic or hospital with complications or additional questions. by discussing various emotions during post-procedure counseling, doulas support women by listening to their feelings. some women may feel relief and joy after the procedure, while other may feel despair, regret, grief, or shame. when a doula listens to and supports a patient, they validate their emotions and indirectly validate their abortion decision, thereby improving the quality of the experience. lastly, the integration of doulas into routine abortion care allows physicians and staff to concentrate on the procedure itself.41 the doula can offer patient-centered, hands-on care to the patient while the rest of the healthcare team focuses on their own technical tasks.42 doula support can also decrease the need for more clinic staff in the procedure room by “decreasing the redirection of clinic staff resources,” thus creating a more efficient medical environment.43 as the historical role of a doctor playing every role is becoming more obsolete, and the lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) 5 idea of a multi-faceted, integrative healthcare team is becoming the norm, it makes sense that an abortion doula can fill a niche on a healthcare team for emotionally laden procedures like abortions. the niche that the doula fills is to support, comfort, and be present with the patient throughout the entirety of the procedure in a nonjudgmental way. while nurses and doctors can be supportive, sympathetic, and caring, their jobs and roles include other responsibilities that do not allow them to be a continuous presence for the patient throughout their visit.44 by having a person on the healthcare team whose job is to provide patient support, even if it is simply to hold their hand, the patient is more likely to be treated as a whole and provided better quality medical care. conclusion inaccurate information, stigma, and quality of care barriers are only a few of the many problems facing patients who want to receive an abortion. each problem poses ethical challenges while also impeding quality medical care and adding to patients’ emotional burdens. inaccurate facts and stigma hinder an informed decision, and thereby, threaten patient autonomy. the stigma of abortion can also lead to patients experiencing more negative emotions. furthermore, healthcare barriers include a wide range of problems, from understaffed clinics to provider burn-out, all of which affect the quality and access to care for patients seeking an abortion. abortion doulas are part of the solution to these problems. they are an extra resource, a set of hands for the patients to hold in the procedure room, and an expert in providing emotional and social support for the patient. they can enhance a patient’s decision-making skills, support the patient’s emotional well-being, answer factual questions, counter stigma, and help provide quality medical care. therefore, abortion doulas enhance patient autonomy, promote beneficence, improve access to quality abortion care, and fill a necessary role during the abortion process. 1 shakouri, shireen rose "the doula project." ed. lee, shannon2019. print. 2 shakouri, shireen rose "the doula project." ed. lee, shannon2019. print. 3 onyenacho, tracey. "abortion doulas help people navigate the process. they say their work was more crucial than ever in the p andemic." the lily 2021. web. 12/29/2021 2021 4 onyenacho, tracey. "abortion doulas help people navigate the process. they say their work was more crucial than ever in the pandemic." the lily 2021. web. 12/29/2021 2021 5 onyenacho, tracey. "abortion doulas help people navigate the process. they say their work was more crucial than ever in the p andemic." the lily 2021. web. 12/29/2021 2021 6 dukehart, coburn. "doulas: exploring a tradition of support." the baby project. national public radio 2011. web2021. 7 roberts, sam. "dana raphael, proponent of breast-feeding and use of doulas, dies at 90." new york times 2016. web2020. 8 roberts, sam. "dana raphael, proponent of breast-feeding and use of doulas, dies at 90." new york times 2016. web2020. 9 scott, k. d., p. h. klaus, and m. h. klaus. "the obstetrical and postpartum benefits of continuous support during childbirth. " j womens health gend based med 8.10 (1999): 1257-64. print. 10 scott, k. d., p. h. klaus, and m. h. klaus. "the obstetrical and postpartum benefits of continuous support during childbirth. " j womens health gend based med 8.10 (1999): 1257-64. print. 11 chor, j., et al. "doulas as facilitators: the expanded role of doulas into abortion care." j fam plann reprod health care 38.2 (2012): 123-4. print. 12 nash, elizabeth; gold, rachel benson; mohamed, lizamarie; ansari-thomas, zohra; capello, olivia "policy trends in the states, 2017." guttmacher instititue 2018. web. 13 richardson, chinue turner; nash, elizabeth. "misinformed consent: the medical accuracy of state -developed abortion counseling materials " guttmacher policy review 9.4 (2006). print. lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) 6 14 buchbinder, mara, et al. "“prefacing the script” as an ethical response to state-mandated abortion counseling." ajob empirical bioethics 7.1 (2016): 48-55. print. 15 buchbinder, mara, et al. "“prefacing the script” as an ethical response to state-mandated abortion counseling." ajob empirical bioethics 7.1 (2016): 48-55. print. 16 richardson, chinue turner; nash, elizabeth. "misinformed consent: the medical accuracy of s tate-developed abortion counseling materials " guttmacher policy review 9.4 (2006). print. 17 richardson, chinue turner; nash, elizabeth. "misinformed consent: the medical accuracy of state -developed abortion counseling materials " guttmacher policy review 9.4 (2006). print. 18 blevins, christy a., et al. "the posttraumatic stress disorder checklist for dsm-5 (pcl-5): development and initial psychometric evaluation." journal of traumatic stress 28.6 (2015): 489-98. print. 19 richardson, chinue turner; nash, elizabeth. "misinformed consent: the medical accuracy of state-developed abortion counseling materials " guttmacher policy review 9.4 (2006). print. 20 pellegrini, c. a. "trust: the keystone of the patient-physician relationship." j am coll surg 224.2 (2017): 95-102. print. 21 shakouri, shireen rose "the doula project." ed. lee, shannon2019. print. 22 chor, julie, et al. "factors shaping women’s pre-abortion communication with members of their social network." journal of community health 44.2 (2019): 265-71. print. 23 harris, amy a. "supportive counseling before and after elective pregnancy termination." journal of midwifery & women’s health 49.2 (2004): 105-12. print. 24 chor, julie, et al. "factors shaping women’s pre-abortion communication with members of their social network." journal of community ` health 44.2 (2019): 265-71. print. 25 watson, katie. the scarlet a oxford university press, 2018. print. 26 altshuler, a. l., et al. "a good abortion experience: a qualitative exploration of women's needs and preferences in clinical care." soc sci med 191 (2017): 109-16. print. 27 watson, katie. the scarlet a oxford university press, 2018. print. 28 norris, a., et al. "abortion stigma: a reconceptualization of constituents, causes, and consequences." womens health issues 21.3 suppl (2011): s49-54. print. 29 watson, katie. the scarlet a oxford university press, 2018. print 30 altshuler, a. l., et al. "a good abortion experience: a qualitative exploration of women's needs and preferences in clinical care." soc sci med 191 (2017): 109-16. print. 31 altshuler, a. l., et al. "a good abortion experience: a qualitative exploration of women's needs and preferences in clinical care." soc sci med 191 (2017): 109-16. print. 32 norris, a., et al. "abortion stigma: a reconceptualization of constituents, causes, and consequences." womens health issues 21.3 suppl (2011): s49-54. print. 33 basmajian, alyssa. "abortion doulas." anthropology now 6.2 (2014): 44-51. print. 34 amram, natalie lea, et al. "how birth doulas help clients adapt to changes in circumstances, clinical care, and client preferences during labor." j perinat educ.2: 96-103. print. 35 dennis, amanda, ruth manski, and kelly blanchard. "a qualitative exploration of low-income women's experiences accessing abortion in massachusetts." women's health issues 25.5 (2015): 463-69. print. 36 harris, amy a. "supportive counseling before and after elective pregnancy termination." journal of midwifery & women’s health 49.2 (2004): 105-12. print. 37 chor, j., et al. "integrating doulas into first-trimester abortion care: physician, clinic staff, and doula experiences." j midwifery womens health 63.1 (2018): 53-57. print. 38 jerman j, jones rk and onda t. "characteristics of u.s. abortion patients in 2014 and changes since 2008." guttmacher instititue 2016. web. 39 chor, julie, et al. "factors shaping women’s pre-abortion communication with members of their social network." journal of community health 44.2 (2019): 265-71. print. 40 chor, julie, et al. "factors shaping women’s pre-abortion communication with members of their social network." journal of community health 44.2 (2019): 265-71. print. 41 chor, j., et al. "integrating doulas into first-trimester abortion care: physician, clinic staff, and doula experiences." j midwifery womens health 63.1 (2018): 53-57. print. lee, hold my hand: how abortion doulas improve abortion care, voices in bioethics, vol. 8 (2022) 7 42 chor, j., et al. "integrating doulas into first-trimester abortion care: physician, clinic staff, and doula experiences." j midwifery womens health 63.1 (2018): 53-57. print. 43 chor, j., et al. "doula support during first-trimester surgical abortion: a randomized controlled trial." am j obstet gynecol 212.1 (2015): 45.e1-6. print. 44 basmajian, alyssa. "abortion doulas." anthropology now 6.2 (2014): 44-51. print. introduction jhia jackson, taking a broad perspective, voices in bioethics, 2013 © 2013 jhia jackson. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. taking a broad perspective on medical education jhia jackson keywords: science, philosophy, humanities, 21st, science needs the humanities. medicine needs philosophy. we are at a point where research and technologies are intersecting with fundamental issues of what it means to be human, to be alive, and to exist in a global society. to ask a person to answer these questions and act on their conclusions using purely scientific facts is no longer a viable option: the interpretation of these “scientific facts” carry too much moral and societal weight. as medicine advances and is able to delve deeper into personal realms that are no longer limited to bodily concerns, medical schools in the united states have expanded their curr icula to better prepare their students for the realities of the medical profession’s role in the twenty-first century. on the west coast, the university of washington school of medicine requires m.d. students to complete at least four “non-clinical selective credits” prior to any clinical curriculum. these credits are department-approved electives that are meant to enhance the student’s medical education, without involving direct patient care, and can then serve to inform their future patient interactions. some of the departments that students are encouraged to choose from include bioethics and humanities, global health, and psychiatry and behavioral science. as one scrolls through some of the specific course offerings, one notices that they involve multidisciplinary approaches to medical questions and specifically address themes such as the role of spirituality in healthcare and the impact of society on one’s health. these are courses that will not only aid in students’ understanding of the physician-patient relationship, but will also challenge them to consider the impact of their research for the medical community and society as a whole. the university of washington is just one example of this trend in medical education. many other universities, including those with a strong reputation and history of success in clinical practice and research, are taking a broader view in what a medical education should entail. within the “education” section of its website, johns hopkins school of medicine explicitly states: “education in medical history, ethics, even literature informs and expands the learning experience.” its mission statement goes on to include a section regarding “the social context of medicine” and directly describes the need to “[u]nderstand and respond to factors that influence the social, behavioral, and economical factors in health, disease, and medical care.” the inclusion of these sentiments may then serve as a framework for all aspects of learning, even in clinical or laboratory-based work. the university of washington and johns hopkins university are not the only american universities following this trend. the “about us” or “curriculum” sections of most schools highlight terms such as compassion, humanity, and ethics. with new information technologies allowing the general public greater and more expedient access to knowledge of medical events, graduate medical programs cannot afford to ignore the need for humanities in medical education. enabling students with the tools to best debate the moral a nd social implications of their actions can only lead to a better sense of responsibility and accountability. scientific advancements without this type of self-knowledge and regulation will only serve to undermine the credibility of medicine in the public sphere. hopefully, the success of medical schools taking such a broad perspective in their curriculum will trickle down and allow undergraduate pre-medical students the same access to the seemingly jhia jackson, taking a broad perspective, voices in bioethics, 2013 2 self-contained realms of both science and the humanities. a greater knowledge and interest in one should not exclude access to the other. related articles: "science’s humanities gap" by gary gutting september 18, 2013. the new york times http://opinionator.blogs.nytimes.com/2013/09/18/sciences -humanities-gap/?_r=0 "science is not your enemy" by steven pinker august 6, 2013. new republic http://www.newrepublic.com/article/114127/science-not-enemy-humanities "medicine’s search for meaning" by david bornstein september 18, 2013. the new york times http://opinionator.blogs.nytimes.com/2013/09/18/medicines-search-for-meaning/ http://opinionator.blogs.nytimes.com/2013/09/18/sciences-humanities-gap/?_r=0 http://www.newrepublic.com/article/114127/science-not-enemy-humanities http://opinionator.blogs.nytimes.com/2013/09/18/medicines-search-for-meaning/ curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) © 2014 henry curtis. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. revisiting jacobson: an analysis of the modern day implications of jacobson v. massachusetts henry curtis abstract jacobson shows the utilitarian nature of governmental policy. when it comes to most public health actions, the government will act to provide the greatest amount of good for the greatest number of people. ultimately, via examining multiple examples of socio-medical policy, we will find that jacobson is a supreme court case that goes under the radar in terms in spite of its important impact on everyday life. introduction in recent years, public health and the law have frequently interacted. a variety of issues have led to the government stepping in to create legislation that affects the individual in order to protect the general public. these actions are grounded in the 1905 supreme court case jacobson v. massachusetts. jacobson set the stage for almost all public health law to follow. however, the case has had more than just a legal impact. in fact, jacobson has made its mark on both societal policies and trends in healthcare and medicine. the case set a precedent for the valuing of public health over individual liberties when the two come into conflict. more generally, jacobson shows the utilitarian nature of governmental policy. when it comes to most public health actions, the government will act to provide the greatest amount of good for the greatest number of people. ultimately, via examining multiple examples of socio-medical policy, we will find that jacobson is a supreme court case that goes under the radar in terms in spite of its important impact on everyday life. analysis let us begin with the first and most obvious instance of jacobson affecting society today: vaccination policy. there are two primary ways that vaccinations can affect the individual: through mandated vaccinations for children starting school, and by vaccination orders during a public health emergency. starting with the former and most prevalent example, school entry requirements across the country are influenced by vaccination public health policy. curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 2 every state in america requires students to be vaccinated against certain diseases before entering public or private school.[1] the mandated vaccinations usually include one inoculation against mumps, measles, and rubella (mmr), another to prevent diphtheria, tetanus, and pertussis (dtap), as well as others to combat polio, influenza, varicella, and hepatitis b. such policies have been in place in the united states since the 1960s and 1970s, when a measles outbreak spread across the country. states also have laws in place that allow them to mandate vaccinations during a public health emergency, such as an outbreak of a communicable disease. the decision of whether to invoke the law lies with governors, state boards of health, or state health officers.[2]for example, in arizona the governor has the right during a state of emergency “to issue orders that mandate treatment or vaccination of persons who are diagnosed with illness resulting from exposure or who are reasonably believed to have been exposed or who may reasonably be expected to be exposed.”[3] the law is written to give the government a wide range of powers in such circumstances. with a severe outbreak, just about everybody in a specific population would fall under such law. other states have similarly legislated powers, with the differences being who decides when a situation is dire enough to trigger these powers and how they are carried out. jacobson’s impact in these cases is evident in states’ exemption policies. all states will exempt someone from vaccination for medical reasons; essentially, a person cannot be forcibly vaccinated if he is allergic to the vaccine. about a dozen states also recognize philosophical objections, while more allow for religious exemptions. if [1] religious or philosophical beliefs against vaccinations are sincerely and conscientiously held, and if the objector can provide proof of the belief (such as showing membership in a religious group that does not allow vaccinations), then the individual can be declared exempt. aside from these instances, everyone is subject to vaccination laws. the logic in the jacobson decision shows itself here. according to justice john harlan, who wrote the majority opinion, “upon the principle of self-defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members.”[4] although this applies to public health emergencies, the line of thought is still the same for school vaccination: when it comes to questions involving public health, the government values the protection of the general population over the rights of the public. jacobson has a direct corollary to disease prevention, as seen in the case involving reverend henning jacobson, who did not trust the safety of smallpox vaccine.[5] at the turn of the last century, massachusetts was facing an epidemic. in 1900, there were 100 cases of smallpox reported in the state; by 1902, that number had risen to 2,314, with 284 reported deaths. the state mandated vaccinations for the general public in order to curb the spread of the disease. this was before religious or philosophical objections had been established, so everyone had to participate. jacobson refused, and instead of paying a five-dollar fine (around $150 today), he sued the state. the case eventually made it all the way to the supreme court, which ruled in favor of the state. this precedent of using utilitarian calculation in public health law shows itself not just in vaccination policy, but other areas as well. for instance, the impact of jacobson can be seen in quarantine law. the government has specific powers when it comes to quarantining individuals in times of public health emergencies. fidler, gostin, and markel comment on this area: “public health authorities possess a variety of powers to restrict the autonomy or liberty of persons who pose a public health threat.… legal authority to exercise these powers in the united states can be found curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 3 at local, state, and federal levels.”[6] in times of emergency and disease outbreak, then, the government has the right to quarantine or isolate individuals for the benefit of the general population. two specific examples of this both involve tuberculosis. the first is the tb outbreak in new york city in the early 1990s. as gasner, et al., comment, “in 1992, new york city reported 3811 cases of tuberculosis, nearly three times the number of cases reported 15 years before. the commissioner of health could issue orders compelling a person to be examined for suspected tuberculosis, to complete treatment, to receive treatment under direct observation, or to be detained for treatment.”[7] for the city, the nature of the disease warranted quarantining individuals. if they do not complete treatment—it can take months to completely cure a patient of the disease—drug-resistant strains evolve. these strains of the disease are much tougher to treat and are more often fatal. therefore, to prevent drug-resistant tb from spreading, the city quarantined individuals who had the disease and isolated those who refused treatment. the protocol was a success, reported gasner: “new york city’s tuberculosis-control program has been highly successful; new cases decreased by 54.6 percent and cases of multidrugresistant disease by 87.3 percent between 1992 and 1997.”[8] by removing individuals from the general population, the city effectively curbed the spread of the disease and helped prevent drug-resistant strains from developing. another example of quarantine being used for tuberculosis is the andrew speaker incident, in 2007.[9] speaker was planning to travel abroad when it was discovered that he had a multidrug-resistant strain of tb. the georgia department of public health, in collaboration with the centers for disease control, advised speaker not to leave the country and was planning legal action to keep him from going abroad. before health officials could reach him, however, he had already departed for europe. speaker was tracked down in rome. the cdc reminded him of his diagnosis and warned to not to travel on commercial aircraft because of the threat he posed. he defied the order and flew to prague for a few days before coming back to north america, to montreal. he then traveled by car to new york, where he was ordered to bellevue hospital for evaluation and potential isolation. once he arrived, he was issued a federal quarantine order, the first of its kind since 1963. speaker was kept in isolation for several months to complete his treatment. he was transferred to multiple facilities, and a portion of his lung was removed, before he was finally declared noncontagious. the actions of the cdc and the new york commissioner of health show jacobson’s application. the supreme court’s decision in the case set up a “rule of reasonableness” when it comes to public health actions. according to fidler, et al., “following the ‘rule of reasonableness’ established in jacobson…courts insisted that use of quarantine power be justified by ‘public necessity’ and that states may not act ‘arbitrarily’ or ‘unreasonably.’”[10]jacobson gave the outlines for when quarantine is allowable and justified. in the cases above, public necessity was established by the contagiousness and lethality of tb. the actions were deemed reasonable and non-arbitrary because they were utilized equally among all non-compliant tb patients. recalling justice harlan’s specific usage of the term “self-defense,” the impact that jacobson truly has in situations such as these is clear. we see public health law not as a routine form of policy but as a response to an attack. the court established that the government has the right to defend the population against external health threats. the quarantines that resulted from the tb outbreaks clearly show this type of reaction. a more literal application of self-defense stemming from jacobson comes from the so-called war on terror. bioterror specifically presents an interesting challenge for governments. as annas elaborates: “bioterrorism—the curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 4 deliberate release of a harmful agent to intimidate civilians and their government—constitutes a threat to public health that differs from any other public health threat that our country has faced. an act of bioterrorism is both a state and federal crime.… because of our…transportation system, communicable diseases can be spread in a short period of time.”[11] prior to september 11, the united states did not have a specifically coordinated bioterror attack plan. according to annas, the only reason that former president bill clinton became engaged in the issue is because he read a tom clancy novel in which a bioterror attack occurred in the united states. after a wave of anthrax attacks after 9/11, hospitals, cities, states, and federal officials came around to setting protocols for dealing with bioterror attacks. this has included stockpiling vaccines, improving the public health infrastructure, and training emergency personnel to recognize and be able to treat diseases such as anthrax poisoning, smallpox, and bubonic plague, the most likely afflictions to be caused by a terrorist act. however, the model state emergency health powers act, enacted on october 23, 2001, utilized jacobson’s logic the most straightforward. the original model of the act allowed government officials to declare a state of public health emergency. this declaration, according to annas, “gives state public health officials the authority to take over all health care facilities in the state, order physicians to act in certain ways, and order citizens to submit to examinations and treatment, with those who refuse to do so subject to quarantine or criminal punishment.”[12] the act gives public health officials immense authority. they can commandeer health care facilities, and physicians and citizens who fail to follow the orders of public health personnel are subject to criminal penalties. on top of this, as in the tb cases, individuals who are deemed a “public health risk,” which includes being at risk of contracting a communicable disease, having a contagious condition, or having possibly been exposed, are subject to either quarantine or isolation. quarantine and isolation are also options if, as before, an individual refuses to be vaccinated or treated for specific conditions. it is clear that the logic of jacobson is in play here as well. as annas writes about the health powers: the model act is based on the belief that in public health emergencies, there must be a trade-off between the protection of civil rights and effective public health interventions. there is, of course, precedent for this belief, and the preamble to the model act cites the 1905 case jacobson v. massachusetts in stating the proposition that “the whole people covenants with each citizen, and each citizen with the whole people, that all shall be governed by certain laws for the ‘common good.’”[13] when it comes to the war on terror, civil liberties get pushed to the side for the protection of the public at large. whether all instances of such are justifiable is a different story. however, the logic behind the jacobson decision plays a key role in how we approach terrorism. the self-defense rhetoric that harlan used in his majority opinion applies more here than anywhere else. we are utilizing public health measures to quite literally defend ourselves against outside threats. for public health officials attempting to combat the effects of bioterror, the protection of the majority curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 5 is vastly more important than the civil liberties of the individual. if ensuring the well-being of the general population requires the restriction of rights for the everyday person, so be it. two final instances in which the logic of jacobson reigns supreme are of a more medical nature than the examples discussed above. first, the effectiveness of and importance placed on vaccinations today reflect the rationale behind the actions of the state of massachusetts in jacobson. the reason the case even occurred was because of the effect that vaccinations have on public health. massachusetts mandated smallpox vaccinations in response to an outbreak. the results speak for themselves. because of widespread vaccination policies, smallpox has all but been eradicated. another disease, polio, has been entirely eliminated from the united states because of vaccination efforts.[14] however, continued vaccinations play a key role in prevention. according to the american society of health pharmacists, “it would only take one person with polio virus coming from another country to bring the disease back here if we were not protected by vaccine.”[15] there have been other instances in the past few years that show the importance of vaccination to public health. measles, preventable with the common mmr vaccine, is normally a disease of the past because of mandatory vaccination regulations. however, an outbreak occurred in indiana in 2005 in an area where vaccination levels were low.[16] a study in the new england journal of medicine concluded that “high vaccinations levels in the surrounding community and low rates of vaccine failure averted an epidemic. maintenance of high rates of vaccination coverage, curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 6 including improved strategies of communication with persons who refuse vaccination, is necessary to prevent future outbreaks and sustain the elimination of measles in the united states.”[17] clearly, vaccination programs are a critical part of preventing more disease outbreaks from occurring—an affirmation of the logic behind jacobson, one hundred years after the case was decided. the reason why vaccination programs are so important is because they work. as the previously cited study shows, the only areas where diseases that are preventable via vaccines are prevalent are areas where people don’t get vaccinated. the reason why massachusetts health professionals were so insistent that individuals be vaccinated in 1902 is because vaccinations were shown to work. we can still see the results today, when we recognize that smallpox is essentially a disease of the past. the rationale used in determining why the actions of massachusetts in jacobson were so important is the same being utilized today. herd immunity is another public health concept in use today that had corollaries in jacobson. known more gently as community immunity, herd immunity refers to the concept that if enough people in a population are vaccinated against a disease, it will eventually die out. a disease needs to continue to be transmitted in order for it to survive. if the line of transmission stops, the disease dies out. this is why smallpox and polio are nonexistent in the united states. still, certain levels of vaccination need to be maintained in order for the disease to remain suppressed. according to the cdc, smallpox and polio require a minimum vaccination rate of 80 to 85 percent of the population, whereas diseases such as measles and diphtheria require rates upward of 94 percent.[18] it is critical for individuals to be vaccinated, even when a disease is rare, for two reasons. first, as the american society for health pharmacists noted before, if we stop immunizing against polio and someone from another country with the disease comes to the united states, incidences of the disease will increase again. the only reason why polio and other rare diseases haven’t reappeared in the united states is because we maintain herd immunity levels. second, certain individuals cannot be vaccinated for medical reasons. some people are allergic to various components of the vaccine, be it the dead cells used to create immunity, additives used to preserve the vaccine, or the material used to keep the cells suspended in solution. since these people cannot receive the vaccination, herd immunity levels need to be maintained them. although the concept of herd immunity was unknown in the early 20th century, essentially the same logic was used in the lead-up to jacobson. the only way for an entire community to be protected is if as many people as possible get vaccinated. medical officials at the time understood the concept of allergic reactions, so those who could not receive the vaccination didn’t. however, they mandated that everyone else had to. we follow essentially the same line of thinking today when crafting public health vaccination policy concerning vaccinations, but we now have a better understanding of the role of herd immunity in the protection of the general population, meaning the importance of vaccinations that the state of massachusetts saw in jacobson has increased exponentially. curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 7 conclusion if anyone argues that case law from hundreds of years ago has no impact on everyday life, jacobson is the clear rebuttal. from public health policy to medical innovation and discovery, the logic utilized in that decision still applies today. the basic utilitarian calculation that the greatest good ought to be given for the greatest number of people informed both the decision itself and the ramifications of it that we see today. from our responses to global bioterror to vaccination policy for children about to start school, the rhetoric used in the jacobson decision rings as true today as it did more than a hundred years ago. the government still places a greater importance on public health than on individual liberties, especially in times of emergency. it is clear that jacobson v. massachusetts has an indelible impact on public health policy and the social views of medicine that will continue for the next hundred years and beyond. [1] welborn, angie a. et al, “mandatory vaccinations: precedent and current laws” crs report for congres s, january 18, 2005, http://www.fas.org/sgp/crs/rs21414.pdf, pg 2-3 [2]ibid, pgs. 3-4 [3]ibid [4]jacobson v. massachusetts, 197 u.s.11 (1905), ***31, accessed via lexis nexis [5] parmet, wendy e., richard a. goodman, and amy farber. "individual rights versus the public's health — 100 years after jacobson v. massachusetts" new england journal of medicine352, no. 7 (2005): 652-654. [6] fidler, david, lawrence gostin, and howard markel. "through the quarantine looking glass: drug-resistant tuberculosis and public health governance, law, and ethics." the journal of law, medicine, and ethics 35, no. 4 (2007): pg. 620 [7] gasner, m. rose, khin lay maw, gabriel e. feldman, paula i. fuj iwara, and thomas r. frieden. "the use of legal action in new york city to ensure treatment of tuberculosis." new england journal of medicine 340, no. 5 (1999): pg. 359 [8]ibid [9] fidler, pg. 617-8 [10]ibid, pg. 621 [11] annas, george j.. "bioterrorism, public health, and civil liberties." new england journal of medicine 346, no. 17 (2002): pg. 1337 [12]ibid, pg. 1338 [13]ibid, pg. 1399 [14] “polio vaccine”, american society of health pharmacists, 2011, http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601177.html [15]ibid [16] parker, amy a. et. al, “implications of a 2005 measles outbreak in indiana for sustained elimination of measles in the united states”, new england journal of medicine, vol. 335, 3 august 2006, pgs. 447-455 http://www.fas.org/sgp/crs/rs21414.pdf http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601177.html curtis, revisiting jacobson, voices in bioethics, vol. 1 (2014) 8 [17]ibid [18] “history and epidemiology of global smallpox eradication.” slideshow, center for disease control. december 22, 2003. http://www.bt.cdc.gov/agent/smallpox/training/overview/pdf/eradicationhistory.pdf this work is licensed under a creative commons attribution 4.0 international license. how to cite curtis, h. (2014). revisiting jacobson: an analysis of the modern day implications of jacobson v. massachusetts. voices in bioethics, 1. retrieved from https://journals.library.columbia.edu/index.php/bioethics/article/view/6478 http://www.bt.cdc.gov/agent/smallpox/training/overview/pdf/eradicationhistory.pdf https://creativecommons.org/licenses/by/4.0/ https://journals.library.columbia.edu/index.php/bioethics/article/view/6478 https://journals.library.columbia.edu/index.php/bioethics/article/view/6478 https://creativecommons.org/licenses/by/4.0/ zimmerman, aca “salvage” over “demolition,” voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, ms candidate columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “salvage” over “demolition”1: saving the aca post ruth bader ginsburg anne zimmerman* abstract the death of ruth bader ginsburg brings up uncertainty over many issues that depend on supreme court decisions. this paper explores the impact of the court on the aca and the ability of millions of americans to access quality healthcare. specifically, the issues before the court concern the survival of the mandate in the absence of the tax penalty that was repealed in 2017, the ability of the aca to survive without the mandate, and in the worst case scenario, the limitation of the remedy to the states opposed to the aca’s survival. this paper argues that judicial restraint and consistency, both conservative ideals, should save the aca. regardless of the toothless mandate, the aca is operational and many aspects of it, including the medicaid expansions, have little or nothing to do with the mandate. keywords: aca, affordable care act, supreme court, scotus, ruth bader ginsburg, health insurance mandate, severability introduction the aca2 is at the mercy of a changing and politicized us supreme court. the replacement for ruth bader ginsburg could be outcome determinative for california v. texas 3 with oral arguments scheduled for november 10, 2020, a week after the presidential election. the justices applying judicial consistency, common sense, and ethical reasoning may save the aca. regardless of the court, a legislative change could be outcome determinative depending on congressional majorities. in the moments since the death of ruth bader ginsburg, the media has suggested the aca is doomed.4 if conservative justices would behave with judicial restraint, the chances of keeping the law intact would improve. zimmerman, aca “salvage” over “demolition,” voices in bioethics, vol. 6 (2020) 2 the aca provided access to care to many people who did not have healthcare coverage. the ethical basis for the aca was coverage while its primary goals also included cost containment: a financially workable system to provide universal healthcare coverage. through the aca, many people who were not eligible for medicaid became eligible through the medicaid expansions.5 employer-based and private insurance were held to higher standards of coverage eliminating skeleton plans. those with preexisting conditions and those wanting coverage for adult offspring benefit from provisions in the aca as well. other legislation like the sunshine act providing transparency in industry payments to doctors are also part of the aca.6 in addition to the expected ethical goals of ensuring that more people have access to care, the aca included the mandate, a provision designed for universal coverage, insurance industry buy-in, and to negate the free riding that occurs when people use emergency rooms without the ability to pay.7 the aca’s broad ethical basis ranged from liberal ideas surrounding universal healthcare to conservative ideas like taking responsibility, paying one’s own way instead of free riding, and using market forces rather than implementing a single payer plan. with ethical goals of justice and access to care, the aca succeeded in decreasing the rate of uninsured which remains under 9 percent.8 i. background in nfib v. sebelius, the court held that the aca individual mandate9 was enforceable within congressional tax power.10 the 2017 tax cuts and jobs act repealed the tax penalty for remaining uninsured.11 while it is odd, and seemingly unbelievable, a texas federal court later decided that the repeal of the financial penalty for failing to purchase insurance invalidates the mandate.12 the fifth circuit effectively held that the threat that one must buy insurance or nothing will happen was less acceptable than the seemingly harsher threat that one must buy insurance or pay a penalty. the fifth circuit remanded the case to the district court to decide on the issue of severability when the supreme court decided to review. ii. the mandate absent the tax penalty nfib, the 2012 case, came to an odd conclusion: the mandate is not coercive or required; it is a choice to buy insurance or pay the penalty. rather than upholding the mandated aspect outright (the coercive aspect that insurance is required), the court muddied the water by holding the mandate was not appropriate to regulate interstate commerce. while the fine operated as a tax and a penalty, the legislation itself was not dependent on the tax and it should not be vulnerable to a tax repeal. by honoring the tax argument and denying the argument that a mandate to purchase insurance simply is constitutional, the court placed the mandate on shaky ground. now, four of the five justices that upheld the mandate as a use of tax power remain on the court. 13 a new justice appointed immediately could mean the law’s destruction; a new moderate or progressive justice appointed after the presidential election could save the law ensuring millions of americans continued access to healthcare. in texas v. us, the case brought after the tax repeal,14 the fifth circuit majority opinion suggested that the mandate could snowball into more coercive requirements like mandating healthy food. the problem with that part of the opinion is that it exposes an anti-aca bias and an underlying judicial motive. the fifth circuit ignored nfib by presenting in dicta an objection to the aca mandate that has nothing to do with the amount or value of the tax. there are signs of judicial activism behind the fifth circuit majority: the judges disliked the premise of the law which may have sparked the judges in the majority to agree that the tax repeal should invalidate it. the core issue the supreme court now agrees to resolve (if the parties have standing) is whether the repeal of the tax did sink the mandate. (the texas district court and the fifth circuit concluded that it did.) there is zimmerman, aca “salvage” over “demolition,” voices in bioethics, vol. 6 (2020) 3 no precedent for a court rewriting a law because the fine or tax penalty fails to bring in government revenue. (if parking tickets in a community were set at $0 with a system that issues warnings instead, would that mean everyone can park anywhere—that the illegal spots become legal by lack of a price tag on the ticket?) in hill v. wallace an old case about a tax and interstate commerce, the court held the law unconstitutional rather than evaluating its value without the tax.15 in hill, the tax was hefty and designed to control market behavior in the grain market; it was not a mere penalty but a larger market interference. also, the hill court objected primarily to the magnitude of the tax, not the ability to regulate interstate commerce. the tax was the meat of the law, not a mere small section. the premise that government revenue is required for the validity of any law accompanied by a tax penalty is incorrect. if it were true, it would follow that the myriad of laws on the books that do not result in fines would also be void. for example, many federal property liens are on the books. if the government has not brought in tax revenue that way, the underlying law would be invalid under the fifth circuit logic and language. a local level analogy would be that if restaurants in a jurisdiction fail inspections but are not fined, the regulation requiring standards could become void. laws should not depend on their remedies leading to tax revenue even if the remedy and law were instituted under the power of congress to tax. implementing a law that on its face serves a public good but is truly designed only to raise tax revenue through punishments is an unacceptable use of legislative power. for example, the motives behind parking and speeding ticket quotas are questionable. “addicted to fines” points out how many counties rely on fines to supplant revenue – fines are a huge problem contrary to the libertarian ideals that many of the conservative justices value.16 generally, fines are hardly relevant to whether the underlying laws can or cannot exist. iii. severability if the supreme court agrees with the fifth circuit and holds the mandate invalid absent the tax, it could also hold that without the mandate the whole law is invalid (the severability issue) hurting the ability of millions of americans to access healthcare. severability, the ability of a law’s unconstitutional portion to be struck while the rest remains, is the subject of a messy inconsistent three-pronged test that asks whether the law can work without the unconstitutional clause (independence), whether congress would have passed the law absent the unconstitutional provision, and the newer prong that asks whether the remaining law would be consistent with congressional intent.17 in murphy v. ncaa, justice alito passed up severability in favor of invalidating an entire law arguing the issue be sent back to congress to make a better law.18 justice ginsburg believed in “salvage” over “demolition.” 19 the idea of severability would be consistent with conservative views that suggest opposition to judicial overreach, a preference for restraint, and analyzing laws as written without as much concern for legislative intent and context. severability maintains the actual text, not just the congressional intent or any debatable aspect. yet, conservative justices tend to oppose severability, possibly due to an opposition to legislation seen as impacting freedom. the liberal justices sometimes favor severability either because of respect for the power of other branches of government, but possibly because liberal ideology is behind the underlying law. severability cannot be equated with judicial activism—striking down an entire law demonstrates activism more. in nfib, the court decided against severability when it held the mandatory aspect of the medicaid expansions were unconstitutional although the majority did not speak to the severability in the context of the mandate because it saved the mandate. the majority opinion and the dissent were predictably divided along partisan lines regarding severability. contrary to popular belief about conservative justices avoiding legislating from the bench, the dissent was described as “more like a policy brief than a judicial opinion, and the oral argument on severability often resembled a legislative committee hearing on insurance regulation.”20 zimmerman, aca “salvage” over “demolition,” voices in bioethics, vol. 6 (2020) 4 the history of severability in the supreme court has been confusing, partisan, and activist.21 a presumption of severability is important to prevent judicial trouncing of congressional action. alaska airlines v. brock affirmed a two-pronged test to determine severability but added congressional intent. the court looked to whether the legislature would have enacted the law without the provision and whether the law can function without the stricken section. the court added a glimpse into legislative intent by asking whether the same legislative intent is fulfilled by the law as it would operate without the stricken clause or provision. in alaska airlines the court did not invalidate any more of a law than necessary and all nine justices agreed on the severability of the unconstitutional provisions. one article aptly suggests that the court should not “bring down a giant by its toe.”22 in us v. booker, breyer wrote for the majority striking down a mandatory minimum law (the mandatory use of federal sentencing guidelines) while maintaining the bulk of the sentencing reform act.23 the three recent severability cases are suspicious: in nfib and booker, the court severed the unconstitutional provision from the law but in murphy, it seems ginsburg was right to suggest that a political preference for legalized betting and for states’ rights governed the decision to strike down the entire federal law. normally, there is an ideological split under which liberal justices look to congressional intent more than conservative ones. however, justice scalia, now replaced with justice gorsuch, was more lenient toward his conservative colleague’s use of congressional intent than the liberal justices’ use of it evidencing a lapse in judicial restraint.24 his decisions indicated an arbitrary analysis of severability that leads to results based on the merits of the underlying legislation. gorsuch did agree with the majority in the murphy case indicating a willingness to strike down an entire law. justice thomas has had some severability oddities—in a case where he did agree with ginsburg on severability, one of his contentions in a concurrence was that the court should never review an entire statute when a plaintiff brings a controversy over one part.25 to adhere to thomas’ murphy dicta, texas would need to establish standing to challenge any and all other provisions. thomas’ murphy language also turned on a preference for statutory interpretation over congressional intent; he was especially critical of the concept of looking into whether congress would have passed the law without the unconstitutional section. yet in nfib, thomas sided with the dissent finding the mandate and the medicaid expansion mandate were both integral to the entire law.26 i assert the severability issue has essentially solved itself. all three prongs point to a healthy aca that is accomplishing many of the myriad of intended goals. the aca has been chugging along without mandate enforcement since the tax repeal demonstrating that the law works without the mandate. the medicaid expansions not only remain intact, but more states have accepted them. the web of federal and state infrastructure supporting the aca remains intact. through individual insurance markets and the employerbased markets, individuals have been hurt by executive orders watering down the aca, but the markets are operational. while the mandate over time likely would have created a more robust market, the markets are surviving. the medicaid expansions, the requirements concerning preexisting conditions, or children under 26 remaining on the parents’ insurance, do not rely on the mandate. the latter two requirements arguably should always have existed as a measure of insurance industry corporate responsibility without any need for the mandate as a bargaining chip for the government to entice the insurance industry. both a congressional intent test and a hypothetical question asking whether congress would have adopted the law without the mandate should be rephrased. if conservative justices were to ignore congress’ mindset and to operate with judicial restraint, the mandate if found unacceptable would be severed and the remainder of the aca salvaged. to apply the second and third prongs, if congress had known the aca would work without it, i assert it would have passed the law without the mandate. it should be a hindsight test, not a search of zimmerman, aca “salvage” over “demolition,” voices in bioethics, vol. 6 (2020) 5 what congress knew at the time. really, the big picture was that the aca legislature wanted more people to have insurance and they do. avoiding congressional intent with a stronger presumption in favor of severability (when the rest of the law is constitutional) would be more consistent with the roles of the three branches of government and would limit the court’s participation in writing laws. voters choose legislators making it a key to the democratic process. the justices cannot willy-nilly invoke severability when they want to save a law and deny severability when they want to strike it down in its entirety. if the severability approach is to depend on legislative intent, justices will find many laws salvageable. if severability reflected conservative judicial restraint, clauses would be severed and bodies of law would continue as written, something that does not coexist with the conservative justices’ decision-making history. iv. enforceability if both the mandate and the severability are decided in favor of texas invalidating the entire law, one possible saving grace is that the court agreed to further review enforceability. if the entire aca is invalid, the court could still decide that the law can be enforced where it does not injure the party seeking relief. that issue before the court specifically means that the court could find texas and the other 17 states that are plaintiffs would not be hurt by the continuation of aca provisions in california and the 16 states aligned with california. even conservative justice clarence thomas has supported targeted relief for the party claiming damages, here texas, et al.27 conclusion there is hope for many reasons. for now, there are eight justices and it would take one conservative to side with roberts and the more liberal-leaning justices. their record on judicial overreach should at least lead to a finding of severability. beyond both the mandate and the severability, conservative leaning justices do not like expansive remedies that overreach the ask. texas wants to strike down the law but if it is not damaged by the continuation of provisions in other states, it has no basis to receive grandiose remedies that affect so many outside the plaintiff states. because simply adding a small penalty would suit the nfib ruling and bring this farce to an end, a legislative change to the tax act28 may matter more for access to healthcare than the appointment of a new supreme court justice. congress should simply reinstate the tax penalty. 1 murphy v. ncaa, 138 s. ct. 1461 (2018) in dissent, ruth bader ginsburg suggests precedent for “a salvage rather than a demolition operation.” see also michael c. dorf, “whither severability after murphy v ncaa?” dorf on law. may 17, 2018 http://www.dorfonlaw.org/2018/05/whither-severability-after-murphy-v-ncaa.html 2 patient protection and affordable care act, 42 usc § 18001 et seq. (2010) 3 california, et al., petitioners v. texas, et al., us supreme court docket: “the motions of the solicitor general for divided argument and of the u.s. house of representatives for enlargement of time for oral argument and for divided argument are granted, and the time is allotted as follows: 30 minutes for california, et al., 10 minutes for the u.s. house of representatives, 20 minutes for the solicitor general, and 20 minutes for texas, et al. the motion of ohio and montana for leave to participate in oral argument as amici curiae, for enlargement of time for oral argument, and for divided argument is denied. vided.” https://www.supremecourt.gov/docket/docketfiles/html/public/19-840.html 4 https://www.vox.com/21446256/ruth-bader-ginsburg-death-supreme-court-obamacare-case 5 42 usc § 1396 et seq. 6 42 usc § 6002. 7 emtala is the law allowing people to use emergency rooms. it is a government mandate to hospitals to provide care regardless of insurance status. often, the hospitals do not recoup the cost from the patient – the cost ends up societally divided. the aca zimmerman, aca “salvage” over “demolition,” voices in bioethics, vol. 6 (2020) 6 mandate whether through subsidized healthcare, medicaid expansions, or the mandate decreased the free rider problem. emergency medical treatment and labor act, 42 us code § 1395dd (1986) 8 kaiser family foundation. https://www.kff.org/uninsured/state-indicator/rate-byage/?dataview=1&currenttimeframe=0&sortmodel=%7b%22colid%22:%22location%22,%22sort%22:%22asc%22%7d rates have changed from 18 percent in 2010 (approx. 47 million people) to a low around 7.9 percent (27 million people), and now slightly up as executive orders have weakened the aca. 9 26 usc §5000a (the mandate); §5000a (b)(1) (the shared responsibility) and §§5000a(c), (g)(1) (the provision specifying collecting the penalty like a tax) 10 national federation of independent business v. sebelius 567 us 519 (2012) the court held the mandate was an unconstitutional limitation on interstate commerce but could remain effective as a tax penalty. rather than a coercive measure, it is a choice to purchase or pay the penalty. 11 tax cuts and jobs act s. 2254 — 115th congress: tax cuts and jobs act.” www.govtrack.us. 2017. september 20, 2020 https://www.govtrack.us/congress/bills/115/s2254 12 texas v. united states, 340 f. supp. 3rd 579 (n.d. texas 2018); texas v. united states, (5th cir dec 18 2019) https://www.ca5.uscourts.gov/opinions/pub/19/19-10011-cv0.pdf 13 in nfib v sebelius, justices roberts, ginsburg, breyer, sotomayor, and kagan were in the majority. justices scalia and kennedy, now replaced by kavanagh and gorsuch, as well as alito and thomas dissented. 14 tax cuts and jobs act s. 2254 — 115th congress: tax cuts and jobs act.” www.govtrack.us. 2017. september 20, 2020 https://www.govtrack.us/congress/bills/115/s2254 15 hill v. wallace, 259 u.s. 44 (1922) 16 mike maciag, “addicted to fines,” governing: the future of states and localities, september 2019. https://www.governing.com/topics/finance/gov-addicted-to-fines.html 17 alaska airlines, inc. v. brock 480 u.s. 678 (1987) added the legislative intent. 18 murphy v. ncaa, 138 s. ct. 1461 (2018) 19 eric fish, severability as conditionality, emory law journal vol 64, issue 5. fish argues in favor of a presumption of severability. https://law.emory.edu/elj/content/volume-64/issue-5/articles/severability-asconditionality.html#:~:text=the%20supreme%20court's%20first%20severability,175%e2%80%9376%20(1803). 20 fish 21 john c. nagle, “severability,” 72 n.c. l. rev. 203 (1993-1994). nagle argues that a law should be assumed severable absent a severability clause and he criticizes the question of whether congress would have passed the law without the unconstitutional clause in favor of a more traditional legislative intent question which is increasingly part of the severability question. available at: https://scholarship.law.nd.edu/law_faculty_scholarship/153 22 fish. 23 us v booker 24 brudney, james j., and corey ditslear. "liberal justices' reliance on legislative history: principle, strategy, and the scalia effect." berkeley journal of employment and labor law 29, no. 1 (2008): 117-73. accessed september 22, 2020. http://www.jstor.org/stable/24052420. 25 murphy v. ncaa, 138 s. ct. 1461 (2018) in a concurrence, justice thomas argues in favor of a new severability test that would avoid a debate over legislative intent. 26 national federation of independent business v. sebelius, oyez, https://www.oyez.org/cases/2011/11-393 (last visited sep 21, 2020). 27 susannah luthi, “ginsburg’s death leaves obamacare in greater danger than ever,” politico, september 19, 2020. https://www.politico.com/news/2020/09/19/what-happens-to-obamacare-ginsburg-418406 28 tax cuts and jobs act s. 2254 — 115th congress: tax cuts and jobs act.” www.govtrack.us. 2017. september 20, 2020 https://www.govtrack.us/congress/bills/115/s2254 https://www.govtrack.us/congress/bills/115/s2254 https://www.ca5.uscourts.gov/opinions/pub/19/19-10011-cv0.pdf https://www.govtrack.us/congress/bills/115/s2254 https://www.govtrack.us/congress/bills/115/s2254 howard, leaving a legacy, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. leaving a legacy: adolescent and young adult end-of-life care planning louisa howard keywords: end of life, adolescent, ethics introduction end of life (eol) care has expanded into a vital component of medical practice, as patients and their providers partake in pertinent discussions before it is too late. these efforts have historically focused largely on the geriatric population, leaving out the younger patients whose needs must also be considered. each year, more than 11,000 adolescents and young adults (ayas) aged 15-34 die from cancer and other lifethreatening conditions.[1] traditionally, grief-stricken parents are forced to make decisions on their adolescent or young adult child’s behalf, often with little guidance as to what their child would have wanted. although parents of patients under 18 serve as the legal decision-maker, this does not mean that the patients do not want to have a say in how they spend their last days, or what happens after their death. it is now strongly suggested that providers approach the young adults directly, allowing them to voice their opinions and document their preferences. an innovative planning guide has paved the way in assisting ayas with life threatening illnesses convey their choices, opening up avenues for crucial and compassionate conversations previously not discussed. a shift is beginning to take place as whispered conversations outside a patient’s room between doctor and parent are replaced with candid and collaborative discussions focused specifically on the patient’s desires. ____________________________________________________________ howard, leaving a legacy, voices in bioethics, vol. 1 (2014-15) 2 analysis the planning-guide that has received such praise, voicing my choices™, is the first of its kind to be produced for—with the input from—adolescent and young adult patients. it was designed with the intention to offer patients with a life threatening illness the opportunity to have a voice in a wide range of important matters, from naming a health care agent and making decisions on the extent and types of life support they want, to how they would like to be comforted, supported, and remembered. voicing my choices™ also allows ayas to voice preferences on funeral/memorial planning, as well as organ/body donation, if they desire to do so. the guide was developed by researchers at the pediatric oncology branch of the national cancer institute and the national institute of mental health at the national institutes of health (nih). this team of researchers worked with ayas over the course of approximately 10 years to evaluate interest in a developmentally appropriate advance care planning guide, review five wishes® (an existing advance care planning guide for adults), and assess helpfulness and stressfulness of eol care planning. ayas also reported preferences on guide content, format and design.[2] using the qualitative and quantitative data, nih researchers created a guide specifically for aya patients. voicing my choices™ differs from adult guides in that it incorporates color, simplified wording, and a glossary of terms. most importantly, it addresses issues most developmentally appropriate for ayas, including additional questions pertaining to peer relationships and the legacy they wish to leave behind.[3] since its publication by the non-profit, aging with dignity, in october 2012, more than 20,000 copies have been distributed both nationally and internationally to over 70 medical centers. the widely successful guide has since been translated into spanish, italian, french and slovak.[4] the movement to include young patients in their own eol planning faces many challenges. doctors are not always properly trained to approach these topics with ayas, as such a delicate topic requires careful conversation. there also permeates a widespread thought that ayas may not be able to fully comprehend eol care needs, or worse, would be psychologically harmed by such a discussion. some providers also worry that parents or patients might not respond positively to the guide in fear that by participating, they are signaling a loss of hope for the future. for an older individual, who has lived longer and perhaps taken the time for thoughtful reflection, this conversation might come with less anxiety and less surprise than for a young patient— one who needs to plan for eol while he or she is just beginning to form a sense of identity, develop independence and plan for the future. however, the overwhelmingly positive response from patients and parents, thus far, demonstrates that this novel guide should be incorporated into all aya eol care. the key to effectively spread this initiative involves training healthcare providers to appropriately present the information. intuition and empathy, although crucial components, are not enough to guide doctors and other providers in discussing eol options for patients. health care providers must also hone effective communication skills to guide their patients through the difficult, yet ultimately gratifying, process of voicing their choices. fortunately, the developers of the guide released guidelines on how to best introduce such conversations and how to effectively utilize an advance care-planning guide.[5] it is recommended that eol discussions be a routine part of clinical care, begin near to the time of diagnosis, and continue throughout the course of a patient’s care. conclusion not only can the guide help give a voice to the patients, but it can also lift a weight off of the overwhelmed parents who can begin to feel at ease knowing that they can honor their child’s preferences. with the aid of provocative questions like “what gives you strength or joy” and “what do you wish to be howard, leaving a legacy, voices in bioethics, vol. 1 (2014-15) 3 forgiven for,” patients who have felt powerless can begin to claim at least some control over a situation that has felt out of their control. this guide can help assuage the common fear among medically ill ayas that they are too young to leave a lasting legacy. it is actually this exact time in life when one begins to explore his or her identity and cultivate a sense of self. with the guidance of compassionate health care providers, these patients can now move forward with the comfort of knowing their voices have been and will continue to be heard. zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, ms candidate columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the california gig economy law: just how far will employers go to avoid providing health insurance? anne zimmerman* abstract app-based drivers deserve the protections afforded employees for fairness, to maintain the current healthcare system, and to avoid free-riding and corporate welfare. a ballot proposal challenging the new california law introduced to enforce corporate responsibility undermines workers’ rights. this paper examines the ethics and the practical implications of ab5 and proposition 22. keywords: gig economy, healthcare, health insurance, aca, workers’ rights, corporate ethics, labor law, employment law, bioethics, healthcare policy introduction employer-based insurance models work when the laws compelling employers to offer insurance are enforced. corporate failure to provide insurance to full time employees undermines the system and results in corporate welfare: the government pays to subsidize healthcare plans for workers who should receive employer-based insurance. this paper focuses on the role of employer-based healthcare in the current healthcare system in the united states and the controversy surrounding a california law enforcing a definition of employee crucial to the us healthcare system. employers must treat certain workers in the gig economy as employees for fairness and to avoid corporate welfare. employer-based insurance is in keeping with the approach of the affordable care act (aca); if employers are not held accountable, the current us healthcare system is at risk. there is longstanding debate over the role of government and how much people should pay to support the healthcare of others through taxes. american views fall along a long continuum from libertarian beliefs that a zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) 2 healthcare mandate is beyond the amount of freedom necessary for human flourishing to the concept of healthcare as a human right that the government should provide to everyone. the current system, which relies on the role of employers as payers, represents middle ground. employer based healthcare plans, the aca individual marketplace for subsidized and unsubsidized purchases, and the myriad of government run systems like tricare, medicaid, medicare, and the children’s health insurance fund each are crucial to the system as a whole. analysis a. california law ab5 and ballot proposition 22 gig economy refers to jobs that are short-term, freelance, and generally involve a direct to customer service. independent contractors and freelancers often operate in the gig economy indefinitely indicating a shift away from steady long-term employment. assembly bill 5 (ab5) in california was passed to help workers in the gig economy. 1 corporations have been treating workers central to the businesses’ primary purpose as independent contractors absolving the corporations from providing benefits that would be legally mandated if the workers were categorized as employees. the bill requires certain corporations operating in the gig economy to provide healthcare insurance, paid sick leave, disability insurance, and unemployment insurance. in olson v. california, us district court, central district of california, western division, corporations (mostly driving apps) sought an injunction to stop the law from taking effect.2 they did not succeed and the law went into effect january 1, 2020. may 5, 2020, in california v. uber, the california attorney general sued app-based driving companies uber, lyft, postmates, doordash, instacart and others (the defendants) for failure to comply.3 ab5 codified a three-pronged test: a worker is an employee unless the employer can demonstrate the worker is free of the company’s control, the work performed is not central to the business, and the worker has an independent business in the same industry as the work performed. the test, known as the abc test,4 puts app-based drivers, essential to car service and delivery businesses, in the category of employees. on august 10, a judge ordered the defendants to treat drivers as employees and provide the mandated benefits.5 then, a california appellate court granted an emergency stay to the defendants.6 prior to the stay, the defendants had created a ballot proposal (proposition 22) to override ab5 through an exemption for app-based drivers that includes a minor compromise.7 the ballot measure deprives workers of employee rights but offers a meager stipend for healthcare insurance and offers to cover on the job injuries.8 the stay will allow the companies to continue their noncompliance through october and likely through the november 3 election when the ballot proposal will be decided. b. corporate political power and social media the emergency order allows time for voters to weigh in on the rights of app-based drivers. uber, lyft and a few others have spent $111 million dollars on the yes on proposition 22 campaign.9 the emergency stay caters to the desires of corporations who should be subject to labor and employment laws designed to ensure workers’ rights. corporations have an outsized influence on policy exacerbated by lax campaign finance laws and citizens united. 10 the prop 22 campaign is declaring that prop 22 will protect app-based drivers. that could imply to workers that prop 22 would improve conditions for them. i assert it conveys a well-known threat: uber and lyft will stick around if workers vote for prop 22 to neuter ab5. a court’s involvement should not result in an opportunistic appeal to voters using misinformation, undue influence, and unmatchable zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) 3 advertising dollars. workers’ rights advocates are unlikely to have $111 million dollars to use in a savvy social media and television campaign appeal to the voters. the ballot proposal suggests a winner-take-all mentality. elected officials paid to legislate represent the voters. the california uber lawsuit is part of a trend that empowers the corporation over the elected officials. a proposition brought to the voters11 might bring a result that works against the least empowered many of whom do not vote. california’s ballot proposition is corporate power run amok. the california ballot proposal process fails to distinguish between ballot access for organizations representing the marginalized and corporations.12 all special interests must go through the same process despite the prohibitive costs of running an expensive campaign to support a measure. the defendants even paid people to get the necessary petition signatures. the costly yes on proposition 22 campaign evidences the economic incentive to misclassify drivers as independent contractors rather than employees to evade social and legal responsibilities.13 c. corporate welfare, the free rider, and fairness by putting more people in the individual market, companies are shifting the cost of healthcare to the government in the form of subsidies. aca subsidies for people who work for one company full time are corporate welfare. aca subsidies should benefit people without other sources of healthcare insurance. the court held that app-based drivers are employees by the three-prong definition. while their incomes vary according to location, hours driving, time spent without a customer, and surge pricing shifts, many are eligible for aca subsidies.14 corporations should spend the money on health insurance so that taxpayers do not have to. subsidies for health insurance are based on the federal poverty rate. if income is equal to or below the 138 percent of poverty threshold, individuals become eligible for medi-cal based on the aca medicaid expansions. income-based subsidies are available for those earning from 138 percent of federal poverty up to 400 percent of the federal poverty rate.15 usually, the free rider argument is that the insured or hospital systems should not support the people who choose not to insure themselves which was the case under emtala.16 here, the free rider argument is that the government should not pay to insure people who work full time for large corporations that should pay for their insurance. for the defendants, medicaid and subsidies for the drivers are corporate welfare. the gig economy is a new model that distorted the definition of an independent contractor. ab5 would be a valuable reset that forces new industries that meet large demand and provide innovative services to behave the way traditional corporations are expected to: simply provide insurance. under ab5, the app-based corporations would still profit immensely from the primary benefit of their business model: avoiding paying for the cars.17 like airbnb does not own houses or properties, uber, lyft, doordash, instacart, and postmates do not own the most basic equipment necessary for their services. drivers bear the burden of purchase, upkeep, and storage of vehicles among many other business costs. the corporations already benefit from the gig economy by not purchasing the expensive assets. the misuse of the term entrepreneur is a driving factor in the gig economy. drivers are not truly entrepreneurs; they are workers performing a form of relatively unskilled labor. the us glorifies entrepreneurship for qualities like drive, innovative ideas, and grit, none of which are necessary to join uber. many uber drivers happen to have grit and the determination to seek loans, purchase cars and insurance, and sign on with uber but those traits are not signs of entrepreneurial spirit as much as they are signs of doing tasks necessary to join the app zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) 4 based sector. in the app-based sector, the entrepreneurs developed the software and created the corporations. the entrepreneurship claims are an excuse to justify a practice that exacerbates income inequality.18 the independent contractor designation evades fairness in how the money is earned and shared; the employee designation makes up for a missing corporate ethic. the argument that the independent contractor arrangement favors the drivers is also invalid. the gig economy offers perks like control over hours worked, but the more drivers are trying to earn a living, the more hours they drive and the job becomes full time. while driving an uber or lyft may be a second or third job for workers, an economy in which one job is not enough if problematic. when the workers do work the number of hours that comprises full time work for one company, they must be entitled to benefits. working the hours without receiving the benefits hardly can be described as freedom or control over one’s schedule. drivers doing the essential work in the app-based driving businesses take on risks that are sometimes not worth the low earnings. there are many financial and legal problems in the app-based driving industry. drivers take on debt to purchase cars, insurance, and safety equipment like cameras. the gig economy creates desperation and provides drivers with temptation to break laws. all in a day’s (dirty) work tells the personal stories of task rabbit, uber, and airbnb workers stumbling into illegal activity condoned and ignored by their corporate executives. from driving drug dealers, mailing drugs illegally, to violating housing laws, the gig economy laborers take on personal risks for which their corporations claim to bear no responsibility.19 d. implications for a lasting healthcare structure the defendants’ failure to provide insurance to the app-based drivers undermines the us system, possibly pushing the country toward a single payer plan unnecessarily. the individual markets were not meant for people who work full time for large corporations. since the aca mandate was undermined, the drivers might choose not to insure themselves. the drivers would then become or remain free riders in the sense relevant before the aca: they would use emergency rooms for care and then the insured would bear the costs that are not shifted to public programs or charities.20 as a result, the country risks a return to the systemic pressure that led to the aca. in a politically charged atmosphere where cries of socialism abound, a single payer plan may not be politically feasible. i also argue it is not the best route based on the principles behind providing access to healthcare for all and the economics.21 some argue the opposite: that the drivers would add people to the individual market creating a healthier larger healthcare insurance customer base, increasing demand, and untethering insurance from employment.22 while these are worthy goals, the hourly income of the drivers is evidence that many would require subsidies and essentially cause a market inefficiency rather than drive a robust free market.23 e. the job creator responsibility the app-based group is leveraging their power as job creators by threatening to leave california. many argue that had uber and lyft simply shut down in california as they threatened to do, more responsible and innovative companies would immediately fill the gap. if the court had not issued the stay, and instead called uber and lyft’s bluff, and the corporations gave up the lucrative california market, other competitors would possibly drive prices down.24 if corporations are to argue that their status as job creators calls for special exemptions, then they should be held to labor and employment laws and pay a living wage. zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) 5 f. will consumers just have to pay more? some argue that if ab5 is enforced, the cost of the insurance would be passed on to the consumer. while that would seem unfortunate, it is possible that prices have been artificially low due to the failure of the companies to provide benefits. passing some of the cost on remains preferable to leaving drivers uninsured or financially burdened by the costs of their insurance. a wealth transfer from customers to workers could be a beneficial outcome.25 heavier competition in the industry could drive down the prices to balance out attempts to pass along the entire cost to consumers. a lack of competition has plagued the industry of app-based driving services both for transportation and deliveries, especially since uber acquired postmates. conclusion drivers are the mainstay of the app-based driver industry. fairness calls for treating workers central to the business as employees. allowing the defendants to treat workers like independent contractors is corporate welfare: taxpayers will continue to pay for subsidies on the aca exchanges while uber’s ceo enjoys a package with cash and stock worth over $42.4 million dollars.26 with $14 billion in revenue in 2019 and a market cap of almost $60 billion, should uber really be subsidized by the taxpayers? healthcare insurance for app-based drivers falls within the already established rights of employees. an industry-influenced expensive social media campaign that is not concerned with workers’ rights should not be permitted to undermine the moral code enforced by labor and employment law. 1 section 2750.3 of california labor code. ab5 codified and clarified dynamex operations west inc. v. superior court of los angeles, (2018) 4 cal. 5th 903 (cal. sup. ct. april 30, 2018). 2 2:19-cv-10956. also, in 2015, several uber drivers sued uber demanding treatment as employees and not independent contractors. the california labor commission sided with the drivers and awarded damages. berwick v. uber technologies, superior court of california (2015) link to state labor commission award:https://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?article=1988&context=historical 3 california v. uber, lyft, and does 1-50, complaint: https://oag.ca.gov/system/files/attachments/press-docs/202005-05%20-%20filed%20complaint.pdf, referred to as the people v. uber. 4 in 2004, the massachusetts legislature adopted the abc test. see st. 2004, c. 193, § 26, effective july 19, 2004. 5 link to the august 10 ruling. order cgc-20-584402 filed in the superior court of the state of california, county of san francisco: https://assets.documentcloud.org/documents/7032764/judge-ethan-schulman-order-on-lyft-anduber.pdf see also "california judge orders uber and lyft to consider all drivers employees." all things considered, august 10, 2020. gale general onefile (accessed august 31, 2020). https://link-galecom.ezproxy.cul.columbia.edu/apps/doc/a632756257/itof?u=columbiau&sid=itof&xid=3511136b. https://www.npr.org/2020/08/10/901099643/california-judge-orders-uber-and-lyft-to-consider-all-drivershttps://leginfo.legislature.ca.gov/faces/billcompareclient.xhtml?bill_id=201920200ab5 https://law.justia.com/cases/california/supreme-court/2018/s222732.html https://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?article=1988&context=historical https://oag.ca.gov/system/files/attachments/press-docs/2020-05-05%20-%20filed%20complaint.pdf https://oag.ca.gov/system/files/attachments/press-docs/2020-05-05%20-%20filed%20complaint.pdf https://assets.documentcloud.org/documents/7032764/judge-ethan-schulman-order-on-lyft-and-uber.pdf https://assets.documentcloud.org/documents/7032764/judge-ethan-schulman-order-on-lyft-and-uber.pdf https://www.npr.org/2020/08/10/901099643/california-judge-orders-uber-and-lyft-to-consider-all-drivers-employees#:~:text=the%20judge%20said%20uber%20and,insurance%2c%20workers'%20compensation%20and%20paid zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) 6 employees#:~:text=the%20judge%20said%20uber%20and,insurance%2c%20workers'%20compensation%20and%2 0paid 6 people of the state of california v. uber technologies, inc. et al., division 4, case number a160706, 1st apellate district. https://appellatecases.courtinfo.ca.gov/search/case/dockets.cfm?dist=1&doc_id=2325037&doc_no=a160706&requ est_token=niiwlsemxkw3w1bnscmtvetimfw6uvxfjsjewzpsucagcg%3d%3d see also charlie osborne, “emergency order keep uber & lyft running in california,” zdnet, august 21, 2020. https://www.zdnet.com/article/emergency-order-keeps-uber-lyft-running-in-california/ 7 tina bellon, norma geleana, “california court ruling gives voters last word,” reuters, august 20, 2020. https://www.reuters.com/article/us-uber-california/california-court-ruling-gives-voters-last-word-over-uber-lyftworker-rights-iduskbn25g21s 8 https://yeson22.com/get-the-facts/ 9 dara kerr, “a totally different ballgame: inside uber and lyft's fight over gig worker status,” cnet, august 28, 2020. https://www.cnet.com/features/uber-lyfts-fight-over-gig-worker-status-as-campaign-against-labor-activistsmounts/ investigations revealed an aggressive social media campaign fueling the controversy. the defendants hired 19 firms to support the prop 22 initiative. 10 citizens united v. federal election comm'n, 558 u.s. 310 (2010) 11 description of how special interests get initiatives on the ballot in california: https://calmatters.org/explainers/california-november-2020-ballot-propositions-final-list/ 12 https://calmatters.org/explainers/california-november-2020-ballot-propositions-final-list/ 13 malos, stan, vogelgesang lester gretchen, and meghna virick. "uber drivers and employment status in the gig economy: should corporate social responsibility tip the scales?" employee responsibilities and rights journal 30, no. 4 (12, 2018): 239-251. doi:http://dx.doi.org.ezproxy.cul.columbia.edu/10.1007/s10672-018-9325-9. http://ezproxy.cul.columbia.edu/login?url=https://www-proquestcom.ezproxy.cul.columbia.edu/docview/2128364636?accountid=10226. 14 jason millman, “why uber loves obamacare,” washington post, november 17, 2014. https://www.washingtonpost.com/news/wonk/wp/2014/11/17/why-uber-loves-obamacare/ aca subsidies are available for individuals making $16,105 to $46,680 and families of four making $32,900 to $95,400. 15 based on 2018 levels, according to california, the federal poverty rate is $12,140 for individuals, $16,460 for a family of two, $20,780 for a family of three, $25,100 for a family of four, $29,420 for a family of five, $33,740 for a family of six, $38,060 for a family of seven, $42,380 for a family of eight. the following covered california income restrictions apply to adults: • 0 to 138 percent of fpl: qualification for medi-cal (a medicaid program) • > 138 to 400 percent of fpl: qualification for a subsidy on a covered california plan the breakdown of the subsidies between 138 and 400 percent of fpl is as follows: • > 138 to 150 percent: you also qualify for the silver enhanced 94 plan • > 150 to 200 percent: you also are eligible for the silver enhanced 87 plan • > 200 to 250 percent: you also qualify for the silver enhanced 73 plan https://www.healthforcalifornia.com/blog/how_do_you_report_your_income_to_covered_california_when_it_fluct uates; https://www.healthforcalifornia.com/covered-california/income-limits https://www.npr.org/2020/08/10/901099643/california-judge-orders-uber-and-lyft-to-consider-all-drivers-employees#:~:text=the%20judge%20said%20uber%20and,insurance%2c%20workers'%20compensation%20and%20paid https://www.npr.org/2020/08/10/901099643/california-judge-orders-uber-and-lyft-to-consider-all-drivers-employees#:~:text=the%20judge%20said%20uber%20and,insurance%2c%20workers'%20compensation%20and%20paid https://appellatecases.courtinfo.ca.gov/search/case/maincasescreen.cfm?dist=1&doc_id=2325037&div=4&doc_no=a160706&request_token=niiwlsemxkw3w1bnscmtvetimfw6uvxfjsjewzpsucagcg%3d%3d https://appellatecases.courtinfo.ca.gov/search/case/dockets.cfm?dist=1&doc_id=2325037&doc_no=a160706&request_token=niiwlsemxkw3w1bnscmtvetimfw6uvxfjsjewzpsucagcg%3d%3d https://appellatecases.courtinfo.ca.gov/search/case/dockets.cfm?dist=1&doc_id=2325037&doc_no=a160706&request_token=niiwlsemxkw3w1bnscmtvetimfw6uvxfjsjewzpsucagcg%3d%3d https://www.zdnet.com/article/emergency-order-keeps-uber-lyft-running-in-california/ https://www.reuters.com/journalists/tina-bellon https://www.reuters.com/journalists/norma-geleana https://www.reuters.com/article/us-uber-california/california-court-ruling-gives-voters-last-word-over-uber-lyft-worker-rights-iduskbn25g21s https://www.reuters.com/article/us-uber-california/california-court-ruling-gives-voters-last-word-over-uber-lyft-worker-rights-iduskbn25g21s https://yeson22.com/get-the-facts/ https://www.cnet.com/features/uber-lyfts-fight-over-gig-worker-status-as-campaign-against-labor-activists-mounts/ https://www.cnet.com/features/uber-lyfts-fight-over-gig-worker-status-as-campaign-against-labor-activists-mounts/ https://calmatters.org/explainers/california-november-2020-ballot-propositions-final-list/ https://calmatters.org/explainers/california-november-2020-ballot-propositions-final-list/ https://www.washingtonpost.com/news/wonk/wp/2014/11/17/why-uber-loves-obamacare/ https://www.healthforcalifornia.com/blog/how_do_you_report_your_income_to_covered_california_when_it_fluctuates https://www.healthforcalifornia.com/blog/how_do_you_report_your_income_to_covered_california_when_it_fluctuates https://www.healthforcalifornia.com/covered-california/income-limits zimmerman, california gig economy law, voices in bioethics, vol. 6 (2020) 7 16 menzel, paul, “the cultural right to a basic minimum of accessible health care,” kennedy institute of ethics journal. 2011; 21(1):79-119. 17 https://www.thestreet.com/personal-finance/education/how-much-do-uber-lyft-drivers-make-14804869 18 ahsan, mujtaba. "entrepreneurship and ethics in the sharing economy: a critical perspective: jbe." journal of business ethics 161, no. 1 (01, 2020): 19-33. doi:http://dx.doi.org.ezproxy.cul.columbia.edu/10.1007/s10551-0183975-2. http://ezproxy.cul.columbia.edu/login?url=https://www-proquestcom.ezproxy.cul.columbia.edu/docview/2073877713?accountid=10226. 19 alexandrea j. ravenelle, hustle and gig, (berkeley: university of california press, 2019), ch. 6 all in a day’s (dirty) work. 20 menzel. 21anne zimmerman, reframing the healthcare debate: targeted problems and solutions (2020) master’s thesis, archived by columbia university. https://doi.org/10.7916/d8-yg1m-w324 22 david dranove and craig garthwaite, “uber and the twisted logic of the affordable care act’s employer mandate,” the healthcare blog, june 25, 2015. https://thehealthcareblog.com/blog/2015/06/25/uber-and-the-twisted-logic-of-the-affordable-care-acts-employermandate/ 23millman. see also christina farr, “who's responsible for your uber driver's health coverage?” npr, october 11, 2015. https://www.npr.org/sections/health-shots/2015/10/11/447157698/who-s-responsible-for-your-uber-drivers-health-coverage 24 paris marx, “uber, lyft want to defy california's gig economy law. the state should call their bluff.” nbcnews.com think, august 17, 2020. https://www.nbcnews.com/think/opinion/uber-lyft-want-defy-california-s-gig-economy-law-state-ncna1236686 25 this outcome could also be environmentally beneficial and encourage more use of public transportation. 26 sissi cao, “big uber shareholders rebel on ceo’s huge pay package amid coronavirus layoffs,” observer, may 13, 2020. https://observer.com/2020/05/uber-ceo-pay-shareholder-backlash-coronavirus/ also see: https://www.businessinsider.com/uber-ceo-dara-khosrowshahi-salary-total-compensation-45-million-in-2018-20194#:~:text=uber%20paid%20its%20top%20five%20executives%20%24143%20million,officer%2c%20who%20receive d%20%2447.3%20million%20in%20total%20compensation. https://www.thestreet.com/personal-finance/education/how-much-do-uber-lyft-drivers-make-14804869 https://thehealthcareblog.com/blog/2015/06/25/uber-and-the-twisted-logic-of-the-affordable-care-acts-employer-mandate/ https://thehealthcareblog.com/blog/2015/06/25/uber-and-the-twisted-logic-of-the-affordable-care-acts-employer-mandate/ https://www.npr.org/sections/health-shots/2015/10/11/447157698/who-s-responsible-for-your-uber-driver-s-health-coverage https://www.npr.org/sections/health-shots/2015/10/11/447157698/who-s-responsible-for-your-uber-driver-s-health-coverage https://www.nbcnews.com/think/opinion/uber-lyft-want-defy-california-s-gig-economy-law-state-ncna1236686 https://observer.com/2020/05/uber-ceo-pay-shareholder-backlash-coronavirus/ https://www.businessinsider.com/uber-ceo-dara-khosrowshahi-salary-total-compensation-45-million-in-2018-2019-4#:~:text=uber%20paid%20its%20top%20five%20executives%20%24143%20million,officer%2c%20who%20received%20%2447.3%20million%20in%20total%20compensation. https://www.businessinsider.com/uber-ceo-dara-khosrowshahi-salary-total-compensation-45-million-in-2018-2019-4#:~:text=uber%20paid%20its%20top%20five%20executives%20%24143%20million,officer%2c%20who%20received%20%2447.3%20million%20in%20total%20compensation. https://www.businessinsider.com/uber-ceo-dara-khosrowshahi-salary-total-compensation-45-million-in-2018-2019-4#:~:text=uber%20paid%20its%20top%20five%20executives%20%24143%20million,officer%2c%20who%20received%20%2447.3%20million%20in%20total%20compensation. illes, harms of secondhand smoking, voices in bioethics, (2013) © 2013 judit iles. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. data torturing, the harms of secondhand smoking, and why disputing the indisputable is still worth our while judit illes keywords: secondhand smoking, data torturing, scientific integrity introduction last february, smokers in new york city were left with even fewer options, as mayor bloomberg passed anti-smoking legislation that prohibits lighting up on beaches, in parks, and in pedestrian plazas such as times square.1this legislative initiative was just one in a series of nationwide attempts to clear the air for nonsmokers. in similar spirit, some companies, many in the medical sector, have begun adopting anti-tobacco policies, under which job applicants must undergo urine tests for nicotine and existing employees who smoke must quit, or face termination.2 even the courts are taking their cues from public health officials. parents who are smokers must now prepare to bear the brunt of their nasty habits in custody disputes.3 the value of anti-tobacco has thus officially branded itself onto our national ethos—and besides evil big tobacco and those smelly smokers’ groups, who’s complaining? analysis the science on secondhand smoking, also known as environmental tobacco smoke (ets), appears settled. according to a 2007 report by the world health organization, there is “indisputable evidence” that secondhand smoking causes disease and premature deaths in adults and children.4 the official websites of the mayo clinic and the mount sinai medical center reiterate the certainty of these risks.5,6 yet some experts in the realm of public health and epidemiology have taken it upon themselves to challenge the indisputable by analyzing the methodology and rigor of studies that anti-tobacco advocates have used in advancing their agenda.7 the work of these scientific watchdogs exposes the extent to which anti-tobacco health advocates have engaged in unethical practices like data torturing and publication bias. many of these advocates have also been revealed to have close ties with pharmaceutical companies that manufacture smoking cessation medications. the media has rarely picked up on this, so let us examine a few of these ethically dubious practices.8 data torturing georgetown university law professor robert a. levy and rosalind b. marimont, formerly a mathematician at the national institutes of health (nih), have documented the various ways in which “junk science has replaced honest science” in the battle against tobacco.9 in their article “lies, damned lies, & 400,000 smoking related deaths,” they detail how over the years government agencies such as the environment protection agency (epa), the centers for disease control (cdc), and the surgeon general have engaged in data torturing. 10 in data torturing, data are manipulated enough to “confess” the researcher’s desired results.11 torturing techniques range from doing meta illes, dangers of secondhand smoking, voices in bioethics, (2013) 2 analysis, cherry-picking information, and faking the significance of the results to misclassification and statistical manipulation such as failing to control confounding variables. data torturing is often difficult to detect, as it requires asking the right scientific questions and working through all of the raw data from a study, which may in part explain why these illegitimate practices quietly continue over time. in fact, even though many of the government reports that created the initial impetus for smoking bans have been discredited, the false scientific theories originating from these works continue to be perpetuated. for example, in a 1993 report, the epa declared ets to be a dangerous carcinogen that kills 3,000 americans yearly.12 five years later, federal judge william l. osteen found that the epa had “cherry-picked” its data and that “the agency withheld significant portions of its findings and reasoning in striving to confirm its a priori hypothesis.”13 in his 2006 report, the united states surgeon general ominously concluded, “there is no risk free level of exposure to secondhand smoke.”14 this is known as the “no threshold theory,” which proposes that a substance that is carcinogenic at high doses must also be proportionately carcinogenic at small doses. but scientists claus and bolander posit that this theory is at odds with “all the fundamental principles of cell biology.”15 according to dr. elizabeth miller, former president of the american association for research on cancer, “chemical carcinogenesis is a strongly dose-dependent phenomenon.”16 in the same report, the surgeon general also claimed, “even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack.” but michael b. siegel, a professor of community health sciences at the boston university school of public health, explains that “the surgeon general’s statement conflates the temporary negative effects of secondhand smoke on the circulatory system, which have been shown to occur with short-term exposure, with heart disease, a process that requires repeated exposure and recurring damage to the coronary arteries.”17 despite the multitude of errors contained in the surgeon general’s report, it continues to be referenced by public health officials and anti-smoking activists. publication bias publication bias is another disconcerting trend that has plagued anti-tobacco advocacy. it tends to occur when researchers undertake a study with a hypothesis in mind (ets causes lung cancer, for example), but then opt not to publish the data when they fail to lend credence to their initial hypothesis. the world health organization reportedly engaged in this practice in 1998 when it withheld the findings from the 12-center, seven-country european study it had commissioned to examine the link between ets and lung cancer.18 it eventually did publish the findings, with a press release headlined “passive smoking does cause lung cancer,” even though the researchers had failed to find any statistically significant risk of lung cancer among spouses of smokers or those exposed to ets in the workplace.19 the study also concluded that “no association between childhood exposure to environmental tobacco smoke and lung cancer exist.”20 another source of publication bias relates to the difficulties authors experience when publishing studies that question the assumptions about ets’ potential dangers.21 certain peer-reviewed journals have officially stopped considering papers about studies in which a tobacco company may have a financial interest, or whose authors have some link to the tobacco industry.22 such policies cast doubt on the integrity of the peer-review process, which is supposed to be about judging a study on its scientific merits, not on its sources. tobacco industry–sponsored studies may very well be biased, but the same can be said of governmentor nonprofit–sponsored studies. peer-review journals should not be expressing an affinity for one type of bias, and they should certainly not dismiss the potential utility of industry-sponsored studies. illes, dangers of secondhand smoking, voices in bioethics, (2013) 3 conflicts of interest finally, while it is a well-known and increasingly talked about fact that pharmaceutical companies exert a considerable amount of financial pressure on physicians and the editors of peer-reviewed journals, pharma’s strong ties to anti-tobacco lobbyists and public health officials have, for the most part, evaded public scrutiny. between 1992 and 2000, the robert wood johnson foundation, the philanthropic arm of johnson & johnson (but which owns johnson & johnson stock), invested more than $300 million in the united states in financing anti-tobacco activities and "grass roots" antismoking groups and runs the smoking cessation leadership center.23,24 similarly, pharmacia corporation and glaxo smith kline, both major manufacturers of cessation therapies, have been very supportive of anti-tobacco health advocacy.25 even the world health organization has designated pharmaceutical companies as “its official partners,” further illustrating how intertwined public health organizations are with the pharmaceutical industry.26 more worrisome still, many public health officials involved in shaping standards and policies are financially conflicted. for example, it has been revealed that the chair of the joint commission (a body that sets standards for the accreditation of hospitals and health care facilities) has and is receiving grant funding from nabi pharmaceuticals, which is in the late stages of developing a nicotine vaccine.27 the influence of this presumed conflict is already apparent: the newest standards stipulate that every patient should be treated with smoking cessation drugs.28 promoting disclosure may be the first step toward limiting the impact of potential conflicts. prohibiting the participation of those with grant funding and other financial ties to the pharmaceutical industry in standard-setting procedures may be an even more effective solution, although politically less palatable. conclusion why scientific integrity still matters even if we air out all the dirty laundry on ets research, it is clear that anti-tobacco laws are here to stay. but we should be honest about the reasons for their existence, which have as much to do with convenience and deterrence (or perhaps more) as with endangering the health of nonsmokers. the data on the impacts of secondhand smoke is vast, and certainly not all of it is bogus, but government action initiated in the name of the public good can take on increasingly coercive dimensions if public health officials are permitted to engage in unethical practices in a consistent manner, as has been the case among anti-tobacco researchers and advocates. the rising antagonism toward smokers in our society should also concern us. public health advocates should not be ostracizing a segment of our population in its clampdown on smoking. instead of fear-based negative messaging, public health advocates should focus on limiting the hyperbole and reporting the facts. if they choose to do otherwise, then along with achieving the erosion of smoking in american society, they will succeed in losing the public’s trust. 1ed pilkington, “new york's smoking ban extended to parks and beaches,” the guardian online, may 23, 2011, last accessed october 25, 2011, http://www.guardian.co.uk/society/2011/may/23/new-yorks-smoking-ban-extended. 2a.g. sulzberger, “hospitals shift smoking bans to smoker ban,” the new york times online, february 10, 2011, http://www.nytimes.com/2011/02/11/us/11smoking.html?pagewanted=all. 3smith v. smith. 1996 wl 591181 (tern. ct. app. oct. 11, 1996). see generally sobie, merril. “second hand smoke and child custody determinations — a relevant factor or a smoke screen?” 1997, pace law faculty publications, paper 364, http://digitalcommons.pace.edu/lawfaculty/364. http://www.guardian.co.uk/society/2011/may/23/new-yorks-smoking-ban-extended http://www.nytimes.com/2011/02/11/us/11smoking.html?pagewanted=all http://digitalcommons.pace.edu/lawfaculty/364 illes, dangers of secondhand smoking, voices in bioethics, (2013) 4 4“policy recommendations on protection from exposure to second-hand tobacco smoke,” world health organization, 2007, last accessed october 25, 2011, http://www.who.int/tobacco/publications/second_hand/protection_second_hand_smoke/en/index.html. 5mayo clinic staff, “secondhand smoke: avoid dangers in the air,” mayo clinic online, may 6, 2010, last accessed october 25, 2011, http://www.mayoclinic.com/health/secondhand-smoke/cc00023. 6m.s. krisha mccoy, “secondhand smoke exposure,” the mount sinai medical center, diseases & conditions, last accessed october 25, 2011, http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/tobacco-usedisorder#secoosure. 7see for example michael siegel, “a smoking ban too far,” the new york times online, may 5, 2011, http://www.nytimes.com/2011/05/06/opinion/06siegel.html. 8but see gio batta gori, “the bogus 'science' of secondhand smoke,” the washington post online, january 30, 2007, http://www.washingtonpost.com/wp-dyn/content/article/2007/01/29/ar2007012901158.html. 9robert a. levy and rosalind b. marimont, “lies, damned lies, and 400,000 smoking-related deaths,” regulation 21, no. 4 (1998): 24, http://www.cato.org/pubs/regulation/regv21n4/lies.pdf. 10ibid. 11j.s. mills, “data torturing,” the new england journal of medicine 329, (1993): 1196-9. 12robert a. levy and rosalind b. marimont, “lies, damned lies, and 400,000 smoking-related deaths,” regulation 21, no. 4 (1998): 24, http://www.cato.org/pubs/regulation/regv21n4/lies.pdf. 13 “the osteen decision,” july 17, 1998, http://www.tobacco.org/documents/980717osteen.html. 14“the health consequences of involuntary exposure to tobacco smoke: a report of the surgeon general,” office of the surgeon general, u.s. department of health and human services, june 27, 2006, http://www.surgeongeneral.gov/library/secondhandsmoke/. 15c. claus and k. bolander, the threshold principle: a law of nature. environmental carcinogenesis, r.e. olson (ed.) marcel dekker, ny (in press). cited in edward contoski, “secondhand smoke: the “no threshold” scare,” http://amlibpub.blogspot.com/2008_01_01_archive.html. 16cited in edward contoski, “secondhand smoke: the “no threshold” scare,” http://amlibpub.blogspot.com/2008_01_01_archive.html. 17see for example michael siegel, “a smoking ban too far,” the new york times online, may 5, 2011, http://www.nytimes.com/2011/05/06/opinion/06siegel.html. 18victoria macdonald, “passive smoking doesn't cause cancer – official,” sunday telegraph, march 8, 1998, http://www.forces.org/articles/files/passive1.htm. see also, the official report of the study which was eventually published: p. boffetta, “multicenter case-control study of exposure to environmental tobacco smoke and lung cancer in europe” journal of national cancer institute 90, no. 19 (1998): 1440-50, october 7, 1998. contra see chapman, simon, “the hot air on passive smoking,” published march, 21 1998, bmj 316: 945. 19robert a. levy and rosalind b. marimont, “lies, damned lies, and 400,000 smoking-related deaths,” regulation 21, no. 4 (1998): 24, http://www.cato.org/pubs/regulation/regv21n4/lies.pdf. http://www.who.int/tobacco/publications/second_hand/protection_second_hand_smoke/en/index.html http://www.mayoclinic.com/health/secondhand-smoke/cc00023 http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/tobacco-use-disorder#secoosure http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/tobacco-use-disorder#secoosure http://www.nytimes.com/2011/05/06/opinion/06siegel.html http://www.washingtonpost.com/wp-dyn/content/article/2007/01/29/ar2007012901158.html http://www.cato.org/pubs/regulation/regv21n4/lies.pdf http://www.cato.org/pubs/regulation/regv21n4/lies.pdf http://www.tobacco.org/documents/980717osteen.html http://www.surgeongeneral.gov/library/secondhandsmoke/ http://amlibpub.blogspot.com/2008_01_01_archive.html http://amlibpub.blogspot.com/2008_01_01_archive.html http://www.nytimes.com/2011/05/06/opinion/06siegel.html http://www.cato.org/pubs/regulation/regv21n4/lies.pdf illes, dangers of secondhand smoking, voices in bioethics, (2013) 5 20ibid. 21michael j. mcfadden and david w. kuneman, “a study delayed: helena, mt’s smoking ban and the heart attack study,” american council on science and health online, july 12, 2007, http://www.acsh.org/factsfears/newsid.990/news_detail.asp. 22jeff stier, “is there such a thing as an objective science journal?” american council on science and health online, february 25, 2010, http://www.acsh.org/healthissues/newsid.1868/healthissue_detail.asp. 23http://www.pharmalot.com/2011/04/foundations-conflicts-of-interest-and-drugmakers/. 24w. hamilton, pharmaceutical multinationals: buying governments, selling antismoking, 2000, http://www.forces.org/evidence/money/introph.htm. 25http://www.forces.org/evidence/pharma2/connection.htm. 26“who launches partnership with the pharmaceutical industry to help smokers quit,” world health organization, http://www.who.int/inf-pr-1999/en/pr99-04.html. 27http://www.jointcommission.org. 28michael siegel, “chair of panel setting joint commission standards on smoking cessation for hospitals is financially conflicted,” the rest of the story: tobacco news analysis and commentary, october 17, 2011, http://tobaccoanalysis.blogspot.com/2011/10/blog-post.html. http://www.acsh.org/factsfears/newsid.990/news_detail.asp http://www.acsh.org/healthissues/newsid.1868/healthissue_detail.asp http://www.forces.org/evidence/money/introph.htm http://www.who.int/inf-pr-1999/en/pr99-04.html http://tobaccoanalysis.blogspot.com/2011/10/blog-post.html introduction analysis conclusion ducar, clinical refusal to provide care to lgbtq families, voices in bioethics, vol. 1 (2014-15) © 2015 dallas ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. religious clinicians refuse to provide care to lgbtq families dallas m. ducar keywords: religion, ethics, clinical refusal introduction while lgbtq persons are being welcomed at altars around the nation, sexual and gender orientation is still not protected within many clinical spaces. last month the detroit free press reported on a lesbian couple, krista and jami contreras, who brought their six day old baby girl to a pediatric office and were refused care by their chosen physician, dr. vesna roi.1 the parents were upset when they were told by a different pediatrician that dr. roi had “prayed about it” and had come to the conclusion that she could not treat the baby due to her religious beliefs. analysis the contrerases had previously met with dr. roi and decided that she was a good choice as she was known for having a “holistic approach.” dr. roi did apologize to the couple, stating that she had never meant to hurt either person, but she stood by her belief that she would not treat the child and has the freedom not to do so. moreover, dr. roi may be within her legal rights to deny lgbtq couples services due to her own religious convictions. while michigan’s laws do ban discrimination on the basis of religion, race, sex, and marital status, it does not include sexual or gender orientation.2 even if the michigan legislature were to amend this law to add protection for lgbtq couples, this would not apply across the nation. furthermore, laws that will block existing state and local laws protecting the lgbtq community against discrimination are now being considered and signed into action. mississippi enacted similar legislation last year, arizona legislation was vetoed by the governor, but indiana’s new religious objections law has been defended against critics by the state’s governor, mike pence. the indiana law prohibits state and local laws that “substantially burden” the ability of citizens to follow their religious beliefs. moreover, this measure does not only apply to individuals, but associations and businesses as well. governor pence claims the bill was intended to ensure that religious liberty is fully protected under the law. however, religious and non-religious groups have expressed concern that the law supports discrimination against lgbtq persons. some leaders have gone so far as to call the law protection for "hate and bigotry.” while this law may be intended to ensure “religious liberty,” it grants doctors the right to refuse to treat patients on the basis of sexual orientation or gender identity, which directly conflicts with the ama code of ethics.3 despite the needs of the patient, a physician can refuse care in indiana and other states, due to the patient’s sexual orientation, gender identity, or in the case of the contreras’ baby, patient’s affiliated with those who identify as lgbtq. these new laws do not only affect physicians and their patients, but also influence care in hospitals and ducar, clinical refusal to provide care to lgbtq families, voices in bioethics, vol. 1 (2014-15) 2 other clinical organizations. some states do not allow joint adoption of a child, depriving one parent of custodial rights over the child, including authorizing emergency medical treatment. citing these laws, some hospitals refuse to let a gay parent visit their hospitalized child.4 even if the recent legislation in indiana is amended, as governor pence has recently stated would happen, there must be active protections for lgbtq persons.5 all patients must be protected to receive equal medical treatment under the law. conclusion patients are human beings, whatever their sexual orientation or gender identity. most iconic spiritual figures advocate for “healing the sick” without caveat. instead, in states like indiana, religious clinicians now have the right to refuse to heal the sick and to discriminate against their patients. one state having passed a law like this is one too many. protections for some minority groups, such as the lgbtq community, can now be undermined by states and localities, harming not only on the lgbtq community, but on the next generation of innocent children as well. active change must be made now for the well being of future generations. 1http://www.freep.com/story/news/local/michigan/macomb/2015/02/18/discrimination-birth/23640315 2http://www.legislature.mi.gov/(s(bgyredgnk3o0snm1lp03jd0s))/mileg.aspx?page=getobject&objectname=mcl37-2202 3http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion1005.page? 4 http://well.blogs.nytimes.com/2009/05/12/how-hospitals-treat-same-sex-couples/ 5 http://abcnews.go.com/politics/indiana-gov-mike-pence-handled-religious-freedom-law/story?id=30026937 bolzon, gene-edited dogs, voices in bioethics, vol. 1 (2014-15) © 2015 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. first gene-edited dogs reported in china julia bolzon keywords: gene-edited dogs, biotechnology introduction although china’s elimination of the one-child policy headlined news last month, a quieter headline also appeared: that of the first gene-edited dog. while reporters joked about the ability to now custom-make pets, the genetic engineering of animals in china is neither a new nor even a recent development. what does this phenomenon mean for our rapidly advancing biotech world? analysis scientists from key laboratory of regenerative biology at the guangzhou institutes of biomedicine and health were the first to report having created a beagle with double the amount of muscle mass by deleting the myostatin gene. this was a preliminary trial of sorts, because the further goal is to create dogs with mutations that mimic human diseases such as parkinson’s and muscular dystrophy. researcher liangxue lai says the goal of such research is to show that dogs can be a better disease model for biomedical research than mice or pigs, as they are closer to humans in metabolic, physiological, and anatomical ways. as such, beagles are being bred at a rate of more than 2000 a year for research at the guangzhou general pharmaceutical research institute.1 the myostatin deletion was made through crispr technology, which is the newest and most precise method of dna editing technology in widespread use today.2 although it’s now common to see crispr’s use in biotechnology, this does not diminish the fact that there is a growing trend in china specifically to modify animals using this technology. animals that have already been cloned and modified with crispr in china include goats, rabbits, rats, monkeys, and also humans. a different team in the guangzhou province modified the genes of non-viable human embryos this past april.3 the 2012 documentary dna dreams by bregtje van der haak chronicles the work of bgi (beijing genomics institute) china’s leading “maverick” genomics research institute and the largest genomics lab in the world.4 van der haak was specifically interested in following the lives of the extremely young scientists who make this work a reality, such as 18-year old zhao bowen. he dropped out of high school to lead the cognitive genomics laboratory, an initiative seeking the genetic basis of intelligence by analyzing the dna of 2000 gifted bolzon, gene-edited dogs, voices in bioethics, vol. 1 (2014-15) 2 children. bgi was created in 1999 so that china could participate in the human genome project. today, it is an independent research institute with more than 4000 employees.5 also featured was an embryologist in charge of creating mini-pigs: genetically modified pig embryos made more susceptible to disease (for example, type ii diabetes) who are then cloned to be studied as model organisms.6 in other provinces in china, bgi has experimental farms that clone cows and sheep as part of their “ark biotechnology” enterprise, whose focus is the mass production of transgenic (genetically altered cross-species) cloned animals.7 but what is behind china’s intense drive for genetic engineering and cloning? duanqing pei of the chinese academy of sciences notes that the efforts are part of a “national scientific priority” and also “part of china’s effort to establish world-class research.”8 yet dna dreams offers another perspective: the country’s cultural tone. van der haak was drawn in by “the dichotomy of her own cultural experience in europe verses the enthusiastic attitudes toward new technology in hong kong, where the average person has two mobile phones and there’s an intense interest in the high-tech developments on the horizon.”9 to be sure, a technologically oriented society driven by efficiency, production, and a “scientific” mindset is not unique to china. yet a european or american attitude towards genetic manipulation still maintains a certain degree of hesitance and caution, while china exhibits a totally embracing, uninhibited approach. 10 the scientists of bgi see a fascination with understanding organisms in terms of their genetic make-up, evident in their push to understand the connection between genes and intelligence. but the documentary also reveals something curious about the personal lives of these young scientists. of the 4000 employees at bgi, over 90% are born after 1980, placing them in their 20s and early 30s. they have a fixation with being smart or ‘productive.’ moreover, they see science and technology as the way in which to better the human condition, precisely by becoming smarter. the general trend was, if we can improve humans, then why not do it? van der haak says: “when you think of dna and genetic manipulation and what’s made possible by mapping the complete human dna in combination with information technology – and you consider that china has had a one-child policy for 30 years, and they think about having the best child possible before it’s even born… it becomes a bit worrying and interesting, to say the least.” conclusion bgi and other such institutions in china are described as maverick. not only are they non-governmental and not externally regulated, but they also exist to push the boundaries of what is currently possible by simply going ahead and doing it. does the lack of hesitancy or caution towards using technology on animal life carry any implications on how human life is then viewed and treated in the lab? although a first and imperfect attempt at gene-edited beagles, the result of knocking out the myostatin gene has implications for human therapy: u.s. doctors are attempting to block myostatin in gene-therapy experiments to slow muscle loss in boys suffering from duchenne muscular dystrophy. the question of gene editing / genetic engineering in humans at the embryonic stage is still an open question, but is not one limited by “if” (i.e. should we do it), rather, by a matter of when. the application of this technology needs to be better perfected before it can be used “safely,” which is exactly what the animal trials enable. george church (a world leader in the gene-editing field) says that the alteration of larger animals such as dogs opens the path for use in humans by allowing people to see that “it works.”11 thus the precedent china has already set for animal genetic engineering opens the door to successful human engineering. yet this “maverick” mindset leads to experiments that open pandora's box, forever changing the landscape of technoscience interventions in the same way that edwards and steptoe changed the landscape of human reproduction through ivf, which was initially performed solely on animals. one could obviously argue that this was for the better, however, with the first children born from ivf only just now reaching their 30s, we’re seeing that the effects of assisted and third-party reproduction aren’t so harmless.12 the power now wielded to create (clone) and manipulate (engineer/edit) animal life means that human life is also no longer beyond our technological manipulation. what does genetic engineering and cloning say about what a human being is? we would do well to ask what is implicated by such bolzon, gene-edited dogs, voices in bioethics, vol. 1 (2014-15) 3 attitudes towards biotechnology on the meaning of human life, before rather than after the fact. 1 http://www.technologyreview.com/news/542616/first-gene-edited-dogs-reported-in-china/ 2 see my earlier article ‘the genome, conception, and human destiny’: http://voicesinbioethics.org/2015/08/27/the-genomeconception-and-human-destiny/ 3 http://www.technologyreview.com/news/536971/chinese-team-reports-gene-editing-human-embryo/ 4 https://vimeo.com/58285542 5 bgi’s goal is to “sequence the genome of every living thing,” and is responsible for a number of different projects concerning sequencing and analyzing dna (two which are featured in the documentary include an understanding of the genetic basis of iq and also cloning genetically altered animals for research purposes). 6 this is exactly what lai’s team is doing with dogs, but see also yunnan key laboratory of primate biomedical research, which “used crispr to augment the neurological development of monkeys to test the feasibility of creating primate disease models for better understanding human conditions like autism, schizophrenia and alzheimer’s disease.” see: larson, christina. “china’s bold push into genetically customized animals,” scientific american, november 17, 2015. http://www.scientificamerican.com/article/china-s-bold-push-into-genetically-customized-animals/ 7 http://www.bab-genomics.com/list.aspx?catid=159 8 regalado, antonio. “first gene-edited dogs reported in china,” mit technology review. october 19, 2015. http://www.technologyreview.com/news/542616/first-gene-edited-dogs-reported-in-china/ 9 “professor castells hosts discussion on new documentary ‘dna dreams’ and the technology of journalism’s future,” april 4, 2013, http://annenberg.usc.edu/news/around-usc-annenberg/professor-castells-hosts-discussions-new-documentary-“dnadreams”-and 10 van der haak says of her experience: “in europe and america, the attitude toward technology and especially genetic manipulation is more critical and always has fear mixed in. and there’s the idea that nature is better than manmade things. even for non-believers, it’s still a deeply christian culture. an american researcher would hesitate to say that ‘the cloned embryo under my microscope is life that i created,’” ibid. 11 for a related example, the genetic engineering of pigs is helping to make xenotransplantation a reality, that is, the crossspecies transplant of pig organs into humans, by eliminating the risk of animal pathogens/disease being transferred in the process. george church is behind such research: http://www.economist.com/news/science-and-technology/21674493-genomeengineering-may-help-make-porcine-organs-suitable-use-people-no-pig 12 see, for instance, liza mundy’s everything conceivable: how the science of assisted reproduction is changing men, women, and the world (2008). howard, the risks in presuming, voices in bioethics, vol. 1 (2014-15) © 2015 louisa howard. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the risks in presuming louisa howard transplant, organ donation, bioethics introduction organ transplantation brings up a myriad of bioethical issues, especially with regard to informed consent. in the us, an “opt-in” approach is practiced, in which patients’ organs will not be harvested unless they or their next-of-kin have provided written consent. many people across the globe also advocate for the “optout” approach in which everyone is an organ donor unless they have withdrawn consent. it is important to emphasize that this system is still based upon informed consent, since every citizen should hopefully be aware of the nation’s organ donation policy. however, these valuable and necessary systems are by no means implemented globally, even in other developed countries. recently, russia made global headlines when a group of doctors at moscow city clinical hospital no. 1 removed a patient’s organs after her death from an automobile accident, unbeknownst to both the dying patient or her grieving parents. analysis the organ harvesting and subsequent transplantation incidents may have forever gone unreported to the family if it were not for the mother filing paperwork in connection with the case against the other driver. while reviewing documents, she came across a puzzling forensic report that explicitly detailed the removal of seven of her daughter’s organs. an article distributed by the moscow times states that this event was not the only one of its kind that has happened in russia. in 1992, a federal law on human organ and tissue transplantation created more confusion than clear guidelines on the issue (the moscow times, “russia’s unknown, unwilling organ donors”). as the article states, the text is full of flaws that could potentially lead a healthcare personnel to secretly harvest organs. there exists a “presumption of consent” by the individual or a close family member to the postmortem removal of organs for use in transplantation. the main issue lies in the lack of respect to the patient’s family—in the lack of commitment to inform the family. although, presumably, the act of organ removal will subsequently help one or many other patients survive, this beneficence does not outweigh the necessary need for informed consent. furthermore, the absence of formal, in-writing consent might lead to unrecorded transplant of organs, which could then very well end up in the hands of organized criminals waiting to sell the unrecorded organs on the black market— opening a door into the dark abyss of organ trafficking. as the moscow times article highlights, russia’s current policy of presumed consent harmfully affects the public’s view not only on organ transplantation but also on healthcare professionals and the patient-doctor relationship. full disclosure and transparency lie at the heart of medicine, and cases such as the one described can lead to severe lack of trust in healthcare professionals. it is vital that russia, and any other country with a similar organ transplantation policy (or none for that matter) move to an informed consent method, whether it be either the “opt-in” or “opt-out” approach, in order to uphold a patient’s autonomy as well as maintain the trust of altruistic patients or their families who plan to willingly donate organs. howard, the risks in presuming, voices in bioethics, vol. 1 (2014-15) 2 interestingly, the russia constitutional court’s defense for presumed consent stems from their belief that it is “’inhumane”’ to bring up the question of donating organs right after a family has just been informed of their relative’s death. in my opinion, the real inhumane act is going behind the family’s back and performing the removal under the notion of “presumed consent.” this policy easily leads to varying interpretations of the word “presumed” and is much too vague to serve as a policy on an issue as grave and controversial as organ donation. conclusion in all circumstances globally, the best policy is not even informed consent, but rather, prior consent. if every passport, driver’s license, or other form of identification stated a patient’s desire to potentially serve as an organ donor, then the muddled process of obtaining informed consent can be altogether bypassed in most instances. although all alternatives consequently bring up their own ethical dilemmas, especially with the growing demand for organs and small supply; it is a significant improvement from russia’s current “presumed consent” approach. introduction conclusion moorthy, putting patient concerns on the policy agenda, voices in bioethics, vol. 7 (2021) * gyan moorthy, ms candidate columbia university © 2021 gyan moorthy. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. putting patient concerns on the policy agenda: the need for a unified, independent patient lobby gyan moorthy* abstract the interests of patients at most levels of policymaking are represented by a disconnected patchwork of groups focusing on disease, age, ethnicity, or gender, like susan g. komen, the aarp, and the naacp. these groups compete with one another for funding and are ill-equipped to compete with groups representing the interests of healthcare professionals, pharmaceutical and medical device companies, hospitals, and insurance providers. the result is an imbalance – big health has more financing and power, resulting in healthcare policy that does not adequately reflect patient concerns, especially the concerns of p oor or otherwise vulnerable patients. these big health groups also misrepresent patient concerns to further their own interests, and patients are seldom in a position to push back. while some suggest the creation of a unified, independent patient lobby to interface directly with policymakers and the public, it is not altogether clear how such a lobby could be formed or how to focus its efforts to have the intended impact. though there are structural obstacles to the development of a unified, independent pat ient lobby, such a lobby could successfully pressure the appropriate officials or lawmakers to address the issues that affect most patients. today’s culture values patient input, and with key aca provisions at risk, patients should begin organizing so they can influence policymaking – potentially with a little help from bureaucrats. to get off the ground, a patient lobbying group analogous to phrma, the aha, or the ama would have to commit to a big tent philosophy, and it would have to fight hard to maintain its independence. keywords: patient, age, disease, gender, ama, philosophy, policymaking, big health introduction currently, the interests of patients at most levels of policymaking are represented by a disconnected patchwork of groups focusing on disease, age, ethnicity, or gender, like susan g. komen, the aarp, and the naacp. these groups compete with one another for funding and are ill-equipped to compete with groups moorthy, putting patient concerns on the policy agenda, voices in bioethics, vol. 7 (2021) 2 representing the interests of healthcare professionals, pharmaceutical and medical device companies, hospitals, and insurance providers. the result is an imbalance – big health has more financing and power, resulting in healthcare policy that does not adequately reflect patient concerns, especially the concerns of poor or otherwise vulnerable patients. these big health groups also misrepresent patient concerns to further their own interests, and patients are seldom in a position to push back. while some suggest the creation of a unified, independent patient lobby to interface directly with policymakers and the public, it is not altogether clear how such a lobby could be formed or how to focus its efforts to have the intended impact. analysis nearly all americans will be patients at some point in their life, so patients are a diverse group. they have a range of unique interests informed by their disease, age, location, socioeconomic situation and, to some extent, political views. the differences that exist between individual patients are much greater than the differences between different pharmaceutical companies or even different physicians. but this does not mean that patients have nothing in common. most patients have similar expectations about the confidentiality of their records or protections that should be afforded to them if their treating physician asks them to participate in a research trial. they want to be able to receive care at the nearest emergency department and to choose their doctors. they all hate surprise medical billing, and most are troubled by the high price of prescription drugs. a strong patient lobby might be able to successfully pressure congress into taking action on these issues, or at least help advance the conversation by serving as a counterweight to the influence of other lobbies. the 2001 bipartisan patient bill of rights, sponsored by senators john mccain (r, az) and edward kennedy (d, ma), would have expanded hmo coverage requirements and enabled employees to sue their employers if their claims were denied.1 it failed after a sustained lobbying and public information campaign by insurance companies and employers, linked through the deceptively -named health benefits coalition.2 several efforts to end surprise medical billing and promote price transparency have similarly failed or been stalled, in part because the american hospital association (aha) complained that the changes would be too difficult to implement during the covid-19 pandemic.3 the affordable care act (aca) enacted some popular changes, including an elimination of coverage exclusions for people with pre -existing conditions, closure of the medicare part d “donut hole,” and expansion of coverage to age 26. 4 a patient lobby might have been able to secure more benefits, e.g., coverage requirements for dental, vision, and mental health services. but the need to protect the aca may be a better impetus for the formation of a strong patient lobby. the aca has already been gutted by the trump administration’s actions to end certain insurance subsidies and congress’s decision to repeal the penalty associated with the individual mandate, resulting in premium increases.5 cuts to funds that facilitate sign-ups on the exchanges also resulted in premium increases. the individual mandate is the subject of yet another supreme court challenge. if the legislation is struck down, already weakened protections for pre-existing conditions will be in jeopardy.6 the changes to the aca may galvanize patients to organize. already, the general public’s interest in health policy has increased and appears to remain strong, unlike the waning enthusiasm following the failure of the clinton healthcare plan. nevertheless, there are significant practical and cultural obstacles to the formation of a unified, independent patient lobby in the united states, and limits to what such a lobby could reasonably accomplish. patients are a diverse group, and on a variety of issues, they can hardly be considere d a group at all. the healthcare system consists of many interlocking parts. a provision to significantly benefit one moorthy, putting patient concerns on the policy agenda, voices in bioethics, vol. 7 (2021) 3 group of patients, e.g., those on medicaid, may not only come at the expense of insurance companies, but at the expense of other groups of patients. it is doubtful that most better-off patients would be willing to make sacrifices for the more disadvantaged among them. research funding is limited, and if it is allocated to curing childhood leukemia, it may not be allocated to curing joint dis ease in the elderly. then there is the problem of what is actually necessary to promote patient welfare. patients often do not know exactly what will benefit them, whether their town really needs a level iv neonatal intensive care unit or whether pharmaceutical companies should be able to advertise off-label drug uses. even if they agree on general problems, they may not agree on solutions. patient groups are also susceptible to industry influence. the prestige of larger, well-established patient advocacy groups makes them attractive investments. according to a 2017 study in the new england journal of medicine, more than 80 percent of the largest 104 patient advocacy groups accepted money from drug, medical device, and biotechnology companies. several groups did not disclose sources of funding or did not disclose what proportion of their budget came from each donor. many also have company executives on their governing boards.7 when diverse patient advocacy groups have banded together to increase their clout, industry has always been a part of the conversation. the results have been predictable. for example, the american cancer society, the american heart association, and the american diabetes association, as well as various pharmaceutical and biotechnology companies are all members of the national health council, an organization founded to advocate for those living with chronic diseases and disabilities. these companies provide the majority of the council’s funding and have strong representation on its board. in 2016, the council came out strongly in favor of a deal between the fda and pharmaceutical companies to speed the approval of new drugs as part of the reauthorization of the prescription drug u ser fee act. it also campaigned energetically for the 21st century cures act, which was criticized by watchdogs as another attempt at weakening the fda’s protection of consumers from dangerous drugs and medical devices.8 it is possible that patients really believed they would benefit from these changes, and perhaps some will, but the changes will chiefly benefit the pharmaceutical industry, the legitimacy of which is boosted by its partnerships with patient groups. since the 1960s, medical culture has undergone dramatic changes. patients are seen more as partners in health and well-being than passive slabs of clay. their individual value systems and social context are incorporated into care plans. the result has been more satisfied patients, more cost-effective care delivery, and better health outcomes.9 these productive partnerships could extend into policymaking by expanding the physician-patient dyad, or physician-patient-hospital triad, to include more actors. keeping interest high and ensuring that the voices of some patients do not drown out the voices of others will be a challenge. to begin to broaden patient groups at the local level, hospitals and clinics can host community meetings, where patients, healthcare providers, and administrators talk about the issues affecting them and brainstorm solutions. trust grows over time. perhaps patients can secure more forgiving medical debt repayment programs, reforms to arbitration procedures, more permissive visitation policies, or transparency in ethics and quality improvement committee deliberations and re commendations. local patient groups can help steer conversations and exert gentle pressure, where necessary. they can ensure that hospitals and physicians do not blindly follow national guidelines but tailor them to meet the specific needs of the local population. they can publish lists of institutions or physicians who engage productively with them, potentially costing others goodwill and business. state and national institutions involved in health policy creation can also attempt to incorporate patient voices into their deliberations. unlike in germany, where all health committee hearings feature testimony moorthy, putting patient concerns on the policy agenda, voices in bioethics, vol. 7 (2021) 4 from the same several spitzenverbände (national associations of various interests) and all meetings and briefs are made accessible online, us legislation is deliberated in a haphazard, back-and-forth process that involves a lot of back-room dealing.10 that is, there is no single table at which american patient groups can sit to have far-reaching impact; they must establish themselves at multiple levels and learn to play a lobbying game that other interests have been playing a lot longer. but state public health departments in addition to the centers for medicare & medicaid services (cms) and the department of health and human services (hhs) could establish public/patient advisory boards or include patient advocates as agenda setters in various sub-departments. some short-term results could be more generous medicaid eligibility and coverage requirements or accelerated certificate-of-need hearings for the creation of new medical infrastructure. in the long-term, the institutionalized representation of patient voices at various places in the bureaucracy could provide the basis for the development of a unified patient lobby. these boards could vie for increased influence through membership in a formalized, state, regional, or national organization. local patient advocacy groups could be incorporated as well.11 after consolidation, the lobby might expand its purview and meaningfully pressure legislatures on issues like surprise medical billing, high prescription drug prices, and privacy protections. the lobby’s success may depend on its commitment to issues on which there is little disagreement between patients. to ensure the continued independence of the patient l obby, sunshine laws mandating funding transparency could be expanded.12 importantly, this unified patient lobby could include existing patient advocacy groups that could continue to pursue their own goals independently, much as various pharmaceutical companies, hospitals, and physicians do outside of the pharmaceutical research and manufacturers of america (phrma), the aha, or the american medical association (ama). the whole is greater than the sum of its parts: a unified patient lobby can (1) push for action on issues where patients generally agree, like surprise medical billing, (2) indirectly further the goals of each constituent organization, e.g., through a push for global increases in disease and disability research, and (3) slowly raise the level of public debate, encouraging and sustaining broader and more informed public attention to the health policy development process. ideally, a unified patient lobby would also elevate previously-unheard voices. as patients with various backgrounds and interests work with one another to achieve their common goals, they may find that they have other things in common as well. they may also see that improving the health of some parts of the population has important spillover effects for others. for example, healthy workers are more productive, and healthy parents can be more engaged in their children’s lives, setting them up for success. in the same way that the aarp has special divisions to promote the particular interests of its black and hispanic members, an umbrella patient lobbying group could allocate some resources to promoting the interests of disadvantaged patients. most importantly, however, it could create a tighter sense of community among patients, pushing society to become more compassionate and understanding. james morone would warn that creating mechanisms for increasing the representation of disaffected or marginalized groups is not a panacea. this “democratic wish” could begin a social and political process that ends in circumstances similar to those that initially brought it about: political stalemate.13 but i argue that the stalemate is avoidable, and that group representation can further democracy. disease, age, ethnicity, and gender groups like the american association of pediatrics (aap), which ca mpaigns for policies that benefit children’s health, should continue to represent patient interests as well. within the unified patient lobby, experts on cost and quality, including those who suggest unpopular solutions like certain changes to moorthy, putting patient concerns on the policy agenda, voices in bioethics, vol. 7 (2021) 5 medicare, should be heard and, in many cases, heeded. a unified, independent patient lobby could help to restore balance to a policymaking process dominated by other well-funded, well-organized interests. conclusion patients in the united states are a diverse group, with complicated and often contradictory interests. however, they do share some common interests including expectations of confidentiality, freedom to choose their providers, and a hatred of surprise medical billing. though there are structural obstacles t o the development of a unified, independent patient lobby, such a lobby could successfully pressure the appropriate officials or lawmakers to address the issues that affect most patients. today’s culture values patient input, and with key aca provisions at risk, patients should begin organizing so they can influence policymaking – potentially with a little help from bureaucrats. to get off the ground, a patient lobbying group analogous to phrma, the aha, or the ama would have to commit to a big tent philosophy, and it would have to fight hard to maintain its independence. with time, it might become more ambitious and catalyze substantive changes in the arena of patient access and care. 1 us congress. senate. 2001. bipartisan patient protection act. s1052. 107th congress. introduced in senate june 14, 2001. https://www.congress.gov/107/bills/s1052/bills-107s1052es.pdf. 2 brubaker, bill. 2001. “patients’ bill’s foes back away from ad.” washington post, april 12, 2001. https://www.washingtonpost.com/archive/business/2001/04/12/patients-bills-foes-back-away-from-ad/53377e06-e173-4bd08e5b-797c172c34fc/. 3 lapointe, jacqueline. 2020. “surprise billing action needed, but hospitals urge congress to wait.” revcycleintelligence, august 6, 2020. https://revcycleintelligence.com/news/surprise-billing-action-needed-but-hospitals-urge-congress-to-wait. 4 engel, jonathan. 2018. unaffordable. madison and london: the university of wisconsin press. 5 kamal, rabah, rachel fehr, marco ramirez, and katherine horstman. 2018. “how repeal of the individual mandate and expansion of loosely regulated plans are affecting 2019 premiums.” kff. october 26, 2018. https://www.kff.org/healthcosts/issue-brief/how-repeal-of-the-individual-mandate-and-expansion-of-loosely-regulated-plans-are-affecting-2019premiums/. 6 simmons-duffin, selena. 2019. “trump is trying hard to thwart obamacare. how’s that going?” npr, october 14, 2019. https://www.npr.org/sections/health-shots/2019/10/14/768731628/trump-is-trying-hard-to-thwart-obamacare-hows-thatgoing. 7 mccoy, matthew s., michael carniol, katherine chockley, john w. urwin, ezekiel j. emanuel, and harald schmidt. 2017. “conflicts of interest for patient-advocacy organizations.” new england journal of medicine 376 (9): 880–85. https://doi.org/10.1056/nejmsr1610625. 8 hilzenrath, david s. 2016. “in fda meetings, ‘voice’ of the patient often funded by drug companies.” project on government oversight (pogo). https://www.pogo.org/investigation/2016/12/in-fda-meetings-voice-of-patient-often-funded-by-drugcompanies/. 9 vahdat, shaghayegh, leila hamzehgardeshi, somayeh hessam, and zeinab hamzehgardeshi. 2014. “patient involvement in health care decision making: a review.” iranian red crescent medical journal 16 (1). https://doi.org/10.5812/ircmj.12454. 10 redman, eric. 2000. the dance of legislation: an insider’s account of the workings of the united states senate. 1st edition. seattle: university of washington press. 11 this is just one possible means by which a unified patient lobby could be formed. others include slowly, in a grass-roots fashion, by wealthy benefactors or through consolidation of existing disease-specific groups in a more substantive way than has https://www.kff.org/health-costs/issue-brief/how-repeal-of-the-individual-mandate-and-expansion-of-loosely-regulated-plans-are-affecting-2019-premiums/ https://www.kff.org/health-costs/issue-brief/how-repeal-of-the-individual-mandate-and-expansion-of-loosely-regulated-plans-are-affecting-2019-premiums/ https://www.kff.org/health-costs/issue-brief/how-repeal-of-the-individual-mandate-and-expansion-of-loosely-regulated-plans-are-affecting-2019-premiums/ moorthy, putting patient concerns on the policy agenda, voices in bioethics, vol. 7 (2021) 6 been done to date. i do not claim to know which is most feasible, or if any of them are. but ev en if they are not, it is important to think about, as future leaders, interested parties, etc. can shape culture and institutions such that they become feasible. 12 karas, laura, robin feldman, ge bai, so yeon kang, and gerard f anderson. 2019. “pharmaceutical industry funding to patient-advocacy organizations: a cross-national comparison of disclosure codes and regulation” 42 (2): 33. 13 morone, james. 1998. the democratic wish: popular participation and the limits of american government. new haven and london: yale university press. abstract introduction sanchez, purdue pharma’s deceptive research misconduct, voices in bioethics, vol. 7 (2021) * jason sanchez, ms candidate columbia university © 2021 jason sanchez. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. purdue pharma’s deceptive research misconduct: the importance of the use of independent, transparent, current research jason sanchez* abstract: big pharma must meet bioethical standards to prevent the misuse of its products and to foster public trust in the greater scientific arena. independent, transparent research is crucial to the ethical distribution of safe and effective pharmaceuticals. research must be current and reflect the population to which it is applied. competing peer-reviewed published works should be cited in promotional materials so that prescribers and patients can draw informed conclusions and see areas where there is disparate research. keywords: purdue pharma, oxycontin®, bioethical principles, research ethics, misconduct introduction though “big pharma” has a negative connotation to the general public, in many instances this connotation is unwarranted and can hamper pharmaceutical advancement. through venture capital and financing, pharmaceutical businesses produce new drugs quickly, allowing them to make large profits. however, ulterior financial motives have led certain companies to prioritize transactional values above the health of the consumers, which reflects the companies’ disregard for bioethics. this collision of values garners public distrust and negative attitudes toward pharmaceutical companies. for example, purdue pharmaceuticals blatantly disregarded standards of bioethics when it propelled its self-proclaimed breakthrough drug, oxycontin®, into the lives of many americans. the company’s success came at an extremely high cost: a death toll in the hundreds of thousands from opiate misuse.1 purdue pharma violated bioethical standards and laws written to protect consumers and the public. this paper will specifically address purdue pharma’s research methods and their potential biases. it argues that drug research must be current and accurate, use a sample demographic that reflects the target population, and address the potential for misuse of a drug. sanchez, purdue pharma’s deceptive research misconduct, voices in bioethics, vol. 7 (2021) 2 analysis a. bioethics applied to the business of medication purdue pharma has developed pharmaceuticals for more than 100 years; over that period, its executives specifically steered the company toward advances in pain management. although purdue pharma is ultimately a business, its products can affect the lives of consumers in uniquely dangerous ways. therefore, the actions of pharmaceutical companies demand the serious consideration of bioethical principles. arguably, pharmaceutical companies act with beneficence because the medications they produce treat illnesses or alleviate conditions that negatively affect health. oxycontin was originally approved for prescribed use every 12 hours and was heralded as a solution to pain in end-of-life cancer care and other chronic, painful conditions.2 yet, drugs for pain management are implicated in the opioid epidemic. to apply the principle of beneficence to their practices, pharmaceutical companies must ensure that the benefits of their drugs outweigh the risks by conducting extensive research into the product’s safety and efficacy. pharmaceutical companies must also minimize risks of the medication that may arise from misuse. in purdue pharma’s case, it was necessary to perform extensive research into oxycontin’s biological effects on its broad target population. however, purdue pharma marketed oxycontin as a safe and nonaddictive pain reliever based on only a handful of misrepresented, outdated, and narrow studies. the company used the findings from the cited articles out of context and they did not provide credible evidence. this ties into the next bioethical principle: nonmaleficence. purdue pharma has a bioethical obligation to address the risks of their product even if it is used outside of a clinical setting. purdue pharma did not address the risks of addiction to oxycontin and even hid incriminating data, which led to its liberal use by prescribers.3 drug developers are not absolved of the responsibility to reduce the potential harm done to the public due to misuse of the drug. oxycontin was among the most abused medications in the opioid epidemic.4 not only did purdue pharma fail to take responsibility for its part in the opioid epidemic, it also did not take steps to reduce harm. nonmaleficence extends beyond harm reduction. bioethical principles must apply to pharmaceutical companies to ensure public safety and honest business practices. purdue pharma pled guilty to fraud and kickback conspiracies, admitting to its role in the opioid epidemic and providing evidence that the company acted in an unprincipled way to profit from people rather than treat them.5 in excerpts from old studies, purdue pharma referred to other opioids created before oxycontin, using the research out of context and inappropriately, and failing to address conflicts of interest. the court ruling that held the company accountable for its role in the opioid epidemic conveys the immorality of its research practices and decisions. bioethical principles compel pharmaceutical companies to maintain an ethical landscape that protects consumers and especially vulnerable patients. maleficent actions and business practices led to a crisis that profoundly impacted society and led to a vast number of people becoming addicted to or dying from opioids. these dismal consequences speak to the need to improve institutional bioethics, to create mechanisms that prevent similar wrongdoing, and to hold companies accountable for their maleficent actions. it is helpful to understand how purdue pharma used research inappropriately to institute principled policies. b. overgeneralization, fraud, and conflict of interest in citing research studies sanchez, purdue pharma’s deceptive research misconduct, voices in bioethics, vol. 7 (2021) 3 while purdue pharma marketed oxycontin through brochures, the marketing literature asserted it had a low or nonexistent risk of addiction. purdue pharma’s emails to doctors argued for higher doses of oxycontin.6 the company cited research studies and a paragraph-long publication in the new england journal of medicine to justify its claims about the safety and efficacy of higher dosages of oxycontin. in 1980, hershel jick and jane porter contributed a one paragraph letter to the editor in the new england journal of medicine expressing that they found an extremely low rate of addiction in closely monitored hospitalized patients.7 purdue pharma used this paragraph to add credibility to their claims that oxycontin is highly unlikely to be an addictive substance. this article from 1980, which was not accompanied by any research, had been cited 608 times by 2017, mostly to support the contention that opioids were not addictive.8 purdue pharma grossly misrepresented the findings indicated by jick and porter in several ways. first, jick and porter’s article is not a research article as it has no empirical data, methodology, or discussion about the conducted study. the company should not have used it as evidence to support its claims. additionally, jick’s letter was published 15 years before oxycontin’s fda approval but was cited three years after its approval in the brochure.9 purdue pharma should have cited more recent data. in some brochures, purdue pharma did not disclose the study demographic as hospitalized inpatient individuals and claimed that in a “survey of more than 11,000 opioid-using patients, taken over the course of several years, [they] found only four cases of documented addiction.”10 jick and porter concluded that hospitalized patients without history of addiction only had a low risk of addiction when exposed to low doses of narcotics. these patients were not offered opioids for home use and the study did not follow the patients post-discharge. the findings should not have been generalized outside the study demographic. the fact that the drug was studied in the hospital setting is crucial. there is a difference between someone who cannot leave the hospital due their medical condition and someone who can willingly go to a doctor’s office to ask for a prescription. in the hospital setting, there are methods to strictly control the dispensing of medications, unlike in certain circumstances where use is not monitored.11 purdue neglected to address the differences between hospitalized patients and the general public. oxycontin was marketed for inpatients and outpatients based partly on this survey study that considered only the inpatient population. purdue pharma regularly cited a questionnaire-based study, written by samuel perry and george heidrich and published in 1982, that reported analgesic methods used during debridement of wounds in burn facilities throughout the united states.12 arguably, the study was not misinterpreted, and its findings do apply to a portion of oxycontin’s intended demographic. yet, the study should not be generalized beyond hospitalized burn patients as their use of the drug was both monitored in a controlled environment and used for a specific painful condition. the study does not justify the use of oxycontin in acute, non-cancer related pain. however, makers of oxycontin claimed that the drug could treat a wide variety of pain syndromes, from mild lower back pain to severe acute trauma. purdue pharma cannot rely on research derived from hospitalized burn patients to justify the use of oxycontin in multiple conditions. to make broad claims, a more representative pool of subjects is required. purdue pharma’s use of the perry and heidrich study should be strictly scrutinized. the respondents to the questionnaire were nurses, clinicians, and physicians who assessed the pain of hospitalized burn patients. medical professionals can succumb to biases like everyone else. they may have felt compelled to uphold the reputation of their facility by indicating no incidence of addiction. addiction has long been stigmatized; when the study was conducted, the popular paradigm was that addiction could be attributed to a person’s lifestyle. only recently has addiction been seen as an illness rather than a lifestyle choice. while there may have been confounding factors that influenced the results of the questionnaires, there is no indication that there had been any follow-up investigation with the respondents. sanchez, purdue pharma’s deceptive research misconduct, voices in bioethics, vol. 7 (2021) 4 according to the people of the state of california v. purdue pharma, purdue pharma funded research to investigate the addictiveness of oxycontin. lawrence robbins, who led the research, found that “8 % of the patients who took oxycontin to treat concurrent migraines displayed enough addictive behavior to qualify for prescription abuse.”13 in another study from 1998, robbins observed addictive behavior in 13 percent of patients taking oxycontin for chronic daily headache.14 instead of relying on the robbins study, purdue pharma used the perry and heidrich study to push their narrative of a nonaddictive drug. the perry and heidrich study fails to provide empirical data, methodology, or procedures from individual facilities. in addition, the study did not provide records from the hospitalized burn patients and did not address posthospitalization opioid use. this study is a poor choice as evidence of oxycontin’s nonaddictive properties. when referring to studies in its brochures, the company paraphrased and made unsupported claims. gary franklin, a physician and professor at the university of washington, wrote interagency guideline on opioid dosing for chronic non-cancer pain for the state of washington, which recommended strict restrictions and dosages for opioid use.15 in response to washington’s guidelines, purdue pharma argued for higher dosages and claimed that opioids were safe. they claimed that the classification of oxycontin was faulty.16 in an email sent to franklin to influence the policy, the company referred to studies that were either partially or fully funded by purdue pharma. notably, one study was conducted by employees of the company.17 arguably, if pharmaceutical companies are ethically bound to ensure product safety, they are also obligated to fund research into those drugs. during the process of product development, the company does the research. however, financial incentives can create a conflict of interest that may sway the researchers or the company’s use of the research. company researchers may feel obligated to produce results that would benefit purdue pharma, also creating a conflict of interest. a literature review of financial conflicts of interest in biomedical research “showed a statistically significant association between industry sponsorship and pro-industry conclusions.” 18 purdue pharma was deceitful and should have used independent research. as a result of the studies by robbins, the company knew oxycontin’s addictive potential and yet did not disclose the findings in their communications. years later, jick stated in an npr podcast that he regretted writing that old one-paragraph piece with porter in the new england journal of medicine. jick commented on the unexpected result, admitting, “it was used by drug companies who created these…these new opioids and concluded that they were not addictive…but that’s not in any shape or form what we suggested…in our letter.”19 conclusion while purdue pharma is bound by bioethical principles, its actions left a lasting scar on the pharmaceutical industry, medical community, and the nation. several practices contributed to mistrust of big pharma and the broader scientific community: committing acts of fraud and deceit, ineffectually generalizing research to people outside of study demographics, and using outdated, biased research. purdue pharma, which made more than 35 billion dollars selling oxycontin, later pled guilty to felony wrongdoing and reached a settlement of 8.3 billion. the company may be repurposed as a public benefit company.20 while the purdue pharma story is haunting, a few lessons should not be overlooked. the quality of safety research matters. independent, transparent research is crucial to the ethical distribution of safe and effective pharmaceuticals. research must be current and reflect the population to which it is applied. competing peer-reviewed published works should be cited in promotional materials so that prescribers and patients can draw informed conclusions and see areas where there is sanchez, purdue pharma’s deceptive research misconduct, voices in bioethics, vol. 7 (2021) 5 disparate research. big pharma must meet bioethical standards to prevent the misuse of its products and to foster public trust in the greater scientific arena. 1 wide-ranging online data for epidemiologic research (wonder). atlanta, ga: cdc, national center for health statistics; 2020. available at http://wonder.cdc.go 2https://www.fda.gov/media/85029/download#:~:text=on%20april%2026%2c%20fda%20approved,alternative%20treatment% 20options%20are%20inadequate. 3 the united states department of justice. (2020, november). opioid manufacturer purdue pharma pleads guilty to fraud and kickback conspiracies (no. 20-1282). office of public affairs. https://www.justice.gov/opa/pr/opioid-manufacturer-purduepharma-pleads-guilty-fraud-and-kickback-conspiracies 4 cicero, t.j., inciardi, j.a., & munoz, a. (2005). trends in abuse of oxycontin and other opioid analgesics in the united states: 2002-2004. the journal of pain, 6(10), 662-672. https://doi.org/10.1016/j.jpain.2005.05.004 5 the united states department of justice. (2020, november). opioid manufacturer purdue pharma pleads guilty to fraud and kickback conspiracies (no. 20-1282). office of public affairs. https://www.justice.gov/opa/pr/opioid-manufacturer-purduepharma-pleads-guilty-fraud-and-kickback-conspiracies 6 van zee, a. (2009). the promotion and marketing of oxycontin: commercial triumph, public health tragedy. american journal of public health, 99(2), 221-227. https://doi.org/10.2105/ajph.2007.131714 7 jane porter & herschel jick, addiction rare in patients treated with narcotics, 302 new eng. j. med. 123 (1980) 8 leung, p. t. m., macdonald, e. m., stanbrook, m. b., dhalla, i. a., & juurlink, d.n. (2017). a 1980 letter on the risk of opioid addiction. new england journal of medicine, 376(22), 2194-2195. https://doi.org/10.1056/nejmc1700150 9 jane porter & herschel jick, addiction rare in patients treated with narcotics, 302 new eng. j. med. 123 (1980) u.s. food & drug administration. (2020, december). timeline of selected fds activities and significant events addressing opioid misuse and abuse. https://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-opioidmisuse-and-abuse 10 the people of the state of california v. purdue pharma l.p., case no. 19stcv19045 [jccp no. 5029 prescription opioid cases] 11 inpatient vs. outpatient: comparing two types of patient care. medical blog | st. george’s university | the sgu pulse. https://www.sgu.edu/blog/medical/inpatient-versus-outpatient/ 12 perry, s., & heidrich, g. (1982). management of pain during debridement: a survey of u.s. burn units. pain, 13(3), 267-280. https://doi.org/10/1016/0304-3959(82)90016-1 13 california v. purdue pharma. 14 california v. purdue pharma. 15 interagency guideline on opioid dosing for chronic non-cancer pain: an educational pilot to improve care and safety opioid treatment. (2007, march). washington state agency medical director’s group. http://www.agencymeddirectors.wa.gov/files/retired%20opioid%20guidelines.pdf; doc 40-10. ex. 10. letter from purdue to dr. franklin. case no. 19-23649 purdue pharma l.p. retrieved from https://restructuring.primeclerk.com/purduepharma/homedocketinfo sanchez, purdue pharma’s deceptive research misconduct, voices in bioethics, vol. 7 (2021) 6 16 letter from purdue to dr. franklin. case no. 19-23649 purdue pharma l.p. retrieved from https://restructuring.primeclerk.com/purduepharma/home-docketinfo 17 markenson, j. a., croft, j., zhang, p.g., & richards, p. (2005). treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial. the clinical journal of pain, 21(6), 524-535. https:// doi.org/10/1097/01.ajp.0000146215.86038.38; gimbel js, richards p, portenoy rk. controlled-release oxycodone for pain in diabetic neuropathya randomized controlled trial. neurology, 2003;60(6):927-934; zautra aj, smith bw. impact of controlledrelease oxycodone on efficacy beliefs and coping efforts among osteoarthritis patients with moderate severe pain. clin j pain. 2005;21(6):471-477; portenoy rk, farrar jt, backonja mm, et al. long-term use of controlled-release oxycodone for non cancer pain: results of a 3-year registry study. clin j pain. 2007;23(4):287-299 18 bekelman, j. e., li, y., & gross, c. p. (2003). scope and impact of financial conflicts of interest in biomedical research. jama, 289(4), 454. https://doi.org/10/1001/jama.289.4.454 19 greene, d. (producer). (2017, june 16). doctor who wrote 1980 letter on painkillers regrets that it fed the opioid crisis [audio podcast] retrieved from https://www.npr.org/transcripts/533060031 20 mann, b. (2020, november 17). federal judge approves landmark $8.3 billion purdue pharma opioid settlement. npr. https://www.npr.org/2020/11/17/936022386/federal-judge-approves-landmark-8-3-billion-purdue-pharma-opioidsettlement#:~:text=federal%20judge%20approves%20landmark%20%248.3%20billion%20purdue%20pharma%20opioid%20set tlement,-facebook&text=a%20federal%20bankruptcy%20judge%20approved,and%20the%20department%20of%20justice. the obligation to prevent winter 2015 the obligation to prevent: prescribing human flourishing dallas m. ducar follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 over the last decade, the number of americans who took a single prescription drug increased by ten percent while the use of multiple prescription drugs increased by twenty percent.1 according to the centers for disease control and prevention (cdc), almost half of the u.s. population uses prescription drugs. the most commonly prescribed drugs are those used to manage high blood pressure and heart disease for patients 60 years of age and older.2 additionally, the most commonly prescribed drugs for people ages 20 to 59 were antidepressants.3 this increase in prescription drug usage comes at a high price. in the past decade, the national pharmaceutical bill has more than doubled to a hefty $234 billion.4 this cost is expected to increase with the rise in population, the increase in acute and chronic medical conditions, and the growing cost of new pharmaceuticals. as these numbers continue to rise, it is important for healthcare providers (hcps) and patients to seriously reconsider the value of pharmaceutical intervention. current u.s. healthcare models emphasize the role of hcps in fixing rather than foreseeing problems. a new, forward-looking preventive model could be effective in improving the public’s health outlook and would also reduce the need for bandaging health concerns by averting them altogether. health comprises dynamic and complex processes which encompass various mental and physical states. similarly, preventive care relies on the dynamic and complex mechanisms at work within the purview of healthcare systems, as well as outside of them. agencies both inside and outside this system have the ability to offer preventive care measures and have good reason to do so. in this essay, i will focus on the obligation that healthcare systems, hcps, and governments are tasked with to provide and implement preventive care measures. moreover, i will offer possible solutions to current barriers in this type of care, which will provide insight into future directions. encouraging preventive care in the clinical setting organizations such as hospitals, health systems, and accreditation programs have the ability to create an atmosphere that encourages a preventive model. unfortunately, doctors-in-training spend less time with patients now than they have in the past. a recent study in 2013 conducted by researchers from the university of maryland and johns hopkins university observed two different internal medicine training programs for a total of 900 hours.5 the researchers found that most of the doctors’ time was spent on indirect patient care such as writing notes, entering orders, and talking with other providers. more shockingly, researchers found that interns allocated only twelve percent of their time – the equivalent of eight minutes each day – to each patient. preventive care begins with a didactic conversation – talking to a patient about lifestyle, beliefs, and aspirations. this approach enables hcps to care more appropriately for the patient as a whole and to provide interventions, which can result in substantial long-term effects. however, a new provider’s experiences can strongly influence her method of practicing.6 the new providers trained in u.s. programs and schools have the potential to reform our methods of practicing medicine. however, current institutional demands can shape what a future provider perceives as acceptable and unacceptable. a voices in bioethics 3 provider who hardly has time to converse with a single patient will be hard-pressed to recognize the signs and symptoms of disease before it manifests. moreover, if a new provider is taught that spending eight minutes or less with a patient is standard, little room is left for the much needed conversations that may encourage behavioral change. if more time is devoted to patient-doctor interactions, specific behavioral interventions could significantly increase a patient’s quality of life. health systems must also promote preventive prescriptions. instead of utilizing the prescription pad for pharmaceutical interventions when treating an illness, hcps should have the ability to write prescriptions that promote complete physical, mental, and social well-being. organizations such as health leads work to connect low-income patients with basic health-related resources.7 a patient may continually return to a physician’s office with complaints of respiratory problems; however, the etiology of this condition may be due to poor ventilation – a problem that medication neither addresses nor can resolve. health systems partnering with health leads can prescribe food, fuel, housing, and, in the example of the patient with respiratory issues, proper ventilation. preventive prescriptions can decrease costs and preclude less chronic and reoccurring diseases that are due to environmental factors.8 taking time to talk proper preventive care would rely on a strong fiduciary relationship between the patient and hcp. however, this certainly would require time, which is lacking in many clinical settings. even if healthcare systems change their teaching methods and encourage physicians to spend more time with each patient, the hcps must also ensure an appropriate amount of time is spent with the patient. not only does a limited amount of time result in inadequate observations and diagnoses, but it also can lead to lower patient satisfaction, negative outcomes, and inappropriate prescribing.9 hcps require time to talk with the patient, address hopes, discuss fears, and inspire long-lasting changes in regimens. the responsibility to be present with the patient requires the hcp to exercise proper self-care. primary care physicians are just one of many groups of providers who are reporting less time with their patients, which consequently results in greater stress and burnout.10 moreover, patients of more satisfied hcps are more likely to show up for appointments and adhere to treatment.11, 12 encouraging self-care not only improves the metrics over which hospital advisory boards debate, but also encourages a trusting and caring relationship between hcps and patients. more time allows for an extended conversation about smoking cessation or the risks of over-eating, and may encourage preventative behavioral change before it may be too late. if given adequate time, hcps can focus on instilling long-lasting change through behavioral treatment rather than solely relying on pharmacological intervention. for example, in psychiatric treatment, the combined effects of psychotherapy and medications indicate faster recovery rates, decreased rate of relapse, improved compliance and satisfaction, and lower long-term health costs.13 in bariatric medicine, hcps who provide voices in bioethics 4 nutritional counseling have been shown to increase cost-effectiveness and are estimated to extend the life-span of patients.14 patients also show a two-fold increase in smoking cessation when hcps intervene and speak directly to their patients about smoking, agree upon a quit date, and schedule follow-up visits.15 behavioral interventions, when implemented prudentially, have the potential to save money and lives. educating patients on the value of proper nutrition and exercise could help to lessen the impact of chronic conditions such as cardiovascular disease or diabetes. instead of prescribing a betablocker, hcps could act earlier in the patient’s life by writing prescriptions for daily cardiovascular exercise or for complete servings of fruits and vegetables with every meal. whether the intervention is aimed at fostering personal meaning or developing a personal diet, behavioral intervention offers specialized care without immediately prescribing pharmaceuticals that appear to work for the average patient. constructing for health the duty to provide preventive care does not rest solely in the hands of hcps or the health system – the surrounding community should also be responsible and held accountable. governments can encourage preventive care and thereby improve community health by structuring environments towards healthy choices. for instance, rates of daily walking have declined drastically in the united states in recent decades, contributing to increased respiratory problems and childhood obesity.16 promoting urban design of communities to maximize ease of walking, rather than driving, is one simple way for governments to encourage this change. moreover, communities that provide shared pedestrian-friendly public spaces are likely to see increased social interaction and a feeling of belonging in the community. on a city-wide level, localities can work to create biophilic cities that encourage a healthy rapport between human beings and other living organisms. human interaction with nature has shown to reduce stress, aid in recovery from illness, enhance academic performance, and moderate the effects of childhood illness.17 urbanists and city planners can advance this design rather than view such healing effects as an afterthought. implementing biophilic design can also help to eliminate food scarcity and encourage proper nutrition by supporting community gardens. initiatives such as biophilic cities, guerrilla gardening, and pedestrian-friendly communities can encourage a more equitable distribution of environmental preventive healthcare resources across communities. a lifetime of difference with the rise in chronic conditions and prescription drug usage, it is imperative for health systems, hcps, and governments to consider more effective and less costly alternatives. spending more time with the patient, considering behavioral interventions, and constructing environments to promote healthy behavior will contribute to this process. preventive models have the ability to extend access to healthcare by reshaping environments while reducing patient costs and stressors. incentivizing increased time with the patient and the use of prescriptions for basic utilities and goods can start now within our health systems. we should be having these necessary conversations and encouraging voices in bioethics 5 preventive care throughout society. the decision to handle health conditions solely as curative rather than integrating preventive care is a moral decision and there is good reason to integrate both into modern healthcare. health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.18 by encouraging preventive measures, we not only aid in healing, but also foster well-being connectedness, and human flourishing. similar to health, prevention is multi-faceted and depends on many agents and parties to produce meaningful change. changes such as spending additional time with patients, encouraging behavioral interventions, and changing our very landscapes have the potential to make a difference for a lifetime. 1 gu, qiuping, charles f. dillon, and vicki l. burt. "prescription drug use continues to increase: us prescription drug data for 2007-2008." nchs data brief 42 (2010): 1-8. 2 ibid. 3 ibid. 4 almashat, sammy, charles preston, timothy waterman, and sidney wolfe. "rapidly increasing criminal and civil monetary penalties against the pharmaceutical industry: 1991 to 2010." washington dc: public citizen's health research group (2010). 5 block, lauren, robert habicht, albert w. wu, sanjay v. desai, kevin wang, kathryn novello silva, timothy niessen, nora oliver, and leonard feldman. "in the wake of the 2003 and 2011 duty hours regulations, how do internal medicine interns spend their time?." journal of general internal medicine 28, no. 8 (2013): 10421047. 6 hafferty, frederic w. "beyond curriculum reform: confronting medicine's hidden curriculum." academic medicine 73, no. 4 (1998): 403-7. 7 "health leads." health leads. accessed january 14, 2015. 8 sayer, caroline, and thomas h. lee. "time after time—health policy implications of a three-generation case study." new england journal of medicine 371, no. 14 (2014): 1273-1276. 9 dugdale, david c., ronald epstein, and steven z. pantilat. "time and the patient–physician relationship." journal of general internal medicine 14, no. s1 (1999): 34-40. 10 friedberg, mark william, peggy g. chen, kristin r. van busum, frances aunon, chau pham, john caloyeras, soeren mattke et al. factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. rand corporation, 2013. 11linn, lawrence s., robert h. brook, virginia a. clark, allyson ross davies, arlene fink, and jacqueline kosecoff. "physician and patient satisfaction as factors related to the organization of internal medicine group practices." medical care (1985): 1171-1178. 12 dimatteo, m. robin, cathy donald sherbourne, ron d. hays, lynn ordway, richard l. kravitz, elizabeth a. mcglynn, sherrie kaplan, and william h. rogers. "physicians' characteristics influence patients' adherence to medical treatment: results from the medical outcomes study." health psychology 12, no. 2 (1993): 93. 13 teasdale, john d., zindel v. segal, j. mark g. williams, valerie a. ridgeway, judith m. soulsby, and mark a. lau. "prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy." journal of consulting and clinical psychology 68, no. 4 (2000): 615. 14 olsen, jens, ingrid willaing, steen ladelund, torben jørgensen, jens gundgaard, and jan sørensen. "costeffectiveness of nutritional counseling for obese patients and patients at risk of ischemic heart disease." international journal of technology assessment in health care 21, no. 02 (2005): 194-202. 15 wilson, douglas m., d. wayne taylor, j. raymond gilbert, j. allan best, elizabeth a. lindsay, dennis g. willms, and joel singer. "a randomized trial of a family physician intervention for smoking cessation." jama 260, no. 11 (1988): 1570-1574. voices in bioethics 6 16 ewing, reid, tom schmid, richard killingsworth, amy zlot, and stephen raudenbush. "relationship between urban sprawl and physical activity, obesity, and morbidity." american journal of health promotion 18, no. 1 (2003): 47-57. 17 beatley, timothy, biophilic cities: integrating nature into urban design and planning, washington, dc: island press, 2010. 18 constitution of the world health organization as adopted by the international health conference, new york, 19-22 june, 1946. cohen, flint revisited, voices in bioethics, vol. 6 (2020) * tracey l. cohen, jd, candidate ms bioethics, columbia university © 2020 tracey cohen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. flint revisited: the media’s overwhelming indifference to the existence and impact of environmental racism tracey l. cohen* abstract the government changes to the water source in flint, michigan’s exposed many people to lead in their water. lead exposure disproportionately impacted the black community in flint. this paper argues that more media attention should have focused on the racial aspects of the flint water crisis. the media has an ethical obligation to expose environmental racism and injustice. keywords: environmental ethics, lead poisoning, access to water, flint, epa, vulnerable populations i. introduction lead is a neurotoxin so potent that major environmental agencies, including the world health organization (who) and the environmental protection agency (epa), have found that there is absolutely no safe level of exposure, especially for children who are the most vulnerable to its effects.1 despite there being no safe level of lead exposure for children, the epa has established a 15 parts-per-billion (ppb) limit on lead in drinking water. 2 in flint, michigan, an impoverished and predominantly black city, 3 the tap water that tens of thousands of children consumed and bathed in from april 2014 to october 2015 exceeded 15 ppb, with at least one sample registering greater than 1,000 ppb.4 while many are familiar with the flint crisis due to its extensive media coverage, the impact that race played in the disaster was largely neglected by the mainstream media. classic environmental racism was mostly ignored. the mainstream media overwhelmingly failed in their ethical obligation to report the environmental justice aspect of the calamity. cohen, flint revisited, voices in bioethics, vol. 6 (2020) 2 with the renewed awareness concerning racial justice taking place around the world, it is an instrumental time to bring the issue of environmental racism into focus. the media plays a key role in this task. indeed, the media is ethically obligated to bring the issue of racism in all of its forms to the forefront before a wide, public audience. environmental racism, which may easily be overlooked amidst more overt forms of prejudice, is no exception. it is imperative that we revisit how the issue of race was handled by the media during one of the more recent, and highly publicized environmental catastrophes. ii. contamination and deception the flint water crisis began when flint government officials decided to switch from the detroit water system to the highly contaminated flint river, which historically had served as a repository for industrial waste.5 the move was motivated by cost.6 prior to the switch, several government officials had voiced concerns that the flint river water was corrosive and posed a public health hazard.7 a slew of emails between government officials, exchanged well in advance of the switch, discussed the public health concerns around using the flint river as a water source.8 in addition, there was a study conducted in 2011 demonstrating that the river was unsuitable as a water source since it was hazardously corrosive.9 nevertheless, the switch ensued in april 2014. the corrosive flint river water ate away at the city’s ancient pipes leaching the pipes’ disintegrating lead interior coating into the water.10 notably, the city failed to implement any anti-corrosion controls in blatant violation of the requirements of federal law, and subsequently proceeded to misrepresent to the epa that such controls were in place.11 flint’s water supply not only was dangerously corrosive and contaminated with lead, but it also contained hazardous and illegal levels of e. coli, total coliform bacteria, and total trihalomethanes (tthm).12 soon after the switch, flint residents began complaining that the water smelled horrid, was brown, caused rashes, and was making them ill.13 around the same time, general motors (gm) complained that it could no longer use the water at its manufacturing plant because it was corroding car parts.14 flint officials outright disregarded private citizens’ concerns15 and even went so far as to belittle, deride, and accuse worried residents of acting in furtherance of a political agenda.16 behind the scenes, however, officials quietly changed gm’s water supply source and began using bottled water for themselves and for government office visitors.17 amid mounting concerns regarding water quality, flint officials offered citizens sham assurances that the water had been tested and was safe.18 however, water samples had actually failed lead testing by exceeding federally mandated criteria.19 to remedy this, officials skewed the data reported to the epa so the water would pass muster.20 flint officials continued to deny there was any problem with the water even after independent testing conducted by a team from virginia tech (vt), commissioned by a mother whose children were sickened by the water, uncovered exceedingly high levels of lead in flint’s water supply.21 again, officials accused the vt scientists of bad science and acting pursuant to a hidden agenda.22 when the contaminated water supply caused two large-scale, deadly outbreaks of legionnaires’ disease that killed twelve people,23 flint officials blamed the disease on a local hospital.24 on september 24, 2015, a local pediatrician, dr. mona hanna-attisha, released the results of an independently commissioned study that tested elevated blood lead levels in flint’s children.25 the study found that the blood lead levels in the children had doubled and, in some cases, even tripled from the period preceding the switch to the flint river.26 the study was largely the impetus for the office of flint’s governor, rick snyder, to finally cohen, flint revisited, voices in bioethics, vol. 6 (2020) 3 issue – after a year and a half – a press briefing announcing that flint would be switching back to the detroit water system.27 the alleged reason for the reversion back to detroit water, according to the release, was that detroit water “will be easier to manage” since it comes from “a more stable source than the river” and residents will have “more confidence in this water source.”28 the change came too late: around 100,000 people,29 including tens of thousands of children,30 had already been poisoned. iii. the devastating aftermath lead cannot be eliminated from the human body and is a cumulative toxin.31 lead poisoning includes, among other things, brain and nervous system damage, slowed growth and development, learning and behavior problems, hearing and speech problems, and lowered iq.32 the damage is life long,33 and, according to recent studies, can even lead to epigenetic effects upon affected children’s grandchildren.34 as dr. philip landrigan and dr. david bellinger, two experts in childhood lead poisoning, have explained: lead is a devastating problem. it damages children’s brains, erodes intelligence, diminishes creativity and the ability to weigh consequences and make good decisions, impairs language skills, shortens attention span, and predisposes to hyperactive and aggressive behavior. lead exposure in early childhood is linked to later increased risk for dyslexia and school failure.35 lead exposure also exacerbates the ill effects of poverty.36 therefore, flint’s children, who were already suffering from malnutrition and other stressors associated with being destitute, were at an even higher risk of harm from lead.37 for a year and a half, these young children were exposed leaving them ill, struggling with behavioral issues, and falling behind in school.38 according to an epidemiologic assessment conducted by the cdc from may 17-19, 2016, more than 50 percent of families in flint reported that at least one member of the household had an increase in behavioral health concerns since october 2015 requiring behavioral health services.39 the same percentage reported that at least one member of their household experienced a decline in physical health due to the water switch. 40 therefore, the children of flint who started out with a disadvantage in life due to poverty now have to contend with another hurdle to overcome: damage from lead poisoning. iv. the bioethical principles and the impact of environmental racism the actions of flint governmental officials were not merely negligent – they were criminal acts. officials knew flint water was toxic but allowed countless people, especially children, to be sacrificed for financial savings. so far, prosecutors in michigan have brought criminal charges against 15 flint government officials for their role in the crisis.41 flint officials’ actions were also egregious breaches of their bioethical obligations to flint’s citizens. unquestionably, government officials breached the duties of beneficence and non-maleficence owed to their constituents by enacting environmental practices that were extremely harmful to residents and then failing to protect them from that harm. officials also failed to honor residents’ right to autonomous decision making by denying them the information necessary to give informed consent. cohen, flint revisited, voices in bioethics, vol. 6 (2020) 4 officials also violated the duty of distributive justice. the bioethical principle of distributive justice demands that all people, regardless of race, socioeconomic class, religion, and ethnicity, be treated equally. environmental justice, which can be viewed as a form of distributive justice, is the “fair treatment and meaningful involvement of all people regardless of race, color, national origin or income with respect to the development, implementation and enforcement of environmental laws, regulations and policies.” 42 the victims in flint were not only poor, but they were also predominantly black. dr. robert bullard, dean of the school of public health at texas southern university, said the flint crisis is classically illustrative of environmental racism,43 which is a violation of both distributive and environmental justice. environmental racism is “any environmental policy, practice or directive that differentially affects or disadvantages (whether intended or unintended) individuals, groups or communities based on race or colour.”44 as dr. bullard has explained, the flint disaster which included a cover-up, shirking of responsibility, and denial that there was ever any problem can be starkly juxtaposed against how environmental issues are addressed in predominantly white areas.45 the role of environmental racism in the flint crisis was also documented in an independent report (the report) commissioned by gov. synder and released on or about march 23, 2016. in the report, a panel of experts analyzed the underpinnings of what occurred in flint and concluded that: the facts of the flint water crisis lead us to the inescapable conclusion that this is a case of environmental injustice. flint residents, who are majority black or african american and among the most impoverished of any metropolitan area in the united states, did not enjoy the same degree of protection from environmental and health hazards as that provided to other communities.”46 v. the media’s collective failure to address environmental racism in flint the report’s focus on the civil rights violations in flint rightly portrayed flint governmental officials as perpetrators of environmental racism. the report, which also contained several remedial recommendations, was highly publicized in several periodicals, including the new york times (nyt).47 in its coverage of the report, the nyt noted: the five-member panel put a spotlight on a long-running civil rights issue: whether minorities and the poor are treated differently when it comes to environmental matters, relegating them to some of the most dangerous places in the country: flood prone areas of new orleans that were devastated after hurricane katrina; highly polluted parts of detroit and the bronx; and “cancer alley” in louisiana, where residents who live near factories suffer disproportionately from disease.48 among other things, the nyt also quoted in its article rep. dan kildee, whose district includes flint, who stated, “i could not imagine this happening in an affluent community that was not a majority minority community and the same reaction occurring.”49 the nyt’s coverage did not end with its article regarding the report and its disturbing findings. indeed, two days following publication of its article on the report, the nyt published an editorial entitled “the racism at the heart of flint’s crisis.”50 the editorial opens with the line “[a]n important new report makes clear the principal cause of the water crisis in flint, mich: the state government’s blatant disregard for the lives and health of poor black residents of a distressed city.”51 the editorial proceeds to discuss the report and the role cohen, flint revisited, voices in bioethics, vol. 6 (2020) 5 that race played in the flint crisis, observing that “[w]hile [the report] avoids using the word “racism,” it clearly identifies the central role that race and poverty play in this story.”52 the nyt’s inclusion of the issue of environmental racism in its coverage of flint is an exception among mainstream media. while many mainstream media outlets heavily covered the flint crisis and collectively did an excellent job uncovering the scandal, most failed to discuss or even mention the racial inequities fueling the disaster. included among these periodicals is a major us news outlet – the washington post (wp). on march 23, 2016 – the same day that the nyt published its article concerning the report – the wp released an article entitled “scathing independent report blames state officials for flint water crisis.”53 while the article correctly observes that the report lays blame for the flint crisis squarely at the feet of flint governmental officials, it wholly sidesteps discussion of one of the key contributing factors to the crisis central to the report: the issue of race. notably, the wp article is completely devoid of any mention of the word race or the topic of race.54 in fact, aside from a few articles that mention, in passing, the role of environmental injustice in flint, a search using key terms in the wp’s search function was unable to produce any wp articles about flint that focus on the impact that race played in the crisis there. the report’s central focus on environmental racism should have made the topic a critical point of discussion in the mainstream media. even if there had been no report, environmental racism served as a basis for the criminal disregard of flint’s residents, warranting a serious and pervasive national conversation. the media’s lapse in discussing environmental racism could have been fueled by the same indifference that led to the water crisis. vi. conclusion environmental racism is insidious and can persist undetected. however, it can be just as devastating as overt prejudice and can cause life-long physical damage. environmental racism is arguably a manifestation of the larger problem of structural racism. tackling it will require vast reforms, not only in environmental policy and practice, but in housing, tax, and other policies that historically have disadvantaged and oppressed people of color. however, the media must empower people with information before we can prevent environmental racism and attempt to repair its ruins. the media bears a special responsibility to report on environmental racism. the major media outlets that failed to discuss the issue of race as a motivating factor behind the flint crisis were derelict in their responsibility to bring environmental racism to light. the public is not served by this type of journalism – nor are the people of flint or the victims of the next environmental disaster that may be caused by environmental racism. 1 cdc website, health effects of lead exposure, https://www.cdc.gov/nceh/lead/prevention/health-effects.htm; who website, lead poisoning and health, https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health 2 environmental protection agency website, https://www.epa.gov/ground-water-and-drinking-water/basic-information-aboutlead-drinking-water https://www.cdc.gov/nceh/lead/prevention/health-effects.htm https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health https://www.epa.gov/ground-water-and-drinking-water/basic-information-about-lead-drinking-water https://www.epa.gov/ground-water-and-drinking-water/basic-information-about-lead-drinking-water cohen, flint revisited, voices in bioethics, vol. 6 (2020) 6 3 united states census bureau, https://www.census.gov/quickfacts/fact/table/flintcitymichigan/pst045219); 4 ruckart, p.z., et al. “the flint water crisis: a coordinated public health emergency response and recovery initiative.” j public health manag pract. 25 (suppl 1 lead poisoning prevention): s84-s90, s85 (january 1, 2011). https://journals.lww.com/jphmp/fulltext/2019/01001/the_flint_water_crisis__a_coordinated_public.14.aspx; flint water advisory task force, final report, p. 25. march 2016. https://www.michigan.gov/documents/snyder/fwatf_final_report_21march2016_517805_7.pdf; hanna-attisha, m. “the future for flint’s children.” the new york times. march 26, 2016. https://www.nytimes.com/2016/03/27/opinion/sunday/thefuture-for-flints-children.html 5 natural resources defense council, https://www.nrdc.org/stories/flint-water-crisis-everything-you-need-know 6 hanna-attisha, m, et al. “elevated blood lead levels in children associated with the flint drinking water crisis: a spatial analysis of risk and public health response.” am j public health. 106:283-290, 283 (2016). https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4985856/ 7 flint water advisory task force, final report, pp. 20-21; kennedy, m. “lead-laced water in flint: a step-by-step look at the makings of a crisis.” npr. april 20, 2016. https://www.npr.org/sections/thetwo-way/2016/04/20/465545378/lead-laced-waterin-flint-a-step-by-step-look-at-the-makings-of-a-crisis 8 flint water advisory task force, final report, pp. 20-21 9 gostin, l.o. “lead in the water: a tale of social and environmental injustice.” jama. 315:19:2053-2054, 2053. https://jamanetwork.com/journals/jama/fullarticle/2521956 10 ruckart, p. s85 11 gostin, p. 2053; flint water advisory task force, final report, pp. 22-23, 32 12 hanna-attisha, p. 283; kennedy. tthm is a carcinogenic disinfection byproduct that occurs when chlorine interacts with organic matter, such as human waste, in the water. 13 hanna-attisha, p. 283; flint water advisory task force, final report, p. 41 14 campbell, c., et al. “a case study of environmental injustice: the failure in flint.” international journal of environmental research and public health. 13:951, 2 (2016). https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5086690/; kennedy 15 gostin, p. 2053; hanna-attisha, p. 283. 16 bosman, j., davey, m., smith, m. “as water problems grew, officials belittled complaints from flint.” the new york times. january 21, 2016. https://www.nytimes.com/2016/01/21/us/flint-michigan-lead-water-crisis.html 17 ruckart, p. s85; flint water advisory task force, final report, p. 22 18 flint water advisory task force, final report, p. 41; bosman 19 flint water advisory task force, final report, pp. 48, 55; kennedy 20 gostin, p. 2054; flint water advisory task force, final report, pp. 54-55 21 flint water advisory task force, final report, pp. 25-26; kennedy https://www.census.gov/quickfacts/fact/table/flintcitymichigan/pst045219 https://journals.lww.com/jphmp/fulltext/2019/01001/the_flint_water_crisis__a_coordinated_public.14.aspx https://www.michigan.gov/documents/snyder/fwatf_final_report_21march2016_517805_7.pdf https://www.nytimes.com/2016/03/27/opinion/sunday/the-future-for-flints-children.html https://www.nytimes.com/2016/03/27/opinion/sunday/the-future-for-flints-children.html https://www.nrdc.org/stories/flint-water-crisis-everything-you-need-know https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4985856/ https://www.npr.org/sections/thetwo-way/2016/04/20/465545378/lead-laced-water-in-flint-a-step-by-step-look-at-the-makings-of-a-crisis https://www.npr.org/sections/thetwo-way/2016/04/20/465545378/lead-laced-water-in-flint-a-step-by-step-look-at-the-makings-of-a-crisis https://jamanetwork.com/journals/jama/fullarticle/2521956 https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5086690/ https://www.nytimes.com/2016/01/21/us/flint-michigan-lead-water-crisis.html cohen, flint revisited, voices in bioethics, vol. 6 (2020) 7 22 kennedy 23 ruckart, p. s85 24 bellware, k. “there may have been dozens more deaths linked to the flint water crisis than previously known.” the washington post. september 12, 2019. https://www.washingtonpost.com/nation/2019/09/12/there-may-have-been-dozensmore-deaths-linked-flint-water-crisis-than-previously-disclosed/ 25 ruckart, p. s85 26 hanna-attisha, p. 285 27 carravallah, l.a., et al. “lessons for physicians from flint’s water crisis.” ama journal of ethics. 19:10:1001-1010, 1003 (2017). https://journalofethics.ama-assn.org/article/lessons-physicians-flints-water-crisis/2017-10; flint water advisory task force, final report, p. 25; kennedy, m. 28 kennedy 29 carravallah, p. 1001 30 flint water advisory task force, final report, p. 36 31 who website, lead poisoning and health, https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health 32 cdc website, health effects of lead exposure, https://www.cdc.gov/nceh/lead/prevention/health-effects.htm 33 hanna-attisha, m. “flint kids: tragic, resilient and exemplary.” american journal of public health. 107:5:651-652, 651 (2017). https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5388977/. 34 hanna-attisha, p. 286 35 campbell, pp. 2-3 36 hanna-attisha, p. 286 37 ibid. 38 green, e.l. “flint’s children suffer in class after years of drinking the lead-poisoned water.” the new york times. november 6, 2019. https://www.nytimes.com/2019/11/06/us/politics/flint-michigan-schools.html 39 ruckart, p. s86 40 ibid. 41 boufides, c.h., et al., “learning from flint water crisis: restoring and improving public health practice, accountability and trust.” the journal of law, medicine & ethics. 47 s2:23-36, 25 (2019). https://journals.sagepub.com/doi/full/10.1177/1073110519857310 42 bullard, r.d., “dismantling environmental racism in the usa.” local environment: the international journal of justice and sustainability. 4:1:5-19, 7 (1999). https://content.ebscohost.com/contentserver.asp?t=p&p=an&k=1694191&s=r&d=eih&ebscocontent=dgjymmto50seqlq4 yovsolcmseiep7rsskq4s7awxwxs&contentcustomer=dgjympgot02xqrvluepfgeyx44dt6fia. 43 campbell, p. 4 https://www.washingtonpost.com/nation/2019/09/12/there-may-have-been-dozens-more-deaths-linked-flint-water-crisis-than-previously-disclosed/ https://www.washingtonpost.com/nation/2019/09/12/there-may-have-been-dozens-more-deaths-linked-flint-water-crisis-than-previously-disclosed/ https://journalofethics.ama-assn.org/article/lessons-physicians-flints-water-crisis/2017-10 https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health https://www.cdc.gov/nceh/lead/prevention/health-effects.htm https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5388977/ https://www.nytimes.com/2019/11/06/us/politics/flint-michigan-schools.html https://journals.sagepub.com/doi/full/10.1177/1073110519857310 https://content.ebscohost.com/contentserver.asp?t=p&p=an&k=1694191&s=r&d=eih&ebscocontent=dgjymmto50seqlq4yovsolcmseiep7rsskq4s7awxwxs&contentcustomer=dgjympgot02xqrvluepfgeyx44dt6fia https://content.ebscohost.com/contentserver.asp?t=p&p=an&k=1694191&s=r&d=eih&ebscocontent=dgjymmto50seqlq4yovsolcmseiep7rsskq4s7awxwxs&contentcustomer=dgjympgot02xqrvluepfgeyx44dt6fia cohen, flint revisited, voices in bioethics, vol. 6 (2020) 8 44 bullard, pp. 5-6 45 campbell, p. 4 46 ibid., pp. 4-5 47 davey, m., bosman, j. “emails show michigan aides worried about flint’s water a year before acting.” the new york times. february 26, 2016. https://www.nytimes.com/2016/02/27/us/emails-show-michigan-aides-worried-about-flints-water-a-yearbefore-acting.html 48 ibid. 49 ibid. 50 the editorial board. “the racism at the heart of flint’s crisis.” the new york times. march 25, 2016. https://www.nytimes.com/2016/03/25/opinion/the-racism-at-the-heart-of-flints-crisis.html 51 ibid. 52 ibid. 53 dennis, b. “scathing independent report blames state officials for flint water crisis.” the washington post. march 23, 2016. https://www.washingtonpost.com/national/health-science/scathing-independent-report-blames-state-officials-for-flint-watercrisis/2016/03/23/82692d52-f12f-11e5-a61f-e9c95c06edca_story.html 54 ibid. https://www.nytimes.com/2016/02/27/us/emails-show-michigan-aides-worried-about-flints-water-a-year-before-acting.html https://www.nytimes.com/2016/02/27/us/emails-show-michigan-aides-worried-about-flints-water-a-year-before-acting.html https://www.nytimes.com/2016/03/25/opinion/the-racism-at-the-heart-of-flints-crisis.html https://www.washingtonpost.com/national/health-science/scathing-independent-report-blames-state-officials-for-flint-water-crisis/2016/03/23/82692d52-f12f-11e5-a61f-e9c95c06edca_story.html https://www.washingtonpost.com/national/health-science/scathing-independent-report-blames-state-officials-for-flint-water-crisis/2016/03/23/82692d52-f12f-11e5-a61f-e9c95c06edca_story.html holmquist, sex & alzheimer’s disease, voices in bioethics, vol. 1 (2014-15) © 2015 stephanie holmquist. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. sex & alzheimer’s disease: deciding in advance stephanie holmquist keywords: ethics, sexuality and ethics, alzheimer’s introduction when former iowa legislator, seventy-eight-year-old iowan henry rayhons was accused of sexual assault against his wife, it was headline news. in april, 2015 mr. rayhons was acquitted.1 his wife, donna, had been an alzheimer’s disease (ad) patient living in a local care facility. mrs. rayhons is now deceased. the details of the case suggest that the nursing home did not adequately communicate its opinion to mr. rayhons that his wife had become incapable of consenting to sex. this detail, combined with general social discomfort in addressing sexuality in dementia patients, complex family dynamics, and poor prosecutorial judgment, seem to have led to the charges against mr. rayhons. most of the discussion of the rayhons case has focused on declining decisional capacity during the course of ad and its implications for consenting to sex. in the nursing home setting, capacity to consent becomes a public question, subject to staff opinion and medical evaluation. analysis traditionally, sexual assault was legally impossible within marriage. it was not until the 1970s that a right of spousal refusal to sex was generally recognized in law, reflecting gains in women’s equality. mr. rayhons was prosecuted under a 1989 iowa state law that includes inability to consent in defining marital rape.2 in contrast to the 1970s, the legal construction of sexual consent for unmarried adults is now a fraught issue, especially for college students. california has recently moved to require its public universities and colleges to implement an “affirmative consent standard” so that agreeing to sexual activity is “conscious, and voluntary,” as well as “ongoing throughout a sexual activity.”3 neither the legal conception of sexual consent in marriage nor the explicit “affirmative consent” model is helpful in structuring sexual relations between ad patients and the spouses or partners they have committed to prior to the onset of their disease. rather, understanding desire for physical closeness and sex as expressions of enduring appetites distinct from rational capacity to consent is more appropriate. as daniel reingold, an elder care expert, was quoted in the new york times, “touch is one of the last pleasures we lose. . . . so much of aging and so much of being in a long-term care facility is about loss, loss of independence, loss of friends, loss of ability to use your body. why would we want to diminish that?”4 this desire for physical intimacy, including sex, continues even as cognitive ability declines, and it ought to be respected. we can expect the management of sex and ad to be a continuing subject of debate and policy struggles. in 2013 the ad population in the us was estimated to exceed 13 million, with a potential increase to 13.8 million americans by 2050.5 for couples concerned with preserving their privacy and autonomy in this arena, one possible tool is an holmquist, sex & alzheimer’s disease, voices in bioethics, vol. 1 (2014-15) 2 expanded use of the advance healthcare directive. advance directives are generally crafted to specify preferences for medical treatment when we cannot speak for ourselves or to name someone to speak for us— or both. in response to increased anxieties over living with late-stage ad, some advance directives now include highly specific language on when and how to withhold food and water by mouth so that death is not prolonged by unwanted feeding and hydration. while sexual contact is not a medical treatment, it may be an important contributor to the both the physical and emotional welfare of the ad person who is beyond cogent verbal expression of desire. advance directives could simply include language specifying that one’s spouse or designated partner retained authority to decide whether sexual expression between the partners was wanted and appropriate. it would be sensible also to establish some very advanced degree of incapacity beyond which even a designated spouse could not chose to engage sexually with their ad partner. authorizing one’s partner to decide on physical contact does leave room for exploitation. in ethical matters, good choices are often about designating which agent should be empowered to decide correctly, but also to make an honest mistake on our behalf. for the moment, many physicians and institutions will construe a lack of robust ability to consent with incapacity to desire and benefit from sexual contact. this is a failure that potential patients may wish to be spared. in established partnerships decisions about sexual relations ought to be left to the partners, absent some compelling reason to the contrary. leaving the decisions to partners does create some risk even a well-intentioned person may misread her ad loved one. but unless signs of coercion or abuse are clear, then the consequences of misreadings are less burdensome than the excess conservatism of healthcare professionals and institutions. conclusion people diagnosed or concerned about ad should be able to set out in writing in advance that they and their spouse or established partner retain a zone of privacy with regard to sexuality. limiting the decision on sexuality to a written directive is one plausible protection for the ad spouse against an exploitative partner. sensitive care for people with ad includes extending their enjoyment of daily pleasures as long as possible, including the satisfaction of physical intimacy. since the medical and caregiving communities’ ability to cope effectively with sexual consent practices in the context of dementia is still developing, patients and their partners can benefit from taking control of their privacy and welfare by advance directive. 1 tony leys and grant rodgers, “rayhons: 'truth finally came out' with not guilty verdict,” the des moines register online, april 22, 2015, http://www.desmoinesregister.com/story/news/crime-and-courts/2015/04/22/henryrayhons-acquitted-sexual-abuse/26105699/ 2 dana dovey, “iowa rep henry rayhons arrested for marital rape after alleged sexual contact with alzheimer’sstricken wife,” medical daily, august 19, 2014, http://www.medicaldaily.com/iowa-rep-henry-rayhons-arrestedmarital-rape-after-alleged-sexual-contact-alzheimers-298730. 3 california sen. bill no. 967 (2013–2014 reg. sess.), “student safety: sexual assault.” https://leginfo.legislature.ca.gov/faces/billnavclient.xhtml?bill_id=201320140sb967. 4 pam belluck, “sex, dementia and a husband on trial at age 78,” the new york times online, april 13, 2015, http://www.nytimes.com/2015/04/14/health/sex-dementia-and-a-husband-henry-rayhons-on-trial-at-age78.html?_r=0. http://www.desmoinesregister.com/staff/17679/tony-leys/ http://www.desmoinesregister.com/staff/17605/grant-rodgers/ holmquist, sex & alzheimer’s disease, voices in bioethics, vol. 1 (2014-15) 3 5 liesi hebert et al., “alzheimer disease in the united states (2010–2050) estimated using the 2010 census.” neurology 80, no. 19 (2013): 1778-1783. doi: 10.1212/wnl.0b013e31828726f5. kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) * kalina kamenova, phd, research director, canadian institute for genomics and society hazar haidar, phd, assistant professor, université du québec à rimouski (uqar) © 2021 kamenova & haidar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the first baby born after polygenic embryo screening: key issues through the lens of experts and science reporters kalina kamenova, hazar haidar* abstract this article examines the bioethical discourse on polygenic embryo screening (pes) in reproductive medicine in blogs and news stories published during 2021 in response to the first baby’s birth using polygenic risk scores (prs) derived from genome-wide association studies. we further contextualize the findings by synthesizing the emerging peer-reviewed bioethics literature on the issue, which has emphasized considerations regarding the child-parent future relationship, equity of access, and the absence of professional guidelines. our media content analysis has established that expert opinion was prominently featured in news coverage, with bioethicists and other academics contributing 38 percent of articles and providing extensive commentary on ethical, social, and policy implications in the articles written by journalists. the overall perspective towards the use of pes was primarily negative (59 percent of the articles), without significant differences in negativity and positivity between experts and science reporters. this indicates a shift from the predominantly neutral attitudes towards the technology in media discourse prior to its deployment in clinical settings. there is heightened awareness that offering these tests to prospective parents is unethical and can create unrealistic expectations, with the two most prominent arguments being uncertainty about the prediction accuracy of polygenic risk scores in this context (72 percent of the articles) and the potential of pes to lead to a eugenic future of human reproduction that normalizes the discrimination of people based on their genetics (59 percent of the articles). keywords: polygenetic embryo screening, reproductive ethics, unified patient lobby, patient autonomy introduction the possibility of using genetic technologies to engineer the perfect baby has long haunted the public imagination. while some techno-utopians have openly advocated for human genetic enhancement, many critics have warned that advances in dna technology come with myriads of ethical dilemmas and kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 2 potentially dangerous social consequences. literary and cinematic works have offered dystopian visions of our genetic futures—from aldous huxley’s powerful socio-political fantasy in his book brave new world (1932) to cult classics of sci-fi cinema, such as blade runner (1982) and gattaca (1997), there has been no shortage of ominous predictions that genetic engineering would lead to a new form of eugenics, which would ultimately create new social hierarchies grounded on genetic discrimination. moreover, concerns about the use of genetic and genomic technologies for social control have been entangled with deep philosophical questions about personal autonomy, the right of the child to an open future, and the morality of changing, improving, or redesigning human nature.1 the perennial debate on human enhancement was recently reignited with a new controversy over the use of pre-implantation screening of embryos using polygenic risk scores.2 while the profiling of ivf embryos to detect hereditary, monogenetic diseases has been widely accepted, some companies are now pushing the envelope with unrealistic promises of tests that can predict genetic possibilities for desirable traits such as a child’s intelligence, athletic ability, and physical appearance. one event that prompted a public outcry in late 2021 was news about the birth of the first baby from an embryo selected through polygenic testing, a girl named aurea.3 although the embryo screening in aurea’s case was used to decrease the likelihood for certain health conditions, many commentators believed that it signaled a real possibility of embryo selection for non-medical reasons becoming a commercial procedure in the foreseeable future, especially in the largely unregulated us fertility market.4 in the past, there have been discrepancies in how ethical and policy issues arising from advances in reproductive medicine have been viewed by experts (e.g., bioethicists, philosophers, legal scholars) and presented in the news. like other advances in medical genetics, gene editing and screening technologies have been frequently characterized by exaggeration, sensationalism, and hype around clinical possibilities.5 moreover, news media have often amplified the anticipated health benefits of genetic testing while overlooking uncertainty associated with its clinical validity and emerging ethical concerns, as shown in a recent study of the media portrayal of non-invasive prenatal testing (nipt).6 the issue of polygenic embryo screening (pes) initially gained traction in the media in 2017 when the new jersey biotech startup genomic prediction made headlines with claims that its testing technology could identify and avoid implanting embryos with very low iqs.7 the company also claimed that it had the capability to identify embryos with high iqs, although it committed not to offer that procedure for ethical reasons.8 the media coverage of polygenic risk scoring of human embryos between 2017 and 2019 was previously analyzed in a study published in bmc medical ethics in september 2021.9 this media content analysis has established that while most news articles were neutral towards the technology, one of the most significant critiques raised by science reporters was the absence of solid scientific evidence for the technology’s predictive accuracy and its practical value in ivf settings. it has also identified five major ethical concerns articulated by science reporters that have also been addressed in the academic discourse and within broader policy debates on reproductive technologies: a slippery slope towards designer babies, well-being of the child and parents, impact on society, deliberate choice, and societal readiness. in this article, we examine the discourse on pes in bioethics blogs, opinion articles, and news stories published in 2021, with a specific focus on reactions to the birth of the first polygenic risk score baby. we compare the perspectives of experts and science reporters to establish their attitudes towards pes, the main ethical themes in press coverage, and the key issues highlighted for a future policy debate. we also juxtapose our findings to the previous study of media coverage to establish if the case of baby aurea has raised any new issues and pressing ethical concerns. kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 3 i. polygenic embryo screening in reproductive medicine while complex diseases and human traits result from a combination of genetic, lifestyle, and environmental factors, genomic medicine is quickly gaining momentum, and demands for genetic tests in clinical practice have significantly increased. scans and analyses of genomes from various populations, a research area known as genome-wide association studies, have enabled scientists and researchers to identify genetic differences or variants associated with a particular trait or medical condition. these variants can be combined into a polygenic risk score that predicts an individual’s traits or increased risk for a certain disease. for instance, pes have been used to predict a range of diverse common conditions, from diabetes and cancer to attention deficit issues10 and, in some cases, well-being in general.11 this testing modality relies on the probabilistic susceptibility of individuals to certain diseases to offer personalized medical treatments and inform therapeutic interventions. polygenic embryo screening uses polygenic risk scores to assess an embryo’s statistical risks of developing diseases (e.g., cardiovascular diseases) and potentially traits (e.g., intelligence, athletic ability, among others) and is performed in an ivf setting. it is currently marketed by several us companies such as myome, orchidhealth, and genomic prediction to prospective parents as a method to screen pre-implantation embryos for health and non-health related conditions and is accessible to those who can afford to pay for it. as stated in a recent report on companies bringing pes into reproductive medicine, genomic prediction has already made their test for polygenic disorders, lifeview, available to couples. in contrast, orchid health has only recently invited couples to an early-access program for their testing technology, and myome is still in the process of launching its own test.12 in september 2021, bloomberg first reported the birth of baby aurea using screening conducted by genomic prediction. she was born after her parents used ivf and subsequently pes to select from 33 candidate pre-implantation embryos in 2020.13 aurea’s embryo was deemed to have the best genetic odds of avoiding conditions such as breast cancer, diabetes, heart disease, and schizophrenia in adulthood. it is worth noting that genomic prediction made the announcement almost one year following aurea’s birth, thus delaying the media’s reaction to this development and the ensuing bioethical and policy debates. ii. ethical, social, and policy implications some important ethical, social, and regulatory considerations regarding the development and clinical use of pes have been raised within the academic community. the bioethics literature on the issue, however, appears rather thin, which is not surprising given that prior to 2021, the possibility of using this screening method in clinical practice was largely hypothetical. other genomic technologies that have enabled polygenic embryo selection, such as whole-genome sequencing and pre-implantation genetic diagnosis, have received more attention from bioethicists, legal scholars, and ethical, legal, and social implications (elsi) researchers. our analysis of the emerging literature has shown that some proponents of pes advocate its current use and go as far as to suggest a permissive regulatory environment for the purpose of outpacing the ethical concerns and potential restrictions once the technology becomes widely available. this approach suggests that embryo selection should be allowed for or against any trait associated with higher odds for better health and well-being in general, often without further discussion of what accounts for wellbeing.14 scholars applying the principle of procreative beneficence to defend the use of pes have also argued for regulation that addresses issues of justice and equality and expands access to the procedure for those who are currently unable to afford it. by contrast, opponents have argued that the clinical utility of this embryo selection method is yet to be proven, and its current use may create unrealistic expectations in parents, making it an unethical practice to offer the procedure as part of ivf treatments.15 they state kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 4 that predictive models from prs have been developed with data from genomes of adult populations. therefore, extrapolating results for embryo screening, along with the absence of a research protocol to validate its diagnostic effectiveness, is dangerous and misleading.16 another layer of complexity is added because prs already faces many translational hurdles that would undermine its predictive value assessment for certain traits or diseases. scientists have noted that prs take into consideration the genetic component of a particular trait putting aside the effects of other non-genetic factors, such as lifestyle and environment, which might interfere and influence the calculation of these scores.17 discussions on the ethics and societal implications of pes in the bioethics literature can be grouped into three distinct categories: 1) relational issues between parents and the future child (e.g., selection as identity-determining, concerns about the instrumentalization of children and the child’s right to an open future); 2) concerns about social justice and equality (e.g., fears about a new eugenics that establishes new social hierarchy, limited access to the technology due to its cost); and 3) implementation and regulatory concerns (e.g., lack of professional guidelines and advertising of pes by private companies). an important ethical implication of pes relates to the well-being of the future child and the way that selecting children based on their genetic make-up might negatively affect the parent-child relationship. this is in line with previously raised ethical concerns in the literature around cloning and pre-implantation genetic diagnosis that by choosing a child’s genetic predisposition, we are limiting to and, in some cases, denying their right to an open future. for instance, the future child’s options would be restricted if parents chose a genetic predisposition to musicality that might interfere with the child’s ability to make certain life choices.18 on a societal level, there are concerns pes may alter social perceptions of what is “normal” and “healthy,” resulting in discrimination and stigmatization of certain conditions. 19 related to this are fears about encouraging eugenic attitudes that can exacerbate discrimination against people with disabilities. furthermore, one of the main ethical concerns raised is that the growing use of pes might exacerbate societal pressure to use this technology, influencing parents’ decisions to select the embryo with the “best” genetics giving rise to a generation of “designer babies.” 20 finally, direct-to-consumer marketing and clinical introduction of the technology prior to the publication of professional guidelines and in the absence of scientific validity for its use, as well as without appropriate regulatory oversight, is seen as a premature step that might erode public trust.21 iii. news stories and expert commentary on polygenic embryo screening in 2021 we conducted searches on google news using keywords such as “polygenic embryo screening,” “polygenic risk scores,” “baby aurea,” and “embryo selection” and selected blogs and articles from major news sources (e.g., washington post, new york times, wall street journal, la times, guardian, the times, etc.). an additional effort was made to collect all relevant articles from prominent bioethics blogs such as the hastings center bioethics forum, impact ethics, bioethics.net, biopolitical times (center for genetics and society), among others. the time period for the study was one year, from january 1 to december 31, 2021. while most coverage occurred after the bloomberg report on the birth of the first baby using pes, there were a number of news stories and blogs in response to a special report on embryo selection based on polygenic risk scores published in the new england journal of medicine on july 1, 2020.22 this report, which has received significant attention in the press, warns that companies that offer genetic services can create unrealistic expectations in health providers and prospective parents through their marketing practices. it has further emphasized the scientific uncertainty around the predictive results of prs in the context of embryo selection. in general, our search has established that the news media coverage on pes over the past year has revolved around these two events – the nejm report and the announcement about the first kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 5 baby born after pes. in total, we collected 29 publications, of which 12 were blog posts and 17 publications under the general category of “news,” including ten news articles, three opinion pieces/perspective articles, two press releases, and one radio broadcast transcript (see supplementary material). iv. methods for content analysis we utilized an inductive-deductive process to develop coding categories for a systematic content analysis of the blogs and new articles. the first author undertook a close reading of the entire dataset to derive inductively recurrent themes and ethical arguments in the media representations of pes. based on this preliminary analysis, both authors agreed on the categories for textual analysis. the coding book was further refined by using a deductive approach that incorporates themes that have been previously articulated in the scholarly literature on the issue, particularly questions about the perceived attributes of the test, ethical concerns, and emerging policy considerations. the following categories were used to analyze key issues and attitudes towards pes expressed by experts and science journalists: a. claims that pes is unethical because it violates the future child’s autonomy. b. concerns about pes as a step towards eugenics and/or genetic discrimination. c. defenses of pes with arguments that parents have a duty to give the child the healthiest possible start in life (and reduce public health burden). d. claims that the science behind prs-based diagnostics is uncertain, and it will take some time to prove its clinical validity. e. concerns about the equality of access to pes. f. arguments that pes can exacerbate ethnic and racial inequality (e.g., that most polygenic scores are created using dna samples from individuals of european ancestries and predictions may not be accurate in other populations). g. arguments that pes provides health benefits and can help overcome genetic and health inequalities. h. concerns about the negative impact that pes may have on the child-parent relationship. i. arguments about the need for better regulatory oversight of pes. j. suggestions that there is an urgent need for deliberation and debate on the societal and ethical implications of pes. k. concerns that patients and clinicians may get the impression that the procedure is more effective and less risky than it is. l. assessment of whether the article’s perspective towards the use of pes is positive, negative, or neutral. we used yes/no questions to detect the frequencies of mentions in each category, except on the last question, which required a more nuanced, qualitative assessment of the overall tone of the articles. we coded articles as “positive” when the authors viewed the technology favorably and emphasized its potential health benefits over its negative implications. articles that did not condone the current use of pes and expressed strong concerns about the predictive accuracy of this testing method, its readiness for clinical use, and highlighted its controversial ethical and social implications were coded as “negative.” finally, articles that simply presented information about the topic and quoted experts on the advantages and disadvantages of using prs for embryo selection without taking a side or expressing value judgments were coded as “neutral.” acknowledging the complex polysemic nature of media texts, we took into consideration that support or disapproval of pes may be implicit and expressed by giving credence to some experts’ opinions over others. therefore, we coded articles that mostly cited expert opinion favorable to kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 6 pes, or alternatively, presented such views as more credible, as “positive”, while we coded articles that emphasized critical perspectives as “negative.” v. media discourse and expert opinion on pes we found out that perspectives and opinions by experts were prominently featured in both news (17 articles) and blogs (12 articles). the blog posts in our dataset were written by university professors in bioethics (four articles), academics from other disciplines such as medicine, political science, psychology, human genetics, and neurobiology (four articles), and science journalists and editors (four articles). furthermore, three of the news articles in influential newspapers and magazines such as the wall street journal, the washington post, and the scientific american were opinion articles or commentaries contributed by academics (e.g., a psychology professor, specializing in personality, individual differences, and behavior genetics, a sociology professor, and a director of research in a graduate program in human genetics). the remaining 14 news articles in our dataset were written by science reporters, editors, or other staff writers. altogether, experts contributed 38 percent of the media coverage (11 articles) on the issue of pes and its wider societal implications. experts’ comments were also heavily featured in the 18 articles written by science reporters and other media professionals, which accounted for 68 percent of the dataset. of these articles, 17 extensively cited experts with academic and research backgrounds (professors and research scientists), seven articles quoted industry representatives (e.g., ceos and spokespersons of genomic prediction and orchid, other commercial developers), and four articles included opinions by parents seeking pes, particularly aurea’s father, north carolina neurologist rafal smigrodzki, who argued that a parent’s duty is to prevent disease in their child.23 the overall perspective towards the use of pes was mostly negative – 59 percent (17 articles) expressed negative attitudes, while 24 percent (seven articles) were positive and 17% (five articles) were neutral in tone and did not advance arguments in favor or against the technology and its adoption. however, we did not establish significant differences in negativity and positivity between experts and science reporters. for instance, 49 percent of the articles with negative attitudes were written by experts, while 53 percent were authored by science reports. similarly, the articles by experts with positive perspectives on pes accounted for 13 percent of the dataset, while science reporters contributed 11 percent of the positive articles. vi. major themes and issues the most discussed issue in media coverage was the prediction accuracy of polygenic risk scores and the uncertainties regarding the utility of these tests in embryo screening. our analysis has established that 72 percent of the articles (21 out of 29) argued that the science behind pes-based diagnostics is uncertain, and it will take some time to prove its clinical validity. the second most frequently mentioned issue was the potential of pes to lead to a eugenic future of human reproduction. more than half of the articles (59 percent or 17 out of 29) raised concerns that pes could become a step towards a new form of eugenics that could eventually normalize the discrimination of people based on their genetics. despite concerns about the accuracy of pes testing, many articles gave extensive attention to problems concerning equality of access to pes and related diagnostic services, with 49 percent of the articles (13 out of 29) expressing concerns that the procedure is currently offered at a high cost, it is not covered by health insurance plans, and people of lower socioeconomic status cannot afford it. furthermore, 41 percent of the articles (12 out of 29) raise concern that the current use of pes reflects the existing ethnic and racial kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 7 inequalities since most pes are created using dna samples from individuals of european ancestries, and predictions may not be accurate in other populations. although it has been reported that genomic prediction considers offering the procedure to parents of non-european ancestries, their messaging has suggested it would take a significant time to provide them with predictive models that are as relevant as those for european populations.24 the health benefits of this testing technology, its regulation, and the need for a wider debate on how to realize its promise in a responsible manner were also addressed, albeit to a lesser extent. the potential to overcome genetic and health inequalities by selecting healthy embryos with the best odds against diseases and chronic conditions was emphasized in 41 percent of the articles (12 out of 29). the regulation was a topic covered in 38 percent of the articles (11 out of 29), in which the authors argued that better regulatory oversight of pes is needed, especially in the present condition of an unregulated us market for genetic testing. additionally, 38 percent suggested that there is an urgent need for deliberation and public debate on the societal and ethical implications of pes. finally, the issue that patients and clinicians may get the wrong impression that the procedure is more effective and less risky was addressed in 31 percent (nine out of 29). we have established that critical issues about how pes may affect the well-being of the future child and the child-parent relationship have received less attention. for instance, only 17 percent of the articles (five out of 29) supported the clinical use of pes with arguments that parents have a moral obligation to give the child the healthiest possible start in life, a line of thought that is prominent in the bioethics literature on procreative beneficence and procreative autonomy.25 these authors also maintained that the technology has the potential to provide benefits to individuals and reduce the burden of disease and public health expenditure. similarly, just 10 percent of the articles (three out of 29) expressed concerns about the negative impact that pes may have on the child-parent relationship by causing relational asymmetries between generations and limiting the autonomy of the future child. conclusion our content analysis has shown that the media discourse on pes and the birth of baby aurea has been highly influenced by expert opinion. in fact, leading experts from bioethics and a range of other academic disciplines contributed 38 percent of the content in the form of blogs, opinion articles, and commentaries, published on prestigious bioethics fora and in the popular press. furthermore, as our analysis has shown, science reporters have heavily relied on expert opinion in writing stories about the ethical challenges and societal implications of pes. one important finding of our study is the prevalence of negative attitudes towards the technology, as opposed to past media representations of pes, which had been neutral towards the technology. 26 this change in attitudes is likely caused by the amplified voices of bioethics experts reacting to the first clinical use of the technology, which made hypothetical ethical dilemmas a very real possibility. as far as the thematic focus of media representations is concerned, the birth of the first baby using pes has raised ethical concerns similar to those highlighted in the literature on pes and embryo selection through pre-implantation genetic diagnosis, with the most prominent issue being the absence of robust scientific evidence for the predictive accuracy of prs modeling and its practical value in ivf settings. although the critical nature of media discourse can contribute to raising public awareness about the ethical acceptability of the technology, bioethicists should also examine the effect of economic forces and societal pressures to have a perfect child that may be driving prospective parents to seek such unproven genetic interventions. pes is an emerging niche in a large, unregulated market for genetic testing services that has kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 8 the potential to shape the future of reproductive medicine, and there is an urgent need for a policy debate on how it can be developed responsibly and ethically. 1 j. habermas, "the debate on the ethical self-understanding of the species," the future of human nature (oxford, uk: blackwell publishing, 2003): p. 16-100. 2 polygenic risk scores (prs) are used in personalized medicine to predict disease risk in different human populations, not necessarily for risk modelling in embryos. polygenic embryo screening (pes), on the other hand, involves the clinical use of prs modelling from genome-wide association studies of adult populations for selecting embryos with the lowest probability of developing certain health conditions in adulthood. it could potentially be used to select embryos with a higher probability for inheritance of certain physical traits or complex characteristics. 3 c. goldberg, "picking embryos with best health odds sparks new dna debate," bloomberg september 17, 2021. 4 d. conley, "a new age of genetic screening is coming — and we don’t have any rules for it," the washington post june 14, 2021. 5 k. kamenova, a. reshef, and t. caulfield, "angelina jolie's faulty gene: newspaper coverage of a celebrity's preventive bilateral mastectomy in canada, the united states, and the united kingdom," genetics in medicine 16, no. 7 (2014): 522-28. 6 k. kamenova et al., "media portrayal of non-invasive prenatal testing: a missing ethical dimension," journals of science communication 15, no. 2 (2016): 1-19. 7 b. talat, choosing the "smartest" embryo: embryo profiling and the future of reproductive technology, (canadian institute for genomics and society, march 14, 2019), https://www.genomicsandsociety.com/post/choosing-the-smartest-embryo-embryoprofiling-and-the-future-of-reproductive-technology. 8 e. parens, s. p. applebaum, and w. chung, "embryo editing for higher iq is a fantasy. embryo profiling for it is almost here.," statnews, february 12, 2019. 9 t. pagnaer et al., "polygenic risk scoring of human embryos: a qualitative study of media coverage," bmc medical ethics 22, no. 1 (2021): 1-8. 10 e. l. de zeeuw et al., "polygenic scores associated with educational attainment in adults predict educational achievement and adhd symptoms in children," american journal of medical genetics. part b, neuropsychiatric genetics 165b, no. 6 (2014): 51020. 11 a. okbay et al., "genetic variants associated with subjective well-being, depressive symptoms, and neuroticism identified through genome-wide analyses," nature genetics 48, no. 6 (2016): 624-33. 12 f. ray, "embryo selection from polygenic risk scores enters market as clinical value remains unproven," (december 22, 2021). https://www.genomeweb.com/sequencing/embryo-selection-polygenic-risk-scores-enters-market-clinical-value-remainsunproven#.yevwzvhok2w. 13 j. savulescu, "the moral case for eugenics?," iai news, september 28, 2021, https://iai.tv/articles/the-moral-case-for-eugenicsauid-1916. 14 s. munday and j. savulescu, "three models for the regulation of polygenic scores in reproduction," journal of medical ethics 47, no. 12 (2021): 1-9. 15 f. forzano et al., "the use of polygenic risk scores in pre-implantation genetic testing: an unproven, unethical practice," european journal of human genetics (2021). 16 forzano et al., 1-3.; p. turley et al., "problems with using polygenic scores to select embryos," the new england jourmal of medicine 385, no. 1 (2021): 78-86. 17 n. j. wald and r. old, "the illusion of polygenic disease risk prediction," genetics in medicine 21, no. 8 (2019): 1705-7. kamenova & haidar, polygenic embryo screening, voices in bioethics, vol. 8 (2022) 9 18 m. j. sandel, "the case against perfection: what's wrong with designer children, bionic athletes, and genetic engineering," atlantic monthly 292, no. 3 (2004): 50-4, 56-60, 62. 19 h. haidar, "polygenic risk scores to select embryos: a need for societal debate," impact ethics (blog), november 3, 2021, https://impactethics.ca/2021/11/03/polygenic-risk-scores-to-select-embryos-a-need-for-societal-debate/. 20 pagnaer et al., " 1-8. 21 forzano et al., 1-8. 22 turley et al., 78-86. 23 p. ball, "polygenic screening of embryos is here, but is it ethical?," the guardian, october 17, 2021. 24 w. k. davis, "a new kind of embryo genetics screening makes big promises on little evidence," slate, july 23, 2021, https://slate.com/technology/2021/07/prs-model-snp-genetic-screening-counseling.html. 25 j. savulescu, "procreative beneficence: why we should select the best children," bioethics 15, no. 5-6 (2001): 413-26. 26 pagnaer et al., 1-8. niburski, dietary supplements, voices in bioethics, vol. 1 (2014-15) © 2015 kacper niburski. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. dietary supplements: ethical considerations kacper niburski keywords: dietary supplements, morals, ethics introduction if you ever took supplements and didn’t feel any better, it’s probably because you didn’t take any in the first place. recently, the new york times reported that four out of five of the top-selling herbal supplements at four national retailers — gnc, target, walgreens and walmart — did not contain the ingredients listed.1 st. john’s wort, for example, did not contain any st. john’s wort, but instead consisted of garlic, rice, and “a tropical root crop.” garlic, on the other hand, did not contain any garlic. perhaps the supplement provider can add some st. john’s wort to their garlic capsules as a means of ensuring quality control. analysis this isn’t the first-time supplements have been revealed as missing key ingredients. in 2013, it was found using dna fingerprinting that 59% of supposedly natural products tested contained dna barcodes from plant species not mentioned on their labels.2 worse, thirty out of the forty-four of the products substituted their labeled ingredients with other, cheaper materials. these results come as increasing number of americans use such “natural” treatments daily.3 names once so foreign — ginkgo biloba, echinacea, saw palmetto — that gesundheit seemed in order after enunciation have now become commonplace. the industry generates 25 billion dollars in sales annually.4 while money does not grow on trees, it may very well be found in those capsules. mislabeling and missing active ingredients raise bioethical concerns. there is a lot of low hanging ethical fruit. forget that such complementary and alternative medicine (cam) lacks the long-term rigor of scientific study, that the therapeutic effect on particular populations such as lactating woman or children are not known, that the claims of efficacy remain largely unsubstantiated save for the occasional hearsay, and that many of the cam providers lack significant medical training.5,6 forget that even if there is a causal link between one natural product and the abatement of disease, these macromolecules are often isolated in pharmaceuticals and modified for maximum potency.7forget, too, that the stores of these compounds are at best heterogeneous due to variability in temperature and growing conditions,5 that the batches will niburski, dietary supplements, voices in bioethics, vol. 1 (2014-15) 2 inevitably by inconsistent, and that there is no formal standardization process in the us.9 these are branching issues. they are not the root worry. rather, the supplement industry’s unsupported health claims are the real and serious worry. with adulterants and immense variability among samples, any claim to cure or alleviate conditions is suspect, when even supported through a study or two. (for example: cisapride and probiotics have shown some benefits in gastrointestinal motility.10 as a result, doctors cannot prescribe these alternatives. the risk of volatility and of not getting a compound with a known physiological cause-and-effect is too high. so too is the chance of harm. what of possible allergic reactions to or drug interactions with undisclosed ingredients? allowing such substandard care is nothing short of hokum. this is not to discount the noted placebo effect of such treatments. nor is it meant to diminish the perceived exercise of patient autonomy supplementation may promote. complements to traditional healthcare increase the appearance of more choice freedom of decision making. this is centrally an argument for the democratization of medicine. if dietary supplements were pure, tested, and well-studied, it’s reasonable to say that such choices would be more than beneficial. they’d be necessary. but this is not the case. without the most updated information, without the guarantee of purity, and without the wide support of those sworn to provide health— doctors, nurses, and health service practitioners —cam is grasping at straws at best. and hey, straw may already be in one’s multi-vitamin. such concern over honesty in supplement labeling and effectiveness goes beyond mere ethical squabbling. ethics are a reflection of what ought to be whereas law is a mirror of what is. currently, there isn’t. legal regulation surrounding supplements is as unsubstantial as the supplements themselves: they’re hollow, useless, and do nothing at all. conclusion it is important to note this discrepancy between the ethics and legal practice for without statutes, ethics is insufficient. a long-term legal solution is required. recalling the defunct products is the first step. the next is moving away from the chemical-madness of the mislabeled natural craze. secondary measures are too dangerous because as it stands, swallowing a pill does not waste away one’s weighty worries, let alone one’s waistline. 1 o’connor, a. new york attorney general targets supplements at major retailers. the new york times. february 2015, < http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-majorretailers/?_r=1>. 2 o’connor, a. health supplements are often not what they seem. the new york times. may 2013, < http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html>. 3 market watch. june 2013, < http://www.marketwatch.com/story/americas-take-on-vitamins-survey-revealsvitamin-intake-is-on-the-rise-but-healthy-lifestyle-habits-lag-behind-2013-06-26>. 4 maynard, a. are we safe from congress? politics usa. november 2013, < http://www.politicususa.com/2013/11/10/safe-congress-senator-orrin-hatch-politics-vitamins.html>. http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=1 http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=1 http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html niburski, dietary supplements, voices in bioethics, vol. 1 (2014-15) 3 5 newmaster, s et al. dna barcodings detects contamination and substitution in north american herbal products. bmc medicine. 11: 222. 6 brulotte, j. vohra, s. epidemiology of nhp-drug interactions: identification and evaluation.current drug metabolism. 2008;9(10):1049–1054. 7 institute of medicine (u.s.) committee on the use of complementary and alternative medicine by the american public board on health promotion and disease prevention. complementary and alternative medicine in the united states. washington, dc: national academies press; 2005. 8 ernst, e. cohen, m. stone, j. ethical problems arising in evidence based complementary and alternative medicine. journal of medical ethics. 2004. 30, 156-159. 9 ernst, e. the efficacy of herbal medicine:an overview.fundamental clinical pharmacology. 2005;19(4):405–409. 10 muller-lissner, s.a. treatment of chronic constipation with cisapride and placebo.1987;28(8):1033–1038. bellisomo, gambling and accompanying concerns, voices in bioethics, vol. 1 (2014-15) © 2015 randi bellisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. gambling and accompanying concerns spike in march randi bellisomo keywords: ethics, gambling, morals introduction it’s an office tradition that can create camaraderie, boost morale and provide escape from daily routine. march madness pools are estimated to attract more than 50 million workers to bet on brackets as the ncaa men’s basketball tournament begins this month. but for the approximately five million with a gambling addiction, the next few weeks can present temptation, or torture. analysis “it’s riskier than a lot of people think,” said keith whyte, executive director of the national council on problem gambling, sponsoring problem gambling awareness month, now underway. “the guy sitting down the hall could have lost hundreds of thousands of dollars gambling. for him, this could be devastating.” the fbi estimates that more than $2.5 billion is wagered illegally each year on march madness, a time in which calls to the council’s helpline spike. “this has become a national gambling holiday,” whyte said. according to sports analyst danny sheridan, the “madness” of the tournament isn’t the basketball, but the bets. while the buy-in for small office pools may be only one or two hundred dollars, the cost to enter contests within workplaces on wall street easily approaches seven figures. “it gets bigger and bigger each year,” sheridan said.but among many—primarily novice—gamblers entering the action, the first bets may trigger dangerous biological and psychological responses.“no one starts out to be a problem gambler. all gambling starts out recreationally,” whyte said. in problem gamblers, he warns, wagering rewards the same pleasure pathways activated by illegal drugs. if workers experience mood changes, have trouble with time management, change schedules or abandon other interests, they could be developing a problem, said tampa-based psychotherapist and certified gambling counselor damon dye, who points out that many who develop compulsive tendencies do so if they are feeling disconnected in personal relationships, isolated or bored. employers are sometimes challenged in identifying workers struggling, as problem gamblers are often skilled at hiding their addictions. “these are highfunctioning, successful, respected people, who do very well financially and that we look up to,” dye said. among those most prone are those with adhd, comfortable with risk taking, and who have experienced some sort of “big win.” for arnie wexler, that win was $54, earnings that came to the then 17 year-old at a new york racetrack. his “chase” to replicate that one small success set off a decade and a half of gambling that eventually bankrupted his family. wexler admits stealing from employers to pay off debts and wishing that either he or his family would die, so he wouldn’t have to tell them the truth.“i thought about killing myself everyday, but i didn’t have enough guts,” said wexler, now a certified gambling counselor and author of the newly-released autobiography, all bets are off: losers, liars and recovery from gambling.“i would gamble on two bellisomo, gambling and accompanying concerns, voices in bioethics, vol. 1 (2014-15) 2 cockroaches coming out of the carpet, which would come closer,” wexler said. “that’s what a sick gambler does.” however, sports betting was the most appealing for the brooklyn native, and game scores consumed every waking moment. “there were times when i had sex with my wife, and she would say, ‘i think i hear a ball game.’ but even though i would tell her she was crazy; i had a ballgame on the transistor radio under her pillow. “wexler gambled primarily through a bookmaker and maintains that if he were still gambling, he would be in prison; with the availability of credit cards and atms, money is easier to come by. at this time of year, the circumstances are just too tempting. “you have gamblers who are addicted who haven’t gotten help yet, and they’re going to gamble every day,” wexler said. “they will hear march madness promotions and the odds and lines, and that juices them up.” social pressure is also at play, according to dye. if a colleague says they don’t want to participate, don’t push. “for problem gamblers, the gambling urge is setting in, and they’re caught thinking they can’t say anything to get support, so they’re relying on strong will,” he said. “they go along with the bracket, because they don’t want to feel awkward.” lillian ringel, push and pull between the public and professional, voices in bioethics, vol.1, 2014-2015 © 2014 lillian ringel. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. push and pull between the public and professional lillian ringel keywords: self-regulation, vulnerable, physician, individual, germany in order to protect research subjects and to improve patient care, ongoing examination about whether medicine should be a self-regulating profession, or whether the general public should have a role in setting guidelines for the ethical conduct of doctors, is essential. the historical arguments and events that inform, support, and refute selfregulation versus external regulation demonstrate that neither, on its own, is sufficient to ensure that doctors behave ethically. instead, the collaboration between these two seemingly opposite poles has the potential to create the best ethical practices in order to provide strong research and clinical protections to subjects and patients. both physicians and the general public must continue to evaluate the ethical conduct of the medical profession in order to protect the vulnerable and to uphold relevant ethical values. public oversight is necessary, but not sufficient, to assure ethical behavior on the part of physicians and biomedical scientists. unchecked by self-regulation within the biomedical profession, public oversight has the potential to undermine its own valid objectives. though antivivisectionists between the 1860s–1890s by no means comprised the entire nonmedical public corpus, they were nonetheless a formidable force criticizing research practices from outside the medical profession. in the 1890s, when antivivisectionists introduced a bill to congress and brought to the public’s attention their “critiques that emphasized the invasion of human rights that involuntary experimentation entailed,” they had a justifiable argument that science running amok was endangering human values and human beings. public ambivalence at that time was not unfounded: antivivisectionists had in their arsenal claude bernard, a physician, who wrote thirty or so years earlier that although medicine needs vivisection to advance knowledge of physiology and scientific medicine, physicians and surgeons should “never [perform] on man an experiment which might be harmful to him to any extent, even though the result might be highly advantageous to science.” nevertheless, after the antivivisectionists introduced their bill to congress, they undermined themselves: “[their] style of debate…encouraged defenders of research to dismiss accusations of human vivisection.” thus, without checks from within the general research and scientific communities, the antivivisectionists could not pass their heavily one-sided bill to protect research subjects. public oversight alone may also be ineffective and not assure ethical behavior on the part of physicians and biomedical scientists in certain political and social climates. in nazi germany, even though nazi doctors themselves contributed enormously to the medicalization and conceptualization of german society as a body politic, the public’s oversight would have done nothing to stop them: “the nazis medicalized politics as much as they politicized medicine; problems of racial, sexual, or social deviance were transformed into ‘surgical problems’ in need of surgical solutions…[i]t took a powerful state to concentrate and unleash the destructive forces within german medicine.” the medicalization and politicization of perverse values permeated public life. in our own country, even when a public body does oversee and support research in conjunction with the scientific and medical communities, it can still go grossly awry. the public health service, which oversaw the tuskegee syphilis study, was a public body that, along with the doctors involved, allowed social norms to inform “science” throughout the course of the study. lillian ringel, push and pull between the public and professional, voices in bioethics, vol.1,2014-15 2 transparency in public oversight of physicians and biomedical scientists, however, lends an air of legitimacy to the biomedical progress. thus, some degree of public involvement is necessary in order to ensure that doctors and researchers behave ethically. the seattle artificial kidney center’s admissions and policy committee’s (“seattle committee”) determinations of social worth criteria and what satisfies those criteria (i.e., its measurement of people “in accordance with its own middle-class suburban value system…[that] rules out creative nonconformists, who rub the bourgeoisie the wrong way….”) are ethically complicated. yet, the mere fact that the committee existed at all was a step forward. the seattle committee was an imperfect attempt to bring the public into the medical realm to decide how to best allocate a scarce resource. moreover, as shana alexander’s life magazine article demonstrated, once the committee was out in the open, (“open,” meaning the public knew of its existence), it was available for public discourse and judgment, the ultimate effect of which was the amendment of the social security act in 1972 to cover end-stage renal disease. the seattle committee demonstrates how powerful the public can be in overseeing medicine and research, when medicine and research are on board. we must constantly evaluate and reevaluate— both within and without the medical profession—how good a job the general public in conjunction with the medical profession is doing to ensure ethical conduct. neither, on its own, is enough to ensure ethical behavior. public oversight helps to assure ethical behavior on the part of physicians and biomedical scientists, but without the ethical insight and self-reflection of medical professionals, public oversight is powerless on its own. codes of ethics and formal policies between and amongst the public and the medical community create a dialogue that leads to better protections for patients. the biomedical profession’s internal codes are essential to promoting the percivilian ethic of the “profession’s [emphasis in the original] fiduciary responsibility for ‘the ease, the health, and the lives of those committed to their charge,’” and influence policies that change the way medicine interacts with vulnerable populations. for instance, although the defense in the nuremberg doctors’ trial discovered on crossexamination that the american medical association’s (“ama”) principles on human experimentation did not exist in their contemporary form pre-1946, still, those professionally-created principles carried immense influence in the creation of the nuremberg code as written by judges outside of the medical profession as part of their ruling. active public involvement via the government in the form of laws and policies has proven necessary in order to facilitate the goals of professional codes of ethics. in the 1968 hearings in front of the subcommittee on government research of the senate committee on government operations, dr. christiaan barnard asked walter mondale, essentially, to whom science and medicine are accountable. hostile as it may seem, this is the kind of dialogue necessary between the biomedical profession and the public to facilitate advances in science and medicine, all while protecting patients and subjects. the public is essential in creating formal policies and laws that serve as external safeguards on the biomedical profession and that give teeth to the profession’s internal codes. as science and medicine advance, our codes, laws, and policies—both professional and public—can inform our choices even if they have not caught up to scientific advances. members of the medical profession should be accountable to themselves and the public. medicine is inherently a human endeavor, one in which physicians, patients, and the public have a stake. laws, regulations, and codes of ethics are necessary to protect the vulnerable from abuses, but both public bodies and the medical profession must constantly reevaluate and assure compliance with them. establishing transparency within the medical profession and a dialogue between the medical profession and the public will assure scientific progress and ethical practice. hawkins, three-quarter homes, voices in bioethics, vol. 1 (2014-15) © 2015 andrew hawkins. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. three-quarter homes: a complicated policy debate & ethical crossroads andrew hawkins keywords: clinical ethics, homelessness, medical finances, nursing home, rehab introduction bunk beds with dirty, cigarette scarred mattresses blocked windows. mold stained the ceiling of a bathroom at new lots… some homes had broken sinks, holes in the wall… bed bugs crawling on walls and beds. 1 analysis yury baumblit and his company back on track group featured in a recent exposé by the new york times violated the central tenet of medicine and patient care: do no harm. it may be easy to view the current investigation as a microcosm of exploitation and corruption—a law enforcement issue not indicative of a flaw in the larger system. in reality, there has been a recent epidemic of kickback schemes and assistance program fraud. 2,3 a larger issue is at stake with shifts in healthcare administration to outpatient settings. under the new affordable care act (aca), ascension health, a catholic healthcare provider has reported growth in medicaid revenues from outpatient care outpacing increases from inpatient revenue, which suggests increased medicaid outpatient demand.4 the estimated 30 million newly insured people under the aca are expected to increase outpatient visits by 2.6% nationwide under the aca, while the overall volume of medicaid beneficiaries increased by 15% from july through september 2013. 5 , 6 the dominant trend in health care delivery is decentralization into primary care clinics, extended-care facilities, nursing homes and specialized treatment facilities (such as mr. baumblit’s new lot homes). less attention has been paid to ethical challenges in these settings because the cases often lack the drama and urgency common to inpatient care. ethics consultations are infrequent and the moral questions are minute: requests for unneeded services, non-compliance etc.clinical ethics, known for addressing flashy cases, arose in the moral vacuum of the 1970’s. the alliance between patients and physicians had been weakened and trust in the medical guild eroded due to entrenched paternalism. hard-fought mandates protecting patient autonomy and novel ethical principles (non-malevolence, beneficence etc.) stood to prevent abuses. the hospital setting served as the primary incubator for the norms of bioethics. these practices, however, did not translate to the outpatient setting.7 structural constraints and lack of ethics resources make traditional, ethics board review and legal intervention seem cumbersome and costly. thus, a lack of regulatory oversight coupled with an absence hawkins, three-quarter homes, voices in bioethics, vol. 1 (2014-15) 2 of an ethical framework left a void to be filled by unscrupulous entrepreneurs. rather than attending to the impoverished, the current system incentivizes waste and encourages treating patients as commodities. kim barker’s investigation deals with the most invisible, vulnerable population in the united states: patients suffering from drug addiction. she uncovers a slue of ineffective bureaucracy and a network of scammers associated with mr. baumblit involved in medicaid and disability fraud. the unregulated, “hands-off” environment, contributing to the development of the private, for-profit residences known as “three-quarter houses” (a term derived from being in between a halfway home and the street), has a long history. in the fall of 2008, mayor michael bloomberg announced a 51% reduction in overnight shelter capacity. 8 options for individuals struggling with homelessness was drastically reduced, which forced many to exchange their “shelter allowance” paid for by the nyc human resource administration for bunk space in three-quarter homes. operators of these houses profit by neglecting maintenance and almost 90% of suspect addresses had a building code complaint between 2005 and 2012 resulting in a violation.9 remind you; these statistics include only documented cases. three-quarter homes are also allegedly responsible for flagrant violation of tenant rights. according to patient testimonial, landlords illegally evict inhabitants who do not report to mandatory substance abuse treatment. drug users are among the most socially despised members of society. their illicit activity, however, does not justify obviating their right to informed consent. the essential moral function of outpatient addiction treatment facilities should be reintegration of outcasts into society rather than subjecting them to a continuous cycle of relapse for the sake of profit. christopher vogt, a professor of theology at st. john’s university, argues that society ought to view the addict as a ‘neighbor’ and has a moral imperative to participate in harm-reduction.10 the issue of funding outpatient facilities or even properly regulating addiction treatment with taxpayer dollars is politically tenuous. since the 1980’s, new york city has undergone substantial changes in legislation leading to the promulgation of three-quarter houses. patients in public mental health facilities were deinstitutionalized and the city phased out single room occupancy hotels while prison populations expanded significantly.11 the department of homeless services until 2009 responded by outsourcing to unregulated homes by offering rent vouchers.12 government officials are reluctant to expand the already taxed shelter system because of its dangerous reputation. the policy hurdles are apparent and the situation seems bleak—only after a new york times published its investigation did mayor de blasio follow-up with his own. in order to shape an appropriate solution an ethics for outpatient care must be envisioned. the crucial issue for further scholarly discussion is whether clinical ethics can be adapted to the outpatient setting. bioethics is best designed to resolve conflict and address questions in a resource-rich environment. how will our moral considerations need to change to create ethical policy for vulnerable populations? caregiver disloyalty, forprofit care and the consequences of outsourcing are just a sampling of the problems that will need to be addressed in the coming years. fraud arises when the system allows for it and can be prevented by restructuring incentives. in 2011, the centers for medicare & medicaid services (cms) announced that it would be phasing out the “pay and chase” model: claims are paid within 30 days before investigating for inappropriate billing.13 if providers’ claims are analyzed and audited before payment is made for services, revenue flow to physicians or treatment facilities involved in fraud and abuse can be pre-emptively detected. this may imply even greater compliance issues for outpatient facilities with greater scrutiny and larger costs. however, the economics are more complex. the obama administration reported that for every dollar spent investigating health care fraud and abuse from 20112013 resulted in a recovery of $8.10.14 a comprehensive law enforcement action lead by mayor deblasio against three-quarter homes might prove to have latent economic benefits for the city. conclusion hawkins, three-quarter homes, voices in bioethics, vol. 1 (2014-15) 3 public assistance programs must be given the proper funding to implement treatment for stabilization and reintegration. successful programs do exist. utah has reduced chronic homelessness by 72 percent since 2005 through extensive collaboration between community service partners and by providing permanent supportive housing.15 in-home counseling for drug addiction and unemployment has been highly effective. new york city ought to take note and respond to exploitation by three-quarter homes with an ethics of care and empathy. 1 barker, kim. (2015, may 30). a choice for recovering addicts: relapse or homelessness. new york times. http://www.nytimes.com/2015/05/31/nyregion/three-quarter-housing-a-choice-for-recovering-addicts-orhomelessness.html?_r=0 2 clifford, stephanie (2015, march 31). new york doctors are accused of defraiding medicaid 3 chen, c. pearson, s. (2014, april 9). top medicare doctor paid $21 million in 2012, data show 4 cunningham, p. (2015). how are hospitals faring under the affordable care act? early experiences from ascension health. kaiser commission on medicaid and the uninsured. 5 glied, s., ma, s. (2015). how will the affordable care act affect the use of health care services?. the commonwealth fund. 6 medicaid and chip enrollment grows by 8.7 million additional americans. u.s department of health & human services. (2014) 7 barina, rachelle. (2014). ethics outside of inpatient care: the need for alliances between clinical and organizational ethics. hec forum. 8 markee, p. (2008). the bloomberg administration’s plan to reduce shelter for street homeless new yorkers. coalition for the homeless. http://www.coalitionforthehomeless.org/the-bloomberg-administrations-plan-to-reduce-shelter-for-street-homelessnew-yorkers/ 9 three quarter houses: the view from the inside. john jay prisoner reentry institute. http://johnjayresearch.org/pri/files/2013/10/pri-tqh-report.pdf 10 vitale, alex. (2008). city of disorder: how the quality of life campaign transformed new york politics. new york: new york university press. 11 vitale, alex. (2008). city of disorder: how the quality of life campaign transformed new york politics. new york: new york university press. 12 http://www1.nyc.gov/site/nycha/section-8/about-section-8.page 13 medicare’s prepayment review and prior authorization demonstration project for power mobility devices. centers for medicare & medicaid services.http://www.cms.gov/newsroom/mediareleasedatabase/fact-sheets/2011-fact-sheetsitems/2011-11-15.html 14 health care fraud and abuse control program annual report for fiscal year 2013. the department of health and human services and the department of justice. http://oig.hhs.gov/publications/docs/hcfac/fy2013-hcfac.pdf 15 comprehensive report on homelessness. utah department of workforce services. http://jobs.utah.gov/housing/scso/documents/homelessness2014.pdf http://www.nytimes.com/2015/05/31/nyregion/three-quarter-housing-a-choice-for-recovering-addicts-or-homelessness.html?_r=0 http://www.nytimes.com/2015/05/31/nyregion/three-quarter-housing-a-choice-for-recovering-addicts-or-homelessness.html?_r=0 http://www.coalitionforthehomeless.org/the-bloomberg-administrations-plan-to-reduce-shelter-for-street-homeless-new-yorkers/ http://www.coalitionforthehomeless.org/the-bloomberg-administrations-plan-to-reduce-shelter-for-street-homeless-new-yorkers/ http://www1.nyc.gov/site/nycha/section-8/about-section-8.page obiora anekwe, the global phenomenon of skin bleaching, voices in bioethics, vol.1, 2014-2015 © 2014 obiora anekwe. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the global phenomenon of skin bleaching: a crisis in public health (part 1) obiora anekwe keywords: africans, self-perception, identity, color the global issue of skin bleaching or lightening has become a public health crisis of epic proportions. many people of color purchase and use skin bleaching products that later cause skin discoloration, skin cancer and other medical problems. due to the depth of this phenomenon, i will devote a two part series to this issue in order to explore the ethical and public health challenges involved in skin bleaching, especially involving people of color. the issue of skin bleaching is more dangerous and deadly for people of color throughout the world because the practice also affects psychological and physical faculties. the psychological impact for many people of color to lighten one’s skin in order to fit within the larger society’s definition of beauty is now more widespread than ever. skin bleaching also symbolizes more complex psychological issues such as self-perception and self-esteem that have plagued people of color since the advent of international slavery, especially in the americas. for instance, african-americans are often coerced through the mass media to believe that lightening one’s skin through bleaching or lightening products brings greater acceptance into the larger north american society. but i believe coercion can be most effective unconsciously through culturally assimilative brainwashing, which may have a deeper impact on one’s consciousness to choose collective acceptance by the general society rather than individuality based upon positive views of self and one’s own ethnic origins. one of the most recent examples of coercive means to brainwash africans throughout the west african diaspora is most visible in the phenomenon of bleaching one’s skin in order for it to be lighter. this phenomenon has been described as medically risky and psychologically dangerous. recent news reports throughout west and south africa’s media have reported about black women who buy skin whitening products in order bleach their skin tone to look whiter and, in their opinion, more beautiful. although many african women may not view their actions as medically dangerous, numerous medical studies have already indicated that excessive usage of these skin whitening products can have an adverse effect that may cause skin cancer. some african nations have even considered limiting the sale of skin whitening products due to the mass and, sometimes, excessive usage of these products by black women. when interviewed by news outlets, many african women have expressed that media images portraying white women as beautiful greatly influenced their decision to whiten their own skin. furthermore, these women have added that although skin whitening products may have harmful effects, they would still use these products to look and feel more beautiful.1 one has to wonder whether such a mass consumption of these products will eventually cause a self-induced public health crisis within a segment of the larger global population. the reality is that without the conscious awareness of the negative impact of some coercive measures and a strengthening of one’s individual identity, those who are faced with similar issues will not be able to overcome similar challenges. obiora anekwe,phenomenon of skin bleaching, voices in bioethics, vol.1, ,2014-15 2 the ethical issue involved in skin bleaching is that many skin bleaching products cause great harm to customers due to high levels of mercury. thus, many customers who buy these products are endangering the health of their skin, while skin care product companies continue to benefit financially from selling these products. in many instances, customers are uninformed about the medical risks involved in consuming excess amounts of skin lightening creams such as artra. this product, in particular, is globally advertised to encourage women of color to purchase it in order to have lighter and more beautiful skin, according to popular standards of beauty. some critics may point out that people of color who choose to purchase and use skin bleaching products in excess are responsible for their own health risks. but as i see it, when a minority or vulnerable population consumes an excess amount of skin lightening products, a significant global health care phenomenon is at risk of causing physical harm and life-altering health problems to people who otherwise would not face these challenges. according to the world health organization (who), mercury is a common ingredient found in skin lightening soaps and creams. 2 although skin bleaching products are hazardous to one’s health and banned in many countries, these products are available for sale over the internet, providing unlimited access to potential customers. for example, in mali, nigeria, senegal, south africa and togo, 25%, 77%, 27%, 35% and 59% of women, respectively, are reported to use skin lightening products on a regular basis. 3 in 2004, nearly 40% of women surveyed in china (province of taiwan and hong kong special administrative region), malaysia, the philippines and the republic of korea reported using skin lighteners.3 the most dangerous effect of the inorganic mercury contained in skin lightening soaps and creams is kidney damage.2 mercury in these products may also cause physical reactions such as scarring, reduction in the skin’s resistance to bacterial and fungal infections, and also psychological outcomes such as anxiety, depression or psychosis, and peripheral neuropathy. 3-5 more attention needs to be focused on restricting the sale of internet skin lightening products containing mercury because people of color, especially women, are dramatically being affected by exposure to these products. for instance, mercury in soaps, creams and other cosmetic products is eventually discharged into waste water. the mercury then enters the environment, where it becomes methylated and enters the foodchain as the highly toxic methylmercury in fish. pregnant women who consume fish containing methylmercury transfer the mercury to their fetuses, which can later result in neurodevelopmental deficits in the children. 4 unfortunately, a generation of women is negatively being affected by excess usage of these products and in many instances the environment, including the water supply and food chain, is dramatically being affected in countries where people of color live and consume skin bleaching products. therefore, it is reasonable to conclude that skin lightening products have caused a silent, but deadly epidemic in public health that needs to be addressed immediately. although customers have the choice to purchase these products, the larger population is being affected health wise. as bioethicists, it is our utmost responsibility to protect the larger population than to protect individual rights to purchase skin bleaching products that contain mercury. ethical guidelines should be recommended by bioethicists to limit companies from selling skin lightening products on the internet. these universal guidelines can be implemented by monitoring skin care product websites and even restricting how many products a customer may purchase over a period of time. such limits are only a first step in counteracting a systemic problem in public health. a collective effort should be initiated by bioethicists and public health officials globally to prevent companies from gaining high profits while harming obiora anekwe,phenomenon of skin bleaching, voices in bioethics, vol.1, ,2014-15 3 the health of their customers. it will entail the international cooperation of health officials who can recommend ethical solutions to protect our citizens, especially vulnerable groups such as women of color. education is one of the most effective ways to inform the general public about the hazards of skin lightening products that contain mercury. public service campaigns -through television, billboards, and the internet-can inform customers about how the risks of consuming these products affect personal health, the general public, and our environment. such awareness provides customers with the necessary public health information to make reasonable health care decisions. in part two of my next opinion editorial, i will briefly highlight how some international celebrities of color such as sammy sosa have been consumers of skin bleaching products, only to negatively influence the general public’s interest in buying these hazardous products. their actions are also reflective of a larger psycholog ical, physical, and global trend in attempting to lighten one’s skin in order to gain acceptance by the ruling class. as a result, many people of color in nations such as brazil and nigeria have consciously and subconsciously equated beauty with whiteness. this trend is due, in large part, to the negative impact of european colonialism, which encouraged a divide-and-conquer mentality based on social classism, colorism, and racism. globally, women of color have also been increasingly consuming these skin bleaching products that contain mercury because they unfortunately believe that their dark or brown skin is somehow unattractive or ugly. i plan to also argue that additional ethical and public health measures, based on psychological and educational dimensions, should be explored in order to decrease the usage of skin lightening products containing mercury. in many instances, the general public is unaware of the role melanin plays in intelligence and soulfulness. therefore, i will also explore how awareness of the power of melanin and race consciousness could help dispel the myth that whiteness or lighter skin equates beauty and intelligence. in my opinion, such awareness could possibly reduce the public health phenomenon of skin bleaching. reference notes part 1 1. nigerians in america (2013). new survey says nigerian women lead in skin bleaching. retrieved from http://cultureshocknigerians.com/news/new-survey-says-nigerian-women lead-in-skin bleaching/#sthash.c9yf9i5y.dpuf 2. world health organization (2011). mercury in skin lightening products. 3. unep (2008). mercury in products and wastes. geneva, united nations environment programme, http://cultureshocknigerians.com/news/new-survey-says-nigerian-women-%20%20%20%20%20%0d%20%20%20%20lead-in-skin http://cultureshocknigerians.com/news/new-survey-says-nigerian-women-%20%20%20%20%20%0d%20%20%20%20lead-in-skin obiora anekwe,phenomenon of skin bleaching, voices in bioethics, vol.1, ,2014-15 4 division of technology, industry and economics, chemicals branch (http://www.unep.org/hazardoussubstances/linkclick.aspx?fileticket=atotpm ttmu%3d&tabid=4022&language=en-us). 4. glahder cm, appel pwu, asmund g (1999). mercury in soap in tanzania. copenhagen, ministry of environment and energy, national environmental research institute (neri technical report no. 306; http://www2.dmu.dk/1_viden/2_publikationer/3_fagrapporter/rapporter/fr306.pdf). 5. ladizinski b, mistry n, kundu rv (2011). widespread use of toxic skin lightening compounds: medical and psychosocial aspects. dermatologic clinics, 29:111–123. http://www.unep.org/hazardoussubstances/linkclick.aspx?fileticket=atotpmsoled and noah, leveraging machine perfusion, voices in bioethics, vol. 7 (2021) * derek soled and cray noah are both md and mba candidates at harvard medical school and harvard business school © 2021 derek soled and cray noah. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. leveraging machine perfusion to ameliorate geographic disparities in organ allocation derek soled, cray noah* keywords: organ allocation, health disparities, lung transplant, machine perfusion, biotechnology, resource allocation introduction geographic inequities in access to donor lungs have persisted since the first successful lung transplant in 1983. 1 with unanswered questions regarding organ preservation and transport in the early days of transplantation, the united network of organ sharing (unos) understandably incorporated geography in the allocation algorithm. today, geography is still the most influential criterion in the lung allocation algorithm.2 as a result, patients in urban centers often receive transplants before patients in less-resourced rural areas. ex vivo machine perfusion can significantly improve lung procurement and transport, offering longer preservation times before, after, or during transportation. out-of-hospital perfusion centers, a recent addition to the healthcare field, may increase both the number of lungs available and potentially the distance they can travel. before the adoption of machine perfusion becomes commonplace, unos should direct how to integrate machine perfusion into procurement networks best and shed the antiquated geographical confines that govern allocation today and compromise the ethical standards on which the field was founded. analysis i. the past: a history of geographic disparities in lung transplantation since the founding of unos in 1986, patient geography has been the first filter for all lung procurements. in the early days of the field, implementing these so-called donor service areas, while arbitrarily formed, made sense given the unknowns pertaining to lung preservation and transportation. for almost two decades, donor service areas and time on the waitlist governed lung allocation. in 1998, after physician protest and advocacy, the u.s. department of health and human services (hhs) delivered the final rule on organ transplantation to create a more equitable organ allocation system. even then, it was not until 2005 that unos developed the lung allocation score, a quantitative metric that soled and noah, leveraging machine perfusion, voices in bioethics, vol. 7 (2021) 2 considered predicted waitlist survival and transplant benefit. the implementation of the lung allocation score in the u.s. and abroad by eurotransplant was a success by multiple standards, most importantly reducing waitlist mortality to record lows.3 however, a glaring problem remained: the donor service area criterion remained, and arbitrary geographical boundaries continued to govern the distribution of all procured lungs. despite the improvements in waitlist mortality, regions with low rates of lung donation, primarily rural areas, have suffered disproportionately. areas in the lowest quartile of lung availability had an 84 percent increased risk of waitlist death and a 57 percent lower transplantation rate than the top quartile.4 in fact, simply moving to an adjacent donor service area a few miles away might double a patient’s chances of receiving a lung transplant, significantly more than that patient being bumped into a higher lung allocation score bracket.5 that is, driving across an arbitrary border might increase one’s chances of receiving a new set of lungs. unsurprisingly, analysis of data over the last decade shows that donor service areas are independently associated with disparities in access to lung transplants significantly more than any other factor, including gender, ethnicity, diagnosis group, or age. ii. the future: machine perfusion and equity in organ allocation farther allocation distances are associated with sharper drops in waitlist mortality. a model from stanford university demonstrates that expanding the existing 250-mile threshold to a 500-mile threshold would decrease waitlist mortality by 21.3 percent; an expansion of 1000 miles would lower it by 31.8 percent.6 since lungs are already more delicate than other solid organs,7 an expansion would require better and longer preservation. the answer is already here: machine perfusion. ex vivo machine perfusion of organs prior to transplantation has grown remarkably over the past two decades, with recent clinical trial results demonstrating the ability of machine perfusion to resuscitate and assess “marginal” organs prior to transplantation.8 many centers around the u.s. already apply machine perfusion to expand the donor pool and the adoption of machine perfusion as common practice is burgeoning. while the availability of more organs will decrease waiting list mortality, it alone will not address the longstanding geographical disparities. in fact, unless there is deliberate preparation by unos, this new biotechnology could very easily exacerbate geographic disparities. it is currently an expensive technology that is exclusive to urban centers with an already high organ availability. proper foresight before widespread adoption is critical. as machine perfusion will extend the preservation of all solid organs, discussions must start taking place now regarding larger allocation boundaries or even a boundless system altogether. one concern is that organs resuscitated in this manner will have lower efficacy than organs preserved on ice and rapidly transplanted. yet, a recent retrospective study from the toronto group showed that longer perfusion times over 12 hours do not impact patient outcomes,9 and some groups have had success with preservation times over 20 hours.10 in addition to longer preservation times, machine perfusion can easily be made portable. data from a recent international pivotal trial using the organ care system (ocs) from the massachusetts-based company transmedics showed the promising ability of portable machine perfusion to preserve and resuscitate marginal lungs. indeed, while much of the attention around machine perfusion has been about its capability to resuscitate marginal organs, its secondary ability, allowing farther transport of lungs, could end geographic disparities in organ allocation. before it is universally adopted into clinical practice, it is imperative that unos acts now to direct hospitals on how to integrate machine perfusion into procurement networks. soled and noah, leveraging machine perfusion, voices in bioethics, vol. 7 (2021) 3 there also must be preemptive policies regarding out-of-hospital perfusion centers. the first and only example thus far is the private corporation lung bioengineering, located in silver spring, maryland. this standalone center aims to resuscitate and analyze declined lungs via machine perfusion, shipping viable ones to nearby u.s. transplant centers. the company is currently finishing a phase 2 clinical trial assessing the safety of extending lung preservation times with it. unless decisive action is taken now, these centers will continue to open exclusively in urban areas surrounded by high-volume centers. to engage in the unos organ allocation system, private corporations should be required to distribute to rural and previously under-resourced areas. this could be accomplished by setting up satellite campuses or investing in the necessary infrastructure to preserve and deliver organs far distances portably. conclusion we finally have the tools to extinguish the perennial problem of geographic disparities in organ allocation. within the next five to ten years, there will be widespread adoption of machine perfusion, both in hospitals and in out-of-hospital perfusion centers. in an already convoluted organ allocation system, it will further complicate organ allocation and will potentially worsen disparities if action is not taken upfront. establishing regulations to ensure machine perfusion is leveraged in a way that is equitable to all who need solid organ transplants, not only those who live within 250 miles of transplant centers, is crucial. it is necessary for unos to be ahead of the curve, mitigate these potential consequences, and reprioritize the ethical principles on which the field was founded. this example should serve as a model for how biotechnology can ameliorate disparities – geographic or otherwise – in scarce resource allocation in healthcare. 1 lynch, r. j., and r. e. patzer. 2019. "geographic inequity in transplant access." curr opin organ transplant 24 (3): 337-342. https://doi.org/10.1097/mot.0000000000000643. 2 goff, r. r., e. d. lease, s. sweet, a. robinson, and d. stewart. 2020. “measuring and monitoring equity in access to deceased donor lung transplants among waitlisted candidates.” j hear lung transplant 39 (4): s216. https://doi.org/10.1016/j.healun.2020.01.847. 3 egan, t. m. 2018. "from 6 years to 5 days for organ allocation policy change." j heart lung transplant 37 (5): 675-677. https://doi.org/10.1016/j.healun.2017.12.010. 4 benvenuto, l. j., d. r. anderson, h. p. kim, j. l. hook, l. shah, h. y. robbins, f. d'ovidio, m. bacchetta, j. r. sonett, s. m. arcasoy, and program from the columbia university lung transplant. 2018. "geographic disparities in donor lung supply and lung transplant waitlist outcomes: a cohort study." am j transplant 18 (6): 1471-1480. https://doi.org/10.1111/ajt.14630. 5 kosztowski, m., s. zhou, e. bush, r. s. higgins, d. l. segev, and s. e. gentry. 2019. "geographic disparities in lung transplant rates." am j transplant 19 (5): 1491-1497. https://doi.org/10.1111/ajt.15182. 6 mooney, j. j., j. bhattacharya, and g. s. dhillon. 2019. "effect of broader geographic sharing of donor lungs on lung transplant waitlist outcomes." j heart lung transplant 38 (2): 136-144. https://doi.org/10.1016/j.healun.2018.09.007. 7 possoz, j., a. neyrinck, and d. van raemdonck. 2019. "ex vivo lung perfusion prior to transplantation: an overview of current clinical practice worldwide." j thorac dis 11 (4): 1635-1650. https://doi.org/10.21037/jtd.2019.04.33. 8 noah, c. v., p. tratnig-frankl, s. raigani, c. cetrulo, k. uygun, and h. yeh. 2020. “moving the margins: updates on the renaissance in machine perfusion for organ transplantation.” curr transplant reports 7 (2): 1-10. https://doi.org/10.1007/s40472-020-00277-z. https://doi.org/10.1097/mot.0000000000000643 https://doi.org/10.1016/j.healun.2020.01.847 https://doi.org/10.1016/j.healun.2017.12.010 https://doi.org/10.1111/ajt.14630 https://doi.org/10.1016/j.healun.2018.09.007 https://doi.org/10.21037/jtd.2019.04.33 https://doi.org/10.1007/s40472-020-00277-z soled and noah, leveraging machine perfusion, voices in bioethics, vol. 7 (2021) 4 9 yeung, j. c., t. krueger, k. yasufuku, m. de perrot, a. f. pierre, t. k. waddell, l. g. singer, s. keshavjee, and m. cypel. 2017. "outcomes after transplantation of lungs preserved for more than 12 h: a retrospective study." lancet respir med 5 (2): 119-124. https://doi.org/10.1016/s2213-2600(16)30323-x. 10 cypel, m., a. neyrinck, and t. n. machuca. 2019. "ex vivo perfusion techniques: state of the art and potential applications." intensive care med 45 (3): 354-356. https://doi.org/10.1007/s00134-019-05568-3. https://doi.org/10.1016/s2213-2600(16)30323-x https://doi.org/10.1007/s00134-019-05568-3 natarelli, the ethical conundrums of “precision psychiatry”, voices in bioethics, vol. 7 (2021) * gabrielle di sapia natarelli, ms candidate columbia university © 2021 gabrielle di sapia natarelli. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the ethical conundrums of “precision psychiatry” gabrielle di sapia natarelli* keywords: precision psychiatry, mental health, trial-and-error, dsm, biomarkers introduction “precision psychiatry” is one aspect of the growing field of precision medicine. precision psychiatry will provide individualized care tailored to certain biomarkers. the patient’s unique mental health profile is at the core of advancing machine learning models for clinical practice. traditionally psychiatrists used a “trialand-error” approach to standardized drugs, whereas precision psychiatry integrates objectivity with the diagnosis and treatment. 1 the long-term benefits of precision psychiatry include generating effective therapeutic plans for a person, eliminating the emotional burden of the trial-and-error process, and optimizing medications currently on the market for sustained use. to take advantage of the many benefits of precision psychiatry, more mental health practitioners, an effective allocation plan, and the continuation of traditional psychiatry are necessary. precision psychiatry should not supplant traditional psychiatry as not all practitioners and patients will have access to it. analysis the national institute of mental health is working on the research domain criteria (rdoc) project intending to establish an updated classification system for mental health disorders based on a combination of observational and neurobiological findings.2 while this effort is working toward the goal of providing a research-based classification system, the technological tools necessary to arm a physician with a wellendowed toolbox may not be cost-effective in the initial phase.3 to reap the rewards of precision psychiatry, physicians should eventually circumvent the trial-and-error approach to psychiatric care, with its hefty financial burden often thrust upon the patient and family. a. emotional and financial benefits the usual course of diagnosis for mental health disorders involves analyzing symptoms according to the statistical manual of mental disorders (dsm) and the international classification of diseases (icd) developed by the world health organization.4 the promising advances in the accuracy of neuroimaging will prove to natarelli, the ethical conundrums of “precision psychiatry”, voices in bioethics, vol. 7 (2021) 2 be an asset to the field of precision psychiatry. for example, several studies showcase the increased responsiveness to lithium therapy as a predictor of the efficacy of bipolar disorder treatment.5 ultimately, one of the greatest benefits of precision psychiatry is the ability to predict whether a particular person with major depressive disorder will develop antidepressant resistance by the course of their proposed treatment. 5 for 30 percent of people diagnosed with major depressive disorder, the treatment trajectory often ends with treatment resistance.6 by circumventing the trial-and-error algorithm to psychiatric care, the patient’s emotional and financial burden may be reduced. b. justice and access successfully implementing precision psychiatry is no easy feat; it requires interconnectedness, including “big data” storage, research analyzing molecular biosignatures, “computational psychiatry,” communication with experts in the field of neuroimaging and neuroscience, and electronic health records. 7 the success of precision psychiatry would revolutionize the field altogether, with the goal being “to improve the diagnostic process and the choice of a specific treatment using biomarkers derived from peripheral blood, imaging…or neuropsychological tests.”8 however, the success of precision psychiatry is contingent on modifying the healthcare infrastructure, which cannot currently provide equitable access to basic mental health care.9 for example, mental health disorders are the leading cause of lost productivity and disability, with the us incurring an economic cost of $42-53 billion per year.10 one goal of the affordable care act (aca) was to increase insurance coverage for mental health care. however, the us still possesses “one of the highest mental health burdens among high-income countries.”11 access and affordability of psychiatric care in the us is already of utmost concern as one in six adults seeks out care; however, due to the lack of affordability, such required care is unattainable.12 the mismatch between the volume of individuals requiring mental health care and the number receiving it may be due to the relatively low workforce capacity in comparison to other high-income countries.13 the us has a staggeringly low number of mental healthcare professionals compared to canada, including nurses, psychiatrists, psychologists, and social workers, with 105 and 277 professionals per 100,000 individuals, respectively.14 the gap in mental health care is prominent in the us, where one-third of the indigenous population diagnosed with a mental health disorder does not receive any treatment.15 inequity in access to mental health care is still of paramount concern, with basic mental health care needs remaining unmet for many americans.16 precision psychiatry involving advanced technology and interdisciplinary care teams provides individualized psychiatric care, which could prove beneficial. however, the inability to guarantee equitable access to such care calls into question distributive justice and whether the benefits will accrue to those in need. c. saves time precision psychiatry is costly, and communities with limited psychiatric resources may potentially become further disadvantaged. if precision psychiatry is readily available to the masses and is used instead of trial and error, the willingness of people to seek mental health care may rise. a faster route to the discovery of medication combinations optimized for the patient would contribute to building trust and rapport. targeting both the biological and physical manifestations of mental illness not only provide rapid improvement but also decreases the risk of losing patients due to frustration over lack of improvement with pharmacological intervention. providing precision psychiatry decreases the time required for each person to achieve a successful therapeutic regimen, ultimately allowing the physician to invest time in a greater number of patients. the redistribution of mental health care and eliminating mental healthcare deserts are necessary to reap the benefits. natarelli, the ethical conundrums of “precision psychiatry”, voices in bioethics, vol. 7 (2021) 3 d. a humanistic approach establishing rigorous evidence-based criteria for precision psychiatry will not only involve decades of research but may also impact the humanistic aspects of psychiatry. psychiatry involves a humanistic approach to medical care. building a trustworthy patient-physician relationship is the foundation of exemplary care. precision psychiatry provides the crucial benefit of tailoring medical treatments to the predicted response rate of the person.17 however, one must be wary of falling into the trap that precision psychiatry is the answer for mental health disorders. without active intercommunication between varying healthcare disciplines, including social work, the person may be “reduced to an object of big data.”18 a humanistic approach will properly include the ongoing relationship with the psychiatrist and may include some trial and error as well to reflect patient preferences based on side effect profile rather than efficacy alone. conclusion reducing people to either their brain or their computed contribution to “big data” will not benefit precision psychiatry. while it is helpful to understand the root of a patient’s mental illness through neuroimaging and neurological biomarkers, such intrinsically evidence-based medicine must coexist with traditional psychiatric care. precision psychiatry could benefit people with treatment-resistant mental illness by integrating neurological biomarkers as a tool for retrofitting existing medications to the person. used under ethical standards, precision psychiatry is a positive development. distributive justice should be included in the goals of all health care, especially in the distribution of precision psychiatry as it becomes more finetuned and garners broad appeal. during the phasing in period of precision psychiatry, the gap in equitable access to standard mental health care should be resolved. the us needs to better its mental health diagnosis and treatment options to offer both traditional and precision psychiatry to people in need. although it may take several years, even decades for a rigorous set of tools capable of foreseeing medication responsiveness to come to fruition for physicians, such precision psychiatry will be a game-changer. 1 evers, kathinka. “personalized medicine in psychiatry: ethical challenges and opportunities.” dialogues in clinical neuroscience vol. 11,4 (2009): 427-34. 2 menke, andreas. “precision pharmacotherapy: psychiatry's future direction in preventing, diagnosing, and treating mental disorders.” pharmacogenomics and personalized medicine vol. 11 211-222. 19 nov. 2018, doi:10.2147/pgpm.s146110. 3 manchia, et al., p131 4 menke, p 211 5 manchia, mirko et al. “challenges and future prospects of precision medicine in psychiatry.” pharmacogenomics and personalized medicine vol. 13 127-140. 23 apr. 2020, doi:10.2147/pgpm.s198225. 6 manchia, et al., p 131 7 fernandes, brisa s et al. “the new field of 'precision psychiatry'.” bmc medicine vol. 15,1 80. 13 apr. 2017, doi:10.1186/s12916-017-0849-x. 8 menke, p211 9 fernandes, p80 10 williams, leanne m. “precision psychiatry: a neural circuit taxonomy for depression and anxiety.” the lancet. psychiatry vol. 3,5 (2016): 472-80. doi:10.1016/s2215-0366(15)00579-9. 11 tikkanen, roosa et al. “mental health conditions and substance use: comparing u.s. needs and treatment capacity with those in other high-income countries.” commonwealth fund. 21 may. 2020, doi:10.26099/09ht-rj07. natarelli, the ethical conundrums of “precision psychiatry”, voices in bioethics, vol. 7 (2021) 4 12 fernandes, p 80 13 fernandes, p 80 14 fernandes, p 80 15 kohn, robert et al. “mental health in the americas: an overview of the treatment gap.” revista panamericana de salud publica = pan american journal of public health vol. 42 e165. 10 oct. 2018, doi:10.26633/rpsp.2018.165 16 kohn et al., p 165 17 fernandes, p 80 18 stiefel, friedrich et al. “precision psychiatry: promises made-promises to be kept?.” the australian and new zealand journal of psychiatry vol. 53,9 (2019): 841-843. doi:10.1177/0004867419849482. dias, jewel shuping, voices in bioethics, vol. 1 (2014-15) © 2015 matt dias. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. examining clinical ethics: the case of jewel shuping matt dias keywords: amputation, autonomy, body integrity identity disorder, clinical ethics, jewel shuping, maiming introduction the latin phrase primum non nocere, conceptualized in english as non-maleficence, is a fundamental principle of medical ethics, and one that clinicians in the united states swear to uphold through the hippocratic oath.1 in taking the oath, a clinician affirms, “i will use those dietary regimens which will benefit my patients according to my greatest ability and judgment, and i will do no harm or injustice to them” (emphasis added).2 while this ethical guideline may seem unambiguous in theory, in clinical practice the waters can become murky, thus pitting patient autonomy and clinician duties against one another. one such instance came to light in early october, when reports surfaced that a psychologist deliberately blinded a north carolina woman named jewel shuping, per her request. analysis thirty-year-old shuping suffers from body integrity identity disorder (“biid”), a psychiatric condition in which individuals experience an overwhelming, lifelong desire to develop a disability—most often by amputating a limb but sometimes by maiming an organ. even if they are completely healthy, classic biid sufferers feel that their natural body state is incomplete and that only through amputation or maiming can they achieve their “true identity.” 3 the blinding of shuping warrants close inspection, since a clinician irreversibly altered a patient’s physiological experience by maiming an essential organ—creating a conflict between patient autonomy and clinical ethics. despite being born with healthy, functional eyes, shuping self-identified as blind since childhood. for her, the adage that looking into the sun will gravely damage one’s eyesight was not only appealing, but it also became her life’s mission. as a child, shuping would spend hours watching sunspots and solar storms, with the intent of permanently losing her vision. in an interview released in october, shuping recounts, “by the time i was six, i remember that thinking about being blind made me feel comfortable.” indeed, shuping began emulating the lifestyle practices of blind people as she matured—in her teenage years, she sported thick, black sunglasses and walked with a cane, and she was proficient in braille by age twenty. determined to turn her dream into a permanent reality, shuping found a psychologist in the midwest willing to irreversibly damage her eyesight. in 2007, shuping drove across the country to meet with this psychologist who, after observing dias, jewel shuping, voices in bioethics, vol. 1 (2014-15) 2 shuping emulate the life of a blind person for two weeks, agreed to insert numbing drops into each of her eyes, followed by drain cleaner—a poisonous chemical that, when placed in the eyes, leads to vision loss.4 consequently, shuping developed corneal complications, glaucoma, and cataracts. six months later, the damage took full effect, and shuping was completely blind at the age of twenty-one. though shuping initiated this process eight years ago, she began sharing her story only recently, in the hopes of (i) helping others with biid seek clinical help and (ii) reducing the stigma associated with sufferers of this disease by increasing public awareness.5 in evaluating this situation from a rational, informed perspective, one might conclude that shuping’s decision was unconscionable and could have been prevented—but the literature suggests that these desires are uncontrollable for, and overwhelming to, biid sufferers. according to dr. michael first, the preeminent biid expert and professor of clinical psychiatry at columbia university, people who suffer from biid cannot control their need to be disabled. first asserts, “these people are aware that this feeling of theirs is unusual— they know it is coming from within them. they can’t explain it.”6 though there is no cure for biid, the psychologist’s actions are not ethical. unequivocally, pouring drain cleaner into shuping’s eyes was an unsafe, harmful, and unnecessary course of action. while it is true that shuping is an autonomous agent with a right to make choices and request a specific treatment, this right is not absolute, and a clinician is not obligated to honor this right if it conflicts with fiduciary responsibilities. in this case, doing so guaranteed irreversible, unnecessary harm to the patient—shuping herself reflected that she experienced excruciating, burning pain, which the psychologist who administered the treatment would have anticipated. by all measures, there was absolutely no assurance that doing so would guarantee shuping’s longterm happiness, much less lead to an improvement in her mental or physical stability. according to first, “one of the big ethical issues here is that if somebody wants to be an amputee, is competent to make that decision, has this condition, and seeks out amputation, it is not unreasonable because there is a track record of people who have gotten success.”7 but, first cautions, for biid sufferers who are seeking a more severe disability such as blindness, the ethics are questionable: “somebody who wants to be blind is going on faith” and “ethically, to sanction that is a huge problem because we have no idea whether the first person who tries to be [blind] will be horribly disappointed.” without a track record of patients to confirm satisfaction, the potential of post-surgical regret or discontent currently outweighs the potential benefits of a surgery whose end result is a severe crippling of an essential organ. indeed, first maintains, “being an amputee is a bad thing but it is not as bad as being a paraplegic or blind.” while establishing experimental protocols for carefully selected biid patients who failed psychotherapy and medication trials would be advantageous to determine the effectiveness of voluntary amputation as a treatment for biid, to date, no academic medical center has developed a research protocol for such elective surgeries.8 first indicated that the challenge to establish these elective surgeries is not on the psychiatric side—rather, it rests with the surgical community, which thus far has refused to oblige. for clinicians, first articulated four requirements that are necessary for the potential pursuit of an elective surgery: (i) the recognition that the clinician is not disabling somebody; rather, this is the treatment of a condition that has ruined and monopolized someone’s life; (ii) the sufferer must be desperate and have exhausted all reversible possibilities; (iii) the clinician must have evidence that the person is capable and competent to make this decision; and (iv) the presence of a track record where surgeries have been successful and patients have been satisfied with the outcome. first said, “the ethics of doing this for paraplegic or blindness is iffier because of this missing component—we do not know if the treatment would yield a successful outcome.” in a way, shuping’s case is the first for the severity of this disability, but first questions whether there is enough evidence for this to justify a second case. to date, shuping’s psychologist has not been publically identified. while it is not known if this individual is facing prosecution, his medical license has allegedly been suspended in several states. notwithstanding physician-patient confidentiality, the fact that this clinician has not come forward, been subpoenaed, or otherwise called into question is alarming. while shuping claims to be satisfied as a result of this process, the http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=mbf2&depaffil=psychiatry dias, jewel shuping, voices in bioethics, vol. 1 (2014-15) 3 same cannot be said for many of those inspecting this troubling set of circumstances. one such investigator is dr. phil mcgraw, whose interview of shuping airs on november 5. conclusion because biid is an “underground” condition, there are no advocacy groups pursuing legislation due to the condition’s rareness and since “the idea of wanting to be disabled is inherently less acceptable to people.” still, getting the word out may make a difference. first said, “the more it is publicized, the more likely it is for people who actually have biid to feel more comfortable—the fact that it exists gives it a level of legitimacy to justify seeing this as an illness.” *a variation of this story first appeared on bioethics.net, the website of the american journal of bioethics. 1 graduates of nearly all american medical schools recite a version of the hippocratic oath or a similar pledge, thereby adhering to ethical principles and conduct in the practice of medicine. 2 national institutes of health: national library of medicine, history of medicine division. “greek medicine and the hippocratic oath.” translated by michael north. 2002. https://www.nlm.nih.gov/hmd/greek/greek_oath.html 3 see michael first, “desire for amputation of a limb: paraphilia, psychosis, or a new type of identity disorder,” psychological medicine 2005, 35: 919–928, michael first and carl fisher, “body integrity identity disorder: the persistent desire to acquire a physical disability,” psychopathology 2012, 45: 3–14, and www.biid.org. 4 national institutes of health: national library of medicine, medline plus. “drain cleaner poisoning.” september 2015. https://www.nlm.nih.gov/medlineplus/ency/article/002779.htm. 5 see tom midlane, “psychologist blinds woman with drain cleaner because she wanted to be disabled,” mirror uk, october 1, 2015, http://www.mirror.co.uk/news/real-life-stories/psychologist-blinds-woman-drain-cleaner-6552282; tribune media wire, “woman desperate to be blind had drain cleaner poured in eyes, now happier than ever,” fox 31 denver, october 1, 2015, http://kdvr.com/2015/10/01/woman-desperate-to-be-blind-had-drain-clearner-poured-in-eyes-now-happier-than-ever/; and kate pickles, “woman who dreamed about being blind had drain cleaner poured in her eyes…” daily mail online, october 1, 2015, http://www.dailymail.co.uk/health/article-3256029/woman-dreamed-blind-drain-cleaner-poured-eyes-fulfil-lifelongwish-says-happier-ever.html. 6 melkorka licea, “i poured drain cleaner in my eyes to blind myself,” new york post, october 1, 2015, http://nypost.com/2015/10/01/i-blinded-myself-on-purpose-and-have-never-been-happier/. 7 unless otherwise noted, quotations and information stem from my october 2015 interview with dr. michael first of columbia university. 8 michael first and carl fisher, “body integrity identity disorder: the persistent desire to acquire a physical disability,” psychopathology 2012, 45: 3–14. http://www.drphil.com/shows/page/drphil_woman_blind_herself/ http://www.bioethics.net/2015/11/can-clinicians-maim-healthy-organs-the-case-of-jewel-shuping/ https://www.nlm.nih.gov/hmd/greek/greek_oath.html http://www.biid.org/ https://www.nlm.nih.gov/medlineplus/ency/article/002779.htm http://www.mirror.co.uk/news/real-life-stories/psychologist-blinds-woman-drain-cleaner-6552282 http://kdvr.com/2015/10/01/woman-desperate-to-be-blind-had-drain-clearner-poured-in-eyes-now-happier-than-ever/ http://www.dailymail.co.uk/health/article-3256029/woman-dreamed-blind-drain-cleaner-poured-eyes-fulfil-lifelong-wish-says-happier-ever.html http://www.dailymail.co.uk/health/article-3256029/woman-dreamed-blind-drain-cleaner-poured-eyes-fulfil-lifelong-wish-says-happier-ever.html http://nypost.com/2015/10/01/i-blinded-myself-on-purpose-and-have-never-been-happier/ lively, the dual role of the medical device, voices in bioethics, vol. 6 (2020) *cathy lively, jd, ms candidate columbia university © 2020 cathy lively. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the dual role of the medical device representative: supporting the surgeon and selling the product, which role takes priority? cathy lively* abstract surgeons have an increasing strong relationship with the medical device industry prompting several questions about the duty owed to patients and the financial motives of the industry’s sales representatives. keywords: medical device, surgeons, products, medical industry, ethics committees introduction surgeons have an increasingly strong relationship with the medical device industry prompting several questions about the duty owed to patients and the financial motives of the industry’s sales representatives. sales representatives are crucial to the profit-driven medical device industry with $180 billion in us sales revenue for 2017.1 device manufacturers market aggressively. manufacturers’ sales representatives are on the front lines of these marketing efforts, acting as liaisons between surgeon and manufacturer. analysis device representatives perform a dual role both as a clinical advisor to the surgeon and as an agent of the manufacturer. representatives have the expertise to support surgeons and facilitate procedures, but they also have financial motives to influence surgeons to select expensive or brand-specific devices. this relationship creates conflict between the surgeon’s ability to do what is best for the patient and the representative’s ability to make a profit. given the competing interests of surgeons and device representatives, is it not ethically justifiable for representatives to be present in the operating room unless they can be untethered from the commission-based sales structure.2 the pharmaceutical industry’s questionable practices receive substantial media attention. mylan’s astronomical increase in the price of the epipen and purdue’s targeted marketing of oxycontin are two prime examples. by comparison, the practices of the medical device industry receive little attention. both industries have a myopic focus on profit and threaten the integrity of medical practice in similar ways. a november 2018 byline of an npr commentary suggests that medical device representatives “may be wearing out their welcome in the operating room,” though this is primarily because of attention to rising costs and not ethical conflicts.3 lively, the dual role of the medical device, voices in bioethics, vol. 6 (2020) 2 rather than banning representatives from operating rooms, i suggest dividing their roles and restricting sales in the clinical setting. recognized by the american college of surgeons (acs) “by their training, knowledge, and expertise,” representatives provide technical assistance to expedite procedures and facilitate the safe and effective application of products and technologies.4 manufacturers provide representatives with extensive training and education, making them experts in the use of medical devices. because it is not feasible for surgeons to be experts on every device, the support that representatives provide is essential. also, surgeons depend on representatives to provide 24/7 on-call support. over time, representatives learn the surgeons’ specific preferences and style, ensuring the availability of necessary device components and anticipating the need for alternative sizes, instruments, and components. confident that representatives will provide technical support and guidance, surgeons may forego industry-offered training. in short, representatives make surgeons’ jobs easier. nevertheless, the experts providing this support should have no financial motive. representatives depend on surgeons for commission, making their relationship symbiotic. according to healthtrust, the average representative earns a 10 to 25 percent commission on top of their salary.5 simply put, representatives are “upselling” because they have a financial incentive to encourage surgeons to select the most expensive device. manufacturers coach representatives to promote the newest, most expensive models, even if they are not yet proven superior.6 the fda approval process allows manufacturers to bypass stringent premarket testing if the new device has “substantial equivalence” to already marketed products.7 an unofficial quid pro quo exists: representatives provide a concierge level of service, and in return surgeons feel obligated to accept suggestions to use the newer device.8 upselling also has a broad effect on resource allocation. representatives and hospital administrators negotiate contracts and prices with the representative offering what is often a confidential price.9 if the representative is the only one who knows the cost, the surgeon selects the device without being fully informed. the manufacturer bills the hospital, and the hospital bills the insurer or patient. increasingly, payors reimburse on a flat fee per case, meaning the hospital may not recover the actual cost. as with the skyrocketing costs of pharmaceuticals, the overutilization of expensive devices depletes funds, ultimately harming the patient and society. additionally, representatives who observe poor surgical skills may be reluctant to become whistle blowers due to their dependence on commission. in 2014, a survey of representatives found that 40 percent had observed surgeries in which they questioned the surgeon’s competence. in one account, a former orthopedic device representative personally observed a surgery which he described as a “train wreck.” the surgeon, who had refused training, struggled to perform a procedure. the emphasis on profit resonates in the words of the representative’s supervisor: “you just earned $1,000 for three hours’ worth of work, what are you complaining about?”10 the surgeon purchases and the representative protects. due to the nature of surgical procedures, patients are unaware of what happens in the operating room. surgeons owe a fiduciary duty to patients 11 and must focus exclusively on patients’ well-being.12 this fiduciary duty is eroded if the surgeon selects a device for reasons other than clinically-proven efficacy. by contrast, representatives have a fiduciary duty to their employer and any perceived moral duty to patients is secondary. patients are not privy to the conversations or the data and may not be aware of the device selection process. disclosure and patient consent are essential elements of autonomy. despite the recommendations of acs and the not-for-profit watchdog, ecri,13 surgeons do not always inform the patient about representatives’ involvement in their procedure. the surgeon should select clinically proven devices as doing so benefits the patient. if surgeons lack training and skill in using the devices, they can harm the patient. patients may experience poorer outcomes if they are not informed about the role of sales representatives in their procedure. hospital ethics committees can mitigate any ethical concerns. hospitals should complete an ethics review to identify, analyze, and resolve the ethical concerns presented by the representatives’ presence in the clinical setting.14 there is a need for preventive ethics to identify, prioritize, and address this ethical issue.15 this process will lead to interventions, such as policies and procedures prohibiting direct sales during a procedure and restricting the representative’s role to providing resources and support.16 most hospitals do not call an ethics committee meeting unless a doctor reports an ethical breach or conflict. patients tend to not know they can also access the ethics committee. lively, the dual role of the medical device, voices in bioethics, vol. 6 (2020) 3 transparency is critical: hospitals, surgeons, and the medical device industry should inform and educate the public. patients should be encouraged to ask questions about costs and options if the price of devices were public and easily accessible. surgeons need to know the actual cost of devices to discern whether upselling is occurring. patients and insurance companies should ask questions about the surgeon’s device selection criteria and degree of training and experience. they should also ask about the involvement of a device representative during the procedure. conclusion in conclusion, the medical device representative’s dual role should be changed. since the representatives are trained in the products, rather than barring them from the operating room, they could act as trained clinical specialists and drop their role as sales representatives while in the operating room. alternatively, increased device training for surgeons may alleviate the need for representatives in the operating room but this may not be feasible. a compromise would be to allow another employee of the manufacturer who does not operate based on commission to have an advisory role in the clinical setting. hospital ethics committees, surgeons, patients, and the medical device industry can each contribute to a solution that eliminates the conflict and better serves patients, the insurers who pay for devices, and doctors who owe their patients the best care. 1 zacks.com. (2018, june 14). medical device industry outlook june 2018. retrieved from https://www.nasdaq.com/article/medical-device-industry-outlook-june-2018-cm978557 2 the ethical issues include, issues of patient autonomy, and informed consent, the outsourcing of clinical expertise, the surgeon’s over reliance on the representative the representative overstepping boundaries, the delegation of responsibility, the surgeon’s financial gains from the industry, and an array of legal issues. 3 farmer, b. (n.d.). sales reps may be wearing out their welcome in the operating room. retrieved from http://www.krwg.org/post/sales-reps-may-be-wearing-out-their-welcomeoperating-room. 4 1, 2. r. (n.d.). revised statement on health care industry representatives in the operating room. retrieved from https://www.facs.org/about-acs/statements/91-industry-reps-in-or 5 farmer 6 o’connor, b., pollner, f., & fugh-berman, a. (2016). salespeople in the surgical suite: relationships between surgeons and medical device representatives. plos one, 11(8). doi:10.1371/journal.pone.0158510 7 o’connor, b., et al.., p.15 8 o’connor, b., et al., .p.8 9 how much do medical devices costs? doctors have no idea. (n.d.). retrieved from https://www.bloomberg.com/news/articles/2014-01-23/how-much-do-medical-devices-costdoctors-have-no-idea 10 bedard, j., moore, c. d., & shelton, w. (2014). a survey of healthcare industry representatives' participation in surgery: so me new ethical concerns. the journal of clinical ethics, 25(3), 238–244. 11 grundy, q., hutchison, k., johnson, j., blakely, b., clay-williams, r., richards, b., & rogers, w. a. (2018). device representatives in hospitals: are commercial imperatives driving clinical decision-making? journal of medical ethics, 44(9), 589-592. doi:10.1136/medethics2018-104804 12 o’conner, supra.; furrow, b. r., greaney, t. l., johnson, s. h., jost, t. s., & schwartz, r. l. (2018). health law: cases, materials, and problems. st. paul, mn: west academic publishing. 13 ecri.org. a not for profit watchdog that monitors, inter alia, medical devices 14 ethics consultation: responding to ethics questions in ... (n.d.). retrieved from http://www.ethics.va.gov/docs/integratedethics/ec_primer_2nd_ed_080515.pdf 15 integratedethics: an innovative program to improve ethics ... (n.d.). http://www.nasdaq.com/article/medical-device-industry-outlook-june-2018-cm978557 http://www.nasdaq.com/article/medical-device-industry-outlook-june-2018-cm978557 http://www.krwg.org/post/sales-reps-may-be-wearing-out-their-welcomehttp://www.krwg.org/post/sales-reps-may-be-wearing-out-their-welcomehttp://www.facs.org/about-acs/statements/91-industry-reps-in-or http://www.facs.org/about-acs/statements/91-industry-reps-in-or http://www.bloomberg.com/news/articles/2014-01-23/how-much-do-medical-devices-costhttp://www.bloomberg.com/news/articles/2014-01-23/how-much-do-medical-devices-costhttp://www.ethics.va.gov/docs/integratedethics/ec_primer_2nd_ed_080515.pdf lively, the dual role of the medical device, voices in bioethics, vol. 6 (2020) 4 retrieved from http://www.ethics.va.gov/ieoverview.pdf 16 farmer http://www.ethics.va.gov/ieoverview.pdf abstract introduction conclusion zimmerman, reflection, voices in bioethics, vol. 6 (2020) © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a reflection on voices in bioethics, covid-19, and a new website anne zimmerman we are pleased to announce that voices in bioethics has moved to the columbia university libraries. with renewed focus on academic strength, we aim to contribute to the array of bioethics literature by continuing to publish op-eds and research essays. voices in bioethics brings together diverse views through an academically rigorous online format. our articles seek to identify issues as well as present workable long-term solutions. when voices in bioethics started its covid-19 page in march, predictions seemed surreal—it was hard to anticipate the toll the virus would take on the us population. there was an attitude of denial: it cannot happen here. with over twenty-five articles published, we have seen unexpected issues, varying points of view, and practical recommendations. spates of public health advice contradicted themselves leaving the public wary of recommendations, especially inconvenient ones. many argue a renewed trust in medicine, science, and public health will result from covid-19 yet there is evidence of distrust after public health officials were wrong to suggest certain measures like mask wearing would be ineffective and others, like wearing gloves would be highly preventive. when the supply of medical equipment was slow to meet demand, doctors and nurses were overwhelmed, and the number of deaths was rising, public health experts were both revered and blamed. politics added to the turmoil as a divided country saw mask wearers versus the unmasked as teams of democrats and republicans. some republicans tended to push for the right to work, freedom, and prioritizing the economy and jobs. democrats tended to lean into trusting public health wanting to follow orders some of which proved useless, others of which, like stay-at-home orders and closing businesses, saved lives, flattened the curve, and slowed viral transmission. the polarization grew while many shared goals were overlooked. racial violence continued and protests erupted shining a light on long-term injustice, police brutality, and white privilege. the pandemic contributed to the divide as its effects on people were vastly different by race and ethnicity. racial disparity in covid-19 death rates is a different kind of brutality left unaddressed. the protests led to some shift in the political divide and is said to have pulled in some new supporters who have noticed four hundred years in that black lives matter after all. in an uplifting moment, the supreme court confirmed lgbt people do have constitutional protections against discrimination in the workplace, yet three justices disagreed in a scathing dissent. the health and safety of those employees is dependent on fairness and equality and the court’s opinion gives hope that the majority will interpret the constitution appropriately. covid-19 also shows global inequity – many of our authors search for ethical global solutions like pandemic zimmerman, reflection, voices in bioethics, vol. 6 (2020) 2 surveillance, use of artificial intelligence and technology, preparation that allows early testing of novel viruses, and new ways to detect viral outbreaks and limit transmissions. i want to personally thank our student editorial staff and interns for their assistance migrating our documents to the new website while along with alumni editors, they continued to edit documents and attend editing workshops to improve output quality and provide a consistent author experience. as voices in bioethics moves to its next stage, beginning its partnership with the columbia libraries, we hope our submissions will continue to address the difficult arguments, analyzing ethical dilemmas and hard choices. our role in changing times, political division, and technological change in medicine and science is to examine controversies, narrow them, and provide both practical and philosophical commentary. our efforts to understand both sides of polarized discourse while presenting strong and convincing ethical views is challenging. ethics is not just presenting both sides: it is determining what the ethical choice is and how to make that choice through personal behavior and public policy. bolzon, genome conception and human destiny, voices in bioethics, vol. 1 (2014-15) © 2015 julia bolzon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the genome, conception, and human destiny julia bolzon keywords: reproductive technology, genetic engineering introduction earlier this year, a slew of articles were published in various science and technology journals on the controversy surrounding human genome modification – “germline editing” – since the 2012 dna editing technology known as crispr-cas9 was used by scientists from sun yat-sen university to modify the genome of non-viable human embryos. since their publication in protein & cell this past april,1 the widespread use of crispr-cas9 in research has garnered much media attention in the biotech world. the rapid pace at which this technology took off is dizzying, and its potential uses even more so, as reportedly “it could at last allow genetics researchers to conjure everything anyone has ever worried they would—designer babies, invasive mutants, species-specific bioweapons, and a dozen other apocalyptic sci-fi tropes.”2 analysis more specifically, its potential for human gene therapy is enormous: the ability to edit single alleles that code for diseases such as sickle-cell anemia, huntington’s, or cystic fibrosis, to prevent these genetic diseases from being inherited. however, the alluring possibilities of human biotechnology raise intensely difficult and existential questions that we do not often ask or think about. these questions concern our perceptions of the child and child-making, as well as the very origin and destiny of ‘what it is to be human.’ our answers to these questions contain vast implications for the individual identity at hand and also for society as a whole. what are the effects of advancing a technology so fast without our ability to ask what it means, or what it will mean, for us and for the future? to think deeply about the implications of germline engineering is to consider it in the act of generating a child through assisted reproductive technology (art). although the use of arts is no longer alien, their existential effect on the resulting child merits a deeper examination of this method of transmitting human life. consider the stories of donor-conceived children3, whose varying circumstances and feelings towards their coming-to-be all share one thing in common: they owe their existence to the explicit will of the people who ‘made’ them. their ‘being’ would not be if it were not for the desire on behalf of the parent(s) that bolzon, genome conception and human destiny, voices in bioethics, vol. 1 (2014-15) 2 chose them and the technology that made it possible, which can be a very beautiful thing. i recently came across the uk daily mail’s story of 16-year old gracie crane, one of britain’s first adopted embryos who wishes she had never been born4. she was one of three un-selected embryos frozen from an ivf attempt by her genetic parents, and her fate was changed from incineration to adoption through one phone call. the contingency of her being is astounding as is the fact of any person’s existence but hers in a unique way, as she was conceived on the condition of her genetic parents’ will (their wanting a child) and was only made actual with the help of technology. the second moment of contingency (that her embryo happened to be the adopted one that implanted successfully) is only augmented by the first. the point is that this combination of deliberate will and the assistance of technology to bring about said will changes not only how someone has come to be, but also the very meaning of their having-come-to-be, by being existentially dependent on the will of other human beings. this difference is especially relevant to the possibilities for the human germline created by crispr-cas9: enabling scientists and parents to choose not only the existence of their hypothetical child, but also their genetic fate. granted, the intent behind this technological modification is the same as existing methods of genetic “disease prevention” that happens through prenatal genetic screening5, and is also the same idea behind genepeeks inc., which pairs intending parent(s) with an optimal donor to weed out life-threatening, life-changing childhood genetic diseases before any in vitro fertilization occurs. but these examples also illustrate the point that the fate of the future-child is in the hands of the people who want him or her in a way that places another’s will at the very heart of that child’s existence. consider that when a husband and wife naturally conceive a child, he or she is given to them in a way that is beyond their choosing. even their choice to engage in sexual procreation does not guarantee the generation of a child; conception is an event (a surprise) to be welcomed. although there are meaningful differences between the three methods of disease prevention (germline engineering, prenatal screening/embryo selection, and donor-pairing), the same intentionality is involved in the making of a genetic-disease-free child that is not present when a child is conceived as a ‘surprise.’ and so the question becomes: does it matter how we are conceived, and by whom? is there a meaningful difference to the condition of human life when the ‘chance’ or ‘surprise’ nature of a child is removed from the fact of being born? and does a technologically conditioned origin affect the establishment of our personal identity? conclusion with germline editing, a technological intervention at the level of a person’s very genetic make-up constitutes an entirely different footing: no longer one of natural endowment but of technological deliberation at the hands of another. the ethics of genetic interventions and assisted reproduction raise fascinating and difficult questions about the human being and human nature: existential questions that need to be thought about and worked through carefully, as it is not a metaphysically neutral and/or value-void matter for those conceived, nor for society.6 1 liang, puping et al. crispr/cas9-mediated gene editing in human tripronuclear zygotes. protein & cell, april 18 2015. vol 6 (5) 363-372. accessed at: http://download.springer.com/static/pdf/629/art%253a10.1007%252fs13238-015-01535.pdf?originurl=http%3a%2f%2flink.springer.com%2farticle%2f10.1007%2fs13238-015-0153http://download.springer.com/static/pdf/629/art%253a10.1007%252fs13238-015-0153-5.pdf?originurl=http%3a%2f%2flink.springer.com%2farticle%2f10.1007%2fs13238-015-0153-5&token2=exp=1437414006~acl=%2fstatic%2fpdf%2f629%2fart%25253a10.1007%25252fs13238-015-0153-5.pdf%3foriginurl%3dhttp%253a%252f%252flink.springer.com%252farticle%252f10.1007%252fs13238-015-0153-5*~hmac=9dddb4fec7f076622a0f6ed188d377c93351a61efb87b2b7e4498cf7a1e28283 http://download.springer.com/static/pdf/629/art%253a10.1007%252fs13238-015-0153-5.pdf?originurl=http%3a%2f%2flink.springer.com%2farticle%2f10.1007%2fs13238-015-0153-5&token2=exp=1437414006~acl=%2fstatic%2fpdf%2f629%2fart%25253a10.1007%25252fs13238-015-0153-5.pdf%3foriginurl%3dhttp%253a%252f%252flink.springer.com%252farticle%252f10.1007%252fs13238-015-0153-5*~hmac=9dddb4fec7f076622a0f6ed188d377c93351a61efb87b2b7e4498cf7a1e28283 bolzon, genome conception and human destiny, voices in bioethics, vol. 1 (2014-15) 3 5&token2=exp=1437414006~acl=%2fstatic%2fpdf%2f629%2fart%25253a10.1007%25252fs13238-015-01535.pdf%3foriginurl%3dhttp%253a%252f%252flink.springer.com%252farticle%252f10.1007%252fs13238-015-01535*~hmac=9dddb4fec7f076622a0f6ed188d377c93351a61efb87b2b7e4498cf7a1e28283 2 maxara, amy. easy dna editing will remake the world. buckle up. wired. july 22, 2015. accessed at: http://www.wired.com/2015/07/crispr-dna-editing-2/ 3 further reading on donor conceived children: • donor conception network: http://www.dcnetwork.org/about • the anonymous us project: http://anonymousus.org • the institute for american values report my daddy’s name is donor: http://americanvalues.org/catalog/pdfs/donor_final.pdf • the center for bioethics and culture’s documentaries on anonymous donor conception and surrogacy: http://www.cbc-network.org/film/ 4 carrol, helen. donor ivf baby who says ‘i wish i’d never been born.’ uk daily mail online. june 25, 2014. http://www.dailymail.co.uk/femail/article-2669842/donor-ivf-baby-says-i-wish-id-never-born-its-great-ivf-taboo-childfeel-never-knowing-biological-parents-for-family-answer-shattering.html 5 bosley, katrine et al. crispr germline engineering – the community speaks. nature biotechnology. may 2015. 33, 478 – 486. accessed at: http://www.nature.com.proxycu.wrlc.org/nbt/journal/v33/n5/pdf/nbt.3227.pdf 6 for an illustration of combatting ethical views on the issue, compare scientist stephen pinker’s recent comment on bioethics and crispr’s potential with that of ethicist margaret somerville. see: pinker, steven. the moral imperative for bioethics. the boston globe. august 1, 2015. accessed at: http://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-forbioethics/jmekoyzltau9oqv76jrk9n/story.html and somerville, margaret. “immortalizing our genetic selves” in the ethical canary: science, society, and the human spirit. penguin books, canada: 2000. 55-88. http://download.springer.com/static/pdf/629/art%253a10.1007%252fs13238-015-0153-5.pdf?originurl=http%3a%2f%2flink.springer.com%2farticle%2f10.1007%2fs13238-015-0153-5&token2=exp=1437414006~acl=%2fstatic%2fpdf%2f629%2fart%25253a10.1007%25252fs13238-015-0153-5.pdf%3foriginurl%3dhttp%253a%252f%252flink.springer.com%252farticle%252f10.1007%252fs13238-015-0153-5*~hmac=9dddb4fec7f076622a0f6ed188d377c93351a61efb87b2b7e4498cf7a1e28283 http://download.springer.com/static/pdf/629/art%253a10.1007%252fs13238-015-0153-5.pdf?originurl=http%3a%2f%2flink.springer.com%2farticle%2f10.1007%2fs13238-015-0153-5&token2=exp=1437414006~acl=%2fstatic%2fpdf%2f629%2fart%25253a10.1007%25252fs13238-015-0153-5.pdf%3foriginurl%3dhttp%253a%252f%252flink.springer.com%252farticle%252f10.1007%252fs13238-015-0153-5*~hmac=9dddb4fec7f076622a0f6ed188d377c93351a61efb87b2b7e4498cf7a1e28283 http://download.springer.com/static/pdf/629/art%253a10.1007%252fs13238-015-0153-5.pdf?originurl=http%3a%2f%2flink.springer.com%2farticle%2f10.1007%2fs13238-015-0153-5&token2=exp=1437414006~acl=%2fstatic%2fpdf%2f629%2fart%25253a10.1007%25252fs13238-015-0153-5.pdf%3foriginurl%3dhttp%253a%252f%252flink.springer.com%252farticle%252f10.1007%252fs13238-015-0153-5*~hmac=9dddb4fec7f076622a0f6ed188d377c93351a61efb87b2b7e4498cf7a1e28283 http://www.dcnetwork.org/about http://anonymousus.org/ http://americanvalues.org/catalog/pdfs/donor_final.pdf http://www.cbc-network.org/film/ http://www.nature.com.proxycu.wrlc.org/nbt/journal/v33/n5/pdf/nbt.3227.pdf http://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for-bioethics/jmekoyzltau9oqv76jrk9n/story.html http://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for-bioethics/jmekoyzltau9oqv76jrk9n/story.html the quest for ethical isometric principles in cross-cultural biomedical research-an opinion winter 2015 the quest for ethical isometric principles in cross-cultural bioethical research emmanuel a. kornyo follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 preamble it is undeniable that contemporary corpus of biomedical research continues to gather unprecedented volumetric proportions sometimes beyond the assimilative powers of many scholars even within the scientific community. we also see an increasing trend of pharmaceutical companies relocating their operational outputs and research interests in many emerging/developing countries such as india, south africa, ghana, brazil and mexico.1 these countries have different and unique socio-linguistic dispositions that are different from those of the researchers. since 2002, nearly 15% of clinical researches registered with the fda have been conducted in developing countries.2 one of the major challenges emanating from this research has been the clash between competing ethical norms during these researches. this is evident when researchers from industrial worlds find and construe certain norms in developing world as unethical. thus an internal conflict of ethical norms poses a conundrum for the researcher. should the researcher respect the local norms that might be seemingly at variance with his own norms? should the researcher ignore these local norms and thus impose his own norms on the local people? in a seminal paper on this ethical phenomenon, ezekiel emanuel proposes certain ethical “frameworks” or “benchmarks” for investigators conducting research in developing countries.3 he calls for greater transparency, disclosures and accountability on the part of researchers to minimize risks and avoid exploitation among others.4 many scholars contend that the researcher should not impose his native norms to the local folks, as this may constitute a kind of “ethical imperialism.”5 but the researcher may also encounter certain norms that contravene international norms such as the declaration of helsinki, nuremberg code and fda regulations and is under obligation to act appropriately and accordingly. for instance, a researcher may discover that in certain places, the notion of consent is accepted by the elder/chief of the community on behalf of the people. if the researcher decides to seek individual consent from participants devoid of the permission from the community leaders such as the chief, the chief may not trust him and this may undermine integrity of his research work. the intent of most community leaders is to protect their citizenry from perceptive predatory investigators/investors due to certain historical precedents such as colonialism and exploitation. in brief, we see genuine efforts on both parties in ensuring that both “local” and “international” ethical norms are respected in protecting participants from any form of overt or covert exploitation. but this also raises many questions. i believe that the issue of relativism and respect for universal ethical principles constitute a penumbra of ethical issue within global health research context. consequently, this piece proposes ethical isometric principles (eip) that limit such ethical morass. scope in an increasingly globalized world, biomedical research continues to transcend many cultures. which ethical norm should researches follow and why? can researchers and research participants agree on some operational ethical principles especially if there are differences? responses to these questions will constitute the foci of this piece. the first part of this article explores the etymological and conceptual analyses of the ethical voices in bioethics 3 isometric principles. the second part will make an attempt to apply the eip to cross-cultural biomedical research in contemporary times especially in developing world. this will be followed by some perspectives. expose on ethical isometric principles etymologically, isometric is an adjective derived from the juxtaposition of two greek words iso (ίσο) which is transliterated as “equal” and metrikos (μετρικός) which means “measure”. “isometric” implies equality of measure. literally, ethical isometric principles implies the mutual agreement that exists between researchers and human subjects in specific socio-cultural contexts and time. ethical isometric principles (eip) in this piece means certain operational principles that both researcher, participants and designated regulatory entities could agree on during clinical researches such as translating the entire research protocol into local languages/dialects, leveraging formal educational and power differentials between researcher and participants, perspective assessment as a litmus test to insulate stereotypes and prejudices in cross-cultural clinical research, aligning risks-benefits quotients with local perceptions and practices among others. these principles would guarantee equal or even consensus between researchers and participants in biomedical research. in other words, international principles such as respect for autonomy of the individual, nonmaleficence, dignity, justice, informed consent be adhered to especially when conducting research involving human subjects. this paper challenges researchers to establish some kind of linguistic isometricism where research is translated and/or interpreted into the local languages by incorporating appropriate local jargon, conceptions and expressions that are most meaningful to the research participants.6 this will help participants understand and assimilate the entire gamut of the research and also alley any iota of fears participants might have. for example fda regulations (21 cfr 50.25 and 21 cfr 50.27) and the department of health and human service directives (45 cfr 46.116) and 45 cfr 46.117 unequivocally specify that informed consent should be in a language comprehensible to research participants.7 examples in brazil, kenya, sri lanka, many successful hiv aids campaign and researches and preventive campaigns were translated into various local languages for research participants.8 if there are conflicts of competing norms between international and local norms, researchers should look for a kind of "ethical isometric principles (eip). these involve active dialogue and engagement with the local people about norms that may be in tacit conflict or different with ethical principles in order to arrive at a common consensus. if possible an operational “common consensus” could be written so that both researcher and participating communities could use to leverage trust and respect for one another in ensuring that no harm is done to any one during the research. as indicated in the declaration of helsinki and affirmed by the world health organization (who), "every clinical trial must be registered in a publicly accessible database before recruitment of the first subject".9 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=50.27 voices in bioethics 4 another dimension of the eip is that investigators should make conscious efforts to have the scope, protocol, and consent documents reviewed, and if possible approved by local irb (if one exists) prior to approval from their home country or institutional irbs. both local and international irbs should smooth out any concerns they have with the research protocol. the current practice where irb in the investigators place of origin are accepted devoid of any scrutiny from the participant’s locality without meticulous review warrants some modicum of concern and could have synergistic impact on the integrity of the research. furthermore, educational levels of participants should be considered. if possible, participants in developing countries should have a certain level of formal education in ensuring greater protection from exploitation. there may be some exceptions. for instance, if the biomedical research is about a pathogen or particular disease that is endemic to areas where it is difficult to find participants with some formal education, then such a research may continue. the fact is that most people without or with little formal education may be considered vulnerable populations due to the educational differentials that exist between them and researchers. for example, in the infamous tuskegee syphilis project (tsp), many of the research subjects had no formal or little educational backgrounds and barely knew of what was going on.10 involving people with some modicum of formal education will leverage the playing field for research and insulate vulnerable populations from exploitation and implicitly give greater authenticity and credibility to the outcome of the research in cross-cultural contexts. this, i believe, is the quintessence of eip.11 stereotypes and prejudices are powerful and inherently cloud judgments in clinical settings even with the best of good intents from researchers. people differ due to geophysical locations, socio-cultural experiences, educational backgrounds as well as sociopolitical and economic factors. these factors, coupled with intrinsic tendencies in some people to prejudicially stereotype others, are grave issues that need to be addressed in clinical research with cross-cultural dimensions. for example, substantial stereotypic evidence about black males was found in many correspondences between investigators in the tsp that not only devalued other persons but also clouded clinical judgments.12 we see this phenomenon also during nazi atrocities where some people suffered egregiously due to their race and cultural background. to this effect, it is the contention of this paper that every researcher undergo a kind of perceptive assessment either in the participants country or in their own country of origin approved by the irb to ascertain that there are no residues of biases or stereotypic proclivities towards the participants prior to any research. if possible participants should undergo similar assessments prior to the research. this is important because in certain cultures, participants might not readily opt out of a research and they may end up giving information that might undermine the authenticity and objectivity of researches that might be of critical pharmacological and clinical value.13 researchers should carefully weigh the risk involve in research designs to align with local perceptions of risks and benefits. in addition, indices of risks and benefits should be driven by pure scientific necessity and local needs. to ensure greater protection for vulnerable populations, researchers should be in consistent communication with local health directorates and clinics in analyzing risks. a specific plan (either short or long term) voices in bioethics 5 should be put in place to care for participants in the events of injury during clinical trials that involve invasive therapies, such as chemotherapy. all of these should be communicated to participants prior to enrollment into the research. for example, recently many participants in india who enrolled in clinical trials for cervical cancer died, prompting a halt to the trials and ethical inquiries.14 most of the victims were in the control groups. initial investigation conducted by the us office of human research protection suggests that proper informed consent might not have been obtained from the victims. furthermore, the level of risks involved in the research were not well disclosed to participants to the extent that such protocols will not have been approved to take place in the us or any developed country.15 perspectives and conclusion the debate between cultural relativism and universal ethical principles during research continue to pose ethical, policy and legal quagmires. relativism is a serious ethical principle that holds the view that ethics or morality varies from person to person or culture to culture. on the other hand some ethicists have suggested universal ethical principles such as respect for autonomy, justice benevolence, non-maleficence that seem transcends all cultures be followed during biomedical researches. in conducting clinical research, we see these notions generating certain ethical tensions. these issues become even more complex as significant clinical researches take place in many developing countries that may have unique ethical systems. sometimes, some of these local or cultures may easily accept westernized clinical protocols. in some instances the local ethical system may be seemingly and diametrically opposed to general principles of informed consent, autonomy, justice. this piece acknowledges these challenges. this paper has contended and suggests ethical isometric principles as a solution to some of these challenges especially as applicable to the global/cross-cultural nature of conducting clinical researches in developing countries. simply put, when divergent ethical principles occur among the researcher and the local people, it is possible to reach a common consensus that respects both parties and at the same time ensuring that no harm occur to any human subject. as a prominent ethicist poignantly noted: … an ethical framework for research in developing countries must provide more than broad principles. this framework of principles and benchmarks is complex, because ethical evaluation of clinical research is complex. a single ethical principle is rarely absolute; most situations implicate multiple principles. consequently, the various principles and benchmarks will compete and must be balanced against each other—a process that inevitably requires judgment.16 in brief, clinical research/trials are important in general health care for the global community. recruiting participants in developing countries should be carefully aligned with the coefficient of protection for vulnerable human subjects. the contention of this piece is that every effort should be harnessed to ensure that even if there are doubts about the applicability of international ethical norms to specific local situations, some kind of “ethical isotopy” is reached at least by both researchers and participants prior to commencing a clinical research. after all as the aphorism goes medio tutissimus ibis-it is voices in bioethics 6 better to go in the middle of things. or put succinctly, in medio stat virtus-virtue or ethics lies in the middle of two extremes.17 arriving at such an ethical isometric principles will continue to involve open, honest, transparent dialogues for researchers, participants, designated regulatory and neutral agencies involve in biomedical research. 1 glickman, seth et al. "ethical and scientific implications of the globalization of clinical research." new england journal of medicine 360, no. 8 (2009): 816-23. see also, arun bhatt “quality of clinical trials: a moving target in perspectives” clinical research. vol 2, no 4 ( 2011 oct-dec):124–128 2 ibid 3 ezekiel emanuel et al. “what makes clinical research in developing countries ethical? the benchmarks of ethical research” journal of infectious diseases vol 189, no5 (march 1, 2004):930-937 4 ibid. see also ezekiel emanuel et al “what makes clinical research ethical?” jama vol 283 no 20 (2000):2701-2711 5 angell, marcia. "ethical imperialism? ethics in international collaborative research” new england journal of medicine vol 319, no (1988) 6 http://www.ispor.org/workpaper/research practices/protranslation_adaptation.pdf 7wade, mark “translation plays a critical role in global clinical trials” future pharmaceuticals, vol 2, (2006):16-19 and alicia bolaños-medina. “the key role of the translation of clinical trial protocols in the university training of medical translators” journal of specialized translations vol 17, (2012) 8 ibid 9 article 19 of the declaration of helsinki 10 jones j bad blood: the tuskegee syphilis experiment. 2nd ed. ( free press: new york, 1993) 11jennifer hawkins et al. exploitation and developing countries: the ethics of clinical research. (princeton university press, nj 2008) 12 jones j. bad blood ibid 13 ezekiel emanuel et al clinical research ethics (oxford university press; london, 2011). see also angus dawson et al. ethics, prevention and public health (oxford university press; london 2009) see also ankier si dishonesty, misconduct and fraud in clinical research: an international problem in journal of international med. res. (2002 jul-aug) 30(4):357-65 14 agomoni m. ganguli care and consent: the fraught ethics of international clinical trials in the conversation (october 2013) 15 ibid 16 ezekiel emanuel. what makes clinical research in developing countries ethical? the benchmarks of ethical research (2004):930 17 aquinas is purported to have translated it from aristotle http://www.ispor.org/workpaper/research hawkins, mental illness & u.s. gun policy, voices in bioethics, vol. 1 (2014-15) © 2015 andrew hawkins. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “it’s not enough”—mental illness and u.s. gun policy andrew hawkins keywords: gun violence, mental illness, human rights introduction a senseless act of violence carried out in a public setting has once again profoundly disturbed the people of the united states. on october 1st, 2015, 26-year-old gunman christopher harper-mercera killed nine people and wounded nine others at umpqua community college using six guns purchased through a federally licensed arms dealer.1 president barack obama in a white house press conference connected the tragedy to a slew of mass shootings that have taken place in the u.s. in recent years while pointing out their appalling frequency compared to the rest of the world. analysis we are not the only country on earth that has people with mental illnesses who want to do harm to other people. we are the only advanced country on earth that sees these kinds of mass shootings every few months.2 since ethics is concerned with values, we must consider whether the exercise of a “fundamental right” outweighs the danger it poses to the public. unfettered autonomy is a common notion that has been debated in bioethics: does a patient’s right to make treatment decisions outweigh its futility and negative consequences? our scholarly community has the tools to properly analyze policy decisions in the case of mental illness and gun violence to propose a moral solution. my suggestion is to frame this as a discussion of human rights, morality and health—a familiar discourse in the bioethics community—to form the basis for political compromise and greater public awareness. if we look at the health consequences of proliferation of arms in the united states, the data paints a dismal picture. the centers for disease control and prevention report ~33,000 gun-related deaths per year,3 the international action network on small arms (iansa) tallies ~10,000 annual gun homicides in the u.s.4 and for the first time since 1994, annual gun deaths for people under 26 is projected to overtake motor vehicle deaths according to the center for american progress.5 the statistics draw a clear conclusion: the amount of guns per capita is strongly correlated with the number of people who are murdered.6 not only is our experience with gun violence abnormal but also the prevalence of mental illness in the u.s supersedes that of comparable countries. according to the national institute of health, the average american has a 47.4 percent of having any kind of mental health disorder while 27 percent of adults during any 12month period experience a variation of mood disorders, anxiety, anxiety disorders, attention deficit/hyperactivity disorders, or substance abuse.7 the countries with the next highest rates of mental health hawkins, mental illness & u.s. gun policy, voices in bioethics, vol. 1 (2014-15) 2 disorders fall between 18.9 percent and 21.4 percent. our nation seems to be a peculiar outlier. it is important, however, to note that since the 1980s, diagnostic categories have expanded greatly for the “mentally ill”.8 the modern gun rights movement is based upon principles that are summarized by historian j.g.a pocock: the bearing of arms is the essential medium through which the individual asserts both his social power and his participation in politics as a responsible moral being.9 although there is an obvious need for an ethical argument in opposition to this radical form of individualism, the process of blaming deviant members of society is more dangerous. current popular and political discourse—“guns don’t kill people, people do”—assumes mental health causes mass shootings thus exacerbating public anxiety about the mentally ill. examples of articles confirming this correlation follow each of these tragic events. a combination of mental illness, guns and psychiatric medication was seen as the cause of eric harris’ actions in the 1999 columbine high school mass shooting. 10 adam lanza was assigned to a “subgroup of persons with mental illness who were perpetrators of gun crimes.”11 the healthcare community must recognize the transition of “mental illness” from medical designation to a signifier of violent intentions. the association between mental illness and gun violence is not as clear. availability of guns was found to be a more predictive factor than psychiatric diagnoses in the 19,000 annual cases of gun suicide.12 brekke et al., illustrated that for individuals diagnosed with serious mental illness their risk of being assaulted increases rather than their tendency to assault others. 13 metzl and macleish in a novel literature review, mental illness, mass shootings and the politics of american firearms, argue that a public policy that explains the pervasiveness of gun violence in the u.s by attributing it to mental illness would be reactionary and detrimental to society.14 their proposal suggests that cultural stereotypes and social determinants such as race/ethnicity, social class and politics are in closer relation to mass shootings than mental illness. interestingly, a recent washington post article alluded to strongly conservative politics in western oregon and a decline in employment in the local lumber industry as possible contextual influences.15 gun control advocates and gun rights activists are increasingly communicating to the body politic that we must either oppose or support gun control based upon our opinions about these mass shootings. without adequate consideration of empirical evidence, which calls into question whether mental illness causes gun violence, it is quite easy to draw an incorrect conclusion. for example, a distinction is often made in the u.s between african-american and white assailants when theorizing about the etiology of violence. the white male brain is pathologized as a “loner” who is mentally disturbed and obsessed with guns whereas black gun violence is often blamed on “inner city culture.”16 according to this logic, policies such as the national instant criminal background check system improvement act, instituted in 2008 should identify individuals with a previous history of criminal offenses, a majority of which are african-american, but “wont prevent another newtown” shooting by an “insane” white gun fanatic.17 this conjecture, colored by implicit bias, ignores the widespread symptoms of the environment and obfuscates what is an effective public health intervention. if this aberrant line of thinking is taken to its logical conclusion, policies such as those advocated by the national rifle association, allowing guns to be present on school property, can be seen as “commonsense.”18 conclusion those concerned about the health and well-being of our citizens, especially you the reader, cannot remain silent assuming that partisanship concerning gun control will stagnate any legislation brought before congress. your knowledge about the current crisis and its affects on our collective health means that you are ethically obligated to speak out. we must ask: do we have a serious right to bear arms? is mental illness the cause of gun violence? can gun control prevent mass shootings? as summarized by metzl, “gun crimes, mental illnesses, and gun access issues are complexly interrelated, and not reducible to simple cause and hawkins, mental illness & u.s. gun policy, voices in bioethics, vol. 1 (2014-15) 3 effect.”13 there is a questionable association of mental illness with violence while clear evidence supports the correlation between the availability of guns and mass shootings. from a bioethical perspective, this must manifest in political action. 1 according to the associated aress, harper-mercer’s weapons of choice included a glock pistol, a smith & wesson pistol, a taurus pistol and a del-ton assault rifle, according to the associated press. buchanan, l., keller, j., oppel, r., & victor, d. (2015, october 2). how they got their guns. new york times. retrieved october 4, 2015. 2 https://www.whitehouse.gov/blog/2015/10/01/watch-president-obamas-statement-shooting-oregon 3 deaths: final data for 2013. national vital statistics report. centers for disease control and prevention. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf 4 gun violence: the global crisis. iansa.http://www.iansa.org/system/files/globalcrisis07.pdf 5 parsons, c. johnson, a. young guns: how gun violence is devastating the millennial generation. center for american progress. https://cdn.americanprogress.org/wp-content/uploads/2014/02/cap-youth-gun-violence-report.pdf 6 gregg lee carter, the gun control movement (new york: twayne publishers, 1997), p. 3. 7 walton, a. (2011, october 4). why more americans suffer from mental disorders than anyone else. the atlantic. retrieved october 4, 2015. 8 horwitz av. creating mental illness. chicago, il: university of chicago press; 2003. 9 shapiro, i. (1990). jga pocock's republicanism and political theory: a critique and reinterpretation. critical review, 4(3), 433471. 10 breggin p. reclaiming our children: a healing plan for a nation in crisis. new york, ny: basic books; 2000 11 preview: imminent danger. 60 minutes. cbs. 2013. available at: http://www.cbsnews.com/videos/previewimminent-danger. 12 lewiecki em, miller sa. suicide, guns, and public policy. am j public health. 2013;103(1):27--31. 13 brekke js, prindle c, bae sw, long jd. risks for individuals with schizophrenia who are living in the community. psychiatr serv. 2001;52(10):1358--1366. 14 metzl, j. m., & macleish, k. t. (2015). mental illness, mass shootings, and the politics of american firearms. american journal of public health, 105(2), 240-249. 15 tankersley, j. shooting in oregon: where unemployment is high and gun rights are precious. the washington post. http://www.washingtonpost.com/news/wonkblog/wp/2015/10/02/shooting-in-oregon-where-unemployment-is-high-andgun-rights-are-precious/ 16 kennedy-kollar d, charles cad. hegemonic masculinity and mass murderers in the united states. southwest j crim justice. 2013;8(2):62--74. 17 dane l. why more gun control won’t prevent mass shootings. the daily sheeple. december 14, 2013. available at: http://www.thedailysheeple.com/why-moregun-control-wont-prevent-mass-shootings_122013. 18 defilippis, e. campus gun control works. boston review. http://bostonreview.net/us/evan-defilippis-guns-schools-nra-ucsbgu http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf http://www.iansa.org/system/files/globalcrisis07.pdf https://cdn.americanprogress.org/wp-content/uploads/2014/02/cap-youth-gun-violence-report.pdf http://www.washingtonpost.com/news/wonkblog/wp/2015/10/02/shooting-in-oregon-where-unemployment-is-high-and-gun-rights-are-precious/ http://www.washingtonpost.com/news/wonkblog/wp/2015/10/02/shooting-in-oregon-where-unemployment-is-high-and-gun-rights-are-precious/ http://bostonreview.net/us/evan-defilippis-guns-schools-nra-ucsb niburski, crowdsources, voices in bioethics, vol. 1 (2014-15) © 2015 kacper niburski. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. crowdsources kacper niburski keywords: ethics, bioethics, crowdsourcing introduction in entrepreneurship, it isn’t what you have; it's how you sell it. but on crowdsourcing platforms such as kickstarter or gofundme, it is becoming the case that what you have is what you sell: your body. avoiding the side-stepping into the lewd and crass, crowdfunding for a cure – or just a medical expense – has become an increasingly viable option. as us healthcare costs climb from their current $9000 per capita, people are asking strangers to help pay their medical bills for treatments such as wisdom teeth removal ($912) to gastrectomy ($30,487). 1,2this front in electronic generosity, in the birth of a click-away-good-samaritan, has led to other health crowdsourced initiatives. crowdmed is one such platform where people may solicit the advice of volunteer “medical detectives” about their condition.3 both focus on the fundamentals of complexity, where it is not simply the relations between nodes, or people, that is important but the length of these bands. by bringing multifaceted, disparate individuals on a problem, whether financial or medicinal, more solutions are present. these are not necessarily better or worse, just more. more ideas. more opinions. more contributions. whereas a single doctor has one diagnosis with one set pay package against the multitude of possibility, crowdsourcing has a collection of many. the methods have already proven efficacious in self-reported data of multiple sclerosis (which mirrored in-person assessments) or in monitoring infectious disease outbreaks (where in 2010, discussion groups and twitter revealed a cholera outbreak two weeks before haiti’s health ministry issued a report).4,5yet in all its innovative, minted glory, concerns arise. analysis while it may be the case that technology is value-neutral, itself an argument necessary elsewhere, platforms are themselves run by administrators with their own normative judgments. what is permitted is first decided by these individuals. in september 2014, a gofundme fundraiser was shut down for generating money to have an abortion.6 this is despite the woman not having insurance and complications from a “rough, unplanned, and unexpected” pregnancy. form expresses content, and crowdsourcing platforms are further constrained to the offerings of a screen: text and video. for crowdsourced advice, the two-dimensional limitations of language are elevated. how can a history of a patient wiggle out in brief paragraphs? how can a relationship of trust and beneficence be built niburski, crowdsources, voices in bioethics, vol. 1 (2014-15) 2 between people who have never met? what is the liability of a physician who gives guidance? of a volunteer consultant? with no prior association or one that can be built upon, the intricacies of physical contact is lost. this says nothing of the narrative of disease that is contained in a silence or a shoulder shrug and can only be elicited from in-contact screenings. it is no wonder, then, that crowdsourcing is only a compound word away from crowd mentality. if the story is not individualized enough, if it is not devastating, eye-popping sad, if it does not show vulnerability, if is not rare, if it does not make one happy that this terrifying malady isn’t happening to them, then it will not gain traction. money will not aggregate. and the individual will still be left sick, although not eye-popping sick. at its most fundamental, crowdsourced healthcare is compare-and-contrast shopping, a scarcity of resource lent out not by need, but by appeal. by flaunting illness. by showing pictures of vomit to separate oneself from regular up-chuckers and to reveal how much blood has been lost.questions of how accessible this information is also becomes an issue. what if the campaign is successful? is it lauded and presented as a case-study in emotional exhibitionism? what if it is not? in either case, privacy is lost. and while this is the fullest extent of autonomy where an individual can choose to withhold as much or as little as they want, it is not autonomy maintained for good. that is, crowdsourcing doesn't ensure good; it is only a way to it. a doctor wants the best for the patient whereas a donor wishes the best bang for their buck.while to say as much seems a cynical construction of otherwise good intentions, this is not the case. crowdsourcing is a product of the environment it maintains. it is born out of absence and deprivation.the ultimate issue with crowdsourcing thus becomes its self-perpetuating necessity. despite appearing newfangled, it is hardly a novel idea. bake sales and town councils once took their place. in this way, the system has not changed and the solutions carved of need only repurposed. inequality still exists. care is still dismal for some. conclusion the sharing economy that crowdsourced funds and advice represent are attempts to address healthcare’s composite illness. but they are only a band-aid – multiple, different coloured bandages across a wound that is becoming wider, uglier, and more permanent. you. 1 the world bank.health expenditure per capita. <http://data.worldbank.org/indicator/sh.xpd.pcap> 2 park, a. crowdfunding for a cure.time magazine. 2013. <http://content.time.com/time/magazine/article/0,9171,2129795,00.html> 3 crowdmed. <https://www.crowdmed.com/our-mission> 4bove, r. et al. evaluation of an online platform for multiple sclerosis research: patient description, validation of severity scale, and exploration of bmi effects on disease course.plos one. 2013. 5 chunara, r. et al. social and news media enable estimation of epidemiological patterns early in the 201 haitian cholera outbreak.american journal of tropical medicine and hygeine. 2012. 86, 39-45. 6 berman, j. crowdfunding site gofundme won’t let crowds fund abortions.huffington post. 2014. <http://www.huffingtonpost.com/2014/09/11/gofundme-abortions_n_5804228.html> http://data.worldbank.org/indicator/sh.xpd.pcap http://content.time.com/time/magazine/article/0,9171,2129795,00.html https://www.crowdmed.com/our-mission http://www.huffingtonpost.com/2014/09/11/gofundme-abortions_n_5804228.html ahluwalia, access to abortion, voices in bioethics, vol. 6 (2020) * mahika ahluwalia, candidate for bs, mcmaster university © 2020 mahika ahluwalia. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. access to abortion during the pandemic – a fundamental right mahika ahluwalia* keywords: covid-19, abortion, reproductive ethics, reproductive rights introduction amid the ramifications of the covid-19 pandemic, women are encountering issues when seeking timely access to abortion. in the united states and canada, abortion has been legal for decades, and a woman’s decision whether and when to have a child has been respected by the health care system.1 while laws vary among states, in most us states, abortion must occur in a timely manner prior to a certain point in a women’s pregnancy. 2 accommodating abortion requests within the permissible or advisable timeframe has been challenging for health organizations despite abortion being an essential health service. in certain cases, women face an undue burden in violation of the law when they are unable to find timely access to abortion.3 the effects of the pandemic which include reduced socioeconomic status and lack of access to contraception may amplify these cases.4 this paper will discuss the impact of covid-19 on abortion rights. it will argue that abortion should remain an essential service during the pandemic because it strengthens justice and women’s autonomy in health care. background during april 2020, several states in the us attempted to ban healthcare providers from performing abortion, deeming it to be a non-essential surgical procedure.5 these regulations instated during the peak phase of the pandemic contradicted the recommendations of the american college of obstetrics and gynecology (acog), which emphasized that delaying an abortion would render it inaccessible to a woman altogether.6 the impact of the restrictions has been detrimental to the health, psychology, and well-being of american women. with ahluwalia, access to abortion, voices in bioethics, vol. 6 (2020) 2 further progression in pregnancy, the risk of complication increases. in low-income populations, women are likely to resort to dangerous alternatives when not given timely access to abortion.7 analysis unrestricted, time-sensitive access to abortion for all women can prevent the complications and risks associated with late abortion and with unsafe alternatives. furthermore, not all states have practicing gynecologists who are equipped to handle late abortion cases safely, posing a risk of complication and even death for pregnant women.8 when a woman is forced to undergo pregnancy and deliver a child against her will, she has 14 times the regular risk of maternal death.9 access to early abortion is vital for women and prevents relying on later, more dangerous abortions. lack of access to timely abortion may impose difficulties beyond physical health.10 these include unforeseen financial costs such as prolonged medications and a need for psychological treatment for postpartum depression. postpartum depression can emerge for various reasons including a lack of care during unintentional pregnancies. a lack of proper medical care during the pandemic may lead to varying pregnancy outcomes, fetal health, and maternal health. those outcomes often determine financial and mental stability. some women face additional challenges such as becoming pregnant due to sexual abuse, growing up in a lower socioeconomic condition, or being a member of a marginalized group. 11 in these scenarios, the magnitude of trauma faced by women increases drastically, especially if not offered the option to have an abortion. in canada, the state is obligated to provide the medical care necessary for a woman’s psychological and mental well-being. this is essential for all americans, even when resolving covid-19 cases remains a priority for the government. a state government must value the emotional burden a lack of access to abortion can impose on a woman. many american women are continuing to pursue pregnancies willingly during the pandemic. the acog recommends cautioning them and encouraging them to follow protocols to avoid covid-19.12 the data so far indicates that pregnant women are at less risk of death from covid-19 than they were from the h1n1 flu. the risk of severe illness also seems to increase for those with other preexisting conditions as it does for the general population. according to data from the centers for disease control and prevention (cdc), pregnant women are more likely to be hospitalized and taken to the icu following a positive covid-19 test, along with being at a higher risk for complications such as giving birth to a premature infant.13 while many women choose to continue pregnancies, pregnant women with preexisting health conditions may be more susceptible to complications if they were to catch the coronavirus or a similar viral infection.14 the acog advisory strongly recommends pregnant women follow the same strict protocols of masks and social distancing that everyone should be following. the healthcare system in the us must accommodate for timely access to the best quality of care for patients undergoing pregnancies. the protocol for pregnancies does not alleviate the need for access to safe abortion during the pandemic. women with preexisting conditions may weigh the harm of continuing pregnancy and find they need to access abortion services. regardless of the dangers of covid-19 to the pregnant, the government should not use the pandemic as an excuse to limit rights. to use the pandemic as an excuse to limit access to reproductive health services can lead women to carry on pregnancies against their will. to strengthen women’s autonomy, governments should acknowledge the necessity of abortion accessibility during covid-19, and address barriers such as a lack of funding towards women’s health.15 these changes can positively affect the growth of the healthcare system in the us where health providers are equipped to combat the effects of a pandemic while ensuring reproductive justice to ahluwalia, access to abortion, voices in bioethics, vol. 6 (2020) 3 women. telemedicine is an alternative that may be used by hospital organizations to provide women with advice in the realm of reproductive ethics and abortion. through telemedicine, physicians in remote areas may also be able to receive advice from researchers and other experts in the medical field to make informed decisions when providing patient care. early advice may reduce the negative effects of delayed care. conclusion abortion is a fundamental human right in north america, and its presence is essential to a woman’s autonomy. however, restrictions on abortion due to covid-19 have specifically affected women in restrictive states and disproportionately affects those without the resources to travel for healthcare. the pandemic shines a light on inequitable access to timely abortions, an injustice. while prioritizing covid-19 cases is crucial for the government, abortion must remain an essential service. 1 bayefsky, michelle j., bartz, deborah, watson, katie l, “abortion during the covid-19 pandemic ensuring access to an essential health service” new england journal of medicine 382 (may 2020):e47, www.nejm.org/doi/full/10.1056/nejmp2008006. 2 roe v. wade, 410 u.s. 113 (1973). 3 planned parenthood of southeastern pa. v. casey, 505 u.s. 833 (1992). 4 center for reproductive rights, press release, “in the face of covid-19 pandemic, sexual and reproductive health services are essential,” june 4, 2020. https://reproductiverights.org/press-room/face-covid-19-pandemic-sexualand-reproductive-health-services-are-essential 5 erica turret, sara tannenbaum, blake, shultz, katherine, kraschel. “covid-19 does not change the right to abortion.” health affairs, 17 april 2020, www.healthaffairs.org/do/10.1377/hblog20200416.799146/full/. 6 bayefsky, michelle j., bartz, deborah, watson, katie l., “abortion during the covid-19 pandemic ensuring access to an essential health service” new england journal of medicine 382 (may 2020):e47,www.nejm.org/doi/full/10.1056/nejmp2008006. 7 erica turret, et al. 8 erica turret, et al. 9 erica turret, et al. www.healthaffairs.org/do/10.1377/hblog20200416.799146/full/. 10 erica turret, et al. 11 centre for reproductive rights. “press release: in the face of covid-19 pandemic, sexual and reproductive health services are essential”, 4 june 2020, https://reproductiverights.org/press-room/face-covid-19-pandemicsexual-and-reproductive-health-services-are-essential. 12 https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/03/novel-coronavirus-2019 13 “data on covid-19 during pregnancy.” centers for disease control and prevention, 25 september 2020, https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/special-populations/pregnancy-data-on-covid-19.html 14 erica turret, et al. world health organization. “new research helps to increase understanding of the impact of covid-19 for pregnant women and babies.” september 1, 2020, https://www.who.int/news-room/detail/01-092020-new-research-helps-to-increase-understanding-of-the-impact-of-covid-19-for-pregnant-women-and-theirbabies#:~:text=according%20to%20the%20findings%20published,to%20covid%2d19. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/03/novel-coronavirus-2019 ahluwalia, access to abortion, voices in bioethics, vol. 6 (2020) 4 15 rajeshni, naidu-ghelani, “abortions amid covid-19: how women's rights are being impacted by the pandemic.” ipsos, 18 august 2020, www.ipsos.com/en-ca/news-polls/abortions-amid-covid-19-how-womens-rights-are-beingimpacted-pandemic. adira hulkower, a matter of justice, voices in bioethics, vol.1, 2014-2015 © 2014 adira hulkower. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a matter of justice: foster children as human subjects adira hulkower keywords: research ethics, children in april of 2001, i visited emmanuel a. at the incarnation children’s center (“icc”). emmanuel was one of my first clients. 1 he had come into foster care at birth. his mother was young, a recent immigrant, addicted to heroin, and living in poverty. her first two sons were born in nigeria, full-term healthy babies. emmanuel was born eight weeks premature, addicted to heroin and hiv positive. his two older brothers lived with the children’s maternal aunt; emmanuel’s home was the incarnation children’s center, a nursing home for children with aids. in 2002, emmanuel was adopted by his aunt, and i shipped his file to offsite storage. emmanuel’s was not a remarkable case. a decade later i am pursuing a master’s in bioethics. for the past three years i have been a member of the institutional review board (irb) at a large teaching hospital, and i have entered my second decade as an attorney representing children in foster care. my head is clouded with images of foster children and clinical trials, vulnerable subjec ts, and ethical valuations. and suddenly i remember emmanuel and icc. i remember arriving at the brick building on audubon avenue and being ushered upstairs to a large recreation room. the floor was littered with brightly colored toys, the walls camouflage d in children’s art. i had never met a child with aids. the childcare worker who had escorted me to the floor identified emmanuel for me. he was a smaller-than-average four-year-old who was throwing himself over furniture like a miniature pro -wrestler. i remember thinking, “he can’t be emmanuel.” i had studied his records before coming. my emmanuel had a gastronomy tube and was sick with aids. he did and he was. but his feeding tube, i learned, would connect to a port that was invisible under his stri ped polo shirt, and having aids, i learned, doesn’t mean you can’t play. emmanuel and i talked a little and played a little. i remember that. i also remember fighting for his discharge from icc. the commissioner of social services, to whom emmanuel’s care and custody had been committed, and the staff at icc did not believe that his aunt could care for him at home. they claimed his medications were too involved and his illness too progressed for home care. during the winter of 2001, emmanuel was discharged to his aunt’s care and was adopted sometime the following year. i remember and now i wonder: was emmanuel among the roughly 486 foster children enrolled in hiv/aids clinical trials in new york city between 1977 and 2001? what was being delivered through his g -tube? enteral nutrition? experimental drugs? why did we have to fight so hard to get him home? sickness? fear of losing a human subject? could i have known? was there anything to know? in the 1980s, aids tore through this city and left behind children like emmanuel. there were thousands of them; between 1977 and 2006 nearly 4 thousand new york city children were born hiv positive.2 the new york times reported that of these children “who were born hiv positive, as many as one in five...were dying before the age of two and up to 50 percent were dead by four.”3 almost 40 percent of the city’s hiv-positive children were in foster care. children were dying, families and physicians were desperate for options, and the available treatments had never bee n tested in a pediatric population. human subjects were needed to test the safety and efficacy of anti-retroviral drugs, but the subjects had to be small. very small. and the incarnation children’s center was brimming with them. in the winter of 2004, the red brick building on audubon avenue became a symbol of devastating human rights violations. in february of that year, self-proclaimed conspiracy realist liam scheff web-published an article titled “the house that aids built.” in his exposé, scheff excoriates the incarnation children’s center and its affiliates, columbia presbyterian and catholic charities. he alleged that aids-infected children living at incarnation were used as test animals—plied with drugs such as azt and nevirapine, drugs that were not approved for children. these children, scheff said, fell ill from the medications and were left to die. scheff spoke to relatives of the children at incarnation. they reported that their sons, sisters, nieces, and ne phews adira hulkower, a matter of justice, voices in bioethics, vol.1,2014-15 2 were forced into surgeries to insert gastronomy tubes because they refused to take medication that made them sick. the families reported that these surgeries, which were performed at columbia presbyterian, were done without familial consent. scheff alleged that the gastronomy ports were left in children, untended, for years at a time. the new york post quickly picked up scheff’s story, and in july 2004 a new york press headline screamed: “abandoned kids are force-fed experimental aids drugs at a catholic children's home in washington heights. and the city wants it that way.” on november 30, 2004, the bbc aired the documentary guinea pig kidsbased on scheff’s investigation. the opening image: an iv being inserted into the arm of a toddler, arms flailing, as she is being fed into the gaping mouth of an mri machine. by the dawn of 2005, scheff's murmur had grown to an international chorus of outrage. on april 22, 2005, the administration for children’s services (acs) issued a press release acknowledging that “approximately 465 children likely participated in [clinical] trials between 1988 and 2001.” they announced a new contract with the vera institute of justice. vera would conduct an “independent review of acs policy and practice regarding the enrollment of hiv positive children in foster care in clinical drug trials during the late 1980s and 1990s.” among the concerns that the vera institute would investigate were whether the research conducted was “based on sound medical knowledge,” whether proper consent was obtained, and whether the children who were enrolled were monitored diligently and in accordance with the current acs protocols.4 accountability was demanded from incarnation and acs, as well as the sponsors of the trials and the hospitals that had participated. following scheff’s exposé, the alliance for human research protection (ahrp) filed an official complaint with the office for human research protections (ohrp) against columbia university medical center (cumc). after a lengthy investigation, ohrp found that cumc had failed to meet regulatory compliance pursuant to 45 cfr §46.111(a) and (b). the statute places upon irbs the responsibility of making specific determinations prior to approving research and demands they be particularly cognizant of the special problems of research involving vulnerable populations. according to ohrp, the cumc irb failed to meet regulatory requirements because, inter alia, they had not obtained sufficient information regarding safeguards required by statute to protect wards of the state and had failed to obtain sufficient information regarding the selection of wards of the state and foster children as research subjects. additionally, ohrp found that the cumc “records demonstrate[d] a failure…to obtain sufficient information regarding the process for obtaining permission of parents and guardians for wards of the state or foster children.”5 although some of the most sensational allegations lobbed against the incarnation children’s center, acs, and cumc remain unverified or discredited, the vera institute’s final report published in 2009 found serious regulatory and policy violations . among their findings: twenty-one children participated in clinical trials despite acs’s medical advisory panel (map) recommending otherwise; 64 children participated in trials without the map reviewing their cases; there were no signed informed consent documents in the case files of 21 percent of the children enrolled in clinical trials; in some cases where consent was obtained, it was not obtained from a legally authorized person; and in at least 16 cases acs never approved or consented to children in their custody being enrolled in a clinical trial. ultimately, investigative journalism, internal reviews, and the vera institute’s findings confirmed the perpetration of serious human rights violations against children in foster ca re. it has been just under nine years since scheff’s exposé. today, when i mention the prospect of children in foster care participating in clinical research, the responses i receive range from visible shudders to colorful indignation. but i persis t. i recently spoke with the director of a leading new york city adolescent health center that routinely provides standard of care treatment to adolescents in foster care. despite frequent applications to irbs for research approval, the center rarely reque sts approval to enroll wards of the state. when i asked the director why such a large portion of her patient population was so underrepresented in clinical research, her response was short and telling: they’ve never been able to obtain irb approval, so they’ve stopped trying. next, i approached the chair of an irb and asked why research involving wards of the state is rarely (never?) approved. the answer: it’s just too dicey. regulatory compliance is stressful enough without adding controversial research into the mix. adira hulkower, a matter of justice, voices in bioethics, vol.1,2014-15 3 in the three years i sat on an irb, i was involved in the review of over 200 studies and only once saw a submission that allowed for the inclusion of children in foster care. the study was approved, but the approval was conditioned upon the principal investigator amending the research protocol to exclude wards of the state. a fair question is, why should i care? what’s the big deal if children in foster care are excluded from research? in fact, as an attorney for children in care, shouldn’t i find their inclusion as human subjects troublesome, if not offensive? it is precisely because of my decade of representing these children that i balk at a per se exclusion of foster children from clinical research. the child welfare system frequently treats dignity as a disposable commodity. self -respect and clothing are carried in garbage bags from foster home to foster home. for children in care it is meaningful to be allowed to participate, but allowance witho ut opportunity is just a hypothetical construct, another castle in the air. 4, 5 cfr §46.409 explicitly allows for the participation of wards of state in human subject research.6 the statute is clearly drafted with the intent to provide deserved protection to a vulnerable class. had the legislative intent been to exclude the mentally ill, or children, or prisoners, or any of the other protected groups, then “thou shalt not perform research on any vulnerable classes” would have been a better choice. why isn’t that what the legislature chose? isn’t it the safer, more prudent course, the course that will keep us from repeating the horrors of holocaust research, the seed from which human subject protection sprouted and grew wild? children in foster care share the same fate, perhaps to a greater extreme, as other vulnerable classes. overprotection results from the following formula: at some point in recent history, a class was egregiously and offensively experimented upon —the examples are many--the children at willowbrook, prisoners in alabama state penitentiaries, the syphilitic men of tuskegee all provide damning tales of physical and psychological abuse perpetrated on figuratively and literally captive audiences. and from these experiments regulations were born. these regulations present strict parameters, sometimes seemingly unattainable standards, which have had the practical effect of repelling research. but even more unforgiving than the regulations is public memory. the memory of tuskegee and the holocaust victims, willowbrook, and foster children with aids, crowds and clouds the public perception of human subject research. collective memory is a difficult thing to change. the media doesn’t cover uneventful research—who would read that story? while societal response to human rights violations is a vital and often accurate barometer of current ethical culture, public opinion, or fear of it, should not be the final arbiter of what constitutes ethical research. a thoughtful investigator ponde ring the choice of who to include or exclude from research should reflect upon public opinion, but also upo n ethical guidelines and extant legislation. the researcher does not need to look further than the belmont report to learn that the inclusion of vulnerable classes is not just permissible but demanded by the principle of justice. belmont’s foundational que stion of justice is, “who ought to receive the benefits of research and bear its burdens?” the principle of justice demands that those engaged in human subject research carefully weigh its benefits and burdens and ask themselves if their selection of subje cts is fair. are the burdens proportionately allocated? were the burdens accepted knowingly in the spirit of respect for persons? thoughtful research that embodies the spirit of justice takes into account not just who but why. have subjects been selected b ecause they are easy targets without capacity or voice to object? or were they selected because they are representative of the population being studied? are they excluded because to include them would be to exploit their vulnerability or because their inclusion would be an administrative nightmare? the principle of justice stands for children in foster care having the right to be proportionately included within human subject research. they should have the right to reap its benefits and shoulder its burdens. there are many areas of research where participation of children in foster care may provide opportunity for direct benefit to the individual subjects and/or the foster care population, generally. an example is asthma research. inner -city children are disproportionately represented in the pool of asthmatic children, as well as the pool of children in foster care. 7often these children are over-treated and undermonitored.8 pediatric asthma studies abound. an example is a study funded by the national institute of allergies and infectious diseases (niaid), whose study population comprised inner -city children suffering from chronic asthma. among the list of exclusion criteria: living with a foster parent. despite their over -representation in the research population, foster children were excluded. they were deprived of the possibility of direct benefit from the study drug and the inherent benefit in continued close monitoring of their asthma. adira hulkower, a matter of justice, voices in bioethics, vol.1,2014-15 4 a second example is the plethora of studies currently being conducted around therapeutic interventions for post-traumatic stress disorder (ptsd). frequently children in foster care are misdiagnosed with attention deficit hyperactive disorder (adhd ) and oppositional defiant disorder (odd). they present with hyper-arousal and documented cognitive difficulties and are forthwith prescribed psychotropic medication at a rate four times greater than their peers who are not in care. 9 traumafocused cognitive behavioral therapy (tf-cbt) has emerged as a promising treatment modality for ptsd. randomized controlled trials of tf-cbt rarely include foster children, despite the marked prevalence of ptsd in the foster care population. participation in tf-cbt trials has the potential for direct benefit for these children, should they be allowed to participate. not only would it provide them with the possibility of receiving a highly regarded treatment intervention, but the control group in these trials receive consistent standard of care mental health treatment, a service that children in car e wait for indefinitely. additionally, the knowledge gained from this type of research would undoubtedly benefit the foster care population as a whole. opponents may argue that the fact that children in care were over -represented in the aids population situated them perfectly for exploitation. i don’t disagree. they may argue that acs struggles to monitor the health and well -being of its wards without the added level of scrutiny required for those involved in research. i don’t disagree. they may argue that children in foster care frequently lack a parent or caregiver who can monitor the effects of study drugs or advocate for stud y termination. i don’t disagree. but the proper response to these arguments is caution, deliberateness, and accountability, not paternalistic overprotection. today, the legacy of the incarnation scandal is a de facto barring of a foster children from human subject research. this blanket exclusionism is injustice hiding behind the mask of ethical research. for far too long we have allowed ourselves to be blinded by history rather than guided by it. as a research community, we have the responsibility as well as the power to rewrite this legacy. the time has come to renew our commitment to the principle of justice. “to each person an equal share.”10 1 names and identifying information altered to protect privacy. 2 ross, timothy, and anne lifflander, “experience of new york city foster children in hiv/aids clinical trials,” vera institute of justice, new york: 2009. last modified december 31, 2008. http://www.vera.org/project/new-york-city-foster-childrenandhivaids-clinical-trials. 3 scott, janny, “belated charges ignites furor over aids trial,” new york times. last modified july 17, 2005. http://www.nytimes.com/2005/07/17/nyregion/17trials.html?pagewanted=all. 4 the administration for children’s services: press office, 2005, acs contracts with vera institute of justice to conduct historical review of enrollment of foster children in clinical trials for aids treatments . [press release]. http://www.nyc.gov/html/pr/pr05_04_22.shtml. 5 department of health and human services, “letter to harvey r. colten, m.d. and laura l. forese, m.d. columbia university medical center,” may 23, 2005. http://www.hhs.gov/ohrp/detrm_letrs/yr05/m ay05c.pdf. 6 title 45 of the code of federal regulations: §46.409 wards. (a) children who are wards of the state or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is: (1) related to their status as wards; or (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (b) if the research is approved under paragraph (a) of this section, the irb s hall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. one individual may serve as advocate for more than one child. the advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the dur ation of the child's participation in the research and who is not associated in any way (except in the role as advocate or member o f the irb) with the research, the investigator(s), or the guardian organization. adira hulkower, a matter of justice, voices in bioethics, vol.1,2014-15 5 7 department of health and human services, “national survey of child and adolescent well-being,” accessed on october 21, 2011. http://www.acf.hhs.gov/programs/opre/abuse_neglect/nscaw/reports/special_health/special_health.html. 8 baruchin, alaya, “for inner city kids: no room to breathe,” the new york times. last modified august 30, 2007. http://www.nytimes.com/ref/health/healthguide/esn-asthmachildren-ess.html. 9 sessions, david, “psychotropic drug abuse in foster care costs government billions,” politics daily. accessed on october 22, 2011. http://www.politicsdaily.com/2010/06/17/psychotropic-drug-abuse-in-foster-care-costs-government-billions/. 10 department of health and human services, “the belmont report: ethical principles and guidelines for protection of human subjects of research,” washington, dc: government printing, 1979. department of health, education and welfare publication 0578-0012. chapman, cognitive enhancement, voices in bioethics, vol. 1 (2014-15) © 2015 carolyn chapman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. cognitive enhancement for the healthy carolyn chapman keywords: ethics, bioethics, cognitive enhancement, nueroethics introduction healthy high school and college students, as well as working adults, are turning to drugs for cognitive enhancement in increasing numbers. according to a recent national survey, over 6% of college students aged 18-22 reported using adderall non-medically.1 in another survey of u.s. 12th graders, 4% reported using adderall and 2% reported using ritalin—without a doctor’s prescription—in the previous year.2 in a poll of readers conducted by the journal nature, 20% had turned to pharmaceuticals to improve focus, concentration or memory.3 the ny times recently published anecdotal accounts of expanding use of stimulants by working adults, and cited a federal report that indicated emergency room visits caused by non-medical use of prescription stimulants tripled from 2005 to 2011.4 analysis back in 2008, greely et al. published a nature paper advocating for a responsible and thoughtful response to the “growing demand for cognitive enhancement.”5 this group of neuroscientists and bioethicists called for more research to evaluate benefits and risks.5 the authors also recommended that physicians give “serious consideration to the ethics of appropriate prescribing of cognitive enhancers” and that medical organizations formulate professional standards and guidelines.5 greely et al. maintained that competent adults should be able to use drugs for cognitive enhancement, although they did express concern that coercion to enhance cognition might occur directly or indirectly (through, for example, “the need to compete with enhanced classmates and colleagues”).5 they also brought up issues of justice and fairness, and recommended that policies governing the use of cognitive enhancements should avoid exacerbating social inequalities.5 fast forward to 2015, and the presidential commission for the study of bioethical issues (pcsbi) has just released the second volume of a report entitled “gray matters: topics at the intersection of neuroscience, ethics and society.”6 in many ways, the recommendations regarding cognitive enhancement in this report echo those in the 2008 paper. although recognizing that neural modification for healthy adults is controversial, the pcsbi report takes the position that neural modification for healthy adults is neither inherently ethical or unethical, and on balance, seems markedly pro-enhancement: “contemplating novel methods to improve such functions as learning and memory in school or performance in competitive professions is truly exciting.”6 the report points out that many well-accepted activities, like drinking coffee or going to school, might qualify as cognitive enhancement. although putting stimulant use in the same bucket as coffee might strike some as incongruous, the report does acknowledge that using pharmaceuticals for non-therapeutic purposes such as enhancement involves unknown risks, including the potential to become dependent.6 but rather than discourage use of neural chapman, cognitive enhancement, voices in bioethics, vol. 1 (2014-15) 2 modifiers, the pcsbi recommends more research to clarify the risk/benefit ratio for specific uses.6 it calls on professional organizations to “develop guidelines to assist clinicians in responding to requests for prescriptions for interventions to expand or augment neural function.”6 the pcsbi also recommends that access to neural modifiers is “equitable so as not to compound or exacerbate social and economic inequities.”6 more research on the risk/benefit ratio for using these drugs for cognitive enhancement by healthy students and adults is sorely needed. many worry that use of these drugs for cognitive enhancement may lead to addiction and/or act as a gateway for abuse of other drugs. in a recent ny times room for debate, cognitive neuroscientist martha farah acknowledged that adderall users feel more focused and energetic and that the benefits of use can outweigh risks in certain contexts, such as military use.7 however, she cautioned against using the pills to increase productivity for everyday tasks, stressing that “frequency of use is a major determinant of addiction risk” and “regular use on the job is an invitation to dependence.”7 one does not need to search hard to find examples of stories with a bad ending: a 2013 ny times article tells the disturbing story of richard fee, a boy who took his own life after becoming addicted to adderall medication prescribed by his physician.8 the article cites studies that claim that 10% of adolescents and young adults who misuse stimulants become addicted, and that the medications can cause psychotic behavior or suicidal thoughts in 1 of 400 patients.8 another survey found that full-time college students who were nonmedical users of adderall were 3 times more likely to have used marijuana and 8 times more likely to have used cocaine in the past year than those who had not used adderall non-medically.1 patients do ask their physicians for prescriptions for cognitive enhancement purposes6, 9, and many physicians occasionally grant such requests.9 the pcsbi report quotes professor p. reiner at the university of british columbia as saying that physicians are not morally or legally obligated to either prescribe or withhold enhancements. according to reiner, the lack of clear guidance leaves physicians to make decisions on their own about whether or not to prescribe enhancements, despite ”their ambivalence about being gatekeepers for this issue.”6 according to a survey conducted by hotze et al., physicians hold “diverse and sometimes ambiguous” views around the issue of enhancement.9 their study also highlighted interesting inconsistencies in physician views regarding social equity: while a majority of physicians agreed that everyone should have access to enhancements that are legal, most also held that enhancements should not be covered by insurance. medical associations need to put forth clear guidelines to aid physicians in responding to the issue of cognitive enhancement for the healthy. the lack of clear guidance for physicians might well be causing injustices in patient access even today. if some healthy patients are receiving legitimate prescriptions from doctors supportive of cognitive enhancers, it seems unfair that others are committing crimes to gain access to the same pills. because adderall and ritalin are class 2 controlled substances, giving or selling the drug can be prosecuted as a felony.10 possession of the substances without a prescription is also a crime. conclusion the medical community as a whole should evaluate the benefits and risks of neural modifiers for cognitive enhancement in the healthy. studies should be done to understand the risks of intermittent or regular usage of these drugs. if physician review of the evidence suggests that a certain medicine offers a benefit/harm profile that supports offering it to healthy patients, the medical community should take appropriate steps to ensure that patients are aware of their options and that the drug is covered by insurance. alternatively, if the potential harms of cognitive enhancement for healthy adults are too great—including the risk of dependence—physicians should instead work to educate their patients and the public about the dangers of these drugs. even a staunch advocate of cognitive enhancement like julian savulescu concedes that “we don't chapman, cognitive enhancement, voices in bioethics, vol. 1 (2014-15) 3 know how to use these drugs safely because proper scientific studies are not done on the use of enhancement in the real world.”11 the only thing that’s certain is that we need more research to answer these questions, so that medical professional organizations can develop evidence-based professional standards and guidelines for cognitive enhancement in the healthy. 1 substance abuse and mental health services administration. "the nsduh (national survey on drug use and health) report: nonmedical use of adderall® among full-time college students," edited by office of applied studies. rockville, md, april 7, 2009. 2 johnston, l.d., et al. (2014). monitoring the future national survey results on drug use, 1975-2013. volume i: secondary school students. ann arbor, mi: institute for social research, university of michigan and national institute on drug abuse. 3 maher, b. "poll results: look who's doping." nature 452, no. 7188 (2008): 674-75. 4 schwartz, alan. "workers seeking productivity in a pill are abusing a.d.h.d. drugs." the new york times, april 18, 2015. 5 greely, henry, barbara sahakian, john harris, ronald c. kessler, michael gazzaniga, philip campbell, and martha j. farah. "towards responsible use of cognitive-enhancing drugs by the healthy." nature 456, no. 7223 (2008): 702-05 6 presidential commission for the study of bioethical issues. "gray matters: topics at the intersection of neuroscience, ethics and society." washington, d.c., march 2015. 7 presidential commission for the study of bioethical issues. "gray matters: topics at the intersection of neuroscience, ethics and society." washington, d.c., march 2015. 8 schwarz, alan. "drowned in a stream of prescriptions." the new york times, feb 2, 2013. 9 farah, martha. "the risks associated with 'productivity pills' outweigh the benefits." the new york times, april 21, 2015. 10 schwarz, alan. "drowned in a stream of prescriptions." the new york times, feb 2, 2013. 11 savulescu, julian “a.d.h.d. drugs are equalizers in a stressful world, if used properly.” the new york times, april 21, 2015. chapman, cognitive enhancement, voices in bioethics, vol. 1 (2014-15) 4 dichristina, “so sue me”: medical professionals should support strengthening, voices in bioethics, vol. 7 (2021) *wendy dunne dichristina, jd, ms © 2021 wendy dunne dichristina. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “so sue me”: medical professionals should support strengthening title vi anti-discrimination laws wendy dunne dichristina* abstract the author argues that health care professionals can contribute to anti-racism efforts by learning about the shortcomings of title vi and supporting legislative changes that would hold health care organizations accountable for discrimination. keywords: racism, title vi, discrimination, civil rights, ethics, anti-racism introduction through its professional associations and healthcare organizations, the medical community has made numerous anti-racism statements in the past year, including the american medical association’s (“ama’s) organizational strategic plan to embed racial justice and advance health equity. 1 converting these statements into practical change will take time and money. in addition to implementing anti -bias training and education on racism in clinical practice, the medical community should also advocate to enhance and enforce title vi anti-discrimination laws. the current limitations on enforcement conflict with the medical community’s ethical duty to improve health equity and treat all patients with a high standard of care. advocating for legislation that meets the standards of other civil rights laws to hold the healthcare industry legally responsible for discrimination should be part of medical professionals’ anti -racism work. development of civil rights in health care despite the lack of a federal constitutional right to health care, the united states does acknowledge the importance of health and health care through its laws and spending decisions. in 2010, the affordable care dichristina, “so sue me”: medical professionals should support strengthening, voices in bioethics, vol. 7 (2021) 2 act (“aca”) created health insurance options for 20 million additional americans and red uced the gap in healthcare access among populations.2 although it did not ensure a right to health care and it does not guarantee a right to health, healthcare access is an important element of a healthy life and broadening the reach of health insurance is a worthy goal. outside of the aca’s offer of affordable health insurance, only a few stakeholders have gained “weak” statutory rights to publicly funded health care such as incarcerated people, the elderly, disabled, and the very poor.3 yet, the adoption of the public insurance programs medicaid and medicare in 1965, along with title vi of the 1964 civil rights act (“title vi”), did create some rights to sue for discrimination in health care, even for people who are not recipients of medicaid and medicare benefits. under title vi, private institutions that receive federal financial assistance are prohibited from discriminating on the basis of race, color, and national origin.4 initially, this civil rights legislation had a major effect on health care because more than 1000 segregated hospitals immediately integrated their facilities in order to comply with the legislation and participate in medicaid and medicare.5 medical professionals interested in anti-racist work would do well to learn the history of title vi; grassroots support of civil rights laws in the 1960s encouraged huge steps forward in eliminating de jure segregation in health care.6 title vi lacks mechanisms to combat structural racism title vi has been less effective when addressing more subtle forms of discrimination. despite being one of the broadest anti-discrimination statutes, title vi has been referred to as a “sleeping giant” because its full power has not been used to great effect.7 the aca included some attempts to improve title vi’s effectiveness (see below), but much more could be done. like most civil rights laws, title vi discrimination may be alleged as disparate treatment (intentional) or disparate impact. disparate impact claims are challenging to prove and may involve arguments such as how moving a hospital from an inner -city area to a wealthier suburban location will have a disparate impact on the lo cal black population. besides the evidentiary challenges involved in demonstrating disparate impact, such a claim fails unless the plaintiffs can prove that a reasonable explanation for the action, such as cost savings, is a pretext for discrimination.8 title vi claims are also challenging because of the limitation on plaintiffs, the limitation on the scope of defendants, and enforcement issues. in 2001, the us supreme court held that individual plaintiffs cannot sue under title vi for disparate impact claims, requiring a federal agency to do so.9 while hospitals and other entities are potential defendants under title vi, individual medical professionals are not, even though approximately 40 percent of medicaid and medicare reimbursements now go to physic ian and outpatient car.10 the primary enforcement mechanism for title vi healthcare claims is forcing compliance with the law through the threat of withdrawal of federal reimbursement. 11 the threat of financial punishments may harm communities, however, when low-resourced hospitals lose funding or are forced to fund rehabilitation programs.12 inequities between hospitals in different locations currently cannot be addressed under title vi. recent attempts to improve title vi have failed. in the aca, legislators included several updates to title vi that appeared to improve its potential as a tool for reducing healthcare inequities. section 1557 of the aca changed the definition of “federal financial assistance” programs to include medicaid and medicare advantage, thus expanding the pool of possible defendants to include individual providers. 13 however, the department of health and human services issued an implementing rule that specifically did not dichristina, “so sue me”: medical professionals should support strengthening, voices in bioethics, vol. 7 (2021) 3 include medicare part b, so as of now patients cannot bring suit against sue their doctors for title vi discrimination.14 some authors argue that the aca also repealed the supreme court decision that prevented individuals from bringing disparate impact claims under title vi.15 so far, however, courts still interpret title vi as supporting private claims only for intentional discrimination.16 individuals can still bring disparate impact claims to the office of civil rights (“ocr”) and the federal government may take action on their behalf. because of the lack of available private action, however, there is no robust group of title vi attorneys developing these civil rights cases.17 if the legislature wants to encourage private enforcement of title vi discrimination cases, it could also add punitive and compensatory damages to the available remedies, as it did with title vii employment discrimination cases,18 thus empowering plaintiffs and their lawyers to seek private remedies for discrimination in health care. private litigation could be used as an additional lever in strategic approaches to eliminating discriminatory practices and improving health equity. 19 in 2003, the institute of medicine’s committee on understanding and eliminating racial and ethnic disparities in health care recommended that the federal government increase funding for the ocr to encourage investigations into violations of title vi based on systemic discrimination in health care.20 the committee saw such enforcement as a “last line” of defense against systemic racism in health care, and a way to find such suspected racism through proactive investigations. unfortunately, the ocr continues to be “notoriously” underfunded, but future administrations may be encouraged to rectify that problem.21 permitting more individual lawsuits may improve title vi by providing better enforcement mechanisms and broadening the scope of possible defendants. these litigation tools will never bring about a right to health but can reduce inequities in access to and treatment in the healthcare system. health professionals can support such proposals as individuals and through their professional associations. of course, not all stakeholders agree that the federal government should enforce greater access to healt h care; after several states brought suit, the us supreme court struck down the aca provision that would have effectively required states to expand medicaid eligibility.22 in addition, many health professionals will object to individual title vi lawsuits. distinguishing between malpractice litigation and discrimination litigation will be important so that healthcare practitioners do not feel their livelihoods are threatened by title vi. if improving health equity and combating racism is seen part of one’s e thical duty, then medical professionals should embrace a willingness to be held accountable personally, and even more importantly, as part of a healthcare organization. the ama has a well-documented history of racism, and the organization has apologized and sought atonement. part of that history includes a failure to support civil rights legislation in the 1960s and active opposition to medicare, medicaid, and the desegregation of hospital staff. 23 notably, the national medical association, an african american medical association, worked hard to support civil rights laws and integration in the 1960s, but could not convince the “white” ama to follow suit. as part of its anti racism efforts, the ama could work with legislators to craft appropriate changes to title vi and take on the task of educating its membership. health professionals should understand that the shortcomings of title vi in eradicating racism in health care were due to decisions about and interpretations of the law which were influenced by the medical profession itself. educating all the stakeholders about the connections between health, healthcare dichristina, “so sue me”: medical professionals should support strengthening, voices in bioethics, vol. 7 (2021) 4 access, and strong enforcement of our civil rights statutes and regulations is one way that health professionals can actively engage in anti-racism work in the healthcare profession. 1 the ama’s strategic plan to embed racial justice and advance health equity,” american medical association, accessed june 25, 2021, https://www.ama-assn.org/about/leadership/ama-s-strategic-plan-embed-racial-justice-and-advance-health-equity. 2 “how aca narrowed racial ethnic disparities access to health care | commonwealth fund,” accessed march 10, 2021, https://www.commonwealthfund.org/publications/2020/jan/how-aca-narrowed-racial-ethnic-disparities-access. 3 aeyal gross and colleen flood, the right to health at the public/private divide : a global comparative study, new york (cambridge university press, 2014), , 348, https://web-a-ebscohostcom.ezproxy.cul.columbia.edu/ehost/ebookviewer/ebook/ztaynxhuyv9fnzcwmjexx19btg2?sid=5201c555-548f-4599-ae3d857f6911322f@sessionmgr4007&vid=0&format=eb&lpid=lp_261&rid=0. 4 title vi of the 1964 civil rights act, § 2000d (“no person in the united states shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal financial assistance.”) 5 amitabh chandra, michael frakes, and anup malani, “challenges to reducing discrimination and health inequity through existing civil rights laws,” health affairs (project hope) 36, no. 6 (june 1, 2017): 1041–47, 1042, https://doi.org/10.1377/hlthaff.2016.1091. 6 barton smith, “the ‘golden rules’ for eliminating disparities: title vi, medicare, and the implementation of the affordable c are act,” health matrix, 2015, gale onefile: legaltrac. 7 olatunde c. a. johnson, “lawyering that has no name: title vi and the meaning of private enforcement,” stanford law review 66, 6 (june 2014): 1293-1331, at 1294. 8 chandra, frakes, and malani, at 1043. 9 alexander v. sandoval, 532 u.s. 275 (2001). 10 chandra, frakes, and malani, at 1043. 11 see 42 u.s.c. §2000d-1. 12 chandra, frakes, and malani, at 1045. 13 42 u.s.c. §18116. 14 chandra, frakes, and malani, at 1045. 15 sarah g. steege, “finding a cure in the courts: a private right of action for disparate impact in health care,” michigan journal of race & law 16, 439 (april 2011): 439468. 16 see, e.g., lemon v. aurora health care north inc., 19-cv-1384 (e.d. wi feb. 22, 2021). 17 johnson, “lawyering that has no name,” at 1295. 18 pub. l. no. 102-166, § 102, 105 stat. 1071, 1072-72 (codified as amended at 42 u.s.c. § 1981a). 19 sara rosenbaum and sara schmucker, “viewing health equity through a legal lens: title vi of the 1964 civil rights act,” journal of health politics, policy and law 42, no. 5 (october 1, 2017): 771–88, 777, https://doi.org/10.1215/03616878-3940423. 20 institute of medicine (us) committee on understanding and eliminating racial and ethnic disparities in health care, unequal treatment: confronting racial and ethnic disparities in health care, ed. brian d. smedley, adrienne y. stith, and alan r. nelson (washington (dc): national academies press (us), 2003), http://www.ncbi.nlm.nih.gov/books/nbk220358/. dichristina, “so sue me”: medical professionals should support strengthening, voices in bioethics, vol. 7 (2021) 5 21 chandra, frakes, and malani, at 1045. 22 national federation of independent business v. sebelius, 567 u.s. 519 (2012). 23 harriet a. washington et al., “segregation, civil rights, and health disparities: the legacy of african american physicians and organized medicine, 1910-1968,” journal of the national medical association 101, no. 6 (june 2009): 513–27, https://doi.org/10.1016/s0027-9684(15)30936-6. abstract introduction croydon, writing our genetic future, voices in bioethics, vol. 8 (2022) * silvia croydon, associate professor at osaka university, japan © 2022 silvia croydon. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. in it together: why writing our genetic future should not be left to the scientists alone silvia croydon* abstract the public should debate the ethical and social challenges arising from heritable human genome editing (hhge). the notorious case involving he jiankui may have led to the disfavor of gene editing and a precautionary approach. while the de facto global moratorium on hhge is clearly justified considering our current inability to implement it safely and effectively, the difficult ethical considerations should be addressed prior to the ability to initiate widespread hhge. this piece argues that prospective patients and other members of society beyond the scientific community must be included in the conversation. it emphasizes the potential role of those not directly participating in hhge science, calling the broader academic community not simply to wait for scientists’ results and only afterward react. pointing to key historical examples, i contend that scientific progress is intrinsically linked with the surrounding societal discussion and that it is not only scientists who can influence where the hhge story ends. keywords: heritable human genome editing (hhge), clustered regularly interspaced short palindromic repeats (crispr)-cas9, patient well-being, reproductive autonomy, debate introduction i. rogue scientists chinese biophysicist he jiankui announced the world’s first genetically modified babies in 2018. naturally, the treatment aroused the attention of the world’s media, which focused on he’s reckless actions. indeed, in setting up and carrying out the procedure in question, he flouted norms of good scientific practice on a range of levels—errors paid with time in prison. since the he controversy, few scientists have aggressively approached heritable human genome editing (hhge) and challenged the current research norms. the most outspoken exception is the russian molecular croydon, writing our genetic future, voices in bioethics, vol. 8 (2022) 2 biologist denis rebrikov of the pirogov russian national research medical university. he publicly declared his intention to apply clustered regularly interspaced short palindromic repeats (crispr) to embryos to help couples avoid passing serious medical conditions to their children. however, rebrikov met fierce opposition both inside and beyond russia and, with leading crispr scientists and bioethicists abroad describing him as a “cowboy” who had “weak data” and was trying to “grab some attention.”1 so far, rebrikov’s plans have failed to come to fruition. although there are 126 entries listed in a registry of hhge research recently created by the world health organization (who),2,3 it seems that clinical hhge has been paused for the time being. ii. steering the conversation a section of the scientific community has been trying to steer the ethical debate on hhge away from the actions of rogue scientists and back to an issue that is central to the matter—the interests of patients. the majority would agree that the most compelling potential application of germline genome editing is for the prevention of devastating genetic conditions, for example, when both parents carry huntington’s disease, for which “genome editing offers the only prospect of bearing a healthy, genetically related child.”4 despite such justification for scientists to continue pursuing research in the area, there has been a notable reticence in the wider academic community regarding making the ethical case for hhge and clarifying in which medical situations such a technique might be reasonably applied. even among those who recognize that the hhge cases' controversies should not be a reason for panic over designer babies, some believe that starting the ethical debate is premature. a key part of the argument is that the current technological and scientific knowledge available is far from ready to deliver on treatments. a similar stance preventing debate in the wider society is that “difficult questions” about cost, accessibility, and social justice remain.5 whether intended or not, the implication is that the position of wider society in the hhge story should be a reactive one, namely waiting to see what the scientists throw at them and then dealing with it. i argue that there is not only an immediate need for broader academic and societal input on the ethical and social aspects of the hhge debate but that there is a deep symbiosis between scientific progress and its surroundings, whereby science both shapes and is shaped by the societal environment in which it takes place. the who published a position paper, recommendations, and a framework for governance. the framework for governance describes global standards for the governance and oversight of hhge. 6 the position paper emphasized the importance of global and inclusive dialogue,7 and many other boards have also called for broad public engagement. 8 it is imperative that who’s governance framework meets everyone’s needs. after all, as with any medical treatment, it is not the scientist who developed the treatment or the doctor who delivers it that is most important– that honor falls to the patient. in the case of hhge, the beneficiaries include those members of society who hope to reproduce. yet hhge has the potential to impact society. we all should have an opportunity to be a part of world-changing decisions that lead to the creation are made and feel a responsibility to participate. iii. shutting down the academic debate at the 30th annual conference of the japanese association for bioethics, which took place in late 2018 after he’s experiment, the discussion about hhge was shut down quickly. notwithstanding the understandable issues raised with he’s case, one participant after another stood up to voice support for an outright and complete ban on the use of crispr.9 the ban was based on the grounds that editing the human genome croydon, writing our genetic future, voices in bioethics, vol. 8 (2022) 3 would result in a cascade of unforeseen and irreversible consequences for future generations. one participant forcefully argued that “the deoxyribose nucleic acid (dna) rubicon should never be crossed for above all, it was deeply immoral to do so when there was no way of obtaining the consent of those who would actually stand affected—our descendants.”10 another saw it as putting humanity on a slippery slope toward enhancements, and some feared the catastrophic mistakes that might result from their use.11 while the above event provides just one snapshot of the debate that was taking place around the world at the time, it captures the strong reservations in the scientific community. it is a common view, not only in japan, that the human genome is something sacred, a relic handed down from generations, that we ought to treasure and preserve. in support of such a view, religious and other more pragmatic reasons are offered. for example, some may fear the disasters that might befall us if we choose to intervene in the process through which we pass our genetic code from one generation to another. such arguments are certainly still at the heart of the ethical debate, but the foundations upon which they are built are by no means universally accepted. stanford university bioethicist henry greely writes, “the human germline genome” does not exist; instead, each of us has a unique genome.12 greely argues that hhge is no different from the changes our genomes have undergone through numerous medical interventions. for example, synthetic insulin has increased the number of people with dna variations that lead to diabetes. those with this condition would have died as a child in the past. however, now they live long enough to be able to reproduce. similarly, the transition from hunting to farming centuries ago resulted in a greater number of copies in our gene pool of starch-digesting genes. yet greely suggested that, practically, hhge is “not very useful in the nearto midterm” (by which he means “the next several decades”) 13 “mainly because other technologies can attain almost all the important hoped-for benefits of [hhge], often with lower risk,” citing embryo selection and somatic gene editing as two alternative options. greely argued that applying hhge for enhancement beyond disease prevention and is currently not a realistic option because we lack the necessary knowledge. in greely’s opinion, “how worried should we be [about hhge]…? a bit, but not very and not about much.”14 greely’s assertions that other scientific debates should take precedence and that the concerns are not ripe for debate yet are concerning. iv. why shutting down the debate might not be a good idea first, the timeframe described by greely seems somewhat out of line with that described by leading scientists. as far back as 2018, at the same summit where he made his revelations, george q. daley stressed that hhge is scientifically feasible here and that the ethical considerations can no longer be put off: “…a number of groups have applied gene editing now to human embryos in the context of in vitro fertilization and attempting to determine variations of a protocol that would enhance the fidelity and reduce mosaicism. i think there has been an emerging consensus that the off-target problem is manageable, and in some cases even infinitesimal. there are some interesting proofs of principles, like diseases such as beta-thalassemia that could potentially be approached with this strategy.”15 it would also be possible to challenge greely on various other aspects. one of which would be the number of cases to which hhge would be relevant and the kinds of moral allowances that might be made, and each case concludes that more urgency is required in the ethical debate. greely suggests that most people can croydon, writing our genetic future, voices in bioethics, vol. 8 (2022) 4 use preimplantation genetic testing (pgd), which is the embryo selection process, and that perhaps hhge could apply to couples where both have the same autosomal recessive gene.16 greely rules out considering hhge in cases where pgd is applicable. greely concedes pgd does not already represent the answer on this topic, as it often fails to provide couples with enough healthy embryos to transfer. as a resolution to this issue, he points to the creation of eggs using induced pluripotent stem cell (ipsc) techniques, whereby eggs can potentially be created from other cells.17 however, given the extremely limited success of ipscs in the clinical arena to date, in vitro gametogenesis is a highly speculative solution. certainly, the progress of ipsc research is not such a safe bet that placing all our hopes on it at the expense of hhge techniques is currently justified. (also, it should be noted that making eggs using the ipsc technique is hardly an ethical problem-free area itself.) in summary, the cases of couples looking to conceive that greely rules out by pointing to pgd should be kept on the hhge table, as various other scholars have suggested.18 many of us debating hhge are not scientists, so the best we can do is draw from the information we glean from those more technically capable. as a society, we are not just passive observers of science; we should have influence over decisions that impact society. indeed, even if the available science is not yet at a place where we should be worried about large-scale ethical and social concerns, the story will continue to unfold in the future. while greely is happy to see the human race “muddle through” the ethical challenges of scientific breakthroughs, such a position fails to recognize that society at large is far from powerless. v. society influencing scientific progress there are some notable examples of society’s impact on scientific progress. for example, political policies led to the development of nuclear technology for war and strategic deterrence, despite societal objections seen through demonstrations of people protesting using the slogan “no nukes.” furthermore, the bush administration drastically limited the use of embryonic stem cells in the 2000s due to a strong religious and cultural influence on policy.19 societal debate potentially serves as a powerful factor in guiding science. where societal acceptance is ambiguous, science tends to operate on its own. but where science would impact life’s fundamental issues like war, how embryos should be valued, or the end of life, society should weigh in and influence the role of science. societal views on the current global moratorium on hhge could lead to a ban, as has been advocated.20 on the other hand, societal views that value hhge as a way to expand reproductive autonomy may justify permitting its use. opening an ethics debate about it would enable scientists to pursue technologies that society deems justifiable as well as set limits for where they should stop. making this process more difficult, the he affair has clearly colored public discourse on hhge in a way that inhibits debate. in japan, a sequence of questionnaires in 2016, 2018, and 2019 showed that the widely publicized hhge scandal led to a significant decline in the acceptance of genome editing technology in general, particularly for human reproduction. specifically, the surveys revealed a stark rise in disapproval of the technology’s use on fertilized human eggs—from 12 percent in 2018 to 29 percent in 2019.21 the three scientists that conducted these surveys suggested that “the news of the twin babies in china had a substantial influence on the japanese public,” damaging the reputation of hhge.22 it seems likely that the public distaste for hhge was prompted by he’s research rather than considerations about the scientific potential of hhge the change in public opinion may also make politicians and scientists more hesitant when it comes to taking the lead in the hhge debate. ultimately, this can restrict the public discussion of the central ethical challenges of the technology and hinder efforts to determine whether there is a responsible path forward other than an outright ban. stressing the importance of the issue again to potential patients and failing to engage further with the hhge debate is surely not something society croydon, writing our genetic future, voices in bioethics, vol. 8 (2022) 5 should allow. while there are many important ongoing debates about genetics, like biohacking and diy hobbyists, hhge deserves attention as well. in fact, attention to the ethics of hhge should help — more awareness of how these tools can be applied and what germline genome editing is will make people more alert to the existing danger and better understand how to mitigate it. perhaps more importantly, a clear message from society to researchers about what objectives are reasonable to pursue regarding the hhge technologies will facilitate good science. having a publicly determined criterion would allow scientists to not live in fear that they might be blacklisted for seeking progress in grey areas and instead confidently chase progress where it is allowed. vi. what now? hhge is here (or will be soon) and brings many ethical and social challenges. however, the challenges should not be left to individual scientists and couples in desperate situations to manage alone. moving toward how these challenges can be met practically, it is helpful to draw a parallel with the issue of implementing human rights. in the early 21st century, political philosopher michael freeman of the university of essex lamented that implementing human rights had been left to lawyers. although legal experts were clearly essential in putting together the global human rights framework, freeman’s concern was that they were not best placed to understand implementing human rights in various contexts. setting out a broader, interdisciplinary approach, he called for social scientists to tackle these difficult questions, ultimately moving human rights forward around the world. similarly, in medical technology like hhge, scientists are crucial to the story, but at the same time, they are not trained to deal with all the accompanying challenges. bioethicists are also important, clarifying the arguments that society needs to resolve. there is a need for even wider input from across the scholarly community. for instance, as with human rights, international and domestic regulation is required, and clearly, the legal community has a role here. moreover, as described by freeman, since all law is political in its creation and has impacts across society, political scientists and sociologists can provide impactful input. conclusion we are in it together, and we have roles to play in the discussion of hhge. societal discourse does not always trail the scientific reality, but rather, it can condition the path that science will follow. given the importance of what is at stake, not only for the potential patients, but for humanity, we should not leave the hhge debate only to scientists, and we should not leave it until later. 1 cohen j. “embattled russian scientist sharpens plans to create gene-edited babies,” science, 21 oct. 2019. doi:10.1126/science.aaz9337. 2 world health organization. “who issues new recommendations on human genome editing for the advancement of public health,” news release, 12 july 2021, www.who.int/news/item/12-07-2021-who-issues-new-recommendations-on-humangenome-editing-for-the-advancement-of-public-health. 3 world health organization. “human genome editing registry,” https://www.who.int/groups/expert-advisory-committee-ondeveloping-global-standards-for-governance-and-oversight-of-human-genome-editing/registry. 4 daley gq, lovell-badge r, and steffann j. “after the storm–a responsible path for genome editing,” new england journal of medicine 380, no. 10 (2019): 897-9. doi:10.1056/nejmp1900504. https://www.who.int/groups/expert-advisory-committee-on-developing-global-standards-for-governance-and-oversight-of-human-genome-editing/registry https://www.who.int/groups/expert-advisory-committee-on-developing-global-standards-for-governance-and-oversight-of-human-genome-editing/registry croydon, writing our genetic future, voices in bioethics, vol. 8 (2022) 6 5 daley gq, lovell-badge r, and steffann j. “after the storm–a responsible path for genome editing,” new england journal of medicine 380, no. 10 (2019): 897-9. doi:10.1056/nejmp1900504 6 world health organization. “who issues new recommendations on human genome editing for the advancement of public health,” news release, july 12, 2021, www.who.int/news/item/12-07-2021-who-issues-new-recommendations-on-humangenome-editing-for-the-advancement-of-public-health. 7 who 2021. human genome editing: position paper, who expert advisory committee on developing global standards for governance and oversight of human genome editing. 8 daley gq, lovell-badge r, and steffann j. “after the storm–a responsible path for genome editing,” new england journal of medicine 380, no. 10 (2019): 897-9. doi:10.1056/nejmp1900504. 9 30th annual conference of the japanese association for bioethics, 8-9 dec. 2018, kyoto prefectural university, kyoto. 10 30th annual conference of the japanese association for bioethics, 8-9 dec. 2018, kyoto prefectural university, kyoto. 11 30th annual conference of the japanese association for bioethics, 8-9 dec. 2018, kyoto prefectural university, kyoto. 12 greely ht. “why the panic over ‘designer babies’ is the wrong worry,” leapsmag, 30 oct. 2017, leapsmag.com/much-adoabout-nothing-much-crispr-for-human-embryo-editing; greely ht. “crispr’d babies: human germline genome editing in the ‘he jiankui affair’,” journal of law and the biosciences 2019; 6(1): 111–83. doi: 10.1093/jlb/lsz010; greely ht. crispr people: the science and ethics of editing humans (massachusetts: massachusetts institute of technology press, 2021). 13 greely ht. “why the panic over ‘designer babies’ is the wrong worry,” leapsmag, 30 oct. 2017, leapsmag.com/much-adoabout-nothing-much-crispr-for-human-embryo-editing. 14 greely ht. “why the panic over ‘designer babies’ is the wrong worry,” leapsmag, 30 oct. 2017, leapsmag.com/much-adoabout-nothing-much-crispr-for-human-embryo-editing. 15 daley, g. (n.d.). genome-editing-pathways to translation. transcript of the human-genome editing summit 2018 hong kong. retrieved march 17, 2022, from https://diyhpl.us/wiki/transcripts/human-genome-editing-summit/2018-hong-kong/georgedaley-genome-editing-pathways-to-translation/ 16 greely ht. “crispr’d babies: human germline genome editing in the ‘he jiankui affair’,” journal of law and the biosciences 2019: 6(1): 111–83. doi:10.1093/jlb/lsz010. 17 greely ht. crispr people: the science and ethics of editing humans (massachusetts: massachusetts institute of technology press, 2021). 18 rasnich r. “germline genome editing versus preimplantation genetic diagnosis: is there a case in favour of germline interventions?.” bioethics 2020; 34(1): 60–9. 19 murugan, varnee. “embryonic stem cell research: a decade of debate from bush to obama.” the yale journal of biology and medicine vol. 82,3 (2009): 101-3. 20 lander e, baylis f, zhang f, et al. “adopt a moratorium on heritable genome editing,” nature 2019; 567(7747): 165–8. pmid:30867611. 21 watanabe d, sato y, tsuda m, and ohsawa r. increased awareness and decreased acceptance of genome-editing technology: the impact of the chinese twin babies. plos one 2000; 15(1): 1-13. doi:10.1371/journal.pone.0238128. 22 watanabe d, sato y, tsuda m, and ohsawa r. increased awareness and decreased acceptance of genome-editing technology: the impact of the chinese twin babies. plos one 2000; 15(1): 1-13. doi:10.1371/journal.pone.0238128. https://doi.org/10.1371/journal.pone.0238128 https://doi.org/10.1371/journal.pone.0238128 duani, transplant tourists, voices in bioethics, (2013) © maya duani. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. transplant tourists: unwitting beneficiaries of prisoner organ harvest maya duani introduction “every person who travels to china for an organ causes the death of another human,” says dr. torsten trey, a founding member of doctors against forced organ harvesting.1 analysis the reasons for this accusation are not without basis; china has no legislation prohibiting the procurement of organs without consent or donation, primarily from prisoners executed for just that purpose. the most notorious figure in china’s organ-harvesting scheme is wang lijun, vice-mayor and head of police in jinzhou city. wang has blown up headlines recently for an incident wherein he sought to defect from the people’s republic of china (prc). his political dealings have been scrutinized, and yet no article seems to mention wang’s role as director of the “on site psychology research center” (osprc) of the public security bureau of jinzhou, for which he received an award from the guanghua science and technology foundation honoring his organ harvesting efforts. those organs were culled from prisoners, whom the center has been charged with executing in a setup that has been described as akin to “a scientific research lab.” wang also supervised a project entitled “organ transplantation from donors who have been subjected to drug injection”; the project implicates several universities and a military hospital. data collected from these executions is touted as “contributing greatly to the research on subjects like the dying process of the criminal, the physiological changes before and after the injection into a healthy person, the residual tox in in different organs after the injection of the toxin, psychological changes of a person facing death, [and] organ transplant after the injection,” according to a liaoshen evening news article.1 according to david matas, a canadian human rights lawyer, the shift from gunshot execution of prisoners to injection of prisoners is a deliberate effort to paralyze and remove the organs while the body is still animate. “the whole point of drugging in this context is to keep the organ alive while it’s removed, so the organ would be healthier… the disadvantage medically is that the drug taints the organ to an extent, but the organ is kept alive.” 2 the prisoners most at risk for organ-harvesting related executions? falun gong practitioners, who are imprisoned on the basis of their spiritual discipline alone. wang lijun ordered that we “must eradicate them all.” 2 culling organs for transplantation from executed prisoners have been unequivocally repudiated by internationally respected declarations and pronouncements such as the nuremberg code, the helsinki declaration, and the belmont report; the united nations office on drugs and crime has expressly stated that “the reason to oppose organ trafficking is the global injustice of using a vulnerable segmen t of a country or population as a source of organs (vulnerable defined by social status, ethnicity, gender or age).” 1 nevertheless, duani, transplant tourists, voices in bioethics, (2013) 2 executed prisoners have been the primary source of organs and tissues in china since the 1980s, and the system continues to this day. recent changes in chinese regulations have added the requirement that consent for organ donation be obtained from prisoners prior to execution, but consent is often coercive if obtained at all. 2 according to the world health organization, kidney transplants are carried out in 91 countries2; shimazono estimates that 5 to 10 percent of kidney transplants performed worldwide annually are via organ trade. circumstantial evidence shows that over half of the 900 kidney and liver transplants performed in one major transplant center in china in 2004 were for non-chinese citizens from 19 countries. in contrast, the islamic republic of iran allows paid kidney donations but strictly regulates the allocation of organs to non-residents, thereby restricting the international organ trade.4 transplant tourists—those who travel out of their home country to secure organ transplants abroad—should consider that china has yet to develop a system for recovering organs from those who die in hospitals and voluntarily donate their organs, as is international practice; no regional or national system exists for obtaining consent to donate organs pre-mortem from the deceased, or post-mortem from the relatives.2 and yet transplant tourists, who can be on transplant waiting lists in their home countries for months or years, are enticed by the fact that a trip to china yields an organ match in just a sliver of that time; in fact, websites advertise transplants in china in five different languages, and in some cases guarantee availability of a matching organ within two weeks.1 transplant tourists neglect to find out just how the nation can provide organs so quickly—through prisoners executed for just that purpose, violating basic standards of medical ethics and human rights.5 medical staff has even expressly admitted that many of those prisoners are killed for practicing falun gong.5 transplant tourists should also consider that although the practice violates neither current u.s. law nor the national organ transplant act, transplant procedures abroad may use substandard surgical techniques, unhealthy donors, and poor organ matching, and cause post-transplant infections.6 even physicians who are critical of the organ trade end up forced to bear some responsibility for the medical care of those who return to their home countries after an organ transplantation abroad, often with inadequate reports of the operations, and with unknown risks of donor-transmitted infection or donor-transmitted malignancy.1 as posited by budiani-saberi and delmonico, organ harvesting and transplant tourism has turned organs into commodities, and “financial considerations become the priority for the involved parties instead of the health and well being of the donors and recipients.”6 what can be done to rectify this critical ethical crisis? the world health organization has issued the following: while considerable disagreement exists over whether the legally regulated market and the use of financial rewards and incentives are ethically acceptable, the international organ trade could be an issue on which international consensus and policy harmonization could be effectively pursued… the paucity of previous efforts to monitor the international organ trade arguably indicates an inadequate current mechanism to deal effectively with this global issue. establishing a platform on which researchers, policymakers, professional societies and international governing bodies cooperate in gathering and sharing information may be considered an essential step towards a more substantial international health policy.3 the chinese medical society itself, in agreement with the who and the world medical association, has stated that the practice must cease, but efforts thus far seem deficient.8 international conferences continue to allow presentations about organ transplantation in china, and peer-reviewed journals continue to abide articles about the practice as well.5 it is also important to note that the organ harvesting centers in china actually receive technological duani, transplant tourists, voices in bioethics, (2013) 3 support and participation from medical institutions in the u.s. and europe; arthur caplan has stated that he believes that western medical partners may be largely unaware of china’s unethical practices.3 one publication that has decided to declare its opposition to the killing of prisoners for organs is the journal of clinical investigation, which stated in january of this year that they will no longer consider for publication “any submissions pertaining to or containing information about human organ transplantation in china unless there is an attestation that the organ sources are not executed prisoners.” the authors further state that “the international biomedical community, including especially journal editors and editorial boa rds, must not be complicit with the practice of killing on demand to obtain organs from executed prisoners.”2 conclusion doctors against forced organ harvesting is also attempting to shed light on the problem; they want doctors to impress upon their patients that organs in places like china are taken from unwilling prisoners, most of whom are imprisoned for their religious beliefs and who have the organs removed while still alive; they want hospitals and universities to close their doors to visiting chinese transplant physicians; they want medical journals to reject research on transplants in china.1 "medical science cannot build up any knowledge which is based on inhuman and unethical procedures," says dr. trey, thereafter comparing china's organ harvesting to nazi medical experimentation during the holocaust.1 further action to be taken could include pharmaceutical companies ensuring that no executed prisoners are the source of organs used in their studies, and that training of chinese transplant doctors by the international community be predicated on a commitment that trainees will not engage, directly or indirectly, in the use of organs from executed prisoners. these proposals would of course be greatly strengthened by regular inspections of chinese transplant centers by organ transplant professionals in the international community. 9 it’s not as though china is the only country without an established means of obtaining organs ethically, through a system of voluntary donation post-mortem. it has been shown, however, that establishing such a system is not only feasible but also viable. brazil, for instance, launched efforts to create a well -organized national transplant program in the last decade or so, with the number of deceased donors increasing by 161 percent between 1999 and 2010 and the number of solid organ transplants increasing by 121 percent. in fact, by 2009 brazil was the second largest country in absolute number of kidney transplants. thus, there exists no reason why every country cannot establis h a system of deceased organ donation.9 “if another 18,000 executed prisoners with ‘severe brain injury in all cases’ become organ donors in china, and we have not done our utmost to put an end to this practice, we will all have blood on our hands,” conclude danovitch et al. 1 china kills to harvest organs." the ottawa citizen 18 may 2007 2 danovitch, g.m., m. e. shapiro, and j. lavee. "the use of executed prisoners as a source of organ transplants in china must stop." american journal of transplantation 11.3 (2011): 426-28 duani, transplant tourists, voices in bioethics, (2013) 4 3 "the state of the international organ trade: a provisional picture based on integration of available information." bulletin of the world health organization. world health organization, http://www.who.int/bulletin/volumes/85/12/06-039370/en/ 4 caplan, arthur l., howard a. rockman, and laurence a. turka. "editorial position on publishing articles on human organ transplantation." the journal of clinical investigation 122.1 (jan 2012) 5 budiani-saberi, d. a., and f. l. delmonico. "organ trafficking and transplant tourism: a commentary on the global realities." american journal of transplantation 8.5 (2008): 925-29 6"transplant tourism poses ethical dilemma for us doctors." sciencedaily. 26 jan. 2010. web. http://www.sciencedaily.com/releases/2010/01/100126133354.html. 7 the state of the international organ trade: a provisional picture based on integration of available information." bulletin of the world health organization. world health organization, http://www.who.int/bulletin/volumes/85/12/06-039370/en/. 8 danovitch, g.m., m. e. shapiro, and j. lavee. "the use of executed prisoners as a source of organ transplants in china must stop." american journal of transplantation 11.3 (2011): 426-28 9 tsai, pamela. "medical community disturbed by china's organ centers." the epoch times. 6 mar. 2012 10 silva jr., h. tedesco, et al. "the emerging role of brazil in clinical trial conduct for transplantation." the american journal of transplantation 11.7 (jul 2011): 1368-375 http://www.who.int/bulletin/volumes/85/12/06-039370/en/ http://www.sciencedaily.com/releases/2010/01/100126133354.html http://www.who.int/bulletin/volumes/85/12/06-039370/en/ introduction analysis conclusion lively, adding a correction factor, voices in bioethics, vol. 8 (2022) * cathy lively, jd, columbia university ms bioethics © 2022 cathy lively. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. adding a correction factor to the allocation of scarce life-saving resources in a pandemic: one step closer to dismantling structural inequities cathy purvis lively* abstract covid-19 exposed deep-rooted structural inequities. allocation protocols developed during covid-19 may cause furtherance of structural inequalities. in this essay, i specifically address the issue of structural inequities in the context of resource allocation during a period of crisis standard of care. in response to the increasing evidence of structural inequities during the pandemic, physicians and bioethicists douglas white and bernard lo proposed incorporating a correction factor into resource allocation protocols. according to them, this would provide an advantage for disadvantaged individuals. the proposed correction factors use the area deprivation index to determine eligibility. i argue that the correction factor is ethically justified and supported by rawls’s difference principle, daniels’s equality of opportunity, and harris’s double jeopardy argument. i also suggest that the proposed correction factor does not go far enough, particularly if used with other objective factors, such as sofa scoring. at least one study shows that using sofa scoring for resource allocation during covid-19 has a discriminatory effect on non-hispanic black patients. one problem with the correction factor using the adi is that it only applies to those currently in the reflected socioeconomic status. additionally, when only one hospital serves a largely socioeconomically disadvantaged community, all admissions will fall within the targeted category for application of the correction factor. thus, further actions are needed to dismantle structural inequities, such as implementing load balancing or the planned sharing of resources among healthcare systems. keywords: allocation, correction factor, equality, load balancing, resources, protocol introduction covid-19 forced deep-rooted structural inequities to the surface. sars-cov-2 was a novel virus, but the connection between structural inequities and the disparate impact of the virus on marginalized populations lively, adding a correction factor, voices in bioethics, vol. 8 (2022) 2 is not. the history of pandemics reflects how much structural inequities negatively influence health equity.1 the lack of preparedness and response to the structural inequities exemplify “blistering systemic failures.”2 despite warnings from prior threats from sars and h1n1, we were unprepared for covid-19. antommaria and chelen show that one-half of responding hospitals did not have an allocation protocol in place.3 when an influx of critically ill patients and limited resources required implementing a crisis standard of care, many hospitals quickly established protocols addressing the allocation of scarce resources. most crisis standard of care (csc) protocols reflect public health’s utilitarian focus on saving the most lives. 4 the utilitarian focus ignores the disproportionate impact resulting from structural inequities. in december 2020, two physicians and bioethicists, douglas white and bernard lo responded to the increasing evidence of the disproportionate impact of covid-19 on disadvantaged communities by adding a correction factor to their csc resource allocation protocol. the correction factor adjusts triage scores of individuals living in the most disadvantaged neighborhoods by subtracting one point from the triage score.5 patients with lower triage scores are more likely to receive life-saving care. thus, subtracting a point provides an advantage. the correction factor uses a composite measure of disadvantage to determine eligibility called the area deprivation index (adi).6 the adi is a geographic measure of socioeconomic disadvantage that calculates an aggregate disadvantage score on a 10-point scale. the adi measures seventeen elements of disadvantage related to poverty, education, employment, physical environment, and infrastructure.7 the correction factor compensates for structural injustices by using adi scores of patients in the highest quartile of socioeconomic disadvantage or having an adi score of 8 to 10 since the strongest association between adi scores and health outcomes occur at the highest adi levels.8 i. ethical justifications various theories of justice support applying the correction factor in the allocation of scarce resources. rawls’s difference principle provides an ethical justification for the correction factor as it benefits the worse off in the event of resource allocation.9 applying the correction factor and subtracting one point from the triage score admittedly creates inequality among two otherwise like patients, but it is justified under rawls’s theory since it gives the advantage to the least advantaged, addressing equity. norman daniels’ argument for protecting fair “equality of opportunity” also supports the correction factor.10 the correction factor protects the equality of opportunity for those denied access to care because of deep-rooted structural inequities exacerbated by the pandemic. using the correction factor to provide access to life-saving resources compensates patients with diminished opportunities in other arenas like the social determinants of health. derek parfit’s deontic egalitarianism supports the correction factor. under parfit’s view of deontic egalitarianism, justification of giving an advantage to the worse off depends on the reason for the inequality. if the unequal status results from circumstances such as a genetic condition or an accidental injury, like daniel’s equality of opportunity, deontic egalitarianism does not support giving an advantage to the worse-off. if the unequal position results from the unjust actions of another, such as discriminatory treatment of people of color, deontic egalitarianism supports providing the advantage to address the inequity. 11 the disproportionate impact of resource allocation results from unjust treatment such as discrimination and structural inequity.12 lively, adding a correction factor, voices in bioethics, vol. 8 (2022) 3 john harris’s double jeopardy argument adds additional support to the correction factor in that 13 the socioeconomically disadvantaged or those facing racial or ethnic discrimination may have had an increased risk of contracting covid-19 or having a severe case or death due to structural inequities. if the triage procedures do not compensate for the structural inequities and they are precluded access to critical care based only on traditional triage, they will suffer double jeopardy. the correction factor avoids this double jeopardy. ii. operationalizing the correction factor those opposing the correction factor might assert the infeasibility of mitigating inequities during a pandemic.14 yet one large us health system successfully applied similar criteria in allocating remdesivir15 and the national academy of medicine endorsed disparity-mitigating criteria for allocating scarce vaccines.16 applying the correction factor is neither time nor resource intensive. it will not divert resources from the goal of treating illness and reducing morbidity. with the data available about covid-19’s disproportionate impact, not applying an available tool to lessen inequities is an abrogation of ethical duty. one utilitarian argument asserts that we will save fewer lives if the prioritized patients are more likely to die despite interventions. yet society bears responsibility for the social policies that created the disparities. thus, there is an obligation to mitigate those societal problems, even when doing so might save fewer lives.17 some clinicians argue that they should have discretion in determining triage scores. this objection to the correction factor in formulating triage procedures reflects the conflict between clinical and public health ethics. implementing a csc protocol shifts decision-making from the clinician to a triage committee and from an individual focus to a community focus. allowing clinicians to determine triage protocols would increase the risk of decisions based on bias and subjectivity. another open question is whether the correction factor will achieve the intended goal. nancy kass suggests that without evidence to support the effectiveness, we cannot ethically implement the policy. 18 thus, applying the kass analysis, diverting a scarce resource to someone less likely to survive should require proof that doing so systematically would resolve or improve structural inequity. there is limited empirical evidence, but we may proceed with caution based on the presumptive data and the hypothesis that a triage allocation that uses a correction factor could help. computer-based modeling or “tabletop” exercises applying the framework to actual patients but not enacting the protocols could assess the possible effects of the protocols.19 perhaps the most robust rebuttal in response to the opposition of applying a correction factor is in an argument proffered by douglas white that no reasonable triage framework maximizes health outcomes if it creates significant inequalities.20 white’s argument emphasizes the importance of addressing inequity. iii. a more robust version of the correction factor the burdens associated with any public health intervention typically fall into three categories:21 privacy and confidentiality, risk to liberty and self-determination, and justice. most burdens associated with allocating scarce resources fall under the justice category. i not only disagree with the arguments against using a correction factor, but i also argue that the correction factor does not go far enough. first, using the adi neglects consideration of people of color disproportionately affected by covid-19 no longer living in a neighborhood with the highest adi scores. lively, adding a correction factor, voices in bioethics, vol. 8 (2022) 4 based on new research, sequential organ failure assessment (sofa) scores are also potentially discriminatory and not ideal for addressing structural inequity, racism, or ethnic discrimination in the triage setting, although they are applied to triage. 22 second, public hospitals in socioeconomically depressed communities and rural locations may serve a population in which nearly the entire community will have adi scores that qualify for application of the correction factor. iv. relying on adi cannot protect all people disadvantaged due to their race or ethnicity the adi uses seventeen measures of socioeconomic disadvantage. some racial inequality in healthcare is unrelated to socioeconomic status and can be missed by adi. racial inequality in healthcare may be directly related to implicit and explicit bias and past and current discrimination. but the correction factor will not help the black patient not currently residing in a highly disadvantaged neighborhood or experiencing other vestiges of racism in the form of socioeconomic disadvantage. a correction factor that uses more information than adi could make up for some of the weaknesses of sofa as well. v. when all patients have high adi scores what happens when triaging occurs in hospitals serving populations where almost all patients have adi scores of 8 to 10? to illustrate, i will use the example of belle glade, florida, in western palm beach county.23 the overwhelming majority of the neighborhoods served by the one public hospital, lakeside medical center, is at a level 10 state decile, with a few neighborhoods at 8 and 9 state decile.24 during a surge in that hospital, the correction factor will apply to every patient. the hospital must then resort to other considerations, such as random allocation. this potential dilemma suggests the need to consider further steps, such as load balancing, to lessen the inequities. vi. load balancing load balancing is a plan in which hospitals report daily census and available beds. patients are diverted or transferred to hospitals with open beds when one hospital is at maximum capacity. although identified as a method to avoid the need for triaging, i suggest load balancing is also equity balancing, especially when the overwhelmed hospital is in a high adi area. failures in load balancing exacerbate the harm to disadvantaged populations. disadvantaged individuals are more likely to seek treatment in hospitals with limited ability to increase capacity or care for many critically ill patients. during surges in covid-19, hospitals in poor neighborhoods were overrun by admissions and lacked resources to treat, while nearby private hospitals had available beds and resources.25 the arizona department of health services developed an effective load-balancing system to coordinate the statewide transfer of patients from overloaded hospitals to other hospitals. 26 the system dramatically improved access to care for people of color and rural populations.27 one of the state’s foremost responsibilities is safeguarding the health and well-being of people threatened when health systems fail to cooperate. voluntary load balancing is preferable, but if the healthcare systems are unwilling to cooperate and if voluntary efforts are ineffective, state governments should intervene and require private hospitals to take part in load balancing. when needed, public health officials should issue emergency orders to require hospitals to participate in load-balancing efforts, including accepting patient transfers that are not part of their covered population. lively, adding a correction factor, voices in bioethics, vol. 8 (2022) 5 conclusion rawls’s difference principle, daniels’s equality of opportunity, parfit’s deontic egalitarianism, and harris’s double jeopardy argument all justify and may even compel using the correction factor. covid-19 turned academic and hypothetical discussions and debates about allocating scarce resources and making untenable choices of who lives and who dies to real-life responsibilities. once hospitals move to a crisis standard of care, they may need to allocate scarce resources, so having systems in place that can compensate for past inequities and improve fairness in access to care is the ethical imperative. dismantling structural inequities and reassessing allocation protocols should incorporate the correction factor as a new foundational framework and then build on it using load balancing and exercising caution if applying sofa. it is an ethical responsibility to use these tools to dismantle the pervasive structural inequities when allocating scarce resources. 1 goldberg, daniel s. “against the medicalization of public health (ethics).” public health ethics 14, no. 2 (2021): 117–19. https://doi.org/10.1093/phe/phab024. 2 morrissey, mary beth, and jorge l. rivera-agosto. “protecting the public's health in pandemics: reflections on policy deliberation and the role of civil society in democracy.” frontiers in public health 9 (june 1, 2021): 6. https://doi.org/10.3389/fpubh.2021.678210. 3 antommaria, armand h., tyler s. gibb, amy l. mcguire, paul root wolpe, matthew k. wynia, megan k. applewhite, arthur caplan, et al. “ventilator triage policies during the covid-19 pandemic at u.s. hospitals associated with members of the association of bioethics program directors.” annals of internal medicine 173, no. 3 (april 4, 2020): 188–94. https://doi.org/10.7326/m20-1738; chelan, julia s., douglas b. white, stephanie zaza, amanda n. perry, deborah s. feifer, maia l. crawford, and amber e. barnato. “us ventilator allocation and patient triage policies in anticipation of the covid-19 surge.” health security 19, no. 5 (2021): 459–67. https://doi.org/10.1089/hs.2020.0166. 4 lin, janet y., and lisa anderson-shaw. “rationing of resources: ethical issues in disasters and epidemic situations.” prehospital and disaster medicine 24, no. 3 (2009): 215–21. https://doi.org/10.1017/s1049023x0000683x. 5 executive summary allocation of scarce critical care resources during a ...,” april 9, 2021. https://ccm.pitt.edu/sites/default/files/model%20hospital%20policy%20for%20allocation%20of%20critical%20care_2020-0323%20web.pdf. 6. executive summary allocation of scarce critical care resources during a ...,” april 9, 2021. https://ccm.pitt.edu/sites/default/files/model%20hospital%20policy%20for%20allocation%20of%20critical%20care_2020-0323%20web.pdf. 7 https://www.neighborhoodatlas.medicine.wisc.edu/mapping; executive summary allocation of scarce critical care resources during a ...,” april 9, 2021. 8 white, douglas b., and bernard lo. “structural inequities, fair opportunity, and the allocation of scarce icu resources.” hastings center report 51, no. 5 (2021): 42–47. https://doi.org/10.1002/hast.1285 9 mckie, john, and jeff richardson. “the rule of rescue.” social science and medicine 56 (2003): 2407–19 10 daniels, norman. “justice, health, and health care.” essay. in medicine and social justice essays on the distribution of health care, edited by rosamond rodes, margaret p battin, and anita silvers, seconded., 17–33. oxford university press, n.d. 11 brock, dan w. “priority to the worse off in health care resource prioritization .” essay. in medicine and social justice essays on the distribution of health care, edited by rosamond rhodes, margaret battin, and anita silvers, 155–64. oxford university press, n.d. 12 brock, dan w. “priority to the worse off in health care resource prioritization .” essay. in medicine and social justice essays on the distribution of health care, edited by rosamond rhodes, margaret battin, and anita silvers, 155–64. oxford university press, n.d. 13 harris, j. “qualifying the value of life.” journal of medical ethics 13, no. 3 (1987): 117–23. https://doi.org/10.1136/jme.13.3.117. 14 white, douglas b., and bernard lo. “mitigating inequities and saving lives with icu triage during the covid-19 pandemic.” american journal of respiratory and critical care medicine 203, no. 3 (february 1, 2021): 287–95. https://doi.org/10.1164/rccm.202010-3809cp. https://doi.org/10.1093/phe/phab024 https://doi.org/10.7326/m20-1738 https://www.neighborhoodatlas.medicine.wisc.edu/mapping lively, adding a correction factor, voices in bioethics, vol. 8 (2022) 6 15 white, douglas b., and bernard lo. “mitigating inequities and saving lives with icu triage during the covid-19 pandemic.” american journal of respiratory and critical care medicine 203, no. 3 (february 1, 2021): 287–95. https://doi.org/10.1164/rccm.202010-3809cp. 16 white, douglas b., and bernard lo. “mitigating inequities and saving lives with icu triage during the covid-19 pandemic.” american journal of respiratory and critical care medicine 203, no. 3 (february 1, 2021): 287–95. https://doi.org/10.1164/rccm.202010-3809cp. 17 white, douglas b., and bernard lo. “mitigating inequities and saving lives with icu triage during the covid-19 pandemic.” american journal of respiratory and critical care medicine 203, no. 3 (february 1, 2021): 287–95. https://doi.org/10.1164/rccm.202010-3809cp. 18 kass, nancy e. “an ethics framework for public health.” american journal of public health 91, no. 11 (november 2001): 1776– 82. https://doi.org/10.2105/ajph.91.11.1776. 19 white, douglas b., and bernard lo. “mitigating inequities and saving lives with icu triage during the covid-19 pandemic.” american journal of respiratory and critical care medicine 203, no. 3 (february 1, 2021): 287–95. https://doi.org/10.1164/rccm.202010-3809cp. 20 white, supra.12 21 kass, nancy e. “an ethics framework for public health.” american journal of public health 91, no. 11 (november 2001): 1776– 82. https://doi.org/10.2105/ajph.91.11.1776. 22 tolchin, benjamin, carol oladele, deron galusha, nitu kashyap, mary showstark, jennifer bonito, michelle c. salazar, et al. “racial disparities in the sofa score among patients hospitalized with covid-19.” plos one. public library of science, september 17, 2021. https://journals.plos.org/plosone/article?id=10.1371%2fjournal.pone.0257608; sofa is a prognostic scoring system that assigns points for organ failure evidence within six different organ systems. higher sofa scores correlate with higher mortality. new research by tolchin reveals the flaws in sofa due to its failure to account for delays in seeking care and overestimates of black mortality. also see antommaria, armand h., tyler s. gibb, amy l. mcguire, paul root wolpe, matthew k. wynia, megan k. applewhite, arthur caplan, et al. “ventilator triage policies during the covid-19 pandemic at u.s. hospitals associated with members of the association of bioethics program directors.” annals of internal medicine 173, no. 3 (april 4, 2020): 188–94. https://doi.org/10.7326/m20-1738; chelen, julia s., douglas b. white, stephanie zaza, amanda n. perry, deborah s. feifer, maia l. crawford, and amber e. barnato. “us ventilator allocation and patient triage policies in anticipation of the covid-19 surge.” health security 19, no. 5 (2021): 459–67. https://doi.org/10.1089/hs.2020.0166; and pence, gregory e. pandemic bioethics. peterborough: broadview press, 2021. 23 black – population 59.28 % median household income 24,322 population 20,276 education: 31.$ hs; 21.71% less than 95 grade, postsecondary asso-7%, bachelors 6.7, ttps://worldpopulationreview.com/uscities/belle-glade-fl-population 24 neighborhood atlas®. neighborhood atlas mapping. (n.d.). retrieved february 15, 2022, from https://www.neighborhoodatlas.medicine.wisc.edu/mapping 25 white, douglas, keynote address, american society of bioethics and humanities, october 13, 2021, covid-19 at the crossroads, https://eventpilotadmin.com/web/planner.php?id=asbh21 26 angelo, a. (2020, may 26). latest covid-19 model shows arizona can meet a health care surge. retrieved february 15, 2022, from https://communityimpact.com/phoenix/chandler/coronavirus/2020/05/26/latest-covid-19-model-shows-arizona-can-meeta-health-care-surge/ 27 white, douglas, keynote address, american society of bioethics and humanities, october 13, 2021, covid-19 at the crossroads, https://eventpilotadmin.com/web/planner.php?id=asbh21 https://journals.plos.org/plosone/article?id=10.1371%2fjournal.pone.0257608 https://doi.org/10.7326/m20-1738 https://doi.org/10.1089/hs.2020.0166 zimmerman, federal troops in the portland, oregon protests, voices in bioethics, vol. 6 (2020) * anne zimmerman, jd, ms candidate columbia university © 2020 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distributio n, and reproduction, provided the original author and source are credited. federal troops in the portland, oregon protests: race, authoritarianism, and a posse comitatus act violation anne zimmerman* abstract the use of federal troops in the portland oregon protests has a racial element. the motive to disperse the protests could be the disempowerment of those protesting racial injustice cloaked in an innocuous motive like assisting local police in ensuring the safety of civilians and protecting property. the implications for equality, respect, and justice in the us are dire: if federal troops can suppress racial protests in moments of nonviolent protesting, the racist undertones normalize the disparity in other areas like healthcare and access to education and high paying jobs where black people do not experience a level playing field. keywords: justice, racial justice, posse comitatus, insurrection act, free speech, military ethics introduction in portland, oregon, federal troops detained protesters placing several into unmarked cars.1 the authority to use federal trained military, in this case homeland security agents,2 to enforce laws against citizens likely violates the posse comitatus act3 meant to prevent the use of the military in law enforcement. under the insurrection act,4 the federal authority to use the military is extended in certain cases but none applies unequivocally to the oregon fact pattern. the oregon protests are racial protests. protesters want change that embodies the black lives matter movement, equality, and justice. police brutality was the impetus for the protests in the wake of the death of george floyd. the presence of both the police and federal troops escalates the need to protest by those who feel law enforcement is the agitator creating a circular continuous pattern of protest. the use of federal troops in this case has a racial element. the motive to disperse the protests could be the disempowerment of those zimmerman, federal troops in the portland, oregon protests, voices in bioethics, vol. 6 (2020) 2 protesting racial injustice cloaked in an innocuous motive like assisting local police in ensuring the safety of civilians and protecting property. the implications for equality, respect, and justice in the us are dire: if federal troops can suppress racial protests in moments of nonviolent protesting, the racist undertones normalize the disparity in other areas like healthcare and access to education and high paying jobs where black people do not experience a level playing field. in covid-19, the president requested that the states skip the cdc and report their data directly to hhs; the epa is compromising air standards during a pandemic that affects lung capacity; the budget cuts at the noaa limit the ability to research climate change. the seemingly evenhanded actions have racially disparate affects—hhs will release the data as it sees fit, not according to cdc guidelines; air quality affects those in poorer neighborhoods; climate change and adverse weather events hurt those who are more vulnerable, live in lower quality dwellings, are less insured, or are homeless. in portland, the use of the military is part of the pattern. the pattern affects the disenfranchised. even if the actions on their face are neutral, their impact on race can be unconstitutional.5 analysis i. application of the posse comitatus act and the insurrection act the posse comitatus act prevents the military from using its force in executing domestic laws.6 in oregon, the federal “help” is anti-constitutional: the purpose of the use of military is to disband legal protests, something the state and city do not want to use federal troops to achieve. the federal forces suppress people from exercising their rights to assembly and free speech. the mayor of portland and the governor of oregon explicitly stated that they do not want the federal troops present.7 federal military stepping in to perform local police responsibilities against the will of the mayor is feeding racial tensions. the principals behind the posse comitatus act are both anti-militarism and the prevention of abuse of power. the military is not an instrument of civilian law enforcement because there is a moral foundation met by ensuring personal freedom and state autonomy. the act is a moral check on presidential use of the powerful military. the insurrection act provides exceptions to be used in dire circumstances: when states or localities request help (for example, in riots in la after police brutality against rodney king);8 absent a request, the case of “necessity” due to an “unlawful” assemblage or rebellion, or when the actions interfere with federal or state law and the government has issued a proclamation to disperse which has been ignored.9 past examples include civil rights era uses to enforce desegregation that was ordered by federal courts: eisenhower in little rock, arkansas 1957; and kennedy in mississippi in 1962.10 in the case of desegregation, the insurrection act was invoked because those exercising legal rights were met with people unlawfully standing in the way. the act allowed those presidents to protect the marginalized. the role of the military under the insurrection act is to support local law enforcement – the federal government should not direct the actions. in oregon, the protesters who have been arrested were exercising protected first amendment rights. the use of the insurrection act, while arguably to promote public safety and the protection of federal property, could have the effect of quieting protesters based on their message rather than behavior. the los angeles riots in 1992 included numerous deaths, the burning down of buildings, and significant violence. the danger was clear and the destruction was significant. the relationship between people and police has changed. some argue to allow federal troops to intervene would interfere with the relationship between the community and the police, using a heavy hand of government to quiet the marginalized.11 while cities in the us have experienced looting, whether “looting justifies[y] shooting”12 is settled law. federal troops must obey “standing rules for the use of zimmerman, federal troops in the portland, oregon protests, voices in bioethics, vol. 6 (2020) 3 force.”13 had police followed appropriate local use of force guidelines, the very thing being protested would not have occurred. nonetheless, the argument that troops can help, especially when cloaked as law and order style assistance considering looting in some cities, parallels the norms of many who value law and order. those envisioning fairness as a system of punishment for crime rather than fairness as a level playing field for all may support the president’s decision to invoke the insurrection act. while it is a stretch to apply the act to the oregon fact pattern because the help was not requested by the state, the ethics behind the decision reflect public safety despite indifference toward quieting the peaceful demonstrations. the police force in portland is not necessarily against the federal presence and appears to be joining forces with them in some circumstances.14 the federal government argues that the troops are there to diffuse the situation. weeks ago, the local police used tear gas, stun grenades, and acoustic weapons. now, federal troops use similar instruments. the mayor and the citizen organization that oversees the portland police moved to control police behavior and to ban tear gas.15 the bigger issue is the racism, not the protests. the federal government insists they are there to protect portland from “violent anarchists.”16 the government asserts that rather than peaceful protesters, they are detaining those who target federal buildings. the portrayal of protesters as anarchists is unsettling – it could lead people to believe those wanting justice and equality are anti-american when really the values they are protecting by protesting are long held core american principles. wyden and merkley, the two oregon senators, introduced an amendment to the national defense authorization act called the preventing authoritarian policing tactics on america’s streets act.17 the bill would require visible identification on federal troops, disclosure of how many troops would be sent and why, and would limit their authority to participate in crowd control not requested by the state or locality but would still allow the federal government to protect federal property. the amendment addresses prevention of authoritarian tactics and ensures people’s constitutional rights are not violated by federal orders. ii. relationship to racism a racial motive to invoke the insurrection act and use it against protesters is a flagrant abuse of power. using military force in this manner furthers racial tension—why these protests? why now? since 2014, racial protests over the new york city death of eric garner, the ferguson, missouri death of michael brown, the baltimore, maryland death of freddy gray, and the minnesota deaths of philando castile and george floyd all took place in the city of the police brutality as well as in other cities around the country. 18 the protests following the killing of george floyd by a police officer represent a steady progression of increasing awareness of police brutality against black people. if the federal government steps in now to quash the voice of the people, it would cement a federal government relationship pitted against those fighting for racial justice. with all actions, there is an opportunity cost—a different action was foregone to allow the funding for the action taken. in covid-19, black americans die at a disproportionate rate. to help states manage covid-19, the federal government could use its power to manufacture ppe, develop a vaccine or better treatments, and support states’ efforts to supply the best care to the most people. tax revenue is being diverted to suppress people’s rights with a backdrop of racial unrest. when viewed in the context of federal government power, of deaths of black people from covid-19, and from a historical perspective of ascriptive americanism, a theory that the liberal calculus that fed american development and moral backdrop operated alongside racist policies, 19 the use of federal troops is a continuation of racist traditions. the thing in need of repair is the relationship between black americans and zimmerman, federal troops in the portland, oregon protests, voices in bioethics, vol. 6 (2020) 4 the police. the federal government should be taking stronger action against police brutality rather than stepping in where local leaders sense federal troops escalate the tension. the small issue of potential looting should not cloud the large issue of racism. conclusion legal means to prevent the abuse of power should complement ethical concerns driving how the us addresses racism. if a posse comitatus act exception is made when the state does not want federal help, the protests fall within first amendment rights rather than unlawful rebellions or assemblages, and there is not an urgent or immediate danger accompanied by notice and a proclamation to disperse, racism begins to emerge as not only a result of but as a precursor to the federal deployment. in a country with ethics and laws that require equality and justice, the federal action underpins more than a military overreach. like federal decisions in healthcare, mass incarceration, public education, and the environment, placing federal troops in portland is a continuation of seemingly neutral decisions that disproportionately affect people based on their race. 1 npr, all things considered, july 17, 2020. https://www.npr.org/2020/07/17/892277592/federal-officers-use-unmarkedvehicles-to-grab-protesters-in-portland 2 they are customs and border patrol agents and us marshals special operations group. 3 posse comitatus act, 18 u.s.c. section 1385, in 1878. 4 10 u.s.c. §§ 251–255; prior to 2016, 10 u.s.c. §§ 331–335; amended 2006, 2007. 5 yick wo v. hopkins, 118 u.s. 356 (1886) 6 congressional research service, “the posse comitatus act and related matters: the use of the military to execute civilian law,” updated november 6, 2018. https://fas.org/sgp/crs/natsec/r42659.pdf 7 interview of gov. kate brown https://www.koin.com/news/oregon/gov-kate-brown-on-covid-potential-rollbacks-protesters1-on-1-07172020/; associated press, “mayor of portland to trump: get your troops out of the city,” july 17, 2020. https://www.tampabay.com/news/nation-world/2020/07/17/oregon-officials-decry-portland-arrests-by-federal-agentsdressed-in-camouflage/ 8 congressional research service, “defense primer: legal authorities for the use of military forces,” updated january 3, 2020. https://fas.org/sgp/crs/natsec/if10539.pdf 9 congressional research service, “the posse comitatus act and related matters: the use of the military to execute civilian law,” updated november 6, 2018. https://fas.org/sgp/crs/natsec/r42659.pdf 10 the national guard is a state-run successor to the militia and is usually used first in help with natural disasters or to assist police in managing protests and keeping civilians safe. the national guard is not subject to posse comitatus – it is permitted to help with civilian law enforcement. national guard is commonly used in riots although the federal military has been called in when the riots are outside the scope of the national guard’s training or effectiveness. mark f. cancian, senior adviser, international security program, center for strategic and international studies, “use of military forces in the covid-19 emergency,” march 17, 2020. https://www.csis.org/analysis/use-military-forces-covid-19-emergency 11 alicia victoria lozano, “the insurrection act was last used in the 1992 los angeles riots. invoking it again could undo years of police reform, some warn.” nbc news, june 4, 2020. https://www.nbcnews.com/news/us-news/insurrection-act-was-last-used-1992-los-angeles-riots-invoking-n1224356 12 mark nevitt, “the president and the domestic deployment of the military: answers to five key questions,” just security, june 2, 2020. https://www.justsecurity.org/70482/the-president-the-military-and-minneapolis-what-you-need-to-know/ 13 nevitt. 14 https://www.oregonlive.com/news/2020/07/evidence-shows-portland-police-working-with-federal-officers-at-protestscontradicting-city-officials.html https://www.npr.org/2020/07/17/892277592/federal-officers-use-unmarked-vehicles-to-grab-protesters-in-portland https://www.npr.org/2020/07/17/892277592/federal-officers-use-unmarked-vehicles-to-grab-protesters-in-portland https://en.wikipedia.org/wiki/title_10_of_the_united_states_code https://www.law.cornell.edu/uscode/text/10/251 https://www.law.cornell.edu/uscode/text/10/255 https://fas.org/sgp/crs/natsec/r42659.pdf https://www.koin.com/news/oregon/gov-kate-brown-on-covid-potential-rollbacks-protesters-1-on-1-07172020/ https://www.koin.com/news/oregon/gov-kate-brown-on-covid-potential-rollbacks-protesters-1-on-1-07172020/ https://www.tampabay.com/news/nation-world/2020/07/17/oregon-officials-decry-portland-arrests-by-federal-agents-dressed-in-camouflage/ https://www.tampabay.com/news/nation-world/2020/07/17/oregon-officials-decry-portland-arrests-by-federal-agents-dressed-in-camouflage/ https://fas.org/sgp/crs/natsec/if10539.pdf https://fas.org/sgp/crs/natsec/r42659.pdf https://www.csis.org/people/mark-f-cancian https://www.csis.org/analysis/use-military-forces-covid-19-emergency https://www.nbcnews.com/news/us-news/insurrection-act-was-last-used-1992-los-angeles-riots-invoking-n1224356 https://www.justsecurity.org/70482/the-president-the-military-and-minneapolis-what-you-need-to-know/ https://www.oregonlive.com/news/2020/07/evidence-shows-portland-police-working-with-federal-officers-at-protests-contradicting-city-officials.html https://www.oregonlive.com/news/2020/07/evidence-shows-portland-police-working-with-federal-officers-at-protests-contradicting-city-officials.html zimmerman, federal troops in the portland, oregon protests, voices in bioethics, vol. 6 (2020) 5 15 oregon governor kate brown banned tear gas unless there is a declared riot and the use of teargas is announced first. police did not respect the ban. https://www.wweek.com/news/2020/07/01/hours-after-gov-kate-brown-signs-tear-gas-ban-into-lawportland-police-deploy-more-gas-ontoprotesters/#:~:text=on%20june%2030%2c%20oregon%20gov,is%20imminent%20before%20deploying%20it. 16 morgan phillips, “dhs pushes back against claim federal agents detaining portland protesters aren't identifying themselves,” fox news, july 17, 2020. https://www.foxnews.com/politics/dhs-pushes-back-against-claim-federal-agents-detaining-portlandprotesters-arent-identifying-themselves quoting chad wolf, acting secretary, department of homeland security. 17 https://www.merkley.senate.gov/imo/media/doc/ndaa%20crowd%20control%2020.7.20.pdf 18linda poon and marie patino, “citylab university: a timeline of u.s. police protests,” bloomberg news, bloomberg citylab, june 9, 2020. https://www.bloomberg.com/news/articles/2020-06-09/a-history-of-protests-against-police-brutality 19 rogers m. smith, “beyond tocqueville, myrdal, and hartz: the multiple traditions in america,” the american political science review, vol. 87, no. 3 (sep., 1993), pp. 549-566 https://www.wweek.com/news/2020/07/01/hours-after-gov-kate-brown-signs-tear-gas-ban-into-law-portland-police-deploy-more-gas-onto-protesters/#:~:text=on%20june%2030%2c%20oregon%20gov,is%20imminent%20before%20deploying%20it. https://www.wweek.com/news/2020/07/01/hours-after-gov-kate-brown-signs-tear-gas-ban-into-law-portland-police-deploy-more-gas-onto-protesters/#:~:text=on%20june%2030%2c%20oregon%20gov,is%20imminent%20before%20deploying%20it. https://www.wweek.com/news/2020/07/01/hours-after-gov-kate-brown-signs-tear-gas-ban-into-law-portland-police-deploy-more-gas-onto-protesters/#:~:text=on%20june%2030%2c%20oregon%20gov,is%20imminent%20before%20deploying%20it. https://www.foxnews.com/politics/dhs-pushes-back-against-claim-federal-agents-detaining-portland-protesters-arent-identifying-themselves https://www.foxnews.com/politics/dhs-pushes-back-against-claim-federal-agents-detaining-portland-protesters-arent-identifying-themselves https://www.merkley.senate.gov/imo/media/doc/ndaa%20crowd%20control%2020.7.20.pdf https://www.bloomberg.com/authors/auc4draqlce/linda-poon https://www.bloomberg.com/authors/at8ydozwhfs/marie-patino https://www.bloomberg.com/news/articles/2020-06-09/a-history-of-protests-against-police-brutality small, belonging at the table, voices in bioethics, vol. 7 (2021) * pageen manolis small, bsn, ms © 2021 pageen manolis small. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. belonging at the table: moving beyond inclusion in ethics discussions pageen manolis small* keywords: inclusion, nurse, healthcare ethics, discussion, consult, interdisciplinary communication “should we call ethics?” i don’t remember if it was the day nurse or myself, the night nurse, who articulated the question. i do remember that we both thought it was a good idea. we had been “handing off” the same patient for the past several days as each of us worked several consecutive 12-hour shifts. “jordan” was critically ill and wasn’t getting better. my fellow bedside nurse and i shared concerns that jordan’s parents had unrealistic expectations regarding possible outcomes and that jordan was unnecessarily suffering. during one of our handoffs, the critical care resident came up to us to check in on how jordan had done overnight, and one of us posed the question to him: “should we call ethics?” we expressed our concerns about unattainable goals and our discomfort with the amount of suffering jordan was enduring, and our participation in prolonging jordan’s suffering. the resident did not agree that an ethics consultation was warranted. he listened to our concerns and talked through his reasoning. i understood his point but wasn’t sure i agreed. yet, neither the other nurse nor i called ethics ourselves, thinking that the physician’s decision was the determining factor. that experience, and my surrounding uncertainty, was one of the events that led me to become an ethicist several years later. currently, i work both as a nurse and as a clinical ethicist. my roles overlap and inform each other. i spend a lot of time learning about and addressing barriers to ethics consultations. many staff express uncertainty about when a consult is needed, and many non-physician staff think that a physician should decide whether to call for a consult. some staff members are even unaware that any member of a patient’s healthcare team can request a consult. despite often being earlier identifiers of ethical issues, research shows that nurses often do not address ethical issues. when they do address issues, they may not fully explore the ethical issue and all its facets.1 nurses also often face organizational and structural barriers to addressing and resolving ethical issues.2 small, belonging at the table, voices in bioethics, vol. 7 (2021) 2 ethics consultations should be a safe moral space where ethical issues are robustly discussed and fully explored.3 an important part of ethics work is overcoming barriers to the discussion and fostering a sense of belonging at ethics consultations for all relevant participants. we may often talk about who to include in an ethics consultation, which is a necessary discussion to ensure key people are present in the discussion. inclusion is important. healthcare ethics consultation teams are obligated to ensure access for healthcare providers, patients, and any other members of patients’ healthcare team. 4 a broad goal of ethics consultations is to aid in the resolution of ethical conflicts and concerns. this involves understanding diverse perspectives and bringing these perspectives together in a respectful dialogue that seeks to understand different views, enlighten the understanding, and work toward a resolution. ethics consultants and committee members have diverse backgrounds and experience; yet, they may struggle to fully include a similar diversity level from patient care teams. a while back, an ethics consultant colleague of mine was scheduling a consult for a patient. the patient’s primary inpatient nurse had requested the consult. one of the ethics team members strongly expressed that the attending physician needed to be at the consultation, but not as much effort was put into enabling the requesting nurse or another direct care nurse who knew the patient well to participate. physicians are the primary requesters of ethics consultations even though other staff, patients, and family members also identify ethical concerns. certainly, multidisciplinary discussion among the patient care team precipitates many requests. the culture of the physician as a leader lends itself to the physician being the consult requester. however, this tendency is potentially problematic as the requester is then deemed the “point person” and is the first to share the narrative from their perspective, leading to an anchoring bias. ethics consultants must be aware of their biases and actively seek to overcome them. another colleague of mine once shared a case prompted by a question from the nurses, but the formal request came from the attending physician. the consult was via telephone and somewhat informal due to the immediacy of the issue. as the ethics consultant, my colleague spoke only to the attending physician. during the case review, another colleague asked what the nurses thought about the outcome. the consultant admitted that he had not talked with them as part of the process or followed up regarding the outcome and suggested he would strive for better follow up in the future. yet, inclusion by itself is not enough. we must go beyond simply having diverse representation within consults. all participants must know that their insights and perspectives matter and impact the decision. ethics consultants must go beyond inclusion to generate a sense of belonging. while inclusion is inviting someone to speak, belonging generates a sense of value and acceptance of someone’s voice. everyone involved should feel empowered to speak and share their thoughts and ideas. yet, if those ideas are not valued, discussed, and fully considered, empowerment will disintegrate, and inclusion will have little substantive value. these important voices will be lost, and we will have less depth and robustness to our discussion. patients, families, and staff will suffer from this inability to reach the best outcomes. belonging fosters acceptance and valuing of others’ ideas and perspectives. having thorough insight and understanding of the ethical issue at hand helps ensure the best decision is made for the patient. ensuring that the participants feel valued and understand the decision also promotes support of the decision, could reduce the risk of moral distress, and fosters better interdisciplinary communication. another colleague recently shared a case that a nurse called. several nurses attended the consult. during the case review, someone asked what the nurses thought about the outcome. there was a pause, then the consultant carefully replied, “they appreciated that their voices were heard.” i wondered whether the nurses felt more than heard and whether they supported the decision made. did these nurses find the consultation to be successful? would they request an ethics consultation again? small, belonging at the table, voices in bioethics, vol. 7 (2021) 3 participants in ethics consults should understand the rationales used in decision-making. the ethics consultant must synthesize the various perspectives and mediate reasonable recommendations. they must also provide discussion and education to promote understanding of the issue and the ethical recommendation. all parties may not agree, but we can work towards better understanding and acceptance. an important outcome of ethics consultation is the satisfaction of participants.5 feeling like one belonged in the discussion and that one’s insights and comments matter promotes satisfaction and increases the chance that ethics consultation services are evaluated to be useful and likely to be sought again. agreeing that the conflict is resolved can reduce moral distress and enhance communication going forward. sometimes, i think about jordan, the ethical concerns myself and my fellow nurses had about jordan’s care and our associated moral distress. jordan died peacefully a few weeks after my nursing colleague and i brought up our ethical concerns to the resident. some might say it was the best outcome we could have hoped for given the circumstances and that an ethics consult may not have changed the outcome: jordan would still have died, perhaps a little sooner, probably just as peacefully. but an ethics consult could have helped the healthcare team talk through and understand options. it could have helped the staff navigate our own moral distress. it could have facilitated interdisciplinary communication and understanding. those are important outcomes, too, and we need to be careful not to overlook them. 1 pavlish, carol et al. “nursing priorities, actions, and regrets for ethical situations in clinical practice.” journal of nursing scholarship: an official publication of sigma theta tau international honor society of nursing vol. 43,4 (2011): 385-95. doi:10.1111/j.1547-5069.2011.01422.x 2 haahr, anita et al. “nurses experiences of ethical dilemmas: a review.” nursing ethics vol27,1 (2020): 258-272. doi:10.1177/0969733019832941 3 walker, margaret urban. “keeping moral space open. new images of ethics consulting.” the hastings center report vol. 23,2 (1993): 33-40. 4 american society for bioethics and humanities (asbh). core competencies for healthcare ethics consultation, 2nd edition. chicago, american society for bioethics and humanities, 2011. 5 asbh. core competencies. zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) * anne zimmerman, jd, ms candidate columbia university © 2021 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. weeding out disingenuous emergency orders: a consistent ethical justification to determine whether to apply jacobson v. massachusetts’ deferential approach or the tiered scrutiny that would apply absent an emergency anne zimmerman* abstract the most compelling ethical justification for the use of public health police power in an emergency is that the order enacted will have a profound, beneficial effect on the overall emergency: a tight causal nexus. the strong, causal relationship to a largescale goal should protect public health orders that are time sensitive and effective and should be evaluated under jacobson’s test regardless of the type of right infringed. with over 500,000 deaths from covid-19, preparation for future emergencies should include legal and ethical clarity on which orders are evaluated under a deferential approach and which call for heightened or strict scrutiny. keywords: emergency orders, emergency police power, time sensitive, rights, liberties introduction since the covid-19 pandemic began, states and municipalities have used emergency police power, the traditional tool for public health and safety emergencies, disparately, exhibiting wide latitude. some states enacted emergency measures that appear less likely to serve a substantial purpose and may represent overreach or abuse of power while others have taken measures more causally related to public health. the pandemic is coexisting with populism and a dangerous political trend that popularizes absolutism in religious, speech, second amendment, business, and even corporate rights. yet other important rights are threatened by executive orders. it is difficult to sort out which of the many challenged emergency orders are justified. distinguishing free exercise claims from all others or valuing a right to interstate travel above a right to reproductive health services generated confusion during the pandemic. unjustified executive orders and orders that last too long, do not use the least restrictive means, or lack reasonable exceptions are evidence of government overreach and may unnecessarily threaten individual liberties. zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 2 a consistent ethical justification and judicial analysis for emergency orders that infringe fundamental rights would ensure protection of civil liberties while making exceptions to save lives and contain the virus. this paper argues that regardless of the type of right infringed, the ethical factors that justify a temporary infringement of rights in an emergency are the goal of the state action, its relationship to the emergency, and the ability of the order to provide substantial relief. for future national emergencies, clear guidance would help shape the policies that infringe rights allowing those orders most significantly impacting public health and further scrutinizing ancillary ones. this approach differs from the current legal and ethical approaches where, in many courts, the fundamentalness of the right infringed governs the analysis applied. in the early stages of the covid-19 pandemic, a rights-based outcry created hesitance to enact public health measures in some states and remained a pervasive voice that limited public health powers throughout the pandemic. other executive orders less linked to overall outcome set in motion legitimate rights-based challenges. currently, circuits are split on which analysis to apply to certain rights. there is an opening to balance the two competing needs: the need to limit government overreach and the need to protect the public. analysis i. the ethical justification for infringing rights in public health emergencies the moral justification for any order relies on its potential benefits and its ability to accomplish a legitimate public health goal in a reasonable way. ending the pandemic, containment of the virus, and saving lives are appropriate policy goals that justify larger infringements. ancillary policies may justify lesser intrusions. when the least restrictive means possible are employed, although not a legal requirement in emergencies, a balance between rights and public health should emerge. the ability to infringe rights severely, even to force people to quarantine, is well established, making the inconsistent treatment of certain rights over others suspect. freedom to behave in ways that promote viral transmission and social conditions that encourage people to sue their elected officials over restrictions (and local representatives to sue governors) pose challenges to public health police power. public health emergencies are a long-recognized exception to the otherwise substantive applicable caselaw, even when they possibly infringe otherwise fundamental rights.1 jacobson v. massachusetts which allows emergency executive and legislative action under police powers if the action is reasonable, sometimes controls emergency orders.2 when applied to some liberty interest affected by an emergency order, courts interpret jacobson’s deferential rule to operate more like a rational basis test. yet courts apply heightened or strict scrutiny to emergency orders inconsistently based on the type of right. rather than just a cut-out for religious practices, there is a mix of jurisprudence making valuable emergency public health measures increasingly vulnerable to preliminary injunctions. recent circuit court and supreme court cases may have implications even beyond religious freedom. other orders, like restrictions on abortion access, serve less important purposes in the emergency, and their surviving challenges may demonstrate an ethical or judicial lapse. more consistent rules can be developed to distinguish orders to which jacobson’s deferential approach, or a rational basis scrutiny should apply from those calling for heightened, or strict scrutiny even during the public health crisis. rather than applying jacobson inconsistently, the goal of the state action and its relationship to the emergency should govern, something aligned with the dissents in catholic diocese of new york v. cuomo and south bay pentecostal v. newsom (2021), which suggest deference to the state and to experts. 3 public health emergencies by necessity call for public health expertise, consistent with the legislative and executive power jacobson reserved for those with special knowledge of the crisis. in an zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 3 emergency, orders need to be enacted and enforced quickly to have the most impact on public health and safety. “the constitution is not a suicide pact.”4 the law should reflect the ethical justification, something that would preserve fundamental rights from arbitrary subjugation, while honoring the goals of public health and safety within a social compact. one important caveat is that the public health policy should be effective or have a high likelihood of success within a short duration. there should be no opportunity to extend a state of emergency or allow room for unnecessary public health police powers. the ethical obligation of public health officials is high when the public gives up rights to follow intrusive recommendations or requirements. some of the legal challenges to public health orders during the pandemic may reflect a lack of public trust in the public health officials advising government entities. the failure of some orders to adequately protect the population rightly opened the door to challenges, and incorrect assertions like the widespread public health official word that masks would be ineffective decrease public confidence in the entities that exist to protect the public in public health emergencies. the constitutional rights that we value so deeply should not be infringed for orders based on bad advice. this analysis should extend to those orders that are predictably substantially linked to the desired results. ii. jacobson v. massachusetts and deference to policymakers jacobson gives deference to legislatures and state executives in public health (police power).5 in jacobson, justice harlan wrote, “…the police power of a state must be held to embrace, at least, such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety.”6 jacobson’s use of the term “social compact” supported deference to orders supporting public health. in dicta, the court discussed both quarantines and requirements that people join the army against their will, saying “protecting the public collectively from danger” does not depend on “willingness” of the people.7 social compact language is a basis for public health laws and must be balanced to avoid infringing liberty superfluously. rights absolutism has become part of the partisan populist culture, leading to an extreme view of the sanctity of rights and the degradation of social compact theory. jacobson confirms that rights are not absolute. lindsay wiley and stephen vladeck warn that jacobson is used to suspend constitutional rights during emergencies, rights they assert should not be infringed without full judicial review.8 essentially, their argument favors the constitutional caselaw that would apply absent the emergency. rather than suspending the constitution, i assert jacobson operates within it, balances rights and the ability to protect the public, and includes language to prevent abuse of power. although, there may be circumstances where strict scrutiny should apply rather than jacobson. in the majority opinion, justice harlan said, “…in order to prevent misapprehension as to our views, to observe -perhaps to repeat a thought already sufficiently expressed, namely -that the police power of a state … may be exerted in such circumstances or by regulations so arbitrary and oppressive in particular cases as to justify the interference of the courts to prevent wrong and oppression.” the beginning of that quote is noteworthy: the jacobson court predicted that jacobson could be misinterpreted to deny judicial review for arbitrary use of state police power, making it vulnerable to abuse. the jacobson balance affirms state police power to protect public health but does not bar judicial review of legislation or orders to weed out those that do not serve a legitimate public health purpose, or that do so in too invasive a way. jacobson, a 1905 case, was heard before the development of the levels of scrutiny now applied to constitutional cases,9 making it arguably outdated and ripe for clarity. jacobson’s tone and wording sound a lot like the later developed rational basis, the low-level scrutiny often applied to economic or other statutes and orders that infringe rights but do not call for heightened scrutiny.10 zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 4 iii. covid-19 cases vary in their application of jacobson a. covid-19 religion cases in roman catholic diocese of new york v. cuomo, the supreme court per curiam ordered an injunction preventing new york from enforcing an executive order limiting occupancy at religious services.11 gorsuch approached it as a straightforward free exercise case arguing that while some commercial venues deemed essential services had no capacity limits imposed, religious services were being capped at 10 to 25 persons. according to gorsuch, the executive order singled out religion in violation of the first amendment, and he admonished the potential use of jacobson to avoid the traditional strict scrutiny test. yet gorsuch failed to apply employment division, department of human resources of oregon v. smith,12 which holds that states may require individuals to comply with neutral laws. smith confirms that a law that does not target a religion may be upheld. instead, gorsuch looked to church of lukumi babalu aye, inc. v. hialeah.13 in roman catholic diocese of new york, justice kavanaugh declared the new york order not neutral and found it violated smith. kavanaugh extends smith’s neutrality argument beyond reason, as justice sotomayor points out.14 while restrictions in many states treat religious services like other similar events and need not treat them like grocery stores or other businesses where people do not linger, sing, or gather for extended periods, the kavanaugh view broadens the comparable peer group for the sake of the religious neutrality and whittles away at smith. the cases arguably indicate favoritism of religious gatherings. with the use of technology and the varying tests on how integral attending services is to the practice of a particular religion, religion may not have been impacted wrongly or fundamentally, something outside the scope of this article, and specific to peoples’ sincere religious beliefs. like quarantining, which is much more intrusive, the public health benefits of suspending or limiting the size of gatherings are great. in south bay pentecostal church v. newsom (2021)15 kagan, joined by breyer and sotomayor, warns against armchair epidemiology, a warning that comports with deference to health departments, scientists, and experts aligning with jacobson’s holding, yet not mentioning it.16 the kagan, breyer, and sotomayor view alleviates the need to apply lukumi or smith. in one case, a federal court held jacobson does not cover religious liberty, suggesting a limited carve out that may comport with the gorsuch and kavanaugh positions.17 then, the issue not truly resolved yet is whether courts should apply varying degrees of scrutiny like they would in non-emergencies to other constitutional rights as well. b. application beyond religious freedom in national association of theatre owners v. murphy, a covid-19 business closure case, a new jersey court cited jacobson for its rational basis scrutiny, a view that asserts jacobson comports with the later developed rational basis test, 18 also saying, “the covid-19 pandemic is the very sort of health crisis envisioned in jacobson.” 19 the new jersey court cited roberts’ concurrence in south bay pentecostal (2020)20 to back up its assertion that courts must defer to elected officials, something accomplished by applying jacobson. an ethical analysis of business closures should justify them according to their substantial impact on reducing transmission. in bayley’s campground v. janet mills,21 tourism businesses and travelers sued maine challenging executive order 64 which required a 14-day quarantine for people entering maine. the judge took the view that jacobson is inapplicable and too lenient, and that the tiered structure of modern constitutional jurisprudence makes jacobson inapplicable, and perhaps not even good law. judge walker, the federal district court judge, zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 5 stated, “the permissive jacobson rule floats about in the air as a rubber stamp for all but the most absurd and egregious restrictions on constitutional liberties, free from the inconvenience of meaningful judicial review.”22 as all states do, maine had “compelling interests in managing the fallout from the pandemic.”23 the first circuit affirmed. as a matter of law, whether the court was correct to apply the scrutiny based on cases governing the right to interstate travel or the deferential jacobson justification for the use of public health power is unsettled among the circuits. as a matter of ethics, the relationship to the pandemic justified the intrusion. arguably, for consistency, if cases that limit access to abortions reached the supreme court, the justices would have to evaluate them according to the appropriate scrutiny. in in re abbott,24 the fifth circuit applied jacobson avoiding the planned parenthood v. casey undue burden test. later, the eighth circuit similarly justified an arkansas law.25 this is inconsistent with the supreme court analysis in catholic diocese of new york, where the court did not defer to jacobson, although religion is the distinction. like the reasoning in catholic diocese, the eleventh and sixth circuit courts held that the casey undue burden test should govern,26 just like smith or lukumi should govern free exercise cases.27 throughout the states, cases during the pandemic have been brought to protect personal freedoms 28 including second amendment rights, 29 the right to attend school (basic education and educational equality),30 to be free from unconstitutional takings,31 to keep businesses open,32 to be free of wearing a mask,33 to stay home,34 to block or hold a campaign rally,35 rights of other organizations to have equal status in treatment as churches,36 and many other issues. the constitutional challenges indicate how common rights-based objections to limitations on freedom are.37 the heightened or strict scrutiny analysis of religious freedoms could extend to other constitutional claims (as it was applied to the right to travel in bayley’s campground), as many plaintiffs have asserted. that trend may indicate populist views of absolutism of certain rights beyond the rightful protection of long recognized rights. the liberal justices’ approach would weigh the input of elected officials relying on experts more, while the conservative justices’ approach would apply the same level of scrutiny that would apply absent an emergency. as long as there is a tight causal relationship to harm reduction and an end to the crisis, and the orders are tailored to the goal, the dissent in catholic diocese provides a more workable, practical solution that has potential to save many more lives. checks on that power are necessary and exist within the jacobson framework. the justification for reliance on health experts is limited to their ability to deliver on meaningful policies that protect the public. an overuse of jacobson to justify public health laws in the realm of non-emergencies may have contributed to public distrust, something outside the scope here. iv. strength of the causal relationship to the big picture solution, harm reduction, and life saving a. justifying time-sensitive outcome-determinative orders of limited duration among time-sensitive orders, a distinction between actions or executive orders with a direct relationship to a big picture goal in an emergency and those with an indirect relationship could bring the ethics and the law closer. time sensitive emergency orders which are immediately and obviously beneficial, even when they infringe what ordinarily could not be infringed, could be analyzed under the jacobson test that is quite a bit like the rational basis standard found throughout constitutional law, or, if they are analyzed under strict scrutiny, may also be found to serve a compelling interest. they may not, of course, be arbitrary or single out a protected class. the justification for giving a strict scrutiny analysis to free exercise claims but not to other fundamental rights is an inconsistency that should be remedied. yet, under any analysis only those orders tethered to a legitimate goal would survive. zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 6 all emergency measures violate normally held rights—quarantining and stay-at-home orders are arguably larger intrusions on protected rights than an inability to attend church in person, yet a quarantine’s legality is settled law. the ethical justification should be saving many lives and overall containment serving to end the pandemic. pandemic policies, applied fairly, and for a very short time, aiming to eliminate super spreader events should not result in a rights-based outcry, and when they do, arguably courts should use consistent analyses to find the appropriate limitations to those rights. b. availability of the normal legislative process and accountability for orders that are not time sensitive or that solve a less pressing need orders that last too long or that only indirectly help with containment, but that interfere with a constitutional right should rightly fail unless held to the same amount of accountability as nonemergency public health laws. for example, lumping abortion restrictions in an order delaying elective procedures while arguably disingenuous, is also not ethically justified because the goal of the policy does not concern ending the pandemic or containment. it concerns the limited goal of saving a very small portion of a state’s medical resources and personnel for covid-19 care, something that may be achieved many ways. similarly, but pertaining to arguably less fundamental rights, orders preventing people from entering contracts, evicting tenants, and accessing non-pandemic related elective healthcare have only indirect benefits to the overall public health emergency. those orders fulfill worthy narrower goals, but they do not necessarily call for special deference; the goal may not justify the infringement and there may be time for a legislative process as well as a judicial one. in a different emergency, like a hurricane with potential for risking the lives of the population and of rescue workers, a few days of curfew or evacuation enacted to prevent loss of life could be governed by jacobson, while a two-month curfew that would have no direct impact on the immediately pressing emergency even if it had public health benefits and served the common good, e.g., by making clean up easier, calls for more scrutiny. conclusion the most compelling ethical justification for the use of public health police power in an emergency is that the order enacted will have a profound, beneficial effect on the overall emergency: a tight causal nexus. the strong, causal relationship to a largescale goal should protect public health orders that are time sensitive and effective and should be evaluated under jacobson’s test regardless of the type of right infringed. ancillary intrusive public health orders should not get jacobson’s deferential approach. the language gorsuch used to justify strict scrutiny could curtail previously recognized police power and cost lives for the sake of liberty, the precise result jacobson sought to avoid in its “social compact” language. populism is coinciding with the covid-19 pandemic. as things are now, one result could be that, in the beginning of the next public health emergency, theaters, lecture halls, schools, and group fitness classes would be closed but churches open despite their similar risk of disease transmission. the result also could be the wrongful and unnecessary infringement of other rights when the policy is not likely to be outcome-determinative. if the full range of rights exercised absent emergencies remains owed to the people in emergencies, or courts continue disparate analyses of orders infringing those rights, many orders could face preliminary injunctions before they can save lives, while other orders could unnecessarily restrict liberty. that result further undermines trust in public health experts and elected officials. while civil liberties are the pillar of liberal democracy, a temporary (an established shortest possible period) decrease in liberties is imperative to the future enjoyment of those civil liberties. with over 500,000 deaths from covid-19, preparation for future emergencies should include legal and ethical clarity on which orders are evaluated under a deferential approach and which call for heightened or strict scrutiny. there is a decisive question: will the order contain zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 7 the virus, save many lives, or bring the crisis to an end using reasonable means under the circumstances? if so, the order likely deserves the jacobson analysis. 1 they do not equate to suspending constitutional rights; in emergencies, public health policies can infringe on liberty in the short time in accordance with limitations on constitutional rights. but see lindsay f. wiley and stephen i. vladeck, coronavirus, civil liberties, and the courts: the case against “suspending” judicial review, harvard law review forum, vol. 133, no. 9, july 2020. https://harvardlawreview.org/2020/07/coronavirus-civil-liberties-and-the-courts/ (arguing jacobson represents the suspension of rights and should not supplant caselaw that addresses rights absent emergencies.) 2 jacobson v. massachusetts, 197 us 11 (1905). 3 roman catholic diocese of brooklyn v. cuomo, 592 u.s. ____at ___ (per curiam); south bay pentecostal church v. newsom, 592 us __ (2021). 4 smith, george p., ii, "re-shaping the common good in times of public health emergencies: validating medical triage," 18 annals of health law 1 (2009). citing terminiello v. chicago, 337 us 37 (1949) (jackson, j., dissenting). smith also refers to posner, richard a., not a suicide pact: the constitution in a time of national emergency, oxford university press (2006). 5 wendy k. mariner, george j. annas, and leonard glantz, “jacobson v massachusetts: it's not your great-great-grandfather's public health law.” american journal of public health vol. 95,4 (2005): 581-90. doi:10.2105/ajph.2004.055160 (most supreme court citations of jacobson are for public health deference and social compact theory.) “whatever may be thought of the expediency of this statute, it cannot be affirmed to be, beyond question, in palpable conflict with the constitution. nor, in view of the methods employed to stamp out the disease of smallpox, can anyone confidently assert that the means prescribed by the state to that end has no real or substantial relation to the protection of the public health and the public safety.” n jacobson, a smallpox vaccination was required, and those not in compliance were fined five dollars. the vaccination had a clear, obvious relationship to public health. 6 jacobson, at 27. “upon the principle of self-defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members.” 7 jacobson, at 29. 8 lindsay f. wiley and stephen i. vladeck, coronavirus, civil liberties, and the courts: the case against “suspending” judicial review, harvard law review forum, vol. 133, no. 9, july 2020. https://harvardlawreview.org/2020/07/coronavirus-civil-libertiesand-the-courts/ 9 united states v. carolene products company, 304 u.s. 144 (1938), footnote 4, (court applies rational basis test and footnote 4 limits deference to legislatures and the states in economic matters but suggests that legislation that infringes certain fundamental rights should get more serious scrutiny.) see dandridge v. williams, 397 u.s. 471 (1970), justice marshall, dissenting (even if strict scrutiny does not apply, intermediate levels should, establishing a less binary approach to rational basis or strict scrutiny.) 10 jacobson, at 25. (“reasonable regulations”). jacobson has been applied to two distinct subject matters: police power and public health regulation. judges have cited it to justify many state powers including water fluoridation kraus v. cleveland, 163 ohio st. 559 (1953), nonemergency mandatory vaccination for school zucht v. king, 260 u.s. 174 (1922). and a 24 hour wait time before abortions (in a dissent) thornburgh v. american college of obstetricians and gynecologists, 476 u.s. 747 (1986), justice o’connor, dissenting. but see, richards v. texas, 757 s.w. 2d 723 (1988)(case challenging seat belt requirement; judge teague, dissenting cites jacobson for its reference to arbitrary laws, “…if a statute purporting to have been enacted to protect the public health, the public morals, or the public safety, has no real or substantial relation to those objects, or is, beyond all question, a plain, palpable invasion of rights secured by the fundamental law, it is the duty of the courts to so adjudge, and thereby give effect to the constitution.” and teague continues, “given the lack of any evidence that might reflect that the seat belt law has a real substantial relation to the general public health and general public safety, the police power rationale is certainly not applicable to this case according to settled principles that the police power of a state must be held to embrace such reasonable regulations established directly by legislative enactment as will protect the general public health and the general public safety, and not just the health and safety of a few individuals. see gibbons v. ogden, 22 u.s. (9 wheat) 1, 203, 6 l. ed. 23, 71.”) zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 8 11 roman catholic diocese of brooklyn v. cuomo, 592 u.s. ____at ___ (per curiam). 12 494 u.s. 872, (1990) 13 church of lukumi babalu aye, inc. v. hialeah, 508 u. s. 520, 546 (1993). 14 roman catholic diocese, sotomayor dissent (joined by kagan). 15 south bay pentecostal church v. newsom, 592 us __ (2021). (roberts confirms his view of state power but limits it to preclude a ban on religious services. he would defer to the state in the capacity limitation and ban on chanting and singing. gorsuch, joined by thomas and alito, simply applies strict scrutiny as he would for any first amendment case, pandemic or not. barrett, with kavanagh, comments only to say the singing and chanting ban may be acceptable based on facts, but that she otherwise agrees with gorsuch. in sum, the shifting balance of the court demonstrates that post ruth bader ginsburg, free exercise may receive more deferential treatment than public health experts.) 16 south bay pentecostal church v. newsom (2021) (dissent). 17 wendy e. parmet, “rediscovering jacobson in the era of covid-19,” 100 b.u. l. rev. online 117 (2020) http://www.bu.edu/bulawreview/files/2020/07/parmet.pdf (citing first baptist church v. kelly, no. 20-cv-01102, 2020 wl 1910021 (d. kan. apr. 18, 2020).) 18 national association of theatre owners v. murphy, case no. 3:20-cv-8298 (brm) (tjb) 31 (d.n.j. aug. 18, 2020); see https://ij.org/cje-post/a-tale-of-two-cases-and-two-pandemics/ 19 nat’l assoc. of theatre owners, at 30. 20 nat’l assoc. of theatre owners, at 30-31 citing s. bay united pentecostal church v. newsom (2020) roberts concurring. 21bayley campgrounds v. mills, no. 2:20-cv-00176-lew, 463 f. supp. 3d, 22 (d. me. 2020) order on plaintiff’s motion for preliminary injunction https://www.courthousenews.com/wp-content/uploads/2020/05/bayley.pdf. bayley's campground inc v. mills, no. 20-1559 (1st cir. 2021) (first circuit affirms without mentioning jacobson.) 22 the district judge, lance walker, cites lindsay wiley for the assertion that individual rights deserve the substantive constitutional analysis. despite the judge’s disagreement with the maine governor’s application of jacobson, the judge does not issue the injunction the plaintiffs are seeking due to uncertain likelihood of success on the merits.) 23 bayley (1st cir.), at 16. 24 in re abbott, 954 f. 3d 772 (5th cir. 2020). 25 in re rutledge, no. 20-1791 (8th cir. 2020). 26 lindsay f. wiley and stephen i. vladeck, coronavirus, civil liberties, and the courts: the case against “suspending” judicial review, harvard law review forum, vol. 133, no. 9, july 2020. (citing robinson v. attorney general 957 f.3d 1171 (11th cir. 2020) and adams & boyle, p.c. v. slatery, 956 f. 3d 913 (6th cir. 2020)) https://harvardlawreview.org/2020/07/coronavirus-civilliberties-and-the-courts/; see also herbert h. slatery iii, attorney general of tennessee, et al., petitioners v. adams & boyle, p.c., et al. https://www.law360.com/cases/5f874cc95a7879003429af84?article_sidebar=1 and planned parenthood center for choice, et al., petitioners v. greg abbott, governor of texas, et al. https://www.law360.com/cases/5f5928526e30c200346ec69f?article_sidebar=1 the supreme court in january vacated two circuit court abortion decisions (now moot) that applied jacobson to laws that do not on their face further an obvious government purpose in the pandemic. 27 508 u. s. 520, 546 (1993) (requiring a compelling interest and use of the least restrictive means if treating churches differently from comparable secular organizations) 28 “lawsuits about state actions and policies in response to the coronavirus (covid-19) pandemic, 2020-2021,” bollotpedia.org https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid19)_pandemic,_2020-2021 (a list of covid-19 lawsuits concerning restrictive policies.) https://casetext.com/case/church-of-lukumi-babalu-aye-inc-v-city-of-hialeah#p546 https://harvardlawreview.org/2020/07/coronavirus-civil-liberties-and-the-courts/ https://harvardlawreview.org/2020/07/coronavirus-civil-liberties-and-the-courts/ https://www.law360.com/cases/5f874cc95a7879003429af84?article_sidebar=1 https://www.law360.com/cases/5f5928526e30c200346ec69f?article_sidebar=1 https://casetext.com/case/church-of-lukumi-babalu-aye-inc-v-city-of-hialeah#p546 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 zimmerman, weeding out disingenuous emergency orders, voices in bioethics, vol. 7 (2021) 9 29 nra brought lawsuits in many states where gun stores were closed during broad shutdowns of nonessential businesses. for example, see brandy, nra, et al. v. villanueva, (central dist. ca. 2020) case 2:20-cv-02874, complaint for injunctive and declaratory relief (case closed on failure of plaintiff’s to correct a discrepancy.) https://d3n8a8pro7vhmx.cloudfront.net/firearmspolicycoalition/pages/5562/attachments/original/1585333514/2020-3-27-cabrandy-complaint.pdf?1585333514 30 looney v. newsom (lawsuit by parents for right to basic education and educational equality; argued against hybrid and online school.) https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid19)_pandemic,_2020-2021 31 auracle homes, llc v. lamont, no. 3:20-cv-00829 (vab) (d. conn. aug. 7, 2020) ct (right to privately contract, to evict, to use courts for evictions; court denies preliminary injunction); brown v. azar, civil action no. 1:20-cv-03702-jpb (n.d. ga. oct. 29, 2020)(plaintiffs argue cdc eviction moratorium violates limits on supremacy clause, anti-commandeering, and access to courts. court denies preliminary injunction.) 32 friends of danny devito v. wolf, 227 a.3d 872 (pa. 2020) (challenge to pennsylvania’s strict business closures. court denied stay; held order was within governor’s broad emergency powers and statutory authority.) 33 neville v. polis (col) (petition filed august 26, 2020 challenging colorado disaster emergency act and state executive orders. dismissed and colorado court refused to hear appeal.) https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid19)_pandemic,_2020-2021 34 desantis v. fla. educ. ass'n, no. 1d20-2633 (fla. dist. ct. app. dec. 21, 2020)(florida teachers challenged state order to keep schools open arguing local school boards have authority.) 35 state of florida ex rel. jackson v. donald j. trump for president, inc. https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid19)_pandemic,_2020-2021 36 illinois republican party v. pritzker, 973 f.3d 760 (7th cir. 2020) (republican party claim first and fourteenth amendment violations because a state order favored one type of speech over another. district court relied on jacobson. 7th circuit emphasized importance of free exercise yet denied preliminary injunction.) 37 anthony sanders, “a tale of two cases and two pandemics,” institute for justice https://ij.org/cje-post/a-tale-of-two-casesand-two-pandemics/ (as of september 2020, 120 cases had cited jacobson since the pandemic began.) https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ballotpedia.org/lawsuits_about_state_actions_and_policies_in_response_to_the_coronavirus_(covid-19)_pandemic,_2020-2021 https://ij.org/cje-post/a-tale-of-two-cases-and-two-pandemics/ https://ij.org/cje-post/a-tale-of-two-cases-and-two-pandemics/ belisomo, poop, death and other health taboos from ideo’s paul bennett, voices in bioethics, vol. 1 (2014-15) © 2015 randi belisomo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. poop, death and other health taboos from ideo’s paul bennett randi belisomo keywords: death, terminal illness introduction poop. hair removal. amputation. skin lesions. erectile dysfunction. death. those are some of the few taboos remaining in health care, according to paul bennett, chief creative officer of the global design company ideo. the san francisco-based brit has made a career by chipping away at some of the stigma surrounding several items on this list—encouraging colon cancer screenings through educational product design and removing visible signs of handicap from the homes of amputees. now bennett is attempting to kill all taboo tied to the condition that he jokes as having “100 percent market penetration”: death. analysis the designer, now associated with the widely-praised, sensory-engaging zen hospice project, recently addressed a group of health technology entrepreneurs at matter, a shared-office hub in chicago’s merchandise mart. “it’s one of the biggest taboos to stare down and design for,” bennett told the crowd, sharing that the inspiration for his newest interest was his father’s end of life experience. he died 13 years ago from bone cancer. “he was obsessed with maintaining his dignity, and he said ‘if i can’t wipe my own ass, turn me off please.’” bennett’s father asked family members not to visit in his last days, as he did not want to be remembered in such ill health. “he was being a designer, trying to design the one thing he had left– his death,” bennett said. bennett also recognized that this death could have been easier, and less traumatic for his mother. that experience is one from which he said she will recover. bennett knew then that his father’s death should not have had to be that way. in the years since, however, a remarkable shift has occurred. “media is suddenly making death a very hot topic,” he said. “all of the sudden, we’re asking ‘who was i, who am i, and what will i be?” it’s the responsibility of our culture and social development to help others answer those questions. bennett urged those with the talent to do so to help individuals make deaths be as individual as their lives. however, if dying remains so taboo, most of us will remain uncomfortable both learning and sharing what an ideal end of life experience would mean to them. belisomo, poop, death and other health taboos from ideo’s paul bennett, voices in bioethics, vol. 1 (2014-15) 2 bennett offered the following advice to physicians and other care providers discussing end of life issues with patients, for business people working in death-related fields and for family members facilitating important conversations about the topic. his perspective as a designer creatively reframes a familiarand universalproblem. conclusion principles in potentially taboo spaces: 1) confront your own bias – one man’s taboo is another man’s normal – what is taboo is context-specific and it changes with the times 2) expose and normalize –listen acutely to what is being said and not said 3) be vulnerable –where am i? –can i change my viewpoint? 4) embrace the emotional –how do people feel here? –how do they feel about their feelings? 5) use humor – how do i lighten the heaviness? –how do i create a safe space to laugh? 6) meet people where they are –how do i engage people in ways they are ready to take in? –how do i help them take small bites? sebastian agredo, patients on a midnight bus to anywhere, voices in bioethics, 2013 © 2013 sebastian agredo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. patients on a midnight bus to anywhere sebastian agredo keywords: lawsuit, patients, vulnerable introduction the policy is called nevada’s client transportation back to home communities. despite its name, which implies good intent and compassion for the patient being transported, this policy has recently found itself at the center of a lawsuit brought forth by the city of san francisco against the state of nevada. an investigation led by the san francisco attorney’s office has revealed that since 2008, over 1,500 mentally ill patients have been bused out of the rawson-neal psychiatric hospital in las vegas and essentially “dumped” on other cities. the lawsuit asserts that 24 of these patients were left to their own devices upon their arrival in san francisco, given only a small amount of food, and told to call 911 or find a shelter for help. these patients most certainly required further treatment, costing the city and its taxpayers $500,000. what the lawsuit is describing is a case of “patient dumping”, which occurs when a hospital capable of providing the necessary medical care transfers the patient to another facility or simply discharges the patient because of their inability to pay for the required services. not surprisingly, there are federal regulations prohibiting this kind of behavior by hospitals, and violators are punished with stiff monetary penalties and their medicare provider agreements are suspended. what is surprising, however, is that some hospitals are indifferent to the policy or find creative ways to “dump” patients while claiming to have offered necessary care. regardless of their excuses, hospitals have a social duty to ensure that patients who walk through their doors – whether insured or not – are treated justly and discharged with dignity. the matter of expenses should come second. it is not hard to find the glaring bioethical issues that are a part of this developing case, and the story serves to shed a necessary light on a type of practice more prevalent than people think. if the allegations outlined in the lawsuit are true, then the rawson-neal psychiatric hospital has clearly victimized members of a vulnerable population who deserve nothing less than respect and compassionate treatment. those afflicted with mental illness have been the target of abhorrent and cruel treatment throughout history, mostly at the hands of physicians and a society ignorant of the delicacy of their disorder. however, as a modern society learning from the mistakes of the past, we have come to realize that the mentally ill are not a people to be feared or cast out, but nurtured and provided with respectful care. the fact that the staff members in this las vegas psychiatric institution would disregard their professional and moral duty to these patients – regardless of their ability to pay for expenses – shows a lack of understanding and empathy, and one that should be met with swift punishment. this case illustrates that some institutions will forego good judgment and “dump” vulnerable patients in a foreign city, without so much as a hand to guide them to safe care. although the lawsuit brought forth by san francisco did bring this issue to the forefront, it does not seem that any monetary compensation will fix the issue long-term. what the mental health system needs is a better form of communication across state lines and between sebastian agredo, patients on a midnight train to anywhere, voices in bioethics, 2013 2 psychiatric institutions and hospitals in order to ensure that these patients do not get left out in the cold, or alone at a bus stop. san francisco sues nevada over “patient dumping” http://abcnews.go.com/health/san-francisco-sues-nevada-patient-dumping/story?id=20350308 vanderbilt university medical center accused of patient dumping http://www.tennessean.com/article/20130924/news07/309240015/vanderbilt-university-medical-centeraccused-patient-dumping proposal would create tougher penalties for patient dumping http://www.ktnv.com/news/local/bill-proposal-would-create-tougher-penalties-for-patient-dumping225103922.html ____________________________________________________________ http://abcnews.go.com/health/san-francisco-sues-nevada-patient-dumping/story?id=20350308 http://www.tennessean.com/article/20130924/news07/309240015/vanderbilt-university-medical-center-accused-patient-dumping http://www.tennessean.com/article/20130924/news07/309240015/vanderbilt-university-medical-center-accused-patient-dumping http://www.ktnv.com/news/local/bill-proposal-would-create-tougher-penalties-for-patient-dumping-225103922.html http://www.ktnv.com/news/local/bill-proposal-would-create-tougher-penalties-for-patient-dumping-225103922.html sebastian agredo, patients on a midnight train to anywhere, voices in bioethics, 2013 3 analysis the template is used to format your paper and style the text. all margins, column widths, line spaces, and text fonts are prescribed; please do not alter them. you may note peculiarities. for example, the margin at the bottom of the first page in this template measures proportionately more than is customary. this measurement and others are deliberate, using specifications that anticipate your paper as one part of the entire 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(p. 125) conclusion before you begin to format your paper, first write and save the content as a separate text file. keep your text and graphic files separate until after the text has been formatted and styled. do not use hard tabs, and limit use of hard returns to only one return at the end of a paragraph. do not add any kind of pagination anywhere in the paper. do not number text heads-the template will do that for you. a conclusion section is not required. although a conclusion may review the main points of the paper, do not replicate the abstract as the conclusion. a conclusion might elaborate on the importance of the work or suggest applications and extensions. introduction analysis conclusion mitchell, ethical concerns of school closures, voices in bioethics, vol. 6 (2020) * shami-iyabo mitchell, ms candidate columbia university © 2020 shami mitchell. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethical concerns of school closures for low-income school aged children shami-iyabo mitchell* abstract covid-19 forced students to shift to online learning highlighting a disparity in access to the internet. a lack of internet access made it difficult for low-income children to seamlessly transition to an online learning environment. the amount of support provided for educational infrastructure is insufficient; more needs to be done to ensure equality in internet accessibility for school-aged children. the role of government must include a plan to provide computers and internet access to achieve education equity and level the playing field for students of all incomes. keywords: education ethics, access to technology, low-income education, bioethics, poverty introduction covid-19 is the latest threat to educational equity.1 the use of technology for work, school, and social interaction has increased for many americans yet not all have access to technology necessary to fully participate. one of the groups most impacted, but often overlooked, is the youth who were forced to shift from in-person to online classrooms. many k-12 institutions closed schools promptly to ensure the safety of their students, faculty, and staff. however, as reliance on the internet was a necessary precondition to successful online learning, the lack of internet access in low-income communities dealt a devastating setback to children from underprivileged families. many parents recently furloughed from their jobs due to the virus were unable to bear the costs associated with adequate technology for their children’s education. this lack of mitchell, ethical concerns of school closures, voices in bioethics, vol. 6 (2020) 2 access to the internet and computers has been termed in the literature the “homework gap”— which refers to the lack of minimum connectivity children need in order to complete schoolwork at home. covid-19 has highlighted the digital divide among upperand lower-income groups, and the emerging “homework gap” in low-income families must be taken into consideration when attempting to reach the goals of government agencies, policymakers, and educational institutions.2 analysis i. income, race, and lack of internet access as early as march 16, 2020, widespread school closures due to covid-19 began to take place in the united states. some schools remained closed throughout the duration of the academic semester (march-may) while others began to quickly and effortlessly shift to an online platform for student learning and engagement to close out the semester. stonegate elementary in irvine, california was one school that continued online core math and english classes shortly after school closures.3 yet the same cannot be said for new oxford middle school in rural pennsylvania where students have consistently reported not having access to computers and a reliable way to get online.4 in addition, the technology inequities that exist between schools with majority low-income and those with majority high-income students are numerous and the impact of the digital divide on these communities is concerning. roughly one-third (35 percent) of households with children ages 6 to 17 and an annual income below $30,000 a year do not have a high-speed internet connection at home, compared with just 6 percent of households earning $75,000 or more a year.5 if online education becomes the norm for the foreseeable future, a generation of low-income children will be missing months of formal education widening the education gap between poorer and wealthier students. the lack of access to the internet and computers that affects low-income groups disproportionately hurts families of color. school closures heightened the digital divide that existed prior to january 2020. 70 percent of educators assign online work; however, 12 million children do not have wi-fi access.6 the lack of internet access contributes to the increased chronic absenteeism patterns surfacing during this pandemic. chronic absenteeism is characterized as a child missing 15 or more days of school per year7 and has social implications for many school aged children. the rate of chronic absenteeism is particularly high in schools with many lowincome students. chronic absenteeism has been associated with poor academic performance and high dropout rates, and it is an important predictor of both low income in adulthood and poor lifetime health.8 as a result, a generation of low-income children is more likely to socially reproduce another generation of lowincome children. in this country, there is also a racial divide among internet users. a 2017 report from the democratic staff of the joint economic committee found that white residents are more likely to have internet connections in their homes than people of color.9 students of color who are unable to turn in homework assignments or join class sessions will be at an increased risk of failing courses and having to repeat grades. the burden of having to pay for and acquire the internet is not equally distributed and represents an injustice stemming from racial inequity. school closures have also heightened other disparities in low-income households. when there is an infectious disease outbreak transmissible through human-to-human contact like covid-19, the world health organization recommends school closures to limit disease spread.10 however, the closing of all schools for children in grades k-12 should not be taken lightly as school provides a space for students to gain essential social, mental, and educational growth. underprivileged students tend to have fewer educational mitchell, ethical concerns of school closures, voices in bioethics, vol. 6 (2020) 3 opportunities beyond school and the closing of schools has made this disparity ever more present.11 when schools close, some parents facilitate learning for their children. however, some parents with limited time due to work, limited education, and resource constraints cannot provide the oversight necessary. despite schools closing, parents still must work even if that means despite great effort to secure childcare, they must occasionally leave a child without childcare. the child's likelihood of failing to login online for class if the family has access to technology and failure to do educational tasks that do not require computers would then increase. children who are not supervised at home may engage in more risky behaviors.12 these separate but interrelated potential issues demonstrate how educational disparities that previously existed between low and high-income students can be exacerbated by the recent school closures. school closures not only have practical implications like lack of internet accessibility, but they have social ones. schools are used as vehicles of socialization that can provide a potential haven for students with difficult lives at home. when you take away one of the main sources of social interaction and abuse surveillance locations like schools, unforeseen consequences for school aged children and their parents can result. ii. private sector solutions the digital divide is characterized by various barriers to access including cost and internet access. internet providers have sponsored and marketed programs to provide a “solution” to low-income communities without equitable access to the internet. at&t communications, an internet service provider, created a covid-19 response deal for low-income households where participants pay ten dollars a month for internet access. however, ironically, the quickest and most effective way to apply is online. if families do not have access to the internet, then it would most likely follow that they would have limited to no access to a computer in order to apply online. the other option listed is for families to print a form and mail it to the company. however, families without internet access most likely do not have access to a printer. in addition, the program is only offered in 21 states and, as a result, the benefits of the programs are disproportionately spread.13 comcast, another internet provider, offers similar online applications as well as the option of calling over the phone; however, the recipient gets only 60 days of access. in addition, the company provides refurbished computers for $149.99 plus tax.14 although these expenses may seem small, for an unemployed parent with no source of income, ten dollars per month for the internet is a major expense. programs like these are only a temporary solution to the digital divide fraught with limitations like short time periods, barriers to apply, and a price tag rather than free access. through government programs, public schools could potentially provide internet access free to their students. iii. government solutions there are differing opinions of whose responsibility it is to provide internet access. roughly half (52 percent) of democrats and independents who lean toward the democratic party believe it is the federal government’s responsibility to ensure americans have a high-speed internet connection at home during the outbreak. by comparison, a smaller share (22 percent) of republicans and republican-leaning independents hold this view about the government ensuring home broadband access.15 three stimulus packages have been passed to date in response to covid-19: the families first coronavirus response act,16 the coronavirus preparedness and response supplemental appropriations act,17 and the coronavirus aid, relief, and economic security act— also known as the cares act.18 the families first coronavirus response act provided paid sick leave, tax credits, free covid-19 testing, expanded food assistance and unemployment benefits, and increased medicaid funding. the coronavirus preparedness and response supplemental appropriations act provided aid for the food and drug administration(fda) for salaries and expenses, small business administrative costs, the centers for disease control and prevention (cdc), national institutes of health (nih), the office of the mitchell, ethical concerns of school closures, voices in bioethics, vol. 6 (2020) 4 secretary, and other administrative groups and roles. the cares act appropriated funds to aid individuals ($603.7 billion), big businesses ($500 billion), small businesses ($377 billion), state and local governments ($340 billion), and public services ($179.5 billion). of the three bills passed, only 1.5 percent of the aid from the cares act was allocated for the education stabilization fund for all states. there has been widespread agreement that educational institutions will require more than what was allotted so far to continue to provide education to students.19 in a letter to house and senate leadership, 35 us senators are pushing for the next stimulus package to provide $2 trillion to close the “homework gap.”20 some republicans have stalled stating that they want to ensure that money already allocated in past packages is being properly distributed. democrats are looking to include major digital infrastructure upgrades in the next phase of legislation such as changes to broadband and 5g to improve america's remote connectivity. it is the responsibility of government agencies to promote the general welfare of citizens per the preamble to the us constitution. the government generally achieves the aim of providing basic necessities through social improvement programs.21 providing equitable internet access for all students could ultimately disrupt the cycle of poverty in at-risk families. opportunities and growth are limited when access to the internet is unavailable or limited. the government is the appropriate provider of internet because of technologies’ outsized role in participation in society. internet freedom should not only be the right to uncensored internet and net neutrality, but also a right to access to the internet. it would be unjust to have a freedom that can be enjoyed only by the middle class and the wealthy. low-income americans without access to the internet would be unable to access better jobs and create economic wealth. government should strive for the ethical goal of leveling the playing field so that all have equal opportunity. education is a special good that the government provides so that regardless of race or income level, people can secure better paying jobs, save more money, and become less likely to need government assistance in the future. while some may argue that the government does not need to provide internet access, it is a fundamental part of modern education, necessary to the mission of public school for everyone, and essential during the covid-19 pandemic. conclusion this public health crisis has exposed a technological one. schools closed in early march and some were able to smoothly transition to an online platform more quickly than others. many families experienced job loss, death, and uncertainty prior to considering the implications of a lack of internet access. in addition, communities of color struggled with the deaths of innocent black people at the hands of law enforcement adding to their stress, vulnerability, and outrage. the unequal burden of barriers to internet access exacerbates racial inequity, highlighting the need for black lives matter to extend to technology injustice. many of the most vulnerable pockets of our nation, rural and inner-city low-income communities, have limited or no access to computers or the internet; our youth are paying the price for this disparity known as the digital divide. corporate programs like those offered by at&t and comcast simply serve as a band aid to an everbleeding wound. the government is the proper entity to take this on. part of public-school education is ensuring every child has access to the tools necessary to learn. if more is not done to address the lack of internet access for low-income groups, then there will be an entire generation of low-income students who fall behind or drop out of school. the educational and social benefits of an online community during covid19 should be equally shared among all children to create a level playing field and a better future. mitchell, ethical concerns of school closures, voices in bioethics, vol. 6 (2020) 5 1 calhoun, kristine e et al. “the impact of covid-19 on medical student surgical education: implementing extreme pandemic response measures in a widely distributed surgical clerkship experience.” american journal of surgery vol. 220,1 (2020): 44-47. doi:10.1016/j.amjsurg.2020.04.024 2 “as schools close due to the coronavirus, some u.s. students face a digital ‘homework gap’” pew research center, washington, d.c. march 16,2020, https://www.pewresearch.org/fact-tank/2020/03/16/. accessed 19 august 2020. 3 richards, erin. “parents guide to online school: 9 questions that help vet your back-to-school choices' '. 16 july 2020, https://www.usatoday.com/story/news/education/2020/07/16/back-to-school-reopening-online-parents-guide/5416528002/. accessed 20 august 2020. 4 romm, tony. ‘it shouldn't take a pandemic’: coronavirus exposes internet inequality among u.s. students as schools closed their doors. march 16, 2020, https://www.washingtonpost.com/technology/2020/03/16/schools-internet-inequalitycoronavirus/. accessed 18 august 2020. 5 pew research, 2020. 6 united states, congress, senate. united states senate letter. government printing office, 2006, https://www.vanhollen.senate.gov/imo/media/doc/coronavirus%20stimulus%204%20homework%20gap%20funding.pdf. 7 lim, eunjung et al. “effect of sociodemographics, health-related problems, and family structure on chronic absenteeism among children.” the journal of school health vol. 89,4 (2019): 308-318. doi:10.1111/josh.12736 8 goldstein,dana. “as school moves online, many students stay logged out. new york times, 6 april2020,pc1. academic onefile, https://www.nytimes.com/2020/04/06/us/coronavirus-schools-attendance-absent.html. accessed 20 august 2020; robert wood johnson foundation. the relationship between school attendance and health; 2016, http://www.rwjf.org/en/library/research/2016/09/the-relationshipbetween-school-attendance-and-health.html. accessed august 20, 2020; henderson t, hill c, norton k. the connection between missing school and health: a review of chronic absenteeism and student health in oregon; 2014, http://www.attendanceworks.org/wordpress/wpcontent/uploads/2014/10/chronic-absence-and-health-review-10.8.14-finalrevised.pdf. accessed august 18, 2020. 9 america's digital divide.u.s. congress joint economic committee, 2017, https://www.jec.senate.gov/public/_cache/files/ff7b3d0b-bc00-4498-9f9d-3e56ef95088f/the-digital-divide-.pdf. accessed 20 august 2020. 10 world health organization. reducing transmission of pandemic (h1n1) 2009 in school settings. september 2009, https://www.who.int/csr/ resources/publications/reducing_transmission_h1n1_2009.pdf. accessed 9 february 2020. 11 unesco covid-19 educational disruption and response, https://en.unesco.org/covid19/education response. accessed april 13 2020. 12 unesco covid-19 educational disruption and response, https://en.unesco.org/covid19/ education response. accessed april 13 2020. 13 “what at&t is doing to help prevent the spread of coronavirus”. at&t, https://about.att.com/pages/covid-19.html. accessed 18 august 2020. 14 “bring home affordable high speed internet.” comcast, https://www.internetessentials.com/?utm_source=google&utm_campaign=iehsi&utm_medium=search&utm_content=iehsi&g clid=eaiaiqobchmipjv7296l6wivkybach0ewwf4eaayasaaegizzpd_bwe&gclsrc=aw.ds. accessed 13 august 2020. 15 “53% of american say the internet has been essential during the covid-19 outbreak” pew research center, washington, d.c. march 16,2020, https://www.pewresearch.org/fact-tank/2020/03/16/, https://www.pewresearch.org/internet/2020/04/30/53of-americans-say-the-internet-has-been-essential-during-the-covid-19-outbreak/. accessed 19 august 2020. 16 united states, congress, house, families first coronavirus response act. government printing office, 2020. https://www.congress.gov/bill/116th-congress/house-bill/6201. accessed 20 august 2020. 17 united states, congress, house, coronavirus preparedness and response supplemental appropriations act. government printing office, 2020, https://www.congress.gov/bill/116th-congress/house-bill/6074/text. accessed 18 august 2020. 18 united states, congress, house, the coronavirus aid, relief, and economic security (cares) act. government printing office, 2020, https://www.congress.gov/bill/116th-congress/housebill/748?q=%7b%22search%22%3a%5b%22h.r.+748%22%5d%7d&s=1&r=1. 18 august 2020. 19 fratzscher, marcel, et al. "a stable and social europe: fiscal rules, a stabilization fund, insolvency rules, gender quota, gender pension gaps, and education. reports." diw weekly report 9.16/18 (2019): 148-159. 20 “senators markey, van hollen, bennet,and schatz lead colleagues in renewed push to ensure all students can continue education online during coronavirus pandemic”, 2020. united states senator for massachusetts press release, https://www.pewresearch.org/fact-tank/2020/03/16/ https://www.usatoday.com/story/news/education/2020/07/16/back-to-school-reopening-online-parents-guide/5416528002/ https://www.washingtonpost.com/technology/2020/03/16/schools-internet-inequality-coronavirus/ https://www.washingtonpost.com/technology/2020/03/16/schools-internet-inequality-coronavirus/ https://www.vanhollen.senate.gov/imo/media/doc/coronavirus%20stimulus%204%20homework%20gap%20funding.pdf https://www.nytimes.com/2020/04/06/us/coronavirus-schools-attendance-absent.html.%20accessed%2020%20august%202020 http://www.rwjf.org/en/library/research/2016/09/the-relationshipbetween-school-attendance-and-health.html http://www.attendanceworks.org/wordpress/wp-content/uploads/2014/10/chronic-absence-and-health-review-10.8.14-finalrevised.pdf http://www.attendanceworks.org/wordpress/wp-content/uploads/2014/10/chronic-absence-and-health-review-10.8.14-finalrevised.pdf https://www.jec.senate.gov/public/_cache/files/ff7b3d0b-bc00-4498-9f9d-3e56ef95088f/the-digital-divide-.pdf https://about.att.com/pages/covid-19.html https://www.internetessentials.com/?utm_source=google&utm_campaign=iehsi&utm_medium=search&utm_content=iehsi&gclid=eaiaiqobchmipjv7296l6wivkybach0ewwf4eaayasaaegizzpd_bwe&gclsrc=aw.ds https://www.internetessentials.com/?utm_source=google&utm_campaign=iehsi&utm_medium=search&utm_content=iehsi&gclid=eaiaiqobchmipjv7296l6wivkybach0ewwf4eaayasaaegizzpd_bwe&gclsrc=aw.ds https://www.pewresearch.org/fact-tank/2020/03/16/ https://www.pewresearch.org/internet/2020/04/30/53-of-americans-say-the-internet-has-been-essential-during-the-covid-19-outbreak/ https://www.pewresearch.org/internet/2020/04/30/53-of-americans-say-the-internet-has-been-essential-during-the-covid-19-outbreak/ https://www.congress.gov/bill/116th-congress/house-bill/6201 https://www.congress.gov/bill/116th-congress/house-bill/6074/text https://www.congress.gov/bill/116th-congress/house-bill/748?q=%7b%22search%22%3a%5b%22h.r.+748%22%5d%7d&s=1&r=1 https://www.congress.gov/bill/116th-congress/house-bill/748?q=%7b%22search%22%3a%5b%22h.r.+748%22%5d%7d&s=1&r=1 mitchell, ethical concerns of school closures, voices in bioethics, vol. 6 (2020) 6 https://www.markey.senate.gov/news/press-releases/senators-markey-van-hollen-bennet-and-schatz-lead-colleagues-inrenewed-push-to-ensure-all-students-can-continue-education-online-during-coronavirus-pandemic. accessed august 20 2020. 21 “our american government” u.s. government printing office. 20 june 2003. https://www.markey.senate.gov/news/press-releases/senators-markey-van-hollen-bennet-and-schatz-lead-colleagues-in-renewed-push-to-ensure-all-students-can-continue-education-online-during-coronavirus-pandemic https://www.markey.senate.gov/news/press-releases/senators-markey-van-hollen-bennet-and-schatz-lead-colleagues-in-renewed-push-to-ensure-all-students-can-continue-education-online-during-coronavirus-pandemic winter 2015 a case for more generous compensation for human research subjects in non-therapeutic research carolyn riley chapman follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 how much payment participants in human research clinical trials should be allowed to receive continues to stir significant debate. federal regulations state: “an investigator shall seek…consent only under circumstances…that minimize the possibility of coercion or undue influence”.1 when surveyed, institutional review board (irb) members and human subjects protection professionals “indicated considerable ethical concern that payment could constitute coercion or undue inducement”.2 although historically viewed with misgiving, compensating research subjects is both acceptable and ethically warranted by the principles of autonomy, non-maleficence, beneficence and justice, particularly in nontherapeutic research. although current guidelines stress the dangers of paying research subjects too much, we should be more concerned about whether we are paying them too little. one illustrative example involves the analysis of a situation where a commercial entity seeks to recruit healthy volunteers to participate in a phase i clinical trial evaluating the safety, side effects, and appropriate dose range for a new drug. the trial may involve identifying the drug’s maximum tolerated dose, defined as the highest dose that can be taken without unacceptable side effects. this research is non-therapeutic in nature: participants do not stand to reap medical benefit, and, in fact, may undertake significant risk. furthermore, even if the drug is eventually approved by the united states food and drug administration (fda), the volunteers are not likely to benefit from the its commercialization. in contrast, the pharmaceutical company’s shareholders and corporate officers do stand to gain financially from the eventual sale of this new treatment. though the costs of research and development are great, once a drug is approved and on the market, future profits should recoup monetary investments. the fear that compensation causes undue inducement amongst research subjects is based on reasoning that autonomy might be compromised if participants are given enticements that render them unable to make rational decisions that uphold their own selfinterest. an undue inducement occurs when “the offered good leads to poor judgment which makes us take unnecessary, unreasonable, and excessive risk of harm, whether physical harm or the harm of violating important values”.3 many have argued that the rationale for undue inducement is paternalistic, and that restricting the range of options for research participants places unreasonable limits on their freedom.4 as reported in a recent wall street journal article, scientists from the walter reed army institute of research are considering whether to go forward with research that involves infecting healthy people with dengue fever.5 although volunteers will be paid, ethics committees will weigh “what would be reasonable and what would be considered coercive”.5 the article includes a comment from bioethicist dr. arthur caplan, who explains that compensation that would lead participants to dismiss the risks is typically considered too high5. empirical studies also suggest that limits are being placed on compensation to research participants. largent et al. found that 80% of surveyed irb members and human research professionals “judged that the offer of payment constitutes undue influence simply because it motivates someone to do something they otherwise would not”2. these authors argue that the professionals may be “adopting a conception of undue influence in voices in bioethics 3 research that is radically different from the conception they employ in other areas of life”.2 as an example, they suspect that “respondents are unlikely to think that a bioethicist is unduly influenced if the offer of $1,000 as honorarium to give a presentation motivates him to do so when he otherwise would not”.2 we need to consider carefully whether we are paternalistically discounting the ability of research participants to make autonomous decisions and unfairly precluding their opportunities for compensation. compensation provides clear benefits to research participants, thereby upholding the principle of beneficence. contrary to the idea that compensation blinds participants to the risks, some have pointed out that compensation may actually warn would-be volunteers to potential risks. lack of or low payment may create the false impression that participation is risk-free, or even that it provides therapeutic benefit when none is present.4 therefore, providing compensation may benefit the participants in three ways: 1) actual value of the compensation; 2) communication to the participant that they are making a contribution, and 3) communication to the participant that they are taking on risk. with respect to non-maleficence, clearly, most researchers do not intend to cause injury to participants in the course of clinical trials. yet, clinical trials are experimental, and in the case of phase i trials with new drugs and other non-therapeutic research, the effects cannot be completely known. the principle of non-maleficence is violated because there are inherent risks and a chance that participants will be harmed in some way. some voice concern that providing compensation may increase the riskiness inherent in trials, if irbs factor compensation as a benefit to be weighed against potential harms. however, as ezekiel emanuel rightly points out, review committees are tasked to ensure that “the anticipated risks are not excessive and, therefore, that it is reasonable for individuals to participate in the research trial”.3 the committees are also “required not to consider the incentives as a benefit in their assessment”.3 the office for human research protections (ohrp) also “continues to assert that irbs should not consider remuneration as a way of offsetting risks”.6 it is important to note ohrp’s position that “remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for agreeing to participate in research”.6 given that irbs should only approve protocols they believe warrant participation from volunteers without consideration of offsetting compensation, the amount of compensation that is given to participants should not be limited. issues of justice also require examination. the literature suggests that potentially coercive effects of undue inducement are particularly worrisome in vulnerable populations, such as those that are economically or educationally disadvantaged. however, restricting compensation effectively reduces options for those who are already financially strained. particularly in circumstances where a human research subject does not have potential to benefit from participating in research, we must be sure that policies aimed to protect do not enable exploitation. the issues raised in rebecca skloot’s the immortal life of henrietta lacks seem pertinent here. although the researchers that propagated the hela cells obtained from lacks’ tumor did not believe they had infringed upon her rights, one can certainly sympathize with her relatives’ feelings that lacks’ contribution to both voices in bioethics 4 research and commercial products was not adequately compensated.7 we should not expect participants to be motivated by altruism alone. it seems reasonable that participants in clinical trials be compensated. participants may deserve a financial reward when a drug is approved and commercialized. after all, research participants clearly contribute to the process because the drug cannot achieve approval without them. today’s emphasis on avoiding undue inducement may actually have the unintended consequence of allowing corporate sponsors of human research to undercompensate research participants. although undue influence is a valid concern, application of the principles of autonomy, non-maleficence, beneficence, and justice demonstrates that compensation for research participants should be less restrictive. one suggestion is to create a separate mechanism for the evaluation of a research study’s compensation component. the remainder of a research proposal can go through the regular irb review process. another idea might be to allow research participants to receive stock options (i.e., participate in the financial success of a drug if it does eventually make it to market). perhaps medical federal regulations need to be revised and clarified in order to allow research participants to receive the full compensation they deserve. 1. united states department of health and human services, office of the secretary, office of public health and science, office for human research protections, protection of human subjects: title 45, code of federal regulations, part 46, revised january 15, 2009, bethesda, md. 2. emily a. largent, christine grady, franklin g. miller, and alan wertheimer, “money, coercion, and undue inducement: attitudes about payments to research participants,” irb: ethics & human research, 34(1) jan/feb 2012: p. 1-8. 3. ezekiel j. emanuel, “undue inducement: nonsense on stilts?” american journal of bioethics, 5(5), 2005: p. 9-13. 4. ari vanderwalde and seth kurzban, “paying human subjects in research: where are we, how did we get here, and now what?” j law med ethics, 39 (3) 2011: p. 543-58. 5. shirley s. wang, “dengue fever researchers in military weigh infecting volunteers,” the wall street journal, november 13, 2014.http://online.wsj.com/articles/dengue-fever-researchers-in-militaryweigh-infecting-volunteers-1415908102. 6. united states department of health and human services, office of human research protections. “human research protections faq: when does compensating subjects undermine informed consent or parental permission?” october 18, 2013, http://answers.hhs.gov/ohrp/questions/7251. 7. rebecca skloot, the immortal life of henrietta lacks (new york: crown publishers, 2010). ducar, measles and morals, vices in bioethics, vol. 1 (2014-15) © 2015 dallas m. ducar. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. measles and morals: values must take center-stage with science dallas m. ducar keywords: morals, values, ethics, vaccination introduction with the recent measles outbreak, many clinicians are hoping that the news coverage will persuade parents across the country to vaccinate their children. yet, the hope that new scientific messages will change the minds of parents may be unfounded. a recent study found that parents with mixed or negative feelings toward vaccines became less likely to say they would vaccinate a future child after receiving messages that debunked myths about vaccines. 1 in this study, the researchers surveyed a nationally representative group of parents with children living at home, randomly assigning messages to each group. one group received scientific information debunking the vaccine-autism link while a second group received messages in favor of vaccines, and a third were randomized to a control group. the results of the study indicated that parents who saw messages aimed at debunking the vaccine myth were less likely to believe the myth than those who did not receive this information. however, this information also tended to elicit additional concerns that the parents had about vaccines. at the end of the study, the parents were using new arguments to defend their views on the topic. analysis this form of rationalization is often perceived as reasoning by the person involved. psychologists such as jonathan haidt from the university of virginia have noted that, “we may think we’re being scientists, but we’re actually being lawyers.”2 this includes the psychological phenomenon “confirmation bias,” wherein we give more credence to the arguments that support our beliefs. it is not clear that such high-profile events, such as the recent outbreak of measles in disneyland, will change public opinion drastically. ducar, measles and morals, voices in bioethics, vol. 1 (2014-15) 2 when scientific arguments do not work, what is left to convince those who will remain unconvinced? many parents refuse to vaccinate and take advantage of “personal belief exemption” laws, which allow the parents to send their unvaccinated children to school. these exemptions differ from “religious exemptions.” parents with religious exemptions tend to remain stalwart in their original argument when presented with arguments, citing their religious convictions. parents that oppose vaccines for personal belief exemptions do not cite religious conviction; however as cited previously, they can become less likely to vaccinate even after being presented with clear evidence in favor of vaccinations from their clinicians. this same pattern can be seen in other high-profile debates. the intergovernmental panel on climate change reached a scientific consensus years ago, and continues to issue new warnings regarding climate change, but what will more data do for the u.s. population? proponents of gun control continue to gather scientific evidence to support their positions, however opponents typically argue with values. perhaps these advocates might be better off beginning with common values that both sides agree with and build constructively. the scientific community must embrace an area it has previously discarded. the pro-vaccination movement must admit that values and beliefs do shape people’s lives in major ways. constructing core values as a common people will require morals to stand alongside scientific research. the recent outbreak has resulted in an emotional backlash against those skeptical of vaccines. recently there has been quite a bit of politicizing between the two ideologies, democrats have been encouraging vaccinations3 while republicans have been calling for a balance.4 this constant politicization of scientific issues risks isolating groups even further. republicans have attempted to describe the benefits vaccines can bring to a society while also waving the flag of “freedom.” this has been difficult for many of these politicians as they are attempting to hold mutually exclusive positions. one can either support the government’s authority to limit exemptions to promote herd immunity, or one can support the unrestricted freedom of parents in their choice to vaccinate. this contradiction can only be exposed if moral values are championed alongside scientific research in public discourse. conclusion supporting this form of discourse does not mean that these scientific issues should be argued with oppositional political rhetoric, but instead, constructive value-based dialogue. the real crisis is not measles, it is our inability to have a conversation as a nation. we should strike to the root of the crisis and start conversations about our common values. when engaging in these discussions, we must remember that we are all human with concerns, hopes, and morals. we all engage in self-reflection and are all deserving of honest communication. it is important to acknowledge our connectedness rather than risk polarization if we truly wish for our values to be conveyed. outbreaks and scientific evidence may not change minds but discussing the virtues that underpin our society can. 1 nyhan, brendan, jason reifler, sean richey, and gary l. freed. "effective messages in vaccine promotion: a randomized trial." pediatrics 133, no. 4 (2014): e835-e842. 2 haidt, jonathan. "the emotional dog and its rational tail: a social intuitionist approach to moral judgment." psychological review 108, no. 4 (2001): 814. ducar, measles and morals, voices in bioethics, vol. 1 (2014-15) 3 3 http://www.washingtonpost.com/news/morning-mix/wp/2015/02/02/get-your-kids-vaccinated-obama-tellsparents-doubting-indisputable-science/ 4 http://www.nytimes.com/politics/first-draft/2015/02/02/christie-says-parents-should-have-choice-onvaccinations/?hp&action=click&pgtype=homepage&module=photo-spot-region&region=top-news&wt.nav=topnews maboloc, critical pedagogy in the new normal, voices in bioethics, vol. 6 (2020) * christopher ryan maboloc, phd, associate professor, philosophy department, ateneo de davao university, davao city, philippines © 2020 christopher ryan maboloc. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. critical pedagogy in the new normal christopher ryan maboloc* abstract critical pedagogy is an educational approach that challenges students to develop the ability to recognize and criticize dominating theories and evaluate them in their social context. teachers press students to recognize oppression and try to remedy oppression in their culture. despite the lack of in-person interaction between the teacher and the students, the effort to use innovative teaching techniques like critical pedagogy should continue. keywords: global education, critical pedagogy, online learning, covid-19 introduction the coronavirus pandemic is a challenge to educators, policy makers, and ordinary people. in facing the threat from covid-19, school systems and global institutions need “to address the essential matter of each human being and how they are interacting with, and affected by, a much wider set of biological and technical conditions.”1 educators must grapple with the societal issues that come with the intent of ensuring the safety of the public. to some, “these are actually as important as the biological concerns of people.”2 the current global crisis shows that “scientifically, socially, and politically the economy and technosphere are not just related, they are integral to a comprehensive response to major challenges.”3 in developing these responses, scientists, government leaders, and policy makers need to consider the vulnerabilities of people, especially those in “thrown away” groups.4 jerome ravetz explains that “microscopic viral predators cull our populations, as ever, but with a selection that is not natural but social and political.”5 educators must address maboloc, critical pedagogy in the new normal, voices in bioethics, vol. 6 (2020) 2 the underlying vulnerabilities and evaluate the virus as a threat to academic experiences and access to a fair education. analysis i. critical pedagogy by definition, the critical approach to teaching is about the problem-posing method of education developed by paolo freire. in his pedagogy of the oppressed, he proposed a paradigm shift away from the banking method of learning wherein teachers deposit knowledge into the minds of students. critical pedagogy is an educational approach that challenges students to develop the ability to recognize and criticize dominating theories and evaluate them in their social context. teachers press students to recognize oppression and try to remedy oppression in their culture.6 despite the lack of in-person interaction between the teacher and the students, the effort to use innovative teaching techniques like critical pedagogy should continue. online learning is not just about the use of technology, although the internet is crucial in the delivery of content. since human beings are creators of value, they determine the meaning and purpose of technology. in this way, the set of values people have will influence online learning. teachers cannot be more concerned about outcomes than about the process itself. the process is crucial since the ability of the student to think critically is developed in the exchange between the student and the teacher. the teacher cannot simply dump loads of information (deposit knowledge) but must pose problems to test the analytical and critical skills of students.7 education is about how people humanize the world. policy makers miss the point when they focus on the delivery but do not pay attention to the substantive aspect of learning, which is human empowerment. education is meant to expand the freedom of people. education should be seen as an integrative activity. learning is a formative process that aims to develop the human person. without the face-to-face encounter between teacher and students, the challenge is finding ways to make learning an effective means to mold the values of young people. ii. online critical pedagogy & the role of technology physical distance appears to be an impediment in realizing the ideals of learning. the lack of contact between the teacher and the students may prevent a more meaningful interaction since online instruction is impersonal. it can be argued that there is no alternative to some classroom activities, especially laboratory experiments in science courses. the total classroom environment naturally influences the behavior of students when it comes to academic work: the look in the eyes of the professor, the caring ways of a teacher, or the pressure while taking exams contribute to an experience that only a classroom setting can provide. if implemented properly, technology can facilitate the personal relationships between teachers and students while providing meaningful experiences. with the current need for online learning during the covid-19 pandemic, gadgets are indispensable. some would even consider gadgets an extension of the human body. a mobile phone is not just any instrument; it has evolved into a novel way of being in the world. our gadgets are a means of seeing how the outside world unfolds. modern technological tools allow the interface of people in many fields of experience in a globalized environment. computers and other digital devices extend the meaning and value of human maboloc, critical pedagogy in the new normal, voices in bioethics, vol. 6 (2020) 3 freedom. for example, a laptop provided to a poor child can redefine the meaning of and what the future might hold for that child. the device is crucial to the whole learning process. modern tools are critical to selfdiscovery and greater freedom. the values that people embrace will matter in the new normal. the internet has provided a new democratic space that empowers groups and individuals to express themselves and to understand the world.8 in an online class, students and teachers alike need to analyze big picture questions and layers of information. for example, the student in an ethics or philosophy class can reflect on the realities of life. with the proper guidance, online education should help define the meaning of moral commitment and human responsibility. conclusion before the pandemic, policy makers had been pursuing the goals of a globalized economy. they had been fashioning and promoting programs that cater to the interests of a consumer-driven world that has deprived the poor of opportunity. when the pandemic struck, globalization suddenly came to a halt and people realized the things that truly matter in life – family, love, and life itself. the new normal must now emphasize the role of education as a source of inner strength that can empower the person to live well reinforcing values based on a social consciousness. critical pedagogy is possible under the new normal. the distance between the teacher and student does not make the educational process less real and in the absence of a vaccine, online learning is the safest strategy. governments cannot freeze an entire school year since education is the only way out from poverty for millions. the covid-19 pandemic provides a reason to re-imagine teaching using technology to encourage all students to question systems of oppression or greed, as the persistent pursuit of the truth is what education is all about. 1 hartsell, layne, krabbe, alexander, & pastreich, emmanuel. “covid-19, global justice, and a new biopolitics of the anthropocene.” social ethics society journal of applied philosophy 6, no. 2 (2020), 3. 2 ravetz, jerome. “science for a proper recovery: post-normal, not new normal.” issues in science and technology [internet] july 15, 2020. https://issues.org/post-normal-science-for-pandemic-recovery/ 3 hartsell, et al. “covid-19, global justice, and a new biopolitics of the anthropocene,” 6. 4 ravetz, “science for a proper recovery: post-normal, not new normal.” 5 ibid. 6 freire, paolo. pedagogy of the oppressed. (new york: continuum books, 1993). 7 freire writes that in such a situation “instead of communicating, the teacher issues communiqués and makes deposits which the students patiently receive, memorize, and repeat.” see his pedagogy of the oppressed. 8 bakardjieva, maria. internet society. (london: sage publications, 2005). https://issues.org/post-normal-science-for-pandemic-recovery/ hui, ethics of prisoner organ donation, voices in bioethics, (2013) © 2013 katrina hui. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. rethinking the ethics of prisoner organ donation katrina hui keywords: prisoners, organ donation, informed consent introduction since the first successful kidney transplant in 1950, transplantation has quickly become the best and most economical treatment for conditions such as end-stage renal failure. high demand for organs has created a shortage that many nations have struggled to meet. donor rates remain notably low in eastern asia due to a combination of cultural and religious factors. in 1984, the people’s republic of china began the controversial practice of using organs from executed prisoners to address these shortages. the nation quickly came under fire from the international community and organizations including the world medical association, the transplantation society, the international society for heart and lung transplant, and the chinese medical association, all of which condemned the practice as an egregious violation of human rights.20,16,5,11 china’s vice minister of health, huang jiefung, has noted that the country plans to shift away from its reliance on prisoner organs; however, at present, 95 percent of organs in china still come from deceased donors, the majority of whom are executed prisoners.10 analysis setting aside the debate of whether capital punishment should be permissible at all, the death penalty as it is carried out in china is an especially contentious issue. though capital punishment is not unique to the country, china is thought to execute more prisoners per year than any other nation. this number remains high even after adjusting for the large population; china’s rate of execution per capita is believed to be the sixth highest in the world, following saudi arabia, belarus, sierra leone, kyrgyzstan, and jordan.1 in the absence of official published reports, human rights organizations estimate that the number of executions ran as high as 5,000 in 2009. 6 these statistics have brought into question the types of crimes, several of which are nonviolent in nature, that are punishable by death. in 1996, two shanghai men were executed for the theft of badminton rackets and ballpoint pens. 15 inconsistencies in punishment are common; government officials found guilty of embezzling millions have received suspended death sentences, ultimately allowing them to live.8 these cases highlight concerns that criminal punishment in china is liable to corruption and that many citizens are subject to disproportionately harsh punitive measures. while there is no question that capital punishment in china should be reformed, it is important to distinguish between the issues surrounding the broken criminal justice system and the actual ethicality of organ procurement from executed prisoners. major concerns about the use of organs from prisoners include corruption in the judicial process, the use of harvested organs for profit, the lack of informed consent, and the increased burden and inequality in home countries resulting from donations overseas.19 upon scrutiny, it becomes apparent that these criticisms, except for those about informed consent, target the implementation of capital punishment and the unfair distribution of organs rather than the acquisition process itself. indeed, there are salient reasons for using prisoners as org an donors, especially in a country with 1.5 million people on the organ waiting list. this type of organ donation increases the supply of organs, provides prisoners with the opportunity to make amends for their misdeeds, and decreases the hui, ethics of prisoner organ donation, voices in bioethics, (2013) 2 burden of organ donation in home populations.10,19 though practices in china leave much to be desired, it is entirely plausible to conceive an ethical and well-regulated system under which capital prisoners may donate their organs. to its credit, the chinese government has enacted a set of laws, entitled regulations for human organ transplantation, to protect prisoners from abuse. article 23, item 2 of “the tentative provisions regarding utilizing the corpses or organs from the corpses of the capital prisoners” permits the retrieval of organs from executed prisoners only with the consent of the prisoner and his or her family.18 there have been mixed reports about the enforcement of these rules, and corruption in the judicial process clearly breeds suspicion about the ethical nature of obtaining volunteers. however, even with proper enforcement, critics claim that the prisoner population can never freely give consent, insisting that, on because of their environment, prisoners are vulnerable to coercion or undue inducement and may be pressured into giving their consent either out of fear or in hopes of currying favor with authorities or other benefits. some proponents of prisoner organ donation believe that worries about informed consent are faulty and that, in reality, consent is a non-issue. they argue that prisoners, by nature of being prisoners, are stripped of many rights, including, in places that allow capital punishment, the right to live. as rhodes and schiano (2010) state, “without [the prisoners’] consent, others make decisions about where they live, when they wake, when they sleep, what they eat, what they do, if and when they die, and how. prisoners are not allowed to refuse medical treatment or food. prisoners who try to refuse have treatment or food forced upon them. traditionally, the state can even decide on the disposition of a prisoner’s corpse”.14 there is a lack of convincing argument that demonstrates why rights surrounding organ donation are different from other rights that prisoners forfeit when committing a crime. if we accept the restriction of many prisoners’ rights, to condemn the deprivation of the right to donate would reveal an inconsistency in moral judgment. this permissibility of presumed consent, adopted by countries like austria, belgium and spain , further illustrates the false premise of the need for informed consent. presumed consent rests on two notions: “(1) that individual consent for organ donation is not ethically necessary, and (2) that it is good to conserve scarce resources and to avoid w asting them”.14 because the procurement of organs from executed prisoners uses the same rationale, we cannot reasonably deem presumed consent to be acceptable while simultaneously rejecting the use of organs from prisoners. without going to the extreme of defending the removal of a prisoner’s right to consent, it is arguably unethical to disallow prisoners from donating their organs at all. it would be erroneous to assume that prisoners facing execution are not capable of exercising an autonomous choice to donate their organs. many prisoners retain the ability to freely and thoroughly evaluate the pros and cons of such a decision. in fact, many prisoners on death row in the united states have expressed a genuine wish to become organ donors. 13 reasons include a desire for a sense of absolution for their crimes, wanting to help alleviate organ shortages, or some general motivation to aid the cause for personal reasons (e.g., a family member needing an organ or having died from not receiving one in the past). it is worth examining the cultural and religious considerations surrounding organ donation. though there is no official religion in china, the population’s values and practices are heavily influenced by buddhism and taoism, in addition to confucianism. confucian ethics places a heavy emphasis on xiao, or filial piety, which has led to the belief that a person’s body does not belong to him but to his parents and ancestors. the view dictates that one ought to return the body upon death in the same condition in which it was received. xiao explains why organ donation has been met with resistance in china: it is regarded as a violation of the integrity of the body, which would be disrespectful to one’s family.12 however, there may be negotiable limits to this stance. donations to relatives in need, for inst ance, can be viewed under a different light. it is important to recognize that chinese individuals embrace a style of family -oriented decision-making, which differs drastically from western individualism. 18 the tradition of familism gives substantial weight to the opinions and well-being of family members. because of the structure of interdependence among kin, hui, ethics of prisoner organ donation, voices in bioethics, (2013) 3 directed organ donation to save a family member’s life may often be deemed important for the family unit and thus permissible. the protection of bodily integrity may compete with other values. sangha, an organization of buddhists, has not taken an official stance on organ donation, but because the concepts of karma, reincarnation, and compassion are central to buddhist thought, selflessly giving up an organ for another living being may be viewed as a noble and compassionate act.9 this is especially relevant for buddhist prisoners facing death, who may wish to make amends for their crimes in order to be rewarded in their next life.7 taoism, too, stresses the importance of humanity, and so its followers may wish to donate as an act of altruism.10 prisoners may also choose to become donors to show respect for their families; donation gives their relatives a compassionate act by which to memorialize them. 18 providing prisoners with the option to donate their organs is without question in line with respecting their religious and cultural values. the development of an ethical system of prisoner organ donation has relevance that extends beyond chinese borders. organ procurement from prisoners is a practice that has occurred or is occurring in other nations besides china. singapore has had a policy permitting prisoners to donate orders that has been in place since 1972; taiwan used organs from prisoners from 1990 to 1994; and, in france in the 1950s, organs were taken from guillotined prisoners. even prisoners in the united states were once permitted to donate organs.3 conclusion china’s practice of harvesting organs from executed prisoners is far from perfect. to be sure, its criminal justice system is prone to corruption and the country lacks a database and distribution system that would allow for the fair allocation of the scarce resource. but the prisoner population remains a viable source of organs that may help save the lives of thousands. contrary to western opinion, to restrict the practice of organ donation from this cohort altogether would be an affront to autonomy. it is tempting to understate the capacity of prisoners facing execution to give informed consent, yet with proper safeguards, prisoners remain fully capable of deliberating the decision to donate their organs, and may, in fact, possess strong reasons to do so, including respect for family or religious atonement. 1amnesty international. (2004). singapore – the death penalty – a hidden toll of executions. retrieved from http://www.amnesty.org/en/library/asset/asa36/001/2004/en/6de04440-d64e-11dd-ab95a13b602c0642/asa360012004en.html. 2briggs, j. d. (1996). the use of organs from executed prisoners in china. nephrology dialysis transplantation, 11(2), 238-240. 3callender, c. o., kelly, b. s., & rivadeneira, d. a. (1996, february). medical utility versus legal justice: a proposal for the ethical use of prisoner-donated organs. in transplantation proceedings (vol. 28, no. 1, p. 374). 4cameron, j. s., & hoffenberg, r. (1999). the ethics of organ transplantation reconsidered: paid organ donation and the use of executed prisoners as donors. kidney international, 55(2), 724-732. 5chinese medical association. (2007). chinese medical association reaches agreement with world medical association against transplantation of prisioners's organs. medical news today. retrieved from http://www.medicalnewstoday.com/releases/84754.php. 6the dui hua foundation. (fall 2010). reducing death penalty crimes in china more symbol than substance. dialogue. (41). retrieved from http://www.duihua.org/work/publications/nl/nl_pdf/nl_41.pdf. 7evans, r. w. (2008). ethnocentrism is an unacceptable rationale for health care policy: a critique of transplant tourism posi tion statements. american journal of transplantation, 8(6), 1089-1095. http://www.amnesty.org/en/library/asset/asa36/001/2004/en/6de04440-d64e-11dd-ab95-a13b602c0642/asa360012004en.html http://www.amnesty.org/en/library/asset/asa36/001/2004/en/6de04440-d64e-11dd-ab95-a13b602c0642/asa360012004en.html http://www.medicalnewstoday.com/releases/84754.php http://www.duihua.org/work/publications/nl/nl_pdf/nl_41.pdf hui, ethics of prisoner organ donation, voices in bioethics, (2013) 4 8fan, m., & cha, a. e. (2008, december 24). china’s capital cases still secret, arbitrary. the washington post. retrieved from http://www.washingtonpost.com/wp-dyn/content/article/2008/12/23/ar2008122302795.html. 9gillman, j. (1999). religious perspectives on organ donation. critical care nursing quarterly, 22(3), 19-29. 10huang, j. (2007). ethical and legislative perspectives on liver transplantation in the people's republic of china. liver transplantation, 13(2), 193-196. 11international society for heart and lung transplant. (2007). statement on transplant ethics, approved april 2007. retrieved from https://www.dafoh.org/ishlt statement ontran.php 12lam, w. a., & mccullough, l. b. (2008). influence of religious and spiritual values on the willingness of chinese –americans to donate organs for transplantation. clinical transplantation, 14(5), 449-456. 13lin, s. s., rich, l., pal, j. d., & sade, r. m. (2012). prisoners on death row should be accepted as organ donors. the annals of thoracic surgery, 93(6), 1773. 14rhodes, r., & schiano, t. (2010). transplant tourism in china: a tale of two transplants. the american journal of bioethics, 10(2), 3-11. 15richburg, k. b. (1996, july 6). china executes hundreds in crackdown. the washington post. pp. a1 16the transplantation society. (no publication date). policy & ethics. retrieved fromhttp://www.tts.org/index.php?option=com_content&view=article&id=11&itemid=223 17united nations general assembly. (1982, december 18). resolution 37/194, principle 3.retrieved from http://www.un.org/documents/ga/res/37/a37r194.htm. 18wang, m., & wang, x. (2010). organ donation by capital prisoners in china: reflections in confucian ethics. journal of medicine and philosophy, 35(2), 197-212. 19westall, g. p., komesaroff, p., gorton, m. w. and snell, g. i. (2008), ethics of organ donation and transplantation involving prisoners: the debate extends beyond our borders. internal medicine journal, 38: 56–59. doi: 10.1111/j.14455994.2007.01563.x. 20world medical association. (2006). wma council resolution on organ donation in china. retrieved from http://www.wma.net/en/30publications/10policies/30council/cr_5/. http://www.washingtonpost.com/wp-dyn/content/article/2008/12/23/ar2008122302795.html https://www.dafoh.org/ishlt%20-%20statement%20on%20tran.php http://www.tts.org/index.php?option=com_content&view=article&id=11&itemid=2 http://www.un.org/documents/ga/res/37/a37r194.htm introduction analysis conclusion moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) * gyan moorthy, ms candidate, columbia university © 2020 gyan moorthy. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. compulsory covid-19 vaccination? only as a policy of last resort gyan moorthy* keywords: covid-19, vaccination ethics, public health ethics, compulsory vaccination, least restrictive means, bioethics, liberty, covid vaccination, democracy and bioethics, transparency introduction the debate regarding the limits of individual liberty and the state’s obligation to promote the common welfare and to protect its citizens is too important to be left to extremists. as more vaccines make their way through phase iii trials1 and the question of compulsory vaccination presents itself, leaders must address the short and long-term implications of requiring a specific medical intervention (vaccination) as a condition of community membership 2 versus as a condition of participation in school, work, or other activities. transparency and openness to compromise are paramount. broad buy-in on policy which touches such a fundamental human interest, the right of individuals to control their own bodies, is crucial to restore or ensure continued trust in science and american institutions and to prepare the country to combat future problems. this paper argues that universal compulsory vaccination (by state or county) should be implemented only as a policy of last resort. public health officials must first weigh all reasonable alternatives, including educational initiatives, tax credits (rather than penalties), and variously-formulated requirements for vaccination of subsets of the population as a condition of participation in public activities. history in 1902, the board of health of cambridge, massachusetts, using authority delegated to it by the state legislature, required smallpox vaccination or revaccination for all healthy residents above the age of 21. those who refused were subject to a five dollar per day fine. a pastor by the name of henning jacobson was prosecuted, fined, and ultimately ordered committed for refusing to pay that fine. in jacobson v. massachusetts, justice john marshall harlan wrote the majority opinion for a seminal 7-2 supreme court decision upholding the right of the state to compel vaccination under certain circumstances. moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 2 underpinning the court’s conclusion was a tense and uncertain compromise between the tenets of socialcompact theory and theories of limited government.3 although harlan wrote that the constitution guaranteed no “absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint,”4 he underscored that the state’s police powers were limited. the state must always (1) consider the necessity of their exercise, defining its objective as narrowly as is feasible, (2) use “reasonable means” to pursue that objective, (3) impose only burdens that are proportionate to the expected benefit, and (4) avoid inflicting “cruel and inhuman harm” on any person.5 harlan implied that state legislatures were to have wide discretion to deliberate these issues and perform benefits/burdens calculations themselves. jacobson legitimized compulsory vaccination legislation then on the books in 11 states, but such legislation was seldom used. most states vigorously promote vaccination for various diseases through educational initiatives or require it for students seeking to enroll in public school (always with medical and usually with religious or philosophical exemptions) or for certain subsets of the population, like healthcare professionals working in select hospitals and nursing homes.6 mandatory public school vaccination has withstood court challenge,7 but mandatory vaccination of healthcare professionals, when no non-medical exemptions are granted, is of ambiguous legal status.8 since 2000, some states have passed versions of the model state emergency health powers act (msehp), granting their governors the authority to declare public health emergencies and thereafter to compel vaccination of the public, using the national guard if necessary.9 however, no qualifying crisis scenario presented itself until this year. governors contemplating covid-19 vaccination requirements are likely first to develop plans which would make vaccination a condition of participation in various activities, a strategy that, although still controversial, is not the primary subject of this paper. it is unlikely that the federal government would get involved. though it imposes some vaccine requirements for those wishing to immigrate or join the military, it has never established broader vaccination policy, and it is unclear whether it could use its authority, e.g., under the constitution’s commerce clause, to do so.10 practical and ethical considerations after fda approval of a vaccine for covid-19, it is conceivable that some states, or some legislators within them, spurred on by medical and other commentators,11 will wish to compel vaccination not only of children in public schools or of healthcare professionals working in certain settings, but of at-risk groups or of all citizens under their jurisdiction. while it is extremely unlikely that they would authorize the use of force, they might impose fines or tax penalties, as the board of health of cambridge, massachusetts did at the turn of the 20th century. such moves are likely to be challenged in court, and if they make their way to the supreme court, it is not altogether clear how the court would rule or whether its ruling will be delivered in time to be relevant. compulsory vaccination of specific groups, e.g., the elderly or those living in crowded housing or in high-spread neighborhoods, who might be disproportionately black or hispanic, 12 could be struck down on the basis of the 14th amendment’s guarantee of equal protection, which jacobson never addressed. although jacobson has been cited in more than seventy other cases, most dealing with other non-healthor health-related uses of police powers,13 and is well-established precedent, the court has acknowledged several other rights in the intervening years which might lead it to overturn jacobson. these include a right to privacy14 and a right to refuse unwanted medical treatment.15 although it has always balanced these rights against state interests,16 which certainly include preventing the spread of disease, the communitarian spirit of the progressive era has given way to a polarized electorate that includes growing numbers of uncompromising liberty enthusiasts. all fifty states have vaccination mandates for school attendance and several states mandate vaccines for moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 3 healthcare workers demonstrating jacobson’s precedent has survived the development of privacy rights and rights to be free from unwanted bodily intrusions in the healthcare context. the issue of whether jacobson has survived legal progress to the degree that universal compulsory vaccination (rather than school or workplace mandates) would be acceptable remains unanswered. the court now includess several selfdescribed staunch defenders of individual liberty and autonomy who may not give as much weight to public health measures that are seen to infringe upon fundamental freedoms.17 but even if the court were to uphold the essence of jacobson, the particulars of the case before it would determine whether compulsory covid-19 vaccination could proceed. the current court might defer less to the determinations of state or local public health agencies and apply higher or different standards for necessity, reasonable means, proportionality, and avoidance of “cruel and inhuman harm” than did harlan’s majority. on the basis of fairness and minimizing individual burden, it could determine that compulsory vaccination is permissible only when the vaccine is offered at no expense at properly-spaced clinics or other centers, which would be infeasible for many states. the court’s recent backing of a religious challenge to limits on gatherings that new york imposed in response to a second surge of covid-19 infections in october is a tangible indication that the court might require states to offer religious or philosophical exemptions.18 the court may strike down a universal compulsory vaccination policy if it does not believe that a state has done enough to promote voluntary vaccination first, especially considering the additional tools states have at their disposal today. given the probable impact on public order or possible setbacks for vaccines if something should go terribly wrong, a decision against broad compulsory vaccination on the grounds that other policies were not exhausted first may be beneficial to social stability. it is also important to remember that vaccines do carry some risks – hence the existence of a national vaccine injury compensation program. 19 many bioethicists downplay the risks of vaccination for the nonimmunocompromised. alberto giubilini goes further. he has compared the decision not to be vaccinated to tax evasion and has justified compulsory vaccination on the basis of fairness: shared risk for shared reward, rather than harm prevention.20 but even if his argument demonstrated that compulsory vaccination were morally permissible or even morally obligatory, it does not show that compulsory vaccination is good public policy, especially when the vaccine in question is new. i argue that the consequences (loss of social cohesion and trust in the scientific community) would outweigh the benefit of reduced viral spread. that opposition to vaccination is growing21 and that more than 40 percent of americans indicate they would not consent to receive even a cost-free covid-19 vaccine22 should be the starting point for government vaccination policy. while the state has a responsibility to educate its citizens on issues pertinent to the public welfare and to override them when the consequences of not doing so are likely to be disastrous, it must first make good-faith attempts to address all concerns voiced by its citizens, making accommodations when possible. a minority should not be ignored simply because it is a minority, and if it is a large minority, the implications of overriding it for social cohesion and for democracy, must be given attention. some warn that the country is more polarized now than at any time since the civil war,23 and in the age of mass media and social media, compulsory vaccination is likely to become a flashpoint, like mask mandates and social distancing before it. 24 but unlike those mandates, universal compulsory vaccination threatens or comes close to threatening a fundamental liberty interest and is likely to encounter even fiercer resistance, especially if the mandate comes from the federal government. although joe biden’s victory in the presidential election may improve public confidence in a vaccine and in the fda, it is possible that some will still be uncomfortable with how quickly a covid-19 vaccine was developed moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 4 relative to other vaccines.25 they may prefer others take it before they do, particularly if the vaccine receives emergency use authorization.26 pluralism and democracy are virtues, and it would be unethical to disregard the concerns of this group, especially as they are not altogether unreasonable. circumstances may enable broad circumvention of this issue. vaccine roll-out will not be instantaneous, and demand for it may be high enough that governments must use distribution prioritization schemes (granting access to healthcare workers, the elderly, other essential workers, etc. first). over time, if these populations do well, others may become convinced and choose to be vaccinated. alternatively, individual states or the federal government might attempt to push them along, e.g., by denying them access to post offices, schools, or other public property or requiring them to quarantine if they travel but have not received a vaccine, that is, requiring vaccination as a condition of participation in public activities. whether this will bring the total number of vaccinated people up to the level necessary to achieve herd immunity will depend on how effective the vaccine is and whether its protection is permanent.27 paradoxically, if the vaccine is less effective or boosters must be given, more people will need to receive it, but the courts, performing a risk/benefit analysis, are less likely to uphold a mandate. it would also be less ethical for them to do so, as the potential for harm and burden imposed would be greater. finally, many people who support or are ambivalent to vaccination in general will oppose compulsory vaccination for covid-19, either because they oppose the exercise of this type of state power in principle or because they do not believe the necessary threshold has been met. these people may worry that the state will begin to implement measures like compulsory vaccination when no crisis exists or fail to appropriately circumscribe the limits of what constitutes a crisis. as a recent example of executive overreach, president trump once declared a national emergency over immigration at the southern border in order to bypass the legislature and free up spending for a wall (a campaign promise).28 although the who, itself not immune from political influence, publishes parameters for staging pandemics,29 it does not (and cannot) describe a uniform policy on what precise levels of spread, hospitalization, or mortality merit what type of response. there is no law requiring governors or presidents to declare public health emergencies only when case-specific who or similar criteria are met. summary & recommendations it would be difficult to formulate a sustainable, cost-effective universal compulsory vaccination policy that stands up to court scrutiny and strikes a balance between autonomy, respect for bodily integrity, and public health that most people will accept and that does not further marginalize disadvantaged groups. in light of this, i argue that states should have tiered goals for vaccination and use interventions of varying strength and scope to achieve each, communicating transparently to the public and giving heavy weight to people’s concerns. the marginal benefit of pursuing each, more ambitious goal decreases as the less ambitious goals that are subsumed into them are realized. the harms associated with pursuing them may be great. the goal of preventing the overwhelming of medical infrastructure is the most clearly ethical. next, herd immunity is also justifiable if achieved with proper measures. near-universal vaccination would be the most difficult to justify based both on a decreasing marginal value of moving beyond herd immunity and the significant level of government intrusion. the goals represent a paradox: the least ambitious but most widely-accepted goal (flattening the curve) warrants the most intrusive government policy, yet the most intrusive policy would go beyond the stated goal and should not be implemented because it is ethically imperative that the state use moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 5 the least restrictive means to achieve the goal. the most ambitious goal (near-universal vaccination) does not justify universal compulsory vaccination despite being out of reach absent a universal mandate. the support of the public is crucial as a check on government authority and to ensure that the least restrictive means are used to pursue legitimate ends. the public’s input for precisely tailoring vaccination policy to ensure that it is both successful in achieving its goal and ethical will be paramount. what follows is a general framework based on a careful consideration of the issues outlined in the preceding sections of this paper. 1) most ambitious and most controversial: a near-universal vaccination rate this goal is ethical insofar as it prevents the most deaths, which is a proper government interest. however, to achieve it, intrusive policies, including any sort of mandate, are not warranted because a) the marginal benefit of moving past herd immunity is low, b) the goal overreaches widely-accepted government action and so puts government too far out of step with citizens, and c) they would undermine public trust and autonomy. in order to achieve this goal, to minimize morbidity and mortality, the state (individual us state or local governments) should restrict its activities to the active promotion of vaccination in the public school system or via “community conversations” and media campaigns. it should take steps to minimize misconceptions about vaccine safety, including describing the robust vaccine monitoring and approval process. the state must be careful to expend a proportionate amount of resources on this effort, not shifting funding away from other important functions. the federal government should restrict its activity to moral leadership and funding these educational initiatives and vaccine development. 2) moderately ambitious and less controversial: herd immunity to reduce “community spread” to near zero, it is ethical for the state also to implement well-precedented coercive measures like vaccination requirements for school enrollment and for certain healthcare professionals (granting standard exemptions). during a crisis, it may consider eliminating these exemptions, subsidizing vaccination, and establishing honor-system quarantine requirements for those unvaccinated citizens who travel to other states and return. this is in addition to mask mandates or curfews which reduce spread and, because of their unpopularity, may encourage citizens to choose to be vaccinated to bring the crisis to a speedier end. the federal government should ideally restrict its activity to adding to the vaccination requirements for new or continued military service, regulating industries which receive federal funds, imposing international travel bans, as well as providing moral leadership, funding for state initiatives, and guidelines for regional response uniformity. however, depending on the nature of the crisis, the federal government may assist in regulating interstate travel. herd immunity is a realistic and ethically justified goal, yet it is closer to the limit of tolerable government authority. because the public might not accept it, it would be best for social cohesion if it were achieved without a universal compulsory mandate (which would also overshoot the goal). 3) least ambitious and widely accepted: immunity levels sufficient to prevent the overwhelming of medical infrastructure partially because this is the most widely-accepted goal, government should be able to use more intrusive means to achieve it. it balances government interests, autonomy, economic interests, and liberties, and it would add to social cohesion and represent respect for myriad views on what is beneficent. as such, it would warrant the most intrusive policies, including universal compulsory vaccination, yet the government must always use the least restrictive means to achieve an end. if, once it has made vaccines available free of charge moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 6 (and provided tax credits as an incentive), the state has not met this goal, it is ethical for it to consider implementing more coercive tactics. these range from permitting insurance companies to charge higher premiums for those who refuse vaccination to establishing “immunization cards” (attending to the associated privacy and discrimination concerns) and requiring the presentation of such cards before use of state facilities or services, like public transportation, or for avoiding enforceable quarantine after travel. presentation of an immunization card should not be a requirement for welfare eligibility, including medicaid nursing home assistance. if, after some significant period, these tactics fail, the state may consider compulsory vaccination. states should solicit expert and public input for the design of the policy, which may be rolled out from countyto-county based on infection and hospitalization rates. such a policy should have broad opt-out provisions, at least to begin with, and there should be a mechanism to overturn it by referendum. imprisonment should not be one of the considered penalties, but, in accordance with jacobson, paying a fine for failure to become vaccinated should be an option. the federal government should avoid attempting any vaccine mandate of its own, though it may consider withholding highway or other funds from states which refuse to implement even the most basic measures to control the disease’s spread. once the goal of preventing the overwhelming of the medical infrastructure is met, the compulsory vaccination policy should be reconsidered with an eye to limiting it to school or sector-specific mandates, as these have widespread public acceptance. goal level of public acceptance level of permissible government intrusion (after exhausting least restrictive means) level of intrusion necessary to achieve the goal near-universal vaccination low less marginal benefit over herd immunity; overshoots government goals; but arguably beneficent with death prevention encouraging vaccination, but nothing compulsory based on polls of people willing to vaccinate, universal compulsory vaccination would be necessary herd immunity moderate significant benefit over simply preventing medical infrastructure from being overwhelmed; arguably the most beneficent to keep the virus at bay; possibly ties near universal for death prevention vaccination as a condition of participation in various public activities probably vaccination as a condition of participation in various public activities; possibly universal compulsory vaccination in counties encountering more cases protection of medical infrastructure (“flattening the curve”) high values widespread interests like economy and freedom, saves many lives, yet probably not as many as herd immunity universal compulsory vaccination likely achievable with less restrictive measures (masks, social distancing, voluntary vaccination) moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 7 conclusion universal compulsory vaccination should be part of the conversation on covid-19 now only insofar as the purpose is informing citizens that it may eventually be a necessity and that pertinent plans must be developed in advance. despite rising case counts, it is inappropriate for the release of a vaccine to be immediately accompanied by policies requiring members of the general public to receive that vaccine. every reasonable alternative must be exhausted before such policies are implemented, not only because they touch an issue so central in a free society, the right of individuals to make decisions about what is done to their bodies, but also because of the practical obstacles, including inevitable legal challenges and widespread anger and resentment that could undermine the country’s ability to effectively combat this crisis and the crises that lie ahead. 1 corum, jonathan, sui-lee wee, and carl zimmer. 2020. “coronavirus vaccine tracker.” the new york times, november 13, 2020, sec. science. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html. 2 this paper uses “compulsory vaccination” to apply to vaccination mandated for all in the community with fines as an enforcement tool and not to vaccination of a narrower group as a requirement for participation in school, the workplace, or other public spaces and activities. 3 gostin, lawrence o. 2005. “jacobson v massachusetts at 100 years: police power and civil liberties in tension.” american journal of public health 95 (4): 576–81. https://doi.org/10.2105/ajph.2004.055152. 4 see jacobson v. massachusetts, 197 u.s. 11, 25 s. ct. 358 (1905). 5 gostin, lawrence o. 2005. 6 cole, jared p, and kathleen s swendiman. 2014. “mandatory vaccinations: precedent and current laws.” congressional research service. https://fas.org/sgp/crs/misc/rs21414.pdf. 7 see zucht v king, 260 u.s. 174, 43 s. ct. 24 (1922) 8 cole, jared p, and kathleen s swendiman. 2014. 9 institute of medicine (us) forum on emerging infections, stacey l. knobler, adel af mahmoud, and leslie a. pray. 2002. the model state emergency health powers act. biological threats and terrorism: assessing the science and response capabilities: workshop summary. national academies press (us). https://www.ncbi.nlm.nih.gov/books/nbk98412/. 10 ibid. 11 lederman, michael, maxwell mehlman, and stuart youngner. 2020. “defeat covid-19 by requiring vaccination for all. it’s not un-american, it’s patriotic.” usa today, august 6, 2020. https://www.usatoday.com/story/opinion/2020/08/06/stop-coronavirus-compulsory-universalvaccination-column/3289948001/. 12 artiga, samantha, bradley corallo, and olivia pham. 2020. “racial disparities in covid-19: key findings from available data and analysis.” kaiser family foundation. https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-disparities-covid-19-key-findings-available-dataanalysis/. 13 gostin, lawrence o. 2005. 14 griswold v. connecticut, 381 u.s. 479, 85 s. ct. 1678 (1965) 15 cruzan v. director, missouri department of health, 497 u.s. 261, 280 (1990) 16 see mills v rogers, 457 u.s. 291, 102 s. ct. 2442 (1982), washington v. harper, 494 u.s. 210, 110 s. ct. 1028 (1990), among others. 17 amy coney barrett, neil gorsuch and brett kavanaugh, to name a few. see schaff, erin. 2020. “legal scholar warns of potential supreme court changes.” the harvard gazette, october 15, 2020, sec. national & world affairs. https://news.harvard.edu/gazette/story/2020/10/legal-scholarwarns-of-potential-supreme-court-changes/. 18 liptak, adam. 2020. “splitting 5 to 4, supreme court backs religious challenge to cuomo’s virus shutdown order.” the new york times, november 26, 2020. https://www.nytimes.com/2020/11/26/us/supreme-court-coronavirus-religion-new-york.html. 19 health resources & services administration. 2020. “national vaccine injury compensation program.” hrsa.gov. november 2020. https://www.hrsa.gov/vaccine-compensation/index.html. 20 giubilini, alberto. 2020. “an argument for compulsory vaccination: the taxation analogy.” journal of applied philosophy 37 (3): 446–66. https://doi.org/10.1111/japp.12400. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html https://doi.org/10.2105/ajph.2004.055152 https://fas.org/sgp/crs/misc/rs21414.pdf https://www.ncbi.nlm.nih.gov/books/nbk98412/ https://www.usatoday.com/story/opinion/2020/08/06/stop-coronavirus-compulsory-universal-vaccination-column/3289948001/ https://www.usatoday.com/story/opinion/2020/08/06/stop-coronavirus-compulsory-universal-vaccination-column/3289948001/ https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-disparities-covid-19-key-findings-available-data-analysis/ https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-disparities-covid-19-key-findings-available-data-analysis/ https://news.harvard.edu/gazette/story/2020/10/legal-scholar-warns-of-potential-supreme-court-changes/ https://news.harvard.edu/gazette/story/2020/10/legal-scholar-warns-of-potential-supreme-court-changes/ https://www.nytimes.com/2020/11/26/us/supreme-court-coronavirus-religion-new-york.html https://www.hrsa.gov/vaccine-compensation/index.html https://doi.org/10.1111/japp.12400 moorthy, compulsory covid-19 vaccination as a policy of last resort, voices in bioethics, vol. 6 (2020) 8 21 hoffman, jan. 2019. “how anti-vaccine sentiment took hold in the united states (published 2019).” the new york times, september 23, 2019, sec. health. https://www.nytimes.com/2019/09/23/health/anti-vaccination-movement-us.html. 22 reinhart, rj. 2020. “more americans now willing to get covid-19 vaccine.” gallup. november 17, 2020. https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspxh 23 kleinfeld, rachel. 2020. “perspective: the u.s. shows all the signs of a country spiraling toward political violence.” washington post, september 11, 2020. https://www.washingtonpost.com/outlook/america-political-violence-risk/2020/09/11/be924628-f388-11ea-999c67ff7bf6a9d2_story.html. 24 reiss, dorit r., and y. tony yang. 2020. “why a covid-19 vaccine shouldn’t be mandatory.” bill of health: examining the intersection of health, law, bioetechnology, and bioethics (blog). september 15, 2020. http://blog.petrieflom.law.harvard.edu/2020/09/15/covid19-vaccine-mandatecompulsory/. 25 thompson, stuart a. 2020. “opinion: how long will a vaccine really take?” the new york times, april 30, 2020, sec. opinion. https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html. 26 hermes, clint. 2020. “opinion: covid-19 vaccines shouldn’t get emergency-use authorization.” mit technology review, november 13, 2020. https://www.technologyreview.com/2020/11/13/1012098/covid-19-vaccines-fda-emergency-use-authorization-opinion/. on december 2, 2020, the uk approved pfizer and biontech se’s vaccine for emergency use. medicines and healthcare products regulatory agency, uk, press release, “uk medicines regulator gives approval for first uk covid-19 vaccine,” december 2, 2020. https://www.gov.uk/government/news/uk-medicinesregulator-gives-approval-for-first-uk-covid-19-vaccine 27 aschwanden, christie. 2020. “the false promise of herd immunity for covid-19.” nature 587 (7832): 26–28. https://doi.org/10.1038/d41586020-02948-4. 28 vazquez, maegan, and priscilla alvarez. 2020. “white house extends national emergency on the southern border.” cnn, february 14, 2020. https://www.cnn.com/2020/02/13/politics/southern-border-national-emergency-continuation/index.html. 29 who. 2009. the who pandemic phases. pandemic influenza preparedness and response: a who guidance document. world health organization. https://www.ncbi.nlm.nih.gov/books/nbk143061/. https://www.nytimes.com/2019/09/23/health/anti-vaccination-movement-us.html https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspxh https://www.washingtonpost.com/outlook/america-political-violence-risk/2020/09/11/be924628-f388-11ea-999c-67ff7bf6a9d2_story.html https://www.washingtonpost.com/outlook/america-political-violence-risk/2020/09/11/be924628-f388-11ea-999c-67ff7bf6a9d2_story.html http://blog.petrieflom.law.harvard.edu/2020/09/15/covid19-vaccine-mandate-compulsory/ http://blog.petrieflom.law.harvard.edu/2020/09/15/covid19-vaccine-mandate-compulsory/ https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html https://www.technologyreview.com/2020/11/13/1012098/covid-19-vaccines-fda-emergency-use-authorization-opinion/ https://doi.org/10.1038/d41586-020-02948-4 https://doi.org/10.1038/d41586-020-02948-4 https://www.cnn.com/2020/02/13/politics/southern-border-national-emergency-continuation/index.html https://www.ncbi.nlm.nih.gov/books/nbk143061/ castelyn, shifting perceptions of crispr, voices in bioethics, vol. 7 (2021) * camille castelyn, mdiv theology and ethics, phd health ethics university of pretoria, ms bioethics candidate columbia university © 2021 camille castelyn. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. shifting perceptions of crispr: from controversial gene editing tool to indispensable sars-cov-2 variant surveillance tool camille castelyn* keywords: gene therapy, crispr, covid-19, diagnostic testing, public health, clinical trials introduction more than 20 cell and gene therapies are now available to safely minimize genetic diseases such as retinal dystrophy (luxturna), some b-cell lymphomas (yescarta), and b-cell lymphoblastic leukemia (kymriah).1 one such gene-editing tool is clustered regular inter spaced palindromic repeats (crispr) and its associated proteins or crispr-cas. jennifer doudna and emmanuelle charpentier described crispr’s potential as an accurate genome editing tool in 2012. the fda approved the first cell and gene therapy in 2017.2 the fda is continually approving more crispr clinical trials, including therapies to treat sickle cell anemia, cancer, and hiv.3 amid the covid-19 pandemic, the broad potential applications of crispr have extended beyond gene editing. crispr is being used in rapid diagnostic testing to determine not only whether an individual becomes infected with sars-cov-2 but also the specific variant.4 as with many diagnostic tests, scientists still face challenges like speed, sensitivity (the ability of the test to detect viral load), and robustness (the ability of the test to give accurate results in the field). nonetheless, these tests could revolutionize surveillance of the virus and help curb the spread of new variants as they arise. according to the centers for disease control and prevention, there are sars-cov-2 variants of interest, variants of concern, and variants of high consequence. in varying degrees, these may impact the efficacy of different vaccines and treatment plans.5 knowing which variant an individual has or is circulating within a population informs public health policy. castelyn, shifting perceptions of crispr, voices in bioethics, vol. 7 (2021) 2 i. public perceptions of gene editing throughout the decades perceptions about gene editing have fluctuated, especially since the 1970s. support has varied for recombinant dna in which editing a bacterial genome produces human insulin to treat diabetes, genetically modified plants such as antibiotic resistant tobacco, and other genetically modified organisms. human gene editing has a tainted past: consider the teenager jesse gelsinger who tragically died in a gene therapy clinical trial in 1999.6 another gene therapy trial led to the development of leukemia in several young children. 7 in the last two decades, there have been significant improvements in safety and reliability. though scientists have developed various gene therapies over the years, such as viral vector delivery of therapeutic transgenes, transcription activator-like effector nucleases (talens), and zinc finger nucleotides, crispr far surpasses them by safety, accuracy, and ease of use.8 ii. shifting perceptions and broader applications crispr is controversial due to concerns of safety, misuse for non-therapeutic purposes, and uncertainty about the science and technology. yet, there is also an underlying assumption that gene editing for therapeutic purposes would be a good use of crispr. there is an ethical imperative to use crispr therapeutically to safely reduce suffering for people with debilitating genetic diseases if proven safe. however, there is more variation in what would be considered good about uses beyond therapeutic applications, such as enhancement purposes. enhancement is a broad and conceptually laden term. for example, julian savulescu defines enhancement as any change in the person’s state – biological or psychological – which in turn is experienced or judged by the person or people as good. 9 thus, enhancement could include any gene-editing relating to physical, cognitive, aesthetic, or moral enhancement. for example, the public and the scientific community reacted with outrage to the 2018 scandal of he jiankui, a chinese scientist who gene-edited two baby girls to make them hiv resistant. rather than therapeutic gene-editing, this example was widely considered enhancement. the public may perceive the uses of crispr for enhancement as negative, but improved public perception of crispr overall would be beneficial to promote its therapeutic uses. crispr opened an array of possibilities and consequential decisions that lie in the hands of the consumer. a qualitative study done to gauge opinions on twitter found that “#crispr babies” elicited responses of sentiments ranging from positive and neutral to negative, spiking in 2018 with mostly neutral and negative sentiments.10 as cell and gene therapies move to market treating a small number of people with rare genetic diseases, public perceptions of these technologies are already shifting and may shift more over time. the factors influencing this shift toward acceptance might include trust in science,11 trust in the technology or the brand12 that brings it to market, and proven safety and efficacy over time. meanwhile, in this covid-19 pandemic, crispr's beneficial services for the detection of different variants in individuals and populations may positively impact the way it is perceived and accepted by the public. mammoth biosciences 13 and nanyang technological university have developed rapid diagnostic tests called detectr and vanguard, respectively, to detect variants.14 crispr and its associated proteins act as molecular scissors that have the ability to cut a specific section of genetic material with accuracy. it is the exploitation of a bacterial defense mechanism. when a virus infects bacteria, it uses crispr-associated proteins to cut out the bacteriophage’s rna. the bacteria then insert some of the virus rna into its own genome to detect and destroy it in the future. in the vanguard castelyn, shifting perceptions of crispr, voices in bioethics, vol. 7 (2021) 3 diagnostic test, the enzyme enascas12a targets specific sections of the sars-cov-2 genome. guided by two guide rnas, it snips a section of the virus and can detect the virus as well as two mutation sites in the virus. conclusion crispr’s application as a diagnostic testing tool is different from its gene-editing use. however, people may not distinguish the different applications when forming their perceptions of crispr. public confidence in certain technology needs only a push in a certain direction to sway opinion toward mass consumption or disapproval. research investigating people’s perceptions is becoming central to the debates about new technologies.15 the who’s expert advisory committee on developing global standards for governance and oversight of human genome editing, in their position paper (2021), calls for “education, engagement, and empowerment.” 16 they call on the united nations to establish an interagency working group to facilitate global dialogue. the national academies of sciences, engineering, and medicine consensus study report (2020), also calls for public engagement and education about these technologies. 17 diy and biohacking communities have shown an inclination to understand and apply these technologies with or without the guidance of regulators, scientists, or academia.18 perhaps as crispr is used to saved lives during the pandemic, this is a pivotal moment to educate people about crispr and its broad applications. 1 “approved cellular and gene therapy products,” food and drug administration, june 15, 2021, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-genetherapy-products. jim daley, “gene therapy arrives,” scientific american, january 1, 2020, https://www.scientificamerican.com/article/gene-therapy-arrives/. 2 broad institute, “crispr timeline,” n.d., https://www.broadinstitute.org/what-broad/areas-focus/projectspotlight/crispr-timeline. “who owns crispr in 2021? it’s even more complicated than you think,” april 27, 2021, https://synbiobeta.com/who-owns-crispr-in-2021-its-even-more-complicated-than-you-think/. 3 robert sanders, “fda approves first test of crispr to correct genetic defect causing sickle cell disease,” march 30, 2021, https://news.berkeley.edu/2021/03/30/fda-approves-first-test-of-crispr-to-correct-genetic-defectcausing-sickle-cell-disease/. laura brzyski, “excision biotherapeutics has secured $60m to proceed with hiv clinical trial,” philadelphia magazine, march 5, 2021, https://www.phillymag.com/healthcarenews/2021/03/05/excision-biotherapeutics-temple-hiv-clinical-trial/. 4 “a covid-19 test to detect virus variants,” nanyang technological university, march 29, 2021, https://www.ntu.edu.sg/news/detail/a-covid-19-test-to-detect-virus-variants. 5 “sars-cov-2 variant classifications and definitions,” centers for disease control and prevention, july 13, 2021, https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html. 6 nature, “gene-therapy trials must proceed with caution,” nature 534, 590 (2016). https://doi.org/10.1038/534590a. 7 fathema uddin, charles m. rudin, and triparna sen, “crispr gene therapy: applications, limitations, and implications for the future,” frontiers in oncology 10 (august 7, 2020): 1387, doi:10.3389/fonc.2020.01387. 8 ibid. 9 savulescu, j, “ethics and enhancement,” annals new york academy of sciences (2006), 321-338. https://doi.org/10.1038/534590a castelyn, shifting perceptions of crispr, voices in bioethics, vol. 7 (2021) 4 10 martin müller et al., “assessing public opinion on crispr-cas9: combining crowdsourcing and deep learning,” journal of medical internet research 22, no. 8 (august 31, 2020): e17830, doi:10.2196/17830. 11 stephan guttinger, “trust in science: crispr–cas9 and the ban on human germline editing,” science and engineering ethics 24, no. 4 (august 2018): 1077–96, doi:10.1007/s11948-017-9931-1. 12 katherine mobley, “how public perception can make or break a brand, and what it means for employees,” forbes, january 5, 2019, https://www.forbes.com/sites/forbescommunicationscouncil/2019/05/01/how-publicperception-can-make-or-break-a-brand-and-what-it-means-for-employees/?sh=7b81058ad118. 13 james p. broughton et al., “crispr–cas12-based detection of sars-cov-2,” nature biotechnology 38, no. 7 (july 2020): 870–74, doi:10.1038/s41587-020-0513-4. 14 “a covid-19 test to detect virus variants.”; kean hean ooi et al., “an engineered crispr-cas12a variant and dna-rna hybrid guides enable robust and rapid covid-19 testing,” nature communications 12, no. 1 (december 2021): 1739, doi:10.1038/s41467-021-21996-6. 15 dietram a. scheufele et al., “what we know about effective public engagement on crispr and beyond,” proceedings of the national academy of sciences 118, no. 22 (june 1, 2021): e2004835117, doi:10.1073/pnas.2004835117. 16 who expert advisory committee on developing global standards for governance and oversight of human genome editing, “humane genome editing position paper” (who, 2021). 17 international commission on the clinical use of human germline genome editing et al., heritable human genome editing (washington, dc: national academies press, 2020), doi:10.17226/25665. 18 josiah zayner, “2018 genetic engineering for all: the last great frontier of human freedom,” www.leapsmag.com, january 20, 2018, https://leapsmag.com/genetic-engineering-last-great-frontier-humanfreedom/particle-1. arbour, policymaking & court decisions, voices in bioethics, vol. 1 (2014-15) © 2015 kaitlyn arbour. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. implications of policymaking and court decisions on scientific innovation kaitlyn arbour keywords: biotechnology, legislation, patents, policymaking, scientific innovation introduction recent court hearings and legislation proposals regarding biotechnology and biotechnological methods have proven to be unfavorable to several avenues of scientific research and innovation. there exists a tension between interests of the scientific community and the means through which legislation permits scientists to realize those interests. factors larger than those of the scientific community must be taken into account when penning policy, and the same holds true for any interpretation by judiciary bodies. the presence of a strain between advocacy for the scientific community and objectiveness in order to allocate the products of scientific innovation permeates legislative decision-making. in recent years, it appears as though advocacy for private scientific innovation has decreased as issues surrounding distributive justice have increased. analysis there has been a tightening of the reigns by the united states supreme court regarding patent cases involving biotechnology over the past few years. with landmark cases such as prometheus v. mayo (2012) and amp v. myriad genetics (2013) there appears to be a trend of judicial precedence that is unfavorable to scientific innovation.1 in prometheus v. mayo, the court ruled that a patent is ineligible if it is deemed to be applying the laws of nature using conventional methods known to the field. in amp v. myriad genetics, the court ruled that isolated human dna was not patent-eligible, without applying existing case law, relaying that dna is both “unique” in its own right, and a “physical embodiment of laws of nature” and therefore cannot be patented.2 both court decisions were deemed unfavorable by the scientific community. the current dispute over priority filing, scope of claim, and patent-eligibility of crispr/cas9 technology3 will be a critical determination that will likely have adverse legal consequences for the relationship between patent application, litigation, and scientific innovation. the complexity of the bureaucratic process in which patents are granted (through the us patent and arbour, policymaking & court decisions, voices in bioethics, vol. 1 (2014-15) 2 trademark office) leaves much room for error. the factors driving the discrepancies in the patent granting process are no doubt multifaceted, but the influx of patent applications and the limited resources of the patent office create a perfect storm for the spike in patent litigation cases filed within the past decade.4 in addition, court rulings, such as the myriad decision, have left many members of the scientific community confused. the verdict in myriad misunderstands what scientific innovation is and as a result creates a tremendous gray area in which scientists have to be mindful of the law, thereby ignoring the reality of scientific innovation. patents assist scientific innovation due to their allowance of a government-granted monopoly for an extended period of time. however, considerations over the patentability of various prognostic and diagnostic methods may be considered an impediment to public health, precisely because of this monopoly. i assume that one (of many) purposes of policy is to allocate resources, in which case there is a delicate push and pull that occurs between private profits obtained from scientific innovation and public access to novel pharmaceuticals and biologics. while i do believe that the development of private enterprise is a critical component of driving scientific innovation, public access needs to be an equally important consideration. in preceding decades, the former has been granted greater weight, thereby detracting from the latter. these policy implications illustrate larger issues and trends in statutory law. one major piece of legislation that recently passed and has questionable implications for the scientific community is the biologics price competition and innovation act of 2009 (“biosimilars act”). it passed with the intention of promoting innovation of biologics and lowering their price, thereby increasing accessibility to the wider population. the biosimilars act is highly analogous to the hatch-waxman act of 1984, which skyrocketed the production of generic drugs and tremendously lowered the price of small molecule drugs.5 however, controversy exists over whether or not this is a realistic endeavor, given the scientific reality of the nature of biologics and the twelve-year exclusivity granted to innovator companies. the discrepancy between intention and outcome in the biosimilars act is speculative, but may be attributed to the lack of competition faced by biologic innovator companies. conclusion the discontinuity between policymaking, court interpretation, and their implications for scientific innovation that has emerged in recent years appears to be far from over. in fact, it is likely that such trends may lead to a battle between scientific innovation, legislation, and legal jurisdiction. the discontinuity also indicates that there is a delicate balance between the ability of self-regulation in the private sphere to promote scientific innovation and the oversight of government in its ability to properly allocate the products constructed from scientific progress. 1 jost, kenneth. “patent controversies.” cq researcher. cq press, 27 feb. 2015. accessed 10 nov. 2015. 2 morrison, alan j. “rethinking the gene patent.” biotechnology law report 29.6 (2010): 609–14. 3 crispr/cas9 is a molecular technology used for gene editing and gene regulation. 4 barry, chris, et al. “2015 patent litigation study: a change in patentee fortunes.” pricewaterhousecoopers llp, may 2015. 5 lu, ude. “note: biologics price competition and innovation act: striking a delicate balance between innovation and accessibility.” minn j. l. sci. & tech. 15.1 (2014): 613–51. laskin, psychologists ‘not jack bauer,’ voices in bioethics, vol. 1 (2014-15) © 2015 elie laskin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. psychologists ‘not jack bauer,’ says the american psychological association: apa’s decision to ban psychologists from the interrogation room elie laskin keywords: 2015 apa resolution, american psychological association, autonomy, coercion, informed consent, interrogation introduction ask just about any undergraduate student in psychology and it is likely they can list a handful of research studies in which they have participated. whether it is the promise of an extra 2% added to their final grade, the allure of monetary compensation (student budgets are student budgets after all) or intrigue with the discipline itself, volunteering in the role of ‘lab rat’ is common amongst undergraduates. in fact, these students have long played a significant role in shaping evidence-based research and its results. one study found that the average american undergraduate is 4,000 times more likely to be a research participant than an average non-westerner1. it is clear that students are willing to throw themselves into data fields. what happens, however, when individuals are involved in the collection of data to which they have not consented, or do not know about? analysis the issue of autonomy in research is ever complicated when experiments clearly involve unwilling or unknowing subjects. here, there is no question that an ethical boundary is crossed. while experimentation is inherently a foray into the unknown, all subjects from whom data is gathered have rights to understand the risks and implications of participation. unless informed consent is freely provided, some may even say that the data itself is tainted. whether consent is ever completely free of coercion is another question. perhaps the students seeking extra credit were really just swayed by compensation: their choices not completely autonomous. in many other cases, however, it is an axiom that completely autonomous consent is not provided. recall the study by solomon asch in which participants were asked to compare lengths of lines in the company of their peers who were challenged with the same tasks. participants answered alongside asch’s accomplices who insisted that short lines were long lines2. this was not an experiment about line perception at all but rather, an experiment on the coercive forces of conformity. here at columbia university, researchers john darley and bibb latané also could be seen to have crossed an ethical boundary for some when they tested the bystander effect. following the murder of kitty genovese, the researchers led participants to believe that a fire had started in a lab room or worse, that medical emergencies were taking place 3. they wanted to determine whether people were more likely to react to adversity if they were alone versus if others were also witnessing or experiencing the same adversity. the willing but deceived participants of this sort are sources of fascinating research on group dynamics, conflict and conformity. however, when deception and coercion is taken even further in the realm of psychology, the need for an understanding of ethical guidelines is made laskin, psychologists ‘not jack bauer,’ voices in bioethics, vol. 1 (2014-15) 2 even more clear. herein lies the issue at play: data collection during interrogations. recently, the american psychological association (apa) board of directors sought out an independent reviewer, attorney david hoffman, to conduct a report into whether there was real evidence to the rumors that the apa had colluded with the bush administration in interrogations during the war on terror. hoffman’s report found unreported coordination between apa officials and psychologists within the department of defense during the years following 9/11; hoffman concluded that in these years, many psychologists had practiced along loose ethical guidelines for the sake of protecting national security4. following his report, the apa convened for its annual meeting this past august in toronto, canada and by an overwhelming majority voted to prohibit psychologists from taking part in military and national security interrogations. the 2015 apa resolution stated that psychologists should not “conduct, supervise, be in the presence of, or otherwise assist any national security interrogations for any military or intelligence entities”5. the policy does, however, allow psychologists’ involvement in general strategy consultations where human interrogations are concerned. the prohibition against participation in national security interrogations does not apply to situations where detained persons are under the protection of the united states constitution, or where domestic law enforcement interrogations are taking place. perhaps one of the main takeaways from this new apa policy is the renewed establishment of psychologists’ primary mission: to provide mental health services to military persons and/or work for an independent party to protect human rights at facilities where the united nations has deemed violations have taken place. within the resolution there is an explicit acknowledgement that psychologists in any organizational setting may be challenged to behave ethically and in accordance with the apa ethics code which organizes ethical standards for the behavior of psychological practitioners. further, there is a primary acknowledgement that the resolution is in keeping within principle a (beneficence and non-maleficence) of the code to “take care to do no harm”5. conclusion at the epicenter of psychologists’ involvement with human subjects is a central question: should data obtained through anything less than morally acceptable research be deemed usable? whether it be results of a research hypothesis, or the location of a known terrorist group gathered during an interrogation, maybe information collected unethically be thrown away. in the case of interrogations, the role of psychologists as professionals might even be questioned. perhaps psychologists have no place in determining the common good for society and instead, should simply care for and treat individuals. on the other side, maybe ethical boundaries should be loosened to facilitate a greater common good, such as that of national security. regardless, the synthesis between obtaining data and conducting one’s research ethically is not always so easy to achieve. the recent decision by the apa, however, outlines one very definitive stance on where psychology has aligned itself. 1 http://hci.ucsd.edu/102b/readings/weirdestpeople.pdf 2 https://brainmass.com/file/321407/solomon+asch+-+original+article.pdf 3 http://psych.princeton.edu/psychology/research/darley/pdfs/bystander.pdf 4 http://www.apa.org/independent-review/apa-final-report-7.2.15.pdf http://hci.ucsd.edu/102b/readings/weirdestpeople.pdf https://brainmass.com/file/321407/solomon+asch+-+original+article.pdf http://psych.princeton.edu/psychology/research/darley/pdfs/bystander.pdf http://www.apa.org/independent-review/apa-final-report-7.2.15.pdf laskin, psychologists ‘not jack bauer,’ voices in bioethics, vol. 1 (2014-15) 3 5 http://www.apa.org/independent-review/psychologists-interrogation.pdf http://www.apa.org/independent-review/psychologists-interrogation.pdf ayeh, bioethical silence & black lives, voices in bioethics, vol. 1 (2014-15) © 2015 derek ayeh. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. bioethical silence & black lives derek ayeh keywords: genetic modification, human enhancement introduction when confirmation was released that researchers from china had genetically modified human embryos for the first time ever, there was a sudden explosion of activity on the web from the bioethics community. physicians, academics, and anyone else who could claim some affiliation to the field wrote articles for magazines discussing the ethical dimensions of the issue. after all, human enhancement and genetic modification are staples of bioethical discourse. who wouldn’t want to add their two cents and take part in such an important discussion? analysis conversely, when the news of freddie gray’s death became public, i was greeted by a surprising but familiar bioethical silence. surprising because i thought that the relationship between freddie gray’s death and bioethics was rather obvious: here was a man who requested healthcare numerous times but was refused it— the justification being that he was a criminal and either faking his pain or self-inflicting it. while there are likely numerous reasons why freddie gray died, do bystanders have moral responsibilities when they witness an injured person? there’s often debate about whether a bystander has a moral responsibility to intervene. however, as public servants, police officers surely have some ethical responsibility to ensure that even criminals receive medical treatment when badly injured. it is ethically troubling that individuals charged with protecting the public ignored a man who was begging for and needed immediate medical treatment. 1 the dimensions of the situation also intrigued me: even incarcerated individuals are entitled to receive “adequate” healthcare, so on what moral grounds does a police officer stand when he/she ignores the cries for treatment of someone who has been seriously injured? while other aspects of the case concern me, these were questions i was able to ask purely as a student of bioethics— questions i thought bioethicists should have opinions about and be interested in discussing. yet, while bioethicists have had no issue condemning genetic experimentation they seem to sew their mouths shut on the matter of black lives. the lack of any analysis or statement from bioethicists on freddie gray’s case is familiar. just last year, i was greeted by a similar silence from my field in response to eric garner. it is even easier to claim his case is within the realms of bioethical inquiry—those squeamish about discussing race could ask: why was garner refused cpr, the standard of care? while some claimed that garner was still breathing (despite his now famous ayeh, bioethical silence & black lives, voices in bioethics, vol. 1 (2014-15) 2 last words, “i can’t breathe”), the union president for emts and paramedics, israel miranda, was quoted widely as saying that the emergency medical team that arrived at the scene ignored the state protocol of supplying oxygen to an individual having difficulty breathing.2 the ethics of the case are fairly easy— the standard of care exists for a reason, and the refusal to uphold it should have been condemned. even the recent death of sandra bland overlaps with bioethical inquiry. though there is currently dispute over whether her death was a suicide, let’s assume that everything that waller county jail has told the public is true. her intake forms indicate that she attempted suicide in the previous year.3 there is a standard of medical care for inmates who may be actively suicidal or have exhibited past suicidal behavior. waller county jail failed to remove the plastic bag from her cell as a potential tool of self-harm and did not keep her under close surveillance.4 if it was truly a suicide, sandra bland’s death was the result of the jail withholding the standard of care. as bioethicists we know that disregarding the principle of justice is akin to asking for a healthcare scandal. we learn about the tuskegee syphilis study so we can recognize how racism, inequality, and poverty can affect what type of healthcare an individual receives. denouncing medical injustice doesn’t end because the victim isn’t a patient and the crime scene isn’t a hospital. why hasn’t bioethics spoken up about the “black lives matter” movement, especially when the health profession at large has contributed widely to the discussion? medical students have hosted “white coat dieins” to show that they stand in solidarity with the protesters in ferguson and baltimore. public health officials like dr. mary bassett, new york city’s health commissioner, have taken this opportunity to try and educate the public about the connections between health and racism. the health professions have been entrenched in our nation’s conversation over the value of black lives and the problems that persons of color face when they come into contact with the criminal justice system. these professionals didn’t wait for an invitation to speak their minds on these issues, as there was never any question that the health professions belong in this conversation. still, bioethics shies away. leigh turner, associate professor for the center for bioethics at the university of minnesota, has criticized bioethics for exactly this tendency. he believes that the field is obsessed with the “cutting-edge.”5 anytime a new technology or innovation that impacts human health springs up, so do the bioethicists. we are even drawn to ethical issues that are still decades away, while questions of race or inequality fall just outside of our purview. with just a quick search hundreds of papers come up covering human enhancement and cloning. however, bioethics often overlooks poverty, unemployment, and gun violence, leaving them for other healthcare professionals. the academics in our field are fixated on high technology and, as turner points out, it paints a picture of bioethical inquiry as only being useful for addressing the concerns of the upper and middle classes. he likely sees us as the epitome of elitist scholars commenting on the world from our ivory tower. however, i see our field’s silence as a problem for a very different reason than turner’s. the late adrienne asch once wrote “bioethics is at its best when people don’t merely ask each other what their views are, but really take the time to find out what is behind those views.” 6 she believed that bioethical inquiry was a profound tool that could transcend the drudgery of political polarization and get at the foundations of why people believe what they believe. the ideal bioethicist not only articulates his or her own views but also understands what perceptions and life experiences shape those views and can see what values lie behind the views of others. to asch, bioethicists are capable of thinking far beyond simply identifying with the political “left” or “right,” probing further to find out why people think differently in order to stimulate reasonable discourse. i want to believe that adrienne asch is right and that i study bioethics because of its potential to find resolutions through reasonable discourse. her vision of bioethics is truly striking and certainly not what the field always is, but what it should constantly aspire to be. most importantly, it is asch’s bioethics that would be truly useful in our country’s current debate over racism and black lives. it’s hard to even call it a debate— we constantly spend our time talking over one another and raising our voices louder in hopes that someone will hear our views. our country is completely divided on this issue. where some see criminals and rioters ayeh, bioethical silence & black lives, voices in bioethics, vol. 1 (2014-15) 3 others see disenfranchised individuals and suffering communities. conclusion i am not saying that a handful of bioethicists writing about these issues will correct the gap between our perceptions, nor do i think that the field should stop talking about technological advancements. nevertheless, i do believe that we have a place in this important conversation and hope that those in the field with far more experience than i will seize the opportunity to make bioethics more than it is today. 1 payne, ed. “we failed to get freddie gray timely medical care after arrest,” cnn, april 24th, 2015. http://www.cnn.com/2015/04/24/us/baltimore-freddie-gray-death/. 2 mueller, benjamin. “medical workers face scrutiny after man’s death in police custody,” the new york times, july 21, 2014. http://www.nytimes.com/2014/07/22/nyregion/medical-workers-face-scrutiny-after-mans-death-in-policecustody.html?_r=0. 3 mathis-lilley, ben. “sandra bland reportedly told jail staff she’d previously attempted suicide,” slate, july 22, 2015. http://www.slate.com/blogs/the_slatest/2015/07/22/sandra_bland_previous_suicide_attempt_jail_intake_form_disclosed _attempt.html. 4 liebelson, dana. “a texas jail failed sandra bland, even if it’s telling the truth about her death,” huffington post, july 21, 2015. http://www.huffingtonpost.com/entry/sandra-bland-jail-death_55ae9f12e4b07af29d569875. 5 turner, leigh. “bioethics, social class, and the sociological imagination.” cambridge quarterly of healthcare ethics, (2005): pgs. 374-378. 6 asch, a. “big tent bioethics: toward an inclusive and reasonable bioethics.” hastings center report, (2005): pgs. 11-12. http://www.cnn.com/2015/04/24/us/baltimore-freddie-gray-death/ http://www.nytimes.com/2014/07/22/nyregion/medical-workers-face-scrutiny-after-mans-death-in-police-custody.html?_r=0 http://www.nytimes.com/2014/07/22/nyregion/medical-workers-face-scrutiny-after-mans-death-in-police-custody.html?_r=0 http://www.slate.com/blogs/the_slatest/2015/07/22/sandra_bland_previous_suicide_attempt_jail_intake_form_disclosed_attempt.html http://www.slate.com/blogs/the_slatest/2015/07/22/sandra_bland_previous_suicide_attempt_jail_intake_form_disclosed_attempt.html http://www.huffingtonpost.com/entry/sandra-bland-jail-death_55ae9f12e4b07af29d569875 kwolek, alone on an island, voices in bioethics, vol. 7 (2021) * erin kwolek, ms candidate columbia university, md university of calgary © 2021 erin kwolek. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and repr oduction, provided the original author and source are credited. alone on an island: the impact of covid-19 containment measures on access to abortion care in malta erin m. kwolek* abstract malta is a small, predominantly catholic island-nation in the mediterranean ocean where there is a complete ban on abortion – there are no exemptions for rape, incest, fetal anomalies, or to save a pregnant woman’s life. both medical and surgical abortions are illegal. those who choose to end pregnancies have often sought abortion care outside of malta, traveling abroad at great personal cost. medical care in malta is otherwise free at the point of care. options for pregnancy termination within malta are essentially nonexistent as there is great public support for the maltese abortion ban. as the government of malta imposed travel restrictions in the interest of containing the spread of sars-cov2, women faced further limitations in their ability to access safe, effective abortion care in other countries. many women have ordered medications online and have self-managed their abortion care. women who have had abortions or people who facilitate abortions in malta face criminal charges. women who seek medical management of complications of self-managed abortions do so with the possibility of facing legal charges. denying women access to safe and private abortion care can cause significant physical, psychological, and social effects and unfairly harms those experiencing an unwanted pregnancy. given the global covid pandemic and in the event of future pandemics wherein lockdowns may be indicated to maintain public health and safety, the maltese government has a responsibility to ensure access to safe abortion care whether abroad or selfmanaged and such care should be decriminalized. keywords: abortion, malta, reproductive care, covid-19, illegal health care, pregnancy, catholicism kwolek, alone on an island, voices in bioethics, vol. 7 (2021) 2 introduction the official and predominant religion of malta is roman catholicism. this is recognized in article 2 of the constitution of malta; the constitution gives the church the duty and right to “teach which principles are right and which are wrong,” and religious education is compulsory.1 the constitution does afford maltese citizens freedom of religious choice though most citizens in malta are catholic. the maltese criminal code is clear regarding abortion: 241. (1) whosoever, by any food, drink, medicine, or by violence, or by any other means whatsoever, shall cause the miscarriage of any woman with child, whether the woman be consenting or not, shall, on conviction, be liable to imprisonment for a term from eighteen months to three years. (2) the same punishment shall be awarded against any woman who shall procure her own miscarriage, or who shall have consented to the use of the means by which the miscarriage is procured. 242. if the means used shall cause the death of the woman, or shall cause a serious injury to her person, whether the miscarriage has taken place or not, the offender shall, on conviction, be liable to the punishment applicable to willful homicide or willful bodily harm, diminished by one to three degrees. 243. any physician, surgeon, obstetrician, or apothecary, who shall have knowingly prescribed or administered the means whereby the miscarriage is procured, shall, on conviction, be liable to imprisonment for a term from eighteen months to four years, and to perpetual interdiction from the exercise of his profession.2 the language used in the constitution reflects the persistence of catholic values through time and excludes all methods of and exemptions for pregnancy terminations. the prohibitions above apply to cases of rape, incest, and where the pregnant woman's life is in jeopardy – the only other country in the european union with equally restrictive laws is the vatican. however, a key difference between malta and the vatican is that someone living in the vatican wanting an abortion would have easy access to medical services in rome. malta is isolated in comparison. the coronavirus placed additional stress on those seeking abortion care when infection control measures were implemented.3 as malta is an island, travel outside of the country requires travel by boat or plane, both prohibited as part of government-imposed infection control measures. those who did return to malta following international travel were required to quarantine for two weeks and risked fines of up to €10,000.4 while someone in the first trimester of an unwanted pregnancy may have previously been able to plan a quick trip abroad without raising suspicion that they were traveling for abortion care, with travel restrictions in place, such trips were not easily executed. when pregnant women cannot access abortions, whether medical or surgical, they must self-manage their abortion care. i. the harms of a lack of access to care as the pandemic is a time of significant mental, spiritual, and existential distress, the added stress of an unwanted pregnancy can cause great harm to an individual. some may argue that the societal benefits of restricting travel, thus limiting disease spread to individuals and their communities, can outweigh the rights of the individual. but even during a public health emergency, such as a pandemic, it is important that kwolek, alone on an island, voices in bioethics, vol. 7 (2021) 3 medical care continue where possible to ensure robust baseline health of the community. abortion care is essential medical care,5 and in the case of a global infectious pandemic, it would ideally be available locally so as not to harm the community through needless travel abroad. given the significant implications and downstream effects caused by the continuation of an unwanted pregnancy, those seeking abortion care are likely to pursue the options available to them even if there is the potential risk to the individual or their community. underlying the increased challenges regarding access to abortion care is the existing legislation that does not have provisions for emergency care. the potential harms to pregnant women in criminalizing access to abortion care, especially given the ongoing covid-19 pandemic, are significant. the current legislation does not provide exemptions for abortions that would save the woman’s life. rather, the woman and her health care team are at risk of criminal consequences if they implement this lifesaving care. if a woman remains in malta and is unable to self-manage abortion care, or if self-managed care is not medically appropriate or safe, she faces the possibility of dying because of pregnancy continuation. alternately, the woman can leave the country to pursue the appropriate care, though there is the potential for social and financial repercussions, and pandemic travel restrictions severely limit this option.6 ii. injustice malta’s criminalization of all abortions is a significant violation of the bioethical principle of justice. the maltese criminal code legislates no other medical procedures. 7 the burden that results from these restrictions weighs most heavily on maltese women. pregnant women seeking an abortion must either determine a strategy to get such care (potentially violating the criminal code) or continue a dangerous or unwanted pregnancy. although those who seek to support and help women may also face criminal consequences, the criminal code essentially targets women with unwanted or unsafe pregnancies. furthermore, as their request for abortion puts doctors or other facilitators at risk, the potential criminal liability of healthcare professionals is a deterrent to their seeking abortion care. thus, the criminal code undervalues women and creates a crime that categorically applies to women only. restrictive reproductive care policies in malta also create significant socio-economic injustice, which was amplified by stay-at-home orders and travel bans. those who can afford to leave the island to seek medical care abroad are also those who are most likely to have the financial flexibility for a post-travel two-week quarantine. the financial stress associated with seeking medical care abroad or self-managed abortion care disproportionately affects women of low socioeconomic standing. there are non-profit organizations outside of malta that may be able to facilitate access to medically supervised abortion care outside of the country. however, covid-19 travel restrictions likely limited their ability to help women. iii. autonomy and healthcare decisions ultimately, allowing pregnant women access to the reproductive care they require is important for the preservation of individual autonomy. ideally, women would have the assistance of healthcare providers to inform reproductive decisions with accurate, evidence-based information that is free from bias. certainly, where a provider is at risk of criminal charges, a patient is denied the information necessary to make an autonomous choice regarding the appropriateness of such care. the provision of comprehensive and exhaustive information is also essential to the preservation of trust between the medical care team and the patient. abortion care is acceptable in many jurisdictions, and information around this care should be included as part of comprehensive family planning discussions whether the provider is willing to facilitate the care or not. kwolek, alone on an island, voices in bioethics, vol. 7 (2021) 4 iv. denying the consequences of a local ban on abortion there is a perception among those supporting the complete abortion ban that those wanting abortion care, even in pregnancies resulting from rape, can easily travel to other countries to do so. as discussed above, this perception does not consider financial inequities and the burdens on those with limited financial resources.8 people holding this “not in my backyard” stance on abortion may be using the perceived easy international access to abortions as an excuse to avoid considering the consequences of a total ban (for example, the death of pregnant women from pregnancy complications, a woman forced to continue a pregnancy despite severe fetal abnormality that is not compatible with survival upon delivery). because international travel for abortion can no longer be presumed, ban supporters can no longer use it as a shield to avoid grappling with difficult problems. issues like the ethics of permitting a woman to die or forcing a birth resulting from rape or incest would be addressed head-on if the legislators did not dismiss the issues using the assumption women can travel for care. exploration of an ethical justification for a complete ban is sidelined by the perception of the ability to access care elsewhere. conclusion it is an oversimplification to consider the legality of abortion the sole barrier to accessing this care, especially in a country driven by culture and religion. yet abortion and reproductive care are essential to the wellbeing of pregnant individuals and should be part of every health system. the covid-19 pandemic remains a significant public health concern and has highlighted some of the consequences of not having any abortion care available within malta. illegal self-managed abortions remain one of the few options for many pregnant women in the country. it can be challenging to navigate abortion care, particularly in a country where the prohibition of such care is widely accepted, and it is important to allow for provisions that support safe reproductive care. research and examination of the pandemic’s effect on access to abortion care would provide much-needed data. protections and immunity in place for those who sought or delivered such care during the pandemic would be a just response to the restrictive policies. the pandemic has successfully highlighted significant inequities in care, and access to safe and effective abortions for those who wish to have them should be facilitated – whether it be in malta or abroad. 1 “constitution of malta,” 1964., 7. 2 malta criminal code, cap. 9, book first, part ii, title viii, sub-title vii, articles 241-243, available at refworld, accessed april 24, 2021, https://www.refworld.org/docid/5d36fc847.html. 3 different countries in europe responded to the covid-19 pandemic in different ways. hungary, for example, stopped all non-life-threatening surgeries in state hospitals, while in the netherlands, those who had or lived with someone with covid-19 symptoms were restricted from accessing abortion care. caroline moreau et al., “abortion regulation in europe in the era of covid-19: a spectrum of policy responses,” bmj sexual & reproductive health, october 22, 2020, https://doi.org/10.1136/bmjsrh-2020-200724. 4 “covid-19: confirmed patients who ignore isolation orders to be fined €10,000,” times of malta, accessed april 24, 2021, https://timesofmalta.com/articles/view/covid-19-fines-may-be-increased-up-to-10000.780452. 5 elizabeth janiak and alisa b. goldberg, ‘eliminating the phrase “elective abortion”: why language matters’, contraception, 93.2 (2016), 89–92, https://doi.org/10.1016/j.contraception.2015.10.008. 6 of course, it is also important to consider the well-being of women who have unwanted pregnancies and are choosing abortion care. the abortion argument is often framed solely in the context of pregnancies where a kwolek, alone on an island, voices in bioethics, vol. 7 (2021) 5 woman’s health and/or life are in jeopardy or in cases of incest and rape – this neglects the needs of the women who have unwanted pregnancies outside of those circumstances. the continuation of such pregnancies can have significant social and financial consequences for an individual – ensuring that appropriate and safe care can be pursued is essential to the minimization of harm to that individual. legislation that denies any individual the opportunity to seek such care, and that goes so far as to criminalize it, can cause significant emotional and physical harms to pregnant individuals. this can happen regardless of the motivation for pursuing abortion care and the argument is most appropriately framed in general terms to preserve the right to seek abortion care for all pregnant women. 7 malta criminal code, cap. 9, amendments up until 2018, available at refworld, accessed april 24, 2021, https://www.refworld.org/docid/5d36fc847.html. 8 “abortion debate: between progress, catholic morality and patriarchy,” maltatoday.com.mt, accessed april 8, 2021, http://www.maltatoday.com.mt/news/national/100419/abortion_debate_between_progress_catholic_morality_a nd_patriarchy. winter 2015 b.s./m.d. programs: how early is too early? jonathan chevinsky follow this and additional articles at: http://voicesinbioethics.org/ legal disclaimer: the views expressed in the voices in bioethics online journal and on the voices in bioethics website in its entirety, are solely those of the contributing author(s) to the publication, and do not reflect the views of columbia university, its trustees, affiliates, administration, faculty, staff, students, alumni, the editors of this site, and any other member of the columbia university community. moreover, the ideas and information expressed in this publication have not been approved or authorized by columbia university, and the university shall not be liable for any damages whatsoever resulting from any action arising in connection with its publication. columbia university is not responsible for the contents of any off-site information referenced herein. http://voicesinbioethics.org/ voices in bioethics 2 how early can you be expected to know that you want to be a doctor? if you ask medical school essay reviewers i'm sure you'll hear how many thousands of people have known that they wanted to go into medicine ever since they were five years old; but is that too early to actually know? while the average age of acceptance into medical school is 24, suggesting that a significant percentage of students do not matriculate into medical school directly after college, many students begin preparing during high school. that isn't to say that there's a nation of ninth grade students studying for the mcat and writing their personal statements (though in a few years, who knows?) however, students interested in applying to combined undergraduate and medical school programs, more commonly known as bs/md programs, need to fulfill many of the same requirements as undergraduate students applying to medical school in order to be considered a competitive applicant. the question is whether preparing for a career in medicine during high school makes sense or whether it is impossible to know what you want to do with the rest of your life at such an early age. i come from a medical family. at least ten of my relatives are involved in medicine, including fields such as nursing, orthopedic surgery, and oncology. among them, my father, uncle, and sister all attended combined medical programs, making me aware that such a path was an option. i like to believe that hearing about and observing their different experiences gave me enough information to decide that i wanted to pursue medicine at a young age, but perhaps i just conformed to a life in the ‘family business.’ while i'll never fully know what percentage of the idea was mine, i enjoy it so much that it seems unnecessary to go down the chicken or egg rabbit hole. with the goal of potentially applying to bs/md programs, i geared my high school experience toward helping my chances; i took ap biology and chemistry, kept up a respectable gpa, brought my sat score above 1400, and even participated in a weekly program at the university of medicine and dentistry of new jersey called mini medical school, which centered on lectures about various medical topics among other extracurricular medical activities. everything i did either directly helped my chances of getting into a bs/md program or indirectly helped by bolstering my resume. ultimately, i did get into a few programs and am currently going into my junior year of college at one. however, it recently occurred to me that while my program has consumed my past, i am being rewarded for my choices in the present. it dawned on me that bs/md programs are not inherently great or terrible but represent a unique path for highschoolers who have decided that they want to pursue medicine at a young age, and therefore focused their studies on medicine before most pre-med students. considering that in countries like england students normally apply to medical school following their graduation from high school, this is not an outrageous option. unless you are coerced by family members to apply to a bs/md program, a legitimate concern of program interviewers, what such a program offers is invaluable: the ability to abridge your undergraduate education and subsequently reduce the exorbitant cost and extensive medical school process. furthermore, it allows students who want to become physicians to explore other non-medically related interests without having to worry about the medical voices in bioethics 3 school application process looming over their heads. for example, a friend of mine who is also in a bs/md program decided to take a swing dancing class because he had the freedom of knowing a spot was reserved for him in medical school. he no longer felt pressured into allocating all of his time towards medically themed activities. similarly, i am following one of my passions by majoring in creative writing, a discipline that is not a focus of the average premedical student. in an era in which the well-rounded medical professional is viewed as the prototype—as shown by the recent change in the mcat to include social sciences, a shift away from the previous focus solely on the natural sciences—such opportunities to broaden one’s horizons should be encouraged. another clear advantage is that students in such programs are provided with a host of opportunities specific to them. in my case, the biggest advantage is that bs/md students are given a separate advisor specific to the program in question. this enables us to have an authority figure whom we can reference concerning any requirements for their particular combined program and whose primary goal is to ensure that we are able to fulfill said requirements. thanks to our advisors we are given the opportunity to participate certain activates before the rest of the student body such as a seminar class about medical history, hospital internships, and volunteer opportunities. finally, if recognition and reverence is paramount for a student, being a member of a bs/md program is usually indicative of an elevated academic status. it is generally understood that such programs are selective, offering a certain level of prestige to their students. while rewarding, bs/md programs also have their potential drawbacks. college often represents a time where students are in flux: their major, career plans, and social relationships can change multiple times over the course of four years. it stands to reason that any decision made in high school—a time in which your brain is not yet fully developed and you are not yet fully socialized to be an independent, self-sufficient individual—is subject to change upon further experience in college. if acceptance to bs/md programs is contingent on participation in medically-focused extracurricular activities from ninth grade onwards, then there is a chance that some will expend the energy to enter a bs/md program only to realize they are uninterested in becoming doctors. for such individuals, the development of their interests could have been stymied because they pursued a commitment to medicine, not knowing what they really wanted, but hoping to leave that option open. time spent shadowing a doctor may be more effectively used attending a career fair as many possible professions may have been overlooked. one problematic trend that i’ve noticed is that bs/md students don’t feel encouraged to do more than the bare minimum because they already have a guaranteed spot in medical school. while in my experience most students still pursue leadership positions and extracurricular activities, in some cases students have rested on their laurels and accomplished much less over the course of their college careers than their high school careers. in some extreme cases, this has gone as far as to prevent students from meeting the minimum requirements of the program, putting them in a position in which they neither have a reserved spot nor any realistic chance of getting into other medical schools. in such instances, perhaps these students have burnt out from the stress of ensuring that voices in bioethics 4 their high school resumes and transcripts were competitive enough to apply to these combined programs. this returns the discussion to the initial question of how early you can be expected to know that you want to be a doctor. the answer is that insofar as there is no clear consensus about when our career choice must be made and to what extent and at what age others around us influence our decision most, students should be informed about different paths and opportunities, but not coerced into partaking before they are ready. this applies to every career, but most significantly to these combined programs (medicine, pharmaceuticals, engineering, etc.) because they are paths to graduate schools which can provide a student with less stress, more freedom, and more opportunities down the road. that being said, one must be very cautious to avoid a premature decision and if a student is not completely sure about which profession he or she would like to pursue, the safest bet is simply to explore any interests that he or she has and figure it out from there. students who decide during their senior year of college that they are passionate about medicine and decide to pursue a career as a physician will be much happier than those pushed into medical school only to realize that medicine is not for them. however, for the students who feel secure in their passion for medicine, i strongly believe that combined medical programs are an appropriate option given that such students have had the time and opportunity to explore the medical field before making their decision. dale, personhood, critical interests, and the moral imperative, voices in bioethics, vol. 7 (2021) © 2021 samuel dale. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. personhood, critical interests, and the moral imperative of advance directives in alzheimer’s cases samuel dale abstract the moral authority of advance directives (ads) is contingent on one of two metaphysical concepts of personhood common in the west. the first tradition originated in the ideas of david hume and jeremy bentham. hume asserts that the idea of personhood is socially fabricated and that we are nothing more than “bundles” of sensations.” bentham is famous for developing a utilitarian ethical approach predicated on hume’s reductionist theory, a person who asserts the morally right act is the one which maximizes pleasure and minimizes pain. the second metaphysical tradition, which grants moral authority to ads, stems from the work of john locke and john stuart mill. locke conceived of persons as beings that are “rational, concerned, continuing, and self-conscious,” and mill understood that persons act in a manner that maximizes their holistic goods, not only the sum of their experience of pleasure or pain. dworkin’s framework of critical interests and mill’s version of utilitarian ethics support the moral authority of precedent autonomy by defending the narrative quality of life, the important pursuit of higher pleasures, and a dignified characterization of humanity. keywords: advance directive, personhood, utilitarian, dworkin, bentham, hume introduction the moral authority of advance directives (ads) is contingent on one of two metaphysical concepts of personhood common in the west. the first tradition originated in the ideas of david hume and jeremy bentham. hume asserts that the idea of personhood is socially fabricated and that we are nothing more than “bundles” of sensations.”1 bentham is famous for developing a utilitarian ethical approach predicated on hume’s reductionist theory, a person who asserts the morally right act is the one which maximizes pleasure and minimizes pain.2 the second metaphysical tradition, which grants moral authority to ads, dale, personhood, critical interests, and the moral imperative, voices in bioethics, vol. 7 (2021) 2 stems from the work of john locke3 and john stuart mill.4 locke conceived of persons as beings that are “rational, concerned, continuing, and self-conscious,”5 and mill understood that persons act in a manner that maximizes their holistic goods, not only the sum of their experience of pleasure or pain.6 in the 1980s, this metaphysical divergence on personhood materialized in a debate between ronald dworkin, whose reasoning parallels that of locke and mill, and rebecca dresser, who employs an approac h that comports with that of hume and bentham. the debate focused on the real case of an incompetent patient named margo who developed early-onset alzheimer’s and, despite her condition, “or maybe somehow because of it,”7 led a remarkably cheerful life. she no longer identified with the provision in her ad to forgo any life-sustaining medical treatment after she could no longer recognize her loved ones. when she contracted pneumonia, an ethical dilemma emerged as her prior preferences recorded when she was competent conflicted with her contemporary preferences regarding her end-of-life care. dworkin argues that margo’s precedent autonomy, i.e., her past ability to govern her future self through a directive and the corresponding obligation of her current self to follow the directive, has moral authority over her current treatment, but dresser objects, asserting that because margo is now a “new person”8 the ad is no longer relevant.9 in this essay, i argue that precedent autonomy morally authorizes ads when dementia renders patients medically incompetent because it respects their dignity as persons, not merely pleasure -seeking creatures. the case: margo, ‘the happy alzheimer’s patient’ in margo’s logo, dr. andrew firlik describes the life of an alzheimer’s patient he visited frequently while interning in gerontology.10 because she developed the disease at a relatively young age, margo had virtually no physiological problems and lived a “carefree” life consisting of flipping through mystery novels and painting the same image every day during art class.11 firlik describes her life almost romantically, commenting that “there is something graceful about the degeneration her mind is undergoing, leaving her carefree, always cheerful.”12 he does not mention margo’s early stages of dementia which were perhaps characterized by confusion, anxiety, and existential fear, as is often the case with diseases that erode mental capacity.13 still, arguably in her current state margo is happy and therefore should be given noninvasive treatments, like oral antibiotics, to extend her life if she contracts pneumonia. the argument to adhere to her previous wishes against such life-prolonging treatments may seem cruel. however, dworkin argues that to ignore her ad would compromise her autonomy and dignity and constitute the greater cruelty. dworkin contra dresser dworkin uses the framework of experiential and critical interests to defend the moral authority of precedent autonomy. experiential interests roughly parallel bentham’s conception of pursuing pleasure and avoiding pain, whereas critical interests are focused on the actions that lend “genuine meaning and coherence to our lives.”14 critical interests comport with locke’s valuing rationality and with mills’ appreciation of the big picture taken holistically. dworkin’s conception of personhood emphasizes our pursuit of critical interests over and above our pursuit of experiential interests, indicating that there is a moral superiority to critical interests. for example, parents willingly give up sleep to sustain the critical interest of raising children and athletes endure pain to improve their odds of victory. the pursuit of critical interests lends genuine meaning to our lives. in contrast, a life characterized by the constant pursuit of experiential interests is often meaningless. dale, personhood, critical interests, and the moral imperative, voices in bioethics, vol. 7 (2021) 3 dworkin’s dichotomy of interests grounds his view of precedent autonomy because the critical interests encoded in ads represent the “whole person”15 all the relationships, values, and narrative richness of personhood before the onset of late-stage dementia. if we ignore the ad, we disregard the autonomy of margo’s “whole person” in favor of her immediate preferences. dworkin’s view of autonomy argues that we should honor margo’s precedent autonomy even if we believe it conflicts with her best interest because persons have the right to act “out of a distinctive sense of their own character”16 in writing the narrative of their life. ignoring her ad would be "an unacceptable form of moral paternalism”17 because it effectively authors a conclusion to the story of margo’s life that she explicitly wished to avoid, ignoring the strongest living articulation of her autonomy. dworkin further argues the moral authority of margo’s precedent autonomy through the principle of beneficence, the ethical obligation to promote the patient’s welfare.18 it would be cruel to subject margo to a chapter of life that she did not want to lead, a life that conflicts with her critical interests, even if she no longer remembers those interests. thus, to genuinely act in the best interest of the patient, the doctor must adhere to her competent conception of what is best for her “whole person”, not merely her current experiential interests. dresser argues that when patients with incurable dementia lead enjoyable lives, we should ignore their previous wishes. she raises an epistemic and a moral objection to dworkin’s argument in favor of precedent autonomy. her epistemic argument points out that when she wrote the ad, margo did not know what quality her life would have with dementia, therefore carrying out a preference based on such limited information would not respect autonomy.19 this argument fails to recognize that individuals make decisions all the time without knowledge of the outcome, so to disregard margo’s ad because she did not know whether her experiential interests would be fulfilled is unjustifiably paternalistic. furthermore, dresser implicitly asserts that if margo were to know the quality of her life with dementia in advance, she would not have authored the same ad. however, this removes the possibility of margo autonomously prioritizing her critical interests regardless of the experiential outcomes. margo likely did know that people can (and often do) lead enjoyable lives with dementia yet she still chose to word the ad to not prolong life once her critical interests could not be satisfied. dresser’s moral argument against precedent autonomy contends that because margo can no longer recognize her previous preferences, she is a metaphysically distinct person, and that the ad is therefore not applicable. dresser claims that the “drastic psychological alteration that has occurred” to margo has “produce[d] a new person.”20 this metaphysical assertion carries significant moral weight. if we consider margo the alzheimer’s patient to be a distinct individual from the woman who wrote the ad, then executing an ad is akin to sentencing an innocent person to death. however, dresser’s claim is predicated on the flawed assertion that dramatic psychological changes over time produce an entirely new individual. children, for example, undergo substantial psychological changes from infancy to adolescence, yet we regard them as continuous individuals.21 ultimately, we must consider persons rather than pleasureseeking subjects to be the locus of autonomous decision making, therefore moral authority is granted to precedent autonomy in cases like margo’s. locke’s emphasis on rationality also supports following the ad. personal identity, in locke’s view, is meaningfully linked to persistence over time and the ability to rationally self-reflect – abilities which margo presently lacks. he writes in an essay concerning human understanding, “a thinking intelligent being, … has reason and reflection, and can consider itself as itself, the same thinking thing in different times and places.”22 from this diachronic view of identity, locke characterizes persons as agents. margo, in contrast, dale, personhood, critical interests, and the moral imperative, voices in bioethics, vol. 7 (2021) 4 no longer has these abilities and has lost her sense of personhood and agency. it is only through our ability to self-reflect and project our values onto the current situation that we can be said to be persons. dresser makes an erroneous metaphysical assertion in saying that the late-stage alzheimer’s patient is a new person due to “substantial memory loss and other psychological changes.” it is exactly these changes which rob late-stage alzheimer’s patients of their personhood. utilitarianism and advance directives the two founding figures of utilitarian ethics, jeremy bentham and john stuart mill, agreed that the ‘right’ action is the one which maximizes utility in a given situation, but they disagreed on what sorts of consequences constitute utility. bentham focused merely on the quantity of pleasures, asserting that the right action would result in the most favorable balance between pleasure and pain.23 pursuant to this hedonistic calculus which disregards the quality of pleasure, the right action is to ignore mar go’s ad by providing the life-saving treatment. this would be the most ethical choice according to bentham because it produces a greater sum of pleasure than her death, regardless of her prior critical interests. hume’s view of experiences also overvalues pleasure as opposed to cognition. when applied to margo, who essentially experiences a bundle of sensations without the ability to rationally appreciate them, hume’s viewpoint would negate the ad vis a vis bentham’s calculus. yet, margo’s ad concerned ran king the characteristics of life that would justify prolonging it which included experiences like remembering one’s narrative and having meaningful relationships with friends and loved ones. these values transcend the immediate sense data that bentham factors into the utilitarian sum. the philosophies of hume and bentham not only impede dignity, and negate autonomy, they impose a limited, outside view on what persons value. mill criticized bentham’s approach to utilitarianism because it was indiscriminate in its valuation of different pleasures, implicitly leading to the conclusion that distinctly human pleasures “of the intellect, of the feelings and imagination and of the moral sentiments” are no more valuable than animal pleasures “of mere sensation.”24 in mill’s view this degrades the moral status of humans. if our pleasures are no different, then bentham suggests that our moral status is equivalent to that of animals, which is clearly problematic. in an example of the flaws of utilitarian applications, in a purely quantitative utilitarian calculus, the life of an immortal oyster is more desirable after a certain amount of time than the life of the jovial and accomplished composer, joseph hayden.25 if given the choice, i suspect an overwhelming majority of people would prefer to live as a human being that feels pain over an animal that feels only simple pleasures. even though human life is often characterized by stress, uncertainty, and vulnerability, the profound heights of the human condition justify life according to mill’s philosophy. mill’s utilitarianism focused on the quality rather than the quantity of pleasures, and thus he would argue that following margo’s ad will result in the outcome with the greatest utility because she is no longer capable of pursuing higher pleasures.26 her current existence is characterized only by experiential pleasures, which according to mill, is not a life worth living.27 conclusion a consequence of the reductionist view of personhood endorsed by hume, bentham, and dresser is an erroneous moral equivalence between animals and humans and a disregard for human dignity. dworkin’s framework of critical interests and mill’s version of utilitarian ethics support the moral authority of dale, personhood, critical interests, and the moral imperative, voices in bioethics, vol. 7 (2021) 5 precedent autonomy by defending the narrative quality of life, the important pursuit of higher pleasures, and a dignified characterization of humanity. 1 hume, d. & p. h. nidditch (ed.). (1978). a treatise of human nature. oxford: clarendon press. hume posits a distinct ontology of self: “each of us is nothing but a bundle or collection of different perceptions that follow each other enormously quickly and are in a perpetual flux and movement” (hume, 1978, p.131) 2 bentham, j. (1789, 1907). an introduction to the principles of morals and legislation. oxford: clarendon press. 3 locke, j. (1948). an essay concerning human understanding, 1690. 4 mill, j. s. (1861, 1998). utilitarianism, roger crisp (ed.), oxford: oxford university press. 5 rich, b. a. (1997). prospective autonomy and critical interests: a narrative defense of the moral authority of advance directives. cambridge quarterly of healthcare ethics, 6(2), 138-147. chicago 6 mill, j. s. (1861, 1998). utilitarianism, roger crisp (ed.), oxford: oxford university press. 7 firlik, a. d. (1991). margo's logo. jama, 265(2), 201-201. 8 dresser, r. (1995). dworkin on dementia: elegant theory, questionable policy. hastings center report, 25(6), 32-38. 9 dresser, r. (1995). dworkin on dementia: elegant theory, questionable policy. hastings center report, 25(6), 32-38. 10 firlik, a. d. (1991). margo's logo. jama, 265(2), 201-201. 11firlik, a. d. (1991). margo's logo. jama, 265(2), 201-201. 12firlik, a. d. (1991). margo's logo. jama, 265(2), 201-201. 13 menzel, p. t., & steinbock, b. (2013). advance directives, dementia, and physician‐assisted death. the journal of law, medicine & ethics, 41(2), 484-500. 14 dresser, r. (1995). dworkin on dementia: elegant theory, questionable policy. hastings center report, 25(6), 32-38. 15 dworkin, r. (1994). life’s dominion. an argument about abortion, euthanasia and individual freedom. new york: books v, 69-101. 16 dworkin, r. (1994). life’s dominion. an argument about abortion, euthanasia and individual freedom. new york: books v, 69-101. 17 dworkin, r. 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(1789, 1907). an introduction to the principles of morals and legislation. oxford: clarendon press. https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/prospective-autonomy-and-critical-interests-a-narrative-defense-of-the-moral-authority-of-advance-directives/4bbea85dbf610faa6e9c615c0ccfd7ca https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/prospective-autonomy-and-critical-interests-a-narrative-defense-of-the-moral-authority-of-advance-directives/4bbea85dbf610faa6e9c615c0ccfd7ca https://jamanetwork.com/journals/jama/article-abstract/384634 https://onlinelibrary.wiley.com/doi/abs/10.2307/3527839 https://onlinelibrary.wiley.com/doi/abs/10.2307/3527839 https://jamanetwork.com/journals/jama/article-abstract/384634 https://jamanetwork.com/journals/jama/article-abstract/384634 https://jamanetwork.com/journals/jama/article-abstract/384634 https://onlinelibrary.wiley.com/doi/abs/10.2307/3527839 http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf http://web2.slc.qc.ca/sbeaudoin/z_past%20pages/ethics/pdf/dworkin.pdf https://onlinelibrary.wiley.com/doi/abs/10.2307/3527839 https://onlinelibrary.wiley.com/doi/abs/10.2307/3527839 https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/prospective-autonomy-and-critical-interests-a-narrative-defense-of-the-moral-authority-of-advance-directives/4bbea85dbf610faa6e9c615c0ccfd7ca https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/prospective-autonomy-and-critical-interests-a-narrative-defense-of-the-moral-authority-of-advance-directives/4bbea85dbf610faa6e9c615c0ccfd7ca dale, personhood, critical interests, and the moral imperative, voices in bioethics, vol. 7 (2021) 6 24 mill, j. s. (1861, 1998). utilitarianism, roger crisp (ed.), oxford: oxford university press. 26 mill, j. s. (1861, 1998). utilitarianism, roger crisp (ed.), oxford: oxford university press. 27 mill, j. s. (1861, 1998). utilitarianism, roger crisp (ed.), oxford: oxford university press. abstract introduction ahluwalia, legal governance of brain data derived from artificial intelligence, voices in bioethics, vol. 7 (2021) © 2021 mahika ahluwalia. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. legal governance of brain data derived from artificial intelligence mahika ahluwalia keywords: computer, neuroprotection, privacy, autonomy, big brain data, respect, regulate introduction with the rapid advancements in neurotechnological machinery and improved analytical insights from machine learning in neuroscience, the availability of big brain data ha s increased tremendously. neurological health research is done using digitized brain data.1 there must be adequate data governance to secure the privacy of subjects participating in brain research and treatments. if not properly regulated, the research methods could lead to significant breaches of the subject’s autonomy and privacy. this paper will address the necessity for neuroprotection laws, which effectively govern the use of big brain data to ensure respect for patient privacy and autonomy. background artificial intelligence and machine learning can be integrated with neuroscience big b rain data to drive research studies. this integrative technology allows patterns of electrical activity in neurons to be studied in detail.2 specifically, it uses a robotic system which can reason, plan, and exhibit biologically intelligent behavior. machine learning is a method of computer programming where the code can adapt its behavior based on big brain data.3 the big brain data is the collection of large amounts of information for the purpose of deciphering patterns through computer analysis using machine learning.4 the information that these technologies provide is extensive enough to allow a researcher to read a patient’s mind. ai and machine learning technologies work by finding the underlying structure of brain data, whi ch is then described by patterns known as latent factors, eventually resulting in an understanding of the brain’s temporal dynamics.5 through these technologies, researchers are able to decipher how the human brain computes its performances and thoughts. however, due to the extensive and complex nature of the data processed ahluwalia, legal governance of brain data derived from artificial intelligence, voices in bioethics, vol. 7 (2021) 2 through ai and machine learning, researchers may gain access to personal information a patient may not wish to reveal. from a bioethical lens, tensions arise in the realm of patient autonomy. patients are not able to control the transmission of data from their brains that is analyzed by researchers. governing brain data through laws may enhance the extent of patient privacy in the case where brain data is being used through ai technologies.6 a responsible approach to governing brain data would require a sophisticated legal structure. analysis impact on patient autonomy and privacy in research pertaining to big brain data, the consent forms do not fully cover the vast amounts o f information that is collected. according to research, personal data has become the most sought out commodity to provide content to corporations and the web-based service industry. unfortunately, data leaks that release private information frequently occur.7 the storage of an individual’s data on technologies accessible on the internet during research studies makes it vulnerable to leaks, jeopardizing an individual’s privacy. these data leaks may cause the patient to be identified easily, as the degree of information provided by ai technologies are personalized and may be decoded through brain fingerprinting methods. 8 there has been an extensive growth in the development and use of ai. it is efficient in providing information to radiologists who diagnose various diseases including brain cancer and psychiatric disease, and ai assists in the delivery of telemedicine. 9 however, the ethical pitfall of reduced patient autonomy must be addressed by analyzing current ai technologies and creating more options for patient preference in how the data may be used. for instance, facial recognition technology10 commonly used in health care produces more information than listed in common consent forms, threatening to undermine informed consent. facial recognition software collects extensive data and may disclose more information than a person would prefer to provide despite being a useful tool for diagnosing medical and genetic conditions. 11 in addition, people may not be aware that their images are being used to generate more clinical data for other purposes. it is difficult to guarantee the data is anonymized. consent requirements must include informing people about the complexity of the potential uses of the data; software developers should maximize patient privacy.12 furthermore, there is a “human element” in the use of ai technologies as medical providers control the use and the extent to which data is captured or accessed through the ai technologies.13 people must understand the scope of the technology and have clear communication with the physician or health care provider about how the medical information will be used. existing laws for brain data governance a strict system of defined legal responsibilities of medical providers will ensure a higher degree of patient privacy and autonomy when ai technologies and data from machine learning are used. governing specific algorithmic data is crucial in safeguarding a patient’s privacy and developing a gold standard treatment protocol following the procurement of the information.14 certain ai technologies provide more data than others, and legal boundaries should be established to ensure strong performance, quality control , and scope for patient privacy and autonomy. for instance, currently ai technologies are being used in the realm of intensive neurological care. however, there is a significant level of patient uncertainty about how much ahluwalia, legal governance of brain data derived from artificial intelligence, voices in bioethics, vol. 7 (2021) 3 control patients have over the data’s uses.15 calibrated legal and ethical standards will allow important brain data to be securely governed and monitored. once brain signals are recorded and processed from one individual, the data may be merged with other data in brain computer interface technology (bci).16 to ensure a right and ability to retrieve personal data or pull it from the collection, specific regulations for varying types of data are needed.17 the importance of consent and patient privacy must be considered through giving patients a transparent view of how brain data is governed.18 the legal system must address discriminatory issues and risks to patients whose data is used in studies. laws like the general data protection regulation (gdpr) and the california consumer privacy protection act (ccpa) can serve as effective models to protect aggregated data. these laws govern consumer information and ensure the compliance when personal data is collected. 19 california voters recently approved expansion of the ccpa to health data. the washington privacy act, which would have provided rights to access, change, and withdraw personal data, failed to pass. other states should improve privacy as well,20 although a federal bill would be preferable. scientists at the heidelberg academy of sciences argue for data security to be governed in a manner that balances patient privacy and autonomy with the commercial interests of researchers.21 the balance could be achieved through privacy protections like those in the washington privacy act. although the health insurance portability and accountability act (hipaa) provides an overall framework to deter the likelihood of dangers to patient protection and privacy, more thorough laws are warranted to combat pervasive data transfer and analysis that technology has brought to the health care industry.22 breaches of patient privacy under current hipaa regulations include releasing patient information to a reporter without their consent and sending hiv data to a patient’s employer without consent.23 hipaa does not cover information being shared with outside contractors who do not have an agreement with technology companies to keep patient data confidential. hipaa regulations also do not always address blatant breaches on patient data confidentiality.24 patients must be provided with methods to monitor the data being analyzed to be able to view the extent of private information being generated via ai technologies. in health research, the medical purposes of better diagnosis, earlier detection of diseases, or prevention are ethical justifications for the use of the data if it was collected with permission, the person understood and approved the uses of the data, and the data was deidentified. a standard governance framework is required in providing the fairest system of care to patients who allow their brain data to be examined. informed consent in the neuroscience field could reaffirm the privacy and autonomy of patients by ensuring that they understand the type of information collected. laws also could protect data after a patient’s death. malpractice in the scope of brain data could give people a cause of action critical in safeguarding patient’s rights. data breach lawsuits will become common but generally do not cover deidentified data that becomes part of big data collection. a more synchronized approach to the collection and consent process will encourage an understanding of how big data is used to diagnose and treat patients. some altruistic people may even be more likely to consent if they know the largescale data collection is helpful to treat and diagnose people. others should have the ab ility to opt out of sharing neurological data, especially when there is not certainty surrounding deidentification.25 ahluwalia, legal governance of brain data derived from artificial intelligence, voices in bioethics, vol. 7 (2021) 4 conclusion artificial intelligence and machine learning technologies have the potential to aid in the diagnosis and treatment of people globally by extracting and aggregating brain data specific to individuals. however, the secure use of the data is necessary to build trust between care providers and patients, as well as in balancing the bioethical principles of beneficence and patient autonomy. we must ensure the highest quality of care to patients, while protecting their privacy, informed consent, and clinical trust. more sophisticated tools for informed consent will be necessary to ensure that people understand how their data may be used. 1 kellmeyer, p. (2018). big brain data: on the responsible use of brain data from clinical and consumer-directed neurotechnological devices. neuroethics. https://doi.org/10.1007/s12152-018-9371-x 2 ethical dimensions of using artificial intelligence in health care. (2019). ama journal of ethics, 21(2). https://doi.org/10.1001/amajethics.2019.121 3 kellmeyer, p. (2018). big brain data: on the responsible use of brain data from clinical and consumer-directed neurotechnological devices. neuroethics. https://doi.org/10.1007/s12152-018-9371-x 4 kellmeyer, p. (2018). big brain data: on the responsible use of brain data from clinical and consumer-directed neurotechnological devices. neuroethics. https://doi.org/10.1007/s12152-018-9371-x 5 savage, n. (2019, july 24). how ai and neuroscience drive each other forwards. nature news. https://www.nature.com/articles/d41586-019-02212-4. 6 fothergill, b. t., knight, w., stahl, b. c., & ulnicane, i. (2019). responsible data governance of neuroscience big data. frontiers in neuroinformatics, 13. https://doi.org/10.3389/fninf.2019.00028 7 kayaalp, m. (2018). patient privacy in the era of big data. balkan medical journal, 35(1), 8–17. https://doi.org/10.4274/balkanmedj.2017.0966 8 kellmeyer, p. (2018). big brain data: on the responsible use of brain data from clinical and consumer-directed neurotechnological devices. neuroethics. https://doi.org/10.1007/s12152-018-9371-x 9 ethical dimensions of using artificial intelligence in health care. (2019). ama journal of ethics, 21(2). https://doi.org/10.1001/amajethics.2019.121 10 martinez-martin, nicole. “what are important ethical implications of using facial recognition technology in health care?” ama journal of ethics 21, no. 2 (2019). https://doi.org/10.1001/amajethics.2019.180 11 kayaalp, m. (2018). patient privacy in the era of big data. balkan medical journal, 35(1), 8–17. https://doi.org/10.4274/balkanmedj.2017.0966 12 martinez-martin, nicole. “what are important ethical implications of using facial recognition technology in health care?” ama journal of ethics 21, no. 2 (2019). https://doi.org/10.1001/amajethics.2019.180. 13 kayaalp, m. (2018). patient privacy in the era of big data. balkan medical journal, 35(1), 8–17. https://doi.org/10.4274/balkanmedj.2017.0966 14 kayaalp, m. (2018). patient privacy in the era of big data. balkan medical journal, 35(1), 8–17. https://doi.org/10.4274/balkanmedj.2017.0966 ahluwalia, legal governance of brain data derived from artificial intelligence, voices in bioethics, vol. 7 (2021) 5 15 kayaalp, m. (2018). patient privacy in the era of big data. balkan medical journal, 35(1), 8–17. https://doi.org/10.4274/balkanmedj.2017.0966 16 beets, r. (n.d.). webinar data governance. international neuroethics society. https://www.neuroethicssociety.org/webinar-data-2021. 17 price, w. nicholson, 2nd, and i. glen cohen. privacy in the age of medical big data. nat med. 2019;25(1):37-43. doi:10.1038/s41591-018-0272-7 18 price, w. nicholson, 2nd, and i. glen cohen. privacy in the age of medical big data. nat med. 2019;25(1):37-43. doi:10.1038/s41591-018-0272-7 19 price, w. nicholson, 2nd, and i. glen cohen. privacy in the age of medical big data. nat med. 2019;25(1):37-43. doi:10.1038/s41591-018-0272-7 20 grey, stacey. “a new us model for privacy? comparing the washington privacy act to gdpr, ccpa, and more.” future of privacy forum, https://fpf.org/blog/a-new-model-for-privacy-in-a-new-era-evaluating-the-washingtonprivacy-act/ 21 beets, r. (n.d.). webinar data governance. international neuroethics society. https://www.neuroethicssociety.org/webinar-data-2021. 22 pasquale, frank. “protecting health privacy in an era of big data processing and cloud computing.” stanford technology law review 17, no. 2 (2014). https://ncvhs.hhs.gov/wp-content/uploads/2017/11/pasquale-ragoneprotecting-health-privacy-in-an-era-of-big-data-508.pdf 23 vanderpool d. hipaa compliance: a common sense approach. innov clin neurosci. 2019;16(1-2):38-41 24 vanderpool d. hipaa compliance: a common sense approach. innov clin neurosci. 2019;16(1-2):38-41 25 zimmerman, a. (2020). marketing madness: the disingenuous use of free speech by big data and big pharma to the detriment of medical data privacy. voices in bioethics, 6. https://doi.org/10.7916/vib.v6i.5901 https://doi.org/10.7916/vib.v6i.5901 introduction jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) * jazlan jamaluddin, siti nuradliah jamil, mohd azzahi mohamed kamel, family medicine trainee, universiti teknologi mara, malaysia nurul nadia baharum, family medicine specialist, klinik kesihatan bukit cherakah, malaysia © 2021 jamaluddin, jamil, kamel, and baharum. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. doctors strike during covid-19 pandemic in malaysia: between right and wrong jazlan jamaluddin, nurul nadia baharum, siti nuradliah jamil, mohd azzahi mohamed kamel* abstract a strike to highlight the plight facing contract doctors which has been proposed has received mixed reactions from those within the profession and the public. this unprecedented nationwide proposal has the potential to cause real-world effects, posing an ethical dilemma. although strikes are common, especially in high-income countries, these industrial actions by doctors in malaysia are almost unheard of. reviewing available evidence from various perspectives is therefore imperative to update the profession and the complexity of invoking this important human right. keywords: malaysia, contracts, strikes, employees, ethics, pandemic, healthcare system introduction contract doctors in malaysia held a strike on july 26, 2021. covid-19 cases are increasing in malaysia. in june, daily cases ranged between 4,000 to 8,000 despite various public health measures. the r naught, which indicates the infectiousness of covid-19, remains unchanged. during the pandemic, health care workers (hcws) have been widely celebrated, resulting in a renewed appreciation of the risks that they face. 1 the pandemic has exposed flawed governance in the public healthcare system, particularly surrounding the employment of contract doctors. contract doctors in malaysia are doctors who have completed their medical training, as well as two years of internship, and have subsequently been appointed as medical officers for another two years. contract doctors are not permanently appointed, and the system did not allow extensions after the two years nor does it offer any opportunity to specialize.2 last week, parliament did decide to offer a two-year extension but that did not hold off the impending strike.3 in 2016, the ministry of health introduced a contract system to place medical graduates in internship positions at government healthcare facilities across the country jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 2 rather than placing them in permanent posts in the public service department. social media chronicles the issues that doctors in malaysia faced. however, tensions culminated when and contract doctors called for a strike which ended up taking place in late july 2021. background over the past decade, hcw strikes have arisen mostly over wages, work hours, and administrative and financial factors.4 in 2012, the british medical association organized a single “day of action” by boycotting non-urgent care as a response to government pension reforms.5 in ireland, doctors went on strike for a day in 2013 to protest the austerity measures implemented by the eu in response to the global economic crisis. it involved a dispute over long working hours (100 hours per week) which violated eu employment laws and more importantly put patients’ lives at risk.6 the strike resulted in the cancellation of 15,000 hospital appointments, but emergencies services were continued. other major strikes have been organized in the uk to negotiate better pay for hcws in general and junior doctors’ contracts specifically.7 during the covid-19 pandemic, various strikes have also been organized in hong kong, the us, and bolivia due to various pitfalls in managing the pandemic.8 a recent strike in august 2020 by south korean junior doctors and medical students was organized to protest a proposed medical reform plan which did not address wage stagnation and unfair labor practices. 9 these demands are somewhat similar to the proposed strike by contract doctors in malaysia. as each national health system operates within a different setting, these strikes should be examined in detail to understand the degree of self-interest involved versus concerns for patient’s welfare. i. the malaysia strike an anonymous group planned the current strike in malaysia. the group used social media, garnering the attention of various key stakeholders including doctors, patients, government, and medical councils.10 the organizers of the strike referred to their planned actions as a hartal. (although historically a hartal involved a total shutdown of workplaces, offices, shops, and other establishments as a form of civil disobedience, the malaysian contract doctors pledged no disturbance to healthcare working hours or services and intend a walk-out that is symbolic and reflective of a strike.)11 the call to action mainly involved showing support for the contract doctors with pictures and placards. the doctors also planned the walk-out.12 despite earlier employment, contract medical doctors face many inequalities as opposed to their permanent colleagues. these include differences in basic salary, provisions of leave, and government loans despite doing the same job. the system disadvantages contract doctors offering little to no job security and limited career progression. furthermore, reports in 2020 showed that close to 4,000 doctors’ contracts were expected to expire by may 2022, leaving their futures uncertain.13 some will likely be offered an additional two years as the government faces pressure from the workers. between december 2016 and may 2021, a total of 23,077 contract doctors were reportedly appointed as medical officers, with only 789 receiving permanent positions.14 it has been suggested that they are appointed into permanent positions based on merit but the criteria for the appointments remain unclear. those who fail to acquire a permanent position inevitably seek employment elsewhere. during the covid-19 pandemic, there have been numerous calls for the government to absorb contract doctors into the public service as permanent staff with normal benefits. this is important considering a malaysian study that revealed that during the pandemic over 50 percent of medical personnel feel burned out while on duty.15 this effort might be side-lined as the government prioritizes curbing the pandemic. as jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 3 these issues remain neglected, the call for a strike should be viewed as a cry for help to reignite the discussions about these issues. ii. right to strike the right to strike is recognized as a fundamental human right by the un and the eu.16 most european countries also protect the right to strike in their national constitutions.17 in the us, the taft-hartley act in 1947 prohibited healthcare workers of non-profit hospitals to form unions and engage in collective bargaining. but this exclusion was repealed in 1947 and replaced with the requirement of a 10-day advanced written notice prior to any strike action.18 similarly, malaysia also recognizes the right to dispute over labor matters, either on an individual or collective basis. the industrial relations act (ira) of 196719 describes a strike as: “the cessation of work by a body of workers acting in combination, or a concerted refusal or a refusal under a common understanding of a number of workers to continue to work or to accept employment, and includes any act or omission by a body of workers acting in combination or under a common understanding, which is intended to or does result in any limitation, restriction, reduction or cessation of or dilatoriness in the performance or execution of the whole or any part of the duties connected with their employment” according to the same act, only members of a registered trade union may legally participate in a strike with prior registration from the director-general of trade unions.20 under section 43 of the ira, any strike by essential services (including healthcare) requires prior notice of 42 days to their employer. 21 upon receiving the notice, the employer is responsible for reporting the particulars to the director general of industrial relations to allow a “cooling-off” period and appropriate action. employees are also protected from termination if permitted by the director general and strike is legalized. the malaysian contract healthcare workers’ strike was announced and transparent. unfortunately, even after legalization, there is fear that the government may charge those participating in the legalized strike.22 the police have announced they will pursue participants in the strike. 23 even the ministry of health has issued a warning stating that those participating in the strike may face disciplinary actions from the ministry. however, applying these laws while ignoring the underlying issues may not bode well for the covid-19 healthcare crisis. iii. effects of a strike on health care there is often an assumption that doctors’ strikes would unavoidably cause significant harm to patients. however, a systematic review examining several strikes involving physicians reported that patient mortality remained the same or fell during the industrial action.24 a study after the 2012 british medical association strike has even shown that there were fewer in-hospital deaths on the day, both among elective and emergency populations, although neither difference was significant.25 similarly, a recent study in kenya showed declines in facility-based mortality during strike months.26 other studies have shown no obvious changes in overall mortality during strikes by hcws. 27 there is only one report of increased mortality associated with a strike in south africa28 in which all the doctors in the limpopo province stopped providing any treatment to their patients for 20 consecutive days. during this time, only one hospital continued providing services to a population of 5.5 million people. even though their data is incomplete, authors from this study found that the number of emergency room visits decreased during the strike, but the risks of mortality in the hospital for these patients increased by 67 percent.29 however, the study compared the jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 4 strike period to a randomly selected 20-day period in may rather than comparing an average of data taken from similar dates over previous years. this could greatly influence variations between expected annual hospital mortality possibly due to extremes in weather that may exacerbate pre-existing conditions such as heart failure during warmer months or selecting months with a higher incidence of viral illness such as influenza. importantly, all strikes ensured that emergency services were continued, at least to the degree that is generally offered on weekends. furthermore, many doctors still provide usual services to patients despite a proclaimed strike. for example, during the 2012 bma strike, less than one-tenth of doctors were estimated to be participating in the strike.30 emergency care may even improve during strikes, especially those involving junior doctors who are replaced by more senior doctors.31 the cancellation of elective surgeries may also increase the number of doctors available to treat emergency patients. furthermore, the cancellation of elective surgery is likely to be responsible for transient decreases in mortality. doctors also may get more rest during strike periods. although doctor strikes do not seem to increase patient mortality, they can disrupt delivery of healthcare.32 disruptions in delivery of service from prolonged strikes can result in decline of in-patient admissions and outpatient service utilization, as suggested during strikes in the uk in 2016.33 when emergency services were affected during the last strike in april, regular service was also significantly affected. additionally, people might need to seek alternative sources of care from the private sector and face increased costs of care. hcws themselves may feel guilty and demotivated because of the strikes. the public health system may also lose trust as a result of service disruption caused by high recurrence of strikes. during the covid-19 pandemic, as the healthcare system remains stretched, the potential adverse effects resulting from doctor strikes remain uncertain and potentially disruptive. in the uk, it is an offence to “willfully and maliciously…endanger human life or cause serious bodily injury.”34 likewise, the general medical council (gmc) also requires doctors to ensure that patients are not harmed or put at risk by industrial action. in the us, the american medical association code of ethics prohibits strikes by physicians as a bargaining tactic, while allowing some other forms of collective bargaining.35 however, the american college of physicians prohibits all forms of work stoppages, even when undertaken for necessary changes to the healthcare system. similarly, the delhi medical council in india issued a statement that “under no circumstances doctors should resort to strike as the same puts patient care in serious jeopardy.”36 on the other hand, the positions taken by the malaysian medical council (mmc) and malaysian medical association (mma) on doctors’ strikes are less clear when compared to their western counterparts. the mmc, in their recently updated code of professional conduct 2019, states that “the public reputation of the medical profession requires that every member should observe proper standards of personal behavior, not only in his professional activities but at all times.” strikes may lead to imprisonment and disciplinary actions by mmc for those involved. similarly, the mma code of medical ethics published in 2002 states that doctors must “make sure that your personal beliefs do not prejudice your patients' care.”37 the mma which is traditionally meant to represent the voices of doctors in malaysia, may hold a more moderate position on strikes. although hcw strikes are not explicitly mentioned in either professional body’s code of conduct and ethics, the consensus is that doctors should not do anything that will harm patients and they must maintain the proper standard of behaviors. these statements seem too general and do not represent the complexity of why and how a strike could take place. therefore, it has been suggested that doctors and jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 5 medical organizations should develop a new consensus on issues pertaining to medical professional’s social contract with society while considering the need to uphold the integrity of the profession. experts in law, ethics, and medicine have long debated whether and when hcw strikes can be justified. if a strike is not expected to result in patient harm it is perhaps acceptable.38 although these debates have centered on the potential risks that strikes carry for patients, these actions also pose risks for hcws as they may damage morale and reputation.39 most fundamentally, strikes raise questions about what healthcare workers owe society and what society owes them. for strikes to be morally permissible and ethical, it is suggested that they must fulfil these three criteria:40 a. strikes should be proportionate, i.e., they ‘should not inflict disproportionate harm on patients’, and hospitals should as a minimum ‘continue to provide at least such critical services as emergency care.’ b. strikes should have a reasonable hope of success, at least not totally futile however tough the political rhetoric is. c. strikes should be treated as a last resort: ‘all less disruptive alternatives to a strike action must have been tried and failed’, including where appropriate ‘advocacy, dissent and even disobedience’. the current strike does not fulfil the criteria mentioned. as malaysia is still burdened with a high number of covid-19 cases, a considerable absence of doctors from work will disrupt health services across the country. second, since the strike organizer is not unionized, it would be difficult to negotiate better terms of contract and career paths. third, there are ongoing talks with mma representing the fraternity and the current government, but the time is running out for the government to establish a proper long-term solution for these contract doctors. one may argue that since the doctors’ contracts will end in a few months with no proper pathways for specialization, now is the time to strike. however, the hcw right to strike should be invoked only legally and appropriately after all other options have failed. conclusion the strike in malaysia has begun since the drafting of this paper. doctors involved assure that there will not be any risk to patients, arguing that the strike is “symbolic”.41 although an organized strike remains a legal form of industrial action, a strike by hcws in malaysia poses various unprecedented challenges and ethical dilemmas especially during the pandemic. the anonymous and uncoordinated strike without support of the appropriate labor unions may only spark futile discussions without affirmative actions. it should not have taken a pandemic or a strike to force the government to confront the issues at hand. it is imperative that active measures be taken to urgently address the underlying issues relating to contract physicians. as covid-19 continues to affect thousands of people, a prompt reassessment is warranted regarding the treatment of hcws, and the value placed on health care. 1 ministry of health (moh) malaysia, “current situation of covid-19 in malaysia.” http://covid-19.moh.gov.my/terkini (accessed jul. 01, 2021). http://covid-19.moh.gov.my/terkini jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 6 2 “future of 4,000 young doctors who are contract medical officers uncertain,” new straits times november 26, 2020. https://www.nst.com.my/news/nation/2020/11/644563/future-4000-young-doctors-who-are-contract-medical-officersuncertain 3 “malaysia doctors strike, parliament meets as covid strain shows,” al jazeera, july 26, 2021. https://www.aljazeera.com/news/2021/7/26/malaysia-doctors-strike-parliament-meets-as-covid-strains-grow 4 r. essex and s. m. weldon, “health care worker strikes and the covid pandemic,” n. engl. j. med., vol. 384, no. 24, p. e93, jun. 2021, doi: 10.1056/nejmp2103327; g. russo et al., “health workers’ strikes in low-income countries: the available evidence,” bull. world health organ., vol. 97, no. 7, pp. 460-467h, jul. 2019, doi: 10.2471/blt.18.225755. 5 m. ruiz, a. bottle, and p. aylin, “a retrospective study of the impact of the doctors’ strike in england on 21 june 2012,” j. r. soc. med., vol. 106, no. 9, pp. 362–369, 2013, doi: 10.1177/0141076813490685. 6 e. quinn, “irish doctors strike to protest work hours amid austerity,” the wall street journal, 2013. https://www.wsj.com/articles/no-headline-available-1381217911?tesla=y (accessed jun. 29, 2021). 7 “nhs workers back strike action in pay row by 2-to-1 margin,” the guardian, 2014. https://www.theguardian.com/society/2014/sep/18/nhs-workers-strike-pay-unison-england (accessed jun. 29, 2021); m. limb, “thousands of junior doctors march against new contract,” bmj, p. h5572, oct. 2015, doi: 10.1136/bmj.h5572. 8 j. parry, “china coronavirus: hong kong health staff strike to demand border closure as city records first death,” bmj, vol. 368, no. february, p. m454, feb. 2020, doi: 10.1136/bmj.m454; “multicare healthcare workers strike, urging need for more ppes, staff support,” q13 fox, 2020. https://www.q13fox.com/news/health-care-workers-strike-urging-need-for-ppes-risks-on-patientsafety (accessed jun. 29, 2021); “bolivia healthcare workers launch strike in covid-hit region,” al jazeera, 2021. https://www.aljazeera.com/news/2021/2/9/bolivia-healthcare-workers-strike-covid-hit-region (accessed jun. 29, 2021). 9 k. arin, “why are korean doctors striking?” the korea herald, 2020. http://www.koreaherald.com/view.php?ud=20200811000941 (accessed jun. 29, 2021). 10 “hartal doktor kontrak,” facebook. https://www.facebook.com/hartaldoktorkontrak. 11 “hartal,” oxford advanced learner’s dictionary. https://www.oxfordlearnersdictionaries.com/definition/english/hartal (accessed jun. 29, 2021). 12 “hartal doktor kontrak,” facebook. https://www.facebook.com/hartaldoktorkontrak. 13 r. anand, “underpaid and overworked, malaysia’s contract doctors’ revolt amid covid-19 surge,” the straits times, 2021. 14 anand. 15 n. s. roslan, m. s. b. yusoff, a. r. asrenee, and k. morgan, “burnout prevalence and its associated factors among malaysian healthcare workers during covid-19 pandemic: an embedded mixed-method study,” healthc., vol. 9, no. 1, 2021, doi: 10.3390/healthcare9010090. 16 maina kiai, “report by the special rapporteur on the right to freedom of peaceful assembly and association,” 2016. [online]. available: http://freeassembly.net/wp-content/uploads/2016/10/a.71.385_e.pdf. 17 etui contributors, strike rules in the eu27 and beyond. the european trade union institute. etui, 2007. 18 national labor relations board, national labor relations act. 1935, pp. 151–169. 19 ministry of human resources, industrial relations act 1967 (act 177), no. october. 2015, pp. 1–76. 20 article 10 of the federal constitution states that all citizens have the right to form associations including registered trade or labor unions. a secret ballot with two-third majority will suffice to call for a strike required for submission to the dgtu within 7 days as stated in section 25(a) of the trade union act 1959. 21 ministry of human resources malaysia, guidelines on strikes, pickets and lockouts in malaysia. putrajaya, 2011. https://www.wsj.com/articles/no-headline-available-1381217911?tesla=y https://www.theguardian.com/society/2014/sep/18/nhs-workers-strike-pay-unison-england https://www.q13fox.com/news/health-care-workers-strike-urging-need-for-ppes-risks-on-patient-safety https://www.q13fox.com/news/health-care-workers-strike-urging-need-for-ppes-risks-on-patient-safety https://www.aljazeera.com/news/2021/2/9/bolivia-healthcare-workers-strike-covid-hit-region http://www.koreaherald.com/view.php?ud=20200811000941 https://www.facebook.com/hartaldoktorkontrak https://www.oxfordlearnersdictionaries.com/definition/english/hartal https://www.facebook.com/hartaldoktorkontrak http://freeassembly.net/wp-content/uploads/2016/10/a.71.385_e.pdf jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 7 22 ordinance emergency which was declared in malaysia since 12 january 2021. under the ordinance emergency, the king or authorized personnel may, as deemed necessary, demand any resources. 23 “malaysia doctors strike, parliament meets as covid strain shows,” al jazeera, july 26, 2021. https://www.aljazeera.com/news/2021/7/26/malaysia-doctors-strike-parliament-meets-as-covid-strains-grow 24 s. a. cunningham, k. mitchell, k. m. venkat narayan, and s. yusuf, “doctors’ strikes and mortality: a review,” soc. sci. med., vol. 67, no. 11, pp. 1784–1788, dec. 2008, doi: 10.1016/j.socscimed.2008.09.044. 25 m. ruiz, a. bottle, and p. aylin, “a retrospective study of the impact of the doctors’ strike in england on 21 june 2012,” j. r. soc. med., vol. 106, no. 9, pp. 362–369, 2013, doi: 10.1177/0141076813490685. 26 g. k. kaguthi, v. nduba, and m. b. adam, “the impact of the nurses’, doctors’ and clinical officer strikes on mortality in four health facilities in kenya,” bmc health serv. res., vol. 20, no. 1, p. 469, dec. 2020, doi: 10.1186/s12913-020-05337-9. 27 g. ong’ayo et al., “effect of strikes by health workers on mortality between 2010 and 2016 in kilifi, kenya: a population-based cohort analysis,” lancet glob. heal., vol. 7, no. 7, pp. e961–e967, jul. 2019, doi: 10.1016/s2214-109x (19)30188-3. 28 m. m. z. u. bhuiyan and a. machowski, “impact of 20-day strike in polokwane hospital (18 august 6 september 2010),” south african med. j., vol. 102, no. 9, p. 755, aug. 2012, doi: 10.7196/samj.6045. 29 m. m. z. u. bhuiyan and a. machowski, “impact of 20-day strike in polokwane hospital (18 august 6 september 2010),” south african med. j., vol. 102, no. 9, p. 755, aug. 2012, doi: 10.7196/samj.6045. 30 m. ruiz, a. bottle, and p. aylin, “a retrospective study of the impact of the doctors’ strike in england on 21 june 2012,” j. r. soc. med., vol. 106, no. 9, pp. 362–369, 2013, doi: 10.1177/0141076813490685. 31 d. metcalfe, r. chowdhury, and a. salim, “what are the consequences when doctors strike?” bmj, vol. 351, no. november, pp. 1–4, 2015, doi: 10.1136/bmj.h6231. 32 d. waithaka et al., “prolonged health worker strikes in kenyaperspectives and experiences of frontline health managers and local communities in kilifi county,” int. j. equity health, vol. 19, no. 1, pp. 1–15, 2020, doi: 10.1186/s12939-020-1131-y. 33 the study has shown that there were 9.1% reduction in admissions and around 6% fewer emergency cases and outpatient appointments than expected. an additional 52% increase in expected outpatient appointments cancelations were made by hospitals during that period. d. furnivall, a. bottle, and p. aylin, “retrospective analysis of the national impact of industrial action by english junior doctors in 2016,” bmj open, vol. 8, no. 1, p. e019319, jan. 2018, doi: 10.1136/bmjopen-2017-019319. 34 d. metcalfe, r. chowdhury, and a. salim, “what are the consequences when doctors strike?” bmj, vol. 351, no. november, pp. 1–4, 2015, doi: 10.1136/bmj.h6231. 35 r. essex and s. m. weldon, “health care worker strikes and the covid pandemic,” n. engl. j. med., vol. 384, no. 24, p. e93, jun. 2021, doi: 10.1056/nejmp2103327. 36 m. selemogo, “criteria for a just strike action by medical doctors,” indian j. med. ethics, vol. 346, no. 21, pp. 1609–1615, jan. 2014, doi: 10.20529/ijme.2014.010. 37 malaysian medical association, “malaysian medical association official website.” https://mma.org.my (accessed jun. 29, 2021). 38 m. toynbee, a. a. j. al-diwani, j. clacey, and m. r. broome, “should junior doctors strike?” j. med. ethics, vol. 42, no. 3, pp. 167–170, mar. 2016, doi: 10.1136/medethics-2015-103310. 39 r. essex and s. m. weldon, “health care worker strikes and the covid pandemic,” n. engl. j. med., vol. 384, no. 24, p. e93, jun. 2021, doi: 10.1056/nejmp2103327. 40 m. selemogo, “criteria for a just strike action by medical doctors,” indian j. med. ethics, vol. 346, no. 21, pp. 1609–1615, jan. 2014, doi: 10.20529/ijme.2014.010; a. j. roberts, “a framework for assessing the ethics of doctors’ strikes,” j. med. ethics, vol. 42, no. 11, pp. 698–700, nov. 2016, doi: 10.1136/medethics-2016-103395. https://mma.org.my/ jamaluddin, et al., doctors strike during covid-19 pandemic in malaysia, voices in bioethics, vol. 7 (2021) 8 41 “malaysia doctors strike, parliament meets as covid strain shows,” al jazeera, july 26, 2021. https://www.aljazeera.com/news/2021/7/26/malaysia-doctors-strike-parliament-meets-as-covid-strains-grow lee, canadian and american art law, voices in bioethics, vol. 1 (2014-15) © 2015 katarina lee. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a comparison of canadian and american art law katarina lee keywords: gametes, healthcare coverage, reproductive ethics, in vitro fertilization introduction a couple of weeks ago, reporter tom blackwell wrote an article entitled “couples paying most canadian donors for their eggs, breaking controversial fertility law, study finds.”1 unfortunately, much of the dialogue in response to the article has either been misinformed or a series of sweeping generalizations of american law in regard to gamete compensation. the purpose of this article is to clarify the differences in canadian and american law surrounding gamete donation and in vitro fertilization (“ivf”) using these gametes. analysis first, it should be noted that assisted reproductive technologies (“arts”) are regulated very differently in canada and the united states. in 2004, canada passed the assisted human reproduction act (“ahra” or the “act”) as federal oversight to the fertility industry in canada. parts of the act have since been ruled unconstitutional, but compensation for gamete donation has remained expressly prohibited. 2 the main precursor to this act was the royal commission on new reproductive technologies, a commission that was established by brian mulroney’s administration in 1989. the commission produced a report entitled proceed with care that was issued in november 1993 and contained 293 recommendations about assisted reproduction.3 during the eleven years between the commission’s issued report and the passage of ahra, a different bill addressing many of these new reproductive technologies failed, evidently slowing down the political process.4 additionally, in 2006 a federal body called assisted human reproduction canada (“ahrc”) was created to monitor the fertility industry and enforce ahra, but in 2012 the federal budget cut the entirety of ahrc’s funding.5 in the united states, there is no federal oversight to arts and, as a result, the fertility industry is highly unregulated. the only federal act is the fertility clinic success rate and certification act of 1992, which requires fertility clinics to self-report successful ivf procedures annually.6 the primary “governing body” is a professional governing body called the american society for reproductive medicine (“asrm”)—and its affiliate organization, the society for assisted reproductive medicine (“sart”)—which produce non-binding guidance documents for fertility practitioners.7 this means that a fertility specialist or clinic pays an annual fee to be a part of asrm and presumably follow their guidelines, but there is no legal obligation to do so. the asrm has released guidelines about appropriate compensation for donors’ gametes; however, this does not preclude individuals from contracting to purchase gametes for non-recommended sums of money.8 lee, canadian and american art law, voices in bioethics, vol. 1 (2014-15) 2 second, the healthcare structures financially supporting arts are drastically different in canada and the united states. this is directly related to the healthcare payment structures currently in place in both countries. canada primarily has a government-funded medical system. each canadian province and territory is required to provide coverage for healthcare that is deemed “medically necessary.” however, individual provinces and territories have deference to expand the breadth of what is considered to be medically necessary.9 the united states’ healthcare payment system is a multi-payer system consisting primarily of: (1) employer-provided insurance, (2) medicare, and (3) medicaid.10 employer-provided insurance can be insurance that the employer has purchased from a health insurer to provide to its employees, or an employer can be self-insured, meaning that the employer pays the medical costs of the employee directly (in this situation, the employer will often hire an outside administrator to manage this). there are significant rules, regulations, and requirements to be eligible for medicare and medicaid, but typically medicare is the government program for those above sixtyfive and medicaid is the government program that provides health coverage for individuals and families based upon income, disability, age, and pregnancy.11 note that there are other payers as well, including insurance provided by the united states military.12 in canada, it is expressly prohibited to compensate gamete donors; however, depending on the province, the provincial government may subsidize ivf.13 historically, quebec had the most generous ivf compensation laws, including coverage for ova donation and up to nine rounds of ivf, but due to increased costs, the provincial government will be limiting their benefits in the near future.14 however, the province of ontario recently expanded its coverage. 15 notably, not all government assistance is characterized by forthright payment of ivf procedures, as the province of manitoba provides a tax break for individuals who undergo ivf.16 the main rationale behind government support of arts is that infertility is a disease and therefore should fall under government-subsidized medical care. there is no federal law that requires insurance coverage for infertility treatments in the united states.17 the three typical methods of payment for arts, including ivf with donor gametes, are personal funds, employer benefits, or generous insurance. according to resolve, an american non-profit that supports infertile individuals and couples, currently fifteen states have laws that require insurance to cover infertility needs, some including ivf procedures.18 nonetheless, the great majority of ivf treatments in the united states are paid through private means.19 the argument behind prohibiting funding for art coverage is that fertility treatments are not medically necessary. conclusion the purpose of this article is not to suggest that one system is better than the other. to the contrary, i would be remiss not to highlight that both systems are highly fragmented, inconsistent, and suffer from great deficiencies. fundamentally, there are two questions that need to be addressed: (1) whether infertility should be classified as a disease, and (2) if infertility is a disease, should public funds be used to “cure” the disease? one of the reasons why proponents of government funding and government legislation requiring insurance coverage for arts argue that infertility is a disease is that funding medically unnecessary procedures is typically not deemed an appropriate use of limited medical care dollars. for example, elective cosmetic surgery is usually paid for through private means, as it seems unjust to spend limited dollars on medically unnecessary procedures when those dollars could be spent on basic primary care. regardless if infertility is classified as a disease, determining resource allocation still poses ethical questions. moreover, government funding and requirements for art funding may be contrary to the ethical and religious beliefs that individuals hold. typical ethical concerns about arts include the creation, freezing, and disposition of embryos, concerns about exploiting individuals for their gametes, and medical risks associated with the procedures and age(s) of the intended parent(s). considering all of these ethical concerns and financial burdens these procedures have on lee, canadian and american art law, voices in bioethics, vol. 1 (2014-15) 3 governments, private means remains the most permissible measure of payment for arts. 1 tom blackwell, couples paying most canadian donors for their eggs, breaking controversial fertility law, study finds, national post, (sept. 23, 2015), http://news.nationalpost.com/health/couples-paying-most-canadian-donors-for-their-eggs-breakingcontroversial-fertility-law-study-finds. 2 sonya norris, reproductive technologies: surrogacy, and egg and sperm donation, science and technology division, (2006), http://www.parl.gc.ca/content/lop/researchpublications/prb0035-e.pdf. 3 canadian fertility and andrology society, response to the report of the royal commission on new reproductive technologies: a summary, http://www.ncbi.nlm.nih.gov/pmc/articles/pmc1337406/pdf/cmaj00058-0050.pdf. 4 norris, supra note 2. 5 anne kingston, assisted human reproduction canada: the budget cut everyone missed, (apr. 2, 2012), maclean’s, http://www.macleans.ca/society/science/assisted-human-reproduction-canada-the-budget-cut-everyone-missed/. 6 centers for disease control and prevention, the fertility clinic success rate and certification act, http://www.cdc.gov/art/nas/policy.html. 7 society for assisted reproductive technology, http://www.sart.org. 8 american society for reproductive medicine and society for assisted reproductive technology, recommendation for gamete and embryo donation: a committee opinion, (jan. 2013), https://www.asrm.org/uploadedfiles/asrm_content/news_and_publications/practice_guidelines/guidelines_and_minim um_standards/2008_guidelines_for_gamete(1).pdf; american society for reproductive medicine ethics committee report, financial compensation of ooctye donors, 88 fertility and sterility 2, (aug. 2007), http://www.sart.org/uploadedfiles/asrm_content/news_and_publications/ethics_committee_reports_and_statements/financ ial_incentives.pdf. 9 health canada, canada health act – frequently asked questions, http://www.hc-sc.gc.ca/hcs-sss/medi-assur/faq-eng.php. 10 jessica c. smith et. al., health insurance coverage in the united states: 2014, united states census bureau, http://www.census.gov/content/dam/census/library/publications/2015/demo/p60253.pdf?eml=gd&utm_medium=email&utm_source=govdelivery. 11 department of health and human services, what’s medicare?, (june 2015), https://www.medicare.gov/pubs/pdf/11306.pdf; medicaid, eligibility, http://www.medicaid.gov/medicaid-chip-program-information/by-topics/eligibility/eligibility.html. 12 smith, supra note 10. 13 infertility network, insurance/ivf funding, (sept. 3, 2015), https://www.infertilitynetwork.org/insurance. 14 elizabeth church, ontario government sets age limit at 43 for ivf coverage, globe and mail, (oct. 1, 2015), http://www.theglobeandmail.com/news/national/ontarios-liberal-government-to-fund-a-cycle-of-ivf-forwomen/article26616360; government of quebec, quebec assisted reproduction program, http://sante.gouv.qc.ca/en/programmes-et-mesures-daide/programme-quebecois-de-procreationassistee/fecondation-in-vitro/. 15 id.; rob ferguson, ontario to cover in-vitro fertilization treatments, the star, (oct. 1, 2015), http://www.thestar.com/news/queenspark/2015/10/01/ohip-to-cover-in-vitro-fertization-treatments.html 16 government of manitoba, faq’s about the fertility treatment tax credit, http://www.gov.mb.ca/finance/tao/fttc_faq.html#question3. lee, canadian and american art law, voices in bioethics, vol. 1 (2014-15) 4 17 cbs news, “appalling” law prevents ivf coverage for veterans, (june 5, 2015), http://www.cbsnews.com/news/law-preventsivf-coverage-military-veterans/; resolve, the affordable care act and infertility, (feb. 17, 2014), http://www.resolve.org/getinvolved/the-center-for-infertility-justice/public-policy/the-affordable-care-act-and-infertility.html. 18 resolve, insurance coverage in your state, http://www.resolve.org/family-building-options/insurance_coverage/statecoverage.html. 19 jen christensen, record number of women using ivf to get pregnant, cnn, (feb. 18, 2014), http://www.cnn.com/2014/02/17/health/record-ivf-use/. lively, the high infant mortality among non-hispanic white infants in appalachia, voices in bioethics, vol. 6 (2020) * cathy lively, jd, ms candidate columbia university © 2020 cathy lively. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the high infant mortality among non-hispanic white infants in appalachia: is whiteness a factor? cathy lively* abstract while the prevalence of poverty in appalachia and the delta is high, political preferences may inform the lack of access to healthcare and to healthy lifestyles that contributes to infant mortality. keywords: poverty, healthcare ethics, income disparity, socioeconomic status, infant mortality introduction the infant mortality rate in both appalachia and the delta is higher than in other parts of the us.1 the appalachian region covers 428 counties in thirteen states. while appalachia is economically disadvantaged,2 the delta is the most economically depressed area in the us.3 the high infant mortality rate in both regions is under addressed and deserves closer attention and action. certain aspects of white culture, including a distrust of government services, contribute to the stark infant mortality disparity among regions. analysis although the us infant mortality rate decreased from 2017, 15 states and the district of columbia had higher infant mortality rates than the national rate.4 one 2017 study compared infant mortality in appalachia with the rest of the us.5 although infant mortality declined across the us, the mortality rate was still 16 percent higher in appalachia than in the rest of the us.6 the researcher documented the relationship between poverty and infant mortality in appalachia concluding that the disparities between appalachia and the rest of the us lively, the high infant mortality among non-hispanic white infants in appalachia, voices in bioethics, vol. 6 (2020) 2 would remain without corrective intervention. 7 the recommendations included an investment at various government levels, including increased access to high-quality, affordable healthcare.8 the national center for health statistics reported that for infants born to hispanic and non-hispanic black women, there was no notable difference in the infant mortality between the delta and the rest of the us.9 infants born to nonhispanic white women in the delta and appalachia had a higher mortality than the rest of the us. the high infant mortality rate in appalachia traces back to 1976. in 2012, the journal of rural health published the results of research covering 1976-1980 and 1996-2000. 10 the research documented higher infant mortality rates in appalachian counties. the research focused on white infant mortality based on the small number of infant deaths among other races in those counties. 11 the infant mortality disparity between appalachian and non-appalachian counties did not improve over the two decades of study. race and culture might be the cause of the substantial difference between the infant mortality rate for non-hispanic whites in the delta and appalachia compared to the rest of the us. a. poverty as a cause several researchers document poverty as a contributory factor. 12 poverty creates barriers in access to healthcare, education, and prenatal care.13 yet, there must be something else. research shows that areas with a majority black population reflect poorer health outcomes for all races. 14 appalachia, as reported in the appalachian region census in may 2019, is overwhelming non-hispanic white.15 on that basis, race is not a factor. the delta and appalachia “both have been hit hard by the epidemic of people addicted to opioid painkillers.”16 west virginia and kentucky had the highest rates of drug abuse deaths in the nation.17 yet, the national center for health statistics did not include the opioid crisis as a cause of infant mortality. b. race and class politics in “dying of whiteness”, jonathan metzl suggests a conservative movement purporting to make white america “great” actually harmed the lower and middle-income white individuals who supported conservative policies over the past decades.18 the regions required investment at various levels of government.19 the delta regional authority (dra) and the appalachian regional commission (arc) provide this assistance. the dra and the arc are a collaborative effort between governments at the federal, state, and local levels to address the needs of the respective communities. in 2017, president trump's proposed budget eliminated funding for both programs.20 metzl found that while wanting access to affordable care, many voters in trump country associate government intervention in healthcare with race and class politics.21 this deep-rooted perception is linked to racism.22 despite the recognized need for affordable healthcare, many white residents of the southern states vehemently resisted medicaid expansion. metzl compared the opposition to the affordable care act (aca) in tennessee to the opposition to the civil rights bill of 1964, the national health insurance proposed in 1995, and the johnson administration’s creation of medicare and medicaid in 1965. 23 in both eras, the misconceptions of non-white people’s use of government resources caused opposition from white people. strong spiritual belief, commitment to family, and community form the cultural fabric of appalachia. 24 in tennessee, many people are suspicious of elites and government even asserting “government or elitist interference of colonization.” yet the expressed deep brand or corporate loyalty, family values, and community loyalty. historian c. vann woodward describes “the divided mind” of the south as mostly white lively, the high infant mortality among non-hispanic white infants in appalachia, voices in bioethics, vol. 6 (2020) 3 men trying to participate in the economy and creating wealth but holding fast to prejudices not part of the more liberal states’ ethos. the policies and sentiments found throughout the delta and appalachia bolster the identity of ‘whiteness,’ making whiteness a risk category. 25 the members of the affected communities who cling to entrenched dogmas are harming their own ability to access healthcare, better education, and the equal playing field that would allow for a more stable local economy. the recommendations suggested by various researchers will not be effective if the community rejects what it considers government or elitist interference. c. recommendation the communities most impoverished must be educated in the spheres of policy and economics. the american tradition of many people in rural states voting against their economic interests causes the disconnect that prevents them from accessing healthcare and healthy lifestyles. an educational push should encourage civics to overcome prejudices and propel fact-based education. the stigma of government programs like snap and medicaid in appalachia and the delta can be overcome. infant mortality in a country as wealthy as the us is an unacceptable outcome. by including family values, the values of hard work, paying one’s own way, and including religious outlets, the electorate can be pushed to educate people, possibly leading to reform. conclusion in the delta and appalachia, family values and community belief systems prevent people from seeking the help needed to combat infant mortality. access to healthcare, healthy food, good jobs, and strong educations can propel the regions to move toward economic safety. leaving behind trumpism, racism, and a distrust for government could be beneficial to the people. poverty alone is not the cause. policies, voting habits, and rhetoric that condemn the possible solutions as liberal or elitist cause the disconnect in infant mortality rates. maintaining a values system that glorifies whiteness undermines success. any approach will need to come from within the communities but should aim to destigmatize government assistance and improve education. education to increase health literacy is crucial in areas where healthcare access is limited due to political choices. merely providing information is insufficient. a complex and integrated intervention can help transform cultural deeply held beliefs that harm the ability of the population to take steps to ensure healthy pregnancies and infants. 1 driscoll, a. k., & ely, d. m. (n.d.). maternal characteristics and infant outcomes in appalachia and the delta. maternal characteristics and infant outcomes in appalachia and the delta (11th ed., vol. 68). national center for health statistics national vital statistics report. 2 singh, g. k., & siahpush, m. (2014). widening rural–urban disparities in life expectancy, u.s., 1969–2009. american journal of preventive medicine, 46(2). doi: 10.1016/j.amepre.2013.10.017; appalachia then and now: examining changes to the appalachian region since 1965. (n.d.). retrieved from https://www.arc.gov/research/researchreportdetails.asp?report_id=113. https://www.arc.gov/assets/research_reports/appalachiathenandnowcompiledreports.pdf 3 driscoll, p. 1 https://www.arc.gov/research/researchreportdetails.asp?report_id=113 https://www.arc.gov/assets/ lively, the high infant mortality among non-hispanic white infants in appalachia, voices in bioethics, vol. 6 (2020) 4 4 infant mortality in the united states, 2017: data from the period linked birth/infant death file https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_10-508.pdf 5 singh, p. 1425 6 singh, p. 1425 7 singh, p. 1431 8 singh, p. 1430 9 driscoll, p.8 10 yao, n., matthews, s. a., & hillemeier, m. m. (2011). white infant mortality in appalachian states, 1976-1980 and 1996-2000: changing patterns and persistent disparities. the journal of rural health, 28(2), 174–182. doi: 10.1111/j.17480361.2011.00385.x 11 yao, p. 174. 12 eudy, r. l. (2008). infant mortality in the lower mississippi delta: geography, poverty and race. maternal and child health journal, 13(6), 806–813. doi: 10.1007/s10995-008-0311-y; gortmaker, s. l. (1979). poverty and infant mortality in the united states. american sociological review, 44(2), 280. doi: 10.2307/2094510 ; hillemeier, m. m., lynch, j., harper, s., raghunathan, t., & kaplan, g. a. (2003). relative or absolute standards for child poverty: a state-level analysis of infant and child mortality. american journal of public health, 93(4), 652–657. doi: 10.2105/ajph.93.4.652; singh, supra. 13 eudy, r. l. (2008). infant mortality in the lower mississippi delta: geography, poverty and race. maternal and child health journal, 13(6), 806–813. doi: 10.1007/s10995-008-0311-y 14 coughlin, s. s., thompson, t. d., seeff, l., richards, t., & stallings, f. (2002). breast, cervical and colorectal carcinoma screening in a demographically defined region of the us. cancer, 95, 2211–2222.; laveist, t. a. (2003). racial segregation and longevity among african americans: an individual-level analysis. health services research, 38(6p2), 1719–1734. doi: 10.1111/j.14756773.2003.00199.x 15 the appalachian region: a data overview from the 2013-2017 ... (n.d.). retrieved from https://www.arc.gov/research/researchreportdetails.asp?report_id=159., may 2019, https://www.arc.gov/assets/research_reports/dataoverviewfrom2013to2017acs.pdf 16 chia, a. e. (2019, may 22). a closer look at infant mortality rates in two of the most impoverished u.s, region. the washington post. 17 singh, supra. ; chia, a. e. (2019, may 22). a closer look at infant mortality rates in two of the most impoverished u.s, region. the washington post. singh gk, siahpush m.widening socioeconomic inequalities in us life expectancy, 1980–2000. int j epidemiol. 2006;35(4):969– 79. 18 metzl p.16 metzl, jonathan, m. (2020). dying of whiteness: how the politics of racial resentment is killing america’s heartland. s.l.: basic books. 19 singh gk, siahpush m.widening socioeconomic inequalities in us life expectancy, 1980–2000. int j epidemiol. 2006;35(4):969– 79. 20 mcgill, b. (2017, may 22). programs in trump country stand to lose much in budget cuts. wall street journal. 21 metzl p.84 22 metzl p.16 23 metzl p.18 24 mental health disparities: appalachian people psychiatry.org. (n.d.). retrieved from https://www.psychiatry.org/file library/psychiatrists/cultural-competency/mental-health-disparities/mental-health-facts-for-appalachian-people.pdf. 25 metzl, supra. https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_10-508.pdf https://www.arc.gov/research/researchreportdetails.asp?report_id=159 https://www.arc.gov/assets/research_reports/dataoverviewfrom2013to2017acs.pdf https://www.psychiatry.org/file%20library/psychiatrists/cultural-competency/mental-health-disparities/mental-health-facts-for-appalachian-people.pdf https://www.psychiatry.org/file%20library/psychiatrists/cultural-competency/mental-health-disparities/mental-health-facts-for-appalachian-people.pdf yu, lasik surgery: the true risk of complication? voices in bioethics, vol. 6 (2020) * md candidate, uq-ochsner © 2020 megan yu. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. lasik surgery: do the advertising and risk disclosures reflect the true risk of complication? megan yu* keywords: lasik, misleading advertising, marketing ethics, risk disclosure, informed consent introduction lasik surgery, one of the most common elective procedures worldwide, aims to decrease or eliminate the need to wear glasses or contact lenses by reshaping the cornea’s curvature to restore the eye’s refractive power.1 there is a popular belief among the public that the procedure is “virtually foolproof”,2 which is largely shaped by lasik advertising and marketing techniques.3 however, recent studies and news reports suggest that complications after lasik surgery are not uncommon and that many eye centers and lasik advertisements continue to promise “20/20 vision or your money back” or fail to disclose possible lasik complications.4 in fact, a recent study conducted by the u.s. food and drug administration (fda) found that 1 to 4 percent of participants were dissatisfied with the visual complications after lasik surgery.5 misleading information provided to the public about the procedure contributes to the popularity of lasik. this paper discusses the ethical issues currently associated with both advertising and physicians’ disclosures of risks surrounding the procedure and provides recommendations to address these lasik complications. lasik is the most popular procedure used to correct the refractive error, which includes myopia and hyperopia.6 using this procedure, the ophthalmologist reshapes the cornea by removing eye tissue in different areas depending on the patient’s condition.7 a flap approximately the size of a contact lens is formed using a femtosecond laser. this flap folds back in place and adheres to the corneal surface.8 yu, lasik surgery: the true risk of complication? voices in bioethics, vol. 6 (2020) 2 analysis misleading lasik advertising & failure to disclose business relationships misleading advertisements that portray lasik surgery as a complication-free procedure are unethical. many eye centers continue to display misleading advertisements by using phrases such as “20/20 vision or your money back” or “package deals.”9 direct to consumer advertisements created by ophthalmology groups, laser vision centers, and other lasik providers make inflated claims regarding the efficacy or safety of lasik surgery. for instance, some feature images that imply patients who had undergone lasik surgery would be permanently free from glasses or claim lasik surgery is a “safe and painless” alternative to glasses and omit any relevant complications of lasik surgery. 10 complex bioethical issues arise from false and misleading advertising. any partnership ophthalmologists have with the companies that manufacture lasik surgery equipment undermines physician integrity and may create pressure on ophthalmologists not to disclose lasik surgery’s risks and limitations. deceptive marketing tactics and business profits may also interfere with the physician’s professional obligation to patients and entice a patient to undergo risky surgery. these issues violate the principle of non-maleficence because they expose patients to unnecessary risks violating physicians’ obligations not to harm patients. patients also suffer financially, as they may have to pay thousands of dollars for a procedure that may be ineffective or harmful. ophthalmologists also violate the principles of virtue ethics and beneficence because physicians should display virtuous qualities, such as integrity and honesty in their practice and should promote good to their patients. the american academy of ophthalmology (academy) and the fda should oversee the behavior of ophthalmologists to ensure any financial or professional ties they have with the manufacturers that make the lasers for lasik surgery do not override the professional obligation to disclose the risks and limitations of lasik surgery. government and professional associations should also discourage scientific journals from publishing studies where the authors have financial or professional ties with manufacturers that make the lasers used in lasik surgery unless full disclosure is made clear. financial ties and perverse incentives to overtreat are ethical issues that undermine trust. failure to disclose possible complications of lasik surgery by ophthalmologists the fda and the academy have issued statements that compel ophthalmologists to properly inform patients of the indications, limitations, and complications of lasik surgery and the lasers used during this procedure in 2008, 2009, and 2011.11 yet some ophthalmologists neglect to disclose possible lasik surgery complications to patients or fail to take the time to answer patients’ questions regarding lasik surgery,12 which could cause long-term medical harm to the patient. in 2019, two canadians filed a lawsuit against lasik md clinics for neglecting to warn them that they could potentially develop corneal neuralgia after lasik surgery,13 which is a rare complication of lasik surgery that is often misdiagnosed as dry eye.14 some patients have reported years of suffering from debilitating eye pain and visual symptoms such as glares and halos,15 and some patients who had undergone lasik surgery testified at an fda meeting that they experienced impaired vision after lasik surgery that resulted in job loss and social isolation. suicides have also been reported.16 based on patient reporting of adverse events, ophthalmologists must disclose serious consequences. yu, lasik surgery: the true risk of complication? voices in bioethics, vol. 6 (2020) 3 a failure to disclose complications of any medical procedure is a severe ethical breach. in the us, canterbury v. spence set forth a strong stance on failure to disclose rare severe side effects.17 informed consent is a cornerstone of bioethics—patients must know the risks before they agree to undergo any procedure. the moral foundation of informed consent is the protection of bodily integrity and respect for autonomy. 18 patients have a fundamental liberty interest in being free of non-consensual bodily intrusion. without accurate information, informed consent has not transpired; the agreement to undergo the procedure is based on misinformation. doctors must disclose risks to educate the patient. it is the doctor’s duty to ensure that the patient is informed. failing to disclose lasik surgery’s possible complications violates the principles of virtue ethics and nonmaleficence as it withholds knowledge from patients that is essential to the sound management of their health. it also tarnishes the doctor-patient relationship's fiduciary nature as patients may place less trust in their physicians after discovering they withheld essential knowledge from them. there is moral value in the life-changing benefits of lasik surgery restoring one’s vision can be life-changing for many patients. those who previously had to rely on glasses or contact lenses to see clearly could feel empowered and gain more autonomy after having lasik surgery. lasik helps patients avoid having contact lens intolerance. a successful lasik surgery also allows patients to pursue certain professions or sports that they previously could not, such as becoming a chef or swimming. the ethics of advertising to enable potential lasik patients to learn more about lasik are compelling. more patients with poor vision will learn about an important solution. advertising brings patients to doctors who must discuss the procedure realistically. advertising lasik would be ethically prohibited if it drew in patients with unrealistic expectations, and the doctor did not clearly state the efficacy, risks, and side effects. continuing to allow advertising is the better moral choice as it allows many in need of help to seek it. however, it is a moral choice that is dependent on truth-telling and full disclosure by doctors. despite the life-altering benefits of lasik surgery, ophthalmologists have a professional obligation to patients and the public to provide truthful, informative advertising of lasik surgery and ensure patients fully understand the purpose, benefits, limitations, and complications of lasik surgery before having the procedure. beneficence should compel ophthalmologists to act in the best interests of patients, as the intended purpose of lasik surgery is to help patients improve their vision. lasik can be a life-changing improvement ethically compelling its availability to patients for whom it is the right fit. appropriate advertising and risk disclosure empower the patient in making an informed decision to undergo lasik surgery. actions to ensure an ethical process for patients deciding to undergo lasik surgery to ensure full transparency, ophthalmologists should confirm patients understand the nature, purpose, and risks of the procedure by encouraging them to ask questions during consultations and taking the time to answer their questions. they should ensure patients read and understand the fine print of informed consent forms and screen for patients who may not be suitable for lasik surgery. physicians also should substantiate any claim they made with the latest evidence from scientifically robust clinical studies. if an advertisement claims “90% of lasik patients achieve 20/40 vision or better,”19 the ophthalmologist should corroborate the claim with a reliable clinical study and ensure his outcomes do not differ significantly from the study’s outcomes. ophthalmologists should verify they did not omit any relevant information regarding the yu, lasik surgery: the true risk of complication? voices in bioethics, vol. 6 (2020) 4 effectiveness or nature of lasik surgery as the omission might influence the patient’s decision to undergo surgery.20 any claim made in advertisements and marketing materials, whether implicitly or explicitly, must provide an accurate impression of lasik surgery.21 for instance, a lasik advertisement that features a man throwing away his glasses might cause patients to believe they would be permanently free from glasses or contact lenses after lasik surgery. federal and global organizations, such as the academy and the fda should promote public awareness about lasik’s risks and benefits and continue to regulate any promotional material that ophthalmologists use to promote lasik surgery. the fda should take action if an eye center in violation of the policies chooses not to comply. the academy and the fda should also prohibit ophthalmologists from classifying lasik surgeries “successful” based on achieving “20/20 or 20/40 or better vision” after surgery if a complication was reported.22 conclusion physicians must bar misleading advertisements and fully disclose the complications of lasik surgery to patients. through these measures, patients would make more informed choices about whether they should undergo lasik surgery. rather than marketing lasik to those with minor vision impairment or with higher risk profiles, ophthalmologists must behave according to the ethical foundation of their profession. even with relatively few risks, doctors must be certain to minimize risk by evaluating patient eligibility for lasik, cautioning all patients about the risks, and ensuring proper advertising and marketing practices. lasik can give people enhanced vision expanding career and athletic opportunities and make life simpler with less need for contacts, and glasses for the right candidates. 1 tran, khai et al., “laser refractive surgery for vision correction: a review of clinical effectiveness and cost-effectiveness,” cadth rapid response report: summary with critical appraisal, june 22, 2018. https://www.ncbi.nlm.nih.gov/books/nbk532537. 2 rabin, roni, “blurred vision, burning eyes: this is a lasik success?” june 11, 2018. https://www.nytimes.com/2018/06/11/well/lasik-complications-vision.html. 3 lasikcomplications.com, “the lasik report: a call for the discontinuation of a harmful procedure,” april, 2008. https://www.lasikcomplications.com/the-lasik-report.pdf. 4 rabin, roni, 2018; the associated press, “witnesses tell of suffering after lasik,” april 25, 2008. https://www.nytimes.com/2008/04/25/business/aplasik-web.html; eydelman, malvina et al., “symptoms and satisfaction of patients in the patient-reported outcomes with laser in situ keratomileusis (prowl) studies,” jama ophthalmology 135, no. 1 (2018): 13-22; u.s. food and drug administration, “what are the risks and how can i find the right doctor for me?” august 8, 2018. https://www.fda.gov/medical-devices/lasik/what-are-risks-and-how-can-i-find-right-doctor-me; american academy of ophthalmology, “guidelines for refractive surgery advertising,” october 2008. https://www.aao.org/about/policies/guidelinesrefractive-surgery-advertising 5 eydelman, malvina et al, p. 13 6 wilkinson, john et al., “refractive eye surgery: helping patients make informed decisions about lasik,” american family physician 95, no. 10 (2017): 637-644 7 wilkinson, john, et al., p. 638 8 wilkinson, john, et al., p. 639 other procedures, such as laser-assisted subepithelial keratomileusis, epithelial lasik, femtosecond laser extraction, and small incision lenticular extraction, have been developed that have similar effectiveness as lasik but their long-term outcomes are unknown. some contraindications to lasik surgery include corneal abnormalities, pregnancy, uncontrolled diabetes, uncontrolled glaucoma, and significant cataracts, and patients with abnormal wound healing, controlled diabetes, glaucoma, a history of herpetic keratitis, or systemic autoimmune disease should be cautioned before https://www.ncbi.nlm.nih.gov/books/nbk532537 https://www.nytimes.com/2018/06/11/well/lasik-complications-vision.html https://www.lasikcomplications.com/the-lasik-report.pdf https://www.nytimes.com/2008/04/25/business/aplasik-web.html https://www.fda.gov/medical-devices/lasik/what-are-risks-and-how-can-i-find-right-doctor-me https://www.aao.org/about/policies/guidelines-refractive-surgery-advertising https://www.aao.org/about/policies/guidelines-refractive-surgery-advertising yu, lasik surgery: the true risk of complication? voices in bioethics, vol. 6 (2020) 5 undergoing lasik surgery. some complications of lasik surgery include dry eye, visual symptoms (including glare, halos, and starbursts), diffuse lamellar keratitis, and infections, with dry eye and visual symptoms accounting for 20-40 percent and 20 percent of the complications, respectively. (wilkinson 639, 640 & 641) 9 u.s. food and drug administration, 2018; american academy of ophthalmology, 2008 10 american academy of ophthalmology, 2008 11 u.s. food and drug administration, “fda letter to eye care professionals (may 22, 2009)” may 22, 2009. https://www.fda.gov/medical-devices/lasik/fda-letter-eye-care-professionals-may-22-2009; u.s. food and drug administration, “fda letter to eye care professionals (september 23, 2011)” september 23, 2011. https://www.fda.gov/medicaldevices/lasik/fda-letter-eye-care-professionals-september-23-2011; american academy of ophthalmology, 2008 12 aubry, allison, “some patients say life after lasik not perfect,” may 1, 2008. https://www.npr.org/templates/story/story.php?storyid=90070220 13 favaro, avis et al., “lasik md patients allege nerve damage, file class action lawsuit,” november 21, 2019. https://www.ctvnews.ca/health/lasik-md-patients-allege-nerve-damage-file-class-action-lawsuit-1.4697069 14 theophanous christos et al., “corneal neuralgia after lasik,” optometry and vision science 92, no. 9 (2015): e233-e240 15 robin, roni, 2018 16 the associated press, 2008 17 canterbury v. spence, 464 f. 2d 772 (1972) 18 schoendorff v. society of new york hospital, 106 n.e.93 (n.y. 1914)(every patient has the right to decide what is done with “his own body.”) 19 american academy of ophthalmology, 2008 20 american academy of ophthalmology, 2008 21 american academy of ophthalmology, 2008 22 lasikcomplications.com, 2008 https://www.fda.gov/medical-devices/lasik/fda-letter-eye-care-professionals-may-22-2009 https://www.fda.gov/medical-devices/lasik/fda-letter-eye-care-professionals-september-23-2011 https://www.fda.gov/medical-devices/lasik/fda-letter-eye-care-professionals-september-23-2011 https://www.npr.org/templates/story/story.php?storyid=90070220 https://www.ctvnews.ca/health/lasik-md-patients-allege-nerve-damage-file-class-action-lawsuit-1.4697069 butchart, on the status of rights, voices in bioethics, vol. 7 (2021) * liam butchart, candidate, md, ma renaissance school of medicine at stony brook university © 2021 liam butchart. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. on the status of rights, legal and philosophical liam butchart* abstract in cases where the law conflicts with bioethics, the status of rights must be determined to resolve some of the tensions. this paper considers the origins of both legal and philosophical rights, arguing that rights per se do not exist naturally. even natural rights that are constitutional or statutory came from relationships rather than existing in nature. once agreed upon, rights develop moral influence. keywords: rights, contractualism, law, bioethics, philosophy, interpretation introduction i. the question of rights the language of rights is omnipresent in current discourse in law, bioethics, and many other disciplines. rights dialogue is frequently contentious – some thinkers take issue with various uses of rights in the modern dialogue. for example, some criticize “rights talk,” which heightens social conflict when used as a “trump” against disfavored arguments.1 others are displeased by what is termed “rights inflation,” where too many novel rights are developed, such that the rights these scholars view as “more important” become devalued.2 some solutions have been proposed: one recommendation is that rights should be restricted to extremely important or essential ones. some supreme court justices make arguments for applying original meanings in legal cases.3 conflict over the quantity and status of rights has long been a subject of debate in law and philosophy. even jefferson had to balance his own strict reading of the constitution with tendencies to exceed the plain text of the document.4 this thread of discourse has grown in political prominence over the years, with more supreme court cases that suggest newly developed (or, perhaps, newly recognized) rights. the theoretical conflict between textualists and those looking to intent or context could lead to repealing rights to abortion, sterilization, or marital privacy and deeply impacts our daily lives. bioethics is ubiquitous, and rights discourse is fundamental. this paper analyzes the assumptions that underlie the existence of rights. the law is steeped in philosophy, though philosophical theories have an often-unacknowledged role. this is especially true in cases that navigate difficult bioethical issues. as a result of this interleaving, the ontological status of rights is necessary to resolve some of the theoretical tensions. butchart, on the status of rights, voices in bioethics, vol. 7 (2021) 2 many philosophers have either argued for or implicitly included human rights in their theories of morality and legality. however, there is no universally accepted definition of rights; various philosophers have their own approaches. for example: louden comments, “rights are permissions rather than requirements. rights tell us what the bearer is at liberty to do”; martin thinks that a right is “an established way of acting”; hohfeld concludes that all rights are claims.5 similarly, there is dissent about the qualities of rights: the declaration of independence characterizes rights as unalienable, but not all thinkers agree. nickel comments, “inalienability does not mean that rights are absolute or can never be overridden by other considerations. . . perhaps it is sufficient to say that [human] rights are very hard to lose.”6 this discord necessitates additional analysis. “many people tend to take the validity of. . . rights for granted. . . however, moral philosophers do not enjoy such license for epistemological complacency.”7 because of the fundamental impact that political and moral philosophy enacted as the law have, this paper considers the origins of both legal and philosophical rights, arguing that rights per se do not exist naturally. even natural rights that are constitutional or statutory came from relationships rather than existing in nature. once agreed upon, rights take on moral force. ii. legal rights: from case to constitution bioethics and law sometimes address rights differently. three supreme court cases marked the development of privacy rights in the united states: griswold v. connecticut (1965), roe v. wade (1973) and cruzan v. director, missouri department of health (1990). these cases shape the normative dialogue and consider complex moral quandaries. griswold v. connecticut concerned providing contraception to married couples in contravention of state law. justice douglas writes for the majority that, based in “a right of privacy older than the bill of rights,” legally protected zones of privacy extend from the text of the constitution. “specific guarantees in the bill of rights have penumbras, formed by emanations from those guarantees that help give them life and substance.”8 writing in dissent, justice black argues that there is not a broad right to privacy included in the provisions of the constitution, and expresses concern over “dilut[ion] or expans[ion]” of enumerated rights by terms such as privacy, which he characterizes as abstract and ambiguous – and subject to liberal reinterpretation.9 he concludes that the government does have the right to invade privacy “unless prohibited by some specific constitutional provision.”10 also dissenting, justice stewart finetunes the argument: rather than look to community values beyond the constitution, the court ought to rely solely on text of the document, in which he “can find no such general right of privacy in the bill of rights, in any other part of the constitution, or in any case ever decided by this court.”11 thus, griswold v. connecticut is an example of the tensions within the supreme court over strict textualism or broader interpretations of the constitution that look to intent and purpose. roe v. wade held that there is a right to privacy found through the due process clause of the fourteenth amendment that includes the right to make medical decisions including abortion. while the conclusion – that there is a constitutionally protected right to abortion, with certain limits seems to expand the griswold doctrine of privacy rights, dissent to the ruling stems from much the same concern as before. justice rehnquist writes: a transaction resulting in an operation such as this is not "private" in the ordinary usage of that word. nor is the "privacy" that the court finds here even a distant relative of the freedom from searches and seizures protected by the fourth amendment to the constitution, which the court has referred to as embodying a right to privacy.12 butchart, on the status of rights, voices in bioethics, vol. 7 (2021) 3 however, he then departs from the stricter approach of justices black and stewart: i agree… that the "liberty," against deprivation of which without due process the fourteenth amendment protects, embraces more than the rights found in the bill of rights. but that liberty is not guaranteed absolutely against deprivation, only against deprivation without due process of law.13 this is a tempering of the stricter constructionism found earlier, where more latitude is allowed for the interpretation of the text of the constitution, even though there are clearly limits on how far the words may be stretched, with the genesis of a new right. later, in planned parenthood of southwestern pennsylvania v. casey, the court further refined roe v. wade implementing an “undue burden” test.14 in cruzan v. director, missouri department of health, the court held that there is a general liberty interest in the refusal of medical treatment. the case continues the tradition of griswold and roe v. wade ensuring a liberty that is beyond the text, but also allows states to impose a strict evidentiary burden to shape how the right is exercised. the court affirmed the lower court’s decision that “because there was no clear and convincing evidence of nancy [cruzan’s] desire to have life-sustaining treatment withdrawn. . . her parents lacked authority to effectuate such a request.”15 the supreme court found that the clear and convincing evidentiary burden applied by the missouri supreme court was consistent with the due process clause. justice scalia notes that even though he agrees with the court’s decision, he finds this judgment unnecessary or, perhaps counterproductive, because the philosophical underpinnings of the case “are neither set forth in the constitution nor known to the nine justices of this court any better than they are known to nine people picked at random from the kansas city telephone directory” and should be left to the states to legislate as they see fit. 16 he goes on to further argue that the due process clause “does not protect individuals against deprivations of liberty simpliciter”; rather, it protects them from infringements of liberty that are not accompanied by due process.17 justice scalia’s textualist position likely influenced his remarks.18 comparing these cases, i argue there is a distinct effort to make the constitution amenable to contemporary mores and able to address present issues that is moderated by justices who adhere to the text. the legal evolution of rights that are beyond the text of the constitution may reflect social norms as well as the framers’ intent. rights are protected by the constitution, but the constitution is mutable, through both case law and legislation. prior to the adoption of the constitution, the declaration of independence declared: we hold these truths to be self-evident, that all men are created equal, that they are endowed by their creator with certain unalienable rights, that among these are life, liberty and the pursuit of happiness.--that to secure these rights, governments are instituted among men, deriving their just powers from the consent of the governed.19 the declaration of independence gives insight into rights prior to the constitution by referring to a priori rights extended by a creator, sheltered and supported by the state.20 for earlier evidence of rights, supreme court cases often reference english common law doctrines. the common law was informed by preexisting principles and drew on a historical body of thought: philosophy. exploring philosophy can give insight about the evolution of law. iii. philosophical rights: issues of ontology a moral right, the precursor to many legal rights, in some ways is a claim that bears moral weight. one relevant distinction is between positive and negative rights: a positive right is a claim on another to do butchart, on the status of rights, voices in bioethics, vol. 7 (2021) 4 something for the right holder; a negative right is a claim on others to leave the rights holder alone. some rights are per se (that is, rights that have a de novo ontological origin) and some are constructed (rights that are secondary to some other theoretical apparatus). we must appeal to the state of nature to understand the origin of rights. if rights exist in the state of nature, they are de novo; if not, they are constructed. the state of nature is the theoretical realm where there are no social conventions or no normative rules. the theoretical state of nature is stateless. hobbes writes about the state of nature. he constructs the person within as incorporating two normative qualities: the law of nature, “whereby individuals are forbidden to do anything destructive of their lives or to omit the means of self-preservation,” and the right of nature, where the person has the “right to all things” – those things required for self-preservation.21 similarly, more contemporary philosophers have also inferred that the right to freedom is a natural right.22 i argue that nature allows every person the freedom to all things, or a natural right against limitation on freedom. every person has the capacity to do whatever they want, in accordance with their reason; liberty, rather than being a normative claim, is a component of the essence of beings. yet both nature and other people pose some limitations. early modern contractarians’ status theories maintain that human attributes engender rights. 23 a specific formulation of human status ethics can be found in kantian deontology. from the autonomous and rational will, kant evolves his categorical imperative: “act only according to that maxim whereby you can at the same time will that it should become a universal law.”24 without (or before) law, philosophers suggested behaviors should reflect moral rights. like rawls, i maintain that the state of nature includes both a scarcity of resources and individuals with whom we may develop conflicts of interest.25 individually, we are vulnerable to others, and because of that natural vulnerability, we have an inclination toward self-interest.26 therefore, we eventually find the state of nature unsatisfactory and move to create a civil society. then the subsequent pathway to creating “rights” is well known. people agree on them and act accordingly. then, they are enshrined in the law.27 i attribute the impetus to move from the state of nature toward government to interpersonal interaction that creates a form of the social contract. rawls qualitatively describes this when he notes the “identity of interests” that powers interpersonal cooperation.28 to me, the development of positive social relations has three components. the first is the human capacity for empathy. empathy is commonly accepted by psychologists as universal.29 kittay deepens the concept of human empathy, arguing that there is a “register of inevitable human dependency” – a natural sense of care found in the human experience of suffering and decay and death to which we all eventually succumb, necessitating a recognition of interdependence and cooperation.30 the second is the importance of identity in generating social cooperation.31 there is a sense of familial resemblance that resonates when we see others in our lives, forming the base of the identification that allows us to create bonds of mutual assent. a microsociety develops when people are exposed to each other and acts as a miniaturized state, governed by what is at first an implicit social contract. an internal order is generated and can be codified. the third component of social relations is the extension of the otherness-yet-sameness beyond human adults. mirroring connects the fully abled adult man and the woman, as well as the child, the physically and mentally disabled, and could extend to animals as well.32 butchart, on the status of rights, voices in bioethics, vol. 7 (2021) 5 therefore, to me, it seems that rights do not exist per se in the state of nature, but because of our human capacities, relationships yield a social contract. this contract governs interpersonal relations with normative power: rights are constructed. once constructed based on people in micro-society and then larger groups, rights were codified. negative rights like those found in the u.s. constitution allow people in liberal society to codify nearly universal ground rules in certain arenas while respecting minority views and differing priorities. however, the social contract is not absolute: it may be broken by any party with the power to enforce their will upon the other and it will evolve to reflect changing standards. so, there is a subtle distinction to be made: in unequal contractual social relations, there are not constructed rights but rather privileges. in a social relationship that aims at equal status among members, these privileges are normative claims – rights that are not inherent or a priori but mandated to be equally applied by society’s governing body. in this way, i differ from rawls. to me, justice is a fundamental moral principle only for societies that aim at cooperation, where advancing the interests of all is valued.33 conclusion from liberty to law social contractualism purports to provide moral rules for its followers even when other ethical systems flounder in the state of nature. relationships consider the needs and wants of others. rights exist, with the stipulation that they are constructed under social contracts that aim for equality of application. i also suggest that contractualist approaches may even expand the parties who may be allowed rights, something that has significant bearing on the law and practical bioethics. the strict/loose constructionism debate that has played out in the supreme court’s decisions focuses on whether rights are enumerated or implied. theoretical or implicit contracts may be change quickly, based on the power dynamics in a social relationship. theoretical bounds of the social contract (possibly including animals, nonhumans, etc.) may be constricted by an official contract, so these concerns would need to be adjudicated in the context of the constitution. in certain cases, strict interpretation reflects the rights determined by the social compact and limits new positive rights; in others, a broad interpretation keeps government out of certain decisions, expanding negative rights to reflect changing social norms. the negative rights afforded in the constitution provide a framework meant to allow expansive individual choices and freedom. the underlying social compact has more to do with the norms behind societal structure than forcing a set of agreed upon social norms at the level of individual behavior. the constitution’s text can be unclear, arbitrary, or open to multiple meanings. the literary theorist may be willing to accept contradiction or multiple meanings, but the legal scholar may not. the issue of whether the social compact is set or evolving affects constitutional interpretation. the law is itself may be stuck in a state of indeterminacy: the law, in the eyes of the framers, was centered on a discourse steeped in natural, human rights, attributed to a creator. today, there is an impulse toward inherent human dignity to support rights. the strict/loose constructionism debate concerns interpretation.34 in conclusion, rights have no ontological status per se, but are derived from a complex framework that springs from our relationships and dictates the appropriateness of our actions. while the constitution establishes the negative rights reflecting a social compact, interpretations recognize the limitations on rights that are also rooted in societal relationships. the author would like to thank stephen g. post, phd, and caitlyn tabor, jd, for providing feedback on early drafts of this paper. butchart, on the status of rights, voices in bioethics, vol. 7 (2021) 6 1 mary ann glendon, a world made new: eleanor roosevelt and the universal declaration of human rights (new york: random house, 2001), 14. 2 james griffin, on human rights (oxford: oxford university, 2008). 3 maurice cranston, what are human rights? (london: bodley head, 1973). 4 barry balleck, “when the ends justify the means: thomas jefferson and the louisiana purchase,” presidential studies quarterly 22, no. 4 (1992): 679-680. 5 robert louden, “rights infatuation and the impoverishment of moral theory,” journal of value inquiry 17 (1983): 95; rex martin, a system of rights (oxford: oxford university, 1993), 1; wesley hohfeld, fundamental legal conceptions (new haven: yale university, 1919), 36. 6 james nickel, "human rights", the stanford encyclopedia of philosophy (summer 2019 edition), ed. edward n. zalta, accessed 27 april 2021, https://plato.stanford.edu/archives/sum2019/entries/rights-human/. 7 andrew fagan, “human rights,” internet encyclopedia of philosophy, ed. james fieser and bradley dowden, accessed 27 april 2021, https://iep.utm.edu/hum-rts/. 8 griswold v. connecticut 381 u.s. 479 (1965), para. 18, https://www.law.cornell.edu/supremecourt/text/381/479. 9 griswold v. connecticut 381 u.s. 479 (1965), para. 69 https://www.law.cornell.edu/supremecourt/text/381/479. 10 griswold v. connecticut 381 u.s. 479 (1965), para. 69 https://www.law.cornell.edu/supremecourt/text/381/479. 11 griswold v. connecticut 381 u.s. 479 (1965), para. 92 https://www.law.cornell.edu/supremecourt/text/381/479. 12 roe v. wade 410 u.s. 113 (1973), 172, https://www.law.cornell.edu/supremecourt/text/410/113%26amp. 13 roe v. wade 410 u.s. 113 (1973), 172-173, https://www.law.cornell.edu/supremecourt/text/410/113%26amp. 14 planned parenthood of southeastern pa. v. casey, 505 u.s. 833 (1992), https://supreme.justia.com/cases/federal/us/505/833/#:~:text=casey%2c%20505%20u.s.%20833%20(1992)&text=a%20person %20retains%20the%20right,the%20mother%20is%20at%20risk. 15 cruzan v. director, missouri department of health 497 u.s. 261 (1990), https://www.law.cornell.edu/supct/html/881503.zo.html. 16 cruzan v. director, missouri department of health 497 u.s. 261 (1990), https://www.law.cornell.edu/supct/html/881503.zo.html. 17 cruzan v. director, missouri department of health 497 u.s. 261 (1990), https://www.law.cornell.edu/supct/html/881503.zo.html. 18 it is worth noting that some of the supreme court’s conservatives – like scalia, thomas, roberts – have expressed explicit disdain for the right to privacy introduced in griswold. jamal greene, “the so-called right to privacy,” uc davis law review 43 (2010): 715-747, https://scholarship.law.columbia.edu/faculty_scholarship/622. 19 national archives. “declaration of independence: a transcription.” july 4, 1776; reviewed july 24, 2020, https://www.archives.gov/founding-docs/declaration-transcript. 20 however, the reference to a creator has come to mean a natural right and a priori best describes it rather than a religious underpinning. to borrow from husserl, this approach will be bracketed out. https://plato.stanford.edu/archives/sum2019/entries/rights-human/ https://iep.utm.edu/hum-rts/ https://www.law.cornell.edu/supremecourt/text/381/479 https://www.law.cornell.edu/supremecourt/text/381/479 https://www.law.cornell.edu/supremecourt/text/381/479 https://www.law.cornell.edu/supremecourt/text/381/479 https://www.law.cornell.edu/supremecourt/text/410/113%26amp https://www.law.cornell.edu/supremecourt/text/410/113%26amp https://www.law.cornell.edu/supct/html/88-1503.zo.html https://www.law.cornell.edu/supct/html/88-1503.zo.html https://www.law.cornell.edu/supct/html/88-1503.zo.html https://www.law.cornell.edu/supct/html/88-1503.zo.html https://www.law.cornell.edu/supct/html/88-1503.zo.html https://www.law.cornell.edu/supct/html/88-1503.zo.html https://scholarship.law.columbia.edu/faculty_scholarship/622 https://www.archives.gov/founding-docs/declaration-transcript butchart, on the status of rights, voices in bioethics, vol. 7 (2021) 7 21 djc carmichael, “hobbes on natural right in society: the ‘leviathan’ account,” canadian journal of political science 23, no. 1 (1990): 4-5. 22 hla hart, “are there any natural rights?” the philosophical review 64, no. 2 (1955): 175. 23 warren quinn, morality and action (cambridge: cambridge up, 1993), 170. 24 immanuel kant, groundwork of the metaphysic of morals, trans. james ellington, 3rd ed. (indianapolis: hackett, 1993), 30. 25 john rawls, a theory of justice: revised edition (cambridge: belknap, 1999), 109. 26 js mill, remarks on bentham’s philosophy, in collected works of john stuart mill, vol. x, ed. jm robson (toronto: u of toronto press, 1985), 13-14. 27 rex martin, a system of rights (oxford: oxford university, 1993), 1; kenneth baynes, “kant on property rights and the social contract,” the monist 72, no. 3 (1989): 433-453. 28 john rawls, a theory of justice: revised edition (cambridge: belknap, 1999), 109. 29 frederik von harbou, “a remedy called empathy: the neglected element of human rights theory,” archives for philosophy of law and social philosophy 99, no. 2 (2013): 141. 30 eva feder kittay. learning from my daughter: the value and care of disabled minds (oxford: oxford up, 2019), 145-146. 31 jane gallop, “lacan’s ‘mirror stage’: where to begin,” substance 11, no. 4 (1983): 121; lacan, jacques. the seminar of jacques lacan: book x: anxiety: 1962-1963, trans. cormac gallagher, 26-27, https://www.valas.fr/img/pdf/the-seminar-of-jacqueslacan-x_l_angoisse.pdf. (in lacanian psychoanalytic theory, human development necessitates both recognition of the self and the separation of the self from the other.) 32 lacan, jacques. the seminar of jacques lacan: book x: anxiety: 1962-1963, trans. cormac gallagher, 27-28, https://www.valas.fr/img/pdf/the-seminar-of-jacques-lacan-x_l_angoisse.pdf. 33 there is an interesting discussion to be had about whether social contract theory allows for this gradation in quality of contracts, or whether the two are fundamentally different phenomena. i cannot answer this question here; john rawls, a theory of justice: revised edition (cambridge: belknap, 1999), 102-103. 34 ruthellen josselson, “the hermeneutics of faith and the hermeneutics of suspicion,” narrative inquiry 14, no. 1 (2004): 2-4. https://www.valas.fr/img/pdf/the-seminar-of-jacques-lacan-x_l_angoisse.pdf https://www.valas.fr/img/pdf/the-seminar-of-jacques-lacan-x_l_angoisse.pdf https://www.valas.fr/img/pdf/the-seminar-of-jacques-lacan-x_l_angoisse.pdf rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) * caelan rathke, colorado christian university © 2021 caelan rathke. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the women who don’t get counted caelan rathke* abstract the current incarceration facilities for the growing number of women, are depriving expecting mothers of adequate care crucial for the child’s mental and physical development. programs need to be established to counteract this. keywords: pregnancy, incarcerated individuals, unequal care, postnatal care, nursery programs introduction currently, diana sanchez was eight months pregnant when she was arrested for identity theft and put in a prison cell in denver. at five a.m., two weeks after being incarcerated, she announced to a deputy outside her cell that she was going into labor. footage from a camera in her cell shows her pacing anxiously or writhing in her bed for the five hours preceding the arrival of her son. she banged on the door and begged for help. all she received was an absorbent pad. she gave birth alone in her prison cell on july 31, 2015, around 10:45 am. at 11:00 am, a prison nurse walked in to cut the umbilical cord and take sanchez’s newborn baby without offering postnatal care. sanchez was later sent to a hospital, and her baby was separated from her until she was put on probation. in 2018, on behalf of her three-year-old son, sanchez sued denver health and denver sheriff department and won a $480,000 settlement.1 though many more men are incarcerated than women, the rate of growth of female incarceration has exceeded that of male incarceration for decades. one study estimated that 231,000 women are currently incarcerated in the us,2 80 percent of whom are mothers, and 150,000 pregnant.3 another recent study of 1,396 incarcerated pregnant women found that 92 percent had live births, 6.5 percent had stillbirths or miscarriages, and 4 percent terminated the pregnancy. the authors found that there is no system of reporting pregnancy outcomes in us prisons. there is a noteworthy ethical lapse in mental, emotional, and medical care that threatens the well-being of pregnant women in prison. according to carolyn sufrin, “pregnant incarcerated people are one of the most marginalized and forgotten groups in our country… and women who don't get counted don't count.” rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) 2 4 poor documentation, visibility, and transparency contribute to the systemic abuse of incarcerated women. studies document women giving birth alone in cells and shackles in solitary confinement. their complaints regarding contractions, bleeding, and other pains of labor are often ignored.5 i. prenatal care in american prisons diana sanchez was not offered any prenatal care after she was incarcerated. and neither she nor her son received appropriate postnatal care.6 sanchez was on medication for opioid withdrawal while pregnant, which could have been detrimental to her baby’s health.7 there is an unacceptable absence of preand postnatal care in most us prisons. a lack of regulation makes the availability of perinatal care unpredictable and unreliable. several studies confirmed that there is not a standard for prenatal care for women incarcerated during pregnancy. 8 knowledge of the appropriate mental and physical care pregnant women require, addiction support, and support for maternal-infant bonding all exists outside the prison system and ought to be used as a benchmark. at the very least, pregnant women, birthing women, and new mothers should not be placed in solitary confinement or shackled. 9 in the prenatal arena, depriving an individual of adequate healthcare is not appropriate and could be cruel and unusual. only 18 percent of funding in prisons goes to health care for the prisoners. that is roughly $5.7 thousand per prisoner, according to an nih study done in 2015.10 there should be an adequate amount of funding for the health needs of incarcerated pregnant women. by depriving pregnant women of healthcare, the prisons are depriving the fetus of adequate care. ii. respect for autonomy during incarceration women maintain healthcare autonomy even when incarcerated. the purpose of a prison sentence is retribution for crimes and rehabilitation to prevent reoffending.11 the separation of a mother and newborn causes significant developmental and psychological harm to the child and the parent. parent-child separation does not serve the purpose of retribution or rehabilitation and is authorized only due to prisons’ limited space and resources that make it difficult to accommodate children, as well as a state interest in children’s best interests or the custody rights of the other parent. when it is possible to keep a family together, prisons should make every effort to do so for the health of the mother-child relationship. incarcerated people may become a burden to family or society due to prison medical neglect. for example, diabetes and hypertension, which can occur during pregnancy, can worsen without treatment. the inability to access the care they would otherwise want and need endangers women and poses a burden to the healthcare system after incarceration, depersonalizing individuals convicted of crimes must be placed in the context of historical eugenics practices. state-sanctioned sterilization and efforts to prevent women from reproducing were widespread during the early 20th century.12 cases of coerced and nonconsensual sterilization of incarcerated women and men evidence the history of eugenics. 13 abortions are offered to some incarcerated women. 14 however, many incarcerated women are denied the right to see healthcare providers to thoroughly discuss abortion or other options.15 although the abortions are consensual, the quality of consent is questionable. iii. prison nursery programs, “i need something to live for…” indiana women’s prison (iwp), a max security female prison, has a program called wee ones that enables women convicted of nonviolent crimes to spend 30 months bonding with their newborn child. it is one of rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) 3 eight programs in the country that allows pregnant mothers to spend the last few months of their sentence with their children. it is a voluntary program that allows pregnant offenders a private room in a housing unit. it offers parent education, resources that are accessible after release, and career education. the program application process and the rules to which women must adhere to remain in the program are stringent. the programs generally have a zero-tolerance policy. even simply sleeping in the same bed as the child or arguing with other mothers can result in termination from the program. kara, a pregnant woman incarcerated for drug possession, had a history of abuse in her family and tended to act out in anger against her peers in the program. she was learning how to have healthy reactions to anger when handling her child, but her temper ultimately led to her removal from the program. her son was placed in foster care, and kara returned to the regular cells. in an interview before her transfer, she told the camera that charlie gave her a purpose. with tears in her eyes, she said, “charlie was my way of life here [...] i need something to live for [,] and i screwed up.”16 pregnancy in prison can be a way to improve quality of life for some women. studies demonstrate that nursery programs improve mental health of the incarcerated women. 17 the secure attachment of the infant to its primary caregiver promotes healthy development in the child and a bonded relationship with the mother.18 the close bond between mother and child in prisons has been shown to decrease recidivism and to reduce the burden on the foster care system.19 women who do not qualify for these programs, or are incarcerated in prisons without them, are separated from their newborn babies and their other children. the disconnect can lead to the child rejecting the incarcerated mother once she is released.20 programs like wee ones honor women’s autonomy while they are incarcerated. during interviews, the women expressed that although raising a child in that environment is difficult, it was better than not being with their children. while rocking a baby in her lap, one inmate expressed her frustrations with wee ones but then paused to express gratitude and said, “after all, it’s prison. and prison ain’t supposed to be nice.”21 the ethical issue of autonomy reflects a more difficult dilemma in the prison landscape. iv. counter arguments: do the nursery programs work for the children and the women typically, newborns are taken from their incarcerated mothers within two to three days of birth and sent to live with a relative or placed in foster care. many women are never reunited with their babies. there is much debate over whether the programs are beneficial to the children. one ethical issue is whether children, as innocents, are being punished either by being in the prison system or by being separated from their mothers. skeptics, like james dwyer, have argued against keeping innocent babies in the custody of incarcerated mothers asserting that there is little evidence demonstrating that the programs rehabilitate the women.22 dwyer commented on the “reckless” hopefulness the programs provide: "it might, in fact, be the babies distract them from rehabilitation they should be doing instead. […] they're so focused on childcare and have this euphoria — they think they'll be just fine when they get out of prison and they're not. we just don't know."23 one study showed that 58 percent of incarcerated women are arrested again after release, 38 percent are reconvicted, and 30 percent return to prison within three years.24 dwyer uses this data to argue that the programs are not worthwhile. however, the data is not limited to the special population that had the prison nursery experience. the data applies to all incarcerated women limiting its applicability. more importantly, rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) 4 there is compelling evidence to support prison nursery programs.25 the programs do decrease recidivism26 and prison misconduct,27 and they allow women to create stronger bonds with their children.28 bev little argues that allowing mothers to bond with their babies only delays the inevitable separation and will cause trauma and have other ill effects on the baby. 29 but others feel that stronger maternal-fetal attachment is best for both parties. there is evidence that the bond, once formed, is long-lasting. later in life, there is less drug addiction among children who stayed in the nursery rather than being separated from their mothers.30 another counterargument is that the policies in prison nurseries are not as useful for motherhood outside of the facility; thus, an issue with recidivism occurs because the women are less prepared for motherhood upon release from prison. prison nursery programs establish methods and procedures for successful motherhood that are unique to operation within correctional environments. yet, fortunately, parenting classes offered by prisons and jails emphasize sacrifice, self-restraint, and dedicated attention to the baby. these classes aptly apply to motherhood outside of prison.31 one incarcerated mother experiencing addiction, kima, was described as ambivalent toward her pregnancy. “it’s something about knowing but not knowing that makes me not accountable or makes me think i’m not accountable,” kima shared.32 after the nurse confirmed her pregnancy, she acknowledged fear and knew she would be held accountable to the baby. the occurrence of pregnancy ambivalence is common.33 a study of a population of prisoners from rhode island found that 41 percent of the women expressed ambivalent attitudes about pregnancy. 70 of the women from a population in san francisco expressed ambivalent or negative attitudes towards pregnancy.34 but the ambivalence of some women toward pregnancy is not a reason to prevent women who feel differently from reaping the full benefits of programs that support them during pregnancy. another counterargument is that prison is becoming a comfort that women might seek if they are homeless or housing insecure. for example, evelyn was released from a san francisco jail after being arrested for using cocaine. she was 26 weeks pregnant and had a four-year-old son in the custody of her aunt. following her release, she was homeless and using drugs in the streets. she felt that her only hope of keeping her baby safe was to go back to jail. like kima, she had been in and out of jail from a young age. she grew accustomed to and dependent on the care provided there. while incarceration can provide a home and a nursery, there is no ethical reason to argue for making prison less comfortable by separating babies and children from incarcerated women. instead, these facts suggest we are not doing enough for women outside prisons either. conclusion many experts stress the dearth of research and information on these women and their babies. there is no empirical data to show how big the problem is, but there is evidence that programs providing nursery care for the children of incarcerated women have many benefits. because the research is not largescale enough, many pregnant women in the prison system are ignored. many women give birth in unacceptable conditions, and their children are taken from them the moment the umbilical cord is cut. while the us incarcerates too many women, a movement to expand prison nurseries could help new mothers bond with their children. strong educational programs could aid in lowering the rates of recidivism by providing therapeutic resources for mothers.35 rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) 5 there is a growing problem of mass incarceration in the us as many women are placed in correctional facilities. most of these women are convicted of possession or use of illegal substances.36 many women come from disadvantaged backgrounds, poverty, and have experienced addiction. depriving an expectant mother of adequate care is cruel and irresponsible both to the mother and her innocent child. the criminal justice system is harming children both mentally and physically. reform of the system is needed to provide the basic care those children need. programs like iwp’s wee ones are necessary for physical, psychological, and social development. a program that offers a place for mothers to raise their babies in the community of other mothers would incentivize and facilitate healthy parental habits. further programs for mothers who are released from prison would give them valuable resources to keep them from returning and encourage healthy relationships between the mother and the baby. 1 li, d. k. video allegedly shows woman giving birth in denver jail cell alone, with no assistance. denver: nbc news, 2019. 2 kajstura, aleks. “women's mass incarceration: the whole pie 2019.” prison policy initiative, 29 oct. 2019, https://www.prisonpolicy.org/reports/pie2019women.html. (“including those in prisons, jails, and other correctional facilities.”) 3 swavola, e, k riley and r subramanian. "overlooked: women and jails in an era of reform." vera institute of justice august 2016. 4 sufrin, c. pregnant behind bars: what we do and don't know about pregnancy and incarceration allison chang. 21 march 2019. transcript. 5 sufrin, c., 2019. (suffrin expressed that she had seen such practices firsthand working as an ob/gyn for incarcerated women.) 6 padilla, m. “woman gave birth in denver jail cell alone, lawsuit says,” new york times, sep. 1, 2019. 7 li, d. “video allegedly shows woman giving birth in denver jail cell alone, with no assistance,” nbc u.s. news, apr. 29. 2019. 8 knittel, a. and c. sufrin. "maternal health equity and justice for pregnant women who experience incarceration." jama network open 3.8 (2020). a study in ontario, canada, coincided with a study done in australia. 9 sufrin, c., et al. "pregnancy outcomes in us prisons, 2016–2017." p. 803-804. 10 sridhar, s., r. cornish and s. fazel. "the costs of healthcare in prison and custody: systematic review of current estimates and proposed guidelines for future reporting." frontiers in psychiatry 9.716 (2018). 11 kifer, m., hemmens, c., stohr, m. k. “the goals of corrections: perspectives from the line” criminal justice review. 1 may 2003 12 perry, d. m. "our long, troubling history of sterilizing the incarcerated." the marshall project: sterilization of women in prison 26 july 2017. rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) 6 13 rachel roth & sara l. ainsworth, if they hand you a paper, you sign it: a call to end the sterilization of women in prison, 26 hastings women's l.j. 7 (2015); see skinner v. oklahoma ex rel. williamson, 316 u.s. 535 (1942) (procreation considered a fundamental right; fact pattern of male sterilization in prison based on type of crime.) 14 sufrin, c., m. d. creinin, j. c. chang. “incarcerated women and abortion provision: a survey of correctional health providers.” perspectives on sexual and reproductive health. p. 6-11. 23 march 2009. 15 kasdan, d. “abortion access for incarcerated women: are correctional health practices in conflict with constitutional standards?” guttmacher institute. 26 march 2009. 16 born behind bars. season 1, episode 5, “they can take your baby away,” produced by luke ellis, francis gasparini, & jen wise, aired on 15 nov. 2017 a&e networks 17 bick, j., & dozier, m. (2008). helping foster parents change: the role of parental state of mind. in h. steele & m. steele (eds.), clinical applications of the adult attachment interview (pp. 452–470). new york: guilford press. 18sroufe, l. a., b. egeland, e. a. carlson, w. a. collins. (2005). the development of the person: the minnesota study of risk and adaptation from birth to adulthood. new york: guilford press. 19 goshin, l. s., & byrne, m. w. “converging streams of opportunity for prison nursery programs in the united states.” journal of offender rehabilitation. 15 apr 2009. 20 babies behind bars. dirs. w. serrill and s. o'brien. 2015. another iwp pregnant woman is taylor. at the time of the show, she was pregnant and expecting twins. in interviews throughout the episode, she expressed how her pregnancies in prison had put her in a better mood and felt beneficial to her. she had tried to sign up for the nursery program for her previous pregnancy, but her sentence was too long to get it. her child was sent to live with a caregiver, and when taylor was on probation, taylor’s daughter didn’t want to be around taylor. taylor was so distraught that she messed up and went back, this time, pregnant with twins. after she was reincarcerated, she was able to be accepted into wee ones. she expressed to the camera man that the program might help her feel more like a mother so that when she gets out, she will have someone to care for. taylor, kara, and many other women depend on their children or their pregnancy for a purpose while behind bars. they relied on their babies to be a boon for them. 21 babies behind bars. dirs. w. serrill and s. o'brien. 2015. 22 corley, c. "programs help incarcerated moms bond with their babies in prison." criminal justice collaborative (2018). 23 corley, c. "programs help incarcerated moms bond with their babies in prison." criminal justice collaborative (2018). 24 owen, b. & crow, j. “recidivism among female prisoners: secondary analysis of the 1994 bjs recidivism data set” department of criminology california state university (2006) p. 28 25 prison nursery programs: literature review and fact sheet for ct. diamond research consulting, 2012, www.cga.ct.gov/2013/juddata/tmy/2013hb-06642-r000401-sarah diamond director, diamond research consulting-tmy.pdf. rathke, the women who don’t get counted, voices in bioethics, vol. 7 (2021) 7 26 new york department of correction services (nydocs). (1993). profile of participants: the bedford and taconic nursery program in 1992. albany, ny. department of correction services.rowland, m., & watts, a. (2007). washington state’s effort to the generational impact on crime. corrections today. retrieved september 12, 2007, from http://www. aca.org/publications/pdf/rowland_watts_aug07.pdf. 27 carlson, j. r. (2001). prison nursery 2000: a five-year review of the prison nursery at the nebraska correctional center for women. journal of offender rehabilitation, 33, 75–97. 28 carlson, j.r. 29 little, b. "what happens when a woman gives birth behind bars?" a+e networks, 29 october 2019. <https://www.aetv.com/real-crime/what-happens-when-a-woman-gives-birth-in-jail-or-prison>. 30 margolies, j. k., & kraft-stolar, t. when “free” means losing your mother: the collision of child welfare and the incarceration of women in new york state 1, 9 (correctional association of n.y. women in prison project 2006) 31 sufrin, c. jailcare: finding the safety net for women behind bars. berkeley: university of california press, 2017. 32 sufrin, c. jailcare: p. 155. 33 peart, m. s. & knittel, a. k. “contraception need and available services among incarcerated women in the united states: a systematic review.” contraception and reproductive medicine. 17 march 2020 34 larochelle, f., c. castro, j. goldenson, j. p. tulsky, d.l. cohan, p. d. blumenthal, et al. “contraceptive use and barriers to access among newly arrested women.” j correct health care. (2012) p. 111–119. 35 goshin, l., & byrne, m. (2009). “converging streams of opportunity for prison nursery programs in the united states.” journal of offender rehabilitation. 2009. p.271–295. 36 elizabeth swavola, kristine riley, ram subramanian. overlooked: women and jails in an era of reform. new york: vera institute of justice, 2016. mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) © 2022 suzanne mistretta. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. amending federal regulations to counteract language barriers in the informed consent process suzanne mistretta abstract as english is the predominant language of research protocols in the united states, non -english speaking subjects face language barriers during clinical trial enrollment. federal regulation 45 c.f.r. 46 requires that a research subject receive information about a clinical trial “in language understandable to the subject or the legally authorized representative." a researcher may enroll a subject using short-form consent when a longform translation in the subject’s native language is not available. however, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. united states department of health and human services (hhs) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier. the code of federal regulations should also establish a standard for quality translation services and interpreters. this paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non compliance areas. this author recommends an amendment to federal policy, wh ich is important because it helps ensure the rights of study participants under the principle of justice. keywords: research ethics, language barriers, clinical trials, informed consent introduction as english is the predominant language of research protocols in the united states, non-english speaking subjects face language barriers during clinical trial enrollment. law requires that a research subject should receive information about a clinical trial “in language understandable to the subject or the legally authorized representative.”1 this law states that a researcher may enroll a subject using a “short-form” consent when a “long-form” translation in the subject’s native language is not available.2 however, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. furthermore, the law does not outline a standard for quality translators. united states department of health and human services (hhs) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier.3 the code of federal regulations should also establish a standard for quality translation services and interpreters. this paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non -compliance areas. mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) 2 i. draft guidance in 1995, hhs issued a policy memo clarifying the informed consent process for individuals who do not speak english.4 the policy states that the witness required for the signing of consent documents should be fluent in both languages and that the study team should issue a translated short form.5 the guidance still does not require an official translator in the short-form process. however, if used, the translator may serve as witness as well.6 the policy does not mention the translator’s language proficiency requirements or whether the institution must provide the translator.7 in 2014, hhs issued draft guidance to expand upon the requirements for informed consent. per its disclaimer, the guidance is non-binding and not intended for implementation.8 first, the guidance attempts to clarify the phrase “language understandable”, by adding “the information presented to pote ntial subjects is in a language, and at a level they can comprehend, including an explanation of scientific and medical terms.” 9 the draft guidance also notes that all potential research subjects needing translation might have a low level of health literacy and education. suppose the research subjects expect a non-english speaking group of participants for enrollment. in that case, the guidance suggests that the researchers provide a long-form translation of study materials before an institutional review board (irb) initial review of the “appropriately translated consent documents (i.e., either a long form or a short form with written summary).”10 to satisfy the guidance, researchers would need to provide multiple translations of the same document as the study progresses and the irb proposes edits to the long-form english document. because translating the informed consent forms is costly and time consuming, having a long form available is not always feasible or practical. foreseeing this problem, hhs outlined three steps for what to do when a subject’s language is not expected or planned for in the population. first, the guidance suggests that the investigator “determine that there is sufficient justification to enroll the subject without using a translated long-form to document the subject’s informed consent.” 11 although this provision protects non-english-speaking subjects from uninformed consent, it adds a barrier to enrollment. the investigator must justify the registration of the individual based on the individual’s language. the justification process may delay enrollment, placing individuals at a disadvantage based on their language. if the researcher can adequately justify and use the short -form consent process, the investigator must then translate the long-form consent. after the subject starts participating in research, the investigator then provides the long-form translated document. ii. short form and noncompliance vagueness in the federal regulations has caused disparate interpretation among institutions, leading to noncompliance.12 each institution has its own interpretation of 45 cfr 46, also known as the common rule, which protects vulnerable research subjects and provides research teams with a short -form template.13 as noted above, the regulations do not require a translator, nor do they specify the translator’s specific role or qualifications.14 hhs has not made it clear whether the witness may be a member of the study team or related to the patient, or whether the witness providing interpretation must be independent. furthermore, it is not clear if the witness is overseeing merely the signing of the document or serving as a witness to the informed consent process.15 in review of noncompliance areas, the institution should clarify the use of shortform consent, the witness’s role, and impose qualification requirements for translators.16 each institution will have its own resources and interpretations. therefore, non-english speakers will find different translation quality across many research institutions. an individual may receive a different research experience and quality of language resources based on location and the degree to which their language was expected by the research team. this barrier is an implicit form of discrimination and violates the principle of justice. mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) 3 iii. equitable selection of subjects minority populations are underrepresented in research due to a lack of cultural competence and language barriers to subject recruitment.17 paradoxically, minority populations are most impacted by many of the diseases for which there are clinical trials.18 in 2015, researchers surveyed 10,000 studies registered on clinicaltrials.gov.19 the authors found, “english fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010.”20 researchers who often exclude non-english speaking ethnic minorities claim that diversity may impact whether the studied intervention’s effect is noticed.21 this manipulation of the subject population goes against the principle of justice outlined in the belmont report. of 14,367 clinical research studies registered on clinicaltrials.gov between 2010 and 2020, 18.98 percent required subjects to be fluent in english.22 regulations and institutions do not compel researchers to include non-english speaking subjects; the researcher is not breaking any federal regulations by excluding them. from an ethical standpoint, the deliberate exclusion based on an inability to read/write in english is inequitable and unjust. in 2018, researchers reviewed enrollment rates and staff competency for subject enrollment.23 researchers found low levels of cultural competency among research staff and a misunderstanding of the federal regulations.24 in 2005, researchers reviewed the importance of cultural competency training for healthcare providers. 25 authors synthesized data based on 34 programs and found that competency programs improved provider “knowledge, attitudes, and skills, and patients’ ratings of care.” 26 however, cultural competency programs did not improve or impact patient compliance and health outcomes. 27 authors requested more research to evaluate cultural training’s impact on researcher bias and attitudes toward subject inclusion.28 iv. institutional barriers in 2018, researchers conducted a review of approximately 1,500 clinical trial s at boston children’s hospital and its anesthesia research unit to identify enrollment barriers for non -english-speaking subjects.29 the researchers discovered that the number of potential non-english speaking subjects increased, while the number of studies approved to enroll non-english speaking subjects did not grow at the same rate.30 of 1,492 studies that were open to enrollment between 2011 and 2016, 714 did not allow non -english speaking subjects. 31 the institution cited six barriers to enrollment that precluded these minority -language populations (table 1).32 mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) 4 the barriers described in categories 1, 3, and 5 are due to a lack of translators, funding, or validated translated material. categories 2, 4, and 6 may reflect an implicit bias on the institution’s part and suggest a lack of cultural understanding. some researchers33 called on the institution to increase cultural awareness and to provide resources to address the effects of the language barrier on enrollment. 34 however, with no set standard on the institutional level, it is up to the researchers to address this discrepancy and uphold the principle of justice. the uneven distribution of resources requires the research subjects to counteract their own language barrier. in many clinical cases, as time is of the essence, a person may need to seek several research options before participating in their desired study. until each institution discloses its barriers and noncompliance, we have no way of knowing the full extent of this problem. v. policy recommendations the current hhs regulations and draft guidance are not sufficient to resolve implicit bias and logistical problems that arise when enrolling non-english speaking subjects. hhs should take the following actions. first, hhs should translate short-form consent forms for the most common languages in the us. hhs should then publish the translated documents for use as a template on its website for centers that lack adequate translation resources. second, hhs should create a federal database of qualified translators who meet language proficiency benchmarks established by hhs. individuals listed on this database should provide written translation of study materials and verbal translations during the consent process. the database should contain individuals affiliated and unaffiliated with an institution to track credentials and verify language proficiency. third, hhs should create a federal fund for institutions to draw from when they need resources for long-form translations or translators. hhs should amend the common rule to add specificity. it should define the role of the w itness in the shortform consent process to eliminate unequal interpretations across study sites. second, it should mandate that the irb obtain strong justification for the exclusion of subjects based on english -fluency criteria. third, it should recommend cultural competency programs for investigators at the institutional level. mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) 5 vi. limitations the proposed actions and policy may face objections from the federal government and industry. at the federal level, the government may not have the resources or funding needed to establish a nationwide registry of translators or quality check for fluency. hhs may need to develop a separate office to track these credentials and select a proficiency baseline. perhaps an independent organization should be contracted by the government to perform these quality checks on a regional basis and call on the states to help fund the project. also, the federal government may not have adequate resources to create a national fund for institutional-level translation services. one solution may be to include a flat rate of translation in the site budget during start-up activities. the government would be responsible for translations for governmentsponsored research when the institution cannot feasibly provide a translation. research centers can pull from the translator database for institutional studies if they cannot transla te in-house. for pharmaceutical corporation-led protocols, industry sponsors may not appreciate the added cost of translation. however, by mandating the fee, the government would eliminate systemic discrimination based on english fluency. vii. support researchers should show support for more specific guidance on the institutional level, granted they receive adequate resources to meet the regulations. by clarifying the use of a translator and the role of a witness, and establishing common resources, every institution will benefit. furthermore, it is crucial to hold institutions accountable for supporting cultural competency initiatives. these programs do not need to be intensive or expensive; there are many resources available to the public on websites such as youtube. institutions should make cultural competency programming a mandatory requirement for staff training during the orientation and continuing education. encouraging cultural competency programs will improve provider attitudes and subject treatment. conclusion federal regulations do not require the use of resources when enrolling a subject who is non -english speaking, nor do they mandate the inclusion of “unexpected” populations based on language. lack of clarity and specificity on the federal level places the onus of responsibility on the institution to mitigate language barriers. the lack of universal policy leads to an unequal research experience among institutions and locations. furthermore, clinical trial sponsors may manipulate data based on li miting the study population and engaging in studies that overly represent homogeneous populations. influencing the study population will skew results and will not lead to generalizable knowledge. to uphold the principle of justice, the research community must gather its resources to support non-english speaking subjects who wish to participate in research. 1 “45 c.f.r. 46 faqs,” 45 c.f.r. §46.116 (a)(3), office for human research protections, last modified 2018, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/45-cfr46/index.html#:~:text=basic%20regulations%20governing%20the%20protection,were%20first%20published%20in%201974. 2 office for human research protections, “45 c.f.r. 46 faqs.” 3 “protection of human subjects, 45 c.f.r.§ 46,” united states department of health and human services, last modified 2018, https://www.ecfr.gov/cgibin/retrieveecfr?gp=&sid=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=part&ty=html. 4 office for human research protections, 45 c.f.r. §46.117(b)(2), “45 c.f.r. 46 faqs.” 5 the researcher can orally present the information to the subject or lar, with a witness present, and provide a short-form of consent with a brief written summary of the research. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/45-cfr-46/index.html#:~:text=basic%20regulations%20governing%20the%20protection,were%20first%20published%20in%201974 https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/45-cfr-46/index.html#:~:text=basic%20regulations%20governing%20the%20protection,were%20first%20published%20in%201974 https://www.ecfr.gov/cgi-bin/retrieveecfr?gp=&sid=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=part&ty=html https://www.ecfr.gov/cgi-bin/retrieveecfr?gp=&sid=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=part&ty=html mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) 6 6 “informed consent of subjects who do not speak english,” office for human research protections, last modified february 25, 2016, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-englishspeakers/index.html. 7 lad, pramod m., and rebecca dahl. "overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the ‘short form.’” accountability in research 21, no. 5 (2014): 315-320. https://doi.org/10.1080/08989621.2013.848801. 8 “informed consent information sheet guidance for irbs, clinical investigators, and sponsors draft guidance,” office of the commissioner, last modified 2014, https://www.fda.gov/media/88915/download. 9 office of the commissioner, “informed consent information sheet guidance.” 10 office of the commissioner, “informed consent information sheet guidance.” 11 office of the commissioner, “informed consent information sheet guidance.” 12 lad and dahl, “regulatory and compliance issues.” 13 lad and dahl, “regulatory and compliance issues.” 14 lad and dahl, “regulatory and compliance issues.” 15 lad and dahl, “regulatory and compliance issues.” 16 lad and dahl, “regulatory and compliance issues.” 17 staples, jeanine n. et al., "language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low english fluency patients." applied cancer research 38, no. 1 (2018): 1-7. https://doi.org/10.1186/s41241-018-0065-9. 18 staples et al., “language as a barrier.” 19 egleston, brian l. et al., "characteristics of clinical trials that require participants to be fluent in english." clinical trials 12, no. 6 (2015): 618-626. https://doi.org/10.1177/1740774515592881. 20 egleston et al., “characteristics of clinical trials.” 21 egleston et al., “characteristics of clinical trials.” 22 muthukumar av, morrell w, bierer be (2021) evaluating the frequency of english language requirements in clinical trial eligibility criteria: a systematic analysis using clinicaltrials.gov. plos med 18(9): e1003758. https://doi.org/10.1371/journal.pmed.1003758 https://doi.org/10.1080/08989620600654043. 23 staples et al., “language as a barrier.” 24 staples et al., “language as a barrier.” 25 beach, mary catherine et al., "cultural competency: a systematic review of health care provider educational interventions." medical care 43, no. 4 (2005): 356. https://doi.org/10.1097/01.mlr.0000156861.58905.96. 26 beach et al., “cultural competence,” 8. 27 beach et al., “cultural competence,” 8. 28 beach et al., “cultural competence,” 8. 29 bernier, rachel et al., "inclusion of non‐english‐speaking patients in research: a single institution experience." pediatric anesthesia 28, no. 5 (2018): 415-420. https://doi.org/10.1111/pan.13363. 30 bernier et al., “inclusion of non-english-speaking patients.” https://doi.org/10.1080/08989621.2013.848801 https://www.fda.gov/media/88915/download https://doi.org/10.1186/s41241-018-0065-9 https://doi.org/10.1177/1740774515592881 https://doi.org/10.1097/01.mlr.0000156861.58905.96 https://doi.org/10.1111/pan.13363 mistretta, amending federal regulations to counteract language barriers, voices in bioethics, vol. 8 (2022) 7 31 bernier et al., “inclusion of non-english-speaking patients.” 32 bernier et al., “inclusion of non-english-speaking patients.” 33 lad and dahl, “regulatory and compliance issues.” 34 bernier et al., “inclusion of non-english-speaking patients.” abstract introduction kirkwood, when research serves good purposes, voices in bioethics, vol. 7 (2021) * kenneth kirkwood, phd western university © 2021 kenneth kirkwood. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. when research serves good purposes: three additional considerations to determine the ethical use of ill-gotten research kenneth kirkwood* keywords: research ethics, unethical experiments, exploitation, experiments, methodology, atrocity introduction it is a classic ethical dilemma to have something of potential value that comes at a tremendous cost to others.1 to access the good, you must have the bad. for decision-makers, it becomes an onerous task of deciding if they would deny the world something 'good' or create something bad to achieve the good. weighing the two possible outcomes has proven timelessly frustrating to those well-intentioned people who wish to "do the right thing." medical research has yielded data derived from unethical situations wherein research participants were vulnerable and whose consent was questionable, absent, or not sought. the rules currently governing research allow for broad use of ill-gotten data. while providing a deterrent to unethical research practices, stricter rules still would allow some use of data. this paper argues the permissibility depends primarily on the nature of the unethical data collection and the potential benefits. analysis the american medical association (ama) places additional obligations on researchers who utilize data obtained from unethical experiments. the code of medical ethics opinion 7.2.2 2 recommends that researchers and peer reviewers should take the following steps to best handle such data: (a) disclose that the data derived from studies do not meet contemporary standards for the ethical conduct of research. (b) clearly describe and acknowledge the unethical nature of the experiment(s) from which the data are derived. (c) provide ethically compelling reasons for which the data are being released or cited, such as the need to save human lives when no other relevant data are available. (d) pay respect to those who were the victims of the unethical experimentation. kirkwood, when research serves good purposes, voices in bioethics, vol. 7 (2021) 2 the ama does not go far enough to protect past research victims or prevent future research ethics violations. three additional considerations beyond the limitations offered by the apa are needed for ethical use of the data: who collected the data and ran the experiments, who would benefit from the data, and how much additional benefit would ensue from its use. a specific focus on data generated by nazis whose research subjects were imprisoned in concentration camps highlights the ethical challenge. i. who created the data? medical research generated during the holocaust subjected innocent people to torture in the name of science. arguments can be made against the use of such data on the grounds that using the data represents a further indignity to those who suffered such horrific conditions and persecution. however, some of the data that emerged out of the holocaust was not created by oppressors at the expense of the oppressed. rather it grew out of the horrific conditions and was amassed by fellow prisoners. one prominent example is myron winick's work on hunger and disease, which edited the detailed records of jewish physicians working in the warsaw ghetto, who traced the progression of starvation in stunning detail.3 one obvious difference is that the jewish physicians were not responsible for the conditions under which the data was gathered. but if we ask ourselves if their work represents a further indignity to those who had their starvation documented, the answer is not so clear. in this way, it is important to determine the explicit purpose of medical research as opposed to data generation as one aspect of the violation. to record the medical symptoms of a 'subject' who is, as you are, a victim of the circumstances with no other recourse, is different in kind from 'subjecting' a person to the condition in the first instance. therefore, an analysis of the person doing the research provides an added limitation on using research performed by an oppressor yet allows some lenience for research by fellow victims. research performed by oppressors must have a significantly higher marginal benefit over other available or collectable data. ii. who gains from the data? is it of sufficient benefit? (an effort to expand part c of the ama unethical experimentation rules) in the spirit of contrition and commitment to the truth of historical ignominies, such as the holocaust, the ama created these best practices for physicians dealing with any ill-gotten data. in the case of the holocaust, the period that has passed since 1945 would suggest that most, if not all, perpetrators of this research are deceased. however, prior to using data, modern researchers should ensure that there is no gain to be had on the part of the families of the perpetrators. when a large organization can offer mea culpa and seemingly genuine pledges toward reconciliation while still enjoying the advantages gained over others by virtue of their wrongdoing, it undermines sincerity, creates an incentive for more researchers to engage in unethical data collection, and would be an injustice to the relatives of victims. this matter may become more relevant going forward as private ownership and patents could play a role in sustaining the fiscal or reputational benefits to those who conduct science devoid of ethics. the belmont report lays out a risk-benefit equation which states that research that posed significant risks to the participants must also carry sufficient benefits to those who take risks. this element suggests two aspects that speak to the "justness" of a research project: first, a balance must be struck between potential harms and potential benefits; second, those who took risks must not be precluded from accessing the benefits of the products a successful trial would create.4 kirkwood, when research serves good purposes, voices in bioethics, vol. 7 (2021) 3 researchers must evaluate whether the data is both scientifically valid and usable from a methodological point of view, but also if what the use of the data promises is sufficiently compelling to benefit the progress of science. second, the data must refer to some aspect of human health or illness, the amelioration of which would create an empirical improvement to all social and economic classes of humanity. the social justice issues embedded in the ethical use of the data are overlooked by the ama. while the ama suggests saving human lives makes the use of ill-gotten data acceptable, it fails to address any effort to make up for the wrongdoing. examples of added considerations could be the use of the research to benefit people who were research subjects or their descendants or a broader race or ethnic group that was victimized. examples of groups subjected to unethical research in the 20th century include residential schools for aboriginal canadians,5 senior citizens,6 and typically, members of socially deprived and undervalued populations.7 the more reliable scientific data that emerged from nazi experimentation is in the areas of hypothermia,8 malnutrition and starvation,9 and anatomical studies.10 it is impossible to justify the use by the ama criteria alone. if the research benefited relatives and descendants of nazi prisoners or the broader marginalized community of which they belonged, its use might be considered ethical if there were no other way to obtain comparable data. the value and impact of nazi science is minimal at this point, with much more reliable data available, but this type of transgression continues. there are modern examples of data procured in breach of ethics that still lend themselves to this question. conclusion these suggestions would add complexity and substance to the ama's code of medical ethics opinion. beyond that scope, the considerations offered here would contribute to a stronger statement about the obligations and prohibitions in circumstances in which data was wrongfully collected. too often, one could default to a brash 'means-to-an-ends' approach, especially when issues of funding and measured productivity come into the equation. the considerations here recognize that data gathered during the holocaust is particularly sensitive. by eliminating any encouragement of unethical practices, a stricter test for the use of ill-gotten research is a deterrent but recognizes that sometimes the benefits call for the use of the research. the considerations also recognize that one legacy of such data is to create good in the modern-day, even as we recognize the shameful context of its creation and existence. 1 marcus, ruth b; moral dilemmas and consistency. journal of philosophy. 1980;77(3):121-136. 2 american medical association. opinion 7.2.2 release of data from unethical experiments code of medical ethics. https://www.ama-assn.org/delivering-care/ethics/release-data-unethical-experiments. accessed january 3, 2021. 3 winick, 1979. 4 freedman, b. scientific value and validity as ethical requirements for research: a proposed explanation. irb: rev hum subj res. 1987;17(6):7-10. 5 mosby, i. administering colonial science: nutrition research and human biomedical experimentation in aboriginal communities and residential schools, 1942–1952. histoire sociale/social history. 2013;46(91): 615-642. 6 beecher, h. ethics and clincial research. n engl j med. 1966;274:1354-1360 7 rawlinson, p. of mice and men: violence and human experimentation. state crime journal. 2013;2(1):72-90. 8 fernardez, j.p. et al; rapid active external rewarming in accidental hypothermia. jama.1970;212:153 kirkwood, when research serves good purposes, voices in bioethics, vol. 7 (2021) 4 9 winick, m. (ed.). hunger disease. new york, ny: wiley; 1979. 10 norton, s.a.; on first looking into pernkopf's atlas (part 1). arch dermatol. 2001;137:549-551 kang, to abort or not to abort, voices in bioethics, (2013) © 2013 jane kang. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. to abort or not to abort: that is the question in south korea jane kang keywords: abortion, south korea, policy introduction the debate over abortion and contraception continues to this day, even here in the united states. 1,2 however, unlike the united states, there are some countries where abortion is illegal. one of those countries is south korea. although abortions are illegal in south korea (except in certain circumstances), they are not a rare occurrence. for several reasons, legalizing abortion in south korea has recently been a topic of great debate. korean women have expressed their desire to legalize abortion, yet the government, the social expectations of women, and some groups in the medical community hinder them from having this right to choose and being in charge of their own reproductive capability. analysis an anti-abortion government in 1953, the korean criminal code made abortions illegal. in 1973, the maternal and child health act allowed doctors to perform abortions within the first 28 weeks of pregnancy in cases of rape or incest, when a woman’s health is in danger, or when a pregnant woman or her spouse has certain communicable or hereditary diseases. in 2009, the abortion law in south korea was revised so that the deadline for a legal abortion was moved from 28 weeks to 24 weeks, and certain diseases (such as viral hepatitis) were removed from the list of accepted reasons for abortion. in late 2009, a report on declining birth rates was released by the presidential council for future & vision. in the council’s report, various suggestions for increasing the birth rate were proposed, one of them being an anti -abortion campaign. at this point, the debate on abortion became much more heated, and legislators were motivated to stringently enforce punishments for illegal abortions.1 unlike in the united states, the issue of abortion has not been politically charged in south korea, until 2010. there was even an article in the new york times around this time, discussing the growing and intensifying debate in south korea.2 in january 2010, president lee myung bak scheduled public hearings to discuss a revised abortion law. the government also ran a campaign to discourage abortions. subway ads stated, “with abortion, you are aborting the future.” in the past, the government provided family planning services free of charge. due to a significant decrease in fertility rates, the government now charges fees for family planning services, hoping this will discourage couples from practicing any form of birth control.3 if a woman gets an illegal abortion, she could be sentenced to prison for up to a year and fined the equivalent of about $2,000. a physician who performs an illegal abortion could be punished with up to two years in prison, although if the woman was harmed from the abortion, the sentence could be up to three y ears; if the woman died, the sentence could be up to five years. in addition, a physician can lose his or her license for up to seven years. 3 kang, to abort or not to abort, voices in bioethics, (2013) 2 although these laws are in place, these punishments are rarely enforced. from the early 1960s to late 1990s, the korean government actually encouraged women to get abortions to prevent overpopulation. the korean government no longer encourages abortions, but the abortion rate seems to have increased substantially. since many abortions go unreported, the actual abortion rate is likely higher. since 1971, the korea institute for health and social affairs (kihasa) has attempted to estimate the rate of induced abortion. the kihasa does this every three years by using the national family health and fertility survey. in 2006, the estimated rate of induced abortion in south korea was 105 cases per 1,000 married women aged 15 to 44 years.3 since this survey included only married women, it underestimates the rate of induced abortions in other groups of women, such as single wome n or teenagers. this seems to emphasize the government’s implicit disapproval of premarital sex, which is in line with societal prejudices. because induced abortions are illegal in korea (except in a few special cases, as noted), and reporting is not mandatory, it is difficult to estimate the number of abortions performed yearly. ahn and colleagues published an article in 2012 that gives estimates of induced abortions in south korea. they surveyed 25 hospitals and 176 private clinics in 2005 and found that an estimated 342,433 induced abortions were performed in south korea (rate of 29.8 per 1000 women aged 15 to 44 years). they found that the abortion rate was slightly higher in women who were single (31.6 per 1000 women) versus married (28.6 per 1000 women).5 south korea is thought to have one of the highest abortion rates in the world. there are many reasons for this, but one important issue is the stigma associated with taking oral contraceptive pills (ocps), particularly for unmarried women. therefore, korean women may use abortion as a form of birth control rather than preventing pregnancy with ocps. stigma associated with oral contraceptive use negative attitudes toward contraception are still prevalent in many countries. in asian countries the use of ocps is very low, with only 1.8 percent of married korean women reporting use of ocps. oral contraceptives have been the least preferred method of contraception in korea despite their availability without a prescription (as of last year, ocps are no longer available over the counter, however).4 there are many reasons that contribute to this, including the belief that ocps are not safe, and women not having adequate or accurate information about them. what is encouraging is that the more knowledgeable young korean women are about ocps, the more positive attitudes they have toward using them.5 overall, ocp use is increasing as well. however, it seems that young adults need to be better informed about contraception. a study of college students in korea found th at they generally lacked knowledge regarding emergency contraceptive pills (ecp) and had misconceptions about their safety. of these college students, 76.3 percent of them had heard of ecps, and of sexually active students 13.2 percent of them used ecps.6 additionally, a large reason for the hesitance in using oral contraceptives is the stigma associated with taking ocps. the societal assumption is that a single or unmarried woman should not need ocps because she should not be sexually active. many korean women also believe that ocp use is appropriate only for married women. therefore, a single or unmarried woman asking for ocps is viewed negatively, which can discourage her from obtaining them. to complicate matters, on may 7, 2012, the korean food and drug administration (kfda) announced that ocps, which used to be available over the counter, now must be obtained with a prescription. this makes them even more inaccessible for korean women, since they usually do not see a gynecologist on a regular basis. on the other hand, emergency contraception, or the morning-after-pill, is now available over the counter. however, emergency contraception is a less effective way of preventing pregnancy and can cause more side effects, compared to ocps. if taking oral contraceptives as an unmarried woman is considered shameful in south korea, therefore hindering them from obtaining ocps (women have blogged about how some pharmacists make ethical judgments about them when they ask for oral contraceptive medication), then more women will have unintended pregnancies kang, to abort or not to abort, voices in bioethics, (2013) 3 if they are unable to get an abortion. since abortions are illegal in south korea (except in rare circumstances), this only adds to the problem. the reproductive rights of korean women are seriously undermined, since they may face cultural scorn if they use oral contraception, but are not allowed to undergo a legal abortion, except in a few rare instances. still, many women in korea illegally use abortion as the primary method of birth control. the kfda’s decision to make ocps available only by prescription will further hinder south korean women’s access to ocps. views of the medical profession the medical profession in korea may also be indirectly (or directly) encouraging some of the culturally accepted beliefs about appropriate ocp use. most of the ocp-related research is done with married women. additionally, physician-based anti-abortion organizations have recently formed; they use ethical principles rather than low birth rates or religion to support their arguments. one such organization, known as gynob, was formed in october 2009. in 2010, there were 680 obstetricians and gynecologists in this organization. one of the objectives of this group is to end all abortions in korea, except for those that are needed to sav e the mother’s life. in december 2009, another anti-abortion physician group was formed, called the korean prolife doctors association. it is not completely clear if korean physicians’ reluctance to perform abortions is contributing to the availability of abortions in korea. unfortunately, the director of the korea sexual violence relief center noted that of the women who came to the center for counseling, many were denied abortions (even in one rape case). 3 the korean association of obstetrics and gynecologists, on the other hand, is opposed to gynob's objectives, fearing that if all abortions are made illegal, then there will be a rise in unsafe abortions, which could endanger the health of mothers, and in the number of abandoned children. it seems that th e medical profession in korea is very much divided on this issue as well. conclusion women in south korea are not given the right to choose to have an abortion; yet because of cultural stigma or fear of societal scorn, they may be less likely to use ocps t o prevent pregnancy. additionally, the kfda recently decided to make ocps available by prescription only, which will only further discourage the use of them. by avoiding the use of ocps, women then rely on induced abortion as their main form of birth control. if they are unable to receive an abortion (either legally or illegally), then they are basically forced to carry their pregnancy to term. this is especiall y damaging for an unmarried woman in korea, since having a child outside of marriage is perceived as shameful. although ecps are now available over the counter, it is not yet clear what effect this will have on the rates of induced abortions or unintended pregnancies. if society does not allow women to freely use ocps without fear of being judged or m arginalized, then abortion should be made legal. alternatively, societal beliefs could be changed, but it could take generations for them to evolve. allowing abortions may be the easiest way to preserve south korean women’s reproductive rights. providing a safe, nonjudgmental, and easily accessible way of providing oral contraception could be another option. the kfda’s recent decision to make ocps unavailable over the counter has made the latter option more difficult. currently, it seems that the government and society are viewing south korean women more as bearers of children than as individuals with reproductive rights. the beliefs that society imposes on them only restrict women’s rights to reproductive choice. south korean women today are cornered with no real choices—or are faced with very difficult ones. 1trubek, louise, “the unfinished fight over contraception” the new york times, march 1, 2012, http://www.nytimes.com/2012/03/02/opinion/contraception-war-goes-on.html. kang, to abort or not to abort, voices in bioethics, (2013) 4 2pear, robert, “senate rejects step targeting coverage of contraception,” the new york times, march 1, 2012, http://www.nytimes.com/2012/03/02/us/politics/senate-kills-gop-bill-opposing-contraception-policy.html. 3wolman, andrew, “abortion in korea: a human rights perspective on the current debate over enforcement of the laws prohibiting abortion,” the journal of international business and law 9, no.1 (spring 2010): 153-174. 1 choe, sang-hun, “south korea confronts open secret of abortion,” the new york times, january 5, 2010, http://www.nytimes.com/2010/01/06/world/asia/06korea.html. 4ahn hs, seol hj, lim je, et al., “estimates of induced abortion in south korea: health facili ties survey,” j obstet gynaecol res 38, no.1 (january 2012): 324-8. 5 lee j, jezewski ma, “attitudes toward oral contraceptive use among women of reproductive age: a systematic review,” ans adv nurs sci 30, no.1 (january-march 2007): e85-103. 6lim h, cho y, “a study on knowledge and attitude about oral contraceptives in university students,” j korean community health nurs acad soc 16, no.2 (2002): 412–422. 7kang hs, moneyham l, “use of emergency contraceptive pills and condoms by college students: a survey,” int j nurs stud 45, no.5 (may 2008): 775-83. http://www.ncbi.nlm.nih.gov/pubmed?term=%22lee%20j%22%5bauthor%5d http://www.ncbi.nlm.nih.gov/pubmed?term=%22jezewski%20ma%22%5bauthor%5d http://www.ncbi.nlm.nih.gov/pubmed?term=%22kang%20hs%22%5bauthor%5d http://www.ncbi.nlm.nih.gov/pubmed?term=%22moneyham%20l%22%5bauthor%5d introduction analysis conclusion barrett, negotiating democracy and deontology, voices in bioethics, vol. 6 (2020) * tyler barrett, ms, mps © 2020 tyler barrett. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. negotiating democracy and deontology in a pandemic: consequentialism and the impetus to vote tyler barrett* keywords: deontology, utilitarian, consequentialism, voting, voting ethics, covid-19, usps, mail-in voting i. introduction citizen change, a celebrity-led, nonpartisan voter engagement campaign popularized the slogan “vote or die.” this coarse directive was intended to evoke an urgent sense of duty for democratic participation.1 the phrase represents deontological (or duty-based) ethics applied to democracy, and it is poorly suited for application during a deadly pandemic. this paper argues that deontological appeals for democratic participation are inappropriate during the covid-19 pandemic. instead, voters should consider consequentialist rationales for voting. ii. covid-19’s effect on american democracy from march 2020, many primary voters in the united states faced an unforeseen dilemma: to risk exposure and transmit a potentially fatal virus or eschew participation in the democratic process. due to the rapid spread, some states were unequipped or unwilling to postpone primaries and provide alternatives to traditional in-person voting.2 contact tracing research shows that polling places can significantly spread the barrett, negotiating democracy and deontology, voices in bioethics, vol. 6 (2020) 2 virus.3 in the run-up to the 2020 general election, some states have expanded access to mail-in voting. still, significant challenges persist. nearly a quarter of the american population is ineligible to use covid-19 as a reason for voting by mail, meaning they will have to vote in person.4 of those who are eligible to vote by mail, various barriers exist such as the need to request an absentee ballot and the uncertainty of safe and on-time delivery.5 politicization of the push for mail-in voting has led to an erosion of trust in the united states postal service (usps) and its ability to protect voting integrity .6 iii. voting as a categorical imperative the use of deontology as a guide to ethical decision-making derives in large part from the categorical imperative articulated by immanuel kant. the categorical imperative is a moral obligation that can be universally applied, independent of outcome.7 thus, participants in a democracy vote not because they are convinced that it will have a particular effect, but because it is a universal duty. it is the right thing to do. further, an action deemed necessary as a categorical imperative would encourage others to do the same. a deontological argument for voting concludes that accepting the duty of democratic participation is important because it would be immoral to abstain, yet expect others to uphold the democracy.8 to this end, american democracy has a history of deontological efforts to instill the duty of voting, from nonpartisan voter engagement campaigns to lobbying efforts for compulsory voting.9 defining voting as a civic duty may also solve the rational choice conundrum that questions why people vote believing their vote may be insignificant.10 during the covid-19 pandemic, public health efforts have sought to instill a duty to halt its spread through directives to stay home and avoid contact with others.11 this competing deontology may in some cases be mutually exclusive with that of democratic duties, and alternative frameworks can provide decisional clarity. iv. consequentialism as an alternative to democratic deontology opposite duty-based arguments for decision-making are those based on consequentialism, the theory that the intended or actual results of an action are what determines whether or not the action is ethical.12 given the competing and in some cases, mutually exclusive interests of health versus participation in a functioning democracy during the covid-19 pandemic, consequentialist reasoning offers voters a more flexible approach to decision-making. voters have the option to vote in person, to vote absentee by mail, or not to vote. the deontological argument for voting removes the third option so a voter is left with options that could expose the voter, fellow citizens, and those handling ballots to the virus. consequentialist reasoning considers factors that deontological arguments ignore: whether voting is worth potentially sacrificing health, how likely voting is to affect an outcome or produce change, how significant the health risks are in a particular setting, and how risk is mitigated. a consequentialist approach to democratic engagement also allows a voter to evaluate the utility of potential results. if voters are highly vulnerable to covid-19 and lack access to a safe polling place, arguably they should consider not voting, especially if their only concern is the presidential election and if their state’s electoral college history demonstrates entrenchment that would either already lead to their candidate winning or disenfranchise them as voters. states like mississippi, louisiana, and south carolina have unhealthy populations and election commissions that have not widely instituted safe voting measures.13 absent any barrett, negotiating democracy and deontology, voices in bioethics, vol. 6 (2020) 3 widespread vaccination, a duty-based approach to voting may lead voters to take an undue risk of harm with little benefit or influence over the outcome of the election. because of its asymptomatic spread, even voters thought to be low-risk may need to consider the possibility of spreading the virus to those that are more vulnerable. a nursing home worker must evaluate a different set of consequences than a graphic designer. conversely, individuals may find that the consequences of abstention are greater than the perceived risks of voting. voters may consider the potential political harm from inaction or the possibility that their vote could help decide a close race or ballot measure. in swing states, the harm of not voting could outweigh the risks. consequentialism allows individuals to distinguish varying degrees of significance a course of action may have. arguments for a deontological approach to voting may rightly point out that few elections are without flaw or susceptibility to risk of some kind. even those voting electronically may be vulnerable to hacking. however, the challenges incurred due to the magnitude and severity of the covid-19 pandemic require layers of reasoning more suited for consequentialism than duty-based ethics. even a consequentialist approach that assesses voting as too risky does not necessitate political inaction. abstaining voters in states that have not made mail-in voting widely available can participate in other forms of democratic participation, including mobilizing fellow citizens through phone or email and petitioning the government for safer electoral measures. such action could have positive outcomes that extend beyond the immediate push for a more accessible democracy. in swing states, greater political consequences demand prioritizing participation. v. conclusion the covid-19 pandemic has presented unforeseen complications to democracy, resulting in practical challenges and moral dilemmas. in many states, potential voters face a decision that could affect not only their own health but the health of their community and democracy. voters should be able to consider each factor and the respective risks involved alongside their own values before making a decision. the blanket rigidity of a “vote or die” mentality or any such deontological democratic command is unsuitable in the time of a deadly pandemic. consequentialist approaches that consider the potential outcomes of a voter’s preferences, circumstances, health, and risk assessment offer more flexible guidance for ethical decision making. 1 drake, latoya. "commodification of voting: celebrity, spectacle and social movements." master’s thesis, georgetown university, 2006. https://repository.library.georgetown.edu/bitstream/handle/10822/551593/etd_lfd.pdf?sequence=4&isallowed=y 2 rakich, nathaniel. “there have been 38 statewide elections since the pandemic. here’s how they went.” fivethirtyeight. august 3, 2020. https://fivethirtyeight.com/features/there-have-been-38-statewide-elections-during-the-pandemic-heres-how-theywent/ https://repository.library.georgetown.edu/bitstream/handle/10822/551593/etd_lfd.pdf?sequence=4&isallowed=y https://fivethirtyeight.com/features/there-have-been-38-statewide-elections-during-the-pandemic-heres-how-they-went/ https://fivethirtyeight.com/features/there-have-been-38-statewide-elections-during-the-pandemic-heres-how-they-went/ barrett, negotiating democracy and deontology, voices in bioethics, vol. 6 (2020) 4 3 cotti, chad d., bryan engelhardt, joshua foster, erik t. nesson, and paul s. niekamp. the relationship between in-person voting, consolidated polling locations, and absentee voting on covid-19: evidence from the wisconsin primary. no. w27187. national bureau of economic research, 2020. https://www.nber.org/papers/w27187 4 love, juliette, matt stevens, and lazaro gamio. “where americans can vote by mail in the 2020 elections.” the new york times. august 14, 2020. https://www.nytimes.com/interactive/2020/08/11/us/politics/vote-by-mail-us-states.html 5 love, et al. 6 levine, sam. “trump’s usps attacks are already undermining confidence in vote by mail. the guardian. august 20, 2020. 7 kant, immanuel. groundwork for the metaphysics of morals. translated by allen w. wood. new haven: yale university press, 2002. 8 “is it irrational to vote?” the economist. october 23, 2012. https://www.economist.com/democracy-in-america/2012/10/23/isit-irrational-to-vote 9 working group on universal voting. “lift every voice: the urgency of universal civic duty voting.” brookings institute. (2020). https://www.brookings.edu/wp-content/uploads/2020/07/br_lift_every_voice_final.pdf 10 goldfarb, robert s., and lee sigelman. "does ‘civic duty’ ‘solve’ the rational choice voter turnout puzzle?" journal of theoretical politics 22, no. 3 (2010): 275-300. 11 nixon, nicole. “california may be flattening its coronavirus curve, but officials say social distancing still a ‘civic duty.” capradio. april 1, 2020. https://www.capradio.org/articles/2020/04/01/watch-live-gov-gavin-newsom-update-on-covid-19/ 12 sinnott-armstrong, walter. "consequentialism." in stanford encyclopedia of philosophy. revised june 3, 2019. https://stanford.library.sydney.edu.au/entries/consequentialism/ 13 america’s health rankings annual report 2019. united health foundation in partnership with the american public health association. (2019). https://assets.americashealthrankings.org/app/uploads/ahr_2019annualreport.pdf https://www.nber.org/papers/w27187 https://www.nytimes.com/interactive/2020/08/11/us/politics/vote-by-mail-us-states.html https://www.economist.com/democracy-in-america/2012/10/23/is-it-irrational-to-vote https://www.economist.com/democracy-in-america/2012/10/23/is-it-irrational-to-vote https://www.brookings.edu/wp-content/uploads/2020/07/br_lift_every_voice_final.pdf https://www.capradio.org/articles/2020/04/01/watch-live-gov-gavin-newsom-update-on-covid-19/ https://stanford.library.sydney.edu.au/entries/consequentialism/ https://assets.americashealthrankings.org/app/uploads/ahr_2019annualreport.pdf poutoglidou, fraud and deceit in medical research, voices in bioethics, vol. 8 (2022) *associated with department of clinical pharmacology, school of medicine, aristotle university of thessaloniki, thessaloniki revised sept. 27, 2022. © 2022 poutoglidou et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. fraud and deceit in medical research: insights and current perspectives frideriki poutoglidou, marios stavrakas, nikolaos tsetsos, alexandros poutoglidis, aikaterini tsentemeidou, georgios fyrmpas, petros d. karkos* abstract the number of scientific articles published per year has been steadily increasing; so have the instances of misconduct in medical research. while increasing scientific knowledge is beneficial, it is imperative that research be authentic and bias-free. this article explores why fraud and other misconduct occur, presents the consequences of the phenomenon, and proposes measures to eliminate unethical practices in medical research. the main reason scientists engage in unethical practices is the pressure to publish which is directly related to their academic advancement and career development. additional factors include the pressure to get research funds, the pressure from funding sources on researchers to deliver results, how scientific publishing has evolved over the years, and the over-publication of research in general. fraud in medical research damages trust and reliability in science and potentially harms individuals. keywords: fraud, misconduct, undue influence, research ethics, publish, unified patient lobby introduction since the introduction of evidence-based medicine (ebm) in the early 1990s, scientific articles published per year have increased steadily. no one knows the exact number of scientific articles published per year, but several estimates point to around 2,000,000.1 ebm aims to integrate the clinical experience and the best available scientific knowledge in managing individual patients. 2 the ebm model is based on the accumulation of as much clinical and research data as possible, which has propelled a significant rise in research. unfortunately, its incentive structure has also led to a rise in research misconduct. “fraud in science has a long history.”3 cases of misconduct began to surface in the late 1980s and increased during the 1990s. experts suggest that today fraud is “endemic in many scientific disciplines and in most countries.” 4 in recent reporting, the majority of cases of scientific fraud involved falsification and poutoglidou, fraud and deceit in medical research, voices in bioethics, vol. 8 (2022) 2 fabrication of the data, while plagiarism was much less frequent. 8 percent of scientists and 10 percent of medical and life-sciences researchers admitted to falsifying data at least once between 2017 and 2021 in a dutch study of 6,813 researchers, while more than half engaged in at least one questionable research practice. 5 questionable research practices include research design flaws or unfairness in decisions surrounding publication or grants.6 in an older study, closer to 2 percent of those surveyed reported having engaged in falsification or fabrication,7 while in a more recent survey of 3,000 scientists with nih grants in the united states, 0.3 percent of the scientists responding admitted fabricating research data and 1.4 percent of them admitted plagiarizing. 8 these numbers are almost certainly not reflective of the true incidence of fraud as many scientists admitted that they engaged in a range of behaviors beyond fabrication, falsification, and plagiarism that undermine the integrity of science, such as changing the results of a study under pressure from a funding source or failing to present data that contradicts one’s previous research. it is also unclear whether surveys are the best method to investigate misconduct because a scientist answering the survey may be unsure of anonymity and may not be truthful. this article explores why misconduct occurs, presents the consequences, and proposes measures to eliminate unethical practices in medical research. in the 1999 joint consensus conference on misconduct in biomedical research, “scientific fraud” was defined as any “behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards.”9 analysis i. the scientific publishing landscape there are several reasons scientists may commit misconduct and engage in unethical practices. there is an increasing pressure to publish, which the motto "publish or perish reflects.” 10 the number of scientific papers published by a researcher is directly related to their academic advancement and career development. similarly, academic institutions rely on scientific publications to gain prestige and access research grants. pressure to get research grants may create environments that make it challenging to research integrity. researchers are often tempted to alter their data to fulfill the desired results, separately report the results of one research in multiple end publications, commonly referred to as “salami publication,” or even simultaneously submit their scientific articles to more than one journal. this creates a vicious cycle in which the need for funding leads to scientific misconduct, which in turn secures more research funding. meanwhile, the pressure from the funding sources cannot be overlooked either. although researchers must report the role of the funding sources, selection and publication bias often may advantage articles that support the interests of the financial sponsor. disclosure does not alter the conflict of interest. the growing number of scientific articles published per year has practically overwhelmed the pee r-review system. manuscript submissions are often reviewed superficially or assigned to inexperienced reviewers; therefore, misconduct cases may go unnoticed. the rise of “predatory” journals that charge authors publication fees and do not review work for authenticity and the dissemination of information through preprints has worsened the situation. the way that profits influence scientific publishing has very likely contributed to the phenomenon of misconduct. the publishing industry is a highly profitable business.11 the increased reliance on funding from sources that expect the research to appear in prestigious, open-access journals often creates conflicts of interest and funding bias. on the other hand, high-impact journals have not given space to navigate poutoglidou, fraud and deceit in medical research, voices in bioethics, vol. 8 (2022) 3 through negative results and previous failures. nonsignificant findings commonly remain unpublished, a phenomenon known as “the file drawer problem.” scientists often manipulate their data to fit their initial hypothesis or change their hypothesis to fit their results, leading to outcome-reporting bias. ii. misconduct concerning the reporting and publishing data the types of misconduct vary and have different implications for the scientist’s career and those relying on the research. for example, plagiarism is generally not punished by law currently unless it violates the original author’s copyright. nevertheless, publishers who detect plagiarism implement penalties such as rejection of the submitted article and expulsion of the author. while plagiarism can be either accidental or deliberate, in either case, it is a serious violation of academic integrity as it involves passing off someone else’s “work or ideas” as one’s own.12 plagiarism can be “verbatim” (copying sentences or paragraphs from previously published work without using quotation marks or referencing the source) or rephrasing someone’s work or ideas without citing them. in “mosaic” plagiarism, the work plagiarized comes from various sources. “self-plagiarism” is defined as an author’s reproduction of their previous publications or ideas in the same or altered words. according to most scientific journals, all authors of an article in part must have contributed to the conception and design of the study, drafted the article, revised it critically, or approved of its final version.13 the use of a ghost author (usually a professional writer who is not named an author) is generally not ethical, as it undermines the requirement that the listed authors created the article. moreover, wasteful publication is another practice that contributes to misconduct. wasteful publication includes dividing the results of one single study into multiple end publications (“salami slicing”), republishing the same results in one or more articles, or extending a previously published article by adding new data without reaching new conclusions. wasteful publication not only skews the scientific databases, but also wastes the time of the readers, the editors, and the reviewers. it is considered unethical because it unreasonably increases the authors’ citation records. authors caught engaging in such behaviors may be banned from submitting articles for years while the submitted article is automatically rejected. wasteful publication is an example of how the pressure to publish more articles leads to dishonest behavior, making it look like a researcher has conducted more studies and has more experience. conflicts of interest are not strictly prohibited in medicine but require disclosure. although disclosure of financial interests is a critical step, it does not guarantee the absence of bias. researchers with financial ties to a pharmaceutical company funding their research are more likely to report results that favor the sponsor, which eventually undermines the integrity of research.14 financial sponsors should not be allowed to influence publication; rather authors need to publish their results based on their own decisions and findings. iii. misconduct in carrying out scientific research studies common forms of fabrication include concealing negative results, changing the results to fit the initial hypothesis, or selective reporting of the outcomes. falsification is the manipulation of experimental data that leads to inaccurate presentation of the research results. falsified data includes deliberately manipulating images, omitting, or adding data points, and removing outliers in a dataset for the sake of manipulating the outcome. in contrast to plagiarism, this type of misconduct is very difficult to detect. scientists who fabricate or falsify their data may be banned from receiving funding grants or terminated from their institutions. falsification and fabrication are dangerous to the public as they can result in people poutoglidou, fraud and deceit in medical research, voices in bioethics, vol. 8 (2022) 4 giving and receiving incorrect medical advice. relying on falsified data can lead to death or injury or lead patients to take a drug, treatment, or use a medical device that is less effective than perceived. thus, some members of the scientific community support the criminalization of this type of misconduct.15 research involving human participants requires respect for persons, beneficence, justice, voluntary consent, respect for autonomy, and confidentiality. violating those principles constitutes unethical human experimentation. the declaration of helsinki is a statement of ethical principles for biomedical research involving human subjects, including research on identifiable human material and data. similarly, research in which animals are subjects is also regulated. the first set of limits on the practice of animal experimentation was the cruelty to animals act passed in 1876 by the parliament of the united kingdom. currently, all animal experiments in the eu should be carried out in accordance with the european directive (2010/63/eu),16 and in the us, there are many state and federal laws governing research involving animals. the incentives to compromise the ethical responsibilities surrounding human and animal practices may differ from the pressure to publish, yet some are in the same vein. they may generally include taking shortcuts, rushing to get necessary approvals, or using duress to get more research subjects, all actions that reflect a sense of urgency. iv. consequences of scientific misconduct fraud in medical research damages science by creating data that other researchers will be urged to follow or reproduce that wastes time, effort, and funds. scientific misconduct undermines the trust among researchers and the public’s trust in science. meanwhile, fraud in medical trials may lead to the release of ineffective or unsafe drugs or processes that could potentially harm individuals. scientific misconduct is associated with reputational and financial costs, including wasted funds for research that is practically useless, costs of an investigation into the fraudulent research, and costs to settle litigation connected with the misconduct. the retraction of scientific articles for misconduct between 1992 and 2002 accounted for $58 million in lost funding by the nih (which is the primary source of public funds for biomedical research in the us).17 of retracted articles, over half are retracted due to “fabrication, falsification, and plagiarism.” 18 yet it is likely that many articles that contain falsified research are never retracted. a study revealed that of 12,000 journals reviewed, most of the journals had never retracted an article. the same study suggests that some journals have improved oversight, but many do not.19 v. oversight and public interest organizations the committee on publication ethics (cope) was founded in 1997 and established practices and policies for journals and publishers to achieve the highest standards in publication ethics.20 the office of research integrity (ori) is an organization created in the us to do the same. in 1996, the international conference of harmonization (ich) adopted the international good clinical practice (gcp) guidelines.21 finally, in 2017 the parliamentary office of science and technology (post) initiated a formal inquiry into the trends and developments on fraud and misconduct in research and the publication of research results.22 despite the increasing efforts of regulatory organizations, scientific misconduct remains a major issue. to eliminate unethical practices in medical research, we must get to the root of the problem: the pressures put on scientists to increase output at the expense of quality. poutoglidou, fraud and deceit in medical research, voices in bioethics, vol. 8 (2022) 5 in the absence of altered incentives, criminalization is a possibility. however, several less severe remedies for reducing the prevalence of scientific misconduct exist. institutions first need to foster open and frank discussion and promote collegiality. reducing high-stakes competition for career advancement would also help realign incentives to compromise research ethics. in career advancement, emphasis should be given to the quality rather than the quantity of scientific publications. the significance of mentorship by senior, experienced researchers over lab assistants can bolster ethical training. adopting certain codes of conduct and close supervision of research practices in the lab and beyond should also be formalized. the publication system plays a critical role in preserving research integrity. computer-assisted tools that detect plagiarism and other types of misconduct need to be developed or upgraded. to improve transparency, scientific journals should establish clear authorship criteria and require that the data supporting the findings of a study be made available, a movement that is underway. preprint repositories also might help with transparency, but they could lead to people acting on data that has not been peer reviewed. finally, publishing negative results is necessary so that the totality of research is not skewed or tainted by informative studies but does not produce the results researchers hoped. consistently publishing negative results may create a new industry standard and help researchers see that all data is important. conclusion any medical trial, research project, or scientific publication must be conducted to develop science and improve medicine and public health. however, the pressures from the pharmaceutical industry and academic competition pose significant threats to the trustworthiness of science. thus, it is up to every scientist to respect and follow ethical rules, while responsible organizations, 23 regulatory bodies, and scientific journals should make every effort to prevent research misconduct. 1 world bank. “scientific and technical journal articles”. world development indicators, the world bank group. https://data.worldbank.org/indicator/ip.jrn.artc.sc?year_low_desc=true. 2 masic i, miokovic m, muhamedagic b. “evidence based medicine new approaches and challenges.” acta inform med. 2008;16(4):219-25. https://www.bibliomed.org/mnsfulltext/6/6-1300616203.pdf?1643160950 3 dickenson, d. “the medical profession and human rights: handbook for a changing agenda.” zed books. 2002;28(5):332. doi: 10.1136/jme.28.5.332. 4 ranstam j, buyse m, george sl, evans s, geller nl, scherrer b, et al. “fraud in medical research: an international survey of biostatisticians, iscb subcommittee on fraud. control clin trials. 2000;21(5):415-27. doi: 10.1016/s0197-2456(00)00069-6. 5 gopalakrishna, g., riet, g. t., vink, g., stoop, i., wicherts, j. m., & bouter, l. (2021, “prevalence of questionable research practices, research misconduct and their potential explanatory factors: a survey among academic researchers in the netherlands.” metaarxiv. july 6, 2021. doi:10.31222/osf.io/vk9yt; chawla, dalmeet singh, “8% of researchers in dutch survey have falsified or fabricated data.” nature. 2021. https://www.nature.com/articles/d41586-021-02035-2 (the dutch study’s author suggests the results could be an underestimate; she also notes an older similar study that found 4.5 percent.) 6 chawla. 7 fanelli d. how many scientists fabricate and falsify research? a systematic review and meta-analysis of survey data. plos one. 2009;4(5):e5738. doi:10.1371/journal.pone.0005738 8 martinson bc, anderson ms, de vries r. “scientists behaving badly” nature. 2005;435(7043):737-8. https://www.nature.com/articles/435737a. poutoglidou, fraud and deceit in medical research, voices in bioethics, vol. 8 (2022) 6 9 munby j, weetman, df. joint consensus conference on misconduct in biomedical research: the royal college of physicia ns of edinburgh. indoor built environ. 1999;8:336–338. doi: 10.1177/1420326x9900800511. 10 stephen beale “large dutch survey shines light on fraud and questionable research practices in medical studies published in scientific journals,” the dark daily, aug 30, 2021. https://www.darkdaily.com/2021/08/30/large-dutch-survey-shines-light-onfraud-and-questionable-research-practices-in-medical-studies-published-in-scientific-journals/ 11 buranyi s. is the staggeringly profitable business of scientific publishing bad for science? the guardian. june 27, 2017. https://www.theguardian.com/science/2017/jun/27/profitable-business-scientific-publishing-bad-for-science 12 cambridge english dictionary. https://dictionary.cambridge.org/us/dictionary/english/plagiarism 13 international committee of medical journal editors. defining the role of authors and contributors http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html 14 resnik db, elliott kc. “taking financial relationships into account when assessing research.” accountability in research. 2013;20(3):184-205. doi: 10.1080/08989621.2013.788383. 15 bülow w, helgesson g. criminalization of scientific misconduct. med health care and philos. 2019;22:245–252. 16 directive 2010/63/eu of the european parliament and of the council of 22 september 2010 on the protection of animals used for scientific purposes. official journal of the european union. https://eurlex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2010:276:0033:0079:en:pdf 17 stern am, casadevall a, steen rg, fang fc. “financial costs and personal consequences of research misconduct resulting in retracted publications,” elife. 2014;3:e02956. doi: 10.7554/elife.02956. 18 brainard, jeffrey and jia you, “what a massive database of retracted papers reveals about science publishing's ‘death penalty': better editorial oversight, not more flawed papers, might explain flood of retractions,” science, oct 25, 2018 https://www.science.org/content/article/what-massive-database-retracted-papers-reveals-about-science-publishing-s-deathpenalty 19 brainard and you. 20 doherty m, van de putte lbacope. guidelines on good publication practice; annals of the rheumatic diseases 2000;59:403404. 21 dixon jr jr. the international conference on harmonization good clinical practice guideline. qual assur. 1998 apr-jun;6(2):6574. doi: 10.1080/105294199277860. pmid: 10386329. 22 “research integrity terms of reference.” science and technology committee, 14 sept. 2017, committees.parliament.uk/committee/135/science-and-technology-committee/news/100920/research-integrity-terms-ofreference/. gottesman, patient autonomy in direct primary care, voices in bioethics, vol. 8 (2022) * sara gottesman, md, dell medical school at the university of texas © 2022 sara gottesman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. patient autonomy in direct primary care sara gottesman* keywords: patient autonomy, direct primary care, informed decision, equitable distribution, insurance introduction patient autonomy is a cornerstone of medical ethics in the united states. for patients to exercise their autonomy, they must not only be informed about their medical conditions and possible interventions, but their choices must also be considered and respected even when the clinician favors a different treatment. achieving a relationship conducive to trust and autonomy often requires a strong bond between patient and physician,1 as well as a willingness of the physician to share power and engage in honest discussion. direct primary care (dpc) practices, in which patients directly pay a physician a flat fee for their services, can offer opportunities to meet these requirements for patient autonomy. because dpc practices have a unique structure and payment model, physicians have significant time with patients and power can be shared more evenly between the two. though there has been discussion in the literature about some ethical risks and shortcomings of dpc practices, particularly around equitable access to care,2 changes to patient autonomy in this model have thus far been underexplored. background health insurance has played a role in medical care for many patients in the united states since the 1930s,3 and now patients rarely see a physician without their insurance company’s involvement. dpc practices came about first in the 1990s with a small number of physicians seeking to develop a new model of care,4 and have continued to grow in number, with many current dpc physicians seeking a way to spend more time with their patients. the practice model is characterized by patients paying a monthly retainer fee for a defined set of primary care services. the services vary from practice to practice but often include frequent visits and more accessibility to the doctor outside of regular business hours. dpc practices sometimes also include discounted prescriptions and labs.5 though similar to concierge medicine, which also functions on gottesman, patient autonomy in direct primary care, voices in bioethics, vol. 8 (2022) 2 a retainer model, dpc practitioners do not bill patient insurance and are generally less costly for the patient.6 additionally, concierge medicine provides more luxury services and caters to patients in higher economic classes.7 for both models, patients may choose (or in some states, are required) to purchase additional health insurance to cover health services not offered by their personal doctors, such as coverage for inpatient stays. analysis i. potential to improve knowledge and informed decision making in dpc practices, patients can spend more time with their doctors, and appointments are often available for same-day scheduling.8 as a result, the doctor can better understand a patient’s medical history, home life, risk factors, and build a more trusting relationship with the patient. these extended interactions could allow physicians to put forward interventions more in line with their patients’ goals, allowing the patients to feel heard. a patient in such a relationship may be more willing to speak up about their wishes. more time together can also be an opportunity for patient education and in-depth discussions about specific conditions, prognosis, or treatment plans. though data about patient behavior in dpc practices is lacking, it is possible that patients could use frequent appointments to further their understanding of their conditions. patients could consider questions at home and return to the physician’s office a few days later, ready for a more fruitful and complex discussion. this improved relationship and better patient understanding of treatment risks and benefits could foster patient autonomy, as both informed decision making and mutual understanding about goals are important. ii. potential to ameliorate power asymmetry dpc practices contribute to patient autonomy because they encourage power-sharing. dpc practices facilitate it in multiple ways, for instance, by granting the patient control over scheduling. unlike in a feefor-service practice where patients often wait weeks for an opening in a doctor’s schedule, dpc practices are characterized by shorter wait times for appointments, often offering same-day or same-week visits.9 though it may seem insignificant, this feature allocates power to the patient. instead of fitting appointment times to the physician’s schedule, dpc patients have the additional freedom to choose visits convenient to them and aligned with the urgency of their medical issues. additionally, because patients have more control over scheduling visits, they can be more active in setting the agenda for appointments, ensuring they address the issues most important to them. these changes in scheduling promote more patient control, empowerment, and autonomy. the fee structure of a dpc practice also affects power sharing and patient autonomy. each patient on the patient panel directly pays the practice a monthly fee without involvement of insurance. while generally less than with concierge medicine, the fees can be somewhat high and the patient panel may be small, meaning the financial “worth” of a single patient can be substantial. just a few patients leaving might represent a big loss to the practice, incentivizing physicians to consider their patients’ wishes in order to retain them. furthermore, not only is each patient financially valuable to the practice, but also the direct nature of the payment can contribute to a change in attitude about services rendered. in dpc, both parties are aware of the direct financial value that the patient brings to the practice as there is no obfuscation by insurance processing. the patient, paying the doctor directly for care and access, may feel more like they are owed a certain level of care and could take their money elsewhere if their needs are unfulfilled. patients could leverage their power in this arrangement to express their views and ensure their wishes are respected, using this power to increase their autonomy. gottesman, patient autonomy in direct primary care, voices in bioethics, vol. 8 (2022) 3 in the best case, more patient autonomy could result in better shared decision-making between doctor and patient, with both agreeing on a plan of action for patient care. this decision-making sharing could be most meaningful to patients with many chronic health problems; however, these patients are often less wealthy. 10 even with reductions in annual fees over the last two decades, dpc practices often charge between $500 and $1,499 per year, and this does not include the cost of hospitalization or the cost of insurance that patients choose – or may be required – to buy for coverage of services their dpc doctor does not offer.11 notably, dpc practice covers some of the same services that patients can get through insurance, but it does not supplant the need or requirement for overall insurance. the remaining concern that dpc practices could be unaffordable for some patients12 should not discourage its use for patients able to pursue it and for doctors forming practices. iii. traditional systems could learn from dpc practices even if dpc practice remains available to only small numbers of patients – either because of panel size, affordability, or geographic location – its model could be implemented outside of dpc to improve patient autonomy. for example, many systems would benefit from scheduling modifications like pre-visit planning with the team directly seeing the patient,13 ensuring that the patients’ needs are addressed effectively at their visits and mimicking some of the patient control over agenda-setting seen in dpc models. the direct payment aspect of dpc could be partially reproduced with upfront clarity about patient-specific service copays to provide price transparency, if not the financial leverage of patients in dpc models. these adaptations would not provide all the patient autonomy benefits as seen in dpc but they may remediate problems in standard practice models. conclusion overall, the dpc model provides opportunities and examples to support patient autonomy through the transfer of information and power from the doctor to the patient. though its application may be limited due to cost and availability, the potential to encourage autonomy through better doctor-patient relationships, more patient visits, more meaningful interactions, and reduced wait time for appointments makes dpc a valuable model of care. physicians have an ethical imperative to make patient education and autonomy central to their practice. such physicians will likely strive to support patient autonomy regardless of the setting in which they practice. 1 tonelli, mark r, and mark d sullivan. “person‐centered shared decision making.” journal of evaluation in clinical practice, vol. 25, no. 6, 2019, pp 1057–1062. doi:10.1111/jep.13260 2 wible, andy. “the ethics of direct primary care.” open journal of philosophy, vol. 9, no. 1, 2019, pp 35-44. doi:10.4236/ojpp.2019.91003 3 ross, joseph s. "the committee on the costs of medical care and the history of health insurance in the united states." einstein quarterly 19.3 (2002): 129-134. 4 pya. “a primer on the direct primary care model: past, present, and future.” white paper. 2018. http://www.pyapc.com/wpcontent/uploads/2018/12/a-primer-on-the-direct-primary-care-model-white-paper-pya.pdf 5 rowe, kyle et al. “direct primary care in 2015: a survey with selected comparisons to 2005 survey data.” kansas journal of medicine, vol. 10,1 3-6. 15 feb. 2017 6 adashi ey et al. “direct primary care: one step forward, two steps back.” jama. vol 320, no. 7, 2018, pp 637–638. doi:10.1001/jama.2018.8405 gottesman, patient autonomy in direct primary care, voices in bioethics, vol. 8 (2022) 4 7 carnahan sj. concierge medicine: legal and ethical issues. j law med ethics. 2007;35(1):211-215. doi:10.1111/j.1748720x.2007.00125.x 8 rowe, kyle et al. “direct primary care in 2015: a survey with selected comparisons to 2005 survey data.” kansas journal of medicine vol. 10,1 3-6. 15 feb. 2017 9 ibid. 10 chokshi da. income, poverty, and health inequality. jama. 2018;319(13):1312–1313. doi:10.1001/jama.2018.2521 11 rowe, kyle et al. “direct primary care in 2015: a survey with selected comparisons to 2005 survey data.” kansas journal of medicine vol. 10,1 3-6. 15 feb. 2017 12 doherty, robert, and medical practice and quality committee of the american college of physicians. “assessing the patient care implications of "concierge" and other direct patient contracting practices: a policy position paper from the american college of physicians.” annals of internal medicine vol. 163,12 (2015): 949-52. doi:10.7326/m15-0366 13 matulis, john c, and rozalina mccoy. “patient-centered appointment scheduling: a call for autonomy, continuity, and creativity.” journal of general internal medicine vol. 36,2 (2021): 511-514. doi:10.1007/s11606-020-06058-9 vargo, death with dignity, voices in bioethics, vol. 8 (2022) * anna vargo, ms candidate columbia university © 2022 anna vargo. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. death with dignity in canada: no longer limited to only the terminally ill anna vargo* keywords: medical aid in dying, active euthanasia, end-of-life, dignity, canada, mental illness introduction if a terminally ill individual suffers from enduring pain and exhausts all other treatment options, upholding death with dignity through medical assistance in dying (maid) is how physicians can mercifully respect bodily integrity. and when death is already imminent, a physician has two options: let the disease take the patient's life or act compassionately to end suffering by medically assisting consented death.1 but what happens if death is not reasonably foreseeable? this paper discusses the recent expansion of maid to the non-terminally ill and the anticipated 2023 expansion to those with exclusively mental illnesses. the right to suicide in canada has existed since 2016, after the case of carter v. canada, whereby the supreme court made a revolutionary change to the canadian charter of rights and freedoms, allowing access to maid for those seeking an end to their current suffering.2 in short, this decision permits maid for those individuals with "grievous and irremediable" medical conditions. 3 the initial law, under bill c-14, created the right to receive maid; however, the right was only for those patients with naturally foreseeable deaths, that is, a terminal illness.4 i. expansion to non-terminal illness five years after this initial implementation of maid, new legislation (bill c-7) repealed the provision requiring terminal illnesses for maid eligibility, thereby allowing access for even those individuals "whose natural death is not reasonably foreseeable." 5 in addition, the law removed the distinction between terminal and non-terminal illness for purposes of the right to receive medical assistance in dying (maid). the ability of non-terminally ill individuals to receive maid raises critical ethical considerations, precisely, respect for persons, justice, beneficence, non-maleficence, and whether there exists an overall sense of vargo, death with dignity, voices in bioethics, vol. 8 (2022) 2 compassion. ultimately, the expanded maid policy is warranted as it protects and upholds bioethical principles. to be eligible for maid in canada, one must have a medical condition causing intolerable physical or psychological suffering "that cannot be relieved in a manner that the patient finds to be acceptable."6 much like other medical treatment decisions, suffering and quality of life are subjective matters; therefore, they are "best determined by the individual patient."7 the 2020 annual report on maid use in canada cites the most common reason for pursuing the procedure as a loss of ability to partake in meaningful activities (84.9 percent), followed by a loss of ability to perform activities of daily living (81.7 percent).8 the report also concludes that the primary underlying condition for those receiving maid in 2020 was cancer (69.1 percent).9 when comparing euthanasia laws in the united states to those in canada, it is interesting to analyze the difference in policy through a cultural lens. while both westernized countries' healthcare rights are built on respect for patient autonomy, the us tends to stress the overriding freedom of individualism (also reflected in its private-payer system) compared to its northern neighbor. more precisely, 58 percent of americans value the freedom to pursue life goals over the importance of guaranteeing that no one is in need, versus 43 percent of canadians.10 the value of protecting the 'overall collective' feels stronger in canada over the united states. so, perhaps it is not that the canadian euthanasia laws emphasize greater individualism; instead, they represent a shift toward liberalism and utilitarianism to maximize the overall well-being of individuals at their end of life through public policy. although bioethics is a relatively new and emerging field, north american countries remain at the forefront of its advances. canada has taken a more progressive approach by promoting more inclusive end-of-life dignity through maid. with the expansion of the law to include non-terminal illnesses, canadian physicians can act compassionately in the patient's best interest. by putting individuals with "grievous and irremediable" medical conditions out of unnecessary pain, they may fulfill their obligation to beneficence and non-maleficence. individuals have a protected right to make choices for themselves, no matter the timeline of their suffering. canada's new maid law upholds the fundamental ethical principle of bodily autonomy by respecting adults suffering from grievous and irremediable medical conditions to self-govern and die on their own terms. the law's newly broadened capacity allows each person in the collective more autonomy. from an individualistic perspective, this value of self-determination should be assessed as paramount when making decisions about one's personal medical care; therefore, protection of autonomy must extend when making end-of-life choices, no matter if the given medical condition is foreseeably terminal or not.11 the new maid legislation in canada supports respect for persons by allowing individuals to choose how they would like to address such intolerable pain or suffering while ensuring the decision is not coerced by "external pressures or a temporary period of despair."12 the consent process is slightly different for the newly expanded law. those who are not terminally ill will have a final consent requirement. consent should be an ongoing process. the new legislation drops the last consent requirement to better protect the patient's initial decision, in case the patient loses the capacity to make the decision. however, this relaxed rule for final consent is permitted only for terminally ill individuals, thereby protecting the decision of those who have already been approved for maid, even if capacity is lost down the line. for those individuals whose death is not "reasonably foreseeable" but still intolerably suffering, the law still requires final consent before the procedure. if all informed consent and vargo, death with dignity, voices in bioethics, vol. 8 (2022) 3 eligibility requirements are fulfilled, this represents the most compassionate route to put such individuals out of pain and uphold non-maleficence. it seems unjust to allow assistance in dying for terminal illnesses but not those with detrimental suffering in such personal matters. both terminal and non-terminal conditions can contribute to significant pain or distress and harm an individual's quality of life—an essential component of beneficence.13 if such subjective suffering makes individuals believe that their lives are not worth living and wish to engage in maid, denying such maid requests may be wrong. bioethical non-maleficence should ask the law for recognition of more types of suffering. those opposed to the recent expansion of maid may argue that permitting euthanasia of non-terminally ill individuals ignores "the intrinsic worth or dignity of a person."14 but maid does not belittle the value of individuals; allowing people more control over their death need not be framed as devaluing their life. balancing freedom of choice while protecting those with diminished autonomy is a complicated issue that bioethicists debate. ii. maid for mental illness the profound change in canadian euthanasia law does not stop there. the nation will allow maid for individuals whose justification for maid is solely a psychiatric condition causing intolerable suffering. although the current bill specifies that individuals "whose sole underlying medical condition is a mental illness" are not eligible to receive maid, there has been a two-year limit on the blanket ban.15 on march 17, 2023, individuals suffering from mental illness, as their only medical condition, will become eligible for maid. permitting the right to suicide for such vulnerable groups without terminal illnesses could open a pandora's box of downstream attacks on justice. without eliminating stigma, including access for individuals with mental illnesses and disabilities may increase the perceived pressure of being a 'burden’ to society. this dangerous cascade could indirectly imply to these vulnerable individuals that their lives are not worth living—encouraging them to end their lives prematurely. 16 in addition, the healthcare system already marginalizes these groups. therefore, more significant pressures to seek maid will impose an undue burden on their absolute moral worth. this slippery slope has the potential to fuel greater mistrust between vulnerable groups and public policy. conclusion iii. so, what should be done? since the arguably major problem of legalizing maid for non-terminally ill individuals is the slippery slope encouraging suicide and furthering discrimination, policy officials should closely examine how such existing laws have played out in the benelux nations. medical aid in dying still has profound benefits for individuals suffering from intolerable pain, both terminal and non-terminal. it is also crucial to acknowledge the subjectivity in determining when non-terminal suffering is intolerable or when mental illnesses are untreatable. officials must implement comprehensive and researched safeguards to eliminate possible errors, misuse, and abuse. already, extensive assessments, medical opinions, and waiting periods are required for those with non-terminal illnesses seeking maid. translational law based on evidence-based practices will hopefully eliminate subjective interpretation and enable practitioners to best respect end-of-life dignity while ensuring against misuse for non-terminally ill vargo, death with dignity, voices in bioethics, vol. 8 (2022) 4 patients. additionally, intensive collaboration and education are needed to reduce stigmatized views of those living with mental illnesses or disabilities to prevent the felt burdens to society. a human-rights-based approach that supports illness and disability inclusion by encouraging counseling, support, and community services will help protect these vulnerable groups from feeling pressured to pursue maid while upholding end-of-life dignity and overall bodily integrity. the expansions of maid to the non-terminally ill and those using it exclusively for mental illness are justified only if societal safeguards that express the value of those with physical and mental illness are well broadcasted, and stigma plays no role in each case. 1 spina, bernadette. "ethical justifications for voluntary active euthanasia." persp. on l. & pub. int. 3 (1998): 71. 2 carter v. canada. "scc 35591." (2015). 3 health canada. "medical assistance in dying." (2021). https://www.canada.ca/en/health-canada/services/medical-assistancedying.html 4 health canada. (2021). 5 pesut, barbara, sally thorne, david kenneth wright, catharine schiller, madison huggins, gloria puurveen, and kenneth chambaere. "navigating medical assistance in dying from bill c-14 to bill c-7: a qualitative study." bmc health services research 21, no. 1 (2021): 1195. https://doi.org/10.1186/s12913-021-07222-5. 6 health canada. "second annual report on medical assistance in dying in canada 2020." (2020). https://www.canada.ca/en/health-canada/services/medical-assistance-dying/annual-report-2020.html#4_0. 7 landry et al. (2015) 8 health canada. (2020) 9 health canada. (2020) 10 pew research center. "americans and canadians." (2004). https://www.pewresearch.org/global/2004/01/14/americans-andcanadians/. 11 landry, joshua t., thomas foreman, and michael kekewich. "ethical considerations in the regulation of euthanasia and physician-assisted death in canada." health policy 119, no. 11 (2015): 1490-98. https://doi.org/10.1016/j.healthpol.2015.10.002. https://www.sciencedirect.com/science/article/pii/s0168851015002535. 12 health canada. (2021). 13 varelius, jukka. "medical expertise, existential suffering and ending life." journal of medical ethics 40, no. 2 (2014): 104-07. 14 narbekovas, a., and k. meilius. "why is the ethics of euthanasia wrong?" [in eng]. med etika bioet 11, no. 3-4 (2004): 2-6. 15 health canada. (2021) 16 komrad, mark s. "first, do no harm: new canadian law allows for assisted suicide for patients with psychiatric disorders." psychiatric times (2021). https://www.psychiatrictimes.com/view/first-do-no-harm. kim, reflecting on “tia”, voices in bioethics, vol. 7 (2021) * rowan kim, ms candidate columbia university © 2021 rowan kim. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. mainstream media’s obsession with africa: reflecting on “tia” during the covid-19 pandemic rowan kim* keywords: africa, global health, global ethics, bioethics, media ethics, balanced news we who grew up texting, instant messaging, and emailing are blessed with native fluency in internet slang that varies according to country and language. growing up in sub-saharan africa, my schoolmates and i particularly loved to say tia or, “this is africa.”1 largely popularized through the 2006 film, “blood diamond”,2 tia was the answer to all of the idiosyncrasies that accompanied living in the middle of the second-largest continent. pulled over by local traffic police who demand a “cold drink”? tia. helped push the school bus out of a massive pothole during monsoon season? tia. reached for your nokia brick only to pull a similarly sized cockroach from your purse? tia. largely isolated from the rest of the world, disease hysteria triggered by bird flu, sars, and mers passed by sub-saharan africa as a faroff echo – my community was preoccupied with more imminent threats like malaria and cholera. the 2013 ebola epidemic was the first time i was exposed to the narrow focus and broad indifference with which the wider world regards africa. mass hysteria over an “african disease” that threatened us shores exhibited narrow focus3 while broad indifference manifested as radio silence following the resolution of cases in the us and europe. the outbreak lasted until 2016 but coverage waned after 2015, when the only ebola patients outside of africa were expats shipped home for recovery.4 as a freshman in college, my new british friends asked whether my family was at risk (they were not) and whether it was safe for me to go home for the holidays (it was). the 2013 outbreak primarily affected west africa, on the opposite side of the continent. but to my college friends, africa was a disease-ridden monolith. tia, that is africa. to the indifferent journalist, africa is a convenient narrative device. by refusing to think of parts of africa as anything other than the whole, we reduce a continent of 54 nations to a single entity – smaller and more manageable. the same occurred at the height of covid-19 anxieties. as the healthcare systems of “more developed” countries threatened imminent collapse, a cry rattled across the globe: what will the africans do? 5 military-enforced lockdowns?6 will we have to take care of their citizens again?7 while catching up with some friends in july 2020, i resisted an eyeroll as an acquaintance, grinning smugly, announced a new ebola outbreak plaguing congo.8 (he probably meant drc but he did not specify, and i am not sure he knew the difference.) a quick google search confirmed the news, reported with glee in all major news media.9 the zoom call erupted in a flurry of sighs as my friends contemplated the new threat to us soil. ever the party pooper, i emphasized that the outbreak was nothing new. the ebola virus takes its name from its eponymous river in the drc kim, reflecting on “tia”, voices in bioethics, vol. 7 (2021) 2 and the congolese government had only just announced the end to a two-year struggle with ebola in april.10 soon afterwards, the world lost interest; al-jazeera posted its last ebola article on july 25.11 concurrently, coverage on ‘africa’s covid-19 crisis’ dwindled, eclipsed by worldwide #blm protests, unrest in belarus, and the us elections. as the attention on other world events settled, the “developed” world checked in with “poor, underdeveloped” africa.12 despite concerns about cramped south african townships and the veracity of disease reports in nigeria,13 the number of covid-19 cases and death rates in the continent have stayed low.14 citing a young population, existing contacttracing infrastructure, and cross-immunity from other coronaviruses, several published articles analyze africa’s mortality statistics.15 some, as pointed out by ghanaian journalist, karen attiah, strive to paint the successes of african covid-19 responses with stereotypical images of poverty and instability. after all, tia. but while the world was not looking, african healthcare systems rallied. wild poliovirus was completely eradicated from the continent in august.16 uganda began developing its own covid-19 testing kits in may.17 covid-19 cases were limited to ten of africa’s 54 countries while the drc’s leading ebola expert18 reported that the new outbreak was under control. 19 though there are still economic concerns due to reduced import-export activity between countries, africa stands strong as second waves in europe threaten to overrun hospitals.20 a year from the beginning of the covid-19 pandemic, the who shared concerns of a lack of justice and equality in global vaccine distribution. 21 higher income countries have had enough stock to vaccinate one fourth of their population, on average, while low income countries are limited to around 1 in 500.22 however, a headline in cbs news implies that the low vaccination rate in south africa is due to a domestic class struggle between the rich and poor citizens,23 rather than an issue of vaccine nationalism. there are some reporters in western news media, like peter mwai who reports for the bbc, who portray african healthcare systems in a balanced way. seeking out unbiased writers’ articles is the best way to ensure exposure to balanced news. however, this is an exercise that many readers overlook because they depend on headlines for information. the bias is systematic, and the reliability of a few reporters is outweighed by countless examples of careless copy editing. as evidenced by the cbs news clip, quick turnaround time for publishing live television broadcast clips online leads to sloppy research, injecting prejudices in news media. perhaps it is too early to celebrate. but as western media spotlights claims that africa was spared due to herd immunity from previous coronaviruses blazing through poverty-stricken neighborhoods, it does not seem so bad to rebuff the stereotype.24 the us currently leads in total covid-19 cases, followed by india, brazil, and france. south africa does not even break the top ten. morocco, next in line, resides comfortably at 32.25 for the moment, we can be proud. decades of experience building infrastructure around highly contagious diseases paid off. many public health officials in african governments acknowledged and addressed covid-19’s potential early. aggressive lockdowns were effective in reducing community transmission. this is africa. 1 abdullah, kia. “‘this is africa’: useful mantra or ugly prejudice?” atlas &amp; boots. atlas &amp; boots, december 24, 2019. https://www.atlasandboots.com/tia-this-is-africa/. 2 blood diamond. blood diamond archer meets maggie (tia) this is africa. united states: warner bros., 2006. https://www.youtube.com/watch?v=3frhm9hw5bi. 3 lupkin, sydney. “ebola in america: timeline of the deadly virus.” abc news. abc news network, november 17, 2014. https://abcnews.go.com/health/ebola-america-timeline/story?id=26159719. kim, reflecting on “tia”, voices in bioethics, vol. 7 (2021) 3 4 bbc. “ebola: seventh british health worker sent home.” bbc news. bbc, march 16, 2015. https://www.bbc.com/news/health31908301. 5 nyenswah, tolbert. “africa has a covid-19 time bomb to defuse.” world economic forum. world economic forum, april 6, 2020. https://www.weforum.org/agenda/2020/04/africa-covid-19-time-bomb-defuse/. 6 noko, karsten. “the problem with army enforced lockdowns in the time of covid-19.” opinions | al jazeera. al jazeera, april 2, 2020. https://www.aljazeera.com/opinions/2020/4/2/the-problem-with-army-enforced-lockdowns-in-the-time-of-covid-19/. 7 picheta, rob. “coronavirus pandemic will cause global famines of 'biblical proportions,' un warns.” cnn. cable news network, april 22, 2020. https://www.cnn.com/2020/04/22/africa/coronavirus-famine-un-warning-intl/index.html. 8 who. “ebola virus disease – democratic republic of the congo.” world health organization. world health organization, july 9, 2020. https://www.who.int/csr/don/26-june-2020-ebola-drc/en/. 9 fisher, nicole. “new ebola outbreak in congo creates unparalleled challenges during a pandemic.” forbes. forbes magazine, august 10, 2020. https://www.forbes.com/sites/nicolefisher/2020/08/10/new-ebola-outbreak-in-congo-creates-unparalleledchallenges-during-a-pandemic/?sh=4f4a88015877.; bbc world service. “ebola virus.” bbc news. bbc, july 17, 2020. https://www.bbc.com/news/topics/cjnwl8q4qj1t/ebola-virus.; al jazeera. “'great concern' as new ebola outbreak grows in western dr congo.” democratic republic of the congo | al jazeera. al jazeera, july 14, 2020. https://www.aljazeera.com/news/2020/7/14/great-concern-as-new-ebola-outbreak-grows-in-western-dr-congo. 10 yeung, peter. “'enormous relief' as ebola outbreak in drc to be declared over.” democratic republic of the congo | al jazeera. al jazeera, april 10, 2020. https://www.aljazeera.com/news/2020/4/10/enormous-relief-as-ebola-outbreak-in-drc-to-bedeclared-over. 11 al jazeera. “western drc ebola cases up to 60 as who warns of funeral risks.” democratic republic of the congo | al jazeera. al jazeera, july 20, 2020. https://www.aljazeera.com/news/2020/7/20/western-drc-ebola-cases-up-to-60-as-who-warnsof-funeral-risks. 12 mobarak, ahmed mushfiq, and rifaiyat mahbub. “opinion: what the us can learn from how african countries handled covid.” cnn. cable news network, november 3, 2020. https://www.cnn.com/2020/11/03/africa/africa-coronavirus-lessonsopinion-intl/index.html.; makoni, munyaradzi. “the world could learn a lot from how africa is handling covid-19.” wired uk. wired uk, november 2, 2020. https://www.wired.co.uk/article/covid-19-africa. 13 mckenzie, david. “africa's battle against covid-19 will be won or lost here.” cnn. cable news network, july 6, 2020. https://www.cnn.com/2020/07/06/africa/western-cape-south-africa-coronavirus-epicenter-intl/index.html.; peralta, eyder. “why forecasters can't make up their mind about africa and the coronavirus.” npr. npr, june 10, 2020. https://www.npr.org/sections/goatsandsoda/2020/06/10/872789379/why-forecasters-cant-make-up-their-mind-about-africaand-the-coronavirus. 14 mwai, peter. “coronavirus: what's happening to the numbers in africa?” bbc news. bbc, november 5, 2020. https://www.bbc.com/news/world-africa-53181555. 15 attiah, karen. “opinion | africa has defied the covid-19 nightmare scenarios. we shouldn't be surprised.” the washington post. wp company, september 22, 2020. https://www.washingtonpost.com/opinions/2020/09/22/africa-has-defied-covid-19nightmare-scenarios-we-shouldnt-be-surprised/.; lock, helen. “the uk has seen more deaths from covid-19 than the whole of africa. here are 6 reasons why.” global citizen. global citizen, november 4, 2020. https://www.globalcitizen.org/en/content/uk-more-deaths-covid-19-africa-reasons-why/.; deutsche welle. “covid-19 in africa: milder-than-expected pandemic has experts puzzled: dw: 14.09.2020.” dw.com. deutsche welle, september 14, 2020. https://www.dw.com/en/covid-19-in-africa-milder-than-expected-pandemic-has-experts-puzzled/a-54918467.; smith, chris. “scientists can't explain puzzling lack of coronavirus outbreaks in africa.” new york post. new york post, september 7, 2020. https://nypost.com/2020/09/04/scientists-cant-explain-puzzling-lack-of-coronavirus-outbreaks-inafrica/?link=td_mansionglobal_new_mansion_global.11147f181987fd93. kim, reflecting on “tia”, voices in bioethics, vol. 7 (2021) 4 16 scherbel-ball, naomi. “africa declared free of wild polio in 'milestone'.” bbc news. bbc, august 25, 2020. https://www.bbc.com/news/world-africa-53887947. 17 achan, jacky. “dr. wayengera: the man behind uganda's covid-19 testing kits.” new vision | uganda news. new vision, may 30, 2020. https://www.newvision.co.ug/news/1518668/dr-misaki-wayengera-uganda-covid-19-test-kits. 18 mukwege, denis. “jean-jacques muyembe tamfum is on the 2020 time 100 list.” time. time, september 23, 2020. https://time.com/collection/100-most-influential-people-2020/5888331/jean-jacques-muyembe-tamfum/. 19 mwai. “coronavirus: what's happening to the numbers in africa?” (2020); afp. “dr congo's latest ebola outbreak 'under control.” cgtn africa. cgtn, october 18, 2020. https://africa.cgtn.com/2020/10/18/dr-congos-latest-ebola-outbreak-undercontrol/. 20 dillon, conor, and gabriel borrud. “belgium's covid-19 health care collapse: 'it will happen in 10 days': dw: 30.10.2020.” dw.com. deutsche welle, october 30, 2020. https://www.dw.com/en/belgiums-covid-19-health-care-collapse-it-will-happen-in10-days/a-55451750. 21 mwai, peter. “covid-19 africa: what is happening with vaccines?” bbc news. bbc, april 8, 2021. https://www.bbc.com/news/56100076. 22 miao, hannah. “who says more than 87% of the world's covid vaccine supply has gone to higher-income countries.” cnbc. cnbc, april 10, 2021. https://www.cnbc.com/2021/04/09/who-says-poor-countries-have-received-just-0point2percent-ofworlds-vaccine-supply.html. 23 patta, deborah. “protests over ‘shocking imbalance’ of covid vaccine distribution in south africa.” cbs news. cbs interactive, april 11, 2021. https://www.cbsnews.com/video/protests-over-shocking-imbalance-of-covid-vaccine-distribution-in-southafrica/#x. 24 harding, andrew. “coronavirus in south africa: scientists explore surprise theory for low death rate.” bbc news. bbc, september 2, 2020. https://www.bbc.com/news/world-africa-53998374. 25 worldometers.info. “coronavirus cases.” worldometer. worldometer, november 9, 2020. https://www.worldometers.info/coronavirus/. moore, using hiv/aids education as a model for female genital cutting education, voices in bioethics, vol. 6 (2020) * farley moore, ms candidate columbia university © 2020 farley moore. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. using hiv/aids education as a model for female genital cutting education: respecting culture while educating communities farley moore* abstract while the prevalence of fgc is still quite high, there have been human rights movements and ideological shifts away from the practice. many countries have recently passed laws that prohibit fgc, even if it takes place in other jurisdictions. since legislation was passed that makes fgc illegal in most countries where it is still routinely practiced, these women have also been pushed to the fringes of society. fgc may be practiced under worse conditions, where infection is more likely. where it is illegal, after the procedure, the woman is less likely to seek medical help because of fear. the people performing fgc will also be more likely to keep the girl or woman from seeking medical attention in the case of an emergency to avoid consequences for themselves. keywords: fgc, fgm, cultural respect, oppression, feminism, autonomy, global health, human rights introduction female genital cutting (fgc), referred to by many global health organizations as female genital mutilation (fgm), has been practiced for centuries, mostly in africa, malaysia, and indonesia. 1 fgc is a term that encompasses multiple acts, including removal of the clitoris, removal of the labia minora, narrowing of the vaginal opening, and pricking, piercing, or cauterization. justifications for fgc include maintaining sexual propriety, safety for women and children, and solidifying cultural identity.2 while the prevalence of fgc is still quite high, there have been human rights movements and ideological shifts away from the practice. many countries have recently passed laws that prohibit fgc, even if it takes place in other jurisdictions. in 31 countries for which prevalence data is available, 30 years ago, one in two women between the ages of 15 and 19 had undergone some form of fgc; today that number is about one in three, or 34 percent.3 however, a review of the current laws related to fgc show that legislating against fgc pushes it into secrecy. as fgc is moore, using hiv/aids education as a model for female genital cutting education, voices in bioethics, vol. 6 (2020) 2 so closely tied to cultural identity, education about fgc, and the context of cultural female oppression may be more useful than laws in limiting the practice of nonconsensual fgc. i. background: weaknesses of legislation as an approach to end nonconsensual fgc most women that undergo fgc live in rural areas and lack a traditional education.4 since legislation was passed that makes fgc illegal in most countries where it is still routinely practiced, these women have also been pushed to the fringes of society. fgc may be practiced under worse conditions, where infection is more likely.5 where it is illegal, after the procedure, the woman is less likely to seek medical help because of fear. the people performing fgc will also be more likely to keep the girl or woman from seeking medical attention in the case of an emergency to avoid consequences for themselves. these conditions come together to create serious social justice concerns. one study in iran found that, “…less educated mothers and mothers living in rural areas had more positive attitudes towards fgm and feel more social pressure to allow fgm.”6 there are many social justice issues that need to be addressed in these communities in order to end forced fgc while tolerating women’s autonomous decisions to undergo consensual fgc. legislation is not the best way to end the practice. as of 2019, 60 countries had adopted laws against fgc, including 24 african countries.7 the penalties for violating these laws range from imprisonment to fines, but some countries do not enforce punishments. for example, in kenya, only 74 individuals were prosecuted in the two years since the law against fgc was passed there. in contrast, burkina faso successfully convicted 241 people in one year.8 leaving the fate of fgc to legislation will not be enough. more needs to be done to protect underage girls from suffering forced fgc in the immediate future. i argue that those who view fgc through a western lens should not presume to force our views on other people. the effects of legislation, whom it will impact, and what consequences may arise need to be examined in cultural context. education is not as forceful as legislation is. while education without legislation making fgc illegal leaves room for women to make the choice to undergo fgc, the culture should be educated to meet the human rights approach. as no one from an outside culture is in the position to mandate people’s consensual cultural actions, education is a better tool to discourage the practice. legislation demands compliance and forces a complete abandonment of a way of life. if compliance is forced through legislation, a cultural gap is left in which women could suffer consequences ranging from being unmarriageable to becoming a social outcast.9 i do agree with the stance that fgc should be approached as a practice that is harmful and dangerous to women, but attempting to force its end without education would only cause another kind of harm for these women. fgc should come to a more natural end through education as communities shift their cultural beliefs to align with what they learn about the painful practice. cultural pressures and lack of education may prohibit even a consenting adult woman from making an autonomous choice to undergo fgc. education should inform both the women and the community about the coercive forces that could convince women to make choices against their best interest. once education has been delivered and risks explained, i assert there is nothing else an outsider can ethically do to prevent a woman from making the decision to undergo fgc. a similar choice that we are more familiar with is making a living organ donation to a family member. doctors can educate the donor on the risks and explain the pressure they may feel from the family to donate, but can never know if the decision was solely the choice of the donor or if there was familial or cultural pressure. using legislation to prevent an adult woman from undergoing fgc voluntarily is another way of limiting her autonomy. another issue with legislation is the lack of input from the community. people that participate in fgc are not likely to have a voice in government, and therefore do not have any say in guiding the legislation.10 when moore, using hiv/aids education as a model for female genital cutting education, voices in bioethics, vol. 6 (2020) 3 these groups feel that they have been left out of the decision-making process they are less likely to follow the regulations. ii. education as a means of reducing fgc and eliminating nonconsensual fgc a parallel of the legislation versus education debate surrounding fgc focuses on the spread of hiv in countries that have criminalized homosexual behavior. there is strong evidence from multiple quantitative studies11 that shows an increase in hiv transmission in countries that criminalize homosexual behavior. a study in the caribbean commissioned by unaids discovered that, “the hiv prevalence among men who have sex with men (msm) rose from 1 in 15 in countries where homosexuality is not criminalised to 1 in 4 in countries where it is criminalised”.12 as msm communities were criminalized, it became more difficult to seek health care, and concerns of stigma heightened. as expected, creating legislation against msm only pushed it further underground, leading to greater transmission of hiv. legislating fgc poses a similar risk. while in some countries, such as cote d’ivoire, nigeria, ethiopia, and kenya legislation against fgc has resulted in reduction of the practice, in others, including chad and sierra leone, the practice has actually increased.13 legislation of msm is inherently different than fgc because msm is entered into for mutual satisfaction and the participants are not coerced into the act by cultural oppression like those participating in fgc. pain and risk are necessary results of fgc. fgc is less likely to be voluntary than msm. however, legislating both behaviors leads people engaging in the acts to the fringe of society where they may fail to seek medical attention. in both cases, education would mean that people willingly participating would be counseled to take greater precautions, leading to more safety overall. criminalization can also serve to prevent concurrent methods from being as useful. “experts have repeatedly concluded that, rather than slowing the spread of hiv, the criminalisation of homosexuality seriously impedes the effectiveness of measures designed to reverse the hiv pandemic.”14 if homosexual behavior is illegal, then doing public health outreach would not work because no one would want to admit that they engage in illegal behavior. likewise, once you have made fgc illegal, doing community outreach and education would be less effective. going into a community that participates in fgc, educating the people about risks, and then still encouraging women to make their own choices would effectively be condoning illegal behavior. school based hiv/aids education has become a proven intervention strategy in limiting transmission. without school-based education about hiv/aids, “… there would have been no turning back the epidemic among injection drug users in european capital cities; and the 20-30% declines in new infections recently reported in no less than 22 countries in sub-saharan africa…”15 hiv education in schools includes information on condom use, drug injection, how to prevent hiv transmission, seeking testing, getting counseling after infection, and how to manage infection.16 education provides many more avenues for people at risk for hiv. the legislation of homosexual behavior does not even address risks, such as transmission by intravenous drug use, but serves to prevent people from seeking resources out of fear of being punished under the law. there are numerous gaps in legislation that can be covered by education. iii. community-based education one of the most important issues with using legislation instead of education is the lack of community input. instead of having western organizations come into communities that practice fgc, community members should have the tools to implement the education themselves. the tools may include doing small training programs for individuals interested in becoming educators or providing materials about best practices. it is important that the western organizations do not write the material themselves. community members are moore, using hiv/aids education as a model for female genital cutting education, voices in bioethics, vol. 6 (2020) 4 the only ones who know the nuances of their culture, and how best to approach the topic of changing a timehonored tradition. the materials should cover the risks of fgc, and address women’s autonomy. providing framework and assistance when asked should be the extent of western interference in these cultures. this model resembles the facilitator model that has been used in egypt.17 much of the research done using the facilitator model is aimed at the complete eradication of fgc, however this work does not include eradication research because, while that is a secondary goal of education, the immediate goal is promoting safe practices and eliminating child and nonconsensual fgc. in addition to using facilitators from the community, it would also be beneficial to include general community education unrelated to fgc. there is a complex set of social justice issues that underlies fgc. they must be addressed at the community level. “…i[i]lliteracy, gender inequality, and low socio-economic development…” 18 contribute to a lack of autonomy and informed consent. individuals inside these communities want to be advocates and learn how to influence lasting change, as seen in the egypt study on facilitators. conclusion while i believe that education is the best approach to stopping fgc, there are still ethical issues that need to be addressed. for example, education takes time, and in that time many more girls and women may be forced to undergo some form of fgc. it is my hope that with education, the legislation making fgc illegal will become unnecessary as women learn about the dangers of the procedure and as cultural norms shift to empower women. the legal issue with fgc should be limited to its use on minors and non-consenting adults. if an adult woman who is educated about both the procedure and the context of oppression still wants to undergo fgc, then i believe she should be able to, and that it should be beyond the scope of her country’s government to control her actions. where there is true autonomy, westerners should not interfere by imposing restrictive laws on the voluntary choices of people who operate with different cultural norms. 1 lightfoot-klein, h. (1991). prisoners of ritual: some contemporary developments in the history of female genital mutilation. retrieved from http://www.fgmnetwork.org/articles/prisonersofritual.htm 2 llamas, j. (2017, april). female circumcision: the history, the current prevalence and the approach to a patient. retrieved from https://med.virginia.edu/family-medicine/wp-content/uploads/sites/285/2017/01/llamas-paper.pdf 3 unicef. (2020, february). female genital mutilation (fgm). retrieved from https://data.unicef.org/topic/childprotection/female-genital-mu 4 besera, ghenet, and amira roess. “the relationship between female genital cutting and women's autonomy in eritrea.” international journal of gynecology & obstetrics 126, no. 3 (2014): 235–39. https://doi.org/10.1016/j.ijgo.2014.03.038. 5 monahan, kathleen. “cultural beliefs, human rights violations, and female genital cutting.” journal of immigrant & refugee studies 5, no. 3 (2007): 21–35. https://doi.org/10.1300/j500v05n03_02. 6 pashaei, tahereh, koen ponnet, maryam moeeni, maryam khazaee-pool, and fereshteh majlessi. “daughters at risk of female genital mutilation: examining the determinants of mothers' intentions to allow their daughters to undergo female genital mutilation,” march 31, 2016. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4816284/. 7 nabaneh, satang, and adamson s. muula. “female genital mutilation/cutting in africa: a complex legal and ethical landscape.” international journal of gynecology & obstetrics 145, no. 2 (2019): 253–57. https://doi.org/10.1002/ijgo.12792. moore, using hiv/aids education as a model for female genital cutting education, voices in bioethics, vol. 6 (2020) 5 8 ibid., 254. 9 kathleen monahan dsw, lcsw, bcd (2007) cultural beliefs, human rights violations, and female genital cutting, journal of immigrant & refugee studies, 5:3, 21-35. https://doi.org/10.1300/j500v05n03_02 10 ibid., 256. 11 laverack, p. (2015). criminalising homosexuality and public health: adverse impacts on the prevention and treatment of hiv and aids. human dignity trust. retrieved from https://www.humandignitytrust.org/wp-content/uploads/resources/5.criminalisation-public-health-and-hiv.pdf 12 ibid., 6. 13 nabaneh, satang, and adamson s. muula. “female genital mutilation/cutting in africa: a complex legal and ethical landscape.” 14 ibid., 5. 15 aggleton, peter, ekua yankah, and mary crewe. “education and hiv/aids—30 years on.” aids education and prevention 23, no. 6 (2011): 495–507. https://doi.org/10.1521/aeap.2011.23.6.495. 16 centers for disease control. (1998, january 29). guidelines for effective school health education to prevent the spread of aids. retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/00001751.htm 17 abdel-tawab, nahla, and sahar hegazi. rep. critical analysis of interventions against fgc in egypt. washington d.c.: population council, 2000. https://knowledgecommons.popcouncil.org/cgi/viewcontent.cgi?article=1028&context=departments_sbsr-rh. 18 abdel-tawab, nahla, and sahar hegazi. rep. critical analysis of interventions against fgc in egypt. washington d.c.: population council, 2000. wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) * leslie e. wolf, j.d., m.p.h., university professor and professor of law at georgia state university college of law pooja parikh, b.b.a. georgia state university honors college in atlanta, georgia courtney anderson, j.d., ll.m., associate professor of law at georgia state university college of law paul a. lombardo, j.d., ph.d., regents’ professor and the bobby lee cook professor of law at georgia state university college of law © 2022 wolf et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. engaging diversity: a new approach to bioethics teaching leslie e. wolf, pooja parikh, courtney anderson, paul a. lombardo* abstract recent events have caused the field of bioethics to reflect on its failure to tackle topics tied to structural racism and lack of diversity. we developed a model undergraduate bioethics course to demonstrate the importance of bioethics in diverse communities and encourage students from many backgrounds to consider careers in bioethics. this paper describes our approach to course development, student experiences, and lessons. acknowledgments: this work was supported by a grant from the greenwall foundation. the content is solely the responsibility of the authors and does not necessarily represent the official views of the greenwall foundation. keywords: diversity, bioethics, course, curriculum, inclusion, justice, education, structural racism introduction the covid-19 pandemic and the racial reckoning following the high-profile killings of unarmed black people in the summer of 2020 prompted discussion and reflection about diversity – or the lack thereof – in bioethics. commentators have criticized the field for its failure to tackle topics tied to structural racism and wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) 2 its impact on the health and well-being of people of color. the work of diverse scholars is often overlooked or not identified within bioethics.1 conversations about structural racism were taking place at the same time we were developing a model undergraduate bioethics course that aimed to demonstrate the relevance of bioethics to diverse communities with the hope of encouraging students from diverse backgrounds to consider careers in bioethics. traditional bioethical teaching may seem disconnected from the experiences of diverse students and their communities. quintessential bioethics issues, like informed consent and advance directives, are predicated on assumptions about how patients access health care and interact with doctors. those interactions and assumptions may be inconsistent with the lived experiences of students and their families. housing or structural issues, like the prison industrial complex, are often not addressed in bioethics curricula. in developing our course, we sought to provide a firm grounding in bioethics, while introducing a broader array of topics, highlighting the work of diverse scholars, and focusing more attention on the principle of justice. while one of our goals in creating this course was to inspire diverse students to pursue bioethics, we recognized that most students will not. nevertheless, we suggest exposure to bioethical principles and analysis would prove beneficial to all students and could lead to positive outcomes, regardless of their chosen careers. we decided to focus on an undergraduate course with the intention of increasing diversity in the pipeline of students considering additional studies in bioethics before applying to graduate school. we started this work in 2019 and taught our first course in the spring of 2020. we did not anticipate that course would unfold within the context of a global pandemic and a racial reckoning that would bring pervasive systemic inequities to the forefront of bioethical discussions. but those circumstances underscored the need for teaching bioethics in a more inclusive way. i. core principles in course approach several core principles guided our course development. first, in addition to identifying topics with greater relevance to diverse communities, we wanted to tap into our students’ perspectives. we explicitly recognized the importance of our students’ lived experiences to our discussions. we invited students to share their experiences, as they felt comfortable, in class discussions and assignments. we engaged the students through short written and oral assignments. we also used peer commentary to develop our students’ appreciation of their own expertise. we acknowledge that, despite our intentions, we did not always meet our goals. we attribute our shortcomings to the persistence of old habits like lecturing rather than inviting more active learning, as well as the challenges of rapidly moving the class online. second, when we selected course materials, we highlighted the work of diverse scholars in our readings, video selections, and guest lecturers. given that traditional bioethics discusses diverse communities primarily in the context of scandals like the tuskegee study of untreated syphilis in the negro male, we sought to identify examples of bioethics research that has a positive impact on diverse communities. we asked our guest lecturers to talk not only about their work, but also their career paths and personal experiences, creating additional models for our students. as an extension of this project, we recruited additional diverse scholars to create videos about ten minutes in length that are particularly well-suited to classroom use. the videos have been made publicly available.2 wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) 3 ii. course content we believe that our course material and how it was delivered contributed to our students’ experience in the course. it was critical that students understood traditional bioethical concepts. at the same time, we were expanding that curriculum. accordingly, we started with traditional bioethics curriculum and readings and evaluated where we could introduce new cases, readings, perspectives, and topics. as in a traditional course, our students learned the dominant bioethics theories and principles and discussed topics like the doctor-patient relationship, rationing, consent, and confidentiality. however, our students also explored the concept of capacity in the context of the criminal justice system and the various ways the private prison and probation industry systemically abuse marginalized populations. additionally, students learned about the laws and policies surrounding housing and welfare systems that adversely affect impoverished populations and the resulting stigmatization. the covid-19 pandemic introduced additional curriculum topics including the differential impact of the pandemic on diverse communities within the united states and globally. in this section, we provide specific examples of our approaches, with more detail in the annotated version of our syllabus (appendix 1) and additional resources (appendix 2). for course materials, we chose a mix of traditional and contemporary bioethics articles, legal cases, articles from the news, and videos from various sources. these materials exposed students to foundational bioethical materials, while offering additional perspectives for a more complete view that illuminates areas in need of reconsideration, expansion, or change. for example, the first class explored the ethics of doctorpatient relationships by discussing health challenges experienced by serena williams during childbirth. using the counter-storytelling technique developed to illuminate diverse perspectives, students learned about the health disparities that black women experience during pregnancy and birth across the socioeconomic spectrum and explored the systemic factors that contribute to those poor health outcomes. students also watched a video, the sad life of the caged teen,3 that tells the story of a man who, after his family was killed in what was then the belgian congo, was enslaved and put on display in america. it vividly demonstrates how race-based beliefs and behaviors led to persisting systemic disparities. in contrast, traditional bioethics videos including who shall live? seattle god committee4 introduced students to the perennial bioethics problem of rationing, but also demonstrated – visually and through description – the lack of representation in many such bodies. our students also read the landmark welfare case, wyman v. james, that established the rule that home visits for confirmation of eligibility for social services are not “searches” under the fourth amendment.5 the court concluded that these home visits were voluntary because individuals could refuse, even though those who refused such a visit would be ineligible for the needed case benefits. we used this case to challenge students to consider how context can affect our understanding of informed consent and voluntary action. similarly, students read an article about the settlement of a case following kalief browder’s suicide after spending two of three years in solitary confinement in rikers island jail while awaiting trial for allegedly stealing a backpack. 6 this case forced students to confront the consequences of removing personal autonomy, as well as issues surrounding racism and mental health. we used a variety of stories to demonstrate how power dynamics and cultural differences in the healthcare, penal, and other systems can impact individuals and disadvantage communities, with long-term, systemic consequences. in keeping with our goal of tapping into students’ expertise, we asked students to select a topic to explore in both a reflective essay and a more in-depth research paper. the topics our students selected reflected issues related to criminal justice, immigration, access to medical care, and discrimination in medical treatment. their personal experiences and those of their communities informed their selection and wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) 4 analysis. our students also engaged in structured peer reviews, which, judging from their comments when providing updates on their progress, provided valuable, constructive feedback that informed their final projects. we regularly asked our students to share their findings with the class, which allowed for focused attention on topics that our students considered important and for greater peer-to-peer learning. finally, we spoke directly about our goals for the course and our desire to support our students in their career goals, whether they were interested in pursuing bioethics as a career. we also asked guest lecturers to talk about their own career trajectories, including challenges they faced, to provide models for our students. some of our students reached out to us to discuss their futures, seek advice about graduate or professional school, request letters of recommendation, learn more about our work, and ask us to connect them to others. many of our students already had plans for graduate school, and the small class size may have contributed to their willingness to approach us. nevertheless, our express invitation and stated commitment to supporting them may have helped our students overcome inhibitions about making requests of us. iii. student experience we offered the course twice, in spring 2020 and spring 2021, through the honors college at georgia state university (gsu) in atlanta, georgia. gsu is a national leader in enrolling and graduating students from historically disadvantaged populations. of the 51,000 students currently enrolled at gsu, 68 percent of the students are non-white, 58 percent are eligible for pell grants, and a majority are the first in their families to go to college. students graduate at similar rates, regardless of race, ethnicity, or socioeconomic status.7 the honors college reflects the broader georgia state student body. in the first year, the class of 16 included five black students and four asian students. in the second year, the class of 10 had six asian students and three black students. students included undergraduate sophomores, juniors, and seniors at gsu, whose majors spanned the health sciences, social sciences, business and technology, mathematics, liberal arts, and arts. these students were intrinsically motivated to take this course ― most of them had an interest in learning more about bioethics. one student stated, “i registered for this course hoping to access material and professionals that could help educate me and provide insight that will improve my own decision-making processes to be more considerate of bioethical dilemmas.” we geared the course toward high-performing students, with the objective of providing students with a better understanding of how bioethics affects their area of study. unsurprisingly, a number of the students already had plans for graduate or professional school. during both semesters we taught the course, we surveyed the students during the first week of class and after they completed the course providing a $20 gift card as an incentive to complete the survey. we refer to the survey as it was one way to gauge the program’s success from the viewpoint of the students. the georgia state university institutional review board deemed this research exempt under 45 cfr §46.104(d)(2)(ii). twenty-three of twenty-six (88 percent) completed the pre-course survey (fourteen of sixteen (87.5 percent) in 2020 and nine of ten (90 percent) in 2021); nineteen students of twenty-six (73 percent) completed the post-course survey (ten of sixteen (62.5 percent) in 2020 and nine of ten (90 percent) in 2021). the lower completion rate during the first year of the course may reflect the disruption resulting from the rapid pivot to online teaching in march 2020. in 2021, the course we planned and taught a hybrid course. additionally, students were not required to answer all questions, resulting in different response rates by question and by preand post-course surveys. wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) 5 the survey consisted primarily of questions graded on a likert scale, where one represented a strong agreement with the statement, two agreement, three disagreement, and four strong disagreement. despite not providing an option for “neither agree nor disagree,” our enterprising students found a way to select that option. we saw a positive change between the pre-course and post-course survey scores for the statement, “i understand what bioethics means.” although students expressed uncertainty in the pre-course survey (mean of 2.5, range of 2-4), student scores reflected an improved confidence in their understanding of what bioethics means by the end of the course (mean of 1.1, range of 1-2). similarly, students who completed both the preand post-course surveys expressed greater confidence that they could “identify at least three topics within bioethics” (average change of 1.45 from pre-course mean of 2.46 to post-course mean of 1). although students started with a favorable view of bioethics (pre-course mean = 1.92), their views were more positive at the end of the course (post-course mean = 1.25). we saw similar, small positive shifts in students’ view of the relevance of bioethics to their own lives (+.23), and their communities (+.68), but they started with positive views with little room for additional increase. students’ agreement with the statement “i could see incorporating bioethics in my career” increased slightly from the preto post-course survey (pre-course mean 1.8, post-course mean 1.18). we also asked two open-ended questions: (1) what does bioethics mean to you? and (2) why do you view bioethics favorably or unfavorably? in the pre-course survey, students commonly defined what bioethics meant to them as involving issues related to medicine, health, technology, and biology. for example, one student said that “bioethics means to me as ethical issues that arise from medical and/or biological practices and/or research.” another said, “it has to do with the intersections between ethics, science, and medicine.” only one student mentioned justice, referring specifically to discrimination. however, in the post-course survey, students’ conceptions of the meaning of bioethics were broader (e.g., “medicine, research, policy, and daily life” and “medical, political, or other systematic treatment of people” “our lives” and “not only . . . the healthcare system, but . . . other systems”). in addition, multiple students specifically referenced justice or equity. for example, one student described bioethics as “the study of ethics issues in cases . . . involving the medical, political, or other systemic treatment of people. the goal of studying bioethics is to learn where these issues and injustices stem from so that they can be corrected, hopefully leading to new guidelines for the betterment of individuals and groups.” they also saw broader application of bioethics principles and approaches. for example, contrast what student f said pre-course (above) with the following post-course survey: “bioethics means the study of ethical issues emerging in the biological and medical fields of policy. however, bioethics can be applied to any field, including law, policy, research, and/or public health.” similarly, student n stated, “an aspect of bioethics is present in every community crisis and not only pertains to healthcare. bioethics ties morals to all parts of the community from law, policing, education, housing, etc.” in post-course surveys, students noted that bioethics can illuminate complex issues with diverse perspectives, helping move society forward. students’ explanations for their favorable view of bioethics after completing the course also reflect their view of the broader application of its principles and approaches. one student described it as “a useful lens for viewing many societal issues” (student a); another commented that “bioethics reminds us that situations are multi-colored and -sided, and things are more complex than simple” (student b). finally, several students commented on bioethics’ role in bringing disparities and other injustices to light. wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) 6 we are cognizant that we are dealing with a small, self-selected group. however, these responses suggest that our approach to the course opened students’ minds to the scope of bioethics and its relevance to a broader range of topics that are relevant to their lives. iv. discussion overall, our efforts to engage diverse students and demonstrate the relevance of bioethics to diverse communities was successful. working together and taking advantage of our combined expertise enabled us to teach a course that provides a strong foundation in bioethics that considers additional factors linked to profound and disparate health effects. the data demonstrate some evidence of a small positive change in the students’ view of bioethics and its relevance to their communities. the high scores at both the beginning and end of the course probably reflect the selection bias inherent in an elective course. some of them are considering how to use their new insights in their careers. because of the dominance of white scholars in the field, we could not rely only on “classic” pieces. we saw the need for a new curriculum as the syllabi we had used for years did not address structural racism or include diverse voices. we did not abandon “classic” pieces entirely, but rather thought about each piece and what other materials could and should be included to expand our understanding. we aimed to add context to the pieces and make them relatable to the students. one of our stated goals was to recognize and empower our students as experts, in part by creating opportunities for discussion and limiting times where we lectured (avoiding the “sage on the stage” presentation style). our survey results suggest our class engaged our students, but there is still room for improvement. the rapid pivot to online only in spring 2020 and the decision to offer the course in a hybrid format in spring 2021 likely led to more lecturing than we would have planned. there was little time to deploy best practices for online learning, and even the best online (or hybrid) courses were disrupted by technological issues. the burdens of the pandemic on students, including physical and mental illness, trauma, loss, and caregiving responsibilities all provided more challenges. we suggest that designing the course to allow students to take responsibility for part of class sessions provides a consistent, more active role that fosters engagement. we suggest having instructors provide the relevant background for a topic to enable the student leading the discussion the following week to prepare. for example, if the first topic of discussion is the principle of autonomy, the professor should start that week’s course addressing the principle of autonomy, what it means, and how it plays a role in society, etc. based on that and the readings, a student chosen in advance would lead a discussion that stimulates critical thinking and elicits perspectives from their classmates. the student would develop open-ended questions (some of which could be suggested by their classmates) that allow for exploration of the topic, as well as share examples, stories, etc. to help further illustrate the topic. the student may also ask classmates to role-play, play devil’s advocate, or take some other approach that they think will engage their classmates. this structure allows students to play different, vital roles during class, gives them an opportunity to shape their learning, and creates another opportunity for students to work with the instructors. conclusion in sum, we were successful in developing an engaging bioethics class that highlighted the work of diverse scholars and demonstrated the relevance of bioethics to diverse students. we share our experience, our approach, and our resources in the hopes that other bioethics teachers will seek to diversify their coursework. we firmly believe such efforts are necessary to broaden the field and create a more inclusive wolf et al., engaging diversity, voices in bioethics, vol. 8 (2022) 7 bioethics and, thus, better address the complex issues we face. our work is simply the beginning, and we will continue to advance these goals. 1 clarence h. braddock, 3rd, “racism and bioethics: the myth of color blindness,” american journal of bioethics 21 (2021): 28; jessica p. cerdena, “race-conscious bioethics: the call to reject contemporary scientific racism,” american journal of bioethics 21 (2021): 48; stephen estime & brian williams, “systemic racism in america and the call to action,” american journal of bioethics 21 (2021): 41; paul macneill, et al., “bioethics as engaged activity,” american journal of bioethics 21 (2021): 64; keisha ray, “black bioethics and how the failures of the profession paved the way for its existence,” the hastings center bioethics forum, accessed june 16, 2022 https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-professionpaved-the-way-for-its-existence/; keisha ray, “in the name of racial justice: why bioethics should care about environmental toxins,” hastings center report 51 (2021): 23; jenny reardon, “why and how bioethics must turn toward justice: a modest proposal,” hastings center report 50 (2020): s70; patrick t. smith, “racism, broadly speaking, and the work of bioethics: some conceptual matters,” american journal of bioethics 21 (2021): 7; yolanda y. wilson, “racial injustice and meaning well: a challenge for bioethics,” american journal of bioethics 21 (2021): 1; ruqaiijah yearby, race based medicine, colorblind disease: how racism in medicine harms us all, american journal of bioethics (2021): 19. 2 bioethics: inclusive voices. georgia state university, college of law, reading room. https://readingroom.law.gsu.edu/bioethics/ 3 “the sad life of the caged teen | ota beng,” accessed june 16, 2022 https://www.youtube.com/watch?v=klql6d3vn2c. 4 “who shall live? seattle god committee” (1965), accessed june 16, 2022 https://www.youtube.com/watch?v=fmay5zw1loa. 5 wyman v. james, 91 s.ct. 381 (1971). 6 benjamin weiser, “kalief browder’s suicide brought changes to rikers. now it has led to a $3 million settlement,” new york times, january 24, 2019 https://www.nytimes.com/2019/01/24/nyregion/kalief-browder-settlement-lawsuit.html. 7 richard fausset, “georgia state, leading u.s. in black graduates, is engine of social mobility,” new york times, may 15. 2018, https://www.nytimes.com/2018/05/15/us/georgia-state-african-americans.html; georgia state university, “student success programs,” accessed june 16, 2022 https://success.gsu.edu/. “2018 status report, georgia state university complete college georgia,” accessed june 16, 2022 https://success.gsu.edu/download/2018-status-report-georgia-state-university-complete-collegegeorgia/?wpdmdl=6472128&ind=1536948724169. https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-profession-paved-the-way-for-its-existence/ https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-profession-paved-the-way-for-its-existence/ https://readingroom.law.gsu.edu/bioethics/ https://www.nytimes.com/2019/01/24/nyregion/kalief-browder-settlement-lawsuit.html https://success.gsu.edu/ https://success.gsu.edu/download/2018-status-report-georgia-state-university-complete-college-georgia/?wpdmdl=6472128&ind=1536948724169 https://success.gsu.edu/download/2018-status-report-georgia-state-university-complete-college-georgia/?wpdmdl=6472128&ind=1536948724169 wang, early response to covid-19, voices in bioethics, vol. 8 (2022) * jennifer wang, ms columbia university © 2022 jennifer wang. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. early response to covid-19: a pre-vaccine policy comparison jennifer wang* keywords: global response, covid-19, public health policies, pandemic, global ethics, strategy introduction when the covid-19 pandemic swept the globe, governments and healthcare systems scrambled to control it. while most of the global public health community agreed that actions against the covid-19 pandemic needed to be prompt and efficient, there were disagreements on what those actions should be. some governments opted to adopt a containment strategy while others implemented mitigation measures; each had reasons to support their course of action, whether rooted in governmental structures, scientific findings, beliefs, or ethical and moral values. however, the dramatically different response strategies may have led to disparate results. this divide is furthered when ethical and moral values and cultural norms are added to this equation. in this paper, i will examine china and korea, two countries that implemented a preventative containment strategy, and the united states of america and the united kingdom, which adopted mitigation strategies. i will examine the differences in their outcomes and whether there is a “correct” response to pandemics like covid-19. i. response in china and korea after its initial discovery in december 2019, covid-19 rapidly spread beyond china to surrounding countries, including south korea, japan, and singapore. china implemented swift measures drawing on its experience with the sars outbreak. measures included lockdowns, contact tracing, testing all individuals exposed to the virus, and consequently enforcing isolation and quarantine provisions.1 during the early stages, the public health systems and the national government moved to a “health care to all” system to avoid nationwide spread. the government and all sectors of society were mobilized to track, contain, and adapt to the overall state of the epidemic.2 covid-19 continued and spread in china during lunar new year wang, early response to covid-19, voices in bioethics, vol. 8 (2022) 2 celebrations when population movement within the country was at its peak. thus, wuhan entered lockdown to control the number of infected people leaving the city to contain the virus;3 even in areas where there were few to no cases, the general population of china voluntarily abided by measures like those implemented in wuhan. the measures included wearing masks, social distancing, and following stayat-home orders. furthermore, healthcare workers from all over the country volunteered to travel to hubei, where wuhan is, and assembled several fangcang shelter hospitals.4 fangcang hospitals were designed based on emergency medical care cabins that were used after two devastating earthquakes in china and served as temporary quarantine housing and hospital facilities.5 they are mobile, have fast deployment, and can adapt quickly to different environments. at the start of the pandemic, wuhan converted gymnasiums, convention centers, sports arenas and training centers, factories, and other venues into fangcang hospitals. although temporary, these quarantine hospital facilities were equipped with full medical equipment and personnel, allowing for complete medical functions for “treatment, disease monitoring, diagnosis and other clinical tasks.”6 teams of psychologists were also assigned to each hospital to provide counseling for patients.7 beyond separating those who were infected from the rest of the population and thus having more control over the community spread of the virus, fangcang hospitals played a vital role in reducing patient density in traditional hospitals and medical centers by expanding treatment capacities.8 south korea reported its first covid-19 case in january 2020, and, within days, the government activated the central disaster and safety countermeasures headquarters. 9 similar to china, south korea used existing epidemic protocols and implemented the 3ts strategy, prioritizing testing, tracing, and treatment.10 high-capacity screening facilities and working with the private sector to ensure an adequate supply of tests made south korea’s efforts successful.11 the south korean government strictly regulated self-isolation and quarantine. contact tracing efforts used various data sources, “including credit card transactions and closed-circuit television footage.”12 the government also placed stringent restrictions on travel, beginning with designated entry lines and questionnaires, but expanding to include temperature checks, testing for all travelers at the border, and a mandatory fourteen-day monitored quarantine for anyone entering the country.13 the majority of the population responded immediately with compliance, with national weekly movement decreasing by 38 percent between february 24, 2020, and march 1, 2020, compared to the corresponding week the previous month. schools swiftly closed across the nation, and the entire country transitioned to remote learning until the gradual reopening in may and june 2020.14 there was some discontentment within the population, especially with the south korean government’s practice of publicly announcing the names of individuals who tested positive.15 critics of this practice say it is an infringement of patient privacy and can even be viewed as an invitation to public bullying.16 however, even with some dissatisfaction with government regulations, a survey of 1,200 south koreans in september 2020 asking people to agree if they were satisfied with the government’s response showed that the overwhelming majority either agreed or strongly agreed (44.08 percent and 19.75 percent, respectively), and less than 20 percent of the respondents either disagreed or strongly disagreed (11.50 percent and 5.08 percent, respectively).17 regulations surrounding isolation and quarantine were strict and applied to those with confirmed cases of covid-19, anyone who traveled internationally, or individuals suspected to be infected. individuals were required to use the self-quarantine safety protection app that tracked location for fourteen days to ensure that quarantine protocols were followed.18 case officers monitored the app, and violators not only faced a wang, early response to covid-19, voices in bioethics, vol. 8 (2022) 3 substantial fine but were also required to wear electronic wristbands that would alert the officers if the individual left the location of their mobile device.19 ii. the western response: the uk and us covid-19 was reported in many western nations around january 2020. however, unlike south korea, many countries did not immediately respond to the outbreak with surveillance and containment strategies but had a wait-and-see approach. as the pandemic worsened, they gradually adopted mitigation strategies to combat the disease as it progressed. while the us adopted a combination of containment and mitigation strategies, a concrete response from state and federal governments did not occur until march 2020.20 even then, many states did little to address the pandemic. although equipped with a robust healthcare system, a shortage of ventilators and hospital beds became evident in some localities early on. the us healthcare system failed to acknowledge the pandemic and prepare a coordinated response in time to stop the momentum of the disease.21 the goal became “flattening the curve” (keeping the number of cases that needed hospital care low enough to avoid overwhelming the hospital system) as it was clear containment would be impossible. once tests were developed, poor coordination of testing efforts and insufficient resources to test at the necessary scale to provide comprehensive national surveillance of the disease further hindered efforts to contain infected individuals and decelerate its spread.22 eventually, regulations and mitigation measures were implemented, including mask mandates, school closures, caps or bans on in-person gatherings, and the closure of non-essential businesses. 23 however, enforcement of these measures proved difficult, and people instigated protests against many of the recommended policies and requirements. the uk and the us both encountered a shortage of personal protective equipment for healthcare workers.24 however, a more prominent problem arose from the uk’s initial response to the pandemic. the uk first said covid-19 was like influenza and therefore did not call for emergency measures to deter its spread.25 furthermore, in the first few weeks of the pandemic, the uk government believed herd immunity was the best course of action, stating that most people would have mild symptoms,26 and the population would become mostly immune to the virus once enough people were infected.27 in theory, herd immunity was a potentially effective strategy. the public health authorities thought that if the threshold for herd immunity was reached, enough people would have developed protective antibodies against any future infection. 28 however, the risks of covid-19 were high and the cases “would lead to high rates of hospitalization and need for critical care, straining health service capacity past the breaking point.” 29 furthermore, while getting covid-19 would offer some natural immunity against reinfection, reinfection remained a possibility, especially during the early stages of the pandemic when vaccines were unavailable.30 later, when vaccines were available, a study showed that an unvaccinated person who contracted the virus was more than twice as likely to become reinfected than a fully vaccinated person.31 the uk government also expressed concern for “behavioral fatigue.”32 it claimed that if restrictions were enforced pre-emptively and prematurely, people might become progressively “uncooperative and less vigilant.”33 regarding the concern for “behavioral fatigue,” numerous behavioral scientists stated that they were unconvinced that this reason was enough to hold off implementing restrictions. there was a lack of evidence of this phenomenon, and a group of 681 uk behavioral scientists said in an open letter that “[s]uch evidence is necessary if we are to base a high-risk public health strategy on it.”34 fortunately, this strategy only remained under consideration for a short period. after rapid increases in confirmed cases and deaths due to covid-19, the uk government implemented more strict measures, like city lockdown, school wang, early response to covid-19, voices in bioethics, vol. 8 (2022) 4 closures, and the closure of non-essential businesses.35 these restrictions took legal effect on march 26th, 2020 – around two weeks after the first proposal of the “herd immunity” strategy.36 iii. comparing the two approaches the eastern and western countries experienced significant outbreaks of covid-19. however, looking at the mortality rate and new confirmed cases, the differences between the two categories of response to covid-19 are significant. as of december 31, 2020, the mortality rate per 100,000 population for china and south korea were 0.3 and 1.8, respectively, and new confirmed cases per day per 100,000 population were 87 and 1,029, respectively. however, the mortality rates per 100,000 in the us and the uk were 107 and 108, respectively, and they had up to 234,133 and 56,029 new confirmed cases every day, respectively.37 as of july 2022, total deaths in china were 22, 99438 (population 1.45 billion)39 and in south korea 24,794 40 (population 51.36 million) 41 compared to 1,015,093 42 in the us (population 335.03 million)43 and 182,72744 in the uk (population 68.62 million).45 further differences can be seen in the varying sectors of society, such as healthcare systems and authority models, political structures, and cultural customs among these countries, which in turn affect the response and control strategies. 46 in the us and the uk, rights-based political structures affected the response, making tracking and surveillance more problematic early on. but western countries did have strict lockdowns and quarantines. china and south korea maintained a proactive approach by “identifying and managing cases, tracking and isolating close contacts, and strictly restricting or controlling population movement when feasible and appropriate.”47 in contrast, the uk implemented nationwide lockdowns early on, and the us restrictions varied among states. both the uk and the us focused on treating the severe cases and those with underlying conditions rather than proactively preventing new cases from developing in the early pandemic.48 they did shift gears to mass testing schemes and attempts to slow transmission. by the time they implemented cohesive strategies, covid-19 was widespread. due to their slow initial responses, they needed to manage an onslaught of cases while trying to prevent transmission. iv. ethical implications the “west vs. rest” culture divide emerges when comparing the covid-19 response strategies of east asian countries to those of western countries. the differences in their strategies further highlight the differences in the prevailing moral values influencing public policy. the preventative stance adopted by many east asian countries shows a stronger collective identity among citizens. but it also may show more substantial governmental power and less appetite for protest. in contrast, the mostly non-interfering nature of western governments’ actions shows a reliance on the “autonomous and unanimous responsibility of individuals.”49 the moral values in the us also may reflect the prioritized position of personal rights and the suspicion of intrusive government policies. culturally, the populations of south korea and china are generally more tolerant of personal data-sharing and monitoring, suggesting there is less concern for autonomy or privacy. however, many people in the us and uk would consider the use of location tracking apps and electronic bracelets to be violations of individual autonomy and privacy.50 sectors of the western world also argue that mandating masking or social distancing imposes on individual autonomy and free will. mask-wearing was an existing practice in east asian countries, even without mandates or pandemics. individuals wear masks for common colds and influenza and do not consider a mask requirement an infringement of their autonomy. furthermore, whether it is due to the authoritarian nature of the government or not, there is a general tendency toward public compliance and accepting government policies in many east asian countries,51 and the lack of public wang, early response to covid-19, voices in bioethics, vol. 8 (2022) 5 dissent played an important part in making combating covid-19 easier for countries like china and south korea. the lack of initiative from western nations arguably violates the bioethical principles of beneficence and nonmaleficence.52 for example, the promotion of the “herd immunity” strategy from the uk government and consequently the government’s inaction, risked the well-being of its citizens. the government failed to avoid the harm that covid-19 brought. similarly, by delaying its response until nearly two months after the initial case was reported, the us also violated the principle of non-maleficence. the success seen in south korea and china during the early pandemic better exemplifies beneficence and nonmaleficence. the strategy of contact tracing and strict containment saved lives. the consequences of the restrictions varied across the countries as well. not everyone can afford to selfisolate or quarantine and being required to do so can significantly impact many individuals’ well-being. furthermore, not everyone’s occupation allows them to work from home and business closures disadvantaged portions of the population disparately. for those who are essential workers, school closures may also burden parents who do not have access to affordable childcare. the stringent restrictions regarding quarantine and self-isolation in east asian countries also harmed people disparately, raising problems surrounding the principle of justice. however, the speed at which china had covid-19 contained allowed people there to return to their normal lives quickly. compared to some western countries’ waves of lockdown and reinforcement of restrictions, the “zero-covid” strategy in countries like china showed success, at least during the early stages of the pandemic. the contact tracing and containment was likely financially beneficial. while the pandemic resulted in substantial economic growth downgrades and global recessions, regions like east asia were estimated to grow by around 0.5 percent. in comparison, the economy in regions like europe contracted by around 4.7 percent.53 conclusion china arguably had an advantage in combating covid-19 since the outbreak was relatively concentrated in one region. this allowed early detection of symptoms and quick containment of the virus. other countries, like the us, had new cases on both coasts early in the pandemic; thus, containment was more challenging than it was in china. however, the delayed and reluctant response from countries like the us and the uk did not benefit the well-being of their populations and proved to put more stress on their healthcare systems. while mass tracking of people is politically contentious, the promptness of actions many east asian countries employed at the beginning of covid-19 seemed to be the more effective course of action that best protected the well-being of their citizens. 1 chen, haiqian, et al. “response to the covid-19 pandemic: comparison of strategies in six countries.” frontiers in public health, vol. 9, september 30, 2021, pp. 1-11. doi: 10.3389/fpubh.2021.708496. 2 chen, et al. 3 chen, et al. 4 chen, et al. 5 wang, ke-wei, et al. “fangcang shelter hospitals are a one health approach for responding to the covid-19 outbreak in wuhan, china.” one health, vol. 10, august 29th, 2020, pp. 1-6. doi: 10.1016/j.onehlt.2020.100167. https://www.sciencedirect.com/science/article/pii/s2352771420302688. wang, early response to covid-19, voices in bioethics, vol. 8 (2022) 6 6 wang. 7 wang. 8 wang. 9 kim, june-ho, et al. “emerging covid-19 success story: south korea learned the lesson of mers.” our world data, university of oxford, march 5, 2021. https://ourworldindata.org/covid-exemplar-south-korea. 10 chen, haiqian, et al. 11 kim, et al. 12 kim. 13 kim. 14 scott, dylan and jun michael park. “south korea’s covid-19 success story started with failure.” vox, april 19, 2021. https://www.vox.com/22380161/south-korea-covid-19-coronavirus-pandemic-contact-tracing-testing.. 15 scott and park. 16 rich, timothy s., et al. “what do south koreans think of their government’s covid-19 response?” the diplomat, october 7, 2020. https://thediplomat.com/2020/10/what-do-south-koreans-think-of-their-governments-covid-19-response/. 17 rich, et al. 18 kim, et al. 19 kim, et al. 20 chen, et al. 21 chen, et al. 22 chen, et al. 23 chen, et al. 24 chen, et al. 25chen, et al. 26 chen, et al. 27 o’grady, cathleen. “the u.k. backed off on herd immunity. to beat covid-19, we’ll ultimately need it.” national geographics, march 20, 2020. https://www.nationalgeographic.com/science/article/uk-backed-off-on-herd-immunity-to-beat-coronavirus-weneed-it. 28 “herd immunity and covid-19: what you need to know.” mayo clinic, april 20, 2022. https://www.mayoclinic.org/diseasesconditions/coronavirus/in-depth/herd-immunity-and-coronavirus/art-20486808?p=1. 29 o’grady. 30 o’grady. 31 mayo clinic, april 20, 2022. 32 yong, ed. “the uk’s coronavirus ‘herd immunity’ debacle.” the atlantic, march 16, 2020. https://www.theatlantic.com/health/archive/2020/03/coronavirus-pandemic-herd-immunity-uk-boris-johnson/608065/. 33 yong. wang, early response to covid-19, voices in bioethics, vol. 8 (2022) 7 34 harvey, nigel. “behavioral fatigue: real phenomenon, naïve construct or policy contrivance?” frontiers in psychology, vol. 11, november 6, 2020. doi: 10.3389/fpsyg.2020.589892, quoting a march 16, 2020 open letter to the uk government. 35 chen, et al. 36“timeline of uk coronavirus lockdowns, march 2020 to march 2021.” institute for government analysis. https://www.instituteforgovernment.org.uk/sites/default/files/timeline-lockdown-web.pdf. 37 chen, et al. 38 “china: who coronavirus disease (covid-19) dashboard.” world health organization, 2022, https://covid19.who.int/region/wpro/country/cn. 39 “china population.” worldometer, 2022, https://www.worldometers.info/world-population/china-population/. 40 “the republic of south korea: who coronavirus disease (covid-19) dashboard.” world health organization, 2022, https://covid19.who.int/region/wpro/country/kr. 41 “south korea population,” worldometer, 2022, https://www.worldometers.info/world-population/south-korea-population/. 42 “the united states of america: who coronavirus disease (covid-19) dashboard.” world health organization, 2022, https://covid19.who.int/region/amro/country/us. 43 “united states population,” worldometer, 2022, https://www.worldometers.info/world-population/us-population/. 44 “the united kingdom: who coronavirus disease (covid-19) dashboard.” world health organization, 2022, https://covid19.who.int/region/euro/country/gb. 45 “u.k. population,” worldometer, 2022, https://www.worldometers.info/world-population/uk-population/. 46 chen, et al. 47 chen, et al., p 6. 48 chen, et al. 49 festing, marion, tobias schumacher and yong-yueh lee. “how cultural norms and values shape national responses to the covid-19 pandemic.” the london school of economics and political science, april 15, 2021. https://blogs.lse.ac.uk/businessreview/2021/04/15/how-cultural-norms-and-values-shaped-national-responses-to-the-covid-19pandemic/. 50 festing, et al. 51 festing, et al. 52 beauchamp, tom l. and james f. childress. principles of biomedical ethics. (new york: oxford university press, 2009). 53 “the global economic outlook during the covid-19 pandemic: a changed world.” the world bank, june 8, 2020. https://www.worldbank.org/en/news/feature/2020/06/08/the-global-economic-outlook-during-the-covid-19-pandemic-achanged-world. cable, false hopes, voices in bioethics, (2013) © 2013 jennifer cable. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. false hopes, informed consent: the problem of therapeutic misconception and stage i clinical trials jennifer cable keywords: clinical trials, dying, therapeutic misconception introduction in america, with our closely held values of optimism and perseverance, we are very often loath to confront death and dying; cancer patients are told to fight, to hold on to a positive attitude, to nurture faith and hope. our doctors are trained to heal us, to cure us, but rarely to gently guide us toward accepta nce of our own mortality. we will grasp at a chance, any chance, to keep fighting, to turn things around. we believe that medicine will aid us in this fight; never counsel us to give up fighting. and when we hear “probability,” we think, “a chance.” no issue so brightly illuminates these themes as the participation of terminal cancer patients in stage 1 clinical trials. having exhausted all other treatment methods, these patients are offered a chance to continue chemotherapy, with a new experimental regime. the researchers explain that the only purpose of a stage 1 trial is to determine appropriate dosing levels, and few patients, if any, will see any therapeutic benefit. while patients may fully understand the purpose of the trial, they simultaneously belie ve that they will be the exception, that they will reap the benefit. enrolling in the trial is an expression of hope for one’s future, not an expression of altruistic sacrifice . patients may have intellectually understood the purposes and demands of participation, but they have fundamentally misunderstood their chance of benefit from the study. analysis patients enrolling in many types of clinical trials can be affected by what has been termed therapeutic misconception. these patients confuse the goal of the trial with the goals of individual treatment: the goal of a clinical trial is to gather sufficient data over a population; the goal of a clinical intervention is to provide benefit to the individual patient. the patient as subject mistakenly believes that the goal of the trial is to provide treatment that will be beneficial in treating the patient’s illness. in a stage 1 clinical trial, as in a placebo control trial, this misconcepti on is troubling due to the strong possibility that the individual patient will not receive the intervention in sufficient dosage to be effective, if he receives it at all. when a patient enrolls in such a study because he has exhausted all other options, and is terminally ill, the moral dimensions of therapeutic misconception and its impact on informed consent must be addressed. in technical terms, the requirements of informed consent have been met; researchers have informed the patient of the significant risks of enrolling in the trial and have explained that the likelihood of the patient receiving a direct benefit is very low. however, the patient is motivated to participate in the trial by a false hope in the possible benefit. even when a researcher is completely truthful, the layperson’s understanding of the facts presented may be cable, false hopes, voices in bioethics, (2013) 2 colored by a psychological need to express hope, cultural expectations around illness (especially cancer), or an overestimation of the probability of benefit. sulmasy et al. distinguish between therapeutic misestimation, in which the patient has a h igh expectation of therapeutic benefit and incorrectly understands the probability of benefit, and therapeutic optimism, in which patients have a high expectation of therapeutic benefit but understand correctly that the aggregate probability of benefit is low.1 sulmasy et al. show that patients may not be engaging in a “full-fledged” version of therapeutic misconception (i.e., “the purpose of this trial is to cure ovarian cancer”), but instead overestimate the possibility of benefit, either on the whole or for themselves. however, patients reported that their primary motivation for enrolling in a stage 1 clinical trial was for an individual benefit, with a secondary altruistic motive to further research that will help others suffering from the same disease. although there is certainly a spectrum of therapeutic misconception, in all of these cases the researcher must confront the psychological and emotional components of participation in stage 1 clinical trials if fully informed consent is to be obtained. jansen et al. report that unrealistic optimism is also endemic in phase i, phase i/ii and phase ii clinical cancer trials, but it has no significant relationship to the participants’ understanding of the trials’ purpose (it is not “full -blown” therapeutic misconception); this suggests that patients can continue to engage in unrealistic optimism even after being fully informed and educated about the content of a trial. 2 kass et al. emphasize the importance of how oncologists use language to represent the trial to potential participants; in their survey of oncologists’ communication with patients about involvement in stage 1 clinical trials, they found that although oncologists explain that stage 1 trials only measure safety and dosing, they also refer to the trials as “treatment with uncertain therapeutic effects.”3 this resulted in 17 percent of patient respondents saying that the purpose of the study was to cure their cancer, with 17 percent correctly stating the purpose as measuring dosing and safety. researche rs concluded that this misconception could be addressed with more precise language on the part of clinicians and researchers. although these are all relatively recent studies, this is not a new issue in stage 1 clinical trials, as a recent survey of 25 yea rs of scholarship on this subject has shown.4 typical standards of informed consent in this case must be expanded to ensure that research is not conducted on terminally ill subjects whose consent is predicated on the false belief that they will benefit fro m participation. it is deeply troubling that such patients might spend their last years or months dealing with the inconvenience and pain of undergoing experimental treatment when there is no possibility of benefit, instead of spending that time with friends and family. some individuals would place a high value on contributing to research that furthers the scientific body of knowledge of their own disease, yet it’s more likely that most patients would not choose to spend their limited remaining time as subjects in clinical trials if they did not believe they might offer them some benefit. this raises an important question: is therapeutic misconception in some ways necessary to conduct stage 1 clinical trials, especially in oncology? is it therefore acceptable? i believe it is possible to both confront therapeutic misconception and continue stage 1 clinical trials. therefore, researchers and clinicians must address therapeutic misconception if stage 1 clinical trials are to be conducted ethically. some would argue that it might not make sense to confront therapeutic misconception if it is a powerful expression of hope and faith, or if it provides a psychological benefit to a patient. however, this sort of popular pseudo science (promulgated in bestsellers like the secret) has no basis in reality. coyne et al. showed, in a study of more than 1,100 participants with head and neck cancer, that emotional well-being is not correlated with better overall survival rates.5 more interesting is the argument that some patients may feel obligated to express optimism to support their families, or because of cultural expectations to “fight” cancer, or a belief that a positive attitude will lead to a positive outcome.6 if this is the case, optimism may be more performed than believed, and there is less of an ethical obligation for the researcher to confront it in the informed consent process. however, research consistently shows a sizable portion of patients continuing to engage in genuine therapeutic misconception, believing th at the purpose of the trial is to provide them with an individual benefit. cable, false hopes, voices in bioethics, (2013) 3 some say that it may not benefit individual patients to indulge in unrealistic optimism but it will benefit patients as a whole. there is, after all, a necessity to develop new treatments, especially in the area of terminal cancers. agrawal and emanuel argue that in fact patients sometimes do benefit from stage 1 clinical trials; it is not pure delusion on the part of the patient to enroll in a trial hoping for some personal benefit. 7 they write that patients with advanced cancer who enroll in stage 1 trials do so as an expression of their personal values, and that more than 70 percent of patients understand that they may not directly benefit, even if they hope that they will personally benefit. i believe the distinction between understanding and hope is a valid one, but agrawal and emanuel employ this language to argue against “the critics” of stage 1 clinical trials. i don’t believe that 70 percent is high enough to satisfy concerns of informed consent, and they do not adequately confront the ethical problems posed by therapeutic misconception. although i have focused mainly on the mind-set of the patient, researchers play a significant role in reducing or propagating therapeutic misconception. the role of language and communication in the conversations between oncologist and patient was discussed earlier; oncologists themselves presented trials as a sort of treatment, adding to the therapeutic misconception.8 researchers may be tempted to overlook therapeutic misconception expressed by their patients when enrolling patients in trials that will further their research. they may also genuinely believe that participation in the trial might positively affect their patients’ outcomes (as agrawal and emanuel argue that some stage 1 trials do). often, over years of work with a patient, an oncologist may come to closely identify with that patient’s struggle and encourage her onward, sometimes instilling in her a false hope for improvement. oncol ogists are human, and, like the rest of us, they find it difficult to confront the reality of death and dying; better to push patients to enroll in trials than inform them that there is little more to be done than make hospice arrangements. for both patien t and oncologist, if there is a chance, even if very slim, they will feel compelled to try. in experiments on man, henry beecher recommended that there be a clear separation between the roles of clinician and researcher if research is to be performed ethically. such a separation of roles when it comes to stage 1 clinical trials would help to combat therapeutic misconception. the patient must have a source of expert opinion whose aim is not the furthering of research but his health and well-being. by ensuring that no doctor is both researcher and clinician, we can more effectively guide patients to a full understanding of the burdens of participation and the slim probability of benefit. importantly, as independent parties, we can stress that the goal of trials is not to provide benefit to patient themselves (although this may be a fortunate side effect). further, palliative services should be available to patients before they decide to give up treatment (many insurance companies insist that patients be in full hospice care); professionals in palliative care could discuss end-of-life planning with patients and help them to decide if participation in a clinical trial is an appropriate use of their remaining time. a simple scale of independently administered questions for potential participants could test whether patients are engaged in therapeutic misconception; these patients could then have another information session about the trial, or they could be considered unsuitable subjects. institutional review boards should discuss this issue with researchers to ensure that all methods of informed consent address the problem of therapeutic misconception. conclusion some may argue that this will overburden an already highly bureaucratic system and increase the cost of developing new drugs, costs that would then be passed on to consumers and taxpayers. however, all of these recommendations make use of pre-existing resources in hospital and clinical settings. and the new healthcare law will require end-of-life counseling, through which more holistic and unbiased advice can be offered to the patient. in the end, our primary goal should be to satisfy the necessary conditions for ethical research. research methods and hospital bureaucracy should evolve to meet ethical requirements; ethics should not be distorted to fit the needs of cable, false hopes, voices in bioethics, (2013) 4 research or bureaucracy. by confronting the problem of therapeutic misconception, we can ensur e that consent is truly informed and that participation in stage 1 clinical trials is ethical. an ethical procedure for informed consent and enrollment in these trials is possible—a procedure that does not take advantage of individual patients’ false hopes for benefit or their reluctance to confront the reality of terminal disease—if several modifications are made to the existing system. 1sulmasy, d. p. et al., “the culture of faith and hope,” cancer 116, (2010): 3702–3711. doi: 10.1002/cncr.25201 2lynn a. jansen, paul s. appelbaum, william m.p. kelin, neil d. weinstein, william cook, jessica s. fogel, and daniel p. sulmasy, "unrealistic optimism in early-phase oncology trials," irb: ethics & human research 33, no.1 (2011): 1-8 3nancy kass, holly taylor, linda fogarty, jeremy sugarman, steven n. goodman, annallys goodwinlandher, michael carducci and herbert hurwitz, “purpose and benefits of early phase cancer trials: what do oncologists say? what do patients hear?” journal of empirical research on human research ethics: an international journal 3, no.3 (september 2008): 57-68 4paul s. appelbaum, charles w. lidz, franklin g. miller and jonathan kimmelman, “twenty-five years of therapeutic misconception,” the hastings center report 38, no.2 (march april 2008): 5-7 5 coyne jc, pajak tf, harris j, konski a, movsas b, ang k, watkins bruner d; radiation therapyoncology group, “emotional wellbeing does not predict survival in head and neck cancer patients: a radiation therapy oncology group study,” cancer 110, no.11 (december 2007): 2568-75 6 sulmasy, et al 7manish agrawal, ezebiel j. emanuel, “ethics of phase 1 oncology studies: reexamining the arguments and data,” jama 290, no.8 (2003): 1075-1082 8kass, et al introduction analysis conclusion lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) * cathy purvis lively, jd, columbia university ms bioethics © 2021 cathy purvis lively. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. social isolation of older adults in long term care as a result of covid-19 mitigation measures during the covid-19 pandemic: protecting the individual or a means to an end? cathy purvis lively* abstract in response to the threat of covid-19, cms issued unprecedented restrictions severely limiting the liberty of older adults residing in long-term care. older adults are identified as at a high risk of becoming infected through exposure to sars-cov-2 and of suffering the most severe morbidity and mortality. while protecting the individual from disease, the restrictions also had a determinantal effect. the restrictions exacerbated social isolation and loneliness, two pervasive public health concerns within the older adult population. legally, the restrictions pass constitutional muster. the ethical analysis presents more questions and debates. initially, the restrictions to protect the older adult were grounded in public health ethics and bioethics principles. however, the ethical lines become blurred as the risk of harm secondary to isolation increased over the time that the restrictions remained in effect. the ethical point of view becomes more divergent considering the restrictions also preserved medical resources for the greater good of society, arguably diverting them to serve younger people. we have a moral obligation to reduce social isolation and recognize the older adult as a valuable member of society with equal worth and dignity. keywords: pandemic, long-term care, public health, resources, social isolation, loneliness introduction in response to the threat of covid-19, cms issued unprecedented restrictions severely limiting the liberty of older adults residing in long-term care. older adults are identified as at a high risk of becoming infected from exposure to sars-cov-2 and from suffering the most severe morbidity and mortality. while protecting the individual from disease, the restrictions also had a determinantal effect. the restrictions exacerbated social isolation and loneliness, two pervasive public health concerns within the older adult population. legally, the restrictions pass constitutional muster. the ethical analysis presents more questions and debates. initially, the restrictions to protect the older adult were grounded in public health ethics and bioethics principles. however, the ethical lines become blurred as the risk of harm secondary to isolation increased over the time that the restrictions remained in effect. the devastation of covid-19 within the older adult population extends beyond the immediate risk and harm of infection. lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 2 at the beginning of the covid-19 pandemic, experts determined that older adults, especially those living in long-term care, were at a greater risk of becoming infected and depleting scarce medical resources. two days after who declared the pandemic, the centers for medicare & medicaid services (cms) followed the centers for disease control (cdc) recommendations and announced mitigation measures that required long-term care facilities to (1) restrict volunteers and nonessential personnel from entering the facility; (2) cancel all group activities and communal dining; (3) screen residents and health care personnel for fever and respiratory symptoms; and (4) encourage residents to stay in their rooms. the social isolation resulting from the mitigation measures posed a credible threat to five core domains of healthy aging: (1) promoting health; preventing injury and managing chronic conditions; (2) cognitive health; (3) physical health; (4) mental health; and (5) facilitating social engagement.1 i. social isolation and loneliness covid-19 highlighted two pervasive public health concerns confronting older adults—social isolation and loneliness. social isolation is an objective deficit in the number of relationships and the frequency of contact with family, friends, and the community.2 social isolation is a risk factor for loneliness. loneliness is the subjective perception of a lack of meaningful relationships.3 loneliness has three dimensions: (1) absence of a significant person to provide emotional support and affirm one’s value as a person; (2) absence of a small group of people seen regularly, such as a card group; and (3) absence of a larger network group of people who provide support by being together as a group, for example, church services or rotary meetings.4 covid-19 restrictions affected all three dimensions. social isolation can be as dangerous as smoking fifteen cigarettes per day, earning its designation as a public health priority.5 isolation increases the risk of cardiovascular disease, obesity, anxiety, and depression. loneliness can lead to depression, alcoholism, and suicidal thoughts.6 some studies found that loneliness is also a factor in cognitive decline. for example, caregivers reported that 63 percent of older adults with cognitive impairment experienced cognitive decline during the covid-19 pandemic.7 in 2017, the american association of retired persons (aarp) reported that social isolation accounted for $6.7 billion in additional medicare spending although only 14 percent of older adults in the us reported being socially isolated.8 approximately 24 percent of community-dwelling older adults in the us are socially isolated. forty-three percent of adults aged 60 and older report feeling lonely. those living in long-term care report loneliness at a rate of at least double of community-dwelling older adults.9 who defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”10 a broad definition of health highlights the detriment of social isolation in older adults. there is a moral obligation to mitigate the effect of isolation.11 the additional medicare spending costs attributable to the effects of social isolation secondary to covid-19 will be extraordinary. providing social support will directly benefit older adults and indirectly benefit society by reducing medicare spending associated with the effects of social isolation. combating the pervasiveness of social isolation requires immediate collaborative community action. many long-term care residents who depend on visits from family and friends to socialize increasingly felt lonely, abandoned, and despondent,12 increasing the risk of feeling grief and loss, including individual and collective trauma reactions. 13 also, normally social opportunities, medical, and legal appointments defaulted to telephone or virtual appointments. the cessation of in-person medical appointments interfered with optimal management of chronic conditions and preventive care. some older adults lack access to the technology, are unfamiliar with technology, or cannot use technology for other reasons. at lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 3 least one study supports the potential for older adults to benefit from technology and suggests that training could promote long-term benefits in older adults aged 80 years and over. 14 focusing on technological advances specific to older adults with input from older adults should be a priority. when communal dining abruptly stopped, residents had to eat all their meals alone in their rooms. older adults often mention the difficulty of eating meals alone, especially if recently divorced, widowed, or otherwise separated from a spouse or partner. closure of the exercise facilities limited the ability of an older adult to stay physically active. reduced physical activity creates long-term adverse health effects.15 ii. measures to mitigate isolation to facilitate some contact, long-term care facilities devised window visits. the resident remained safely inside the locked facility, standing or seated in front of a window. visitors stood outside in the grass or parking lot. any conversation took place over the telephone. to simulate physical contact, residents and visitors pressed their palms together, separated by the glass barrier. the window visits recall the prison visits depicted in movies and television. in late june 2020, cms relaxed the restrictions and advised that long-term care facilities could resume some communal activities and permit outdoor visits. although cms eased the restrictions, interpersonal contact remained minimal. outdoor visits required scheduling an appointment during limited hours of availability. the facilities limited the visits per week and the duration of each visit to thirty minutes. in addition, the staff enforced wearing personal protective equipment and maintaining physical distancing. several impracticalities diminished the optimism of the relaxed restrictions. residents could leave their rooms for meals but remained physically separated at a distance that prevented any meaningful interaction. similarly, the limitations on the in-person visits presented problems. non-resident spouses with mobility challenges found the outdoor access difficult, if not impossible. residents or spouses with hearing and vision losses experienced challenges in communicating while sitting outside, six feet apart, and wearing masks.16 iii. legal precedent for emergency measures the primary legal issue stems from the conflict between individual liberty and the public good or health. jacobson v. massachusetts provides a framework for balancing individual liberty rights and the public good during a pandemic.17 jacobson clarified an essential point of law the rights and liberties secured by the us constitution are not absolute.18 faced with a pandemic, a community has the right to protect members of the community. 19 jacobson outlines four standards for imposing public health mandates during a pandemic. first, the state overreaches when it uses public health powers unnecessarily.20 second, the state must use the least restrictive means to prevent harm. 21 third, the state must use reasonable means expected to prevent or ameliorate a health threat.22 finally, the intervention must not pose an undue risk.23 the guidelines in jacobson, established during the smallpox pandemic, apply to covid-19. in response to the threat of covid-19, public health authorities enacted mandates to protect the public, especially older adults, against the highly contagious and virulent virus. the cms restrictions specifically addressed older adults living in long-term care facilities. while the cms directives obstructed residents’ liberties, they also contradicted the assisted living facility social model, which places autonomy and independence at the forefront. lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 4 given the gravity of harm and the uncertainties in the early phases of the pandemic, the restrictions were arguably the least restrictive means to manage the immediate threat. the effectiveness varied from facility to facility, with many deaths throughout the us in long-term care facilities. while valuable early in the pandemic, at some point the continuation of the mitigation measures increased social isolation and its associated risks. in jew ho v. williamson, the supreme court overturned a quarantine order to contain the bubonic plague.24 the officials enforced the order only against a targeted ethnic population which did not present an identified risk. 25 in reaching its decision, the court determined that the quarantine order was not a reasonable regulation to prevent the spread of the bubonic plague. rather, it was racially motivated. the court ruled that the government cannot impose public health orders in a racially invidious manner.26 there are similarities between jew ho and the cms restrictions. like the quarantine order in jew ho, the restrictions targeted a specific population. but with covid-19 older adults were an identified high-risk population because of their susceptibility to infection and severe illness. during the early phases of the pandemic, the directives were reasonable to accomplish the purpose of preventing the spread in the identified high-risk population. they were not discriminatory according to the rule of law in jew ho. the argument supporting the constitutionality of the cms restrictions wanes as the length of the safety precautions increased. iv. ethical analysis of the lengthy social isolation the cms restrictions require the ethical analysis of harm, proportionality, reciprocity, and transparency. as well as analysis under the principles of autonomy, beneficence, non-maleficence, and justice. a. harm and proportionality as previously discussed, older adult long-term care residents were more susceptible to covid-19 and to severe physical effects requiring hospitalization. in addition, older adults are more likely to die from covid19. based on a totality of the circumstances and what we knew about the virus in the early phases of the pandemic, the restrictions were the least restrictive means to protect this high-risk population. but the question of proportionality requires ongoing assessment and re-evaluation. while the initial uncertainty and chaos justified the restrictions, as the pandemic continued and the risk of harm from the restrictions increased, the pendulum began to swing. at some point, upon proof or likelihood of safety, less restrictive alternatives should have been adopted. b. reciprocity the concept of reciprocity is a core principle of public health and requires the balancing of the benefits and burdens of the social cooperation.27 when individuals sacrifice their liberty for the benefit of others, they should not be penalized as a result of making the sacrifice, and thus society owes a reciprocal obligation to the individuals, such as providing individuals support and not discriminating against them.28 residents did not have any input or choice when cms and the administrators stripped away their autonomy and liberties. while the restrictions protected the individual resident from the direct harm of infection, the restrictions also protected society from the indirect harm of the depletion of scarce medical resources. public health officials identified long-term care residents as most likely to require significant medical resources. one talking point repeatedly broadcast was the need to prevent the depletion of hospital beds, ventilators, medications, and supplies. most assisted-living facilities are for-profit, and residents pay for lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 5 their food, shelter, and personal needs. what does society owe these long-term care residents in return for the liberty they sacrificed for the benefit of society at large? at the very least, i suggest we owe these individuals the commitment to conduct research exploring and addressing the effects of the restrictions. c. transparency by government, the media, and the long-term care facilities the communications from government and public health officials about the pandemic and the restrictions were opaque, leaving unanswered questions, doubts, and speculation. some facilities provided families with basic information communicated through robocall messaging, with words of encouragement, painting rosy pictures of the residents' sequestered daily lives. public health officials assert the common good and protecting the public’s safety and health justify paternalism and compulsory powers. 29 one counterargument is that the compulsory interventions or restrictions push paternalism to new levels.30 the covid-19 pandemic and the mitigation interventions highlight this tension between libertarian and epidemiological models based on (1) shortages that triggered rationing and prioritization; and (2) measures that safeguarded public health but infringed on individual rights.31 d. autonomy, beneficence, and non-maleficence through a bioethical lens, we immediately see the clash between the cms restrictions and the long-term care residents’ autonomy. however, autonomy is not absolute. there was a benefit for the individual resident: the protection from a deadly virus. thus, i argue that the initial restrictions were beneficent. yet i also point to the deleterious secondary physical and emotional effects of the isolation and assert that the restrictions should have been safely modified as new information on viral spread and safety came about. we can accept the beneficence of protecting the high-risk resident from a deadly disease while acknowledging the associated harm. however, at some point, we must also ask if the harm experienced due to prolonged severe restrictions reached a level that exceeded the boundaries of beneficence and became maleficent. perceiving the long-term care resident as a passive recipient of care is paternalistic and antithetical to autonomy and a person-centered approach.32 instead, society must recognize older adults as essential stakeholders in policymaking. the direct and active involvement of older adults allows the individual to retain agency rather than becoming a passive recipient of care.33 prioritization of the older adult as an autonomous active participant counters ageism and promotes autonomy. e. justice justice calls for analysis of several discrepancies. first, the special protection of long-term care residents seems justifiable due to their special vulnerability. cms treated long-term care facilities alike. most community-dwelling older adults could decide whether to adhere to stay-at-home restrictions and were not subject to the same level of enforcement that existed within long-term care facilities. the restrictions were far more oppressive for long-term care residents. in response to the assertion that selective lockdown discriminates against older adults, the same arguments discussed above demonstrate the morally relevant justification: older adults are more likely to require hospitalization and die from covid-19.34 one convincing argument against restrictions on older adults echoing kant’s categorical imperative argues that selectively restricting older adults for the good of other people amounts to treating older adults as a means to an end for others.35 while the restrictions imposed on the individual might slow the spread of lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 6 the disease within the specific long-term care facility, which protects that individual resident, they also impose on the individual resident to serve the greater good: the preservation of scarce medical resources. the second application pushes the restrictive measures closer to violating kant’s categorical imperative by treating the older adult as a means to the end of others. that is, younger people and those living outside of long-term care would have more hospital resources available to them if long-term care residents were more severely isolated keeping them from needing hospitalization. from a kantian perspective, the categorical imperative demands respecting the dignity of persons—kant’s supreme (formal) principle.36 when we consider the restrictions, i suggest that we must also consider the impact on dignity. it has been suggested that dignity is the “overarching principle of bioethics.” 37 in the context of an analysis of the socially isolating covid-19 mitigation measures on older adults in long-term care facilities, we should consider the relational aspect of dignity, recognizing the adult as having value and equal worth. the protracted imposed isolation of older adults to preserve medical resources devalues older adults. ongoing covid-19 restrictions should be analyzed for their unjustified harms. a second justice concern outside the scope here is that long-term care facilities are resourced differently, and had different results due to quality of care, number of staff, infection control protocols, and previous health infraction records. conclusion the myopic focus on mortality ignores the risks of morbidity secondary to the devastating effects of social isolation on the older adult’s health and quality of life. the paternalistic prevention eclipsed the resident’s autonomy. at some point, the attention and priority must shift. when formulating policies, we must figure out at what point or in which situations the negative impact of restrictions outweighs the protective benefits. although the restrictions may have slowed the spread of covid-19, we must not discount the negative consequences, which may be long term. from an ethical perspective, we must acknowledge the harm that has occurred within this population and accept the responsibility to redress the harm and prevent repeating the mistakes. the prolonged restrictions stretched legal and ethical boundaries. the mixed purpose of the restrictions (protecting the individual resident and preserving healthcare resources) makes the ethical analysis more challenging. yet doing something for someone’s own good is still paternalistic and problematic. the public health justification includes the collective. we must confront the tough questions about the efficacy of pandemic mitigation measures and the mitigation measures’ adverse consequences. leaving the doors to long-term care facilities open during the pandemic would have exposed every resident and staff member to a contagion that presented a significant risk of morbidity and mortality. but locking the doors exacerbated social isolation and loneliness, increasing the risk of morbidity and mortality. julian savulescu may be correct that there was no desirable solution. we must still work to find better solutions that will reduce social isolation and recognize the older adult as a valuable member of society with equal worth and dignity. 1 coronavirus disease 2019 (covid-19) nursing homes & long-term care facilities. (n.d.). retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html. lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 7 2escalante, e., golden, r. l., & mason, d. j. (2020). social isolation and loneliness: imperatives for health care in a post-covid world. jama health forum, 1(12),e201597. https://doi.org/10.1001/jamahealthforum.2020.1597. 3 d'cruz, m., & banerjee, d. (2020). ‘an invisible human rights crisis’: the marginalization of older adults during the covid-19 pandemic – an advocacy review. psychiatry research, 292, 113369. https://doi.org/10.1016/j.psychres.2020.113369. 4 simard, j., & volicer, l. (2020). loneliness and isolation in long-term care and the covid-19 pandemic. journal of the american medical directors association, 21(7), 966–967. https://doi.org/10.1016/j.jamda.2020.05.006. 5 escalante, e., golden, r. l., & mason, d. j. (2020). social isolation and loneliness: imperatives for health care in a post-covid world. jama health forum, 1(12). https://doi.org/10.1001/jamahealthforum.2020.1597. 6 simard, j., & volicer, l. (2020). loneliness and isolation in long-term care and the covid-19 pandemic. journal of the american medical directors association, 21(7), 966–967. https://doi.org/10.1016/j.jamda.2020.05.006. 7 batsis, j. a., daniel, k., eckstrom, e., goldlist, k., kusz, h., lane, d., … friedman, s. m. (2021, january 26). promoting healthy aging during covid‐19. american geriatrics society. https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17035. 8 escalante, e., golden, r. l., & mason, d. j. (2020). social isolation and loneliness: imperatives for health care in a post-covid world. jama health forum, 1(12), e201597. https://doi.org/10.1001/jamahealthforum.2020.1597. 9 simard, j., & volicer, l. (2020). loneliness and isolation in long-term care and the covid-19 pandemic. journal of the american medical directors association, 21(7), 966–967. https://doi.org/10.1016/j.jamda.2020.05.006. 10 world health organization. frequently asked questions. https://www.who.int/about/frequently-askedquestions. 11 chu, c. h., donato‐woodger, s., & dainton, c. j. (2020). competing crises: covid‐19 countermeasures and social isolation among older adults in long‐term care. journal of advanced nursing, 76(10), 2456–2459. https://doi.org/10.1111/jan.14467. 12 gardner, w., states, d., & bagley, n. (n.d.). the coronavirus and the risks to the elderly in long-term care. journal of aging & social policy. https://pubmed.ncbi.nlm.nih.gov/32245346/. 13 campbell, a. d. (2020). practical implications of physical distancing, social isolation, and reduced physicality for older adults in response to covid-19. journal of gerontological social work, 63(6-7), 668–670. https://doi.org/10.1080/01634372.2020.1772933. 14 radwan, e., radwan, a., & radwan, w. (2020). challenges facing older adults during the covid-19 outbreak. european journal of environment and public health, 5(1), em0059. https://doi.org/10.29333/ejeph/8457. 15 plagg, b., engl, a., piccoliori, g., & eisendle, k. (2020). prolonged social isolation of the elderly during covid-19: between benefit and damage. archives of gerontology and geriatrics, 89, 104086. https://doi.org/10.1016/j.archger.2020.104086 . 16 chu, c. h., donato‐woodger, s., & dainton, c. j. (2020). competing crises: covid‐19 countermeasures and social isolation among older adults in long‐term care. journal of advanced nursing, 76(10), 2456–2459. https://doi.org/10.1111/jan.14467. 17 jacobson v. massachusetts, 197 u.s. 11 (1905). 18 jacobson. lively, social isolation of older adults in long term care, voices in bioethics, vol. 7 (2021) 8 19 jacobson. 20 jacobson. 21 jacobson. 22 jacobson. 23 jacobson. 24 jew ho v. williamson, 103 f.10 (c.c.n.d. cal., 1900). 25 jew ho v. williamson . 26 jew ho v. williamson. 27 viens, a. m. (2008). public health, ethical behavior and reciprocity. the american journal of bioethics, 8(5), 1–3. https://doi.org/10.1080/15265160802180059. 28 upshur, r. (2003, november 1). the ethics of quarantine. retrieved from https://journalofethics.amaassn.org/article/ethics-quarantine/2003-11. 29 kamweri, j. m. m. (2013). the ethical balance between individual and population health interests to effectively manage pandemics and epidemics (dissertation). 30 argued by ken wing professor emeritus, seattle university school of law. kamweri, j. m. m. (2013). the ethical balance between individual and population health interests to effectively manage pandemics and epidemics (dissertation). 31 interests to effectively manage pandemics and epidemics (dissertation). 32 chu, p. 2457. 33 d'cruz, p.7. 34 savulescu, j., & cameron, j. (2020). why lockdown of the elderly is not ageist and why levelling down equality is wrong. journal of medical ethics, 46(11), 717–721. https://doi.org/10.1136/medethics-2020-106336. 35 hugh mclachlan, professor emeritus of applied philosophy, 36 heinrichs, b. (2010). single-principle versus multi-principles approaches in bioethics. journal of applied philosophy, 27(1), 72-83. doi:10.1111/j.1468-5930.2009.00474.x. 37 gedge, e. by impact ethics · in c. e. (2015, july 27). what is dignity and does bioethics need to talk about it? impact ethics. https://impactethics.ca/2015/07/27/what-is-dignity-and-does-bioethics-need-to-talk-about-it/, citing, the 2005 unesco declaration of bioethics and human rights https://en.unesco.org/themes/ethics-scienceand-technology/bioethics-and-human-rights. chaucer and deturk, the part of the primary care provider in our national, voices in bioethics, vol. 6 (2020) *katie chaucer & monika deturk are both dnp candidates at connell school of nursing, boston college. © 2020 katie chaucer & monika deturk. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the part of the primary care provider in our national awakening to systemic racism katie chaucer* and monika deturk* keywords: racism, doctors, social awakening, primary care introduction racism makes people sick. as the united states navigates a social awakening, primary care providers (pcps) need to join the movement by addressing the impact of racism on our society. as community leaders, all pcps, including medical doctors, doctors of osteopathy, physician assistants, and adva nced practice nurses, are morally called to combat systemic racism. pcps need to consider how traditional treatment modalities, such as drug prescription and lifestyle modifications, may perpetuate systemic racism and inflict further injustice upon the health of black americans. furthermore, as physical healers, pcps are professionally bound to address systemic racism as its detrimental physical effects ravage those marginalized by our racialized society. analysis the effects of allostatic overload demonstrate that racism causes physical illness. allostatic overload refers to the physical effects of chronically adapting to negative experiences over one’s lifetime.1 it predisposes people to chronic disease, predicts an increase in all-cause mortality, and is highly correlated with racial discrimination.2 after controlling for socioeconomic status and other adverse health behaviors, researchers have shown that black participants have consistently higher allostatic load scores than white participants. 3 the outcomes of the covid-19 pandemic have dramatically affected communities of color, demonstrating the relationship between the physical effects of allostatic load and racism. during this pandemic, black americans are dying at three times the rate of white americans.4 if we are truly committed to providing care that lives up to high ethical standards, we should start by investigating structures of inequity within our practices to improve the health of patients of color. below, we propose a three -tier intervention strategy, employing interventions in practice, patient, and personal levels of care. at the practice level, pcps could use their voices to advocate for patients on a macro scale. for example, they could support initiatives that provide patients with bus fare or child care, prioritize the accessibility of clinic chaucer and deturk, the part of the primary care provider in our national, voices in bioethics, vol. 6 (2020) 2 interpreters, or create more flexible clinic hours. 5 in addition, pcps should consider using third-party organizations, such as health leads, that would connect their patients with social solutions like housing, transportation, and healthy foods.6 we also suggest that a clinician pair with a member of the community to create a one-page clinician reference of local resources. this type of intervention is shown to increase referrals to support services, improve patient employment, and raise the number of children accessing childcare, while reducing the use of homeless shelters.7 pcps may become advocates of social change in two unique ways: by dismantling societal systems that perpetuate inequity and by addressing patients’ manifestations of these systems. both stem from pcps’ ethical and fiduciary role; they both require moral agency or the ability to act in the face of deeply rooted systemic obstacles. to address the public health emergency of racism and advocate for their population’s health, pcps should address the social structures that have an undeniable effect on health. this kind of comprehensive care will often extend past the traditional prescriptive relationship. social workers are not exclusively responsible for performing assessments of societal effects on healthcare. it is crucial that pcps perform initial assessments to identify inequities to meet ethical expectations and fulfill their fiduciary role. on a patient level, pcps should routinely assess patients’ social determinants of health (sdoh) by discussing their living environment, financial circumstances, education, support systems, and experiences with racial segregation.8 it is important to investigate social challenges in a sensitive and empathetic way by using validated and reliable assessment questions, such as “do you ever have difficulty making ends meet at the end of the month?”9 sensitively documenting the results of these screenings of the medical record allows for a seamless multidisciplinary approach and assessment over time. by starting these difficult conversations, pcps display beneficence toward their patients and a fide lity to their profession. in accordance with the professional commitments of providers, pcps engage in these conversations to assess and improve patients’ circumstances and to promote their integrated wellness. however, conflict can arise between provider intentions of beneficence and patient autonomy or privacy. patients may choose not to disclose situations they perceive as embarrassing, ranging from food insecurity to unhealthy housing conditions or debt. in such situations, it is important for pcps to r espect the patient’s desire for confidentiality and personal decision making. it should be the patient’s choice and not the provider’s choice to avoid the conversation. pcps have demonstrated their ability to investigate other sensitive patient issues such as suicidal ideation, teenage sexual activity, and substance use concerns. pcps should not avoid the topic of racial inequity due to their own unease surrounding this topic. regardless of an individual patient’s response to a sdoh assessment, pcps who routinely screen all of their patients communicate that they truly care about the betterment of their patients, are a trusted resource, and are readily available for future assistance. on a personal level, all pcps should understand their implicit bias by taking a confidential racial implicit bias assessment. this commitment to self-assessment requires introspection and confrontation of automatic, pervasive cultural assumptions. it is essential that all pcps take time to identify their subconscious biases because without knowledge of the problem, no solution would be offered. pcps should also consider supporting the social movements and political parties that align with racial justice initiatives. as we begin to envision new policies under a new presidential administration, focus should be placed upon expanding coverage and quality of healthcare for people of color. while this process of introspection may be jarring and unfamiliar, all pcps have a professional responsibility to be aware of deeply rooted assumptions that inform biased assessments or behaviors. eradicating bias is necessary. otherwise, unchecked biases can lead to unintended harm in the form of both subtle micro chaucer and deturk, the part of the primary care provider in our national, voices in bioethics, vol. 6 (2020) 3 aggressions, which erode the trust between pcp and patient, and overt differences in p atient care. the effect of provider racial bias has been shown to delay referrals to specialists, to create disparity in assessment and treatment of pain, to defer routine cancer screenings, and even to reduce the rate of cardiac catheterization for black patients experiencing chest pain.10 the deleterious effect of bias reaches nearly every corner of healthcare. non-maleficence should serve as the natural ethical motivation for pcps to check their implicit bias on a regular basis. providers acting on implicit or explicit bias harm those they are responsible for protecting. once aware of the existence and impact of bias, introspective pcps will recognize the moral impetus to make changes. conclusion both the hippocratic oath and the american nurses association’s code of ethics and interpretive statements imply that pcps are united in their professional and ethical obligations to serve the whole patient. one manifestation of these obligations is taking actionable steps to reduce racism. the task of addressing the sdoh can be daunting in scope; however, to identify the effects of systematic racism or social injustice at the practice, patient, and personal levels is a concrete action. connecting marginalized patient populations to local resources can make small differences that produce significant change. pcps are important leaders in making systemic changes due to the unique role they play in communities. it is vital that they work toward identifying and dismantling structures of racial oppression in our society as we seek to improve the health of our nation. “not everything that is faced can be changed, but nothing can be changed until it is faced.” james baldwin 1 finlayson, judith.”you are what your grandparents ate: what you need to know about nutrition, experience, epigenetics & the origins of chronic disease.” toronto, robert rose inc. 2019. 2 tomfohr, lianne m., meredith a. pung, and joel e. dimsdale. "mediators of the relationship between race and allostatic load in african and white americans." health psychology 35.4 (2016): 322. 3 duru, o. kenrik, et al. "allostatic load burden and racial disparities in mortality." journal of the national medical association 104.1-2 (2012): 89-95. 4 pilkington, ed. “black americans dying of covid-19 at three times the rate of white people.” may 20, 2020, the guardian, https://www.theguardian.com/world/2020/may/20/black-americans-death-rate-covid-19-coronavirus, accessed on 6/24/2020. 5 andermann, anne. "taking action on the social determinants of health in clinical practice: a framework for health professionals." cmaj 188.17-18 (2016): e474-e483. 6 health leads. “health leads.” 2020, healthleadsusa.org/ accessed on 6/24/2020. 7 garg, arvin, et al. "addressing social determinants of health at well child care visits: a cluster rct." pediatrics 135.2 (2015): e296-e304. 8 artiga, samantha and orgera, kendall. “key facts on health and health care by race and ethnicity.” kaiser family foundation, november 12, 2019, https://www.kff.org/report-section/key-facts-on-health-and-health-careby-race-and-ethnicity-health-status/ , accessed 6/24/2020. 9 brcic, v., eberdt, c., & kaczorowski, j. (2011). development of a tool to identify poverty in a family practice setting: a pilot study. international journal of family medicine, 2011. 10 m. unequal treatment: confronting racial and ethnic disparities in health care (with cd). national academies press, 2003, p. 12875. doi.org (crossref), doi:10.17226/12875. https://doi.org/10.17226/12875 introduction wolemonwu, human challenge trials for a covid-19 vaccine, voices in bioethics, vol. 6 (2020) * victor chidi wolemonwu, phd researcher, ma, acmlb, department of philosophy, university of sheffield, uk © 2020 victor wolemonwu. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. human challenge trials for a covid-19 vaccine: should we bother about exploitation? victor chidi wolemonwu* keywords: human challenge trials, covid-19, vaccine ethics, research ethics, bioethics, global poverty introduction safe and effective vaccines are yet to be developed and distributed for the treatment of the virus that causes covid-19. “vaccine trials are notoriously lengthy, with optimistic estimates of 12 to 18 months to vaccine rollout.”1 safe and effective vaccine development within the shortest possible time requires adopting a medical research strategy like human challenge trials. a few weeks ago, experts in the fields of bioethics, philosophy, medicine, computer sciences some of whom are nobel laureates and some prominent businessmen sent a signed letter to dr. francis collins, the director of the national institutes of health (nih), calling on the government to embark on human challenge trials to accelerate the development and distribution of a covid-19 vaccine. according to the 125 signatories to the letter, human challenge trials are indispensable during the covid-19 pandemic as successful development of vaccines through this method would help improve human health and well-being, and save countries from a looming social and economic meltdown. 2 human challenge trials involve fewer participants, are not restrained by the rate of natural infections, and can be completed in much less time than conventional vaccine trials.3 there is a potential projection that if vaccines are not developed quickly, the global poverty index may increase from 600 million pre-pandemic to one billion before the end of 2020.4 some bioethicists argue that government and medical scientists should adhere strictly to the best ethical standard to ensure that research volunteers are not exploited in any way despite the severity of the pandemic.5 the 125 experts that signed the letter to the nih recognize the need to mitigate any possible ethical issue of exploitation that might arise if the government endorses human challenge trials. though the letter fails to highlight and address the ethical issue of possible incentivization of the human challenge trials, i argue that advertised incentives as a recruitment strategy undermine the the benefit of recruiting individuals wolemonwu, human challenge trials for a covid-19 vaccine, voices in bioethics, vol. 6 (2020) 2 to participate out of altruism. given the high poverty index rate, the government and medical scientists could, in effect, be taking advantage of the vulnerability of those who are socially and economically impoverished, treating them as mere means to some scientific end. analysis human challenge trials: mitigating possible exploitation challenge trials involve a deliberate exposure of healthy research participants to pathogens to study how people contract the disease and how resistance can be attained in order to develop a vaccine. these trials have proven useful in the past for the advancement of scientific knowledge through the development of vaccines for cholera, malaria, and smallpox. some bioethicists caution about the reliance on human challenge trials to address the covid-19 pandemic. shah et al. contend that “given the stakes of exposing volunteers to potentially fatal risks, it would be a mistake to rush the implementation of challenge trials without adequately considering what it will take for them to make a difference.”6 their concern stems from the fact that little is known about covid-19 and there is no standard treatment. the experts highlighted four basic criteria to ensure that human challenge trials meet high ethical standards. the criteria are that only young, healthy participants should be enrolled; the highest quality medical care should be provided for participants; the ethical and scientific review must be of the highest standard; and the autonomy of participants must be respected. these principles are aimed at mitigating ethical challenges that had arisen in the past, especially, the issue of lack of consent and the risk of exposure of research participants to harm. additionally, this paper explores compensation as an incentive to participate. i. age of permissible participation the experts noted that potential participants should be healthy youths who are within the age range of 20 and 29 because they are less likely to die of the virus when exposed. some bioethicists and scientists agree with this requirement. verity et al., for instance, argue that the fatality ratio of people within that age range is .0778–.398 (.193 per cent).7 according to some reports, healthy persons of 19 years and under may be less likely to suffer adverse events like hospitalization or death when they are infected with covid-19. however, those in the age range of 20 to 44 years seem to be at higher risks for hospitalization, icu admission, or death (due to the devastating consequences of the virus like cardiac complications, multisystem inflammatory syndrome, or stroke).8 so, there is no guarantee that the participants in that age range will be free from any adverse events when they are exposed to the virus. to be valid, researchers will have to address the problem of applying the results to the elderly population. if the participants are all 29 and under, a vaccine may produce either better, stronger antibodies or weaker and fewer antibodies in them than in the elderly. transparency about research limitations is crucial. ii. protection of participants from harm the experts suggested that participants should be provided with the highest quality medical care and also be monitored frequently to mitigate any possible harm that may arise due to their exposure to the virus. nir eyal et al. note that “any volunteers in whom infection was confirmed (during the challenge trials) should receive excellent care for covid-19, including priority for any scarce life-saving resources, in state-of-the-art facilities.”9 it is not clear how proper resource distribution would be made between challenge trials and other wolemonwu, human challenge trials for a covid-19 vaccine, voices in bioethics, vol. 6 (2020) 3 medical emergencies. many hospitals in the us and other parts of the world with high incidents of covid-19 are overwhelmed by an increasing number of patients in icus and other inpatient units with covid-19. there are scarcities of medical care facilities and resources as hospitals and icus are under intense pressure due to the surge.10 it is reasonable to use resources for challenge trials but in some areas, there are not available resources. it is also important to ensure that adequate provisions, both in terms of health facilities and manpower are made available for the care of patients already in precarious situations whether due to covid19 or other diseases like cancer. an increase in the number of fatalities has occured when there were fewer resources to cater to the health and well-being of critically ill patients with covid-19 and other chronic ailments.11 prioritizing the health and well-being of volunteers for challenge trials over those of critically ill covid-19 patients is morally problematic. to resolve this moral dilemma, the challenge trials must take place where there are ample hospital beds, critical care doctors, and where a surge in covid-19 cases is not expected. some states within the us and some countries have flattened their curve, are past the overwhelming volume of hospital stays, and have state-of-the-art medical facilities. the trials should take place where other patients’ care will not have to be compromised and where the research participants will have access to care. iii. standard of ethics boards the experts also suggested that ethical and scientific review must be of the highest standard. beyond the usual fda and irb review process, they suggested a robust public discussion and an additional independent ethics and science taskforce.12 however, it is unclear how this will pan out. also, the letter did not explain whether consensus-based ethical decision making would be adopted to resolve conflicting moral issues that may arise during the review process. the challenge with a consensus-based ethical decision is that members may agree with it without recourse to whether such decision is morally appropriate. members may agree because they want to act in solidarity with the proposer of the decision or because they have a special stake in the outcome. to avoid decisions that do not comport with proper ethics, a decision-making procedure with accountability is required. iv. respect for participants’ autonomy the experts emphasized that the autonomy of participants must be respected. although voluntary informed consent is necessary as it tends to protect the rights of research participants to accept risks, participants may make irrational decisions. 13 individuals who are incompetent to make decisions like children should be excluded. researchers should provide a tool to ensure that potential participants understand the risks of participation. “the wish of informed volunteers to participate in the trial ought to be given substantial weight.”14 there is an ethical concern about enrolling volunteers who may want to participate in the challenge trials due to some motivations other than altruism. some may have a psychological misconception of risk or desire to take on risk; others are motivated by compensation. researchers should assess autonomy to be certain that participants understand risks and have freely decided to participate. v. ethical concern about advertised financial incentives the success of clinical research depends on the availability of participants. according to the council for international organizations of medical sciences (cioms) ethical guidelines, financial or material incentives are wolemonwu, human challenge trials for a covid-19 vaccine, voices in bioethics, vol. 6 (2020) 4 essential aspects of clinical research.15 incentives induce individuals to get involved in something inherently good. the inherent goodness of clinical research is that it is scientifically and socially valuable as long as there is a sound research design.16 the compensation is made to attract participants who are altruistic and who believe in the research goals or who have certain qualities the researchers need. according to dickert and grady, incentives are like wages because although research participation does not require much expertise, it, however, requires “time, effort, and the endurance of undesirable or uncomfortable procedures.” 17 as unskilled labour, researchers and their sponsors are ethically required to pay participants incentives “on a scale commensurate with that of other unskilled but essential jobs.”18 some see compensation as coercive undermining the voluntary aspect of informed consent.19 some bioethicists, however, contend that the use of incentive as a recruitment strategy is morally problematic because it seems to reduce research participation to a kind of commercialized venture where services are paid for. many research participants are desperately looking for ways to address their economic needs. employing incentives as a recruitment strategy targets vulnerable, and economically impoverished groups. financial incentivization in clinical research is morally problematic because it is used to "attract the poor and socially disadvantaged, while those who profit most from the outcome of these studies are the better-off members of society."20 researchers should not approach vulnerable groups that may be incentivized by desperation and more tempted to ignore the risks. there is significant debate over whether compensation for clinical trial participation is ethical. compensation can be appropriate if it is not coercively high. to ensure enough participants and that low-income people have the opportunity to participate, the challenge trials should compensate to cover their living expenses or any lost income but should not offer additional payments that could be coercive. conclusion the covid-19 pandemic has worsened the global poverty. adopting an expedient research procedure like human challenge trials which would accelerate vaccine development for covid-19 is morally imperative. volunteers who participate in the challenge trials should be motivated to advance human health and wellbeing rather than driven by their economic needs. it is morally necessary to eliminate the possibility of motivations based on financial desperation, or a distorted understanding of the risks. researchers must use fair methods to attract those able to digest the scientific risks and societal benefits while avoiding taking advantage of marginalized groups. 1 weinberg, justin, “philosophers, epidemiologists & others call for human challenge trials for covid-19 vaccine,” daily nous, july 16, 2020, https://dailynous.com/2020/07/16/philosophers-epidemiologists-others-call-humanchallenge-trials-covid-19-vaccine/. 2 open letter, “challenge trials for covid-19,” 1 day sooner, july 2020, https://1daysooner.org/openletter. https://1daysooner.org/openletter wolemonwu, human challenge trials for a covid-19 vaccine, voices in bioethics, vol. 6 (2020) 5 3 ferguson, kyle and caplan, art, “accepting the challenge: covid vaccine challenge trials can be ethically justified,” the hasting centre, june 29, 2020, https://www.thehastingscenter.org/accepting-the-challenge-covidvaccine-challenge-trials-can-be-ethically-justified/. 4business standard, “study says global poverty may surge to over 1 billion, warns asian nations,”, june 12, 2020, https://www.business-standard.com/article/pti-stories/study-warns-of-poverty-surge-to-over-1-billion-due-tovirus-120061200112_1.html. 5 mateus, benjamin, “human challenge trials are being pushed to develop a vaccine against the coronavirus,” world socialist web site, may 5, 2020, https://www.wsws.org/en/articles/2020/05/05/vacc-m05.html. 6 shah, seema k. et al., "before deliberately infecting people with coronavirus, be sure it’s worth it," the new york times, june 2, 2020, https://www.nytimes.com/2020/06/02/opinion/coronavirus-vaccine-challengetrials.html?action=click&module=opinion&pgtype=homepage. 7 verity, robert et al., “estimates of the severity of coronavirus disease 2019: a model-based analysis,” the lancet: infection diseases, vol 20, (march 2020): 669-677, https://doi.org/10.1016/ s1473-3099(20)30243-7, 673. 8 radcliffe, shawn, “nearly 40% of those hospitalized for covid-19 are under 55,” health line, march 19, 2020, https://www.healthline.com/health-news/covid-19-isnt-just-dangerous-for-older-adults. 9 eyal, nir et al., “human challenge studies to accelerate coronavirus vaccine licensure," the journal of infectious diseases, vol. 221, (may 2020): 1753. 10 phua, jason et al., "intensive care management of coronavirus disease 2019 (covid-19): challenges and recommendations," the lancet: respiratory medicine, vol 8, (may 2020): 506-17. https://doi.org/10.1016/s22132600(20)30161-2; aziz, shadman et al., "managing icu surge during the covid-19 crisis: rapid guidelines," intensive care medicine. vol. 46, no. 7, (2020): 1303-1325, doi:10.1007/s00134-020-06092-5. 11 leclerc, thomas et al., "prioritisation of icu treatments for critically ill patients in a covid-19 pandemic with scarce resources," anaesthesia, critical care pain medicine, vol. 39, no. 3, (june 2020): 334, doi: 10.1016/j.accpm.2020.05.008. 12 open letter, “challenge trials for covid-19.” 13 dawson, liza et al., “severe acute respiratory syndrome coronavirus 2 human challenge trials: too risky, too soon,” the journal of infectious diseases, vol. 222, (june 2020): 514–6, doi: 10.1093/infdis/jiaa314. 14 open letter, “challenge trials for covid-19.” for more on ethical guidelines on human challenge trials, cf. world health organization. standards and operational guidance for ethics review of health-related research with human participants. geneva: world health organization; 2011; expert committee on biological standardization. human challenge trials for vaccine development: regulatory considerations. geneva: world health organization, 2016. 15 cioms-who, international ethical guidelines for health-related research involving humans, 4th. geneva, 2016. 16 grant, ruth w. and sugarman, jeremy, "ethics in human subjects research: do incentives matter?," journal of medicine and philosophy, vol. 29, no. 6, (december 2004): 726. 17 dickert, neal, grady, christine, “what’s the price of a research subject? approaches to payment for research participation,” the new england journal of medicine, vol. 341 no. 3, (november 1999): 199. 18 dickert and grady, what’s the price of a research subject?,” 200. https://www.thehastingscenter.org/accepting-the-challenge-covid-vaccine-challenge-trials-can-be-ethically-justified/ https://www.thehastingscenter.org/accepting-the-challenge-covid-vaccine-challenge-trials-can-be-ethically-justified/ https://www.wsws.org/en/articles/2020/05/05/vacc-m05.html https://www.nytimes.com/2020/06/02/opinion/coronavirus-vaccine-challenge-trials.html?action=click&module=opinion&pgtype=homepage https://www.nytimes.com/2020/06/02/opinion/coronavirus-vaccine-challenge-trials.html?action=click&module=opinion&pgtype=homepage https://www.healthline.com/health-news/covid-19-isnt-just-dangerous-for-older-adults https://doi.org/10.1016/s2213-2600(20)30161-2 https://doi.org/10.1016/s2213-2600(20)30161-2 wolemonwu, human challenge trials for a covid-19 vaccine, voices in bioethics, vol. 6 (2020) 6 19 malmqvist, erik, “paid to endure: paid research participation, passivity, and the goods of work,” the american journal of bioethics, vol. 19, no. 9 (august 2019): 11. 20 faden, ruth r. et al., a history and theory of informed consent (oxford: oxford university press, 1986), 354. kaewkungwal et al. also argued raised concerned about the ethical permissibility of targeting the economically impoverished population for human challenge trials. for more on this view, cf. kaewkungwal, jaranit et al. 2019. “conducting human challenge studies in lmics: a survey of researchers and ethics committee members in thailand.” plos one, 14(10): e0223619.https://doi.org/10.1371/journal.pone.0223619. smith, applying the defense production act to pharmaceuticals, voices in bioethics, vol. 7 (2021) * gabriella smith, ms bioethics columbia university © 2021 gabriella smith. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the bioethical problems in applying the defense production act to pharmaceuticals: a case study of horizon’s tepezza gabriella smith* keywords: defense production act, resource allocation, tepezza, covid-19, vaccine development introduction since the start of the covid-19 pandemic, there have been calls for the president to invoke a korean-warera law, the defense production act (“dpa”), to effectively nationalize the supply of critical medical supplies (e.g., n-95-grade masks, ventilators) and speed up vaccine production. the reasoning for employing the dpa is simple: it can immediately ramp up the industrial production of critical supplies and material resources and direct their distribution to areas of greatest need.1 the trump administration used the dpa 18 times to aid vaccine development.2 the biden administration has followed suit, invoking the dpa in february.3 while the defense production act has enabled a massive mobilization of crucial resources for vaccine development, it has also had negative, downstream effects, which raise ethical concerns surrounding resource allocation. evaluating the effect of the dpa on tepezza (teprotumumab-trbw; horizon therapeutics), a non-covid-19 medication, demonstrates how the dpa is not adequately designed to address pharmaceutical manufacturing, and point to a potential need for further legislation. analysis by its nature, the dpa is a very blunt and fast-moving instrument that should be used sparingly. originally signed into law by president truman at the outset of the korean war in 1950, the dpa gives the president the authority to order private sectors to produce essential goods in times of emergency.4 in particular, it allows the president to compel corporations to immediately prioritize orders from the federal government irrespective of previously agreed-upon contracts. the typical rules of supply and demand economics are overridden, and legally binding agreements are nullified. thus, the power of the dpa facilitates its ability to redirect resources in a swift, absolute manner. over the years, the general scope of the dpa has steadily extended beyond military preparedness to include natural disasters and homeland security. in january 2001, both president clinton and president g. w. bush invoked dpa powers to ensure that emergency supplies of electrical power and natural gas continued smith, applying the defense production act to pharmaceuticals, voices in bioethics, vol. 7 (2021) 2 flowing to california utilities during the 2000 2001 energy crisis. 5 in 2017, the federal emergency management agency (fema) used the dpa to prioritize contracts for food, bottled water, and the restoration of electrical systems after hurricane maria struck puerto rico.6 december 2020 had a record number (65,000) of us covid-19 deaths and over 118,000 covid-19 patients in u.s. hospitals.7 vaccines were still predominantly being allocated to healthcare workers and residents of long-term care and assisted living facilities. while the federal government created demand for covid-19 vaccines by contracting with pharmaceutical and manufacturing companies, vaccine supply remained low. private companies needed more time to alter their production schedules and get out of existing contracts before they could fulfill the government contracts. the government invoked the dpa to expedite vaccine production, enabling companies to break existing contracts and start production. on december 17, 2020, horizon therapeutics, a biopharmaceutical company, announced that its drug tepezza would experience a serious supply shortage8 due to the abrupt cancellation of manufacturing slots at horizon’s sub-contractor catalent pharma solutions. catalent, a drug manufacturer, packager, and distributor, was also a producer of moderna’s new covid-19 vaccine, manufacturing both tepezza and the moderna vaccine on the same production line. operation warp speed, used the dpa to direct the immediate reallocation of catalent’s manufacturing slots to moderna.9 the abrupt disruption of tepezza production had a “dramatic effect” on patients.10 tepezza is the only fda-approved medication to treat adults with thyroid eye disease (ted), also known as graves’ ophthalmopathy, a rare autoimmune condition wherein the muscles and fatty tissues behind the eye become inflamed, causing the eyes to push forward and bulge outward. symptoms include eye pain, light sensitivity, difficulty closing the eye, and, in severe cases, blindness.11 while ted impacts a small number of individuals, the disease can be incapacitating, preventing individuals from performing important daily activities, like driving or working. on the prescribed course of treatment for ted, patients take a total of eight intravenous injections of tepezza, one every three weeks.12 when supplies were disrupted, some patients stopped receiving tepezza in the middle of treatment. while the effects of stopping midway are unknown, symptoms may worsen during the hiatus or premature stoppage. people who had not yet begun treatment had to delay starting, sometimes remaining in pain and risking vision loss from optic nerve compression. to alleviate symptoms, some patients may have opted for eye surgeries instead of waiting for tepezza.13 when the federal government invoked the dpa, it inadvertently put two interests at odds with each other – providing medication for a rare but serious disease and speeding up vaccination rates against the coronavirus. prior applications of the dpa affected the supply and demand of machinery and raw materials – not pharmaceuticals, which have a direct and immediate impact on human health. in 1967, for instance, president johnson invoked the dpa requiring chrysler to prioritize production of the m1 abrams tank, the army’s new main battle tank, over cars. around the same time, president johnson also used the dpa to expand chemical plants’ production of herbicides, such as 2,4,5-t and 2,4-d, to make agent orange.14 most recently, the trump administration used the dpa to require ge and 3m to prioritize the production of critical medical equipment (e.g., ventilators, personal protective equipment).15 none of these examples impacted access to pharmaceuticals. there are, however, significant ethical issues at stake in the use of the dpa to abruptly alter pharmaceutical manufacturing, even temporarily. catalent was just one of many moderna covid-19 vaccine manufacturers. the number of doses of tepezza needed to supply patients was small given the low prevalence of ted. an investor reported that if horizon had access to the facility for even a few hours, it smith, applying the defense production act to pharmaceuticals, voices in bioethics, vol. 7 (2021) 3 could have met the demand. 16 if operation warp speed had worked more closely with horizon therapeutics and asked catalent to briefly make additional doses given its short manufacturing time, the negative effects on patients with ted could have been avoided. but the dpa, by design, approaches an emergency from a utilitarian perspective, rapidly redirecting resources to achieve the greatest good for the greatest number of people. a significant portion of the american population, including tepezza’s patient population, was at risk of contracting the coronavirus and experiencing severe symptoms, and the dpa order had the potential to save many lives. but pharmaceutical supply chains are complex, fragile, and highly time sensitive. a sudden disruption can have a significant, long-lasting effect on patients’ health. we need to be cognizant of these ethical issues and weigh competing claims before proceeding. the decision to employ the dpa to take over the assembly line of tepezza resulted in de facto rationing of supplies without proper ethical analysis. during the covid-19 pandemic, we have been fortunate that the dpa did not do more damage to the supply chains of life-saving drugs. conclusion we should reconsider whether the dpa, in its current form, should apply to the pharmaceutical industry. the government should carefully analyze the ethics before redirecting pharmaceutical production. instead, the federal government should create a different process in the dpa, which i call the “pharmaceutical dpa”, for assessing when to divert pharmaceutical production, perhaps with a goal of preserving the ability to produce drugs for serious illnesses, even if the illnesses are rare. while a pharmaceutical dpa could still compel pharmaceutical and manufacturing companies to prioritize government contracts and break preexisting contracts, the companies should have more latitude to decide when and how to start complying with the dpa’s directives. with a new two-tiered law, the federal government would have the ability to redirect non-pharmaceutical resources as it does currently and pharmaceutical ones in a way that gives a limited amount of discretion to pharmaceutical companies. given that so many excess doses of the vaccine remain unused,17 arguably the diversion of resources away from tepezza did not effectively further the government‘s target vaccination goals due to a decision by many people not to receive the vaccine. production of tepezza resumed in april 2021, not because the dpa was lifted, but because horizon submitted a prior approval supplement (pas) to the food and drug administration (fda) to support the increased scale production of tepezza by other manufacturers.18 although the short-term supply shortage has been corrected, the case of tepezza shows that the dpa needs to be carefully reconsidered in the context of the pharmaceutical industry because of the potential consequences to patients. if the dpa were flexible enough to allow catalent to manufacture tepezza for a few more hours in total, the company could have avoided the shortage. the creation of a pharmaceutical dpa would prevent this from happening in the future, enabling the original act’s provisions to be used more like a scalpel than a blunt instrument. 1 fox, l., collins, k., & holmes, k. “pressure mounts for trump to actually use defense production act,” cnn, (2020), accessed july 23, 2021, https://www.cnn.com/2020/03/20/politics/defense-production-act-trump/index.html 2 “statement from the press secretary,” trump white house archives (2020), accessed july 23, 2021, https://trumpwhitehouse.archives.gov/briefings-statements/statement-press-secretary-123020/ 3 court, e. & wingrove, j. “biden team to use dpa for vaccine manufacturing, testing,” bloomberg (2021), accessed july 23, 2021, https://www.bloomberg.com/news/articles/2021-02-05/biden-team-to-use-dpa-for-vaccine-manufacturingtesting?srnd=premium https://www.cnn.com/2020/03/20/politics/defense-production-act-trump/index.html https://trumpwhitehouse.archives.gov/briefings-statements/statement-press-secretary-123020/ https://www.bloomberg.com/news/articles/2021-02-05/biden-team-to-use-dpa-for-vaccine-manufacturing-testing?srnd=premium https://www.bloomberg.com/news/articles/2021-02-05/biden-team-to-use-dpa-for-vaccine-manufacturing-testing?srnd=premium smith, applying the defense production act to pharmaceuticals, voices in bioethics, vol. 7 (2021) 4 4 “the defense production act of 1950: history, authorities, and considerations for congress,” congressional research service (2020), accessed july 23, 2021, https://fas.org/sgp/crs/natsec/r43767.pdf 5 else, d. h. “defense production act: purpose and scope,” congressional research service (2009), accessed september 23, 2021, https://sgp.fas.org/crs/natsec/rs20587.pdf 6 “the defense production act: the obscure law that industry and government should be talking about today (and for the foreseeable future,” dorsey & whitney llp, accessed september 24, 2021, https://www.dorsey.com/newsresources/publications/client-alerts/2020/03/the-defense-production-act 7 “us sees a record number of covid-19 deaths in december,” center for infectious disease research and policy (2020), accessed july 23, 2021, https://www.cidrap.umn.edu/news-perspective/2020/12/us-sees-record-number-covid-19-deathsdecember 8 “horizon therapeutics plc announces short-term tepezza® (teprotumumab-trbw) supply disruption due to governmentmandated (operation warp speed) covid-19 vaccine production,” horizon therapeutics (2020), accessed july 22, 2021, https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-announces-short-term-tepezzar 9 kansteiner, f. “horizon’s tepezza supply dwindles as manufacturer catalent pivots to warp speed vaccines” fierce pharma (2020), accessed july 23, 2021, https://www.fiercepharma.com/manufacturing/horizon-faces-tepezza-disruptions-asmanufacturer-catalent-tapped-for-warp-speed 10 kuchler, h. “push to make covid vaccines causes us drug shortages,” financial times (2021), accessed july 22, 2021, https://www.ft.com/content/b3ac261e-2675-4679-9356-53aa6d812ad7 11 “fda approves first treatment for thyroid eye disease,” fda (2020), accessed july 22, 2021, https://www.fda.gov/newsevents/press-announcements/fda-approves-first-treatment-thyroid-eye-disease 12 “tepezza dosing and administration” tepezza, accessed july 23, 2021, https://www.tepezza.com/hcp/tepezza-dosing-andinfusion-information 13 it should be noted that there are currently no academic sources on the effects of the tepezza shortage to the ted patient population. 14 bell, d. “’a little-known bill of great national significance’: the uses and evolution of the defense production act, 1950 – 2020,” us army heritage and education center (2020), accessed september 23, 2021, https://ahec.armywarcollege.edu/documents/defense_production_act_1950-2020.pdf 15 “applying the defense production act,” fema (2021), accessed september 23, 2021, https://www.fema.gov/pressrelease/20210420/applying-defense-production-act 16 author personally attended a small group conversation with the investor and attests to the accuracy of the statement. 17 eaton j., murphy, j. “15 million covid vaccine doses thrown away in the u.s. since march, new data shows,” nbc news (2021), accessed october 1, 2021, https://www.nbcnews.com/news/us-news/america-has-wasted-least-15-million-covid-vaccine-dosesmarch-n1278211 18 “statement on tepezza® (teprotumumab-trbw) availability,” horizon (2021), accessed july 22, 2021, https://www.horizontherapeutics.com/media-center/horizon-resources/statement-on-short-term-tepezza-supply-disruption https://fas.org/sgp/crs/natsec/r43767.pdf https://www.dorsey.com/newsresources/publications/client-alerts/2020/03/the-defense-production-act https://www.cidrap.umn.edu/news-perspective/2020/12/us-sees-record-number-covid-19-deaths-december https://www.cidrap.umn.edu/news-perspective/2020/12/us-sees-record-number-covid-19-deaths-december https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-announces-short-term-tepezzar https://www.fiercepharma.com/manufacturing/horizon-faces-tepezza-disruptions-as-manufacturer-catalent-tapped-for-warp-speed https://www.fiercepharma.com/manufacturing/horizon-faces-tepezza-disruptions-as-manufacturer-catalent-tapped-for-warp-speed https://www.ft.com/content/b3ac261e-2675-4679-9356-53aa6d812ad7 https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease https://www.tepezza.com/hcp/tepezza-dosing-and-infusion-information https://www.tepezza.com/hcp/tepezza-dosing-and-infusion-information https://ahec.armywarcollege.edu/documents/defense_production_act_1950-2020.pdf https://www.fema.gov/press-release/20210420/applying-defense-production-act https://www.fema.gov/press-release/20210420/applying-defense-production-act https://www.horizontherapeutics.com/media-center/horizon-resources/statement-on-short-term-tepezza-supply-disruption o’malley, telemental health, voices in bioethics, vol. 8 (2022) * nick o’malley, ms candidate columbia university, oms ii at nyit college of osteopathic medicine © 2022 nick o’malley. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. telemental health: a saving grace or an inadequate vessel? nick o’malley* abstract the covid-19 pandemic has brought about the advent of many new telehealth technologies as providers have been forced to shift their practice from the clinic to the cloud. perhaps, none of these fields has been as widely advertised and expanded as telemental health. while many have lauded this change, it is important to question whether this method of practice is truly beneficial for patients, and further whether it benefits all patients. this paper critically examines the current structure of telemental health interventions and compares them to more traditional in-person interactions, reflecting on the unique benefits and challenges of each method, and ultimately concluding that telemental health is the wrong modality for certain patients and modalities. keywords: telemedicine, mental health, telehealth, healthcare access, healthcare technology introduction as the e-health revolution rapidly progresses, scientists, healthcare professionals, and technology experts are attempting to determine which areas of medical practice will best adapt to changing dynamics. two key professions that are ripe for this kind of disruption are psychiatry and psychology. the american psychiatric association, along with its partners in the american telemedicine association, states that “telemental health in the form of interactive videoconferencing has become a critical tool in the delivery of mental health care. it has demonstrated its ability to increase access and quality of care, and, in some settings, to do so more effectively than treatment delivered in-person.”1 this claim, though appearing bombastic, is also reflected, though with more nuance, by the american psychological association. for its part, the american psychological association states that “the expanding role of technology and the continuous development of new technologies that may be useful in the practice of psychology present unique opportunities, considerations, and challenges to practice.”2 thus, the point of this paper will be to examine whether the rapidly expanding system of telemental health is ethical based on its adherence to accepted standards of care, privacy concerns, and concerns about the boundaries of the patient-provider relationship. o’malley, telemental health, voices in bioethics, vol. 8 (2022) 2 i. standard of care concerns one of the most considerable objections to the broader implementation of telemental health services is the speculation that it is less effective than in-person treatment. it would follow that a system that is broadly implemented would not only fail to be beneficent, but it would also fail to be non-maleficent. providers would be knowingly providing an ineffective treatment. some may argue that such a system would also violate the principle of justice. it would create an unequal system of care in which those patients who could afford to see their therapist in person would benefit more than those who could not. however, data from a wide variety of sources at first glance, would seem to contradict these fears.3 a review of the literature regarding the implementation of telemental health in geriatric patients, for example, showed that telemental health was as good as in-patient psychiatric care in several areas, including the diagnosis of dementia, nursing home consultations, and in conducting psychotherapy for geriatric patients and their caregivers. 4 on the other end of the age spectrum, a review of nineteen randomized controlled trials and one clinical trial demonstrated high comparative effectiveness between telemental health interventions in children and adolescents.5 hailey et al. found that telemental health interventions were effective in over half of the 65 studies reviewed. these studies encompassed a diverse and wide-ranging number of psychiatric disciplines, including child psychiatry, post-traumatic stress disorder, dementia, cognitive decline, smoking cessation, and eating disorders. methods included phone and web-based interventions.6 indeed, the data is not just limited to outpatient settings. for example, reinhardt et al. conducted a literature review of studies about telemental health visits for psychiatric emergencies and crises. they found that no studies reported a significant statistical difference in diagnosis or disposition among psychiatric patients who presented to the emergency department. in addition, their review demonstrated a reduction in length of stay, reduction in time to care, and decreased costs among these patients. the authors also reviewed literature pertaining to crisis response teams and patients with severe mental illness. both studies demonstrated that telemental health visits for these patients were similar, if not better, than face-to-face visits. in addition, both patients and practitioners showed high satisfaction with these services. 7 thus, the implementation of telemental health is limited to out-patient settings and could feasibly be implemented in the in-patient and emergency settings. there is, however, one particularly glaring gap in telemental health services: group therapy. perhaps the most famous example of group therapy is alcoholics anonymous, but group therapy has expanded to include many different modalities. group therapy is a common intervention for many mental illnesses and can be incredibly effective in treating diseases ranging from ptsd to borderline personality disorder.8 in a pilot study comparing a video teleconference based dialectical behavioral therapy (dbt) group to an inperson dbt group, lopez et al. found that while patients had similar levels of cohesion with the facilitator, participants in the video teleconference group saw less group cohesion than their peers in the in-person group. further, while many patients in the video teleconference group believed that the convenience offset the adverse effects, many also wished for an in-person group. attendance was also significantly higher in the video teleconference group.9 thus, while the video teleconference group did report some positives, some significant differences raise ethical questions. how well does a group do without cohesion? for example, if a person needing to be consoled breaks down and cries in front of the group, the in-person response may be different from the video conference. in the in-person group, other group members may place a gentle hand on the shoulder of the grieving person or maybe even hug them. the group facilitator or group members in the video o’malley, telemental health, voices in bioethics, vol. 8 (2022) 3 conference group could say the same words of consolation as those in the in-person group. however, there still seems to be some missing action. the idea of physical touch, in this way, can mean a lot more than just a small action. van wynsberghe and gastmans argue that this kind of deprivation may lead to feelings of depersonalization.10 and, to an extent, their supposition is supported by the data presented by lopez et.al. the low level of group cohesion in the video conference group could suggest that other group members seem unimportant to the participants. they are simply things on a screen, not real people. dr. thomas insel, former national institute of mental health director writes that while technology may hold the key to improving mental health on the population level, there is a human-sized piece of the puzzle missing from these interventions. the solution, he asserts, lies somewhere in the integration of these two types of experiences, one that he terms “high-tech and high-touch.” 11 the lack of touch and physical presence is an obstacle for both patients and providers. at best this may lead to a slightly poorer providerpatient relationship and at worst may result in poorer quality care. ii. privacy & confidentiality concerns privacy and confidentiality are among the most serious concerns for practitioners and patients, made more complex by the advent of e-health. major news outlets provide plenty of examples of breaches of confidentiality of people’s electronic records. even significant systems, often thought to be secure, used to facilitate direct contact between people in the wake of covid-19, like zoom, have been breached. not too long ago, "zoom bombing” was a national phenomenon, appearing in online classrooms, often sharing explicit or politically motivated content. psychiatric patients are susceptible to issues surrounding privacy and confidentiality, and they may even come from communities that ostracize and stigmatize mental illness. these concerns must be taken seriously. of course, both the american psychiatric association and the american psychological association address privacy concerns. both organizations note in their guidelines that relevant hipaa regulations apply to telehealth and doctors must use apps and videoconferencing tools with the highest levels of security.12 interestingly, the american psychiatric association takes these instructions one step further. it requires providers to be in a private room during telehealth videoconferences or calls and that people seeking care also have a private space so that any conversations are not overheard. this not only prevents violations of privacy but reassures the therapeutic relationship between provider and patient.13 while providers can take these steps to ensure their patients’ privacy, an internet connection may not guarantee privacy. many privacy issues are more easily mitigated in a clinical space. for example, walls and doors can be soundproofed, or white noise can be played in the waiting room to ensure that therapeutic conversations are not overheard. and while the american psychiatric association asks providers to mitigate these risks as they would in their respective clinics, there is another layer to online privacy. providers should be concerned about telecommunications providers, how they collect information, and what types of information they collect.14 if, for example, the patient must navigate to the practitioner’s webpage to enter into the therapy portal, that information might be tracked and used to generate personalized ads for the patient. if a person suffering from severe paranoia started receiving ads for psychiatric medication, they may react negatively to the invasion of privacy. that type of targeted advertising could even exacerbate a mental health condition. the scandals surrounding the national security administration (nsa) in recent years have added another layer of complexity to the issue of privacy. whistleblowers like edward snowden, revealed that the o’malley, telemental health, voices in bioethics, vol. 8 (2022) 4 government was collecting metadata from text messages, videos, and social media. government surveillance is an added risk of mental health videoconferencing.15 the government would not be bound by the rules that require privacy with few exceptions like the tarasoff law, which could require disclosure to stop a violent act as a clinical care provider. the government might judge someone a risk based on illgotten surveillance data, wrongly add a person to a watch list, or engage in further surveillance of a patient whom non-clinicians working in government assess to be a potential danger. protection from government surveillance is a fundamental ethical endeavor. yet government as a collector of data without a warrant or with easily attained fisa and other warrants is problematic. scenarios may seem far-fetched but are within the realm of possibility. secondly, the provider must envision how this might hinder care. for example, patients aware of the possibility of government surveillance may be reluctant to show up to online meetings if they show up at all. perhaps they are so sensitive to these issues that they stop checking with their therapist altogether. it is easy to see how a person who has schizophrenia and shows signs of paranoia may avoid telehealth for fear of being tracked. of course, one could also have privacy concerns about a therapist’s office. perhaps patients are nervous about being seen in the office or parking lot. they might worry about being overheard. these concerns, however, can be mitigated fairly simply, for example, patients could find anonymous means of transportation and practitioners can soundproof their offices. thus, in both the office and the videoconference, concerns can be mitigated easily and tangibly, but not eliminated entirely. mental health providers should use the highest quality communication services with end-to-end encryption to bolster online privacy. iii. boundary issues and professionalism the boundaries here are philosophical, not physical. both the american psychiatric association and the american psychological association work to ensure that the patient-professional boundaries are kept as close to normal as possible. both organizations expect practitioners to maintain the highest levels of professionalism when dealing with patients using telemental health services. 16 practitioners are responsible for enforcing boundaries through informing their patients about appropriate behavior so that patients are discouraged from calling at inappropriate times absent an emergency. videoconferencing systems and multi-layered protections like passwords and gatekeeping would prevent patients from logging into another patient’s appointment. these boundaries exist for a good reason. a 2017 report demonstrated that there is an escalating shortage of psychiatrists.17 nearly 1 in 5 people in the us has a mental health condition.18 mental health providers are nearly overwhelmed, therefore inappropriate, frequent, and unnecessary contact add another level of complexity to treating patients. mental health providers need to be stewards of the resource they provide. they must concentrate on the patient they are with. they also must guard themselves against burnout, because dealing with patients too often, even though technology allows for it, will lead to them being less effective for the rest of their patients. while these professional boundaries must be policed carefully, practitioners should also be careful of having boundaries that are too high. thus, providers must balance between too much intimacy and too little. 19 presence and physical touch have symbolic meaning. being with a person reaffirms their personhood, and both provider and patient can feel that. humans are relational beings, and a physical relationship often comforts people. it may also legitimize and reinforce the patient through sensation and o’malley, telemental health, voices in bioethics, vol. 8 (2022) 5 perception. there may be something inherently missing from the practice of telemental health, as exemplified by the group members’ inability to console others in group therapy sessions over teleconference. 20 the screen may also be an agent of depersonalization. it may make the patient’s complaints seem less real. or perhaps the patient may feel as though they are not being heard. although the evidence of telemedicine’s successes above may seem to contradict this, none of the studies that extoll the benefits of telemental health have follow-up periods greater than one year. and while many studies show that patients are highly satisfied with telemental health, measurements of satisfaction are not standardized. it remains unclear whether patients benefit enough from their telemental sessions or whether they require more regular sessions to stay as satisfied as they were with in-person mental health care. perhaps as time goes on, patients become more frustrated with telemental health. the research must answer these questions, but currently, it does not sufficiently address metaphysical arguments against telemental health. conclusion privacy is a key practical issue that remains. although providers try to combat issues of privacy by using high-level conferencing software, which has end-to-end encryption,21 surveillance and breaches may occur. while not suitable for all kinds of patients, telemental health services prove to be effective for groups of people that otherwise may not have been able to receive care over the past two years. there are some settings, such as group therapies, that are best suited for in-person meetings. although online sessions encourage individuals to show up regularly, their downsides are not yet known. there is incredible power in the idea of presence, and humans are inherently relational beings. for some, a lack of contact is unwelcomed and makes therapy less satisfying. opportunities to use in-person clinical care remain a priority for some patients, and healthcare providers should further investigate prioritizing inperson care for those who want it. telemental health could be beneficial for emergencies, natural disasters, vulnerable groups, or when patients cannot get to their provider's office. however, for now, telemental health should not take a leading role in providing mental health treatment. 1 chiauzzi e, clayton a, huh-yoo j. videoconferencing-based telemental health: important questions for the covid-19 era from clinical and patient-centered perspectives. jmir ment health, 2020. doi:10.2196/24021 2 joint task force for the development of telepsychology guidelines for psychologists. guidelines for the practice of telepsychology. american psychologist, 2020. 791–800. doi.org/10.1037/a0035001 3 gentry mt, lapid mi, rummans ta. geriatric telepsychiatry: systematic review and policy considerations. am j geriatr psychiatry. 2019 doi: 10.1016/j.jagp.2018.10.009; campbell r, o'gorman j, cernovsky zz. reactions of psychiatric patients to telepsychiatry. ment illn. 2015;7(2):6101, 2015. doi:10.4081/mi.2015.6101; malhotra s, chakrabarti s, shah r. telepsychiatry: promise, potential, and challenges. indian j psychiatry, 2013. doi: 10.4103/0019-5545.105499; reinhardt i, gouzoulis-mayfrank e, zielasek j. use of telepsychiatry in emergency and crisis intervention: current evidence. curr psychiatry rep, 2019. doi: 10.1007/s11920-019-1054-8 4 gentry, lapid, and rummans, geriatric telepsychiatry 5 abuwalla, zach & clark, maureen & burke, brendan & tannenbaum, viktorya & patel, sarvanand & mitacek, ryan & gladstone, tracy & voorhees, benjamin. long-term telemental health prevention interventions for youth: a rapid review, 2017. internet interventions. doi.11. 10.1016/j.invent.2017.11.006. https://psycnet.apa.org/doi/10.1037/a0035001 o’malley, telemental health, voices in bioethics, vol. 8 (2022) 6 6hailey d, roine r, ohinmaa a. the effectiveness of telemental health applications: a review, 2008. can j psychiatry. doi:10.1177/070674370805301109. 7 reinhardt, gouzoulis-mayfrank, and zielasek, use of telepsychiatry in emergency and crisis intervention 8 kealy, david & piper, william & ogrodniczuk, john & joyce, anthony & weideman, rene. individual goal achievement in group psychotherapy: the roles of psychological mindedness and group process in interpretive and supportive therapy for complicated grief, 2018. clinical psychology & psychotherapy. doi:10.1002/cpp.2346. schwartze d, barkowski s, strauss b, knaevelsrud c, rosendahl j. efficacy of group psychotherapy for posttraumatic stress disorder: systematic review and meta-analysis of randomized controlled trials. psychother res, 2019. doi: 10.1080/10503307.2017.1405168; wetzelaer p, farrell j, evers sm, jacob ga, lee cw, brand o, van breukelen g, fassbinder e, fretwell h, harper rp, lavender a, lockwood g, malogiannis ia, schweiger u, startup h, stevenson t, zarbock g, arntz a. design of an international multicentre rct on group schema therapy for borderline personality disorder. bmc psychiatry, 2014. doi: 10.1186/s12888-014-0319-3 9 lopez, amy et al. “therapeutic groups via video teleconferencing and the impact on group cohesion.” mhealth, 2020. doi:10.21037/mhealth.2019.11.04 10 van wynsberghe a, gastmans c. telepsychiatry and the meaning of in-person contact: a preliminary ethical appraisal. med health care philos, 2009. doi: 10.1007/s11019-009-9214-y. 11thomas insel, “tech can help solve our mental health crisis. but we can’t forget the human element.,” substack newsletter, big technology (blog), january 27, 2022, https://bigtechnology.substack.com/p/tech-can-help-solve-our-mental-health. 12 armstrong, c. m., ciulla, r. p., edwards-stewart, a., hoyt, t., & bush, n. best practices of mobile health in clinical care: the development and evaluation of a competency-based provider training program, 2018. professional psychology: research and practice. doi.org/10.1037/pro0000194 13 armstrong, c. m., ciulla, r. p., edwards-stewart, a., hoyt, t., & bush, n. best practices of mobile health in clinical care: the development and evaluation of a competency-based provider training program 14 sabin je, skimming k. a framework of ethics for telepsychiatry practice. int rev psychiatry, 2015. doi:10.3109/09540261.2015.1094034 15 lustgarten, s. d., & colbow, a. j. ethical concerns for telemental health therapy amidst governmental surveillance, 2017. american psychologist. doi.org/10.1037/a0040321 16 armstrong, c. m., ciulla, r. p., edwards-stewart, a., hoyt, t., & bush, n. best practices of mobile health in clinical care: the development and evaluation of a competency-based provider training program 17 merritt hawkins. an overview of the salaries, bonuses, and other incentives customarily used to recruit physicians, physician assistants and nurse practitioners, 2018. http://physicianresourcecenter.com/wp-content/uploads/2018/09/merritt-hawkins2018-review-of-physician-and-advanced-practitioner-incentives.pdf 18 bose, j., hedden, s., lipari, r., park-lee, e. key substance use and mental health indicators in the united states: results from the 2015 national survey on drug use and health, 2015. https://www.samhsa.gov/data/sites/default/files/nsduh-ffr12015/nsduh-ffr1-2015/nsduh-ffr1-2015.pdf 19 sabin and skimming. a framework of ethics for telepsychiatry practice 20 van wynsberghe and gastmans, telepsychiatry and the meaning of in-person contact 21 lustgarten and colbow, ethical concerns for telemental health therapy amidst governmental surveillance https://psycnet.apa.org/doi/10.1037/pro0000194 https://psycnet.apa.org/doi/10.1037/a0040321 monday, ethics of cognitive restructuring, voices in bioethics, vol. 6 (2020) * osebor ikechukwu monday, department of arts and humanities, delta state polytechnic ogwashi-uku pmb 1030, nigeria © 2020 osebor ikechukwu monday. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethics of cognitive restructuring: a rehabilitation of rape victims and offenders osebor ikechukwu monday* abstract the effects of rape include post-traumatic stress disorder (ptsd). ptsd reawakens traumatic memory linked to sexual violence, creating depression and anxiety. retributive justice (punishing the offender) has been the commonly used solution to combat sexual misconduct, aiming to deter rape, punish the offender, and help the victim. while some argue retributive justice is an ethical response to rape, the offenders’ punishment does not solve the long-term problem. rehabilitation that addresses cognitive behavior and restructures thinking would offer incarcerated offenders a chance to become nonviolent and victims a chance to control their ptsd. keywords: cognitive restructuring, ethics, rape, sexual assault, retribution, nigeria introduction ethics is the study of moral principles and why people make moral and immoral decisions. it focuses on how people ought to behave based on their moral compass or values, and society’s shared values, laws, and traditions. since rape and sexual assaults are becoming more common in nigeria, the country must add psychological rehabilitation and prevention programs. in nigeria, the role of women is primarily in service to men and rape is especially common among african adolescents. mental healthcare remains stigmatized in nigeria compared to western countries. this paper argues that access to cognitive restructuring would help both the perpetrators and the victims of rape.1 while cognitive restructuring is not new, in nigeria there has not been access to mental healthcare for victims who need it and for perpetrators who are later released back into society. monday, ethics of cognitive restructuring, voices in bioethics, vol. 6 (2020) 2 analysis the important ethical issues surrounding rape include the lack of consent and harm to victims, as well as the greater societal values of feminism and nonviolence. in the context of rape, “consent is, without doubt, the most important concept…the “criminality” of sexual offenses derives largely from a sexual act performed without one or more parties’ consent to that act.”2 therefore, by not mutually agreeing to the sexual act to occur, the offender takes away the victims’ autonomy. although rape statutes vary, all require a lack of consent to determine that rape has occurred. an age of consent determines that minors are not able to give informed consent to sexual acts. rape can reflect a premeditated decision to rape the victim. however, the mindset required may include indifference toward consent or a lack of understanding consent. a. background rape is a psychosocial assault. it involves the use of physical force but also involves social factors underlying the rapist’s thoughts or development. there are different ways to count rape based on reporting, prosecution, or conviction creating statistical disparities in the numbers of rape cases worldwide.3 there are also different situations in which rape occurs: rape within marriage, date rape, rape by strangers, rape of a minor, systematic rape, and sexual slavery. although women are often reluctant to use “rape” or “sexual assault” to describe coerced or unwanted sexual experiences that involve a romantic partner,4 these instances are nonetheless considered rape and their perpetrators should be convicted. in the us, date rape is discussed and prevention is addressed while in nigeria many may not report abuse by a romantic partner. in 2013, only 28 out of 100 rape cases in nigeria were reported to the police and the percentage of reported cases has continued to decrease over the years despite the consistent increase in the number of incidents.5 the oddness of the underreporting of rape and sexual violence in nigeria is underlined by the deficiencies of government to establish structures that would encourage victims to boldly come out. childhood sexual abuse has serious long-term effects. adverse childhood experiences can result in a higher risk for physical and psychological disorders including ptsd, feelings of anger, self-blame, sleeplessness, lack of energy, depression, substance abuse, and suicide.6 “the prevalence of this violence ranges between 15 and 40% in sub-saharan africa, with studies showing rates of sexual coercion and abuse among female adolescents in nigeria between 11 and 55%.”7 these rates show there are serious consequences for victims of rape and sexual assault. memories of unanalyzable fragments of what rape victims have seen, heard, done, and felt can trigger ptsd, a common problem among survivors. in rare circumstances, a person with severe ptsd may attack oneself, insult oneself, or engage in extreme violence.8 however, many victims are able to survive rape, recover from the trauma, and find success making peace with the devastating event. b. cognitive restructuring cognitive restructuring refers to a “structured, collaborative therapeutic approach in which distressed individuals are taught how to identify, evaluate, and modify the faulty thoughts, evaluations, and beliefs that are considered responsible for their psychological disturbance.”9 cognitive restructuring is a therapy that harnesses the psychological ability to think about and refute irrational thoughts. the psychotherapeutic procedure is an emotive treatment that gives rape victims a sense of agency and control over negative thoughts or bad mental habits. cognitive restructuring is a philosophy of mind and social control therapy. it is monday, ethics of cognitive restructuring, voices in bioethics, vol. 6 (2020) 3 a technique in cognitive behavioral therapy, which helps people identify and alter traumatic disorder. 10 cognitive rebuilding is psychosocial education that redirects thoughts encouraging the suppression of unwanted thoughts. it is a committed real-world theory which provides relief for patients suffering from a psychosocial disorder. however, the theory is unsuitable for patients with complex mental health needs or learning difficulties. c. helping victims of rape the rape and murder of vera uwaila omozuwa, a microbiology student at the redeemed christian church of god, benin city, sparked reactions across nigeria.11 this assault prompted the nigerian senate to pass a bill on sexual violence. the bill seeks to promote and protect ethical standards in tertiary institutions. in addition, it seeks to protect students against sexual harassment including that by educators in tertiary institutions. the bill also proposes up to 14 years jail term for offenders.12 however, reinforcing rape via institutions may pose a problem of victim reporting because of the fear of stigmatization. this fear may contribute to the maintenance of rape-accepting attitudes in possible perpetrators of future campus sexual violence.13 hopefully, new laws and measures will be accompanied by procedures to voice complaints without fear of intimidation or slander. there are many approaches to help rape victims so that they can achieve lasting good mental health. victims benefit from compensation and punishment of the perpetrator (retributive justice). cognitive restructuring is the best approach to rape victims’ rehabilitation because it offers active solutions rather than just analyzing their past. the intertwined neurological, behavioral, and social consequences of ptsd caused by rape are not well understood by policymakers, thus psychologists and doctors may be better suited to help victims.14 after the rape incident, cognitive restructuring should be adopted to help victims adequately recover from the trauma.15 d. retributive justice retributive justice is a legal, moral, and political philosophy. it is a theory of punishment that means 'payback debt.' retributive justice affirms the punishment of rape offenders rather than rehabilitation to address their violent behavior.16 retributive justice focuses on punishments like fines and imprisonment. the punishment is justified because of the immoral action of the rapist. in criminal justice, the solutions or punishments serve varying purposes: keeping perpetrators of crimes away from potential victims and the public, punishing them, rehabilitating them, and altering behavior patterns. there is no empirical evidence to show that rapists are properly rehabilitated while incarcerated, demonstrating that many prison sentences serve primarily as punishment. retributive justice as the sole reason for incarceration is undesirable because it does not help the assailant return to society. e. how cognitive restructuring can help both victims and assailants rape victims can perform better and return to their normal state of mind with cognitive therapy. cognitive restructuring should be recommended as psychotherapy for both rape victims and offenders.17 cognitive restructuring would help to track the accuracy of thought among rape victims and offenders. however, cognitive restructuring may not show immediate improvement for victims of ptsd because patients must participate to achieve the benefits. the therapy is highly active; people who do not actively participate daily monday, ethics of cognitive restructuring, voices in bioethics, vol. 6 (2020) 4 may not achieve the desired benefits. 18 often, in nigeria, victims and assailants are not matched with professionals trained in psychotherapy. the vast majority of rape victims are thus abandoned to themselves, leaving them unidentified, unprotected, and uncared for.19 conclusion psychological treatment is useful for decreasing anxiety and depression, improving self-control, and solving mental health issues. cognitive restructuring must apply in the legal parlance for the rehabilitation of rape victims and offenders. societal benefits would ensue if the law provided psychotherapy for both victims and aggressors. victims would still know their perpetrators are convicted and punished, while also knowing both they and their perpetrators are on the road to psychological recovery. 1chiazor, i. a., ozoya, m. i., udume, m. &egharevba, m. e. taming the rape scourge in nigeria: issues and actions. gender &behaviour, 14 (3), 2016, 7764-7785 2 some notes on consent and sexual offences (part one) (2013). https://philosophicaldisquisitions.blogspot.com/2013/09/somenotes-on-consent-and-sexual.html 3gordon, lp violence against women. nova publishers. (2002): pp. 4–6. isbn 978-1-59033-455-3 4adams-clark, a a, smith, c p.; bhuptani, prachi h.; and freyd, j j. "university crime alerts: do they contribute to institutional betrayal and rape myths?," dignity: a journal on sexual exploitation and violence (2020): 56. doi: 10.23860/dignity.2020.05.01.06 5 richard a. a. international journal of criminology and sociological theory, vol. 7, no. 2, december 2014, 1-14 6kristen, w. s., jennifer, s., daphne, k., and molly, c. the long-term health outcomes of childhood abuse. an overview and a call to action. j gen intern med. 2003 oct; 18(10): 864–870.doi: 10.1046/j.1525-1497.2003.20918.x 7morenike o. folayan, morolake odetoyinbo, abigail harrison, and brandon brown..rape in nigeria: a silent epidemic among adolescents with implications for hiv infection. glob health action. 2014; 7: 10.3402/gha.v7.25583. 8rose, k., p 15. 9david a. clark . cognitive behavioral therapy, first edition. edited by stefan g. hofmann. john wiley & sons, ltd. published 2014 doi: 10.1002/9781118528563.wbcbt02 10david a. clark . cognitive behavioral therapy, first edition. edited by stefan g. hofmann. john wiley & sons, ltd. published 2014 doi: 10.1002/9781118528563.wbcbt02 11emmanuel, a. rape and murder of student in church sparks outrage across nigeria. the guardian newspaper(2020). 7-2. https://www.theguardian.com/global-development/2020/jun/02/and-of-student-in-church-sparks-outrage-across-nigeria 12for an act to prevent, prohibit and redress sexual harassment of students in tertiary educational institutions and for matters connected therewith, 2019”.https://ndlink.org/wp-content/uploads/2020/02/anti-sexual-harassment-in-tertiary-bill2019.pdf 13rose, k., p 15. 14rose, k., p 15. 15odera, h. punishment and terrorism in africa. east africa. breau. kampala (1976). p.50-55. 16lexcico. retributive justice. oxford english dictionary. https://www.lexico.com/definition/retributive_justice. 17https://www.theguardian.com/global-development/poverty-matters/2013/nov/25/rehabilitation-survivor-sexual-violence-warconflict 18david a. clark . cognitive behavioral therapy, first edition. edited by stefan g. hofmann. john wiley & sons, ltd. published 2014 doi: 10.1002/9781118528563.wbcbt02 19michael l. what are some of the criticism of cbt (cognitive behavioral therapy) as a psychological therapy or scientific theory (2018).https://www.quora.com/what-are-some-of-the-criticism-of-cbt-cognitive-behavioral-therapy-as-a-psychologicaltherapy-or-scientific-theory. j gen intern med. 18(10): 864–870.doi: 10.1046/j.1525-1497.2003.20918.x https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1494926/ https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4142225/ https://www.theguardian.com/global-development/2020/jun/02/and-of-student-in-church-sparks-outrage-across-nigeria https://ndlink.org/wp-content/uploads/2020/02/anti-sexual-harassment-in-tertiary-bill-2019.pdf https://ndlink.org/wp-content/uploads/2020/02/anti-sexual-harassment-in-tertiary-bill-2019.pdf https://www.quora.com/what-are-some-of-the-criticism-of-cbt-cognitive-behavioral-therapy-as-a-psychological-therapy-or-scientific-theory https://www.quora.com/what-are-some-of-the-criticism-of-cbt-cognitive-behavioral-therapy-as-a-psychological-therapy-or-scientific-theory https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1494926/ moorthy, recruiting psychology students, voices in bioethics, vol. 6 (2020) * gyan moorthy, ms candidate columbia university © 2020 gyan moorthy. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. recruiting psychology students to participate in faculty/department research: ethical considerations and best practices gyan moorthy* keywords: research ethics, informed consent, inducement, psychology research, student research, irb, university research introduction introductory psychology courses often have high enrollments and present department faculty and staff with a large pool of potential research subjects.1 at many institutions, professors make participation in department research a course requirement or offer extra credit as a participation incentive. early participation is thought to benefit students by exposing them to the research process and to techniques they may encounter in the future.2 many students who choose to participate are pleased with their experience and feel more connected to their departmental community.3 nevertheless, the unique faculty-student relationship raises important questions about the ethics of student participation in faculty or department research.4 analysis the primary issues are informed consent and voluntariness. students should decide to participate in research of their own free will, and their participation should be a reflection of their own values and desires.5 however, faculty are in a position of authority over students, who may see their approval as crucial for academic and professional advancement. students may fear that declining opportunities to participate in department research will leave them struggling to complete time-consuming “alternate assignments,” prevent them from obtaining strong letters of recommendation, or earn them a negative reputation in the department, potentially impacting their performance in future courses. these problems could be exacerbated if research participation is not anonymous or if it becomes synonymous with what a “model student” would do.6 even perceived pressure can impact a decision to participate, and there is some evidence that younger students moorthy, recruiting psychology students, voices in bioethics, vol. 6 (2020) 2 and students of color perceive more pressure to participate than their peers.7 this issue is significant because it can skew the subject pool and place a disproportionate burden on already disadvantaged groups. in addition, it threatens to undermine students’ trust in the research enterprise and their relationship with professors outside of research. voluntariness is also threatened by offering extra credit as an incentive for research participation. extra credit may constitute undue inducement: it may be so attractive to students that they will do more than what is appropriate to get it. nearly 85 percent of students at one large state university said they would participate in research for as little as a 3-5 percent boost to their final averages.8 while this may be a problem with student culture rather than extra credit itself, it is something that faculty must take into account. moreover, because of circumstances outside their control, some students may be denied either the opportunity for extra credit (if no comparable alternatives are available) or the educational benefits associated with research participation. some students do not have time to participate in research because they work multiple jobs or have other commitments, including travel for sports. some students are left-handed or have braces and so are ineligible for many studies using functional magnetic resonance imaging (fmri) electroencephalography (eeg) and other, similar techniques.9 but much of this has been discussed in the literature, and with the help of the office for human research protections (ohrp), some universities have even developed semi-satisfactory solutions.10 i wish to expand on the solutions i believe are most important, as well as to propose others rooted in my belief that soliciting students to participate in research is only ethical if they derive real, long-term educational benefit from it. to my knowledge, no university has implemented all of these measures. first, psychology departments should ensure there are sufficient and diverse research opportunities available for all students who wish to participate. not only does this promote fairness for students with packed schedules, it increases educational benefit by exposing students to different research techniques. another means of ensuring that students derive personal benefit from research participation is to require “experimental debriefs” soon after participation. debriefs should include a q&a session. if professors award extra credit for research participation, they must also offer alternate assignments that require the same amount of time and energy to complete. professors should advertise alternate assignments vigorously and emphasize that students who choose to complete them will not be viewed negatively by course faculty or others in the department. perhaps a committee of students and faculty can come together to decide what an appropriate amount of extra credit might be, or whether extra credit should be off the table altogether.11 the answer will depend largely on institutional culture. if sufficient participation can be achieved through advertising, if extra credit is not traditionally offered in other courses for other assignments, or if faculty feel comfortable making research participation a course requirement, extra credit for research participation should probably not be offered. to ensure participation remains voluntary throughout the research process, students who withdraw from a study for any reason should receive the same credit or extra credit as students who complete that study. most studies are short and require little effort, so it is unlikely that students will abuse this policy. to minimize the possibility of coercion or undue influence, and to allow professors to fulfill their primary duty to students (as teachers), students should book their research participation or alternate assignments through an online, department-wide system that course professors agree not to regularly monitor for student moorthy, recruiting psychology students, voices in bioethics, vol. 6 (2020) 3 participation.12 students should not be able to participate in research that their professor directly oversees. exceptions may be made for small departments to ensure that sufficient studies are available. this system could tabulate points derived from research participation or alternative assignments and update course professors on students’ progress before grades are due. while implementation may be costly and complicated for larger departments, they are the most likely to have the requisite resources and manpower. transparency is key. universities should publish a general policy for research on students. while all proposed experiments filter through the same set of institutional review boards (irbs), a published standard holds irbs accountable and motivates them to explicitly incorporate consideration of the outlined ethical issues into their initial and continuing reviews of relevant studies. it also helps ensure parity and equal protection for student subjects across departments. the ethical rationale for each of these safeguards should be explained to students. they should understand what it means to give informed consent in the context of a power differential and what might be an inappropriate incentive for participation in research. despite the widely acknowledged importance of research ethics, it receives little attention in introductory courses. even if some students do go on to take research methodology courses, where these issues are properly fleshed out, most will not, and asking them to participate in department research studies, using “exposure to the research process” as a justification, cannot be ethically done without including a discussion of this key component of research. moreover, frank discussions of these issues may influence institutional/department culture such that students who choose not to participate feel less like they are “letting down” their professors or that they are simply “too sensitive.” perhaps the possible racial differences in perceived pressure to participate will diminish as well. one might argue that college students are not truly so vulnerable a population. unlike children, they are capable of performing their own risk-benefit analyses. theoretically, it should not matter if they are asked to participate in research studies run by their professors or if they can earn a marginal amount of extra credit by doing so; existing informed consent standards already account for these and other issues likely to arise. furthermore, unlike prisoners, students cannot be considered a “captive” population. they are free to enroll in other courses, to “vote with their feet.” and even if they were as vulnerable as children or prisoners, it does not seem reasonable to require that they derive direct benefit from research participation because psychology research seldom poses more than minimal risk. this actually protects college students more than children13 and, in some ways, more than prisoners.14 however, college students are susceptible to peer pressure and depend on the approval of their mentors, who can double as research investigators. it is unreasonable to expect them to challenge a system erected by those with authority over them. without departmental efforts to ensure students personally benefit from research participation, they are nothing more than a population of convenience, which is unjust.15 conclusion it is crucial that all universities acting as research institutions prioritize the integrity of the research enterprise and the professor-student relationship. students should be free to participate in faculty or department research if they so choose – there’s benefit to be had! – but it must really be them doing the choosing. moorthy, recruiting psychology students, voices in bioethics, vol. 6 (2020) 4 1 adair, j. g. (2001). ethics of psychological research: new policies; continuing issues; new concerns. canadian psychology/psychologie canadienne, 42(1), 25–37. https://doi.org/10.1037/h0086877 2 bowman, l. l., & waite, b. m. (2003). volunteering in research: student satisfaction and educational benefits. teaching of psychology, 30(2), 102–106. 3 cartmell, a. (2016). students as research participants: a study of their experiences [ph.d., capella university]; plaut, e. (2020, october 24). dartmouth psychology’s “t-point” program (g. moorthy, interviewer) [telephone]. 4 adair, j. g. (2001); bartholomay, e. m., & sifers, s. k. (2016). student perception of pressure in faculty-led research. learning and individual differences, 50, 302–307. https://doi.org/10.1016/j.lindif.2016.08.025; office for human research protections (2011b). chapter 6: special classes of subjects. in institutional review board guidebook. retrieved from http://wayback.archive-it.org/org745/20150930182815/http://www.hhs.gov/ohrp/archive/irb/irb_chapter6.htm 5 university of waterloo: office of research ethics. (2014, january 28). conducting research in classes or with students as participants. uwaterloo.ca. https://uwaterloo.ca/research/office-research-ethics/research-humanparticipants/pre-submission-and-training/human-research-guidelines-and-policies-alphabetical-list/conductingresearch-classes-or-students-participants 6 ibid. 7 bartholomay, e. m., & sifers, s. k. (2016). 8 midzinski, a. l. (2010). students’ perceptions of coercion in research [master’s thesis, utah state university]. 9 plaut, e. (2020, october 24). 10 examples include the university of waterloo, boise state university, the metropolitan state university of denver, the university of kentucky, etc. 11 bartholomay, e. m., & sifers, s. k. (2016). 303. 12 dartmouth college. (2017). psyc 001: introductory psychology course syllabus. hanover, nh: thalia wheatley, paul whalen, bill kelley & todd heatherton. 13 45 cfr § 46.306 14 45 cfr § 46.404 15 national commission for the protection of human subjects of biomedical and behavioral research. (1979). the belmont report: ethical principles and guidelines for the protection of human subjects of research. retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html https://doi.org/10.1037/h0086877 https://doi.org/10.1016/j.lindif.2016.08.025 http://wayback.archive-it.org/org-745/20150930182815/http:/www.hhs.gov/ohrp/archive/irb/irb_chapter6.htm http://wayback.archive-it.org/org-745/20150930182815/http:/www.hhs.gov/ohrp/archive/irb/irb_chapter6.htm https://uwaterloo.ca/research/office-research-ethics/research-human-participants/pre-submission-and-training/human-research-guidelines-and-policies-alphabetical-list/conducting-research-classes-or-students-participants https://uwaterloo.ca/research/office-research-ethics/research-human-participants/pre-submission-and-training/human-research-guidelines-and-policies-alphabetical-list/conducting-research-classes-or-students-participants https://uwaterloo.ca/research/office-research-ethics/research-human-participants/pre-submission-and-training/human-research-guidelines-and-policies-alphabetical-list/conducting-research-classes-or-students-participants https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) * vishnu subrahmanyam, ms chemistry pondicherry university, ms candidate bioethics ku leuven © 2021 vishnu subrahmanyam. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. a public health reset through contractualism vishnu subrahmanyam* abstract public health ethics has been contingent on a political landscape leading to several operational hurdles, especially during global health emergencies. several scholars have pointed out that liberal decision-making has prevented public health institutions from achieving their goals. thus, the need for a substantive outlook on public health has never been stronger. first, this article highlights the ethical tension and limitations of a presumptive approach to public health that a vaccination policy might produce in a liberal political landscape. second, influenced by the works of angus dawson, this article emphasizes the importance of a substantive approach to public health, especially in a post-covid era. last, it looks at how tm scanlon’s theory of contractualism aids in framing a substantive approach to health policy design and the added advantages of the theory. keywords: public health, covid-19, contractualism, policy design, substantive approach introduction a public health intervention like a vaccination program for covid-19, let alone a mandatory one, faces difficulties in implementation as it presents a clash between the role of the government and liberty of its citizens.1 the clash stems from public health operating in a liberal political landscape that accords great regard for individual liberty. the government, in good conscience, is right in feeling morally obligated to act in ways that serve to prevent the pandemic from escalating. to represent the citizens, governments and policymakers prioritize achieving and maintaining herd immunity. the tension of the state versus individual liberty questions the extent to which governments can go to implement a vaccination policy. in trying to balance the considerations of individual liberty and the scope of the state to impose an intervention, the nuffield council on bioethics came up with a design known as the ‘intervention ladder.’2 the takeaway from the intervention ladder is that the state has the burden of proof in justifying reasons for implementing a particular policy.3 such justified trade-offs envisioned from the intervention ladder have subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 2 guided policymakers in their attempt to design and shape interventions. however, public health ethics and even the intervention ladder view public health through a presumptive or a moderate liberal lens.4 in a presumptive approach or a moderate-liberal approach to public health, policymakers regard values like liberty or autonomy as more prominent when weighed against values like creation of public goods and their maintenance.5 a libertarian approach favors liberty and autonomy even more strongly. the substantive view of public health holds that values, such as liberty and autonomy, do not automatically hold precedence over community-oriented values such as public goods creation.6 some have critiqued the intervention ladder endorsed by the nuffield council of bioethics. angus dawson remarks that the intervention ladder as a metaphor prevents the act of climbing. he claims the ladder assumes that liberty is the only guiding principle in policymaking. such a view neglects any responsibility the citizens have in achieving public goods and maintaining them.7 the emphasis on the drawbacks of a presumptive approach, especially in a situation like the covid-19 pandemic, leads us to question should public health undergo a redefinition? the approach in public health focusing on non-interference stems from traditional clinical bioethics.8 however, i argue that public health ethics in a pandemic should accord less emphasis to individual liberty and evaluate every ethical value on a level playing field. individual liberty provides less platform for action in situations where the community has not established herd immunity. accountability for the harm principle and maintenance of public goods override concerns surrounding liberty.9 angus dawson argues that with more participation in a vaccination program, protection of public goods from disease can be created faster.10 characterizing public health as an antagonist to individual liberty undermines the confidence in public health institutions and interventions for which public trust is vital. although the government may propose a mandatory vaccination policy when voluntary measures fail to meet public health requirements, clear scientific evidence and accountability for public welfare should be the guiding principle. thus, resetting the parameters gauging a public health intervention is the starting point to prepare for future pandemics. in resetting the parameters, angus dawson suggests that utilitarianism or contractualism could serve as philosophical frameworks that may aid in framing a substantive approach to public health.11 evaluating utilitarianism and contractualism according to the covid-19 facts would help clarify which is better suited to framing a substantive public health approach. i. is utilitarianism substantive? under utilitarianism, the morbid circumstances of the covid-19 pandemic urge us to act in ways that translate to maximizing the overall good. utilitarianism is a philosophical theory that prides itself on maximizing the best of outcomes for the maximum number of people. in an ideal utilitarian framework, a morally right act does good for all. utilitarians consider utility the single determining variable that should guide actions. 12 the actionable aspect of a utilitarian framework is its ability to quantify thresholds or markers that mostly dwell in the abstract. in utilitarianism and the pandemic, savulescu et al. outline certain determinants as aids in applying utilitarianism.13 looking at the aids in the context of a mandatory vaccination policy in light of covid-19, shows some pitfalls of utilitarianism. the first utilitarian aid is to save the maximum number of lives.14 rightly so, an intuitive starting point in a pandemic with striking mortality rates is attempting to save the most lives. however, implementing and justifying a policy with the aim of saving the highest number of lives is complex. while a high number of subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 3 deaths is a concern, it is reductionist to concentrate only on the end goal and not the means through which such a goal is attained. the second utilitarian aid is the length of life.15 the length of benefit gained from an outcome is crucial for utilitarians. the duration of a benefit determines the quantity of good produced. as an extension, younger people should then, theoretically, count for more than older individuals in prioritizing benefits. such prioritization has been a matter of concern during the covid-19 pandemic. while it is true that younger people might tend to benefit more, the pathology of covid-19 goes against such logic. elderly populations have experienced disproportionately more severe cases. therefore, prioritizing youth when the elderly are suffering more of the harm would be ethically contentious.16 the third utilitarian aid is the quality-of-life post-intervention. 17 through measures such as qalys and dalys, 18 utilitarians have attempted to quantify each individual's quality after an intervention. this quantification can result in connecting an individual’s quality of life to their social worth. from a utilitarian viewpoint, a person's ability to produce relevance in society becomes a key determinant in shaping public policy. by extension, people born with disabilities such as mental illness or late-stage dementia can be overlooked merely because they lack "social value.”19 and yet, “taboo trade-offs occur when we are forced to put a finite monetary value on these sacred values [life, health, ability], when we acknowledge that there is a maximum ‘price’ that we want to pay to uphold values that should be of ‘infinite’ value.” 20. as such, it is unethical to place a value on someone's life based on the duration or quality of life they may have after an intervention. besides creating difficulty in assessing the quality of life, measures such as qalys do not address the nuances in providing healthcare. in economic evaluation of mental health interventions, luyten et al. discuss several operational changes that account for these nuances.21 utilitarians believe in a moral indifference between actions and omissions as the fourth aid.22 it does not matter how a result is achieved as long as it benefits the common good. putting forward a bad policy is the same as not putting forward a policy. in the ever-changing and unpredictable dynamics of the covid-19 pandemic, actions and omissions have different moral implications. equating them often places an unfair burden on lawmakers, leaving them emotionally and morally exhausted as they weigh the advantages and risks of various outcomes. actively avoiding social biases, feelings, intuitions, and heuristics is the fifth aid.23 the pandemic elicits strong feelings and aggressively tests beliefs. during the pandemic, some profoundly troubling ethical dilemmas stemmed from bias. in a utilitarian system, a mandatory vaccination policy aimed at crossing the threshold for herd immunity may overlook groups of people who are vulnerable due to a lack of access to the social determinants of health. attempting to avoid feelings and intuitions all the time does not always result in the creation of a fair policy. anti-vaccination activists use emotion to further their cause, hence it is critical that politicians consider the feelings at stake for the general public when enacting a mandatory vaccination policy. while utilitarianism has benefits such as developing simple operationalizable concepts, providing a quantitative check, and balance sheet of risks and benefits, it is based on an ethical dystopia. utilitarian policies can treat people as a means to an end by focusing solely on outcomes. utilitarianism rests on a presumptive outlook toward public health by replacing liberty with utility. it ignores fair and just distribution and allocation of resources. utilitarianism is not the most ethical approach to pandemic vaccination policy. subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 4 ii. is contractualism substantive? the libertarian and utilitarian frameworks assume positive and negative connotations to different actions. they hold that certain acts are right and certain acts are wrong. a libertarian might hold that unnecessary infringement of individual liberty is not acceptable, while a utilitarian might be of the opinion that actions that contribute to disutility are unfavorable for the promotion of the greatest happiness principle.24 contractualism is a philosophy that values the social contract. a contractualist approach begins its discourse by arguing that actions have inherent neutrality.25 by saying that, “being valuable is not always a matter of being ‘to be promoted’”26, scanlon does not neglect the value of certain actions but urges us to respond to value through other means, as well as to find value in plurality. in what we owe to each other, scanlon finds morality through the ability to reason while attributing inherent neutrality to our actions. a discourse in contractualism does not begin by presuming that values such as liberty or autonomy hold precedence among other ethical values, i.e., it is not presumptive in its approach. instead, he locates morality in the ability to reason and find justifications for certain actions. thus, compared to utilitarianism, contractualism allows for a substantive approach by holding all the relevant ethical values in a level playing field. liberty would gain precedence when justifications for safeguarding it are strong and cannot be reasonably rejected. the same goes for other values, such as promoting public goods. in short, an action is termed wrong when “the principle that allows for it, can be reasonably rejected.”27 for scanlon, justifiability to others is the normative determinant of right or wrong.28 he proceeds to say that the value of justifiability is the underlying premise of our duties. additionally, verweij argues that treating people rationally occurs by treating them in “ways they cannot reasonably reject.” 29 by disregarding any a priori assumptions about the importance of different values, people can find and construct values that cannot be reasonably rejected as they would be justified. scanlon believes that this can be attained if we reflect on what we owe to each other. iii. the inherent moral neutrality allows for a substantive approach a contractualist approach has implications for framing a substantive approach to public health. these values have been adapted from scanlon and verweij, and the elaboration has been framed in the context of covid-19. the inherent neutrality of principles that contractualism holds becomes crucial while devising a public health intervention. the covid-19 pandemic presents a situation where otherwise acceptable ethical principles require scrutiny. a blank state where there are no a priori principles that suggest which acts are morally justified and which are not helps us navigate the operational principles involved in a vaccination policy. thus, values such as liberty, utility, and autonomy are viewed on the same level as the creation of public goods, fairness in contribution, and avoiding collective harm. a. arriving at principles starting with the inherent neutrality, the state, policymakers, and the public can identify ethical principles that would form a part of the vaccination policy smorgasbord. in a public health framework where negotiation is a crucial aspect in its implementation, it is important that all the stakeholders aim to find principles that are acceptable for everyone. this would culminate with principles of action that would produce the least number of complaints by all the parties involved. if an individual has very strong reservations against a principle, these cannot be outweighed by weaker reservations held by others.30 subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 5 b. reasonable rejection as a marker of deliberation a mandatory vaccination policy in a contractualist framework would then have to incorporate reasonable rejection. a framework based on reasonable rejection includes a variety of moral considerations that shape well-being and provide a basis for fairness, choice, and responsibility. scanlon makes an important remark in the thesis of what we owe to each other: the acceptability of a principle depends on a one-by-one assessment of the strength of individuals' reasons for rejecting the principles compared to any existing alternatives. in other words, for scanlon, what is foundational for contractualism is not minimizing what is undesirable but constructing principles no one can reasonably reject. in the context of covid-19, a person should be able to justify the level of precaution he takes to anyone who would bear the risk of exposure. each individual would then have strong reasons for contributing to herd immunity with regard to their duty to protect the vulnerable. the justification to forego vaccination would need to be strong.31 the difference in a contractualist approach is that it provides a platform for valid concerns from the public. this allows more room for dialogue and for individual liberty, which seems to form a significant part of the critique. a plan of action that allows for individual concerns such as safety, efficacy, and strong medical reasons to forego vaccination encourages inclusivity in policymaking. another public concern is that public health institutions have alienated themselves from society in general.32a dialogue between the stakeholders would remedy such a notion and help redefine public health according to how dawson and verweij view “public”– as a social entity/target as well as a mode of intervention (requiring collective action).33 contractualism, like the rest of the ethical frameworks, has its own set of critiques. in obligatory precautions against infection, marcel verweij argues that a contractualist theory inadvertently ends up asking for excessive precautions. the first claim that contractualism asks for excessive precautions arises from the fact that a contractualist approach does not consider the consequences of individual actions.34 he believes that since consequences are not weighted, one individual’s wish to forego precautionary measures does not justify another’s non-compliance towards precaution, culminating in the other having to take excessive precautions. he also criticizes the contractualist deliberation for its failure to focus on the consequences of individual acts but on creating universalizable principles.35 while this may seem true, such a conclusion rests on the fact that the consequences of individual acts are not weighted. however, an excerpt from verweij’s paper offers evidence that contractualism does weigh individual acts: suppose that we both aim to find moral principles that regulate our interaction and that can be accepted by both of us. if you then propose a principle that imposes many risks on me but none for you, then it would be reasonable if i were to reject it (especially if there are alternative principles that would yield much lower risks).36 both a consequentialist approach and a contractualist approach share the language of risks and burdens. for the utilitarian, risks and burdens are consequences of an action, whereas, for the contractualist, they are consequences of accepting or rejecting a principle. in the excerpt above, when an individual assesses the risks imposed, a consequentialist way of thinking is incorporated in contractualism and consequences to individuals do matter and are weighed. verweij’s contention that a contractualist approach does not focus on individual consequences is not supported, and, as a logical extension, the argument of excessive precautions begins to fade. subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 6 being vaccinated would absolve us of having to take excessive precautions. upon crossing the threshold of herd immunity, excessive precautions such as masks, social distancing, rigorous testing preas well as posttravel, and obsessively checking our phones for exposure can be done away with. the covid-19 pandemic has immersed us in routines of excessive precautionary measures that it has become normalized for most of us. thus, being vaccinated and covering society with a blanket of herd immunity removes the need for excessive precautions. iv. bridging what “is” and what “ought” to be although contractualism presents a perspective that best suits a substantive approach to public health, it appears desirable only in theory. there exists a distinct reality outside of academia – politics, societal engagement, and governance reflect a different picture. this can be thought of as the gap between the is and the ought. we could envision and claim that a mandatory vaccination policy ought to be implemented in a certain manner, however, it might not be. in her paper, realizing bioethics’ goals in practice: ten ways “is” can help “ought,” mildred z. solomon provides several reasons for this disconnect.37 the general theme is the importance of empirical research – the need to find a balance between normative assumptions and empirical evidence – and how policymakers can, in turn, use such evidence to fine-tune the policy design process. contractualism can prove especially useful to bridge the divide between is and ought. theories of libertarian philosophy and utilitarianism rest on a design based on a normative approach that values liberty and utility and should guide the policymaking process. however, contractualism separates itself from these theories since constructing principles justifiable for all, and the idea of reasonable rejection must rely on empirical evidence. engagement between various stakeholders and recognizing the plurality in values helps bridge the disconnect between the is and the ought. this is more important in the context of a mandatory vaccination policy since its requirement arises only if voluntary vaccination policies fail. knowing why vaccination rates are low and how better to reach herd immunity will be important empirical evidence that can fine-tune the policy. in re-enchanting democracy as a mode of governance, patsy healey acknowledges that a struggle for political change often focuses on installing new policy designs.38 healey provides a list of qualities to keep in mind when designing a more people-centered policy initiative. the first quality is recognizing a shared, diverse, and conflictual political community where distributive justice is vital. the second is to foster is respect for different arguments, positions, and feelings— considering groups with conflicting values as adversaries but not enemies. the third quality is that of an ‘intelligent’ and multi-sided discussion of issues and reasoning ‘in public.’ the fourth is the fostering of respect for the role of the government while simultaneously recognizing the complexities of interactions. the fifth, and a key value in the context of the covid-19 pandemic, is fostering respect for people who perform public services. liberalism and utilitarianism create combative ethical discourse around those qualities, while contractualism could elevate shared public values. while liberal democracies arguably have the makings of those qualities, public engagement must be fostered at an intellectual level to promote cohesion. another important aspect to consider is the question of what a framework should aim to answer. in building an ethical framework for covid-19 resource allocation: the how and why, angus dawson addresses the goal of a framework, especially at the time of a pandemic.39 he stresses the importance of context in constructing a framework and urges to engage with a diverse group of people. value-laden normative subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 7 approaches such as the libertarian and utilitarian frameworks provide less opportunity for different stakeholder claims. dawson then argues that explicit discussions provide more clarity and help policy makers better understand the role of context in shaping a framework. dawson asserts that a frame chosen sympathetically can help the public better appreciate the moral content involved in deliberation, whereas aiming for goals such as liberty and utility is a distraction from the workings of reality. in evaluating stakeholders, those with lower incomes often are unable to work remotely. they face a greater risk of covid-19 due to workplace exposure as well as commutes and living conditions.40 although a mandatory vaccination policy has the clearly defined goal of achieving herd immunity, ensuring distributive and procedural justice should not be viewed as being mutually exclusive. conclusion societal change relies on justifiable goals, policies, and a multitude of viewpoints. as such, a contractualist approach best accommodates a multitude of views of what we owe each other. moving forward, if pandemic-type circumstances do disseminate within the constructs of our society, public policy should further consider contractualist approaches as a healthy, inclusive means. 1 luyten, jeroen. "mutual moral obligations in the prevention of infectious diseases." in justice, luck & responsibility in health care, pp. 85-100. springer, dordrecht, 2013. 2 council, nuffield bioethics. "public health: ethical issues." nuffield council on bioethics (2007) 3 dawson, angus j. "snakes and ladders: state interventions and the place of liberty in public health policy." journal of medical ethics 42, no. 8 (2016): 510-513. 4 dawson, angus, ed. public health ethics: key concepts and issues in policy and practice. cambridge university press, 2011. 5 dawson, angus. "resetting the parameters." public health ethics (2011): 1-19. 6 dawson, angus, ed. public health ethics: key concepts and issues in policy and practice. cambridge university press, 2011. 7 dawson, angus j. 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"explicit cost-effectiveness thresholds in health care: a kaleidoscope." social justice research 32, no. 2 (2019): 155-171. 20 (luyten and denier, 2019, p.10) 21 luyten, jeroen, huseyin naci, and martin knapp. "economic evaluation of mental health interventions: an introduction to cost-utility analysis." evidence-based mental health 19, no. 2 (2016): 49-53. 22 savulescu, julian, ingmar persson, and dominic wilkinson. "utilitarianism and the pandemic." bioethics 34, no. 6 (2020): 620632. 23 savulescu, et al. 24 mill, john stuart. "utilitarianism, ed. george sher." (2001). 25 scanlon, thomas m. "précis of" what we owe to each other"." (2003): 159-161. 26 scanlon 2003 p.159) 27 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 28 scanlon, thomas m. "précis of" what we owe to each other"." (2003): 159-161. 29 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 30 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 31 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 32 financial times, 2021, “covid is the enemy, not the government” sunil jain april 26 accessed 14 may 2021 https://www.financialexpress.com/opinion/covid-is-the-enemy-not-the-government/2240340/ 33 dawson, angus, ed. public health ethics: key concepts and issues in policy and practice. cambridge university press, 2011. 34 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 35 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 36 verweij, marcel. "obligatory precautions against infection." bioethics 19, no. 4 (2005): 323-335. 37 solomon, mildred z. "realizing bioethics' goals in practice: ten ways “is” can help “ought”." hastings center report 35, no. 4 (2005): 40-47. 38 healey, patsy. "re-enchanting democracy as a mode of governance." in connections, pp. 61-78. routledge, 2017. 39 dawson, angus. "building an ethics framework for covid-19 resource allocation: the how and the why." journal of bioethical inquiry 17, no. 4 (2020): 757-760. https://www.financialexpress.com/opinion/covid-is-the-enemy-not-the-government/2240340/ subrahmanyam, a public health reset through contractualism, voices in bioethics, vol. 7 (2021) 9 40 schmidt, harald, lawrence o. gostin, and michelle a. williams. "is it lawful and ethical to prioritize racial minorities for covid19 vaccines?." jama 324, no. 20 (2020): 2023-2024. cohen, the next pandemic, voices in bioethics, vol. 8 (2022) *tracey l. cohen, jd, ms, university of miami miller school of medicine institute for bioethics & health policy. © 2022 tracey l. cohen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the next pandemic: a pragmatic and ethical discussion about the looming threat of antibiotic resistance tracey l. cohen, jd, ms* keywords: antibiotic resistance, bioethics, justice, animal ethics, prescription medicine abstract antibiotics are useful to stave off infection, though their misuse can be detrimental by creating drug-resistant infections. it is essential that we closely examine the leading causes of antibiotic resistance and consider the serious clinical and ethical ramifications around the issue. this paper will aim to achieve these goals, as well as to propose practical solutions directed towards combating this looming crisis. introduction as drug companies race to develop vaccines and treatments in response to the covid-19 pandemic, other impending public health threats may easily be forgotten and tucked away for another day. experts are warning that “the same governmental inaction that helped foster the rapid, worldwide spread of the coronavirus may spur an even deadlier epidemic of drug-resistant infection…”1 dr. jeffrey r. strich, a researcher at the national institutes of health clinical center remarked, “if there’s anything that this covid-19 pandemic has taught the world, it is that being prepared is more cost-effective in the long run.”2 antibiotic resistant infections cause an estimated 700,000 annual deaths globally.3 according to the centers for disease control, in the united states alone, drug resistant infections sicken 2.8 million people annually and are responsible for at least 35,000 deaths each year.4 the united nations has suggested that, if the problem is not soon addressed, antibiotic resistant infections could kill up to 10 million people by 2050.5 cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 2 the genesis of antibiotic resistance is complex and multifaceted. successfully combating antibiotic resistance will require a global response. this paper will closely examine the leading causes of antibiotic resistance. it will also devote discussion to the clinical and ethical ramifications of antibiotic use and misuse. lastly, the paper will propose practical measures that countries, such as the us, should be taking now to help stem this ever-evolving public health emergency. i. antibiotic misuse antibiotic resistance develops when bacteria are exposed to antibiotics, and propelled by the forces of evolutionary selection, mutate over time to adapt to the antibiotics.6 this process is greatly accelerated when bacteria are overexposed to antibiotics.7 overexposure occurs in two primary ways – the first is through overuse/misuse of antibiotics in humans and the second is misuse/overuse in animals. a. in humans according to studies, treatment decisions involving antibiotics, including whether to use an antibiotic, which antibiotic to use, and the appropriate duration of such use, are incorrect in 30 percent to 50 percent of cases.8 antibiotics may be overprescribed in cases where they are not truly needed, or the wrong type or dosage of antibiotic can be prescribed. these issues can contribute to the problem of antibiotic resistance.9 in many cases, faulty clinical determinations can be attributed to the lack of available microbial testing. consequently, healthcare providers are unable to properly identify and classify bacteria, thus impairing their ability to make clinically sound treatment decisions. in one us study involving hospitalized patients suffering from community acquired pneumonia, for example, a pathogen was identified in only 7.6% of cases.10 there is existing technology, specifically polymerase chain reaction (pcr) and semiquantitative pcr, that accurately identifies pathogens in approximately 89 percent of cases.11 however, this technology is not widely used. when healthcare providers do use testing, they often rely upon culture testing, which is not rapid response and can delay proper treatment assessments.12 as a result, providers may substitute inappropriate antibiotics in the interim. another type of antibiotic misuse among humans occurs when patients stop their antibiotic regimens prematurely, thereby allowing harmless bacteria, not fully eradicated due to the abbreviated treatment, to acquire resistance. this resistance is then genetically transferred to dangerous bacteria.13 antibiotic resistance is also an unfortunate, frequent occurrence in developing countries where antibiotics are often available without a prescription and can be accessed through unregulated supply chains.14 developing nations also frequently suffer from a dearth of standard antibiotic treatment guidelines, which further precipitates antibiotic overprescribing.15 cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 3 b. in animals approximately half of the world’s consumption of antibiotics is for agricultural purposes.16 in the us, only 20 percent of antibiotic sales are intended for human use, while the remaining 80 percent is for use in livestock.17 despite this gross disparity, only 10 percent of publications discussing antibiotic resistance address the role that misuse of antibiotics in animals plays.18 antibiotic misuse in animals contributes to antibiotic resistance. farmers and agribusinesses widely distribute antibiotics, through feed or water, to healthy animal populations for nontherapeutic purposes -including for growth promotion and disease prevention.19 the need for antibiotic use for disease prevention arises when animals’ living quarters are cramped and prone to disease.20 low concentrations of antibiotics have routinely been observed in the gastrointestinal tracts of livestock.21 the presence of sub-therapeutic levels of these drugs fosters the growth of resistant bacteria and antibiotic resistance genes in the animals’ guts.22 when the animals that have developed these resistant bacteria and genes are used as sources of food, both the bacteria and genes are passed along to the food supply, contaminating milk, meat, and eggs.23 because the antibiotics used in animals are those that have critically important human applications, the resistant bacteria and genes that develop in response to these drugs can destroy the prospect of their use as effective treatment options in both animals and humans.24 according to the environmental working group, supermarket meat and poultry contain extremely high levels of antibiotic resistant bacteria. specifically, ground turkey was found to contain 79 percent resistant bacteria, pork 71 percent, ground beef 62 percent, and chicken 36 percent.25 while antibiotic resistant bacteria may be killed with proper levels of heat (from cooking, for instance), antibiotic resistance dna that accompanies the bacteria is not always eradicated. this resistance can then be transferred to the humans who consume it, conferring resistance upon otherwise benign bacteria in their digestive systems.26 resistant bacteria and genes contained in animal waste can also enter the environment as pollutants, settling in the ground, air, and water systems.27 this further increases the transmissibility of antibiotic resistance from animals to humans and, ultimately, from human to human when a person acquires an antibiotic resistant infection from food and/or the environment and passes it along to others.28 another unintended adverse consequence of antibiotic use in animals is that foods like meat, milk, and eggs often contain antibiotic residues.29 since up to 90 percent of antibiotics are excreted through an animal’s waste, the drugs may also pollute the ground and groundwater.30 unnecessarily prolonged exposure to antibiotics increases the risk of acquiring bacterial resistance and/or an antibiotic resistant infection. the constant exposure to antibiotics can have other adverse health effects, ranging from drug hypersensitivity to carcinogenic effects.31 ii. ethical considerations and obligations of stakeholders a. tackling antibiotic resistance created through the healthcare sector cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 4 first, with respect to antibiotic misuse in humans, there needs to be vastly scaled-up pathogenic testing. this will help ensure that treatment decisions involving antibiotics are made with empirical data, rather than being an exercise in supposition. increased testing would lead to a reduction in unnecessary antibiotic prescriptions and scripts for the wrong antibiotic. pcr technology should be made widely available, at least until more effective testing is developed. at the most basic level, physicians should seek out this testing to make it available in their practices and hospitals. thirdparty payors should be poised to approve the costs associated with these tests, since they may expedite improvements in patients’ health, thereby resulting in an overall cost savings. the pharmaceutical industry should also develop accurate, rapid testing technology. rapid testing could abbreviate patients’ immediate illnesses, because knowledge provided by testing can help physicians quickly determine proper diagnoses. this will allow them to immediately prescribe the correct antibiotics. finally, on a global level, countries that lack regulations around antibiotic access and use must implement sufficient restrictions. addressing antibiotic resistance on a global level is imperative. like with covid-19, from a pragmatic and ethical perspective, we must create global solutions to antibiotic resistance to prevent resistant bacteria from spreading.32 b. ethical considerations around antibiotic prescriptions for human use some ethicists have argued that antibiotics are a public good, and their overuse can result in a sort of “tragedy of the commons.”33 in order to ensure the equitable distribution of antibiotics for all patients, society must create disincentives around antibiotic use. one such proposal involves taxing patients who use antibiotics for “minor and self-limiting” infections.34 however, patients should not be punished for following their physicians’ recommendations. things like taxing schemes unjustifiably interfere with the doctor-patient relationship and can result in adverse clinical consequences for patients. others have asserted that physicians owe a duty of care to both present and future patients. pursuant to this argument, physicians are ethically justified in increasing the risk of harm to present patients by a “small” amount by denying them antibiotics, if, in doing so, they are decreasing a significant risk of harm to future patients.35 as per the hippocratic oath, physicians have an obligation first and foremost, to their current patients. this duty includes the obligation to act for the good of the patient (with beneficence) and to prevent harm from befalling the patient (non-maleficence). nowhere in the oath does it say that “a little” harm is acceptable. failing to provide a patient with an antibiotic when it is warranted in order to “preserve” the drug for use by future patients is a violation of the physicians’ bioethical obligations to the patient. there are cases where it may be in patients’ best interests to avoid antibiotics, thus decreasing their own risk of antibiotic resistance from superfluous use. however, physicians must make these determinations cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 5 on a case-by-case basis, relying on clinical evidence, rather than an impermissible ethical imperative to future patients. it is also a breach of the patient’s right of autonomy if the patient believes the physician is acting strictly in his or her best interest and relies on the physician’s treatment recommendations due to this belief. from a clinical perspective, a “small” amount of harm could easily become a “large” amount of harm, depending upon the patient and the infection at issue. a physician could also misjudge the level of risk involved in depriving a patient of an antibiotic, thereby creating an increased risk of morbidity or mortality for the patient. this is not to imply that the physician is never justified in proposing a reasonable waiting period before prescribing an antibiotic in order to determine if the illness is self-limiting and begins to improve on its own. however, again, this decision should be driven strictly by clinical criteria and the best interest of the present patient. in addition, proposals that seek to disincentivize antibiotic use can be clinically and ethically dangerous. although prudence around antibiotic use is necessary, physicians should not be dissuaded from prescribing them when, in the physicians’ clinical judgements, they are necessary. without antibiotics, seemingly benign infections can quickly turn deadly. untreated bronchitis can rapidly progress to pneumonia. untreated strep throat can lead to heart damage. a lingering urinary tract infection can induce sepsis.1 iii. combating antibiotic resistance created by the agricultural sector as one scholar aptly observed, “[t]he current debate on the ethics of [antimicrobial resistance] is heavily and disproportionately focused on the use of antibiotics in humans…this focus reflects the traditional discourse in medical ethics…”36 it seems relevant to note the seeming irrationality of ethicists advocating for withholding antibiotics from people while failing to consider the widespread, indiscriminate, unregulated use of antibiotics in the agricultural sector. the bottom line is that the focus on antibiotic use in humans, while important, cannot overshadow the substantial role that antibiotic use in animals has played in the antibiotic resistance crisis. there are several key stakeholders that are under an ethical obligation to take immediate action. the fda should create a rule immediately banning the non-therapeutic use of antibiotics in healthy animals. the fda took a small step in 2017 towards limiting antibiotic use in healthy animals when it finally restricted farms from using medically important drugs as growth promotion agents for animals.37 this move, however, has been described as grossly insufficient. for one, 1 as an aside, taxation schemes on antibiotics may also discourage antibiotic development by the pharmaceutical industry or biotechnology startups. already strapped for profits on antibiotics, as discussed further below, taxes will only worsen the situation. cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 6 antibiotics can still be used in healthy animals for purposes other than growth promotion, such as for “preventive health” purposes or in “times of stress,” which the fda never clearly defines.38 therefore, the newly imposed restriction is easy to circumvent. farms simply can purchase antibiotics for use as a “preventive health” measure rather than for growth promotion purposes.39 to complicate matters further, at least 30 percent of antibiotics intended for animals have labels that lack any parameters around duration of use, meaning they can be used indefinitely throughout animals’ lives.40 farms and pharmaceutical companies are still promoting “growth” as an ancillary benefit of antibiotics, encouraging their unbridled use.41 the next measure that the fda must implement is the elimination of crowded, inhumane animal conditions in farms which create the need to administer “preventive” antibiotics. it is well established that “[a]ntibiotics are used at subtherapeutic levels to promote growth and to prevent disease in the extremely crowded conditions that food animals are raised in.”42 the conditions present in many livestock farms has been compared to crowded hospitals “where everyone is given antibiotics, patients lie in unchanged beds, hygiene is nonexistent, infections and reinfections are rife, waste is thrown out the window, and visitors enter and leave at will.”43 eliminating crowded conditions will greatly reduce the need for preventive antibiotics. finally, the fda must establish a surveillance and enforcement mechanism to ensure proper compliance with limiting antibiotic use in healthy animals and addressing crowded conditions. surprisingly, and notwithstanding the documented link between antibiotic use in animals and adverse human health effects, the fda lacks any means of monitoring farms’ use of antibiotics in animals. the only measure it uses to assess possible antibiotic use is the sale of antibiotics to farms.44 the pharmaceutical and chemical companies that manufacture the antibiotics are required to provide this information to the fda.45 although reports have indicated that around 80 percent of antibiotics are sold for agricultural purposes, the fda contends that it cannot discern actual use from these numbers. at the same time, the fda has failed to create any other rules that would establish an alternative means of monitoring use.46 as a new york times investigation revealed, public health investigators are often unable to access the most basic information regarding a farm’s practices.47 the agricultural industry constructs roadblocks so that the government’s access to farms, and how they are using antibiotics in animals, is hindered.48 further complicating the matter are conflicts of interest where livestock industry executives hold high positions on advisory committees for government agencies, such as the us department of agriculture (usda).49 the usda does have a monitoring system that studies antibiotic use in the agricultural sector.50 however, as an expert in a recent washington post article opined, “[t]he usda’s oversight is laissez-faire. they test such a small fraction it can’t even be taken seriously…and they rotate the drugs they are testing for, because they can’t afford to test for all of them. they just don’t have the funds to do it. we raise 9 billion animals, and they test hundreds of cattle, not even thousands.”51 the usda’s antibiotic surveillance system also relies upon agricultural industry self cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 7 reporting, using voluntary questionnaires,52 which calls into question the completeness and veracity of the data. in addition to the us government, the pharmaceutical industry must also help reign in imprudent antibiotic use in the agricultural sector. in 2007, legislation was introduced that would have required drug manufacturers to phase out use of antibiotics for healthy animals.53 the meat and poultry industries, and several major pharmaceutical companies opposed the legislation.54 it is ethically incumbent upon the pharmaceutical industry to support the fight against antibiotic resistance. the industry creates the products, doing a great deal of good, so some may argue they should not be tasked with overseeing poor uses of their products. but the pharmaceutical industry should encourage measures that ensure the responsible use of their products. it should also refrain from touting the “ancillary benefits” of antibiotics, such as “growth promotion,” which encourages their injudicious and illegal use. consumers pay the ethical price of all three industries’ actions. people eating animal products have no opportunity to consent to the use of antibiotics. although they may choose antibiotic-free meat and dairy, or choose not to consume animal products, people do not have the opportunity to consent to the presence of antibiotic residues, antibiotic resistant bacteria, and resistance genes in their food supply, and they may not be aware of the risks. consumers bear the burden while industries profit. while there are animal food products designated “organic,” and their producers allege that no antibiotics were used in their production use, these foods tend to be significantly more expensive than food that is not organic. therefore, those in lower socio-economic brackets are forced to buy foods that are detrimental to their health, while those in higher brackets can afford healthier food products. this is a violation of the ethical principle of distributive justice. industry must work to find innovative ways to level the playing field and make all food safe for consumers, regardless of economic disposition. simply put, no consumer should have to worry about antibiotics, antibiotic resistant bacteria, or resistance genes in their food supply. iv. creating incentives around antibiotic development addressing antibiotic resistance by chipping away at its causes is an important approach, though it is not sufficient to truly win the antibiotic resistance war. since, even with mitigation of causal factors, resistance is inevitable on some level. therefore, we must also address the crisis from the tail-end. this involves ensuring that, when resistance does occur, we are prepared for it. in order to do this, new classes of antibiotics that have the potential to treat resistant pathogens must be developed. the current landscape for antibiotic research and development is a barren one. pharmaceutical companies have largely bailed on this area and biotechnology startups are going bankrupt pursuing this venture. as a recent new york times piece noted, “[i]n the 1980s, there were 18 major pharmaceutical companies developing new antibiotics; today there are three.”55 pharmaceutical companies prefer to focus on the development of drugs for chronic diseases, cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 8 which ensure long term, continuous profits.56 antibiotics, on the other hand, tend to be prescribed on a short-term basis for acute infections. this limits their inherent capacity to generate profits.57 finally, physicians tend to be reluctant to use new antibiotics, further limiting companies from recouping their investments.58 bioethicist dr. ezekiel emanuel has suggested using government-sponsored prize money for approved new classes of antibiotics, stating that “[t]he prestige, bragging rights and renewed sense of mission created by such a prize would alone make an investment in research worthwhile.”59 twenty pharmaceutical companies are pooling their capital and using it to fund smaller, biotechnology companies dedicated to developing antibiotics in collaboration with the world health organization. the companies recently announced that they are creating a $1 billion fund for biotech start-ups. the pool, called the amr action fund, will be short-term but intended to provide an investment “amid a collapsing antibiotics industry.” the money will go to approximately 24 companies already working on promising drugs.60 although the foregoing approaches are laudable, they are not sustainable. each new antibiotic can cost $2.6 billion to develop.61 the establishment of non-profit organizations dedicated to the research and development of new antibiotics may be a more promising approach. as an article published in the new england journal of medicine in 2019 explained, nonprofits “don’t face pressure to generate continuous revenue growth to drive up shareholder value – venture capitalist investors demand very high rates of return over short periods. there is also less pressure to increase drug prices.”62 some nonprofits, such as the tb alliance and the medicines for malaria venture, have proven to contribute to antibiotic development.63 ultimately, the challenge for nonprofits will be to raise enough funds. perhaps pharmaceutical funds, such as the amr action fund, coupled with government funding, could be directed toward non-profits’ antibiotic development efforts. conclusion antibiotic resistance is a growing concern for everyone around the globe and the problem demands our collective, focused attention. as the world health organization has observed, the antibiotic resistance crisis may seem slow-moving, and abstract compared to the covid-19 pandemic.64antibiotic resistance needs more attention and solutions. as one public health expert has warned, “…one day, all of us…will need an antibiotic. a world in which antibiotics no longer work is something that should terrify everyone.”65 1 jacobs, a. “doctors heavily overprescribed antibiotics early in the pandemic.” the new york times. (june 4, 2020). 2 jacobs, a. 3 “no time to wait. securing the future from drug resistant infections. report to the secretary general of the united nations.” world health organization. (april 2019). available at : https://www.who.int/antimicrobialresistance/interagency-coordination-group/iacg_final_summary_en.pdf?ua=1 https://www.who.int/antimicrobial-resistance/interagency-coordination-group/iacg_final_summary_en.pdf?ua=1 https://www.who.int/antimicrobial-resistance/interagency-coordination-group/iacg_final_summary_en.pdf?ua=1 cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 9 4 “about antibiotic resistance.” the centers for disease control. available at: https://www.cdc.gov/drugresistance/about.html 5 jacobs, a. “doctors heavily overprescribed antibiotics early in the pandemic.” the new york times. (june 4, 2020). 6 munthe, c. et. al. “health-related research ethics and social value: antibiotic resistance intervention research and pragmatic risks.” bioethics. 33:335-342 (2019). 7 “antibiotic resistance – key facts.” world health organization. available at: https://www.who.int/newsroom/fact-sheets/detail/antibiotic-resistance 8 ventola, c.l. “the antibiotic resistance crisis.” pharmacy and therapeutics. 40:4:277-283 (2015). 9 ventola, c.l. 10 ventola, c.l. 11 ventola, c.l. 12 parsonage, b., et al. “control of antimicrobial resistance requires an ethical approach.” frontiers in microbiology. 8:2124 (november 2, 2017). 13 chin, t. “antibiotic resistance.” health affairs. (may 21, 2015). 14 manyi-loh, c. “antibiotic use in agriculture and its consequential resistance in environmental sources: potential public health implications.” molecules. 23:795 (2018). 15 “antibiotic resistance – key facts.” world health organization. available at: https://www.who.int/newsroom/fact-sheets/detail/antibiotic-resistance 16 littmann, j. et al. “the ethical significance of antimicrobial resistance.” public health ethics. 8:3:209-224 (2015). 17 chin, t. “antibiotic resistance.” health affairs. (may 21, 2015); he, y. “antibiotic resistance genes from livestock waste: occurrence, dissemination, and treatment.” npj clean water. 3:4 (2020). 18 he, y. “antibiotic resistance genes from livestock waste: occurrence, dissemination, and treatment.” npj clean water. 3:4 (2020). 19 manyi-loh, c. 20 manyi-loh, c. 21 he, y. “antibiotic resistance genes from livestock waste: occurrence, dissemination, and treatment.” npj clean water. 3:4 (2020). 22 he, y. “antibiotic resistance genes from livestock waste: occurrence, dissemination, and treatment.” npj clean water. 3:4 (2020); manyi-loh, c. “antibiotic use in agriculture and its consequential resistance in environmental sources: potential public health implications.” molecules. 23:795 (2018). 23 he, y. “antibiotic resistance genes from livestock waste: occurrence, dissemination, and treatment.” npj clean water. 3:4 (2020); manyi-loh, c. “antibiotic use in agriculture and its consequential resistance in environmental sources: potential public health implications.” molecules. 23:795 (2018). 24 “reports offer valuable information on antibiotic stewardship in u.s. agriculture.” the pew charitable trusts. (september 12, 2019). available at: https://www.pewtrusts.org/en/research-and-analysis/factsheets/2019/09/reports-offer-valuable-information-on-antibiotic-stewardship-in-us-agriculture 25 supermarket meat still superbugged, federal data show. environmental working group. (june 28, 2018). available at: https://www.ewg.org/research/superbugs/ 26 verraes, c. at al. “antimicrobial resistance in the food chain: a review.” international journal of environmental research and public health. 10:2643-2669 (2013). 27 he, y. “antibiotic resistance genes from livestock waste: occurrence, dissemination, and treatment.” npj clean water. 3:4 (2020); 27 manyi-loh, c. “antibiotic use in agriculture and its consequential resistance in environmental sources: potential public health implications.” molecules. 23:795 (2018). 28 manyi-loh, c. “antibiotic use in agriculture and its consequential resistance in environmental sources: potential public health implications.” molecules. 23:795 (2018). 29 manyi-loh, c. 30 ventola, c.l. “the antibiotic resistance crisis.” pharmacy and therapeutics. 40:4:277-283 (2015). 31 manyi-loh, c. “antibiotic use in agriculture and its consequential resistance in environmental sources: potential public health implications.” molecules. 23:795 (2018). https://www.cdc.gov/drugresistance/about.html https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2019/09/reports-offer-valuable-information-on-antibiotic-stewardship-in-us-agriculture https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2019/09/reports-offer-valuable-information-on-antibiotic-stewardship-in-us-agriculture cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 10 32 addressing antibiotic resistance from a global perspective will entail assisting developing nations in building infrastructure and developing rules and enforcement capabilities around antibiotic use in humans and animals. the vast nature of this topic, and its inherent challenges, warrants a separate discussion. 33 littmann, j. et al. “the ethical significance of antimicrobial resistance.” public health ethics. 8:3:209-224 (2015). 34 giubilini, a. “antibiotic resistance as a tragedy of the commons: an ethical argument for a tax on antibiotic use in humans.” bioethics. 33:776-784 (2019). 35 leibovici, l. et al. “ethical dilemmas in antibiotic treatment.” journal of antimicrobial chemotherapy. 67:12-16 (2012); littmann, j. et al. “the ethical significance of antimicrobial resistance.” public health ethics. 8:3:209-224 (2015). 36 littmann, j. et al. “the ethical significance of antimicrobial resistance.” public health ethics. 8:3:209-224 (2015). 37 “antibiotic/antibiotic resistance – food and food animals.” the centers for disease control. available at: https://www.cdc.gov/drugresistance/food.html; mckenna, m. “after years of debate, the fda finally curtails antibiotic use in livestock.” newsweek. january 2017. 38 guidance for industry, #213. the food and drug administration. available at: https://www.fda.gov/media/83488/download; fda must ensure that all animal antibiotics have defined durations of use.” the pew charitable trusts. available at: https://www.pewtrusts.org/en/research-andanalysis/articles/2019/04/01/fda-must-ensure-that-all-animal-antibiotics-have-defined-durations-of-use; mckenna, m. “after years of debate, the fda finally curtails antibiotic use in livestock.” newsweek. january 2017. 39 mckenna, m. “after years of debate, the fda finally curtails antibiotic use in livestock.” newsweek. january 2017. 40“fda must ensure that all animal antibiotics have defined durations of use.” the pew charitable trusts. available at: https://www.pewtrusts.org/en/research-and-analysis/articles/2019/04/01/fda-must-ensure-that-all-animalantibiotics-have-defined-durations-of-use; mckenna, m. “after years of debate, the fda finally curtails antibiotic use in livestock.” newsweek. january 2017. 41 hakim, d., richtel, m. warning of ‘pig zero’: one drugmaker’s push to sell more antibiotics.” the new york times. (june 7, 2019). 42 duckenfield, j. “antibiotic resistance due to modern agricultural practices: an ethical perspective.” journal of agricultural and environmental ethics. 26:333-350 (2013). 43 duckenfield, j. 44 “questions and answers: summary report on antimicrobials sold or distributed for use in food-producing animals.” the food and drug administration. available at: https://www.fda.gov/industry/animal-drug-user-fee-actadufa/questions-and-answers-summary-report-antimicrobials-sold-or-distributed-use-food-producing-animals; richtel, m. “tainted pork, ill consumers and an investigation thwarted.” the new york times. august 4, 2019. 45 fda website. “questions and answers: summary report on antimicrobials sold or distributed for use in foodproducing animals.” available at: https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/questions-andanswers-summary-report-antimicrobials-sold-or-distributed-use-food-producing-animals 46 fda website. 47 richtel, m. “tainted pork, ill consumers and an investigation thwarted.” the new york times. august 4, 2019. 48 richtel, m. 49 richtel, m. 50 usda website. “antimicrobial resistance overview.” https://www.usda.gov/topics/animals/onehealth/antimicrobial-resistance-overview-amr# 51 reiley, l. “some beef ‘raised without antibiotics’ tests positive for antibiotics in study.” washington post. april 7, 2022. 52 usda website. “antimicrobial resistance action plan.” https://www.usda.gov/sites/default/files/documents/usdaantimicrobial-resistance-action-plan.pdf; usda. “antimicrobial use and stewardship on u.s. feedlots, 2017” https://www.aphis.usda.gov/animal_health/nahms/amr/downloads/amu-feedlots_1.pdf 53 chin, t. “antibiotic resistance.” health affairs. (may 21, 2015). 54 chin, t. https://www.cdc.gov/drugresistance/food.html https://www.fda.gov/media/83488/download https://www.pewtrusts.org/en/research-and-analysis/articles/2019/04/01/fda-must-ensure-that-all-animal-antibiotics-have-defined-durations-of-use https://www.pewtrusts.org/en/research-and-analysis/articles/2019/04/01/fda-must-ensure-that-all-animal-antibiotics-have-defined-durations-of-use https://www.pewtrusts.org/en/research-and-analysis/articles/2019/04/01/fda-must-ensure-that-all-animal-antibiotics-have-defined-durations-of-use https://www.pewtrusts.org/en/research-and-analysis/articles/2019/04/01/fda-must-ensure-that-all-animal-antibiotics-have-defined-durations-of-use https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/questions-and-answers-summary-report-antimicrobials-sold-or-distributed-use-food-producing-animals https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/questions-and-answers-summary-report-antimicrobials-sold-or-distributed-use-food-producing-animals https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/questions-and-answers-summary-report-antimicrobials-sold-or-distributed-use-food-producing-animals https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/questions-and-answers-summary-report-antimicrobials-sold-or-distributed-use-food-producing-animals https://www.usda.gov/sites/default/files/documents/usda-antimicrobial-resistance-action-plan.pdf https://www.usda.gov/sites/default/files/documents/usda-antimicrobial-resistance-action-plan.pdf https://www.aphis.usda.gov/animal_health/nahms/amr/downloads/amu-feedlots_1.pdf cohen, the next pandemic, voices in bioethics, vol. 8 (2022) 11 55 jacobs, a. “crisis looms in antibiotics as drug makers go bankrupt.” the new york times. (december 26, 2019). 56 duckenfield, j. “antibiotic resistance due to modern agricultural practices: an ethical perspective.” journal of agricultural and environmental ethics. 26:333-350 (2013). 57 littmann, j. et al. “the ethical significance of antimicrobial resistance.” public health ethics. 8:3:209-224 (2015). 58 jacobs, a. “crisis looms in antibiotics as drug makers go bankrupt.” the new york times. (december 26, 2019). 59 emanuel, e. “how to develop new antibiotics.” the new york times. (february 24, 2015). 60 jacobs, a. “drug giants create fund to bolster struggling antibiotic start-ups.” the new york times. (july 9, 2020). 61 jacobs, a. “crisis looms in antibiotics as drug makers go bankrupt.” the new york times. (december 26, 2019). 62 nielsen, t.b. “sustainable discovery and development of antibiotics – is a nonprofit approach the future?” the new england journal of medicine. 381:6:503-505 (2019). 63 nielsen, t.b. 64 jacobs, a. “drug giants create fund to bolster struggling antibiotic start-ups.” the new york times. (july 9, 2020)(citing dr. peter beyer, senior adviser at the world health organization). 65 jacobs, a. (quoting dr. everly macario, public health expert at the university of chicago medicine). glick, application to medical aid in dying, voices in bioethics, vol. 7 (2021) * shimon m. glick, md, professor, faculty of health sciences, ben gurion university of the negev © 2021 shimon m. glick. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the pitfalls of the ethical continuum and its application to medical aid in dying shimon m. glick* keywords: religion, bioethics, medical aid in dying, moral philosophy, beliefs, euthanasia, continuum introduction religion has long provided guidance that has led to standards reflected in some aspects of medical practices and traditions. the recent bioethical literature addresses numerous new problems posed by advancing medical technology and demonstrates an erosion of standards rooted in religion and long widely accepted as almost axiomatic. in the deep soul-searching that pervades the publications on bioethics, several disturbing and dangerous trends neglect some basic lessons of philosophy, logic, and history. the bioethics discourse on medical aid in dying emphasizes similarity over previously recognized important distinguishing features. for example, it overplays a likeness between assistance in dying and the withdrawal of life-saving technology. in many bioethics’ topics, arguments based on a logical continuum are used to question the lines demarcating important moral differences. i. the line between ethical and not: logic based on continuum careful case selection, often either end of a continuum, allows the tearing down or ridiculing of many rules and codes across most professions and fields of interest. this situation holds true for traffic laws as well as medical ethics guidelines. it is relatively simple for those who desire to attack a particular viewpoint by selecting a case that makes that position seem untenable. in the ethics realm, good and bad medicine exist at opposite ends of an ethical continuum, with many practices lying in between. for example, much of medical ethics exists between the nazi criminal physicians and the most sainted nurse or physician. a gradual progression occurred over less than two decades from a utilitarian position that supported limited euthanasia for those with certain mental illnesses to genocide. german society embraced a utilitarian ethic in which the value of human life no longer was intrinsic but instrumental.1 glick, application to medical aid in dying, voices in bioethics, vol. 7 (2021) 2 many morally significant points on a continuum were then ignored as the misguided utilitarian policy rampantly continued. a point in the continuum to distinguish between ethically justifiable and that which is not can be difficult to identify compared to the two extremes. this continuum is not unique to ethics but can be applied to almost any other aspect of human life and endeavor. between a severely ill schizophrenic person and a superbly well-adjusted individual, there is a continuum of mental and psychological function. the existence of a continuum should not paralyze thinking and prevent us from drawing lines and identifying moral differences based on objective criteria as well as moral philosophy. yet, by focusing on a continuum, many bioethicists use logic to disregard dividing lines between an "ethical" and an "unethical" act. unfortunately, sometimes bioethicists draw revolutionary conclusions that would change the scope of medical practices which is accepted as ethical. there are many examples of similar shifts on the continuum. many authors argue for the ethical permissibility of abortion by pointing out that the human fetus is no different in various characteristics, one arguing it is as like an ape or chick as it is like a person,2 and does not achieve unique human and individual characteristics until well into the first year of life. 3 while human fetuses arguably do not have certain distinctive qualities of personhood, most people shy away from the logical next conclusion: permitting infanticide. for example, joshua lederberg condemns infanticide, in the face of biological illogic, because of our emotional commitment to infants, to me, a relatively weak explanation. sir francis crick suggests we might consider birth at two days of life in order to decide whether an infant is a "suitable" member of society.4 giublini and minerva suggest that infanticide should be permissible since late pregnancy abortions are permissible, arguing there is no significant difference between a fetus just before birth and an infant just after birth.5 clearly the continuum approach would allow for subjective arguments in favor of later infanticide at other points many days post-birth. years ago, with a cynical tone, i mentioned infanticide as a further step on the continuum beyond abortion, and i was rightly shouted down as being deliberately provocative to assert the logic would ever stretch so far. while it is not an accepted mainstream position, the movement in academic settings from widespread condemnation to limited possible acceptance of infanticide has taken place in an incredibly short time. public opinion and medical opinion in these areas have shifted dramatically in a short time. in another area, from a biological and chemical point of view, there is a continuum from man down to a single carbon atom. yet, it would not seem logical to ignore the emotional differences, the meaning of personhood, or the moral distinction between killing an insect and killing a person. ii. a false continuum: medical aid in dying i assert that there has been an erosion of ethical guidelines in recent years attributable to using continuums to camouflage important distinctions. james rachels’ work on active and passive euthanasia, which contends that the two are ethically identical, exemplifies that logic. 6 he illustrates this thesis, using a continuum to compare different scenarios with like consequences as morally equivalent, by comparing the deliberate drowning of a child with a deliberate failure to rescue a drowning child when easily able to do so. the author's comparison proposes that since much of the medical profession has already made peace with withholding treatment in order to hasten death, consistency inexorably demands that we permit active euthanasia as well.7 when permission for active euthanasia was first introduced, it was limited exclusively to patients suffering severely from an intractable, incurable, and irreversible disease. these guidelines have been continuously glick, application to medical aid in dying, voices in bioethics, vol. 7 (2021) 3 eroded. there is now a substantial serious consideration for permitting active euthanasia of healthy elderly individuals who feel that they have completed their lives and are "tired of living."8 there are many moral and factual differences along the ethical continuum. in human life, there is a difference between a live baby and a fetus, between a viable fetus and one that is not, between a fetus and a zygote, and between a zygote and a sperm cell. similarly, there is a difference between pulling a trigger to kill someone and not interfering in preventing his death, which is reprehensible though both may be. there is a difference between not resuscitating an 80-year-old man with cancer when his heart stops and injecting him with a fatal dose of potassium chloride. i argue that an overt act of taking life repels civilized human beings is to be commended and encouraged as the reverence for human life or even for just a moment of human life is one of the great contributions of our civilization. conclusion as an orthodox jew, i feel that divinely inspired guidelines that have stood the test of centuries shape my beliefs, and such guidelines contradict medical aid in dying. i cannot speak to the viewpoint of those who do not access religion in defining their moral stance, nor do i implicate them in the current bioethics' trends, as i am not aware of the personal role of religion in the lives of most such authors. while many nonreligious people have a firm philosophical grounding and oppose medical aid in dying, i suggest that in the absence of any religious or other absolute standards, developing logically defensible ethical guidelines may be challenging. at the least, religion may play a role in defining the points on the continuums that are ethically meaningful and refuting the trending beliefs that if the endpoint is the same, allowing different methods of arriving at that end are somehow ethically equal. the continuum of ways death may result does not negate analysis of whether death is brought about in ways that recognize the importance of life. the german philosopher hans jonas said, "it is a question whether without restoring the category of the sacred, the category most thoroughly destroyed by the scientific enlightenment, we can have an ethics able to cope with the extreme powers that we possess today and constantly increase and are compelled to use."9 while countries vary on the role of religion in policy, with many emphasizing freedoms of religion, a recent position paper released by a group of jewish, christian, and moslem leaders (the three abrahamic religions) suggested the need for agreement on the unique sanctity of human life.10 i would recommend that such a document serve as an example of consensus on critical foundational bioethical guidelines for democratic secular societies. 1 alexander l (1949) medical science under dictatorship. new england journal of medicine, 241, p39-47 doi10.1056/nejm194907142410201 2 lederberg j. (1967) a geneticist looks at contraception and abortion, annals of internal medicine 67, sup 2, 25-27. https:/doi.org/10.7326/0003-4819-67-3-25 3 ibid. 4 editorial, sociology: logic of biology. nature 220, 429 (1968) https://www.nature.com/articles/220429b0 5 giublini a minerva f (2013) after-birth abortion: why should the baby live. j med ethics 39, 261 6 rachels j (1975) active and passive euthanasia. new england journal of medicine 292, 78-80 7 ibid. glick, application to medical aid in dying, voices in bioethics, vol. 7 (2021) 4 8 cohen-almagor r euthanizing people who are "tired of life". in euthanasia and assisted suicide-lessons from belgium. ch 11 of euthenasia and assisted suicide, cambridge university press pp173-187. 2017 and doi; https://doi.org/10.1017/9781108182799.012 9 hans jonas, technology and responsibility: reflections on the new tasks of ethics, 1972, found as chapter ix, philosophical essays, 1980. https://inters.org/jonas-technology-responsability 10 a position paper of the abrahamic monotheistic religions on matters concerning the end-of life. vatican press 28 october 2019 https://press.vatican.va/content/salastampa/en/bollettino/pubblico/2019/10/28/191028f.html https://doi.org/10.1017/9781108182799.012 https://inters.org/jonas-technology-responsability subrahmanyam and bhatt, repurposing the ladder, voices in bioethics, vol. 7 (2021) * vishnu subrahmanyam, ms chemistry, ms candidate bioethics, ku leuven rohin bhatt, candidate llb, gujarat national law university © 2021 vishnu subrahmanyam and rohin bhatt. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. repurposing the ladder: liberty, choice, and autonomy as applied to india’s covid-19 vaccination drive vishnu subrahmanyam, rohin bhatt* keywords: autonomy, public health, public health ethics, liberty, policy, harm principle introduction in 2007, the nuffield council of bioethics introduced the “intervention ladder” as a guiding framework1 to evaluate the impact on individual liberty of various public health measures. one criticism of the ladder is that it reflects a narrow view of liberty, yet other researchers adapted the intervention ladder to incorporate a more autonomy-based view. recently, academics and public health officials have used intervention ladders as guides in framing policies, particularly covid-19 pandemic policies.2 analyzing the indian covid-19 vaccination drive under these two ladders can illuminate the concepts of liberty underlying those ladders and help determine the best framework on a philosophical basis. analysis i. case study: the indian covid-19 vaccination drive on january 16, 2021, india attempted a public vaccination drive.3 the drug regulatory body central drugs standards control organization (cdsco) approved two vaccines, covishield and covaxin, for emergency use.4 the approval was granted despite a clear lack of phase 3 clinical trial data for both of these vaccines.5 covishield, produced by the serum institute of india, is the indian variant of the astra-zeneca vaccine that has shown an average efficiency of 70.4 percent after trials in the uk.6 covaxin, manufactured by bharat biotech in collaboration with the indian council of medical research (icmr) national institute of virology, was developed and manufactured in india. 7 subrahmanyam and bhatt, repurposing the ladder, voices in bioethics, vol. 7 (2021) 2 covishield relied on the safety and efficacy data from large trials conducted in brazil, south africa, and the uk with 24,000 participants and a small cohort for the indian study. covaxin was given approval based only on phase-1 trial data. 8 an article published in the lancet called for further efficacy data from the covaxin study.9 the officials associated with bharat biotech, as well as the indian council of medical research, maintained that fast production of the vaccine does not indicate a compromise in safety, even though they had little data to produce. 10 however, transparency is key to vaccination policy, which requires public participation. the media reported that the covaxin clinical trials compromised research integrity by providing a monetary incentive of around 7 euros, to research subjects. people’s university, a private medical college and hospital, recruited survivors of the bhopal gas tragedy for the covaxin study. the participants were told that they were being provided a vaccine against covid-19 without clarifying that data was being collected for their clinical study. there was no record of informed consent from these participants for the covaxin study.11 the media reported the death of a 42-year-old individual who received his first dose on december 23, 2020. 12 although it was reported that the cause of death was not linked to the vaccine, the death added to vaccine hesitancy. the vaccines were provided for free to the frontline healthcare workers with no choice on which vaccine the recipients would receive.13 similarly, in the us, some people do not have a choice between pfizer or moderna. in the uk and the us, data from phase 3 trials are known with a periodic follow-up after the administration of the second dose.14 the who developed a tracking system for covid19 vaccine recipients which was updated on march 19, 2021, to reflect the results of covaxin phase 3 trials.15 india eliminated choice although the two vaccines approved for emergency use did not have the depth of research that those used elsewhere had. the intervention ladder, discussed below, which uses proportionality and the harm principle to justify the lack of choice between the vaccines in the uk and the us, should not be applied to india’s vaccination policy. ii. the nuffield intervention ladder the foundational principle underlying the nuffield intervention ladder is mill’s conception of individual liberty from prominent work, on liberty.16 however, the council recognizes that the intervention ladder is conceived on a broader interpretation of mill’s liberty, using the principle of proportionality as a tool for justification i.e., the desired effect from the intervention is proportional to the loss incurred in liberty.17 as shown in table 1, an ideal intervention that is least infringing would then be no intervention at all. an intervention that would be more difficult to justify would be one that significantly restricts individual liberty. intuitively, eliminating occupies the topmost rung on the ladder. the metaphor of the ladder suggests that as one climbs up the rungs of the ladder, stronger justifications would be required. table 1: examples of interventions at each level of the intervention ladder adapted and improvised from the nuffield council of bioethics report, 2007. eliminate choice compulsory isolation of patients with infectious disease restrict choice removing processed foods from the racks of the supermarket as means to promote healthy food subrahmanyam and bhatt, repurposing the ladder, voices in bioethics, vol. 7 (2021) 3 guide choice: disincentives increasing tax on cigarettes to prevent people from smoking. guide choice: incentives fiscal benefits for switching to bicycles as a mode of transport guide choice: change in default policy switching fries for salad as a side dish enable choice offer participation vouchers or coupons for a ‘stopsmoking program’ provide information educational campaigns to increase vaccination/safe sex practices do nothing or simply monitor the situation a voluntary vaccination policy is one public health intervention that is acceptable and justifiable in terms of the principle of proportionality as well as mill’s harm principle, with emphasis on diminishing individual liberties when actions might result in harm to others.18 although a vaccination policy in the context of a global pandemic seems justifiable through the lens of the intervention ladder, the indian modus operandi is unique because of inherent problems with the original conception of the intervention ladder. by pausing to elaborate and reflect on the indian context as a case study, we can demonstrate that individual liberty should not be the sole variable in framing justifiability. iii. critiquing the nuffield intervention ladder & adding a precautionary approach in his paper, ‘snakes and ladders: state interventions and the place of liberty in public health policy’, angus dawson criticizes the intervention ladder’s focus on individual liberty,.19 and its inability to account for the different treatment of incentives and disincentives and the role of information. public health institutions require public participation to restrict the infectious spread of covid-19. the lack of transparency and minimal information surrounding the vaccines have been a major hurdle in increasing public participation. it is contradictory to think that the public does not require information about interventions and have the ability of self-determination to guide them, when in fact self-determination presupposes possession of relevant information. a voluntary vaccination policy can be seen as sitting on either the lowest rung (providing information) or the rung of enabling choice, as a vaccination campaign does both. however, in india, the precautionary principle should also be applied as providing the choice should not permit ‘harm’. the precautionary principle holds that anything that poses a risk to human health or the environment should be avoided or accompanied by precautionary measures. in india, because the clinical trials were smaller and there is less proof of safety and efficacy, a vaccination requirement, or a public health campaign to encourage vaccination violates the principle. the proportionality principle governing the intervention ladder only requires that the benefits of the intervention justify the restrictions on liberty. the intervention ladder should prevent requiring healthcare worker vaccination without a choice of vaccine because a free choice requires transparency and more information than is available from the small early-stage clinical trials. actions surrounding the vaccines in india do not reflect proper precaution or a proportionate and thus acceptable restriction on liberty. if there is no ability to choose between the two possible vaccines, then they should not be mandatory for healthcare workers. subrahmanyam and bhatt, repurposing the ladder, voices in bioethics, vol. 7 (2021) 4 the indian government and its officials have urged healthcare worker compliance by invoking the seriousness of the pandemic and the alarming rates of mortality rather than providing transparent data pursuant to the regulatory mechanisms of the vaccine clinical trial. for a healthcare worker, the duty to provide service and a stronger obligation to do so in the time of a pandemic already imposes certain restrictions on their liberty. the lack of choice in opting for a preferred vaccine puts it on a higher rung on the intervention ladder and thus requires stronger justifications. this case study reveals how the same public health intervention falls on different rungs of the intervention ladder depending on the target group in consideration. or to put this simply, choice is contextual. table 2: the ethical values at stake when it comes to “choice” protecting liberty of citizens and according to liberty primal importance a case-by-case approach in evaluating the implications of choice; as seen for the healthcare worker ensuring proportionality and precautionary principles does self-determination require relevant prior information? uphold the presumptive approach in public health address the need for a more substantive approach to public health iv. an autonomy-based intervention ladder liberty and autonomy differ slightly: liberty revolves around the constraints on the ability to act, whereas autonomy stresses on the independence and the authenticity of the willingness to act.20 it is thus possible for an individual to be autonomous but unfree, as can be seen from the inability to opt for a preferred vaccine.21 figure 1 shows an adapted schematic of an autonomy-based intervention ladder as proposed by griffiths et al. figure 1: an adapted schematic of the autonomy-based intervention ladder proposed by griffiths, p.e and west, c. subrahmanyam and bhatt, repurposing the ladder, voices in bioethics, vol. 7 (2021) 5 in comparing the original intervention ladder with their proposal, we see that the autonomy-based model allows for a negative scale in terms of its effects on autonomy. thus, on this ladder, actions can be autonomy-enhancing or autonomy-diminishing. such a model challenges the one-directional view of the ladder and rearranges interventions on a scale that ranges from negative to positive. a few interventions that were shown to have restrictive effects on liberty now have reinforcing effects when viewed through the lens of autonomy. thus, providing information and educating can be seen as positive reinforcements for autonomous choice rather than infringing on individual liberty. the autonomy-based intervention ladder requires the state to implement interventions and design policies in a manner that reinforces autonomy. information and education allow individuals to be free and equal participants in public health discourses. as seen in the original intervention ladder restricting choice, as well as eliminating it, still fall in the negative, autonomy-infringing side of the ladder. thus, requiring stronger justifications for their implementation. the only difference between the two is the manner in which the new model ensures the availability of a choice when the precautionary, as well as the proportionality principle, have not been met to a sufficient extent. ensuring choice and exercising it becomes much more relevant in making people autonomous. the frontline worker thus can opt for a vaccine they prefer. thereby, helping them navigate the moral conundrum of opting to get vaccinated, easing their moral burden. it also places strict vigilance over regulatory mechanisms that are involved in clinical trials since the burden of proof now involves providing information as a clear operational motive. this ameliorates public tendencies of hesitancy can be alleviated in this respect. an autonomy-based intervention ladder is not in conflict with mill’s conception of liberty since mill himself does not automatically assume a cost to liberty when the state seems to employ public education campaigns to inform the public.22 conclusion the original intervention ladder was conceived to remedy the hurdles that a traditional liberal landscape brings in implementing a public health intervention and to protect individual liberties. the intervention ladder assumes an inverse relationship between public health and freedom. rethinking the intervention ladder from a different perspective allows a proper role of the dissemination of information, recognizing that consent relies on information. an autonomy ladder acts as a starting point for rethinking public health and how it can foster autonomy as well as impede it. by focusing on autonomy, the benefits that can be gained from educational and informational campaigns are viewed as reinforcing autonomy. autonomy is vital to liberty. covid-19 has brought a unique set of ethical issues that have questioned conventionally accepted frameworks and calls for a substantive, alternative approach to public health ethics. 1 nuffield council on bioethics, “public health: ethical issues.” nuffieldbioethics.org, nov 13, 2007. www.nuffieldbioethics.org/publications/public-health. accessed 9 may 2021. 2 giubilini a, the ethics of vaccination [internet]. cham (ch): palgrave pivot; 2019. chapter 3, “vaccination policies and the principle of least restrictive alternative: an intervention ladder.” 2018 dec 29, 2018. www.ncbi.nlm.nih.gov/books/nbk538385/. 3 dash, sachinta. “india begins its covid-19 vaccination drive — here’s a look at how the world’s largest vaccine rollout is set to take place.” business insider india, january 16, 2021, www.businessinsider.in/india/news/india-will-begin-its-covid-19vaccination-drive-tomorrow-heres-everything-you-need-to-know/articleshow/80281740.cms. accessed 9 may 2021. subrahmanyam and bhatt, repurposing the ladder, voices in bioethics, vol. 7 (2021) 6 4 special correspondent, “coronavirus | india approves covid-19 vaccines covishield and covaxin for emergency use,” the hindu, january 3, 2021, www.thehindu.com/news/national/drug-controller-general-approves-covishield-and-covaxin-in-india-foremergency-use/article33485539.ece. accessed 9 may 2021. 5 thiagarajan, kamala, “covid-19: india is at centre of global vaccine manufacturing, but opacity threatens public trust.” bmj, january 28, 2021. www.bmj.com/content/372/bmj.n196, 10.1136/bmj.n196. 6 thiagarajan, kamala. 7 bharat biotech, “covaxin india’s first indigenous covid-19 vaccine | bharat biotech.” www.bharatbiotech.com/covaxin.html. 8 prasad, r. “coronavirus | vaccine dilemma — to take or not to take covaxin.” the hindu, january 15, 2021, www.thehindu.com/sci-tech/health/vaccine-dilemma-to-take-or-not-to-take-covaxin/article33577223.ece. 9 ella, raches, et al. “safety and immunogenicity of an inactivated sars-cov-2 vaccine, bbv152: a double-blind, randomised, phase 1 trial.” the lancet infectious diseases, vol. 21, no. 5, january 21, 2021, pp. 637–646, www.thelancet.com/journals/laninf/article/piis1473-3099(20)30942-7/fulltext, 10.1016/s1473-3099(20)30942-7. 10 thiagarajan, kamala. 11 thiagarajan, kamala. 12 nichenametla, prasad. “bhopal volunteer’s death unrelated to covaxin, says bharat biotech.” deccan herald, 9 jan. 2021, www.deccanherald.com/national/bhopal-volunteers-death-unrelated-to-covaxin-says-bharat-biotech-937199.html. 13 thiagarajan, kamala. 14 thiagarajan, kamala. 15 world health organization, “draft landscape of covid-19 candidate vaccines.” www.who.int/publications/m/item/draftlandscape-of-covid-19-candidate-vaccines. accessed 9 may 2021. 16 john stuart mill. on liberty. 1859. s.l., arcturus publishing ltd, 1859. 17 nuffield. “public health: ethical issues.” 18 john stuart mill. on liberty. p 13. 19 dawson, angus j. “snakes and ladders: state interventions and the place of liberty in public health policy.” journal of medical ethics, vol. 42, no. 8, may 23, 2016, pp. 510–513, 10.1136/medethics-2016-103502. 20 griffiths, p.e., and c. west. “a balanced intervention ladder: promoting autonomy through public health action.” public health, vol. 129, no. 8, august 2015, pp. 1092–1098, pubmed.ncbi.nlm.nih.gov/26330372/, 10.1016/j.puhe.2015.08.007 21 thaler, richard h, and cass r sunstein. nudge: improving decisions about health, wealth, and happiness. london, penguin books, 2008. 22 griffiths, p.e., and c. west. hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) * george hernandez, valeria saldana, sotonye douglas ms, anna-leila williams phd, mph, frank h. netter md school of medicine at quinnipiac university amy miyako williams, mfa, squeaky wheelz productions © 2021 hernandez et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. partnership with a theater company to amplify voices of underrepresented-in-medicine students george hernandez, valeria saldana, sotonye douglas, amy miyako williams, anna-leila williams* abstract medical education has a long history of discriminatory practices. because of the hierarchy inherent in medical education, underrepresented-in-medicine (urim) students are particularly vulnerable to discrimination and often feel they have limited recourse to respond without repercussions. urim student leaders at a usa medical school needed their peers, faculty, and administration to know the institutional racism and other forms of discrimination they regularly experienced. the students wanted to share first-person narratives of their experiences; however, they feared retribution. this paper describes how the medical students partnered with a theater company that applied elements of verbatim theater to anonymously present student narratives and engage their medical school community around issues of racism and discrimination. the post-presentation survey showed the preponderance of respondents increased understanding of urim student experiences, desired to engage in conversation about inclusion, equity, and diversity, and wanted to make the medical school more inclusive and equitable. responses from students showed a largely positive effect from sharing stories. first-person narratives can challenge discriminatory practices and generate dialogue surrounding the experiences of urim medical students. authors of the first-person narratives may have a sense of empowerment and liberation from sharing their stories. the application of verbatim theater provides students the safety of anonymity, thereby mitigating fears of retribution. keywords: narratives, medical education, underrepresented, discrimination, inclusive, diversity hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 2 introduction the field of medicine has a long history of discriminatory practices toward racial and ethnic minorities, women, and members of the lgbtq+ community.1 because of the inherent hierarchy in medical education, medical students are particularly vulnerable to discriminatory practices and may feel they have limited recourse to respond to discrimination.2 underrepresented-in-medicine (urim) students experience “death by a thousand cuts,” often with the perception that they are alone to shoulder and overcome injurious behavior inflicted by peers, faculty, and administrators. i. social impetus and desire for change spring 2020 saw the confluence of three social exigencies in the united states: the disproportionate burden of the covid-19 pandemic on people of color; 3 wide-spread awareness of racist police brutality; 4 and resurgence of demands for equity within medicine by the white coats for black lives organization.5 urim student leaders at the frank h. netter md school of medicine at quinnipiac university, ct, usa, felt compelled to awaken their medical school community to the bias and discrimination they faced regularly. the urim student leaders (15 people representing student national medical association, latinx medical student association, netter pride alliance, asian pacific american medical student association, student government association, and white coats for black lives) met regularly with the medical school dean and associate deans to address issues of culture and institutional racism. they needed their peers, faculty, and administration to know that institutional racism and other forms of discrimination were present in the school of medicine, despite vision and mission statements that prioritize equity and inclusion. to that end, in addition to advocating for policy changes, the urim student leaders wanted to share personal stories from their classmates with the hope that the narratives had the power to instigate change for the better at the school of medicine. they wanted to be heard and seen and to have their perceptions recognized and valued; yet, they could not shake the fear of retribution if they were truly honest about their experiences. therefore, the students concluded that anonymous storytelling was the safest approach. ii. foundational deliberations and partnership to anonymizing their stories, the students first had to deliberate two foundational features: one: how to account for a plurality of opinions and make decisions? two: how to speak about their personal experiences and maintain anonymity? the 15 urim student leaders elected three students (gh, vs, sd) to organize the event and imbued the three organizers with decision-making capacity. the three students, named the crossroads organizers, arrived at decisions by consensus. with the aim of maintaining student anonymity, a faculty member (aw) suggested the students investigate using a theater company to present their stories – the premise being that the actors would provide anonymous cover for the students while speaking the students’ words. having a script comprised exclusively of storytellers’ words is a foundational technique of verbatim theater.6 the students decided the crossroads organizers would meet theater company representatives to seek assurance that their stories would be presented with respect and appropriate representation. squeaky wheelz productions7 is a theatrical production company specializing in giving voice to the stories of minoritized individuals. hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 3 iii. recruit story authors the crossroads organizers used email and social media platforms such as facebook, groupme, and instagram to invite medical students to author stories. authors were given three weeks to submit their stories via an anonymous survey drop on google forms, thus assuring that no one, including the crossroads organizers, knew the identity of the story authors. iv. work with the theater company the crossroads organizers met with the director of the theater company (amw) multiple times to discuss logistics for the production. the director guided the medical students to refine their goals for the audience and authors (see theater company process) and establish the timeline and task list to arrive at a finished product promptly. initially, the crossroads organizers thought it would be a good idea to have the authors and actors meet to discuss their specific stories and roles. however, after further discussion, they decided that meeting would compromise the anonymity of the student authors and might discourage them from coming forward. instead, they let the authors know they had the option of meeting their actor. in the google forms survey, the crossroads organizers provided the opportunity for authors to list specific demographic characteristics of the actor they wanted to portray their story. for example, a latinx author could choose to have a latinx actor portray their story. v. theater company process the squeaky wheelz actors and director met to discuss how best to use their artistic skills to serve the students’ goals. given that the collaboration occurred amid the covid-19 pandemic, there were health, safety, technology, and geography parameters that informed the creative decisions. actors were recorded individually, and then the footage was edited to create one cohesive piece. using video meant that in addition to the artistic choices about casting, tone, pacing, and style (which are elements of an in-person event), there were also choices about editing, sound, and mise-en-scéne (“putting in the scene” or what is seen on screen). the squeaky wheelz director collaborated with the crossroads organizers about the project goals for their audience and colleagues. for example, the theater company encouraged the crossroads organizers to consider questions such as: do they want to tell the viewer what to feel? if a student author identified their race or ethnicity in their story, should casting reflect that as well? is there anything they would like the audience to know in a disclaimer, or should the stories stand on their own? consequent to the discussions, the theater company made the decision to not include music or sound (often used in film to dictate emotion), to cast actors of the same race or ethnicity if the author included such identifiers, and to create an introduction for the piece. the introduction stated: “the stories you are about to hear are the true, lived experiences of students in this program, read by actors. students submitted these words anonymously. we, the actors, ask you to listen.” the crossroads organizers expressed their goal was to share the stories authentically and to be clear that these were real experiences, not fictional accounts performed by actors. to serve these goals artistically in the mise-en-scéne, each actor was filmed in front of a plain white wall, in a medium-close-up, and holding a piece of white paper in the bottom corner of the frame from which they read the story. the actors looked straight to the camera for most of their reading, occasionally looking down to the paper to indicate that these words belonged to someone else visually. hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 4 actors were directed to “read the words,” not “perform the story” – to communicate the words simply and clearly rather than projecting an assumed emotionality behind the story. this choice was made for two reasons: one, the stories were submitted anonymously, and an assumed emotion may have been inaccurate to the author’s intention; two, without projecting assumed emotionality, the audience has permission to feel and think for themselves in response. all the actors worked independently to prepare for their virtual shoot dates. they also were available if any student authors wanted to meet about their personal stories. [one author chose to meet with their actor.] the final production, comprised of 16 student stories, was entitled netter crossroads: a discourse on race, gender, sexuality, and class. vi. finding the audience knowing the unique features and importance of the video as a tool to increase awareness of institutional racism and discrimination within the school community, the crossroads organizers aimed to secure as large a viewing audience as possible. to that end, they sought and obtained approval from the dean of the school of medicine to show the video during the annual state of the school address, which historically is delivered on the first day of classes and attracts a sizable cross-section of students, faculty, and staff. the crossroads organizers asked the dean and associate deans to make event attendance mandatory to engage as many students and faculty as possible in active reflection about discrimination, racial inequality, and social injustice within the medical education community. the deans agreed to make attendance mandatory for first-year medical students and to strongly encourage all other students, faculty, and staff to attend. the annual state of the school address is typically an in-person event. because of the covid-19 pandemic, all university events had to be hosted virtually on zoom. the crossroads organizers valued the real-time shared experience of viewing the video as a community, so they decided to divide the video into four short segments. the shorter length increased the likelihood that the video’s audio and visual quality was not affected. between the video segments, the crossroads organizers presented national data about underrepresentation in medicine. vii. attendee feedback the 2020 state of the school event had 279 attendees who watched the video, netter crossroads: a discourse on race, gender, sexuality, and class, in real-time. the audience was comprised of medical students, medical school faculty, staff, and administrators, and university administrators. a four-question likert-scale survey and open-response field disseminated after the event indicated the vast preponderance of attendees were favorably impressed by the crossroads video (see table 1). approximately 84 percent (67/80) of respondents strongly agreed or agreed with the statement that their understanding of urim student experiences had increased based on the presentation. approximately 82 percent (66/80) of respondents strongly agreed or agreed with the statement that the crossroads presentation effectively conveyed the challenges of urim students. seventy percent of respondents (56/80) strongly agreed or agreed with the statement that they were more inclined to engage in conversation about inclusion, equity, and diversity since seeing the crossroads presentation. approximately 77 percent (62/80) of respondents strongly agreed or agreed that since seeing the crossroads presentation, they wanted to learn more about how to help make the medical school more inclusive and equitable. hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 5 table 1. likert-scale survey results after viewing crossroads video (n=80). the crossroads presentation increased my understanding of the experiences of students who are underrepresented in medicine. the crossroads presentation effectively conveyed the challenges experienced by students who are underrepresented in medicine. since seeing the crossroads presentation, i am more inclined to engage in conversation with people at netter about inclusion, equity, and diversity. since seeing the crossroads presentation, i want to learn more about how i can help make netter a more inclusive and equitable community. strongly agree 39 40 35 43 agree 28 26 21 19 neutral 5 6 15 10 disagree 4 3 4 5 strongly disagree 2 3 3 1 the open-response field attracted 24 commentators who largely made favorable comments. representative favorable comments included: “that was a great presentation. i wish i could hear more from students like that.” “a big thank you to the students who conveyed their stories to the actors – that was a heavy lift.” “hearing the stories of people at netter made this presentation hit close to home.” “the crossroads presentation was outstanding and really opened my eyes to things that i had no idea were happening or that i had never even thought about.” “definitely we need to hear more of these voices. very powerful and moving session!” “it was powerful to hear real students’ experiences, played by actors…it communicated to me that netter is…really committed to improving diversity and inclusion.” representative unfavorable comments include: “i found this style confrontational instead of conversant/dialogue, and that may have been what the students were going for…but dialogue might have been just as, if not more, effective…” “i fear that welcoming new students virtually to our school by sharing stories of bias, racism, and sexism at our own institution may have left them feeling even more isolated and insecure.” “we need less of these presentations.” viii. student author survey after the assembly, the crossroads organizers posted announcements on their social media sites inviting the student authors to respond to two queries about their experiences of sharing their stories. since the student authors were anonymous and unknown to the crossroads organizers, they could not directly query hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 6 the student authors. instead, the posted announcement asked for open responses to the following questions: a) how did writing and sharing your personal experience at netter make you feel? b) how did viewing your story portrayed by actors during the state of the school address make you feel? six of the sixteen student authors put their responses anonymously in a google forms survey drop. the authors indicated a range of feelings about writing and sharing their personal experiences. several authors expressed appreciation for the process and the psychotherapeutic effects. “i feel as though it was an opportunity for my voice to be heard in an anonymous way.” [student author #3] “empowered to get that frustration out.” [student author #4] “it helped me process some thoughts and emotions that were bothering me subconsciously. i was allowing things like microaggressions affect me without actually addressing the issues.” [student author #6] others focused on the value of having an audience for their experience. “i feel as though at school, i am never in safe spaces to be able to share my concerns, and that my voice is never heard. i just appreciated being able to vent to someone else about my experiences other than my friends.” [student author #3] “before this presentation i had only shared my feelings about being viewed as a minority at school privately with my close friends. hearing someone else’s stories normalized my feelings of isolation (unfortunately).” [student author #5] two authors expressed concern about how their stories would be received. “a little worried about the reaction.” [student author #1] “vulnerable, scared, apprehensive.” [student author #2] the authors also had a range of responses about their experience of seeing their stories portrayed by actors. for some there was a sense of exuberance and activation. “really empowered!” [student author #1] “the actors were excellent and really funneled our voices. viewing both my story and the other students’ [stories] made me realize there is so much work that needs to be done in predominantly white medical schools.” [student author #5] others conveyed hopefulness. “heard…like attempts were made to at least take my experience seriously.” [student author #2] some students experienced conflicting and even negative emotions. “it made me feel sad, but also proud…” [student author #3] hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 7 “the negative stress racism and discrimination that plays on underrepresented medical students is traumatizing and completely unfair. we are all trying to succeed as future physicians and none of us should carry the burden of feeling targeted based on our skin color or physical features. viewing the other stories made me feel angry that these micro/macro-aggressions are tolerated every single day.” [student author #5] “it made me feel vulnerable that my experience was on display for the community to see.” [student author #6] and finally, there was mention of the psychodynamic processing that took place from seeing their experiences. “i felt that it was relatively therapeutic.” [student author #3] “it also helped me work through the emotions that i had been suppressing.” [student author #6] conclusion discriminatory practices often go unnoticed or unmentioned in the medical education setting. failure to address discriminatory practices leads to isolation, stress, and disempowerment. to mitigate these harms, the medical school curriculum should enable conversations and events about racism and other forms of discrimination. urim student narratives can aid faculty and student development. after viewing the stories, facilitated conversations could address questions such as the following: a) what could you do to prevent this scenario from ever even occurring? b) now that it has occurred, how will you support this student? c) what structural changes and/or policies need to be in place for corrective action to be effective? d) if the scenario in the video happened to you, what would you do next? e) why would you make that choice? f) alternatively, if you witnessed this happen to a student or faculty member, what would you do? g) why would you make that choice? h) what are the potential personal and professional consequences of your choice? in alignment with the published literature, our small sample of student author respondents experienced positive therapeutic effects from the process of writing and sharing their stories.8 at the same time, seeing other authors’ stories of discrimination portrayed by actors ignited anger and sadness for some of our students as they recognized the depth of trauma within the community. partnership with a theater company provides students the safety of anonymity when telling their stories, thereby allaying their fears of retribution. while some student authors maintained a sense of vulnerability despite the anonymity, they also expressed a sense of empowerment, hopefulness, and pride. medical educators and administrators must take bold steps to address institutional racism in a meaningful way. health humanities, including theater, can help the medical education community recognize and overcome the harms imposed on urim students by institutional racism and other forms of discrimination and awaken capacity for compassionate, respectful, relationship-based education. hernandez et al., partnership with a theater company, voices in bioethics, vol. 7 (2021) 8 1 hess, leona, palermo, ann-gel, and david muller. 2020. “addressing and undoing racism and bias in the medical school learning and working environment” academic medicine, 95, no. 12 (december): s44-s50. https://pubmed.ncbi.nlm.nih.gov/32889933/ 2 naif fnais et al., “harassment and discrimination in medical training: a systematic review and meta-analysis,” academic medicine 89, no. 5 (2014): 817-827, https://doi.org/10.1097/acm.0000000000000200; melody p. chung et al., “exploring medical students’ barriers to reporting mistreatment during clerkships: a qualitative study,” medical education online 23, no. 1 (december 2018): 1478170, https://doi.org/10.1080/10872981.2018.1478170 3 “racial data transparency,” coronavirus resource center, johns hopkins university & medicine, accessed july 15, 2021, https://coronavirus.jhu.edu/data/racial-data-transparency 4 radley balko, “there’s overwhelming evidence that the criminal justice system is racist. here’s the proof,” washington post, june 10, 2020, https://www.washingtonpost.com/graphics/2020/opinions/systemic-racism-police-evidence-criminal-justicesystem/. 5 “wc4bl,” white coats for black lives, accessed may 15, 2021, www.whitecoats4blacklives.org. 6 will hammond and dan steward, eds., verbatim: contemporary documentary theatre (london: oberon books, 2012). 7 “our vision,” squeaky wheelz productions, accessed june 30, 2021, www.squeakywheelzproductions.com/. 8 james pennebaker and joshua smyth, opening up by writing it down: how expressive writing improves health and eases emotional pain, 3rd ed (new york, london: the guilford press, 2016). https://doi.org/10.1097/acm.0000000000000200 https://doi.org/10.1097/acm.0000000000000200 https://doi.org/10.1080/10872981.2018.1478170 https://coronavirus.jhu.edu/data/racial-data-transparency http://www.whitecoats4blacklives.org/ http://www.squeakywheelzproductions.com/ brogan, the next era of biomedical research, voices in bioethics, vol. 7 (2021) * james brogan, medical student candidate at albert einstein college of medicine © 2021 james brogan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the next era of biomedical research: prioritizing health equity in the age of digital medicine james brogan* keywords: biomedical research, health equity, race and justice, inclusive, structural racism introduction the history of biomedical research in the united states is both inspiring and haunting. from the first public demonstration of anesthesia in surgery at massachusetts general hospital to the infamous tuskegee experiment, we see the significant advances made for the medical field and the now exposed power dynamics that contribute to injustices when they are left unmonitored.1 over the past century, biomedical research led to positive change but also reinforced structural racism. henrietta lacks, whose tissue was used without her consent to generate hela cells, and the tuskegee study research subjects, who were denied an existing treatment for syphilis, exemplify how biomedical research in the us has been a vector for exploiting minority groups in exchange for knowledge creation. as we usher in the age of computational medicine, leaders of the field must listen to calls from communities around the country and world to decrease the prevalence of structural racism in the next wave of medical advances.2 we are vulnerable to perpetuating structural racism through algorithms and databases that will drive biomedical research and aid healthcare systems in developing new methods for diagnosing and treating illness. with guidelines from governmental funding agencies and inclusivity of racial and ethnic minorities in research and development communities, we can inch closer to a more just future for our nation's health. background many health systems rely on commercial software to store and process their patient’s data. this software commonly comes with patented predictive algorithms that help providers assign a risk score to patients based on health needs. however, biases held by algorithm developers can reflect racial disparities and incorporate them in the algorithms if proper counterbalances are not in place to audit the work of algorithm designers. 3 despite the recent digitization of healthcare data across the united states, racial bias has already found its way into healthcare algorithms that manage populations. brogan, the next era of biomedical research, voices in bioethics, vol. 7 (2021) 2 analysis i. use of algorithms one landmark study that interrogated a widely used algorithm demonstrated that black patients were considerably sicker than white patients at a given risk score, evidenced by signs of uncontrolled disease.4 the algorithm predicted the need for additional help based on past expenditures, and we historically spend less on black patients than white patients. rectifying this bias would lead to three times as many black patients receiving additional resources. the algorithm produces a treatment gap due to a history of unequal access to care and lower spending on people of color compared to white people in the healthcare system. the disconnect between the clinical situation and historical resource allocation exemplifies how certain predictors may produce an outcome that harms patients. the study shows that using a proxy measure for healthcare spending to quantify how sick a patient is instead of using physiologic data can amplify racial disparities. this example highlights the need for collaboration between clinicians, data scientists, ethicists, and epidemiologists of diverse backgrounds to ensure model parameters do not perpetuate racial biases. ii. use of big data in algorithm creation in addition to eradicating algorithms that make decisions based on proxy measures encoding racial inequities, we must also be diligent about the content of databases employed in algorithm development. racial disparities in a database may result from the intentional selection of a homogenous population or unintentional exclusion due to systemic issues such as unequal distribution of resources. for example, a genetic study conducted in a scandinavian country is more likely to be racially homogenous and not generalizable to a broader population. applying algorithms derived from homogenous populations to either diverse populations or to different homogenous populations would fail to account for biological differences and could result in a recess of care when used beyond the appropriate population. additionally, companies like apple or fitbit could de-identify consumer data collected using their wearable sensors and make it available in research. this is problematic because the demographic distribution of people who have access to their technology may not reflect the general population. to combat these potential disparities, we must construct freely accessible research databases containing patients with diverse demographic characteristics that better model the actual populations that a given model will serve. iii. government-based safeguards armed with an understanding of how systemic bias is integrated into algorithms and databases, we must strive to construct safeguards that minimize systemic racism in computational biomedical research. a potential way to step forward as a society would be aligning incentives to produce the desired results. governmental agencies wield enormous power over the trajectory of publicly funded research. therefore, it is crucial that computational biomedical research funding is regulated by procedures that encourage diverse researchers to investigate and develop healthcare algorithms and databases that promote our nation's health. for example, the national institutes of health (nih) has set forth two large initiatives to catalyze equitable growth of knowledge and research in healthcare artificial intelligence (ai). the first initiative is the artificial intelligence/machine learning consortium to advance health equity and researcher diversity (aim-ahead), which focuses on increasing diversity in researchers and data within ai/machine learning (ml). the program states that “these gaps pose a risk of creating and continuing harmful biases in how ai/ml is used, how algorithms are developed and trained, and how findings are interpreted.” increased participation of researchers and communities currently underrepresented in ai/ml brogan, the next era of biomedical research, voices in bioethics, vol. 7 (2021) 3 modeling can prevent continued health disparities and inequities. programs like aim-ahead are crucial to reducing the risk of creating and continuing harmful biases in biomedical research. with the four key focus areas of partnerships, research, infrastructure, and data science training, aim-ahead and its future incarnations can promote health equity for the next era of medicine and biomedical research. the second initiative announced by the nih is known as the bridge to artificial intelligence (bridge2ai) program.5 this program has a different approach to tackling systemic racism and bias by focusing on the content and process of ai/ml research. two key components of ai/ml research are rich databases and algorithm development protocols. to develop reproducible and actionable algorithms, researchers must have access to large, well-labeled databases and follow best practices in their development of algorithms. however, large databases are not readily available across the healthcare research ecosystem. as a result, many investigators struggle to gain access to databases that would enable them to carry out ai/ml research at their home institution. a movement toward more freely available databases like the medical information mart for intensive care (mimic) and electronic intensive care unit (eicu) through the physionet platform created at the massachusetts institute of technology laboratory for computational physiology can improve access to data for research.6 by adopting the practice of freely available databases commonly used in the ai/ml research communities outside of medicine, mimic and eicu lowered the barrier to entry for data scientists interested in health care. the improved access from mimic and eicu has led to over 2,000 publications to date. while this is a solid foundational step for the healthcare ai/ml research community, it is essential to reflect on progress and ensure that freely accessible databases are racially and geographically diverse. in this manner, bridge2ai will facilitate the expansion of healthcare databases that are ethically sourced, trustworthy, and accessible. without government programs such as aim-ahead and bridge2ai, the us biomedical research community is at higher risk of perpetuating systemic racism and biases in how ai/ml is used, how algorithms are developed, and how clinical decision support results are interpreted when delivering patient care. iv. private sector standards even with the proper incentives delivered from governmental agencies, there can be a disconnect between the public and private sectors, leading to racial bias in algorithms used in patient care. privately funded ai/ml algorithms used in care decision making should be held to the same ethical standards as those developed by publicly funded research at academic institutions. publicly funded research is usually peer reviewed before publication, giving reviewers a chance to evaluate algorithmic bias or deficiencies. algorithms used in care may have avoided similar scrutiny. corporations have an inherent conflict between protecting intellectual property and providing transparency of algorithmic design and inputs. the food and drug administration (fda) is responsible for regulating ai/ml algorithms. it has classified them as software as a medical device (samd), focusing on the development process and benchmarking.7 the importance of holding privately funded algorithm development to the same standards as publicly funded research is highlighted in a september 2020 review of fda approved ai/ml algorithms. all samd approved by the fda are registered by private companies.8 regulators must be well-versed in structural racism and equipped to evaluate proprietary algorithms for racial bias and maintain oversight as population data drifts occur and the algorithms continue to optimize themselves. the fda role is crucial to clinical use of samd. conclusion computational decision support using algorithms and large databases has the potential to transform the way we deliver care. however, governments should plan how they will prevent structural racism and associated inequities from running rampant in the new systems. racial bias and mistreatment are brogan, the next era of biomedical research, voices in bioethics, vol. 7 (2021) 4 engrained in the history of medical research. in the newly formulated digital world, these biases are potentially even more dangerous. they now can propagate quietly in the background, masked under layers of computer code that very few people understand how to write and interpret. it will be possible for a doctor to unconsciously propagate bias because an algorithm is nudging the doctor’s behavior to make the best treatment decision for their patient. healthcare leaders must be vigilant in guiding the development of algorithms and databases to minimize systemic racism. guidance from funding agencies to uphold minimum quality standards, a transparent vetting process for algorithms by governing bodies like the fda, and a diverse community of researchers and developers will allow us to curb the spread of structural racism in research and build equitable tools for diagnosing and treating illness. the real question is: will the age of digital medicine also lead to a more equitable healthcare system? 1 about the usphs syphilis study. accessed august 18 2021. https://www.tuskegee.edu/about-us/centers-ofexcellence/bioethics-center/about-the-usphs-syphilis-study; mgh. mgh firsts. accessed august 18 2021. https://libguides.massgeneral.org/mghhistory/firsts. 2 geneviève ld, martani a, shaw d, elger bs, wangmo t. structural racism in precision medicine: leaving no one behind. bmc medical ethics. 2020;21(1):1-13. 3 barocas s, selbst ad. big data's disparate impact. calif l rev. 2016;104:671. 4 obermeyer z, powers b, vogeli c, mullainathan s. dissecting racial bias in an algorithm used to manage the health of populations. science. 2019;366(6464):447-453. 5 nih. bridge to artificial intelligence. accessed august 17 2021. https://commonfund.nih.gov/bridge2ai. 6 physionet. physionet: the research resource for complex physiologic signals. accessed august 17 2021. https://physionet.org. 7 fda. software as a medical device (samd). accessed august 16 2021. https://www.fda.gov/medical-devices/digital-healthcenter-excellence/software-medical-device-samd. 8 benjamens s, dhunnoo p, meskó b. the state of artificial intelligence-based fda-approved medical devices and algorithms: an online database. npj digital medicine. 2020;3(1):1-8. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study https://libguides.massgeneral.org/mghhistory/firsts https://commonfund.nih.gov/bridge2ai https://physionet.org/ https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) *anne zimmerman, jd, fordham university school of law, candidate, ms bioethics, columbia university © 2021 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. public policy through the lens of necessity: post-death organ donation anne zimmerman, jd* abstract the supply of organs available for transplant does not meet the demand. attempts to increase the supply through policy initiatives that alter the system of explicit consent in post-death organ donation must rely on sound ethics and philosophy. presumed, implicit, and normative consent each pose problems in liberal, pluralistic society where autonomy is highly valued. this paper explores whether the elements of necessity as a legal defense would supply the moral heft to justify an opt-out policy in light of the organ shortage. keywords: organ donation, necessity, normative consent, presumed consent, implicit consent, informed consent introduction necessity can drive people’s behavior to extremes, and at times, can provide an excuse for otherwise criminal, illegal actions that, under normal circumstances, would be morally wrong. the law can be somewhat generous. in regina v. dudley and stephens, a british court held that you cannot kill someone to eat him despite dire need.1 mercy or clemency was left to the crown. necessity is not a defense to homicide except in cases of self-defense or a just war. yet, other necessity cases show there is some room for leniency in crimes and that necessity may provide a partial or total defense in tortious wrongdoing. maybe you can steal a piece of bread or damage property to save a life that is in imminent danger. while most agree, organ donation is not an area where the medical community should allow or encourage someone’s life to be taken for the sake of saving another, post-death organ donation is an arena where some suggest necessity, or at least high demand, should shape policy, and provide a moral defense for zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) 2 policies that normally would offend a sense of freedom, individuality, and autonomy. some may categorize organ donation as an area where there is a moral duty to act, while others may find it superfluous, an extra kindness beyond that which is morally required. if it is morally compulsory, does moral compulsion justify creating a legal obligation? analyzing organ donation through the lens of the traditional requirements of necessity sheds light on the issue of whether necessity could morally justify acting without explicit donor prior consent. is organ retrieval ever a justifiable trespass to save a life? while an opt-out system entered freely, by vote or referendum, speaks to rules that people agree to for the sake of living in liberal society, it is also problematic given the american notions of personal choices and liberty.2 this paper argues that necessity does not provide enough moral heft to switch to an opt-out or mandated donation system, and that organ donation is a moral good although not necessarily a moral requirement. undertaking a system that does not require opting in poses a risk to individualism in pluralistic liberal society, something recognized under the current system of organ procurement. analysis evidence suggests that countries with opt-out policies have a donor rate of 25 to 30 percent higher than that in countries requiring explicit consent, yet the reason for increased rates is multifactorial.3 generally, opt-out policies would further the public health community’s priority of procuring more organs to meet the needs of those waiting.4 one problem with explicit consent requirements is that more people wish to donate than actually register, creating an unfulfilled potential in opt-in programs. to divide organ procurement into two broad categories, there are programs that operate with explicit consent (opt-in, the current us system) and programs which are essentially opt-out, presumed consent programs (any programs that do not require explicit consent). while the moral and ethical distinctions and the logistics may vary, the distinctive feature in the programs not requiring explicit consent is that government or society sees post-mortem organs as something available for use as a public good, or for the common good, making explicit consent unnecessary or even immoral.5 those attempting to justify opt-out programs within the bioethics concepts of autonomy and informed consent offer presumed, implicit, or normative consent as acceptable to override a need for explicit consent. many countries justify their program based on presumed consent, the prevailing theory whereby consent is presumed unless a person explicitly expressed opposition to donation.6 presumed consent is based on the concept that most would agree, while it acknowledges that some may not agree, placing the burden on them to opt out.7 some argue that presumed consent is justified because removing an organ from someone who does not wish it to be donated is no worse than failing to remove one from someone who does wish to be a donor.8 the argument is weak as arguably leaving a body alone should not be compared to the unwanted invasion post death. in many circumstances, organs are not appropriate for transfer due to health of the tissue, incompatibility with realistic recipients, or if the circumstances of the death do not allow for procuring the organs. there is no right to donate. some argue that implicit consent (inaction is the consent) is a better rationale for opt-out programs.9 implicit differs from presumed consent in that with implicit consent there is evidence the person was aware and had the opportunity to voice objection. the failure to object is consent where with presumed consent, inaction is not actual consent, but merely a substitute for it. the philosophy of normative consent10 holds that because consenting to donate organs is the morally right action, consent is unnecessary—normative consent theory would compel actions based on social norms presupposing that all (or most) agree that withholding the consent is morally wrong. that is, withholding consent would be considered void and society’s need for the organs would prevail in accordance with social norms. normative consent, like presumed and implicit, is controversial. normative consent goes the furthest in compelling a behavior deemed morally right and makes the broadest assumption about prevailing beliefs. zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) 3 none of presumed, implicit, or normative consent apply well to the us where choice and autonomy are embedded in the legal structure. several states have addressed the possibility of presumed consent policies, but none have adopted opt-out policies.11 a 2019 study found that in the us, 34 percent would opt out if an opt-out system were implemented.12 in colorado, 56 percent opposed adoption of an optout system.13 recommended policies vary: in some countries, people’s rights arguably do not include the right to control what happens to one’s body after death. one extreme would be assuming no people want to donate other than with explicit consent, like the us, or forbidding organ donation, as technically a theocracy might. the other extreme would include forcing everyone to donate without exceptions for philosophical or religious objections, a seemingly totalitarian option. most opt-out programs fall in between, offering the ability to opt-out and various ways to register one’s choice.14 the devastating shortage of organs provides the moral impetus to publicize and promote organ donation. it is a moral good but the degree to which it is a moral good varies and is personal. one study shows that in the us, people view organ donation as “extraordinary altruism” rather than ordinary.15 under some views, acting as a good samaritan is a moral requirement where other actions are superfluous, and go beyond that morally required. some jurisdictions have good samaritan laws protecting those who undertake dangerous altruistic actions, and a few jurisdictions have laws creating a duty to rescue. ethics literature distinguishes morally compelled acts from superfluous morally good acts that go above and beyond the ordinary. 16 the debate that compares rescuing a drowning child (a clear moral duty) to donating to humanitarian aid (a debated moral duty) is relevant in that the public categorizes organ donation both ways. 17 because many see a duty to donate organs as extra rather than a moral duty, and generally donations are seen as going to an unknown person in need rather than a friend, relative, or neighbor (there is no other relationship supporting a moral duty), societal necessity could supply a potential justification for a change of policy. but as a society, adopting a policy would depend on how we see helping unknown people in need, and whether altruism, even when it is morally compelled, should be legally compelled. the immediate question is whether the elements of legal necessity could justify an opt-out policy, or any intrusion on the body of a silent or undesignated potential post-death donor. this analysis asks whether necessity could be used to eliminate the need for consent altogether. a. the lens of necessity in regina v. dudley, the starving people lost at sea killed and ate their fellow shipmate thereby saving their own lives. acting out of necessity, the defendants committed murder and received no reprieve from the court. in the us, necessity is not a defense to murder.18 yet, necessity is applicable to many crimes and torts, absolving guilt or acting as a partial excuse counteracting the full force behind awarding damages. necessity can act as a mitigating circumstance under the law. analyzing the moral impetus for an opt-out policy or required organ donation through a lens of necessity poses several issues concerning the imminent danger to those waiting for organs, the alternatives, and the nature of the act of using a body part after death (is it property or something more special?) without the explicit consent of the donor or a legitimate proxy. the situation of necessity looks like this: person a encounters danger x and does act y which deliberately imposes on person b (harming person or property) to avoid danger x. the legal elements of necessity as a defense generally include a threat of imminent harm, an action that would prevent the harm and cause a lesser harm, and the absence of a less intrusive or a legal alternative to prevent the imminent harm.19 the role of necessity varies by jurisdiction in the us. courts have found prisoners may not use the necessity defense of escaping poor conditions,20 yet generally escaping a prison fire would be a good use of the defense. in criminal necessity, prior to roe v. wade, doctors used saving the life of a woman as a necessity defense to performing an illegal abortion.21 in tortious necessity, examples could include using someone zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) 4 else’s well water to put out your own fire; driving a bus into a building to avoid going off a cliff (damaging property to save lives); or burning someone’s land to stop a spreading wildfire (saving lots of land or furthering a public good by harming a small plot of privately owned land).22 the wildfire example is similar to organ donation because it involves addressing a public shortage by way of a personal intrusion. in the organ procurement arena, entity a (the government through policy, the hospital, or the doctor) does y (extract or keep the organs viable without explicit permission) harming b (the dead donor’s family, the dead donor’s former autonomous self, society) to avoid danger x (a death from the inability to procure an organ in time). i. without the policy (or the individual organ) would the harm to the potential organ recipient be imminent? the necessity itself is the dire need for the organ, but also could be the societal emergency need for many organs as the shortage is substantial.23 private health necessity would be more like the necessity defense as it exists in legal structures where the excuse is based on immediately meeting the need of the person waiting for the organ. necessity is theoretically relevant to public health needs as well. a need for an organ is an imminent emergency. yet, the link between public policy and one person’s organ is muddled. in a case of private necessity, many things could stand in the way of the organ going to a defined recipient. in the public health context, there is necessity, but the imminence runs to the entire public. public policy is not about saving each life, rather it tends to concern large numbers, creating a system that works for all and ranks recipients. some potential recipients can be kept alive other ways and decreasing demand for organs is an important strategy as well. in other imminent public policy contexts, solutions are not sparked by similar necessity. for example, many would argue gun control legislation or universal access to quality health care would save many lives, but the imminence we look to for emergency powers is not met. for covid-19 policies, imminence did allow state governments to act out of necessity. ii. difficulty defining the harm the harm to the unwilling or silent donor must be defined so that it can be compared to the harm (possible or definitive death) of the potential recipient. with an eye on proportionality, the breach of integrity against the dead donor’s wishes or the dead donor’s body is significant. generally, to use the defense of necessity, the defendant would need to show the act is necessary to avoid a larger or more serious harm, e.g., destroying property may be necessary if it is the only way to save a life, and that no greater harm would come from the act. necessity as a basis for a legal defense would require demonstrating that saving a life trumps the risk of violating the wishes of the donor. analyzing the breach relies on how a body post death is valued. if its parts become property, and a nonconsensual taking of it is just a property violation (a crime or a tort), arguably it does not amount to an equal or greater harm than the harm of the potential recipient’s death. most people would agree that saving a life trumps improper use of someone’s property, making the necessity defense appropriate as far as weighed harms. however, using a heart after death is quite different from using personal property, like the dead person’s watch. some may argue that a body, after death, is really just abandoned property in the absence of an advance directive declaring bodily intactness as a personal value. if a dead body is something more special than ordinary property, preventing harm to it may be more important than using it to save a life. in liberal society, there is a long-presumed moral right to decide what becomes of one’s body after death. it is something many people include in a will, and those who do not would be subject to the wishes of family members, or, in the absence of them, the government may provide guidance and even cremation and burial. bodies, alive or not, are considered sacrosanct even to secular people, governments, and organizations. individuals vary greatly on whether they would allow any intrusion; many opt for cremation to avoid embalming or intrusion. i would argue that, for some people, dignity during life includes direction of one’s own body after death. the organs, which could be property of the family of the deceased, must also be evaluated in terms of bodily integrity. while many argue that a person cannot be harmed after zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) 5 death,24 the harm is not danger to the body, it is danger to dignity. an opt-out system pursuant to which silence itself would equal willingness to donate poses risks to those who wish not to donate but have not successfully opted out. additionally, after death, estates often address harms to reputation or actions that go against the deceased person’s wishes. the risk that someone who meant to opt out did not could be evaluated as fundamental, and as something to which an estate could rightly object. or, is a body, after death, just abandoned property, in the absence of an advance directive declaring bodily intactness as a personal value? while many agree it becomes more of an object than a person, i.e., that personhood is special and the body is not, the risk is that for some, the post-death body is sacred but the paperwork to opt-out was not finished is too strong to ignore. the nonconsenting dead donor could be someone who explicitly stated an opposition to allowing organs to be harvested and donated or someone who spoke against organ donation broadly, someone who opposed opt-out systems and failed to opt-in by designating himself a donor on a driver’s license or in a public registry, or someone whose family is acting as proxy and opposing. in evaluating opt-out policies, or any policy to go ahead when consent is not attainable after death, the harm to society must be weighed. while death to someone awaiting donation is devastating, i argue that public policy must consider the combined affront to individual choice, flourishing, bodily integrity even after death, and the plurality of reasons to forgo donating organs, which, from the perspective of some individuals, could trump the ability to save someone’s life. educating the public about the process of organ retrieval and the importance should vastly increase the number of donors without a need to presume consent. organ donation should be free and fair, not a result of coercive government action. while it may be easier to see the value in continued life for the recipient and the harm in the failure to procure an organ in time to save the life, the risk of the esoteric harm in violating wishes not to donate or misinterpreting silence on the issue touch on a fundamental liberty interest. opt-out policies vary in rigor, but they open the possibility of an intrusion that deeply affects how society values individuals and their control of their postdeath bodies. smaller intrusions for public health are permissible (rules on shipping, storage, and burial), but opt-out policies send the signal that government has a large role in what are for some deeply personal issues, something objectionable to many people in the us. iii. alternatives and promoting health if there were alternative solutions that would solve the need for organs, there would not be a necessity argument. for now, the requirement of legal necessity that no other alternatives exist is met. however, the search for alternatives to organ transplantation may be pushed forward due to the ongoing shortage of organs. organs created in labs through ectogenesis, medicines to make organs unnecessary (like synthroid makes a thyroid unnecessary), and long-term health and lifestyle improvements may alter the demand for organs and move society toward a healthier future. while in many current cases, there is a lack of alternatives, the future should bring technological advances and good health decreasing the demand for organs. conclusion while the doctrine of necessity cannot quite support opt-out systems where liberty interests are heavily valued, necessity does provide a moral impetus to become an organ donor. in a system with pluralistic views, liberty to make a wide variety of personal choices, and bodily integrity that extends to one’s ability to choose what becomes of one’s body post-death, explicit consent is the acceptable platform for organ donation. while, to many of us, it is arguably morally compulsory to donate organs, to some it is not. organ donation may violate some people’s personal beliefs, philosophy, or religion. necessity would be a solid argument to nudge individuals to behave in the preferred way – helping someone in need is a moral good, whether deemed morally compulsory or an act of extraordinary altruism. zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) 6 necessity is not quite able to justify a pure opt-out policy—whether it could justify an isolated instance of imposing on the body of an unwilling or silent donor after death should be addressed case by case. necessity in the post death arena may include leaving an injured or dead body behind on a hiking trail in the wilderness if it is impossible to survive while carrying it. if someone wants my organs, be sure to wait until i am dead. and, if it comes down to a donner party situation, i think i would taste best grilled. 1 regina v. dudley and stephens, 14 q.b.d. 273 (1884). 2 data from colorado where opt-out has been discussed indicate that many would opt out of donation. 3 alejandra zúñiga-fajuri, “increasing organ donation by presumed consent and allocation priority: chile,” bulletin of the world health organization 2015;93:199-202. doi: http://dx.doi.org/10.2471/blt.14.139535 the world health organization supports opt-out policies. the chile experience also attributes success to offering the donor’s family priority on waitlist for organs. but see glazier a, mone, t. “success of opt-in organ donation policy in the united states.” jama. 2019;322(8):719–720. https://jamanetwork.com/journals/jama/article-abstract/2748178 doi:10.1001/jama.2019.9187 arguing opt-out systems do no not improve organ donation rates. see https://www.statista.com/statistics/624834/state-designated-organ-donors-among-us-adults-by-state/ for data on the number of registered donors by state. rates vary from 32 percent (texas) to 69 percent (colorado). see “'opt out' policies increase organ donation” stanford university, sparq, https://sparq.stanford.edu/solutions/opt-out-policies-increase-organ-donation citing davidai, s., gilovich, t., & ross, l. (2012). the meaning of default options for potential organ donors. proceedings of the national academy of sciences, 15201-15205, stating 90 percent register as donors in opt-out policy countries. 4 the reasoning presented also applies to policies that would keep organs vital without explicit consent or to the use of use of temporary organ preservation technologies. verheijde, joseph l et al. “presumed consent for organ preservation in uncontrolled donation after cardiac death in the united states: a public policy with serious consequences.” philosophy, ethics, and humanities in medicine: pehm vol. 4 15. 22 sep. 2009, doi:10.1186/1747-5341-4-15. additionally, organ perfusion technology to save organs ex vivo as well as any effort to preserve organs in the body post-brain death invoke similar moral quandaries. 5 ethics of deceased organ donor recovery without requirement for explicit consent or authorization, hhs white paper (december 2016) https://optn.transplant.hrsa.gov/resources/ethics/ethics-of-deceased-organ-donor-recovery/ paper notes the current culture of individualism is reason to continue the explicit consent donor system we have. 6 dalal, aparna r. “philosophy of organ donation: review of ethical facets.” world journal of transplantation vol. 5,2 (2015): 4451. doi:10.5500/wjt.v5.i2.44 7 ethics of deceased organ donor recovery without requirement for explicit consent or authorization, hhs white paper (december 2016) https://optn.transplant.hrsa.gov/resources/ethics/ethics-of-deceased-organ-donor-recovery/ 8 gill, michael b. “presumed consent, autonomy, and organ donation.” the journal of medicine and philosophy vol. 29,1 (2004): 37-59. doi:10.1076/jmep.29.1.37.30412 9 saunders ben. “opt-out organ donation without presumptions.” journal of medical ethics 2012;38:69-72. 10 saunders, ben. “normative consent and opt-out organ donation.” journal of medical ethics vol. 36,2 (2010): 84-7. doi:10.1136/jme.2009.033423 11 dalal, aparna r. “philosophy of organ donation: review of ethical facets.” world journal of transplantation vol. 5,2 (2015): 4451. doi:10.5500/wjt.v5.i2.44 see also glazier a, mone t. success of opt-in organ donation policy in the united states. jama. 2019;322(8):719–720. doi:10.1001/jama.2019.9187 (nine states have considered amending uniform anatomical gift act (uaga) to an opt-out system. uaga is based on gifting rather than consent.) 12 https://www.donatelifecolorado.org/blog/presumed-consent-or-opt-out-what-does-it-mean/ 13 https://www.donatelifecolorado.org/blog/presumed-consent-or-opt-out-what-does-it-mean/ 14 in new york, in 2010 a motor donor bill that would provide the ability to opt-out on the driver’s license application failed to pass. under that approach, applicants who do not decline would be automatically registered. nys assembly bill 9865, february 4, 2010. in 2017, an executive order compelled state agencies to provide opportunities to register donors, modernized the donor registry, added organ donation registry to the insurance marketplaces, and allowed 16and 17-year-olds to register at the time of applying for driver’s licenses. so far, all opportunities to register reflect explicit consent and are not opt-out. https://www.governor.ny.gov/sites/governor.ny.gov/files/atoms/files/eo_171.pdf 15 “'opt out' policies increase organ donation,” stanford university, sparq. https://sparq.stanford.edu/solutions/opt-outpolicies-increase-organ-donation citing davidai, s., gilovich, t., & ross, l. (2012). the meaning of default options for potential organ donors. proceedings of the national academy of sciences, 15201-15205 http://dx.doi.org/10.2471/blt.14.139535 https://www.statista.com/statistics/624834/state-designated-organ-donors-among-us-adults-by-state/ https://sparq.stanford.edu/solutions/opt-out-policies-increase-organ-donation https://stanford.box.com/s/yohfziywajw3nmwxo7d3ammndihibe7g https://optn.transplant.hrsa.gov/resources/ethics/ethics-of-deceased-organ-donor-recovery/ https://optn.transplant.hrsa.gov/resources/ethics/ethics-of-deceased-organ-donor-recovery/ https://sparq.stanford.edu/solutions/opt-out-policies-increase-organ-donation https://sparq.stanford.edu/solutions/opt-out-policies-increase-organ-donation https://stanford.box.com/s/yohfziywajw3nmwxo7d3ammndihibe7g https://stanford.box.com/s/yohfziywajw3nmwxo7d3ammndihibe7g zimmerman, through the lens of necessity: post-death organ donation, voices in bioethics, vol. 7 (2021) 7 16 dalal, aparna r. “philosophy of organ donation: review of ethical facets.” world journal of transplantation vol. 5,2 (2015): 4451. doi:10.5500/wjt.v5.i2.44 17 james, scott m. “good samaritans, good humanitarians.” journal of applied philosophy, vol. 24, no. 3, 2007, pp. 238– 254. jstor, www.jstor.org/stable/24355041. accessed 23 jan. 2021. 18 theoretically, there is a limited exception that could allow the murder of one or two to save many, e.g., a civilian killing a mass shooter although that is more likely analyzed as an extension of self-defense. 19 toledano, enbar. "necessity." the encyclopedia of criminology and criminal justice, jay s. albanese, wiley, 1st edition, 2014. http://ezproxy.cul.columbia.edu/login?qurl=https%3a%2f%2fsearch.credoreference.com%2fcontent%2fentry%2fwileycacj%2f necessity%2f0%3finstitutionid%3d1878. accessed 22 jan. 2021. 20 u.s. v. bailey, 444 u.s. 394 (1980) (held prison escapees may not use the defense of necessity having escaped poor conditions and failed to surrender thereafter.) see 409-415 for when necessity may justify the prison escape and the requirement to surrender oneself when the danger is rectified. 21 toledano, enbar. "necessity." the encyclopedia of criminology and criminal justice, jay s. albanese, wiley, 1st edition, 2014. 22 id. 23 109,000 people in the us are currently waiting for transplants. https://www.organdonor.gov/statistics-stories/statistics.html 24 glazier a, mone t., success of opt-in organ donation policy in the united states. jama. 2019;322(8):719–720. doi:10.1001/jama.2019.9187 neyra, limited access to research involving incarcerated persons, voices in bioethics, vol. 7 (2021) * oskar neyra, ms candidate columbia university © 2021 oskar neyra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. limited access to research involving incarcerated persons as a result of protectionism oskar neyra* abstract overall, failure to include incarcerated people in ethically conducted research should not be the standard, as many health-related risks in this population are still unexplored. fostering participation of incarcerated individuals in ethically conducted research could provide generalizable knowledge to manage chronic disease, mental health, and substance abuse disorders in this unique and high-risk patient population. moving forward, improvements are required to facilitate the inclusion of incarcerated people in research. keywords: incarcerated individuals, vulnerable individuals, research, overprotective policy, prisoners introduction exploitative research practices have negatively impacted, and even victimized, vulnerable populations. while research ethics frameworks acknowledge that there are “disadvantaged sub-segment[s] of the community, requiring utmost care, specific ancillary considerations, and augmented protections in research,”1 increased protection has limited the ability of incarcerated individuals to participate in research autonomously and consensually. protecting vulnerable incarcerated people in this case limits their opportunity compared to other, better-situated populations. background the known benefits of research participation for incarcerated individuals are early access to a drug during the trial, a chance to continue the drug even if supply is limited (first in line), and financial compensation. there are also benefits to incarcerated populations as a whole because much research is not easily generalizable to them. incarcerated people should have access to groundbreaking scientific discoveries and be able to contribute to improving the lives of other incarcerated people. yet, some argue that because not all scientific research has a positive outcome, research participation places incarcerated people, who are already at risk, at unjustifiably high risk. in other words, they argue that principles of non-exploitation dictate we err on the side of non-inclusion. neyra, limited access to research involving incarcerated persons, voices in bioethics, vol. 7 (2021) 2 rigorous research protections in the united states originated after world war ii, during which nazi attorneys likened unethical experiments on jewish people and others to practices common in u.s. correctional facilities.2 with increased public awareness of research abuses in the wake of the infamous tuskegee syphilis study, congress appointed a national commission to create guidelines for research involving vulnerable populations, including the incarcerated. 3 constituted under the department of health, education, and welfare (dhew), the commission produced report and recommendations: research involving prisoners (hereinafter the “dhew report”).4 the report recommended that incarcerated people “receive a fair share of the benefits of research,” and encouraged such research to be aimed toward improving “prisoners’ health and/or investigate the causes and effects of incarceration.”5 these regulations were incorporated into the 1979 belmont report and later into the “common rule.”6 however, many groups representing vulnerable or minority populations, such as women’s rights advocacy and aids support groups, requested revisions of the dhew report to ensure that a “fair share of the benefits of research” was realized for minority populations, whose interests had not been originally considered.7 this awareness campaign eventually led the national institutes of health (nih) to loosen restrictions on vulnerable groups’ participation in research of more than minimal risk. participation became acceptable provided that the improvement of the health of participants or the group was a priority.8 currently, research involving incarcerated people must be defined within one of the following four categories: (1) minimal-risk studies on possible causes, effects, and processes of incarceration and criminal behavior; (2) minimal-risk studies of prisons as institutional structures or of prisoners as incarcerated persons; (3) research on conditions particularly affecting prisoners as a class; (4) research on practices that are intended and deemed likely to improve the health or well-being of participants.9 a recondite fifth category – by means of a hhs secretarial waiver – grants approval to certain department of health and human services (hhs) studies solely intended to “(1) describe the prevalence or incidence of a disease by identifying all cases, and (2) study potential risk factors associations for a disease.”10 other requirements include limiting risk levels to those comparable for non-incarcerated populations, offering only non-coercive compensation, and the inclusion of a prisoner-representative in the irb committee.11 analysis i. justice and the opportunity to participate these safeguards are vital for ensuring incarcerated peoples’ protection from exploitation and harm. 12 however, when combined with certain state and local measures, they burden the population they are meant to serve by eliminating or severely limiting research opportunities.13 from 2008 to 2012, no nih funding was granted to research in california prisons, while rhode island doc (with about only 1 percent of california’s incarcerated population) reported 13 nih grants totaling $16 million in the same time period.14 californiabased correctional research is restricted by state law that broadly defines and prohibits “biomedical research” on incarcerated people.15 meanwhile, rhode island has no such state laws.16 the u.s. incarcerated population includes a disproportionate number of ethnic and racial minorities, people with mental illnesses, and people with serious infectious diseases like hiv.17 barring them from participating in research is discriminatory because they suffer disproportionately from a lack of understanding of their neyra, limited access to research involving incarcerated persons, voices in bioethics, vol. 7 (2021) 3 conditions. other studies may also not easily be generalizable to incarcerated people, who are in a unique environment. treatment effectiveness in the incarcerated population for many conditions is unknown and thought to be highly variable.18 to respect incarcerated peoples’ dignity and “right to science” (more below), a reasonable balance between valuing their autonomy and protecting them from exploitative practices must be found. 19 over time, a pattern of overprotection has grown, creating a tension between subject protection and scientific progress.20 ii. autonomy and protection from coercion the initial concern about including incarcerated people in research was that prisons are “inherently coercive environments.” coercion in this context could be exacerbated by financial *chart from: lerner bh. subjects or objects? prisoners and human experimentation. n engl j med. 2007 may 3;356(18):1806-7. doi: 10.1056/nejmp068280. pmid: 17476006. retrieved from https://www-nejmorg.ezproxy.cul.columbia.edu/doi/full/10.1056/nejmp068280 compensation, the prospect of earlier parole, and even the chance to alleviate boredom. 21 but the incarcerated actively seek participation in research, and this should be recognized. research outside of prisons is not coercion-free, and within prisons with proper precautions, incarcerated people are able to make autonomous decisions. “as respect for prisoners also requires recognition of their autonomy,” 22 incarcerated people should have many of the same opportunities that others have. it is important to consider incarcerated peoples’ perspectives. one study suggested that incarcerated people may not fear involvement in research as much as lawmakers think (only 7.3 percent distrust research or researchers).23 instead, it is family members, correctional officers, and nurses who often discourage incarcerated people from joining a study because their participation may create more work for them.24 another study found that “few prisoners endorsed feeling exploited by their participation [in research],” and many would like “to participate as a means of gaining access to a treatment that was not readily available to them.”25 other people do not accurately represent incarcerated people’s wishes, and their speculation should not be a basis for regulations restricting research participation. iii. international human rights and a right to science https://www-nejm-org.ezproxy.cul.columbia.edu/doi/full/10.1056/nejmp068280 https://www-nejm-org.ezproxy.cul.columbia.edu/doi/full/10.1056/nejmp068280 neyra, limited access to research involving incarcerated persons, voices in bioethics, vol. 7 (2021) 4 the right to science is recognized as a human right in international law. 26 overprotective research participation policies create novel injustices by blocking access to groundbreaking scientific advances that benefit incarcerated groups.27 both the universal declaration of human rights (udhr) and the international covenant on economic, social, and cultural rights (icescr) indicate that every person has the right “to share in scientific advancement and its benefits” and “to enjoy the benefits of scientific progress and its application.”28 according to van westendorp, et al., the right to science, which “must be respected and protected,” consists of four parts: (1) access by everyone without discrimination to the benefits of science and its applications, including scientific knowledge; (2) opportunities for all to contribute to the scientific enterprise and freedom necessary to facilitate scientific research; (3) participation of individuals and communities in decision-making and the related right to information; (4) and an enabling environment fostering the conservation, development, and diffusion of science and technology.29 despite the existence of international guidelines, the right to science has not been systematically applied at a state level.30 overprotective restrictions are unjust, as incarcerated people in some cases are denied the opportunity to reap the benefit of early access to important therapies. failing to facilitate their inclusion in research limits scientific progress and restricts benefits with respect to the incarcerated population as a whole.31 as an example, consider the state of mental healthcare for the incarcerated. a 2012 systematic review identified a high incidence of psychiatric disorders in incarcerated people, especially major depression and psychiatric illnesses, which are related to substance abuse and higher mortality rates.32 the lack of mental health studies on the incarcerated population prevents knowledge of this special population from reaching physicians in the community where formerly incarcerated people will eventually seek care. it also limits how effectively they are treated when in prison. iv. how to improve the system moving forward, improvements are required to facilitate the inclusion of incarcerated people in research. one step is to build buy-in from key prison officials. for example, researchers could involve the prison’s chief medical officer and collaborate with prison administrators, potentially listing them as co-investigators on their research studies. 33 other recommendations include the establishment of an advisory council consisting of prison leaders and an inmate liaison committee (ilc) in charge of communicating feedback and updates to inmates. 34 also, designating a “point person” can help the research team navigate the penitentiary system’s intricacies. 35 these considerations open various communication pathways for incarcerated people. in fact, the appointment of key personnel in charge of working closely with incarcerated people to amplify their voices may be the first necessary step, and it could provide the impetus for yet more change. for recruitment, it is useful to publish articles in prison newsletters, plan co-authorship with prison staff, use visuals to explain the study, and implement certificates of confidentiality. 36 it is also important to be transparent, not engage in aggressive marketing of the opportunity, and avoid coercion. neyra, limited access to research involving incarcerated persons, voices in bioethics, vol. 7 (2021) 5 conclusion overall, failure to include incarcerated people in ethically conducted research should not be the standard, as many health-related risks in this population are still unexplored.37 compared to the non-incarcerated population, accessible enrollment of incarcerated people in research studies is not currently being facilitated. they lack access to the internet, cannot look up research opportunities independently due to the inherent nature of their incarceration, and have restricted telephone privileges, etc. under normal circumstances, the excessive advertising of research opportunities would be considered coercive. however, in a prison setting, implementation of these recruitment strategies may be the only way to inform this vulnerable population about the available research opportunities outside of prison. state legislatures should relax protective regulations when they interfere with autonomy and a right to science. indeed, there is a delicate line that must be clearly defined to avoid undue coercion, but it is the state leaders’ responsibility to do so to ensure extension of the benefits of science and technology to all parts of the population. fostering participation of incarcerated individuals in ethically conducted research could provide generalizable knowledge to manage chronic disease, mental health, and substance abuse disorders in this unique and high-risk patient population. 1 shivayogi p. (2013). vulnerable population and methods for their safeguard. perspectives in clinical research, 4(1), 53–57. https://doi.org/10.4103/2229-3485.106389 2 ahalt, c., haney, c., kinner, s., & williams, b. (2018). balancing the rights to protection and participation: a call for expanded access to ethically conducted correctional health research. journal of general internal medicine, 33(5), 764–768. https://doi.org/10.1007/s11606-018-4318-9 3 ahalt, et al. 4 ahalt, et al. 5 ahalt, et al. 6 ahalt, et al. 7 ahalt, et al. 8 christopher, paul p., garcia‐sampson, lorena g., stein, michael, johnson, jennifer, rich, josiah and lidz, charles, “enrolling in clinical research while incarcerated: what influences participants’ decisions?” hastings center report 47, no. 2 (2017): 21– 29. doi: 10.1002/hast.686. retrieved from https://onlinelibrary-wiley-com.ezproxy.cul.columbia.edu/doi/full/10.1002/hast.686 9 christopher, et al. 10 “prisoner research faqs.” hhs.gov, www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html 11 christopher, et al. 12 ahalt, et al. 13 ahalt, c., haney, c., kinner, s., & williams, b. (2018). balancing the rights to protection and participation: a call for expanded access to ethically conducted correctional health research. journal of general internal medicine, 33(5), 764–768. https://doi.org/10.1007/s11606-018-4318-9 14 ahalt, et al. 15 ahalt, et al. 16 ahalt, et al. 17 lerner bh. subjects or objects? prisoners and human experimentation. n engl j med. 2007 may 3;356(18):1806-7. doi: 10.1056/nejmp068280. pmid: 17476006. retrieved from https://www-nejmorg.ezproxy.cul.columbia.edu/doi/full/10.1056/nejmp068280 18 mathijs van westendorp, steven lierman, walking the line: balancing access to research and protecting prisoners, medical law review, volume 28, issue 1, winter 2020, pages 65–92, https://doi-org.ezproxy.cul.columbia.edu/10.1093/medlaw/fwy041 19 van westendorp, et al. 20 gostin, l. o., vanchieri, c., pope, a., & research, i. of m. (us) c. on e. c. for r. to d. r. for p. of p. i. in. (2007). the ethical framework for research involving prisoners. in www.ncbi.nlm.nih.gov. retrieved from https://www.ncbi.nlm.nih.gov/books/nbk19885/ neyra, limited access to research involving incarcerated persons, voices in bioethics, vol. 7 (2021) 6 21 lerner bh. subjects or objects? prisoners and human experimentation. n engl j med. 2007 may 3;356(18):1806-7. doi: 10.1056/nejmp068280. pmid: 17476006. retrieved from https://www-nejmorg.ezproxy.cul.columbia.edu/doi/full/10.1056/nejmp068280 22 lerner. 23 christopher, et al. 24 christopher, et al. 25 christopher, et al. 26 van westendorp, et al. 27 lerner. 28 van westendorp, steven lierman, walking the line: balancing access to research and protecting prisoners, medical law review, volume 28, issue 1, winter 2020, pages 65–92, https://doi-org.ezproxy.cul.columbia.edu/10.1093/medlaw/fwy041 (the charter of fundamental rights of the european union (eu charter) takes it a step further by stating that “scientific research shall be free of constraints.”) 29van westendorp, et al. 30 van westendorp, et al. 31 van westendorp, et al. 32 fazel, s., hayes, a. j., bartellas, k., clerici, m., & trestman, r. (2016). mental health of prisoners: prevalence, adverse outcomes, and interventions. the lancet. psychiatry, 3(9), 871–881. https://doi.org/10.1016/s2215-0366(16)30142-0 33 apa, z. l., bai, r., mukherejee, d. v., herzig, c. t., koenigsmann, c., lowy, f. d., & larson, e. l. (2012). challenges and strategies for research in prisons. public health nursing (boston, mass.), 29(5), 467–472. https://doi.org/10.1111/j.1525-1446.2012.01027.x 34 apa, et al. 35 apa, et al. 36 apa, et al. 37 ahalt, et al. https://doi-org.ezproxy.cul.columbia.edu/10.1093/medlaw/fwy041 yu, modernizing and expanding universal eye care coverage after vision 2020, voices in bioethics, vol. 6 (2020) * megan yu, md candidate, uq-ochsner © 2020 megan yu. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. modernizing and expanding universal eye care coverage after vision 2020: a call for a new approach to global, equitable access megan yu* abstract preventable ocular impairment impacts quality of life immensely. contributing factors include a lack of resources and professionals, stigma surrounding eyeglasses, the availability of local treatments that generate poor results, and affordability. this paper argues that vision 2020 did not meet the eye care needs of the global population. more should be done to ensure eye examinations and glasses are made available. keywords: eye care, vison health, access to care, scarcity, ophthalmology, distributive justice introduction on february 18, 1999, the world health organization launched vision 2020 to eliminate preventable, treatable blindness by 2020.1 today, low-income nations continue to lack access to prevention-based eye care.2 the leading causes of vision impairment in 2015 were cataracts and uncorrected refractive errors, particularly in low-income nations. currently, 123.7 million people have uncorrected refractive errors and 57.1 million people have cataracts. 3 826 million people have uncorrected farsightedness (presbyopia), most prevalent in rural areas among low-income countries.4 these findings suggest there may be global disparities in access to eye care resources. preventable ocular impairment impacts quality of life immensely. for instance, people living with uncorrected refractive errors can have difficulty cooking, recognizing faces, and showering.5 cataracts can cause driving difficulties and increase risk of injuries.6 access to eye care is vital to performing activities of daily living. this paper discusses the factors that contribute to the immense burden of vision impairment among low-income yu, modernizing and expanding universal eye care coverage after vision 2020, voices in bioethics, vol. 6 (2020) 2 nations, the impact preventable vision impairment has on societies, and some ethical issues and recommendations that should be considered when expanding eye care coverage. analysis i. contributing factors to the vision impairment burden among low-income nations resource availability a lack of trained ophthalmic professionals and equipment remains one of the greatest barriers to reducing the global prevalence of avoidable ocular impairment, especially in low-income nations. 7 despite an overall increase in total ophthalmologists and optometrists, very few eye healthcare workers are available in rural settings.8 over 10 percent of the world’s blind population (4.8 million blind individuals) live in africa, where there are not enough ophthalmologists to care for them. 9 even if there were enough ophthalmologists worldwide, there are shortages in optometrists and other allied ophthalmic personnel critical to providing comprehensive eye services. 10 approximately one ophthalmologist is available to address the needs of 446,000 individuals in sub-saharan africa. 11 there are drastic differences in the distribution of eye professionals among anglophone, francophone, and lusophone africa, with the greatest number of professionals available in anglophone africa.12 many lowand middle-income nations do not have sufficient ophthalmic equipment or infrastructure. of about 120 healthcare settings in africa, only 38 percent had an ascan, a device essential for cataract surgery.13 the majority of eye services in low-income nations are offered in secondary or tertiary hospitals, which are primarily located in urban areas, fueling the inequity in rural access to healthcare resources.14 gender and resource accessibility many demographic factors affect accessibility to eye resources. in some low-income nations, women have lower cataract surgical coverage and poorer visual outcomes than men. 15 many factors such as “limited financial decision-making power” for women and a lower likelihood for them to travel beyond their community contribute to the gender inequity.16 increasing socioeconomic disadvantage, poor health literacy, and lack of knowledge on healthcare resource availability also prevent individuals from accessing eye resources.17 local remedies the presence of local remedies and unlicensed health providers, such as illicit drug sellers or spiritual healers, may divert individuals from ophthalmologists and cause delays in eye treatment. 18 couching, which is an ancient treatment for cataracts, is still widely practiced in nigeria.19 it involves moving the cataractous lens from the visual axis into the vitreous cavity either surgically or through non-invasive methods, such as “repeated blunt trauma” to the eye or applying a plant extract topically.20 individuals living in rural regions are more likely to be couched rather than visit an ophthalmologist, and only 9.7 percent of those who were couched had a good outcome.21 affordability individuals with lower socioeconomic status are less likely to seek eye resources. they cannot afford to forego earnings for their basic living needs, which can explain nonattendance at eye care appointments.22 costs yu, modernizing and expanding universal eye care coverage after vision 2020, voices in bioethics, vol. 6 (2020) 3 involved in receiving eye care, transportation to appointments, and pharmaceutical interventions are common barriers to accessing eye resources. 50 percent of people in low-income nations live more than one hour from a city, making travel difficult for appointments.23 additionally, many adults do not have health insurance, which affects their ability to afford eye services. in trinidad and tobago, “private sector ophthalmologists provide 80 percent of all eye care services but less than 20 percent of the adult population has health insurance.”24 acceptability in some societies, eyewear is not accepted and wearing glasses is seen as a disability.25 indigenous populations are more likely to access eye services if they are culturally appropriate and integrated into their communitybased health service.26 ii. impact of uncorrected vision impairment on societies uncorrected vision impairment has tremendous impact on societies. apart from poor health, it causes increased social isolation, decreased employment, diminished educational opportunities, and increased morbidity.27 uncorrected refractive errors could result in a global productivity loss of us $202 billion annually; it would take us $28 billion to resolve this issue.28 up to 94 percent of individuals living with farsightedness in low-income nations remain uncorrected or under-corrected.29 these findings highlight the need to propose radical solutions to achieve access to affordable corrective measures like eyeglasses and contact lenses. iii. the ethical imperative in eye care basic vision correction is life altering. those in rural poverty in low-income countries should have access to glasses as a minimum standard of justice. glasses could change someone’s ability to become educated, achieve job success, and reach a better standard of living. in wealthy countries like the us that do not have universal healthcare coverage, access to glasses is a priority even for the poorest people. an individual’s ability to autonomously achieve their own goals rests on the ability to correct simple vision problems. a lack of eyeglasses threatens autonomy and may require dependence on others for driving and reading. uncorrected vision also limits job opportunities requiring manual tasks like farming, operating cash registers, managing small shops or businesses, and using computers and phones. for many women, eyeglasses are necessary for weaving, knitting, and sewing to incur income. living without glasses could also lead to a progressive deterioration in mental health and an inability to engage in social and community activities. ophthalmologists, optometrists, and other eye health professionals have a professional obligation to serve the needs of their patients and engage in activities that promote public awareness of eye health issues. however, all doctors are not obligated to care for those in poverty in developing countries. justice and autonomy should compel governments, with the help of global nonprofits and health organizations to act in the best interests of their communities, to avoid preventable morbidity, and to level the playing field, and allow each person equal opportunities. they should also support transparent, equitable allocation of eye care resources, and use more effective strategies than those implemented in the vision 2020 initiative. governments concerned with directing resources to communities equitably should consider eyecare necessary, distribute it fairly, and serve the marginalized. to meet the needs of the community and fully incorporate eye care in national health strategic plans, governments of low-income nations should allow their citizens to participate in determining what eye health yu, modernizing and expanding universal eye care coverage after vision 2020, voices in bioethics, vol. 6 (2020) 4 goals should be achieved. respecting the community’s autonomy to engage in discussions would ensure vulnerable populations can voice their concerns regarding their access to eye care resources. distributive justice should supersede cost-benefit analysis to ensure certain interventions or subpopulations are not neglected. while scarcity leads to allocation plans that prioritize certain interventions, distributive justice is achievable. to avoid prejudice against the elderly who tend to have vision problems, eyecare plans should not depend on subjective views of quality of life or remaining years. providers should be able to stretch resources to cover even the most marginalized by using the most economical solutions such as eyeglasses rather than laser surgery to correct vision. iv. moving forward to achieve universal eye care coverage because most eye care delivery in low-income nations is offered at secondary or tertiary hospitals and is restricted to urban settings, providing incentives to rural eye practitioners and training locals to perform eye care is imperative.30 enhanced training of primary health staff, training eye health professionals that are not ophthalmologists, and promotion of regular eye exams and eye safety could be effective.31 countries should implement programs that destigmatize eyeglasses, improve health literacy, and integrate eyecare into primary care. to address scarcity of resources, low-income countries should “shift from out-of-pocket payments toward mandatory prepayments with pooling of funds” and prioritize vulnerable populations.32 the median out-ofpocket spending on health constitutes more than 40 percent of healthcare spending in low-income nations, placing a tremendous financial burden on many families.33 these nations should estimate coverage costs they cannot meet even with pooled funds and appeal to nonprofits, the international community, and the physician community to meet the costs of basic care. alternative financial sources, including “national insurance or performance-based financing” may be helpful.34 overall, health systems research is important to evaluate the global prevalence of preventable visual impairment, since there is dearth of data in this area.35 conclusion visual impairment is still prevalent in low-income nations 21 years after vision 2020 was launched. the global community and individual governments have an ethical responsibility to reduce the tremendous burden preventable visual impairment has on people in low-income nations. new approaches are necessary to provide affordable, equitable eye care coverage. while scarce resources call for difficult choices, by prioritizing those with correctable vision loss regardless of age or income and using the least expensive solutions (like eyeglasses), countries can achieve distributive justice. individuals able to correct their vision problems can act autonomously to access more jobs, activities, and opportunities. while global organizations are needed for research, financing, and application, strategic plans should also involve all stakeholders within the healthcare system so local government agencies, healthcare providers, patients, and communities can come together to create a solution. regulatory frameworks should elevate the standard of living by providing access to vision care that ensures autonomy, beneficence, and justice. yu, modernizing and expanding universal eye care coverage after vision 2020, voices in bioethics, vol. 6 (2020) 5 1 world health organization, “prevention of blindness and visual impairment,” 2020. https://www.who.int/blindness/partnerships/vision2020/en/. 2 healio, “vision 2020 reaches landmark year”, january 2, 2020. https://www.healio.com/news/ophthalmology/20191226/vision2020-reaches-landmark-year. 3 world health organization website. https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment see also flaxman, seth et al., “global causes of blindness and distance vision impairment 1990-2020: a systematic review and metaanalysis,” the lancet: global health 5, no.12 (december 2017): e1221-e1234. https://doi.org/10.1016/s2214-109x(17)30393-5. 4 fricke, timothy et al., “global prevalence of presbyopia and vision impairment from uncorrected presbyopia,” ophthalmology 125, no. 10 (october 2018): 1492-1499. https://doi.org/10.1016/j.ophtha.2018.04.013. 5 kandel, himal et al., “impact of refractive error on quality of life: a qualitative study,” clinical & experimental ophthalmology 45, no. 7 (september/october 2017): 677-688. https://doi.org/10.1111/ceo.12954 6 informedhealth.org, “cataracts: overview”, october 10, 2019. https://www.ncbi.nlm.nih.gov/books/nbk390302/. 7 world health organization, “world report on vision”, 2019. https://www.iapb.org/wp-content/uploads/world-vision-reportaccessible1.pdf. 8 world health organization, 2019, p. 36; world health organization, 2019, p. 37 9 gilbert, suzanne et al., “recruiting and distributing eye health workers,” community eye health, 31, no. 102 (2018): 45-47; world health organization, global data on health impairments, 2010. https://www.who.int/blindness/globaldatafinalforweb.pdf 10 world health organization, 2019, p. 37 11 graham, ronnie, “facing the crisis in human resources for eye health in sub-saharan africa,” community eye health, 30, no. 100 (2017): 85-87. 12 graham, p. 87 13 patel, daksha et al., “ophthalmic equipment survey 2010: preliminary results,” community eye health 23, no. 73 (september 2010): 22-25. 14 world health organization, 2019, p. 37 15 ramke, jacqueline et al., “effective cataract surgical coverage: an indicator for measuring quality-of-care in the context of universal health coverage,” plos one (march 1, 2017): e0172342. https://doi.org/10.1371/journal.pone.0172342; lewallen, s et al., “cataract surgical coverage remains lower in women,” british journal of ophthalmology 93, no.3 (december 17, 2008): 295298. http://dx.doi.org/10.1136/bjo.2008.140301 16 world health organization, 2019, p. 38 17 ramke, p. e0172342; world health organization, 2019, p. 38 18 world health organization, 2019, p. 38 19 gilbert, clare et al., “couching in nigeria: prevalence, risk factors and visual acuity outcomes,” ophthalmic epidemiology 17, no. 5 (october 2010): 269-275. https://doi: 10.3109/09286586.2010.508349. 20 gilbert, p. 270 21 gilbert, p. 269 22 world health organization, 2019, p. 38 23 weiss, d et al., “a global map of travel time to cities to assess inequalities in accessibility in 2015,” nature 553 (january 10, 2018): 333-336. 24 braithwaite, tasanee et al., “health system dynamics analysis of eyecare services in trinidad and tobago and progress towards vision 2020 goals,” health policy and planning 33, no. 1 (january 1, 2018): 70-84. 25 world health organization, 2019, p. 39; adeoti, c, “beliefs and attitude towards spectacles,” nigerian journal of clinical practice 12, no. 4 (december 2009): 359-361; castanon holguin, aaron et al., “factors associated with spectacle-wear compliance in school-aged mexican children,” invest ophthalmol vis sci 47, no. 3 (march 2006): 925-928. 26 turner, angus et al., “eye health service access and utilization in the national indigenous eye health survey,” clinical & experimental ophthalmology 39, no.7 (september/october 2011): 598-603. 27 honavar, santosh, “the burden of uncorrected refractive error,” indian journal of ophthalmology 67, no. 5 (may 2019): 577578. 28 fricke, tr et al., “global cost of correcting vision impairment from uncorrected refractive error,” bulletin of the world health organization 90, no.10 (july 12, 2012): 728-738. 29 frick, kevin et al., “the global burden of potential productivity loss from uncorrected presbyopia,” ophthalmology 122, no. 8 (august, 1, 2015): 1706-1710. 30 world health organization, 2019, p. 37 https://www.who.int/blindness/partnerships/vision2020/en/ https://www.healio.com/news/ophthalmology/20191226/vision-2020-reaches-landmark-year https://www.healio.com/news/ophthalmology/20191226/vision-2020-reaches-landmark-year https://doi.org/10.1016/s2214-109x(17)30393-5 https://doi.org/10.1016/j.ophtha.2018.04.013 https://doi.org/10.1111/ceo.12954 http://informedhealth.org/ https://www.ncbi.nlm.nih.gov/books/nbk390302/ https://www.iapb.org/wp-content/uploads/world-vision-report-accessible1.pdf https://www.iapb.org/wp-content/uploads/world-vision-report-accessible1.pdf https://doi.org/10.1371/journal.pone.0172342 http://dx.doi.org/10.1136/bjo.2008.140301 yu, modernizing and expanding universal eye care coverage after vision 2020, voices in bioethics, vol. 6 (2020) 6 31 world health organization, 2019, p. 123; world health organization, 2019, p. 51 32 world health organization, 2019, p. 110 33 world health organization, “public spending on health: a closer look at global trends,” 2018, https://apps.who.int/iris/bitstream/handle/10665/276728/who-his-hgf-hf-workingpaper-18.3-eng.pdf?ua=1. 34 blanchet, p. 1326-1327 35 world health organization, 2019, p. 84; world health organization, “universal eye health: a global action plan 2014-2019,” 2013, https://www.who.int/blindness/ap2014_19_english.pdf?ua=1. https://apps.who.int/iris/bitstream/handle/10665/276728/who-his-hgf-hf-workingpaper-18.3-eng.p https://www.who.int/blindness/ap2014_19_english.pdf?ua=1 bhatt, why non-clinicians should not be doing clinical ethics, voices in bioethics, vol. 8 (2022) * rohin bhatt, ms bioethics candidate, harvard medical school © 2022 rohin bhatt. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. why non-clinicians should not be doing clinical ethics rohin bhatt* “an expert is someone who knows some of the worst mistakes that can be made in his subject, and how to avoid them.” ― werner heisenberg keywords: bioethicists, clinical ethics, ethics consults, authoritarian, expert, moral philosophy introduction bioethicists have long debated the question of expertise in clinical ethics and who gets a say in bedside clinical ethics consults.1 from seattle’s famous god committee that decided on the allocation of kidneys, to clinical ethicists at a suburban hospital in ohio, clinical ethics ‘experts’ have been central to bioethics and its development.2 however, it is time to question what expertise in clinical ethics means, and if there can ever be such an expert. does expertise mean proficiency in clinical care or the ethics part of clinical ethics? should professionals who are not healthcare practitioners be involved in clinical ethics discussions? in this paper, i argue that clinical ethics consults involving non-clinicians should be done away with for two reasons: first, they lack clinical medical experience to properly analyze the ethical issues, and second, moral expertise should give way to medical expertise. although clinical ethics consultants might venture into areas of clinical expertise with a bona fide intention of helping patients or surrogates, their judgment is often based on knowledge of ethical theories. 3 however, bioethicists have cautioned against a casuistic method and signalled for clinical ethicists to have clinical experience and medical education.4 while it is perfectly possible to familiarize oneself with the law and ethics, i argue that it is not possible to appreciate the complexity of certain medical decisions entirely without medical experience.5 bedside ethical conundrums are unique and impact every patient differently. thus, when an ethics consultant or a healthcare practitioner draws on a single bedside dilemma, and applies the knowledge gained from it to a different patient or a different dilemma, they may find themselves creating bad rules and ignoring autonomy. as non-clinicians who sit on ethics committees have no bedside clinical experience, their magnitude of transformative experiences (experiences that give the subject knowledge that would otherwise be otherwise unavailable)6 is limited. the clinicians develop such bhatt, why non-clinicians should not be doing clinical ethics, voices in bioethics, vol. 8 (2022) 2 experiences over time giving care. the ethics committee members do not have a similar way to gain experience. this also speaks to the importance of a phenomenological reading of clinical ethics decisions. specifically, clinical ethics consultants without sufficient medical expertise may fail to guide patients in the best way possible in making medical decisions. a confined and parochial, or purely philosophical, approach that non-clinicians often use might not be in the best interests of the particular patient. if they were to venture into clinical situations to comment on the ethical aspect, they could step into matters they know little about which might end up causing harm to the patient. we, as bioethicists, would be doing a disservice to patients if we let non-clinicians claim the moral high ground in the face of medical advice. as scofield puts it, “(clinical) ethics consultation is and can only be what it purports not to be—a moral, if not an ethics, disaster. it has acted unprofessionally because … of its failure to do what a profession worthy of the name would do.”7 i. medical expertise may be more appropriate than moral expertise an idea that a clinical ethics consult should be conducted by clinicians themselves comports with the makeup of clinical ethics committees. they are usually comprised primarily of medical professionals, but increasingly hospitals are attracting more ethics professionals who are not healthcare practitioners. as hauschildt and de vires note, “a closer examination suggests that clinical ethicists are likely to be clinicians themselves and that clinical considerations are often the ultimate authority in defining what is, and is not, determined to be ethical.”8 in cases that are reported to ethics consults, 63 percent show a disagreement between the patient and the doctor about the course of treatments.9 those disagreements speak to ethical issues. for example, if a doctor recommends palliative care and patient wants to pursue an aggressive course of treatment, the ethical dilemma is built into the clinical care decision. while we would like to think that ethicists on hospital ethics committees deliberate on philosophical nuances of treatment (or the lack thereof), i argue that clinical ethics consults focus on resolving clinical ambiguities and reaching consensus, which ultimately relies on clinical judgment. an ethics consultant may not be able to appreciate the medical nuances of the situation. studies conducted have clearly demonstrated that most ethics consults are called in when there is a lack of communication.10 what would serve the patients, in this case, is perhaps investing the money that is spent in training and employing non-clinician consultants into teaching doctors and nurses how to communicate better. ii. authoritarian ethics consults as with healthcare workers delving into ethics advice, in clinical ethics consults, there is a risk that the consultant might adopt an “authoritarian approach” 11 and impose his or her values, priorities, and/or religious convictions on the patients and their families. it is inevitable that in the work of bioethics, the personal meets the professional. even if they do not mean to impose their values on the patients, there is strong empirical data to suggest that in most clinical ethics consults, patients end up following recommendations of the ethics committees. for example, in a study conducted of 229 clinical ethics consults, approximately 88 percent of the recommendations were followed. certain types of consults such as initiating a palliative care treatment or proceeding with life-sustaining intervention had a 100 percent compliance rate with the ethics committee’s advice. 12 additionally, studies have shown that clinicians frame consults in a way that nudges the patients in making decisions that maximize their welfare and is seen as an acceptable form of paternalism.13 yet, patients likely do not appreciate paternalistic nudges. in the studies, most questions were about futility or the withdrawal of life-sustaining treatment. arguably, these questions require clinical expertise and not ethical expertise. a clinician or a nurse may be better suited to help guide the patient’s family because they would be able to comprehend and explain the bhatt, why non-clinicians should not be doing clinical ethics, voices in bioethics, vol. 8 (2022) 3 complexity of the clinical case to the family better. if the idea of a clinical ethics consult is to further patient autonomy, it is failing. iii. addressing counterarguments two arguments may challenge a proposal as radical as kicking all the ethics consultants who are not also medical professionals or healthcare practitioners out of clinical ethics consults or committees: first, the argument that a broader variety of professionals should have a say in bioethics; and second, that ethics committee members may relate to patients more effectively than some physicians and other healthcare workers do. yet, these claims are not strong rebuttals. as bioethics developed within philosophy, it may have lost sight of the day-to-day ethical issues that arise in the clinic. komesaroff argues that the task of handling clinical ethics consults is only one that clinicians can handle, and there is a need to separate bioethics from clinical ethics. he suggests that the time is ripe for clinical ethics to be considered through the lens of micro-ethics and established as an area of research distinct from bioethics.14 i agree and assert that there is a need to distinguish the broader ethical debate from the work of everyday clinical practice, a work where clinicians are best suited to handle the issues, perhaps a subcategory of bioethics. this will involve the need for redefining the relationship between the macro ethical work of bioethics, and the micro ethical work of everyday medical/clinical ethics which happens at the bedside.15 what is required in a clinical ethics setting, in my opinion, is for the doctor not to frame the issue in terms of bioethical or large philosophical concepts such as autonomy or deontology, but to talk to the patient and more importantly, listen to the patient. a smooth communication structure, if put in place, would help alleviate fear and establish a common ground on which decisions can be reached in clinical settings. that is, i see clinical ethics as also not necessary to the doctor-patient relationship but argue that better communication would help patients make important decisions. the ethics ultimately would belong to the patient, with the clinician providing necessary data that will help guide patient decision making and do no more. the second issue is relatability. clinicians are often constrained by their vocabulary and medical expertise and may not be able to break down the complex pathology of a disease to the patients. thus, some may argue that non-clinicians, not held back by the jargon, would be able to relate to the patient. as i proposed earlier, the money spent hiring and training clinical ethics consultants could be redirected to teaching doctors how to be more effective communicators. that would perhaps further patient autonomy. nurses may also make effective interlocutors between patients and doctors in cases where the doctor cannot get through to the patient. nurses are often involved more in the day-to-day dealing with the patient and thus know the patient and their families closely. secondly, they possess the requisite medical knowledge to help the patients through decision-making processes. yet the current shortage of nurses also poses issues in this realm. some doctors and nurses make a point to get to know the patients, their beliefs, and their goals of care and could thus be better at helping patients arrive at decisions by using open jargon-free communication. conclusion much of this paper stems from my experiences as a master of bioethics candidate at harvard medical school. as a non-clinician who studied clinical ethics for a semester, under excellent guidance, i often found myself turning to friends who had clinical experience with questions about the medical aspects of case discussions. more often than not, the clinical insight that they gave me helped me better understand the choices that were before me as a purported expert in simulations. i have been plagued with the question bhatt, why non-clinicians should not be doing clinical ethics, voices in bioethics, vol. 8 (2022) 4 would i be qualified to consult in clinical ethics, after a master of bioethics degree at harvard medical school? my answer would be an unequivocal no. while i expect to be highly qualified to weigh in at the policy level and i have been provided the skillset necessary for in-depth philosophical analysis of complex bioethical issues, i have not become, and i suggest others are not as well, a moral expert (if there is such a thing). the hubris of a bioethicist should not get in the way of patient care. i do not mean to say through this paper, that non-clinicians are to be brushed aside is bioethical discussions. lawyers, ethicists, chaplains, and the diverse set of people that are attracted to the work of bioethics provide an incredibly diverse set of skills, knowledge, and views that the clinicians often miss. they discuss and bring in perspectives from a variety of vantage points which have been instrumental in furthering the debates in bioethics. but as i have argued, they need not populate clinical ethics committees where they are at risk of exerting moral expertise, especially as their ethics position on a case may not be grounded in a deep enough understanding of the medical issues at hand. instead, they should be used in broad policy-making decisions, framing issues, debating in print and digital media, and on irbs. bioethics is “everyone’s business”,16 but clinical ethics should not be. 1 jan crosthwaite, ‘in defence of ethicists. a commentary on christopher cowley’s paper’ (2005) 8 medicine, health care and philosophy 281 <http://link.springer.com/10.1007/s11019-005-0085-6> accessed 11 december 2021, jukka varelius, ‘is ethical expertise possible?’ (2008) 11 medicine, health care and philosophy 127 <http://link.springer.com/10.1007/s11019-007-9089-8> accessed 11 december 2021, christopher cowley, “a new rejection of moral expertise,” medicine, health care and philosophy 8, no. 3 (november 2005): 273–79, https://doi.org/10.1007/s11019-005-1588-x.ana s. iltis and lisa m. rasmussen, “the ‘ethics’ expertise in clinical ethics consultation,” journal of medicine and philosophy 41, no. 4 (august 2016): 363–68, https://doi.org/10.1093/jmp/jhw013. 2 albert r. jonsen, “the god squad and the origins of transplantation ethics and policy,” journal of law, medicine & ethics 35, no. 2 (2007): 238–40, https://doi.org/10.1111/j.1748-720x.2007.00131.x. 3 albert r. jonsen, “casuistry as methodology in clinical ethics,” theoretical medicine 12, no. 4 (december 1991): 295–307, https://doi.org/10.1007/bf00489890. 4 matthew a. butkus, “the necessity of clinical experience in medical ethics expertise,” in moral expertise: new essays from theoretical and clinical bioethics, ed. jamie carlin watson and laura k. guidry-grimes (cham: springer international publishing, 2018), 227–44, https://doi.org/10.1007/978-3-319-92759-6_13. 5 butkus. 6 l. a. paul, “what you can’t expect when you’re expecting,” res philosophica 92, no. 2 (2015): 149–70, https://doi.org/10.11612/resphil.2015.92.2.1.7 giles r. scofield, “what is medical ethics consultation?” journal of law, medicine & ethics 36, no. 1 (2008): 95–118, https://doi.org/10.1111/j.1748-720x.2008.00241.x. 8 katrina hauschildt and raymond de vries, “reinforcing medical authority: clinical ethics consultation and the resolution of conflicts in treatment decisions,” sociology of health & illness 42, no. 2 (february 2020): 307–26, https://doi.org/10.1111/14679566.13003. 9 katrina hauschildt and raymond de vries, ‘reinforcing medical authority: clinical ethics consultation and the resolution of conflicts in treatment decisions’ (2020) 42 sociology of health & illness 307 <https://onlinelibrary.wiley.com/doi/10.1111/14679566.13003> accessed 12 december 2021, g duval, ‘what triggers requests for ethics consultations?’ (2001) 27 journal of medical ethics 24 <https://jme.bmj.com/lookup/doi/10.1136/jme.27.suppl_1.i24> accessed 12 december 2021. bhatt, why non-clinicians should not be doing clinical ethics, voices in bioethics, vol. 8 (2022) 5 10 raymond de vries, “regarding bioethics: a sociology of morality,” perspectives in biology and medicine 60, no. 1 (2017): 74– 92, https://doi.org/10.1353/pbm.2017.0020. 11 h. tristram engelhardt, “core competencies for health care ethics consultants: in search of professional status in a postmodern world,” hec forum: an interdisciplinary journal on hospitals’ ethical and legal issues 23, no. 3 (september 2011): 129– 45, https://doi.org/10.1007/s10730-011-9167-4. 12 jessica richmond moeller et al., “functions and outcomes of a clinical medical ethics committee: a review of 100 consults,” hec forum 24, no. 2 (june 2012): 99–114, https://doi.org/10.1007/s10730-011-9170-9. 13 ajay aggarwal, joanna davies, and richard sullivan, “‘nudge’ in the clinical consultation – an acceptable form of medical paternalism?,” bmc medical ethics 15, no. 1 (december 2014): 31, https://doi.org/10.1186/1472-6939-15-31. 14 paul a. komesaroff, “from bioethics to microethics: ethical debate and clinical medicine,” in troubled bodies, ed. paul a. komesaroff (duke university press, 1995), 62–86, https://doi.org/10.1215/9780822379782-004. 15 robert sokolowski, moral action: a phenomenological study (bloomington: the catholic university of america press, 2017). 16 amy gutmann, everybody wants to go to heaven but nobody wants to die: bioethics and the transformation of health care in america, first edition (new york: liveright publishing corporation, 2019). mehta, catch me if you can, voices in bioethics, vol. 8 (2022) * ravij mehta, ms candidate columbia university © 2022 ravij mehta. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. catch me if you can: india’s approach to covid-19 ravij mehta* keywords: india, covid-19, pandemic response, personal autonomy, beneficence, migrant workers introduction my legs ached as we sat crammed into the back of my family's car, weaving through congestion, hurtling over india’s bumpy asphalt roads. as our driver yelled “masks up,” we begrudgingly dug our fingers into our pockets, trying to pull our masks on prior to driving past yet another “covid-19 checkpoint.” because we were all vaccinated, boosted, and had been tested for covid-19 multiple times in the past week, like most people, we donned masks solely for the purpose of moving through the checkpoints with ease. immediately upon my arrival in india, i was acutely aware of the country’s efforts to curb the spread of covid-19. this observance quickly morphed into astonishment: the rigorous and unrelenting restrictions were, without a doubt, much more universally applied than the ones with which i was familiar in the us. since the start of the pandemic, india has used strict mask policies enforced by regular police checkpoints throughout cities. those who do not abide by the mandate are often pulled over and harshly punished. these punishments notoriously include beatings and heavy fines. 1 additionally, covid-19 “command centers” were set up in states across india to mitigate policy differences. india’s states vary drastically by culture and ethnicity and therefore have different local policies. to an outsider, such as myself, india’s response, although draconian at times, seemed more effective than those i had dealt with in my home country. the united states, which places more value on autonomy than india, had a vastly different approach, mainly influenced by politics. governors and their contingencies continue to hold conflicting views on what encompasses beneficence in the case of covid-19. at times, i was even unable to recall which mandates were in effect when, as they seemed to change almost weekly. at home in the us, newscasters highlighted the inconsistency in policies between districts as close as fortyfive minutes apart. in fact, some states allowed individuals to dine indoors without any proof of vaccination, while other states, like california, had long mandates requiring people to “shelter in place.”2 because of my knowledge of these shortfalls in the us’s response, upon arrival, i was under the impression that the covid mehta, catch me if you can, voices in bioethics, vol. 8 (2022) 2 19 response in india exemplified effective enforcement. the us, i felt, was lacking india’s stringent procedures for controlling the spread of covid-19. however, after spending an extended period of time in several cities within india, i realized that its covid-19 response had serious flaws—ones that infringe on bioethical tenets. analysis the inherent weaknesses in india’s medical and political structure suddenly became apparent to me. the restriction on personal autonomy, without providing sufficient centralized oversight, caused an abundance of injustices around me. witnessing police officers shake down innocent citizens on the street under the pretenses of covid-19 enforcement highlighted the damaging effects of infringing on autonomy. in an effort to curb the spread of covid-19, blinded by worry and political hunger, india simultaneously turned its back on autonomy, beneficence, and justice. i understood that the covid-19-related corruption i saw firsthand was not all that was occurring throughout the country. there were reports of devastating stories about individuals victimized by the unequal distribution of covid-19 relief. for example, when india imposed the world’s largest lockdown, millions of people were left stranded hundreds of miles from home.3 “it wasn’t the coronavirus … [that these stranded migrants] feared,” it was the lack of government transparency and support,4 for they now had to travel to and from work by foot, blindly and helplessly navigating the road and city closures. the decision to shut down india overnight affected poorer individuals and already-struggling migrant workers in disparate ways; this represents a lack of equal opportunity and a failure to uphold the principle of justice for those who needed it most.5 these stories made me rethink the morality behind what was going on with india’s response. although innovative on paper, india’s struggle to find a balance between authoritarian control over their citizens' health and a general concern for the well-being of certain communities poses a serious issue. the execution has quickly transformed into an abuse of power,6 and while the us fumbles to make unanimous, clear-cut decisions, india disregards the ethical impact of their mandates. they sacrificed in personal rights what they gained in swift, decisive action. unfortunately, for indian citizens, india is not reflecting a relaxation of any mandate checkpoints or control centers despite covid-19 evolving to be an endemic disease and exhibiting less dangerous strains, especially when those exposed are vaccinated. corruption has become rampant; citizens throughout the country exploit the system regularly to avoid harsh punishments or restrictions on their freedom. the corruption, however, does not only fall on the receiving end of those everyday citizens burdened with regulations. on the few occasions that my mask was tangled inside my pocket, perhaps stuck to my keys or in a location harder to find, police officers found an opportunity to profit at my expense. upon seeing that i was unable to put the mask on in time, they would run up to the car, beating on it until we complied with their requests. their motive was always the same: a bribe of around ten us dollars, which is the equivalent to a day’s worth of salary for a police officer in india.7 while i assumed this was an anomaly only present in the region i was driving through, i later found out that this type of encounter was quite common. “catch me if you can,” was the typical response of our driver as we learned to navigate through these moneymaking checkpoints. with the accelerator redlining, i could look back, observing the police officer already turned away in defeat, his eyes looking for his next score. when analyzing the impact of covid-19 on a country like india, the high population density is an integral factor. indian communities are especially vulnerable to infectious diseases due to the population density. mehta, catch me if you can, voices in bioethics, vol. 8 (2022) 3 they also experience low education rates and a poor public health infrastructure. for example, india has one doctor per 11,000 people.8 moreover, there are few covid-19 testing sites in the country, and within that, a smaller percentage that are operating ethically. as i witnessed during my time in india, most covid19 testing sites can guarantee a negative test if you pay a small fee over the standard amount. conclusion during my time in india, i saw firsthand the issues that arise when autonomy, beneficence, and justice are not given their proper value. in a panic to curb the spread of the virus, india put little thought into valuing its people’s autonomy. the country can be abruptly shut down without any notice, causing the economy to come to a screeching halt and, with it, the livelihoods of millions of businesses and workers. india’s government also seriously overlooked the principle of justice, for those who were already disadvantaged were hit much harder than others with better financial standing. furthermore, the shutdown of the country split up families of migrant workers and led to numerous deaths.9 public transportation is integral in india, and its halt during the pandemic reverberated throughout the country. the results of india’s covid-19 response are a message that should be broadcast across the world, warning that there is no situation in which careful thought and attention should not be paid to the tenets of bioethics. 1 yeung, jessie. “a police officer is wearing a coronavirus helmet to warn people to stay inside.” cnn, cable news network, 30 mar. 2020, https://www.cnn.com/2020/03/30/asia/coronavirus-helmet-chennai-intl-hnk-scli/index.html. 2 althouse, benjamin m et al. “the unintended consequences of inconsistent pandemic control policies.” medrxiv : the preprint server for health sciences 2020.08.21.20179473. 28 oct. 2020, doi:10.1101/2020.08.21.20179473. preprint.; “'masking works': austin fights back as texas loosens covid-19 restrictions.” the guardian, guardian news and media, 14 mar. 2021, https://www.theguardian.com/us-news/2021/mar/14/austin-fights-texas-loosens-covid-19-restrictions-masks. 3 slater, joanna, et al. “india's abrupt lockdown forced millions to walk, bike and hitchhike home. many lives will never be the same.” the washington post, wp company, 1 apr. 2021, https://www.washingtonpost.com/world/2021/04/01/indiacoronavirus-lockdown-migrant-workers/. 4 adhikari, anindita, et al. “manufactured maladies: lives and livelihoods of migrant workers during covid-19 lockdown in india.” the indian journal of labour economics, vol. 63, no. 4, 2020, pp. 969–997, https://doi.org/10.1007/s41027-020-00282-x. 5 “covid-19: amid india's corruption and profiteering are shining examples of courage and selflessness.” sky news, https://news.sky.com/story/covid-19-amid-indias-corruption-and-profiteering-are-shining-examples-of-courage-and-selflessness12291519. 6 bhasin, swati. “‘grave misconduct’: hyderabad cops seen taking bribe on camera, suspended.” ndtv.com, ndtv, 11 may 2020, https://www.ndtv.com/telangana-news/hyderabad-police-constables-seen-taking-bribe-on-camera-suspended-2226833. 7 ibid. 8 youkta, kumari, and rajendra narayan paramanik. “epidemiological model for india's covid ‐19 pandemic.” journal of public affairs, vol. 21, no. 4, 2021, https://doi.org/10.1002/pa.2639.; “1.3 billion people. a 21-day lockdown. can india curb the coronavirus?” science, https://www.science.org/content/article/13-billion-people-21-day-lockdown-can-india-curb-coronavirus. 9 “separated due to lockdown, family members are now counting down days.” the economic times, https://economictimes.indiatimes.com/news/politics-and-nation/separated-due-to-lockdown-family-members-are-nowcounting-down-days/articleshow/75508298.cms?from=mdr. strand, pregnancy clauses, voices in bioethics, vol. 7 (2021) * gianna r. strand, ms in bioethics, columbia university © 2021 gianna r. strand. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. pregnancy clauses: the ethically unfounded exemption to advance care directives gianna r. strand* abstract all people deserve the legal ability to outline their care decisions in advance and expect their decisions to govern during a pregnancy. however, until advance directives govern without pregnancy exceptions, people will not uniformly retain the ability to formulate autonomous decisions about their health care planning. keywords: advanced directives, pregnancy, reproductive ethics, fetus, abortion, autonomy introduction in the last few years, states have passed increasingly restrictive laws regarding abortion and reproductive health care. recent legislation in alabama effectively banned the procedure altogether, while more than a dozen states have passed or are currently in the process of enacting so-called “fetal heartbeat laws,” which ban abortion at roughly six weeks post-conception after the detection of electrical activity in what could develop into fetal cardiac tissue.1 while courts rarely uphold outright bans and broad sweeping legislation, they garner significant media and public attention.2 in practice, however, often smaller legislative changes that garner the least attention have the most significant impact by steadily chipping away at healthcare rights. few people realize the ethical impact of the poorly understood legal means by which a pregnant woman has already lost her right to make autonomous healthcare decisions over her body using an advance directive in nearly every state. background advance directives are one of modern medicine’s most powerful yet underused tools. most clinicians and patients think of advance directives as being only for the elderly or terminally ill. this association stems from the 1991 congressional patient self-determination act that requires hospitals, nursing homes, and hospice agencies receiving federal funding to inform patients of their legal right to prepare an advance directive. the 2015 announcement by the center for medicare and medicaid services (cms) to reimburse strand, pregnancy clauses, voices in bioethics, vol. 7 (2021) 2 for advance directives without requiring a diagnosis code recognizes that all adult patients can benefit from advance directives regardless of illness or life expectancy. 3 providers should be aware of a small but significant exemption found in most state advance directive laws. this exemption, commonly known as the pregnancy clause, invalidates the advance directive of a pregnant woman, negating autonomy. the pregnancy clause can lead to treatment against medical standards of care and places private interests over public health. advance directive statutes are frequently amended, but currently, only eight states allow patients to write their pregnancy-related wishes into their advance directive and guarantee that their instructions will be followed. eleven states automatically invalidate advance directives during pregnancy, while 18 states permit physicians to disregard a pregnant woman’s (or her proxy’s) wishes based on the likelihood of viability, pain, and suffering, or conscientious objector clauses. thirteen states remain silent on whether an advance directive is binding during pregnancy or have contradictory statutes.4 viability has no standard definition for the purposes of the clauses and viability-based pregnancy clauses can lead to the same loss of rights as pregnancy clauses that invalidate advance directives due to pregnancy without any exceptions. many may wonder about the clinical relevance of pregnancy clauses. the likelihood that a woman will need to effectuate an advance care directive while pregnant is higher than many people would realize. this situation is most commonly assumed to occur in instances of a brain-dead pregnant woman, of which there are a few cases reported each year. but brain death and persistent vegetative states are just two reasons to look to an advance directive. advance directives more commonly apply to patients with dementia, strong religious objections to medical care, or during cancer treatments, surgery, or acute injury with temporary loss of capacity. in surgery or acute lapses of capacity, a proxy may be asked to make decisions if complications arise. the number of women potentially affected by pregnancy clauses is significant. each year, 75,000 pregnant women will undergo non-obstetrical surgery;5 one in 1,500 pregnant women will be diagnosed with cancer; 6 and an estimated 250,000 americans will exhibit early-onset alzheimer’s symptoms between the ages of 30 and 50.7 analysis though pregnancy clauses are a seemingly narrow focus, they can nullify an entire advance directive and restrict care not related to the fetus. by negating entire advance directives, the clauses negate proxy appointments, allowing decision-makers other than the intended proxy. providers and proxies are left with little guidance over who can make decisions on behalf of the patient. many states will appoint a biological family member as the surrogate decision maker if there is no designated proxy or the directive is invalid. the outdated language and assumptions about nuclear families found in these structures could significantly impact unmarried couples, same-sex partnerships, and relationships that do not meet state-defined partnership standards where the courts may appoint someone other than the woman’s significant other even when she designated them as a proxy.8 members of religious groups whose doctrines prohibit certain medical therapies must be informed that if they become pregnant, their autonomous ability to decide about medical care through an advance directive and their right to freely practice religion can be voided entirely. in addition to infringing on patient autonomy, pregnancy clauses also restrict how clinicians might practice medicine by mandating medically inappropriate treatments against the provider’s recommendations. for example, illinois’s pregnancy clause stipulates that “if you are pregnant and your health care professional thinks you could have a live birth, your living will cannot go into effect.”9 this clause places providers in a strand, pregnancy clauses, voices in bioethics, vol. 7 (2021) 3 difficult position of sacrificing their therapeutic obligation to their patients. it may require them to use futile therapy against the patient’s best interest and without regard for prolonged pain and suffering. pregnancy clauses are void of any consideration of the best clinical interest of the patient or the fetus and instead promote conservative rhetoric that all potential fetal life is paramount. numerous medical and chromosomal conditions are incompatible with life or present significant potential disabilities that may be accompanied by pain and suffering. the same conditions also pose risks to the mother, including death. accordingly, the medical profession recognizes that there are instances in which it may not be in the best medical interest of the mother or the fetus to continue the pregnancy. yet providers are seemingly required by pregnancy clauses to violate codes of conduct and subject pregnant patients and their nonviable fetuses to treatments to which other patients would not be subjected. without evidence of a patient’s clear and convincing intentions, states have an interest in protecting life, preventing suicide, and maintaining the ethical integrity of the medical profession that could interfere with the person’s ability to refuse care.10 the legal defense of pregnancy clauses is that the state’s interest in fetal life is sufficiently important to override the mother. as established in planned parenthood v. casey (1992), however, the state’s interest only exists for fetal life post-viability.11 therefore, to allow the state interest to override the person’s advance directive when the fetus is not yet viable violates casey. individuals have a legal and ethical interest in maintaining bodily privacy, integrity, and freedom from unwanted touching. they have the right to appoint a proxy or use a directive to govern care in the case of incapacity. even when contemplating brain death, organ donation, and whether to be cremated or buried, there is an expectation that personal wishes will govern. honoring an advance directive allows providers to uphold the integrity of the medical profession by respecting the principles of autonomy and beneficence. pregnancy clauses are inherently unethical as their creation was not to further the integrity of the medical or legal profession, nor protect a state’s interest in the patient’s life. in 2016, the american college of obstetricians and gynecologists issued a committee opinion that pregnancy is not an ethical exemption to the right of capable patients to refuse treatment. 12 the right to direct treatment while pregnant is consistent with modern medical practice, while the legislative promotion of a singular abstract interest in potential fetal life to the exclusion of all other medical and ethical considerations is not in line with the profession’s values.13 many pregnancy clauses are politically motivated, reflecting anti-abortion legality lobbying efforts and attempts to win over conservative voters. when alaskan attorney general harold m. brown argued the state’s pregnancy clause was unconstitutional, governor bill sheffield – a democrat in a historically red state – enacted the bill anyway. georgia’s governor bill kemp narrowly won his election, with some crediting his aggressive messaging against immigration and abortion. 14 with either advance directives, proxies, or even friends and relatives who know what the person (if not incapacitated) would have wanted, courts and legislatures should not have leeway to force care that a person, if conscious, would have refused.15 the ability to harness advance directive law to force invasive and unwanted treatment upon a pregnant patient’s body continues to occur out of the fear of legal uncertainty. the lack of uniformity between states in their pregnancy clauses further adds to the confusion. many advance directive statutes create a conditional proposition: if a provider acts in accordance with the carefully drawn circumstances of an advance directive, the provider is granted protective immunity from accusations of malpractice or wrongful death for that conduct. it is neither illegal nor unethical to remove a ventilator, for example, from a patient who has directed such a course of action in an advance directive. a pregnancy clause may remove that strand, pregnancy clauses, voices in bioethics, vol. 7 (2021) 4 immunity making the unethical act of ignoring the directive legal, but the ethical act of following it (removing a ventilator, for example) could subject the practitioner to liability. 16 without a pregnancy clause, providers retain the ability to both follow an advance directive and to act in the best medical interest of their patient. pregnancy clauses create confusion over the permissibility of medical acts in an attempt to coerce providers into making decisions that violate the rights of their patients and their own ethical codes of conduct. pregnancy clauses are a fallacy of consequentialist ethics in which the morality of the outcome justifies actions. under consequentialist reasoning, any violation to the woman is justified if the fetus develops and results in a live birth. this reasoning is further faulty as it incorrectly assumes that mechanically ventilating an unconscious, sick, dying, or dead body will result in a live birth. consequentialist theories should be limited to situations with predictable ends. ethical medical providers refute consequentialism in certain contexts because it treats patients as a means to an end to produce benefit for others. in pregnancy, ignoring advance directives to achieve the chance that a fetus might survive is not justified by consequentialism. pregnancy clauses also fail through the lens of deontological ethics in which an action must be ethical in and of itself and not based on outcomes. the choice to respect autonomy through an advance directive should be followed uniformly absent special circumstances. proponents of pregnancy clauses may argue that pregnancy is an appropriate exception because a woman “has chosen to lend her body to bring [a] child into the world.” 17 minnesota and oklahoma echo this belief in their statutes, which contain an unjustified rebuttable presumption that all female patients would want life-sustaining treatment if they are pregnant.18 pregnancy should not abrogate the rights of a person to assign a proxy for access to an abortion or to control her medical treatment. pregnancy exclusions are not grounded in the ethical “best interest” standards for the mother or the fetus. instead, they are rooted in outdated expectations of female gender roles, which reaffirm a legislative assumption that a pregnancy is more morally valuable than a woman’s autonomy. conclusion all people deserve the legal ability to outline their care decisions in advance and expect their decisions to govern during a pregnancy. providers and the government do not have to approve of a person’s care decisions or values, but medical practitioners must respect a person’s right to dictate their own health narratives. with the push for more patients to execute advance directives, providers and patients must be aware that their advance directives may succumb to the authority of pregnancy clauses. until advance directives govern without pregnancy exceptions, people will not uniformly retain the ability to formulate autonomous decisions about their health care planning. advance directive law will continue to be hijacked by politically motivated legislators. when seeking to address inequities in healthcare laws and access, it is essential to take a closer look at not only the headline cases but also the clauses and exemptions to laws seemingly designed to benefit patients. strand, pregnancy clauses, voices in bioethics, vol. 7 (2021) 5 1 for proposed and current abortion legislation and maps, see https://www.guttmacher.org/state-policy# and anne godlasky, nicquel terry ellis, and jim sergent, “where is abortion legal? everywhere, but…” usa today, may 15, 2019, updated april 23, 2020 https://www.usatoday.com/in-depth/news/nation/2019/05/15/abortion-law-map-interactive-roe-v-wade-heartbeat-billspro-life-pro-choice-alabama-ohio-georgia/3678225002/ 2 https://www.guttmacher.org/state-policy# (many bills fail in legislatures and are not enacted.) 3 department of health and human services centers for medicare & medicaid services; 42 cfr part 405, 410, 411, 414, 425, and 495; “medicare program; revisions to payment policies under the physician fee schedule and other revisions to part b for cy 2016; final rule.” 4 demartino, e. s., sperry, b. p., doyle, c. k., chor, j., kramer, d. b., dudzinski, d. m., & mueller, p. s. (2019). us state regulation of decisions for pregnant women without decisional capacity. jama, 321(16), 1629–1631. https://doi.org/10.1001/jama.2019.2587; villarreal, elizabeth. “pregnancy and living wills: a behavioral economic analysis.” the yale law journal forum. vol. 128 (2019); 1052-1076. 5 “surgery during pregnancy.” intermountain healthcare: fact sheet for patients and families, (2018). https://intermountainhealthcare.org/ext/dcmnt?ncid=520782026 6 basta, p. bak, a. roszkowski, k. “cancer treatment in pregnant women”. contemporary oncology, 19, no. 5 (2015): 354–360 7 “31-year-old woman fights alzheimer's while pregnant.” san francisco globe. 9 july 2015, sfglobe.com/2015/02/19/31-year-old-woman-fights-alzheimers-while-pregnant. 8 “health care proxies.” human rights campaign, https://www.hrc.org/resources/health-care-proxy. 9 illinois department of public health website, statement of illinois law on advance directives and dnr orders, http://www.idph.state.il.us/public/books/advdir4.htm. 10 in the matter of karen quinlan, 355 a.2d 647 (1976); cruzan v. director, missouri department of health, 497 u.s. 261 (1990); and in re conroy 486 a.2d 1209 (1985). 11 planned parenthood of southeastern pennsylvania v. casey, 505 u.s. 833 (1992). 12 the american college of obstetricians & gynecologists committee on ethics, committee opinion no. 664: refusal of medically recommended treatment during pregnancy, (2016). 13 lederman, anne d. “a womb of my own: a moral evaluation of ohio’s treatment of pregnant patient’s with living wills”. case w. res. l. rev. vol. 45:351 (1995); 351-377. 14 tavernise, sabrina. “the time is now: states are rushing to restrict abortion, or to protect it.” the new york times, 15 may 2019. 15 cruzan. 16 mayo, t.m. “brain-dead and pregnant in texas.” the american journal of bioethics, vol. 14, no. 8 (nov. 2014); 15-18. 17 in re a.c., 573 a. 2nd 1244 (1990). 18 johnson, kristeena l. “forcing life on the dead: why the pregnancy exemption clause of the kentucky living will directive act is unconstitutional.” kentucky law journal. vol. 100 (2011-12); 209-233. https://www.guttmacher.org/state-policy https://www.guttmacher.org/state-policy https://doi.org/10.1001/jama.2019.2587 ahluwalia, addressing education and wages to close the gap in health disparities, voices in bioethics, vol. 7 (2021) © 2021 mahika ahluwalia. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. addressing education and wages to close the gap in health disparities mahika ahluwalia keywords: social determinants of health, health disparities, public health, bioethics introduction the covid-19 pandemic has been instrumental in shining a light on disparities in health and outcomes that have existed for decades in the united states.1 certain marginalized groups, including hispanic, black, and native americans, face lack of access to treatments and face challenges in accessing high quality care.2 mortality rates within these groups are higher in comparison to those of white americans and to the general population. 3 this paper argues that addressing education and wages, two of the social determinants of health, and pre-existing health conditions, would contribute to lowering the number of severe covid-19 cases4 and improve health in the us, making fewer people vulnerable to the effects of diseases like covid-19. analysis a. covid-19 comorbidities according to many scientific studies, patients with covid-19 with cardiovascular disease, hypertension, diabetes, congestive heart failure, chronic kidney disease and cancer have a greater risk of mortality compared to covid-19 patients without these comorbidities. tailored infection prevention and treatment strategies targeting this high-risk population might improve survival.5 one way to alleviate the burden of covid-19 on minorities would be to increase access to immediate treatments for their pre-existing conditions. another study reported that rates of hypertension, diabetes, and respiratory conditions are most prevalent among black americans, even after controlling for factors like smoking, age, gender, and body composition.6 this could be due to structural racism and due to socioeconomic factors, that affect living and working conditions. for example, the burden of exposure to environmental pollutants is disproportionately borne by the black population. 7 research has shown that there are social determinants, which influence an individual’s health outcome. 8 when states do not advance health through public policy in education, the workplace, living situations, and healthcare, some people will be less likely to achieve good health.9 issues within these social determinants have led to these pre-existing conditions within black americans as well other racial minorities. 10 the pandemic has revealed the ahluwalia, addressing education and wages to close the gap in health disparities, voices in bioethics, vol. 7 (2021) 2 disparity in health care due to the increased covid-19 cases and deaths within minority populations.11 solving the disparities would foster better long-term health, lessen the death toll in the case of a future pandemic with similar (and possibly also with other) comorbidities. b. strucutral inequities systemic racism and structural problems that affect poor and marginalized communities in the us have made it harder for some americans to receive high quality education, find jobs that pay well, live in middle to high income areas, access the financial system, and find reliable healthcare coverage. as demonstrated by marmot and wilkinson in the social determinants of health: the solid facts, their health is affected by their lack of access. 12 this paper analyzes the impact of quality of education and wages and job opportunity on health. a. education education in the us is partly funded at the local level. as local income determines the tax base, communities with lower socioeconomic status tend to have more crowded or poorly funded public schools. states vary in their policies to remedy the amount of money per pupil. a student in a particular area with higher funding as a result of higher local property tax, will have access to more fiscal resources in public schools, in comparison to their counterpart student in an area with lower funding. 13 racial discrimination in education exists in the us, and some black americans are still unable to access schooling on par with their white peers. in addition, over the past decade, funding has been eliminated for policies including the early learning opportunity act (2006) which would have helped inner city students.14 high school graduation rates in the us also vary by race and ethnicity with black, hispanic, and native american people lagging behind.15 almost 12 percent of black americans, 15 percent of native americans, and 29.5 percent of hispanic americans do not finish high school compared to only six percent of white americans.16 poor high school graduation rates restrict socioeconomic mobility. a quality education is one of the social determinants of health. it is crucial to address the quality of education being provided to all americans as it will ensure the diversification of individuals in a variety of professional jobs and decrease the representation of minorities suffering from weaker health (i.e., preexisting conditions) due to working in stressful environments with lower wages and long hours. for lowincome individuals, the stresses encountered by children during early phases of life sometimes make acquiring an education more challenging. growing up in a lower income household, in an impoverished neighborhood, in an area without adequate learning resources, or living in a crowded home may add to stress. therefore, improving the quality of early education would improve outcomes for low-income families’ children. this may be achieved by increasing funding for federal education programs and specifically assisting low-income neighborhoods in facilitating pre-school education by introducing special education grants. the state government of georgia enacted a program known as “bright from the start” in the public school system, which provided integrated early childcare, nutrition services, and parent education by coordinating funding between the state and public school system.17 programs like these lead to stronger cognitive and social development in children, which contribute to their academic success. federal grants provided to lower income neighborhoods would provide them with more educational resources. a higher ahluwalia, addressing education and wages to close the gap in health disparities, voices in bioethics, vol. 7 (2021) 3 socioeconomic status as a result of a better-quality education would decrease the risk of hypertension, diabetes, and cardiovascular disease, known comorbidities affecting covid-19 outcome. better socioeconomic status also predicts better overall health.18 b. job opportunities when professional careers remain out of grasp due to education level, minorities continue to work in overcrowded cities in jobs which place them at a high risk of exposure to covid-19.19 in order to support themselves, those without significant savings or the ability to work from home must continue to go out to work. black americans comprise only 1.4 percent of the top one percent of income earners, yet they make up 13.6 percent of the population of the us.20 black and hispanic individuals are more likely to work in service or low-wage jobs, where workers are closer together and often use public transportation to commute.21 although there have been efforts by the government to increase the breadth of job opportunities for racial minorities, black americans and immigrants are paid less as many works in minimum wage jobs.22 minimum wages vary by state and sometimes by municipality, and the cost of living also varies greatly throughout the us. to counter the issue of occupational stratification in the american job market, the unfair distribution of high paying jobs created by institutional racism should be remedied.23 due to the pandemic, unemployment rates have risen across the board. however, black americans have been disproportionately affected. unemployment was already high among black-american men, and they now have a 50 percent higher unemployment rate than white americans. 24 according to data from the economic policy institute, 1 in 9 americans in a professional career are black americans, whereas 1 in 6 front line essential workers are black americans as a result of the relationship between employment and health outcomes, those in low-wage jobs are likelier to have conditions such as high blood pressure. many of the health conditions correlated with employment and less socioeconomic status cause susceptibility to covid-19.25 state governments could act to pass higher minimum wages or to supplement wages during the pandemic so that workers who are especially susceptible or have pre-existing conditions can afford to stay home. other, healthier workers could do those jobs if the government could provide a workable safety net allowing companies to hire while some employees stay home. in the long run, decreasing wage gaps would ensure beneficence to minorities who disproportionately work in low-wage jobs. while the types of jobs that pay low wages will continue, the wages themselves can increase, especially with better minimum wage legislation. wages and job type remain a crucial social determinant of health, and it is important to address the wage gap in order to reduce the disparity of pre-existing conditions and severity of covid-19 infections in americans. conclusion the covid-19 pandemic highlighted the disparities in education, income, and type of job. the critical issue of the marginalization and mistreatment of black, hispanic, and native americans is now evidenced by covid-19 deaths. improving overall population health and eradicating health disparities requires ensuring greater access to the things associate with socioeconomic wellbeing like education and jobs. policies that address the social determinants of health, specifically in the field of education and wages, ahluwalia, addressing education and wages to close the gap in health disparities, voices in bioethics, vol. 7 (2021) 4 would improve health outcomes. they by fostering an inclusive approach, the us government could make preventive care and treatment accessible to all regardless of race, ethnicity, and income, contributing to decreased chances of contracting pre-existing comorbidities amongst minorities. while immediate attention to pre-existing conditions could stave off deaths among the most vulnerable, long-term solutions addressing the social determinants of health could promote well-being and improve immune systems and outcomes for those groups now experiencing more cases of high blood pressure, heart disease, and obesity. 1 “covid-19 pandemic highlights longstanding health inequities in u.s.” harvard school of public health website, april 14, 2020. https://www.hsph.harvard.edu/news/hsph-in-the-news/covid-19-pandemic-highlights-longstandinghealth-inequities-in-u-s/ 2 krouse, helene. “covid-19 and the widening gap in health inequity” 163, no. 1 (may 5, 2020). 3 krouse, helene. 4 riley, wayne j. “health disparities: gaps in access, quality and affordability of medical care.” transactions of the american clinical and climatological association. american clinical and climatological association, 2012. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3540621/. 5 sentongo p, sentongo ae, heilbrunn es, ba dm, chinchilli vm (2020) association of cardiovascular disease and 10 other pre-existing comorbidities with covid-19 mortality: a systematic review and meta-analysis. plos one 15(8): e0238215. https://doi.org/10.1371/journal.pone.0238215 6 opara, f., hawkins, k., sundaram, a., merchant, m., rasmussen, s., & holmes, l. (2013). impact of comorbidities on racial/ethnic disparities in hypertension in the united states. isrn public health, 2013, 1-8. doi:10.1155/2013/967518 7 vann r. newkirk, ii “trump's epa concludes environmental racism is real,” the atlantic february 28, 2018. a new report from the environmental protection agency finds that people of color are much more likely to live near polluters and breathe polluted air—even as the agency seeks to roll back regulations on pollution. https://www.theatlantic.com/politics/archive/2018/02/the-trump-administration-finds-that-environmentalracism-is-real/554315/ 8 kaplan, george a. “social determinants of health, 2nd edition. m marmot and r wilkinson (eds). oxford: oxford university press, 2006, pp. 376, $57.50. isbn: 9780198565895.” international journal of epidemiology 35, no. 4 (2006): 1111–12. https://doi.org/10.1093/ije/dyl121. 9 kaplan. 10 opara, f., hawkins, k., sundaram, a., merchant, m., rasmussen, s., & holmes, l. (2013). impact of comorbidities on racial/ethnic disparities in hypertension in the united states. isrn public health, 2013, 1-8. doi:10.1155/2013/967518 11 apm research labs 12 kaplan, george a. “social determinants of health, 2nd edition. m marmot and r wilkinson (eds). oxford: oxford university press, 2006, pp. 376, $57.50. isbn: 9780198565895.” international journal of epidemiology 35, no. 4 (2006): 1111–12. https://doi.org/10.1093/ije/dyl121. 13 biddle, bruce j. “a research synthesis / unequal school funding in the united states.” beyond instructional leadership 59 (may 2002): 48–59. 14 “education and education policy as social determinants of health.” ama journal of ethics 8, no. 11 (2006): 756– 61. https://doi.org/10.1001/virtualmentor.2006.8.11.pfor1-0611. ahluwalia, addressing education and wages to close the gap in health disparities, voices in bioethics, vol. 7 (2021) 5 15 the condition of education preprimary, elementary, and secondary education high school completion public high school graduation rates indicator may (2020) 16 educational attainment, by race and ethnicity race and ethnicity in higher education (equityinhighered.org) 17 “education and education policy as social determinants of health.” ama journal of ethics 8, no. 11 (2006): 756– 61. https://doi.org/10.1001/virtualmentor.2006.8.11.pfor1-0611. 18 kaplan, george a. “social determinants of health, 2nd edition. m marmot and r wilkinson (eds). oxford: oxford university press, 2006, pp. 376, $57.50. isbn: 9780198565895.” international journal of epidemiology 35, no. 4 (2006): 1111–12. https://doi.org/10.1093/ije/dyl121. 19 “health equity considerations and racial and ethnic minority groups.” centers for disease control and prevention. centers for disease control and prevention. accessed december 6, 2020. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. 20 thegrio. “who are the black '1 percent'?” thegrio, september 28, 2019. https://thegrio.com/2011/11/21/who are-the-black-1-percent/. 21 “covid-19 pandemic highlights longstanding health inequities in u.s.” harvard school of public health website, april 14, 2020. https://www.hsph.harvard.edu/news/hsph-in-the-news/covid-19-pandemic-highlights-longstandinghealth-inequities-in-u-s/ 22 saenz, rogelio. “the inequities of job loss and recovery amid the covid-19 pandemic.” unh, august 12, 2020 https://carsey.unh.edu/publication/inequities-job-loss-recovery-amid-covid-pandemic. 23 ataguba, ochega a., and john e. ataguba. “social determinants of health: the role of effective communication in the covid-19 pandemic in developing countries.” global health action 13, no. 1 (2020): 1788263. https://doi.org/10.1080/16549716.2020.1788263. 24 saenz, rogelio. “the inequities of job loss and recovery amid the covid-19 pandemic.” unh, august 12, 2020 https://carsey.unh.edu/publication/inequities-job-loss-recovery-amid-covid-pandemic. 25 elise gould and valerie wilson. june 1, 2020. “black workers face two of the most lethal pre-existing conditions for coronavirus-racism and economic inequality.” economic policy institute. accessed december 6, 2020. https://www.epi.org/publication/black-workers-covid/. https://nces.ed.gov/programs/coe/indicator_coi.asp https://nces.ed.gov/programs/coe/indicator_coi.asp https://www.equityinhighered.org/indicators/u-s-population-trends-and-educational-attainment/educational-attainment-by-race-and-ethnicity/ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html moorthy, humanizing the physician-patient relationship, voices in bioethics, vol. 8 (2022) * gyan moorthy, ms, candidate, md, university of pennsylvania school of medicine © 2022 gyan moorthy. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. humanizing the physician-patient relationship: how gift-giving and -receiving can be ethical gyan moorthy* keywords: gift-giving, autonomy, benefit, physician-patient relationship, personal, value, culture introduction gift-giving by patients or their families to physicians has happened since there were patients and physicians, and in many places, it’s still quite common. it’s also potentially problematic, and the why and how of it offer important insight into the physician-patient relationship and human relationships more broadly. yet ethicists, regulators, and the public have not paid much systematic attention. in the united states, no federal or state legislation directly addresses it. only in the past two decades did the american medical association (ama) release guidance to physicians about it. that guidance, which permits physicians to accept certain gifts by certain patients under certain circumstances, namely, when it will not influence their medical judgment or cause hardship to the gift-giver, is vague and incomplete – indeed, it’s all of 200 words. 1 other physician professional organizations have little to add. 2 a few academics and opinion columnists have studied or reflected on the psychology of gift-giving and -receiving and recommended everything from categorical rejection of patient gifts3 to erring on the side of accepting them, provided they are of modest value, and the motivation behind them can be discerned.4 however, insufficient attention has been paid to the when and where of those gifts or the significance of clinic-, hospitalor other systemslevel ethical safeguards. analysis when deciding whether they will accept a gift from a patient or their family, physicians must balance the possibility that the gift could cloud medical judgment, lead to favoritism, exploitation, and slippery slopes, or pressure other patients to give, and perhaps even debase the meaning of medical treatment, against the prospect that gift-giving could increase patient trust and satisfaction, as well as empower patients and respect their autonomy and culture.5 performing this harm-benefit calculation case by case is challenging moorthy, humanizing the physician-patient relationship, voices in bioethics, vol. 8 (2022) 2 and time-consuming. unsurprisingly, many physicians opt simply to tell would-be gift-giving patients that they appreciate the sentiment, but, as a rule, they accept no gifts. i submit many physicians do this also because they are unaware of how meaningful giving a gift can be for patients or anyone in a disadvantaged position with respect to the gift recipient. they may also not know that there are simple accountability mechanisms they can institute that may prevent many of the possible adverse consequences of gift-giving and -receiving in the context of the physician-patient or physician-patient-family relationship. unfortunately, many instances in which accepting a gift would have led to net benefit are foregone. it is my belief a consensus could quickly be formed about which types of gifts would clearly be wrong to accept. few would defend the physician who agrees to use a patient’s villa in the bahamas or welcomes expensive jewelry or lewd photos. the timing and intent of a gift also matter. few would forgive the physician who accepted even a modestly valuable voucher to eat at a patient’s restaurant while their eligibility for transplant was being debated or after they had run out of opioid painkillers and were denied a prescription renewal. on the other hand, i doubt even charles weijer or the college of physicians and surgeons of prince edward island, which views accepting gifts from patients as “boundary crossing,”6 would demand an orthopedic surgeon turn down the happy picture a pediatric patient drew after recovering from a hip injury and resuming sports. they are also unlikely to criticize an oncology team that graciously receives a fruitcake baked by the sister of an elderly cancer patient after the decision was made and agreed to, around christmastime, not to initiate another round of chemotherapy. these unlikely refusals may be because rejecting those gifts, all things considered, would seem cruel. but it might also be because there is disagreement about what constitutes a gift: whether it must be a tangible object (are heartfelt thank-yous and hugs not also “gifts”?) or whether it must be something that requires the physician actively do something, e.g., get on a plane. these disagreements about definitions may also partially underlie disagreements about practice. suppose a patient in a sparsely populated, heavily wooded part of maine takes it upon himself to offer a sack of apples from his orchard to his internist, who regularly waives fees for those who cannot pay them or will make a house call at any time of the night. in that case, the internist may not consider the apples a gift. he may not think of them as payment or re-payment either. they may exist in some in-between category, much like the knitted slippers brought in by a patient in whose culture “thank you” is seldom said. but clearly, some things are widely perceived as gifts or to have substantial gift-like character. should they, at least, be rejected? i don’t think so. the act of gift-giving and -receiving can be a sort of ritual and gradually lead to trust and closeness.7 perhaps a shy patient whose wife previously sent chocolates to his physician around christmastime will come to see the physician as a part of his extended family. perhaps he needs to do so to feel comfortable talking about his erectile dysfunction. gifts can be expressions of caring.8 perhaps an elderly texan patient imagines her younger physician, whom she has known for thirty years and often sees at the grocery store, as her son and asks to prepare a homecoming mum (traditionally a chrysanthemum flower corsage) for his children’s school dance. perhaps doing so will give her purpose, make her feel useful, as all her own children have moved away. giving gifts may also provide patients with a sense of control and help them feel as if less of a power imbalance exists between them and their physician. perhaps a young judge, who is not used to not being in control, and was previously misdiagnosed with rheumatoid arthritis, is now struggling to come to terms with his lupus. perhaps giving the physician who made the correct diagnosis a moderately-priced bottle of scotch restores his confidence or sense of pride. moorthy, humanizing the physician-patient relationship, voices in bioethics, vol. 8 (2022) 3 gifts are also undoubtedly important to the recipient. when medical providers receive a gift, they may interpret it as a sign that they are valued. while it would be wrong to practice medicine to receive gifts or expect them, there are times, like when ers and icus are overwhelmed because of a viral pandemic,9 which threatens the will to continue working, and most anything (within reason) that bolsters resolve can be considered good. there is also no obvious distinction between the satisfaction physicians normally receive on seeing their patients recover or being thanked or smiled at and what they feel when they receive a small or “token” gift, like a plate of homemade cookies. the point is that the physician-patient relationship is a human one. many advocate it should be personal, that physicians should be emotionally invested in their patients, care about and have compassion for them in ways that professional oaths do not fully capture.10 this dynamic is particularly important in primary care or when the physician-patient relationship continues for long periods. according to one israeli study, many patients even wish for a relationship with their physician akin to friendship. those who felt they had such a relationship were more satisfied with their care than those who believed the relationship was businesslike.11 the precedent for this “friendship between unequals” goes back at least to the time of erasmus, some five hundred years ago. 12 there may be good reasons for physicians to draw the line before friendship, but if accepting certain gifts builds intimacy, and that intimacy does not cross over into an inappropriate relationship, e.g., a sexual or romantic relationship, and if it has the chance to improve healthcare outcomes through improved mood or early disclosure of problems, i think it should be done. physicians have a prima facie duty to do good for their patients.13 most physicians want to do good for their patients and respect their traditions and preferences. i suspect that accepting the gifts from the patients in the examples above would do a lot of good, or at least that rejecting them could do significant harm, including making them or their families feel estranged from the medical community, impeding future care. physicians might be more comfortable accepting gifts if receiving gifts would not subject them to scrutiny or penalty. they also may feel better if they knew that receiving gifts would not harm their patients and that rejecting gifts might. they should document all gifts they receive.14 this will enable them to detect if gifts from a particular patient are increasing in frequency or lavishness or changing markedly in character, which could warrant attention. i maintain this “gift log” should be maintained in common with everyone at the clinic or in the relevant hospital department and potentially made available to hospital administration for audit. investigation might be necessary if a gift is given (and accepted) with no explicable context, e.g., not near holiday season or after a treatment milestone is achieved. when possible, gifts should be shared communally, such as placing fruit baskets or chocolates in the staff room. other gifts, like artwork, can be displayed on the walls. others should be encouraged to hold physicians accountable if they feel patients who have given gifts receive preferential treatment, including something as seemingly small as priority for appointment bookings. appearances matter and even the appearance of impropriety can affect the public’s trust in medicine. the culture of medicine has already changed such that nurses now reproach physicians they feel violate the standard of care,15 and this would be an extension of that trend. depending on the set-up of the practice, a staff member can be designated for receiving gifts and politely declining those that ought to be declined. staff members should tell patients, who give gifts in full view of other patients, that they cannot do so in the future. physicians can politely rebuff patients who wish to give inappropriate gifts, or gifts at inappropriate times and suggest they donate to charity instead. medical practices and hospitals should develop a gift policy in consultation with staff and patients to avoid needlessly rejecting gifts that benefit both doctor and patient and to avoid pressuring patients into giving gifts. the policy should be flexible to account for the crucial human element in any provider-patient relationship and the cultural nuances of any moorthy, humanizing the physician-patient relationship, voices in bioethics, vol. 8 (2022) 4 practice setting. psychiatrists, who work with particularly vulnerable patients, may need to be more vigilant when accepting gifts.16 conclusion though we tend to think health innovation occurs in urban medical centers and spreads outward, there may be something big-city physicians can learn from their rural colleagues about personalized patientphysician relationships. the value of gifts is only one example. normalizing the acceptance of patient gifts in appropriate restricted circumstances has the added benefit of shining a spotlight on the acceptance of patient gifts in dubious ones. by bringing an already fairly common practice into the open and talking about it, we can create policies that respect patients as persons, prevent abuse, and deconstruct the stereotype of the austere and detached physician. while there is no reason to think that gift-giving would get out of control if appropriate safeguards are put in place, the medical community can always re-evaluate after a period, or an individual medical practice can re-evaluate based on the circumstances of their practice environment. gift-giving, especially when gifts are of small monetary value, should be recognized as a culturally appropriate gesture with meaning far beyond that monetary value. it is best governed by reasonable gift-giving policies, not banned altogether. 1 council on ethical and judicial affairs. “ethics of patient-physician relationships.” in ama code of medical ethics, 11. chicago: american medical association, 2021. https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/code-of-medicalethics-chapter-1.pdf. 2 sulmasy, lois snyder, and thomas a. bledsoe. “american college of physicians ethics manual.” annals of internal medicine 170, no. 2_supplement (january 15, 2019): s1–32. https://doi.org/10.7326/m18-2160; committee on bioethics. “pediatrician-familypatient relationships: managing the boundaries.” pediatrics 124, no. 6 (december 1, 2009): 1685–88. https://doi.org/10.1542/peds.2009-2147. 3 weijer, charles. “no: gifts debase the true value of care.” western journal of medicine 175, no. 2 (august 2001): 77. 4 lyckholm, laurie j. “should physicians accept gifts from patients?” jama 280, no. 22 (december 9, 1998): 1944–46. https://doi.org/10.1001/jama.280.22.1944; spence, sean a. “patients bearing gifts: are there strings attached?” bmj 331, no. 7531 (december 22, 2005): 1527–29. https://doi.org/10.1136/bmj.331.7531.1527; gaufberg, elizabeth. “should physicians accept gifts from patients?” american family physician 76, no. 3 (august 1, 2007): 437; caddell, andrew, and lara hazelton. “accepting gifts from patients.” canadian family physician 59, no. 12 (december 2013): 1259–60. 5 see above commentators and drew, jennifer, john d. stoeckle, and j. andrew billings. “tips, status and sacrifice: gift giving in the doctor-patient relationship.” social science & medicine 17, no. 7 (january 1, 1983): 399–404. https://doi.org/10.1016/02779536(83)90343-x. 6 college of physicians and surgeons of prince edward island. “respecting boundaries.” accessed april 4, 2021. https://cpspei.ca/respecting-boundaries/. 7 the atlantic’s marketing team. “what gifting rituals from around the globe reveal about human nature.” the atlantic, 2018. https://www.theatlantic.com/sponsored/hennessy-2018/what-gifting-rituals-around-globe-reveal-about-human-nature/2044/. 8 parker-pope, tara. “a gift that gives right back? the giving itself.” the new york times, december 11, 2007, sec. health. https://www.nytimes.com/2007/12/11/health/11well.html. 9 harlan, chico, and stefano pitrelli. “as coronavirus cases grow, hospitals in northern italy are running out of beds.” washington post. accessed april 4, 2021. https://www.washingtonpost.com/world/europe/italy-coronavirus-patients-lombardyhospitals/2020/03/12/36041dc6-63ce-11ea-8a8e-5c5336b32760_story.html. https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/code-of-medical-ethics-chapter-1.pdf https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/code-of-medical-ethics-chapter-1.pdf https://doi.org/10.7326/m18-2160 https://doi.org/10.1542/peds.2009-2147 https://doi.org/10.1001/jama.280.22.1944 https://doi.org/10.1136/bmj.331.7531.1527 https://doi.org/10.1016/0277-9536(83)90343-x https://doi.org/10.1016/0277-9536(83)90343-x https://cpspei.ca/respecting-boundaries/ https://www.theatlantic.com/sponsored/hennessy-2018/what-gifting-rituals-around-globe-reveal-about-human-nature/2044/ https://www.nytimes.com/2007/12/11/health/11well.html https://www.washingtonpost.com/world/europe/italy-coronavirus-patients-lombardy-hospitals/2020/03/12/36041dc6-63ce-11ea-8a8e-5c5336b32760_story.html https://www.washingtonpost.com/world/europe/italy-coronavirus-patients-lombardy-hospitals/2020/03/12/36041dc6-63ce-11ea-8a8e-5c5336b32760_story.html moorthy, humanizing the physician-patient relationship, voices in bioethics, vol. 8 (2022) 5 10 frankel, richard m. “emotion and the physician-patient relationship.” motivation and emotion 19, no. 3 (september 1, 1995): 163–73. https://doi.org/10.1007/bf02250509. 11 magnezi, racheli, lisa carroll bergman, and sara urowitz. “would your patient prefer to be considered your friend? patient preferences in physician relationships.” health education & behavior 42, no. 2 (april 1, 2015): 210–19. https://doi.org/10.1177/1090198114547814. 12 albury, w. r., and g. m. weisz. “the medical ethics of erasmus and the physician-patient relationship.” medical humanities 27, no. 1 (june 2001): 35–41. https://doi.org/10.1136/mh.27.1.35. 13 beauchamp, tom l., and james f. childress. principles of biomedical ethics. 7th edition. new york: oxford university press, 2012. 14 caddell and hazelton, 2013. 15 see, e.g. peplau, hildegard e. “a glance back in time: nurse-doctor relationships.” nursing forum 34, no. 3 (1999): 31–35. https://doi.org/10.1111/j.1744-6198.1999.tb00991.x and ahmad, ahmir. “the doctor-nurse relationship: time for change?” british journal of hospital medicine (2005), september 27, 2013. https://doi.org/10.12968/hmed.2009.70.sup4.41642. 16 hundert, edward m. “looking a gift horse in the mouth: the ethics of gift-giving in psychiatry.” harvard review of psychiatry 6, no. 2 (january 1, 1998): 114–17. https://doi.org/10.3109/10673229809000319. https://doi.org/10.1007/bf02250509 https://doi.org/10.1177/1090198114547814 https://doi.org/10.1136/mh.27.1.35 https://doi.org/10.1111/j.1744-6198.1999.tb00991.x https://doi.org/10.12968/hmed.2009.70.sup4.41642 https://doi.org/10.3109/10673229809000319 hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) * johanna t. crane, ph.d., anthropologist, associate professor, alden march bioethics institute kara simpson, lcsw-r, director of social work, behavioral health service, nyc h+h jacobi jennifer breznay, md mph, program director division of geriatrics, co-chair, bioethics committee, maimonides medical center, brooklyn, ny ashley l. stewart, infection prevention coordinator, carthage area hospital david n. hoffman, jd, lecturer in bioethics, columbia university. general counsel, claxton hepburn medical center. © 2021 hoffman et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. vaccine hesitancy narratives johanna t. crane, kara simpson, jennifer breznay, ashley l. stewart, david n. hoffman* introduction in this collection of narratives, the authors describe their own experiences with and reflections on healthcare worker vaccine hesitancy. the narratives explore each author’s engagement with different communities experiencing vaccine hesitancy, touching on reasons for hesitancy, proposed solutions, and legal aspects. author’s names appear above their narratives. keywords: vaccine hesitancy, healthcare workers, covid-19, emergency approval, vaccine mandate, medical distrust, bioethics i. johanna t. crane vaccine hesitancy, defined as “a delay of acceptance or refusal of vaccination despite the availability of vaccination services,” 1 is a worldwide but locally shaped phenomenon that pre-dates the covid-19 pandemic. 2 contrary to some portrayals, vaccine hesitancy is not the same as the more absolute antivaccination stance, or what some call “anti-vax.” many people who are hesitant are not ideologically opposed to vaccines. hesitancy is also sometimes framed as anti-science, yet reluctance to vaccinate is often about managing risk, trustworthiness, and doubt in the context of uncertainty; it represents an effort to “talk back to science” about unaddressed needs and concerns.3 in the us, the newness of the vaccines, the unprecedented speed at which they were developed, and their remaining under emergency use authorization at first complicated public confidence. political polarization hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) 2 and racial and social inequality shape vaccine acceptance and public distrust as well. while vaccine acceptance has increased in the months since the vaccines first became available, many eligible individuals have not yet been vaccinated, including a significant number of healthcare workers.4 vaccine hesitancy among healthcare workers may seem surprising, especially given their frontline experience – i confess that it surprised me at first. but when i began interviewing health care workers for a study on covid vaccine roll-out at community health centers, i learned to take a more complex view. although the study was focused on patient vaccine access,5 many of the frontline health care workers we spoke with also described hesitancy among some of their colleagues (and, in a few cases, themselves). from these conversations, i learned that these “healthcare heroes” are also regular people and members of communities. their concerns about covid vaccination often reflect the prevailing concerns advanced in their communities, such as worries about vaccine side effects and safety. like other workers, some fear missing work and losing income, as not all healthcare employers offer paid time off for vaccination or recovery. (importantly, reluctance to vaccinate is highest among healthcare workers in lower-paid positions with little job security, such as clerks, housekeepers, patient care assistants, and home health aides.) 6 for some healthcare workers of color, the protection offered by the vaccine sits in tension with both current and historical experiences of medical abuse and neglect. some interviewees, fully vaccinated themselves, rejected the framework of “hesitancy” entirely, arguing that black and brown reluctance to be vaccinated first should be understood through the lens of “self-protection”. due to the nature of their work, healthcare workers have faced great social pressure to vaccinate and vaccinate first. this is understandable, given that vaccination against covid-19 protects not only workers themselves but aligns with the ethical duty to prevent harm to patients by reducing the risk of transmission in healthcare settings. when the fda approved covid-19 vaccines under emergency use authorization in december 2020, many healthcare workers were extremely grateful to be designated “1a” – the first group prioritized to receive the shots.7 for many bioethicists, prioritization of healthcare workers represented a recognition of the extreme risks that many front-line workers had endured since the onset of the pandemic, including critical shortages in ppe. but it is important to remember that for some workers, going first may have felt like serving as guinea pigs for new vaccines that had yet to be granted full fda approval. for these individuals, the expectation that they would vaccinate first may have felt like an additional risk rather than a reward. healthcare workers who are hesitant to vaccinate may feel ashamed or be subject to shaming by others;8 this may make it difficult to discuss their concerns in the workplace. throughout the pandemic, healthcare workers have been lauded as “heroes”, and some healthcare employers have promoted vaccination among their workforce as a “heroic” action. this messaging implies that waiting to vaccinate is shameful or cowardly and is echoed in opinion pieces and op-eds describing unvaccinated people as “selfish” or “free riders.”9 by fostering the proper dialogue, we can respond respectfully to hesitancy among healthcare workers while still working towards the goal of increased vaccination. we in the bioethics and medical community should be willing to listen to our colleagues’ concerns with respect. top-down approaches aimed at “correcting” hesitancy cannot address the more fundamental issues of trust that are often at stake. instead, there must be dialogue over time. conversations with a trusted healthcare provider have a crucial role.10 blaming and shaming rhetoric, whether explicit or implicit, gets us nowhere – in fact, it likely moves us backward by likely exacerbating any existing distrust or resentment that workers may hold toward their employers.11 lastly, the onus of trust must be with institutions, not individuals. there is a lot of talk about getting hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) 3 communities of color, and black people, particularly, to "trust" healthcare institutions and the covid vaccines. this racializes trust and puts the burden on harmed communities rather than on institutions acting in trustworthy ways.12 dialogue, respect, and trustworthiness must guide us even in the new era of workplace mandates. mandates make these strategies even more important as we look toward an uncertain future. as heidi larson, founder of the vaccine confidence project, recently said, “we should not forget that we are making people's future history now. are people going to remember that they were treated respectfully and engaged?”13 ii. kara simpson since the release of the vaccine for covid-19 in late 2020, there have been robust discussions within the medical community, the media, and political arenas about vaccine hesitancy among healthcare workers. the public became aware that healthcare workers, the first group to become eligible for the vaccine, were not rushing to “take the shot.” many people’s opinions were aligned by race, ethnicity, socioeconomic status, and political affiliation. people of color were one of the first groups to be labeled vaccine hesitant as our experiences of distrust of the medical community and the politicization of the vaccine explained the low turnout. 14 it was not uncommon to hear, “this vaccine just came out; let’s wait and see if there are side effects.” interestingly, many people in the healthcare community and in the public did not understand why healthcare workers of color remained hesitant. trust is a vital component of any viable relationship, especially in the clinical realm. to have successful health outcomes, it is essential for clinicians to build trusting relationships with their patients and peers. many people of color are distrustful towards the medical institution due to the years of systemic racism and abuses that they have experienced, witnessed, or learned about. healthcare workers of color are not excluded from the experiences of their communities outside of work. in fact, i assert that healthcare of color may have an additional burden of hesitation because of their lived experiences of distrust in receiving care and inequality within their professional environment. these dual traumas can work in tandem to strengthen hesitancy. i assert that building trusting clinical relationships will address hesitancy over time. currently, many healthcare workers are worried about vaccine mandates. for a group of people that have experienced intergenerational enslavement and marginalization, mandates feel coercive and serve as a reminder of how “lesser” bodies are considered unworthy of voice, fundamental human rights, independent decision making. to call the vaccine mandate paternalistic would be an understatement. an unintended result of vaccine mandates will be the reinforcement of hesitancy and distrust of the medical institution as trust and coercion cannot coexist. this mandate will give more power to the conspiracy theories and harm those who already do not seek or receive adequate health care because of systemic inequalities. furthermore, mandates can also dissuade people of color from becoming healthcare workers, and others may leave the field. in essence, vaccine hesitancy is a symptom of a much larger problem: the distrust of the medical establishment. as bioethicists, our mission should be to support interventions that foster “trustworthiness” of the institutions rather than those that cause trauma. several organizations have proposed mask mandates and weekly testing as a measure to protect the population at large and still respect the autonomy of the unvaccinated.15 hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) 4 iii. jennifer breznay i work in a very large community teaching hospital in brooklyn, and we were extremely hard hit by covid in march 2020. i worked on inpatient medical units and witnessed a lot of suffering. and after nine months of fear and despair about covid’s toll, i felt tremendous frustration in december when i heard that many healthcare workers would reject the vaccine. as the co-chair of the bioethics committee, i drafted a statement recommending vaccination for all employees. when the draft was revised and approved by the bioethics committee, i began to discuss it with employees, and i appreciated different perspectives i had not heard before. in the end, rather than releasing the statement, we directed our efforts at creating a dialogue. i also volunteer at a not-for-profit which operates seven early childhood education centers in northern brooklyn. the executive director invited me to collaborate on strategies to encourage staff vaccination, and we decided to offer a zoom conference to 20 members of the staff. i was extremely nervous about how the audience would perceive me, a white doctor whom they did not know. i felt awkward about coming to them with an agenda. and there was also the question of whether i was an appropriate messenger compared to a person of color. yet, i felt like i shouldn't back away from this. so, i chose to simply disclose my discomfort at the beginning of the zoom. i said, “thanks for having me. you know, as a white physician, i understand you might have concerns about trusting what i say. four hundred years of inequity and abuse by the healthcare system can create a lot of mistrust, but i’m here to try to answer your questions.” ultimately the executive director reported that the zoom was successful in stimulating a lot of conversation among the staff about the vaccine. i think the critical piece is the intimate but open conversation, where you can elicit values. iv. ashley l. stewart in the rural areas of our state, healthcare institutions are inextricably tied to their communities. rural hospitals hire from, serve, and function in the community where they are located. successful implementation of a vaccine roll-out in such rural areas requires explicit recognition of the role and influence of the community. after identifying issues common to the area, rural institutions can address them. even when rural institutions find that healthcare worker concerns seem to be unique or personal, they are often related to the larger concerns of the community.16 community-based increased vaccine hesitancy may coincide with an underlying issue, such as lack of information rather than principled or experience-based resistance.17 when the vaccines became available, rural vaccination coordinators encountered a wealth of misinformation that left many people initially undecided. compounding this lack of information, workers expressed a sense of fear about the professional consequences of voicing concerns, especially in tight-knit communities. many workers expressed concern about being judged merely for sharing their questions or decisions.18 they also felt that saying or doing something to promote the value of vaccination might change their relationship with members of the community where they live and work.19 as there was a fear of engaging in productive conversations, it was difficult for them to find valuable information, and the lack of information discouraged them from being vaccinated. vaccine coordinators wanted to get information to the entire community based on the most current research and release unbiased, consistent, and timely information from sources all people in the community could trust, including from multiple sources at once. communication must focus on answering many types of questions, which must often be done in private or anonymously. hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) 5 where poorly supported or incorrect information is widely available, sharing objective information is crucial to turning the tide of distrust. if the healthcare community dismisses concerns or assumes that answering questions based on misinformation is a waste of time, the community-based institutions will further the distrust. some may feel that vaccine coordinators should not address misinformation directly, yet avoidance has been widely unsuccessful.20 being respectful and non-judgmental in answering questions posed by people who do not know what is true can be hard, but in rural communities, answering completely and honestly without judgment is a critical component of any effort to inform people. telling people to get vaccinated “for the greater good” can sound the same as being told not to get a vaccine because it is “bad” if both sources of information fail to back up their claims. ultimately rural institutions are respected because they are a resource to their communities, a priority we must preserve. it is also critical to treat everyone respectfully regardless of vaccine status. 21 people may perceive mandates, divisive policies, or disrespectful treatment of people based on vaccination status as discriminatory or coercive, weakening the appeal of vaccination. such practices may make people less trusting and more anchored to their position as they come to see vaccination proponents as untrustworthy or authoritarian. we must work to maintain respect for human autonomy. using unethical means to achieve even a just end will not lead to a “greater good” but rather to the perception that people in positions of authority would achieve a result “by any means necessary.” v. david n. hoffman the central moral quandary that arises whenever vaccine hesitancy among healthcare workers is discussed is whether workers who refuse to get vaccinated should or could be fired. we should clarify that we are applying a definition of mandate in the employment context for private employers, the violation of which results in loss of employment. government-controlled provider organizations are just now weighing in on this topic and are generally pursuing strategies that impose periodic, usually weekly, testing requirements for those workers who decline to get vaccinated. in the private sector, employers can require their employees to do a great many things as a condition of employment, and one of them is to get vaccinated against covid -19. in the most prominent case to date, just such a mandate gave rise to a lawsuit in texas involving houston methodist hospital. in that case, 170 employees asserted that an employer should not be allowed to force them to get vaccinated. the judge held that, while no employer can force an employee to get vaccinated, no employer is obligated to continue the employment of any employee who declines to follow rules established by that employer, including the obligation to get vaccinated.22 in texas, what the judge said is you are not being forced to get vaccinated, but your employer is allowed to set limits and conditions on employment, including vaccination. employees do not have an obligation to get vaccinated, but they also have no right to their jobs. that is because of a widely misunderstood legal concept: “employment at will.” employment at will sounds like a rule that employees can do what they want at work, but in fact, employment at will means only that you can quit your job whenever you want (we do not permit indentured servitude). at the same time, your employer can fire you at any time, for any reason or no reason, unless the reason is a pretext and involves one of the protected statuses (race, color, religion, sex or national origin, and in some jurisdictions gender orientation, gender identity). generally, any employers, including hospitals, can decide that if someone is not willing to get a vaccination, or if they are not willing to complete sexual harassment training or participate in the hospital’s infection hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) 6 control program, that is the employee’s right, but it will mean that an employer can similarly decline to continue providing employment. the evolution of this hesitancy discussion will be influenced by the narrower debate playing out in the court of public opinion, and the courts of law, over the enforceability of new york’s recently enacted vaccine mandate. regardless of whether that mandate survives, with or without medical and religious exemptions, healthcare employers will be left with a profound ethical dilemma. at the end of all the litigation, if there is a religious exemption, employers will always be burdened with the responsibility to determine whether an individual employee has asserted a genuine and sincere religious objection to vaccination and whether the employer is able to provide an accommodation that is safe and effective in protecting the interests of co-workers and patients. the anticipated federal mandate, which reportedly will have a test/mask alternative, will only make this ethical task more challenging. this leads to the final point in this analysis, which is that while private employers, including hospitals, can deprive an individual of their employment if those individuals refuse to get vaccinated, just because an employer can do so does not mean it should do so.23 1 macdonald ne. vaccine hesitancy: definition, scope and determinants. vaccine. 2015;33(34):4161-4164. doi:10.1016/j.vaccine.2015.04.036 2 larson hj, de figueiredo a, xiahong z, et al. the state of vaccine confidence 2016: global insights through a 67-country survey. ebiomedicine. 2016;12:295-301. doi:10.1016/j.ebiom.2016.08.042 3 larson h. stuck: how vaccine rumors start and why they don’t go away. oxford university press; 2020; benjamin r. informed refusal: toward a justice-based bioethics. sci technol hum values. 2016;41(6):967-990. doi:10.1177/0162243916656059 4 deepa shivaram, in the fight against covid, health workers aren't immune to vaccine misinformation september 18, 2021. npr special series: the coronavirus. https://www.npr.org/2021/09/18/1037975289/unvaccinated-covid19-vaccine-refuse-nurses-heath-care-workers 5 crane jt, pacia d, fabi r, neuhaus c, and berlinger n. advancing covid vaccination equity at federally qualified health centers: a rapid qualitative review. accepted and awaiting publication at jgim. 6 ashley kirzinger. “kff/the washington post frontline health care workers survey vaccine intentions.” kff, 22 apr. 2021, https://www.kff.org/report-section/kff-washington-post-frontline-health-care-workers-survey-vaccine-intentions/. 7 johanna crane, samuel reis-dennis and megan applewhite. “prioritizing the ‘1a’: ethically allocating scarce covid vaccines to health care workers.” the hastings center, 21 dec. 2020, https://www.thehastingscenter.org/prioritizing-the-1a-ethicallyallocating-covid-vaccines-to-health-care-workers/. 8 “'i'm not an anti-vaxxer, but...' us health workers' vaccine hesitancy raises alarm.” the guardian, guardian news and media, 10 jan. 2021, https://www.theguardian.com/world/2021/jan/10/coronavirus-covid-19-vaccine-hesitancy-us-health-workers. 9 gerson m. if you are healthy and refuse to take the vaccine, you are a free-rider. washington post. april 15, 2021. 10 crane jt, pacia d, fabi r, neuhaus c, and berlinger n. advancing covid vaccination equity at federally qualified health centers: a rapid qualitative review. accepted and awaiting publication at jgim. 11 larson h. stuck : how vaccine rumors start and why they don’t go away. oxford university press; 2020. hoffman et al, vaccine hesitancy, voices in bioethics, vol. 7 (2021) 7 12 benjamin r. race for cures: rethinking the racial logics of ‘trust’ in biomedicine. sociology compass. 2014;8(6):755-769. doi:10.1111/soc4.12167; warren rc, forrow l, david augustin hodge s, truog rd. trustworthiness before trust — covid-19 vaccine trials and the black community. n engl j med. published online october 16, 2020. doi:10.1056/nejmp2030033 13 offri d. heidi larson, vaccine anthropologist. new yorker. published online june 12, 2021. accessed august 11, 2021. https://www.newyorker.com/science/annals-of-medicine/heidi-larson-vaccine-anthropologist 14 razai m s, osama t, mckechnie d g j, majeed a. covid-19 vaccine hesitancy among ethnic minority groups. bmj 2021; 372 :n513 doi:10.1136/bmj.n513 15 dasgupta, sharoda, et al. “differences in rapid increases in county-level covid-19 incidence by implementation of statewide closures and mask mandates — united states, june 1–september 30, 2020.” annals of epidemiology, vol. 57, sept. 2021, pp. 46– 53., https://doi.org/10.1016/j.annepidem.2021.02.006. 16 do, tuong vi c et al. “covid-19 vaccine acceptance among rural appalachian healthcare workers (eastern kentucky/west virginia): a cross-sectional study.” cureus vol. 13,8 e16842. 2 aug. 2021, doi:10.7759/cureus.16842; danabal, k.g.m., magesh, s.s., saravanan, s. et al. attitude towards covid 19 vaccines and vaccine hesitancy in urban and rural communities in tamil nadu, india – a community-based survey. bmc health serv res 21, 994 (2021). https://doi.org/10.1186/s12913-021-07037-4 17 scott c. ratzan md, mpa, ma, lawrence o. gostin jd, najmedin meshkati phd, cpe, kenneth rabin phd & ruth m. parker md (2020) covid-19: an urgent call for coordinated, trusted sources to tell everyone what they need to know and do, journal of health communication, 25:10, 747-749, doi: 10.1080/10810730.2020.1894015 18 huang, pien. “some health care workers are wary of getting covid-19 vaccines.” npr, npr, 1 dec. 2020, https://www.npr.org/sections/health-shots/2020/12/01/940158684/some-health-care-workers-are-wary-of-getting-covid-19vaccines. portnoy, jenna. “several hundred virginia health-care workers have been suspended or fired over coronavirus vaccine mandates.” the washington post, wp company, 4 oct. 2021, https://www.washingtonpost.com/local/covid-vaccine-mandatehospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html. 19 jennifer a. lueck & alaina spiers (2020) which beliefs predict intention to get vaccinated against covid-19? a mixed-methods reasoned action approach applied to health communication, journal of health communication, 25:10, 790-798, doi: 10.1080/10810730.2020.1865488 20 lockyer, bridget, et al. “understanding covid-19 misinformation and vaccine hesitancy in context: findings from a qualitative study involving citizens in bradford, uk.” health expectations, vol. 24, no. 4, 4 may 2021, pp. 1158–1167., https://doi.org/10.1101/2020.12.22.20248259. scott c. ratzan & ruth m. parker (2020) vaccine literacy—helping everyone decide to accept vaccination, journal of health communication, 25:10, 750-752, doi: 10.1080/10810730.2021.1875083. 21 zimmerman, anne. columbia academic commons, 2020, toward a civilized vaccination discussion: abandoning the false assumption that scientific goals are shared by all, https://academiccommons.columbia.edu/doi/10.7916/d8-rzh0-1f73. 22 bridges, et al v. houston methodist hospital et al, https://docs.justia.com/cases/federal/districtcourts/texas/txsdce/4:2021cv01774/1830373/18 23 david n. hoffman, “vaccine mandates for health care workers raise several ethical dilemmas,” hasting center bioethics forum. august 2021. https://www.thehastingscenter.org/vaccine-mandates-for-health-care-workers-raise-several-ethicaldilemmas/ https://www.npr.org/sections/health-shots/2020/12/01/940158684/some-health-care-workers-are-wary-of-getting-covid-19-vaccines https://www.npr.org/sections/health-shots/2020/12/01/940158684/some-health-care-workers-are-wary-of-getting-covid-19-vaccines griffin, conscientious objection of emergency contraception, voices in bioethics, vol. 8 (2022) * fiona griffin, ms candidate columbia university © 2022 fiona griffin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. conscientious objection to emergency contraception in the context of covid-19 fiona griffin* keywords: emergency contraception, covid-19, reproductive ethics, abortion, pregnancy, pharmacists, conscientious objection, rape-related pregnancy introduction emergency contraception is formally recognized as the only effective way to prevent pregnancy after sexual intercourse by the world health organization.1 the word emergency is used due to the brief time during which it is efficacious. it is useful only when administered within 72 hours of a sexual encounter.2 when pharmacists withhold emergency contraception, they permanently eliminate the only window of opportunity in which the emergency contraception can take effect. if patients do not find another source of contraception, they may become pregnant. yet, both abortion and pregnancy present more risks to patient health than emergency contraception.3 conscientious objection deserves heightened scrutiny. in light of both dobbs v. jackson women’s health organization4(allowing states to limit access to abortion) and the covid-19 pandemic, emergency contraception is an important tool that people must be able to access to prevent pregnancy. analysis so why are providers allowed to bar access to such invaluable care? conscientious objection is the refusal to perform a task because of a personal value or belief. conscientious objection to the dispensing of emergency contraception is legal in several states including idaho, arkansas, georgia, missouri, arizona, and south dakota. 5 there are no exceptions made for sexual assault. in texas, which also permits pharmacists to refuse to distribute emergency contraception, there were 13,509 forcible rape cases in 2020, the highest number in all fifty states.6 with many states imposing strict limits on accessing abortion care, emergency contraception is more important than ever. emergency contraception is also an important tool for people who oppose abortion for themselves, but whose health would be endangered by a pregnancy. conscientious objection to emergency contraception considering dobbs could be even more punitive to women who need or wish to avoid pregnancy. once pregnant, women in some states may have griffin, conscientious objection of emergency contraception, voices in bioethics, vol. 8 (2022) 2 few options. emergency contraception also avoids the moral conundrum that abortion creates for many pregnant women. avoiding pregnancy is generally far safer, simpler, and less morally charged than abortion care. advocates supporting conscientious objection frequently mistake emergency contraception for an abortifacient. however, emergency contraception does not terminate a pregnancy. instead, it prevents fertilization or implantation from occurring. some argue that distinction should negate religious rationales.7 however, religion is a common rationale for conscientious objection to providing emergency contraception. in the initial months of the government-mandated covid-19 lockdown, rates of sexual assault and rape escalated.8 rape crisis centers surveyed across the country reported a 40 percent increase in demand for their services. 9 societal repercussions of covid-19 include economic insecurity, social isolation, quarantine, and job loss, all of which have been associated with an increased risk for sexual assault.10 in the context of strained hospital resources and limited in-person medical and mental health resources, access to emergency contraception became increasingly important for sexual assault victims during the pandemic. several arguments have been set forth to justify placing limitations on conscientious objection.11 first, pharmacists choose to enter a profession bound by fiduciary duties. these duties demand that pharmacists respect the autonomy and dignity of individual patients. 12 a pharmacist that withholds emergency contraception is infringing on a patient’s autonomy. secondly, pharmacists are expected to prioritize the needs of their patients over their own. the principle of beneficence obligates clinicians to act in the interests of their patients.9 in the act of requesting emergency contraception, patients express their intentions and interests. a pharmacist’s denial of emergency contraception violates the principle of beneficence and directly counters patient interests. states allowing pharmacists to withhold emergency care risk contributing to increasing rates of unwanted pregnancies. they fail to recognize the wrongdoing to patients by prioritizing the rights of the withholding pharmacists over the rights of people seeking emergency contraception. denying patient access to emergency contraception neglects the principle of nonmaleficence, as this objection significantly compromises patient health. patients denied contraception after sexual assault face increased mental and physical health risks. covid-19 exacerbated the risk of psychological harms as social isolation impacted rates of anxiety and depression.13 covid-19 further exposed social and political unrest, racial and other forms of discrimination, and widening health disparities. 14 sexual and reproductive health services were scaled back and essential support services including hotlines, crisis centers, protection, and counseling services were disrupted. 15 the limitations disproportionately burdened patients who lack access to alternative healthcare channels.16 for example, patients in rural settings may not have access to the alternative healthcare channels available in metropolitan or suburban settings. counterarguments include that pharmacists deserve autonomy. forcing them to provide emergency contraception infringes the pharmacist’s ability to make an autonomous decision. however, emergency contraception is significantly different from other types of birth control pills due to the rushed timeframe. a pharmacists’ refusal to dispense emergency contraception imposes the pharmacist’s moral and social values on patients who are in immediate need of care. if pharmacists choose to prioritize their own social and moral values above their professional duties, they fail to fulfil their job obligations. one solution, or middle ground, would be allowing the objector to recommend a nearby pharmacy as long as there is one griffin, conscientious objection of emergency contraception, voices in bioethics, vol. 8 (2022) 3 that is open and convenient. many support that stance despite its inconveniencing the patient. other alternatives may entail pharmacists switching shifts to times when emergency contraception is least in demand or working in groups to avoid personally dispensing emergency contraception. yet, absent these simple alternatives, conscientious objection that causes a person to become pregnant who otherwise would not have is ethically impermissible. conclusion in conclusion, conscientious objection to emergency contraception should be eliminated, especially considering the other hardships posed by the pandemic. conscientious objection of emergency contraception under the circumstances of covid-19 is an unethical stance that violates the bioethical principles of autonomy, beneficence, nonmaleficence, and justice. 1 world health organization. 2014. “emergency contraception.” world health organization, november 28, 2014. https://www.who.int/reproductivehealth/topics/family_planning/ec/en/ 2 cu-iuds are highly effective as emergency contraception (283) and can be continued as regular contraception. upa and levonorgestrel ecps have similar effectiveness when taken within 3 days after unprotected sexual intercourse; however, upa has been shown to be more effective than the levonorgestrel formulation 3–5 days after unprotected sexual intercourse glasier af, cameron st, fine pm, et al. ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. lancet 2010;375:555–62. http://dx. doi. org/10. 1016/s0140-6736(10)60101-8external iconpubmedexternal icon. raymond e, taylor d, trussell j, steiner mj. minimum effectiveness of the levonorgestrel regimen of emergency contraception. contraception 2004;69:79–81. http://dx. doi. org/10. 1016/j. contraception. 2003. 09. 013external icon 3 american college of obstetricians and gynecologists. 2019. “access to emergency contraception.” acog, december 2019. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/07/access-to-emergency-contraception 4 597 us _ (2022) 5 national conference of state legislators. 2018. “pharmacist conscience clauses: laws and information.” national conference of state legislators, september, 2018. https://www.ncsl.org/research/health/pharmacist-conscience-clauses-laws-andinformation.aspx 6 statistica. 2021. “total number of forcible rape cases reported in the united states in 2020, by state.” statista, june 30, 2021. https://www.statista.com/statistics/232524/forcible-rape-cases-in-the-us-by-state/ 7 planned parenthood. 2016. “difference between the morning-after pill and the abortion.” planned parenthood, 2016. https://www.plannedparenthood.org/files/3914/6012/8466/difference_between_the_morningafter_pill_and_the_abortion_pill.pdf 8 katherine a. muldoon et al. “covid-19 pandemic and violence.” 9 taylor walker. 2020. “a second, silent pandemic: sexual violence in the time of covid-19.” primary care review, may 1, 2020. http://info.primarycare.hms.harvard.edu/review/sexual-violence-and-covid 10katherine a. muldoon et al. “covid-19 pandemic and violence.” bmc med, february 5, 2021. https://doi.org/10.1186/s12916020-01897-z 11 beauchamp tl, childress jf. principles of biomedical ethics, 5th ed. new york city, ny: oxford university press; 2001. https://www.who.int/reproductivehealth/topics/family_planning/ec/en/ https://www.cdc.gov/reproductivehealth/contraception/mmwr/spr/references.html http://dx.doi.org/10.1016/s0140-6736(10)60101-8 http://dx.doi.org/10.1016/s0140-6736(10)60101-8 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=20116841&dopt=abstract http://dx.doi.org/10.1016/j.contraception.2003.09.013 http://dx.doi.org/10.1016/j.contraception.2003.09.013 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/07/access-to-emergency-contraception https://www.ncsl.org/research/health/pharmacist-conscience-clauses-laws-and-information.aspx https://www.ncsl.org/research/health/pharmacist-conscience-clauses-laws-and-information.aspx https://www.statista.com/statistics/232524/forcible-rape-cases-in-the-us-by-state/ https://www.plannedparenthood.org/files/3914/6012/8466/difference_between_the_morning-after_pill_and_the_abortion_pill.pdf https://www.plannedparenthood.org/files/3914/6012/8466/difference_between_the_morning-after_pill_and_the_abortion_pill.pdf http://info.primarycare.hms.harvard.edu/review/sexual-violence-and-covid https://doi.org/10.1186/s12916-020-01897-z https://doi.org/10.1186/s12916-020-01897-z griffin, conscientious objection of emergency contraception, voices in bioethics, vol. 8 (2022) 4 12 ken baum and julie cantor. 2004. “the limits of conscientious objection – may pharmacists refuse to fill prescriptions for emergency contraception.” new england journal of medicine, november 4, 2004. https://www.nejm.org/doi/full/10.1056/nejmsb042263 13 min luo et al. 2020. “the psychological and mental impact of coronavirus disease 2019 (covid-19) on medical staff and general public a systematic review and meta-analysis.” psychiatry research, sep. 2020. https://doi.org/10.1016/j.psychres.2020.113190 14 tai, d., shah, a., doubeni, c. a., sia, i. g., & wieland, m. l. (2021). the disproportionate impact of covid-19 on racial and ethnic minorities in the united states. clinical infectious diseases: an official publication of the infectious diseases society of america, 72(4), 703–706. https://doi.org/10.1093/cid/ciaa815 ; chen, j. a., zhang, e., & liu, c. h. (2020). potential impact of covid-19-related racial discrimination on the health of asian americans. american journal of public health, 110(11), 1624– 1627. https://doi.org/10.2105/ajph.2020.305858; strassle, p. d., stewart, a. l., quintero, s. m., bonilla, j., alhomsi, a., santanaufret, v., maldonado, a. i., forde, a. t., & nápoles, a. m. (2022). covid-19-related discrimination among racial/ethnic minorities and other marginalized communities in the united states. american journal of public health, 112(3), 453–466. https://doi.org/10.2105/ajph.2021.306594; johnson-mann, c., hassan, m., & johnson, s. (2020). covid-19 pandemic highlights racial health inequities. the lancet. diabetes & endocrinology, 8(8), 663–664. https://doi.org/10.1016/s2213-8587(20)30225-4 15 elisabeth roesch et al. 2020. “violence against women during covid-19 pandemic restrictions.” bmj, may 7, 2020. https://doi.org/10.1136/bmj.m1712 16 delan devakumar et al. 2020. “racism and discrimination in covid-19 responses.” the lancet, april 1, 2020. https://doi.org/10.1016/s0140-6736(20)30792-3 https://doi.org/10.2105/ajph.2020.305858 https://doi.org/10.2105/ajph.2021.306594 https://doi.org/10.1016/s0140-6736(20)30792-3 kim, end-of-life care, voices in bioethics, vol. 6 (2020) * jiseop kim, ms candidate columbia university © 2020 jiseop kim. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. covid-19 tells us we have work to do in end-of-life care: a plea to improve medical education jiseop kim* keywords: medical education, palliative care, end-of-life care, medical students, covid-19 introduction the covid-19 pandemic uncovered the need to improve end-of-life training for doctors and medical students. with only .7 percent of physicians accredited with a palliative care license (about 6,000 out of 900,000 physicians in the us),1 other doctors need to fill in and “assuage the patients’ fears and physical symptoms, honestly and thoroughly.”2 doctors, regardless of what specialty they practice, should receive endof-life training so that they are prepared for pandemics like covid-19 or other disasters. many doctors treating terminally ill patients are unprepared to provide the same level of care as the trained physicians due to the lack of training and experience. analysis i. background a survey of us medical schools shows that palliative education is varied.3 the number of instruction hours offered for palliative care ranges from two to 80 hours. moreover, over half of the 51 medical schools in the survey reported occasional incorporation of end-of-life care into coursework that lasts only for a couple weeks. less than one third of medical schools reported offering a course or clerkship that is focused on the end of life.4 medical students interested in palliative care in schools with no reported palliative care course or rotation must actively seek seminars and visit hospices on their own time. insufficient time in a palliative care setting, lack of faculty expertise, and lack of funding toward palliative care make it challenging to integrate end-of-life care into the medical school curricula. 5 the pandemic has proven the importance of palliative care competency and that “it cannot be relegated” to minimal classroom time and random clinical exposures.6 senior medical students have reported that they feel much better prepared to care for dying patients after some formal training.7 kim, end-of-life care, voices in bioethics, vol. 6 (2020) 2 doctors have reported that the lack of experience and exposure makes them unprepared to take care of the terminally ill. they do not feel confident especially when assessing mental capacity.8 they describe their experiences in caring for patients at the end of life as, “being thrown in the deep end.”9 hospitals in the us promote the idea that healthcare is about treating people to keep them alive. the culture does not encourage doctors or medical students to learn about palliative care. 10 notably, medical students have stated that hospital culture portrays death as a “taboo” and equates it to a failure.11 most healthcare providers state that if they do learn effective palliative care, it is through “trial and error” while “doing the job.”12 clinicians who use guesswork potentially could provide unwanted interventions or fail to meet the needs of their patients creating unnecessary suffering. ii. covid-19 palliative care the demanding conditions and limited resources resulting from the covid-19 pandemic force doctors to do more guesswork in treating their patients. real patients tend to be different from model patients in medical textbooks. for example, a doctor can have “an elderly patient in respiratory failure who has hypertension, diabetes, and cancer… there are studies that offer prognostic or therapeutic insights into several of these demographics but rarely all of them at once.”13 even if there were no covid-19 pandemic, most new doctors would need to make fast and accurate decisions despite limitations of the educational setting. with covid-19 a hands-on education in end-of-life care is crucial. with the rapidly deteriorating conditions of patients and severely limited resources during the pandemic, even trained palliative care physicians face challenges to effectively deliver treatment. clinicians claim that making quick decisions based on short discussions is challenging. “across the country, coronavirus has disrupted normal palliative care measures. conversations are much more abbreviated.”14 while palliative doctors are finding new challenges, those without training are encountering more severe challenges. the “coronavirus disease 2019 shared decision making tool” provides useful information. for instance, it asks physicians to assess the likelihood of survival and to ask patients whether they have advanced directives. while guidelines can help, a thorough education would complement all available guidelines. providing comprehensive education around palliative care will help familiarize doctors with the range of guidelines and specific palliative care issues like pain management, patient requests, shared family decision making, legal rights, and medical choices. “in the new era of covid-19, the protocols aren’t clear. some hospitals are considering a do-not-resuscitate (dnr) order for all infected patients.”15 dedicated palliative care, and in some cases, hospice, is not available for covid-19 patients because of limited facilities. some healthcare facilities are completely ignoring patients’ wishes to be treated at all. the lack of physicians trained in palliative care available to consult coupled with a lack of clear guidelines leads to rash decisions, which can risk the life of patients. doctors need to understand conditions necessary to ensure that consent is explicit and made with a complete understanding of treatment options even if almost every treatment is palliative or experimental. clinicians emphasize the “need to be able to communicate effectively with patients and their families early on to understand their wishes and be able to provide high-quality palliative care in the intensive care unit (icu) and eventually hospice, given the shortage of resources.”16 patients are making decisions based on their own interpretations of statistics and fear when doctors do not meet patients’ end-of-life needs. there is not enough guidance for patients to make proper, well-informed decisions. the lack of time and resources should not kim, end-of-life care, voices in bioethics, vol. 6 (2020) 3 hinder the decision-making process and cause patients to make decisions that are contrary to their interests or beliefs. many doctors have used media and literature to argue that there is a need for more people to write advanced directives during this time.17 doctors must inform patients of all of their options so that patients and their lawyers or assigned hospital administrators can ensure documentation reflects the patients’ preferences. patients base end-of-life decisions on how dire their prognosis is, something only the doctor can convey and discuss. therefore, it is important for doctors to have an end-of-life skillset. iii. the disconnect: doctors treating covid-19 are not prepared enough for end-of-life discussions with patients for doctors to better understand end-of-life issues, medical schools must define basic palliative care competencies and integrate them into the medical school curriculum. in surveys, many healthcare providers have stated that they struggle to have end-of-life discussions with patients and family members.18 adding palliative care training in medical school should further a future physician’s ability to devise treatment methods to serve the patients’ best interests. additionally, medical schools and health organizations must work together to increase funding for courses covering palliative care to encourage basic competency among a broader array of doctors. by reserving palliative care training for those pursuing it as a specialty, schools allow general medical students to graduate without the minimum level of competency necessary. the media have also reported the availability of palliative care hotlines for potential patients during covid19.19 many doctors have complained that the use of these hotlines is difficult because identifying cues doctors usually notice in person is challenging over the phone. 20 therefore, there is a need to train students to communicate with their patients over the phone or through video. there must be a user-friendly system that allows physicians to discuss pressure and stress with their peers whether it be through clinical meetings or through hospital vlogging networks. increased social support for doctors will ensure that they are not “thrown into the deep end.” 21 support systems should also allow clinicians to inquire about their cases. ongoing workshops, continuing education classes, and professional seminars or webinars must provide contemporaneous training for doctors inexperienced in palliative care thrust into covid-19 care. some may argue that palliative training for all doctors is unnecessary since the pandemic is an unusual situation and such a large number of deaths in a short period is unprecedented. while some doctors may never use their palliative training, the pandemic has shown the danger of being unprepared. stakes are high in a crisis, and the benefits of training every doctor outweigh the costs. doctors take many classes outside of their specialties that might not be put to use. basic competency in many areas is part of well-rounded core training necessary to be a doctor. furthermore, almost all doctors will encounter palliative issues at some point. absent covid-19, an ability to discuss death, priorities, and treatment options with patients is a basic medical skill that every doctor should have. some argue that palliative care is worse due to scarcity: if we had enough ventilators, facilities, and ppe, the issues would be resolved. however, the scarcity issue should be separated from physician training, education, and preparation. regardless of scarcity, doctors lacking skills central to their profession are failing to communicate end-of-life options effectively. kim, end-of-life care, voices in bioethics, vol. 6 (2020) 4 conclusion physicians must provide the best palliative care possible at a time when people need their healthcare providers the most: near the end of their lives and during times of extreme suffering. improved education will allow doctors to master approaches that meet patients’ and families’ goals and expectations. medical school education is central to the us system and palliative care must become a priority in the curriculum. if doctors are graduating without the basic skills surrounding end-of-life care, the us system will remain weak, especially in times of crisis. 1 association of american medical colleges. “active physicians with a u.s. doctor of medicine (u.s. md) degree by specialty, 2017.” december 2017. https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-mddegree-specialty-2017. kolbe, laura. “coronavirus has given doctors a new job: palliative care.” the washington post. april 23, 2020. https://www.washingtonpost.com/outlook/2020/04/23/coronavirus-has-given-doctors-new-job-palliative-care/. 2 kolbe, laura. “coronavirus has given doctors a new job: palliative care.” the washington post. april 23, 2020. https://www.washingtonpost.com/outlook/2020/04/23/coronavirus-has-given-doctors-new-job-palliative-care/. 3 horowitz, robert, robert gramling, timothy quill. “palliative care education in us medical schools.” medical education 48, no. 1 (january 2014): 59-66. https://onlinelibrary.wiley.com/doi/abs/10.1111/medu.12292. 4 horowitz, p. 60 5 horowitz, p. 61 6 horowitz, p. 62 7 horowitz, p. 63 8 campbell, ruth. “lessons learnt about end of life care.” the bmj 359, (november 2017). https://doi.org/10.1136/sbmj.j2929. 9 campbell p. 1 10 gibbins, jane, rachel mccoubrie, karen forbes. “why are newly qualified doctors unprepared to care for patients at the end of life?” medical education 45, no. 4 (april 2011): 388-99. https://www.ncbi.nlm.nih.gov/pubmed/21401687. 11 gibbins, p. 394 12 gibbins, p. 398 13 kolbe, “coronavirus has given doctors a new job.” 14 smith, alex. “palliative care on the front lines of covid: podcast with darrell owens.” geripal. march 23, 2020. https://www.geripal.org/2020/03/palliative-care-on-front-lines-of-covid.html. 15 gold, jessica, shoshana ungerleider. “it’s time to get serious about end-of-life care for high-risk coronavirus patients.” time. march 30, 2020. https://time.com/5812073/endof-life-coronavirus/. https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2017 https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2017 https://www.washingtonpost.com/outlook/2020/04/23/coronavirus-has-given-doctors-new-job-palliative-care/ https://www.washingtonpost.com/outlook/2020/04/23/coronavirus-has-given-doctors-new-job-palliative-care/ https://onlinelibrary.wiley.com/doi/abs/10.1111/medu.12292 https://doi.org/10.1136/sbmj.j2929 https://www.ncbi.nlm.nih.gov/pubmed/21401687 https://www.geripal.org/2020/03/palliative-care-on-front-lines-of-covid.html https://time.com/5812073/endof-life-coronavirus/ kim, end-of-life care, voices in bioethics, vol. 6 (2020) 5 16 gold, jessica, “it’s time to get serious about end-of-life care.” 17 span, paula. “do you want to die in an i.c.u.? pandemic makes question all too real.” the new york times. april 24, 2020. https://www.nytimes.com/2020/04/24/health/coronavirus-icu-advanced-directives.html. 18 horowitz, p. 63 19 stone, will. “coronavirus disrupts hard decisions about end-of-life treatment.” npr. april 30, 2020. https://www.npr.org/2020/04/30/848179318/coronavirus-disrupts-hard-decisions-about-end-of-life-treatment. 20 stone “coronavirus disrupts hard decisions about end-of-life treatment.” 21 campbell, p. 1 https://www.nytimes.com/2020/04/24/health/coronavirus-icu-advanced-directives.html https://www.npr.org/2020/04/30/848179318/coronavirus-disrupts-hard-decisions-about-end-of-life-treatment moorthy, the care children deserve, voices in bioethics, vol. 7 (2021) * gyan moorthy, ms candidate columbia university © 2021 gyan moorthy. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the care children deserve: some thoughts on the effort to open a children’s hospital in el paso, tx gyan moorthy* keywords: children’s hospitals, immigrants, children, primary care, underserved introduction i. the need for a children’s hospital el paso, texas did not receive a children’s hospital until 2012, much later than would be expected given its demographics and geographic isolation. by that time, there were already nearly 250 children’s hospitals spread across the united states, some in areas far smaller, far older, and in far closer proximity to other urban centers.1 without accounting for its substantial population of undocumented immigrants,2 el paso is the country’s 22nd largest city (and situated in its 70th most populous county).3 the nearest american city of comparable size is phoenix, az, located about 350 miles away. moreover, el paso has a decidedly young demographic skew: more than 28 percent of the population is under the age of 18, compared to 26.5 percent of the population in texas and 23.1 percent of the population nationally.4 this gap is expected to widen in the coming years.5 el paso children also have less access to care than children in cities with comparable populations and population structures. though the situation has improved in the last decade, el paso contains several health professional shortage areas (hpsas) for primary care, dental health, and mental health. this is in addition to many medically underserved areas (muas) for primary care, specialty care, dental health, and mental health.6 this means that el paso children wait longer for their appointments and are often seen by tired and overworked providers. before the el paso children’s hospital (epch) opened its doors, if these children needed advanced care, they had to leave the city, and many simply did not have the resources to do so. it is more difficult to assess the quality of the care that they were able to receive locally, as few systematic reviews of pediatric outcomes in the region were conducted during that period. nevertheless, several el paso physicians look back and describe an “unacceptably low” standard of care.7 regardless, access and quality are interrelated, and children’s hospitals tend to promote both.8 moorthy, the care children deserve, voices in bioethics, vol. 7 (2021) 2 ii. why did it take so long? there are several reasons why el paso did not receive a children’s hospital until years after the need for it became apparent to forward-thinking physicians and other interested parties, including select parent groups. a) there were no wealthy benefactors willing to establish a children’s hospital endowment, forcing the hospital’s proponents to ask the taxpayers to issue $120 million in bonds for the project.9 however, el paso is fairly poor. the median annual household income is approximately $42,000, more than $17,000 below the state average and $25,000 below the national average.10 property values are low, and texas does not do much to redistribute funds from wealthier to poorer parts of the state, so resources for community development are limited and spending priorities must be chosen carefully. b) the wealthier, less-hispanic parts of el paso were reluctant to fund a project that was billed primarily as a means of assisting poor, hispanic children. c) two previous children’s hospital projects had fallen through after their for-profit sponsors pulled out, and some el pasoans were hesitant to try again. d) tenet healthcare, the owners of el paso’s largest for-profit hospital network, opposed the project. they feared competition for the basic services they provided in their “children’s wing,” and perhaps knew that they might no longer get away with providing substandard pediatric care. when, over their objections, the project appeared on the ballot they launched a vigorous advertisement campaign against it. some physicians joined them. e) low levels of education and civic engagement in el paso, coupled with an underdeveloped sense of entitlement, led to complacency. there was a lack of political will for a big project like the children’s hospital because many el pasoans did not think that they deserved better than what they were getting. they were accustomed to a certain quality of care and a certain level of access to care. if they were not content with the status quo, they were at least tolerant of it. this last point is worth elaborating upon. fewer than 24 percent of el pasoans complete a bachelor’s degree, compared to nearly 32 percent of texans and nearly 35 percent of americans.11 the city’s high school graduation rate is just above 75 percent, nearly 10 percent below the corresponding national and state rates.12 additionally, the majority of available jobs are low-paying and physically demanding, so many welleducated el pasoans choose to make their lives elsewhere (“brain drain”).13 poverty and limited english proficiency compound upon low levels of education to lower access to the instruments of democracy and erode democratic culture, and they make the population more susceptible to manipulation by powerful interests – on any side. tenet healthcare’s advertising campaign was better funded than the campaign for the children’s hospital, and physicians and experts lined up on both sides which created confusion. in addition, and perhaps counterintuitively, given el paso’s poor and largely hispanic population (>80 percent),14, 15 trust in the healthcare system is high.16 one possible explanation is exceptional quality of care, though all the facts suggest this is not the case. other explanations include a high degree of physician-patient ethnic concordance, a cultural deference to authority and underentitelment, that is, the belief that one deserves less than what dispassionate others conclude s/he deserves. any population can grow accustomed to the status quo and poverty, lack of education, and membership in an otherwise vulnerable group can prevent information filtering in from outside the city – nationwide trends – from really “taking hold.” moorthy, the care children deserve, voices in bioethics, vol. 7 (2021) 3 however, in el paso, the situation is still more complicated. many el pasoans have family in mexico and cross the border regularly for shopping or recreation. in many ways, el paso and ciudad juárez form a single community, and even el pasoans who have been in the country their entire lives tend to maintain a strong connection to mexico. this is relevant because the quality of medical care in mexico (though improving) is low,17 and expectations for what the government (or any large entity) will do for the common man lower still.18 el paso voters ultimately made the decision to fund the construction of a children’s hospital, though by a margin of less than 2 percent and with fewer than 12 percent of eligible voters weighing in.19 the el paso children’s hospital has more than delivered on its community health improvement promises. it has reduced pediatric outmigration for subspecialty and surgical care by more than 80 percent, substantially increased the county’s physician workforce, and launched several successful preventive health and health education programs. in addition, it has promoted cutting-edge research on a slew of pediatric conditions and helped to increase the city’s physician retention rate.20 but there have been some serious hiccoughs along the way, including a bankruptcy crisis in 2015 that caused almost half of the hospital’s board to resign,21 and there is still a lot of work to be done.22 iii. a better approach to building children’s hospitals the difficulty in opening a children’s hospital in el paso serves as an important starting point for a discussion on the principles of ethical governance. most agree that when the private sector fails to address an important community need, it is the responsibility of the government to intervene. however, people differ on what they consider an “important community need” and the precise role of government in filling needs. they may also prefer that government intervention occur at the local, state or federal level, or some combination of the three, depending on the issue before them. five separate feasibility studies were conducted in the lead-up to the 2007 vote. all agreed that el paso needed a children’s hospital.23 ,but none discussed how much it needed a children’s hospital, i.e., what tradeoffs would be appropriate for the community to make in order to build one. nor could they. people will always prioritize differently. perhaps a delay in funding a children’s hospital would allow for a restructuring of the school system. americans usually prefer to decide such issues at the ballot box, either directly or through their representatives. however, for projects like a children’s hospital, where not all community members are informed enough on the pertinent issues to perform a cost/benefit analysis, and the risks of not acting can be severe, some other mechanism, or some supplementary mechanism, of deciding on the issue is more appropriate. in determining whether and what types of state intervention are justified, ethicists weigh several competing concerns: beneficence (the good that is likely to come to the community, folding in the harm to certain stakeholders), justice (in this case, for children, in terms of access to and quality of care) and autonomy (of the voters). however, in many communities across the country, after the need for a children’s hospital is demonstrated24 if local voters and their representatives weigh in at all, it need only be to decide on zoning and other logistical issues because wealthy benefactors are willing to foot the bill.25 in communities like el paso, where no such benefactors make themselves known, voters or their representatives are asked to make a much more difficult decision: whether to fund a children’s hospital by raising taxes on themselves. that may not be fair to them, especially if their community is already poor, and it is certainly not fair to the children whose health and quality of life are at stake. moorthy, the care children deserve, voices in bioethics, vol. 7 (2021) 4 though el paso did eventually vote to fund a children’s hospital, similarly situated communities may vote differently, and their children could suffer as a result, just as el paso children suffered during the delay. communities like el paso may also be in a poor position to make truly autonomous decisions on this issue. poverty and lack of education can lead to confusion or ambivalence owing to lack of information or access to the tools necessary to become informed. for-profit hospital chains unwilling to establish their own children’s hospitals, and others who stand to lose out, can use their considerable power to unduly influence the debate, which can also be inaccurately cast as one about redistributing resources from wealthy white households to poor, “undeserving” ethnic minorities. but one need not accept an argument about diminished community autonomy to conclude that some form of state or federal intervention to tip the scales on specific children’s hospital projects is ethically permissible. this is partially because the autonomy concern, with respect to the children’s hospital issue, is a red herring. as noted above, voters and local officials in most communities barely weigh in on children’s hospital projects at all. projects which, it is important to stress, concern the welfare of a non-voting vulnerable group and so maybe should not be subject to majoritarianism to begin with! moreover, if a state or the federal government were to establish a uniform process for determining whether a community needs a children’s hospital, e.g. delegating authority to a health planning agency that performs regular and transparent health infrastructure assessments and proactively issues “certificates of need” (as opposed to issuing them only after an application by interested parties), the democratic process is respected more than if a children’s hospital were simply foisted upon a community by wealthy benefactors. if the state or federal government were also to help qualifying local communities obtain their children’s hospitals, much local hesitancy about the hospital would shrink. one may wonder whether this is just “kicking the problem up to another level of government.” there is, after all, no assurance that political will for building children’s hospitals in needy communities will be higher at the state or federal level than at the local level. it may even be lower, as state and federal officials are more emotionally removed from the conditions on the ground. however, a key difference is that the reliance on a single governmental agency – one that has the resources to perform thorough, less biased assessments – removes a lot of the extraneous variables with bearing on the success of a children’s hospital project. such an agency focuses only on the first part of the project, establishing that the hospital is necessary. this is a lower hurdle to clear, and it provides momentum for the next parts of the process, which may include varying degrees of state or federal government intervention, all of which could also be managed by a different agency. this system also makes capture by powerful interests difficult. not only do these interests often appear less powerful at the state or federal level than locally, but a health planning agency applies objective criteria in making its determinations, and the next steps occur “in a different house.” finally, state or federal involvement leads to parity across communities and sounder resource management because children’s hospitals generally serve areas outside the communities in which they are situated. once a certificate of need has been issued to a community indicating that it needs a children’s hospital, the state26 may (1) build the hospital using its own funds or funds appropriated to it for that purpose by the federal government or (2) let the local community take the lead, providing subsidies on a sliding scale to ensure that the communities which struggle to afford a children’s hospital still get one. for a variety of political and budgetary reasons, this latter route is more realistic, and it has the advantage of building local community buy-in, which could be important if the children’s hospital is to successfully recruit personnel, moorthy, the care children deserve, voices in bioethics, vol. 7 (2021) 5 receive referrals from local physicians and actively participate in the local medical education/research enterprises. a certificate of need issued by an impartial government agency as part of its mandate might itself be enough to persuade a local community to take action. it could spur proponents to organize, if they had not done so earlier, and could be used as ammunition in their advertisement campaigns. but if the community is still apathetic or hesitant, the state can launch educational initiatives, including those aimed at changing underentitlement, and help it negotiate with for-profit hospital chains to see if they can be incentivized to take a children’s hospital project on. the state may also consider issuing different types of certificates of need and, for the highest level, require that the community build a children’s hospital, in the same way that it (often) requires it to have police or fire protection. subsidies would almost certainly have to be offered for this to be politically viable (and ethically acceptable). conclusion there are several issues with this framework, including precisely how a financially infeasible but necessary children’s hospital can be made feasible. details will have to be filled in. nevertheless, it is something worth investigating. it could significantly improve the current situation, in which communities like el paso are essentially left to fend for themselves. disclaimer: the author has family associated with the el paso children’s hospital. chetan moorthy and sadhana chheda are his parents. chheda served as board secretary and works at children’s as a neonatologist. moorthy contracts with children’s to provide radiology services. both have practiced in el paso for decades, and their experience is drawn upon to support some of the article’s claims, particularly those for which no hard data has been collected. 1 casimir, georges. 2019. “why children’s hospitals are unique and so essential.” frontiers in pediatrics 7 (july). https://doi.org/10.3389/fped.2019.00305. 2 pew research center’s hispanic trends project. 2019. “metro area u.s. unauthorized immigrant population estimates, 2016 and 2007.” pew research. march 11, 2019. https://www.pewresearch.org/hispanic/interactives/unauthorized-immigrants-bymetro-area-table/. 3 “city and town population totals: 2010-2019.” 2020. united states census bureau. https://www.census.gov/data/tables/timeseries/demo/popest/2010s-total-cities-and-towns.html. 4 “el paso, texas: demographic profile.” 2017. eptx. 2017. https://www.elpasotexas.gov/economic-development/businessservices/data-and-statistics/population. 5 “community health needs assessment 2014.” 2014. el paso children’s hospital. https://elpasochildrens.org/wpcontent/uploads/2019/08/epch-chna-report-final-9-29-14-v3.pdf. 6 ibid. 7 moorthy, chetan, and sadhana chheda. 2020. conditions in el paso, texas: physician services and patient perceptions. interview by gyan moorthy. in-person. 8 “all children need children’s hospitals.” n.d. national association of children’s hospitals and related institutions. accessed november 29, 2020. https://www.upstate.edu/gch/pdf/academics/allchildren.pdf. https://doi.org/10.3389/fped.2019.00305 https://www.pewresearch.org/hispanic/interactives/unauthorized-immigrants-by-metro-area-table/ https://www.pewresearch.org/hispanic/interactives/unauthorized-immigrants-by-metro-area-table/ https://www.census.gov/data/tables/time-series/demo/popest/2010s-total-cities-and-towns.html https://www.census.gov/data/tables/time-series/demo/popest/2010s-total-cities-and-towns.html https://www.elpasotexas.gov/economic-development/business-services/data-and-statistics/population https://www.elpasotexas.gov/economic-development/business-services/data-and-statistics/population https://elpasochildrens.org/wp-content/uploads/2019/08/epch-chna-report-final-9-29-14-v3.pdf https://elpasochildrens.org/wp-content/uploads/2019/08/epch-chna-report-final-9-29-14-v3.pdf https://www.upstate.edu/gch/pdf/academics/allchildren.pdf moorthy, the care children deserve, voices in bioethics, vol. 7 (2021) 6 9 schalden, mary. 2015. “children’s hospital timeline.” el paso times, october 5, 2015. https://www.elpasotimes.com/story/news/2015/10/05/childrens-hospital-timeline/73394588/. 10 “el paso, texas: demographic profile.” 2017. 11 ibid. 12 “high school graduation rate data for el paso, tx.” 2018. open data network. 2018. https://www.opendatanetwork.com/entity/1600000us4824000/el_paso_tx/education.graduation_rates.percent_high_school_g raduate_or_higher?year=2018. 13 anderson, lindsey. 2015. “more people leave el paso for elsewhere than other major cities.” el paso times, july 22, 2015. https://www.elpasotimes.com/story/news/local/2015/07/22/more-people-leave-el-paso-elsewhere-than-other/71987220/. 14 “el paso, texas: demographic profile.” 2017. 15 armstrong, katrina, karima l. ravenell, suzanne mcmurphy, and mary putt. 2007. “racial/ethnic differences in physician distrust in the united states.” american journal of public health 97 (7): 1283–89. https://doi.org/10.2105/ajph.2005.080762. 16 moorthy, chetan, and sadhana chheda. 2020. 17 barber, ryan m., nancy fullman, reed j. d. sorensen, thomas bollyky, martin mckee, ellen nolte, amanuel alemu abajobir, et al. 2017. “healthcare access and quality index based on mortality from causes amenable to personal health care in 195 countries and territories, 1990–2015: a novel analysis from the global burden of disease study 2015.” the lancet 390 (10091): 231–66. https://doi.org/10.1016/s0140-6736(17)30818-8. 18 lagos, lorenzo felipe. 2012. “institutional trust: the case study of mexican state institutions.” student perspectives on institutions, choices, and ethics 7 (4): 39. 19 “final election results (2007).” 2007. el paso county elections department. https://el-paso-countyelections.s3.amazonaws.com/documents/files/000/000/300/original/election_results_final.pdf?1450312070. 20 “2018 annual community benefit report.” 2018. el paso children’s hospital. https://elpasochildrens.org/wpcontent/uploads/2018/11/epch_communityreport_2018_small.pdf. 21 flores, aileen b. 2015. “taxpayers still owe $116m for construction of el paso children’s hospital.” el paso times, may 27, 2015. https://www.elpasotimes.com/story/news/local/2015/05/27/taxpayers-still-owe-116m-construction-childrenshospital/31261601/. 22 moorthy, chetan, and sadhana chheda. 2020. 23 “history of el paso children’s hospital.” 2020. el paso children’s hospital. 2020. https://elpasochildrens.org/about-us/. 24 in many states, a “certificate of need” must be obtained before new healthcare facilities can be created. see mercatus center. 2015. “how state certificate-of-need (con) laws affect access to health care.” medium. december 23, 2015. https://medium.com/concentrated-benefits/how-state-certificate-of-need-con-laws-impact-access-to-health-care-b8d3ec84242f for more. certificates of need may slow the founding of hospitals in some areas, but they could also spur it when political will is low or absent. 25 moorthy, chetan, and sadhana chheda. 2020. 26 given federal/state separation of powers, it is very unlikely that the federal government would be directly involved at this step. https://www.elpasotimes.com/story/news/2015/10/05/childrens-hospital-timeline/73394588/ https://www.opendatanetwork.com/entity/1600000us4824000/el_paso_tx/education.graduation_rates.percent_high_school_graduate_or_higher?year=2018 https://www.opendatanetwork.com/entity/1600000us4824000/el_paso_tx/education.graduation_rates.percent_high_school_graduate_or_higher?year=2018 https://www.elpasotimes.com/story/news/local/2015/07/22/more-people-leave-el-paso-elsewhere-than-other/71987220/ https://doi.org/10.2105/ajph.2005.080762 https://doi.org/10.1016/s0140-6736(17)30818-8 https://el-paso-county-elections.s3.amazonaws.com/documents/files/000/000/300/original/election_results_final.pdf?1450312070 https://el-paso-county-elections.s3.amazonaws.com/documents/files/000/000/300/original/election_results_final.pdf?1450312070 https://elpasochildrens.org/wp-content/uploads/2018/11/epch_communityreport_2018_small.pdf https://elpasochildrens.org/wp-content/uploads/2018/11/epch_communityreport_2018_small.pdf https://www.elpasotimes.com/story/news/local/2015/05/27/taxpayers-still-owe-116m-construction-childrens-hospital/31261601/ https://www.elpasotimes.com/story/news/local/2015/05/27/taxpayers-still-owe-116m-construction-childrens-hospital/31261601/ https://elpasochildrens.org/about-us/ https://medium.com/concentrated-benefits/how-state-certificate-of-need-con-laws-impact-access-to-health-care-b8d3ec84242f hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) * david n. hoffman, jd, lecturer in bioethics, columbia university, general counsel, claxton hepburn medical center anne zimmerman, jd fordham university, ms bioethics columbia university, editor-in-chief voices in bioethics camille castelyn, mdiv theology and ethics, phd health ethics university of pretoria, ms bioethics candidate columbia university srajana kaikini, phd, assistant professor of philosophy, krea university © 2022 hoffman et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. expanding the duty to rescue to climate migration david n. hoffman, anne zimmerman, camille castelyn, srajana kaikini* abstract since 2008, an average of twenty million people per year have been displaced by weather events. climate migration creates a special setting for a duty to rescue. a duty to rescue is a moral rather than legal duty and imposes on a bystander to take an active role in preventing serious harm to someone else. this paper analyzes the idea of expanding a duty to rescue to climate migration. we address who should have the duty and to whom the duty should extend. the paper discusses ways to define and apply the duty to rescue as well as its limitations, arguing that it may take the form of an ethical duty to prepare. keywords: duty to rescue, climate migration, climate change, vulnerable, refugees, global introduction climate migration creates a special setting for a duty to rescue. a duty to rescue is a moral rather than legal duty and imposes on a bystander to take an active role in preventing serious harm to someone else. examples of circumstances range from person-to-person intimate rescue to saving those in poverty, even in distant parts of the world.1 since 2008, an average of twenty million people per year have been displaced by weather events. 2 circumstances like being thrust from homes under the threat of fire, mudslide, and flooding vary greatly from long-term changes like land becoming too arid for crops or temperatures increasing annually gradually pushing up the number of heat-related deaths, with the area slowly becoming uninhabitable. imminence in fleeing affects resettling and need for rescue with important implications for how the duty to rescue might apply. hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 2 this paper reevaluates the ethical framing of the duty to rescue and, while it is arguably a stretch, applies it to climate migration. climate migration has become common and is expected to increase due to rises in sea level, increases in weather events that make areas uninhabitable, and changes to land that preclude farming or other necessary land uses. we argue that a duty to rescue may help highlight who has moral obligations to whom. because the problem is so large in scope, we suggest a change in the ethical limits to humans' duty to rescue other humans who are in distress. we imagine an expansion or extension of the duty to rescue to meet some of the basic needs created by climate migration. yet how it should expand, and how much depend on ethical framing and practical limitations. i. expanding the geographical boundaries two commonly recognized emergencies, hurricane katrina in the case of weather events and the current covid-19 pandemic, provide a historical and current backdrop to evaluate ethical obligations as more disasters displace people. a significant reassessment of the ethical scope of an obligation to rescue in the case of weather events will be limited by the ability to render aid to those in distress in the case of a planetwide weather catastrophe. the problems may overwhelm the ability to rescue or the reasonableness of attempting rescue. the extent of the moral obligation borne by humans to other humans in the case of a weather event has been largely defined by its locality and limited geographic influence. whether we are imagining the scope of ethical obligation in the case of hurricane, flood, tornado, drought, or wildfire events, the perceived ethical obligation is significantly defined by the limited impact of these weather events on people outside the zone of the weather event's direct impact, yet close to that zone. a hurricane affecting new orleans will not have immediate impact on the residents of california or even those on the northeast coast of the united states until a later time. wildfires in the pacific northwest do not impair the ability of those in the rest of the country to come forward with assistance. but as climate migration crosses international borders, and climate events occur simultaneously in many regions, a more expansive duty to rescue may provide the ethical impulse to help those who live afar or migrate long distances. in this respect, the need for help in the event of widespread climate migration due to global warming is more like a pandemic than a weather event. its broad impact area diminishes the capability of nearly the entire balance of the human population to help due to those populations' awareness that they will, in short order, have the same need for the same resources, from the same cause. those living near current flood zones may find their historically safe havens are also a flood zone. those previously best positioned to rescue may find themselves also needing to relocate. thus, we may observe the need for new rescuers. ii. the rule of rescue the rule of rescue as defined by al jonsen describes the moral impetus or knee jerk reaction to save identifiable people facing death.3 a duty to rescue has since been expanded beyond imminent death and beyond the near and identifiable. but there are limitations. for example, by most accounts, the ethical duty tends not to require extreme bodily risk or financial depletion. in comparing good samaritans to humanitarians, scott m. james argues the duty to rescue arises from unique dependence, but the ethical obligation to help strangers through humanitarian aid is of a different nature.4 the wrongness of failing to help is arguably more egregious when one is in a unique position to help. like in the tragedy of the commons, where there is no unique positioning, when the global community is called upon to help, each individual in it may feel less obliged to do so. climate migration falls in between—it requires helping strangers, yet it may move forward without anyone seeing themselves as uniquely positioned to help until hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 3 those strangers become part of communities, at which time, there may be more moral justification to help a community member in need. generally, arguments about good samaritans hinge on extraordinary acts, praiseworthy because they are acts of compassion, not obligation. now all us states have good samaritan laws5 which protect helpers from liability for help gone wrong or for a failure to succeed once engaged in an act of rescue. extraordinary help as a moral good is thus somewhat encouraged through legal protection, but not imposed. conversely, jobs like firefighting, search and rescue, and emergency medical care tend to oblige employees to take on risks that would be extraordinary if undertaken by the average bystander, yet they are rendered ordinary rescue as part of the job. three states, minnesota, rhode island, and vermont have a broad duty to rescue, adding legal considerations to an otherwise moral conundrum. the laws do not require bystanders to take on risk for the sake of rescuing strangers.6 the moral duty will require looking beyond law, but it is unclear how the moral duty to rescue should be distributed in the case of climate migration. a bare minimum would prevent taking advantage of newcomers, paying sub-minimum wage, and discriminating against them. yet such a minimum is hardly rescue. iii. an ethical rather than legal duty the difficulty in defining the duty to rescue as a legal obligation is that it is difficult to determine the extent of risk a rescuer ought to be required to take. the nature of this ethical duty is also arguably tied to the experiences of both the rescuer and the rescued. there are subjective aspects like what someone perceives as a danger that make it difficult to write enforceable laws requiring rescue. it is one thing to expect a rescuer to step into several inches of relatively warm water to lift a person lying face down in a pond and enable them to breathe. it is something altogether different to expect that rescuer to dive into frigid water and attempt to extricate someone trapped in a submerged automobile. as the legal philosopher h.l.a. hart observed, it is always easier to define application of the core intention of any rule, whether law or ethical norm. it is more difficult to create legal certainty about how the law applies to what he described as “penumbra circumstances”. in the case of a hurricane, it is easier to define what surplus resources are available in areas geographically remote from the impact of the storm and demand, as a moral obligation, that those nearby but outside the area provide assistance. it is more difficult to obligate people, organizations, or governments to supply a quantity of medication or some number of ventilators to an adjacent community when they expect to imminently need them for their own community. in the early stages of climate migration, the ethics of extreme weather event assistance, a common application of the duty to rescue, will be useful and appropriate. the rising sea levels first experienced by island nations in the south pacific7 will not render those living in other coastal communities, those with greater available “high ground”, unable to supply resources to those in need. but when sea level rise and climate change affect more communities simultaneously, albeit in varying degree, the task of defining what response is ethically obligatory becomes increasingly complicated. pinpointing the obligations of those communities which are resource rich to those communities which are resource deprived, and of those partly affected to those more severely affected may become necessary. the limitations of the traditional duty to rescue could expand to meet the needs. iv. contribution to the problem many argue that the duty to rescue may depend on any appropriate claim of those needing rescue. one issue is whether preferential claims among those who can identify the source of the harm should call for a greater duty or whether everyone in need should be approached as like candidates for rescue, shaping the hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 4 duty as equal across those on the receiving end. as climate change does have human-made causes, there are strong arguments to impose a greater ethical duty on any entity that caused the climate-related problems leading to the mass exodus. while the global north is often implicated in pollution that causes migration, industries like energy, transportation, and agriculture are tied to climate change and associated with significant greenhouse gas emissions.8 practices like directing agriculture to less sustainable single crop growth generally made land less farmable. yet it is difficult to place blame and identify specific causal relationships as most migration is due to many factors. a movement toward greater accountability can be reframed as a greater duty to rescue, a duty to engage in the extraordinary. the fossil fuel industry, for example, should have a larger obligation than the average person. similarly, some may argue anyone unjustly enriching themselves while contributing to climate change or people who over-consume have an elevated duty to rescue.9 climate change lawsuits demonstrate an eagerness to hold governments and corporations accountable, despite difficulty proving causation. v. the most vulnerable one ethical dimension of climate migration that remains unexplored is how a duty to rescue applies to vulnerable populations who stand to be left behind or unable to migrate without assistance. researchers from the global north working across the global south are increasingly observing the phenomenon of ethics dumping, where the research ethics of some countries are imposed on research subjects in other countries.10 in that vein, rescuers should be careful not to impose unwelcome cultural standards or exploit people who are in the process of migrating. there is a gap in discussions reflecting voices that have been left out. the duty to rescue is incomplete without an attempt to understand the ethical experiences of those being rescued. the actual people affected by climate migration who are the least likely to have the means to migrate, or to do so without extreme hardship, should have a voice informing the global community including those in a position to carry out rescue. people who have the means and are young and healthy may easily make decisions to avoid the catastrophic consequences that climate migration brings. however, what about those who are left behind? for example, especially recognizing cultural differences, the homeless community, disabled community, refugees, the elderly community, and women11 and children may suffer differently and call for more attention. in some parts of the world, human rights are severely constrained. an ethical duty to rescue, with many considerations and variables, may be more justified in the case of those most in need. as climate migration continues and increases significantly, it may be reasonable to ask the local and global community to focus on those least well positioned to migrate successfully. in this context, the use of phenomenology to understand the lived experiences of those migrating, sometimes termed “ethical experiences”, may help flesh out how a duty to rescue takes shape. the discussion of duty and obligation requires an articulation of the ethical experiences (how the local community in need of rescue views the proposed rescue). then, the obligation to interpret the duty as ‘one shall not’ or ‘one must’ can be focused on the migrants’ needs rather than the rescuers’ feelings of obligation.12 a revised theory of the duty to rescue taking into account the asymmetrical experiences of communities involved could ensure that the needs of people whose living situations, gender, ethnicity, age, or race impact their ability to even begin the migration process are considered. in this discussion the rescuing is directed toward communities /collectives of persons migrating, whether at once or across a period of time. often, the climate migrant may not be in a state to articulate the nature of this event when it happens, given its subjective proximity. yet, when communities are given the space and opportunity to articulate their shared values, the ethical action of rescue derives its meaningfulness from the community rather than the rescuers. in other words, allowing climate migrants to explain their feelings can add complexity to what some see as a binary receiver-giver (of rescue) dynamic. hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 5 this is necessary because the concept of vulnerable populations is fraught with problematic assumptions. there have been various definitions and criteria to determine what would constitute vulnerable populations.13 for example, the united nations framework convention on climate change14 identifies and assesses vulnerable populations. these criteria may be helpful. however, they do not provide the full picture. rather than identifying categorical criteria of vulnerable populations, engaging with people who are experiencing climate migration and listening to their current experiences and concerns helps determine need. knowing what people need may prevent the kneejerk reaction to label people who are quite resilient yet have appropriate needs “vulnerable”. proceeding with caution is important because the duty to rescue has hierarchical underpinnings of "us" and "them." often when people swoop in to save, there are good and bad consequences of the intervention. we should proceed with caution because often the helper misses the actual needs of those in need. the only way to combat this would be to make sure that people are empowered to inform those agencies that are able to help. in addition to more practical approaches, large scale oral histories could allow those who have migrated already to share their experiences. it would be important to capture the lived experiences of people who are already experiencing the consequences of climate migration or of other migration like that due to political or economic extreme events. these experiences could shape our analysis of whether people in fact wish for rescue. if so, further conversations can determine best actions as well as give important insight into what resources might be necessary to empower people now and in the future. vi. a duty to rescue as a duty to prepare if we view good samaritans as going above and beyond, then a duty to rescue, something ethically compelled, must bring rescue out of the framework of charity and place it in the context of humanity and obligations. such a view would also support expanding the geographical reach of the otherwise more proximate duty. the duty may be stronger and take shape in a more workable way if it applies to preparing places expecting to see an influx of people due to climate migration and to helping those most in need. the duty may arise out of expectations of what type of community the place welcoming those migrating due to climate should be—does it want to offer good housing, schooling, and medical care as well as economic opportunity to new people? and if so, at what cost, or with which risks? if the newcomers are viewed as community members rather than strangers, a model of acceptance may lead to better preparation. some considerations like whether the actions will reasonably help the persons in need of rescue15 will shape the application of a duty to rescue in the context of climate migration. similarly, ensuring that people have the chance to articulate their values may help communities support the newcomers. new relationships should not be defined as migrant and rescuer. voluntariness in participation and not forcing any action deemed rescue would help ensure the human rights of those migrating. in the united states, president biden issued an executive order addressing impending climate migration steeped in a duty to prepare by making plans for resettlement and to address the impact of climate migration.16 vii. at what risk? as we investigate the ethical obligations to meet even basic needs, we must also ask what level of risk is ethically compelled. there is an extraordinary need to integrate newcomers successfully, but it is difficult to stretch an ethical duty to rescue to require all the prerequisites for successful climate migration. even hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 6 defining success would create deep ethical arguments. as observed in almost all migrations, extraordinary charitable acts may be the key to success, while an ethical duty to rescue must try to require the important government and community-based basics and ensuring respect for human rights. that is, the migrating people should be rescued from circumstances that contradict basic human rights. rather than comparing communities to bystanders, mere places where people will arrive and need to hash out how to find housing, jobs, education, and opportunity, a duty of preparation may be the key to rescue those disenfranchised by migration. there are cultural, personal, physical, psycho-social, and geopolitical issues surrounding how to best help those needing to permanently relocate. ethics arguments will certainly range from “do nothing”, which may fail people, to “do everything”, which could waste taxpayer money in futile over-preparation while failing to actually help. communities must avoid planning exclusively for one scenario only to have it not take place. striking the balance, a duty to rescue as it could apply to climate migration should set goals of societal integration, and providing the basics like education, housing, food, health care, and job opportunity, the precursors to flourishing. recommending the extraordinary, morally preferred but perhaps not compulsory, when charitable actors are participating, or when wrongdoers are compensating, may be more workable than seeing the duty to rescue as compelling people or local governments to take on significant financial and personal risk for newcomers. while humanitarian ethics supports helping everyone, it is likely that people who resettle in advance of a need to flee will find themselves with more choices and opportunities. help is warranted for those with more dire needs. preparing for them may do just that. viii. rescue prior to migration and rescue in the process of resettlement the duty to enable the migration in the first-place hints to the inadequacy of a duty to prepare. the traditional duty to rescue perhaps steps in if rescue looks like those geographically just out of harm's way rescuing those in danger. that resembles the traditional moral requirement, or duty to rescue according to the rule of rescue. humanitarian aid typically provided by many institutions makes sense and is in place, although financial support for additional humanitarian aid is always needed. despite having moved to purportedly more capable communities, migrant communities may be able to develop more egalitarian orders of living. rather than continually being identified as having been rescued, it is important to make sure people keep or make social ties during and after migration. immigrants often face social isolation.17 small shifts in gestural language also have the potential to welcome people and show they are valued. for instance, some migrants may not like questions like “where are you from?” and “what brings you here?” as they emphasize differences over fitting in. conclusion the ethical duty to rescue should be expanded to better match those in need of relocation with a welcome environment and the resources needed to achieve success and fully integrate socially and culturally. expanding a dialogue that includes the voices of people who have recently migrated whether due to violence, poverty, or climate, could properly frame the extent of the duty. if we are to apply the duty of rescue to climate migration, rescuers should avoid labeling people vulnerable, dependent, or needy, although there is reason to focus on those whose needs are the most dire. a soft duty to rescue people during the course of climate migration can come in the form of preparation. people will need help finding housing, education, access to food, and employment. ultimately, to help them help themselves may be the best goal. while the obligations should be borne differently by people, whether due to a special responsibility, or a special relationship that creates a clearer duty, the global community must prepare for its role in rescuing those displaced by climate events. by helping those displaced at the start of the climate hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 7 migration process according to a more commonly held notion of the duty to rescue, and by preparing to incorporate newcomers successfully according to an expanded duty to rescue, effectively a duty to prepare, countries that take on climate refugees may find themselves rewarded by the cultural diversity and workplace talents that people bring. a duty to those at a distance is a reasonable expansion of the duty to rescue. but what one ought to do in the global community varies somewhat from the traditional rule of rescue. 1 singer, p. (1972). famine, affluence, and morality. philosophy and public affairs, 1(3): 229-43. 2 irfan, u. (2022, march 16). why we still don’t yet know how bad climate migration will get. vox. https://www.vox.com/2022/3/16/22960468/ipcc-climate-change-migration-migrant-refugee, citing the international panel on climate change (ipcc) (2022). sixth assessment report, climate change 2022, impacts, adaptation, and vulnerability. https://www.ipcc.ch/report/ar6/wg2/ 3 mckie, j., richardson, j. (2003) the rule of rescue. social science & medicine, 56(12): 2407-2419. https://doi.org/10.1016/s0277-9536(02)00244-7. 4 james, s.m. (2007). good samaritans, good humanitarians. journal of applied philosophy, 24(3):238-254. 5 overview of good samaritan laws. https://worldpopulationreview.com/state-rankings/good-samaritan-law-states 6 fifield, j. (2017, sept. 19). why it’s hard to punish ‘bad samaritans’. stateline blog, pew charitable trusts, https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2017/09/19/why-its-hard-to-punish-bad-samaritans 7 cassella, c. (2019). there’s a climate threat facing pacific islands that’s more dire than losing land, science alert, https://www.sciencealert.com/pacific-islanders-are-in-a-climate-crisis-as-rising-sea-levels-threaten-water; hassan, h. r., and cliff, v. (2019). for small island nations, climate change is not a threat. it’s already here, world economic forum, https://www.weforum.org/agenda/2019/09/island-nations-maldives-climate-change/ 8 for example, lyons, k. (2019). australia coal use is existential threat to pacific islanders, the guardian. https://www.theguardian.com/world/2019/aug/12/australia-coal-use-is-existential-threat-to-pacific-islands-says-fiji-pm 9 cripps, e. (2013). climate change and the moral agent: individual duties in an interdependent world. oxford: oxford university press. 10 schroeder, d., chatfield, k., singh, m., chennells, r., and herissone-kelly, p.. ethics dumping and the need for a global code of conduct. in cham. (ed.)(2019). equitable research partnerships. springerbriefs in research and innovation governance. springer. 2019. https://doi.org/10.1007/978-3-030-15745-6_1 11 giudice l.c., llamas-clark e.f., denicola n., pandipati, s., zlatnik, m.g., decena, d.c.d., woodruff, t.j., conry, j.a. (2021). climate change, women’s health, and the role of obstetricians and gynecologists in leadership, international j gynecol obstet, 155(3), 345-356. 10.1002/ijgo.13958 12 see ferrarello, s. and zapien, n. (2020). ethical experience: a phenomenology, bloomsbury. (for understanding phenomenological determinants of ethical action). 13 mcleman, r.a., hunter, l.m., (2010). migration in the context of vulnerability and adaptation to climate change: insights from analogues. wiley interdiscip rev clim change, 1(3): 450-461. 14 least developed countries expert group. (2018). considerations regarding vulnerable groups, communities and ecosystems in the context of the national adaptation plans: united nations framework convention on climate change. 15 jecker, n.s. 2013. "the problem with rescue medicine." j med philos, 38(1):64-81. 16 white house report. (february 9, 2021), executive order (e.o.) 14013, https://www.vox.com/2022/3/16/22960468/ipcc-climate-change-migration-migrant-refugee https://www.ipcc.ch/report/ar6/wg2/ https://www.sciencealert.com/pacific-islanders-are-in-a-climate-crisis-as-rising-sea-levels-threaten-water https://www.weforum.org/agenda/2019/09/island-nations-maldives-climate-change/ https://www.theguardian.com/world/2019/aug/12/australia-coal-use-is-existential-threat-to-pacific-islands-says-fiji-pm hoffman et al., expanding the duty to rescue to climate migration, voices in bioethics, vol. 8 (2022) 8 “rebuilding and enhancing programs to resettle refugees and planning for the impact of climate change on migration.” (calls on the national security advisor to prepare a report on climate change and its impact on migration. “this report marks the first time the u.s. government is officially reporting on the link between climate change and migration.” https://www.whitehouse.gov/briefing-room/presidentialactions/2021/01/27/executive-order-on-tackling-the-climate-crisis-at-home-and-abroad/ 17 torres, j.m., casey, j.a. (2017) the centrality of social ties to climate migration and mental health. bmc public health, 17: 600. https://doi.org/10.1186/s12889-017-4508-0 saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) * salla saxén, dsocsci, phd student, university of eastern finland heikki saxén, phd, university of tampere © 2021 salla saxén and heikki saxén. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. implementing personalized genetic medicine: interprofessional and patient perspectives on connecting medical research with clinical care salla saxén, heikki saxén* abstract this qualitative interview study explores the implementation of personalized genetic medicine (pgm) for prostate cancer in a major university hospital in finland. we interviewed both staff and patients. university hospital staff (n = 12) were interviewed concerning their views about the promises and challenges of the new medicine. the six patient research subjects taking part in a prostate cancer pgm study were interviewed about their experiences. the two sets of interviews were analyzed separately in a qualitative thematic analysis rooted in the theory of social constructionism. the staff interviews brought out the following themes: entanglement of research and care, professionality, context, scientific breakthrough, technocracy, and emotional engagement. in the patient interviews, the following themes were discovered: personal narrative, autonomy, community, and relationships with staff. these results demonstrate that staff and patients both experience entanglement of research and care but they speak about the implementation process using disparate language. based on the research, we conclude that research design as well as legislative processes would benefit from inclusion of broad perspectives as expressed by those engaged in the experience of research as patients or as practitioners. keywords: genetic medicine, autonomy, community, inclusion, research ethics, prostate cancer, personal narratives saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 2 introduction contemporary advances in biomedical sciences related to genomic sequencing and molecular characterization are changing the landscape of cancer treatment and research at a fast pace.1 even though central questions regarding research ethics (such as uncertainties about ensuring informed consent) 2 remain, cancer patients continue to enroll in personalized medicine research studies. implementation of pm would include “a need for restructuring the healthcare system—detachment of healthcare professionals from the so-called organ-based specialties.”3 this study explores the experiences of the staff and patients involved in clinical research in personalized medicine. to be more precise, in this qualitative social scientific study, we explore the narratives of the stakeholders that are involved in a study of a precision medicine (pm) for genetic prostate cancer taking place at a major university hospital in finland to learn about their experiences and viewpoints. personalized medicine broadly refers to the tailoring of care to patients’ individual attributes, typically in relation to their genomic, genetic, and molecular profile. 4 compared to traditional evidence-based medicine, pm represents a shift toward viewing each disease and patient as biologically unique. 5 proponents of pm advocate moving away from blockbuster drugs in favor of individualized, tailored treatment options that consider each patient’s pharmacogenomics profile. 6 however, this shift raises several issues for consideration, such as how to ethically test drugs in very small patient groups, what conclusions can be appropriately drawn and generalized, and how to establish accessible and equitable practices for implementation in the future.7 the interviewees noted blurring of the line between clinical therapeutic use and research purposes. in this paper, we use the term patient or research patient to mean the research subjects that are patients. increased patient empowerment is achieved when individuals gain control over planning their healthcare services. 8 president barrack obama’s 2015 precision medicine initiative promoted these concepts, advocating for “patient-powered research,” in which “participants will be involved in the design of the initiative and will have the opportunity to contribute to diverse sources of data.”9 this interview-based study focuses on the implementation of personalized genetic medicine (pgm) and is contextually connected to a concurrent biomedical study aimed at the genetic profiling of patient prostate cancer cells to report clinically meaningful results to treating clinicians. we interviewed relevant stakeholders, including staff and research patients, to assess how they view the potential promises and risks of personalized genetic medicine, and whether they see the high expectations of pgm as challenging the traditional boundaries between research and care activities in the lab and clinic. we used the responses provided during the interview process to understand how those involved in prostate cancer pgm research make sense of this new practice. i. data and method a. semi-structured interviews the thematic interviews followed a loosely predesigned form, still giving relative freedom for the interviewees to explore additional topics. we selected participants for this study from current university and hospital staff to participate in an interview with questions involving the following themes: how participants view overall differences between research and care, participant beliefs about whether pgm blurs these boundaries, participant expectations for pgm, and ethical challenges envisioned in the implementation of pgm. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 3 we asked patient research subjects about their motivations for participating in the ongoing pgm study, the differences they see between their clinical care and research participation, the process of giving consent, the sources they used for gathering information related to the study, and the potential hopes and fears they had for the genetic analysis of their prostate cancer cells. b. data collection a total of 19 audio-recorded interviews varying between 45 and 75 minutes in length were collected for this study. interviewed staff members consisted of both university and hospital personnel from the following backgrounds: one bioinformatician, biomedical researchers (n = 4), physician-researchers (n = 3), research nurses (n = 3) and irb members (n = 2). additionally, six patient research subjects were interviewed. we interviewed university and hospital staff between february 2016 and may 2017. the collection of staff interviewees was based on snowball sampling, a method in which the respondents are themselves used to recruit further respondents from their social networks. snowball sampling was used because no clear sample frame exists for the study.10 the patient research subject interviewees were contacted based on their enrollment in the background pgm study during the year 2017. the research subjects for that clinical study had been chosen based on a profile of a high risk for recurrence of prostate cancer. c. theory and analysis while there is no single description of social constructionism, its fundamental claim is that knowledge is not objective in its nature, but rather constantly shaped and sustained by ongoing social processes. what passes as knowledge in a given culture is then, “not a product of objective observation of the world, but of the social processes and interactions in which people are constantly engaged with each other.”11 what emerges from our study is a refined understanding of the social reality of implementing pgm as perceived by those personally involved in it, which we believe is a fruitful and enlightening contribution to the growing literature on personalized medicine. the interviews were analyzed with the qualitative method of thematic analysis, which is “a method for identifying, analyzing, and reporting patterns (themes) within data.”12 the method is used in this study as anchored in the social constructionist epistemology. following braun and clarke, we carried out the analysis process in six phases. the phases were 1) familiarizing ourselves with the data (in which the manual transcription process was a significant element), 2) generating initial codes in the data by color coding the text, 3) searching for initial themes among the codes, 4) reviewing the themes by iterative reading of the data, 5) defining and naming the themes discovered, and 6) writing the final report.13 d. ethical considerations prior to conducting interviews, participants were informed of the study and given the opportunity to refuse or cancel participation at any point. the interview data collected during this study have been used only for the purposes of this study. before proceeding to the interviews, the research plan was also reviewed and accepted by the local ethics committee for humanities and social sciences. 14 participants have been anonymized to protect their identities, as implementing pgm for prostate cancer in finland is limited to a fairly marginal group of professionals and patients. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 4 ii. results the findings of this study are presented in two parts: themes discovered in staff interviews, and themes discovered in the research patient interviews. the transcripts presented below have been translated from finnish into english and have been categorized by their identified themes. iii. staff interviews a. entanglement of scientific research and clinical care our first discovery was that most of the interviewed professionals experienced an entanglement between research and care practices. however, those with irb backgrounds expressed very clear boundaries between the two practices. the following interview excerpt demonstrates the typical entanglement of research and care that we found in our interviews. an interviewed physician perceived research as the best kind of care, giving “the patient many extra benefits.” a: research is care of the patient, it just happens within a research protocol in which some new form of treatment is compared to the old treatment. (…) q: so what do you think, is there a boundary between research and care or not? a: yeah of course in that way that you go through this same procedure we just did [with this interview study], the patient is informed by the study and then gives his consent if he wants to participate, and usually he does, because of course it gives the patient many extra benefits, the monitoring is much closer, and you get the same doctor and nurse, usually quite long relationships with the same staff. physician-researcher the following interviewee illustrates an underlying belief that receiving care in studies that are funded by pharmaceutical companies is beneficial for society, as it relieves government as a payor. patients should be in research studies because it is much cheaper for society, so that there is not so much municipal billing… nobody can really count how much is saved, but of course when the medicine comes from the study there are a lot of savings made, maybe… research nurse interestingly, several of the scientists interviewed constructed the mission of their work in the words of curing patients (in the long run), and not as one might assume, as generating knowledge that might contribute to curing patients in the long run. for me it’s very important that there is a clear goal for why this research is done… (…) i myself experience a strong sense of direction, even if it is in the distant future… (…) the goal is that cancer could be, wiped out, and people cured, that’s how i see it. biomedical researcher however, another participant constructed the two practices as fundamentally separate: saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 5 in clinical care with patients, of course we are concentrating on that patient’s issues, whereas when we are doing research we are looking at, larger entities and phenomena. i think doing both gives great variety to my work. physician-researcher b. professionality: expertise, ethics, trust, and the tolerance of uncertainty professionality was distinguished by those interviewed based on three central dimensions: expertise, following shared ethical standards, and being able to adopt an attitude of tolerance toward uncertainty in the practice. first, expertise, referring to knowledge and skill, was constructed as the center of professionality. however, this quality was defined quite loosely; it was surprisingly hard to describe exactly who is a professional and who is not. the next example shows how a medical professional believes his knowledge and skill can even be associated with someone wearing a clinical uniform, the uniform fostering the basis for the patient’s trust. i don’t think it matters to the patient who asks for the consent, except that the patient probably doesn’t want to talk to someone in a civil outfit, in a pleated skirt or a dress shirt, no, the patient trusts a professional, a doctor or a nurse who can explain… so i don’t think it matters who it is, as long as it’s someone the patient can trust. research nurse one participant asserted that a deeper relationship contributes to trust in patient interactions during the research, distinguished from routine clinical interaction. i form a very deep relationship, with the research patients since they have such an intensive, i mean they have a straight connection to me in every way, even though the doctor is the most important, the nurse still comes before that, like if they wonder about something in the evening they call the nurse, we have a phone 24/7 that the patients can call. (…) i think this is the best personal care there is, very very good personal care, and in most cases, everybody trusts each other, they trust that with me they are in safe hands. research nurse the capacity to endure uncertainty presents another key element in the theme of professionality. clinical work is constant tolerance of uncertainty, you just have to go by the probabilities and, accept that you can never be 100 percent sure, but maybe researchers are like, they have to look for the accurate, precise answer to everything, and so i think that could maybe create some problems for the collaborations… physician-researcher c. context: culture, community, and the efficiency imperative contextual talk refers to the institutional and cultural environment surrounding research and care. most commonly, interviewees mention finnish culture by praising “finnish patients” as more agreeable to research than patients from other countries. this notion was expressed across the wide range of professionals interviewed. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 6 of course, we have always said that they can withdraw from the study if they want, but here, these finnish patients are so kind, and they trust the physician so much, the physician’s authority is so great… (…) we have, such kind patients that they always come [to the research tests], they follow the protocol very strictly. research nurse sometimes we make quite invasive [research] operations, and while we know that finnish patients will participate, we have sat down [with colleagues] to think about it, that… they are giving their consent but are we doing harm… biomedical researcher another contextual factor expressed by interviewed professionals was the benefit of belonging to a work community. the community was portrayed as not only providing knowledge and team effort, but also emotional support for the staff. now that i finally have this office here, the other research nurses are close by, so i can share if i have something on my mind, like stress or something. research nurse a concern regarding imposed demands on clinical efficiency was identified as part of the contextual theme. in these examples, efficiency serves as the first principle to which everything else is to conform, such as ethical recruiting of research patients. time is, right now, a great problem, and because of the lack of it, an individual can vanish into the mass, since we just don’t have enough time for the patients individually. research nurse15 what efficiency does is that the patients are in the hospital for a very short time, they go straight to the operating room, so they are there before that for maximum 2 hours if we’re talking about surgery patients, and this makes the researcher’s work [considering ethical research recruitment] so much more complicated. (…) and it depends on the funding whether the researcher has enough time to spend on properly informing the research subject. irb secretary d. pgm as a scientific breakthrough: progress, ambition, and the critique of the status quo interestingly, even though our informants did not separate clinical care from clinical research clearly, we found a theme of science distinct from the everyday clinical practices. this theme was not defined in terms of the everyday research environment, but instead, as a bird’s eye view: as being able to adopt a broader scale of thinking in a way that was something different from or more than the everyday realities. interestingly, in the theme of science, we found a struggle about the future of pgm and whether to believe pgm is a promising scientific breakthrough instead of science hype. the next samples show an enthusiastic as well as a more skeptical point of view toward pgm. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 7 things can only go to a better direction here since [because of pgm] we will treat people better and better, even though it is obvious that it is not going to cheap, that’s the first question, but i think that in the long term there will be less expenses at a public health level when there you take into account the prevention of diseases and health coaching and things like that. bioinformatician the genetic research eats up a lot of resources and still, from a clinician’s point of view, the outcome is quite small, like for example we still don’t have very good genetic tests that could predict, in a clear way, that a patient has specifically this kind of cancer and it’s going to proceed this way so let’s treat it in this way, like still we have pretty much the same, gleason points and psa tests that we’ve had for the past 50 years, or longer, even though billions have been spent on genetic research. physician-researcher e. pgm as a technocratic challenge: bureaucracy and the law participants identified additional themes involving clinical research in pgm that concern bureaucracy and paperwork, disclosure, and consent requirements taking shape in legislative forums, referred to here collectively as “technocratic”. this theme reflects new legislation, policy, and procedures required for medical research. professionals expressed concern that the current legislation and structures may be standing in the way of valuable scientific improvements. we need new ways to validate the drugs, and the question is, is this ethically on solid ground, since there are reasons, historical reasons for why the process of developing drugs is so complicated. biomedical researcher technocratic practices, like the need for documenting informed consent, were also criticized for being too complicated. in the following sample, a research nurse expressed frustration with having to ask patients recovering from surgery to fill out consent forms. like if we have a bladder cancer patient who has just had surgery in the ward, i have to run in there to ask for a pre-pre-permission, to ask whether they can use a part of his bladder, which is already on the pathologist’s table at that point, for some research… it’s a miracle they even have energy to write when they [the patient] are on the ivs and cannulas and everything, and there i have to say to them, please write down the date and print your name here… research nurse the irb interviewees also presented critical views about the research bureaucracy. we do so much education because the researchers are in such a jungle, i don’t want to blame them, the jungle is absolutely absurd, the clinical researcher has to consider all the legislations, of course they have to have the law, the clauses and the ethical reviews in check, but it takes such a huge amount of time for them to figure it all out. irb secretary saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 8 f. research as emotional engagement and empathy sentiment and empathy play an important role for professionals in their work and attitude toward research, evidencing emotional engagement. over the years i have developed a sort of, doctor’s conscience, i can’t do things if i know that i’m going to do them badly, or wrong, that’s when i won’t get a peace of mind for myself, so i better do things best i can because otherwise it bothers me so much… of course it is a subjective point of view but, i can’t, can’t do things badly or wrong to a patient. physician-researcher one researcher expressed the need to protect herself from feeling emotional toward patients. i see myself as quite a sensitive person, and it has been my conscious choice that, i like that the research patients are anonymous to me, so that the sample (…) is not personified. biomedical researcher a second researcher suppressed emotions surrounding the research because of the gravity of the situation to patients. i have mixed emotions, because for research it is a good thing to get test samples from patients who have metastases in their lymph nodes, not only patients who just have cancer in the prostate. (…) i really feel bad that i can’t be happy that now there is a person somewhere who has had these metastases. biomedical researcher iv. research patient interviews a. personal narrative: life story, worldview, and character personal narratives include reports of personal life situations, illness histories, worldviews, and descriptions of character. we asked patients about their motivations to participate in the pgm study. responses included patients’ complete past medical histories and key moments that led to their diagnosis and subsequent participation in this study. the next example shows that the illness narrative represented to us could even go as far back as the interviewee’s childhood. i haven’t been ill very much, but in 1955, i was born in 1950, so 1955 i got hit by a car, and my right shin was fractured, they fixed it in the local hospital, the surgeon was called [name], as i asked my mother about it later, so this doctor [name] had said to my mother that he fixed the leg and he fixed it well. research patient (interview 1) additionally, personal narratives reflected the collective strength derived from family. it is a really personal thing… the way you deal with something like this… we dealt with things the way that, my son said well, you have made it through worse, he just said you have made it through worse, it is, it really is true that we have always survived, as life has been really long and troublesome, or if not troublesome at least really tough. research patient (interview 6) saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 9 the personal narratives also described worldviews, the below suggesting a lack of desire to have psychosocial support. q: did you get any [psychosocial] support when you first heard the diagnosis? a: it doesn’t really help anything, if you are doomed you are doomed… but for me, it is god up there who takes care. research patient (interview 1) b. autonomy: context and knowledge as the foundation for decision making talk about making decisions, knowledge, and gathering information were categorized as expressions of autonomy and also included talk about knowledge and searching for information as part of the theme. people varied in how much they value information as a key element of decision making. the next two data samples demonstrate the wide range between the interviewees, one seeking information on the internet, the other preferring not to read the provided information or seek other sources. q: was your decision based on what the doctor told you or did you search for knowledge yourself, for example on the internet? a: yes, [the] internet is where you look for knowledge these days, the doctor didn’t really give an opinion… i think reading text and thinking about what you have read is important, things you just hear in a briefing really get lost if you don’t have enough background information, so you can’t really have an opinion and think about it at that point, but of course [the] internet is a little like that too, so you have to be mindful about what you are reading… there are, lots of things you shouldn’t believe in…but i think all sort of medical publications and such, that’s where the information came from. research patient (interview 4) q: did you find out about the research topic independently online or…? a: no… not at all, not at all (with laughter), i also got all those papers [from the staff] too and i didn’t read a single one of them… i decided i won’t read any of it, better if i don’t know, i will go completely ignorant, because i think information increases the pain (laughter). research patient (interview 2) as in the staff interviews, the patients had difficulty keeping the research and the clinical care separate during the interviews. we found the topics were entangled especially because they both took place in the same surroundings, usually organized by the same people. in the next example, the research participant expressed feeling pressure to participate because he was already a patient of the recruiting doctor. this research came up at the point which, [name of doctor] was explaining, before the surgery how the surgery will be done, and so, he introduced the study, asking if i could participate and so, i couldn’t really say no, i couldn’t really say that you just do the surgery but i won’t participate… (laughter) because i think that if someone can benefit [from my participation in the study], then of course it’s a good thing if someone gets help. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 10 research patient (interview 1) participant decisions are made within an already existing and meaningful social network in the hospital environment, with embedded cultural norms in place, such as reciprocity. these findings show how differently people make their decisions and that autonomy appears to be a socially embedded, nuanced, and ambiguous concept, varying from person to person. c. community: receiving support and mirroring experiences being part of a community and sharing experiences was a central theme in our patient interviews. i play table tennis, and the playing community (…) is good for psychological wellbeing, i have been able to talk openly, even at that point when the cancer was diagnosed and so, it makes things much easier when you don’t have to live in secrecy. research patient (interview 4) i went through them [the treatment options] with my wife very thoroughly, and eventually, we made the decision together. research patient (interview 5) however, not everybody accessed support from others: i didn’t really have any social network for support, i just talked with the staff that this is the way things are, what else is there to say about it. research patient (interview 2) social communities with members with similar experiences influenced participants’ decisions. well it wasn’t clear at first, but i thought about it and little by little i decided on the surgery, as it had gone so well for my brother one year earlier, (…) we did talk about the options with the doctor and i was just repeating that i want the surgery, so i made the decision myself, because i knew what the options were. research patient (interview 1) the quotes demonstrate how a social network serves both as a structure for support and therapeutic decision making. d. relationships with staff: alliance and distance we divided patient relationships with staff as those of either alliance or distance. relationships of alliance that cultivated respect, trust, and a feeling of being taken care of resulted in patient satisfaction and gratitude. so the results were discovered and the treatment options, and so we discussed what this and that surgery is, and so, it was very good in many ways, i got all the information i could think of… and, well, the whole process just radiated expertise, and that really awakened trust in me. research patient (interview 3) saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 11 in some cases, the alliance was not necessarily focused on any specific person but instead on the hospital as an institution. whenever i walk through the hospital doors, i let go of all my worries, because i have always thought that there is staff and i have nothing to worry about, i know that they take care of me. research patient (interview 2) the biomedical researcher who also acted as our contact person with the pgm study had a key role in the recruiting process. she would often walk the research patients in the hospital to different locations of the tests. she came there, you see and walked with me, it was totally different, it was sort of safe, to have someone to walk with you and we could talk. otherwise i would have been walking alone, but when she was with me we could talk about different things and i kind of forgot about everything else. i think everyone here should have someone like that… research patient (interview 2) while one could also assume that contacts with staff members in positions of authority would reflect social distance, we found that authority increased the trust and respect and provided a foundation for a staffpatient relationship. in the next sample, the authority of the professor fueled the willingness to participate in the pgm research. yeah i could ask whatever i wanted, and he explained, (…) of course it feels good to get the possibility to talk with the professor like that. research patient (interview 2) interviewees also reported relationships with distance, doubts of whether the staff can be trusted, and stories of not being heard, but much less than they described alliance.16 it was also typical that an alliance was described and compared to another situation in the past in which the patient had not been satisfied. in the next quote, the interviewee talked about his doubts about whether the hospital could be trusted to provide all the necessary care. well it was kind of a shock, or if not a shock then at least i had to think about what i should do now… everything just unfolded from there, people say that we have a good system in finland, but i was asking whether i will get all the scans, the mri, computer scan or the bone scan, or that… because i thought, they will look at me and think that i am old… research patient (interview 6) in the next sample, an interviewee described his experiences with staff that resulted in feelings that he was not getting the help he needed. i think it would really be important that the staff understands the importance of staying in close contact with the patients, to get the patient through all that, and just to generally offer some help, because, with the way things are now i think it is kind of a lonely man’s fight. research patient (interview 5) saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 12 v. discussion in this study, we explored the diversity of voices intertwined with the process of implementing personalized genetic medicine for prostate cancer in a university hospital environment in finland. we embarked on this research with a view that medical research and clinical care are fundamentally separate activities. however, from the outset we found that the data was telling us otherwise. even though “therapeutic misconception” has been documented widely elsewhere, 17 we were surprised by the impossibility of patients keeping the two categories apart, and especially with professionals’ inability to keep them apart. at first, we were frustrated about what seemed like not getting the right answers, but we started to see that the way people mix the categories of research and care is natural in the social process in which the patient and the staff work toward treating the cancer. the two appear naturally entangled in the university hospital environment. making these everyday constructions visible in the finnish context is an important implication of this interview study. another question is whether the differences found between the viewpoints of the professionals and the research patients matter. has the medical establishment, with its institutional policy, law, and scientific method, veered too far from patients’ lifeworld? or are these differences good for the research and care community, reflecting the expertise of professionals and the roles of those seeking care? we have formed the image below to demonstrate the different perspectives relevant to the stakeholders in the process of implementing personalized medicine. the image represents the main viewpoints as a triangle, suggesting that while there are different perspectives, they are part of the same whole. the three main perspectives entangled in the pgm implementation process could be used as an analytical tool for people designing research and healthcare policy. by including more perspectives in the dialogue, and propelling the patient voice that is often silent, the triangle would contribute to the development of policy and research studies. it is important to avoid framing the research process by asking questions that are limited in their perspective. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 13 vi. limitations as our approach to the topic has been a holistic one, we recognize that by compressing so many different voices into the same analysis we have lost nuances and depth that could have been captured better by concentrating on only one perspective. we aimed to capture the diversity of views among the wide spectrum of interviewees and include the range of experiences. the interview data is relatively small, and thus, we have not captured all the possible perspectives that could be important to the topic. yet the purpose of qualitative research is to create empirical understanding of the social reality and to provide data for reflection and discussion. conclusion in the end, we return to the vision of patient empowerment that personalized medicine advocates embrace as one of the flagships for the new era of medicine. this ideal depicts patients having an active agency and a clearer voice in the medical ensemble, from research design to data interpretation. while patients would not engage in research design, their input might alter how researchers incorporate correct perceptions of the hope of therapeutic value, rationales for participating, the ways in which being a patient of the researcher might influence the decision to participate, and the different types of relationship between staff and patients. the results could be more patient-friendly or efficient consent processes, or even the recognition that patients and practitioners are motivated by the potential of the treatment to be a therapeutic remedy and thus the lines between research and clinical care are intertwined. if this vision is taken seriously, those implementing pm will be faced with the challenge of starting a clinical research methodology that incorporates the patient voice and expectations and the practitioner’s perspectives on personal aspects of care provision, compared to the old way in which the patient stays mostly silent. in her book silent partners,18 rebecca dresser claims that research subjects hold an underutilized, silent perspective on the medical research enterprise. dresser argues that by considering the perspectives of the actual research subjects, the research communities would be able to make more informed and ethical research decisions.19 our study aligns with these arguments and helps prove them by incorporating patient stories into the research and weaving their perspective into the triangle of viewpoints that are represented in the research community. staff members also may hold perspectives that are often silent in the research design process. including different perspectives (the voices that flow into the research triangle) at the beginning of the research design process or at the legislative level when developing the regulations covering research would lead to research processes that are more ethical and accountable to those directly involved, especially those involved in a bodily way, and engaged in both sides of the practitioner-patient relationship. however, the question of whether the deliberation necessary to improve research can be done likely comes down whether the medical community is the kind of culture that is willing to seriously include broad perspectives in the research process. according to political scientist scott page, cultures of diversity outperform groups of like-minded experts, which makes diversity worth striving for.20 but, to do this, page claims first “we have to think of sharing ideas not as giving away the shop, but as collectively building the lever to lift the world.”21 curing cancer deserves the benefits of sharing ideas to collectively build that lever. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 14 1 cetnar, j. p. & beer, t. m. (2014). personalizing prostate cancer therapy: the way forward. drug discovery today 19(9): 1483– 1487. doi.org/10.1016/j.drudis.2014.07.006. 2 parens, e. (2015). drifting away from informed consent in the era of personalized medicine. hastings center report 45(4): 16– 20. doi.org/10.1002/hast.470. 3 pavelić et al. 2016, 8. 4 jain, k. (2015.) texbook of personalized medicine. 2nd ed. new york: springer. 5 pavelić, k., kraljević pavelić s. & sedić, m. (2016). personalized medicine: the path to new medicine. in bodiroga-vukobrat n., rukavina d., krešimir p. & sander g. g. (2016). personalized medicine. a new medical and social challenge. new york: springer, 1. 6 ibid., 2. 7 see for example juengst, e. t., settersten, r. a. jr., fishman, j. r. & mcgowan, m. l. (2012). after the revolution? ethical and social challenges in ‘personalized genomic medicine’. personalized medicine 9(4): 429–439. doi:10.2217/pme.12.37; gaisser, s., vignola-gagné, e., hüsing, b., enzing, c. & van der valk, t. (2009). eu policies in personalized medicine-related technologies. personalized medicine 6(1): 93–102. doi.org/10.2217/17410541.6.1.93; brothers, k. b. & rothstein, m. a. (2015). ethical, legal and social implications of incorporating personalized medicine into healthcare. personalized medicine 12(1): 43–51. doi.org/10.2217/pme.14.65. 8 rose, n. (2013). personalized medicine: promises, problems and perils of a new paradigm for healthcare. procedia – social and behavioral sciences 77: 341. doi.org/10.1016/j.sbspro.2013.03.092; see also prainsack, b. (2017). personalized medicine: empowered patients in the 21st century? new york: new york university press. 9 white house (2015). factsheet: president obama’s precision medicine initiative. press release, january 30. accessible at [https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicineinitiative]. 10 elliot, m., fairweather, i., olsen, w. & pampaka, m. (2016). a dictionary of social research methods. online edition. oxford and new york: oxford university press. 11 burr, v. (2003). social constructionism. 2nd edition. london and new york: routledge, 5. 12 braun, v. & clarke, v. (2006). using thematic analysis in psychology. qualitative research in psychology 3(2): 79. 13 ibid. 14 the name of the committee is not disclosed here since it would reveal the location of the study. this is done with regard to the protection of the anonymity of the data. 15 this was the same nurse who also spoke about being able to give the patients “very very good personal care” (quoted in chapter 3.1.2). this is an example of how statements even in the same interviews can be contrary to each other: first the nurse has told us about giving very good personal care, and later she says that such care is really not possible due to the circumstances and lack of time. this shows that as the thematic frame changes in the course of the interview, even the same thing can look very different from different perspectives. 16 this is likely to reflect a bias in our data, as the patients not satisfied with their care and untrusting of the staff might not want to participate in pgm research. 17 see for example a classic article, appelbaum, p. s., roth, l. h., lidz, c. w., benson, p. & winslade, w. (1987). false hopes and best data: consent to research and the therapeutic misconception. the hastings center report 17(2): 20–24; also lidz, c. w. (2006). the therapeutic misconception and our models of competency and informed consent. behavioral sciences and the law 24: 535–546. doi.org/10.1002/bsl.700. saxén and saxén, implementing personalized genetic medicine, voices in bioethics, vol. 7 (2021) 15 18 dresser, r. (2017). silent partners: human subjects and research ethics. oxford: oxford university press. 19 ibid., xiii; see also eder, m., yamoski, a. d., wittman, p. w. & kodish, e. d. (2007). improving informed consent: suggestions from parents of children with leukemia. pediatrics 119(4): e849-59. doi.org/10.1542/peds.2006-2208. 20 page, s. (2007). the difference: how the power of diversity creates better groups, firms, schools, and societies. princeton and oxford: princeton university press. 21 ibid., xviii. cockshaw, the end of factory farming, voices in bioethics, vol. 7 (2021) * rory cockshaw, ms natural sciences candidate university of cambridge © 2021 rory cockshaw. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the end of factory farming: alternatives to improve sustainability, safety, and health rory cockshaw* abstract the uk-based campaign group scrap factory farming has launched a legal challenge against industrial animal agriculture; the challenge is in the process of judicial review. while a fringe movement, scrap factory farming has already accrued some serious backers, including the legal team of michael mansfield qc. the premise is that factory farming is a danger not just to animals or the environment but also to human health. according to its stated goals, governments should be given until 2025 to phase out industrialized “concentrated animal feeding organizations” (cafos) in favor of more sustainable and safer agriculture. this paper will discuss the bioethical issues involved in scrap factory farming’s legal challenge and argue that an overhaul of factory farming is long overdue. keywords: agriculture, animal ethics, animal rights, climate, factory farming, sustainability introduction a cafo is a subset of animal feeding operations that has a highly concentrated animal population. cafos house at least 1000 beef cows, 2500 pigs, or 125,000 chickens for at least 45 days a year. the animals are often confined in pens or cages to use minimal energy, allowing them to put on as much weight as possible in as short a time. the animals are killed early relative to their total lifespans because the return on investment (the amount of meat produced compared to animal feed) is a curve of diminishing returns. cafos’ primary goal is efficiency: fifty billion animals are “processed” in cafos every year. the bioethical questions raised by cafos include whether it is acceptable to kill the animals, and if so, under what circumstances, whether the animals have rights, and what animal welfare standards should apply. while there are laws and standards in place, they tend to reflect the farm lobby and fail to consider broader animal ethics. cockshaw, the end of factory farming, voices in bioethics, vol. 7 (2021) 2 another critical issue applicable to industrial animal agriculture is the problem of the just distribution of scarce resources. there is a finite amount of food that the world can produce, which is, for the moment, approximately enough to go around.1 the issue is how it goes around. despite there being enough calories and nutrients on the planet to give all a comfortable life, these calories and nutrients are distributed such that there is excess and waste in much of the global north and rampant starvation and malnutrition in the global south. the problem of distribution can be solved in two ways: either by efficient and just distribution or by increasing net production (either increase productivity or decrease waste) so that even an inefficient and unjust distribution system will probably meet the minimum nutritional standards for all humans. this essay explores four bioethical fields (animal ethics, climate ethics, workers’ rights, and just distribution) as they relate to current industrial agriculture and cafos. i. animal ethics two central paradigms characterize animal ethics: welfarism and animal rights. these roughly correspond to the classical frameworks of utilitarianism and deontology. welfarists2 hold the common-sense position that animals must be treated well and respected as individuals but do not have inalienable rights in the same ways as humans. a typical welfare position might be, “i believe that animals should be given the best life possible, but there is no inherent evil in using animals for food, so long as they are handled and killed humanely.” animal rights theorists and activists, on the other hand, would say, “i believe non-human animals should be given the best lives possible, but we should also respect certain rights of theirs analogous to human rights: they should never be killed for food, experimented upon, etc.” jeremy bentham famously gave an early exposition of the animal rights case: “the question is not can they reason?, nor can they talk?, but can they suffer? why should the law refuse its protection to any sensitive being?” those who take an animal welfare stance have grounds to oppose the treatment of animals in cafos as opposed to more traditional grass-fed animal agriculture. cafos cannot respect the natural behaviors or needs of animals who evolved socially for millions of years in open plains. if more space was allowed per animal or more time for socialization and other positive experiences in the animal’s life, the yield of the farm would drop. this is not commercially viable in a competitive industry like animal agriculture; thus, there is very little incentive for cafos to treat animals well. rampant abuse is documented.3 acts of cruelty are routine: pigs often have teeth pulled and tails docked because they often go mad in their conditions and attempt to cannibalize each other; chickens have their beaks clipped to avoid them pecking at each other, causing immense pain; cows and bulls have their horns burned off to avoid them damaging others (as this damages the final meat product, too); male chicks that hatch in the egg industry are ground up in a macerator, un-anaesthetized, in the first 24 hours of their life as they will not go on to lay eggs. these practices vary widely among factory farms and among jurisdictions. yet, arguably, the welfare of animals cannot be properly respected because all cafos fundamentally see animals as mere products-inthe-making instead of the complex, sentient, and emotional individuals science has repeatedly shown them to be.4 ii. climate ethics the climate impact of farming animals is increasingly evident. around 15-20 percent of human-made emissions come from animal agriculture.5 and deforestation to create space for livestock grazing or growing crops to feed farm animals. an average quarter-pound hamburger uses up to six kilograms of feed, causes cockshaw, the end of factory farming, voices in bioethics, vol. 7 (2021) 3 66 square feet of deforestation, and uses up to 65 liters of water, with around 4kg of carbon emissions to boot – a majority of which come from the cattle themselves (as opposed to food processing or food miles).6 according to environmentalist george monbiot, “even if you shipped bananas six times around the planet, their impact would be lower than local beef and lamb.”7 the disparity between the impact of animal and plant-based produce is stark. not all animal products are created equally. broadly, there are two ways to farm animals: extensive or intensive farming. extensive animal farming might be considered a “traditional” way of farming: keeping animals in large fields, as naturally as possible, often rotating them between different areas to not overgraze any one pasture. however, its efficiency is much lower than intensive farming – the style cafos use. intensive animal farming is arguably more environmentally efficient. that is, cafos produce more output per unit of natural resource input than extensive systems do. however, environmental efficiency is relative rather than absolute, as the level of intensive animal agriculture leads to large-scale deforestation to produce crops for factory-farmed animals. cafos are also point-sources of pollution from the massive quantities of animal waste produced – around 1,000,000 tons per day in the us alone, triple the amount of all human waste produced per day – which has significant negative impacts on human health in the surrounding areas.8 the environmental impacts of cafos must be given serious ethical consideration using new frameworks in climate ethics and bioethics. one example of a land ethic to guide thinking in this area is that “[it] is right when it tends to preserve the integrity, stability, and beauty of the biotic community. it is wrong when it tends otherwise.”9 it remains to be seen whether cafos can operate in a way that respects and preserves “integrity, stability, and beauty” of their local ecosystem, given the facts above. the pollution cafos emit affects the surrounding areas. hog cafos are built disproportionately around predominantly minority communities in north carolina where poverty rates are high. 10 animal waste carries heavy metals, infectious diseases, and antibiotic-resistant pathogens into nearby water sources and houses. iii. workers’ rights the poor treatment of slaughterhouse workers has been documented in the us during the covid-19 pandemic, where, despite outbreaks of coronavirus among workers, the white house ordered that they remain open to maintain the supply of meat. the staff of slaughterhouses in the us is almost exclusively people with low socioeconomic status, ethnic minorities, and migrants. 11 almost half of frontline slaughterhouse workers are hispanic, and a quarter is black. additionally, half are immigrants, and a quarter comes from families with limited english proficiency. an eighth live in poverty, with around 45 percent below 200 percent of the poverty line. only one-in-forty has a college degree or more, while one-in-six lacks health insurance. employee turnover rates are around 200 percent per year.12 injuries are very common in the fast-moving conveyor belt environment with sharp knives, machinery, and a crowd of workers. osha found 17 cases of hospitalizations, two body part amputations per week, and loss of an eye every month in the american industrial meat industry. this is three times the workplace accident rate of the average american worker across all industries. beef and pork workers are likely to suffer repetitive strain at seven times the rate of the rest of the population. one worker told the us department of agriculture (usda) that “every co-worker i know has been injured at some point… i can attest that the line speeds are already too fast to keep up with. please, i am asking you not to increase them anymore.”13 cockshaw, the end of factory farming, voices in bioethics, vol. 7 (2021) 4 slaughterhouses pose a major risk to public health from zoonotic disease transmission. 20 percent of slaughterhouse workers interviewed in kenya admit to slaughtering sick animals, which greatly increases the risk of transmitting disease either to a worker further down the production line or a consumer at the supermarket.14 moreover, due to poor hygienic conditions and high population density, animals in cafos are overfed antibiotics. over two-thirds of all antibiotics globally are given to animals in agriculture, predicted to increase by 66 percent by 2030.15 the majority of these animals do not require antibiotics; they overuse creates a strong and consistent selection pressure on any present bacterial pathogens that leads to antibiotic resistance that could create devastating cross-species disease affecting even humans. the world health organization predicts that around 10 million humans per year could die of antibiotic-resistant diseases by 2050. 16 many of these antibiotics are also necessary for human medical interventions, so antibiotics in animals have a tremendous opportunity cost. the final concern is that of zoonosis itself. a zoonotic disease is any disease that crosses the species boundary from animals to humans. according to the united nations, 60 percent of all known infections and 75 percent of all emerging infections are zoonotic.17 many potential zoonoses are harbored in wild animals (particularly when wild animals are hunted and sold in wet markets) because of the natural biodiversity. however, around a third of zoonoses originate in domesticated animals, which is a huge proportion given the relative lack of diversity of the animals we choose to eat. q fever, or “query fever,” is an example of a slaughterhouse-borne disease. q fever has a high fatality rate when untreated that decreases to “just” 2 percent with appropriate treatment.18 h1n1 (swine flu) and h5n1 (bird flu) are perhaps the most famous examples of zoonoses associated with factory farming. iv. unjust distribution the global distribution of food can cause suffering. according to research commissioned by the bbc, the average ethiopian eats around seven kilograms of meat per year, and the average rwandan eats eight.19 this is a factor of ten smaller than the average european, while the average american clocks in at around 115 kilograms of meat per year. in terms of calories, eritreans average around 1600kcal per day while most europeans ingest double that. despite enough calories on the planet to sustain its population, 25,000 people worldwide starve to death each day, 40 percent of whom are children. there are two ways to address the unjust distribution: efficient redistribution and greater net production, which are not mutually exclusive. some argue that redistribution will lead to lower net productivity because it disincentivizes labor;20 others argue that redistribution is necessary to respect human rights of survival and equality.21 instead of arguing this point, i will focus on people’s food choices and their effect on both the efficiency and total yield of global agriculture, as these are usually less discussed. regardless of the metric used, animals always produce far fewer calories and nutrients (protein, iron, zinc, and all the others) than we feed them. this is true because of the conservation of mass. they cannot feasibly produce more, as they burn off and excrete much of what they ingest. the exact measurement of the loss varies based on the metric used. when compared to live weight, cows consume somewhere around ten times their weight. when it comes to actual edible weight, they consume up to 25 times more than we can get out of them. cows are only around one percent efficient in terms of calorific production and four percent efficient in protein production. poultry is more efficient, but we still lose half of all crops we put into them by weight and get out only a fifth of the protein and a tenth of the calories fed to them.22 most other animals lie somewhere in the middle of these two in terms of efficiency, but no animal is ever as cockshaw, the end of factory farming, voices in bioethics, vol. 7 (2021) 5 efficient as eating plants before they are filtered through animals in terms of the nutritional value available to the world. due to this inefficiency, it takes over 100 square meters to produce 1000 calories of beef or lamb compared to just 1.3 square meters to produce the same calories from tofu.23 the food choices in the western world, where we eat so much more meat than people eat elsewhere, are directly related to a reduction in the amount of food and nutrition in the rest of the world. the most influential theory of justice in recent times is john rawls’ original position wherein stakeholders in an idealized future society meet behind a “veil of ignorance” to negotiate policy, not knowing the role they will play in that society. there is an equal chance of each policymaker ending up poverty-stricken or incredibly privileged; therefore, each should negotiate to maximize the outcome of all citizens, especially those worst-off in society, known as the “maximin” strategy. in this hypothetical scenario, resource distribution would be devised to be as just as possible and should therefore sway away from animal consumption. conclusion evidence is growing that animals of all sorts, including fish and certain invertebrates, feel pain in ways that people are increasingly inclined to respect, though still, climate science is more developed and often inspires more public passion than animal rights do. workers’ rights and welfare in slaughterhouses have become mainstream topics of conversation because of the outbreaks of covid-19 in such settings. environmentalists note overconsumption in high-income countries, also shining a light on the starvation of much of the low-income population of the world. at the intersection of these bioethical issues lies the modern cafo, significantly contributing to animal suffering, climate change, poor working conditions conducive to disease, and unjust distribution of finite global resources (physical space and crops). it is certainly time to move away from the cafo model of agriculture to at least a healthy mixture of extensive agriculture and alternative (non-animal) proteins. 1 berners-lee m, kennelly c, watson r, hewitt cn; current global food production is sufficient to meet human nutritional needs in 2050 provided there is radical societal adaptation. elementa: science of the anthropocene. 6:52, 2018. doi: https://doi.org/10.1525/elementa.310 2 : lund tb, kondrup sv, sandøe p. a multidimensional measure of animal ethics orientation – developed and applied to a representative sample of the danish public. plos one 14(2): e0211656. 2019. doi: https://doi.org/10.1371/ journal.pone.0211656 3 fiber-ostrow p & lovell js. behind a veil of secrecy: animal abuse, factory farms, and ag-gag legislation, contemporary justice review, 19:2, p230-249. 2016. doi: 10.1080/10282580.2016.1168257 4 jones rc. science, sentience, and animal welfare. biol philos 28, p1–30 2013. doi: https://doi.org/10.1007/s10539-012-9351-1 5 twine r. emissions from animal agriculture—16.5% is the new minimum figure. sustainability, 13, 6276. 2021. doi: https://doi.org/ 10.3390/su13116276 6 capper jl. "is the grass always greener? comparing the environmental impact of conventional, natural and grass-fed beef production systems" animals 2, no. 2: 127-143. 2012. doi: https://doi.org/10.3390/ani2020127 7 monbiot, george. “in trying to reduce the impact of our diets, … their impact would be lower than local beef and lamb.” twitter, twitter, 24 jan. 2020, twitter.com/georgemonbiot/status/1220691168012460032. https://doi.org/10.1525/elementa.310 https://doi.org/10.1371/%20journal.pone.0211656 https://doi.org/10.1371/%20journal.pone.0211656 https://doi.org/10.1080/10282580.2016.1168257 https://doi.org/10.1007/s10539-012-9351-1 https://doi.org/%2010.3390/su13116276 https://doi.org/10.3390/ani2020127 cockshaw, the end of factory farming, voices in bioethics, vol. 7 (2021) 6 8 copeland c. resources, science, and industry division. "animal waste and water quality: epa regulation of concentrated animal feeding operations (cafos)." congressional research service, the library of congress, 2006. 9 leopold a. a sand county almanac, and sketches here and there. 1949. 10 nicole w. “cafos and environmental justice: the case of north carolina.” environmental health perspectives vol. 121:6. 2013: a182-9. doi: 10.1289/ehp.121-a182 11 fremstad s, brown h, rho hj. cepr’s analysis of american community survey, 2014-2018 5-year estimates. 2020. accessed 08/06/21 at https://cepr.net/meatpacking-workers-are-a-diverse-group-who-need-better-protections 12 broadway, mj. "planning for change in small towns or trying to avoid the slaughterhouse blues." journal of rural studies 16:1. p37-46. 2000. 13 wasley a. the guardian. 2018. accessed 08/06/2021 at https://www.theguardian.com/environment/2018/jul/05/amputations-serious-injuries-us-meat-industry-plant 14 cook ea, de glanville wa, thomas lf, kariuki s, bronsvoort bm, fèvre em. working conditions and public health risks in slaughterhouses in western kenya. bmc public health. 17(1):14. 2017. doi: 10.1186/s12889-016-3923-y. 15 global trends in antimicrobial use in food animals. van boeckel tp, brower c, gilbert m, grenfell bt, levin sa, robinson tp, teillant a, laxminarayan r. proceedings of the national academy of sciences may 2015, 112 (18) 5649-5654; doi: 10.1073/pnas.1503141112 16 resistance, iicgoa. "no time to wait: securing the future from drug-resistant infections." report to the secretary-general of the united nations: p1-36. 2019. 17 espinosa r, tago d, treich n. infectious diseases and meat production. environ resource econ 76, p1019–1044. 2020. https://doi.org/10.1007/s10640-020-00484-3 18 “q fever fact sheet.” pennsylvania department of health, 4 jan. 2003. https://www.health.pa.gov/topics/documents/diseases%20and%20conditions/q%20fever%20.pdf 19 ritchie, hannah. “which countries eat the most meat?” bbc news, bbc, 4 feb. 2019, www.bbc.co.uk/news/health-47057341. 20 reynolds, alan. “the fundamental fallacy of redistribution.” cato.org, 11 feb. 2016, 1:22 pm, www.cato.org/blog/fundamental-fallacy-redistribution. 21 patricia justino professor and senior research fellow. “welfare works: redistribution is the way to create less violent, less unequal societies.” the conversation, 20 aug. 2021, theconversation.com/welfare-works-redistribution-is-the-way-to-createless-violent-less-unequal-societies-128807. 22 cassidy e, et al, “redefining agricultural yields: from tonnes to people nourished per hectare.” environmental research letters, v. 8(3), p2-3. iopscience. 2013, http://iopscience.iop.org/1748-9326/8/3/034015 23 poore j, nemecek t. reducing food’s environmental impacts through producers and consumers. science, 360(6392), p987-992. 2018. https://cepr.net/meatpacking-workers-are-a-diverse-group-who-need-better-protections https://www.theguardian.com/environment/2018/jul/05/amputations-serious-injuries-us-meat-industry-plant https://doi.org/10.1007/s10640-020-00484-3 https://www.health.pa.gov/topics/documents/diseases%20and%20conditions/q%20fever%20.pdf http://iopscience.iop.org/1748-9326/8/3/034015 https://science.sciencemag.org/content/360/6392/987 strand, an approach for academic medical centers, voices in bioethics, vol. 8 (2022) * nicolle strand, mbe, mph, assistant professor temple university © 2021 nicolle strand. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. structural racism: an approach for academic medical centers nicolle strand* abstract white bioethicists owe a duty to the field and medicine to participate in anti-racist initiatives in our institutions. given that medicine is steeped in biological essentialist assumptions about race, it is important that, as awareness of health disparities grows, physicians and medical educators are also educated on structural racism as the root cause. bioethicists may be uniquely positioned to participate in and spearhead some of this work. there are many avenues for this kind of advocacy; however, this paper focuses on a faculty development initiative. the initiative entailed several workshops with key educators in an urban medical school. this paper will describe the curriculum, including assignments and breakout activities, and recommend future work. keywords: racism, race, bioethics, health disparities, equity, health equity, advocacy introduction white bioethicists who work in academic medicine have a professional responsibility to confront anti-black racism in our institutions. i want to share my experience running a workshop about structural racism based on the cycle of race essentialism (figure 1). the workshop’s purpose was to shift attention to the sociopolitical forces of domination and oppression that drive racism and to challenge current assumptions like race essentialism. background race essentialism is the “belief in a genetic or biological essence that defines all members of a racial category.”1 medical professionals and larger institutions are only now taking heed of the effects of racism and how they exacerbate racial health disparities in medicine.2 without adequate education surrounding the historical and current forces that lead to these disparities, there is a risk that notions of biological racial essentialism that already persist in medicine will be reinforced. many health professionals incorrectly assume that differences in outcome across races are caused by some inherent or immutable feature of the people who belong to those races. therefore, the focus for providers lies at the bottom of the figure: racial health disparities. strand, an approach for academic medical centers, voices in bioethics, vol. 8 (2022) 2 dorothy roberts made clear in her book fatal invention that race is not a classification of the natural world. it is meaningful only insofar as human behavior and structural oppression have made it meaningful, but it does not delineate distinct biological categories of the human species.3 the right side of the figure lists two categories that i argue are obscured and inherently overlooked by healthcare practitioners. the forces that we must focus on are those at the top of the figure—racism, power, domination, capitalism, and politics. these are the forces that create and enforce race. they create the notion of strict biological differences across racial lines to maintain systems of power and oppression.4 figure 1: root causes of racial disparities are obscured from view to most physicians, the notion that blackness is socially or politically constructed rather than an innate biological reality can be difficult to grasp. healthcare professionals have been treating black and white bodies differently for centuries.5 as racial disparities persist, it is important to take a step back and ensure that doctors are educated about the structural reasons for those disparities. this statement brings us to the role of bioethics and the influence of white bioethicists. in an article earlier this year, dr. keisha ray noted that “bioethics as a whole owes black bioethics and all of the other subgroups that focus on marginalized people’s health a great deal for helping bioethics to remain relevant in a time when people are asking academia to do more to create real, lasting social change.”6 bioethicists like me who work in academia need to push our institutions to make that change. the responsibility is arguably even more significant for those who work in academic medicine, which is part of a more extensive american system that has perpetuated racial disparity.7 i. a curriculum for educating healthcare practitioners at my institution, i designed a workshop series for educators. the group in the workshop was chosen based on each person’s high number of contact hours with medical students. in addition, they were educational leaders responsible for developing and directing curriculum, handling issues and concerns in the classroom, and determining which faculty would have teaching roles. my objectives were to 1) reveal the right part of strand, an approach for academic medical centers, voices in bioethics, vol. 8 (2022) 3 the diagram, showing that structural racism and power were the root causes of racial health disparities, and 2) alleviate discomfort and shame when discussing race and racism. therefore, if the curriculum achieved both objectives, educators would be better equipped to respond empathetically to concerns about racism in medicine and medical school, empowered to work on anti-racist initiatives, and develop trust among one another and with me. my further hope was that we could continue as brainstorming partners in confronting racism. the workshops began with an intentional tone setting to establish commonality and trust. i talked about my whiteness and emphasized that if we couldn't make ourselves vulnerable to being uncomfortable in this space, it would be difficult to be genuine and authentic when discussing race with our students (or patients). i assigned a podcast before each session. the first was about structural racism to establish some facts and a basis of historical knowledge.8 then, i assigned a podcast called truth’s table, featuring a discussion with harriet washington, author of medical apartheid.9 i chose this conversation because it involved three black women discussing the impact of medical apartheid and centuries of abuse of black bodies on modern fears and mistrust of the health care system. i wanted the participants to understand patients’ fears of medicine. the third podcast i chose was howard stevenson discussing the anxiety that can come up when we discuss race—to help normalize this response and move us beyond our gut reaction toward a more thoughtful and mindful response.10 fourth was a podcast with jennifer eberhardt, opening up a discussion about bias and microaggressions.11 and finally, a podcast on anti-racist health systems to start a conversation about moving forward and working together to improve our field.12 during each session, we did one breakout activity. we talked about how we, as non-black people, benefit from systems of oppression. we discussed our reactions to racism being called out—often defensiveness and anger—and worked on brainstorming a more mindful response rooted in empathy and curiosity. we practiced the observe think feel desire (otfd) framework for addressing microaggressions in the classrooms.13 and we practiced handling hot moments in the classroom regarding race and racism. workshop participants conducted a self-assessment following the series. a majority rated themselves as better understanding structural racism and feeling better equipped to handle racism in teaching. but the self-assessment results are neither scientific nor particularly meaningful—i used them primarily as feedback for workshop design. when approached by a black student pointing out racism, i have noticed that faculty who participated are more likely to pause, lower defenses, maintain curiosity and empathy, and seek out other group participants for advice. conclusion attendees valued the workshop and renewed their dedication to anti-racist practices. additionally, our medical school has now formed a curricular anti-racist task force. healthcare practitioners can better serve those seeking care with improved awareness of how past racism influences current behaviors. faculty development is one way of improving the vestiges of structural racism. we may all have different skills from which to draw for this work—faculty development is certainly not the only avenue. however, structural change is likely even more effective. those who have power in academic medicine, mainly when some of that power is derived from whiteness, should engage in anti-racist work in our institutions. strand, an approach for academic medical centers, voices in bioethics, vol. 8 (2022) 4 1 soylu yalcinkaya n, estrada-villalta s, adams g. the (biological or cultural) essence of essentialism: implications for policy support among dominant and subordinated groups. front psychol. 2017;8:900. published 2017 may 30. 2 higgins-dunn, n., feuer, w., lovelace, b., kim, j. coronavirus pandemic and george floyd protests highlight health disparities for black people. cnbc. jun 11, 2020. https://www.cnbc.com/2020/06/11/coronavirus-george-floyd-protests-show-racialdisparities-in-health.html. 3 roberts, d. fatal invention: how science, politics, and big business re-create race in the twenty-first century. new york: the new press; 2011. 4. 4 jordan wd. historical origins of the one-drop racial rule in the united states. journal of critical mixed race studies. 2014;1(1). https://escholarship.org/uc/item/91g761b3 5 amutah, c., et al. misrepresenting race — the role of medical schools in propagating physician bias. nejm. 2021; 384(9): 872877. https://www.nejm.org/doi/full/10.1056/nejmms2025768 6 ray, k. black bioethics and how the failures of the profession paved the way for its existence. hastings center bioethics forum essay. 2020. available at https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-profession-paved-theway-for-its-existence/. 7 ama equity strategic plan. page 25. https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf. accessed dec 28, 2021. 8 tarchichi, t.r., owusu-onsah, s., and brown, t.p. racism in medicine part two – how is race a social determinant of health? phm from pittsburgh podcast. 2020. https://podcasts.apple.com/us/podcast/phm-frompittsburgh/id1176709862?i=1000484987639. accessed november 7, 2021. 9 washington, h.a. you okay, sis? medical apartheid with harriet a. washington. truth’s table. 2019. https://podcasts.apple.com/us/podcast/truths-table/id1212429230?i=1000433010203. accessed november 7, 2021. 10 stevenson, h.c. how to resolve racially stressful situations. tedmed. 2017. https://www.ted.com/talks/howard_c_stevenson_how_to_resolve_racially_stressful_situations/up-next. accessed november 7, 2021. 11 eberhardt, j.l. how racial bias works – and how to disrupt it. ted talks daily. 2020. https://podcasts.apple.com/us/podcast/how-racial-bias-works-how-to-disrupt-it-jennifereberhardt/id160904630?i=1000478505882. accessed november 7, 2021. 12 khazanchi, r., nolen, l., fields, n. antiracism in medicine series – episode 5 – racism, power, and policy: building the antiracist health systems of the future. clinical problem solvers anti-racism podcast series. 2021. https://clinicalproblemsolving.com/2021/01/19/episode-155-antiracism-in-medicine-series-episode-5-racism-power-and-policy/. accessed november 7, 2021. 13 cheung, f., ganote, c., and souza, t. microresistance as a way to respond to microaggressions on zoom and in real life. faculty focus. april 7, 2021. https://www.facultyfocus.com/articles/academic-leadership/microresistance-as-a-way-to-respondto-microaggressions-on-zoom-and-in-real-life/. accessed november 7, 2021. https://www.cnbc.com/2020/06/11/coronavirus-george-floyd-protests-show-racial-disparities-in-health.html https://www.cnbc.com/2020/06/11/coronavirus-george-floyd-protests-show-racial-disparities-in-health.html https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-profession-paved-the-way-for-its-existence/ https://www.thehastingscenter.org/black-bioethics-and-how-the-failures-of-the-profession-paved-the-way-for-its-existence/ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf https://podcasts.apple.com/us/podcast/phm-from-pittsburgh/id1176709862?i=1000484987639 https://podcasts.apple.com/us/podcast/phm-from-pittsburgh/id1176709862?i=1000484987639 https://podcasts.apple.com/us/podcast/truths-table/id1212429230?i=1000433010203 https://www.ted.com/talks/howard_c_stevenson_how_to_resolve_racially_stressful_situations/up-next https://podcasts.apple.com/us/podcast/how-racial-bias-works-how-to-disrupt-it-jennifer-eberhardt/id160904630?i=1000478505882 https://podcasts.apple.com/us/podcast/how-racial-bias-works-how-to-disrupt-it-jennifer-eberhardt/id160904630?i=1000478505882 https://clinicalproblemsolving.com/2021/01/19/episode-155-antiracism-in-medicine-series-episode-5-racism-power-and-policy/ https://www.facultyfocus.com/articles/academic-leadership/microresistance-as-a-way-to-respond-to-microaggressions-on-zoom-and-in-real-life/ https://www.facultyfocus.com/articles/academic-leadership/microresistance-as-a-way-to-respond-to-microaggressions-on-zoom-and-in-real-life/ park, relaxing mask mandates in new jersey, voices in bioethics, vol. 8 (2022) * wesley j. park, md candidate, rutgers robert wood johnson medical school © 2022 wesley j. park. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. relaxing mask mandates in new jersey: a tale of two universities wesley j. park* keywords: mask mandates, recommendation, vaccination rates, university administration, research ethics, public health ethics, face masks, precautionary principle introduction in march of 2022, new jersey governor phil murphy announced that the state would no longer mandate face masks for students, staff, and visitors at schools and childcare centers. two-thirds of new jersey residents already supported this decision.1 soon after, princeton university led the way in learning to live with the virus by making the use of masks optional in most situations. at a time when vaccination rates were already high and omicron hospitalization rates were falling, the decision to relax mask mandates was the right call. yet, rutgers university has extended its mask mandate for the rest of the academic year, with no stated endpoint. in a university-wide email, executive vice president and chief operating officer antonio calcado announced: the university has been clear that the science and data would guide our path forward with respect to the health and safety of our community… use of appropriate face coverings will still be required in all teaching spaces (classrooms, lecture halls, seminar rooms, etc.), teaching labs, computer labs, buses, libraries, and clinical facilities.2 despite the university’s purported commitment to follow “the science and data,” there has been a noticeable lack of transparency regarding the scientific rationale and official endpoint for this extension of the mask mandate. given the same set of scientific data available, these neighboring universities came to opposite conclusions on the need for continued mask mandates. notably, the rutgers mask mandate continues to require students to mask in libraries but not in crowded cafeterias. these discrepancies have led to understandable park, relaxing mask mandates in new jersey, voices in bioethics, vol. 8 (2022) 2 frustration among members of the rutgers community. in response, the rutgers student newspaper objects to “the sense of optics” and “the lack of clear communication,” resulting in “confusion,” arguing that the university administration “needs to be more transparent” and “must communicate and explain the policy changes more effectively.”3 at a time when trust in public health institutions is at an all-time low, ava kamb warns that a lack of transparent messaging can reduce public trust even further.4 instead, kamb argues that public health mandates should use the least restrictive means necessary in order to promote health and civil liberties at the same time. the ethical question is whether university mask mandates should be relaxed. i argue that the use of face masks by healthy individuals has uncertain benefits, which potential harms may outweigh, and should therefore be voluntary. analysis rutgers intends “the science and data” to guide its path forward. as such, it is worth revisiting the controversial science behind mask mandates. from 2019 to 2020, systematic reviews by the world health organization (who) and cochrane acute respiratory infections concluded that the use of face masks by healthy individuals in the community lacks effectiveness in reducing viral transmission based on moderatequality evidence.5 neither study concerned covid-19 specifically. since then, the only two randomized controlled trials of face masks published during the pandemic found little to no benefit.6 yet, the centers for disease control and prevention (cdc) cite many observational and modeling studies (based on empirical assumptions) which suggest that community masking is beneficial.7 these studies support a larger benefit associated with masking, but they use less reliable research methods. based on these non-randomized data and mechanistic plausibility, who’s current position is also supportive of community masking recommendations. but without high-quality evidence, it is difficult to justify a requirement rather than a recommendation. it may be useful to draw an ethical distinction between a recommendation and a mandate in public health. a public health recommendation does not generally undermine individual autonomy because individuals have the choice to follow the recommendation. i argue that recommendations may be justified by a lower standard of proof or a lesser expected benefit precisely because they do not violate individual autonomy. on the other hand, a public health mandate demands compliance using the threat of penalty. to ethically justify an infringement of autonomy, strong evidence that demonstrates a significant health benefit should support a public health mandate. while the recommendation to use masks in accordance with personal preference may be a reasonable precaution—particularly for vulnerable individuals—the higher standards of evidence and benefit that would ethically justify mask mandates have not been met. notwithstanding, one might argue the precautionary principle justifies mask mandates. for example, chinese cdc director-general george gao, medical researcher trisha greenhalgh, and others espouse such a view.8 the precautionary principle holds that it is better to be safe than sorry. in the context of covid-19, the principle has been used to advocate for public health measures which lack high-quality evidence. accordingly, it might be thought that it is safer to implement potentially ineffective mask mandates than to risk forgoing a lifesaving benefit. yet, the precautionary principle is an ill-defined concept that is philosophically problematic. health economist jay bhattacharya and epidemiologist sunetra gupta argue that the precautionary principle cuts both ways because a public health mandate without highquality evidence has both potential benefits and potential harms.9 if the precautionary principle can justify implementing mask mandates due to the risk of forgoing possible benefit, then it might also be able to justify not implementing mask mandates due to the risk of potential harm caused by the intervention. park, relaxing mask mandates in new jersey, voices in bioethics, vol. 8 (2022) 3 it is commonly thought that there is little to lose from the use of face masks, but this is not necessarily true. according to who, cdc, and the european centre for disease prevention and control (ecdc), the harms of face masks may include headaches, difficulty breathing, skin lesions, difficulty communicating, a false sense of security, environmental pollution, impaired learning, delayed psychosocial development, and disadvantages for individuals with cognitive or mental disorders. 10 these include both potential and observed harms drawn from the scientific literature. yet, the negative side effects of masks remain significantly under-investigated. for example, there is emerging mechanistic evidence that prolonged mask use or reuse increases both inhaled and environmental microplastics, the long-term effects of which are unknown.11 the harms related to communication, learning, and psychosocial development are particularly problematic for educational institutions, whose mission is to promote these very things. it is, therefore, possible that masks have done more harm than good. while many observational studies and models support the potential benefits of masks, some interpret these studies to mean that masks clearly work. however, the limited body of randomized data paints a less optimistic picture and cannot be used to rule out an increase in infection from masks.12 other types of studies, less reliable research methods, do rule this out and support masking. bhattacharya and gupta would argue that it is safer to encourage voluntary, evidence-based interventions than to foist these potential harms upon individuals for the sake of uncertain benefits. it remains unclear whether and to what extent the use of face masks by healthy individuals in the community influenced covid-19 mortality. however, it is clear to me that community masking does not meet the higher standard of evidence necessary to justify a mandate and that mask use is associated with potential harm. the already tenuous case for masks continues to weaken with a mixed body of evidence, the availability of effective pharmaceuticals, and widespread natural immunity to covid-19. if public health should aim for the least restrictive means necessary to promote health while respecting civil liberties, then the extension of burdensome mask mandates which lack high-quality evidence is ethically problematic. conclusion given the current state of covid-19, a university mask mandate for a low-risk population with high levels of immunity is not justified. in times of fear and uncertainty, higher education institutions ought to make reasoned policy decisions guided by “the science and data.” it would seem that, of the universities that mandated masks, princeton has emerged as a national leader in mask policy while rutgers lags behind. schools across the nation should take note. 1 rutgers university eagleton institute of politics. two-thirds of new jerseyans agree with lifting school mask mandate, most comfortable returning to normal; half think nj has done “just right” on pandemic. accessed may 14, 2022. https://eagletonpoll.rutgers.edu/wp-content/uploads/2022/03/rutgers-eagleton-poll-covid-march-7-2022.pdf 2 calcado am. return to campus update – january 31, 2022. accessed may 14, 2022. https://coronavirus.rutgers.edu/changesrelated-to-covid-19-protocols 3 the daily targum. rutgers’ new mask policies are more than confusing. accessed may 14, 2022. https://dailytargum.com/article/2022/04/editorial-rutgers-new-mask-policies-are-more-than-confusing 4 kamb a. the false choice between public health and civil liberties. voices in bioethics 2020;6. doi:10.7916/vib.v6i.6297. 5 world health organization global influenza programme. non-pharmaceutical public health measures for mitigating the risk and impact of epidemic and pandemic influenza. geneva: world health organization; 2019; jefferson t, del mar cb, dooley l, et al. park, relaxing mask mandates in new jersey, voices in bioethics, vol. 8 (2022) 4 physical interventions to interrupt or reduce the spread of respiratory viruses. cochrane database of systematic reviews 2020;11(cd006207). doi:10.1002/14651858.cd006207.pub5. 6 abaluck j, kwong lh, styczynski a, et al. impact of community masking on covid-19: a cluster-randomized trial in bangladesh. science 2022;375(6577):eabi9069. doi:10.1126/science.abi9069. (intervention reduced symptomatic seroprevalence by 9.5%; 95% confidence interval = [0.82, 1.00].); bundgaard h, bundgaard js, raaschou-pedersen det, et al. effectiveness of adding a mask recommendation to other public health measures to prevent sars-cov-2 infection in danish mask wearers: a randomized controlled trial. ann intern med 2021;174(3):335-343. doi:10.7326/m20-6817. (trial was conducted in a setting where mask wearing was uncommon and the findings were inconclusive; 95% confidence interval = [0.54, 1.23].) 7 u.s. centers for disease control and prevention. science brief: community use of masks to control the spread of sars-cov-2. accessed may 14, 2022. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-sars-cov2.html 8 zimmerman a. the precautionary principle in mask-wearing: when waiting for explicit scientific evidence is unwise. voices in bioethics 2020;6. doi:10.7916/vib.v6i.5896. (supporting the use of masks early in the pandemic arguing that the harms of masking in the short term were unlikely to be severe or to outweigh the benefits.); greenhalgh t, schmid mb, czypionka t, et al. face masks for the public during the covid-19 crisis. bmj 2020;369:m1435. doi:10.1136/bmj.m1435. 9 bhattacharya j. on the catastrophic misapplication of the precautionary principle. accessed may 14, 2022. https://collateralglobal.org/article/misapplication-of-the-precautionary-principle; gupta s. a betrayal of the precautionary principle. accessed may 14, 2022. https://collateralglobal.org/article/a-betrayal-of-the-precautionary-principle 10 world health organization. mask use in the context of covid-19: interim guidance, 1 december 2020. accessed may 14, 2022. https://apps.who.int/iris/handle/10665/337199; u.s. centers for disease control and prevention; european centre for disease prevention and control. using face masks in the community: first update effectiveness in reducing transmission of covid-19. accessed may 14, 2022. https://www.ecdc.europa.eu/sites/default/files/documents/covid-19-face-masks-community-firstupdate.pdf 11 li l, zhao x, li z, et al. covid-19: performance study of microplastic inhalation risk posed by wearing masks. j hazard mater 2021;411:124955. doi:10.1016/j.jhazmat.2020.124955; ma j, chen f, xu h, et al. face masks as a source of nanoplastics and microplastics in the environment: quantification, characterization, and potential for bioaccumulation. environ pollut 2021;288:117748. doi:10.1016/j.envpol.2021.117748; chen x, chen x, liu q, et al. used disposable face masks are significant sources of microplastics to environment. environ pollut 2021;285:117485. doi:10.1016/j.envpol.2021.117485. 12 bundgaard et al. (inconclusive with a 95% confidence interval = [0.54, 1.23]). lively, covid-19 in the navajo nation, voices in bioethics, vol. 7 (2021) cathy lively, jd © 2021 cathy lively. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. covid-19 in the navajo nation without access to running water: the lasting effects of settler colonialism. cathy lively* keywords: indigenous communities, access, water, disparate, impact abstract although covid-19 affects everyone, its impact on the navajo nation, which calls covid-19 dikos nitsaaigii ndhast’eits’aadah, or “big cough 19,”1 is more profound. the lack of adequate water for personal hygiene exacerbates water-washed infections like covid-19.2 for indigenous communities within the navajo nation in arizona, preventing infectious disease by handwashing is difficult as there is not adequate access to reliable running water. as a community with over 309,000 members, half of whom reside in multigenerational households,3 addressing the systemic challenges limiting the navajo nation’s access to water would reduce the disparate impacts of covid-19. introduction although covid-19 affects everyone, its impact on the navajo nation, which calls covid-19 dikos nitsaaigii ndhast’eits’aadah, or “big cough 19,”4 is more profound. efforts to contain and stop the virus include the three w’s: wear (masks), wait (social distancing), and wash (handwashing). these three actions become onerous for people without the financial resources to purchase masks or hand sanitizer or living in overcrowded conditions. the lack of adequate water for personal hygiene exacerbates water-washed infections like covid19. 5 for indigenous communities within the navajo nation in arizona, preventing infectious disease by handwashing is difficult as there is not adequate access to reliable running water. as a community with over 309,000 members, half of whom reside in multi-generational households,6 addressing the systemic challenges limiting the navajo nation’s access to water would reduce the disparate impacts of covid-19. analysis a. covid-19 in the navajo nation & statistics on poverty several factors contribute to higher mortality rates in indigenous populations, making them especially vulnerable during a health crisis. demographic characteristics, socioeconomic status, availability of epidemicappropriate resources, differential immunity related to health status and prior disease experience, variations in social distancing practices, community organization, and communication infrastructure influence the outcomes of covid-19 patients in the navajo community.7 lively, covid-19 in the navajo nation, voices in bioethics, vol. 7 (2021) 2 the navajo nation has covid-19 infection rates three and a half times higher than those of white americans8 as of january 27, 2021, the navajo department of health identified 53 communities with uncontrolled spread. 9 today, the navajo nation has a poverty rate of over 40 percent. 10 sixty percent of the navajo nation’s residents lack fixed internet access. the broadband access that does exist is sporadic with limited connectivity. .11 lack of internet impedes the provision of critical public health announcements, limiting the navajo nation’s emergency health care. research describing health inequities often excludes native american communities.12 the tribal authorities gather information only about people on the tribal lands and minimal information is available about those living off the reservation.13 racial misclassification of native americans as “other” by researchers further obscures health emergencies within indigenous communities, 14 leading to the exclusion and misrepresentation of native americans in the public health dialog.15 b. history of settler colonialism early settlers from europe introduced pathogens and diseases, like measles, influenza, and smallpox to indigenous populations. many native americans, lacking immunity to european-borne pathogens, succumbed to diseases.16 between 1781 and 1782, the smallpox mortality rate in the native american population ranged from 50 percent to 90 percent.17 later, during the spanish flu epidemic in 1918 and 1919, native americans had mortality rates four times higher than those of the general population, many of whom lived in poverty.18 during the 1860s, navajo people were extracted and placed in captivity by the us for several years before returning to their homelands, entering into treaties with the us government through duress and false promises.19 eventually, the settlers seized and established property rights from native americans through genocide, forced removal, and confinement on reservations supported by the us government.20 testifying before the house energy and commerce committee hearing on july 8, 2020, jonathan nez, president of the navajo nation, attributed the high per capita covid-19 infection rate to the federal government’s breach of responsibility arising from treaties.21 the government failed in its responsibility to protect tribal treaty rights, lands, assets, and resources, including healthcare and infrastructure development guarantees.22 today, the navajo nation continues to encounter broken promises and attacks on their inherent sovereignty.23 over 40 percent of navajo nation households do not have running water in their homes and must rely on hauling water to meet their daily needs. thirty percent of families lack access to reliable, clean drinking water. 24 the acs data shows that native american households are 19 times more likely to lack complete plumbing than white households.25 using the limited water reserves for regular hand washing forces the family to decide between safe drinking water and personal hygiene, including frequent handwashing. for generations, the navajo people have lived in arid regions, such as apache county, arizona. they have confronted increased water scarcity associated with more frequent and intense droughts on the colorado river and water quality challenges caused by decades of uranium mining in the region. 26 water levels are so low that the average use is two to three gallons per day compared to 88 gallons per day in most american households. 27 it can be argued that the affected individuals can resolve the dilemma by relocating rather than demanding assistance. in this instance, financial restraints and poverty would limit relocation. they were forcibly removed from their homes and, ultimately, relocated to reservations by the actions of settlers supported by the us government. it becomes unreasonable to expect individuals who were forced into a location by us officials to bear the burden of relocation to obtain essential resources. relocation would also significantly disrupt navajo lives and tear down deep-rooted cultural networks. the history of forced relocation to reservations and intentional intervening actions by the us, resulting in either direct or indirect damages and diverted water, created a circumstance in which the us government must supply basic provisions for survival, such as water. while this essay focuses on the navajo nation, the lively, covid-19 in the navajo nation, voices in bioethics, vol. 7 (2021) 3 lack of clean water and working plumbing is not unique to this region or population. as of november 2019, two million people living in the us were without access to running water, indoor plumbing, or wastewater services.28 the government must not ignore the lack of access to an essential resource or the governmental actions of environmental racism that have created the situation. c. recommendations as in prior pandemics, the devastating rates of covid-19 in the navajo nation reflect systemic racism and inequities. 29 an ethical breach is responsible for the current condition of the navajo population and its exposure to covid-19. the term environmental racism30 emerged in the 1980s to describe contaminated air, soil, and water segregated along racial and class lines.31 environmental racism, arising from settler colonialism, exists in the navajo nation, resulting in the subsequent failure of the federal government to act fairly and justly to honor its established treaties and to provide housing assistance and water to the navajo people. the federal government maintains its responsibility to uphold its treaty obligations, to ensure equal access to health care, and to provide clean water and access to adequate covid-19 testing and vaccination. the federal government should ensure that all programs designed to alleviate poverty are accessible to the navajo people. the covid19 crisis should not be used as an excuse to ignore systemic challenges. solutions including proper plumbing for water and sewage systems, compatible with the natural environment, should be provided immediately. an ethical obligation exists to provide state or federally funded reparations or programs to remedy the inhumane living conditions resulting from settler colonialism. justice compels the government to address the needs of this overlooked minority. conclusion the conditions within the navajo reservations highlight the structural inequality exacerbated by the covid-19 pandemic. to address these issues, federal and state officials must ensure the protection of tribal treaty rights, land, assets, and resources that will guarantee healthcare and infrastructure development within navajo communities. the navajo nation’s circumstances point to the need for immediate action to address proximal factors such as providing personal protective equipment, covid-19 testing, and treatments while concurrently addressing distal factors, including access to clean running water.32 1 u.s. house energy and commerce committee hearing; addressing the urgent needs of our tribal communities, testimony by jonathan nez, president, navajo nation. congressional documents and publications. (july 8, 2020). https://advance-lexis-com.ezproxy.cul.columbia.edu/api/document?collection=news&id=urn:contentitem:609tmx01-dyvr-p1bk-00000-00&context=1516831. 2 larson, r., & larson, r. “water law and the response to covid-19,” water international, vol. 45, issue 7-8, 716721(2020) https://www.tandfonline.com/doi/full/10.1080/02508060.2020.1835422 3 u.s. house energy and commerce committee hearing (july 8, 2020), p.1.; hlavinka, elizabeth. “cdc confirms soaring covid-19 rate among native americans.” medpage today, 19 aug. 2020; yellow horse, a.j., yang, tc. & huyser, k.r, “structural inequalities established the architecture for covid-19 pandemic among native americans in arizona: a geographically weighted regression perspective,” j. racial and ethnic health disparities (2021). https://doi-org.ezproxy.cul.columbia.edu/10.1007/s40615-020-00940-2 4 u.s. house energy and commerce committee hearing; addressing the urgent needs of our tribal communities, testimony by jonathan nez, president, navajo nation. congressional documents and publications. (july 8, 2020). https://advance-lexis-com.ezproxy.cul.columbia.edu/api/document?collection=news&id=urn:contentitem:609t-mx01-dyvr-p1bk-00000-00&context=1516831 https://advance-lexis-com.ezproxy.cul.columbia.edu/api/document?collection=news&id=urn:contentitem:609t-mx01-dyvr-p1bk-00000-00&context=1516831 https://doi-org.ezproxy.cul.columbia.edu/10.1007/s40615-020-00940-2 lively, covid-19 in the navajo nation, voices in bioethics, vol. 7 (2021) 4 https://advance-lexis-com.ezproxy.cul.columbia.edu/api/document?collection=news&id=urn:contentitem:609tmx01-dyvr-p1bk-00000-00&context=1516831. 5 larson, r., & larson, r. “water law and the response to covid-19,” water international, vol. 45, issue 7-8, 716721(2020) https://www.tandfonline.com/doi/full/10.1080/02508060.2020.1835422 6 u.s. house energy and commerce committee hearing (july 8, 2020), p.1.; hlavinka, elizabeth. “cdc confirms soaring covid-19 rate among native americans.” medpage today, 19 aug. 2020; yellow horse, a.j., yang, tc. & huyser, k.r, “structural inequalities established the architecture for covid-19 pandemic among native americans in arizona: a geographically weighted regression perspective,” j. racial and ethnic health disparities (2021). https://doi-org.ezproxy.cul.columbia.edu/10.1007/s40615-020-00940-2 7 brady, b. r., & bahr, h. m. mortality, and the implications of some neglected eyewitness accounts. american indian quarterly, volume 38, issue 4, (fall 2014)459-491. p. 461. 8 hlavinka. 9 hlavinka. 10 house energy and commerce committee hearing, p.1. 11 house energy and commerce committee hearing, p.1. 12 yellow horse, et al, p.2. 13 yellow horse, et al. 14 yellow horse, et al., p.2. 15 yellow horse, et al., p.2. 16 m. carlos, frank d. lewis, “smallpox and native american mortality: the 1780s epidemic in the hudson bay region,” explorations in economic history, volume 49, issue 3, 2012, pages 277-290, https://doi.org/10.1016/j.eeh.2012.04.003 (2012, april 27) 17 carlos and lewis, p.278. 18 brady and bahr. 19 glenn, e. n. (2015). settler colonialism as structure: a framework for comparative studies of u.s. race and gender formation, sociology of race and ethnicity, 1(1), 58-72. doi:10.1177/2332649214560440 20 glenn, e. n. 21 house energy and commerce committee hearing, p.2. 22 house energy and commerce committee hearing, p.2. 23 house energy and commerce committee hearing, p.1. 24 house energy and commerce committee hearing. 25 the 2019 report considered census bureau data and other quantitative and qualitative studies. the american communities survey (acs) is part of the us census bureau. 26 larson and larson. https://advance-lexis-com.ezproxy.cul.columbia.edu/api/document?collection=news&id=urn:contentitem:609t-mx01-dyvr-p1bk-00000-00&context=1516831 https://advance-lexis-com.ezproxy.cul.columbia.edu/api/document?collection=news&id=urn:contentitem:609t-mx01-dyvr-p1bk-00000-00&context=1516831 https://doi-org.ezproxy.cul.columbia.edu/10.1007/s40615-020-00940-2 lively, covid-19 in the navajo nation, voices in bioethics, vol. 7 (2021) 5 27 mcgraw, g., & fox, r., “closing the water access gap in the united states: a national action plan,” us water alliance, (november 18, 2018). http://uswateralliance.org/sites/uswateralliance.org/files/closing the water access gap in the united states_digital.pdf. 28 mcgraw and fox, p.2. 29 rosenthal, e., menking, p., & begay, m., fighting the covid19 merciless monster: lives on the line -community health representatives' roles in the pandemic battle on the navajo nation. journal of ambulatory care management, volume 43, issue 4 (oct/dec 2020) 301-305. doi:00004479-202010000-00007 30 digdeep, p.o. box 26779, los ángeles, ca 90026, info@digdeep.org, https://digdeep.org 31 lee, t., “cancer alley: big industry, big problems.” msnbc, http://www.msnbc.com/interactives/geography-ofpoverty/se.html. 32 yellow horse, p.8. mailto:info@digdeep.org abstract introduction childers, extending animal cruelty protections, voices in bioethics, vol. 8 (2022) * chad childers, ms bioethics candidate harvard medical school center for bioethics © 2022 chad childers. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. extending animal cruelty protections to scientific research chad childers* keywords: animal ethics, animal-based research, scientific innovation, research ethics, protections introduction on november 25, 2019, the federal law h.r. 724 – the preventing animal cruelty and torture act (pact) prohibiting the intentional harm of “living non-human mammals, birds, reptiles, or amphibians” was signed.1 this law was a notable step in extending protections, rights, and respect to animals. while many similar state laws existed, the passing of a federal law signaled a new shift in public tone. pact is a declaration of growing societal sentiments that uphold the necessity to shield our fellow creatures from undue harm. protecting animals from the harm of citizens is undoubtedly important, but pact does nothing to protect animals from state-sanctioned harm, particularly in the form of research, which causes death and cruelty. it is time to extend and expand protections for animals used in research. background there is a long history of animal experimentation in the us, but no meaningful ethical protections of animals emerged until the 20th century. proscription of human experimentation and dissection led to animals bearing the brunt of harm for scientific and medical progress. for instance, english physician william harvey discovered the heart did not continuously produce blood but instead recirculated it; he made this discovery by dissecting and bleeding out living dogs without anesthesia. 2 experiments like this were considered ethically tenable for hundreds of years. philosophers like immanuel kant, thomas aquinas, and rene descartes held that humans have no primary moral obligations to animals, and that one should be concerned about the treatment of an animal only because it could indicate how one would treat a human.3 during the 20th century, as agriculture became more industrialized and government funding of animal research increased, the social demand for ethical regulations finally began to shift. in 1966, the animal welfare act (public law 89-544) marked the first american federal legislation to protect laboratory animals, setting standards for use of animals in research.4 childers, extending animal cruelty protections, voices in bioethics, vol. 8 (2022) 2 analysis there has been progress in the field of animal research ethics since harvey’s experiments, but much work remains. in the us alone, there are an estimated 20 million mice, fish, birds, and invertebrates used for animal research each year that are not regulated by the animal welfare act. 5 instead, the “3rs alternatives” approach (“reduce, replace, and refine”)6 is one framework used to guide ethical treatment of animals not covered by federal protections. unfortunately, unpacking the meaning and details of this approach only leads to ambiguity and minimal actionable guidance. for instance, an experimenter could reduce the number of animals used in research but subsequently increase the number of experiments conducted on the remaining animals. replace could be used in the context of replacing one species with another. refining is creating “any decrease in the severity of inhumane procedures applied to those animals, which still have to be used.”7 the vague “any” implies that even a negligible minimization would be ethically acceptable.8 an experimenter could technically follow each of the “3rs” with minimal to no reduction in harm to the animals. one must also consider whether it is coherent to refer to guidelines as ethical when they inevitably produce pain, suffering, and death as consequences of research participation. other ethical guides like humane endpoints for laboratory animals used in regulatory testing9 encourage researchers to euthanize animals that undergo intractable pain or distress. this is a fate that an estimated one million animals face yearly in the us.10 however, to use the word “humane” in this context contradicts the traditional meaning and undermines the integrity of the word. taking living creatures, forcing them to experience intractable pain and suffering for human benefit, and killing them is the antithesis of what it means to be humane. during one of my animal ethics classes as a graduate student, our cohort visited an animal research facility to help inform our opinions on animal research. we observed one of the euthanasia chambers for lab mice – an enclosed metal lab bench with a sign above describing methods for euthanasia if co2 asphyxiation were to fail. the methods included decapitation, removal of vital organs, opening of the chest cavity, incision of major blood vessels, and cervical dislocation.11 behind us were rows and rows of see-through shoebox-sized containers housing five mice in each little box. thousands of mice were packed together in this room for the sole purpose of breeding. if the mice were not the correct “type” for research, then they were “humanely” euthanized. “humane,” in this context, has been deprived of its true meaning. one can acknowledge that animal research was historically necessary for scientific progress, but those that currently claim these practices are still required must show empirically and undoubtedly this is true. as of now, this is not a settled issue. in the scientific community, there is contention about whether current animal research is actually applicable to humans.12 many drug researchers even view animal testing as a tedious barrier to development as it may be wholly irrelevant to the drug or medical device being tested. since 1962, the fda has required preclinical testing in animals; it is time to question whether this is necessary or helpful for drug development. conclusion the scientific community should stop viewing animal testing as an unavoidable evil in the search for medical and technological innovation. pact should be amended and extended to all animals and the fda should modify the requirement for preclinical animal testing of all drugs and medical devices. it is time to encourage the scientific community to find alternative research methods that do not sacrifice our fellow animals. we use animals as test subjects because, in some sense, they resemble humans. but, if they are indeed like humans, they should receive similar protections. science builds a better world for humans, but perhaps it is time for science to be more inclusive and build a better world for all creatures. childers, extending animal cruelty protections, voices in bioethics, vol. 8 (2022) 3 1 theodore e. deutch, “text h.r.724 116th congress (2019-2020): preventing animal cruelty and torture act,” legislation, november 25, 2019, 2019/2020, https://www.congress.gov/bill/116th-congress/house-bill/724/text. 2 anita guerrini, “experiments, causation, and the uses of vivisection in the first half of the seventeenth century,” journal of the history of biology 46, no. 2 (2013): 227–54. 3 bernard e. rollin, “the regulation of animal research and the emergence of animal ethics: a conceptual history,” theoretical medicine and bioethics 27, no. 4 (september 28, 2006): 285–304, https://doi.org/10.1007/s11017-006-9007-8; darian m ibrahim, “a return to descartes: property, profit, and the corporate ownership of animals,” law and contemporary problems 70 (n.d.): 28. 4 benjamin adams and jean larson, “legislative history of the animal welfare act: introduction | animal welfare information center| nal | usda,” accessed november 3, 2021, https://www.nal.usda.gov/awic/legislative-history-animal-welfare-actintroduction. 5 national research council (us) and institute of medicine (us) committee on the use of laboratory animals in biomedical and behavioral research, patterns of animal use, use of laboratory animals in biomedical and behavioral research (national academies press (us), 1988), https://www.ncbi.nlm.nih.gov/books/nbk218261/. 6 robert c. hubrecht and elizabeth carter, “the 3rs and humane experimental technique: implementing change,” animals: an open access journal from mdpi 9, no. 10 (september 30, 2019): 754, https://doi.org/10.3390/ani9100754. 7 hubrecht and carter. 8 hubrecht and carter. 9 william s. stokes, “humane endpoints for laboratory animals used in regulatory testing,” ilar journal 43, no. suppl_1 (january 1, 2002): s31–38, https://doi.org/10.1093/ilar.43.suppl_1.s31. 10 stokes. 11 “euthanasia of research animals,” accessed april 21, 2022, https://services-web.research.uci.edu/compliance/animalcareuse/research-policies-and-guidance/euthanasia.html. 12 neal d. barnard and stephen r. kaufman, “animal research is wasteful and misleading,” scientific american 276, no. 2 (1997): 80–82. doomen, radical existentialist exercise, voices in bioethics, vol. 7 (2021) © 2021 jasper doomen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. radical existentialist exercise: strongly disincentivizing procreation as a hypothetical climate change solution jasper doomen abstract the problem of climate change raises some important philosophical, existential questions. i propose a radical solution designed to provoke reflection on the role of humans in climate change. to push the theoretical limits of what measures people are willing to accept to combat it, an extreme population control tool is proposed: allowing people to reproduce only if they make a financial commitment guaranteeing a carbon-neutral upbringing. prior to their existence, there is no obligation to bequeath the earth to next generations. such generations will only exist if they are actually created, and there is no obligation to create them. the lack of existence should not be confused with harm. climate change provides an important reason to stem overpopulation. ironically, fast rates of procreation may lead to the earth becoming uninhabitable for humans altogether. the radical solution that has been proposed here is an unrealistic scenario. for now, the average global birth rate is just over 18 per thousand people, but there is a need to ensure that the number of people is not greater than the planet can endure. while it is better to prevent problems than to solve them, the interest in procreation and its associated joys, usefulness, and cultural value make mass reduction in the population unlikely. keywords: climate change, philosophy, overpopulation, population growth, anti-natalist, benatar, greenhouse gases, carbon footprint introduction the problem of climate change raises some important philosophical, existential questions. i propose a radical solution designed to provoke reflection on the role of humans in climate change. to push the theoretical limits of what measures people are willing to accept to combat it, an extreme population control tool is proposed: allowing people to reproduce only if they make a financial commitment guaranteeing a carbon-neutral upbringing. doomen, radical existentialist exercise, voices in bioethics, vol. 7 (2021) 2 solving the problem of climate change in the long run by halting the procreation of human beings is controversial. in the absence of human beings and consequent climate change, other animals and plant species would benefit from an atmosphere more conducive to prolonging their existence and even improving their ability to thrive. if someone were to invent something to reverse the effects of climate change and improve animals’ lives, then human beings’ presence would be justified by the invention. whether the propagation of the human species is beneficial to anyone or anything but human beings themselves is difficult to answer. perhaps human beings are unfit to tackle this issue, being unable to judge it objectively. managing procreation: an alternative to piecemeal approaches measures aimed at reducing greenhouse gases by nudging individuals and corporations may have a positive effect, but if their behavior is not climate neutral, they continue to contribute to climate change. consequently, as long as the number of people increases, reducing greenhouse gases is at best a mitigation tool. if humans could rely solely on renewable energy, decreasing the population arguably would not be necessary. significantly reducing the number of people appears to provide a solution to both problems: people who do not exist do not contribute to climate change, and renewable energy could meet the demand of a smaller population. one option is to let only those who produce the problem pay for its solution. one could determine the expected annual emission of greenhouse gases per person, assuming an average life expectancy, and calculate the costs to compensate them by, e.g., installing extra solar panels. those expected costs could then be paid by the parents of each new person annually over the first eighteen years of that person’s life by dividing the total expected costs by eighteen. there are also practical difficulties. it would be difficult to determine the payment necessary. what should be done if a child has been born whose parents cannot afford to pay? in addition, child benefits could be canceled, contrary to recent incentives for child births instated in italy,1 where additional benefits will be made available to pay for childcare, and hungary,2 where women with four children or more will be exempted for life from paying income tax. a transition period could exist once the policy has been adopted, since it would be unreasonable to confront those who are already pregnant with costs they could not reasonably have expected. while the analysis is both hypothetical and theoretical, the impracticality is a noteworthy obstacle. there are several practical issues that cannot be addressed here, like the difficulty of calculating the added negative effects of each new individual and the unlikelihood that many citizens will support politicians who propose adopting policies that discourage having children. the upshot of what i have proposed is that climate change can be solved in the long run without financial costs to society as a whole, notwithstanding the transitional measures that would bring costs with them. managing procreation to reduce suffering should this be deemed too harsh a stance, it is important to consider the basic issue of whether it is justified to introduce measures to reduce the number of people in an already overpopulated world, especially if climate change leads to additional suffering. one need not agree with benatar, but his perspective mus t at least be taken seriously: doomen, radical existentialist exercise, voices in bioethics, vol. 7 (2021) 3 it is curious that while good people go to great lengths to spare their children from suffering, few of them seem to notice that the one (and only) guaranteed way to prevent all the suffering of their children is not to bring those children into existence in the first place.3 benatar argues that non-existence is preferable to existence,4 which raises the question why new people should be created at all. those who question whether this planet will be habitable for future ge nerations presuppose that such generations will exist. if people are not brought into existence, they may be said to be deprived of what life has to offer, but life must not be presupposed to be something positive. whether this is the case in fact merits an inquiry of its own. a solution to the problem of climate change despite an increased population does not equate to a positive outcome since it merely means that something negative is removed. after all, solving the problem is not a means to an end, but a means to a means, the latter means being a means to a happy life, which does not automatically ensue from a solution to the problem. benatar, as an anti-natalist, argues that procreation is morally wrong. his basic idea is that there is an asymmetry between pleasure and pain and that the pleasure that is not experienced by someone because that person does not exist is not something bad whereas the absence of pain that is not experienced – for the same reason – is something good.5 accordingly, “the reason why we do not lament our failure to bring somebody into existence is because absent pleasures are not bad.”6 one may question whether such a perspective suffices to prove that coming into existence is always a harm, but the assertion that coming into existence exposes a new being to potential harm is clear. objections a drawback of the proposed radical solution, placing the financial impediment on procreation, is that it will not solve climate change in the short run. a significant drop in the number of people (if that were achieved) may have a positive effect in the long run, but for now the behavior of the people in existence is the problem. other climate change mitigation policies would necessarily continue. additionally, there are important practical reasons to continue to procreate. the benefits for the elderly are paid for by the labor force. it is a problem that new generations are created as mere means to benefit older people. perhaps more troubling, a pyramid scheme is created: by the time those people have themselves become old, a new labor force must have been brought into existence, a process that must presumably continue. if a consideration for people in developing countries to have children is that they cannot provide for themselves at an advanced age, while benefits are either lacking or insufficient, developed countries could collectively fund a pension scheme.7 this may be low-cost if it is tailored to the living standard in the countries in question and given the life expectancy. such a pension scheme should be predicated on the countries’ efforts in reducing the birth rate. if the labor force decreases, the economy may suffer. the focus on economic growth is arguably one of the causes of climate change, but if the number of people is reduced, the living standard does not have to be compromised, since the economy can then still grow. if fewer people began to use natural resources and nonrenewable energy at higher per capita rates, then the procreation might not be beneficial to the climate. it would need to be accompanied by regulations on use. doomen, radical existentialist exercise, voices in bioethics, vol. 7 (2021) 4 one may also object that only wealthy people will be able to afford children. this is correct, but there is no right to have a child one cannot afford. the right to procreate does not entail the right to have as many children as one wants. 8 yet in many countries, like the united states, it is a fundamental right that is constitutionally protected. there are numerous social, emotional, and even biological reasons why people choose to procreate. these may include the joy of having a family, the hope that children may bring in society, and the intergenerational transference of knowledge. people may have a strong desire to raise children or even a religious duty. if someone procures a sports car that is highly polluting, it would be justifiable to impose a tax in such a case (also discouraging future buyers). many taxes and fines are imposed on corporate polluters. procreation is significantly different but if the issue is regarded with some distance, then a climate change prevention tax could be appropriate . some may argue that raising children is expensive already, which nonetheless does not deter people from having children. the tax i propose would be additional and specifically dedicated to carbon neutrality, but it would be difficult to predict whether it would discourage procreation. one last objection may be that for those now dedicated to sustainability for preserving the earth for the sake of future generations, there would be little or no incentive to continue any climate change mitigation efforts at all. if they sense they cannot afford to procreate, they may simply use every natural resource rather than save the earth for animals or for next generations. in a democracy, this problem does not exist if the majority can afford to procreate and agree with legislation on the basis of which such behavior is discouraged or punished. conclusion prior to their existence, there is no obligation to bequeath the earth to next generations. such generations will only exist if they are actually created, and there is no obligation to create them. the lack of existence should not be confused with harm. climate change provides an important reason to stem overpopulation. ironically, fast rates of procreation may lead to the earth becoming uninhabitable for humans altogether. the radical solution that has been proposed here is an unrealistic scenario. for now, the average global birth rate is just over 18 per thousand people, but there is a need to ensure that the number of people is not greater than the planet can endure. while it is better to prevent problems than to solve them, the interest in procreation and its associated joys, usefulness, and cultural value make mass reduction in the population unlikely. some countries have smaller average family size than others and can act as models for reducing population in a less radical way. the need to continue efforts to reduce climate change persists. whether it would curb population growth or not, an additional financial burden applied to neutralizing each person’s offspring’s carbon footprint provides a meaningful thought exercise that could help alleviate the pressure on current climate mitigation strategies. doomen, radical existentialist exercise, voices in bioethics, vol. 7 (2021) 5 1 the local italy, how italy’s new ‘family act’ aims to increase the plunging birthrate (2020), https://www.thelocal.it/20200612/what-you-need-to-know-about-italys-new-family-act/. 2 bbc, hungary tries for baby boom with tax breaks and loan forgiveness (2019), https://www.bbc.com/news/world-europe-47192612. 3 david benatar, better never to have been (oxford: clarendon press, 2006), 6. 4 david benatar, better never to have been (oxford: clarendon press, 2006), 44, 58. 5 david benatar, better never to have been (oxford: clarendon press, 2006), 14, 30, 38. 6 david benatar, better never to have been (oxford: clarendon press, 2006), 35. 7 alastair leithead, “can niger break out of its cycle of poverty?” (bbc, 2017), https://www.bbc.com/news/worldafrica-41018081; sebastien malo, “fewer children, fewer climate risks? niger ponders a controversial option” (reuters, 2019), https://www.reuters.com/article/us-niger-climate-change-familyplanning-iduskbn1wm11e. 8 sarah conly, “the right to procreation: merits and limits,” american philosophical quarterly 42, no. 2 (2005): 105-115, 105, 106. https://www.thelocal.it/20200612/what-you-need-to-know-about-italys-new-family-act/ https://www.bbc.com/news/world-europe-47192612 https://www.bbc.com/news/world-africa-41018081 https://www.bbc.com/news/world-africa-41018081 https://www.reuters.com/article/us-niger-climate-change-familyplanning-iduskbn1wm11e abstract introduction choi, against futility judgments, voices in bioethics, vol. 8 (2022) * william choi, ms bioethics candidate harvard medical school © 2022 william choi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. against futility judgments for patients with prolonged disorders of consciousness william choi* abstract medical futility judgments for patients in prolonged disorders of consciousness (pdoc) frequently lead to withdrawal of life-sustaining treatment (lst), which is the leading cause of death for patients with traumatic brain injuries. the field of disorders of consciousness is pervaded by much uncertainty due to limitations on our current diagnostic tools, treatments, and outcome measures. in contrast, futility judgments are made in empirically tenuous confidence in the patient’s inability to survive or recover meaningfully. despite emerging empirical evidence of pdoc patients’ potential for long-term recovery, an increasing sense of clinical nihilism leads to earlier and more frequent withdrawal of lst. in this paper, i argue against two kinds of futility judgments that may be used to justify the withdrawal of lst for pdoc patients: overly pessimistic predictions about the patient’s likelihood for meaningful recovery and rationing decisions that redirect hospital resources to patients who are more likely to recover. keywords: brain injury, disorders of consciousness, medical futility, life sustaining treatment, care rationing introduction brain injury is one of the leading causes of death and disability among children, young adults, and adults over the age of 75 years in the united states.1 yet we remain far from successfully diagnosing and treating brain injury patients who stay in states of prolonged disorders of consciousness. for this paper, the term “prolonged disorders of consciousness” means a vegetative state or a minimally conscious state, characterized by minimal to no signs of awareness up to and potentially exceeding five years.2 inadequate outcome measures and lack of empirical data for accurately predicting prolonged disorders of consciousness often force clinicians to assess patients based on their medical experience, knowledge of the medical literature, and clinical intuitions.3 futility judgments are clinical judgments made by healthcare providers about their patient’s health that can lead them to discontinue life-sustaining treatment. dan brock describes two different types of futility judgments. the first is a “true” futility judgment due to the perceived lack of expected benefit in treating the patient. the second is a hidden rationing decision in which choi, against futility judgments, voices in bioethics, vol. 8 (2022) 2 the minor or unlikely benefit of treatment for the patient is not worth the cost in scarce hospital resources.4 in this paper, i will critique the use of either kind of futility judgments to support the withdrawal of lifesustaining treatment for patients with prolonged disorders of consciousness. i. futility judgments about likelihood futility judgments reflect pessimism about the likelihood of a patient’s survival or recovery of consciousness. one of the most common reasons for withdrawing life-sustaining treatment from traumatic brain injury patients is the medical team’s perception of the patient’s poor chance of survival.5 however, in a field characterized by much uncertainty, it seems imprudent to make futility judgments that project certainty or make the patient’s prospects of recovery or survival seem impossible. the unreliability of current bedside methods to determine consciousness and the inconsistent clinical trajectory of prolonged disorders of consciousness create considerable room for error in making predictions about the patient’s course of recovery. despite such uncertainty, clinicians often end patients’ lives based on empirically tenuous beliefs regarding the patient’s inability to recover.6 the grounds for futility judgments are further undermined by emerging data about the likelihood of longterm functional recovery in many patients with prolonged disorders of consciousness. for example, a recent study demonstrated that patients who failed to emerge from traumatic disorders of consciousness within 28 days, the minimum standard timeframe for prolonged disorders of consciousness, could still recover various target behaviors underpinning functional independence after four weeks.7 the potential for patients to recover beyond this limited timeframe should motivate clinicians to sustain their patients’ lives to better understand the entire course of prolonged disorders of consciousness as it evolves. even if clinicians remain unconvinced by the empirical evidence, prevailing judgments about futility can lead to increasingly premature withdrawal of life-sustaining treatment for patients with prolonged disorders of consciousness. for example, one multicenter study on level one trauma centers in canada found that 70 percent of traumatic brain injury deaths were attributable to the withdrawal of life-sustaining treatment, and more than half of them occurred within the first 72 hours of injury.8 when clinicians use futility to justify decisions to withdraw life-sustaining treatment, they risk ending the lives of individuals who may have survived and recovered. this, in turn, inflates mortality rates for prolonged disorders of consciousness and creates a self-fulfilling prophecy that reinforces the notion of very low odds of recovery.9 clinicians do not remove life-sustaining treatment without any evidence. but futility is not absolute. for example, suppose it is defined too broadly and includes cases where survival rates are low, but survival is possible. in that case, futility should not justify the removal of life-sustaining treatment. in those cases, other ethical justifications would be necessary. ii. futility judgments about benefit futility judgments also arise from pessimism about the actual benefit of the potential treatments. another common reason for withdrawing life-sustaining treatment for traumatic brain injury patients is the clinical team’s belief in a poor long-term prognosis.10 based on their experience and data, clinicians who harbor pessimistic thoughts about the prognosis for patients with prolonged disorders of consciousness may inform the family members that the patients would not achieve meaningful recovery. they argue that continuing life-sustaining treatment would bring about no benefit to their wellbeing. however, these beliefs can be predicated on prejudiced perceptions about the quality of life of individuals with disabilities choi, against futility judgments, voices in bioethics, vol. 8 (2022) 3 or chronic illnesses, a phenomenon commonly referred to as the disability paradox. 11 the paradox describes the discrepancy between patients with disabilities who report a quality of life much higher than non-disabled individuals would predict their ratings. therefore, withdrawing life-sustaining treatment from populations with prolonged disorders of consciousness based on unjustified perceptions about what their quality of life might look like perpetuates ableist assumptions about what outcomes are acceptable to them. some clinicians might respond that if they simply defer to the patient’s perspectives on being kept in a state of prolonged disorders of consciousness, perhaps through prior consultations with the patient or a family member’s knowledge, they can satisfy the patient’s subjective notion of wellbeing. in cases where the patient’s wishes are documented, the clinician’s judgment about the benefits (or lack thereof) of lifesustaining treatment would not matter as much. the decision can be based on the patient’s expressed preferences. however, studies demonstrate that a significant proportion of people who initially rated prolonged disorders of consciousness as a fate “worse than death” also wanted to receive life-sustaining treatment. after a discussion with a researcher about this contradiction, they increased their health rating of prolonged disorders of consciousness.12 this change demonstrates a psychological discordance between people’s pessimistic perception of prolonged disorders of consciousness versus their preferences for being kept alive despite this perception. clinicians should conscientiously navigate this discrepancy rather than act upon their initial prejudices against prolonged disorders of consciousness. by being mindful of their ableist biases and their patients, physicians can prevent pessimism from influencing their judgments about the benefits of continuing life-sustaining treatments. discussions would ensure that patients are well informed when they create health directives or assign proxies for their care. in addition, the patient’s values and advance care decisions should be reassessed over time in conversation with the family, if possible, to ensure that treatment decisions reflect a more accurate and up-to-date understanding of the prognostic outcomes. iii. hidden rationing decisions some judgments about futility are hidden rationing decisions. “true” futility judgments evaluate the prospective benefit of treating a patient regardless of the resource costs, while rationing decisions evaluate treatments in the context of limited resources for other patients. a physician who determines the futility of continuing life-sustaining treatment might decide that the treatment would not be worth the cost to other patients who are more likely to benefit from the same resources. if healthcare resources ought to be distributed to maximize health utility for the highest number of patients, futility judgments for prolonged disorders of consciousness patients are justified. life-sustaining treatments would be “wasted” on those patients compared to healthier patients. 13 however, prioritizing treatment for patients with a greater likelihood of survival based on the principle of utility maximization creates a healthcare system that is unwilling to take necessary risks to advance future therapies and build medical knowledge. medical progress cannot be made if we pursue only treatments for those with the highest chances of survival or recovery. by providing life-sustaining treatment to facilitate the entire clinical course for prolonged disorders of consciousness, we can devote resources to improving the care, rehabilitation, and outcomes for those patients. therefore, resource allocation is morally justified by its potential to benefit future populations of patients with prolonged disorders of consciousness, even if many individual cases will not result in a successful recovery.14 some physicians may respond that their role requires them to make clinical decisions that account for other patients since they must work within the practical reality of limited resources. they might argue that the choi, against futility judgments, voices in bioethics, vol. 8 (2022) 4 physician’s duties are not bound to a single patient but to a network of societal constraints that require them to consider elements of distributive justice in their clinical care. almost every medical decision is performed within the context of contractual obligations to a democratic society that expects a just distribution of healthcare resources.15 withdrawing life-sustaining treatment from patients with prolonged disorders of consciousness to direct those resources to other patients may be morally justified and obligatory for physicians to fulfill their societal duties properly. although the physician’s obligations might extend to such societal duties, simply allocating resources to those most likely to benefit from treatment seems contrary to the principles of justice that undergird democratic society. we protect the most vulnerable members of our community, such as older adults and children, based on a principle of social solidarity that demands respect for all persons regardless of their weaknesses or dependence. 16 withdrawing life-sustaining treatment from patients with prolonged disorders of consciousness based on beliefs about their lack of deservedness of medical treatment violates the respect we ought to accord them as vulnerable persons in need of social assistance. the principle of non-abandonment should apply. rationing decisions do not justify “futility” judgments for prolonged disorders of consciousness patients since they contravene principles of social justice and impede medical progress for patient populations with lower rates of recovery. conclusion futility judgments presume a lack of likely benefit of treatment. they lead to frequent and premature withdrawals of life-sustaining treatment. the prevalence of prognostic uncertainty in the case of prolonged disorders of consciousness should incentivize clinicians to sustain rather than end their patients’ lives. by doing so, they can prevent a self-fulfilling prophecy from inflating mortality rates. clinicians’ pessimism about the patients’ quality of life can also distort how they communicate the “benefits” of treatment to the patient, and they ought to conscientiously mitigate ableist biases. in addition, hidden rationing decisions disguised as futility judgments can fail to recognize the protections we grant to the most vulnerable members of society. although physicians should be mindful of their societal obligations for resource allocation, those obligations should not displace their primary duty to their patients. timothy quill’s defense of the patient’s right to medical non-abandonment demonstrates “a world of difference between facing an uncertain future alone and facing it with a committed, caring, knowledgeable partner who will not shy away from difficult decisions when the path is unclear.”17 as such, by advocating for their patients’ rights to life-sustaining treatment and refraining from making hasty futility judgments, clinicians can honor their enduring commitment to each patient’s wellbeing as they navigate the uncertain terrain of prolonged disorders of consciousness together. 1 “report to congress: traumatic brain injury in the united states | concussion | traumatic brain injury | cdc injury center.” 2019. january 31, 2019. https://www.cdc.gov/traumaticbraininjury/pubs/tbi_report_to_congress.html. 2 foster, charles. 2019. “it is never lawful or ethical to withdraw life-sustaining treatment from patients with prolonged disorders of consciousness.” journal of medical ethics 45 (4): 265–70. https://doi.org/10.1136/medethics-2018-105250. 3 hemphill, j. claude, and douglas b. white. 2009. “clinical nihilism in neuro-emergencies.” emergency medicine clinics of north america 27 (1): 27–viii. https://doi.org/10.1016/j.emc.2008.08.009. 4 brock, dan. 2021. “health care resource prioritization and rationing: why is it so difficult?,” 25. 5 turgeon, alexis f., françois lauzier, jean-françois simard, damon c. scales, karen e.a. burns, lynne moore, david a. zygun, et al. 2011. “mortality associated with withdrawal of life-sustaining therapy for patients with severe traumatic brain injury: a choi, against futility judgments, voices in bioethics, vol. 8 (2022) 5 canadian multicentre cohort study.” cmaj : canadian medical association journal 183 (14): 1581–88. https://doi.org/10.1503/cmaj.101786. 6 schneiderman, lawrence j. 1990. “medical futility: its meaning and ethical implications.” annals of internal medicine 112 (12): 949. https://doi.org/10.7326/0003-4819-112-12-949. 7 giacino, joseph t., mark sherer, andrea christoforou, petra maurer-karattup, flora m. hammond, david long, and emilia bagiella. 2020. “behavioral recovery and early decision making in patients with prolonged disturbance in consciousness after traumatic brain injury.” journal of neurotrauma 37 (2): 357–65. https://doi.org/10.1089/neu.2019.6429. 8 turgeon, alexis f., françois lauzier, jean-françois simard, damon c. scales, karen e.a. burns, lynne moore, david a. zygun, et al. 2011. “mortality associated with withdrawal of life-sustaining therapy for patients with severe traumatic brain injury: a canadian multicentre cohort study.” cmaj : canadian medical association journal 183 (14): 1581–88. https://doi.org/10.1503/cmaj.101786. 9 hemphill, j. claude, and douglas b. white. 2009. “clinical nihilism in neuro-emergencies.” emergency medicine clinics of north america 27 (1): 27–viii. https://doi.org/10.1016/j.emc.2008.08.009. 10 turgeon, alexis f., françois lauzier, jean-françois simard, damon c. scales, karen e.a. burns, lynne moore, david a. zygun, et al. 2011. “mortality associated with withdrawal of life-sustaining therapy for patients with severe traumatic brain injury: a canadian multicentre cohort study.” cmaj : canadian medical association journal 183 (14): 1581–88. https://doi.org/10.1503/cmaj.101786. 11 albrecht, g. l., and p. j. devlieger. 1999. “the disability paradox: high quality of life against all odds.” social science & medicine (1982) 48 (8): 977–88. https://doi.org/10.1016/s0277-9536(98)00411-0. 12 golan, ofra g., and esther-lee marcus. 2012. “should we provide life-sustaining treatments to patients with permanent loss of cognitive capacities?” rambam maimonides medical journal 3 (3): e0018. https://doi.org/10.5041/rmmj.10081. 13 brock, dan. 2021. “health care resource prioritization and rationing: why is it so difficult?25. 14 giacino, joseph t., yelena g. bodien, david zuckerman, jaimie henderson, nicholas d. schiff, and joseph j. fins. 2021. “empiricism and rights justify the allocation of health care resources to persons with disorders of consciousness.” ajob neuroscience 12 (2–3): 169–71. https://doi.org/10.1080/21507740.2021.1904055. 15 misak, cheryl j., douglas b. white, and robert d. truog. 2014. “medical futility.” chest 146 (6): 1667–72. https://doi.org/10.1378/chest.14-0513. 16 golan, ofra g., and esther-lee marcus. 2012. “should we provide life-sustaining treatments to patients with permanent loss of cognitive capacities?” rambam maimonides medical journal 3 (3): e0018. https://doi.org/10.5041/rmmj.10081. 17 quill, timothy e., christine k. cassel, and ann intern med. 1995. “nonabandonment: a central obligation for physicians.” annals of internal medicine, 368–74. knio, the right to choose, voices in bioethics, vol. 7 (2021) * laila knio, candidate at unc, and ms candidate in narrative medicine at columbia university © 2021 laila knio. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the right to choose: the psychiatric patient and medical aid-in-dying laila knio* abstract with the increasing legalization of maid across the world, the question of whether psychiatric patients with refractory mental illness should have access to this health service is a topic of ethical debate. even so, with present-day autonomy encouragement, and the right to die, a psychiatric diagnosis should never automatically preclude a patient from making decisions about their treatment, including the use of maid. keywords: end-of-life care, advanced directives, physician-assisted suicide, medical aid-in-dying, capacity introduction likely, no matter where we live in the world, we have similar wants: to be healthy, to be happy, to be in a community, to make our own decisions about our lives. the first and last of these wants are the primary concerns of medicine. diseases are treated, suffering is alleviated, chronic illnesses are managed – to the extent possible. along the way, patient autonomy is encouraged. perhaps the greatest manifestation of this autonomy is evidenced in the increasing availability of physician-assisted suicide or medical aid-in-dying (maid). with important nuances, the criteria that patients must meet to participate in maid are generally similar: a patient must be over the age of 18, able to state a voluntary desire to end their own life, and two independent physicians must verify their decision-making capacity. yet, clinical criteria for accessing this option differ. in u.s. jurisdictions where maid is legal, patients must have a terminal illness with a 6-month prognosis.1 in holland and belgium, the presence of “intractable pain” is sufficient.2 with the increasing legalization of maid across the world, the question of whether psychiatric patients suffering from refractory mental illness should have access to this means of relieving suffering is under continual debate. the ethical implications of denying autonomous decision-making to psychiatric patients at the end of life will be discussed – along with suggestions for clinical practice. knio, the right to choose, voices in bioethics, vol. 7 (2021) 2 i. medical aid-in-dying and the psychiatric patient there are three main arguments against allowing a patient with psychiatric suffering to pursue maid. the first is that patients with severe mental illness may have impaired decision-making capacity. this impaired capacity generally encompasses the following four criteria: the ability to express a choice, the ability to understand the information presented, the ability to appreciate the “medical consequences of the situation,” and the ability to engage with different choices of treatment.3 these criteria are impaired to varying degrees across the spectrum of mental illnesses. for instance, about 50 percent of patients with schizophrenia hospitalized for an acute episode displayed at least one element of impaired capacity, compared with 20-25 percent of those admitted with an acute depressive episode. in contrast, depression treated on an outpatient basis may not be associated with any impairment in capacity.4 the second argument against allowing a patient with psychiatric suffering to pursue maid is that suicidality itself can manifest as a common symptom of psychiatric disorders (including major depressive disorder). in this context, a patient with severe mental illness who has requested maid, following appropriate treatment, may in fact no longer wish to die. the fear of wrongly fulfilling a maid request in this context alienates the notion of liberally applying maid to the psychiatric population. a literature review found that between 8 percent and 47 percent of patients in the netherlands and oregon who requested maid presented with depression, while 2-17 percent of those who pursued maid to completion had “depressive symptoms.” in the netherlands, patients with depression were significantly less likely to be granted euthanasia/maid requests.5 providers are rightfully afraid of making a mistake that will cost a life. kious and battin phrase the dilemma simply: “when is it worse that someone die, whether from suicide or with physician assistance, who could have been helped, and when is it worse that someone whose suffering could only be alleviated by death continue to suffer?”6 it is doubtful that this question will ever have a sufficient answer. the third argument, that calkins and swetz fervently pose, claims that “allowing the psychiatrically ill to participate in [maid] will compromise the patient-clinician relationship and the relationship of medicine with the public as a whole… fundamentally alter[ing] the clinician’s role as healer and trusted advisor.”7 this argument stems from western medicine’s bias of preserving life at whatever cost, the idea being that any deviation from this goal constitutes an abandonment of the patient. calkins and swetz’s suggestion that all patients with severe, persistent mental illness who might request maid do so inappropriately vastly overestimate the capacity of current psychotropic pharmacology to alleviate pain and suffering. there remain patients who have diligently run the gamut of available treatment options and remain debilitated by their disease. allowing for participation in maid can instead be a testament to the strength of a patientclinician relationship: that this patient, after presenting the topic of maid to their “healer and trusted advisor,” is met with a provider who willingly and carefully listens to their reasons for requesting this option, rather than rejecting the notion out of hand. if deemed appropriate, and after careful fulfillment of the remaining maid criteria, the relationship can then shift towards an end-of-life alliance – therapeutic in and of itself, one in which the goal is not further treatment but a peaceful end. however, attitudes about the appropriateness of maid for patients with severe mental illness differ, even among psychiatrists. in a survey of 457 psychiatrists in switzerland – one of the few countries in which maid can be granted “on the basis of a primary psychiatric diagnosis,” 29.3 percent of respondents indicated some degree of support for the availability of maid to patients with severe and persistent mental illness – an acceptance rate that parallels that of medical providers.8 among a profession dedicated to preserving life, there remains much (reasonable) caution about hastening its end. knio, the right to choose, voices in bioethics, vol. 7 (2021) 3 ii. the psychiatric advance directive the ambiguity over whether patients with psychiatric illnesses should be allowed to make their own treatment decisions is not limited to the end of life. for patients with predominantly medical conditions who no longer have the capacity to make decisions about their care (for instance, patients with advanced dementia), clinicians can defer to previously stated wishes as expressed in an advance directive or per the discretion of a healthcare proxy. this deferred decision-making is sometimes referred to as substituted judgment. 9 as a correlate, patients suffering from mental illness can complete a psychiatric advance directive (pad) to indicate what treatments they would or would not want should they lose decisional capacity. these are often informed by prior, traumatic hospitalizations (for instance, a patient may request not to undergo involuntary electroconvulsive shock therapy, or receive specific antipsychotics, or may decline all psychiatric management). yet, in contrast to advance directives guiding medical treatment, pads are frequently (and legally) overridden if they violate “accepted clinical standards.”10 at their discretion, physicians can override any part or all of a patient’s pad if it violates what they deem to be acceptable care. rather than a “let-the-patient-decide” law, the actual influence of pads on clinical management is often minimal – shrinking its effect to a “let the doctor decide whether the patient gets to decide” law.11 for example, pennsylvania’s pad statute (act 194) specifies three instances in which physicians can override a patient’s directive. first, a physician maintains the right to involuntarily admit a patient under civil commitment law. second, a physician may override any part of a patient’s pad so long as they make “every reasonable effort” to have the patient transferred to a provider willing to adhere to the patient’s request. third, the act protects any physician who violates a patient’s pad request from “criminal or civil liability or discipline[e] for unprofessional conduct” who is deemed to have acted in “good faith” based on accepted clinical guidelines.12 in pennsylvania’s fairly standard pad legislation, the physician is virtually untouchable. north carolina’s “advance instruction for mental health treatment” documentation explicitly communicates its limitations to the patient: the opening paragraph states, “your instructions may be overridden if you are being held in accordance with civil commitment law.”13 of course, neither is it sustainable to adhere to all pad requests. consider the case of hargrave v. vermont. the second circuit court of appeals upheld the durable power of attorney (dpoa) of nancy hargrave (a patient with schizophrenia who was civilly committed) to refuse treatment. as applebaum notes, “if large numbers of patients were to complete advance directives such as nancy hargrave’s, declining all medication, hospitals might well begin to fill with patients whom they could neither treat nor discharge.”14 notably, this case is an exception rather than the rule. broad legislation emulating hargrave will not act towards the betterment of all patients with severe mental illness. but, in the conversation on the applicability of maid for psychiatric patients, it is worth noting how frequently and readily these patients’ wishes are overlooked, even when they have been expressed and properly documented in a state of decisional capacity (as must be the case when completing a psychiatric advance directive). iii. the way forward while those with mental illness deserve both fierce protection and robust mental health treatment, they also have a right to define what quality of life is acceptable. when determining the point at which treatment of a psychiatric illness becomes futile – and thus the option of pursuing maid more readily permissible – the concept of “qualitative futility” is particularly generative. focus turns towards a patient’s first-person experience of illness and an understanding of their “subjective view about the quality of an outcome.” 15 this perspective shifts away from the statistical probability that a certain treatment will succeed and instead incorporates the lived reality of a patient’s illness narrative. for example, in the world health knio, the right to choose, voices in bioethics, vol. 7 (2021) 4 organization’s published report on the treatment of cancer pain, the phrase “total pain” identifies the physical and non-physical components of suffering, including “the noxious physical stimulus and also psychological, spiritual, social, and financial factors.”16 for severely ill patients with treatment-refractory mental illness, an understanding of “qualitative futility” and “total pain” could be the most humane way to approach who should and should not qualify for maid. in one take on how patients with mental illness have the right to define what consists of an acceptable quality of life, kious and battin posit that if a patient’s decision to pursue maid is voluntary and if the patient possesses decision-making capacity, their request should be granted “irrespective of whether their underlying medical diagnosis is physical or mental, terminal or nonterminal.”17 while this option should, of course, be withheld from patients suffering from an acute exacerbation in which the patient may not achieve decisional capacity, it is nevertheless true that psychiatric illness, even in severe cases, is often episodic, undergoing periods of remission when a patient may be symptom-free.18 during these periods of lucidity, the patient’s perception of quality of life should be examined with great care. another option offered by kious and battin to identify psychiatric patients who may be appropriately pursuing maid is to create two “metric[s] for suffering” – one for physical and one for mental illnesses. for psychiatric patients who wish to end their lives, this establishes a threshold above which suffering becomes “unbearable,” opening the door for a legitimate conversation about maid between patient and physician (should the patient request it). suffering below this threshold would remain grounds for involuntary admission to an inpatient facility.19 the question remains: how do we gauge severe enough suffering to die and suffering that is not? in exploring this question, zhong et al.’s understanding that a person with mental illness pursuing maid must be evaluated differently proves valuable. the authors suggest that rather than focusing on “point capacity” (the ability to make a specific decision), an evaluation of “global capacity” should instead be conducted a style of evaluation that is interested in “fully contextualiz[ing]” the patient’s choice to pursue maid. this requires asking not only about medical and psychiatric history but also family and relationship history, trauma history, education and employment history, and includes a rigorous collection of collateral information from family and friends who can confirm the patient’s wishes. 20 an additional benefit of evaluating for “global capacity” should the choice of maid be followed to completion is the illumination, no matter how slight, that might be provided to relatives and friends. this prior justification for, and understanding of, the patient’s decision might dull the sharpness of loss for family and friends – healing insight that may be inaccessible in the case of unassisted suicide. while kious and battin express concern that it is “deeply unclear” how to measure the dimensions of suffering given that “we cannot wholly trust first-person reports,” these narratives nonetheless form the substrate of psychiatry and serve as the diagnostic tool of most gravitas available to providers of mental illness.21 they must be trusted. or, as the old medical adage goes, they can be trusted and confirmed. it is no accident that in the who’s “cancer pain relief” manual, the first step of pain assessment is to “believe the patient’s complaint of pain.”22 the lived experience of a patient with severe, refractory mental illness can challenge physician hesitation about the appropriateness of maid. in the previously cited study in which 29.3 percent of swiss psychiatrists reported general support for the availability of maid in cases of refractory mental illness, the percentage curiously swelled when presented with three clinical vignettes (in each, the patient is stated to have decision-making capacity to “refuse further treatment”). in the case of a 37-year old female with a 26-year history of anorexia nervosa, ten prior hospitalizations, a weight of 52 pounds, general muscle weakness, and low bone density, who no longer wishes to undergo force-feeds, 35.4 percent of respondents indicated that they would support her choice of maid.23 in the case of a 33-year old male with knio, the right to choose, voices in bioethics, vol. 7 (2021) 5 a 16-year history of schizophrenia, who has failed numerous trials of anti-psychotic regiments and electroconvulsive shock therapy, who has “never been free from positive or negative symptoms,” and whose persisting illness has left him severely isolated, 32.1 percent indicated that they would support his choice of maid. and in the case of a 40-year-old male with persistent suicidal ideation for 20 years, whose symptoms have been refractory to numerous trials of anti-depressants, anti-psychotics, mood stabilizers, combination therapy, psychotherapy, and electroconvulsive shock therapy, who plans to commit suicide “in the near future,” 31.4 percent of respondents indicated that they would support his choice of maid. with generous and nuanced attention to a patient’s “total pain,” following careful evaluation of their “global capacity,” and after a thorough review of all treatment trials and any available therapeutic options yet un-tried (assessing “psychiatric futility”), those who are suffering from severe, refractory mental illness should be granted similar access to maid as patients suffering from cancer, als, and other organic causes of disease. we cannot adequately police the “badness of suffering.”24 conclusion in summary, a psychiatric diagnosis should never automatically preclude a patient from making decisions about their treatment, including deciding to end one’s own life with the help of a licensed provider. medical aid-in-dying is associated with a safe, certain, and painless death. in the circumstances where it would be applicable, it serves as a less fraught option than unassisted suicide. we owe anyone who is ceaselessly suffering that much. or, at the very least, we owe this equally fraught topic an honest conversation. 1 calkins, bethany c., and keith m. swetz. “physician aid-in-dying and suicide prevention in psychiatry: a moral imperative over a crisis.” the american journal of bioethics, vol. 19, no. 10, 2019, pp. 68–70, doi:10.1080/15265161.2019.1653398. 2 montanari vergallo, gianluca et al. “euthanasia and physician-assisted suicide for patients with depression: thought-provoking remarks.” rivista di psichiatria vol. 55,2 (2020): 119-128. doi:10.1708/3333.33027 3 appelbaum, paul s. “assessment of patients’ competence to consent to treatment.” new england journal of medicine, vol. 357, no. 18, 2007, pp. 1834–40, doi:10.1056/nejmcp074045. 4 appelbaum, paul s. “assessment of patients’ competence to consent to treatment,” 1834–40. 5 levene, ilana, and michael parker. “prevalence of depression in granted and refused requests for euthanasia and assisted suicide: a systematic review.” journal of medical ethics vol. 37,4 (2011): 205-11. doi:10.1136/jme.2010.039057 6 levene, ilana, and michael parker. “prevalence of depression in granted and refused requests for euthanasia ...” 205-11. 7 calkins, bethany c., and keith m. swetz. “physician aid-in-dying and suicide prevention in psychiatry,” 68–70. 8 hodel, martina a et al. “attitudes toward assisted suicide requests in the context of severe and persistent mental illness: a survey of psychiatrists in switzerland.” palliative & supportive care vol. 17,6 (2019): 621-627. doi:10.1017/s1478951519000233 9 appel, jacob m. “trial by triad: substituted judgment, mental illness and the right to die.” journal of medical ethics, 2021, pp. 1–4. doi:10.1136/medethics-2020-107154. knio, the right to choose, voices in bioethics, vol. 7 (2021) 6 10 swanson, jeffrey w et al. “superseding psychiatric advance directives: ethical and legal considerations.” the journal of the american academy of psychiatry and the law vol. 34,3 (2006): 385-94. 11 swanson, jeffrey w et al. “superseding psychiatric advance directives,” 385-94. 12 ibid 13 “advance directive for mental health treatment." nc secretary of state. web. 13 july 2021. <https://www.sosnc.gov/forms/by_title/_advance_healthcare_directives>. 14 appelbaum, paul s. “law & psychiatry: psychiatric advance directives and the treatment of committed patients.” psychiatric services (washington, d.c.) vol. 55, no. 7, 2004, pp. 751–763. doi:10.1176/appi.ps.55.7.751 15 zhong, rocksheng, et al. “physician aid-in-dying for individuals with serious mental illness: clarifying decisionmaking capacity and psychiatric futility.” the american journal of bioethics, vol. 19, no. 10, 2019, pp. 61–63, doi:10.1080/15265161.2019.1654018. 16 world health organization. (1986). cancer pain relief. world health organization. https://apps.who.int/iris/handle/10665/43944 17 kious, brent m., and margaret (peggy) battin. “physician aid-in-dying and suicide prevention in psychiatry: a moral crisis?” the american journal of bioethics, vol. 19, no. 10, 2019, pp. 29–39, doi:10.1080/15265161.2019.1653397. 18 kious, brent m., and margaret (peggy) battin. “physician aid-in-dying,” 29–39. 19 ibid 20 appelbaum, paul s. “law & psychiatry,” 751–763. 21 kious, brent m., and margaret (peggy) battin. “physician aid-in-dying,” 29–39. 22 world health organization, cancer pain relief. 23 hodel, martina a et al. “attitudes toward assisted suicide requests,” 621-627. 24 kious, brent m., and margaret (peggy) battin. “physician aid-in-dying,” 29–39. https://apps.who.int/iris/handle/10665/43944 garbuzova, addressing infertility with uterine transplant, voices in bioethics, vol. 7 (2021) * elizaveta garbuzova, ms candidate columbia university © 2021 elizaveta garbuzova. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. addressing infertility with uterine transplant: an ethical analysis of three categories of donors elizaveta garbuzova* keywords: organ donation, living donor, uterine transplant, deceased donor, infertility introduction the first live births via uterine transplant using deceased donors (utx) occurred in brazil in 20171 and in the united states in 2019.2 prior to that, living donors were the source of uteruses for transplant, with the first successful birth in sweden in 2014, and the first successful birth in the us in 2017. this achievement in reproductive technology gives women with absolute uterine factor infertility (aufi) the option to become a biological parent. in the us, 120,000 women of childbearing age are affected by aufi.3 without utx, their only option for having genetically related children is through gestational surrogacy. since some religions and cultures prohibit the use of surrogates to achieve motherhood and surrogacy is illegal in many countries, some women would not otherwise have the chance to have biological children. for instance, china, finland, germany, iceland, and other countries prohibit any form of commercial or altruistic surrogacy making adoption the only option for becoming a mother. however, in many cultures, biological ties are central to the understanding of the family. for example, in the middle east, adoption is uncommon because biological connections are crucial. 4 therefore, the only option these women would choose to become a mother is utx. the exclusive value of utx to these women is being able to experience pregnancy. thus, utx gives unique benefits to these women that adoption or surrogacy would not. the procedure entails surgery on a living or deceased donor to acquire the uterus. then, the recipient undergoes transplantation followed by a course of immunosuppressive medication. after in vitro fertilization (ivf), the embryo is implanted into the transplanted uterus. if the pregnancy progresses, the child is delivered by c-section and the uterus is removed either simultaneously or later. this paper argues that both deceased and living donors should be permitted, while increased-risk donors should not be eligible. garbuzova, addressing infertility with uterine transplant, voices in bioethics, vol. 7 (2021) 2 analysis i. permitting living donors or limiting all utx to deceased donors the ethics of using a uterus from a deceased donor differs from using one from a living donor. the biggest concern for living donation is that it exposes the donor to unacceptable risks, especially considering that the procedure is elective and not life-saving. in other types of transplants, the sacrifice is warranted because the organ is needed to save the recipient's life. for instance, living kidney donations protect against kidney failure.5 the uterine donor undergoes a four to eight-hour surgery to acquire the uterus for no potential health benefit to themselves or arguably, to the recipient.6 utx is not a life-saving procedure. some argue that because there is no imminent threat to the health of patients with aufi, it is unnecessary to expose live donors to risks of utx. while treating aufi is not technically medically necessary, many women find infertility debilitating to their physical and mental health. as a result, women want their infertility treated. now that utx with deceased donors has been successful, the ethical justification for continuing to allow living donation could be questioned. utx from deceased donors cannot harm the donor and thus has a different overall risk-benefit calculation. it is reasonable to believe that opponents of living donation may view utx from deceased donors as ethically permissible. from the public health and ethical perspective, retrieving uteruses from deceased donors is a preferable option for the following reasons: first, there is no medical risk to the donor; thus, public resources do not need to be allocated to resolving the potential complications from the procedure. additionally, acquiring a uterus from a deceased donor takes less time than from a living donor. 7 using deceased donors also decreases operating room visits compared to living-donor uterus acquisition, and allocates more time for the operating room to perform other procedures. however, without living donors, the pool of available uteruses for transplantation narrows. in 2017, there were 2,200 deceased female donors aged 18-47 in the us, defined as those willing to donate, not those with a procurable and usable uterus, or even a uterus at all.8 2,200 is an extremely low number of potential uterus donors considering that there are more than 120,000 women with aufi in the us. not every available uterus is suitable for donation; each must pass quality control. these donors could have had a hysterectomy, no pregnancies (having had a pregnancy makes the uterus more suitable for transplant), papillomavirus infection, or other conditions that would prevent them from being uterus donors. 9 therefore, the number of potentially suitable uteruses from deceased donors is probably lower than 2,200. there is significant uterus scarcity. to expand the donor pool, living-donor transplants should be allowed to continue. using living donors respects individual autonomy. the uterus does not serve a vital purpose and women who have had successful pregnancies and do not want to become pregnant again can donate without a concern for their own fertility. because most living donors are related to the recipients, they will also benefit from this procedure since it would enable them to have family relationships, perhaps becoming an aunt or grandparent. by decreasing wait time, allowing living donors also would provide the option of utx while women are younger and more likely to achieve pregnancy since the ivf would be more likely to succeed increasing the chances that utx would result in a child. ii. increased-risk donors to further expand the pool of donors, some favor making organs from “increased-risk” donors available to recipients. increased-risk donors range from those with a history of iv drug use or certain sexual or garbuzova, addressing infertility with uterine transplant, voices in bioethics, vol. 7 (2021) 3 behavioral histories. 10 the main risk associated with transplantation from increased-risk donors is the possibility of transmission of infections like hiv, hepatitis b, or hepatitis c. whether the scarcity of transplantable uteruses makes it ethical to include increased-risk donors in the utx donor pool, assuming there is still a scarcity once other qualified living donors are permitted depends on the risks and benefits. the organs of increased-risk donors are offered to patients for life-saving procedures such as a liver transplant.11 for example, since the donor pool in south africa is small, in one case, the best option was for a child to receive a partial liver transplant from his hiv-positive mother. the donation was approved to save the life. the risk of hiv infection, and the need for lifetime antiretroviral therapy paled in comparison to death due to the unavailability of a deceased or low-risk liver donor.12 yet, utx is not a lifesaving procedure. because infertility treatment is not lifesaving, the risks do not outweigh the benefits. increased-risk donations use the organs that otherwise may have been disposed of (or rejected by potential recipients) categorically even if a donor did not actually have the underlying disease like hiv, hepatitis b, or hepatitis c.13 yet increased-risk donations pose ethically unacceptable risks to the recipient and their fetus in the case of utx. if the patient remained on the waitlist for a uterus transplant, she and the resulting fetus would forgo the risks associated with using an increased-risk donor. it is possible that being on a waitlist could be psychologically traumatizing for a patient. this does not justify the potential to expose the woman and possibly a fetus to hiv, or hepatitis b or hepatitis c if an increased-risk donor provided a uterus and had an undetected condition while infertility may be devastating to the women wanting utx, utx should not be treated as a life-saving procedure. therefore, it is unethical to expand the donor pool to include increased-risk donors. iii. potential downsides of the availability of uterine transplant the availability of utx to the public may impose additional pressure on women affected by infertility to try an additional burdensome procedure before giving up genetic motherhood. in cultures where family ties are important, the spouse or family members may pressure women to undergo utx for the benefit of having biological children. moreover, it may add overall pressure on the women to become mothers and exacerbate the deficiency stigma on infertile women. moreover, the availability of utx may compromise the future of many children who are waiting for adoption. adoption may start to be seen by others only as a last resort after attempting to have biological children. this is problematic because there are many already existing children who need parental love. these downsides can be addressed by assurances that women freely enter utx. counseling and assurances that women are acting of their own accord and not under duress or societal pressure can mitigate the downsides. the autonomy and the choice to engage in new assisted reproduction should not be dismissed out of a fear that women are choosing utx for the wrong reasons. conclusion utx offers women with aufi unique benefits like the experience of pregnancy and having children genetically related to them. a woman deciding whether to receive a uterus from a living or deceased donor, or not to undergo utx at all should understand the risks and benefits, including the risk of the utx not resulting in a viable pregnancy. doctors or hospitals should decide whether to perform utx on a case-bycase basis. increased-risk donation that could expose the recipient and fetus to transmissible disease should be prohibited because the risks associated with increased-risk donation are not morally justified by utx. remaining on the transplant list would be safer. while increased-risk utx should be prohibited, other living garbuzova, addressing infertility with uterine transplant, voices in bioethics, vol. 7 (2021) 4 donor procedures should be continued to widen the donor pool. living-donor utx will empower the donor since she will voluntarily make the decision to donate, helping another person. women with infertility whose only chance to have a biological child should not be limited to uteruses supplied by deceased donors. 1 france 24, “first baby born after uterus transplant in france,” france 24 (france 24, february 17, 2021), https://www.france24.com/en/live-news/20210217-first-baby-born-after-uterus-transplant-in-france. 2 “for the first time in north america, a woman gives birth after uterus transplant from a deceased donor,” health essentials from cleveland clinic (health essentials from cleveland clinic, july 9, 2019), https://health.clevelandclinic.org/for-the-first-timein-north-america-woman-gives-birth-after-uterus-transplant-from-deceased-donor/. 3 max m. maurer et al., “first healthy baby after deceased donor uterus transplantation: birth to a new era?” transplantation 103, no. 4 (2019): pp. 652-653, https://doi.org/10.1097/tp.0000000000002627. 4 yassari, n. “adding by choice: adoption and functional equivalents in islamic and middle eastern law.” the american journal of comparative law, 63(4), 927-962. retrieved april 22, 2021, from https://www.jstor.org/stable/26425445 (acknowledges that traditional islamic law prohibits adoption but arguing jurisdictions have worked around the prohibition to create avenues toward adoption.) 5 though some people might argue that dialysis would be an option, generally kidney transplants are justified by medical necessity and a transplant both saves the life and significantly improves quality of life compared to dialysis. 6 “uterus transplants: a new door opens,” penn medicine, april 29, 2019, https://www.pennmedicine.org/news/internalnewsletters/system-news/2019/may19/uterus-transplants-a-new-door-opens. 7 niclas kvarnström et al., “live versus deceased donor in uterus transplantation,” fertility and sterility 112, no. 1 (2019): pp. 2427, https://doi.org/10.1016/j.fertnstert.2019.05.029, 25. 8 max m. maurer et al., “first healthy baby after deceased donor uterus transplantation: birth to a new era?” transplantation 103, no. 4 (2019): pp. 652-653, https://doi.org/10.1097/tp.0000000000002627, 653. 9 max m. maurer et al., “first healthy baby after deceased donor uterus transplantation: birth to a new era?” transplantation 103, no. 4 (2019): pp. 652-653, https://doi.org/10.1097/tp.0000000000002627, 653. 10 shelly bansal et al., “risky business: taking the stigma out of high-risk donation in lung transplantation,” the annals of thoracic surgery 100, no. 5 (2015): pp. 1787-1794, https://doi.org/10.1016/j.athoracsur.2015.05.065, 1787. the centers for disease control (cdc) define the high-risk donor if a person meets one or more of the following criteria: “1) men who have had sex with other men in the last 5 years, 2) a history of intravenous drug abuse, 3) persons who have hemophilia, 4) persons who have engaged in sex for money or drugs in the past 5 years, 5) persons who have engaged in sex with individuals who have highrisk behaviors or those that are suspected to have hiv, 6) anyone who has been exposed to hiv in the last 12 months, 7) inmates, and 8) children born to mothers who had hiv or mothers who met the criteria for high risk. 11 jean botha et al., “hiv and solid organ transplantation: where are we now,” current hiv/aids reports 16, no. 5 (april 2019): pp. 404-413, https://doi.org/10.1007/s11904-019-00460-7, 404. harriet rosanne etheredge et al., “needs must: living donor liver transplantation from an hiv-positive mother to her hivnegative child in johannesburg, south africa,” journal of medical ethics 45, no. 5 (2019): pp. 287-290, https://doi.org/10.1136/medethics-2018-105216. (a partial liver transplant was done from an hiv-positive mother to an hiv-negative child in south africa in 2017). 12 botha, et al. https://www.jstor.org/stable/26425445 garbuzova, addressing infertility with uterine transplant, voices in bioethics, vol. 7 (2021) 5 13 david s. goldberg and josh levitsky, “transplanting livers from hcv ‐infected donors into hcv ‐negative recipients: promise but mind the pitfalls,” american journal of transplantation 19, no. 5 (december 2018): pp. 1264-1265, https://doi.org/10.1111/ajt.15193, 1264. siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) * haaris siddiqi © 2021 haaris siddiqi. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. protecting autonomy of rohingya women in sexual and reproductive health interventions haaris siddiqi* abstract rohingya women face challenges that ought to be acknowledged and addressed to ensure that when they seek health care, they can act autonomously and decide freely among available options. self-determination theory offers valuable insight into supporting these women within their unique situations. keywords: rohingya women, autonomy, reproductive health, paternalism, informed consent, muslim introduction in august of 2017, military and paramilitary forces in myanmar began purging the rohingya muslim population from the country, motivated by anti-muslim prejudice of the buddhist political and social majority. mass murder, property destruction, kidnapping, torture, and sexual violence still affect rohingya communities. as a result, more than a million individuals have fled myanmar. 1 as of february 2021, approximately 880,000 rohingya muslims have taken refuge in cox’s bazar, bangladesh, the site of the largest refugee camps in the world.2 the public health focus in these camps is on treatment of physical ailments and infectious diseases.3 while women of reproductive age and adolescent girls experience the highest level of violence among rohingya communities in both myanmar and bangladesh, they have consistently lacked access to sufficient sexual and reproductive care. in 1994, the women’s commission for refugee women and children exposed issues surrounding the sexual and reproductive health of displaced populations and propelled the recognition of srh as a human right.4 human rights interventionists and public health officials have made progress in the integration of sexual and reproductive health education, facilities, and resources into refugee camps in cox’s bazar. this includes the introduction of menstrual cleanliness facilities and educational conversations. however, rohingya women and male cultural leaders, or gatekeepers, remain reluctant to accept these resources and education.5 the prevalence of gender-based violence against women and restrictive policies enforced by siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 2 the bangladesh government heighten the barriers to the effective introduction of sexual and reproductive health resources and services.6 a wealth of literature has pushed for the extension of clinical duties of beneficence and non-maleficence in the diagnosis and treatment of refugee and asylum-seeking communities. 7 additionally, extensive research on rohingya refugee communities has searched for ways to work around the complex social history and to accommodate power structures by integrating gatekeepers into srh discussions.8 however, as interventions have sought to overcome cultural and religious barriers, they have largely overlooked the protection of autonomy of sexual and reproductive health patients in cox’s bazar. this paper argues two points. first, attempts at improving outcomes in cox’s bazar ought to lead to rohingya women’s autonomy and self-determination, both in mitigating control of male leaders over sexual and reproductive decisions and in ensuring the understanding and informed consent between patients and providers. second, policy decisions ought to ensure post-treatment comprehensive care to shield rohingya women from retribution by male community members. self-determination theory offers guidance for state leaders and healthcare providers in pursuing these goals. i. barriers to sexual and reproductive health services for rohingya women as part of its anti-muslim narrative, the buddhist majority has painted rohingya women as hyperreproductive. false narratives “of a rohingya plan to spread islam by driving demographic shifts” and accusations against rohingya women for having “unusually large families” have motivated violent behavior and discriminatory regulations against rohingya communities.9 in reality, demographic data shows that “the rohingya population has remained stable at 4% since 1980.”10 in 2013, the government of myanmar imposed regulations on rohingya families in the rakhine state, the region with the highest population of rohingya muslims, enforcing a two-child limit and requiring that rohingya women obtain government authorization to marry and take a pregnancy test before receiving such permission. the majority has also subjected rohingya females to acts of sexual violence to ostracize them and “dilute” rohingya identity.11 as a result, rohingya women in cox’s bazar experience unique illnesses and vulnerabilities requiring imminent treatment. due to national policies in bangladesh, “rohingya [women] cannot receive hiv/aids testing and treatment in camps; birth control implants delivered by midwives; and comprehensive abortion care.”12 additionally, in accordance with patriarchal rohingya community structure, male gatekeepers hold high authority over sexual and reproductive decisions of women, evidenced by the persistence of genderbased violence within refugee camps and traditional practices such as the marriage of minor girls to older rohingya men.13 surveys of community members reveal that cultural and religious stigma against sexual and reproductive health care exists among these male gatekeepers as well as rohingya women.14 due to their cultural and political position, rohingya women are subject to unique power relations. this paper analyzes the ethical dilemmas that arise from two of those power relations: rohingya women’s relationships with male gatekeepers and their relationships with interventionist healthcare providers. ii. ethics of including male community members in decisions affecting women’s healthcare autonomy a november 2019 survey of rohingya women in cox’s bazar that had married or given birth within the past two years found that “around one half of the female rohingya refugees do not use contraceptives, mainly because of their husbands’ disapproval and their religious beliefs.”15 there are widespread misconceptions such as the belief that islam does not permit the use of contraceptives. 16 the existence of such misconceptions and the power husbands and male leaders hold over the delivery of treatment creates dilemmas for healthcare practitioners in conforming to ethical principles of care. siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 3 iii. beneficence in providing care to refugees while public health scholars and government officials hold divided opinions on the level of treatment required to fulfill refugees’ right to sexual and reproductive health care, most support enough care to ensure physical and psychological well-being.17 beneficence requires that healthcare providers and states “protect the rights of others[,] prevent harm from occurring to others[, and] remove conditions that will cause harm to others.” 18 under the principle of beneficence, there is a duty to provide sexual and reproductive treatment to rohingya women in cox’s bazar that is comparable to that received by citizens of the host state. in addition, the ethical principle of nonmaleficence may call for the creation of specialized care facilities for refugee communities, because a lack of response to refugees’ vulnerability and psychological trauma has the potential to generate additional harm.19 in response to gendered power relations among the rohingya community, husbands and male leaders are included in decisions surrounding maternal health and sexual and reproductive care for women. for example, healthcare professionals “have been found to impose conditions on srh [sexual reproductive health] care that are not stated in the national… [menstrual regulation] guidelines, such as having a husband’s permission.”20 the refugee healthcare community could do more to mitigate the potential of retribution taken by male community members against women that accept care by dispelling common misconceptions and precluding male community members from influencing female reproductive choices.21 however, some current practices allow the infiltration of male community leaders and husbands into the diagnosis, decision-making, and treatment spaces. deferring decisions to male leaders for the sake of expediency risks conditioning women’s access to care on male buy-in and diminishes rohingya women’s autonomy over their sexual and reproductive health. iv. male influence and female autonomy ensuring patients control their own treatment decisions is an essential component of the ethical obligation of healthcare professionals to respect patients’ autonomy. while patients can exercise their autonomy to accept the direction of the community, their autonomy is undermined when “external sources or internal states… rob [such persons]… of self-directedness.”22 sexual and reproductive health research on rohingya women revealed that the presence of male family members during conversations “made female respondents uncomfortable to speak openly about their srh [sexual and reproductive health]related experiences.”23 the same study found that when male family members were absent, rohingya women were more transparent and willing to discuss such topics.24 these findings indicate that the mere presence of male family members exerts control over rohingya women in conversations with practitioners. male involvement also stalls conversations between providers and rohingya women which may harm the achievement of understanding and informed consent in diagnosis and treatment spaces.25 women do have the option of bringing their male community leaders and family members into sexual health discussions. yet healthcare providers ought to monitor patients individually and avoid programmatic decision making regarding male involvement in the treatment space. while it is the ethical imperative of health interventionists and the state of bangladesh to fulfill the duties of care required by the principles of beneficence and non-maleficence, the sole prioritization of expanding sexual and reproductive health care in cox’s bazar risks ignoring autonomy. v. ethics of paternalism in provide-patient relations rohingya women’s negative beliefs about contraceptives, such as the belief that they cause irreversible sterilization, are the second largest factor inhibiting their use.26 to an extent, the rohingya are justified in siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 4 their skepticism. prior to the 1990’s, bangladesh used nonconsensual sterilization as a mechanism of population control to attain access to international aid. though the international conversation surrounding reproduction shifted its focus towards reproductive rights following the 1994 un international conference on population and development, delivery of reproductive care in the global south is frequently characterized by lack of transparency and insufficient patient understanding of the risks and consequences of treatment. additionally, women’s lack of control impacts follow-up care and long-term contraception. for example, when women seek the removal of implantable contraceptives, healthcare professionals often refuse to perform the requisite operation.27 patients must understand the risks of treatment in their own culture and circumstances where societal views, misconceptions, or fears may influence healthcare practices. healthcare providers need to recognize the coercive potential they hold in their relations with patients and guard against breaches of patient autonomy in the delivery of treatment. in accordance with the principle of beneficence, healthcare providers treating refugees or individuals seeking asylum ought to abide by the same fiduciary responsibilities they hold toward citizens of the host state.28 when patients show hesitancy or refusal toward treatment, healthcare providers ought to avoid achieving treatment by paternalistic practice such as “deception, lying, manipulation of information, nondisclosure of information, or coercion.” 29 although well-intentioned, this practice undermines the providers’ obligation to respect patients’ autonomy.30 the hesitancy of rohingya women to accept some sexual or reproductive health care does not justify intentional lack of transparency, even when that treatment furthers their best health interests. however, paternalistic actions may be permissible and justified during medical emergencies.31 vi. informed consent respecting rohingya women’s autonomy also places affirmative duties on healthcare providers to satisfy understanding and informed consent. however, language barriers and healthcare providers’ misconceptions about rohingya religion and culture impede the achievement of these core conditions of autonomy for rohingya women. 32 in an interview, a paramedic in cox’s bazar described the types of conversations healthcare providers have with rohingya women in convincing them to accept menstrual regulation treatment, a method to ensure that someone is not pregnant after a missed period: “we tell them [menstrual regulation] is not a sin… if you have another baby now, you will get bad impact on your health. you cannot give your children enough care. so, take mr [menstrual regulation] and care for your family.” 33 this message, like others conveyed to rohingya women in counseling settings, carries unvalidated assumptions regarding the beliefs, needs, and desires of clients without making a proper attempt to confirm the truth of those assumptions. healthcare providers’ lack of cultural competence and limited understanding of bangladesh’s national reproductive health policy complicates communication with rohingya women. additionally, the use of simple language, though recommended by the who’s guideline on bangladesh’s policy, is inadequate to sufficiently convey the risks and benefits of menstrual regulation and other treatments to rohingya women.34 for informed consent to be achieved, “the patient must have the capacity to be able to understand and assess the information given, communicate their choices and understand the consequences of their decision.” 35 healthcare providers must convey sufficient information regarding the risks, benefits, and alternatives of treatment as well as the risks and benefits of forgoing treatment.36 sexual and reproductive health policies and practices must aim to simultaneously mitigate paternalism, promote voluntary and informed choice among rohingya women, and foster cultural and political competency among healthcare providers. siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 5 vii. self-determination theory self-determination theory is a psychological model that focuses on types of natural motivation and argues for the fulfillment of three conditions shown to enhance self-motivation and well-being: autonomy, competence, and relatedness.37 according to the theory, autonomy is “the perception of being the origin of one’s own behavior and experiencing volition in action;” competence is “the feeling of being effective in producing desired outcomes and exercising one’s capacities;” and, relatedness is “the feeling of being respected, understood, and cared for by others.”38 bioethicists have applied self-determination theory to health care to align the promotion of patient autonomy with traditional goals of enhancing patient wellbeing. studies on the satisfaction of these conditions in healthcare contexts indicate that their fulfillment promotes better health outcomes in patients.39 like principlism, self-determination theory in cox’s bazar could allow for increased autonomy while maximizing the well-being of rohingya women and behaving with beneficence fostering self-determination requires that healthcare professionals provide patients with the opportunity and means of voicing their goals and concerns, convey all relevant information regarding treatment, and mitigate external sources of control where possible.40 in cox’s bazar, health care organizations in the region and the international community can act to ensure women seeking health care are respected and able to act independently. a patient-centered care model would provide guidelines for the refugee setting. 41 providers can maximize autonomy by utilizing language services to give srh patients the opportunity and means to voice their goals and concerns, disclose sufficient information about risks, benefits, and alternatives to each procedure, and give rationales for each potential decision rather than prescribe a decision. they can promote the feeling of competence among patients by expressly notifying them of the level of reversibility of each treatment, introducing measures for health improvement, and outlining patients’ progress in their srh health. finally, they can promote relatedness by providing active listening cues and adopting an empathetic, rather than condescending, stance.42 healthcare organizations ought to provide training to promote cultural competency and ensure that practitioners are well-versed on national regulations regarding sexual reproductive health care in bangladesh to avoid the presumption of patients’ desires and the addition of unnecessary barriers to care. increased treatment options would make autonomy more valuable as women would have more care choices. given the historical deference to international organizations like the un and world bank, multilateral and organizational intervention would likely bolster the expansion of treatment options. international organizations and donors ought to work with the government of bangladesh to offer post-treatment comprehensive care and protection of women who choose treatment against the wishes of male community members to avoid continued backlash and foster relatedness.43 conclusion rohingya women in cox’s bazar, bangladesh face unique power relations that ought to be acknowledged and addressed to ensure that when they seek health care, they are able to act autonomously and decide freely among available options. while providers have duties under the principles of beneficence and nonmaleficence, patient well-being is hindered when these duties are used to trump the obligation to respect patient autonomy. current approaches to achieving sexual and reproductive health risk the imposition of provider and communal control. self-determination theory offers avenues for global organizations, siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 6 bangladesh, donors, and healthcare providers to protect rohingya women’s autonomous choices, while maximizing their well-being and minimizing harm. disclaimer: as a male educated and brought up in a western setting, i acknowledge my limitations in judgement about rohingya women’s reproductive care. their vulnerability and health risks can never be completely understood. to some extent, those limitations informed my theoretical approach and evaluation of rohingya women srh care. self-determination theory places the patients’ experiences and judgement at the center of decision-making. my most important contributions to the academic conversation surrounding rohingya women are the identification of dilemmas where autonomy is at risk and advocating for self-determination. 1 hossain mahbub, abida sultana, and arindam das, “gender-based violence among rohingya refugees in bangladesh: a public health challenge,” indian journal of medical ethics (june 2018):1-2, https://doi.org/10.20529/ijme.2018.045. 2 “un teams assisting tens of thousands of refugees, after massive fire rips through camp in bangladesh,” united nations, last modified march 23, 2021, https://news.un.org/en/story/2021/03/1088012#:~:text=the%20kutupalong%20camp%20network%2c%20which, (as%20of%20february%202021). 3 hossain et al., “gender-based violence,” 1-2. 4 benjamin o. black, paul a, bouanchaud, jenine k. bignall, emma simpson, manish gupta, “reproductive health during conflict,” the obstetrician and gynecologist 16, no. 3 (july 2014):153-160, https://doi.org/10.1111/tog.12114. 5 margaret l. schmitt, olivia r. wood, david clatworthy, sabina faiz rashid, and marni sommer, “innovative strategies for providing menstruation-supportive water, sanitation and hygiene (wash) facilities: learning from refugee camps in cox's bazar, bangladesh,” conflict and health journal 15, no. 1 (feb 2021):10, https://doi.org/10.1186/s13031-021-00346-9. 6 s m hasan ul-bari, and tarek ahmed, “ensuring sexual and reproductive health and rights of rohingya women and girls,” the lancet 392, no. 10163:2439-2440, https://doi.org/10.1016/s0140-6736(18)32764-8. 7 janet cleveland, and monica ruiz-casares, “clinical assessment of asylum seekers: balancing human rights protection, patient well-being, and professional integrity,” american journal of bioethics 13, no. 7 (july 2013):13-5, https://doi.org/10.1080/15265161.2013.794885.; christine straehle, “asylum, refuge, and justice in health,” hastings center report 49, no. 3 (may/june 2019):13-17, https://doi.org/10.1002/hast.1002. 8 hossain et al., “gender-based violence,” 1-2.; schmitt et al., “innovative strategies,” 10. 9 audrey schmelzer, tom oswald, mike vandergriff, and kate cheatham, “violence against the rohingya a gendered perspective,” praxis: the fletcher journal of human security, last modified february 11, 2021, https://sites.tufts.edu/praxis/2021/02/11/violence-against-the-rohingya-a-gendered-perspective/. 10 schmelzer et al., “violence against.” 11 schmelzer et al., “violence against.” 12 liesl schnabel, and cindy huang, “removing barriers and closing gaps: improving sexual and reproductive health and rights for rohingya refugees and host communities,” center for global development: cgd notes (june siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 7 2019):6, https://www.cgdev.org/sites/default/files/removing-barriers-and-closing-gaps-improving-sexual-andreproductive-health-and-rights.pdf. 13 schnabel and huang, “removing barriers,” 4-9.; andrea j. melnikas, sigma ainul, iqbal ehsan, eashita haque, and sajeda amin, “child marriage practices among the rohingya in bangladesh,” conflict and health journal 14, no. 28 (may 2020), https://doi.org/10.1186/s13031-020-00274-0. 14 nuruzzaman khan, mofizul islam, mashiur rahman, and mostafizur rahman, “access to female contraceptives by rohingya refugees, bangladesh,” bull world health organ, 99, no.3 (march 2021):201-208, https://doi.org/10.2471/blt.20.269779. 15 khan et al., “access to,” 201-208. 16 khan et al., “access to,” 201-208. 17 ramin asgary, and clyde l. smith, “ethical and professional considerations providing medical evaluation and care to refugee asylum seekers,” american journal of bioethics 13, no. 7 (july 2013):3-12, https://doi.org/10.1080/15265161.2013.794876.; cleveland and ruiz-casares, “clinical assessment,” 13-5.; straehle, “asylum,” 13-17. 18 tom l. beauchamp, and james childress, principles of biomedical ethics. eighth edition, (new york, ny: oxford university press, [1979] 2019), 219. 19 beauchamp and childress, “principles,” 155.; straehle, “asylum,” 15. 20 maria persson, elin c. larsson, noor pappu islam, kristina gemzell-danielsson, and marie klingberg-allvin, “a qualitative study on health care providers' experiences of providing comprehensive abortion care in cox's bazar, bangladesh,” conflict and health journal 15, no. 1 (jan 2021):3, https://doi.org/10.1186/s13031-021-00338-9. 21 rushdia ahmed, bachera aktar, nadia farnaz, pushpita ray, adbul awal, raafat hassan, sharid bin shafique, md tanvir hasan, zahidul quayyum, mohira babaeva jafarovna, loulou hassan kobeissi, khalid el tahir, balwinder singh chawla, and sabina faiz rashid, “challenges and strategies in conducting sexual and reproductive health research among rohingya refugees in cox's bazar, bangladesh,” conflict and health journal 14, no. 1 (dec 2020):83, https://doi.org/10.1186/s13031-020-00329-2.; khan et al., “access to,” 201-208. 22 beauchamp and childress, principles, 102. 23 ahmed et al., “challenges and strategies," 6. 24 ahmed et al., “challenges and strategies," 7. 25 beauchamp and childress, principles. 26 khan et al., “access to,” 201-208. 27 kalpana wilson, “towards a radical re-appropriation: gender, development and neoliberal feminism,” development and change 46, no. 4 (july 2015):814–815, https://doi.org/10.1111/dech.12176. 28 asgary and smith, “ethical and professional,” 3-12. 29 beauchamp and childress, “principles,” 231. 30 beauchamp and childress, “principles,” 231. 31 beauchamp and childress, “principles.” https://doi.org/10.1080/15265161.2013.794876 https://doi.org/10.1186/s13031-020-00329-2 siddiqi, protecting autonomy of rohingya women, voices in bioethics, vol. 7 (2021) 8 32 beauchamp and childress, “principles.” 33 persson et al. “a qualitative study,” 8. 34 persson et al. “a qualitative study.” 35 christine s. cocanour, “informed consent-it's more than a signature on a piece of paper,” american journal of surgery 214, no. 6 (dec 2017):993, https://doi.org/10.1016/j.amjsurg.2017.09.015. 36 cocanour, “informed consent,” 993. 37 richard m. ryan, and edward l. deci, “self-determination theory and the facilitation of intrinsic motivation, social development, and well-being,” american psychologist 55, no. 1 (jan 2000):68-78. 38 johan y.y. ng, nikos ntoumanis, cecilie thøgersen-ntoumani, edward l. deci, richard m. ryan, joan l. duda, geoffrey c. williams, “self-determination theory applied to health contexts: a meta-analysis,” perspectives on psychological science 7, no. 4 (july 2021):325-340, https://doi.org/10.1177/1745691612447309. 39 ng et al., “self-determination theory.”; nikos ntoumanis, johan y.y. ng, andrew prestwich, eleanor quested, jennie e. hancox, cecilie thøgersen-ntoumani, edward l. deci, richard m. ryan, chris lonsdale & geoffrey c. williams, “a meta-analysis of self-determination theory-informed intervention studies in the health domain: effects on motivation, health behavior, physical, and psychological health,” health psychology review 15, no. 2 (feb 2020), https://doi.org/10.1080/17437199.2020.1718529. 40 leslie william podlog, and william j. brown, “self-determination theory: a framework for enhancing patientcentered care,” the journal for nurse practitioners 12, no. 8 (sep 2016):e359-e362, https://doi.org/10.1016/j.nurpra.2016.04.022. 41 podlog and brown, “self-determination theory.” 42 podlog and brown, “self-determination theory.” 43 podlog and brown, “self-determination theory.” https://doi.org/10.1016/j.amjsurg.2017.09.015 lam, reviving the place of philosophy in bioethics, voices in bioethics, vol. 8 (2022) * ryan lam, mbe harvard medical school © 2022 ryan lam. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. escaping the shadow: reviving the place of philosophy in bioethics ryan lam* “after buddha was dead, they still showed his shadow in a cave for centuries – a tremendous, gruesome shadow. god is dead; but given the way people are, there may still for millennia be caves in which they show his shadow. – and we – we must still defeat his shadow as well!” – friedrich nietzsche1 keywords: philosophy, morality, communication, bioethics, rationalism, resocialization, existentialism introduction friedrich nietzsche famously declared that “god is dead!”2 but lamented that his contemporaries remained living in the shadow of god. for nietzsche, the morality of his time was still based in the christian tradition, even though faith in god was waning. bioethics lives under a similar shadow: the shadow of enlightenment era-rationalism. bioethics curricula focus on principles derived from kantian deontology and utilitarianism. the allure of maintaining a moral framework that provides a rational method that can be handily applied to any situation remains strong. the principlist approach advanced by tom beauchamp and james childress is taught to nearly all medical students in the united states, 3 and is essentially the canonical ethical framework of bioethics. in this model, the principle of autonomy is kantian in nature, and the principles of beneficence and non-maleficence are utilitarian in nature.4 moreover, the framework is presented as an approach that, when applied rationally to any healthcare scenario, will yield an outcome “considered moral.”5 this reflects a faulty conception of philosophy that plagues much of bioethics, wherein the only contribution of philosophy pertinent to bioethics is moral philosophy elucidated by european thinkers in the enlightenment era. the landscape of moral philosophy has evolved significantly from the 18th century. however, the bioethical world has not kept up with the philosophical world, remaining instead in the shadow of antiquated moral thinking. also lacking in bioethics are other disciplines of philosophy, such as philosophy of language, existentialism, and aesthetics, which are often given no consideration at all. the lam, reviving the place of philosophy in bioethics, voices in bioethics, vol. 8 (2022) 2 inclusion of both modern moral philosophy and other fields of philosophy are necessary if bioethics is to survive its transition into modernity. i. the shadow of enlightenment enlightenment era philosophers such as immanuel kant argued that one need only employ reason to obtain knowledge; emotion bore no relevance when determining ethical behavior. kant’s moral theories thus privileged a duty to act according to moral imperatives over feelings. other enlightenment era philosophers such as john locke developed systems that attempted to quantify human goods and human ills. this quantification potentially reduces human welfare and suffering to utility. today, in the world of philosophy, such a “neutral analysis,” as cora diamond noted, is “dead or moribund.”6 bernard williams remarked that such moral philosophy is “empty and boring,”7 and g. e. m. anscombe stated that it “no longer generally survives.” 8 and yet, just as the atheists in nietzsche’s world dwelt in the moral code of a dead god, bioethicists still pursue a unified moral system that takes an input, applies some moral rules, and generates a moral outcome, like the four principles approach that beauchamp and childress laid out. 9 some detractors of principlism take issue with their approach for not being unified enough and want to replace it with a procedural framework that is even more systematic and complicated. they argue that the resulting moral framework would be a “comprehensive decision procedure for arriving at answers”10 that retains the “impartiality that is an essential part of morality.”11 the shadow of rationalist morality has caused bioethical decision making to become detached and rigid, when bioethics should concern itself with the humans whose lives it affects. a rational, divorced-fromemotion way of thinking ultimately fails to yield satisfactory results when decisions are made by and for emotional beings. dr. paul farmer, among others, championed the idea that bioethics should be dephilosophized, as philosophy, cold and calculated, fails to adequately respond to the realities of those worst off.12 instead, dr. farmer emphasized the inclusion of the social sciences, like sociology and anthropology, in bioethics. undoubtedly, dr. farmer was on the right track; bioethics should certainly engage directly with the people whom its decisions involve. if the narrow band of moral philosophy currently found in bioethics – that of stringent rationalism – were all that philosophy had to offer, i, too, would advocate for a dephilosophization. ludwig wittgenstein notes that to attempt to capture the complexity of moral thinking in a manner that employs reason alone and casts aside emotion is a “hopeless task,” like reconstructing a sharp image “from a blurred one.”13 unfortunately, bioethics is mired in the remnants of this hopeless task. to dr. farmer, the dominant moral framework was too restrictive and was unresponsive to the social and humanitarian needs of those whom bioethics is meant to help. as such, he wished to free bioethics from the shadow of a morality derived from rationalist thinkers. ii. beyond rationalism like nietzsche, who tried to resolve europe’s post-religion vacuum by providing his society with a new way to live, dr. farmer wanted to replace the rationalist philosophy upon which bioethics was built with a “resocialization” of the field.14 i agree with dr. farmer’s call for resocialization, as well as his denouncement of philosophy as it exists in bioethics. evaluating risks and benefits along a predetermined array of moral principles is far too rigid and impersonal to guide what are often the most important decisions one will make. for dr. farmer, the most needed change was restoring the social element of bioethics. however, in advocating for this resocialization, dr. farmer casts philosophy as the antithesis of social science, noting that “few would regard philosophy … as a socializing discipline.”15 i disagree. rationalist moral philosophy may be lacking in socializing force, but there are other fields of philosophy that are responsive to our social lam, reviving the place of philosophy in bioethics, voices in bioethics, vol. 8 (2022) 3 reality. rather than de-philosophizing bioethics, it makes more sense to replace the antisocial philosophies predominant in bioethics with prosocial philosophies better suited to it. of course, the contribution of philosophy to bioethics is more than moral theories from the enlightenment era. there are more recent philosophical contributions from outside the field of moral philosophy that have roused bioethical interest. jennifer blumenthal-barby, et al., argue for philosophy’s continued place in bioethics, citing derek parfit’s “non-identity problem,” which altered the landscape of reproductive ethics, and david chalmers’ contributions to philosophy of consciousness, which have implications for the moral status of brain organoids.16 still, these are narrow applications of philosophy to highly specialized areas of bioethics, which not all bioethicists are inclined to delve into. philosophy in bioethics should not be confined to niche applications in specialist fields but should influence all bioethical thought. fortunately, there remains untapped a wealth of philosophical disciplines that pertains to exactly this. philosophy of language investigates the nature of meaning and understanding in communication, which is a necessary social action. successfully deciphering and conveying moral values in discourse is a bioethicist’s bread and butter, as is resolving disagreements and reaching agreements. indeed, it is often the case that miscommunication lies at the root of an impasse between a doctor and a patient. an understanding of the nature of the disagreement would help resolve the conflict, as different types of disagreements require different interventions for resolution. for instance, a “substantive disagreement,”17 in which two parties use the same terms in the same ways and have a fundamental disagreement on which outcome is more desirable, can be resolved only if one party yields to the other. on the other hand, a “merely verbal dispute,”18 in which two parties use the same terms to represent entirely different concepts and values, requires a standardization of terminological usage for its resolution. as such, no one can overstate the moral importance of successful communication in bioethics, and an exploration of language itself would prove invaluable to a bioethicist’s training. existentialism is another subset of philosophy that acknowledges the social nature of human existence, noting that one’s being in the universe is concomitant with the existence of others sharing the same universe. 19 thus, there is the recognition that whatever existence is, it is not complete without the existence of others. with this as a starting point, existentialists examined how to live meaningfully with others in this world. since ethics crucially involves others, it is no surprise that existentialists pondered how to live moral lives. existentialist conceptions of morality did not revolve around acting in accordance with a set of rules, but rather, recognized individual freedom in choosing how to act and emphasized acting authentically. in this vein, bioethicists should commit to doing what is right rather than committing to applying a set of principles. existentialism, while part of the broader bioethics literature, is less common throughout bioethics curricula and deserves more prominence. martin heidegger, for instance, emphasized the difference between two types of thinking: “calculative thinking” and “meditative thinking.” heidegger characterizes calculative thinking as a computation, wherein from some given starting conditions “definite results”20 are determined, and contrasts this with meditative thinking, which he describes as “thinking which contemplates the meaning which reigns in everything that is.”21 heidegger was critical of the pervasiveness of calculative thinking, seeing it as the “ground of thoughtlessness,”22 in which we only relate to the world in a meaningless, mechanical way. this is the emphasized type of thinking in rationalist conceptions of morality popular in bioethics; from a set of starting conditions, a series of rules are applied, and a moral outcome is calculated. such a technique, however, discounts the personal meaning individuals place on the aspects of their lives relevant to their decision making, as well as the meaning in committing to doing what is right. under calculative thinking, lam, reviving the place of philosophy in bioethics, voices in bioethics, vol. 8 (2022) 4 such a commitment, is reduced to rote rule-following. a turn to meditative thinking would ensure that bioethical decisions comport with living meaningful lives. even aesthetics, a discipline devoted to examining beauty and taste,23 has a place in bioethics. just as the viewing of a painting, the listening of a song, or the reading of a book elicits an effective response, hearing a patient’s story leaves an emotional imprint. the recounting of a traumatic moment imparts sadness, and a joyous occasion begets joy in the listener as well. as acknowledged in the field of everyday aesthetics, these aesthetic experiences often spur us to act:24 the unsightly appearance of a polluted riverbank drives us to remove the trash; the presence of sorrow in one’s life drives us to ameliorate it. to be mindful of aesthetic experiences and allow them to affect us emotionally is paramount to the motivation of a bioethicist to serve the patient, not out of an obligation to a job description, but out of a desire to truly avail the patient of their anguish. for example, the new field of narrative medicine utilizes critical reading and literary techniques to train clinicians and bioethicists in emotional understanding and listening skills that stress the social aspects of medicine beyond rational analysis and decision making. conclusion dr. farmer is absolutely correct; bioethics is in dire need of resocialization. it should not be the case that the justification for a moral action is essentially that “the rules say so,” or that simply by teaching such rules to medical students, the very act of making bioethical decisions that diverge from those determined by principles can be seen as an act of “bad faith … hubris or, worse, malpractice.”25 as bioethicists are coming to realize, the rationalist philosophical traditions that bioethics was founded upon are past their expiry, and the time for change is now. indeed, as dr. farmer urges, “socializing disciplines” like anthropology, history, political economy, and sociology are necessary to humanize the field of bioethics.26 so too, however, can philosophy be a socializing discipline, if we know where to look. bioethics should evolve. its new goal should be to focus on meaningful human relationships, and to phase out rigid, impersonal modes of moral thinking. the limited sampling of unsatisfying moral theories from hundreds of years ago leaves many bioethics students cold, and it is easy to see why bioethicists are ready to part ways with philosophy. i believe this is a move in the wrong direction; there is a place for philosophy in the future of bioethics. just as bioethics needs a resocialization, it is also needs of a re-philosophization. these enrichments complement one another. there is more to bioethics than mechanically determining the right course of action in a healthcare setting. bioethics engages with the most ancient of philosophical questions: questions of what makes human existence meaningful, what makes us who we are, how we want to relate to others, how and why we feel, what our place in the world is, how we can communicate what we think, and why our moral intuitions are so compelling. we would be remiss if we did not begin to investigate additional contributions to morality from a wider range of philosophies that try to provide answers to such questions, as they offer a richness to moral thinking that cannot be gleaned from traditional bioethical approaches alone. 1 friedrich wilhelm nietzsche, the gay science: with a prelude in german rhymes and an appendix of songs, ed. bernard williams, josefine nauckhoff, and adrian del caro, cambridge texts in the history of philosophy (cambridge, u.k. ; new york: cambridge university press, 2001), 109. 2 nietzsche, 120. lam, reviving the place of philosophy in bioethics, voices in bioethics, vol. 8 (2022) 5 3 daniel c o’brien, “medical ethics as taught and as practiced: principlism, narrative ethics, and the case of living donor liver transplantation,” the journal of medicine and philosophy: a forum for bioethics and philosophy of medicine 47, no. 1 (february 1, 2022): 97, https://doi.org/10.1093/jmp/jhab039. 4 k. d. clouser and b. gert, “a critique of principlism,” journal of medicine and philosophy 15, no. 2 (april 1, 1990): 219–36, https://doi.org/10.1093/jmp/15.2.219. 5 o’brien, “medical ethics as taught and as practiced,” 97. 6 cora diamond, “having a rough story about what moral philosophy is,” new literary history 15, no. 1 (1983): 168, https://doi.org/10.2307/468998. 7 bernard williams, morality: an introduction to ethics, canto ed (cambridge ; new york: cambridge university press, 1993), xvii. 8 g. e. m. anscombe, “modern moral philosophy,” philosophy 33, no. 124 (january 1958): 1, https://doi.org/10.1017/s0031819100037943. 9 tom l. beauchamp and james f. childress, principles of biomedical ethics, 7th ed (new york: oxford university press, 2013), 13. 10 clouser and gert, 233. 11 clouser and gert, “a critique of principlism,” 235. 12 paul farmer and nicole gastineau campos, “rethinking medical ethics: a view from below,” developing world bioethics 4, no. 1 (may 2004): 17–41, https://doi.org/10.1111/j.1471-8731.2004.00065.x. 13 ludwig wittgenstein, philosophical investigations, ed. joachim schulte, trans. p. m. s. hacker, 4th edition (chichester, west sussex, u.k. ; malden, ma: wiley-blackwell, 2009), 40. 14 farmer and campos, “rethinking medical ethics,” 20. 15 farmer and campos, 20. 16 jennifer blumenthal-barby et al., “the place of philosophy in bioethics today,” the american journal of bioethics: ajob, june 30, 2021, 3–5, https://doi.org/10.1080/15265161.2021.1940355. 17 brendan balcerak jackson, “verbal disputes and substantiveness,” erkenntnis 79, no. s1 (march 2014): 31–54, https://doi.org/10.1007/s10670-013-9444-5. 18 c. s. i. jenkins, “merely verbal disputes,” erkenntnis 79, no. 1 (march 1, 2014): 11–30, https://doi.org/10.1007/s10670-0139443-6. 19 steven crowell, “existentialism,” in the stanford encyclopedia of philosophy, ed. edward n. zalta, summer 2020 (metaphysics research lab, stanford university, 2020), https://plato.stanford.edu/archives/sum2020/entries/existentialism/; anita avramides, “other minds,” in the stanford encyclopedia of philosophy, ed. edward n. zalta, winter 2020 (metaphysics research lab, stanford university, 2020), https://plato.stanford.edu/archives/win2020/entries/other-minds/. 20 martin heidegger, discourse on thinking, harper torchbooks (new york, ny: harper & row, 1969), 46. 21 heidegger, 46. 22 heidegger, 45. 23 nick zangwill, “aesthetic judgment,” in the stanford encyclopedia of philosophy, ed. edward n. zalta, winter 2021 (metaphysics research lab, stanford university, 2021), https://plato.stanford.edu/archives/win2021/entries/aestheticjudgment/. 24 yuriko saito, “aesthetics of the everyday,” in the stanford encyclopedia of philosophy, ed. edward n. zalta, spring 2021 (metaphysics research lab, stanford university, 2021), https://plato.stanford.edu/archives/spr2021/entries/aesthetics-ofeveryday/. lam, reviving the place of philosophy in bioethics, voices in bioethics, vol. 8 (2022) 6 25 o’brien, “medical ethics as taught and as practiced,” 112. 26 farmer and campos, “rethinking medical ethics,” 20. shen, student subjects in research, voices in bioethics, vol. 7 (2021) * amanda shen, ms candidate columbia university © 2021 amanda shen. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. student subjects in research: an ethical approach amanda shen* abstract students represent a vulnerable population within faculty-led research at universities because of the incentivized extra credit option. therefore, other forms of participation in should be offered, to ensure that their choice to undergo becoming a student participant is fully their autonomous choice. keywords: research ethics, students, psychology research, undue influence, sampling introduction extra credit— two words college students love hearing. as an undergraduate student, i was no different. ranging from subjects like chemistry to psychology to political science, there was no lack of extra credit opportunities in the courses i took to fulfill my social science major and pre-medical requirements. participating in my professors’ research studies seemed to be a mutually beneficial opportunity at first glance; i would receive a few extra points to buffer my grade in case i did poorly on an exam, and my professors would be able to easily recruit the participants they needed to churn out scientific findings. background social sciences research, especially psychology research, which has been labeled “the science of the behavior of the college sophomore,” routinely includes students. for instance, 77 percent of all articles in two major psychology journals included research done with students.1 there is literature describing how common recruitment of students from undergraduate or medical school classes in the us is, a practice documented since the 1920s.2 indeed, students enrolled in the psychology 10 course at ucla, for example, are not just incentivized to do so, but in fact, are “required to serve as psychological research subjects for shen, student subjects in research, voices in bioethics, vol. 7 (2021) 2 a total of six hours or write three abstracts on articles from psychology journals, or do a combination of both.” 3 professors widely use student participants in academic research because of their accessibility, convenience, and willingness to participate. however, such prevalent recruitment of undergraduate students as study subjects poses several ethical questions, necessitating more stringent regulation. analysis incentivizing research participation with rewards may unduly influence students, tempting them to participate in research they would otherwise not want to engage. according to the association for clinical research professionals, undue influence “implies that individuals will agree to participate in research without a rational consideration of the information provided in the informed consent process”.4 undue influence typically involves providing financial incentives to individuals in great need of money, but undue influence pertains to non-financial incentives as well. for instance, my general chemistry professor offered authorship promises to students who could travel to mexico and bring back samples of alcohol served at resorts for his study, which aimed to analyze the chemical content of resort alcohol. more often, professors use extra credit as an incentive. though such an incentive may not seem highly harmful, students who are worried or anxious about their grades are in a particularly vulnerable position and may very well fail to deeply consider the risks or implications of participating in research that offers extra credit. especially in intensive courses that may be graded on a curve, additional credit may seem like an unspoken requirement rather than an option. this was the case in some of my undergraduate courses; my organic chemistry professor offered extra credit to students who completed writing assignments designed to measure whether writing explanations of chemical reactions affected student understanding and performance in the course. unsurprisingly, the majority of students participated in the research study, seeing it as integral to their grades. furthermore, students are subject to an inherent, unbalanced power dynamic between themselves and their instructors. a student’s academic or professional standing may rely on the professor, who may boost grades or agree to write a letter of recommendation. academic faculty members are on a payroll and thus retain a primary fiduciary responsibility to teach, educate, and protect their students. 5 however, many faculty members also advance and develop new scientific and academic knowledge through research positions. in studies that have student participants, professors can experience a conflict of interest while exercising their roles as researchers and instructors. these dual roles are especially risky in a study when a student participant must divulge personal information, which is then accessible to the professor. students ought to participate in research out of their own volition, without the added pressure of benefits and risks reflected in their grades, recommendations, or professor relationships. it is also essential to consider the ethical principle of justice in this space and whether findings from the research using student samples are meant to be implemented in policy or clinical efforts within a broader, more diverse population. a 2010 study published in the journal behavioral and brain sciences found that two-thirds of subjects in american psychology research were undergraduates studying psychology.6 this finding raises the question of how such a disproportionate sampling has impacted the effect of clinical psychology on populations who may not have similar levels of education or socioeconomic status as the average college student. in general, student samples have historically been much more homogenous than non-student samples, which often leads to difficulties in replicating findings in the general population.7 nevertheless, researchers have an obligation to society to produce equitable results, and their research designs and sampling methods ought to reflect that. shen, student subjects in research, voices in bioethics, vol. 7 (2021) 3 i. counterarguments and benefits of student research granted, there is undoubtedly valuable research that seeks to study student populations exclusively, resulting in data relevant to student populations specifically. additionally, critics may contend that research involving student subjects rarely poses major risks that call beneficence into question. one may also argue that research participation can be a helpful, behind-the-scenes learning experience for students to experience how to conduct research. some studies and research designs involving students provide tangible benefits to students. for instance, studies that supplement current course material would provide valuable insight into key concepts and, thus, be acceptable. ii. recommendations so how can institutions and individuals better regulate and ensure ethical practices within this area which has gone relatively unchecked? first, researchers should make an effort to randomly select a diverse sample if they intend the research to have far-reaching implications. student participants are certainly easier to obtain and more accessible, but as the belmont report states, “the selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.”8 academia must seriously re-evaluate whether students are being “systematically selected” simply because of their accessibility, through additional training modules or educational videos upon hire. this isn’t to say that research should completely exclude student participation; rather, researchers should make more of an active effort to recruit a variety of participants without solely targeting students through student-specific incentives like extra credit. there are unique ethical dilemmas that arise with power imbalances and convenient sampling. thus, research that necessitates student-specific sampling must be carried out and regulated carefully. research incentives can still be offered, but any incentive involving extra credit should be coupled with a diverse range of alternatives that take a similar amount of time to complete. the ability to participate in and contribute to research is a privilege; working students may not be able to take time off to participate in research, so researchers should offer them some other compensated work that suits their schedules. also, students and non-students should receive similar compensation, something impossible if extra credit is the form of compensation. to avoid a conflict of interest, professors should avoid recruiting current students for their personal research. separating roles may also address some pressing concerns about the confidentiality of subjects, who might feel more comfortable answering research questions without the fear of having their own professor read or listen to them. a much better method for enrolling student participants is to randomly assign students who have voluntarily signed up through an online platform to studies run by professors who are not directly related to the student. during studies that use student participants, informed consent and attention to general research ethics are essential. from the start, students should be educated about informed consent and how power may alter the voluntariness of their consent. students should also be clear about the incentives available to them, the risks of participating in such research, the ensured confidentiality of their responses, and their ability to opt-out of the study at any time. even after the study concludes, students should be able to voice any concerns through an anonymous survey or hotline. simultaneously, researchers and professors should debrief participants. ultimately, these post-study efforts would increase the transparency of research shen, student subjects in research, voices in bioethics, vol. 7 (2021) 4 involving student subjects while furthering the field of academia by identifying areas of ethical improvement. conclusion currently, most universities and irbs have guidelines for research involving student subjects and there are various federal and state regulations protecting research subjects.9,yet students remain susceptible to a host of ethical issues, including undue influence, lack of justice, and the sense they would be penalized for opting out. with increased and standardized oversight initiatives such as the ones outlined above, universities can work towards ensuring a more ethical space for students to participate in and learn from the research efforts of faculty members. 1 burnett jj, dune pm. an appraisal of the use of student subjects in marketing research. journal of business research. 1986;14(4):329-343. doi:10.1016/0148-2963(86)90024-x 2 prescott hm. using the student body: college and university students as research subjects in the united states during the twentieth century. journal of the history of medicine and allied sciences. 2002;57(1):3-38. doi:10.1093/jhmas/57.1.3 3 “sona instructions for undergraduate participants • ucla department of psychology.” ucla department of psychology, 14 sept. 2021, https://www.psych.ucla.edu/undergraduate/subject-pool-experiment-participation/sona-instructions-forundergraduate-participants/. 4 borasky, david, et al. “paying subjects to take part in research: a new perspective on coercion and undue influence.” acrp, 13 mar. 2019, https://acrpnet.org/2019/03/12/paying-subjects-to-take-part-in-research-a-new-perspective-on-coercionand-undue-influence/. 5 ferguson, linda m., et al. “students' involvement in faculty research: ethical and methodological issues.” international journal of qualitative methods, vol. 3, no. 4, 2004, pp. 56–68., https://doi.org/10.1177/160940690400300405. 6 giridharadas, anand. “a weird way of thinking has prevailed worldwide.” the new york times, the new york times, 25 aug. 2010, https://www.nytimes.com/2010/08/26/world/americas/26iht-currents.html. 7 peterson, robert a. “on the use of college students in social science research: insights from a second-order meta-analysis.” journal of consumer research, vol. 28, no. 3, 2001, pp. 450–461., https://doi.org/10.1086/323732. 8 office for human research protections (ohrp). “the belmont report.” hhs.gov, 16 june 2021, https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xbenefit. 9 u. s. department of education protection of human subjects. home. https://www2.ed.gov/about/offices/list/ocfo/humansub.html. published august 4, 2020; students as subjects. massachusetts institute of technology couhes. https://couhes.mit.edu/guidelines/students-subjects. accessed december 2, 2021. accessed november 28, 2021. neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) * oskar neyra, ms candidate columbia university © 2021 oskar neyra. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. reproductive ethics and family: an argument to cover access to art for the lgbtq community oskar neyra* abstract assisted reproductive technology can be a beneficial tool for couples unable to reproduce independently; however, it has historically discriminated against the lgbtq+ community members. given the evolution and acceptance of lgbtq rights in recent years, discrimination and barriers to access reproductive technology and health care should be readdressed as they still exist within this community. keywords: lgbtq+, art, reproductive ethics, infertility, surrogacy, equality introduction in recent years, the lgbtq+ community has made great strides toward attaining equal rights. this fight dates back to 1970 when michael baker and mcconnell applied for a marriage license in minnesota.1 after the county courthouse denied the couple's request, they appealed to the minnesota supreme court. baker and mcconnell’s dispute reached the us supreme court. baker v. nelson2 was the first time a same-sex couple attempted to pursue marriage through higher courts in the us.3 because the couple lost the case, baker changed his name to a gender-neutral one, and mcconnell adopted baker, allowing baker and mcconnell to have legal protections like the ability to receive certain inheritances. baker and mcconnell received a marriage license from an unsuspecting clerk from blue earth county, where they wed on september 3, 1971.4 background the supreme court’s decision left individual state legislatures the option to accommodate same-sex couples’ rights constitutionally. as a result, some states banned same-sex marriage, while others offered alternative options such as domestic partnerships. with many obstacles, such as the defense of marriage act (doma) and president bush’s efforts to limit marriage to heterosexual people, massachusetts became the first state to legalize gay marriage in 2003. 5 other states slowly followed. finally, in 2015 the us neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 2 supreme court made same-sex marriage legal in all 50 states in obergefell v. hodges, 6 marking an important milestone for the lgbtq+ community’s fight toward marriage equality. the obergefell v. hodges decision emphasized that members of the homosexual community are “not to be condemned to live in loneliness, excluded from one of civilization's oldest institutions,” thus granting them the right to “equal dignity in the eyes of the law.”7 this paper argues that in the aftermath of the wide acceptance of lgbtq rights, discrimination and barriers to access reproductive technology and health care persist nationally. procreation also faces discrimination. research supports that children’s overall psychological and physical welfare with same-sex parents does not differ compared to children with heterosexual parents. 8 some others worry about the children’s developmental health and argue that same-sex male couples’ inability to breastfeed their children may be harmful; however, such parents can obtain breast milk via surrogate donation.9 further concerns regarding confusion in gender identity in children raised by same-sex parents are not supported by research in the field indicating that there are “no negative developmental or psychological outcomes for a child, nor does it result in differing gender identity, gender role behavior or sexual partner preference compared to opposite-sex parents.”10 analysis i. desire to procreate the american perception toward same-sex unions has evolved “from pathology to deviant lifestyle to identity.”11 in 2001, only 35 percent of americans favored same‐sex marriage, while 62 percent favored it in 2017.12 the “gay marriage generation”13 has a positive attitude toward same-sex unions, arising from the “interaction among activists, celebrities, political and religious leaders, and ordinary people, who together reconfigured americans’ social imagination of homosexuality in a way that made gay marriage seem normal, logical, and good.”14 same-sex couples’ right to build a biological family and ability to do so using modern reproductive technology is unclear. the data generated by the lgbtq family building survey revealed “dramatic differences in expectations around family building between lgbtq millennials (aged 18-35) and older generations of lgbtq people,” 15 which may be in part attributable to recent federal rulings in favor of same-sex couples. three important results from this survey are that 63 percent of lgbtq millennials are considering expanding their families throughout parenthood, 48 percent of lgbtq millennials are actively planning to grow their families, compared to 55 percent of non-lgbtq millennials; and 63 percent of those lgbtq people interested in building a family expect to use assisted reproductive technology (art), foster care, or adoption to become parents.16 there are 15.9 million americans who identify as lgbtq+ (6.1 million of whom are 18 to 35 years old); thus, an estimated “3.8 million lgbtq+ millennials are considering expanding their families in the coming years, and 2.9 million are actively planning to do so.”17 yet access and affordability to art, especially in vitro fertilization (ivf) and surrogacy for same-sex couples, has not been consistent at a national level. the two primary problems accessing art for the lgbtq community are the lack of federal law and cost. a federal law that guaranteed coverage would address both problems. ii. art for same-sex couples all same-sex male (ssm) couples and same-sex female (ssf) couples must involve third parties, including surrogates or egg or sperm donors.18 art involves the legal status of “up to two women (surrogate and egg donor),” the intended parents, and the child for ssm couples. 19 while sometimes necessary for neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 3 heterosexual couples using art, an egg or sperm from someone other than the intended parents or a surrogate will always be necessary for the lgbtq people seeking art. art, in particular ivf, is essential for infertile couples unable to conceive on their own. unlike other industrialized countries (such as canada, the united kingdom, sweden, germany, and australia), the us does not heavily oversee this multibillion-dollar industry. 20 the american society for reproductive medicine does provide lengthy guidelines to fertility clinics and sperm banks; however, state lawmakers have been less active as they seem to avoid the controversy surrounding controversial topics like embryo creation and abortion.21 as a result, states “do not regulate how many children may be conceived from one donor, what types of medical information or updates must be supplied by donors, what genetic tests may be performed on embryos, how many fertilized eggs may be placed in a woman or how old a donor can be.”22 iii. a flawed definition of infertility the who defines the medical definition of infertility as “a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after twelve months or more of regular unprotected sexual intercourse.”23 this antiquated definition must be updated to include social infertility to integrate samesex couples’ rights.24 in the us, single individuals and lgbtq couples interested in building a family by biological means are considered “socially infertile.”25 if insurance coverage is allotted only to those with physical infertility, then it is exclusive to the heterosexual community. although some states, such as new york, discussed below, have directly addressed this inequality by extending the definition of infertility and coverage of infertility treatments to include all residents regardless of sexual orientation, this is not yet the norm everywhere else. the outdated definition of infertility is one of the main issues affecting same-sex couples’ access to art, as medical insurance companies hold on to the formal definition of infertility to deny coverage. iv. insurance coverage for ivf figure 1: infertility coverage per state. retrieved and adapted from https://resolve.org/what-are-myoptions/insurance-coverage/infertility-coverage-state/ massachusett s connecticut delaware maryland new hampshire new jersey new york states with infertility insurance laws states with ivf insurance laws states with fertility preservation laws https://resolve.org/what-are-my-options/insurance-coverage/infertility-coverage-state/ https://resolve.org/what-are-my-options/insurance-coverage/infertility-coverage-state/ neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 4 insurance coverage varies per state and relies on the flawed definition of infertility. as of august 2020, 19 states have passed laws requiring insurance coverage for infertility, 13 of which include ivf coverage, as seen in figure 1. also, most states do not offer ivf coverage to low-income people through medicaid.26 in states that mandate ivf insurance coverage, the utilization rate was “277% of the rate when there was no coverage,”27 which supports the likelihood that in other states, the cost is a primary barrier to access. when insurance does not cover art, art is reserved for wealthy individuals. one cycle of art could cost, on average, “between $10,000 and $15,000.”28 in addition, multiple cycles are often required as one ivf cycle only has “about a 25% to 30%” live birth success rate.29 altogether, the total cost of successful childbirth was estimated from $44,000 to $211,940 in 1992.30 on february 11, 2021, new york governor andrew m. cuomo “directed the department of financial services to ensure that insurers begin covering fertility services immediately for same-sex couples who wish to start a family.”31 new york had recently passed an ivf insurance law that required “large group insurance policies and contracts that provide medical, major medical, or similar comprehensive-type coverage and are delivered or issued for delivery in new york to cover three cycles of ivf used in the treatment of infertility.”32 but the law fell short for same-sex couples, which were still required to “pay 6 or 12 months of out-of-pocket expenses for fertility treatments such as testing and therapeutic donor insemination procedures before qualifying for coverage.”33 cuomo’s subsequent order made up for gaps in the law, which defined infertility as “the inability to conceive after a certain period of unprotected intercourse or donor insemination.”34 cuomo’s order and the law combine to make new york an example other states can follow to broaden access to art. v. surrogacy access to surrogacy also presents its own set of problems, although not exclusive to the lgbtq community. among states, there are differences in how and when parental rights are established. states in dark green in figure 2 allow pre-birth orders, while the states in light green allow post-birth parentage orders. prebirth orders “are obtained prior to the child’s birth, and they order that the intended parent(s) will be recognized as the child’s only legal parent(s) and will be placed on the child’s birth certificate,” while postbirth parentage orders have the same intent but are obtained after the child’s birth. 35 for instance, states can require genetic testing post-birth, possibly causing a delay in establishing parentage. 36 although preventable through the execution of a health care power of attorney, a surrogate mother could be the legal, medical decision-maker for the baby before the intended parents are legally recognized. on february 15, 2021, gestational surrogacy – the most popular type of surrogacy in which the surrogate has no figure 2: us surrogacy map. retrieved and adapted from https://www.creativefamilyconnections.com/ussurrogacy-law-map/ neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 5 biological link to the baby – was legalized in new york, 37 but it remains illegal in some states such as nebraska, louisiana, and michigan.38 in addition, the costs of surrogacy are rising, and it can cost $100,000 in the us.39 medicaid does not cover surrogacy costs, 40 and some health insurance policies provide supplemental surrogacy insurance with premiums of approximately $10,000 and deductibles starting at $15,000.41 thus, “surrogacy is really only available to those gay and lesbian couples who are upper class,”42 leaving non-affluent couples out of options to start a family through biological means. vi. a right to equality and procreation some argue that same-sex couples should have the right to procreate (or reproductive rights). based on arguments stemming from equal rights and non-discrimination, same-sex couples who need to use art to procreate should have access to it. the need to merge social infertility into the currently incomplete definition of fertility could help same-sex couples achieve access through insurance coverage. the human right of equality and non-discrimination guarantees “equal and effective protection against discrimination on any ground.”43 the united nations later clarified that “sexual orientation is a concept which is undoubtedly covered” 44 by this protection. the right to procreate is not overtly mentioned in the us constitution; however, the equal protection clause states that “no state shall make or enforce any law which shall abridge the privileges or immunities of citizens of the united states… without due process of law.”45 in fact, some states have abridged the reproductive privileges of some us citizens by upholding prohibitive and intricate mechanisms that deter same-sex couples from enjoying the privileges other citizens have. the supreme court acknowledged procreation as a “fundamental”46 personal right, in skinner v. oklahoma, mandating that the reproductive rights of individuals be upheld as the right to procreate is “one of the basic civil rights of man”47 because “procreation [is] fundamental to the very existence and survival of the race.”48 in eisenstadt v. baird, the courts also supported that “the decision whether to bear or beget a child” fundamentally affects a person.49 i argue that this protection extends to same-sex couples seeking to procreate. finally, obergefell v. hodges held that the due process and equal protection clauses ensure same-sex couples the right to marriage, as marriage “safeguards children and families, draw[ing] meaning from related rights of childrearing, procreation, and education.”50 by implicit or explicit means, these cases align with the freedom to procreate that should not be unequally applied to different social or economic groups. yet, the cases do not apply to accessing expensive tools to procreate. as heterosexual and the lgbtq community face trouble accessing expensive art for vastly different reasons, especially ivf and surrogacy, the equal rights or discrimination argument is not as helpful. for now, it is relevant to adoption cases where religious groups can discriminate.51 the insurance coverage level may be the best approach. while the social norms adapt and become more inclusive, the elimination of the infertility requirement or changing the definition of infertility could work. several arguments could address the insurance coverage deficit. under one argument, a biological or physical inability to conceive exists in the homosexual couple trying to achieve a pregnancy. depending on the wording or a social definition, a caselaw could be developed arguing the medical definition of infertility applies to the lgbtq community as those trying to procreate are physically unable to conceive as a couple planning to become parents. one counterargument to that approach is that it can be offensive to label people infertile (or disabled) only because of their status as part of a homosexual couple.52 neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 6 conclusion in the last 50 years, there has been a notable shift in the social acceptance of homosexuality.53 marriage equality has opened the door for further social and legal equality, as evidenced by the increased number of same-sex couples seeking parenthood “via co-parenting, fostering, adoption or surrogacy” – colloquially referred to as the ‘gayby boom’.54 however, some prejudice and disdain toward lgbtq+ parenting remain. equitable access to art for all people may be attainable as new technology drives costs down, legislators face societal pressure to require broader insurance coverage, and social norms become more inclusive. 1 eckholm, e. (2015, may 17). the same-sex couple who got a marriage license in 1971. retrieved april 08, 2021, from https://www.nytimes.com/2015/05/17/us/the-same-sex-couple-who-got-a-marriage-license-in-1971.html 2 eckholm, e. 3 a brief history of civil rights in the united states: a timeline of the legalization of same-sex marriage in the u.s. (2021, january 27). retrieved april 08, 2021, from https://guides.ll.georgetown.edu/c.php?g=592919&p=4182201 4 eckholm, e. 5 a brief history of civil rights in the united states: a timeline of the legalization of same-sex marriage in the u.s. (2021, january 27). retrieved april 08, 2021, from https://guides.ll.georgetown.edu/c.php?g=592919&p=4182201 6 a brief history of civil rights in the united states 7 a brief history of civil rights in the united states 8 lee, j., & bolzendahl, c. (2019). acceptance and rejection: patterns of opinion on homosexuality in the united states and the world. sociological forum, 34(4), 1026-1031. doi:10.1111/socf.12562 9 lee, j., et al. 10 lee, j., et al. 11 lee, j., et al. 12 lee, et al. 13 lee, et al. 14 lee, et al. 15 lgbtq family building survey. (2020, july 02). retrieved april 08, 2021, from https://www.familyequality.org/resources/lgbtq-family-building-survey/ 16 lgbtq family building survey. (2020, july 02). retrieved april 08, 2021, from https://www.familyequality.org/resources/lgbtq-family-building-survey/ 17 lgbtq family building survey. (2020, july 02). retrieved april 08, 2021, from https://www.familyequality.org/resources/lgbtq-family-building-survey/ 18 mackenzie, s. c., wickins-drazilova, d., & wickins, j. (2020). the ethics of fertility treatment for same-sex male couples: considerations for a modern fertility clinic. european journal of obstetrics & gynecology and reproductive biology, 244, 71-75. doi:10.1016/j.ejogrb.2019.11.011 neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 7 19 mackenzie, et al. 20 ollove, m. (2015, march 18). states not eager to regulate fertility industry. retrieved april 08, 2021, from https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2015/3/18/states-not-eager-to-regulatefertility-industry 21 ollove, m. 22 ollove, m. 23 world health organization. (2020, september 14). infertility. world health organization. https://www.who.int/news-room/fact-sheets/detail/infertility 24 leondires, m. p. (2020, march 19). fertility insurance mandates & same-sex couples. retrieved april 08, 2021, from https://www.gayparentstobe.com/gay-parenting-blog/fertility-insurance-mandates-same-sex-couples/ 25 lo, w., & campo-engelstein, l. (2018). expanding the clinical definition of infertility to include socially infertile individuals and couples. reproductive ethics ii, 71–83. https://doi.org/10.1007/978-3-319-89429-4_6 26 mohapatra, s. (2015). assisted reproduction inequality and marriage equality. chicago-kent law review, 92(1). retrieved april 08, 2021, from https://scholarship.kentlaw.iit.edu/cgi/viewcontent.cgi?article=4146&context=cklawreview 27 mohapatra, s. 28 mohapatra, s. 29 mohapatra, s. 30 mohapatra, s. 31 governor cuomo announces new actions to expand access to fertility coverage for same sex couples as part of 2021 women's agenda. (n.d.). 32 health insurers faqs: ivf and fertility preservation law q&a guidance. (n.d.). retrieved april 08, 2021, from https://www.dfs.ny.gov/apps_and_licensing/health_insurers/ivf_fertility_preservation_law_qa_guidance 33 governor cuomo announces new actions to expand access to fertility coverage for same sex couples as part of 2021 women's agenda. (n.d.). retrieved april 08, 2021, from https://www.governor.ny.gov/news/governorcuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couplespart#:~:text=february%2011%2c%202021,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20o f%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20sta rt%20a%20family. 34 leondires, m. p. 35 assisted reproduction parentage proceedings information: academy of adoption and assistive reproduction attorneys (aaaa). (2019, march 14). retrieved april 08, 2021, from https://adoptionart.org/assistedreproduction/parentage-proceedings/ 36 assisted reproduction parentage proceedings information. https://www.governor.ny.gov/news/governor-cuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couples-part#:~:text=february%2011%2c%202021-,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20of%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20start%20a%20family https://www.governor.ny.gov/news/governor-cuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couples-part#:~:text=february%2011%2c%202021-,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20of%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20start%20a%20family https://www.governor.ny.gov/news/governor-cuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couples-part#:~:text=february%2011%2c%202021-,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20of%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20start%20a%20family https://www.governor.ny.gov/news/governor-cuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couples-part#:~:text=february%2011%2c%202021-,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20of%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20start%20a%20family https://www.governor.ny.gov/news/governor-cuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couples-part#:~:text=february%2011%2c%202021-,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20of%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20start%20a%20family https://www.governor.ny.gov/news/governor-cuomo-announces-new-actions-expand-access-fertility-coverage-same-sex-couples-part#:~:text=february%2011%2c%202021-,governor%20cuomo%20announces%20new%20actions%20to%20expand%20access%20to%20fertility,part%20of%202021%20women's%20agenda&text=cuomo%20today%20directed%20the%20department,wish%20to%20start%20a%20family neyra, reproductive ethics and family, voices in bioethics, vol. 7 (2021) 8 37 governor cuomo reminds surrogates and parents of their new insurance rights and protections during gestational surrogacy. (n.d.). retrieved april 08, 2021, from https://www.governor.ny.gov/news/governor-cuomoreminds-surrogates-and-parents-their-new-insurance-rights-and-protections-during 38 u.s. surrogacy map: surrogacy laws by state. (2020, december 23). retrieved april 08, 2021, from https://www.creativefamilyconnections.com/us-surrogacy-law-map/ 39 mohapatra, s. 40 beitsch, r. (2017, june 29). as surrogacy surges, new parents seek legal protections. retrieved april 08, 2021, from https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2017/06/29/as-surrogacy-surges-newparents-seek-legalprotections#:~:text=medicaid%20does%20not%20cover%20surrogacy,and%20intended%20parents%20at%20risk. 41 where to find surrogacy insurance? (2017, november 02). retrieved april 08, 2021, from https://surrogate.com/intended-parents/surrogacy-laws-and-legal-information/where-can-i-find-surrogacyinsurance/ 42 mohapatra, s. 43 international covenant on civil and political rights. (n.d.). retrieved april 08, 2021, from https://www.ohchr.org/en/professionalinterest/pages/ccpr.aspx 44 united nations. (2003). human rights in the administration of justice: a manual on human rights for judges, prosecutors and lawyers. 45 u.s. const. amend. xiv, § 1. 46 skinner v. oklahoma, https://caselaw.findlaw.com/us-supreme-court/316/535.html (june 1, 1942). 47 skinner v. oklahoma 48 skinner v. oklahoma 49 eisenstadt v. baird, https://www.lexisnexis.com/community/casebrief/p/casebrief-eisenstadt-v-baird (march 22, 1972). 50 obergefell v. hodges 51 higgins, t. (2021, june 17). supreme court sides with catholic adoption agency that refuses to work with lgbt couples. cnbc. https://www.cnbc.com/2021/06/17/supreme-court-sides-with-catholic-adoption-agency-thatrefuses-to-work-with-lgbt-couples.html. 52 bowerman, m., may, a., & rossman, s. (2017, april 24). should the definition of infertility be more inclusive? usa today. https://www.usatoday.com/story/news/nation-now/2017/04/22/same-sex-couples-covered-infertilityinsurance/100644092/. 53 mackenzie, et al. 54 mackenzie, et al. soled, combating systemic racism in healthcare, voices in bioethics, vol. 7 (2021) * derek soled, candidate md, mba, harvard university © 2021 derek soled. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. distributive justice as a means of combating systemic racism in healthcare derek soled* abstract covid-19 highlighted a disproportionate impact upon marginalized communities that needs to be addressed. specifically, a focus on equity rather than equality would better address and prevent the disparities seen in covid-19. a distributive justice framework can provide this great benefit but will succeed only if the medical community engages in outreach, anti-racism measures, and listens to communities in need. keywords: health inequity, health disparity, covid-19, health equity, socioeconomic, marginalized introduction covid-19 disproportionately impacted communities of color and lower socioeconomic status, sparking political discussion about existing inequities in the us.1 some states amended their guidelines for allocating resources, including vaccines, to provide care for marginalized communities experiencing these inequities, but there has been no clear consensus on which guidelines states should amend or how they should be ethically grounded. in part, this is because traditional justice theories do not acknowledge the deep-seated institutional and interpersonal discrimination embedded in our medical system. therefore, a revamped distributive justice approach that accounts for these shortcomings is needed to guide healthcare decisionmaking now and into the post-covid era. background three terms – health disparity, health inequities, and health equity – help frame the issue. a health disparity is defined as any difference between populations in terms of disease incidence or adverse health events, such as morbidity or mortality. in contrast, health inequities are health disparities due to avoidable systematic structures rooted in racial, social, and economic injustice. 2 for example, current data demonstrate that black, latino, indigenous americans, and those living in poverty suffer higher morbidity and mortality rates from covid-19.3 finally, health equity is the opportunity for anyone to attain his or her full health potential without interference from systematic structures and factors that generate health inequities, including race, socioeconomic status, gender, ethnicity, religion, sexual orientation, or geography.4 soled, combating systemic racism in healthcare, voices in bioethics, vol. 7 (2021) 2 analysis health inequities for people of color with covid-19 have led to critiques of states that do not account for race in their resource allocation guidelines.5 for example, the massachusetts department of public health revised its covid-19 guidelines regarding resource allocation to patients with the best chance of shortterm survival.6 critics have argued that this change addresses neither preexisting structural inequities nor provider bias that may have led to comorbidities and increased vulnerability to covid-19. by failing to address race specifically, they argue the policy will perpetuate poorer outcomes in already marginalized groups. as the inequities in covid-19 outcomes continue to be uncovered and the data continue to prove that marginalized communities suffered disproportionately, we, as healthcare providers, must reconsider our role in addressing the injustices. our actions must be ethically grounded in the concept of justice. i. primary theories of justice the principle of justice in medical ethics relates to how we ought to treat people and allocate resources. multiple theories have emerged to explain how justice should be implemented, with three of the most prominent being egalitarianism, utilitarianism, and distributive. this paper argues that distributive justice is the best framework for remedying past actions and enacting systemic changes that may persistently prevent injustices. an egalitarian approach to justice states all individuals are equal and, therefore, should have identical access to resources. in the allocation of resources, an egalitarian approach would support a strict distribution of equal value regardless of one’s attributes or characteristics. putting this theory into practice would place a premium on guidelines based upon first-come, first-served basis or random selection. 7 however, the egalitarian approach taken in the uk continues to worsen health inequities due to institutional and structural discrimination.8 a utilitarian approach to justice emphasizes maximizing overall benefits and achieving the greatest good for the greatest number of people. when resources are limited, the utilitarian principle historically guides decision making. in contrast to the egalitarian focus on equal distribution, utilitarianism focuses on managing distributions to maximize numerical outcomes. during the covid-19 pandemic, guidelines for allocating resources had utilitarian goals like saving the most lives, which may prioritize the youthful and those deemed productive in society, followed by the elderly and the very ill. it is important to reconsider using utilitarian approaches as the default in the post-covid healthcare community. these approaches fail to address past inequity, sacrificing the marginalized in their emphasis on the greatest amount of good rather than the type of good. finally, a distributive approach to justice mandates resources should be allocated in a manner that does not infringe individual liberties to those with the greatest need. proposed by john rawls in a theory of justice, this approach requires accounting for societal inequality, a factor absent from egalitarianism and utilitarianism.9 naomi zack elaborates how distributive justice can be applied to healthcare, outlining why racism is a social determinant of health that must be acknowledged and addressed.10 until there are parallel health opportunities and better alignment of outcomes among different social and racial groups, the underlying systemic social and economic variables that are driving the disparities must be fixed. as a society and as healthcare providers, we should be striving to address the factors that perpetuate health inequities. while genetics and other variables influence health, the data show proportionately more exposure, more cases, and more deaths in the black american and hispanic soled, combating systemic racism in healthcare, voices in bioethics, vol. 7 (2021) 3 populations. preexisting conditions and general health disparities are signs of health inequity that increased vulnerability. distributive justice as a theoretical and applied framework can be applied to preventable conditions that increase vulnerability and can justify systemic changes to prevent further bias in the medical community. during a pandemic, egalitarian and utilitarian approaches to justice are prioritized by policymakers and health systems. yet, as covid-19 has demonstrated, they further perpetuate the death and morbidity of populations that face discrimination. these outcomes are due to policies and guidelines that overall benefit white communities over communities of color. historically, us policy that looks to distribute resources equally (focusing on equal access instead of outcomes), in a color-blind manner, has further perpetuated poor outcomes for marginalized communities.11 ii. historical and ongoing disparities across socio-demographic groups, the medical system exacerbates historical and current inequities. members of marginalized races,12 women,13 lgbtq people,14 and poor people15 experience trauma caused by discrimination, marginalization, and failure to access high-quality public and private goods. through the unequal treatment of marginalized communities, these historic traumas continue. in the us, people of color do not receive equal and fair medical treatment. a meta-analysis found that hispanics and black americans were significantly undertreated for pain compared to their white counterparts over the last 20 years.16 this is partly due to provider bias. through interviewing medical trainees, a study by the national academy of science found that half of medical students and residents harbored racist beliefs such as “black people’s nerve endings are less sensitive than white people’s” or “black people’s skin is thicker than white people’s skin.”17 more than 3,000 indigenous american women were coerced, threatened, and deliberately misinformed to ensure cooperation in forced sterilization. 18 hispanic people have less support in seeking medical care, in receiving culturally appropriate care, and they suffer from the medical community’s lack of resources to address language barriers.19 in the us, patients of different sexes do not receive the same quality of healthcare. despite having greater health needs, middle-aged and older women are more likely to have fewer hospital stays and fewer physician visits compared to men of similar demographics and health risk profiles.20 in the field of critical care, women are less likely to be admitted to the icu, less likely to receive interventions such as mechanical ventilation, and more likely to die compared to their male icu counterparts.21 in the us, patients of different socioeconomic status do not receive the same quality of healthcare. lowincome patients are more likely to have higher rates of infant mortality, chronic disease, and a shorter life span.22 this is partly due to the insurance-based discrimination in the medical community.23 one in three deaths of those experiencing homelessness could have been prevented by timely and effective medical care. an individual experiencing homelessness has a life expectancy that is decades shorter than that of the average american.24 iii. action needed: policy reform while steps need to be taken to provide equitable care in the current pandemic, including the allocation of vaccines, they may not address the historical failures of health policy, hospital policy, and clinical care to eliminate bias and ensure equal treatment of patients. according to an applied distributive justice framework, inequities must be corrected. soled, combating systemic racism in healthcare, voices in bioethics, vol. 7 (2021) 4 rather than focusing primarily on fair resource allocation, medicine must be actively anti-racist, anti-sexist, anti-transphobic, and anti-discriminatory. evidence has shown that the health inequities caused by covid19 are smaller in regions that have addressed racial wealth gaps through forms of reparations.25 distributive justice calls for making up for the past using tools of allocation as well as tools to remedy persistent problems. for example, brigham and women’s hospital in boston, ma, began “healing arc,” a pilot initiative that involves acknowledgement, redress, and closure on an institutional level. 26 acknowledgement entails informing patients about disparities at the hospital, claiming responsibility, and incorporating community ideas for redress. redress involves a preferential admission option for black and hispanic patients to specialty services, especially cardiovascular services, rather than general medicine. closure requires that community and patient stakeholders work together to ensure that a new system is in place that will continue to prioritize equity. of note, redress could take the form of cash transfers, discounted or free care, taxes on nonprofit hospitals that exclude patients of color,27 or race-explicit protocol changes (such as those being instituted by brigham and women’s hospital that admit patients historically denied access to certain forms of medical care). in new york, for instance, the new york state bar association drafted the covid-19 resolutions to ensure that emergency regulations and guidelines do not discriminate against communities of color, and even mandate that diverse patient populations be included in clinical trials.28 also, physicians must listen to individuals from marginalized communities to identify needs and ensure that community members take part in decision-making. the solution is not to simply build new health centers in communities of color, as this may lead to tiers of care. rather, local communities should have a chance to impact existing hospital policy and should also use their political participation to further their healthcare interests. distributive justice does not seek to disenfranchise groups that hold power in the system. it aims to transform the system so that those in power do not continue to obtain unfair benefits at the expense of others. the framework accounts for unjust historical oppression and current injustices in our system to provide equitable outcomes to all who access the system. in this vein, we can begin to address the flagrant disparities between communities that have always – and continue to – exist in healthcare today.29 conclusion as equality focuses on access, it currently fails to do justice. instead of outcomes, it is time to focus on equity. a focus on equity rather than equality would better address and prevent the disparities seen in covid-19. a distributive justice framework can gain traction in clinical decision-making guidelines and system-level reallocation of resources but will succeed only if the medical community engages in outreach, anti-racism measures, and listens to communities in need. there should be an emphasis on implementing a distributive justice framework that treats all patients equitably, accounts for 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https://doi.org/10.1353/cpr.2011.0041. 28 new york state bar association. 2020. “new york state bar association house of delegates: revised covid-19 resolutions.” https://nysba.org/app/uploads/2020/10/final-health-law-section-covid-19-resolutions_10-8-20-1-1.pdf. 29 egede, l. e. 2006. “race, ethnicity, culture, and disparities in health care.” journal of general internal medicine 21 (6): 667669. https://doi.org/10.1111%2fj.1525-1497.2006.0512.x https://doi.org/10.2105/ajph.2013.301480 https://doi.org/10.1186/s40985-016-0043-2 https://doi.org/10.1089/jwh.2009.1701 https://doi.org/10.1503/cmaj.071541 https://doi.org/10.1503/cmaj.071112 https://doi.org/.10.2105/ajph.92.1.99 https://doi.org/10.1371/journal.pone.0165651 https://doi.org/10.2105/ajph.2015.302668 https://doi.org/10.12688/wellcomeopenres.15151.1 https://doi.org/10.1016/j.socscimed.2021.113741 http://bostonreview.net/science-nature-race/bram-wispelwey-michelle-morse-antiracist-agenda-medicine http://bostonreview.net/science-nature-race/bram-wispelwey-michelle-morse-antiracist-agenda-medicine https://doi.org/10.7326/m20-6203 https://doi.org/10.1353/cpr.2011.0041 https://nysba.org/app/uploads/2020/10/final-health-law-section-covid-19-resolutions_10-8-20-1-1.pdf https://doi.org/10.1111%2fj.1525-1497.2006.0512.x griffin, forced sterilization, voices in bioethics, vol. 8 (2022) * fiona griffin, ms candidate columbia university © 2022 fiona griffin. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. forced sterilization: cases from namibia fiona griffin* keywords: global ethics, forced sterilization, coercion, namibia, informed consent, human rights introduction forced sterilization of women around the globe is a human rights violation and bioethical concern. in the past, countries enacted laws to forcibly sterilize women deemed unfit to procreate. although many of these laws have been retracted, the practice persists under the guise of public health. more recently, women living with hiv have been targets of nonconsensual sterilization. consent is frequently obtained while under duress or threat, or not obtained at all. nonconsensual sterilization has been documented in chile, the dominican republic, mexico, namibia, south africa, and venezuela.1 in 2015, three women who were sterilized without consent sued the supreme court of namibia, which did not find evidence that the doctors engaged in discrimination by performing or recommending the procedures due to the patients' hiv status.2 i. what is forced and coerced sterilization? forced sterilization is any sterilization that takes place without a patient’s informed consent. in healthcare settings, it occurs when women seeking sexual and reproductive health care are sterilized without their knowledge or the opportunity to provide informed consent. the practice is used as a means of permanent contraception. surgery is the most common sterilization method. women may unknowingly have a hysterectomy, the blocking and severing of fallopian tubes, or they may be administered a medication that causes the fallopian tubes to seal, thus preventing fertilization. nonconsensual sterilization may result from misinformation, financial incentives, or intimidation tactics obliging women to approve of the procedure.3 ii. namibia: a case study namibia presents a crucial bioethical injustice despite its perceived legislative success in curbing forced sterilization. in 2008, the international community of women living with hiv/aids (icw) and the namibian women’s health network (nwhn) documented mass violations of sexual and reproductive health rights. the report recorded breaches of informed consent when testing for hiv, denial of information to women with hiv, and divulging or risking confidential patient information.4 griffin, forced sterilization, voices in bioethics, vol. 8 (2022) 2 between 2005 and 2007, three women were coerced into bilateral tubal ligation when seeking reproductive health care. in 2012, the women filed a suit against the namibian government for constitutional violations.5 their claims included infringements of their rights to dignity, liberty, and to make decisions about starting a family. in addition, the women claimed the procedures were discriminatory due to the women’s hiv status. in 2015, the namibian high court ruled in the women’s favor and rendered the sterilizations unlawful. however, the court failed to conclude that the acts were discriminatory. 6 iii. autonomy in the traditional western view of bioethics, autonomy is defined as self-rule, freedom from the control and limitations of others. autonomy requires informed consent and the absence of coercion. if a person’s choice is based on manipulation, coercion, or compulsion, consent is not truly voluntary, and if it is based on misinformation, it is not informed, violating autonomy.7 eight hours into labor, a nurse informed one of the plaintiffs that she must undergo a hysterectomy. the plaintiff was presented with official documentation to consent to the procedure, which was not explained to her. the documentation referred only to the sterilization procedure using an abbreviation. she was dependent on the clinician’s assistance in the birthing procedure. she was not aware of the nature of the procedure because she did not understand the options and consequences in the consent document. the healthcare workers made no effort to inform the woman of her right to abstain from the procedure, which she did not understand was a sterilization procedure. she did not learn that she was sterile until returning to the clinic to obtain retroviral medication for her child.8 the consent was neither voluntary nor informed, undermining autonomy. iv. beneficence the principle of beneficence consists of the moral obligation to do good and has been described as requiring one to act for another’s benefit or to further a patient’s interests. what constitutes the patient’s good is related to both the patient’s view of her good and what allows her to pursue her own conceptualization of “good.” beneficence from a physician’s viewpoint might also concern what the physician thinks is good or best for the patient. studies asking women, “have there been any positive or good changes in your life ever since you found out that you were sterilized,” report no positive outcomes.9 by ignoring the interests of patients, beneficence is abandoned. by performing forced sterilizations, healthcare workers deprive women of the right to bear children in the future. this directly violates the notion of prioritizing a patient’s interests. in namibia, patriarchal cultural values about reproduction, marriage, and child-rearing instill expectations on women to bear and rear children.10 forcibly sterilizing women ignores heightened cultural pressures and the psychosocial outcomes for women who cannot become pregnant. sterilization risks discrimination against women with hiv. in addition, a woman who is forcibly sterilized may suffer abuse from a spouse who was excluded from the decision, leading to compounding adverse effects on physical and psychological well-being. beneficence also calls for ending discrimination. coerced sterilization is partly based on mistaken beliefs about vertical hiv transmission.11 although proper medication can prevent mother-to-child transmission, clinicians who are ill-informed about transmission resort to sterilization. women subjected to forced sterilization suffer immense physical harm at clinicians' hands. consequential physical health problems include heavy menstrual bleeding, severe abdominal pain, and lower limb weakness. these physical health problems increase financial difficulties and the need for health services, griffin, forced sterilization, voices in bioethics, vol. 8 (2022) 3 placing additional financial, physical, and emotional stress on patients. clinicians’ disregard for the sociocultural consequences is non-beneficent and a bioethical lapse. the sterilizations come under the backdrop of pervasive victimization of women, discrimination, and gender-based violence, made worse in the aftermath of sterilization.12 among women forcibly sterilized in latin american countries, pregnant women with hiv are six times more likely to be forcibly sterilized than pregnant women with hiv whose diagnosis was unknown to themselves and their physicians.13 equivalent findings have been documented in southern africa.14 by perpetuating hiv-discriminatory beliefs that deem women unworthy of reproduction, clinicians subject patients to harmful discrimination and freely discount the principle of justice. v. through a human rights lens nonconsensual sterilization is recognized as an “act of torture, and cruel, inhumane, and degrading treatment” by the united nations human rights committee. torture is defined as intentionally inflicted suffering on a person for an improper purpose or if that purpose is based on discrimination. 15 the united nations has condemned forced sterilization as a violation of the rights to health, bodily integrity, freedom from violence, freedom from torture, freedom from discrimination, and to decide the number and spacing of their children. the right to health is guaranteed under the international covenant on economic, social, and cultural rights (icescr). the right to information is guaranteed under the international covenant on civil and political rights (iccpr).16 there is also a long recognized right to informed consent under which healthcare practitioners provide the information necessary for people to make an informed choice. practitioners must disclose the risks and benefits of a procedure. in the actions leading to the 2015 lawsuit in namibia, the women were unaware that they had been made sterile until they returned to a healthcare facility. and, they had not been given a choice. the doctors told them they ‘must’ undergo the procedure. the clinicians failed to provide clear and comprehensible information and did not confirm that the patients understood the consequences of the process. using the patient care framework (hrpc), healthcare facilities and governments can reduce stigma and discrimination. hrpc acknowledges the systematic nature of forced and coerced sterilization and calls for seeking out and trying to eliminate involuntary and coerced sterilization. to comply with the hrpc, countries must investigate and abolish all instances of coerced sterilization in an effective and just manner. in the courts, better human rights argumentation and the ability to challenge legal deficiencies would improve plaintiffs’ ability to win cases. conclusion the bioethics community should take action to end coerced sterilizations as they violate the four principles of bioethics set forth by beauchamp and childress. in namibia, the case of the three plaintiffs demonstrates the need for more bioethical attention, as the disregard for autonomy, beneficence, nonmaleficence, and justice were clear. employing a human rights framework emphasizes the structural origins of the practice and calls for governments to seek out and end coerced sterilization. if coerced sterilization does occur, courts that prosecute it can be a deterrent and can work toward righting the wrong through the justice system. griffin, forced sterilization, voices in bioethics, vol. 8 (2022) 4 1 open society foundations, “against her will: forced and coerced sterilization of women worldwide.”, (2011): 2-10 (accessed august). 2 nyasha chingore-munazvo, katherine furman, annabel raw and mariette slabbert, “chronicles of communication and power: informed consent to sterilisation in the namibian supreme court’s lm judgment of 2015,” theoretical med bioethics 38 (april 2017): 145-162, https://doi.org/10.1007/s11017-017-9405-0 3 mindy jane roseman, aziza ahmed, and jennifer gatsi-mallet, “at the hospital there are no human rights’: reproductive and sexual rights violations of women living with hiv in namibia,” no. 128-130 (july 2012), http://dx.doi.org/10.2139/ssrn.2220800. 4 roseman, ahmed, and gatsi-mallet, “at the hospital,” 4. 5 lm and others v. government of the republic of namibia (i 1603/2008, i 3518/2008, i 3007/2008) at 4. the judgment notes the plaintiffs’ claims that the unlawful conduct violated the plaintiff’s rights guaranteed under the constitution of the republic of namibia, in particular, her right to life (article 7) , her right to human dignity (article 8), and her right to found a family (article 14). (2012) nahc 211, https://namiblii.org/na/judgment/high-court/2012/211. 6 chingore-munazvo, furman, raw and slabbert, “chronicles of communication and power,” 146. 7 jukka varelius, “the value of autonomy in medical ethics,” med, health care philos 9 (october 2006): 377-388, https://doi.org/10.1007/s11019-006-9000-z. 8 chingore-munazvo, furman, raw and slabbert, “chronicles of communication and power,” 142-147. 9 kudzai bakare & shelene gentz, “experiences of forced sterilisation and coercion to sterilise among women living with hiv (wlhiv) in namibia: an analysis of the psychological and socio-cultural effects,” sexual and reproductive health matters, 28 no.1, https://doi.org/10.1080/26410397.2020.1758439. 10 bakare & gentz, “experiences of forced sterilization.” 11 open society foundations, “against her will.” 12 tamil kendall and claire albert, “experiences of coercion to sterilize and forced sterilization among women living with hiv in latin america,” wiley online library 18, no. 1 (march 2015), https://doi.org/10.7448/ias.18.1.19462. 13 kendall and albert, “experiences of coercion.” 14 chingore-munazvo, furman, raw and slabbert, “chronicles of communication and power.” 15 open society foundations, “against her will.” 16 priti patel, “forced sterilization of women as discrimination,” public health reviews 38, no. 15 (july 2017), https://doi.org/10.1186/s40985-017-0060-9. https://doi.org/10.1007/s11017-017-9405-0 http://dx.doi.org/10.2139/ssrn.2220800 https://doi.org/10.1007/s11019-006-9000-z https://doi.org/10.1080/26410397.2020.1758439 https://doi.org/10.7448/ias.18.1.19462 https://doi.org/10.1186/s40985-017-0060-9 zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) copyright cc-by anne zimmerman 2021 the trauma of disregard: doing justice to parental healthcare values in conflicts in pediatric medical care anne zimmerman, jd, ms keywords: parental healthcare values, parental decision, trauma, bioethics, refusals, informed consent abstract studies and policy advancement have long excluded a keystone niche within the development of the healthcare decision-making process: the parental perspective. incorporating accounts of parents who have encountered traumatic occurrences in the healthcare system can help develop a respect for their healthcare values and allow doctors understand the parent’s positions and emotions and adjust accordingly. this paper argues that healthcare practitioners have failed to appreciate the weight and negative effects of actions violating parental healthcare values. introduction re-theorizing the experience of the parent in the hospital setting could better inform hospital policy, physician behavior, and ethics committees about the impact of their behaviors and decisions. public policy and debate as well as hospital policy around the role of parents in zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 2 healthcare decision making fail to incorporate the lived experience of parents, a failure that leads to one-sided actions and policies. much of the research about parents in the medical care setting does not grasp the breadth of parental experiences and the strength of parental healthcare values. specifically, the negative impact of the doctor or organization’s decision not to respect parental healthcare values on parents’ respect for healthcare practitioners, hospitals, and even pharmaceutical companies and public health professionals is not deeply explored in the literature but it may have long-lasting impact on the parents, the family unit, and the child. this paper argues that bioethics research studies have by and large failed to grasp the parent experience often by design, language, and conceptual framework. a movement toward constructivism and phenomenology or narrative-based accounts might align with treatment of parents as equals in social status and present an ethical framework that does justice to the trauma in the lived experience of parents. i. a preference or a healthcare value the crux of the failure of the current theory regarding parental decision-making stems from a misunderstanding that parental “preferences” are often a placeholder for healthcare values. a disregard of parental opinions, decisions, or feelings results in the sense of invisibility, disregard, and even abandonment as a decision maker. losing control over a young child’s healthcare decisions is traumatic for parents.1 i argue the trauma stems from the depth of the parents’ healthcare values, not from a disagreement over preferences. studies use the word preference,2 but parental healthcare values are much deeper, more important, personal, and even reflective of constitutional rights. for example, preference may be appropriate when discussing acetaminophen versus ibuprofen, but i would use healthcare values when discussing palliative care versus chemotherapy.3 most parental medical decisions fall into murkier territory: for example, whether to choose antianxiety medicines, opioids for pain relief, or firstor secondgeneration anticonvulsants for epilepsy, when there are safe, efficacious alternatives, a contentious subject that seems uncontentious when framed as a mere preference. furthermore, parents may prefer proven alternatives which are incorrectly associated with doing nothing. there may be room for rethinking the role and application of the standard of care to be more inclusive under safe circumstances. there are also liberties that some parents value more deeply than others, leading to questions of which authorities are in a position to decide, and why they hold that power.4 parental liberty must not outweigh child safety, but it is a well-established cornerstone of free society. healthcare values should be defined not just as “preferences, concerns, and expectations”5 but as deeply held beliefs, the violation of which affects people personally. healthcare values dictate personal behaviors and can be limited when those behaviors violate a law, as possible in cases of medical neglect. healthcare values in a liberal democracy are moral values that may be legally protected parenting rights as elucidated and limited by courts.6 healthcare values in the broad sense encompass a policy view on how people should access care and who should pay (one person’s healthcare values may prioritize freedom of choice while another person’s might zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 3 prioritize access to care for everyone; such values may dictate voting behavior). on a personal level, healthcare values may address whether natural or herbal remedies should be exhausted before medicines are tried or whether medicines should be tried first even if they have severe side effect profiles. or they may dictate whether there is a moral responsibility to keep as healthy as possible using lifestyle, exercise, and diet, and if so, whether that moral responsibility should or should not be considered in policy. healthcare values also connect to other values. for example, certain diets are environmentally friendly and correlated with prevention. those adhering to such diets may have varying healthcare values, favoring either reason to varying degrees, health-wise something that may benefit them depending on environmental, genetic, and other health influences. moving away from “preference” to “healthcare values” better highlights the importance of parental choice as a tenet of sociopolitical, family, individual, or community life in a liberal democracy. ii. the role and nature of bioethics research the misunderstanding of healthcare values as preferences has resulted in a research methodology that too often calculates parental healthcare values through a numerical lens of efficiency and patient satisfaction. while i acknowledge the need for empirical research, empirical research methods that try to identify issues or incorporate ways to improve care are not the best approach to ensuring that highly personalized healthcare values are respected. health care as a consumer endeavor has moved toward patient engagement and partnership through various new models, yet the models and the literature continue to be healthcare practitioner-driven7 rather than reflective of the individual experience of parents. the “partnership in care” approach looks to patients as active partners or experts, values the patient experience, and aims to harness the expertise developed by patients as they know about living with medical conditions and accessing services.8 this model is especially helpful from a customer service perspective and leads to a smoother process and an appreciation of the many skills parents develop. it also provides a mechanism for the healthcare organization to promote sharing information, enabling parents to learn from each other. but this model is insufficient to address the role of parents as decision makers, conflicts between practitioners and parents, and the deeper moral issues involved in care, which go well beyond customer service in that they impact families in daily life and arguably shape their attitudes toward medicine, the pharmaceutical industry, and public health. there are studies that look at how the family would be affected by a care decision, and how to evaluate parental and surrogate decisions, especially refusals of care.9 the “family surrogate decision-making models”10 tended to exhibit paternalism in study structure, as the studies focused on the attitudes and preferences of physicians, reflected the use of physiciancentric language (whether they are “accepting of”), and assumed that it was up to the physician to decide how much the family mattered. that is, the family voice was nowhere in the research method. while there has since been progress and significant attention to patient experiences and healthcare quality, parental healthcare values are not addressed in a fully informative, holistic, zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 4 experiential way in the research or literature, which tends to be written by, or subject to peer review by, physicians. some studies remain logistical. for example, in a study of the nicu in which the design did include parental perceptions, the family meetings were considered from a customer service perspective concluding that parents would like to be better prepared for meetings.11 the study, while informative about meeting preparation and logistics, did not offer a mechanism for including parental healthcare values or inform methods to solve moral disagreements over treatment decisions in the nicu. an article evaluating the “four quadrants approach” in decision making in burn scenarios said, “in our experience, patients and family members are unlikely to make appropriately informed decisions during this acute period.”12 that language is a red flag in several ways: it negatively stereotypes families and patients; it is dismissive of patients; and it implies doctors adequately decide for patients. a 2016 article asserts, “the various perspectives of nurses, chaplains, physicians, social workers, lawyers, and others bring variety to the debate and serves the patient in the best way possible.”13 the direct voice of the person receiving care is absent in the “variety.” despite a recognition of the importance of care decisions to the parents, there is no pervasive, acceptable framework for assessing the impact on the parents of a violation of healthcare values. the literature on refusals is generally one-sided and revolves around efficacy. in doing so it may inflate the costs to the child of a parental decision the healthcare practitioners dislike while ignoring many of the undocumented costs to the child, family unit, and parents of a decision forced on parents. alexander kon recognizes the unreasonable expectations healthcare providers may have and their view of “death as failure.” he recommends that “healthcare providers enter any such conversations with an open mind and a willingness to listen first and talk later.”14 his examples of cases of practitioners coming around to the parent point of view are so vastly different from the many experiences in which practitioners have been unbudging, righteous, or willing to engage in duress that there may be a need to collect more stories, especially from the point of view of those parents whose decisions were not respected in non-dangerous situations where there was no potential harm or no imminent harm. kon specifically addresses the life-at-all-costs attitude that practitioners may have, which reflects healthcare values. the kon method appears to exist more in theory than in practice, representing an aspiration, not a reality. in the arena of refusals, parents’ views may be disregarded in favor of the doctor’s recommendation even if there are multiple solutions with similar efficacy.15 i suggest that one of the reasons could be the insufficiency of the body of research to account for the lived experience. that insufficiency may distort the physician’s view of the importance, leaving them unaware of the detriment to the parents or family unit. physicians do not know how parents feel and how the parents’ future engagement with the healthcare system may be negatively impacted. one hypothesis seemingly untested is that the physician believes the parents will be indifferent to or thankful for the unwanted intervention, or for a failure to provide something the parents wanted, or for any conflict’s resolution in the physician’s favor. the doctor and hospital may think all is well zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 5 that ends well. i argue physicians underestimate the role of the helplessness, hopelessness, loss, and grief of an ignored parent in the lived experiences of that parent. the result may include an irreconcilable distrust for the doctor, hospital, medical profession, public health profession, and even the government. the trauma experienced by parents seems overlooked by the literature. iii. “doing justice”: a new approach to critiquing research methods thomas teo argues that the quality of research methodology is based on “the degree to which a method is doing justice to the object…,” something central to the ethics of the research.16 when a research design fails to incorporate viewpoints, the ethics of the research become compromised. in the narrow sense, doing justice to parental healthcare values likely requires subjective information, parental lived experiences as described by them. yet studies that recommend overriding parental refusals, even if the refusals were based on healthcare values, generally reflect research methods that rely on efficacy alone, completely numbers-based endeavors.17 for example, studies based only on medical statistics are used to address refusals of chemotherapy and depression and anxiety medicines.18 parents can be declared wrong even when they understand the efficacy data, have valid reasons, offer an equally efficacious alternative, or when the care refused is not guaranteed to help or cure the condition, or it has severe side effects. for now, in the bulk of the research, efficacy numbers often serve as the sole justification for overriding the parents’ wishes. but does such research do justice to the issue? in the broad sense, certain bioethics studies do not do justice because they do not contextualize a family’s political, socioeconomic circumstances. sometimes an injustice may be done when there is an acceptance of a refusal by a wealthy parent, and not only a failure to accept a poor parent’s refusal, but neglect charges against the poor parent refusing. is the poor parent less entitled to healthcare values that conflict with those of the physician? similarly, many cite racial bias in the context of pediatric medical care.19 if parental healthcare values involve quality of life concerns, limited medicalization in favor of natural remedies, or broader values like socioeconomic circumstances that influence the decision, it is difficult to see some of the questionnaires and studies in the bioethics literature as deep enough to take on the topic. the parental role in health care is the subject of a great deal of literature, but the literature fails to do justice to the trauma of the lived experience of the parents, leading to policies and practices that fall short for families. as is, the current research methods employed by bioethicists, predominantly published in journals with doctors as peer reviewers or holding positions on the journals’ boards, aiming to define or limit the role of parents in healthcare decision making do not do justice to breaches of parental healthcare values. bioethicists sometimes suggest majority views should dictate; for example, one author suggests the rightness of overriding based on evidence that doctors usually override refusals of chemotherapy at 33 percent or better efficacy.20 moral rightness based on current practices can disenfranchise minority viewpoints, and even lead to unconstitutional results. for example, many parents prefer anxiety medication or add medication for their child. yet that prevalent preference alone should not invalidate those whose healthcare values indicate otherwise. disease creep and zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 6 treating conditions of regular life (moods or physical conditions that used to be widely accepted, not seen as needing treatment) are contrary to many people’s values, something seen in aging with a push to use medical advances to keep people “young.”21 it may be that within a certain zone, physicians will “allow” parents to make minor decisions, but the more serious the problem and the greater the efficacy, the less physicians will succumb to parental influence,22 a distinct insult to the role of parents. in exploring the role of patients as research subjects from the views of both hospital staff and the patient-subjects, salla saxén and heikki saxén argue that a “careresearch nexus” must combine the “bird’s eye view of the doctors and researchers with the personal views, life story, and social network of the patient.”23 the same concepts could extend to parents in their involvement in the delivery of care to their children. the saxén triangle24 puts medical professionals and the patient’s personal criteria on a more even playing field. in referencing the healthcare conflicts resolved in favor of physicians rather than parents, the existing research also fails to do justice by not reflecting the weight of individual constitutional rights including the right to refuse care, violations of which feed the resulting trauma parents endure. autonomy in bioethics literature speaks to decisions that direct care but does not acknowledge the weight of constitutional rights, or the feelings that accompany a violation of rights. “autonomy rights” might be a better phrase than just autonomy to situate autonomy even more forcefully at the top among the four principles. some articles tee up a weighing process in which potential benefits to the child appear in conflict with the parents’ choice when often they are not. in the dominant discussions, the parents appear to be uneducated, misinformed, or ill-motivated.25 yet broadscale research also confirms the overprescribing, overuse, and heavy use of pharmaceuticals that many professionals within medicine and the natural and social sciences question.26 for example, overprescribing is implicated in the opioid epidemic. the on-the-ground parental experience is not often contextualized properly with the largescale data. the unwillingness to go along with a sea change in emotional health care when understood in the context of overprescribing27 requires a deep look at values, where values arise, who has authority to determine norms for other people and why, and how a violation of deeply held values affects people and society. yet some argue that a parental refusal to approve medicine for anxiety and depression is medical neglect even if there is not an imminent danger --the american association of pediatrics includes the failure to provide for “emotional-behavioral” needs in its definition of neglect.28 historically, emotional needs were met with nonmedical emotional support by families, friends, and community, rather than within a healthcare system. continuing such longstanding traditions is values-based and reflects a historic norm. medicine need not be used to resolve societal issues. when more is presumed better at the individual level, parents wishing to refuse medicines are forced to defend their healthcare values. yet the parents are often supported by the epidemiology and largescale public health data.29 parents going along with recommendations are not asked to defend their choice, despite known risks to children and the context of significantly zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 7 more pharmaceutical use among children and adolescents. informed consent reflects going along with the physician, while informed refusal’s inherent conflict is treated differently.30 research on overuse of prescription drugs should dominate individual treatment discussions, leading to a balanced perspective where all parents are alerted to the concerns, and those choosing medicines weigh the pros and cons fully informed. research is generally supported by a presumption of verifiable, observable patterns. positivism limits what is included in the sphere of “genuine knowledge,” based on its philosophical presumptions about the nature of knowledge, and limitations on what can logically be concluded.31 arguably, when parental healthcare values are ignored, positivism could yield a picture of the observable results. using proxies to represent hurt, anger, and trauma could be informative and objective. an approach steeped in logical analysis of the data could shed light on the ill effects that some bioethicists acknowledge.32 constructivism and theories rooted in the lived experience include diverse points of view and a fuller picture of the social world in contrast to positivism and other reality-oriented correspondence theory.33 by accounting for emotions, social circumstances, and worldview, constructivism looks for human perception. separating the person designing the research from the research can prove difficult. possibly parents themselves are the best researchers, but they do not have the means to put together research studies. phenomenology, whose iterations allow for the chronicling of subjective experiences, could elucidate parental experiences more accurately, and be a logical platform for those researchers interested in how parents feel and what parents do in response to those feelings when their healthcare values are violated or ignored. yet it is important to see the logic: when their healthcare values are ignored, parents logically and predictably experience trauma and develop distrust. iv. beyond research: exploring the lived experience due to the richness, individuality, and diversity of parental healthcare values, they may not be best served by traditional bioethics empirical research. one problem with bioethics research and with professional applied ethics in the fast-paced hospital environment is that something that is a problem for one family might be especially valued by another. from the customer service approach, a hospital or physician might want to please a majority. from a healthcare values standpoint, an approach that accommodates the most views (even if only one person holds the view) without risking the child’s safety is warranted. healthcare values, whether seen on a continuum or otherwise charted, are personal and may look most accurate on a scatterplot. for example, someone may firmly avoid opioids and antidepressants, but use generous amounts of nsaids or acetaminophen. they are not anti-medicine, yet they are discriminatory in its use. another discriminating parent might approve of opioids but not acetaminophen based on side effect concerns or its possible failure to address the pain as well. most parents fit somewhere in the middle ground but vary greatly as to how they engage with medicine in their lives. there are vastly different views on quality of life, on what makes life worth living, and on how to harness medicine in a way that aligns with their healthcare values. people vary significantly on the appropriate amount of distrust of pharmaceutical companies, government in its regulatory roles, zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 8 and for-profit hospitals, if any. healthcare values are broad and deep. data on parental conflicts does not reveal how much the conflict means to the parent. whether lacking data or engaging in vestiges of paternalism, physicians in my experience underestimate the trauma caused when parents are forced to deviate from values dear to them. beyond that disconnect, it is unpredictable whether physicians would behave differently if they knew the trauma they trigger likely leads to significant dislike for the profession of medicine, public health, and the pharmaceutical industry. conclusion while more empirical research and a phenomenological approach could yield supporting data, i assert that the trauma resulting when physicians disregard healthcare values is more significant than currently understood, has emotional and psychological effects, and contributes to long-term distrust. efficacy data, medical traditions, and research on ways to incorporate patient or parent preferences do not cover the moral rightness or wrongness because they fail to adequately measure or account for the type and degree of the actions’ harm. the research or a collection of narratives that i would recommend gathering would do justice to the topic by aiming to understand to what degree trauma, distrust, and dislike result from infractions (the parent data), and how the healthcare system as a whole and even public health is harmed by the lack of trust (the public data). narratives by parents might elucidate the stories of the many parents who feel disenfranchised, whose voices were not heard, who were unable to protect their children from medicines,34 who could not get a diagnosis because the facts they relayed to doctors did not correspond well to scans,35 who experienced a lack of empathy in a system they needed, and who could not instill healthcare values in their children due to competing information presented without enough context like broad data on overprescribing and addiction. a personal narrative of the lived experience of an inability to operate according to one’s healthcare values would be a valuable addition for physicians so that they may fully digest the extent of the emotional trauma that parents experience when their healthcare values are ignored.36 zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 9 1 this paper addresses those younger than would be expected to “assent”, those situations where the conflict is between parents and the doctor, or where the person receiving care agrees with the parents. as per many laws and provisions, the ability to seek care when parents are neglectful, abusive, or absent is well documented. and new york offers clarity on the ability to seek certain types of care without parental input. see nyclu, teenagers, health care, and the law: a guide to minors’ rights in new york state, 3rd ed, 2018. https://www.nyclu.org/sites/default/files/thl.pdf 2 bullock dr, vehe rk, zhang l, correll ck. telemedicine and other care models in pediatric rheumatology: an exploratory study of parents’ perceptions of barriers to care and care preferences. pediatric rheumatology. 2017;15(1). doi:10.1186/s12969-017-0184-y; gafforini s, turbitt e, freed gl. lower urgency paediatric injuries: parent preferences for emergency department or general practitioner care. emergency medicine australasia. 2016;28(5):564-568. doi:10.1111/1742-6723.12651; tomlinson d, bartels u, gammon j, et al. chemotherapy versus supportive care alone in pediatric palliative care for cancer: comparing the preferences of parents and health care professionals. cmaj. 2011;183(17):e1252-e1258. doi:10.1503/cmaj.110392 3 tomlinson, et al. 4 shapiro, m. pediatric depression: when does parental refusal for treatment constitute medical neglect? journal of the american academy of child & adolescent psychiatry. 2018;57(6):363-365. doi:10.1016/j.jaac.2018.02.014 5 marzorati c, pravettoni g. value as the key concept in the health care system: how it has influenced medical practice and clinical decision-making processes. j multidiscip healthc. 2017;10:101-106, p. 102. published 2017 mar 21. doi:10.2147/jmdh.s122383 6 meyer v. state of nebraska, 262 u.s. 390 (1923); pierce v. society of sisters, 268 u.s. 510 (1925); prince v. commonwealth of massachusetts, 321 u.s. 158 (1944). 7 gustavsson s, gremyr i, kenne sarenmalm e. designing quality of care contributions from parents. journal of clinical nursing. 2015;25(5-6):742-751. doi:10.1111/jocn.13050 (researchers conclude that healthcare professionals overvalue their importance for value creation and underestimate the ability of parents to influence quality.) 8 bouabida, p.5. 9 for example, see rhodes r, holzman i. the not unreasonable standard for assessment of surrogates and surrogate decisions. theoretical medicine and bioethics. 2004;25(4):367-386. doi:10.1007/s11017-004-3138-6; see winters jp. when parents refuse: resolving entrenched disagreements between parents and clinicians in situations of uncertainty and complexity. the american journal of bioethics. 2018;18(8):20-31. doi:10.1080/15265161.2018.1485758 citing gillam l. the zone of parental discretion: an ethical tool for dealing with disagreement between parents and doctors about medical treatment for a child. clinical ethics. 2015;11(1):18. doi:10.1177/1477750915622033 (recognizing overriding parents can cause harm.); about refusal of opioids, see moreno‐galvan a, marron jm, marsiglio am. how should we approach parental refusals of opioids on behalf of children in the perioperative setting? a practical approach based on ethical theory. pediatric anesthesia. 2020;30(8):852-858. doi:10.1111/pan.13941 (the authors evaluate the best interests, harm principle, zone of parental discretion, and lainie friedman ross’s constrained parental autonomy.); ross, lf. against the tide: arguments against respecting a minor's refusal of efficacious life-saving treatment. cambridge quarterly of healthcare ethics. 2009;18(3):302-315. doi:10.1017/s0963180109090471 (arguing in favor of treatment against a minor’s or the parents’ will when survival rate is 75 percent or more regardless of intrusiveness of the treatment.) 10 hardart g, truog r, attitudes and preferences of intensivists regarding the role of family interests in medical decision making for incompetent patients. critical care medicine. 2003; 31 (7): 1895-1900. doi: 10.1097/01.ccm.0000084805.15352.01. 11 drago m, lorenz jm, hammond j, hardart ge, morris mc. how to hold an effective nicu family meeting: capturing parent perspectives to build a more robust framework. journal of perinatology. 2021. doi:10.1038/s41372-021-01051-4 12 teven, cm, and gottlieb, lj. the four-quadrant approach to ethical issues in burn care. ama journal of ethics. 2018;20(6):595-601. doi:10.1001/journalofethics.2018.20.6.vwpt1-1806 zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 10 13 hajibabaee f, joolaee s, cheraghi ma, salari p, rodney p. hospital/clinical ethics committees' notion: an overview. j med ethics hist med. 2016;9:17. published 2016 dec 18, citing powell lt. hospital ethics committees and the future of health care decision making. hosp mater manage q. 1998;20(1):82–90. 14 p 9 kon aa. when parents refuse treatment for their child. jonas healthcare law, ethics, and regulation, 2006;8(1):5-11. doi:10.1097/00128488-200601000-00003 15 zimmerman, a. “opting out: the importance of parental informed refusals,” report. p. 5. archived june 2021, columbia university. https://doi.org/10.7916/d8-phnj-6476 16 teo, t. (2021). “doing justice” in psychological methodology: from science and experiments to anecdotes. new ideas in psychology, 61, 100854. https://doi.org/10.1016/j.newideapsych.2021.100854 17 ross, 2009. 18 see zimmerman, 2021. 19 lang, k., dupree, c., kon, a., dudzinski, d. calling out implicit racial bias as a harm in pediatric care. cambridge quarterly of healthcare ethics. july 1, 2016. https://doi.org/10.1017/s0963180116000190 20 pope, tm. parental treatment refusals: what your responsibilities are when mom and dad decline cancer treatment for a child. asco post, july 25, 2019. https://ssrn.com/abstract=3427271 for data on doctors treating despite parental refusals, see talati ed, lang cw, ross lf. reactions of pediatricians to refusals of medical treatment for minors. journal of adolescent health. 2010;47(2):126-132. doi:10.1016/j.jadohealth.2010.03.004 (with 80 percent 5-yr survival, doctors treated 325 of 404 over family refusals.) 21 anton s. d., woods, a. j., ashizawa, t., barb, d., buford, t. w., carter, c. s., clark, d. j., cohen, r. a., corbett, d. b., cruz-almeida, y., dotson, v., ebner, n., efron, p. a., fillingim, r. b., foster, t. c., gundermann, d. m., joseph, a. m., karabetian, c., leeuwenburgh, c., manini, t. m., … pahor, m. “successful aging”: advancing the science of physical independence in older adults. ageing research reviews, 2015;24(pt b), 304–327. https://doi.org/10.1016/j.arr.2015.09.005 22 ross lf. ethical issues raised by the media portrayal of adolescent transplant refusals. pediatrics. 2020;146(supplement 1). doi:10.1542/peds.2020-0818h (arguing the greater the efficacy, the less voice a parent should have, even if the treatment is extremely intrusive, can impact quality of life immensely, and the underlying condition is grave.) 23 saxén, s., and h. saxén. implementing personalized genetic medicine: interprofessional and patient perspectives on connecting medical research with clinical care. voices in bioethics, 2021;7. doi:10.52214/vib.v7i.8487. 24 saxén and saxén, p.12. 25 “brain tumour boy ashya king free of cancer, parents say,” bbc news, bbc.com, march 23, 2015. https://www.bbc.com/news/uk-england-32013634 (the media did not understand that aysha king’s family was seeking a better treatment, one which has since become standard of care for those who can afford it.) 26 fox nj, ward kj. pharma in the bedroom . . . and the kitchen. . . . the pharmaceuticalisation of daily life. sociol health illn. 2008;30(6):856-868. doi:10.1111/j.1467-9566.2008.01114.x 27 marcia angell. the epidemic of mental illness: why. the new york review, july 2011. https://www.nybooks.com/articles/2011/06/23/epidemic-mental-illness-why/ (angell suggests there has been expansion of the criteria for mental illness and a trend toward using drugs before other modalities.) 28 shapiro. 29 marcia angell. the epidemic of mental illness: why. the new york review, july 2011. https://www.nybooks.com/articles/2011/06/23/epidemic-mental-illness-why/ (angell suggests there has been expansion of the criteria for mental illness and a trend toward using drugs before other modalities.) 30 zimmerman, 2021. 31 patton, mq, qualitative research and evaluation methods, 3rd edition, thousand oaks, ca.: sage publications; 2002. 32 gillam, l. (recognizes overriding parents can cause harm.) 33 patton, p. 96. https://ssrn.com/abstract=3427271 https://doi.org/10.1016/j.arr.2015.09.005 https://www.nybooks.com/articles/2011/06/23/epidemic-mental-illness-why/ https://www.nybooks.com/articles/2011/06/23/epidemic-mental-illness-why/ zimmerman, the trauma of disregard, voices in bioethics, vol. 7 (2021) 11 34 osterweil n. kids and antidepressants: a growing problem. webmd. https://www.webmd.com/depression/features/kids-antidepressants-growing-problem. published february 2, 2004. accessed june 21, 2021. (article describes risks and a personal example of a suicide by a 13 year old taking zoloft.) 35 caron rm. co-producing healthcare in a volume vs. value-based healthcare system: perspective of a parent of a patient and a health professions’ educator. patient experience journal. 2019;6(2):16-19. doi:10.35680/23720247.1373 36 for an example of a narrative woven into a report on the importance and societal value of refusals, see zimmerman, a., 2021; and, for a narrative about the experience trying to get appropriate care, see caron, rm. (a health educator chronicles tribulations in achieving a diagnosis for her daughter and notes lacking empathy and difficulty getting doctors to pay attention to the person rather than the scans.) goodman et al., should the fda limit placebo-controlled trials, voices in bioethics, vol. 8 (2022) * max goodman, bs connor pedersen, ba © 2022 goodman et al. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. should the food and drug administration limit placebo-controlled trials? max goodman, connor pedersen* abstract randomized placebo-controlled trials are often used in clinical research, though there are ethical concerns regarding their use. the food and drug administration (fda) has rejected international stances on placebocontrolled trial use in favor of the bioethical principles of autonomy, beneficence, nonmaleficence, and justice. the fda permits placebo-controlled trials in three circumstances: when there are no established treatments available, when their use would be of negligible harm to the patient, and when there are compelling reasons for their use. however, in some cases, the fda’s approval of placebo-controlled trials violates bioethical principles. ultimately, the fda should overhaul its practices regarding the use of placebo-controlled trials. keywords: food and drug administration, placebo-controlled trials, bioethics, declaration of helsinki, international ethical guidelines for biomedical research involving human subjects, belmont report introduction randomized placebo-controlled clinical trials (pcts) are considered the most rigorous method of understanding the efficacy of an intervention and, as a result, are widely used in clinical research. 1 however, there are ethical concerns regarding placebo controls, including their use in the study of deadly diseases or when effective treatments already exist, though poor oversight and lax rules have largely permitted pct research, even under those conditions. 2 the fda prefers pcts for most interventional research and considers them essential to test the efficacy of drugs. between 2006-2011, 40 percent of fdaapproved clinical trials used a placebo alone for comparison. the fda has been lagging in altering its policies goodman et al., should the fda limit placebo-controlled trials, voices in bioethics, vol. 8 (2022) 2 regarding pcts, only advising against pct research in select oncological cases for the first time in 2019 in a nonbinding guidance. it is our belief that the fda should change its approach and prohibit the use of placebo controls in clinical trials where effective treatments already exist. i. brief history of pcts and the fda in contemporary research practices, pcts are used to evaluate whether an intervention is effective by comparing it to a control group that received a treatment designed to have no real effect (placebo). throughout the 20th century there have been numerous bioethical tragedies, including but not limited to the holocaust and the tuskegee syphilis study.3 these and other transgressions have become an impetus for establishing ethical research standards preventing human exploitation in the name of science. the declaration of helsinki, adopted in 1964, a nonbinding instrument, restricts the use of pcts. clause 33 of the declaration of helsinki states that new medical interventions should be tested against previously demonstrated interventions and placebos should be used only if there is no existing intervention with narrow exceptions. clause 33 says the effectiveness of a new intervention must be tested against those of the best current proven intervention (s), except in the following circumstances: where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. extreme care must be taken to avoid abuse of this option.4 the fda has largely ignored this and deemed placebo controls the gold standard, stating that “pcts are necessary to control for placebo effect of investigational medicinal product.”5 the fda has even refused to approve drugs that are tested against established treatments instead of against placebos, notably atenolol.6 by stretching the “methodological” exception and failing to define harm reasonably, the fda does not meet the spirit behind helsinki’s conditions for allowing pcts. when the declaration of helsinki was revised in 2000 to increase restrictions, the director of medical policy for the fda’s center for drug evaluation and research considered it “unpardonable” and abandoned any compliance with it in 2008.7 the fda’s past statements and actions have supported its belief that drug approval hinges on the use of placebos. while the fda has rejected the declaration of helsinki’s stance on placebos, it has remained faithful to the guidelines of other bioethical codes such as the international ethical guidelines for biomedical research involving human subjects and the council for international organization of medical science’s guidelines for biomedical research involving human subjects. the international ethical guidelines for biomedical research involving human subjects permits pcts if the consequences are negligible, when methodologically advantageous, and when responses have been historically erratic. 8 the council for international organization of medical science’s guidelines for biomedical research involving human subjects echoed the declaration of helsinki in guideline 11, stating that a “‘placebo may be used: when there is no effective intervention; when withholding an established, effective intervention would expose to, at most temporary discomfort, or delay in relief symptoms; when use of an established, effective goodman et al., should the fda limit placebo-controlled trials, voices in bioethics, vol. 8 (2022) 3 intervention as comparator would not yield scientifically reliable results and the use of the placebo would not add risk of serious or irreversible harm to subjects.”9 the belmont report notes three ethical principles: beneficence, respect for persons (autonomy), and justice. the common rule requires irbs for human research and reflects principles noted in the belmont report. the belmont report covers three applications of its principles: informed consent, selection of research subjects, and risk-benefit assessments.10 in 1979, beauchamp and childress established the four principles approach to bioethics including autonomy, beneficence, nonmaleficence, and justice. while pcts were not mentioned in these reports, the principles in them permit placebo controls as long as subjects are informed of the risks of participating and risks are minimized. the fda has since followed that approach. these guidelines have made pcts ethically ambiguous, and there are moral counterpoints to be made. ii. fda-pct conditions the fda has permitted pct use under three conditions. the first condition is when there is no proven intervention for the medical condition under the study. this means treatment has either not been found for a disease or has not yet been translated into clinical practice and is not controversial. the second condition is when there is negligible harm to the patient from delaying or forgoing an available treatment. in this scenario, a placebo is not suspected to cause damage and the available treatment is meant for mild conditions that pose low-risk adverse effects, which is said to justify its use. the final condition is when there are compelling methodologic reasons for the use of the placebo. this scenario is for situations where outcomes fluctuate for complex reasons making other research methods likely to be unreliable. this condition for pct use is also justified when it is not possible to administer the intervention to the experimental group because of economic, social, or administrative factors, in which case it is believed to be better to have results of some kind than none at all.11 we will argue each condition is unethical to the current degree it is practiced. iii. condition one: lack of established treatment placebo use in cases where no established treatment exists would not typically be considered unethical. however, placebos continue to be used in numerous clinical trials approved by the fda, many of which already have standard interventions.12 in addition, the lack of head-to-head drug trials, in favor of placebo, has had no benefit on clinical guidelines and practices. the direct comparison of drugs in head-to-head trials gives physicians and buyers a better understanding of the effectiveness of a drug and allows for the creation of more robust clinical guidelines. instead, under the pct model, the market is saturated with a plethora of drugs to choose from. while each one may be better than placebo, it can be difficult to understand how each treatment compares to another, which may be harmful to patients. a recent study has shown that nearly 90 percent of new drugs do not perform better than existing options.13 there is an ethical cost to be considered when devoting financial resources and effort to create new drugs that are inferior to existing treatments and have not led to changes to clinical practice. while the fda claims to follow the bioethical principles of beneficence and nonmaleficence, its choice of approving treatments through placebo controls, despite the existence of standard interventions, counters these guidelines. iv. condition two: negligible harm from delayed treatment the international ethical guidelines for biomedical research involving human subjects argues that placebos are acceptable if there is only “temporary discomfort or a delay in relief of symptoms,” a stipulation that the fda follows. however, what constitutes temporary is arbitrary, as there is no absolute reference of time prescribed, nor is there a defined proportion relative to total life expectancy available. goodman et al., should the fda limit placebo-controlled trials, voices in bioethics, vol. 8 (2022) 4 for example, many patients in trials for terminal illnesses have a limited therapeutic window and a reduced life expectancy, so they value time differently from someone with a non-terminal illness. additionally, there is no consensus of what constitutes harm when withholding treatment; placebos are often used in trials for major depressive disorder, yet this population has statistically higher rates of self-harm and suicide without treatment compared to the general population.14 serious risks can be incurred due to a placebo intervention by not offering experimental treatment, without excusing the psychological harm withholding a treatment may have on a patient should it be unblinded. nevertheless, the fda has used the umbrella term of “temporary discomfort” to justify the widespread use of pcts, but the vagueness of this language results in human suffering. v. condition three: compelling methodological reasoning finally, the fda authorizes placebo use in cases where for compelling scientifically sound methodological reasons, the use of placebo is necessary to determine the efficacy or safety of an intervention, and the parties who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. the condition includes cases where pct is believed to be necessary to demonstrate efficacy, such as in trials of psychoactive drugs where evidence is inconsistent due to disease heterogeneity and demonstrating equivalence to an established treatment is insufficient. there are also arguments that pcts, while not necessary, may be beneficial in generating socially valuable knowledge. however, whether a placebo control demonstrates efficacy is not sufficient to justify its use. when considering the ethical use of pcts, investigators must weigh the social value gained against the risks of no treatment in the control. unfortunately, the risk-benefit analysis is often controversial. for example, in 2001, the fda initially responded positively to a placebo-controlled trial of surfaxin in infants with acute respiratory distress syndrome in latin america. however, the trial was deemed exploitative by a public watch group when it was revealed that the drug was already fda-approved in the united states, and the manufacturer of that drug was undertaking another study with the same drug in europe without any placebos. to justify withholding treatment from a vulnerable population in a developing country, the manufacturer stated that they would be providing a drug that would otherwise be unavailable to many participants, and the risks would be compensated by upgrades to the host country’s medical infrastructure. despite the fda’s initial approval and the manufacturer’s attempt to quell public outcry, objections by the public led to the removal of the placebo arm from the trial. while the fda believes there may be methodologically compelling reasons to utilize pcts, they have demonstrated a lack of judgment necessary to balance the gains against their inherent losses, requiring the public to step in. conclusion based on the ambiguous bioethical guidelines that the fda follows, and the moral justifications described in this paper, its preference of pcts is unethical. we suspect the overreliance of pcts has resulted in harm to research participants and the general population, which is why the fda should change its policy. we propose that pcts be used only for diseases that lack an established treatment, as decreed by clause 33 of the declaration of helsinki. other measures that would satisfy clause 33, the belmont report, and the common rule are the use of large retrospective observational trials for comparison rather than a prospective placebo group. ultimately, it is ethically necessary that the fda modify their practices regarding drug approval and more stringently scrutinize pcts as well as adopt more favorable approaches to other comparative models. goodman et al., should the fda limit placebo-controlled trials, voices in bioethics, vol. 8 (2022) 5 acknowledgements we sincerely thank dr. gregory james smith, jd, dbe for his patience and guidance in both the research and writing of this paper. 1 simmonds a. ethics of placebo-controlled trials in developing countries: the search for standards and solutions. the morningside review. https://journals.library.columbia.edu/index.php/tmr/article/view/5507. published may 1, 2011. accessed april 21, 2022; 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ibrahim ms, ovosi jo, bello-ovosi bo. randomized controlled trials: ethical and scientific issues in the choice of placebo or active control. annals of african medicine. 2017;16(3):97-100. doi:10.4103/aam.aam_211_16; sorscher s, abudagga a, almashat s, carome m, wolfe s. placebo-onlycontrolled versus active-controlled trials of new drugs for nine common life-threatening diseases. open access journal of clinical trials. 2018;volume 10:19-28. doi:10.2147/oajct.s156054; mezher m. fda finalizes guidance on placebos and blinding for cancer trials. regulatory affairs professionals society (raps). http://www.raps.org/news-and-articles/news-articles/2019/8/fda-finalizesguidance-on-placebos-and-blinding-fo. published august 28, 2019. accessed april 21, 2022. 3 wma declaration of helsinki – ethical principles for medical research involving human subjects. the world medical association. http://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-humansubjects/. published july 9, 2018. accessed april 21, 2022. 4 wma declaration of helsinki, clause 33. 5 ovosi jo, ibrahim ms, bello-ovosi bo. randomized controlled trials: ethical and scientific issues in the choice of placebo or active control. ann afr med. 2017;16(3):97-100. doi:10.4103/aam.aam_211_16; 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federal policy for the protection of human subjects ('common rule'). hhs.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/regulations/common-rule/index.html. published june 16, 2021. accessed april 21, 2022. goodman et al., should the fda limit placebo-controlled trials, voices in bioethics, vol. 8 (2022) 6 11 millum j, grady c. the ethics of placebo-controlled trials: methodological justifications. contemporary clinical trials. 2013;36(2):510-514. doi:10.1016/j.cct.2013.09.003; center for drug evaluation and research. institutional review boards (irbs) and protection of human subjects in clinical trials. u.s. food and drug administration. https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials. published september 11, 2019. accessed april 21, 2022. 12 center for drug evaluation and research. new drug therapy approvals 2020. u.s. food and drug administration. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drugtherapy-approvals-2020#first-in-class. published january 8, 2021. accessed april 21, 2022. 13 light dw, lexchin j, darrow jj. institutional corruption of pharmaceuticals and the myth of safe and effective drugs. journal of law, medicine & ethics. 2013;41(3):590-600. doi:10.1111/jlme.12068 14 lahey t. the ethics of clinical research in lowand middle-income countries. ethical and legal issues in neurology. 2013:301313. doi:10.1016/b978-0-444-53501-6.00025-1 subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) * vishnu subrahmanyam, integrated ms chemistry pondicherry university, ms candidate bioethics ku leuven © 2021 vishnu subrahmanyam. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. expanding conflicts of interest in public health research vishnu subrahmanyam* abstract non-profit and non-governmental organizations (npos/ngos) often receive research funds from private for-profit corporations through corporate social responsibility (csr). harm industries such as tobacco and alcohol have utilized this opportunity to clear themselves of any blame in contributing to the disease burden, thus obscuring the real danger of their products. the association of public health institutions with such harmful industries has given rise to both financial and non-financial conflicts of interest (cois). to resolve conflicts that arise out of this association, institutions have sought prohibition and full disclosure models. this article highlights the necessity to expand conflict of interest and include industries of implicit harm (fast fashion, mining, cosmetics, and sugary drinks) and not limit itself to just tobacco and alcohol. simultaneously, the article underlines the hurdles in such an expansion. in conclusion, the article provides a hybrid model for conflict assessment that attempts to account for the limitations of a prohibition model as well as a full disclosure model. keywords: harm industries, conflict of interest, public health, corporate responsibility, disclosure introduction as public health research lacks funding, corporations fill a funding gap by allocating money to nongovernmental organizations and non-profits.1 however, the financial involvement of private corporations in public health research raises questions about conflicts of interest and research integrity.2 conflicts of interest must be a consideration in the philosophical framework that public health institutions ought to adopt. subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 2 the recent focus on promoting a “socially conscious capitalistic environment” has led to the inception of corporate social responsibility3 or an obligation of corporations to address social concerns their products or operations might bring about. corporations engage in responsible actions to improve transparency and be more accountable for their actions.4 some corporations are motivated to be good corporate citizens through ethically profitable practices; they recognize a self-imposed obligation to use their resources to protect, and benefit society and they adhere to a social contract.5 corporate social responsibility has strong parallels with entrepreneurial philanthropy. by investing in research, that benefits the socio-economically disadvantaged, social responsibility initiatives further social goals.6 there are two distinct problems with corporate social responsibility models: first, they attempt (but fail) to make up for a poor corporate endeavor like selling cigarettes. some companies abuse their responsibilities and produce unhealthy goods or engage in practices that are contrary to social good. furthermore, their philanthropic engagement may be ill-motivated. it enables them to access the sociopolitical domain, benefit from tax breaks, and profit directly from the “generosity” label without changing their core practices.7 second, corporate social responsibility leads to conflicts of interest in public research. corporations fund public health research as a way to “act” responsible and to further a social goal.8 corporations that fund research at academic institutions, and non-profits pose financial conflicts of interest.9 i. conflict of interest: funding effect and ethical engagement arguably, tobacco and alcohol industries are in stark contrast to the goals of public health. 10 their involvement in and contribution towards public health research may be motivated by a desire to improve their reputation. harm industries engaging in public health research create a fundamental ethical tension.11 many scholars have defined conflict of interest in a variety of ways. in this article, we take the definition of conflict of interest as "a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary or a competing interest" 12 thus, a financial conflict of interest occurs when funding leads to the risk of compromising the research project that is financed by the corporation. "funding effect" was coined after a study showed significant differences in research outcomes of private and public-funded drug efficiency safety studies.13 privateindustry-sponsored research produced commercially favorable outcomes in comparison to publicly sponsored studies.14 research sponsored by the tobacco industry had scientists produce biased data, often making the best case for industrial interests.15 receiving funds from for-profit corporations has also led to reduced dissemination of unfavorable results and under-reporting of negative findings. 16 there is not enough research to assess the value of corporate funding to those in academics. 17 qualitative and quantitative empirical research may help shape best practices when engaging with private corporations. corporate social responsibility creates an illusion of righteousness. tobacco companies have funded public health research designed to influence tobacco control policies. 18 corporations have used research to further the narrative that personal responsibility plays an outsized role in alcohol consumption, thereby ignoring the social determinants of addiction and programs that include alcohol supply reduction. 19 a similar narrative has pervaded the sugary drinks discussion.20 while there are many considerations, there is no homogenous policy to help tackle conflicts of interest in public health research.21 academic journals mandate declaring financial conflicts of interest. 22 however, declarations should attempt to incorporate an institutional view of values and not restrict themselves to subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 3 personal convictions. rather than approaching each conflict of interest and using declarations, journals should evaluate conflicts of interest in terms of risk. such an evaluation also would address embedded research practices that may appear ethical on the surface but represent unrecognized bias. 23 the mohammed ali effect is a good example of this phenomenon. self-reporting of ethical research behavior by scientists is under representative of actual occurrences of misconduct simply because peers are held to different standards than self.24 ii. the prohibition model – a deontological framework the prohibition model discards any research in association with industries that would create a conflict of interest.25 academic institutions or journals that prohibit research by industry limit the ability of harm industries to engage in philanthropic public health research that may reflect pro-industry bias. the nonassociation with harm industries draws from kant’s categorical imperative. in from the groundwork of the metaphysics of morals, kant26 believes that moral behavior exists a priori. if we consider ethics a posteriori, we only deal with what we ‘already did,’ which is not the basis for a moral system. in a kantian analysis, non-association with harm industries is the starting point of ethical behavior. furthermore, in metaphysics of morals, kant27 outlines the motivations to act. he posits that ethical actions are motivated by duty and not by self-interest or immediate inclination. thus, the prohibition model grounds itself in strong ethical imperatives. however, it would limit public health research funding. iii. the disclosure model: conflicts of interest are inevitable the disclosure model claims that transparent disclosure procedures are enough to manage conflicts of interest. often, a placating response to any concern is the disclosure of otherwise unavailable information.28 any disclosure should include enough information about the nature, scope, duration, and monetary forces within the for-profit organizational web to allow institutions to assess the risk to their own reputation of engaging in partnership or publishing research conducted by corporations.29 in addition to transparency, disclosure allows for weighing risks and benefits by assessing proportionality. the proportionality principle requires that the benefits of the association or accepting funds from for-profits be great to justify the conflict of interest. 30 as a result of full disclosure, there is scope for increased accountability from private corporations and public health scholars to ensure that values are upheld throughout the association. however, disclosure is not always effective as it does not prevent or remedy a conflict of interest. 31 disclosure rests on a presumption of wrongdoing and can deter prospective corporate engagement in public health research. however, the risk of deterring research participation is not a concern strong enough to loosen the values a public health institution must strive to achieve. values such as transparency, proportionality, precautionary measures, and accountability make it easier to navigate disclosure requirements. disclosure as a standalone method is not a foolproof technique.32 thus, a tailor-made model that can switch between the prohibition model and the disclosure model on a case-by-case basis might be more effective. furthermore, academics need to ensure reasonable confidence that corporations would disclose financial conflicts of interest as the disclosure requirement often acts on an honor system. in case of non-compliance, either terminating the ties or establishing a legal recourse could be sought as alternatives. subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 4 iv. the case for expanding the definition of conflicts of interests many industries are explicitly harmful to people. tobacco and alcohol corporations engage in actions and create products that work against the ideals of public health. industries like fast fashion, cosmetics, and many others that are seemingly harmless contribute significantly to the deterioration of public health through their treatment of workers, environmental impacts, and lobbying efforts that include relaxing laws meant to protect consumers and workers. the fashion industry produces large amounts of inexpensive clothing by outsourcing labor to lowerand middle-income countries, 33 creating environmental and occupational hazards for their citizens. many countries lack institutional structures to prevent abuse of workers. 34 fast fashion also leads to the production of solid waste that ends up in landfills with no efficient mechanism for its disposal. 35 the cosmetic industry releases a great number of micro-plastics into aquatic systems through face products which lead to a shift in their chemical composition.36 the gambling industry harms health as gambling is addictive and can financially harm individuals, families, and interpersonal relationships. 37 the mining industry has occupational hazards such as inhaling of toxic substances as well as environmental hazards.38 the sugary drink industry increases the burden of obesity, diabetes, and cardiovascular disease.39 a prohibition model works well with industries that explicitly harm. thus, non-association with the tobacco and alcohol industry becomes obvious. the difficulty in deciphering conflict of interest through association arises when public health institutions are looking to expand their non-association to industries of implicit harm. when looking to expand non-association into industries such as mining, fast fashion, sugary drinks, etc., we need to move away from a one-size-fits-all approach. disclosure is not enough as it does not resolve the risk of bias; it merely provides transparency. yet, a prohibition model would require academic institutions and journals to research funding relationships as well as harmful practices and would lead to less funding for research. v. the traffic light model: a tailor-made hybrid of prohibition and disclosure academic institutions, non-profits, and public health organizations might shape market practices and unearth latent intentions to contradict the social determinants of health if they are able to eliminate bias in public health research. this section presents a hybrid model for conflict-of-interest assessment and resolution that takes the metaphor of a traffic light. figure 1 represents a schematic of the hybrid. figure 1: a schematic of the traffic light hybrid subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 5 as the schematic represents, industries that project values against public health, such as tobacco and alcohol, fall under the red light and hence can be put under non-association, i.e., the prohibition model. expanding non-association to industries implicit in their harms, such as fast fashion, sugary drinks, mining, companies that exploit labor, would require us to proceed with the disclosure model. as mentioned before, disclosure would require assessing the conflict of interest in terms of proportionality, transparency, accountability, and ensuring that the precautionary principle has been met. providing a legal recourse at every significant point during research might be helpful to eliminate conflicts that surface during the intermediate stages of research. the entire disclosure model falls under the yellow light urging us to go slow and err on the side of caution. the green light comprises pro-public health values corporations and exercises impactful operational methods that do not devalue public health goals. however, this should not be taken for face value. any suspicion of conflict must be dealt with disclosure, and risk-based assessment should precede every funding decision. the three categories serve as a starting point for public health researchers to invest more in building a framework that helps assess such conflicts. conflicts of interest are rather dynamic and require constant attention. examining research practices and funder objectives is crucial. the impact of private corporations on public health research needs to be widely discussed in the academic community. although the hybrid provides a starting point in designing a more dynamic and flexible framework, the presence of an institutional conflict of interest policy and committee with independent review and oversight of research is also a necessity.40 considering decreased federal funding, scholars have argued the necessity for corporate funding. besides meeting the financial demand, corporate funding has brought in benefits such as employment opportunities, access to otherwise unavailable tools and technology, and turning academic research into commercially viable practice.41 although the goals of public health research, such as the creation of public goods, affordable and safe housing, access to vaccines, etc., may seem utilitarian, it is important to understand that corporations influence research practices that are more deontological in nature. research integrity has to do with ethical conduct of research and shaping best practices. thus, an efficient way to deal with research practice and bias is by invoking the kantian categorical imperative grounded in procedural ethics rather than consequentialist ethics. a kantian perspective allows considering conflicts of interest as an institutional value. in addition to focusing on individual research practices, public health institutions need to develop an institutional conflict of interest framework where values of a public health institution shape corporate engagement. another closely related discourse that has a significant bearing on corporate involvement is commercial determinants of health. it considers corporations as contributors to disease burden and holds them as part of a structural problem.42 by shaping research practices and investing in designing conflicts of interest policies, public health institutions can redefine the narrative of accountability. by actively evaluating financial links within the corporation and assessing risks of bias and influence in research, public health institutions can check the power imbalance that corporations tend to misuse. 43 more importantly, furthering a narrative that defines disease burden in terms of corporate contribution signals support to those who fight against the injustices perpetrated by large scale corporations. people from lowerand middle-income countries and several indigenous communities have been forced out of their neighborhoods for corporate expansion. 44 as a public health institution, it is important to support vulnerable groups outpowered and forced into poor living conditions by global corporations. subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 6 conclusion the consumption of tobacco, alcohol, polluting motor vehicles, and other products of disease-promoting corporations have presented a significant struggle in improving public health. engaging with such corporations through corporate social responsibility ventures into highly contentious ethical territory. from a fundamental difference in the values endorsed, for-profit corporations present a conflict of interest in public health research. public health institutions should be wary of the influence of corporate funding provided through social responsibility programs. academic bias and the use of corporate social responsibility as a backdoor to legitimizing questionable practices are problematic. the prohibition and disclosure models independently do not perform efficiently against the dynamic nature of conflicts of interest. the hybrid model for institutional conflict-of-interest policy incorporates both the prohibition and disclosure models and allows for switching between them on a case-by-case basis. managing corporate power requires dealing with conflict of interests broadly and as a risk-susceptibility issue rather than an occurrence issue. 1 denier, y. (2008). mind the gap! three approaches to scarcity in health care. medicine, health care and philosophy, 11(1), 7387. 2 gupta, a., holla, r., & suri, s. (2015). conflict of interest in public health: should there be a law to prevent it? indian j med ethics, 12(3), 172-7. 3 de vries, h. (2016). invited commentary: corporate social responsibility and public health: an unwanted marriage; resnik, d. b. (2019). institutional conflicts of interest in academic research. science and engineering ethics, 25(6), 1661-1669. 4 lee, k., & bialous, s. a. (2006). corporate social responsibility: serious cause for concern. tobacco control, 15(6), 419-419. 5 macassa, g., da cruz francisco, j., & mcgrath, c. (2017). corporate social responsibility and population health. health science journal, 11(5), 1-6. 6 harvey, c., gordon, j., & maclean, m. (2021). the ethics of entrepreneurial philanthropy. journal of business ethics, 171(1), 3349. 7 harvey, c., gordon, j., & maclean, m. (2021). the ethics of entrepreneurial philanthropy. journal of business ethics, 171(1), 3349. 8 resnik, d. b. (2019). institutional conflicts of interest in academic research. science and engineering ethics, 25(6), 1661-1669. 9 royo bordonada, m., & garcía lópez, f. (2018). what is and what is not a conflict of interest in public health research. european journal of public health, 28(suppl_4), cky213-750. 10 de vries, h. (2016). invited commentary: corporate social responsibility and public health: an unwanted marriage. 11 lee, k., & bialous, s. a. (2006). corporate social responsibility: serious cause for concern. tobacco control, 15(6), 419-419. 12 gupta, a., holla, r., & suri, s. (2015). conflict of interest in public health: should there be a law to prevent it?. indian j med ethics, 12(3), 172-7. 13 krimsky, s. (2013). do financial conflicts of interest bias research? an inquiry into the “funding effect” hypothesis. science, technology, & human values, 38(4), 566-587. 14 ibid. 15 ibid. subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 7 16 nakkash, r. t., mugharbil, s., alaouié, h., & afifi, r. a. (2017). attitudes of public health academics toward receiving funds from for-profit corporations: a systematic review. public health ethics, 10(3), 298-303. 17 nakkash, r. t., mugharbil, s., alaouié, h., & afifi, r. a. (2017). attitudes of public health academics toward receiving funds from for-profit corporations: a systematic review. public health ethics, 10(3), 298-303. (an attempt to review the research failed as there was not data on the “attitudes of public health academics towards receiving funds from for-profit corporations.”) 18 de vries, h. (2016). invited commentary: corporate social responsibility and public health: an unwanted marriage. 19 yoon, s., & lam, t. h. (2013). the illusion of righteousness: corporate social responsibility practices of the alcohol industry. bmc public health, 13(1), 1-11. 20 gupta, a., holla, r., & suri, s. (2015). conflict of interest in public health: should there be a law to prevent it?. indian j med ethics, 12(3), 172-7. 21 shamoo, a. s., & resnik, d. b. (2015). responsible conduct of research (3rd ed.). new york: oxford university press. 22 resnik, d. b. (2019). institutional conflicts of interest in academic research. science and engineering ethics, 25(6), 1661-1669. 23 field, m. j., & lo, b. (eds.). (2009). conflict of interest in medical research, education, and practice. 24 fanelli, d. (2009). how many scientists fabricate and falsify research? a systematic review and meta-analysis of survey data. plos one, 4(5), e5738. 25 field, m. j., & lo, b. (eds.). (2009). conflict of interest in medical research, education, and practice. 26 kant, i. (2008). groundwork for the metaphysics of morals. yale university press. 27 kant, i. (2008). groundwork for the metaphysics of morals. yale university press. 28 field, m. j., & lo, b. (eds.). (2009). conflict of interest in medical research, education, and practice. 29 ibid. 30 childress, james f., r. gaare bernheim, r. j. bonnie, and a. l. melnick. "introduction: a framework for public health ethics." essentials of public health ethics 1 (2015): 1-20. 31 fleishman, j. l. (1981). the disclosure model and its limitations. hastings center report, 15-17. 32 ibid. 33 bick, r., halsey, e., & ekenga, c. c. (2018). the global environmental injustice of fast fashion. environmental health, 17(1), 1-4. 34 anguelov, n. (2015). the dirty side of the garment industry: fast fashion and its negative impact on environment and society. crc press. 35 wicker, a. fast fashion is creating an environmental crisis. newsweek. september 1, 2016; available from: https://www.newsweek.com/2016/09/ 09/old-clothes-fashion-waste-crisis-494824.html. accessed 13 aug 2021 36 alabi, o. a., ologbonjaye, k. i., awosolu, o., & alalade, o. e. (2019). public and environmental health effects of plastic wastes disposal: a review. j toxicol risk assess, 5(021), 1-13. 37 wardle, h., reith, g., langham, e., & rogers, r. d. (2019). gambling and public health: we need policy action to prevent harm. bmj, 365. 38 hendryx, m. (2015). the public health impacts of surface coal mining. the extractive industries and society, 2(4), 820-826. 39 flynn, a., & okuonzi, s. a. (2016). coca-cola's multifaceted threat to global public health. the lancet, 387(10013), 25. subrahmanyam, expanding conflicts of interest in public health research, voices in bioethics, vol. 7 (2021) 8 40 resnik, d. b. (2019). institutional conflicts of interest in academic research. science and engineering ethics, 25(6), 1661-1669. 41 bayer, r., & sampat, b. n. (2016). corporate funding for schools of public health: confronting the ethical and economic challenges. american journal of public health, 106(4), 615-618. 42 mckee, m., & stuckler, d. (2018). revisiting the corporate and commercial determinants of health. american journal of public health, 108(9), 1167-1170. 43 daube, m. (2018). shining a light on industry research funding. american journal of public health, 108(11), 1441. 44 munarriz, g. (2008). rhetoric and reality: the world bank development policies, mining corporations, and indigenous communities in latin america. international community law review, 10(4), 431-443. hart, advance directives and research advance directives, voices in bioethics, vol. 7 (2021) * dean evan hart, ma hofstra university, ms in bioethics columbia university, od, f.a.a.o. © 2021 dean evan hart. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. advance directives and research advance directives: preserving legacy and autonomy in alzheimer’s disease dean evan hart* abstract this paper explores a way to ensure a person’s autonomy and legacy are preserved during the experience of dementia due to alzheimer’s disease. due to the profound effect the disease has on memory, the “person of the lifetime” (the person’s past experiences and their future aspirations prior to disease progression) becomes seemingly disconnected from the “person of the moment,” or the person experiencing memory loss. thus, directives are important to recognize and maintain continuity of person. yet, a person’s “legacy,” based on the person’s values and philosophy, can serve as a bridge between those two identities. ultimately, people with significant memory loss from alzheimer’s disease are unable to secure their own legacy due to the diminishing ability to make autonomous decisions as the disease progresses. a legal system that codifies the ability to create a requirement to honor ads and research advance directives (rads) can best secure the autonomy of the person of the lifetime, and thus the person’s legacy, of the person alzheimer’s disease. keywords: autonomy, alzheimer’s disease, cognitive function, decisional capacity, advanced directives introduction at present, there is no effective treatment or cure for alzheimer’s disease’s cognitive decline and ensuing dementia. while the definitive diagnosis is confirmed only after death via brain autopsy, alzheimer’s is diagnosed by symptoms and scans. 1 over the course of an eight-to-twelve-year post-diagnosis period, people progressively lose memory and cognitive functions in an irreversible pattern.2 because alzheimer’s disease remains incurable despite significant scientific research into its causes, its biological qualities,3 and its symptoms, many people with alzheimer’s disease may wish to document care choices in advance while they have capacity to do so. those experiencing early-stage alzheimer’s disease or mild cognitive impairment wanting to determine the best path for their private and public future life’s agenda must have the legal tools needed to make sound plans for their future. hart, advance directives and research advance directives, voices in bioethics, vol. 7 (2021) 2 i. preserving legacy: the benefits of advance directives for people with alzheimer’s disease a legacy is the part of a patient that will persist into the future, even after death. autonomy can be increased by permitting alzheimer’s patients to document their legacy and wishes prior to significant cognitive impairment. whether a legacy is in others’ memories of personality traits or is something concrete like a business, named building, charity, or a cookie recipe, many people with alzheimer’s disease wish their person of a lifetime to be remembered. many do not want to be remembered only as they are in the end of life, or as the cognitively impaired person of the moment. i argue that the best legacy for oneself is defined by one’s own autonomy and his or her most personal, private philosophy and values. when third-party caregivers or healthcare workers seek to impose their views of the best interests on the person of the moment, they may be disrespecting that person’s legacy interests. having an ad that the caregivers must respect can help all stakeholders make decisions with moral legitimacy. the preservation of the person of the lifetime can be maximized by focusing on both past and present life experiences. significant memory loss from alzheimer’s disease interrupts the usual relationship between the person of the lifetime and the person of the moment, who may understand the present but may experience near-complete shortand long-term memory loss.4 reconciling these two “personhoods” in one person in a formal process best serves the legacy for alzheimer’s patients by assessing various perspectives and providing a decision-making framework for caregivers and stakeholders. i assert that the autonomy of the person of the lifetime deserves equal or more weight than a decision-making third party when the person of the moment lacks capacity to make a healthcare decision. this argument is compatible with samuel dale’s argument that “precedent autonomy morally authorizes ads when dementia renders patients medically incompetent because it respects their dignity as persons, not merely pleasure-seeking creatures.”5 dale relies on dworkin’s view that critical interests should carry more weight than “experiential interests.”6 the pursuit of critical interests gives meaning to human life and is encoded in ads to represent the whole person.7 nevertheless, the person of the moment has value and can enjoy the pursuit of happiness. treatment for alzheimer’s disease focuses on comfort and happiness as a driver for the patient’s best interests, thus attending to the needs of the person of the moment while balanced with the interests in an ad if it conflicts, to not damage the legacy. the person of the moment needs care to avoid pain and arguably to achieve some happiness, while simultaneously relying, insofar as still possible, on the person of the lifetime to obtain peace and contentment.8 respecting alzheimer’s ads is consistent with the strong individualism inherent in the us. the rule of law attempts to maximize autonomy and theoretically to ensure individual rights.9 in the us and other liberal democracies, recognizing the power and inalienable rights of the individual involves securing the right to make one’s own decisions. yet, as with other individual rights, there are situations where ads are not absolute and where laws limit their full effect. some statutory and regulatory restrictions make it legally difficult to honor ads, especially with respect to nutrition and hydration directives.10 arguably that is a poorly considered approach; notably, at least one scholar, corinna porteri, argues that “statutes that disregard or invalidate ads are discriminatory against the life lived.”11 ii. the benefits of research advance directives for people with alzheimer’s disease the scientific research necessary to better treat people who have alzheimer’s disease requires engaging patients in research. a major bioethical question immediately arises: how can we obtain informed consent from a person unable to weigh different options and risks/rewards properly? research advance directives hart, advance directives and research advance directives, voices in bioethics, vol. 7 (2021) 3 (rads) could allow advanced consent for participation in research and could place limits on the consent.12 people who have alzheimer’s disease should be able to express their desires in ads during the early stages or before diagnosis. directives must be able to allow people to express a desire to join clinical trials. the national bioethics advisory committee in the us recommended rads,13 which allow people to join studies when the treatment or medicine would benefit them, and possibly when it would benefit the larger public and has some potential to benefit the person.14 porteri asserts that rads should include consent based on the type and degree of risk, as it is impossible to predict the types of treatment or the anticipated side effects in future studies.15 ultimately, the person’s autonomy of a lifetime should take precedence because further research offers patients hope for both their legacy and the legacies of others. still, there may be cases in which the societal interest in protecting the person takes precedence. societal interests may include preserving dignity and avoiding suffering. it may be necessary to safeguard people by limiting participation to low-risk studies and requiring additional consent from a proxy or caregiver. rads are appealing because they guide decisions, as do ads; their unique appeal that is specific to rad as part of ad is that the certainty of a permanently preserved legacy of valuing medical research in writing could take precedence over the uncertainty facing the person of the moment. at present, these are still tenuous grounds, requiring philosophical and other solutions. a moral question arises regarding the ability to change one’s mind after the threshold established for ads and rads takes effect. how can it be known if patients would have changed their minds given current circumstances and the often-lengthy progress of alzheimer’s disease? if a person wanted to withdraw an ad or rad and expressed an unwillingness to engage in research, there is a moral argument that the person of the moment must not be deprived of a right to withdraw. by limiting the ad and rad to treatment and research decisions after significant memory loss occurs, those with mild cognitive impairment certainly would decide about research for themselves, possibly with the input of family, friends, or doctors. early diagnosis permits time for the patient to alter ads before they develop significant memory loss. when patients understand the progression of the disease, their autonomous decisions regarding their care should be honored. porteri asserts the ads are the necessary proof of the person’s desires and thus should govern when capacity is lost.16 bodily integrity, philosophical belief, and autonomy must be respected once the capacity to make decisions is lost. iii. recommendations capacity is task-specific; therefore, determining when the healthcare ad should be implemented must be based on capacity testing.17 this process turns ads into a framework for interpreting the person of the lifetime’s wishes as applied to the person of the moment. for example, dying in battle is quite a different memorial outcome compared to experiencing a vegetative state while fed artificial hydration and nutrition through a feeding tube. establishing the desired legacy of the person with alzheimer’s disease in an ad allows the patient more autonomy to choose how they wish to be remembered.18 one problem with our current system for ads is that it deviates substantially from state to state. the patient self determination act does not prescribe how state laws should address significant memory loss. 19 therefore continuity of person is not assumed in all state laws. a federal law that supports the acknowledgment of ads would be preferable. the right to determine how you live and die is a fundamental choice and should not depend on the state in which one lives. hart, advance directives and research advance directives, voices in bioethics, vol. 7 (2021) 4 fortunately, perspectives between stakeholders and other parties align in many cases, and their expressed wishes respect the person of a lifetime. to maintain the patient’s dignity during disease progression for a greater proportion of alzheimer’s patients, states should honor ads and rads. currently, ads offer an unpredictable degree of protection, especially as patients move from state to state. unpredictable factors include judicial discretion, shifts of thinking within the body politic, and the power of stakeholders with interests at odds with those of the person of the lifetime. judicial discretion should be limited to invalidating only those ads that were based on fraud, undue influence, or incapacity at their inception. administrative personnel and other stakeholders should not have authority to redefine a person’s legacy once the person reaches the stage at which they no longer have capacity. ads and rads could include dispute resolution mechanisms as well as directives with respect to those persons the person of the moment does not want involved in their care. in declaring the continuity of person yet acknowledging the differences due to significant memory loss, giovanni boniolo concludes, “we have to respect them and their choices and decisions as long as they are capable of choosing and deciding. then, when this capacity has vanished, we must continue respecting not only them, but also the choices and decisions they made.”20 boniolo is absolutely correct; one is capable of creating ad until they are not. a sharper scientific approach would base the point at which one no longer has capability to make decisions on biological or clinical markers. the law should ensure that ads and rads made prior to that point govern care and research decisions. conclusion permitting an unfaithful surrogate or an administrator with a different philosophy to reinterpret patient desires based on current circumstances would create a “slippery slope,” compromising the known wishes of a person with alzheimer’s disease as preserved in writing. ads and rads are the best opportunities for people with early alzheimer’s disease, or those who recognize the risk of dementia, to preserve their legacy and to use their autonomy to govern care of the significantly memory-impaired person of the moment. preserving the legacy of patients in binding documents avoids the quagmire of courts, doctors, surrogates, and caregivers. ultimately, ads and rads can maintain continuity of the person of a lifetime’s dignity even when that person experiences cognitive impairment, evolving into the person of the moment. 1 weller j, budson a. current understanding of alzheimer's disease diagnosis and treatment. f1000res. 2018;7:f1000 faculty rev-1161. published 2018 jul 31. doi:10.12688/f1000research.14506.1 2 gauthier s, leuzy a, racine e, rosa-neto p. diagnosis and management of alzheimer's disease: past, present and future ethical issues. progress in neurobiology. 2013;110:102-113; naylor m, karlawish j, arnold s et al. advancing alzheimer's disease diagnosis, treatment, and care: recommendations from the ware invitational summit. alzheimer's & dementia. 2012;8(5):445452. 3 the combination of tau proteins becoming defective, creating neurofibrillary tangles, and β amyloid plaques building up in the neural connections of the brain prevents neural functioning, resulting in brain cell incapacity and death; zetterberg h, schott j. biomarkers for alzheimer’s disease beyond amyloid and tau. nat med. 2019;25(2):201-203.; qin k, zhao l, gregory c, solanki a, mastrianni j. “dual disease” tgad/gss mice exhibit enhanced alzheimer’s disease pathology and reveal prpc-dependent secretion of aβ. sci rep. 2019;9(1). doi:10.1038/s41598-019-44317-w; qin k, zhao l, gregory c, solanki a, mastrianni j. “dual disease” tgad/gss mice exhibit enhanced alzheimer’s disease pathology and reveal prpc-dependent secretion of aβ. sci rep. 2019;9(1). 4 kitwood t. dementia reconsidered, revisited: the person still comes first. 2nd ed. new york: open university press; 2019. hart, advance directives and research advance directives, voices in bioethics, vol. 7 (2021) 5 5 dale s. personhood, critical interests, and the moral imperative of advances directives in alzheimer's cases. voices in bioethics. 2021;7:1-6. 6 dale s. personhood, critical interests, and the moral imperative of advances directives in alzheimer's cases. voices in bioethics. 2021;7:1-6, citing dworkin r. (1994) life’s dominion; an argument about abortion, euthanasia, and individual freedom. 1st ed. new york: vintage books. 7 dale s., 2021. 8 person m, hanssen i. joy, happiness, and humor in dementia care: a qualitative study. creative nursing. 2015;21(1):47-52.; yeaman p, ford j, kim k. providing quality palliative care in end-stage alzheimer disease. american journal of hospice and palliative medicine®. 2012;30(5):499-502. 9 kim s. the ethics of informed consent in alzheimer disease research. nature reviews neurology. 2011;7(7):410-414.; porteri c. advance directives as a tool to respect patients’ values and preferences: discussion on the case of alzheimer’s disease. biomed central medical ethics. 2018;19(1).; naue u. ‘self-care without a self’: alzheimer’s disease and the concept of personal responsibility for health. medicine, health care and philosophy. 2008;11(3):315-324. 10 sieger ce, arnold jf, ahronheim jc. refusing artificial nutrition and hydration: does statutory law send the wrong message?. j am geriatr soc. 2002;50(3):544-550. doi:10.1046/j.1532-5415.2002.50124.x 11 porteri c. advance directives as a tool to respect patients’ values and preferences: discussion on the case of alzheimer’s disease. biomed central medical ethics. 2018;19(1). 12 buller t. advance consent, critical interests and dementia research. journal of medical ethics. 2014;41(8):701-707.; jongsma k, van de vathorst s. dementia research and advance consent: it is not about critical interests. journal of medical ethics. 2014;41(8):708-709.; jongsma k, perry j, schicktanz s, radenbach k. motivations for people with cognitive impairment to complete an advance research directive – a qualitative interview study. biomed central psychiatry. 2020;20(1). 13 national bioethics advisory commission (nbac) research involving persons with mental disorders that may affect decision making capacity. rockville: national bioethics advisory commission; 1998. https://pubmed.ncbi.nlm.nih.gov/12747354/ 14 porteri c. advance directives as a tool to respect patients’ values and preferences: discussion on the case of alzheimer’s disease. biomed central medical ethics. 2018;19(1). https://pubmed.ncbi.nlm.nih.gov/29458429/ ; jongsma k, van de vathorst s. dementia research and advance consent: it is not about critical interests. journal of medical ethics. 2014;41(8):708-709. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.997.8037&rep=rep1&type=pdf 15 porteri c. advance directives as a tool to respect patients’ values and preferences: discussion on the case of alzheimer’s disease. biomed central medical ethics. 2018;19(1). https://pubmed.ncbi.nlm.nih.gov/29458429/ 16 porteri c. advance directives as a tool to respect patients’ values and preferences: discussion on the case of alzheimer’s disease. biomed central medical ethics. 2018;19(1). 17 mcdonald a, d'arcy r, song x. functional mri on executive functioning in aging and dementia: a scoping review of cognitive tasks. aging medicine. 2018;1(2):209-219; sclan s, reisberg b. functional assessment staging (fast) in alzheimer's disease: reliability, validity, and ordinality. int psychogeriatr. 1992;4(3):55-69; appelbaum p, grisso t. assessing patients' capacities to consent to treatment. new england journal of medicine. 1988;319(25):1635-1638; fisher c, appelbaum p. diagnosing consciousness: neuroimaging, law, and the vegetative state. journal of law, medicine & ethics. 2010;38(2):374-385. 18 menzel p. ethical perspectives on advance directives for dementia the hastings center. the hastings center; 2018. https://www.thehastingscenter.org/ethical-perspectives-advance-directives-dementia. accessed december 8, 2018. https://pubmed.ncbi.nlm.nih.gov/29458429/ http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.997.8037&rep=rep1&type=pdf https://pubmed.ncbi.nlm.nih.gov/29458429/ hart, advance directives and research advance directives, voices in bioethics, vol. 7 (2021) 6 19 hr 5835 omnibus budget reconciliation act of 1990, title iv, section 4206. us congress. 20 boniolo, g. demented patients and the quandaries of identity: setting the problem, advancing a proposal. hpls 43, 21 (2021). https://doi.org/10.1007/s40656-021-00365-y garbuzova, reidentification of individuals from mri, voices in bioethics, vol. 7 (2021) * elizaveta garbuzova, ms candidate columbia university © 2021 elizaveta garbuzova. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. ethical concerns about reidentification of individuals from mri neuroimages elizaveta garbuzova* keywords: neuroimage, mri, reidentification, ai, facial reconstruction, confidentiality introduction in the us, more than three million people have magnetic resonance imaging (mri) scans daily.1 mris are the most common way to image the brain, and detect tumors, brain injuries, strokes, aneurysms, sclerosis, and other conditions.2 after the procedure, the images are usually kept by the hospital or other medical facility. thousands of neuroimages are shared among the researchers to increase the data available for studies and enable scientific discovery. i. reidentification using ai and facial recognition the possibility of the reidentification of an individual using ai and facial recognition technology is an ethical concern. ai can reidentify a person from the scan by reconstructing the face.3 despite the steps taken to deidentify the patient, such as removing or changing the name, age, identification number, gender, and postal code, according to the mayo clinic researchers, the software still can reidentify individuals from deidentified scans.4 the mayo clinic’s study shows that ai was 83 percent successful in reidentifying the person by analyzing the scans.5 in most cases, scientists can share anonymized information without the patient's consent.6 the only way to anonymize the scan and to remove any personal data that can lead to reidentification is to blur the image, which would compromise the ability to read and analyze the scan, defeating the purpose of sharing the data. one of the fundamental values in the relationship between a physician and a patient is respect for autonomy and privacy. when subjects enter a clinical study, the researchers guarantee confidentiality. yet, it seems impossible to protect a patient's privacy when sharing brain scans. potential mri image reidentification impacts research participants, healthcare providers, and government regulating bodies. i suggest that modified informed consent and the introduction of data misuse liability could improve accountability to the patient while still allowing societal health benefits associated with data sharing for research and education. furthermore, i advocate patients who agree to data sharing be granted a small financial reward as a sign of recognition of their contribution to the medical field. garbuzova, reidentification of individuals from mri, voices in bioethics, vol. 7 (2021) 2 ii. privacy privacy is a fundamental human right and especially important when sensitive medical information is shared. deidentification can expose a research subject to unfortunate events, including but not limited to increasing cost of insurance, discrimination, and humiliation. 7 “this identification would result in an infringement of privacy that could include diagnoses, cognitive scores, genetic data, biomarkers, results of other imaging, and participation in studies or trials.”8 in the same study that found the 83 percent successful reidentification, ai wrongly identified 15 percent of the patients.9 misidentification may lead researchers to overlook relevant information. suppose a certain type of tumor develops predominantly in men, and patient x is a man and has the tumor and is not aware of it. if ai incorrectly labeled patient x female and skipped the tumor detection analysis of her scan, the ai would fail to detect her condition. internal bias in ai may harm the patients even further. iii. who benefits from sharing scans? patients who are willing to risk their privacy are not directly benefiting from sharing their brain images in their health care. the research is usually designed for the common good and for improving medical care and diagnosis generally. often, current patients benefit future patients. stimulating the development of treatment for future patients is an important societal benefit, but patients should know they may not benefit from sharing scans.10 (in some cases, patients will benefit from research involving their own scans.) iv. research and the importance of sharing data data sharing is essential for the research and development of new medical treatments that would benefit current and future patients. i argue that patients have a duty to contribute to this process by providing images because they are beneficiaries of data derived from previous patients. the existing images increase the sample size,11 producing more valid and generalizable results. if patient x is using a certain cancer treatment, patient x is arguably indebted to past patients who contributed health data to the medical research. because of such a gracious act by another patient, x is benefitting and thus has a duty to assist future patients by sharing data. it is wrong to be a free rider in society. in addition to past patient research, institutions use both public and private resources to train the physicians who treat patient x and to build hospitals where patient x seeks treatment while the argument i promote is likely not strong enough to compel participation in risky clinical trials, and it does not negate a moral right to refuse, it promotes participation in scientific research as a moral good, and sometimes, an obligation. despite the low risk that the data would not be protected to the highest degree, patients ought to share it with scientists to give back to society. furthermore, scientists may not have enough incentive to share the data.12 deidentification is a time-consuming manual process that society underappreciates. despite the overall benefit to the community and the scientists’ dedication and curiosity, the deidentification process is an obstacle to data sharing that would benefit society. recognizing the risk to patient privacy and the difficulty physicians already face, i argue that a better balance should ensure privacy while incentivizing sharing scans. v. establishing liability: a rule to ensure proper use and prohibit reidentification a government agency such as health canada or the federal drug administration (fda) is interested in promoting clinical studies while protecting the research subjects. yet, health canada recognizes that it is garbuzova, reidentification of individuals from mri, voices in bioethics, vol. 7 (2021) 3 impossible to eliminate the risk of reidentification.13 direct personal identifiers, of course, pose a higher risk to the research subject; yet there should not be a blanket prohibition of neuroimaging share. currently, the risk is diminished by the requirement to sign a data use agreement.14 currently, there is no universal rule on the liability of reidentification breach; rather, there are numerous suggestions to ensure ethical data use. the european and north american multisociety suggests that release of information and data use agreements (dua) are critical tools in making it clear what various stakeholders are permitted or prohibited to do with the data.15 yet, the statement does not impose any liability for dua breach, rather it only goes as far to suggest that data sharing should be traceable.16 i suggest introducing and establishing a clear liability for data misuse. a controlling body, such as the fda or health canada, needs to continuously check data use compliance and, in case of illegal use, apply appropriate penalties. this will strengthen the research subjects’ protection and give more reason for researchers to follow the rules. conclusion as mentioned above, data sharing contributes to society in the long run. therefore, the government must provide incentives to both scientists and patients to contribute to the medical field. the risks of reidentification need to be clearly outlined in the informed consent process, and subjects should be financially rewarded for their images. i suggest a financial reward since there are direct benefits to current patients, yet the scientists and others cut costs by accessing existing data. thus, to be just, the savings from the industry cost-cutting needs to be given to people who are risking their privacy. the financial reward can be as little as five dollars, enough to recognize the good deed of contribution. the neuroimaging data share comes at costs to both researchers and trial participants, yet the burdens and risks can be decreased with the efforts of governmental bodies. 1 conor stewart, “mri scan volume by facility type u.s. 2016 and 2017,” statista, march 24, 2021, https://www.statista.com/statistics/820927/mri-scans-number-in-us-by-facility-type/. 2 “mri,” mayo clinic (mayo foundation for medical education and research, august 3, 2019), https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768. 3 gina kolata, “you got a brain scan at the hospital. someday a computer may use it to identify you.,” the new york times (the new york times, october 23, 2019), https://www.nytimes.com/2019/10/23/health/brain-scanspersonal-identity.html. 4 “mayo clinic studies patient privacy in mri research,” mayo clinic (mayo foundation for medical education and research), accessed july 20, 2021, https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-studies-patientprivacy-in-mri-research/. 5 “mayo clinic studies patient privacy in mri research,” mayo clinic (mayo foundation for medical education and research), accessed july 20, 2021, https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-studies-patientprivacy-in-mri-research/. 6 tonya white, elisabet blok, and vince d. calhoun, “data sharing and privacy issues in neuroimaging research: opportunities, obstacles, challenges, and monsters under the bed,” human brain mapping, april 2020, https://doi.org/10.1002/hbm.25120, 3. 7 jacob l. jaremko et al., “canadian association of radiologists white paper on ethical and legal issues related to artificial intelligence in radiology,” canadian association of radiologists journal 70, no. 2 (2019): pp. 107-118, https://doi.org/10.1016/j.carj.2019.03.001, 110. garbuzova, reidentification of individuals from mri, voices in bioethics, vol. 7 (2021) 4 8 letter to the editor identification of anonymous mri research participants with face-recognition software n engl j med 2019; 381:1684-1686, doi: 10.1056/nejmc1908881. https://www.nejm.org/doi/full/10.1056/nejmc1908881 9 “mayo clinic studies patient privacy in mri research,” mayo clinic (mayo foundation for medical education and research), accessed july 20, 2021, 10 “mayo clinic studies patient privacy in mri research,” mayo clinic (mayo foundation for medical education and research), accessed july 20, 2021, https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-studies-patientprivacy-in-mri-research/. 11 tonya white, elisabet blok, and vince d. calhoun, “data sharing and privacy issues in neuroimaging research: opportunities, obstacles, challenges, and monsters under the bed,” human brain mapping, april 2020, https://doi.org/10.1002/hbm.25120, 2. 12 tonya white, elisabet blok, and vince d. calhoun, “data sharing and privacy issues in neuroimaging research: opportunities, obstacles, challenges, and monsters under the bed,” human brain mapping, april 2020, https://doi.org/10.1002/hbm.25120, 8. 13 william parker et al., “canadian association of radiologists white paper on de-identification of medical imaging: part 1, general principles,” canadian association of radiologists journal 72, no. 1 (march 2020): pp. 1324, https://doi.org/10.1177/0846537120967349, 19. 14 “mayo clinic studies patient privacy in mri research,” mayo clinic (mayo foundation for medical education and research), accessed july 20, 2021, 15 geis jr, brady ap, wu cc, et al. ethics of artificial intelligence in radiology: summary of the joint european and north american multisociety statement. radiology. 2019;293(2):436-440. doi:10.1148/radiol.2019191586. 16 geis, et al. pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) * nefes pirzada, ms candidate columbia university © 2021 nefes pirzada. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. the expansion of turkey’s medical tourism industry nefes pirzada* abstract medical tourism has excellent potential and downfalls, which this paper will extensively cover. while medical tourism has great economic benefits to the host country and calls for the increase of professionalism and skill of physicians, it also influences doctors locating to private hospitals and skewing healthcare costs and access for locals. given the many weights and balances to consider, the discussion of expanding this type of healthcare into turkey is ethically needed. keywords: medical tourism, turkey, health inequality, insurance coverage, economic stimulation introduction i watched from the hotel lobby as a group of men with surgically wrapped heads strolled in line behind a young woman; she was speaking to them in english with a heavy turkish accent. across the room was another group like this one, but the women had bandages on their noses. as a turk, this sight was not new to me: over the years, i witnessed the number of foreigners coming to turkey for medical procedures increase by tenfold. and, i began to see how savvy turkish tourist companies became over time, creating enticing packages for people to tour the beautiful city of istanbul while receiving a hair transplant procedure or rhinoplasty. while i understood why individuals would come to turkey for their procedure ― lower prices, expert physicians, and a lovely tourist destination ― i began to question whether profiting from the health care of others was ethical. this paper examines whether it is ethical for turkey to invest in a growing medical tourism field, which has the potential for significant economic benefits yet could threaten health inequalities between locals and foreigners. further, it will outline why tourists choose turkey as a medical tourism destination, the reasons to favor medical tourism, and the reasons to oppose it. finally, the paper will conclude that turkey should cultivate and invest in medical tourism, with suggestions for expanding the field into a thriving market. pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) 2 analysis by definition, a medical tourist is an individual who travels to a foreign country to experience both cultural tourism and medical treatment.1 global medical tourism is a $55billion industry, and the industry in turkey is experiencing an annual growth rate of 22.6 percent.2 in 2017, more than one million individuals traveled to turkey for medical tourism, putting approximately ten billion dollars of foreign currency into the economy.3 medical tourists who traveled to turkey received, on average, more than one procedure during their stay.4 due to the increasing demand for medical tourism, the ministry of health in turkey emphasized the expansion of medical tourism in its strategic plan, implementing initiatives to grow the industry.5 these initiatives include improving the quality of turkish hospitals and receiving joint commission international (jci) accreditation, which is an internationally recognized quality healthcare index.6 there are multiple reasons why individuals choose turkey as their destination for medical tourism. first, it is easy to travel to: individuals need only an e-visa, which they can easily receive through an online application. 7 in addition, turkey has lower prices compared to the western hemisphere. 8 the turkish government incentivizes medical tourism through lucrative advertising specials. for example, turkish airlines offers discounted airline ticket prices of 50 percent for patients who demonstrate a patient admission document from a turkish certified health institution.9 private hospitals have opened advertising offices in the ataturk airport as well.10 lastly, hotels and hotel chains collaborate with hospitals to offer lucrative tourist packages for patients.11 while these perks and incentives draw people to turkey, the lack of insurance coverage, high cost of treatment, and long wait times in their home countries are the most significant reasons that tourists choose turkey as their medical destination. 12 arab tourists previously traveled to the united states and the united kingdom for medical treatment, but due to the implementation of strict travel sanctions after the september 11 attacks, they have had to look elsewhere.13 for arab tourists, the similarity of culture and religion in turkey, a predominantly muslim country, is also an enticing factor.14 and, while thailand and singapore offer lower health care costs than turkey, the shorter distance from the home country plays an important role in choosing turkey as a medical destination. 15 european tourists choose turkey for different reasons. for example, some surgeries conducted in turkey are not available in europe.16 patients from the balkans and central asia prefer turkey because of turkey’s highly trained physicians and brand new, well-equipped hospitals compared to those in their home countries.17 interestingly, the low costs rank lower in importance than cultural similarity among those seeking care in turkey.18 the most important factor for choosing turkey was quality: most tourists came from countries with a healthcare system marred by a lack of expertise or technological advancement.19 one turkish physician stated, “[turkey] really ha[s] practices, doctors, services, hospitals and treatments that are above world standards in terms of health care.”20 i. ethical permissibility of medical tourism in turkey health tourism has the potential to make a significant impact on the economic and social life of countries.21 as a developing country, turkey cannot afford to overlook this economic possibility.22 the expansion of medical tourism in turkey has allowed the country to reform its healthcare system into one that competes with health care quality in the western hemisphere. since 2010, there has been a significant increase in patients traveling to turkey for health care.23 the ak party in turkey pledged to promote health tourism in its campaign in 2011.24 this inspired health care reform in 2013, with turkey instituting a publicly funded and organized healthcare system.25 in 2013, the turkish government created publicly funded city hospitals. these hospitals were formed for medical tourism, meeting quality levels never-before-seen in the country.26 in 2014, the ministry of health began granting accreditation to medical providers for medical pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) 3 tourism services and supporting translation services, patient transportation, and marketing.27 additionally, strategic initiatives were implemented to increase the number of turkish medical school graduates.28 the number of private medical schools increased from five before 2013 to 24 by the end of 2015.29 a 50 percent tax reduction was granted to healthcare institutions that provided health care to foreigners. 30 finally, turkey began reforming hospital systems to obtain jci accreditation. the growth of medical tourism in turkey has resulted in positive reform of turkey’s healthcare system. turkey has over ten city hospitals in istanbul, with qualified professionals proficient in english and other languages. 31 these hospitals are public and thus open and available for use by the general turkish community, offering excellent quality health care to the country’s citizens. however, private hospitals have also flourished and, in some cases, have drained some of the doctors from public hospitals. with the increase in quality measures and regulatory healthcare committees, such as the health tourism coordination council (saturk), turkey’s healthcare system rivals the west's with highly trained professionals, competitive medical schools, and modern medical facilities.32 turkey has even reached the forefront of medical advancement: the world eye hospital is renowned for its cutting-edge ophthalmology services.33 the investment in medical tourism has allowed turkey to invest more in its private sector as well: the total expenditure on health as a proportion of the gdp rose from 2.4 percent in 1980 to 6.1 percent in 2008,34 with an almost $2 billion national income from medical tourism in 2010. ii. arguments against the ethical permissibility of medical tourism in turkey while public city hospitals were opened with the potential to support the turkish medical tourism industry, private hospitals support 83 percent of the medical tourism market, and the gap between private and public hospitals has been growing yearly.35 private hospitals have mostly opened in urban areas, such as istanbul, ankara, and antalya. 36 as a result, there has been a “brain drain,” in which members of the health workforce have left rural areas and have moved to urban cities where they can make larger profits from the medical tourism industry.37 in addition, the use of public city hospitals has been met with concern regarding whether inequalities in health care between foreigners and turkish citizens will arise. the ministry of health pays rent for the city hospitals in us dollars, exacerbating inflation in the turkish lira currency and increasing reliance on high-paying medical tourists to support the public hospital system.38 due to this pressure, the prices for medical services are not consistently kept at affordable levels for turkish citizens. 39 the head of the private hospitals and health institutions association, resat bahat, stated, “turkish citizens must receive priority for public resources. you cannot treat a libyan or a dutch when your own citizen is shaking at home with pneumonia. you [the public sector] can perhaps engage in medical tourism if you have excess bed capacity. but it is hard to do this [medical tourism] with the public sector.”40 rapid growth has also compromised patient safety and health care quality. while clinics must receive medical tourism certificates to provide treatment, fraud has risen.41 in 2016, six out of ten hair transplant clinics were operating illegally. 42 these clinics offered hair transplants for as low as $800 when the treatment costs approximately $2000 in a ministry of health authorized clinic.43 international patients have complained of inadequate human resources, such as the inability to communicate appropriately and insensitivity to tourists’ cultural features and habits, as well as a lack of facilitators in hospital systems. 44 the most common complaint has been that medical tourism companies fail to direct patients well and follow up after procedures.45 furthermore, multiple turkish physicians have cited cases of malpractice with foreign patients. 46 one turkish physician highlighted the ethical dilemma of turning health care into a commodity: “it is important that healthcare should be provided in such a way that institutions can continue their business without turning into a commercial commodity, ignoring the health and the aspect of the pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) 4 event. all people should have access to health equally.”47 a turkish pulmonologist also supported the idea of the separation between health and tourism, claiming that health care is a subject that requires unique methods to meet its needs, which should be addressed separately from the tourism industry.48 iii. the case for continuing medical tourism while the above arguments demonstrate the difficulties with medical tourism, i argue that it is ethically permissible to invest in and expand turkish health tourism. from a utilitarian perspective, the benefits of medical tourism to turkish citizens outweigh the costs of expansion. since investing in medical tourism, the quality of turkish health care on both public and private levels has increased drastically. turkey has also moved towards implementing more regulations surrounding the quality of health care. 49 international standards for health care have been adopted as well allowing turkish citizens to reap the benefits of the medical tourism industry through access to advanced and high-quality health care.50 while access and affordability for local patients must improve, the very existence of high-quality care and care standards that are better regulated exemplify improvements. investments in medical education have also allowed turkish citizens to gain greater access to higher education throughout the country with more medical seats and the opening of multiple private medical schools.51 in addition, the expansion of the health industry has increased the professional opportunities available in healthcare for turkish citizens. there is no doubt that medical tourism has greatly benefited the turkish economy. turkey aims to be the leading country in medical tourism by 2023, opening economic opportunities within and beyond medicine. the financial benefit is not reserved for the hospital systems and could provide high-paying jobs in hospitality, food service, etc.52 people coming to turkey spend money sightseeing and enjoying hotels, nature, and cities. while concerns about fraud exist, the medical tourism industry in turkey is still relatively new, dating back to 2013. thus, fraud is not widespread, considering the rate at which the industry has grown and its remarkable milestones in quality and patient services. there is no doubt that turkey will continue to reform to meet the demands of various patient populations without compromising the safety and quality of its healthcare commodities. the government has been adept at tracking the industry and can adopt new regulations and enforcement to discourage and punish fraud. in addition to the existing policy guiding the expansion of turkey’s medical tourism industry, more can be done to expand the industry. some argue that barriers to medical tourism growth include inadequate human resources, negative corporate images and perceptions of turkey globally, lack of facilitators, and unsatisfactory quality of care for medical tourists.53 while arab tourists are more at ease in choosing turkey as a health destination because of the shared religion and understanding of islamic accommodations, marketing to european and asian tourists should address the possibility that they may feel uneasy about cultural differences or even that their cultural needs will not be respected or met. therefore, more effort must be directed toward training medical personnel to exercise cultural competency and make hospitals culturally welcoming. this may include offering diverse food choices and ensuring that translators are available during all aspects of the medical tourist experience, starting at the airport. county-specific environmental factors should also be considered before a private hospital can enter the medical tourism market. 54 for example, hospitals should offer tour vouchers to capitalize on the historical sites in cappadoccia. in addition, hospitals in gaziantep should be sure to have signs in arabic, and arab-speaking health personnel, to meet the needs of the large arab population in the area. pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) 5 turkey must also do more to control costs to prevent the exacerbation of inequalities between foreigners’ and citizens’ access to health care. for example, some clinics have been able to circumvent cost regulations by the ministry of health.55 by appointing region-specific regulatory overseers, they can ensure that costs are not prohibiting the local population from seeking necessary health care. conclusion turkey has seen enormous expansion in its medical tourism industry in recent years. through government support and collaboration between the tourism and healthcare sectors, the turkish economy has amassed billions of dollars in revenue annually from medical tourism alone. the investment into the medical tourism industry has placed turkey at the forefront of quality and cutting-edge health care. while medical tourism has contributed enormous benefits to communities and the economy, there is more to do to ensure that health care inequalities between foreigners and turkish citizens do not rise. the medical tourism industry in turkey is not yet perfect; however, the potential is enormous. all things considered, medical tourism stands to help turkey’s economy both through hospital systems and the increased tourism that coincides with travel for medical care. due to expanded demand for services, medical tourism has led turkey to develop its healthcare system and expand the number of people who can become physicians. yet, more must be done to prevent fraud, ensure fair prices that turkish locals can afford, and help public hospitals maintain some of the tourism market shares. overall, medical tourism stands to benefit the people of turkey and is an ethical way to expand the economy. 1 cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79. 2 sag, i., & zengul, f. d. (2019). why medical tourists choose turkey as a medical tourism destination? journal of hospitality and tourism insights, 2(3), 296-306. doi:http://dx.doi.org/10.1108/jhti-05-2018-0031; yıldız, m. s., & khan, m. m. (2019). factors affecting the choice of medical tourism destination: a case study of medical tourists from the arab region in turkey. journal of health management, 21(4), 465-475. 3 sag, i., & zengul, f. d. (2019). why medical tourists choose turkey as a medical tourism destination? journal of hospitality and tourism insights, 2(3), 296-306. doi:http://dx.doi.org/10.1108/jhti-05-2018-0031 4 yıldız, m. s., & khan, m. m. (2019). factors affecting the choice of medical tourism destination: a case study of medical tourists from the arab region in turkey. journal of health management, 21(4), 465-475. 5 yıldız, m. s., & khan, m. m. (2019). factors affecting the choice of medical tourism destination: a case study of medical tourists from the arab region in turkey. journal of health management, 21(4), 465-475. 6 cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79; yıldız, m. s., & khan, m. m. (2019). factors affecting the choice of medical tourism destination: a case study of medical tourists from the arab region in turkey. journal of health management, 21(4), 465-475; yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 7 buljubasic, e. (2019). evaluation of gcc patients' service quality perception towards medical tourism and turkey as a medical tourism destination (doctoral dissertation, marmara universitesi (turkey)). 8 ibid. 9 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. http://dx.doi.org/10.1108/jhti-05-2018-0031 http://dx.doi.org/10.1108/jhti-05-2018-0031 pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) 6 10 buljubasic, e. (2019). evaluation of gcc patients' service quality perception towards medical tourism and turkey as a medical tourism destination (doctoral dissertation, marmara universitesi (turkey)). 11 ibid. 12 yıldız, m. s., & khan, m. m. (2019). factors affecting the choice of medical tourism destination: a case study of medical tourists from the arab region in turkey. journal of health management, 21(4), 465-475. 13 ibid. 14 ibid. 15 buljubasic, e. (2019). evaluation of gcc patients' service quality perception towards medical tourism and turkey as a medical tourism destination (doctoral dissertation, marmara universitesi (turkey)). 16 ibid. 17 sag, i., & zengul, f. d. (2019). why medical tourists choose turkey as a medical tourism destination? journal of hospitality and tourism insights, 2(3), 296-306. doi:http://dx.doi.org/10.1108/jhti-05-2018-0031 18 yıldız, m. s., & khan, m. m. (2019). factors affecting the choice of medical tourism destination: a case study of medical tourists from the arab region in turkey. journal of health management, 21(4), 465-475. 19 sag, i., & zengul, f. d. (2019). why medical tourists choose turkey as a medical tourism destination? journal of hospitality and tourism insights, 2(3), 296-306. doi:http://dx.doi.org/10.1108/jhti-05-2018-0031 20 both an opportunity and threat to turkey health tourism. turkeymedicals.com, turkey ihealth , 2022, https://turkeymedicals.com/health-tourism. 21 sag, i., & zengul, f. d. (2019). why medical tourists choose turkey as a medical tourism destination? journal of hospitality and tourism insights, 2(3), 296-306. doi:http://dx.doi.org/10.1108/jhti-05-2018-0031 22 ibid. 23 akgün, s. (2015). medical tourism in turkey: past, present, and future. seval akgün. european journal of public health, 25(suppl_3). 24 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 25 ibid. 26 ibid. 27 ibid. 28 ibid. 29 ibid. 30 ibid. 31 ibid. 32 ibid. 33 buljubasic, e. (2019). evaluation of gcc patients' service quality perception towards medical tourism and turkey as a medical tourism destination (doctoral dissertation, marmara universitesi (turkey)). 34 ibid; cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79. http://dx.doi.org/10.1108/jhti-05-2018-0031 http://dx.doi.org/10.1108/jhti-05-2018-0031 http://dx.doi.org/10.1108/jhti-05-2018-0031 pirzada, turkey’s medical tourism industry, voices in bioethics, vol. 8 (2022) 7 35 akgün, s. (2015). medical tourism in turkey: past, present, and future. seval akgün. european journal of public health, 25(suppl_3); buljubasic, e. (2019). evaluation of gcc patients' service quality perception towards medical tourism and turkey as a medical tourism destination (doctoral dissertation, marmara universitesi (turkey)). 36 cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79. 37 ibid. 38 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 39 both an opportunity and threat to turkey health tourism. turkeymedicals.com, turkey ihealth , 2022, https://turkeymedicals.com/health-tourism. 40 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 41 both an opportunity and threat to turkey health tourism. turkeymedicals.com, turkey ihealth , 2022, https://turkeymedicals.com/health-tourism. 42 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 43 ibid. 44 cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79. 45 both an opportunity and threat to turkey health tourism. turkeymedicals.com, turkey ihealth , 2022, https://turkeymedicals.com/health-tourism. 46 ibid. 47 ibid. 48 ibid. 49 both an opportunity and threat to turkey health tourism. turkeymedicals.com, turkey ihealth , 2022, https://turkeymedicals.com/health-tourism; yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 50 cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79. 51 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. 52 akgün, s. (2015). medical tourism in turkey: past, present, and future. seval akgün. european journal of public health, 25(suppl_3). 53 cavmak, d., & cavmak, s. (2020). using ahp to prioritize barriers in developing medical tourism: case of turkey. int j travel med glob health, 8(2), 73-79. 54 ulaş, d., & anadol, y. (2016). a case study for medical tourism: investigating a private hospital venture in turkey. anatolia: an international journal of tourism & hospitality research, 27(3), 327–338. https://doiorg.ezproxy.cul.columbia.edu/10.1080/13032917.2016.1191763 55 yılmaz, v., & aktas, p. (2021). the making of a global medical tourism destination: from state-supported privatisation to state entrepreneurialism in healthcare in turkey. global social policy, 21(2), 301-318. https://doi-org.ezproxy.cul.columbia.edu/10.1080/13032917.2016.1191763 https://doi-org.ezproxy.cul.columbia.edu/10.1080/13032917.2016.1191763 quan, contingency standards of care, voices in bioethics, vol. 8 (2022) * alexander quan, mbe harvard medical school © 2022 alexander quan. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. addressing shortcomings in contingency standards of care alexander quan* abstract during a crisis, when healthcare capacity becomes overwhelmed and cannot meet regular standards of patient care, crisis standards of care are invoked to distribute scarce hospital space, staff, and supplies. when transitioning between conventional standards of care and crisis standards, hospitals may have to manage resources under scarcity constraints in an intermediate phase defined as the contingency phase. while much attention has been paid to the ethics of crisis standard of care protocols, contingency measures were more widely implemented, though little exists within the literature on the ethics of contingency measures or a clearly explicated contingency standard of care. this paper addresses three ethical issues with the current contingency response to covid-19: the lack of formalization, the risks of using short-term solutions for prolonged contingency shortages, and the danger of exacerbating health disparities through hospital-level resource allocation. to mitigate these ethical issues, i offer recommendations for reimagining resource allocation during contingency standards of care. keywords: contingency, crisis standards of care, resource allocation, covid-19, public health introduction when transitioning between conventional standards of care and crisis standards, or in situations where shortages do not immediately threaten care delivery, hospitals may have to manage scarce resources in an intermediate phase, known as the “contingency” phase.1 while much attention has been paid to the ethics of crisis standards, less literature covers the ethics of contingency measures or a clearly explicated contingency standard of care. many states and hospital systems do not have contingency standards of care to dictate allocation absent an event triggering crisis standards. crisis standards of care, used when healthcare capacity becomes overwhelmed and cannot meet regular standards of patient care, reflect ethical priorities relevant in times of shortage or other emergencies. these priorities include saving the quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 2 most lives, the stewardship of scarce resources, and justice relating to equitable resource distribution.2 crisis standards of care delineate specialized allocation protocols and triage decision-making bodies at the institutional or state levels. crisis standards of care require formal activation at the state level, and in the absence of clear triggers or governmental willingness to use them, hospitals may adopt informal strategies to manage allocation in the form of contingency measures. the contingency phase is defined by two simultaneous goals: prevent or stall crisis-level scarcity by managing limited resources and providing patient care that is functionally equivalent to usual care. 3 in other words, allocate scarce resources with no significant health consequences to patients. however, this is an unrealistic expectation: meeting a patient’s medical needs and allocating resources on the basis of scarcity instead of medical indications can be at odds, creating an ethical tension. this paper addresses three ethical issues with the current contingency response stemming from this tension: the lack of formalization, the risk of using short-term solutions for prolonged contingency shortages, and the danger of exacerbating health disparities through hospital-level resource allocation. to mitigate these ethical issues, i offer recommendations for reimagining resource allocation during contingency standards of care. i. lack of formalization one shortcoming of current contingency measures is that they fail to meet the same level of procedural detail and clarity as crisis standards. the early covid-19 surges in italy and france demonstrated the pitfalls of bedside allocation in the absence of procedural guidance. the acute scarcity of critical care resources forced doctors in these countries to make allocation decisions at the bedside, which often resulted in de facto age-based allocation as well as experiences of moral distress and shame among providers.4 in france, medical allocation guidelines and statistics were never released to the public, raising concerns over the role of transparency in implementing crisis standards and triage guidelines, and causing the public to question the trustworthiness of provider triage.5 though many states in the us have crisis standards of care that can be implemented in the case of a large-scale triage event, these measures vary widely. a 2020 review of 31 crisis standards of care in the us found that only 18 contained strong “ethical grounding,” 28 used “evidence-based clinical processes and operations,” 21 included “ongoing community and provider engagement, education, and communication,” and 16 had “clear indicators, triggers, and lines of responsibility.”6 the need for standardization, public transparency, and guidelines for crisis standards of care to prevent bedside allocation has been widely recognized. however, these issues remain unresolved by public policy or legislative efforts during the contingency period before (or after) crisis standards apply. a recent public health study that observed triage team members in a high-fidelity triage simulation highlighted the challenges of making equitable frontline allocation decisions. 7 in the simulation, participants nudged patient priority status up or down depending on what they subjectively identified as morally relevant factors. through the simulation, participants reported difficulty separating implicit biases about patient characteristics from their clinical judgment. in the absence of formal institutional or regional guidelines for allocation during contingency-level shortages, there are few to no procedural safeguards against biased, ad hoc, and non-transparent rationing. without formalized or standardized contingency allocation guidance, providers are left to make bedside allocation decisions that are susceptible to individual biases and patterns of unintended discrimination. an example of this susceptibility is seen when hospitals allow patients who no longer benefit from icu resources to continue occupying icu beds. this is based on a first-come-first-served (fcfs) approach to bed allocation. fcfs is often a default for patient intake, which led to disparities in care access during the early quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 3 covid-19 pandemic. media reports of hospitals with “plenty of space” being unwilling to accept patients from overwhelmed, lower-income hospitals illustrate that the fcfs default advantages those who could show up first to a particular hospital: often privileged, well-funded healthcare systems that were inaccessible to low-income communities.8 fcfs is blind to several morally relevant factors, including the likelihood of survival to discharge, reciprocity (i.e. prioritizing healthcare workers), and varying degrees of access to healthcare. therefore, it inappropriately privileges those in proximity to healthcare systems or with social connections enabling greater initial access to care.9 during crisis standards of care, excessive mortality that would result from fcfs is mitigated through formalized system-wide triage protocols based on current patient health status and potential benefit from resources. crisis and contingency standards may provide liability coverage for providers who reallocate critical care beds away from those who no longer benefit during periods of scarcity. this liability coverage shifts bed allocation away from an fcfs model, but only if the policy is well-defined, clearly established, and known to providers. without a formal system to guide the process or transition from the usual method of allocation to the contingency period, contingency decisions about who gets a scarce resource may continue to operate on an implicit fcfs basis, even when approaching crisis levels of scarcity. additionally, these decisions will fall unsustainably on individual providers or transfer center workers, leading to moral distress on the frontlines when hospitals are already strained. lessons from the crisis and contingency responses during covid-19 can improve future contingency responses. there are multiple ways of achieving equity during contingency allocation, ranging from hospital-level to state-level policy changes. state-wide policies and interventions to facilitate resourcesharing can relieve some of the scarcity burdens that hospitals may face during the contingency period. for example, moving icu patients to lower levels of care once they have sufficiently recovered is a challenge for doctors, who often call other hospitals to find open beds. in these situations, providers who do not move patients who no longer benefit from icu beds unknowingly reinforce the fcfs system in which those who arrive first keep the scarce beds, while those who arrive later or wait for one are disadvantaged by having limited access to them. state-wide patient transfer centers, often facilitated by state public health departments, present an alternative by balancing patient needs and bed distribution more equitably and efficiently than individual physicians do, as demonstrated following covid-19 surges in hospitalization.10 these centers aid not only in allocating open tertiary care beds, but also in identifying open beds at lower levels of care and assisting physicians with transferring out patients who can be safely downgraded and no longer benefit from tertiary care resources. however, the simplest solution is to encourage the creation of ethics guidance or protocols for contingency allocation at the hospital level. in hospitals, institutional ethics guidance can help providers navigate difficult decisions and conversations with patients. when providers face time-sensitive allocation decisions, like the allocation of open icu beds, the guidance would be a useful tool for making transparent, principled, and ethically justified allocation decisions in real-time to mitigate the risk of ad hoc or implicit rationing. ii. unsuited for prolonged resource shortages secondly, neither contingency nor crisis standards are currently designed to respond to prolonged strains on the healthcare system. since the start of the pandemic, a prolonged period of staffing shortages began and is projected to persist.11 however, both crisis and contingency standards assume that the system will eventually return to conventional standards of care. for example, as a contingency or crisis standard, many hospitals deferred elective surgeries to preserve limited resources for emergency and life-saving procedures. massachusetts, for instance, issued a public health emergency order that required hospitals quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 4 to defer 50 percent of all non-essential and non-urgent (elective) surgeries. this order demonstrates the use of this contingency measure in response to prolonged staffing and bed shortages. 12 however, the deferral of elective procedures can result in adverse long-term community health consequences. medical conditions typically addressed through elective surgery, such as joint replacement surgeries for osteoarthritis patients, may worsen if delayed. this can result in greater numbers of acute emergencies, the need for more complex surgical procedures later, increased reliance on pain medications, and longer recovery times. 13 without a greater understanding of long-term complications in community health, existing contingency strategies, such as the deferral of elective surgeries, may be unsuitable for prolonged shortages. this becomes a greater threat to patient safety when contingency measures inappropriately take the place of crisis standards, risking the long-term implementation of emergency measures designed for temporary use. although some state emergency planning documents identify indicators and triggers for activating contingency and crisis operations,14 this transition is not always clear in action. for example, new york did not implement crisis standards of care during the early covid-19 pandemic despite being one of the hardest-hit cities in the us.15 other states, including california, texas, and florida, did not activate crisis standards of care, leaving hospitals to implement informal contingency measures that ultimately required allocation strategies very similar or identical to many crisis standards of care protocols. 16 due to the hesitance to activate crisis standards, ad hoc contingency measures and bedside decision-making prevailed over formal triage protocols. if contingency measures are not set forth in objective documents and are inappropriately used in the place of crisis standards, these short-term measures may result in an unfair or non-transparent distribution of scarce resources. when shortages in space, staff, or supplies jeopardize the ability to provide necessary care for critically ill patients under a conventional standard of care, failures to activate crisis standards risk the inappropriate use of ad hoc contingency measures in their place. with clear contingency standards of care, the duration of an ad hoc approach could be limited. crisis standards are defined and activated at the regional or state-wide level, but outside of hospital-specific resource limitations, there are generally no standardized indications or triggers for transitioning into and out of contingency measures. leaving contingency needs to individual hospitals may seem beneficial but defining the contingency period at the hospital level and the crisis period at the state or regional level blurs the line about when it is appropriate for decision makers to activate crisis standards, risking delayed activation or failure to activate them at all. therefore, it is important that state policies implement automatic triggers for activation that clearly delineate between contingency and crisis responses. 17 automatic triggers based on validated metrics like remaining available resources can inform the appropriate decision makers about when they must activate crisis standards. these triggers should be transparent to the public, validated, and updated over time with evolving data. these automatic triggers would prevent confusion, inconsistent guidelines, and inequitable contingency allocation at the hands of distressed providers when crisis standards are needed. defining when to begin crisis standards could help limit the length of the contingency period. this would protect against the inappropriate application of contingency measures to crisis-level scarcity and prolonged shortages that they could not sustainably ameliorate. iii. potential to exacerbate health disparities inconsistencies in contingency allocation open the door to disparities in care and unequal distribution of scarcity burdens among different communities based on their location or health needs. this is a concern because it is unclear whether contingency measures can meet their goal of achieving functionally quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 5 equivalent patient outcomes when resource allocation must be balanced with patient-centered care.18 the care under contingency standards is meant to be functionally equivalent to regular care. the definition assumes (or may wrongly suggest) that any contingency strategy in place to avoid critical scarcity has no significant impact on patient outcomes. while functional equivalence is attainable, there is currently little research into which contingency measures achieve functionally equivalent outcomes and which patient groups may be disproportionately affected by harmful resource allocation strategies. although the transition from contingency standards to crisis standards is defined by the inability to provide functionally equivalent care, the difference in practice may merely be a distinction between visible, immediate sacrifices to patient well-being during crises and less-obvious, long-term decrements in community health due to protracted contingency care alterations. two common contingency measures are cause for concern over disparate patient outcomes and the attainability of functional equivalence. first, restricting emergency room visits by the patient’s degree of need has worrying consequences. in late 2021 and early 2022, hospitals in massachusetts faced widespread staffing shortages, leading to an emergency order that restricted emergency visits to emergency needs.19 while this order is a reasonable method of allocating limited staff in the emergency department during severe shortages, it is doubtful that the outcomes of this restriction were equivalent to usual care. health issues that are soon-to-be emergencies are filtered out until they worsen, resulting in patients overflowing to urgent care clinics or presenting to ers with more severe forms of sicknesses later on. given the empirical evidence demonstrating er treatment and admission disparities that disadvantage black and hispanic patients, such a measure would only exacerbate these disparities by further limiting access to needed care.20 second, altered staffing ratios, which stretch a limited number of providers to meet patient needs during a staffing shortage, are another concerning yet common contingency measure. staffing allocation is often viewed similarly to the allocation of space and medical equipment, such that contingency alterations to staffing operations may not seem like they significantly jeopardize patient care quality and outwardly appear functionally equivalent. 21 however, lower ratios of qualified nurses are associated with poor outcomes such as higher inpatient mortality22 and lower survival rates of in-hospital cardiac arrest for black patients.23 these examples highlight the strong potential for contingency measures to amplify social health disparities, particularly when adopted over a prolonged time frame. lowered standards of care in crisis allocation disproportionately impact racial and ethnic minorities.24 for example, crisis standards of care used clinical scoring systems that were not developed or validated for crisis triage to prioritize access to life-saving treatments during the covid-19 pandemic. this practice actively gives rise to racial health disparities and discrimination against disabled patients.25 not only were the standards inequitable in practice, but they varied widely from state to state and sometimes even from hospital to hospital, creating disparities across and within geographic regions.26 if contingency measures are similarly implemented across hospitals or hospital departments without standardization or advance planning to ensure equitable outcomes, it is likely that the burden of a lower standard of care will fall primarily on disadvantaged patient groups and racial minorities. however, standardization alone may be insufficient. other factors like varying levels of details on patients’ charts between hospitals could produce unfair outcomes if used to determine patient admission or transfer priority, even if the criteria for admissions and transfers are consistent. thus, ongoing monitoring for unintended patterns of disparity must accompany standardization to ensure that blind spots in the allocation process are identified and corrected. quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 6 bioethics has long been preoccupied with the micro-allocation of limited resources within hospitals instead of confronting the structural inequities that underlie broader scarcity and patient needs. the traditional dilemma of allocating limited hospital resources among a certain number of patients overlooks questions about how other resources have already been allocated, which patients were present at the hospital in the first place, where hospitals have (and have not) been built, and whether previous allocation strategies created bias in the broader distribution of resources. therefore, to achieve fairness, bioethicists must pay attention to aspects of the broader distribution of resources, such as social determinants of health and the allocation of preventative resources at the public health level. one strategy for measuring and addressing these disparities is the area deprivation index (adi). the adi quantifies the effects of race, class, and socioeconomic background by geographic region for use in public health research and the prioritization of resources.27 it has shown promise in identifying geographic regions in need of targeted community health efforts for diabetes management based on electronic patient health records.28 the adi and similar tools would be useful in proactively deciding how to allocate public health resources when hospitals are strained. moreover, through using population health and resource data, public health organizations may forecast contingency shortages allowing for the adoption of early measures to mitigate health disparities that might otherwise be amplified from hospital-level contingency allocation decisions. conclusion meeting community health needs during periods of contingency scarcity, both before and after crisis standards of care apply, will require contingency standards of care rather than a bedside ad hoc distribution of scarce resources. while it is not inherently ethically unjustifiable for hospitals to adopt measures that may lower the standard of care during contingency standards, the necessity of these measures requires that bioethicists consider how equity, transparency, and the overall aim of functional equivalence can best be achieved under conditions of scarcity. the long-term health consequences of existing contingency measures, the potential for ad hoc and inconsistent allocation of scarce resources, and the need for consensus about when it becomes appropriate to make the formal transition to crisis standards of care demand further consideration. because contingency measures will likely amplify existing disparities as crisis standards have, hospital-level management of scarcity is inadequate. public health measures should be adopted in parallel to anticipate and manage health needs at the community or state level when resources are strained. 1 altevogt, b. m., stroud, c., hanson, s. l., hanfling, d., & gostin, l. o. (2009). guidance for establishing crisis standards of care for use in disaster situations: a letter report. the national academies press. https://doi.org/10.17226/12749 2 emanuel, e. j., persad, g., upshur, r., thome, b., parker, m., glickman, a., zhang, c., boyle, c., smith, m., & phillips, j. p. (2020). fair allocation of scarce medical resources in the time of covid-19. new england journal of medicine, 382(21), 2049–2055. https://doi.org/10.1056/nejmsb2005114 3 alfandre, d., sharpe, v. a., geppert, c., foglia, m. b., berkowitz, k., chanko, b., & schonfeld, t. (2021). between usual and crisis phases of a public health emergency: the mediating role of contingency measures. the american journal of bioethics, 21(8), 4– 16. https://doi.org/10.1080/15265161.2021.1925778 4 rosenbaum, l. (2020). facing covid-19 in italy—ethics, logistics, and therapeutics on the epidemic’s front line. new england journal of medicine, 382(20), 1873–1875. https://doi.org/10.1056/nejmp2005492 5 orfali, k. (2020). what triage issues reveal: ethics in the covid-19 pandemic in italy and france. journal of bioethical inquiry, 17(4), 675–679. https://doi.org/10.1007/s11673-020-10059-y https://doi.org/10.17226/12749 https://doi.org/10.1056/nejmsb2005114 https://doi.org/10.1080/15265161.2021.1925778 https://doi.org/10.1056/nejmp2005492 https://doi.org/10.1007/s11673-020-10059-y quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 7 6 romney, d., fox, h., carlson, s., bachmann, d., o’mathuna, d., & kman, n. (2020). allocation of scarce resources in a pandemic: a systematic review of us state crisis standards of care documents. disaster medicine and public health preparedness, 14(5), 677–683. https://doi.org/10.1017/dmp.2020.101 7 butler, c. r., webster, l. b., diekema, d. s., gray, m. m., sakata, v. l., tonelli, m. r., & vranas, k. c. (2022). perspectives of triage team members participating in statewide triage simulations for scarce resource allocation during the covid-19 pandemic in washington state. jama network open, 5(4), e227639. https://doi.org/10.1001/jamanetworkopen.2022.7639 8 dwyer, j. (2020, may 14). one hospital was besieged by the virus. nearby was ‘plenty of space.’—the new york times. the new york times. https://www.nytimes.com/2020/05/14/nyregion/coronavirus-ny-hospitals.html 9 persad, g., wertheimer, a., & emanuel, e. j. (2009). principles for allocation of scarce medical interventions. lancet (london, england), 373(9661), 423–431. https://doi.org/10.1016/s0140-6736(09)60137-9 10 mitchell, s. h., rigler, j., & baum, k. (2022). regional transfer coordination and hospital load balancing during covid-19 surges. jama health forum, 3(2), e215048. https://doi.org/10.1001/jamahealthforum.2021.5048 11 aspe. (2022, may 3). impact of the covid-19 pandemic on the hospital and outpatient clinician workforce: challenges and policy responses. aspe. https://aspe.hhs.gov/reports/covid-19-health-care-workforce 12 executive office of health and human services. (2021). baker-polito administration provides covid-19 update on mask advisory, hospital support | mass.gov. https://www.mass.gov/news/baker-polito-administration-provides-covid-19-update-onmask-advisory-hospital-support 13 the lancet rheumatology. (2021). too long to wait: the impact of covid-19 on elective surgery. the lancet rheumatology, 3(2), e83. https://doi.org/10.1016/s2665-9913(21)00001-1 14 for an example of transition planning between crisis and contingency standards, see minnesota department of health. (2021). ethical framework for transitions between conventional, contingency, and crisis conditions in pervasive or catastrophic public health events with medical surge implications (minnesota crisis standards of care). https://www.health.state.mn.us/communities/ep/surge/crisis/framework_transitions.pdf 15 powell, t., & chuang, e. (2020). covid in nyc: what we could do better. the american journal of bioethics, 20(7), 62–66. https://doi.org/10.1080/15265161.2020.1764146 16 persoff, j., & wynia, m. k. (2021). ethically navigating the murky waters of “contingency standards of care.” the american journal of bioethics, 21(8), 20–21. https://doi.org/10.1080/15265161.2021.1939810 17 board on health sciences policy & institute of medicine. (2013). indicators and triggers. in crisis standards of care: a toolkit for indicators and triggers. national academies press (us). http://www.ncbi.nlm.nih.gov/books/nbk202381/ 18 frith, l., draper, h., fovargue, s., baines, p., redhead, c., & chiumento, a. (2021). neither ‘crisis light’ nor ‘business as usual’: considering the distinctive ethical issues raised by the contingency and reset phases of a pandemic. the american journal of bioethics, 21(8), 34–37. https://doi.org/10.1080/15265161.2021.1940363 19 rosseau, m. (2022, january 14). new emergency orders issued to help understaffed mass. hospitals. boston.com. https://www.boston.com/news/coronavirus/2022/01/14/new-emergency-orders-issued-to-help-understaffed-mass-hospitals/ 20 zhang, x., carabello, m., hill, t., bell, s. a., stephenson, r., & mahajan, p. (2020). trends of racial/ethnic differences in emergency department care outcomes among adults in the united states from 2005 to 2016. frontiers in medicine, 7. https://www.frontiersin.org/articles/10.3389/fmed.2020.00300 21 hick, j. l., hanfling, d., & wynia, m. (2022). hospital planning for contingency and crisis conditions: crisis standards of care lessons from covid-19. the joint commission journal on quality and patient safety. https://doi.org/10.1016/j.jcjq.2022.02.003 https://doi.org/10.1017/dmp.2020.101 https://doi.org/10.1001/jamanetworkopen.2022.7639 https://www.nytimes.com/2020/05/14/nyregion/coronavirus-ny-hospitals.html https://doi.org/10.1016/s0140-6736(09)60137-9 https://doi.org/10.1001/jamahealthforum.2021.5048 https://aspe.hhs.gov/reports/covid-19-health-care-workforce https://www.mass.gov/news/baker-polito-administration-provides-covid-19-update-on-mask-advisory-hospital-support https://www.mass.gov/news/baker-polito-administration-provides-covid-19-update-on-mask-advisory-hospital-support https://doi.org/10.1016/s2665-9913(21)00001-1 https://www.health.state.mn.us/communities/ep/surge/crisis/framework_transitions.pdf https://doi.org/10.1080/15265161.2020.1764146 https://doi.org/10.1080/15265161.2021.1939810 http://www.ncbi.nlm.nih.gov/books/nbk202381/ https://doi.org/10.1080/15265161.2021.1940363 https://www.boston.com/news/coronavirus/2022/01/14/new-emergency-orders-issued-to-help-understaffed-mass-hospitals/ https://www.frontiersin.org/articles/10.3389/fmed.2020.00300 https://doi.org/10.1016/j.jcjq.2022.02.003 quan, contingency standards of care, voices in bioethics, vol. 8 (2022) 8 22 musy, s. n., endrich, o., leichtle, a. b., griffiths, p., nakas, c. t., & simon, m. (2021). the association between nurse staffing and inpatient mortality: a shift-level retrospective longitudinal study. international journal of nursing studies, 120, 103950. https://doi.org/10.1016/j.ijnurstu.2021.103950 23 brooks carthon, m., brom, h., mchugh, m., sloane, d. m., berg, r., merchant, r., girotra, s., & aiken, l. h. (2021). better nurse staffing is associated with survival for black patients and diminishes racial disparities in survival after in-hospital cardiac arrests. medical care, 59(2), 169–176. https://doi.org/10.1097/mlr.0000000000001464 24 annas, g. j., & crosby, s. s. (2021). standard racism: trying to use “crisis standards of care” in the covid-19 pandemic. the american journal of bioethics, 21(8), 1–3. https://doi.org/10.1080/15265161.2021.1941424 25 wynia, m. k., & sottile, p. d. (2020). ethical triage demands a better triage survivability score. the american journal of bioethics, 20(7), 75–77. https://doi.org/10.1080/15265161.2020.1779412 26 fink, s. (2020). ethical dilemmas in covid-19 medical care: is a problematic triage protocol better or worse than no protocol at all? the american journal of bioethics, 20(7), 1–5. https://doi.org/10.1080/15265161.2020.1788663 27 knighton, a. j., savitz, l., belnap, t., stephenson, b., & vanderslice, j. (2016). introduction of an area deprivation index measuring patient socioeconomic status in an integrated health system: implications for population health. egems (washington, dc), 4(3), 1238. https://doi.org/10.13063/2327-9214.1238 28 kurani, s. s., lampman, m. a., funni, s. a., giblon, r. e., inselman, j. w., shah, n. d., allen, s., rushlow, d., & mccoy, r. g. (2021). association between area-level socioeconomic deprivation and diabetes care quality in us primary care practices. jama network open, 4(12), e2138438. https://doi.org/10.1001/jamanetworkopen.2021.38438 https://doi.org/10.1016/j.ijnurstu.2021.103950 https://doi.org/10.1097/mlr.0000000000001464 https://doi.org/10.1080/15265161.2021.1941424 https://doi.org/10.1080/15265161.2020.1779412 https://doi.org/10.1080/15265161.2020.1788663 https://doi.org/10.13063/2327-9214.1238 https://doi.org/10.1001/jamanetworkopen.2021.38438 dichristina, nutrition researchers should disclose personal lifestyle habits, voices in bioethics, vol. 8 (2022) * wendy dunne dichristina, jd, ms bioethics © 2022 wendy dunne dichristina. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. “don’t drink, don’t smoke, what do you do?” nutrition researchers should disclose personal lifestyle habits wendy dunne dichristina* keywords: nutrition, diet, wellness, bias, research ethics, dietary choice, disclose, lifestyle introduction “the author eats a pescatarian diet and donates money to animal sanctuaries advocating against factory farming. she also likes donuts.” oversharing from a young research scientist, or necessary disclosure for full evaluation of nutrition research? although most pharmaceutical researchers never ingest the medications they study, all nutrition researchers eat food and make dietary choices every day. moreover, nutritional studies can quickly amplify in the media, encouraging the public to change their diets and buy new products now, with no doctor’s visit or prescription needed. bioethicist john p.a. ioannidis of stanford university advocates for a registry of conflicts of interest involving the food industry and suggests that nutrition researchers disclose their activist work and dietary preferences, if relevant to their particular research.1 these changes to the ethical standards of nutrition research are necessary in today’s fast-paced internet world. analysis nutrition is a difficult and expensive area to research.2 even when diets or vitamin supplementation show positive results in animal studies, follow-up nutritional studies on humans may not yield similar outcomes due to the complicated nature of food -researchers cannot lock up humans and feed them a bland diet plus a b-12 supplement for a year. following numerous research subjects for multiple years may be the only way to determine the effects of a nutritional change, but this is an expensive proposition.3 even when such longitudinal studies are funded and carried out, environmental factors and genetics may undermine the cleanest of studies. nutrition researchers must often rely on observational studies, which only show a correlation between nutrition intake and outcome, not cause and effect.4 however, the weaknesses of correlation studies are often lost on the public in search of instantaneous advice on how to eat “right.” the pressures of research funding may encourage scientists to pursue areas of study that will make a big splash and go viral, leading to more funding and even book deals for some “celebrity” scientists.5 although dichristina, nutrition researchers should disclose personal lifestyle habits, voices in bioethics, vol. 8 (2022) 2 researchers may act out of the desire to pursue excellent research and benefit the public, they are ethically compromised by the need for publicity. the human nutrition industry influences the public’s eating habits and interests, which then influences the researchers in search of grant money. this enmeshment requires diligence in disclosing conflicts, including the personal dietary habits of researchers. dr. ioannidis raises the important point that some conflicts may arise not just from potential book deals but also from more subtle associations: nonprofit organizations may benefit from social media amplification of an affiliated researcher’s work. 6 researchers sometimes advocate for health or environmental improvements they study, perhaps hoping to increase the beneficence of their research to society. this type of advocacy, dubbed the “white hat” bias, may be at odds with the scientific ideal of nonpartisanship and should be disclosed, if not completely discouraged.7 the goal of beneficence in nutrition science would be better served by independent researchers who can conduct nutritional studies and present their data neutrally, allowing for independent replication of data before presentation as a conclusive finding to the consumer. a few unethical researchers have made terrible missteps and overstatements of research findings, leading to confusion, at best, and distrust of the science of nutrition, at worst. in sweden during the 1970s, researchers extrapolated from a study on cells to conclude that ingesting carbohydrates did not lead to weight gain in humans.8 in 2018, a top nutrition researcher left cornell after 13 of his published papers were retracted due to errors including statistical manipulation on inconclusive data sets.9 in the past 40 years, americans have repeatedly changed their diets in response to such nutritional discoveries, adding oat bran to everything, eliminating every possible fat, avoiding all carbohydrates, and currently, eliminating gluten and eating a paleolithic diet. entire food industries are built around each new finding: just look at the explosion of acai “antioxidant” products at any local grocery store. (note: in follow-up studies, antioxidant supplementation has not been shown to have health benefits to humans.10) fad diets have come and gone for hundreds of years and often repeat themselves; a few examples include the “banting” low-carb diet craze of 1863 or the “bile beans” weight loss laxative ads from the 1940s.11 the difference today is that nutrition research can go directly from an obscure scientific journal to an internet craze gobbled up by millions of consumers overnight. unlike falsified or exaggerated data in pharmaceutical research, exciting but inconclusive nutrition research can be implemented by consumers from the comforts of their homes and cannot get “retracted” from the public eye so easily. internet advertising uses “clickbait” ads that are often in the form of regurgitated article headlines at the bottom of webpages known as “chumboxes.”12 consumers clicking on this old, fake or patently wrong nutritional news may waste time and money chasing nutritional perfection without verifying the information with a doctor. some of the recent fad diet news has begun to reuse the old hippocratic phrase “food is medicine,” with some even encouraging people to abandon prescribed medications in favor of novel food cures, or to experiment with untested supplements as “non medicine.” 13 while doctors and nutritional scientists certainly see food as an important component of health, they would not recommend that consumers with serious health issues make dietary changes and ignore physician advice. if genome science now indicates that people react differently to pharmaceuticals due to their genes, isn’t it logical that people may react differently to diet plans based on their genes, age, or other factors?14 medical advice and understanding of nutrition will become even more important and complicated in the genomic age, and it may become crucial for the most accurate nutrition research to be delivered into the hands of the right consumers – food will no longer be a neutral agent of health equipoise, but rather serve as a maleficent force for some people. dichristina, nutrition researchers should disclose personal lifestyle habits, voices in bioethics, vol. 8 (2022) 3 as part of an ethical review, nutrition scientists should consider how the effect of social media and the internet may turn neutral research findings maleficent. it may no longer be sufficient to only insert the standard scientific disclaimers regarding “additional research is needed.” nutrition researchers should insert warnings that no one should adjust a diet without consulting a physician. perhaps an independent interagency commission of the fda and the ftc should look at all the ways nutritional information can be disseminated in the news and provide some sort of additional stamp of approval so that consumers know that advice from companies like goop is not fda approved, but that certain scientific research studies are. the ftc should aggressively pursue claims of deceptive advertising against untested products and require nutrition and diet advice to have clear warnings about the lack of scientific validity and the risks of dietary changes. these steps may seem paternalistic, but internet crazes and celebrity sponsorship of wrongheaded nutritional fads are more than simply annoying: they are dangerous, especially to less-educated, vulnerable consumers and people desperate to lose weight and/or regain health. disclaimers and disclosure of conflicts can help provide some balance of justice in the study of nutrition. the above suggestions require further elaboration and government intervention, but what can nutrition scientists do immediately to stake a claim to ethical research and high standards? as i said above, i do not eat meat and i am against factory farming. must i disclose this if i am a nutrition researcher, especially if i am evaluating diets involving meat? it seems critically relevant that i make a choice, three times a day, to avoid particular foods. some dietary regimens derive from strongly held religious and cultural beliefs, and even when religion is not involved, some people pursue their dietary choices with religious fervor.15 even if i don’t believe these lifestyle choices make a difference in my research, i should still disclose them because of the danger of unconscious bias.16 conclusion in a world in which the heads of major research hospitals fail to disclose financial conflicts involving millions of dollars, this ethical requirement may seem overblown, even silly. but reflecting on these potential conflicts may help researchers understand their own unconscious biases and make readers better understand a researcher’s opinions and findings. in some cases, these disclosures may make the scientific findings even more compelling. for example, if a vegetarian completes a study showing the health benefits of meat, readers may give that study more weight. if a donut lover finds that donuts are unhealthy . . . never mind, some research should never be done. 1 ioannidis, john p. a. and john f. trepanowski, “disclosures in nutrition research: why it is different,” jama 319, no. 6 (february 13, 2018): 547–48, https://doi.org/10.1001/jama.2017.18571. 2 seres, david, “what should we eat to stay healthy? why experts actually have no idea.,” reuters blogs (blog), august 11, 2014, https://www.reuters.com/article/seres-diet-idusl2n0qh1gj20140811. 3 seres. 4 seres. 5 ioannidis, john p. a., “the challenge of reforming nutritional epidemiologic research,” jama 320, no. 10 (september 11, 2018): 969–70, https://doi.org/10.1001/jama.2018.11025. 6 ioannidis, john p. a. and john f. trepanowski, “disclosures in nutrition research: why it is different,” jama 319, no. 6 (february 13, 2018): 547–48, https://doi.org/10.1001/jama.2017.18571. dichristina, nutrition researchers should disclose personal lifestyle habits, voices in bioethics, vol. 8 (2022) 4 7 cope, mark b and david b allison, “white hat bias: examples of its presence in obesity research and a call for renewed commitment to faithfulness in research reporting,” international journal of obesity (2005) 34, no. 1 (january 2010): 84–83, https://doi.org/10.1038/ijo.2009.239. 8 spilde, ingrid, “when science promoted sugar as healthy,” sciencenordic.com, accessed october 19, 2018, http://sciencenordic.com/when-science-promoted-sugar-healthy. 9 o’connor, anahad, “more evidence that nutrition studies don’t always add up,” the new york times, september 30, 2018, sec. sunday review, https://www.nytimes.com/2018/09/29/sunday-review/cornell-food-scientist-wansink-misconduct.html. 10 seres, “what should we eat to stay healthy?” 11 “diet fads go back to mid-1800s news the state journal-register springfield, il,” accessed october 13, 2018, https://www.sj-r.com/story/lifestyle/2011/02/07/diet-fads-go-back-to/41761520007/. 12 cbc news · october 7 and 2016, “diving into internet ‘chum?’ yes, it’s as bad as you’d expect. | cbc radio,” cbc, october 9, 2016, https://www.cbc.ca/radio/spark/330-reality-isn-t-real-utopia-is-creepy-1.3792237/diving-into-internet-chum-yes-it-s-asbad-as-you-d-expect-1.3794213. 13 see, e.g., https://draxe.com/. 14 ioannidis, “the challenge of reforming nutritional epidemiologic research.” 15 ioannidis and trepanowski, “disclosures in nutrition research.” 16 gail geller and paul a. watkins, “addressing medical students’ negative bias toward patients with obesity through ethics education,” ama journal of ethics 20, no. 10 (october 1, 2018): 948–59, https://doi.org/10.1001/amajethics.2018.948. https://www.sj-r.com/story/lifestyle/2011/02/07/diet-fads-go-back-to/41761520007/ zimmerman, religious exemptions for vaccination mandates, voices in bioethics, vol. 7 (2021) *anne zimmerman, jd, ms © 2021 anne zimmerman. this is an open access article distributed under the terms of the creative commons attribution license, which permits unrestricted use, distribution, and reproduction, provided the original author and source are credited. religious exemptions: application of employment division v. smith to covid-19 vaccination mandates anne zimmerman* keywords: vaccine mandate, religious exemption, free exercise, strict scrutiny, bioethics introduction among the many unclear issues as interpretations of employment division v. smith arise in the context of vaccination mandates is a simple question: does any exception to a law at all (whether for a group or an individual) render a law not “generally applicable and religion-neutral” in the eyes of the current supreme court? i. background prior to employment division v. smith,1 sherbert v. verner2 set forth the free exercise test which called for strict scrutiny requiring a compelling state interest and the use of the least restrictive means to achieve the state interest when a law poses a substantial burden to the exercise of religion. sherbert had a broad holding that prior to smith applied to laws whether neutral on their face or not, and whether the asserted discrimination was intentional or not. one issue with sherbert was that judges were not especially adept at judging the sincerity of beliefs and the importance of religious rituals to individuals, making it difficult to determine whether a law imposed a “substantial burden” on the practice of a religion. employment division v. smith holds that laws that are generally applicable and religion-neutral need not be justified by a compelling government interest even if they do have the effect of (unintentionally) burdening a religious practice.3 smith, decided in 1990, altered and narrowed judicial discretion in evaluating neutral laws that may impede the free exercise of religion. justice scalia aligned free exercise with other first amendment rights.4 he also alleviated the need for judges to determine the burden on and the sincerity of religious beliefs in instances of neutral laws. “smith therefore diminished judicial power to grant religious citizens exemptions from their civic obligations...”5 yet a carveout was maintained for laws that have a “mechanism for individualized discretion”; strict scrutiny still applies to those. zimmerman, religious exemptions for vaccination mandates, voices in bioethics, vol. 7 (2021) 2 lukumi6 (1993) reaffirmed yet distinguished smith. in lukumi, the law in question was adopted to ensure that a religious group would be rendered unable to sacrifice animals. the law had numerous exemptions (clearly people may kill animals for many non-essential reasons like hunting and fishing for sport, etc.) and the lawmakers seemed to have the intent of interfering with animal sacrifice. it was not considered generally applicable on various grounds and the lukumi court states, “as we noted in smith, in circumstances in which individualized exemptions from a general requirement are available, the government "may not refuse to extend that system to cases of 'religious hardship' without compelling reason." ibid., quoting bowen v. roy, 476 u. s., at 708 (opinion of burger, c. j.).”7 in lukumi, arguably there were so many exceptions, the rule was clearly targeting religious sacrifices. the court applied strict scrutiny and the law was deemed unconstitutional. ii. the current supreme court and laws outside of smith the current and recent cases indicate that some justices on the supreme court assert that the caselaw supports religious exemptions to a broad array of laws. two arguments support this result: either a limited interpretation of “generally applicable and neutral” or a slightly different tactic which argues that any laws with individual exceptions call for strict scrutiny. (one argument is that those which allow exceptions are not generally applicable and neutral, and thus fall outside of smith and they require strict scrutiny;8 the other is that a law can be generally applicable and neutral, but if it has a system for exceptions, then it is subject to strict scrutiny.9) in john does 1-3 v. mills, the supreme court denied an injunction on october 29, 2021. the case concerns maine’s vaccine mandate and will be heard on the merits. gorsuch dissented from the denial of injunctive relief. he applied smith, lukumi, and fulton v. philadelphia10 saying that because there is a medical exemption, the law is not “generally applicable”11 and strict scrutiny will apply. thomas and alito joined gorsuch. the gorsuch dissent also implies that the maine medical exemption may be somewhat bogus saying maine finds the “mere trepidation over vaccination as sufficient” if it is expressed in medical rather than religious terms.12 justice barrett, joined by kavanaugh, concurred in the denial of the injunction, but clarified that her reasoning was a wish to avoid giving a “merits preview” by enjoining the law, based on the applicants’ likelihood of success, noting the case is “the first to address the questions presented.”13 iii. do medical exemptions negate the possibility of a neutral and generally applicable law? are they a de facto “mechanism for individual exemption”? to me, it seems that under the current law, a medical exemption could make the absence of a religious exemption more problematic. the big issue now is whether barrett and kavanaugh and any (even all) other justices are likely to find the medical exemption is a “mechanism for individual exemptions” or whether it otherwise more simply makes a law not neutral or generally applicable. in previous recent covid-19 cases, the argument of emergency authority was prominent. caselaw regarding emergency use of governmental powers trumped some constitutional arguments and led to disparate covid-19 caselaw.14 for example, some courts applied jacobson v. massachusetts,15 giving deference to public health authorities while others applied strict scrutiny.16 at the supreme court level, zimmerman, religious exemptions for vaccination mandates, voices in bioethics, vol. 7 (2021) 3 justices sotomayor, kagan, and breyer have been more willing to analyze covid-19 regulations according to emergency powers.17 a. in favor of the gorsuch reasoning the gorsuch dissent will require the state to offer proof of some rationale for why a medical exemption would be more acceptable, less dangerous, etc. than a religious one. because there is a medical exemption, the causal nexus between the state’s goals and the restrictions will matter. for example, in fraternal order of police v. newark, a requirement that police be clean shaven was invalidated because there was a medical exception.18 the problem with the rule was that the government interest in uniformity was not violated any more or less whether the person was noncompliant due to medical as opposed to religious reasons. gorsuch correctly applied similar reasoning arguing that those not in compliance with the maine vaccine mandate due to religious exemptions posed no more danger than those noncompliant due to medical conditions.19 an opposing side might argue that by the numbers, and without a need for a doctor’s signature, more people would apply for and receive religious exemptions, thus harming the ability to reach herd immunity more, or posing more risk of community spread. b. but, on the other hand there are many laws with medical exemptions. it would not seem right that they be subject to strict scrutiny for failing to offer religious outs as well. for example, places without motorized vehicles could allow motorized wheelchairs. indeed, the ada may even call for special treatment in many circumstances where religious special treatment would not be granted. disability law often requires variances, changing zoning to allow ramps, or other accommodations.20 it does not appear that every disability accommodation equates to a need to allow a corresponding religious accommodation, nor that strict scrutiny would apply. zoning cases are common where churches seek exceptions from historical landmark regulations and the results of those cases vary.21 yet vaccination is much more personal and the cases may be distinguished. one of the biggest vulnerabilities of the smith ruling is that arguably all laws have an individualized enforcement aspect. while it may not be an official exemption or a “mechanism for individual exemption”, individuals have the ability to use courts to challenge laws, there are laws that rely on wishy washy terms, like “good cause”, and there are groups whose failure to comply with laws may be traditionally ignored. in each of those scenarios, those seeking religious exemptions may have a stronger case, and eventually may chip away at smith. c. would a different built-in exemption preclude application of smith? application of smith may depend on whether the exemption is discretionary or built in. for example, if an exemption said anyone may apply for an exemption with good cause, religious ones should be fairly and equally considered. if an exemption reads anyone with an autoimmune disease is exempt, the class of people exempt would be delineated (unlike the maine language) rather than discretionary as with the open-ended medical exemption language of the maine statute. in the case of a class-like exemption, the zimmerman, religious exemptions for vaccination mandates, voices in bioethics, vol. 7 (2021) 4 argument that the law is neutral and generally applicable would be stronger. smith was not really meant to declare that laws with any categories would be vulnerable to free exercise challenges. similarly, objective criteria in providing exemptions differs. when criteria for exemptions are made clear, the religious argument could be weaker. however, the gorsuch argument that in the end the religious objector poses no more danger to others than the medical (or other maybe conscientious, financial, or physical) objector may be the winning argument. iv. side note: another consideration for neutral laws in roman catholic diocese of new york, justice kavanaugh created a peer group limitation in applying smith. kavanaugh found that a law that limited gatherings at religious services was not neutral. the law had various categories of entity.22 an interesting twist is that other entities similar to churches in objective concrete ways (like theaters) were closed altogether, so arguably religion was favored over those, but disfavored compared to essential businesses (like food stores). the orange and red zones in the challenged cuomo executive order did have specific rules for places of worship. gorsuch referred to lukumi in his concurrence and went directly to strict scrutiny without sincerely entertaining the concept that the executive order was a neutral and generally applicable law. that is in keeping with his dissent in does 1-3 v. mills. yet, it remains possible to argue that laws with objective, defined categories may still be neutral and generally applicable. v. time to abandon jacobson at this juncture of covid-19 jacobson applies in public health emergencies and, while in recent supreme court cases, many justices rightly pointed to the emergency as a reason to compromise important rights, the emergency aspect of the pandemic is waning. in many areas, the positive rate is quite low, businesses are returning to normal, and the vaccination rate is high. as such, the abandonment of strict scrutiny in favor of jacobson’s emergency deference to public health entities, something gorsuch failed to entertain in south bay pentecostal church v. newsom23 anyway, is arguably no longer warranted. deference to the state and to experts must be limited to emergencies. justices kagan, breyer, and sotomayor who rightly cautioned against “armchair epidemiology”24 during the height of the covid-19 pandemic might return to stricter stances on protecting rights as the emergency dies down or becomes localized, and as increasing methods and treatments arise, like the covid-19 pill by merck. the calculus of whether we need strict covid-19 regulations is dynamic. this is not a static emergency with powers to be left in place unconditionally. conclusion the argument that vaccination is a civic and moral obligation that people should engage in regardless of religious beliefs is stronger in an emergency. whether deemed to include a “mechanism for individual exemptions” or just declared not neutral or generally applicable, laws offering any exceptions are more vulnerable to free exercise claims. under the current supreme court composition, anticipating that laws may face strict scrutiny is wise—smith is unlikely to shield seemingly neutral laws in the face of free exercise cases. that is not necessarily a bad outcome in a country that purports to allow religious freedom and can do so safely. strict scrutiny is merely a protection that would ensure the public that zimmerman, religious exemptions for vaccination mandates, voices in bioethics, vol. 7 (2021) 5 laws are meaningful, achieve compelling purposes, and do so without unnecessarily impeding fundamental rights. yet one bad outcome of a rule that says if there are medical exemptions so must there be religious ones is that lawmakers will write laws that are more absolute, rigid, and unyielding to legitimate claims. 1 494 u.s. 872 (1990). https://supreme.justia.com/cases/federal/us/494/872/#tab-opinion-1958253 2 374 u.s. 398 (1963). https://supreme.justia.com/cases/federal/us/374/398/#tab-opinion-1944463 3 smith, at 879 (religion does not excuse people from compliance with neutral laws.) 4 kaplan, carol m., “the devil is in the details: neutral, generally applicable laws and exemptions from smith,” new york university law review, october 2000. https://www.nyulawreview.org/wpcontent/uploads/2018/08/nyulawreview-75-4-kaplan.pdf 5 kaplan, at 1053. 6 lukumi babalu aye, inc. v. city of hialeah 508 u.s. 520 (1993). https://supreme.justia.com/cases/federal/us/508/520/#tab-opinion-1959281 7 lukumi, at 537. 8 keeler v. mayor of cumberland. 940 f. supp. 879 (d. md. 1996) https://law.justia.com/cases/federal/districtcourts/fsupp/951/83/1381605/; kaplan, at 1066. 9 kaplan, at 1062, citing swanson v. guthrie indep. sch. dist., 135 f. supp. 694 (10th cir 1998). 10 fulton v. philadelphia, 593 u.s. __ (2021) 11 does 1-3 v. mills, 595 u.s. ____(2021). gorsuch, dissent, p. 2. https://www.supremecourt.gov/opinions/21pdf/21a90_6j37.pdf 12 does 1-3 v. mills, gorsuch dissent, p. 3. 13 does 1-3 v. mills, barret, concurring. https://www.supremecourt.gov/opinions/21pdf/21a90_6j37.pdf 14 zimmerman, a. “weeding out disingenuous emergency orders: a consistent ethical justification to determine whether to apply jacobson v. massachusetts’ deferential approach or the tiered scrutiny that would apply absent an emergency”. 2021. voices in bioethics, vol. 7, may 2021, doi:10.7916/vib.v7i.8037. 15 197 us 11 (1905). 16 zimmerman, a. 2021. doi:10.7916/vib.v7i.8037. 17 south bay pentecostal church v. newsom (2021), kagan, dissenting, joined by breyer and sotomayor (justices are “not scientists”.) 18 kaplan, at 1079, citing fraternal order of police v. city of newark, 170 f. 3d 359 (3d cir. 1999). 19 does 1-3 v. mills, gorsuch dissent, p. 4. 20 https://www.ada.gov/comprob.htm 21 keeler v. mayor of cumberland (provisions deemed individualized exemptions so religious deserve strict scrutiny and consideration); rector of st. bartholomew’s church v. city of new york (2d cir. 1990)(discretion does not negate smith if it is not discriminatory so religious does not get strict scrutiny); see kaplan at 1066. 22 cuomo executive order established zones. https://esd.ny.gov/cluster-action-initiative-faq 23 592 us __ (2021). https://www.supremecourt.gov/opinions/20pdf/20a136_bq7c.pdf 24 south bay pentecostal church v. newsom (2021) (dissent).