George P. Smith, ll A professor oflaw at Catholic University in Washington, D.C., since 1977, Professor George P. Smith is an established scholar in the field of Bioetbics and Health Law-with over 175 entries in his bibliography, which includes twelve books, the most recent being HUMAN RIGHTS AND BIOMEDICINE (Kluwer 2000). Among his research affiliations at major universities have been those at Chicago, Columbia, Northwestern, Vanderbilt, Virginia, Princeton, California at Berkeley, The Hoover Institution at Stanford, and The Max Planck Institute in Heidelberg. Professor Smith's consultantships have included those with the International Bioetbics Committee for the UNESCO Declaration on The Protection of the Human Genome, The House Committee on Science and Technology of the U.S. Congress, The New South Wales Law Refonn Commission in Australia, and The Heritage Foundation. A Frequent visitor to the University of Cambridge in England, he has held fellowships at Wolfson and Emmanuel Colleges as well as at Clare Hall and Hughest Hall. Professor Smith received an Australian-American Fullbright Foundation Award in 1984 and is a regular visitor to the Continent-holding visiting pro­ fessorships at the University of New South Wales and the University of Sydney. In 1985, the Indiana University Institute of Advanced Study con­ ferred a citation of merit upon Professor Smith for his "path-breaking inter­ disciplinary research and writing on medical and biological issues as they relate to the norms oflaw and ethics." The University also conferred a Distin­ guished Alumni Award upon him in 1985 and an honorary degree in 1998. Professor Smith is the Founding Faculty Editor of The Journal of Contem­ porary Health Law and Policy at Catholic University and a life member of The American Law Institute. THE VAGARIES OF INFoRMED CONSENT George P. Smith, If' INTRODUCTION AND OVERVIEW Within the phrase informed consent, both manipulative and coercive vectors of force can be found. First, the health care provider [M]ust gain the 'consent' of the patient to prove that she was not physically or psychologically forced into a procedure. We then insist that this consent be 'informed, • recognizing that if a patient readily agrees to something about which she understands little or about which she has a false understand­ ing, we have somehow or other abrogated or sidestepped her autonomous decision-making rights.1 The patient-physician relationship is central to the foundations of medical morality. From it emerge normative guidelines that effectuate ideally the end of medicine-to render "a right and good healing action in the interests of a particular patient."2 Technical competence, then, is shaped by this goal and, indeed, the very acts of the medical profession are to be con­ sidered unauthentic if they neglect to fulfill the real expectation of technical competence. 3 It is upon both the patient-physician relationship and the acknowledged technical competence built by a ''participatory moral agency" that forces disclosure of all levels of information necessary for the patient's valid choice or genuine consent to medical treatments. 4 * lL.D. 1998, Indiana University; lL.M. 1975, Columbia University; J.D. 1964, Indiana University;B.S.196l,Indiana University. Professor of Law, The Catholic University of America, Washington, D.C. Parts of this article are drawn from my book, LEOAL AND HEALTHCARE ETHics fOR THB ElDERLY (1996). 1. WIW..ARDGAYLIN&BRUCEJENNINOS, THE PERVERSION OF AUTONOMY 159 (1996). See generally Edmund D. Pellegrino, Patient cl Physician Autonomy: Conflicting Rights and Obligations in the Physician-Patient Relationship, 10 J. CONTEMP. HEAL1ll L. & POL'Y 47 (1994) [hereinafter Pellegrino, Autonomy]; Edmund D. Pellegrino, The Human Person, the Physician and the Physician's Ethics, 621JNACRE Q. 74 (1995) [hereinafter Pellegrino, Human Person]. 2. Edmund D. Pellegrino, Toward a Reconstruction of Medical Morality: The Primacy of the Act of Profession and the Fact of lllness, 4 J. MED. & PHIL. 32, 47 (1979) [hereinafter Pellegrino, Reconstruction]. 3. Id. at49. 4. /d. SeegenerallyDANIELP.SULMASY,THEHEALBR'sCAwNo:ASPIRmJAUTYR>R PHYSICIANSANDOniERHEAL1liCAREPRCHSSIONAlS(1997);'DIOMASSZASZ,THETHEoLOOY OF MEDICINE ch. 1 (1977). 112 INDIANA HEALTH LAW REv1Ew [Vol. 1:109 While the desire for obtaining information may be seen as stronger than the one for actually making the determinative health care decision itself, not every patient welcomes such information.5 Indeed, realizing that most indivi­ duals make decisions rather badly forces many to choose to delegate medical decision-making to others. 6 For those declining to make their own decisions, it is quite simply psychologically attractive to pass responsibility for hard choices to others. 7 When this delegation occurs, it might be wise to consider developing a "full social impact calculus" which in turn considers all the people affected by it8-immediate family members, close friends, social workers as well as spiritual and health care providers. This calculus could be taken when the initial decision for obtaining treatments or accessing them are made. A full social impact calculus would result in some cases even arising where the sum of the social, economic, and medical consequences "on others may outweigh the impact on the person most affected."9 Patient information deficits must be remedied by the physician to the fullest extent possible.10 The information disclosed must be complete, clear, and understandable in the patient's own language so that the patient knows not only the nature of his or her illness, its prognosis, and the alternative modes of treatment, together with their cost and probable effectiveness, but also the degrees of discomfort and the ultimate side effects on the quality of life. This duty of disclosure cannot be exercised by the physician on the grounds of patient ignorance or harm. To do so would underscore the inequality in information between patient and doctor and obstruct the goal of a morally valid consent that in tum is the memorialization of the patient's individual moral agency.11 The physician must always guard against manipulating patient choice and consent in order to simply accommodate his own personal or social philosophy. Setting valid limits on the degree to which manipulated consent is morally permissible is difficult. Two major situations are commonly recognized in which a physician can, and indeed should, exert moral agency for the patient and make the value choice on his behalf. The most common 5. CARLE. SCHNEIDER, THEPRACTICEOFAUTONOMY,PATIENTS,DOCToRS&MEDICAL DECISIONS 110 (1998). See TERRANCE McCONNElL, INAUENABLE RIGHTS: THE LIMITS OF CONSENT IN MEDICINE AND THE LAW 77, 78 (2000) (maintaining the position that physicians are not obligated to comply with such patient wishes because such a waiver is valid only if it is both voluntary and informed). 6. SCHNEIDER,supranote5,at99. SeealsoMARKA.IIAU.ETAL.,HEALTHCARELAW AND ETHICS 208 (6th ed. 2003). 7. SCHNEIDER, supra note 5, at 175. 8. Roger B. Dworkin, Medicall.4w and Ethics in the Post-Autonomy Age, 681ND. L.J. 727,737 (1993). 9. ld. SeegenerallyROGERB.DWORKIN,LIMITs:THEROLEOFTHELAWINBIOETHICAL DECISION MAKING cb. 7 (1996). 10. Pellegrino, Reconstruction, supra note 2, at 50. But see VEATCH, infra note 47 (discussing the therapeutic privilege to withhold information). 11. Pellegrino, Reconstruction, supra note 2, at 50. 2004] VAGARIES OF INFoRMED CoNSENT 113 case is where the patient and/or family request the physician to act according to their wishes-because of their emotional unwillingness or intellectual inability to deal with the immediate situation. In cases of this nature, it would be a failure of the authenticity of his act of profession for the physician not to assume moral agency and decide what course of action should be taken. When dealing with surrogate decision makers, it is even more important for the physician to ascertain with certainty that the surrogate is being guided by the best interests of the patient. 12 The second situation in which a physician should exert moral agency for the patient occurs in emergency cases, in an intensive care or coronary care unit, or in an operating or emergency room. Because of the urgency of the situation, it is impossible for the physician to consult the patient; therefore, he must consult the patient's immediate family or a designated surrogate decision maker. In both of these situations, the physician's Golden Rule should be to act in such a manner as to "accord the patient the same opportunity to express or actualize his own view of what he considers worthwhile," as would be desired by the physician himself.13 This rule, then, reinforces the mandate not only to bring compassion to the patient's illness, but exhibit the mandate as a "conscious advertence" in the act of profession and the act of medicine as well.14 The other party to informed decision-making is obviously the patient. Thus, the ethics of the good patient require truthfulness in the information given to the physician; avoidance of manipulation; faithful following of mutually agreed upon recommendations; self--education for comprehension of the facts disclosed by the physician; promise not to consult another physician (absent suspicion of either dishonesty or malpractice); and acknowledgment of a partial obligation to participate in reasonable therapeutic experiments designed to promote a healing of the patient" s disease or those directed toward the discovery of possible cures for his or her own disease for others (non therapeutic), provided the other rules for professional behavior are followed.15 12. Id. at 51. 13. Id. 14. Id. 15. Id. at 52.54-5 5. See Len Doyal, TheM oral Importance of Informed Consent in Medi­ cal Research: Concluding Reflections, in INFORMEDCONSENTINMEDICALRESEARCH 313 (Len Doyal & Jeffrey S. Tobias eds., 2001) (arguing that certain types of medical research- epide­ miological, for example-should be exempted from the informed consent requirement and, further, that in certain other cases where the research subject is incompetent, as with children having the consent of their parents, or in trauma cases where there is an acceptable risk-benefit ratio). See DANIEL CAlLAHAN, WHATPRICEBE'ITERHEALTH?: JIAZARDSOFTHEREsEARCH IMPERATIVE(2003)(arguingthetherapeuticlnon-therapeuticdistinctiongivesriseto''therapeu­ tic misconception" which arises when "a clinician researcher carries out research of no expected or intended benefit to a patient but which the patient believes will offer a chance of benefit"). See also Guido Calabresi, Reflections on Medical Experimentations in HU1tlll1ls, 98 DAEDALUS 387, 401 (1964) (advocating some form of consent should always be required which seeks to strike a balance between present and future lives). See generally Jonathan Montgomery,lnform- 114 INDIANA HEALTH LAW REviEW [Vol. 1:109 What is seen in totality, then, between the patient and the physician is a set of mutually binding obligations that, if met, assure informed decision-making in health care services. 16 The ongoing debate regarding the efficacy and integrity of the doctrine of informed consent and its application has been termed "oblique and inconclusive,"17 and indeed a little more than a "fairy tale."18 The reason for this state of affairs is attributed to a structural weakness reflecting not only a rapacious health care delivery system that is increasingly cost-conscious, 19 complex, and sophisticated,20 but also by constraints imposed by the tort law system, human psychology, and the physician-patient relationship,21 all of which are largely intractable. 22 Coupled with these foundational issues is the recognition that the adequate levels of both empirical research and analysis, together with comparative risk evaluation necessary to resolve the uncertain­ ties, is not being pursued.23 Yet, for all of the weaknesses, the doctrine of informed consent and its offspring in elder care, negotiated consent,24 serves a significant purpose in contemporary society-both as a construct and often a template for establish­ ing an interdependent relationship, if not therapeutic partnership, between the patient and his or her physician where truth-telling becomes the crux of the doctrine and a true moral relationship between both parties is recognized. 25 The purpose of this Article, then, is to probe the foundations and applications of informed consent in a variety of situations and thereby test its validity. The conclusion to be drawn from this analysis is that while the doctrine has yet to become an integral part of the ethos of medicine, 26 it still provides an important mechanism for maintaining a purposeful discourse ed Consent in Clinical Research with Children, in INroRMED CONSENT IN MEDICAL RESEARCH, supra note 15, at 173. 16. See Arthur L. Caplan, Informed Consent and Provider· Patient Relationships in Rehabilitation, 69 ARCHIVES PHYSICALMED. &REHABHXrATION 312 (1988); Dan W. Brock, The Ideal of Shared Decision Making Between Physicians and Patients, 1 KENNEDY INST. ETHICS J. 28 (1991). 17. Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899, 904-05 (1994). 18. Jay Katz,lnformed Consent-Mustlt Remain a Fairy Tale?, 10 J. CoNTEMP. HEALTH L. &POL'Y 69 (1993). 19. SeegenerallyTIMOTHYS.JOST,DISBNTITLEMENT: THETHREATSFACINGOURPUBUC HEALTHCARE PROGRAMS AND RIGHrS-BASED REsPONSE (2003); ELEANOR D. KINNEY, PROTECTING AMERICAN HEALTH CARE CONSUMERS (2002); George P. Smith, ll, Distributive Justice and Health Care, 18 J. CONTEMP. HEALTH L. & POL'Y 421 (2002). 20. See generally SCHNEIDER, supra note 5. 21. Pellegrino, Autonomy, supra note 1; Pellegrino, Human Person, supra note 1; SCHNEIDER, supra note 5, at 205; Schuck, supra note 17, at 905. 22. Schuck, supra note 17. at 905. 23. /d. 24. See generally Harry R. Moody, From Informed Consent to Negotiated Consent, 28 GERONTOLOGIST 64 (Supp. 1988). 25. GA YLIN & JENNINGS, supra note l, at 55. 26. Katz, supra note 18, at 91. 2004] VAGARIES OF INFORMFD CoNSENT llS between physician and patient and, as such, nurturing and preserving their essential partnership of healing and trust. 27 I. MALPRACTICE AND INFoRMED CONSENT A. Professional or lAy Standards A claim for malpractice is recognized essentially when a patient, as a direct result of a physician's failure to render that level of care consistent with what would have been given by other practicing physicians in the conununity in question, is injured. 28 Thus, the standard of conduct against which the defending physician's behavior is measured is tied to the conduct other similarly situated professionals in the field would have followed under the same or similar circumstances. The end result of this evaluation process is that the objective standard of reasonableness is thereby excluded totally from the evaluation.29 As to the elements of establishing a cause of action for failure to obtain informed consent for either a medical treatment or procedure, there is less uniformity of view.30 Indeed, under older case law, the duty to obtain informed consent for a medical intervention was inherent in the essential idea that nonconsensual touching was, and is, a legal battery.31 Modem case law, however, now takes one of two approaches to the duty to obtain informed consent,32 yet treats the central issue as one ofnegligence.33 27. See geMrally Pellegrino, Autonomy, supra note 1; Pellegrino, Human Person, supra note 1; Edmund D. Pellegrino, Rationing Health Care: The Ethics of Medical Gatekeeping, 2 J. CoNTEMP. HEALTH L. & PoL'Y 23 (1986) [heleiruifter Pellegrino, Gatekeeping]. See also Mark A. Hall, Law, Medicine and Trust, S5 STAN. L. REv. 463, 478 (2002} (maintaining that without a minimal level of trust. patients will neither disclose infonnation to the physician nor follow medical recommendations made to bim or her). 28. Laura Hunter Dietz, Annotation. Physicians, Surgeons, and Other Healers, 61 AM. JUR. 2D PhysiciQns § 202 (1981). See also HAlLET AL, supra note 6, at 201, 203, 210. 29. Dietz, supra note 28. 30. Id. See Aaron D. Twerski & Neil B. Cohen, Informed Decision Making and the Law of Torts: The Myth of Justiciable Caustztion, 1988 U.IU.. L. REV. 007 (1988). 31. Dietz,supranote28,§§ lS0-52. SeeFoWLBRV.HARPERBTAL,LAWOFTORTS§3.2 (2ded. 1986). 32. Hunter L. Prillaman, A Physician's Duty to Inform of Newly Developed Therapy, 6 J. CONTEMP. HEALTH L. & PoL'Y 43, 44 (1990). 33. Dworkin, supra note 8, at 729. Since the 1957 decision in Salgo v. Leland Stanford Jr. University Board ofTrustees, the courts have been emphasizing and developing a negligence offailure to use due care theory of liability. 317 P.2d 170, 181 (Cal. Ct. App. 1959). This theory in tum places the physician in default for failing to educate adequately his patient to the collateral risks involved in the treatment. Indeed. Salgo provided the groundwork for the explosion of cases dealing with informed consent. In Salgo, as now, the physician is confronted with a perplexing problem: namely, how to balance the patient's need to know the risks and alternatives to treatment in order to give an informed consent with the individual patient's mental and emotional condition to accept and understand the medical infonnation. Id. See also 116 INDIANA HEALTH LAW REVIEW [Vol. 1:109 Some states require a professional standard to be followed that in tum imposes a duty upon all physicians to inform their patients of not only the risks, but also the alternatives to any proposed medical treatment in the same manner as other physicians would practicing in the community.34 Accord­ ingly, in a 1981 illinois case,35 the court held that applying the reasonable medical practitioner standard of informed consent meant that there must indeed be specific expert medical testimony "of the necessity to inform patients of possible altematives."36 Consequently, adherence to that level of care given in the relevant community by other practitioners applies both to malpractice actions and the separate action of failure to obtain informed consent.37 Other states choose to apply the lay or prudent patient standard of informed consent, thereby requiring a physician to inform his patient of all sources and degrees of information which an average, ordinary, and reason­ able patient should and would require in order to make an informed decision regarding the need to submit to a proposed treatment therapy. 38 Under this standard of informed consent: [A] physician is liable to his or her patient if (l) the physician fails to disclose any risk in the recommended treatment, or the existence of any alternative method of treatment, that a reasonable person would deem material in deciding whether to undergo the recommended treatment; (2) the patient would have foregone the recommended treatment had he or she known of the undisclosed information; and (3) as a result of David Thomasma & Edmund D. Pellegrino, Medicine, Science, Self-Interest: Value Sets in Conflict in Human Experimentation, in RESEARCH ON HUMAN SUBJECT'S: Ennes, LAw AND SOCIALPOUCY xvii passim (David N. Weisstub ed., 1998). Therefore, under Sal go, a physician owes a duty to his patient to disclose facts necessary to the formation of an intelligent consent and, further, subjects himself to liability for violation of that duty. Sal go, 317 P .2d at 181. At best confusing, the Salgo rule allows plaintiffs counsel to argue that there must be full disclosure because of the established duty to disclose. However, a court may use Salgo as justification for holding in favor of a defendant on the issue of the adequacy of disclosure-sustaining the proposition that the amount of information the physician gave the patient was sufficient for him to understand the risks and alternatives of the proposed treatment. Myers, infra note 44, at 1399. The discretion allowed to physicians has tended to subject them to liability in cases involving high risk and to exonerate them when a court considers the risk to be light. Id. 34. Hondroulis v. Schuhmacher (Hondroulis ll), 553 So. 2d 398 (La. 1988). 35. Ziegert v. S. Chi. Cmty. Hosp., 425 N.E.2d 450 (lll. App. Ct. 1981). 36. Prillaman, supra note 32, at 45. 37. Jd. 38. ld. See generally lNST. OFMED., RESPONSffii.E RESEARCH: A SYSTEMS APPROACH TO PROTECTING RESEARCH PARTICIPANTS (Daniel D. Federman et al. eds., 2003); KENNETH GETZ & DEBORAH BORFITZ, INFoRMED CONSENT: A GuiDE TO THE RISKS AND BENERTS OF VOLUNTEERING FOR CUNICAL 1'RIALs (2002); 45 C.F.R. § 46.101 (2004); 21 C.F.R. § 50.1 (2004). 2004] VAGARIES OF INFORMED CONSENT the recommended treatment, the patient actually suffers an injury the risk of which was undisclosed, or the patient actually suffers an injury that would not have occurred had the patient opted for one of the undisclosed methods of treat­ ment.39 II. THE FOUNDATIONAL PARADIGM 117 The 1972 case of Canterbury v. Spence40 presents a modem, comprehen­ sive, and focal paradigm of the legal concept of informed consent in applica­ tion. In Canterbury, a young boy complaining of back pain submitted to a myelogram which revealed a filling defect. The boy's mother was contacted after the test and an operation was recommended by Dr. William T. Spence, the attending physician, stating that such an operation was "not anymore [serious] than any other operation.'>41 The boy submitted to the operation without being informed that paralysis was a risk of the procedure. Mrs. Canterbury arrived at the hospital after the operation and signed a consent form. The boy fell from his bed a day after the operation while, without assistance, he attempted to void. He thereupon became paralyzed and was required to undergo a second surgery. This time, Mrs. Canterbury signed a consent form before the operation. Years later, the youth ''hobbled about on crutches, a victim of paralysis of the bowels and urinary incontinence. "42 At trial, Dr. Spence testified that there was only a one percent risk of paralysis occurring after this type of surgery. The central issue of the case was the scope and application of the doctrine of informed consent Because there is a duty to disclose risks of a procedure, the scope of that duty should be known. Any standard set in terms of what is done in the medical profession will be at odds with the patient's prerogative to decide on prospective therapy. This "right of self-decision shapes the boundary of the duty to reveal.'>43 In order that the patient's interest in achieving his own determination of treatment is fulfilled, it is the law which must set the standard for adequate disclosure. 44 The test enunciated in Canterbury is that a "risk is thus material when a reasonable person, in what the physician knows 39. Neal v. Lu, 530 A.2d 103, 111 (Pa. Super. Ct. 1987). See also Festa v. Greenberg, 511 A2d 1371 (Pa. Super. Ct. 1986); Salis v. United States. 522 F. Supp. 989 (Pa. D. 1981). 40. Canterbury v. Spence, 464F.2d 772 (D.C. Cir.1972). Accord Wilkinson v. Vesey, 295 A2d676 (R.I.1972). SeealsoCobbsv. Grant.502P.2d 1 (Cal.1972);Natanson v. Kline, 350 P.2d 1093 (Kan. 1960), clarified by 354 P.2d 670 (Kan. 1960); Schloendorffv. Soc'y of N.Y. Hosp., 105 N.E. 92 (N.Y. 1914), overruled on other grounds by Bing v. Thunig, 143 N.E.2d 3 (N.Y. 1957). 41. Canterbury, 464 F.2d at 777. 42. Id. at 776. 43. ld. at 786. 44. See Michael Justin Myers, Comment. Informed Consent in Medical Malpractice, 55 CAL. L. REV. 1396, 1407-10 (1967). 118 INDIANA HEALTH LAw REviEW [Vol. 1:109 or should know to be the patient's position, would be likely to attach signifi­ cance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.',..5 This includes a discussion ofthe inherent and potential dangers of the proposed treatment, the alternatives to that treatment, and the likely results if the patient remains untreated. The courts have noted two exceptions to the general rule of disclosure. The first is where the person is unconscious or otherwise incapable of con­ senting and there is imminent harm that would result from failure to treat, which in tum outweighs any harm threatened by the proposed treatment.46 If possible, consent of relatives should then be obtained. The second exception arises when the disclosure itself threatens the patient and thus becomes infeasible from a medical point of view. The critical inquiry, then, would be whether the physician was guided by sound medical judgment 47 This privi­ lege does not carry with it the paternalistic notion that the physician may remain silent simply because diligence might prompt the patient to forego the physician's recommended therapy.48 The danger of this second exception is that it may be judged by a subjective, hindsight test Canterbury speaks to this concern and resolves it by requiring a determination of whether a prudent person in the patient's position would have decided to undergo treatment "if suitably informed of all perils bearing significance.',..9 This affords opportunity for medical testimony regarding the relevance of certain risks, as well as other testimony by anyone 4.5. Canterbury, 464 F.2d at 787. 46. See Dunham v. Wright, 423 F.2d 940, 941-42 (3d Cir. 1970). 47. See Roberts v. Wood, 206 F. Supp . .579, .583 (S.D. Ala. 1962). See also THOMAS BEAUCHAMP & JAMES CHn.DREss, PRINCIPLES OF BIOM!!DICAL ETHics ch. 3 (1979). A therapeutic privilege exists to withhold information from a patient if it is either considered potentially harmful or it would cause any counter-therapeutic deterioration-no matter bow slight-in either the patient's physical. psychological. Or emotional well being. RoBERT M. VEATCH, MEDICAL ETHics 203-04 (2d ed. 1997). The "urgency of the situation" justifies this exception to the doctrine of informed consenL JAY KATZ, ExPERIMENTATION WITH HUMAN BEINGS: THE AUTHORITY OF THE INvEsTIGATOR, SUBJECI', PROR:SSION AND STATE IN THE HUMAN EXPERIMENTATION PROCESS 37, 84 (1972). See also Kathleen M. Boozang, The Therapeutic Placebo: The Case for Patimt Deception, .54 FLA. L. REv. 687, 746 (2002) (arguing, for example, that if viewed as effec:tive treatment. with a therapeutic effect being achieved by its prescription and use. the repn!Selltation that placebo use is therapy or medicine is neither untrue nor unethical); HAIL ET AL,IIIpra note 6, at 207; George J. Annas, Questing for Grails: Duplicity, Betrayal and &If-Deception in Postmodern Medical Research, 12 J. CoNTEMP. HEAL'IH L. & PoL'Y 297, 300, 314 (1996) (asserting that the very concept of therapeutic research should be eliminated altogether since it c:onfuses the ideology of medicine with the ideology of science). 48. Myers, supra note 44, at 1409-10. Su geMrally Allan Meisel, The "Exceptions" to the lliformed Consent Doctrine: Striking a Balance Between Competing Values in Medical Decisionmaking, 1979 WIS. L. REv. 413. 49. Canterbury, 464 F.2d at 791. 2004] V AGARJES OF INFORMED CONSENT 119 having sufficient knowledge and capacity to testify. The courts thus assume a detenninative role in assessing liability.50 In the pre-Canterbury period, courts sought to enforce a narrower objective test for materiality (reasonable doctor) and a broad-based test for causation (subjective patient). With Canterbury, a broad test for materiality is advanced (reasonable patient) and a narrower objective test for causation (what a reasonable patient would have chosen) preferred. 51 Criticism has been maintained that with Canterbury the courts are incorrectly treating infonned consent as yet another branch of negligent medical practice instead of recognizing the patient's interest in autonomy and his or her right to make an informed choice about medical care. This right is the key interest protected by the infonned consent doctrine. However, these criticisms are muted when hard questions are raised regarding how to value·the protected interest and determine damages for interference thereto. 52 A Alternative Treatment Utilizing either the professional standard or the lay standard of informed consent. a physician is under a duty not only to· inform his patient of appropriate alternative treatments, in addition to the alternative of no treatment at all, but also to describe and evaluate the benefits and the risks of those treatments to his at-risk patient. 53 Not every "conceivable alternative to every detail of treatment'' need be provided, however. 54 Setting the limits of a physician's duty to inform patients of alternative treatments continues to be a struggle for the courts. If a professional standard of informed consent is adhered to, much difficulty in application is alleviated, since a jury panel will seek to decide the issue in conflict by comparing the testimony of competing medical experts." If, however, the lay standard is followed, the jury determination is more complex because an evaluation must be made of what an ordinary, reasonable patient would both want and need to know under similar circumstances. 56 50. Landmark examples of the way in which courts have treated the application of informed consent include: Com v; French. 331 P.2d 850 (Nev. 1958) (physician held liable where mastectomy was performed with a signed consent form, but patient had told physician that she did not want anything removed); DiRosse v. Wein. 24 A.D.2d 510 (N.Y. 1965) (failure to tell of the danger of exfoliative dermatitis from gold treatment for rheumatoid arthritis, resulting in exfoliative dermatitis, imposed liability on the physician); and Darrah v. Kite, 32 A.D.2d 208 (N.Y. App. Div. 1969) (failure to give adequate and timely explanation of the risks of ventricolograms, imposed liability on a neurologist). 51. Twerski & Cohen, supra note 30, at 615 n.30. 52. Jd. at 620 n.47. 53. Prillaman, supra note 32, at 47. 54./d. 55. Jd. at 48. 56./d. 120 INDIANA HEALTH LAW REVIEW [Vol. 1:109 Obviously, a decision reached according to this standard ·requires considerable and complex analysis of the credibility of opinions of opposing experts on varying community standards. Of additional complexity is the court's need to comprehensively instruct a jury on the elements of a medically acceptable alternative before the jury can be allowed to decide whether the average reasonable patient would indeed have wanted to know of the alternative. 57 Medical acceptability is the criterion by which a fact finder determines whether an alternative treatment is to be disclosed. 58 The obvious difficulty here is fully comprehending those components or elements of a particular treatment, especially a new one, that make it acceptable and determine to whom it must be found acceptable.59 "In terms of a doctor's duty to disclose, this issue can be broken down into two parts. First, what criteria, objective or subjective, make a particular treatment acceptable? Second, are there additional factors which create (or excuse) the particular physician's duty to know about the treatment?"60 Every new medical treatment, whether it be surgery, drug therapy or an exotic technique, is initially experimental.61 In those cases where a lay approach to informed consent is followed, it must be first recognized that it cannot be extended effectively to determine what specific alternative treatments are medically acceptable, although it may well indeed be used as a mechanism through which acceptable treatments are revealed. 62 The juries applying the lay standard or approach to determine what a reasonable patient would have considered medically valid and acceptable leads to an interesting quandary for the concerned physician: the physician would never be in a position to know precisely which alternatives he or she must describe. This in turn could drive the physician to describe even quack treatments for fear that a future jury could fmd that a reasonable patient might have wished to be informed of such treatments. 63 A wiser approach acknowledges the standard for medical acceptability is based solely on the perception of the reasonable practitioner.64 Here, the pivotal inquiry would not necessarily be whether a reasonable practitioner would inform a patient of the particular alternative. Rather, the question to be raised would be simply whether an average, reasonable practitioner would 57. Id. 58. Id. at 52. 59. Prillaman, supra note 32, at 52. 60. Id. 61. ld. In a landmark 1990 case in California, it was determined that an individual patient must first give an informed consent to a surgical procedure that would in turn yield tissues which would be transformed, subsequently, through genetic engineering, into commercial products of considerable value. Moore v. Regents of the Univ. of Cal., 793 P.2d 749 (Cal. 1990). 62. Prillaman, supra note 32, at 57. 63./d. 64./d. 2004] VAGARIES OF INFoRMED CoNSENT 121 believe the treatment was a viable, medically acceptable alternative; or stated otherwise, whether it was recognized as an appropriate modality of treatment by a significant number of acknowledged experts in the field. 6S The role of expert testimony then would essentially be to explore both the number and the respectability of those accepting the treatment.66 Developing and following this standard would allow a physician to: [A]void the danger of having to describe the theories of quacks or to. explain treatments too new to have a track record, but could still be held to hav~ a duty to keep up with the relevant literature and other sources of information, and to inform patients of new treatments as they met the criteria of acceptance.67 B. Future Treatment It is often maintained that if a particular medical treatment were to be classified as futile, an attending physician is under no obligation to provide it to his or her patient. Indeed, the assertion goes even further: namely, that the physician needs not even advise a patient of the existence of such treatment.68 Judging the futility of any treatment is, arguably and correctly, a medical matter. 69 No input from the patient is thus required 70 Since a futile treatment offers no benefit to the patient, it .can be argued that a physician has neither obligation to render treatment of a non-~neficent nature nor-for that matter-does a patient have a right to ~d it. 71 Without knowledge of a medical or surgical alternative and without having access to information regarding the pros and cons of each, a patient obviously has few if any tools with which to form a therapeutic alliance with a physician or even enter into a meaningful treatment dialogue with that physician. 72 While the physician avoids conflicts with his or her patient, this veil of silence often robs the. patient of the right to self-determination, all under the guise of medical paternalism. 73 Whenever a treatment is labeled futile, it is exempted from the requirement of discussion. Thus the label itself "becomes a very powerful tool for relieving physicians of the requirement to 65. Id. 66. Id. at 58. 67. Id. 68. SusanM. Wolf, ConflictBetweenDoctorandPatient, 161 L.MED.&HEALTHCARE 197, 198 (1988). 69. Id. 70. Id. 71. Id. 72. ld. at 198. See generally JOSEPHM. JACOB, DocTORS AND RUU!S (1988). 73. See generally AU.ENE. BUCHANAN & DANW. BROCK, DEciDING FOR OTHERs: THE ETHics OF SURROGATE DECISIONMAKING (1989). 122 INDIANA HEALTH LAW REVIEW [Vol. 1:109 talk with their patient. The label marks off. a realm in which it is argued that the requirement does not apply ."74 C. Uninsurable Treatment Options The results of an interesting and disturbing 1988 survey, supported by the American Medical Association's Institute for Ethics and drawn from a random sample of l,l24licensed United States physicians, were published recently?5 Sixty-four percent responded (720 physicians)/6 Respondent physicians empirically validated the belief that physicians are uneasy in describing medically indicated care not covered by insurance.77 Because of restrictions in various health plans, useful patient care was sometimes not offered by thirty-one percent of the reporting physicians in the survey. 78 Within this group thirty-five percent reported, additionally, that this course of action is more common today than it was five years ago.79 On the other hand, sixty-nine percent of the physician-respondents stated that they rarely or never followed this practice.80 One ethical rationale for not offering useful services not covered by insurance is physician discomfort over requests by patients to game the system, or, in other words, manipulate and deceive third party payers in their health plans. 81 Inasmuch as the vast majority of physicians believe such patient requests are unethical, some might avoid such tense encounters by electing not to offer useful but uncovered services. 82 Other reasons proffered for refusing health care infonnation include, rather paternistically, the compassionate desire not to raise levels of expecta­ tion, especially for Medicaid or other economically impoverished patients who have medical coverage restrictions. In other words, "why offer a useful medical service to someone who cannot afford it?"83 Financial pressures on physicians are also seen as a significant determinant in decisions to withhold treatment information. For physicians 74. Wolf, supra note 68, at 199. See generally George P. Smith, ll, Utility and the Principle of Medical Futility: Safeguarding Autonomy and the Prohibition Against Cruel and Unusual Punishment, 12 J. CONTEMP. HEALTH L. & PoL'Y 1 (1996). 75. Matthew K. Wynia et al., Do Physicians Not Offer Useful Services Because of Coverage Restrictions, 22 HEALTHAFF. 190, 191 (2003). 76./d. 77. ld. at 194. 78. ld. at 193. 79./d. 80./d. 81. Wynia et al., supra note 75, at 194. 82./d. 83. Id. at 194-95. See also HALLET AL., supra note 6, at 191. 2004] VAGARIES OF INFoRMED CoNSENT 123 with "more than 25 percent of income at risk'• for patient care costs. the trend is to neglect to offer patients optimal but uncovered services. 84 Sadly. the results of this study parallel-and. indeed. revive-earlier institutional concerns over gag clauses in managed care programs. In the late 1990s, these provisions were thought of as prohibiting physicians, by contract. from discussing with their patients medical service options which were not covered in their health plans. 85 . Adding significantly to present patient mistrust of the medical profession, this 1998 survey confirms the fact that gagging continues, not by contract, necessarily, but for other reasons as noted, all.of which have the ultimate effect of compromising the very doctrine of informed consent. 86 The pivotal ethical concern, then, is: "to what degree is it possible, and a professional obligation, for physicians to try to explain to their patients why some useful services are not coveredT'87 ill. INFORMED DECISION-MAKING AND NEGOTIATED CoNSENT Although it is seen that the foundation of informed consent is now well embedded in both the legal and medical arenas, negotiated consent is far from being as widely accepted. In fact, the ideal of negotiated consent is only beginning to emerge as a viable alternative to the traditional informed consent standard, particularly with application to healthcare for the elderly. The informed consent standard, which is based upon autonomy, emerged from the acute care environment and from a narrowly conceived view of the relationship between professional caregivers (physicians) and those dependent upon them (patients).88 Similarly, the concept of negotiated consent recognizes the ideal of autonomy, yet in a more limited fashion. 89 Negotiated consent recognizes the need for some version of "autonomy respecting paternalism" in the environment of long-term care, particularly involving elderly patients.90 Fundamentally, paternalistic .interventions that serve to 84. Wynia et al., supra note 75, it 194-95. 85. /d. at 196. 86./d. 81./d. 88. Moody, supra note 24, at 64. See Brian F. Hofland, Autonomy in Long Term Care: Baclcground /ssua and a Progr(mrmatic Response, 28 GERONTOLOOIST 3, 4 (1988) (observing tbat "patient ..• autonomy is not a value indigenous to medical contexts. but one imported into medicine from extrinsic social agendas such as tbat of constitutional law and the evolution of individual rights''). See also Dwoddn, supra note 8, at 737 (challenging the view tbat autonomy should be the dominant value in medical law and ethics). 89. Moody, supra note 24, at 64. 90. /d. (quoting DoNALD V ANDEVBBR, PATERNAUSTIC INTERVENTION: THE MORAL BOUNDS ON BENEVOI..ENCE (1986)). Su generally VANDEVEER supra. 124 INDIANA HEALTH LAW REVIEW [Vol. 1:109 enhance autonomy and allow patients to decide and act in keeping with their own values compose the underpinnings of negotiated consent.91 A. Working Principles In light of the unique issues and moral dilemmas involved in long-term care for the elderly, the interactions between patients and practitioners are primarily acute transactions.92 As such, enhancing the autonomy among patients of long-term care facilities is an extraordinarily difficult task. 93 The conditions at hand are very different from those encountered outside of residential care facilities, where informed consent is the prevalent model.94 Recognizing these differences, negotiated consent attempts to address the various concerns involved and balance the involved parties' competing interests.95 Under the negotiated consent standard, many legitimate views must be considered involving the patient, family, and institution. 96 The results are shared or dispersed authority for decision-making in which no single party has the exclusive power of decision97 and a nonalgorithmic process whereby negotiation is not governed by strict deductive rules.98 Instead, negotiation is "more heuristic in its cognitive style, implying less reliance on codes of ethics and more attention to opportunities for discussion .... "99 Even in those instances in which the ideal outcome is not attainable, a common situation among the frail elderly, negotiation serves to make the best of a bad situation."100 In order to implement effectively negotiated consent, there must be active participation by the patient or the patient's surrogate and consultation with all parties holding an interest in the decision. 101 Furthermore, the patient must have at least a cursory knowledge of legal and ethical rights and the 91. Moody, supra note 24, at 64. 92. Id. 93. See Harry R. Moody, Ethical Dilemmas of Nursing Home Placement, 11 GENERA· TIONS 16-23 (1987). The difficulties are heightened by professional interventions that verge on being more social than medical (e.g., eating, bathing, exercise), the patients' need for a degree of regimentation in their lifestyles, and the continuous fluctuation in competency or decisional capacity of the patients. See also Moody, supra note 24, at 64-65. 94. Moody, supra note 24, at 65. 95. Id. 96. !d. at 67. 97. !d. Instead, negotiated consent proposes the structure of a team decision-making pro­ cess, allowing for greater influence and more effective communication. Id. 98. Id. 99. Moody, supra note 24, at 67. 100. Id. 101. Id. The notion exists, particularly with elderly patients, that a patient ought to be aware that negotiations are underway. Furthermore, the patient should know which parties are active participants in the negotiation process, and, ultimately, any decision derived should be presented in such a manner as to be publicly defensible on a wide-scale basis. Id. at 68. 2004] VAGARIES OF INFORMED CONSENT 125 "opportunity for scrutiny and enforcement of those rights through some outside, higher authority .... " 102 In addition, the element of power in the deliberative process plays an integral part of the negotiated consent formula.103 Obviously, little chance for negotiation exists if one party has such superior power as to leave the other party with no chance for deliberation. 104 By the same token, negotiated consent does not insist on absolute equality between the parties, either. 105 Instead, the doctrine essentially supports the concept of "shared decision-making" between the physician and patient in those situations in which it is possible. 106 Although the ideals of virtue and compassion called for in negotiated consent may be sophistic, they are by no means quixotic. The introduction of negotiated consent in health care for the elderly is designed primarily to urge a different set of ideals and emphasize that practitioners must demonstrate virtues alongside the purported rights a patient is assumed to possess. 107 B. New Directions In American society, individuals who reach the age of majority are permitted a broad range of choice.108 They may choose their jobs, their relationships, and the patterns by which they live. 109 These rights of choice, however, are often denied to elderly persons because they are unable to effectuate preference without assistance.110 On November 1, 2002, the United States Census Bureau estimated one in every eight Americans (roughly, 12.3% of the total population) was sixty­ five years of age and over-drawn as such from a total figure of 34.9 million in this age group.111 The American Hospital Association has determined that a 7.9% increase in hospitalization occurs whenever there is a 10% increase in 102. ld. at67. 103. ld. 104. Moody, supra note 24, at 68. 105. /d. Although the physician's base of experience endows physicians with greater facili­ ties to reason more accurately about medical issues than can their patients, the patient has the option of non-compliance and thereby retains an element of power for himself. Id. See also SCHNEIDER, supra note 5, at 110. 106. SeeMoody,supranote24,at68(citingUNITEDSTATES,PREsiDENT'SCOMM.FORTHE STUDY OF ETHICAL PROBLEMS IN MED. & BIOMEDICAL & BEHAVIORAL RESEARCH, MAKING HEALTH CARE DECISIONS: A REPORT ON THE ETHICAL AND LEGAL IMPUCATIONS OF INFORMED CONSENT IN THE PATIENT-PRACTITIONER RElATIONSHIP (1982)). 107. Moody, supra note 24, at 69. 108. Nancy N. Dubler, The Dependent Elderly: Legal Rights and Responsibilities in Agent Custody, in ETHICAL DIMENSIONS OF GERIATRIC CARE 137 (Stuart F. Spieker et al. eds., 1987). 109. ld. 110. Id. 111. U.S. CENSUS BUREAU, Resident Population Estimates of the United States by Age and Sex: April], 1990toJuly 1, 1999, withShort-TermProjectionstoNovember 1, 2000,available at http://www .census.gov/populationlestimates/nationlintfile2-l.txt (last visited Feb. l, 2004 ). 126 INDIANA HEALTH LAW REVIEW [Vol. 1:109 the number of seniors.112 Thus, it is predicted that a majority of hospital services, 51% of inpatient admissions and 59% of beds, will be given over to the elderly by 2027. 113 By 2030, it is predicted this very group will top seventy million people, meaning about one out of every five Americans will be included.U4 As the population of aging citizens grows, so does the need for such citizens to make pivotal decisions regarding their medical treatment.115 Reality dictates that the capacity of elderly patients to make such decisions is often impaired by a higher incidence and prevalence of chronic brain disease,116 coupled with the burden of coping with numerous other medical afflictions. Moreover, the risk for elderly patients may be compounded because they are more likely to be excluded from the medical decision-making process as a result of reduced physician contact, ageism, and paternalism. 117 Even for the elderly patient, informed consent for medical decision­ making has been the standard consent practice in the medical community for a number of years.118 However, for the elderly, this process has failed in a number of areas, one of which is the issue of a patient's competence to consent to treatment. 119 Thus, with the doctrine of negotiated consent as an alternative to the traditional model of informed consent, the needs and desires of elderly patients ideally have a greater chance ofbeing addressed adequately and equitably. Dependent elderly persons pose a special problem for healthcare professionals in that their decisions often require the involvement of helpers and facilitators. 120 Such involvement may result in differing standards of judgment and measures of worth being applied to an elder's individual choice. 121 The results are conflicting value systems that often reflect the competing concerns of institutional and individual self-protection and 112. Laura B. Benko, Boomer Bust?, MODERN HEALTHCARE, July 28, 2003, at 24. 113. /d. See also L.J. Fitten & M.S. Waite, Impact of Medical Hospitalization on Treat· ment Decision-Making in the Elderly, 150 ARCHIVEs INTERNAL MEn. 1717 (1990). See gener· ally James Lubitz et al., Health, Life Expectancy, and Health Care Spending Among the Elderly, 349 NEW ENG. J. MED. 1048 (2003). 114. Betty Booker, Nursing-Home Costs Soar; Local Prices Average $64,000 Annually, RICH. TIMES DISPATCH, Aug. 7, 2003, atAl. llS. Fitten & Waite, supra note 113, at 1717. 116. See id. See also Emre Kokmen et al., Epidemiologic Patterns and Clinical Features of Dementia in a Defined U.S. Population, lOS TRANSACTIONS. AM. NEUROLOGICAL Ass'N. 334-36 (1980); W.A. Rocco et al., The Epidemiology of Dementia. 19 ANN. NEUROLOGY 415, 415-24 (1986). 117. Fitten & Waite, supra note 113, at 1717. 118. Seeid. 119. See id. 120. Dubler, supra note 108, at 137. See generally LJ. Fitten et al., Assessing Treatment Decision-Making Capacity in Elderly Nursing Home Residents, 38 J. AM. GERIATRICS Soc'y 1097 (1990). 121. Dubler, supra note 108, at 137. 2004] VAGARIES OF INFoRMED CoNSENT 127 convenience. 122 In the end, the elderly person is at a great risk of losing the right to decide the course and conduct of his or her life.123 In such a scenario, the model of negotiated consent provides a realistic and viable means by which the interests of all parties involved may be represented. Negotiated consent allows for the interaction of all affected parties, including the patient, family, clergy, and physicians.124 This process assures the presentation of a multitude of differing views while, ideally, preserving the values of the patient. The process of negotiated consent also combats another weakness of the traditional informed consent doctrine. Commonly, informed consent can provoke anxiety and evoke previous experiences, fantasies, and associations for a patient, triggering an occasional primitive defense response. 125 With negotiated consent, the interaction of the parties and the commitment to shared dialogue should reduce the likelihood of such a response, if not completely eliminate it. A further deficiency of the informed consent model, as applied to older patients, is their inability to comprehend the specific elements of informed consent information. 126 Thus, as a group, geriatric patients may have some impairment in providing their informed consent with regard to medical procedures. 127 Because the process of negotiated consent involves, among other things, the friends and family of the patient, it is likely that a greater sense of trust exists among the parties, particularly if the patient needs assistance to comprehend fully the intricacies of the specific consent. However, the doctrine of negotiated consent is certainly not without its shortcomings. First of all, self-determination for long-term care residents is a valid ideal; however, it requires opportunity, capacity, and motivation on their part.128 Although the opportunity and capacity factors receive a majority of the attention within the medical community, the motivational factor must be addressed seriously, particularly with elderly persons.129 If elderly patients 122. ld. 123. Id. 124. Moody, supra note 24, at 67. See also Dworkin. supra note 8, at 737 (arguing for a "full social impact calculus" in the decision-making process). 125. J.P. Hess et al., Some Psychological and Legal Considerations in the Determination of Incompetence in the Elderly, 7 MED. L. 151, 153 (1988). 126. B. Stanley et al., The Elderly Patient and Informed Consent, 252 JAMA 1302, 1305 (1984). 127. Id. The study revealed that, in comparison to their younger counterparts, older patients did show poorer comprehension, yet, generally seemed to make equally reasonable decisions. ld. Thus, significant adverse effects were not noted until the ability to comprehend was considered severely impaired, as in the case of severe senile dementia. ld. 128. Moody, supra note 24, at 69. 129. ld. Moody points out that, especially with elder patients, it is possible to provide opportunities and to safeguard rights, but without motivation, patients will derive no benefits from these acts. ld. It is essentially a patient's own h'berty that he or she must exercise in order to take advantage of the opportunities that are available. ld. 128 INDIANA HEALTH LAw REVIEW [Vol. 1:109 are not sufficiently motivated to exercise the rights being secured for them, the doctrine of negotiated consent serves no additional benefit for the patients. Moreover, entertaining the multitude of opinions necessary for negotiated consent may require an overly burdensome and time-consuming recording process, and could even result in an invitation to litigation should the parties to the negotiation decide later that they are dissatisfied with the outcome.130 Although perhaps a valid criticism, recording the outcome of the negotiation is obligatory for the process of negotiated consent to remain valid. 131 N. CONCLUSIONS Perhaps it is a correct assessment that no meaningful collaboration or hoped-for therapeutic alliance can be achieved between doctor and patient until physicians treat patients as adults and not children; learn that there is a real distinction between the physician's ideas of best treatment and those which are seen as best by their patients; and, furthermore, learn how to acknowledge their own ignorance in diagnosis, as well as treatment and prog­ nosis. Acting in such a manner will allow the patients to better understand the inherent uncertainties in both the art and science of medicine which, in turn, give rise to valid differences of belief based upon clinical experience. 132 Sadly, all too often, the quest for diagnosis and cure, or what has been termed "The Riddle," seduces many physicians and forces them to ignore the realities of pathological processes. 133 In projecting the future of health care for the elderly, the standard of negotiated consent is undoubtedly a more desirable standard to implement for all parties involved than the traditional informed consent Despite the assault on its viability, the imperative of negotiated consent focuses ultimately on the concept of "keep listening" as opposed to "keep talking."134 This goal, even though often times difficult to achieve, may provide the elderly patient with a stronger sense of participation in the direction of his or her medical treat­ ment and, hopefully, with a greater sense of trust and confidence, allow the "ethics of intimacy rather than the ethics of strangers [to] ... take root and flourish."135 Seen as a normative value rather then an empirical constant, 136 perhaps, in reality, the consequences of the doctrine of informed consent are of less 130. Id. at 68. 131. See id. A basic example of what should be recorded is as follows: "Family talked it over and decided in favor of trying the new treatment Patient agreed it was best." Moody, supra note 24, at 68. 132. JAYKATZ, THESILENTWoRIDoFDocToRANDPATIENTxi(1986). 133. SHERWIN B. NULAND, How WE Dm: REFI..OCTioNS oN LIFE's FINAL CHAPTER 249, 265 (1994). 134. Moody, supra note 24, at 70. 135. ld. at69. See generallyHARRYRMooDY,ETHICSIN ANAGINGSOCIETY(l992). 136. Schuck, supra note 17, at 932. 2004] VAGARIES OF INFoRMED CONSENT 129 importance than the values its seeks to promote.137 To be sure, the doctrine needs to be contextualized both procedurally and substantively in legal doctrine.138 Setting new dialogic responsibilities for physicians, however, may not succeed in strengthening the process. 139 Indeed, in the present cost­ conscious health care environment, such an imposition may only serve to further complicate its simple and direct mandate: namely, to provide a knowledgeable atmosphere for a therapeutic partnership or moral agency between physician and patient to occur. 140 In addition, without the doctrine of informed consent, there would be little opportunity to create an atmosphere in which-in health care delivery systems-both interdependence and inter­ relationship are acknowledged, professionally and legally, as practical norma­ tive values. 141 Although the doctrine of informed consent will always remain a relative term, ''with the degree of completeness resting on so many variables including, of course, the nature and reliability of the source," it should be seen as more than an aspirational goal.142 Rather, it can and indeed should serve as a useful construct for embedding the doctrine as an integral part of the ethos of medicine; 143 an ethos tied to a recognition of patient trust and partnership with the physician as the cornerstone of the healing enterprise144 which must always seek to provide "a right and good healing action in the interests of a particular patient."145 In the final analysis, however, it remains for the medical profession, not the legal profession, to formulate and effect a truly contemporary doctrine of informed consent, one, to be sure, that is responsive to the ''proddings of the law," but, more importantly, one that is cognizant of the very complex and nuanced interactions between patientS and their physicians.146 137. /d. at 939. 138. /d. at 951. 139. Id. at 935. 140. Pellegrino, Human Person, supra note 1; Pellegrino, Autonomy, supra note 1; Pellegrino, Reconstruction, supra note 2, at 74. 141. GAYUN &JENNINGS, supra note 1, at 243. 142. Jeffrey S. Tobias, Contemporary Challenges in Clinical Research: Paying Lip Service to Informed Consent, or a Genuine Shift of Gear?, in INFORMEDCONSENriNMBDICAL REsEARCH, supra note 15, at 318-19. 143. Katz, supra note 18, at 91 (arguing that until the doctrine becomes an integral aspect of the ethos of medicine, it is condemned to remain a fairy tale). 144. See generaUy Edmund D. Pellegrino & John L. Harvey, Whom Should the Patient Trust?, AM., Oct. 1, 2001, at 19. 145. Pellegrino, Reconstruction, supra note 2, at 47. 146. Katz, supra note 18, at 71. See generally KATZ, supra note 132.