







































HISTORY OF CLINICAL RESEARCH AND ETHICS


Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 20 

HISTORY OF CLINICAL RESEARCH AND ETHICS 

 

Shamima Parvin Lasker 

Professor & Head of Anatomy, City Dental College, Dhaka  

General Secretary, Bangladesh Bioethics Society  

Email: splasker04@yahoo.com 

 

ABSTRACT: The aim of clinical research is to congregate useful knowledge about the human biology. 

Benefits to the participants are not the purpose of research, although it does secondarily.  Therefore, 

exploitation of human subjects occurred in clinical research. Many people were harmed and basic 

human rights were violated  as a result of their unwillingness participation in research. There have 

been many tragedies throughout the history of research involving human subjects. Every period of 

research scandals have been followed by attempt to initiate some ethical codes to protect the human 

from clinical research. First of such codes is the Nuremberg Code. Thereafter, Helsinky Declaration, 

Belmont Report and lastly Obama Commission on Guatemala syphilis study. To remember history is 

essential so that it‟s not repeated again. Knowledge of the history will provide a better understanding 

to handle the research fairly. Researchers and the healthcare providers have no awareness of the 

history of ethical requirements for clinical research. Therefore, repetition of scandal is being seen. In 

addition, there are few sporadic studies on this issue. Formulation of UNIVERSAL rules and 

regulations is required which will not be limited to a specific tragedy or scandal or the practice of 

researcher in one country. It will provide common understanding and unique values of the research all 

over the world, although their application will require adaptation to particular culture, health condition 

and economic setting.   

Key words: history, clinical research, ethics, Universal rules 

 

INTRODUCTION: Biomedical research has made impressive steps during past century to save the 

human life with new drugs, vaccines and medical devices. But there were many tragedies throughout 

the history of research involving human subjects as the medical research had undergone on utilitarian 

consideration only. Key objective of clinical research was to generate useful knowledge about the 

prophylactic, diagnostic, therapeutic, procedure, etiology and pathogenesis of disease and to increase 

understanding of human biology. Many physicians had been pursued research as it was found 

interesting. Consequently, exploitation of human subjects occurred in clinical research by placing 

some people at risk for the good of others.  

How the human subjects can be protected from the research and how its fruit would be distributed was 

a concern. Therefore, ethical requirements for clinical research is aim at to minimize the possibility of 

exploitation by ensuring research subjects are not merely used but are treated with respect while they 

contribute to social good. In examining and using ethical theories several rules and regulation have 

been justified. These regulations of clinical research are based on a combination of ethical thought 

and history. This article presents the historical basis of these regulations and what should be the 

further step to make research sound and fair in the globe.  

mailto:splasker04@yahoo.com


Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 21 

HISTORY OF EARLY CLINICAL RESEARCH: The 1st recorded clinical research may have begun on 

eighteen century. Scurvy was a threatened disease at that time and tolled the life of British sailors 

abroad. In 1740 James Lind, a surgeon in the Royal Navy of Salisbury was influenced by a report of 

admiral Lord Anson‟s that his crews were appalling losses to scurvy, including one ship which lost 

almost half of its crew to the disease. 

A number of common treatments, including cider, elixir of vitrol, vinegar, leaf past and sea water were 

in use to treat scurvy at that time. Lind was septic of these treatments. He designed a study and chose 

12 sailors and divided into six groups. Five groups received exiting treatments and sixth group who 

received two orange and a lemon each day. Within a week, sailors of group sixth were nearly healthy 

again, while the health of the other subjects had declined significantly. Although Lind noted a dramatic 

treatment effect from citrus, his findings were largely ignored for decade leading to unaccounted and 

unnecessary death. After 50 years (1795), Royal Navy adopted rationing of citrus fruit to their sailors 

at which point scurvy disappeared from Royal Navy. Scurvy study tragically highlights as an important 

challenge of disseminating research result. 

 

SCANDALS AND TRAGEDIES IN NINETEENTH CENTURY’S CLINICAL RESEARCH: This early 

experiment with humans resulted in prevention of serious disease in sailors. Medical research with 

humans is then justifiable because of benefits of many people and society. But there are many 

examples of research that violate the right and dignity of human subject and in some cases cost their 

health or even their lives. Some of such experiments are mention below. 

Case 1: Coley (1892) injected patients with cancer cell to induce artificial erysipelas. He described 

how he begun treatment with a patient who had a sarcoma and only that some consideration patient 

“consented” and cancer cell injection began. What interesting about this statement? “Consented” this 

is not the word that people used in those days. 

 

Case 2: In 1896-1897, a control clinical trail was conducted by Johannes Fibiger from Denmark to see 

the effectiveness of his invented anti-diptherial serum. All hospitalized patients received standard 

treatment or diphtheria serum with standard treatment. After 1 year, 8 died of 239 patients in the 

serum group versus 30 died of 245 patients in the diphtheria serum with standard treatment group.  

Who is the responsible for this death and peril of diseased family is a concern.  

Case 3: Guiseppe Sanarelli (1897), an Italian bacteriologist announced that he isolated bacillus of 

yellow fever. To prove his claim he injected 5 persons with his isolate and produced yellow fever in 

them. Many were quick to criticized Sanareli for yellow fever induction experiment and harm the 

subjects. In 1898, William Osler, Professor of John Hopkins and Oxford University condemns Sanareli 

for deliberately injecting poison of known high degree of virulence into a human being without his 

consent, it is not ridiculous , it is criminal. 

Human experimentation was running heighten at that time and yellow fever was in epidemic in Cuba. 

Walter Reed was commissioned by US Surgeon General to identify the cause of yellow fever.  Yellow 

fever board was establish and proposed Yellow fever research includes:  

 

Self experimentation 

Written consent 

Restriction to adult (older then 24 years) 



Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 22 

Expulsion of children as research participants 

Clearly using the phrase with full „consent‟ in all journal article. 

Payment in Gold ($100).  

Reeds established several safeguard. Reeds designed the written consent form for local workers that 

clearly explain the peril of the undertaking research. He mentioned of offer a payment of $100 

(Payment in Gold) to those who were willing to expose and another $ 100 to those who become ill with 

yellow fever. A written consent was established and our moral responsibility was lessened to a certain 

extent. 

 

SCANDALS AND TRAGEDIES IN CLINICAL RESEARCH IN TWENTIETH CENTURY: In the 20th 

century, the most barbaric experiments were done by Nazi doctors. Some are as follow:  

Experiment 1: Prisoners were put in to low pressure tank to see how long they could survive with little 

oxygen. Many of them died.  

Experiment 2: High altitude experiments: Prisoners were hanging to see how long they could survive 

in high altitude. Many of them died and then autopsied. Those who did not die immediately were put 

under water until they died and autopsy followed.  

Experiment 3: Cold experiment: Prisoners were forced to remain outdoor during winter of -20
0
 

temperature without cloth for 9 to 14 hours or force to remain in a bath of freezing water till death to 

see how long a man can bear cold or what are the consequences of cold till death.  

Experiment 6: Malaria Experimentation: Dr Klaus Karl Schilling, an eminent malaria expert, infected 

more than 1000 prisoners with malaria at Dachau and treated with his experimental anti-malarial drug. 

More than 400 died from complications of treatment with experimental malaria drugs. 

Experiment 7: Twins experiment: where, one baby was exposed to a pathogen and killed and then 

autopsied to determine the natural progression of disease. The other control twin was then sacrificed 

to see what the differences were. It may constitute a very interesting comparison for a scientific 

perspective but such an experiment was not only unethical but inhuman. 

Experiment 9: Hundred of prisoners were killed for accumulation of skeleton for anthropological 

investigation. Those killed were considered prototype of what the Nazi called characteristic sub 

human. 

Experiment 10: To create a genetically pure population (eugenics) the “Law for the Prevention of 

Genetically Diseased Descendants” was passed and sterilization was enforced. Within four years, 300 

000 people had been sterilized. 

The modern history of human subject protections begins with the discovery of Nuremberg Code. In 

December 1946, following world war II, America military tribunal opened criminal proceedings against 23 

German physician and administrator for their willing participation of cruelty against humanity in the name 

of research. Nuremberg Code has 10 basic principal of moral, ethical and legal concept.   

1. Voluntary consent is essential. German physicians conducted medical experiments on thousands of 

prisoners of concentration camp without their consent. Most of the subjects of these experiments died 

or were crippled permanently.  



Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 23 

2. Research must benefit to the society. It is unethical to needless endanger the well being of human 

volunteers if other methods of investigation exist. 

3. Research must be based on preclinical study on animal. 

4. Avoidance of all unnecessary physical and mental suffering and injury.  

5. Avoidance of the death and disability. 

6. Subjects must have the right to end their participation in research.  

7. Preparedness and adequate facilities should ensure to protect the subjects against even remote 

possibility of injury, disability and death. 

8. Preparedness for termination of experiment at any stage of research if continuation of experiment is 

likely to result in injury, disability or death of subjects.  

9. Experiment should be conducted only by scientific qualified persons. 

10. Research risk must be minimized and relative to the anticipated benefit of research. 

However, Nuremberg Code is not the first set of research guidelines. The German themselves had 

developed systematic guidelines in 1931. These guidelines were in force at the time and clearly 

prohibited a great deal of what the Nazi doctors did.  

Before mid ninetieth, US government had no control over manufacturing and dispensing of drug. In the 

late 50s, thalidomide was sold as a sedative to control sleep and nausea through out pregnancy in 

Europe. But it was found that taking this drug during pregnancy caused sever deformities in the baby. 

Many patients did not know that they are taking a drug that was not approved by FDA nor they give 

informed consent. Some 12,000 babies were born with sever deformities. In 1962, Food, Drug and 

Cosmetic Acts were passed into law to ensure drug efficacy and greater drug safety called Kefauver 

Amendments. Under this law, for 1st time drug manufacturers were required of FDA endorsement for 

the effectiveness of their products before marketing.  

In July1963, the legitimacy of the human experimentation was again questioned when research 

performed by Chester M Southam and Emanual E Mandal at the Brooklyn Jewish Chronic Hospital 

where life cancer cells were deliberately injected into elderly patients without their consent to see if 

cancer cell would cause an immune reaction and that would lead to their expulsion from body. The 

researcher argue not informing patient about the experiment that might have caused them needlessly 

psychological distress. Finally, the hospital was sued and had license cancelled.    

Research became coercive when the physician himself turned out to be a researcher. Children and 

adolescents with disabilities were exposed deliberately to hepatitis at New York state hospital in 

Willobrook to find preventive measure for hepatitis that was epidemic at that time. The ward was 

closed to any admission in excuse of over crowdedness but patients were said that the children could 

be admitted if they were placed in research ward. Some children were mentally retarded. Due to high 

critics, the Head of research team Saul Krugman argued that the consent was obtain from their 

parents. 

In 1964, the World Medical Association established & recommended the guidelines for medical 

doctors in biomedical research involving human is known as Helsinki declaration. The declaration 



Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 24 

delaminate the therapeutic research from non-therapeutic research. Issues addressed in the 

declaration are includes:  

 

1. Delaminate practices from research 

2. Research protocol should be reviewed by an independent committee (IRB, ERB etc) prior to 

initiation.   

3. Informed consent is necessary 

4. Risk should not exceed from benefit.  

5. Allow subject representative to consent who cannot consent but willing to take part in research. 

6. Research with human should be based on the results from laboratory and animal experimentation. 

7. Well being of subjects should be take precedence over the interest of science and society. 

Helsinki Declaration was revised in 1975, 1983, 1996, 2000 and it is the basis for Good clinical 

practices used today. 

Scandal seemed to break out everywhere. In 1966 Henry Beecher, Professor of Anesthesiology at 

Harvard Medical School published an article with 22 cases of violation of ethical research with human 

in New England Journal of Medicine. Originally example was 50, due to shortage of space, examples 

were reduced to 22. All the cases were published in reputed medical journal from respected 

researcher of leading medical institute. Beecher aim was not to condemn the researchers but to raise 

awareness to serious ethical problem in conduct of research with human. He wanted to point out that 

unethical activates in united state were very similar to what happened in Nazi doctors. His article had a 

major impact on the development of the regulation. 

The most unethical research in history was Tuskegee Syphilis Study (1932-1972). A research was 

conducted in Tuskegee, Alabama, USA in 1932 on 600 low income African American male. On 400 of 

who were infected with syphilis and 200 were as control and monitored for 40 years to asses the 

natural history of syphilis. Subjects were not told about the disease and denied any treatment even 

though a proven cure (penicillin) was publicly available in the 1940s.  In some cases when subject 

were diagnosed by other physician but researchers intervened the treatment. There was no scientific 

rationale for this study because the natural history of syphilis had already been elicited. Many subjects  

died of syphilis during the study. The study was stopped in 1972 by the US department of health 

education and welfare only after existence of this research was publicized in media. It became a 

political embarrassment. But by the time 74 of the subjects were still alive, Of 40 wives had contracted 

syphilis, 19 babies were born with congenital syphilis. In 1970, compensations were given for the 

survival and for the families of those who died from this study .1997, under mounting pressures; 

President Clinton apologized to the study subjects and their families and granted $ 200,000 for 

creation of Tuskegee University National Center for Bioethics in Research and Health. 

Due to publicity from the Tuskegee Syphilis Study, National Research Act (1974) created the National 

Commission for Protection of Human Subjects of Biomedical and Behavioral Research.  In 1979, 

Commission drafted the Belmont report. It summarized the basic ethical principles as below: 

 

1. Respect for person 

2. Beneficence and  

3. Justice  



Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 25 

These are the corner stone for regulations of research involving human subjects and protection for 

certain vulnerable research subjects e.g. pregnant women, prisoners and children. 

In 1981, Department of Health and Human Service (DHHS) issue regulations based on Belmont 

report. DHHS issued Code of Federal Regulation (CFR), part 45 (public welfare) and part 46 

(protection of human subject). In 1991, the core DHHS regulations (45 CFR Subpart A ) were formally 

adopted by more than 17 Departments and agencies. Now most of the departments of Universities 

and agencies including FDA adopted this rule. This rule is called Common Rule. 

Common rule includes: 
  
1. Documenting inform consent. 
 
2. Requirement for ensuring compliance by research institute 
 
3. Requirements for institutional review board (IRB) membership, function , operations, review of 
research and record keeping. 
 
4. Additional protections for certain vulnerable research subjects (prisons, pregnant women, children, 
retarded patients etc). 

 

FDA is responsible for approval and license the drug and device for sale in USA. They are largely in 
agreement with common rule about the prior IRB review and informed consent. The FDA issued CFR 
Title 21 (food and drugs) of Parts 50 (protection of human subjects) and 46 (Institutional Review 
board). In addition certain federally sponsored and much privacy sponsored research is subject to the 
regulations of the Food and Drug Administration (FDA) at 21 CFR parts 50 and 56.  

After the creation of national commission and implementation of common rules it seemed the 

biomedical research in US was finally on a more secure ethical footing. But in 1990s controversy 

regarding research with human erupted once again. News paper and Magazine features many 

examples. Time magazine picture s a human in a case with caption “medical testing had turn million 

people in to guinea pig”. Several prominent medical research facilities shut down for non compliance 

with US regulation for the protection of human in biomedical research. Research begins to undertaken 

in collaboration with developing country, where the research rules and regulations are not stringent.   

Council for international organization of Medical Science in collaboration (CIOMS, 1993) with WHO 

developed international ethical guidelines for biomedical research with special attention to developing 

country in response to common research as HIV/AIDS. To protect participants as well as research 

enterprise, CIOMS took 20 years to develop guidelines involving participants from developing and 

developed country. The first version relapsed in 1993 including 15 guidelines. 2
nd

 version released in 

2002. Important guidelines of CIOMS are: 

1. Any intervention or product or knowledge generated will be made available for the benefit of the 

population or community (guideline10) 

 

2. Justify the placebo control (guideline 11) when  

a. There is no established intervention. 

 

b. Withholding established intervention would exposes subject with temporary discomfort. 



Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 26 

 

c. When use of established intervention would not yield scientific reliable result. 

 

d. Placebo would not any risk of serious irreversible harm to subject.  

3. Compensation of research injury - it also includes a section on compensation for research for 

injuries not found in other documents.  

International Conference for Harmonization Good Clinical Practice (ICH-GCP) (1996) was 

promulgated in 1996 by international conference for harmonization of technical requirements for 

registration of Pharmaceuticals for human use. It depicts the standard for review committee, 

investigators, and sponsors. It is specific for research on drugs or devices seeking regulatory approval. 

It opposes the active control trial. ICH-GCP is agreed by Europe, USA and Japan.   

 

SCANDALS AND TRAGEDIES IN CLINICAL RESEARCH IN TWENTY FIRST CENTURY: The 

Office for Human Research Protections (OHRP, 2000-2001) provides protection of the rights, welfare 

and wellbeing of subjects involved in research conducted or supported by the U.S. OHRP works to 

ensure that human subjects outside of the United States who participate in research projects 

conducted or funded by DHHS receive the same level of protections as research participants inside 

the United States. This regulation attempted to ensure that future research with human subject would 

be ethical and legal. 

However, Susan Rever, a medical historian, discovered another syphilis study scandal in 2010. Story 

says, female commercial sex workers known to be infected with syphilis sent to Guatemala prisons to 

infect inmates to establish whether penicillin could be used for prophylaxis against STIs. The study 

was begun in 1946-1948 funded by USA Government. More than 1,600 people were infected, of them 

696 with syphilis, 772 with gonorrhea and 142 with chancres. None of the participants consented. In 

2010, Obama apologized on behalf of US. 

As the research in developed country has become strict day by day, the prevalence of pharmaceutical 

drug trials is drastically increasing in developing countries. A clinical trail for a new meningitis drug 

“Trovan” had been conducted by Pfizer in Nigeria in1996. The disease left thousands dead and 

thousands more permanently disabled. Pfizer said it did not get written permission from the parents 

because they were illiterate but said the trail was sanctioned by the Nigerian medical authorities. Pfizer 

came under fire in 2001 for allegedly testing meningitis drugs on Nigerian children. In 2008, another  

trail was conducted by GlaxoSmithKline in the Argentine province of Santiago del Estero to prevent 

pneumonia and related diseases. Seven babies died while taking part in trials. No informed consent 

has been taken in this trail. After several scandals, Indian government was repealed the law in 2005 

that for the drugs safety approval is required from their home countries before being tested in India. 

AstraZeneca has opened a drug-testing facility in Bangalore and Pfizer has done the same in 

Bombay. 

 

DISCUSSION AND CONCLUSION: The Nuremberg Code was the part of the Judicial decision 

condemning the atrocities of the Nazi doctors and so focused on the need for consent and a favorable 

risk benefit ratio but makes no mention of fair subject selection and independent review. Helsinki 

declaration was related to research conducted by physician with patients. It differentiates between 



Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 27 

therapeutic and non therapeutic research. The Belmont report provides broad principals that could be 

used to generate specific rules and regulations to protect vulnerable populations from research in 

response to US research scandals e.g. Tuskegee, Wilobrook etc. CIOMS intends to apply the 

declaration of Helsinki in developing countries and included the compensation for research injury. 

Research funded by US is regulated by DHHS and FDA. OHRP provides protection of the rights, 

welfare, and wellbeing of subjects in research conducted or supported by the U.S.A. both inside and 

outside of the United States. 

As the research in developed country has become strict day by day, the prevalence of pharmaceutical 

drug trials is drastically increased in developing countries. Repetition of scandals is being seen. 

Researchers and the healthcare providers seem are not taking lesson from history of ethical research 

to handle the research fairly and restore the human dignity. Formulation of UNIVERSAL rules and 

regulation (guidelines) is needed which will not be limited to a specific tragedy or scandal or to the 

practice of researchers in one country, although their application will require adaptation to particular 

culture, health condition and economic setting. Research on this line is needed. 

 

REFERENCES:  

1. Brandt AM. Racism and research. The case of the Tuskegee syphilis study. . In Ezekiel JE. Crouch 

RA, Arras JA, Mereno JD and Grady C (editors) 2003, the John Hopkins University Press. Baltimore. 

2. Brody BS. The Ethics of biomedical Research. New York, NY: Oxford University Press; 1998: 

chapter 9. 

3. Beecher H. Ethics and clinical research. In Ezekiel JE. Crouch RA, Arras JA, Mereno JD and Grady 

C (editors) 2003, the John Hopkins University Press. Baltimore. 

4. BBC News. Nigerians angered by drugs trial delay. July 30, 2001. 

http://news.bbc.co.uk/1/hi/world/africa/1465532.stm. (access May 4, 2011). 

5. Council for International Organizations of Medical Sciences. International ethical guidelines for 

biomedical research involving human subjects. Geneva, Switzerland: CIOMS; 1993. 

6. Chan JKL. Taking moral diversity seriously - A discussion of the foundations of global bioethics. In 

Bioethics and Moral Content: National Traditions of Health Care Morality, H. Engelhardt  TH (ed.).  

Kluwer Academic Publishers, 2002, pp.235-249. 

7. DeCastro LD. Exploitation in the use of human subjects for medical 

experimentation.  Bioethics.1995;9:259-268. 

8. Department of health and Human Service. Code of federal regulations. Title 45(Public welfare). part 

46 (Protection of Human subjects (45 CFR 46). US Government printing office. 2005. 

9. Ezekiel JE, Wendler D and Grady C. What Makes Clinical Research Ethical? JAMA. 

2000;283(20):2701-2711. 

10. Fakruddin M, Chowdhury A, Hossain MN, Mannan KSB
.  
Ethics in Clinical Research. Bangladesh 

Journal of Bioethics 2012; 3(3):16-20. 

http://news.bbc.co.uk/1/hi/world/africa/1465532.stm
http://news.bbc.co.uk/1/hi/world/africa/1465532.stm


Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 28 

11. Ghooi RB. The Nuremberg Code-A critique. Perspect Clin Res. 2011 Apr;2(2):72-6. 

12. History of Research Ethics. http://research.unlv.edu/ORI-HSR/history-ethics.html (access October 

5, 2011). 

13. Hearn K. The Rise of Unregulated Drug Trials in South America. October 10, 2011 edition of The 

Nation. http://www.thenation.com/article/163547/rise-unregulated-drug-trials-south-america (access on 

20 January 2012). 

14. Human subject research. http://en.wikipedia.org/wiki/Human_subject_research (Access on 

January 2012). 

15. Katz J. Experimentation with Human Beings. New York, NY: Russell Sage Foundation; 1972. 

16. Katz J, Capron AM, Glass ES. Jewish Chronic Hospital case. In Ezekiel JE. Crouch RA, Arras JA, 

Mereno JD and Grady C (editors) 2003, the John Hopkins University Press. Baltimore. 

17. Kim Y. A common framework for the Ethics of the 21sf Century. Division of Philosophy and Ethics, 

UNESCO, 1999, Paris. http://unesdoc.unesco.org/images/0012/001246/124626Eo.pdf (access on 

December 2011). 

18. Levine RJ. Ethics and regulation of clinical research. 2nd ed. New Haven, Conn: Yale University 

Press; 1988. 

19. Ali MA. What Makes Multinational Clinical Research Ethical & How To Minimize Possible 

Exploitation In Host Country? Bangladesh J Bioethics 2011;2(2):20-23. 

20. Office for Human Research Studies OHRS: http://www.hhs.gov/ohrp/humansubjects/index.html 

(access on March 2012). 

21. Perlman D.  Ethics in clinical research. A history of human subject protections and practical 

implementation of ethical standards. Socra SOURCE  May 2004; 37. 

22. Ruth RDF, Ledere SE and Merono JD. US medical research, the Nuremberg doctors trail and the 

Nuremberg case. A review of finding of advisory committee on human medical experiment. in Ethical 

and regulatory aspect of clinical research.  Ezekiel JE. Crouch RA, Arras JA, Mereno JD and Grady C 

(editors) 2003, the John Hopkins University Press. Baltimore. 

23. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and 

Behavioral Research.  Summing up. Washington, DC: US Government Printing Office; 1983. 

24. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral 

Research.  The Belmont Report: Appendix. Vol 1. Washington, DC: US Government Printing Office; 

1978:chap 9. 

25. The Nuremberg Code. JAMA. 1996; 276:1691.  

26. Vollman J and Winau R. Informed consent in human experimentation before the Nuremberg Code. 

BMJ 1996;313;1445-7. 

27. Weinstein N. Optimistic biases about personal risks. Science 1989;246:1232-3. 

http://research.unlv.edu/ORI-HSR/history-ethics.html
http://www.thenation.com/article/163547/rise-unregulated-drug-trials-south-america
http://en.wikipedia.org/wiki/Human_subject_research
http://unesdoc.unesco.org/images/0012/001246/124626Eo.pdf
http://www.hhs.gov/ohrp/humansubjects/index.html


Bangladesh Journal of Bioethics 2013; 4(1):20-29 

 

 29 

28. World Medical Association. Declaration of Helsinki. JAMA. 1997;277:925-926. 

29. Wertheimer A. Exploitation. Princeton, NJ: Princeton University Press; 1996: chap 1.  

30. Wendler D. The Ethics of Clinical Research. The Stanford Encyclopedia of Philosophy In Edward 

N. Zalta (ed.). Jan 30, 2009. http://plato.stanford.edu/entries (access on November 2010). 

 

 

 

(*** This article has been published in the Proceeding of 13
th
 Asian Bioethics Conference 2013 

Concurrent with Sixth UNESCO Asia Pacific School of Ethics Roundtable.)  

http://plato.stanford.edu/entries

