Human Subject Research

Human subject research

2) identifiable private information (32 CFR 219.102.f). (Lim,1990)[2] As defined by DHHS regulations: “Intervention"- physical procedures by which data is gath- ered and the manipulation of the subject and/or their en- vironment for research purposes [45 CFR 46.102(f)[2] “Interaction"- communication or interpersonal contact between investigator and subject [45 CFR 46.102(f)])[2] “Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual 1946 military human subject research on the effects of wind on humans can reasonably expect will not be made public [45 CFR 46.102(f)] )][2] Human subject research is systematic, scientific inves- “Identifiable information"- specific information that can tigation that can be either interventional (a “trial”) or ob- be used to identify an individual[2] servational (no “test article”) and involves human beings as research subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., so- 1.1 Human subject rights cial science) research.[1] Systematic investigation incor- porates both the collection and analysis of data in or- In 2010, the National Institute of Justice in the United der to answer a specific question. Medical human sub- States published recommended rights of human subjects: ject research often involves analysis of biological speci- mens, epidemiological and behavioral studies and med- • Voluntary, informed consent ical chart review studies.[1] (A specific, and especially • Respect for persons: treated as autonomous agents heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and • The right to end participation in research at any medical devices are evaluated.) Human subject research time[3] in the social sciences often involves surveys, question- naires, interviews, and focus groups. • Right to safeguard integrity[3] Human subject research is used in various fields, in- • Benefits should outweigh cost cluding research into basic biology, clinical medicine, • nursing, psychology, sociology, political science, and Protection from physical, mental and emotional anthropology. As research has become formalized, the harm academic community has developed formal definitions of • Access to information regarding research[3] “human subject research”, largely in response to abuses of human subjects. • Protection of privacy and well-being[4]

1 Human subjects 2 Ethical guidelines

The United States Department of Health and Human Main article: Guidelines for human subject research Services (DHHS) deﬁnes a human research subject as a living individual about whom a research investigator Ethical guidelines that govern the use of human subjects (whether a professional or a student) obtains data through in research are a fairly new construct. In 1906 some reg- 1) intervention or interaction with the individual, or ulations were put in place in the United States to protect

1 2 3 HISTORY OF MEDICAL ABUSE OF HUMAN SUBJECTS subjects from abuses. After the passage of the Pure Food ner experiments, where he tested smallpox vaccines on and Drug Act in 1906, regulatory bodies were gradually his son and neighbourhood children. institutionalized such as the Food and Drug Administra- tion (FDA) and the Institutional Review Board (IRB). The policies that these institutions implemented served to 3.2 World War II minimize harm to the participant’s mental and/or physical well being.

2.1 Nuremberg Code

Main article: Nuremberg Code

In 1947, German physicians who conducted deadly or debilitating experiments on concentration camp prisoners were prosecuted as war criminals in the Nuremberg Tri- als. That same year, the Allies established the Nuremberg Code, the ﬁrst international document to support the con- cept that “the voluntary consent of the human subject is absolutely essential”. Individual consent was emphasized in the Nuremberg Code in order to prevent prisoners of Jewish twins were kept alive to be used in Josef Mengele's medical war, patients, prisoners, and soldiers from being coerced experiments. These children from Auschwitz were liberated by into becoming human subjects. In addition, it was em- the Red Army in January 1945. phasized in order to inform participants of the risk-beneﬁt outcomes of experiments.

2.2 Declaration of Helsinki

Main article: Declaration of Helsinki

The Declaration of Helsinki was established in 1964 to regulate international research involving human subjects. Established by the World Medical Association, the declaration recommended guidelines for medical doctors conducting biomedical research that involves human subjects. Some of these guidelines included the principles that “research protocols should be reviewed by an inde- pendent committee prior to initiation” and that “research Japanese Unit 731 Complex that used humans for experimenta- with humans should be based on results from laboratory tion for biological and chemical weapons, as well as live vivisec- animals and experimentation”. tions and other experiments

Several nations conducted experiments on human sub- 3 History of medical abuse of hu- jects before and during the war, justifying it on grounds man subjects of war exigency.

3.1 18th- 19th century 3.2.1 United Kingdom

Human subject research experiments were recorded dur- De-classified documents of the National Archives re- ing vaccination trials in the 18th century as doctors strug- vealed that during the 1930s and 1940s, the British Army gled to find a preventive of smallpox, which had very used hundreds of Irish and native British Indian Army sol- high mortality rates. In these early trials, physicians used diers as “guinea pigs” in their experiments to determine if themselves or their slaves as test subjects. Experiments mustard gas inflicted greater damage on Indian skin com- on others were often conducted without informing the pared to British skin. It is unclear whether the trial sub- subjects of dangers associated with such experiments. A jects, some of whom were hospitalised by their injuries, famous example of such research were the Edward Jen- were all volunteers.[5] 3.3 Post World War II 3

3.2.2 United States by their digestive systems. Many of the infants expe- rienced diarrhea and anal bleeding. The parents were Main article: Unethical human experimentation in the never informed that their children were being used as test United States subjects.[16]

Fort Detrick in Maryland was the headquarters of US bi- 3.2.4 Germany ological warfare experiments. Operation Whitecoat involved the injection of infectious agents into military Namibian sterilization Dr. Eugen Fischer began [6] forces to observe their effects in human subjects. sterilization experimentation in German-occupied South West Africa during World War I. A supporter of forced sterilization as a means to prevent the growth of inferior 3.2.3 Japan populations and a member of the Nazi Party, Eugen fo- cused his experimentation on mixed-race children in or- Human subject research in Japan began in World War II. der to justify the Nazi Party’s ban on interracial marriage. It continued for some years after. During the American As a result of Fischer’s research in Namibia, Germany occupation of Japan, General Douglas MacArthur gave prohibited marriages between people of different races immunity from prosecution to those Japanese who con- in its colonies.[17] ducted human research, in exchange, the Japanese gave all of the results of their experiments to the United States.[7] 3.2.5 Nazi experimentation on concentration camp prisoners Unit 731, a department of the Imperial Japanese Army located near Harbin (then in the puppet state of Main articles: Nazi human experimentation and Doctors’ Manchukuo, in northeast China), experimented on pris- Trial oners by conducting vivisections, dismemberments, and bacterial inoculations. It induced epidemics on a very large scale from 1932 onward through the Second Sino- Testimony at the Nuremberg Trials after World War II re- Japanese war.[7] It also conducted biological and chem- vealed that Dr. Josef Mengele had conducted medical ex- ical weapons tests on prisoners and captured POWs. periments on numerous prisoners and especially Jewish, With the expansion of the empire during World War Gypsy and other children in Nazi concentration camps. II, similar units were set up in conquered cities such as The Allies developed the Nuremberg Code to try to pre- [18] Nanking (Unit 1644), Beijing (Unit 1855), Guangzhou vent such abuses in the future . During the Nuremberg (Unit 8604) and Singapore (Unit 9420). After the Trials, 23 Nazi doctors and scientists were prosecuted for war, Supreme Commander of the Occupation Douglas the unethical treatment of concentration camp inmates, MacArthur gave immunity in the name of the United who were often used as research subjects with fatal con- States to Shiro Ishii and all members of the units in ex- sequences. Of those 23, 15 were convicted, 7 were con- change for all of the results of their experiments.[7] demned to death, 9 received prison sentences from 10 years to life, and 7 were acquitted.[19] The United States blocked Soviet access to this information. The Soviets prosecuted some of the Unit 731 members during its Khabarovsk War Crime Trials. 3.3 Post World War II In November 2006, Doctor Akira Makino confessed to Kyodo news that he had performed surgery and ampu- 3.3.1 Guatemala tations on condemned prisoners, including women and children, in 1944 and 1945 while he was stationed on Main article: Syphilis experiments in Guatemala Mindanao.[8] Most of Makino’s victims were Moro Mus- [9][10][11][12][13] lims. In 2007, Doctor Ken Yuasa testified From 1946 to 1948 U.S. scientific researchers in to The Japan Times and said that he believes that at least Guatemala infected hundreds of mental patients with 1,000 persons working for the Shōwa regime, includ- sexually transmitted diseases (STD). Researchers from ing surgeons, conducted surgical research on mainland [14] the U.S. Public Health Service (PHS) conducted ex- China. periments on approximately 1,500 male and female pa- In incidents throughout the 1950s, former Unit 731 mem- tients housed at Guatemala’s National Mental Health bers infected prisoners and mental health patients with Hospital.[20] The scientists injected the patients with gon- deadly diseases.[15] In 1958, a large number of infants orrhea and syphilis—and encouraged many of them to were brought to Kobe Medical School and forcibly ad- pass the disease on to others. The experiments were ministered sugar by having needles inserted through their done in cooperation with the Guatemalan government. noses and into their stomachs. A tube was inserted into The PHS carried out the experiments under the guise of their anuses to determine how the sugar was processed syphilis inoculations. In 2010 these experiments were re- 4 3 HISTORY OF MEDICAL ABUSE OF HUMAN SUBJECTS

vealed by Susan Reverby of Wellesley College, who was institutional review boards as an additional layer of over- researching a book on the Tuskegee syphilis experiments. sight regarding research protocols.[24][25] The US Secretary of State Hillary Clinton issued an of- ﬁcial apology to Guatemala.[21] President Barack Obama apologized to President Álvaro Colom, who had called these experiments 'a crime against humanity'.[22] 3.3.4 United States

Main article: Unethical human experimentation in the 3.3.2 Sweden United States In Sweden, the Vipeholm experiments were conducted. Mentally handicapped test subjects were exposed to large Since the late 19th century, numerous human experi- amounts of sugar to induce dental caries. ments were performed in the United States, which were later characterized as unethical. They were often performed illegally, without the knowledge, consent, or 3.3.3 United Kingdom informed consent of the test subjects. Examples have included the deliberate infection of peo- In the United Kingdom (voluntary) human experimen- ple with deadly or debilitating diseases, exposing peo- tation at Porton Down in the 1950s, led to the death of ple to biological and chemical weapons, human radiation Ronald Maddison. experiments, injecting people with toxic and radioactive chemicals, surgical experiments, interrogation/torture experiments, tests involving mind-altering substances, and Beecher Paper In a 1966 paper noted British anesthe- siologist Henry K. Beecher described 22 published med- a wide variety of others. Many of these tests were per- ical studies in which patients had been subjects with no formed on children and mentally disabled individuals. In expected benefit to the patient of the experiment.[23] This many of the studies, a large number of the subjects were has been characterized as unethical. For example, pa- poor, racial minorities, and/or prisoners. tients infused with live cancer cells had been told in one Often, subjects were sick or disabled people, whose doc- study that they were receiving “some cells,” without be- tors told them that they were receiving “medical treating told this was cancer. Though identities of the au- ment.” They were used as the subjects of harmful and thors and institutions had been stripped, the 22 studies deadly experiments, without their knowledge or consent. were later identified as having been conducted by main- In reaction to this, interest groups and institutions have stream researchers and published in prestigious journals worked to design policies and oversight to ensure that fu- within approximately the previous decade. The 22 cases ture human subject research in the United States would had been selected from a set of 50 that Beecher had col- be ethical and legal. lected. He presented evidence that such unethical studies Public outcry over the discovery of government experi- were widespread and represented a systemic problem in ments on human subjects led to numerous congressional medical research rather than exceptions.[23][24] investigations and hearings, including the Church Com- Beecher had been writing about human experimentation mittee, Rockefeller Commission, and Advisory Commit- and publicizing cases that he considered to be bad prac- tee on Human Radiation Experiments, amongst others. tice for nearly a decade. His 1965 briefing to science These inquiries have not resulted in prosecutions. Not all writers and his 1966 paper gained widespread news cov- subjects involved in the trials have been compensated or erage and stimulated public reaction.[24][25] The paper notified that they were subjects of such trials. has been described as “the most influential single pa- In 1962, the Kefauver-Harris Drug Amendment was per ever written about experimentation involving human [26] passed by the United States Congress. This amendment subjects.” The United States Office for Human Re- made changes to the Federal Food Drug & Consumer Act search Protections credits Beecher through this paper as by requiring drug companies to prove both safety and ef- “ultimately contributing to the impetus for the first NIH [27] fectiveness of their products. Consequently, drugs were and FDA regulations.” required to have Food and Drug Administration (FDA) Beecher was instrumental in developing solutions to such approval before being marketed to consumers. Addition- abuses. He noted that a common element in these stud- ally, informed consent became a participation require- ies was that some experimental subjects, such as military ment and rules were put into place. This regulation was personnel or mentally handicapped children in institu- influenced by the results of 1950 use of thalidomide in tions, were not in a position to freely decline consent.[24] Western Europe for pregnant women. They were pre- Beecher believed that rules requiring informed consent scribed the sedative thalidomide, which was inaccurately were not alone sufficient, as truly informed consent was marketed as sleeping pills. Women gave birth to more an unattainable ideal. He worked both to define the rules than 12,000 infants born with deformities due to effects and conditions for informed consent, and to establish from the drug in utero. 4.3 Africa 5

Tuskegee syphilis experiment Main article: 4.3 Africa Tuskegee syphilis experiment Since the late 20th century, African nations have of- From 1932 to 1972, the Public Health Service con- ten been the sites of clinical testing by large interna- tracted with the Tuskegee Institute for a long-term study tional pharmaceutical companies. In some cases, rural of syphilis. During the study, more than 600 African- communities have developed iatrophobia (fear of doc- American men were studied who were not told they had tors) after undergoing or learning of highly controver- syphilis. In an effort to better understand the disease, re- sial medical experimentation. The fundamental distrust searchers denied the men access to the known treatment lies in the potential confrontation of Hobson’s choice: of the antibiotic penicillin. They recorded observations “Experimental medicine or no medicine at all”. Multi- ple cases of ethically questionable experiments have been of the effects of the disease over time. Under the impres- [33] sion they were being treated for “bad blood”, the partic- documented. ipants were given free healthcare by the government.[28] As ineffective treatment was given to the subjects, two- 4.3.1 Depo-Provera in Zimbabwe thirds of the group had died by the end of the 40-year experiment. A leak in 1972 led to cessation of the study and In the late 20th century, Depo-Provera was clinically severe legal ramifications. It has been widely regarded tested on Zimbabwean women. Once approved, the as the “most infamous biomedical research study in U.S. drug was used as a population control measure in the history”.[29] 1970s. Commercial farm owners put pressure on native Because of the public outrage over this, in 1974 Congress women workers to accept the use of Depo-Provera.[34] passed the National Research Act, to provide for pro- Population control interests motivated many of the fam- tection of human subjects in experiments. The Na- ily planning programs. This led to its eventual ban in tional Commission for the Protection of Human Sub- Zimbabwe.[34] jects of Biomedical and Behavioral Research was established. It was tasked with establishing the boundary between research and routine practice, the role of risk- Meningitis testing in Kano, Nigeria A clinical trial in benefit analysis, guidelines for participation, and the def- Nigeria involving the Pfizer drug Trovan to treat meningi- inition of informed consent. Its Belmont Report estab- tis resulted in 200 children being disabled and the deaths lished three tenets of ethical research: respect for per- of 11. Because of these casualties, the Nigerian govern- sons, beneficence, and justice.[30] ment sued Pfizer over whether it had appropriately obtained informed consent in Kano, where the study had taken place.[35][36] Pfizer argued in court that it had met all regulations for drug testing. Many Nigerians mistrust Project MKUltra Main article: Project MKUltra the use of medical vaccines and also refuse to participate in medical trials.[35]

HIV/AIDS short-course AZT testing in Zimbabwe In 1994 United States drug companies began conduct- 4 International clinical drug trials ing trials of the drug AZT on HIV-positive African subjects with the goal of developing treatments to reduce [37] 4.1 Argentina the transmission of HIV/AIDs during childbirth. With funding from the National Institutes of Health (NIH) and Centers for Disease Control (CDC), the program tested “In 2008, in the Argentine province of Santiago del Es- over 17,000 Zimbabwean women for the eﬃcacy of AZT tero, seven babies died while taking part in trials for an in preventing transmission of HIV/AIDS during child- experimental vaccine made by GlaxoSmithKline to pre- birth. Half of the women were given a placebo rather [31] vent pneumonia and related diseases.” than the drug, and the subjects were not informed of the potential dangers of the treatment. According to Peter Lamptey, the head of the AIDS Control and Pre- vention Program, “if you interviewed the people in the 4.2 India study, most wouldn't understand to what they had actually consented.”[37] An estimated 1000 newborns of women In 2005, the legislature repealed a 2004 law that re- in the study contracted HIV/AIDS, although this could quired international companies to ensure that drugs re- have been avoided by treating the women with known ceived safety approval in their home countries before be- drugs. The testing was ceased in 1998 when the CDC ing tested in India. The number of pharmaceutical drug claimed to have obtained suﬃcient data from experi- trials has increased in India.[32] ments in Thailand.[37] 6 5 OTHER EXPERIMENTS

5 Other experiments ple confederates; they were asked to provide answers to a variety of different low-difficulty questions.[42] In every 5.1 Human subjects in psychology and so- scenario, the multiple confederates gave their answers in turn, and the subject participant subject was allowed to ciology answer last. In a control group of participants, the per- centage of error was less than one percent. However, 5.1.1 Stanford prison experiment when the confederates unanimously chose an incorrect answer, 75 percent of the subject participants agreed with Main article: Stanford prison experiment the majority at least once. The study has been regarded as significant evidence for the power of social influence A study conducted by Philip Zimbardo in 1971 examined and conformity.[43] the effect of social roles on college students at Stanford University. Twenty-four male students were assigned to 5.1.4 Robber’s Cave Study a random role of a prisoner or guard to simulate a mock prison in one of Stanford’s basements. After only six A classic advocate of Realistic conflict theory, Muzafer days, the abusive behavior of the guards and the psycho- Sherif's Robber’s Cave experiment shed light on how logical suffering of prisoners proved significant enough group competition can foster hostility and prejudice.[44] to halt the two-week-long experiment.[38] In the 1961 study, two groups of ten boys each who were not “naturally” hostile were grouped together with- 5.1.2 Milgram experiment out knowledge of one another in Robber’s Cave State Park, Oklahoma.[45] The twelve-year-old boys bonded Main article: Milgram Experiment with their own groups for a week before the groups were set in competition with each other in games such as tug- of-war and football. In light of this competition, the In 1961, Yale University psychologist Stanley Milgram groups resorted to name-calling and other displays of re- led a series of experiments to determine to what extent sentment, such as burning the other group’s team flag. an individual would obey instructions given by an exper- The hostility continued and worsened until the end of the imenter. Placed in a room with the experimenter, sub- three-week study, when the groups were forced to work jects played the role of a “teacher” to a “learner” situated together to solve problems.[45] in a separate room. The subjects were instructed to administer an electric shock to the learner when the learner answered incorrectly to a set of questions. The intensity 5.1.5 Bystander Effect of this electric shock was to be increased for every incorrect answer. The learner was a confederate (i.e. ac- Main article: Bystander effect tor), and the shocks were faked, but the subjects were led to believe otherwise. Both prerecorded sounds of elec- The Bystander Effect is demonstrated in a series of fa- tric shocks and the confederate’s pleas for the punishment mous experiments by Bibb Latane and John Darley[45] In to stop were audible to the “teacher” throughout the ex- each of these experiments, participants were confronted periment. When the subject raised questions or paused, with a type of emergency, such as the witnessing of a the experimenter insisted that the experiment should con- seizure or smoke entering through air vents. A com- tinue. Despite widespread speculation that most partici- mon phenomenon was observed that as the number of pants would not continue to “shock” the learner, 65 per- witnesses or “bystanders” increases, so does the time it cent of participants in Milgram’s initial trial complied takes for individuals to respond to the emergency situa- until the end of the experiment, continuing to adminis- tion. This effect has been shown to promote the diffusion ter shocks to the confederate with purported intensities of responsibility by concluding that, when surrounded [39][40] of up to “450 volts”. Although many participants by others, the individual expects someone else to take questioned the experimenter and displayed various signs action.[45] of discomfort, when the experiment was repeated, more than 60 percent of subjects were willing to obey instructions to administer the shocks through the final one.[41] 5.1.6 Cognitive Dissonance

Main article: Cognitive Dissonance 5.1.3 Asch conformity experiments Human subjects have been commonly used in experi- Main article: Asch conformity experiments ments testing the theory of Cognitive dissonance after the landmark study by Leon Festinger and Merrill Carl- Psychologist Solomon Asch's classic conformity experi- smith.[46] In 1959, Festinger and Carlsmith devised a sit- ment in 1951 involved one subject participant and multi- uation in which participants would undergo excessively 7 tedious and monotonous tasks. After the completion of [6] “Hidden history of US germ testing”. BBC News. 2006- these tasks, the subjects were instructed to help the ex- 02-13. Retrieved 2010-05-04. periment continue in exchange for a variable amount of [7] Gold, H (2003). Unit 731 Testimony (5 ed.). Tuttle Pub- money. All the subjects had to do was simply inform the lishing. pp. 109. ISBN 0-8048-3565-9. next “student” waiting outside the testing area (who was secretly a confederate) that the tasks involved in the ex- [8] “Japanese doctor admits POW abuse”. BBC News. 26 periment were interesting and enjoyable. It was expected November 2006. that the participants wouldn't fully agree with the information they were imparting to the student, and after com- [9] AFP A life haunted by WWII surgical killings 2007. plying, half of the participants were awarded $1, and the [10] AFP Japanese veteran haunted by WWII surgical killings others were awarded $20. A subsequent survey showed 2007. that, by a large margin, those who received less money for essentially “lying” to the student came to believe that [11] Ozawa Japanese war veteran speaks of atrocities in the the tasks were far more enjoyable than their highly paid Philippines 2007. [46] counterparts. [12] Parry, “The Australian” Dissect them alive: chilling Impe- rial that order could not be disobeyed 2007. 6 See also [13] Parry, “The Times” Dissect them alive: order not to be disobeyed 2007.

• Human radiation experiments [14] Hongo, Jun. “Vivisectionnist recalls his day of reckon- ing”. The Japan Times. I was afraid during my ﬁrst vivi- • Doctors’ Trial (Part of the Nuremberg Trials) section, but the second time around, it was much easier. By the third time, I was willing to do it. • Duplessis Orphans [15] 43. 1968. pp. • Medical torture 126–136.

• Unethical human experimentation in the United [16] 1979;(No.548)197311pp.18- States 23

• Japanese human experimentations [17] Friedlander, Henry. 1997. The Origins of Nazi Genocide: From Euthanasia to the Final Solution', University of North • Nazi human experimentation Carolina Press

• Non-human primate experiments [18] “Angel of Death: Josef Mengele”. Auschwitz website. Retrieved 11 March 2013. • Statistical unit [19] Mitscherlich, A; Mielke F (1992). “Epilogue: Seven Were • Military medical ethics Hanged”. In Annas GJ & Grodin MA. The Nazi Doctors And The Nuremberg Code - Human Rights in Human Ex- • Vivisection perimentation. New York: Oxford University Press. pp. 105–107.

[20] “Fact Sheet on the 1946-1948 U.S. Public Health Service 7 Notes Sexually Transmitted Diseases (STD) Inoculation Study”. United States Department of Health and Human Services. [1] “Deﬁnition of Human Subject Research”. Research Ad- n.d. Retrieved 2013-04-15. ministration, University of California, Irvine. Retrieved 2012-01-04. [21] “U.S. Apologizes for Syphilis Experiment”. The New York Times. 1 October 2010. Retrieved 2 October 2010. [2] “What is Human Subjects Research?". University of Texas at Austin. Retrieved 2012-01-04. [22] “US medical tests in Guatemala 'crime against humanity'". BBC News. 1 October 2010. Retrieved 2 October 2010. [3] Perlman, David (May 2004). “Ethics in Clinical Research a History Of Human Subject Protections and Practical [23] Beecher, H. K. (1966). “Ethics and Clinical Research” Implementation of Ethical Standards” (PDF). Society of (PDF). New England Journal of Medicine 274 (24): Clinical Research Associates. Retrieved 2012-03-30. 1354–1360. doi:10.1056/NEJM196606162742405. PMID 5327352Reprint in Harkness, Lederer & Wikler, [4] Human Subject & Privacy Protection, National Institute of 2001, PMID 11357216 Justice, 2010-04-20, retrieved 2012-03-30 [24] Rothman, D. J. (1987). “Ethics and Human Experimenta- [5] “Report: Britain Tested Chemical Weapons on Indian tion” (PDF). New England Journal of Medicine 317 (19): Colonial Troops”. Voice of America. 2007-09-02. Re- 1195–1199. doi:10.1056/NEJM198711053171906. trieved 2011-06-02. PMID 3309660. 8 8 EXTERNAL LINKS

[25] Kopp, V. (1999). “Henry Knowles Beecher and [40] Milgram, Stanley (1963). “Behavioral Study of Obedi- the development of informed consent in anesthe- ence”. Journal of Abnormal and Social Psychology 67 sia research”. Anesthesiology 90 (6): 1756–1765. (4): 371–8. doi:10.1037/h0040525. PMID 14049516. doi:10.1097/00000542-199906000-00034. PMID as PDF. 10360876. [41] Blass, Thomas (1999). “The Milgram paradigm after 35 [26] Harkness, J.; Lederer, S.; Wikler, D. (2001). “Laying eth- years: Some things we now know about obedience to au- ical foundations for clinical research” (PDF). Bulletin of thority”. Journal of Applied Social Psychology 29 (5): the World Health Organization 79 (4): 365–366. PMC 955–978. doi:10.1111/j.1559-1816.1999.tb00134.x. as 2566394. PMID 11357216. PDF

[27] “History of the Human Subjects Protection System”. In- [42] Asch, S.E. (1951). “Effects of group pressure on the mod- stitutional Review Board Guidebook. Office for Human ification and distortion of judgments”, In H. Guetzkow Research Protections. 1993. Retrieved 2011-06-03. (Ed.), Groups, Leadership and Men(pp. 177–190). Pitts- burgh, PA: Carnegie Press [28] Gray, Fred D. The Tuskegee Syphilis Study, Montgomery: [43] Milgram, S. (1961). “Nationality and conformity”, Scien- New South Books, 1998. tific America, 205(6).

[29] Katz RV, Kegeles SS, Kressin NR et al. (Novem- [44] Whitley, B.E., & Kite, M.E. (2010). The Psychology of ber 2006). “The Tuskegee Legacy Project: willingness Prejudice and Discrimination. Belmont, CA: Wadsworth. of Minorities to Participate in Biomedical Research”. pp. 325–330. J Health Care Poor Underserved 17 (4): 698–715. doi:10.1353/hpu.2006.0126. PMC 1780164. PMID [45] Mook, Douglass, 2004, Greenwood Press, “Classic Ex- 17242525. periments in Psychology”

[30] National Commission for the Protection of Human Sub- [46] Cooper, Joel. 2007 “Cognitive Dissonance, Fifty Years of jects of Biomedical and Behavioral Research (1978-09- a Classic Theory”, SAGE Publications 30), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (PDF), • AFP (October 31, 2007). “A life haunted by WWII United States Department of Health, Education and Wel- surgical killings”. THE BRUNEI TIMES. Retrieved fare 16 May 2014.

[31] Hearn, Kelly (2011-10-10). “The Other South American • AFP (Oct 28, 2007). “Japanese veteran haunted by Drug War”. The Nation. WWII surgical killings”. AFP. Retrieved 16 May [32] Ahuja, Anjana (05/08/2006). “Poor, sick, desperate. 2014. What more could Big Pharma ask in Indian drug Trials?". The Times. Check date values in: |date= (help) 8 External links [33] Washington, Harriet A. Medical Apartheid, Anchor Books, 2006, p394 • “Human Research Report” - a monthly newsletter on [34] Kaler, Amy. 1998. “A Threat to the Nation and a Threat protecting human subjects to the Men: the Banning of Depo-Provera in Zimbabwe, • 1981,” Journal of Southern African Studies 24(2):p 347 Nuremberg Code • Belmont Report [35] Washington, Harriet A. Medical Apartheid, Anchor Books, 2006, p392-393 • Declaration of Helsinki, 6th edition

[36] “Africa | Nigeria sues drugs giant Pﬁzer”. BBC News. • Universal Declaration on Bioethics and Human 2007-06-05. Retrieved 2010-11-12. Rights by UNESCO

[37] Meier, Benjamin Mason: “International Protection of • Hungry Canadian aboriginal children used in gov- Persons Undergoing Medical Experimentation: Protect- ernment experiments during 1940s Toronto Star, ing the Right of Informed Consent,” Berkeley Journal of 2013 International Law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 −554

[38] Zimbardo, P.G. (2007). The Lucifer Eﬀect: Understand- ing How Good People Turn Evil. New York: Random House.

[39] Milgram, Stanley (1965). “Some Conditions of Obedi- ence and Disobedience to Authority”. Human Relations 18 (1): 57–76. doi:10.1177/001872676501800105. 9

9 Text and image sources, contributors, and licenses

9.1 Text

• Human subject research Source: http://en.wikipedia.org/wiki/Human%20subject%20research?oldid=654752336 Contributors: Damian Yerrick, The Anome, Shii, Rsabbatini, PhilipMW, Michael Hardy, Paul A, Aarchiba, Bloodshedder, Altenmann, Kent Wang, Wayland, DocWatson42, Barbara Shack, Gadfium, Piotrus, Jossi, Phil Sandifer, Adashiel, Wikkrockiana, Vincom2, Selphie, Florian Blaschke, Bumhoolery, Bender235, Konstantin~enwiki, RJHall, FirstPrinciples, Triona, Bendono, Cretog8, Jag123, Idleguy, Hooperbloob, Goat- bear, SlimVirgin, Melaen, Birdmessenger, Ceyockey, Woohookitty, Rickjpelleg, -Ril-, GregorB, Plrk, Gerbrant, BD2412, Teflon Don, Rjwilmsi, Koavf, Tarc, Eubot, Ground Zero, Latka, Gurch, Jrtayloriv, SVTCobra, Bgwhite, RussBot, FrenchIsAwesome, Laserion, Gaius Cornelius, Ihope127, Grafen, Joel7687, Emesik, WAS 4.250, Closedmouth, Jkpjkp, One, Yvwv, SmackBot, KnowledgeOfSelf, Ayocee, Jagged 85, Kintetsubuffalo, Nil Einne, Gilliam, Hmains, Martial Law, Chris the speller, Bluebot, Darth Panda, MaxSem, Alms, Shadow1, Chrylis, Soarhead77, Copysan, Clicketyclack, SirIsaacBrock, Jombo, Kuru, Akendall, John, Cesium 133, Tazmaniacs, Normalityrelief, Toncu, Csari, Rayleung2709, BirdsongMeadow, Lifeartist, VoxLuna, CmdrObot, Ruby Tuesday~enwiki, CWY2190, Penbat, Gregbard, Cydebot, AniMate, A Softer Answer, Dougweller, PKT, Thijs!bot, Epbr123, John robinson, Dfrg.msc, Instance, AntiVandalBot, Fayenatic london, Robert klono, Kauczuk, Qwerty Binary, Gökhan, Dogru144, Flying tiger, Thomas.Hedden, Dekimasu, Appraiser, Whamilton, Swpb, Michael Goodyear, Pugetbill, Courtney Akins, Cgingold, A3nm, YeahIKnow, WLU, Inu2000, CommonsDelinker, Delamorena, Yonidebot, Hodja Nasreddin, Alexb102072, Belovedfreak, MetsFan76, BrettAllen, Djr13, DiamondTear, Sam Blacketer, Migospia, John- fos, Edwinvazquez, Nilli, MVMosin, Mark v1.0, Anna Lincoln, Dtely, Martin451, ProtectWomen, S. M. Sullivan, StillTrill, Cuddlyable3, Wykypydya, Dirkbb, Mingramh, Nog lorp, Helper6860, Flyer22, Jsfouche, Biggarm, COBot, Melcombe, JoeenNc, ClueBot, GorillaWar- fare, TransporterMan, The Thing That Should Not Be, ImperfectlyInformed, Vince529, Anarchonobody, Babando, K8lynw, Parkwells, SamuelTheGhost, Excirial, Redthoreau, M.boli, SDY, Qwfp, DumZiBoT, Smoke003723, Gazimoff, NonvocalScream, Addbot, DOI bot, Jncraton, Glane23, Tide rolls, Lightbot, Al3xil, Jarble, Yobot, AnomieBOT, VanishedUser sdu9aya9fasdsopa, Bluerasberry, LilHelpa, Banjaloupe, Thosjleep, Wikireader41, MerlLinkBot, Wag 7, FrescoBot, Tobby72, Recognizance, Terraplane34, Cs32en, Arcendet, Ci- tation bot 1, Javert, Pinethicket, I dream of horses, Jessamyncp, Gegenwind~enwiki, RjwilmsiBot, Yaush, Wintonian, Syncategoremata, Wikipelli, Idh0854, Bamyers99, Zloyvolsheb, Demonkoryu, Widdywoo, Wayne Slam, Wingman4l7, Palosirkka, ResidentAnthropologist, DASHBotAV, Bruginshale, ClueBot NG, Yambaram, Satellizer, Frerin, Abhijeet Safai, Frietjes, Helpful Pixie Bot, BG19bot, Tomjowler, AlisonLC, DonnieHinz, TraceySwans, BattyBot, B4change1, Darrylsturrock, Sae Harshberger, Rajmaan, Alzyyy, Midnight24x2, Arm- brustBot, Jsp4a, Kahtar, Jakejohnston1, JaconaFrere, Chronopen, Monkbot, BethNaught, Neil Hampshire, Bishaz and Anonymous: 208

9.2 Images

• File:66935A.jpeg Source: http://upload.wikimedia.org/wikipedia/commons/5/51/Child_survivors_of_Auschwitz.jpeg License: Public domain Contributors: USHMM/Belarusian State Archive of Documentary Film and Photography http://collections.ushmm.org/search/ catalog/pa14532 Original artist: Alexander Voronzow and others in his group, ordered by Mikhael Oschurkow, head of the photography unit • File:Commons-logo.svg Source: http://upload.wikimedia.org/wikipedia/en/4/4a/Commons-logo.svg License: ? Contributors: ? Original artist: ? • File:National_Advisory_Committee_for_Aeronautics_wind_tests_(1946).webm Source: http://upload.wikimedia.org/wikipedia/ commons/1/18/National_Advisory_Committee_for_Aeronautics_wind_tests_%281946%29.webm License: Public domain Contributors: Youtube Original artist: National Advisory Committee for Aeronautics, for the US Navy • File:Unit_731_-_Complex.jpg Source: http://upload.wikimedia.org/wikipedia/commons/b/bc/Unit_731_-_Complex.jpg License: Pub- lic domain Contributors: Bulletin of Unit 731 Original artist: Unidentiﬁed

9.3 Content license

• Creative Commons Attribution-Share Alike 3.0