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 de- bilitating 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 in- volved 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).

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