Human Subjects Protection - A Brief History
1947: Nuremberg Code: Nazis physicians are tried at Nuremberg, Germany, for research atrocities performed on Prisoners of war. This resulted in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal.
1953: The Wichita Jury Study: Researcher’s audio-taped jurors deliberating on cases, without their permission. Public criticism about the basic problem of deceiving people for research purposes in a setting where privacy and confidentiality were critically important. It is not appropriate to compromise the integrity of important social institutions, even if it’s the only way to answer important research questions.
1962: Kevauver-Harris Bill: The Kefauver-Harris bill is passed to ensure greater drug safety in the United States after Thalidomide (a new sleeping pill) is found to have caused birth defects.
1964: Helsinki Declaration: The 18th World Medical Assembly meets in Helsinki, Finland, and issues recommendations to guide physicians in biomedical research involving human subjects. The guide was known as the Helsinki Declaration.
1966: The NEJM (New England Journal of Medicine), Ethics of Clinical Research by Henry Beecher Described the ethical violations of 22 studies that had been conducted by well-respected researchers and published in prestigious research journals. It was an unprecedented attempt by a respected member of the research community to focus attention on the need to improve ethical standards.
1932 - 1972: Tuskegee Syphilis Study Public Health Service funded a study to evaluate the natural history of untreated syphilis in human beings. When the study was conceptualized, the basic concept was considered scientifically important and ethically justifiable because there was no know treatment for the disease. The research population included on of the most vulnerable research populations-approximately 300 mostly indigent African American sharecroppers in Macon County, Alabama. The reality is that the subjects did not know that they were part of a research study designed to understand the natural progression of the disease. Many thought there were receiving beneficial medical care. The subjects were followed, untreated, many years after penicillin was known to cure syphilis.
The study was stopped in 1972 after high profile stories in the national media generated public outrage over the blatant exploitation of this vulnerable segment of society. The fact that the federal government directed Tuskegee over such a long period of time has stained the integrity of the American research enterprise. It also catalyzed passage of the National Research Act in 1974.
Congressional Hearings on the Quality of Health Care and Human Experimentation were held in response to public concern about ethical problems in the way medical and social science research was being conducted. This is a partial list:
Willowbrook Hepatitis Study, 1950’s: To understand issues related to the transmission of the hepatitis virus in mentally retarded children who were residents in the Willowbrook State School. The study designed involved intentionally infecting healthy children with hepatis by feeding them a solution made from the feces of children with active hepatitis.
Jewish Chronic Disease Studies, 1960s: Experiments were performed on chronically ill, mostly demented patients in the Jewish Chronic Disease Hospital. The purpose of the research was to determine how a weakened immune system influenced the spread of cancer. To evaluate this, live cancer cells were injected into the blood stream of the subjects.
Milgram Studies of Obedience of Authority, 1960’s: The purpose of the Milgram studies was to understand why people follow the directions of authority figures even when they are told to do things that are cruel or unethical. Subjects were instructed to deliver, at increasingly higher intensities, shocks to others. After they were “debriefed”, subjects complained of extreme psychological distress after understanding the potentially lethal level of shocks administered.
San Antonio Contraceptive Study, 1970’s: The purpose of this study was to determine the efficacy of different kinds of contraceptive pills. The clinic served predominantly indigent patients who had no other place to go for contraceptive advice or medication. The randomized design meant some patients received a placebo. As expected, there were a high number of unplanned pregnancies in the placebo group.
Tearoom Trade Study, 1970’s: Social scientist, Laud Humphries posed as a “watch queen” outside public restrooms, where people gathered to engage in anonymous homosexual behavior. He recorded the license plate numbers and other identifying information, which he used to obtain their names and addresses. He then presented himself at their homes to interview them about their background and family life. Many subjects were living with their family in a situation where it would be devastating to reveal information about homosexual activity. At no time did the subjects understand they were participating in a study about homosexuality. In his published reports, the level of detail was such that the identify of some of the subjects becomes known.
1974: National Research Act: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and Congress passes the National Research Act. This Act requires that all research involving human participants to be regulated.
1979: Belmont Report: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research publishes the Belmont Report: The ethical Principles and Guidelines for the Protections of Human Subjects of Research
1993: Albuquerque Tribunal Publicizes Human Radiation Experiments: The Albuquerque Tribunal publicized 1940s experimentation involving plutonium injections of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment.
1994: National Bioethics Advisory Commission Formed: President Clinton creates the National Bioethics Advisory Commission (NBAC)
1995: Human Radiation Experiments Unethical: The Presidents Advisory Commission on Human Radiation Experiments concludes that some of the radiation experiments from the 1940s were unethical.
1997: Apology to Tuskegee Experimental Subjects: President Clinton issues a formal apology to the subjects of the Tuskegee Syphilis Experiments. NBAC continues investigation into genetics, consent and privacy.
2002: NBAC Charter Not Renewed: The U.S Department of Health and Human Services under President Bush appointee Tommy Thompson decides not to renew the charter of the National Bioethics Advisory Commission (NBAC).