Table.
Evolution of Human Subjects Research and Guidelines
| Year | Event |
|---|---|
| 1932–1972 | Tuskegee Syphilis Study |
| 1939–1945 | Experiments on concentration camp prisoners by Nazi scientists |
| 1946–1974 | Secret human radiation experiments |
| 1946–1948 | Guatemalan STD inoculation studies |
| 1947 | Nuremburg Code |
| 1953 | NIH Clinical Center requires informed consent and independent review |
| 1953–1954 | Sing Sing Prison syphilis inoculation study |
| 1956–1971 | Hepatitis studies at Willowbrook State School for the Retarded |
| 1962 | Kefauver-Harris drug amendments |
| 1963 | Jewish Hospital cancer study |
| 1964 | World Medical Association Declaration of Helsinki |
| 1966 | US Surgeon General policy statement on human subjects research (IRB origin) |
| 1971 | NIH Office for Protection from Research Risks established |
| 1974–1978 | National Commission for the Protection of Human Subjects |
| 1974 | HHS regulations for human subjects research |
| 1975 | CDC Office of Human Research Protections established |
| 1978–1983 | President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research |
| 1979 | Belmont Report released |
| 1981 | HHS 45 CFR 46 and Food and Drug Administration 21 CFR 50, 56 regulations published |
| 1985 | NIH Clinical Center Bioethics Program founded |
| 1991 | 45 CFR 46 (Common Rule) adopted |
| 1993 | CIOMS guidelines released |
| 1994 | Presidential apology for secret radiation experiments |
| 1995 | World Health Organization Guidelines for Good Clinical Practice |
| 1996–2001 | National Bioethics Advisory Commission |
| 1997 | Presidential apology for Tuskegee |
| 1998 | NIH support for bioethics training and research expanded |
| 1999 | NIH support for international research and ethics training |
| 2000 | World Health Organization operational guidelines for ethics committees |
| 2001–2009 | President’s Council on Bioethics |
| 2002 | Secretary’s Advisory Committee on Human Research Protections |
| 2005 | UNESCO Universal Declaration on Bioethics and Human Rights |
| 2009 | Executive order to create Presidential Commission for the Study of Bioethical Issues |
Abbreviations: CDC, Centers for Disease Control and Prevention; CFR, Code of Federal Regulations; CIOMS, Council for International Organizations of Medical Sciences; HHS, Department of Health & Human Services; IRB, institutional review board; NIH, National Institutes of Health; STD, sexually transmitted disease; UNESCO, United Nations Educational, Scientific and Cultural Organization.