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No federal regulation existed for the protection of human subjects and consumer safety prior to the passage of the Pure Food and Drug Act in 1906.
Another critical event in the history of research with human subjects took place in 1946, when a military tribunal began criminal proceedings against 23 German physicians and administrators for war crimes and crimes against humanity. As a direct result of these proceedings, the Nuremberg Code was established, which made it clear that the voluntary and informed consent of human subjects is essential to research and that benefits of research must outweigh risks to human subjects involved.
Other key events in protecting human subjects include:
- The use of thalidomide in the 1950s caused severe deformities in fetuses. The drug had not been approved by the FDA. U.S. Senate hearings resulted in the "Kefauver Amendments" to the Food, Drug, and Cosmetic Act to insure drug efficacy and safety.
- In 1964, the World Medical Associations established guidelines for medical doctors in biomedical research involving human subjects. The Declaration of Helsinki is the basis for good clinical practices today.
- Public Health Service policy required the establishment of the National Advisory Health Council for the prior review of PHS-sponsored research.
- During a research study from 1932 through 1972 called the Tuskeegee Study and funded by the U.S. Public Health Service, 600 low-income African-American males were infected with syphilis, but were not told of their illness. Some were medicated; others were denied treatment. In 1997, President Clinton apologized to the study subjects and their families.
- The National Research Act, passed due to adverse publicity from the Tuskegee Study, created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (July 1974).
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