Timeline of Laws Related to the Protection of Human Subjects

Compiled by Joel Sparks
June 2002

In the past, the role of human research subject has been fraught with danger and suffering. The ancient Hippocratic Oath specified a duty from a physician to avoid harming the patient, but that oath, highly honored today, was not even subscribed to by a majority of doctors at the time. Advances in protection for human subjects have often come in response to particular abuses or scandals. The German atrocities of World War II, some of which were committed in the name of science, led to the Nuremberg Code of international ethics, which in part spelled out the requirement that any human subject must give informed consent to the research undertaken. The disaster of thalidomide in Europe and Canada was largely averted in the United States, but thousands of patients had taken doses without being informed of the drug's experimental nature. The brush with thalidomide helped the U.S. pass the 1962 Kefauver-Harris amendments, which strengthened federal oversight of drug testing and included a requirement for informed consent. A 1966 study of abuses, written by Dr. Henry K. Beecher, helped inform government policies adopted in that year. Likewise, the discovery in the 1970s that unwitting subjects had been allowed to suffer syphilis in the 1930s Tuskegee Experiment preceded a call for tighter regulation of federally-funded human research.

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