Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics.
With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.
[3] The code highlighted 3 key elements (voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions) which later became the foundation for further human research regulations.
[7] Starting in 1932, investigators recruited 399 impoverished African-American sharecroppers with syphilis for research related to the natural progression of the untreated disease, in hopes of justifying treatment programs for blacks.
[7] Even when the results were made public, the initial reaction of the medical scientific community was to exonerate the study and criticize the popular press for interfering with the research.
[15] A later conference in September 1979 organized by Tom Beauchamp, who co-authored the Belmont Report, sought to remedy that by hosting social scientists and ethicists and resulted in an anthology.
[16] However, the conference lacked the official status of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and did not influence subsequent legislation.
[17] In 1975, the Department of Health, Education and Welfare (DHEW) created regulation which included the recommendations laid out in the NIH's 1966 Policies for the Protection of Human Subjects.
[6] Title 45 of the Code of Federal Regulations, known as "The Common Rule," requires that institutional review boards (IRBs) oversee experiments using human subjects.
[6][18] This committee was created to investigate and report the use of human beings as test subjects in experiments involving the effects of ionizing radiation in federally funded research.
[18] The committee attempted to determine the causes of the experiments, and reasons why the proper oversight did not exist, and made several recommendations to help prevent future occurrences of similar events.
[18] In 1995[6] (or 1996 – sources vary[3]) a National Bioethics Advisory Commission was established, opining on issues such as cloning of humans, and research involving mentally disabled.