December 28

1979: The Belmont Report

On July 12, 1974, President Nixon signed the National Research Act which created a commission whose task was to identify basic underlying ethical principles to be used in conducting biomedical research; and the law required codified regulations to protect human subjects during medical research in the United States. Regulations for the Protection of Human Subjects in Biomedical and Behavioral Research–45 C.F.R. 46 — which  established standards for matters such as informed consent, selection of research subjects and Institutional Review Boards (IRBs).

In 1978, 45 CFR 46 Subpart C specifically protects prisoners in biomedical and behavioral research.In 1979 the commission’s recommendations were published in the Belmont Report, which established ethical guidelines for informed consent, beneficence, and justice; and risk assessment and selection of human test subjects.  Notably, the Belmont Report, which addressed human research subjects, was published thirteen years after the Animal Welfare Act (1966)  was enacted to protect animals.1979: National Commission issued The Belmont Report setting forth three basic ethical principles: respect for persons, beneficence, and justice.

In 1980, the FDA issued 21 CFR 50.44 prohibiting the use of prisoners as subjects in clinical trials shifting phase I testing by pharmaceutical companies to non-prison population.

In 1991, 45 C.F.R. 46, Subpart A, became known as the “Common Rule.” Seventeen federal agencies agreed to adopt the principles of the regulations and consistently apply them to subjects in all federally funded research.

 

 


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