Human Subjects Research (45 CFR 46)

Basic regulations governing the protection of human = subjects in=20 research supported or conducted by HHS (then the Department = of=20 Health, Education and Welfare) were first published in 1974. = In the=20 United States, a series of highly publicized abuses in = research led=20 to the enactment of the 1974 National Research Act (Public = Law=20 93-348), which created the National Commission for the = Protection of=20 Human Subjects of Biomedical and Behavioral Research. One of = the=20 charges to the National Commission was to identify the basic = ethical=20 principles that should underlie the conduct of biomedical = and=20 behavioral research involving human subjects and to develop=20 guidelines to assure that such research is conducted in = accordance=20 with those principles. In 1978, the Commission published = =E2=80=9CEthical=20 Principles and Guidelines for the Protection of Human = Subjects of=20 Research,=E2=80=9D also known as the Belm= ont=20 Report, named after the Belmont Conference Center where = the=20 Commission met when drafting the report. The Belmont Report=20 identifies three fundamental ethical principles for all = human=20 subjects research=EF=BF=BDrespect for persons, beneficence, = and justice.

Based on the Belmont Report and other work of the = National=20 Commission, HHS revised and expanded its regulations for the = protection of human subjects in the late 1970s and early = 1980s. The=20 HHS regulations are codified at 45 CFR part 46, subparts A = through=20 D. The statutory authority for the HHS regulations derives = from 5=20 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289.

The regulations found at 45 CFR part 46 are based in = large part=20 on the Belmont Report and were written to offer basic = protections to=20 human subjects involved in both biomedical and behavioral = research=20 conducted or supported by HHS. In 1991, 14 other Federal = departments=20 and agencies joined HHS in adopting a uniform set of rules = for the=20 protection of human subjects, identical to subp= art=20 A of 45 CFR part 46 of the HHS regulations. This uniform = set of=20 regulations is the Federal Policy for the Protection of = Human=20 Subjects, informally known as the =E2=80=9CCommon = Rule.=E2=80=9D In 1995 the Central=20 Intelligence Agency was required by Executive Order to = comply with=20 all subparts of the HHS=20 regulations.

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