How does 45 CFR part 46 relate to the human subjects regulations used by non-HHS federal funding agencies?
The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and FDA revised and made as compatible as possibleunder their respective statutory authoritiestheir existing human subjects regulations. With leadership from HHS, the Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below (each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of 45 CFR part 46, subpart A). • Department of Agriculture (7 CFR part 1c) • Department of Commerce (15 CFR part 27) • Departme
