U.S. Department of Health & Human Services
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How does 45 CFR part 46 relate to the Common Rule and human subjects regulations used by non-HHS agencies?
The current US 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 the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
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. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. The list below displays the agencies and departments that have signed onto the Common Rule and their CFR numbers.
- Agency for International Development (22 CFR part 225)
- Consumer Product Safety Commission (16 CFR part 1028)
- Department of Agriculture (7 CFR part 1c)
- Department of Commerce (15 CFR part 27)
- Department of Defense (32 CFR part 219)
- Department of Education (34 CFR part 97 subpart A)
- Department of Energy (10 CFR part 745)
- Department of Health and Human Services (45 CFR part 46 subpart A)
- Department of Housing and Urban Development (24 CFR part 60)
- Department of Justice (28 CFR part 46)
- Department of Veterans Affairs (38 CFR part 16)
- Department of Transportation (49 CFR part 11)
- Environmental Protection Agency (40 CFR part 26)
- National Aeronautics and Space Administration (14 CFR part 1230)
- National Science Foundation (45 CFR part 690)
In addition, the Central Intelligence Agency must comply with all subparts of 45 CFR part 46 under Executive Order 12333.
Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general. Investigators are encouraged to review the regulations of the funding agency to determine whether additional regulations apply. Also, many agencies have not adopted subparts B, C, or D and grantees of those agencies are not necessarily bound by them. Grantees should consult their funding agency for guidance.
Last Reviewed: 01/20/2011
Related Questions:
- How do subparts B, C, and D of the HHS human research regulations at 45 CFR part 46 relate to subpart A?
- What human research issues are addressed in 45 CFR part 46?
- How can I find out if the 45 CFR 46 human subject research regulations apply to my research?
- How does HHS ensure that regulatory requirements for human research are met?
- Do the human research regulations apply to non-U.S. institutions?
