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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 possible - under their respective statutory authorities - their 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)
• Department of Defense (32 CFR part 219)
• Department of Education (34 CFR part 97)
• 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)
• Consumer Product Safety Commission (16 CFR part 1028)
• Environmental Protection Agency (40 CFR part 26)
• Agency for International Development (22 CFR part 225)
• 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. And, in accordance with the Intelligence Reform and Terrorism Protection Act of 2004 (P.L. 108-458, Section 8306), the Department of Homeland Security adopted policies implementing the protections for human subjects under 45 CFR part 46 for the research that it conducts or supports.

For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. HHS has developed additional regulations for the human subjects research it conducts or supports that apply to particular special populations: 45 CFR part 46 subparts B-D apply to research involving pregnant women, human fetuses, and neonates (subpart B), prisoners (subpart C), and children (subpart D).

Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general.

Last Reviewed: 06/17/2011

• Do the human research regulations apply to non-U.S. institutions?
• Does approval of an institution's assurance of compliance by the Office for Human Research Protections (OHRP) mean that the institution is in full compliance with the Department of Health and Human Services (HHS) Protection of Human Subjects regulations?
• How will I know when my institution’s Federalwide Assurance (FWA) is approved?
• How will the Office for Human Research Protections (OHRP) respond to queries from an FWA institution about human subjects research conducted or supported by a non-HHS department or agency?
• When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?

• Assurance Process