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  1. Clinical Trials and Human Subject Protection

Federal Policy for the Protection of Human Subjects

7 CFR Part 1c; 10 CFR Part 745; 14 CFR Part 1230; 15 CFR Part 27; 16 CFR Part 1028; 22 CFR Part 225; 24 CFR Part 60; 28 CFR Part 46; 32 CFR Part 219; 34 CFR Part 97; 38 CFR Part 16; 40 CFR Part 26; 45 CFR Part 46; 45 CFR Part 690; 49 CFR Part 11; 56 FR 28003

AGENCIES: United States Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Consumer Product Safety Commission; International Development Cooperation Agency, Agency for International Development; Department of Housing and Urban Development; Department of Justice; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; Department of Transportation.

June 18, 1991

ACTION: Final rule.

SUMMARY: This document sets forth a common Federal Policy for the Protection of Human Subjects (Model Policy) accepted by the Office of Science and Technology Policy and promulgated in regulation by each of the listed Departments and Agencies. A Proposed Federal Policy for the Protection of Human Subjects published November 10, 1988 (53 FR 45661) has been revised in response to public comments. The Policy as revised is now set forth as a common final rule. For related documents, see other sections of this Federal Register part.

EFFECTIVE DATE: These regulations shall become effective on August 19, 1991. The Department of Education regulations (34 CFR part 97) take effect either August 19, 1991, or later if Congress takes certain adjournments. If you want to know the effective date of the Department of Education regulations in 34 CFR part 97, call or write Mr. Edward Glassman, Office of Planning, Budget and Evaluation, U.S. Department of Education, room 3127, 400 Maryland Avenue SW., Washington, DC 20202-4132. A document announcing the effective date of the Department of Education regulations will be published in the Federal Register. Institutions currently conducting or supporting research in accord with Multiple Project Assurances of Compliance (MPAs) approved by and on file in the Office for Protection from Research Risks (OPRR) in the Department of Health and Human Services may continue to do so in accord with the terms and conditions of their MPAs. See Supplementary Information for further details.

FOR FURTHER INFORMATION CONTACT: Dr. Joan P. Porter, (301) 496-7005. Office for Protection from Research Risks, National Institutes of Health, Building 31, room 5B59, Bethesda, MD 20892.

For more information and full text, go to https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html 
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