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 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. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.
The list below displays the agencies and departments that have signed onto the Common Rule and their CFR numbers. Hyperlinks are to areas of a department or agency Web site that have been suggested to HHS as entry points for those interested in human subject protection activities of the department or agency.
General information:
- 19 agencies (including HHS) follow the Pre-2018 Requirements
- Of these, 15 agencies are official signatories with the rule codified in their own Code of Federal Regulations (CFR) sections
- 4 departments and agencies follow the Pre-2018 Common Rule because of executive order or statutory mandate (Department of Homeland Security, Social Security Administration, Office of the Director of National Intelligence, and Central Intelligence Agency)
- 20 agencies (including HHS) intend to follow the revised Common Rule (published January 2017, amended January 2018, effective July 2018)
- There is 1 new signatory to the revised Common Rule (Department of Labor)
- 2 agencies that followed the pre-2018 Common Rule because of executive order or statutory mandate have become official signatories to the revised Common Rule (Department of Homeland Security and Social Security Administration)
- 1 original signatory (Department of Justice) intends to become an official signatory to the revised Common Rule
- The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA is not considered a Common Rule agency because its regulations differ from the Common Rule. However, FDA is required to harmonize with the Common Rule whenever permitted by law (see section 1002 of the 21st Century Cures Act, Public Law 114-255)
- You can find more information about the FDA regulations here
Common Rule Departments and Agencies:
| No. | Dept. or Agency | CFR Citation (2018) | Authority | Status under Pre-2018 Requirements | Status under 2018 Requirements |
|---|---|---|---|---|---|
| 1 | Department of Homeland Security | 6 CFR Part 46 | 5 U.S.C. 301; P.L. 107-296, sec. 102, 306(c); P.L. 108-458, sec. 8306. | Follows Common Rule and all subparts per statute (Pub. L. 108-458, title VIII, section 8306) | Common Rule Signatory |
| 2 | Department of Agriculture | 7 CFR Part 1c | 5 U.S.C. 301; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 3 | Department of Energy | 10 CFR Part 745 | 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 4 | National Aeronautics and Space Administration | 14 CFR Part 1230 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 5 | Department of Commerce (National Institute of Standards and Technology) | 15 CFR Part 27 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 6 | Social Security Administration | 20 CFR Part 431 | 5 U.S.C. 301; 42 U.S.C. 289(a). | SSA and HHS split in 1995. Pursuant to the transition rules provided in Section 106 of title 1 of Pub.L. 103-296, SSA has been required to apply the CR to its research. | Common Rule Signatory |
| 7 | Agency for International Development | 22 CFR Part 225 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless otherwise noted. | Common Rule Signatory | Common Rule Signatory |
| 8 | Department of Housing and Urban Development | 24 CFR Part 60 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b) and 3535(d). | Common Rule Signatory | Common Rule Signatory |
| 9 | Department of Justice (National Institute of Justice) | 28 CFR Part 46 | Common Rule Signatory | Intends to become an official signatory | |
| 10 | Department of Labor | 29 CFR Part 21 | 5 U.S.C. 301; 29 U.S.C. 551. | Not a Common Rule Signatory | Common Rule Signatory |
| 11 | Department of Defense | 32 CFR Part 219 | 5 U.S.C. 301. | Common Rule Signatory | Common Rule Signatory |
| 12 | Department of Education | 34 CFR Part 97 | 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474. | Common Rule Signatory | Common Rule Signatory |
| 13 | Department of Veterans Affairs (Office of Research Oversight) (Office of Research and Development) | 38 CFR Part 16 | 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 14 | Environmental Protection Agency (Research and Development) | 40 CFR Part 26 | 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 15 | Department of Health and Human Services | 45 CFR Part 46 | 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b) | Common Rule Signatory | Common Rule Signatory |
| 16 | National Science Foundation | 45 CFR Part 690 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 17 | Department of Transportation | 49 CFR Part 11 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b). | Common Rule Signatory | Common Rule Signatory |
| 18 | Office of the Director of National Intelligence | None | EO 12333 (1981), amended by EO 13284 (2003), EO 13355 (2004), and EO 13470 (2008) | Follows CR because of EO 12333, as amended. | Follows CR because of EO 12333, as amended. |
| 19 | Central Intelligence Agency | None | EO 12333 (1981), amended by EO 13284 (2003), EO 13355 (2004), and EO 13470 (2008) | Follows CR because of EO 12333, as amended. | Follows CR because of EO 12333, as amended. |
| 20 | Consumer Product Safety Commission | 16 CFR Part 1028 | 5 U.S.C. 301; 42 U.S.C. 300v-1(b) | Common Rule Signatory | Common Rule Signatory |
