52. DHHS Regulations - The Common Rule

Updated June 28, 2021

45 CFR 46 Subpart A is known as the Common Rule. The following federal agencies have signed onto the Common Rule:

• Department of Agriculture (7 CFR 1C)
• Department of Energy (10 CFR 745)
• National Aeronautics and Space Administration (14 CFR 1230)
• Department of Commerce (15 CFR 27)
• Consumer Product Safety Commission (16 CFR 1028)
• International Development Cooperation Agency & Agency for International Development (22 CFR 225)
• Department of Housing and Urban Development (24 CFR 60)
• Department of Justice (28 CFR 46)
• Department of Defense (32 CFR 219)
• Department of Education (34 CFR 97)
• Department of Veterans Affairs (38 CFR 16)
• Environmental Protection Agency (40 CFR 26)
• National Science Foundation (45 CFR 690)
• Department of Transportation (49 CFR 11)

The Common Rule describes the basic DHHS policy for the protection of human research participants and is incorporated into University policy for:

• IRB review types and processes;
• criteria for IRB approval (addresses risks/benefits, participant selection, and recruitment and consent processes);
• reporting requirements for investigators and the IRB; and
• IRB committee management and record keeping.

Details about how the University applies the regulations in the Common Rule can be found in Policy 75. Department of Education (DoEd) Regulations for Human subject Research.

For details about regulations in the Common Rule, see the relevant sections of the IRB policy manual.