52. DHHS Regulations: The Common Rule

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 subjects and is incorporated into University policy for

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

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

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