51. DHHS Regulations for the Protection of Human Research Participants

Updated June 23, 2021

The Department of Health and Human Services (DHHS) was the first federal agency to codify regulations governing human research protection.

The Code of Federal Regulations at 45 CFR 46 describes the DHHS requirements for the protection of human research participants. The DHHS regulations require that research involving human participants:

  • be subject to oversight by an IRB to ensure that the rights and welfare of research participants are protected, and
  • meets regulatory and institutional requirements.

The Common Rule

§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.

DHHS Subparts B, C, and D

Subparts B (45 CFR 46.201-.207), C (§46.301-306), and D (§46.401-409) describe requirements for additional protections for populations the DHHS considers vulnerable.

  • Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
  • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
  • Subpart D: Additional Protections for Children Involved as Subjects in Research

IRB policies describe how the University IRB applies the regulatory requirements for research involving pregnant women/fetuses, women with the potential to become pregnant, prisoners (including unexpected incarceration of a research participant) and children.

DHHS Subpart E

Subpart E (§46.501-505) describes the requirements and processes for registration of the IRB. (See IRB policy for designation of the IRB for the University's IRB registration name and number.)

  • Subpart E—Registration of Institutional Review Boards

Application of the Common Rule and Subparts B, C, and D by the University

Through its DHHS Federalwide Assurance (FWA) (specified in the IRB policy for institutional authority), when University or Affiliate investigators are engaged in human research, the University:

  • applies the Common Rule (§46 Subpart A) and Subparts B, C, and D to all human research conducted or otherwise supported by a federal department or agency; and
  • provides equivalent protections for human research that is not conducted or otherwise supported by a federal department or agency through its IRB Flexibility Policy.

See Policy 3. Designation of IRB for Non-Exempt Human Research for information about how the University applies the federal regulations, guidance documents, and other requirements to its Human Research Protection Program.