51. DHHS Regulations for the Protection of Human Research Subjects

Updated July 1, 2019

The Department of Health and Human Services 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 subjects. 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:

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

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.

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

This subpart ( §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.)

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

Through its DHHS FWA (specified in IRB policy for institutional authority), when University or Affiliate investigators are engaged in human subject 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 Subject Research for information about how the University applies the federal regulations, guidance documents, and other requirements to its Human Research Protection Program.