Regulations

The U.S. Department of Health and Human Services codified it’s regulations for the protection of human subjects in research in the code of federal regulations at 45 C.F.R. 46, which includes five subparts. Below, readers can access the regulatory text of subpart A (the Common Rule), including the 2018 revisions to the Common Rule, and subparts B-E. OHRP also provides additional information about the revisions to the Common Rule, the preamble to the revised regulatory text, and the process of revising the Common Rule.

OHRP makes available the full text of the HHS regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and FDA human subject protection regulations.

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45 CFR 46

Read the HHS Policy for Protection of Human Subjects at 45 CFR Part 46, including the two versions of the Common Rule at subpart A.

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Revision of the Common Rule

Find more information about the revision of the Common Rule, including the preamble, timeline of the revisions, and list of related terminologies.

OHRP also makes available information about HHS’s statutory authority, the Federal Departments and Agencies that adhere to the Common Rule, and the U.S. Food and Drug Administration (FDA) regulations, including regulations for the protection of human subjects in research that falls under its jurisdiction.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on March 16, 2021