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.
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.