Common Rule

Type: Concept

As of November 2026, Common Rule has been mentioned in one podcast episode on NIH VideoCast (Sep 2025). Regulatory framework governing human subjects research in the U.S., mentioned in relation to vulnerable groups and IRB review.

The Common Rule is a 1991 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018. It governed Institutional Review Boards for oversight of human research and followed the 1975 revision of the Declaration of Helsinki; it is encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 Subparts A, B, C and D. Subpart A. The Common Rule is the baseline standa