On Jan. 27, 1981, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (DHHS) issued 21 CFR 50 (Protection of Human Subjects). While DHHS rules apply only to federally funded programs, FDA rules apply to any research study on drugs or devices that are regulated by FDA, regardless of funding.

The creation of Institutional Review Boards to assure the protection of research subjects came out of terrible research abuses that resulted in the Belmont Report and federal regulations establishing rules for federally funded research and its independent review.