In 1991, the policy for protection of human subjects in research, promulgated in 1981 by the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services, was adopted by more than a dozen federal entities involved in human subject research and becomes known as the Common Rule.

This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.