Abstract

The Common Rule is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services, which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A, Subpart B, Subpart C, and Subpart D. The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board, and the criteria for approving research.