HHS Regulation for the Protection of Human Research Subjects

The HHS basic policy for protection of human research subjects is referred to as the “Common Rule” because it has been adopted by other federal departments or agencies such as the Departments of Justice and Education. The basic policy provides requirements such as the composition and function of the IRB, criteria for IRB approval, informed consent requirements, and definitions. In addition to the basic policy, HHS also has additional protections for pregnant women, human fetuses and neonates, prisoners, and children, adopted by fewer federal agencies or departments.

This regulation is codified at 45 CFR 46.