Common Rule

The Federal Policy for the Protection of Human Subjects is known as the “Common Rule” because it has been adopted by a number of federal departments and agencies. 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.

HHS and other federal departments and agencies issued final revisions to the Common Rule in 2017; the final rule, also known as the 2018 Requirements, was published in the Federal Register on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018 and June 19, 2018. The revised Common Rule became effective on January 21, 2019.

The U.S. Department of Justice has not adopted the revised Common Rule and still follows the pre-2018 requirements. The U.S. Food and Drug Administration has not yet harmonized their regulations for the protection of human subjects and Institutional Review Boards with the revised Common Rule.

The revised Common Rule regulation is codified at 45 CFR 46 (2018).

The pre-2018 Common Rule regulation is codified at 45 CFR 46 (pre-2018).