FDA’s regulations on human subject protection (21 CFR part 50) and Institutional Review Boards (IRBs; 21 CFR part 56) help to ensure that the rights, safety, and welfare of human subjects participating in FDA-regulated clinical investigations are protected. These regulations generally conform to the Department of Health and Human Services’ (HHS’) Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”), which sets forth requirements for the protection of human subjects involved in research that is conducted or supported by HHS.

In a final rule published on January 19, 2017, HHS and a number of federal departments and agencies made revisions to the Common Rule. The general compliance date for the revised Common Rule is January 21, 2019.

FDA intends to undertake notice and comment rulemaking to harmonize, to the extent applicable, FDA’s regulations with the revised Common Rule. Because FDA has not revised its regulations, FDA is issuing this guidance to reduce confusion and burden associated with complying with two different sets of human subject protection regulations. This guidance is intended to address questions from stakeholders regarding the impact of certain provisions of the revised Common Rule on FDA-regulated clinical investigations during FDA’s rulemaking process.