Guide on Revised ‘Common Rule’ Implications

FDA has released a guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” In 2017, revisions were made to HHS’ Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”), which set a 1/21/2019 compliance date. Because FDA has not revised its regulations, it is issuing this guidance to reduce confusion and burden associated with complying with two different sets of human subject protection regulations.

“If a clinical investigation is conducted or supported by HHS and involves an FDA-regulated product, then the study is subject to both 45 CFR part 46 and 21 CFR parts 50 and 56,” the guidance says. “As FDA has previously described in guidance concerning the protection of human subjects, where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.”