Guidance for IRBs, clinical investigators, and sponsors
United States. Food and Drug Administration. Office of Clinical Policy. issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014. This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions. In a final rule published on January 19, 2017, the Department of Health and Human Services (HHS) and other federal departments and agencies revised the Federal Policy for Protection of Human Subjects. The final rule became effective in 2018 (codified for HHS at 45 CFR 46, subpart A; “the 2018 Common Rule”). The 2018 Common Rule sets forth requirements for the protection of human subjects involved in research that is conducted or supported by federal departments or agencies that have adopted the Common Rule. The revisions include significant changes to the provisions regarding informed consent. FDA is currently engaged in notice and comment rulemaking to harmonize its human subject protection regulations and the 2018 Common Rule to the extent practicable and consistent with other statutory provisions. This guidance does not address possible future changes to the FDA’s informed consent regulations that may be developed as part of our harmonization efforts. FDA may revise this guidance document in the future to reflect any such changes and/or to address questions the Agency receives regarding informed consent. FDA’s informed consent requirements are set forth in FDA’s regulations on Protection of Human Subjects (21 CFR part 50). These regulations apply to clinical investigations regulated by FDA. Throughout this document we primarily provide guidance related to the requirements described in 21 CFR part 50; however, where appropriate we will describe additional regulations pertaining to informed consent found in FDA’s regulations on Investigational New Drug Applications (21 CFR part 312) and Investigational Device Exemptions (21 CFR part 812). The informed consent requirements in FDA regulations are not intended to preempt any applicable Federal, State, or local laws that require additional information to be disclosed for informed consent to be legally effective (21 CFR 50.25(d)). If a clinical investigation as defined at 21 CFR 50.3(c) is conducted or supported by HHS then the study may additionally be subject to 45 CFR part 46. Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed. In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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