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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supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014.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.