Informed Consent Guidance

FDA has published a guidance, Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors, to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with the agency’s informed consent regulations for clinical investigations. The document supersedes a 9/1998 guidance and finalizes a 7/2014 draft guidance.

FDA says the guidance is structured to first present general guidance on its 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.

“This guidance does not address possible future changes to FDA’s informed consent regulations that may be developed as part of our harmonization efforts,” the document says. “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.”