FDA has stated the 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supersedes FDA's guidance entitled "A Guide to Informed Consent," issued in September 1998, and finalizes FDA's draft guidance entitled "Informed Consent Information Sheet," issued in July 2014.
The guidance presents general information 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. The guidance includes detailed descriptions of the content needed for an informed consent, specific responsibilities for the IRB, Clinical Investigator, sponsor and FDA. The Guidance also includes 16 frequently asked questions.