FDA published guidance to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This document provides 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.
Check out the full guidance document here: Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors (fda.gov)