FDA Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors

6th September 2023

FDA Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors

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supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014.

Read More

Back to News Archive