Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors
Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors 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supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent […]