Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors." The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA- regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency's recommendations regarding informed consent and describes FDA regulatory requirements to help assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance finalizes the draft guidance entitled, "Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors," issued on July 15, 2014, and supersedes FDA's guidance entitled "A Guide to Informed Consent," issued in September 1998.