FDA Issues New Guidance on Informed Consent Impacting Medical Product Trials

Dear AHVAP Colleagues,

The U.S. Food and Drug Administration (FDA) issued the final guidance, "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors." This guidance 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 FDA’s recommendations regarding informed consent and describes regulatory requirements to help ensure the protection of the rights and welfare of people participating in clinical trials. This guidance finalizes the draft guidance entitled, “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors,” issued on July 15, 2014, and supersedes FDA’s guidance entitled, “A Guide to Informed Consent,” issued in September 1998.

AHVAP HQ will continue to share important updates with you from the FDA as part of our ongoing collaboration with the agency. 

Warm regards,

Team AHVAP