US Food & Drug Administration (FDA) website page on “Institutional Review Boards Frequently Asked Questions Guidance for Institutional Review Boards and Clinical Investigators”.
It provides guidance for IRBs and clinical investigators on protecting human research subjects.
The page presents Frequently Asked Questions and answers, organised for easy reference.
It is published by the Office of the Commissioner, Office of the Chief Medical Officer, and the Office of Clinical Policy to support compliance with ethical and regulatory standards in clinical research.
