In the United States, the 1962 Kefauver-Harris amendments to the FDA included for the first time a requirement for informed consent of participants.[2] In 1966, a policy statement by the U.S Surgeon General required that all human subject research go through independent prior review.[3] The National Research Act of 1974 institutionalized this review process by requiring that research centers establish Institutional Review Boards (IRBs).[4]