These concerns grew from stories of the abuse of subjects during the World War II trials at Nuremburg, the promotional distribution of thalidomide resulting in numerous children born with birth defects, the administration of cancer cells to chronically ill and senile patients at a hospital in New York, and others. A 1966 article by Henry Beecher brought prominent attention to human research abuses in medical schools and hospitals ciuting 22 cases involving highly questionable ethics. The formal requirements for the establishment of IRBs were outlined in regulations stemming from the National Research Act of 1974 and in FDA regulations issued in 1981. An estimated 3,000-5,000 IRBs can be found across the country. They are most commonly associated with hospitals and academic centers.
Federal regulations require that boards have at least five members with varying backgrounds.
At least one member must have primarily scientific interests, one must have primarily nonscientific interests, and one must be otherwise unaffiliated with the institution in which the IRB resides. A quorum, with at least one member whose interests are primarily nonscientific present, is needed for voting.