institutional review board (IRB)

Sometimes also institutional review committee; American term for ethics committee; any board or other group formally designated by an institution to review biomedical research involving humans as subject, to approve the initiation of and conduct periodic review of such research (investigators have also to report all changes in research activity and all unanticipated problems involving risks to subjects); to meet FDA requirements an IRB shall have at least 5 members, with varying backgrounds, possessing the necessary professional competence, including at least one member from a nonscientific area (lawyer, ethicist, clergy) and who is not otherwise affiliated with the institution; the IRB must consist of both sexes and no member may review a project in which it has conflicting interests; → see also expedited review.