Institutional Review Boards

Institutional Review Boards (IRB) are used to ensure the rights and welfare of people participating in clinical trials both before and during their trial participation. IRBs at hospitals and research institutions throughout the country make sure that participants are fully informed and have given their written consent before studies ever begin. IRBs are monitored by the FDA to protect and ensure the safety of participants in medical research.

An IRB must be composed of no less than five experts and lay people with varying backgrounds to ensure a complete and adequate review of activities commonly conducted by research institutions. In addition to possessing the professional competence needed to review specific activities, an IRB must be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. Therefore, IRBs must be composed of people whose concerns are in relevant areas.

For more information, see the IRB Operations and Clinical Requirements list provided by FDA's Office of Health Affairs. This document is intended to help IRB's carry out their responsibilities for protection of research subjects. Also see the March 13, 1975, Federal Register, and the Technical Amendments concerning "Protection of Human Subjects" (45 CFR Part 46).