FDA regulations define the Institutional Review Board as an appropriately constituted group that has been formally designated to review and monitor biomedical and social science research involving human subjects. In accordance with DHHS and FDA regulations, an IRB has the authority to approve, require modifications of (to secure approval), or disapprove research.

The purpose of IRB review is to ensure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and study materials (e.g., informed consent documents and investigator brochures) to ensure research is conducted in compliance with federal regulations, state laws, and institutional policy, and grounded in the ethical principles of the Belmont Report: Respect for Persons, Beneficence and Justice.