The Institutional Review Board functions as an essential safeguard in clinical research, providing independent oversight to protect human research participants. This committee reviews, approves, and monitors clinical trials to ensure that ethical standards are maintained and that participant rights and welfare are adequately protected. In the United States, IRBs are regulated by the FDA and the Office for Human Research Protections, with specific requirements for composition, procedures, and documentation.

IRB composition must include at least five members with varying backgrounds to ensure complete and adequate review of research activities. The membership must include at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in non-scientific areas, and at least one member who is not otherwise affiliated with the institution and is not part of the immediate family of a person affiliated with the institution. This diverse composition helps ensure that reviews consider both scientific merit and broader ethical and community concerns.

The IRB review process encompasses initial review of proposed research, periodic continuing review of ongoing studies, and review of any amendments or modifications to approved protocols. The board evaluates whether risks to subjects are minimized and reasonable in relation to anticipated benefits, whether selection of subjects is equitable, whether informed consent is adequate, and whether appropriate safeguards are in place to protect the welfare of vulnerable populations. No human subjects research may commence without documented IRB approval, and any subsequent changes to the protocol require IRB review before implementation.