Institutional Review Board (IRB)

In Detail

An Institutional Review Board (IRB) is an independent ethics committee formally designated to review, approve, and provide ongoing oversight of research involving human subjects. IRBs exist at hospitals, universities, and research institutions, and their primary mission is to protect the rights and welfare of research participants. Before any clinical trial can begin, the IRB must review and approve the study protocol, informed consent documents, recruitment materials, and any other materials provided to participants. The IRB evaluates whether the risks to participants are minimized and reasonable in relation to anticipated benefits, whether participant selection is equitable, whether informed consent procedures are adequate, and whether appropriate safeguards exist for vulnerable populations (children, prisoners, pregnant women, and cognitively impaired individuals). IRBs are required by federal regulation (45 CFR 46, the "Common Rule") and must include at least five members with diverse backgrounds, including at least one member who is not affiliated with the institution and at least one member whose primary expertise is in a non-scientific area. The IRB conducts continuing reviews at least annually and can require modifications to the study, suspend enrollment, or terminate a study entirely if participant safety is compromised. IRBs also review reports of adverse events and unanticipated problems. For participants, IRB approval is a critical assurance that an independent body has evaluated the trial's ethical standards before enrollment begins.