Institutional Review Board (IRB)
An independent committee that reviews clinical research protocols to ensure the protection of human participants. IRB approval is required before any trial can begin. In Europe and the UK, the equivalent body is the Research Ethics Committee (REC).
Technical Context
IRBs are composed of at least 5 members including scientists, non-scientists, and community representatives not affiliated with the institution. They evaluate: scientific design (is the study designed to answer the stated question?), risk-benefit ratio (do potential benefits justify the risks?), participant selection (is recruitment fair and non-coercive?), informed consent (is the document complete and comprehensible?), privacy and data protection, and vulnerable population protections. IRBs conduct initial review (before the study starts), continuing review (at least annually), and review of amendments and adverse event reports. Central IRBs can review multi-site trials, reducing duplication. In the US, IRBs are regulated under 45 CFR 46 (Common Rule) and 21 CFR 56 (FDA regulations).