Definition · Plain-language
Institutional Review Board (IRB)
An IRB is the committee that reviews research involving people to make sure it is ethical and protects the rights and welfare of participants.
The step most authors miss
Doing CRediT right? Don’t stop at the statement.
A CRediT statement credits you inside one paper. The recognition CRediT was built for happens when those roles are tied to you, persistently. Sign in with your ORCID — free — and claim your CRediT contributions on casrai.org, the home of the standard. They become a verified, portable part of your identity, not a line that disappears into one PDF.
Free: claim your contributions, then export a journal-ready CRediT statement, schema.org structured data, JATS XML, CSV or BibTeX — and preview your public profile. A membership publishes that profile publicly and verifies the journals you serve.
What an IRB reviews
Before human-subjects research begins, the IRB examines the study design, recruitment, consent documents, data protections and the balance of risks against anticipated benefits. It checks that risks are minimised, that consent is genuinely informed and voluntary, and that subject selection is equitable. The board may approve the protocol, require changes, or withhold approval, and it conducts continuing review of ongoing studies where required.
Levels of review
Not every study receives the same scrutiny. Activities that meet regulatory definitions may qualify as exempt; minimal-risk research may be eligible for expedited review by a single reviewer; and greater-than-minimal-risk research requires review by the convened (full-board) IRB. The board determines the correct pathway; investigators do not self-exempt. This tiered system focuses the most rigorous review where the risk to participants is highest.
Composition and authority
The Common Rule requires an IRB to have at least five members with varying backgrounds, including at least one scientist, one non-scientist, and one member unaffiliated with the institution. Members with conflicting interests must recuse themselves. The IRB’s authority is real: it can suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has caused unexpected serious harm.
Key facts
At a glance
- Definition: committee reviewing human-subjects research ethics
- Stands for: Institutional Review Board
- Authority: Common Rule, 45 CFR 46
- Reviews: risk/benefit, informed consent, subject selection
- Pathways: exempt, expedited, or full-board review
- Members: ≥5, including a non-scientist and a non-affiliated member
Common misconceptions
What people often get wrong
Often heard: The IRB reviews the scientific quality of a grant.
Actually: The IRB focuses on ethics and the protection of human participants; scientific merit is assessed through peer review and sponsor processes.
Often heard: Researchers can decide their own study is exempt.
Actually: Exemption determinations are made by the IRB or its designated reviewers, not self-declared by investigators.
Often heard: Once approved, a study never returns to the IRB.
Actually: IRBs conduct continuing review and oversee amendments and adverse events, and can suspend or terminate approval.
Going deeper
