Usage Examples
- The IRB approved the Phase 2 protocol with minor modifications to the consent form.
- IRB continuing review approval lapsed on the 14th, so enrollment is on hold.
- All twelve sites are running under a single central IRB.
What is IRB (Institutional Review Board)?
An IRB is the committee a research institution formally designates to approve, require modification of, or disapprove human-subject research before it begins, and to re-review it at least annually under FDA rules.
An IRB exists because the party best placed to judge whether a study's risks to subjects are acceptable is not the party whose funding and career depend on running it. FDA and the Common Rule therefore assign that judgment to a designated board, and bar the investigation from starting until that board has reviewed and approved it.
An IRB reviews whether risks to subjects are minimized and reasonable in relation to anticipated benefits, whether subject selection is equitable, and whether informed consent will be sought and documented properly. An IRB does not assess commercial terms, manufacturing quality, or a sponsor's regulatory strategy. Its remit is the protection of the people enrolled, and its jurisdiction ends at that boundary.
An IRB operates through convened meetings at which a majority of members are present, including at least one member whose primary concerns are nonscientific. Minimal-risk categories and minor changes to approved research can instead be handled by the chairperson or designated reviewers under an expedited procedure. An IRB then re-reviews the study on a fixed clock and retains the file for FDA inspection.
Not to be confused with
- Ethics committee (EC/IEC)
- the same protective function under a name used outside the United States. FDA and the Common Rule define only "IRB", and the Part 56 duties attach to whichever body reviews an FDA-regulated investigation, whatever it calls itself locally.
- Data monitoring committee (DMC/DSMB)
- advises the sponsor on accumulating safety data. It has no authority to approve, require modifications in, or disapprove the research; 21 CFR 56.109(a) places that authority with the IRB alone.
- Scientific review committee
- judges scientific merit and feasibility, often before the protocol reaches the IRB. Its sign-off is an institutional policy, not a regulatory precondition; nothing in 21 CFR 56 makes it a substitute for IRB approval.
- Informed consent
- the document and process the IRB reviews, not the reviewing body. An approved consent form is one output of IRB review, never evidence that review occurred.
The obligations split between the FDA rules and the Common Rule, and a federally funded FDA-regulated trial carries both.
What you must do
- 1Obtain IRB review and approval before initiating any clinical investigation that requires prior submission to FDA, and keep the study under continuing review thereafter21 CFR 56.103(a)
- 2Seat at least one member who is not otherwise affiliated with the institution and is not in the immediate family of anyone who is21 CFR 56.107(d)
- 3Conduct continuing review at intervals appropriate to the degree of risk, and never less often than once per year21 CFR 56.109(f)
- 4Retain IRB records for at least 3 years after completion of the research and keep them accessible for inspection and copying21 CFR 56.115(b)
- 5For Common Rule research, document the IRB's determination when continuing review is dropped for a study eligible for expedited review45 CFR 46.109(f)(1)
Common mistakes
Treating IRB approval as a one-time gate
21 CFR 56.109(f) sets a hard annual ceiling on the review interval. If approval lapses, the study is unapproved from the expiration date forward, and every subject visit and dose after that point becomes a deviation you have to disclose and explain in the marketing application.
Applying the Common Rule's continuing-review relief to an FDA-regulated trial
45 CFR 46.109(f)(1) removed mandatory continuing review for expedited-review studies, but 21 CFR 56.109(f) did not change. A study subject to both must satisfy both, which means the annual FDA clock still runs.
Letting IRB records travel with the site's own file retention policy
21 CFR 56.115(b) requires at least 3 years after completion of the research, accessible for inspection and copying. Minutes, member rosters, and approval correspondence are the first things asked for at inspection and cannot be reconstructed after the fact.
When This Matters
- The IRB approved the Phase 2 protocol with minor modifications to the consent form.
- IRB continuing review approval lapsed on the 14th, so enrollment is on hold.
- All twelve sites are running under a single central IRB.
Frequently Asked Questions
IRB approval is required before a clinical investigation that must be submitted to FDA can be initiated, per 21 CFR 56.103(a). The Common Rule adds a parallel trigger: 45 CFR 46 applies to all research involving human subjects conducted or supported by a federal department or agency that adopts the policy. Federally funded studies can fall under both.
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