Expedited Review (IRB)

Expedited review is one of the three IRB review pathways under the Common Rule (45 CFR 46) and, for FDA-regulated research, 21 CFR Part 56 — alongside exempt determinations and full-board review. It applies only to research presenting no more than minimal risk to participants and falling within one of the categories on OHRP’s enumerated expedited-review category list, or to minor changes to research already approved by the IRB. Rather than going before the full convened board, an expedited submission is reviewed by the IRB Chairperson personally, or by one or more experienced reviewers the Chairperson designates from among the board’s voting members, under 45 CFR 46.110 (FDA-regulated research: 21 CFR 56.110).

What makes a study eligible for expedited review

Two conditions both have to be true — eligibility is not a discretionary judgment call made case by case, and neither condition substitutes for the other:

• No more than minimal risk. ’Minimal risk’ means the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests. A study that is otherwise a good fit for one of the enumerated categories still cannot use expedited review if it exceeds minimal risk.
• The research activity fits an OHRP-enumerated category. OHRP (jointly with FDA) maintains a published list of research categories eligible for expedited review, first issued in the Federal Register in 1998 and periodically revisited since. In general terms, the list covers activities such as: certain minor collections of blood or other biological specimens by noninvasive means; certain minor changes in dosage or drug/device use already approved for marketing; data collected through noninvasive procedures routinely used in clinical practice; research on materials (data, documents, records, specimens) already collected or that will be collected solely for nonresearch purposes; collection of voice, video, digital, or image recordings made for research purposes; and research on individual or group characteristics or behavior conducted through survey, interview, oral history, focus group, program evaluation, human-factors evaluation, or quality-assurance methodologies. The list also separately addresses minor changes to previously approved research and, in some circumstances, continuing review of research that itself qualifies as minimal risk. Institutions and IRB members should confirm the exact current category wording directly against OHRP’s published list rather than relying on a paraphrase, since category numbering and wording have been revised over time.

Who conducts it, and what they can (and can’t) decide

Expedited review authority under 45 CFR 46.110 belongs to the IRB Chair personally, or to one or more experienced reviewers the Chair designates from the board’s membership for a given submission — it is not a role every IRB member can exercise on their own initiative. A designated expedited reviewer (including the Chair, acting in that capacity) may exercise all the authorities the full convened board could exercise for that submission, with one specific exception: expedited review cannot be used to disapprove research. If a reviewer conducting expedited review has concerns serious enough that disapproval might be warranted, the study has to be referred to the full board for a decision at a convened meeting instead. Expedited reviewers can approve a submission, approve it with required modifications, or decline to approve it under the expedited procedure and route it to full-board review — but an outright disapproval is reserved to the convened board’s majority vote under 45 CFR 46.108.

IRBs that use expedited review are also required to keep the full board informed: a list of research approved by expedited procedures since the last convened meeting is reported to the board (though the board does not re-vote on it), giving members ongoing visibility into what’s being approved between meetings.

Expedited review vs. exempt vs. full board

The three pathways are frequently conflated, but they answer different questions:

• Exempt means a study is reviewed against one of the Common Rule’s specific exemption categories (45 CFR 46.104) and, if it qualifies, is exempted from most of the Common Rule’s ongoing requirements — it does not mean no review occurs, and it is a distinct determination from expedited review, not a stricter version of it.
• Expedited means the research needs full IRB review (it doesn’t qualify for an exemption) but is eligible for review by the Chair or a designated reviewer rather than the convened board, because it’s minimal risk and fits an enumerated category, or is a minor change to already-approved research.
• Full board is the default pathway: any research that isn’t exempt and doesn’t qualify for expedited review — including anything above minimal risk — must be reviewed and voted on by a quorum of the convened board.

A common misconception is that ’expedited’ guarantees a fast turnaround. It describes who conducts the review (an individual or small number of designated reviewers, rather than the full board at a scheduled meeting), not a service-level commitment on timing — expedited submissions still have to be queued, assigned, and reviewed by IRB staff and reviewers alongside everything else in the office’s workload.

Worked examples

• A minimal-risk survey study collecting anonymous demographic and attitude data fits the expedited category covering survey, interview, and similar methodologies. The IRB Chair reviews it directly between convened meetings and approves it under the expedited procedure, rather than waiting for the board’s next scheduled meeting.
• An already-approved minimal-risk study submits an amendment adding one additional validated questionnaire, with no change to the study’s overall risk profile. This is a minor change to previously approved research, so the Chair (or a reviewer the Chair designates) reviews and approves the amendment under 45 CFR 46.110 rather than sending it back to the full convened board.

Counter-example

A greater-than-minimal-risk clinical trial cannot use expedited review, even if some element of the protocol superficially resembles one of OHRP’s enumerated categories — the minimal-risk threshold is a precondition, not something a category description can override, and the study must go to a convened meeting of the full board. Similarly, a designated expedited reviewer who concludes a submission should be disapproved cannot make that determination under the expedited procedure; disapproval authority is reserved to the convened board, so the reviewer refers the study for full-board review instead.

Related CASRAI content

• IRB Chair — the role with statutory authority to conduct or assign expedited review.
• IRB (Institutional Review Board) — the board itself, its composition, and general regulatory basis.
• Common Rule (45 CFR 46) — the federal framework establishing the exempt/expedited/full-board structure.
• REC (Research Ethics Committee) — the broader international equivalent to a US IRB, often with an analogous proportionate/expedited-style review track.
• Informed consent — a core element every review pathway, including expedited, evaluates.
• IRB/REC Approval Process: What Needs Review and What Doesn’t — how exempt, expedited, and full-board determinations fit together end to end.