Continuing Review (IRB)

Continuing review is the periodic re-review an IRB conducts of previously approved, ongoing research to decide whether approval should continue. Under 45 CFR 46.109(e), an IRB must conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, and not less than once per year, except for the limited categories the revised Common Rule exempts from continuing review entirely under 46.109(f) (research eligible for expedited review, research receiving limited IRB review under certain exemptions, and research that has closed to enrollment and moved solely into data analysis or long-term follow-up using standard-of-care procedures). FDA's parallel provision, 21 CFR 56.109(f), requires continuing review of FDA-regulated research at intervals appropriate to the degree of risk and not less than annually, and does not carry the same 2018 Common Rule exceptions. The operative distinction for a study posing greater than minimal risk: continuing review of that research cannot be conducted through the expedited procedure, because expedited review (whether at initial approval or at a continuing-review interval) is only available for research that is no more than minimal risk. A greater-than-minimal-risk study must therefore go before the full convened IRB, with a quorum present and a majority vote, at every continuing-review interval for as long as the study remains open to enrollment or active intervention -- not just at initial approval.

ByCASRAI Editorial Board

· Last updated 30 Jul 2026

Worked examples

Is an instance

A Phase 2 drug trial involving an investigational agent with known but manageable side effects is approved by the full convened IRB. At its one-year continuing-review date, the study remains open to enrollment and above minimal risk, so it returns to the full board rather than being reviewed by the Chair alone -- the board reviews cumulative adverse-event data, any protocol amendments since the last review, and the current consent form before voting to continue approval.

Is an instance

A behavioral-intervention study was initially reviewed by the full board because one study arm involved a risk of psychological distress above minimal risk. A year later, enrollment has closed and all remaining subjects are only completing already-collected, standard-of-care follow-up assessments. Under 45 CFR 46.109(f)(1)(iii), that narrower activity may no longer require continuing review at all -- a determination the IRB itself makes and documents, not something the study team can assume applies automatically.

Looks similar, but isn't

Not an instance

A minimal-risk survey study that qualified for expedited review at initial approval, and whose risk profile has not changed, can have its continuing review (where still required) conducted by the IRB Chair or a Chair-designated reviewer under the same expedited procedure -- because the minimal-risk threshold, not the fact that time has passed, is what governs which pathway applies.

Not an instance

Submitting a continuing-review report late, or not at all, is a separate compliance failure (approval lapses and enrollment/intervention must stop) rather than a question of which review pathway -- expedited or full-board -- the report was entitled to use.

Continuing review is the periodic re-review an IRB conducts of research it has already approved, to decide whether approval should continue. Unlike initial review of a new protocol, it recurs at set intervals for as long as a study stays open, weighing the study’s accumulated safety data and enrollment status, not just its original risk category.

The governing requirement: interval tied to risk, floor of one year

Under 45 CFR 46.109(e) (the Common Rule), an IRB must conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, and not less than once per year, except as described in 46.109(f). FDA’s parallel provision for FDA-regulated research, 21 CFR 56.109(f), imposes the same structure: continuing review at intervals appropriate to the degree of risk, not less than annually. Neither regulation treats ‘once a year’ as a target — it is a maximum interval; an IRB can and often does require more frequent review (quarterly or semi-annual) for higher-risk protocols, particularly early-phase clinical trials.

Why greater-than-minimal-risk research must go to the full board

Expedited review — whether at initial approval or at a continuing-review interval — is only available for research that is no more than minimal risk and fits one of OHRP’s enumerated expedited-review categories. That eligibility test does not relax over time or because a study has already been through initial full-board review. A study that presents greater than minimal risk cannot use the expedited continuing-review procedure at any point in its life cycle: every continuing-review interval for that study must be conducted by the convened IRB, with a quorum present (including at least one non-scientist member) and approval by majority vote, exactly as required for full-board review generally under 45 CFR 46.108. This is the regulatory nuance most often missed in practice — teams sometimes assume that because a study cleared full-board review once, subsequent continuing reviews can be handled more informally. They cannot, if the study remains above minimal risk.

What full-board continuing review actually examines

At each interval, the convened board typically reviews: cumulative safety and adverse-event data (including, for trials with one, reports or recommendations from a Data and Safety Monitoring Board (DSMB) where applicable); any protocol or consent-form amendments approved since the last review; current enrollment numbers against the approved target; any protocol deviations or unanticipated problems reported in the interim; and whether the current, IRB-approved informed consent form still accurately reflects the study’s known risks. The board then votes to continue approval, require modifications before continuing, or — in the case of serious ongoing concerns — suspend or terminate approval.

The 2018 Common Rule narrowed, but did not eliminate, this requirement

The 2018 revisions to the Common Rule added 46.109(f), which removed the continuing-review requirement altogether (not merely allowed expedited handling of it) for several narrower categories: research eligible for expedited review, research receiving limited IRB review under specific exemption categories, and research that has closed to enrollment and intervention and moved solely into data analysis or standard-of-care follow-up. Where one of those exceptions genuinely applies, the IRB documents that continuing review is not required going forward. Where it does not — which includes essentially all actively enrolling, greater-than-minimal-risk research — the annual (or more frequent), full-board continuing-review obligation under 46.109(e) stands. FDA’s 21 CFR 56.109(f) does not carry the same set of 2018 exceptions, so FDA-regulated studies should not assume HHS-side relief from continuing review applies to the FDA-jurisdiction side of a study without confirming it against 21 CFR Part 56 directly.

Related CASRAI content

Expedited Review (IRB) — the pathway continuing review can use only when a study remains no more than minimal risk.
IRB (Institutional Review Board) — the board conducting continuing review, its composition and quorum requirements.
Common Rule (45 CFR 46) — the federal framework establishing 46.109’s continuing-review requirement.
21 CFR Part 56 — FDA’s parallel IRB regulation, including 56.109’s continuing-review provision.
Risk-Benefit Analysis — the assessment underlying whether a study’s risk level supports continued approval.
Data and Safety Monitoring Board (DSMB) — independent safety oversight that often feeds directly into a full board’s continuing-review decision for higher-risk trials.
IRB/REC Approval Process: What Needs Review and What Doesn’t — how exempt, expedited, and full-board determinations fit together end to end.

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