Examples
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.
Counter-examples
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.
Editorial commentary
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.
Who Owns Continuing Review at a Research Institution
Continuing review is a recurring administrative and scientific obligation, and responsibility for it is typically split three ways. The IRB office or coordinator tracks each open protocol’s approval expiration date and sends renewal reminders well ahead of the deadline — institutions build this reminder cycle deliberately because a lapse is treated as a compliance event, not a paperwork inconvenience. The principal investigator is responsible for submitting a complete continuing-review packet (cumulative safety data, current enrollment figures, any interim protocol or consent changes) on the institution’s own schedule, not merely by the regulatory once-a-year ceiling. The convened IRB (or, where a study genuinely qualifies, a designated reviewer under an expedited procedure) makes the actual reapproval determination, including the interval-setting decision for the next review. For federally funded studies specifically, the funding agency’s program staff generally expect ongoing approval status to be reflected in progress reports, which is a fourth, less direct point of accountability layered on top of the institutional cycle.
What an Auditor or OHRP Reviewer Checks
A compliance reviewer examining a study’s continuing-review history is not just confirming that renewal happened on paper before expiration. Common specific checks include: whether the interval the IRB actually set was documented as risk-based rather than defaulted to the regulatory one-year ceiling without any stated rationale; whether, for a study claiming one of the 2018 Common Rule’s 46.109(f) exceptions from continuing review, the IRB’s file actually documents which specific exception applies and why, rather than simply noting “continuing review not required”; whether a greater-than-minimal-risk study’s continuing review was in fact conducted by the convened board with quorum, not handled administratively; and, most consequentially, whether there is any gap between one approval’s expiration date and the next approval’s effective date — a gap indicates the study operated, even briefly, under a lapsed approval, which is treated as unapproved human-subjects research regardless of how minor the gap or how routine the underlying study.
Checking this against the current guidance
Whether a study still needs full-board continuing review, or now qualifies for one of the 2018 Common Rule’s narrower exceptions, depends on the study’s current enrollment and risk status, not its history. The answer depends on the specific facts of your award, agency, or institution, and the page above states the general rule.
It searches CASRAI’s indexed corpus of research-administration guidance and cites the passage behind each claim, so you can open the source and check it rather than take its word on it — and it says so when the corpus does not cover something instead of guessing. Two questions a day are free while you are signed out, no account and no card. Everything CASRAI publishes stays free to read.
Frequently asked questions
What happens if a study’s continuing review lapses before reapproval?
The study is considered to be operating without IRB approval for the gap period, which most institutions treat as reportable noncompliance regardless of how minor the delay was or how low-risk the study is. Enrollment and most study activities generally have to stop until reapproval is obtained, and the lapse itself is typically documented in the study’s compliance record.
Does a study that has closed to enrollment still need continuing review?
It depends on what the study is still doing. Under the 2018 Common Rule’s 46.109(f) exceptions, a study that has closed to enrollment and moved solely into data analysis or standard-of-care follow-up can be exempted from further continuing review — but that exception has to be affirmatively documented by the IRB, not simply assumed once enrollment closes; a study still conducting interventions or interactions with existing subjects does not automatically qualify.
Can expedited procedures be used for continuing review of a minimal-risk study?
Yes, but only if the study remains no more than minimal risk and fits one of OHRP’s enumerated expedited-review categories at that continuing-review point — the same eligibility test applied at initial review, re-applied fresh at each interval rather than grandfathered in from the original determination.
Who decides how often a study needs continuing review within the one-year ceiling?
The convened IRB (or the reviewer conducting an eligible expedited continuing review) sets the actual interval based on the study’s degree of risk, subject to the regulatory maximum of once per year under 45 CFR 46.109(e) — a higher-risk study, particularly an early-phase clinical trial, is often reviewed quarterly or semi-annually rather than annually.
Does FDA follow the same 2018 Common Rule exceptions for continuing review?
No. FDA’s parallel provision, 21 CFR 56.109(f), does not carry the same set of 2018 exceptions that HHS added to the Common Rule, so an FDA-regulated study should not assume that relief from continuing review on the Common Rule side of a study also applies to its FDA-jurisdiction side without confirming that directly against 21 CFR Part 56.
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.
- IRB Continuing Review guide — the submission timeline and renewal cadence, what happens when approval lapses, and how continuing review differs from a protocol amendment.
Machine-readable encodings
Use in your systems
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