Continuing review is the periodic re-review an IRB conducts of research it has already approved, to decide whether that approval should continue. It is a separate regulatory event from initial approval and from a protocol amendment submitted mid-study — continuing review happens on a recurring schedule for as long as a study remains open, whether or not anything about the protocol has changed. This guide covers when continuing review is actually required, what the 2018 Common Rule revisions eliminated it for, what an IRB examines at each continuing review, and the typical submission timeline researchers should plan around.
The governing rule: 45 CFR 46.109(e)
Under 45 CFR §46.109(e), an IRB must conduct continuing review of research requiring review by the convened (full) board “at intervals appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).” Two things follow directly from that text. First, the one-year figure is a ceiling, not a target — an IRB can and often does set a shorter interval for higher-risk research. Second, the obligation attaches specifically to research that required full-board review; it does not automatically apply to every approved study, because §46.109(f) carves out several categories entirely.
FDA-regulated research follows a parallel provision, 21 CFR §56.109, with materially the same structure: continuing review at intervals appropriate to risk, at least annually, unless a narrower exception applies.
When continuing review is NOT required: the 2018 Common Rule carve-outs
Before the 2018 revisions to the Common Rule took effect, continuing review was close to universal for anything that hadn’t been reviewed on an expedited or exempt basis. The revised rule narrowed that considerably. Under 45 CFR §46.109(f)(1), an IRB does not need to conduct continuing review — unless the IRB itself determines otherwise for a specific study — in three circumstances:
- Research eligible for expedited review under §46.110. If a study qualifies for expedited review (minimal risk plus fits one of the regulatory categories), it is exempt from the mandatory continuing-review cycle, even if it was originally reviewed by the convened board.
- Research previously reviewed under limited IRB review procedures specified in §46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7)/(8) — the narrower review track the 2018 revisions created for certain secondary-research-use and broad-consent scenarios.
- Research that has progressed to the point where it involves only data analysis (including analysis of identifiable private information or identifiable biospecimens) or only accessing follow-up clinical data from procedures subjects would undergo as part of routine clinical care — in other words, a study where active human-subjects interaction and intervention have already ended and only closeout-type activity remains.
This is the single most common source of confusion in this area: many research teams assume every approved protocol needs an annual continuing-review submission by default. Since 2018, that’s no longer true — a large share of expedited-eligible, minimal-risk research is explicitly carved out, and study teams should confirm with their IRB office whether a given protocol is actually in the annual continuing-review cycle or has been designated exempt from it, rather than assuming either way.
Two caveats worth flagging. First, the exemptions in §46.109(f) apply “unless the IRB determines otherwise” — an IRB retains discretion to require continuing review even for an otherwise-exempt study, typically because of accumulated risk information or institutional policy. Second, not every U.S. institution operates under the 2018 revised Common Rule for every study: FDA-regulated research follows 21 CFR Part 56, and some non-federally-funded or industry-sponsored research may be governed by sponsor or institutional policy that is more conservative than the federal floor. Always confirm the applicable framework with the IRB of record before assuming a study is out of the continuing-review cycle.
What continuing review actually examines
Where continuing review is still required, it is not a formality — it is a substantive re-review of the study as it currently stands, not as it was originally approved. IRBs typically evaluate:
- New risk information since the last review. This includes any unanticipated problems or adverse events reported during the interval, external safety findings (e.g., from a data safety monitoring board, sponsor safety report, or published literature), and whether the risk/benefit balance that supported the original approval still holds.
- Adherence to the approved protocol. The IRB looks at whether the study has actually been conducted as approved — enrollment numbers against the approved sample size, any deviations or non-compliance reported, and whether any amendments approved since the last review are reflected consistently in current study materials.
- Adverse events and unanticipated problems. A cumulative summary of adverse events (not just the interval since the last review) is standard, so the IRB can assess whether the event pattern or severity has shifted the study’s risk profile.
- The informed consent process. This covers both the document — is the currently used consent form the IRB-approved version, and does it reflect any amendments — and the process itself, including whether new findings developed during the study (per 45 CFR §46.116(b)(5), where applicable) should be disclosed to already-enrolled participants.
- Continuing appropriateness of the approval overall, including recruitment/enrollment status, any conflicts of interest disclosed since initial approval, and, where relevant, data and specimen management.
The IRB’s authority at continuing review mirrors its authority at initial review: approve continuation, require modifications to secure approval, or disapprove/suspend the research. A lapse in continuing review approval (the study running past its approval expiration date without a completed re-review) generally means all study activities involving human subjects must stop until approval is reinstated — institutions vary in exactly how they handle a lapse administratively, but the underlying regulatory expectation is the same: continued research beyond the approval period without a current IRB determination is not permitted.
Typical submission timeline and renewal cadence
Neither 45 CFR 46 nor 21 CFR 56 specifies a fixed submission lead time — only the outer bound (at least annually, more often if the IRB sets a shorter interval based on risk). In practice, most institutional IRB offices set their own internal deadline, commonly somewhere in the range of 4 to 8 weeks before the current approval’s expiration date, to leave room for staff pre-review, any full-board meeting scheduling, and a revise-and-resubmit cycle if the initial submission is incomplete. This is institutional policy, not a regulatory requirement — always confirm the actual deadline with the specific IRB office of record rather than assuming a standard figure applies. For background on how full-board versus expedited review scheduling generally compares, see How Long Does IRB Approval Take?, which focuses on initial-approval timelines by review category.
A typical continuing-review submission package includes a progress report (enrollment to date, summary of any amendments, deviations, and adverse events since the last review), the current consent form(s) in use, and, for higher-risk or multi-site studies, a cumulative safety summary. Missing the submission deadline is the single most common cause of an approval lapse — building the continuing-review submission into the study’s project timeline, well before the expiration date, is standard practice at institutions with IRB offices experienced in avoiding lapses.
Continuing review vs. protocol amendment: two different triggers
These are often confused because both can result in IRB paperwork mid-study, but they are triggered differently. A protocol amendment is submitted whenever the study team wants to change something about an already-approved protocol — add a study site, change an inclusion criterion, revise the consent form — and must be approved by the IRB before the change is implemented (45 CFR §46.108), except where necessary to eliminate an immediate hazard to participants. Continuing review, by contrast, is triggered by the calendar (or the IRB-set interval), not by a proposed change, and asks a broader question: should this study’s approval continue at all, given everything that’s happened since the last review. A study can have several amendments approved between continuing reviews, and a continuing review can occur with no amendments pending — they are independent obligations that happen to intersect on the same protocol.
Frequently asked questions
Does every IRB-approved study require continuing review?
No. Since the 2018 Common Rule revisions, research eligible for expedited review, research reviewed under certain limited-review procedures, and research that has progressed to data-analysis-only or clinical-follow-up-only activity are not subject to mandatory continuing review under 45 CFR §46.109(f), unless the IRB determines otherwise for that specific study. Confirm the designation with the IRB of record — don’t assume based on the study’s original review type alone.
What happens if continuing review approval lapses?
If a study that requires continuing review is not re-reviewed before its current approval expires, human-subjects research activities generally must stop until the IRB completes the review and reinstates approval. Institutions handle the operational details of a lapse differently, but continuing to enroll or intervene with participants under an expired approval is not permitted under the governing regulations.
How is continuing review different from a protocol amendment?
An amendment is submitted whenever the study team wants to change the approved protocol and must be approved before the change takes effect. Continuing review is scheduled independently of any proposed change — it happens at the IRB-set interval (at least annually for studies that require it) and asks whether the study’s approval should continue, based on everything that’s occurred since the last review.
Does FDA-regulated research follow the same continuing review rule?
FDA-regulated research follows 21 CFR §56.109, which has the same basic structure as 45 CFR §46.109(e) — continuing review at intervals appropriate to risk, at least annually unless a narrower exception applies. The specific carve-out language differs somewhat from the 2018 Common Rule revisions, so studies subject to both frameworks should confirm applicability with the IRB office rather than assuming the Common Rule exceptions apply identically under Part 56.
Related CASRAI resources
See also the dictionary entry for Continuing Review (IRB) for a concise definition, How Long Does IRB Approval Take? for initial-approval timelines by review category, IRB/REC Approval Process: What Needs Review and What Doesn’t for the broader review-pathway picture, and Expedited Review (IRB) for the eligibility criteria that determine whether continuing review is required at all.
