IRB Ready

Continuing Review: What It Is and How to Prepare

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Continuing review is the periodic re-approval of an active IRB protocol. Historically, every approved study required continuing review at least annually. The 2018 Common Rule revisions, codified at 45 CFR 46.109(f), eliminated the continuing review requirement for many minimal-risk studies, but the practical picture is more nuanced than that — your institution's policy, your study's review level, and your funder's requirements all affect whether and when you will file.

What the revised Common Rule actually says

Under the revised Common Rule, continuing review is not required for:

  • Research eligible for expedited review, unless the IRB determines otherwise.
  • Research that has progressed to data analysis only, including analysis of identifiable private information.
  • Research that has progressed to long-term follow-up of subjects.

Continuing review is still required for:

  • Full board studies.
  • Expedited studies where the IRB explicitly requires continuing review.
  • FDA-regulated studies.
  • Studies subject to other regulations (HIPAA, state-level requirements).

Some institutions have retained annual continuing review for all active studies regardless of federal requirements, because the institutional tracking system was built around it. Confirm your institution's policy.

When the review date falls

Your approval letter states the approval period and, when applicable, the continuing review due date. The due date is the date by which the IRB must have completed the continuing review — not the date by which you submit. Most institutions require submission at least 30 days before the due date. Missing the due date means the study lapses.

A lapsed study cannot enroll new participants or collect new data from existing participants until re-approval is obtained. For longitudinal work, a lapse is disruptive; for cross-sectional data collection near a deadline, a lapse can be project-ending.

Set calendar reminders immediately

When you receive your initial approval, set three reminders:

  • 90 days before due date: begin assembling the continuing review packet.
  • 45 days before due date: submit.
  • 30 days before due date: follow up if you have not received confirmation of receipt.

This is mechanical but absolutely critical. More studies lapse because the PI missed a date than for any substantive reason.

What the continuing review packet includes

Your institution has a form, but the content is consistent across institutions:

  1. A progress report: enrollment numbers, withdrawals, adverse events, protocol deviations.
  2. A statement of whether the study remains within the originally approved scope.
  3. Any new risks, literature, or findings that change the risk-benefit analysis.
  4. A summary of amendments approved during the review period.
  5. The current (amended) protocol and consent documents.
  6. A plan for the upcoming review period.

Enrollment numbers matter. Report actual numbers (enrolled, completed, withdrawn, lost to follow-up), not projected. If enrollment is far below target, describe why and what you are doing about it.

Adverse events and unanticipated problems

Continuing review is the formal moment for reviewing adverse events and unanticipated problems, but most institutions require separate reporting within a defined window (often 10 business days) when they happen. Do not wait for continuing review to disclose a serious event. The continuing review summarizes events already reported.

For federally funded research, the unanticipated problem definition is specific and includes any incident, experience, or outcome that is unexpected, related or possibly related to participation, and suggests greater risk than previously known. Our amendments guide covers how amendments and unanticipated problem reports interact.

For grant-connected studies

Grant-funded studies often have separate human subjects progress reporting requirements to the funder (NIH, NSF, foundation). These are not the same as IRB continuing review, though the content overlaps. Coordinate the two. The Complete Grant Architect covers the human subjects sections of federal grant reporting in detail, which is useful for aligning the IRB packet with the funder packet.

When the study is closing

If you are finishing data collection and moving to analysis only, you may be eligible to terminate active continuing review. File a study closure or a transition to analysis-only status, which under the revised Common Rule exempts many studies from further continuing review. Read your approval letter for the specific language your institution uses.

Closure is not the same as simply not filing a continuing review. Close the study formally. An unclosed, unrenewed study in the institutional system creates audit problems years later.

When changes are overdue

Continuing review is a good moment to file any amendments you have been sitting on. Reviewers prefer to see the current state of the protocol in one document rather than reconstructing it from the original plus four amendments. If you have made substantive changes through amendments, the continuing review packet should include the clean, consolidated current versions of the protocol and consent form. See our protocol writing guide for the section structure and the review categories overview for how the review level affects continuing review expectations.

The working habit

Treat continuing review as a natural checkpoint, not a surprise. Maintain a running log during the year: enrollment numbers monthly, amendments as filed, any protocol deviations or participant concerns. At continuing review time you will be assembling from a maintained log, not reconstructing from memory. Reviewers notice the difference, and continuing reviews built from a running log approve faster.

Continuing review is the least glamorous part of the IRB lifecycle and the easiest to let slip. The institutional risk of letting it slip is high; the effort of doing it on time is low. That asymmetry is worth respecting.