Division of Research
Continuing Review of Approved Research
What is Continuing Review?
Continuing Review is the periodic re-evaluation of an ongoing research study by the IRB to:
- Ensure risks remain minimized and reasonable
- Confirm that participant protections are still adequate
- Monitor study progress and compliance
- Approve continued conduct of the research
The IRB must re-approve the study at least annually—unless it qualifies for expedited or limited review under the Revised Common Rule (2018 requirements).
When is Continuing Review Required?
Use this table to determine whether your study requires continuing review:
| Study Type | Continuing Review Required |
|---|---|
| Full Board studies (greater than minimal risk) | Yes — annually or more often if required |
| Expedited studies approved before Jan 21, 2019 | Yes — until IRB transition to Revised Common Rule |
| Expedited studies approved on or after Jan 21, 2019 | Not required (unless the IRB specifically mandates it) |
| Exempt research | Not required |
| FDA-regulated studies | Yes — always required, even under expedited review |
Your IRB approval letter will indicate whether continuing review is required.
What to Submit for Continuing Review
Submit a Continuing Review application using the Huron IRB system, including:
| Document | Description |
|---|---|
| HRP‑212 – Continuing Review Progress Report | Required for all studies under continuing review. Reports enrollment and study status. |
| Brown’s CR Supplement | Used to summarize events, progress, and changes since last approval. |
| Updated Protocol (if applicable) | If changes have been made that haven’t already been reviewed/approved |
| Current Consent Form | The most recent version, including expiration date if applicable |
| Safety/Monitoring Reports | If required by sponsor or oversight body |
| Multi-site Reports (if applicable) | Site-specific progress and coordination documentation (e.g., HRP‑508) |
All materials must be submitted at least 45 days prior to the study’s expiration date to avoid lapses in IRB approval.
What Happens if Continuing Review is Late?
- IRB approval will expire if continuing review is not completed by the expiration date.
- All research activities must stop, including:
- New participant enrollment
- Study interventions or interactions
- Data analysis involving identifiable data
Exception: If stopping would place participants at risk, the PI must request and receive written IRB permission to continue specific procedures for safety.
IRB Review Process
The IRB will evaluate:
- Enrollment progress
- Adverse events and unanticipated problems
- Protocol deviations
- Amendments or modifications
- New literature that may impact risk/benefit
- Compliance with previous IRB determinations
The IRB may request changes, impose conditions, or require additional oversight before re-approving the study.
Best Practices
- Track your study expiration date in your IRB workspace or calendar.
- Begin preparing continuing review at least six weeks before expiration.
- Use the HRP‑212 form within Huron to summarize accurately and concisely.
- Maintain clear records of enrollment logs, deviation logs, and correspondence.
- Notify your sponsor or coordinating center as applicable.