Continuing Review of Approved Research
The Code of Federal Regulations (CFR) requires that the IRB review and approve research projects that required full review “at intervals appropriate to the degree of risk, not less than once per year.” The CFR calls this “continuing review.”
For studies reviewed and approved by IRB after January 21, 2019, continuing review is not required for:
- IRB-determined Exempt Review research
- IRB-determined Expedited Review research
- Research (regardless of review type) that has completed all interventions and now only includes analyzing data
- Research (regardless of review type) that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.
If your study does not meet any of these conditions, it is subject to continuing review annually.
Please also note some federal agencies (e.g., the FDA) did not align with the revised Common Rule. Therefore, some federally sponsored projects that meet one or more of the above conditions may still require continuing review. Check with your sponsor for clarification.