Continuing Review of IRB-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. Therefore, you should submit the Research Project Continuing Review Form (click here to preview this form) via our submission page at least two weeks prior to the end date of your period of research (identified on your Lafayette IRB Decision Letter)

Non-exempt studies approved prior to January 21, 2019, even those that meet the conditions above, are subject to continuing review until, if appropriate, they have been converted to “no review” status. Therefore, you should submit the Research Project Continuing Review Form (click here to preview this form) via our submission page at least two weeks prior to the end date of your period of research (identified on your Lafayette IRB Decision Letter). Lafayette IRB will then make a determination of whether continuing review will be required.

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.