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Continuing review refers to a periodic IRB review of ongoing research activities to ensure that the rights and welfare of participants are protected. The review includes an analysis of the risk/benefit ratio, with special attention to whether new information or unanticipated risks have been discovered since the previous IRB review, and whether any new information regarding the risks and benefits should be provided to participants.
What You Need to Know
- Exempt studies (which have an "e" at the end of the IRB number) do not require continuing review. In addition, some studies approved under the New Common Rule do not require continuing review.
- Continuing review on non-exempt studies must be done at least once per year.
- Courtesy emails are sent as reminders when continuing review is due, beginning 90 days prior to the expiration of the current IRB approval.
- There is NO grace period that allows the conduct of research beyond the expiration date of study approval. Therefore, continuing review and re-approval of research must occur on or before the date when the IRB approval expires.
- To assure that continuing review applications are submitted in a timely manner so that their review occurs prior to the expiration date
- To review and approve IRB continuing review applications as documented by signature on the xForm
- To notify the IRB of a completed study by submitting a Form 107 xForm.