Unless the IRB doesn’t require continuing review for a protocol (e.g. exempt), approved protocols must be re-reviewed at least once per year to allow the IRB to assess the continued participation of subjects in the research. Continuing review is required for all follow-up and data analysis activity (data is being maintained, and/or analyzed, and the identity of participants has not been separated from the research data), even if the study is closed to enrollment and research related interventions are complete. Continuing review is also required for studies that have been suspended, in whole or in part. The renewal period is set by the IRB depending on the nature of the study and risks to the subjects, but in all cases, the renewal period may not be longer than one year.
Expiration and Notifications
The protocol’s expiration date is indicated on the IRB approval letter. As a courtesy, the IRB staff will send one reminder notice by e-mail to the PI to request continuation approximately 60 and 30 days before the study approval expires. The PI retains the responsibility for submitting requests for continuation. If the protocol’s approval expires, the PI must submit a new application for IRB review. The research cannot continue until the IRB approves the new application (including subject enrollment, collecting data, etc.). If research continues beyond the expiration date, it is considered to be unapproved research.
Determining if Renewal is Needed
If a Principal Investigator (PI) is unsure if a protocol needs to be renewed, consider the following questions:
- Will future research activities involve obtaining data through intervention or interaction with human subjects?
- Will future research activities involve obtaining identifiable private information about living individuals? Information is identifiable if subjects can be identified directly or through identifiers linked to subjects. This includes any lists of participants that have not yet been destroyed.
- Will future research activities include analyzing identifiable private information about living individuals?
If the answer is YES to any of these questions, a Renewal Form must be submitted.
If the answer is NO to all of the above questions, a Renewal Form is not required and a Final Report Form may be submitted.
Continuing review and approval must be obtained prior to the end of the day on which approval expires. This means that it is the PI’s responsibility to submit a Renewal Form to the IRB in time for the IRB to review and approve the protocol before its approval period has expired. A request for approval of an amendment may be incorporated into a request for continuation. The PI must indicate that an amendment is being made at time of continuing review and submit the Modification Form along with supporting documentation.
Expedited protocols must be submitted two weeks before the expiration date. Requests for expedited continuation will be forwarded by the IRB staff to the Chair or IRB member for review and approval as they are received.
Full Board Protocols
Protocols requiring full IRB review must be submitted six weeks before the protocol’s expiration date (see Full Board Meeting Dates and Deadlines) to ensure it will be renewed in time. A request for continuation requiring full board review will be placed on the agenda of the next regularly scheduled IRB meeting. The approval period by which subsequent continuing review must occur will be adjusted accordingly.