Continuing review by the IRB is required at least annually for:
- Research involving more than minimal risk
- FDA-regulated research
- Minimal risk federally funded studies approved before January 21, 2019, and
- Any research determined by the IRB to require continuing review.
Please review your study approval letter as it contains information regarding the study approval period (including expiration or check in date). To request a renewal/continuation, add and complete a Renewal form for your study in Cayuse Human Ethics. Be sure to include a clean copy of the previously approved (i.e., not stamped) consent form with your renewal submission so that it can be stamped with new approval period dates.
As a courtesy, the HRPP Office sends out reminder emails before the expiration date; however, it is the PI’s responsibility to monitor approval/expiration dates to ensure IRB approval does not expire. Research activities can continue while the IRB reviews the Renewal/Continuing Review submission as long as the expiration date has not passed. As such, the IRB recommends these be submitted 30-60 days before the expiration date to allow sufficient time for the review process.
There is no grace period extending the conduct of the research past the expiration date. Extensions will not be granted. All study research activities must stop after the expiration date. IRB approval must be obtained before the research activities can resume. If a study is expired for more than 30 days, the study will be administratively closed by the IRB Office. A new application may be submitted for the continuation of the project, which will go through IRB review.
It is important to note that studies that were/are initially approved via expedited review no longer require annual continuing review by the IRB per the Revised Common Rule. However, there are certain studies which the IRB has decided to implement continuing review requirements. If this is the case, an expiration date will be noted on your approval letter. Common reasons for renewals/continuing review include the inclusion of vulnerable populations, complex study procedures, or umbrella protocols. For expedited studies not requiring renewal to be submitted, you will receive an administrative check-in notice every year.
Please review the Expedited Review Policy (PDF) for more information about these requirements.
Exempt determinations are not given expirations. You will receive an administrative check-in notice every year. See Exempt Review Policy (PDF) for more information.
Investigators must complete a Renewal/Continuing Review Form in Cayuse Human Ethics with the following documentation as applicable:
- A copy of the most recent monitoring report, if the study is overseen by an independent monitoring body (e.g., Data Safety Monitoring Board report, Data Monitoring Committee report)
- Any relevant recent literature
- Clean copies of informed consent documents
- Study deviation logs
How do I submit a Renewal/Continuing Review form?
For step-by-step instructions for creating and submitting a renewal/continuing review submission in Cayuse refer to the Cayuse Investigators Guide. Information regarding Renewals/Continuing Review start on slide 60.