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 convened IRB to require continuing review.
Please review your study approval letter as it contains information regarding the study approval period (including expiration date) and the type of review that will be required (Continuing or Administrative) to renew your study approval. To request a continuation, add and complete a Continuing Review/Administrative Update form for your study. Be sure to include a clean copy of the previously approved (i.e., stamped) consent form with your continuing review submission so that it can be stamped with new approval period dates.
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, Wright State still must maintain appropriate oversight and track ongoing research and research personnel credentials. Therefore, Wright State requires that these studies receive administrative/institutional review by the HRPP Office at least every two years. To avoid confusion, this review requires the same form as continuing review by the IRB but does not require review and approval by a voting IRB member to renew the study approval for another two years.
Please review the Expedited Review Policy (PDF) for more information about these requirements.
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 Continuing Review submission as long as the expiration date has not passed. As such, the IRB recommends Continuing Reviews 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.
Exempt determinations are given for three-year periods. If exempt research will continue past this three-year period, the PI must submit a Continuing Review/Administrative Update Form to request extension of the exemption determination for an additional 3 years. If the request is not received, Wright State assumes that no further activity under the original exemption is ongoing and therefore, does not require submission of a Study Closure Form. See Exempt Review Policy (PDF) for more information.
Investigators must complete a Continuing/Administrative Review Form in RSP Gateway 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
How do I submit a Continuation/Administrative Review form?
For step-by-step instructions for creating and submitting a Continuing/Administrative Review submission in RSP Gateway refer to the How to Submit Continuing Review, Amendment, Reportable Event, Study Closure, and Miscellaneous Forms Guide (PDF).