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Study Renewal Submission Guidance

Montclair State University IRB Study Renewal Submission Guidance

The IRB office would like to make all human subjects researchers aware of their obligation to renew (or close) IRB approved studies. We’ve recently adopted this guidance.

Maintaining continuous IRB approval for a study is the responsibility of the Principal Investigator and the Primary Contact. IRB expiration dates are noted on the approval letter and under Study details in the Cayuse IRB study dashboard. Please remember that if you allow your study’s IRB approval to lapse, then you, the IRB, and Montclair State University as an institution may be considered out of compliance with federal regulations.

Please review and follow the timeline below.

Timeline Action
Greater than 60 calendar days prior to Expiration Date: Do not submit your renewal earlier than 60 days prior to Expiration Date.
45 calendar days prior to Expiration date: Cayuse IRB sends reminders of expiration.  This reminder is sent at 45 days before expiration and every 2 weeks thereafter to the PI, primary contacts and CO-PIs. Please make sure to add to your contacts.
45 to 1 calendar days prior to Expiration Date: MSU IRB must receive your Cayuse renewal submission. Information on the renewal process in Cayuse can be found online. (Full board renewals should be submitted no later 20 days prior to expiration.)
Expiration date If you have not submitted your renewal by the expiration date you must submit a Cayuse Incident Report to the IRB. All study activities must be suspended.
MSU IRB approval expires at 12 AM on the Expiration Date listed on the Notification of Approval.  Therefore the Expiration Date represents the first date that the study is no longer approved. At the time of expiration of IRB approval, all study activities, including ascertainment, recruitment, consent, data collection and data analysis, must stop.  If you wish to continue certain activities directly related to subject safety, please e-mail the IRB chair, to request permission to continue those activities until IRB approval is reinstated.
Email of Study Closure After expiration you will receive an email notifying you of Study Closure by IRB office.

At that time you must acknowledge (within 48 hours) that you have suspended all research activities.

Restarting a study after closure If you have received a formal letter of your study’s closure, you will now be required to submit a new initial submission to continue your research. Even when your research activities are now limited to data analysis. They is no way to ‘re-open’ a study after closure.

*This guidance does not apply to any study with an Administrative Check-In date; only to studies with study expiration dates.