Continuing Reviews /Termination Reports (Non-exempt Studies)

Once your project is approved by CORIHS, IRBNet will send those with full project access an e-mail notification 90 and 60 days prior to the expiration of the approval period. You should respond to the first notice as soon as possible, to ensure that there is no lapse in your study approval. If your approval does lapse before you have been re-approved (even if you submitted the continuing review materials), the research activity (including data analysis) must be halted immediately.

Once you receive your e-mailed notice to renew your study:

A. If you do not want to continue the study (including data analysis) past the study expiration date:
• Go into your ‘My Projects’.
• Click on the exact IRBNet package (including same suffix) referenced in the e-mail you received
• Go into project designer, and select 'add new documents'. You will be creating a new package for this study.
• Go into the Library, and download the ‘Application for Continuing Expedited or Full CORIHS Review’.
• Complete the document as a Termination Report, and upload it back into IRBNet.
• Obtain e-signatures of PI and Department Chair.
• Submit the package as a ‘Closed/Final’ report.
• You will receive acknowledgement of the closure by ORC.

B. If you do want to continue the study (including data analysis) past the study expiration date, you first need to determine if you must undergo 'regular' continuing review, or 'Five year' continuing review:

If the first part of the CORIHS # referenced in the e-mail notification (the 'year' part) is 5 years or older than the current year, you must complete a 'Five Year' continuing review, unless:
a) the human subject aspects of your study are now limited to data analysis,
b) enrollment has ended, subjects have completed all research-related intervention AND the study is now limited to long-term follow-up of subjects, OR
c) there has been no enrollment to date AND there has been no increased risk identified (via amendments, SAE's etc) for your study during the time it has been active with CORIHS.

If your study falls into a, b, or c above, or the CORIHS# above shows a year that is not 5 years or older than the current year, you will be able to undergo 'regular' continuing review.

Directions for submitting ‘regular’ and ‘five year’ continuing reviews are available in here

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