Approval for some protocols have expiration dates that may not exceed a year. These include studies reviewed at the full board level and federally funded studies that were reviewed at the expedited level prior to the implementation of the Revised Common Rule. The determined expiration dates will be communicated in study approval letters and automated reminders will be sent out when the study is about to expire.
What happens when approval for a study expires?
After the approval for a study has expired, researchers can no longer conduct any human subjects research until approval is reinstated unless it is determined by the IRB to be in the best interests of already enrolled subjects to continue participating in the research. Contact the REC office if this scenario may apply. The writing up of findings, dissemination of those findings, and analysis of de-identified data can continue after the approval has expired.
Researchers can extend the approval of these studies by submitting a renewal request in Cayuse IRB.
When should a Renewal be submitted?
The renewal submission should be submitted at least two weeks prior to expiration in order to give the IRB adequate time for review. Full Board renewal submissions must be submitted prior to the deadline for the next meeting to be eligible for review at that meeting.
PIs are responsible for ensuring that approval of their protocol does not lapse. Approval lapses when a PI has failed to submit a renewal or when the IRB has not conducted continuing review and re-approved the research by the expiration date of IRB approval.
PIs should submit a renewal request as soon as possible when approval lapses, and the IRB should prioritize review. The IRB must document why the lapse in IRB approval occurred, and, if appropriate, any corrective actions that the investigator, institution, or IRB is taking to prevent any such lapse of approval of the project from occurring again in the future. Protocols will be administratively closed after approval has lapsed for 60 days.
How to submit a Renewal
- Log into Cayuse Human Ethics.
- Locate the study you would like to create a new submission for in Cayuse IRB.
- Click on the study.
- Click on "+ New Submission" in the upper right corner.
- Select "Renewal"
- Once the submission details page loads, click on the "Edit" button to enter into the submission.
- Follow instructions, complete revisions, and answer required questions.
- Complete the submission and have the PI certify that the submission is ready for review.
- The submission should appear in "Pre-Review" if the submission has been successfully been sent out for review.
The IRB will then review your submission and send their determination to the research team via email. A new expiration date will be indicated in the renewal approval letter.