Use the Renewal Submission form in Cayuse Human Ethics:
- To submit an annual administrative check-in (for studies with an administrative check-in date).
- To submit an annual request for continuing review (for studies with an expiration date).
- To allow for expiration date or administrative check-in date change, when requested by ORCA.
You can find the administrative check-in or expiration date on your determination letter. You can also find it by looking at the Study Details page in Cayuse Human Ethics.
Cayuse Human Ethics will send reminder emails to the principal investigator (PI) as the due date approaches, but it is ultimately the PI’s responsibility to obtain continued approval.
If a date passes before renewal
Administrative check-in date
Failure to submit an administrative check-in may result in a processing hold being placed on all submissions from the PI.
Expiration date
Investigators may not continue to conduct research activities involving human subjects beyond the study expiration date without IRB approval. Studies that have expired before a request to renew has been reviewed must cease all human subjects research activities until the IRB review has been completed and the study renewal has been approved.
Create a Renewal Submission
Renewal Submissions should be submitted at least 30 days before the study administrative check-in date or expiration date to allow time for processing and responding to reviewer feedback.
- Log in to Cayuse Human Ethics.
- Find your study on the dashboard in “Approved Studies” and select it.
- In the top right corner select the “+ New Submission” button.
- Choose “Renewal.”
- Select the “Complete Submission” link and follow the instructions to fill out the submission.
- When the submission is complete, follow the instructions for submitting.
- The PI and the co-PI (if applicable) will be sent emails with instructions for certifying the submission in Cayuse. Once all certifications are entered, the submission will be routed to ORCA.
- Once ORCA has received the submission, you will receive an acknowledgment email.
IRB considerations
By conducting annual review (administrative check-in or renewal submissions), the reviewer ensures that the research continues to meet criteria for IRB approval or exemption. The reviewer may request clarification, revisions, and documents during the annual review process. By regulation, the IRB has the authority and the responsibility to take appropriate steps such as terminating or suspending research that is not being conducted in accordance with the IRB’s requirements. Therefore, research may be restricted, modified, or halted altogether.
Considerations during the annual review process:
- Risk assessment and monitoring.
- Adequacy of the process for obtaining informed consent.
- Investigator and institutional issues.
- Research progress.
See OHRP Continuing Review Guidance (2010) for more information.