In October 2023, the Office of Research Ethics and Compliance (OREC) began the process of reorganizing its structure and revising its approach to research ethics and compliance. One area that is currently undergoing changes is the Human Research Protection Program’s (HRPP) approach to continuing review. The HRPP will no longer require continuing review for new studies that are approved and determined to be exempt under the Common Rule. Exempt human subjects research studies will no longer be given expiration dates. This change applies to all new exempt studies, continuing reviews for exempt studies, and for amendements to existing exempt studies submitted on or after 4/8/2024.
What does this mean for me as a researcher?
- For existing exempt studies, researchers do not need to take any action at this time beyond maintaining active IRB approval. Maintaining IRB approval includes submitting for continuing review in accordance with the renewal date provided on the current approval letter.
- Existing exempt research can be transitioned to operate under no continuing review requirements only after being reviewed and determined to no longer require continuing review.
- To assess whether to transition existing research to operate under no continuing review requirements, the HRPP will review new exempt studies, continuing review requests for exempt studies, and amendements to existing exempt studies to determine if continuing review will no longer be required.
- The approval letters issued for new exempt studies, continuing review requests, and for amendements to existing exempt studies submitted on or after 4/8/2024 will reflect the change in the continuing review requirement.