9b. Continuing Review and Downgrade Application
Researchers must file either a Continuing Review/Downgrade to Exempt Application (CRA) or a Closeout Report prior to the expiration date indicated on the approval letter.
The IRB does not have the authority to extend the approval period without a CRA. If approval expires, research activities must cease, and data collected without IRB approval may be subject to restrictions. For non-federally funded studies, PIs who have completed data collection and are engaged in data analysis only may apply for “Downgrade to Exempt” status.
A Primary Investigator must submit a Continuing Review Application (CRA) for IRB approval if:
A PI may request any or all of the following three changes on the Continuing Review form:
Note: For all other changes, you must submit a separate Modification Request Form with the CRA.
For non-federally funded studies, if the PI has completed all data collection but will or may continue to work with identifiable data, the PI may request that the protocol be downgraded to “exempt” status. If approved, the downgraded protocol is exempt from further Continuing Review, and IRB oversight concludes.