Late continuing review info from one site: who is affected?

If a Relying Institution does not provide the information necessary for the Reviewing IRB to re-approve the study prior to expiration, IRB approval will expire for that Relying Institution. However, that Relying Institution’s expiration will not prevent the renewal of other participating Relying Institutions that submitted the necessary renewal information in a timely manner. Upon continuing review, those Site Investigators that have provided the information necessary for the Reviewing IRB to grant a renewal of IRB approval will be notified of the approval. If IRB approval expires for a specific Relying Site Study Team, the IRB POC and Site Investigator from affected institutions will be notified separately.

The Reviewing IRB will also notify the Overall PI and Lead Study Team, of the lapse in IRB approval and any applicable corrective action plans.