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Medical Device » IRB Decision Letters:
The decision letter from the IRB shall include one of the following:
- Approval: approved as submitted with no modification required.
- Approval as revised: approved as revised by Asentral.
- Minor Modifications required: protocol requires specific minor revisions that do not affect the safety of the research subject. The IRB chair or his designee may approve the study upon receipt of the revisions without further review by the convened IRB. If no revisions are received within 120 days, the protocol is considered withdrawn.
- Deferred: substantive issues regarding the protocol and/or consent form must be addressed. Review by the convened IRB of the investigator’s response is required for approval. If the Principal Investigator does not respond within 120 days, the protocol is considered withdrawn.
- Disapproved: questions are of such significance that the IRB feels approval of the study to be unwarranted. Approval of a previously disapproved protocol that has been revised and resubmitted requires full board IRB review.
Protocols receiving a decision for “Minor Modifications Required”
A protocol is not approved until all required modifications are received and approved by the IRB. There may be no activity on the project until these modifications have been approved by the IRB, and the approval letter has been received by the Principal Investigator indicating approval and permission to begin the project. The term of the approval will be indicated, as well as the date that the first progress report is due. Any special conditions that have been applied to the research will also be indicated in the approval letter. Each protocol will receive an IRB Protocol Number; this number must be included on all future correspondence.