IRB Review Notification
The Institutional Review Board will send a written IRB Review Notification (formerly known as 'Report of Action') via email to the investigator shortly after IRB review, whether full or expedited.
The Notification will indicate one of the following:
- The protocol was approved as submitted
- Specific revisions requiring simple concurrence by the investigator are required (with the IRB Chairperson or designated reviewer delegated to approve revisions on behalf of the IRB)
- Approval of the protocol is deferred due to IRB requests for substantive clarifications, protocol modifications, or informed consent document revisions (with subsequent review of the responsive materials by a convened IRB).
Any revisions to the human subjects protocol requested by the IRB should be incorporated into the written protocol, with revision dates on each revised page and on the protocol itself, so that the operative protocol is clearly marked.
The IRB manager will certify IRB review and approval to funding agencies, as required.