Protocol Modification Review

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The IRB Chair or his/her designee will review the request and approve, request clarifications, or refer the request to additional board members for review if the changes are more than minor (i.e., increase risk and/or decrease potential benefits). A request for modification cannot be denied without review by the full board. The PI is notified in writing if changes or clarifications are needed, if the protocol is referred to the full board, and of final approval of the modification. The modification request and all correspondence becomes part of the protocol file.

 

The full board is notified monthly at the convened meeting of all modifications reviewed since the previous meeting.