111.1 Organization Policy on Convened Meeting Primary Reviewer System

August 2013

It is the policy of the Organization that the JHM IRB will use a primary reviewer system to execute its convened meeting protocol review responsibilities for new review, continuing review, or amendment review.  A primary reviewer will be identified for each study.  

The primary reviewer will consider the criteria for approval set forth in DHHS 45 CFR 46.111 and FDA 21 CFR 56.111, as applicable.  The primary reviewer will record the Board’s determinations and the convened review outcome in the eIRB system.