May 2005

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.  Documentation of convened review outcome will be part of the JHM IRB file.