SMART IRB is a “non-share” model of reliance, which means that the IRB responsible for review of research on behalf of other institutions is responsible for all aspects of the IRB review. In other words, the reviewing IRB performs initial review, continuing review, review of amendments (study-wide and those specific to particular institutions), and review of reportable events. With respect to any given institution, there is a single IRB of record overseeing its participation in the research study. In addition, Participating Institutions can use SMART IRB to support one-way reliance relationships (when an institution only relies on another’s IRB or only provides IRB review) and reciprocal reliance relationships (when an institution may for one research study rely on another’s IRB and may for another research study provide IRB review). Institutions can also use SMART IRB to support reliance for a single research study or specific category of research studies or for multiple research studies as the need arises. The SMART IRB Reliance Agreement is designed to be flexible enough to support a broad range of reliance relationships in facilitation of the national goal to increase utilization of single IRBs.
Comments
0 comments
Article is closed for comments.