IRB approval for multisite clinical trials presents a challenge to investigators, regulatory officials, and clinical research staff that often involves time and effort that can delay work on important research protocols.
SMART IRB is a platform designed to streamline the process of initiating multisite human subjects research through web applications, standard operating procedures, and a flexible Master IRB Reliance Agreement.
The platform was created through a national collaboration between Harvard Medical School, University of Wisconsin–Madison, and Dartmouth College with funding from the National Center for Advancing Translational Science.
Team members from Dartmouth College developed the Joinder application to help facilitate institutional signing of the Master IRB Reliance Agreement, which helped gather important information about the institution and their main IRB points of contact.
The University of Wisconsin–Madison teammates created important standard operating procedures that gave member institutions guidance for how to implement single IRB reliance under the new agreement in compliance with the NIH Single IRB Review Policy.
Developers at Harvard Catalyst created the Online Reliance System that guides users from member institutions through the workflow of submitting a request for reliance and allows institutions conducting multisite trials to make determinations regarding IRB reliance.
While successfully helping implement single IRB review, SMART IRB as a platform has yielded extremely interesting data about reliance requests, the total life cycle of a request, and the challenges faced by both investigators and IRB officials.