SMART (Streamlined, Multisite, Accelerated Resources for Trials) IRB is a platform developed to ease challenges of single IRB review. The SMART IRB is designed to help implement the NIH’s Single IRB Reliance Policy, however it is not limited to studies funded by NIH. SMART IRB is a network of IRBs that chose to rely on each other on a study-by-study basis by entering into a master and reciprocal IRB Authorization Agreement. The project is funded by the National Center for Advancing Translational Sciences (NCATS) and led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy.
SMART IRB includes:
A reciprocal reliance agreement (joinder agreement) that allows institutions that join to cede review to of serve as the IRB of Record for participating institution’s IRBs.
- A set of Standard Operating Procedures (SOPs)
- Network of regional SMART IRB ambassadors
- Centralized online system to support sign-on, reliance determinations, etc.
Participating intuitions elect on a case-by-case basis whether or not to cede IRB review. SMART IRB can be utilized for a variety of research projects, from large and complex multi-site clinical trials to smaller two-site collaborations. The overall Principal Investigator works with the Point of Contact at each SMART IRB site to determine an appropriate reliance arrangement, together they will identify the “Reviewing IRB” and the institutions that will rely on that IRB.
More information and a copy of the joinder agreement is available at https://smartirb.org/about-us/. There are currently 152 participating institutions, including 64 CTSA hubs. A list of participants is also available online.
As the site lead for PRIS, you might wish to look through the link and see if your hospital is listed as participating in the SMART IRB. This will help us when we are recruiting sites for future studies, to choose those that are shovel ready for grant funded projects.