SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board) was developed under an NIH grant and is responsive to new NIH policy requiring the use of a single IRB for multi-site research funded by the agency. The UW-Madison Health Sciences IRBs (HS IRBs) office has been centrally involved in the development and roll out of the SMART IRB model, which is streamlining IRB oversight for researchers performing multi-site studies.
UW currently has a federal sub-award from Harvard University to introduce the SMART IRB model, enable implementation of single IRB review, and help harmonize IRB-related processes on a national scale. Nichelle Cobb, PhD, director of the UW HS-IRBs office, was the primary drafter of SMART IRB standard operating procedures. She is currently a member of the NIH/NCATS team providing information and training about the initiative.
Other members of the HS IRBs office, Carol Pech and Mike Bingham, are leading efforts to work with Clinical & Translational Science Award (CTSA) and other sites to help them join SMART IRB and develop and test informatics platforms to support SMART IRB.
At UW, the HS IRBs Office worked with Orly Vardeny, the Office of Clinical Trials, and MARCH to test local implementation of the SMART model. Testing of the SMART IRB model also represents a key collaboration between the HS IRB Office and PCORnet. PCORnet proposes to align its single IRB review efforts with those of NCATS and will ultimately have PCORnet institutions join SMART IRB. Cobb comments,
SMART IRB represents the culmination of a cultural shift for IRBs: we have moved from an internally-focused review of research to a more expansive view that we can work with other institutions to effectively oversee human subjects research and ensure protection of study participants.
We were asked to become involved in the SMART IRB effort because of our work to simplify IRB review for multi-site research. That effort began back in 2007 and is currently exemplified by the Wisconsin IRB Consortium and Greater Plains Collaborative IRB Consortium. The trust and strong relationships we have built with our IRB colleagues throughout the state, region, and now nationally will serve our research teams well as we move forward with implementation of the NIH single IRB review policy.
As part of testing the SMART IRB model during the roll out period, data will be collected about key timeframes surrounding IRB review and study start up across sites. Evaluators will also characterize the challenges posed and successes realized related to the single IRB model from the perspectives of researchers, the reviewing IRB, and institutions ceding IRB review.
If you have any questions about SMART IRB or other reliance partnerships, and whether they are appropriate for your research study, please email the HS IRBs Reliance Team (email@example.com) for assistance. A list of IRB reliance terms and definitions is found on the HS-IRBs website.
A related story about the application of the SMART IRB is available here.