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The SMART IRB platform: A national resource for IRB review for multisite studies
Nichelle Cobb1, Elizabeth Witte2, Maria Cervone2
1Health Sciences IRBs Office, University of Wisconsin - Madison, Madison, WI, USA.
Journal of Clinical and Translational Science
|October 30, 2019
Summary
The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform simplifies single Institutional Review Board (IRB) review for multisite research. It demonstrates the success of a national IRB reliance network, though further harmonization is needed.
Area of Science:
- Clinical Research Administration
- Regulatory Science
- Health Policy
Background:
- Single Institutional Review Board (sIRB) review has become more common for multisite research, supported by numerous reliance agreements.
- The increasing number of agreements presented challenges and highlighted the need for a unified, national approach to IRB reliance.
- Anticipated regulatory changes underscored the necessity for systematizing and simplifying IRB reliance processes.
Purpose of the Study:
- To describe the establishment and implementation of a national IRB reliance network.
- To detail the tenets, operational benefits, and challenges of the SMART IRB Platform's master reliance agreement.
- To assess the utility of a centralized approach to supporting sIRB review.
Main Methods:
- The NIH National Center for Advancing Translational Sciences funded the development of the SMART IRB Platform.
- A collaboratively developed master IRB reliance agreement and supportive resources were created.
- The platform was launched to facilitate the dissemination, adoption, and implementation of sIRB review.
Main Results:
- Over 580 institutions have joined the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.
- The SMART IRB platform is actively used to support single IRB arrangements for multisite research.
- Early success indicates the utility of collaborative and centralized approaches to sIRB review.
Conclusions:
- The SMART IRB Platform demonstrates the effectiveness of a national IRB reliance network in supporting sIRB review.
- Collaborative, flexible, and centralized models are beneficial for managing multisite research oversight.
- Further national harmonization efforts are necessary to optimize sIRB implementation and streamline research processes.
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