The SMART IRB platform: A national resource for IRB review for multisite studies
| Autor: | Barbara E. Bierer, Douglas MacFadden, Aaron Kirby, Maria A. Cervone, Lee M. Nadler, Elizabeth Witte, Nichelle Cobb |
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| Rok vydání: | 2019 |
| Předmět: |
cede review
research ethics single IRB review Harmonization IRB authorization agreement 03 medical and health sciences 0302 clinical medicine Resource (project management) human subject protections Implementation Policy and Community Engagement Institutional review boards 030212 general & internal medicine multicenter clinical research Research ethics 030503 health policy & services Authorization sIRB General Medicine Bioethics reliance agreement Institutional review board Engineering management NIH single IRB policy Special Communications cooperative agreement Business master IRB agreements Translational science 0305 other medical science bioethics |
| Zdroj: | Journal of Clinical and Translational Science |
| ISSN: | 2059-8661 |
| Popis: | Single institutional review board (IRB) review of multisite research increased in frequency over a decade ago with a proliferation of master IRB reliance agreements supporting statewide and regional consortia and disease- and population-specific networks. Although successful, the increasing number of agreements presented significant challenges and illuminated potential benefits of a single, nationwide agreement. Anticipated changes in federal regulations highlighted the need to systematize and simplify IRB reliance. To address these challenges, the NIH National Center for Advancing Translational Sciences funded a project to establish a national IRB reliance network that would support national adoption of single IRB (sIRB) review. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform launched in July 2016 to facilitate dissemination, adoption, and implementation of a collaboratively developed master IRB reliance agreement and supportive tools and resources. More than 580 institutions have joined SMART IRB’s Master Common Reciprocal Institutional Review Board Authorization Agreement and begun using the SMART IRB platform to support sIRB arrangements. Here, we describe the tenets of the agreement and operational benefits and challenges of its use. SMART IRB’s early success affirms the utility of collaborative, flexible, and centralized approaches to supporting sIRB review while highlighting the need for further national harmonization. |
| Databáze: | OpenAIRE |
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