Suchergebnisse

ABSTRACTImplementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH‐funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate. Lessons learned are described. There was a steep learning curve for IRBs and participating sites. IRB submission workload burden shifted from study teams to the data coordinating center, which created new workflow challenges, especially preparing hundreds of consent documents centrally. Despite difficulties encountered with CIRB review, this network is now fully functioning under a CIRB model. Further review and experience are needed to determine whether this shift in IRB review has eliminated duplicative review or regulatory burden from study teams.

ABSTRACTSince the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center assisted the Collaborative Pediatric Critical Care Research Network to transition from using individually negotiated reliance agreements and paper‐based documentation to a new sIRB master agreement and an informatics platform to capture reliance documentation. Lessons learned that can guide other academic institutions and IRBs as they operationalize sIRBs included the need for sites to understand what type of engagement or reliance is required and their need to understand the difference between reliance and activation. Requirements around local review remain poorly understood. Further research is needed to determine approaches that can achieve the NIH vision of reviews becoming more efficient and improving study start‐up times, relieving administrative burden while advancing human research protections.