Serdoz Emily Sheffer, Edwards Terri, Pulley Jill, Beadles Jenni, Ozier Julie, Harris Paul, Bernard Gordon R, Rice Todd W
Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USA.
Human Research Protections Program, Vanderbilt University Medical Center, Nashville, TN, USA.
J Clin Transl Sci. 2022 Mar 23;6(1):e39. doi: 10.1017/cts.2022.376. eCollection 2022.
For decades, the research community called for streamlined Institutional Review Board (IRB) review processes for multisite studies. Department of Health and Human Services and National Institutes of Health (NIH) recognized this need and implemented single IRB (sIRB) of record mandates. However, announcing mandates without sufficient operational guidance and tools is insufficient to foster the desired change. Nearly 4 years into implementation of the NIH's sIRB mandate, operational challenges remain. Fortunately, NIH supports a web-based sIRB platform, the IRB Reliance Exchange (IREx), to facilitate sIRB communication and documentation. IREx has received continuous NIH funding supporting its evolution since 2011 and is now used by over 5,000 Human Research Protection Program and research personnel, 35 sIRBs, and 415 participating sites to operationalize sIRB review and approval on over 400 studies. IREx supports over 2300 reliance relationships with an average of 7 sites per study. The platform is continually used by sIRBs and relying sites, providing a valuable centralized portal for promoting a harmonized sIRB review process. IREx can promote transparency, standardize practice, minimize workflow variation, and mitigate the need for sIRBs to implement significant technical changes to their local electronic systems. IREx has proven to be nimble and adaptable with practice and policy changes over the past decade, as evidenced by continually increasing platform utilization.
几十年来，研究界一直呼吁简化机构审查委员会（IRB）对多中心研究的审查流程。美国卫生与公众服务部和美国国立卫生研究院（NIH）认识到这一需求，并实施了单一记录IRB（sIRB）的授权。然而，在没有足够的操作指南和工具的情况下宣布授权不足以促成预期的变革。在NIH的sIRB授权实施近4年后，操作挑战依然存在。幸运的是，NIH支持一个基于网络的sIRB平台——IRB依赖交换平台（IREx），以促进sIRB的沟通和文档记录。自2011年以来，IREx一直获得NIH的持续资金支持其发展，目前已有超过5000名人类研究保护项目和研究人员、35个sIRB以及415个参与站点使用该平台，以对400多项研究进行sIRB审查和批准。IREx支持超过2300种依赖关系，每项研究平均有7个站点。sIRB和依赖站点持续使用该平台，为促进统一的sIRB审查流程提供了一个有价值的集中门户。IREx可以提高透明度、规范实践、减少工作流程差异，并减少sIRB对其本地电子系统进行重大技术更改的需求。在过去十年中IREx已证明能够灵活适应实践和政策变化，平台利用率不断提高就是证明。
