SMART IRB, A NATIONAL SINGLE IRB RELIANCE PLATFORM TO SUPPORT MULTI-SITE HUMAN RESEARCH STUDIES

项目总结/摘要 SMART IRB平台改变了进行多中心研究和培养 在全国范围内开展合作。部署一个共同依赖协议，由一个 集中的IT平台，提高了进行单一IRB监督和审查的效率。 然而，仍然存在一些障碍，包括研究延迟，合规问题和挑战 研究者在熟悉多中心研究的可靠性审查和执行方面的经验。 此外，还需要对协议作出更多修改，以适应 其他联邦机构。为了克服这些和其他障碍，SMART IRB计划（目标1：加入） 通过开发VA所需的SMART IRB MRA 3.0，扩展SMART IRB的覆盖范围和能力， 美国国防部、能源部和其他联邦机构、卫生中心和研究机构签署SMART IRB。 SMART IRB将在SMART IRB 3.0定稿时，通过 值得信赖的大使网络;（目标2：启用）教育，沟通和提高货币，深度， 通过推进教育和培训资源，将知识转移到 IRB、大使、机构联络点以及内外的监管和网络团队 CTSA。SMART IRB将继续开发更多的教育和培训资源， 以及开发一个工具包和培训机会，针对PI和研究团队， 与单个IRB合作;（目标3：协调）通过以下方式简化、统一和简化工作流程和政策 确定审查IRB、依赖机构和研究者的政策、程序和流程，以及 他们的研究小组，不同，以确定共同的要素和差异，从当前的学习 实践，并提出成功的工作流程。这是设计未来的基本前提 管理全国范围内人类研究保护的全面解决方案。

PROJECT SUMMARY/ABSTRACT The SMART IRB platform has transformed the process of conducting multi-site studies and fostering collaboration on a national scale. The deployment of a common reliance agreement, supported by a centralized IT platform, has led to improved efficiencies in conducting single IRB oversight and review. However, several obstacles remain, including delays in research, compliance issues, and challenges experienced by investigators regarding familiarity with reliance review and execution of multisite studies. Furthermore, additional changes to the agreement are required in order to accommodate the onboarding of additional federal agencies. To overcome these and other barriers, SMART IRB plans to (AIM 1: JOIN) Extend the reach and capacity of SMART IRB by developing a SMART IRB MRA 3.0, necessary for the VA, DoD, DOE, and other federal agencies, health centers and research institutions to sign onto SMART IRB. SMART IRB will re-sign current signatories when SMART IRB 3.0 is finalized, through the engagement of the trusted Ambassador network; (AIM 2: ENABLE) Educate, communicate and improve the currency, depth, and range of SMART IRB competencies by advancing educational and training resources to transfer knowledge to IRBs, Ambassadors, institutional Points of Contact, and regulatory and network teams both within and beyond the CTSAs. SMART IRB will continue to develop additional education and training resources for these constituencies, as well as develop a toolkit and training opportunities targeted to PIs and research teams who work with a single IRB; (AIM 3: HARMONIZE) Reconcile, unify, and simplify workflow and policies by identifying policies, procedures, and processes of Reviewing IRBs, Relying Institutions, and investigators and their study teams that differ in order to identify common elements and differences, learn from current practices, and propose successful workflows. This is an essential predicate to the design of a future comprehensive solution for managing human research protections across the nation.