Describing Variation in IRB Efficiency, Quality and Procedures

* 描述(由申请人提供)： 退伍军人研究保护计划(HRPP)是一个全面的系统，旨在确保参与退伍军人研究的人类受试者受到保护。虽然每个退伍军人医疗中心的人力资源规划包括各种个人和委员会，但机构审查委员会(IRB)是负责根据退伍军人管理局手册1200.05对所有研究活动进行审查、批准和持续监督的主要委员会。尽管退伍军人管理局承诺确保对人类研究对象的保护，但退伍军人管理局在研究监督的质量和效率方面存在差异。这一变化支持需要一种系统的方法来理解和衡量IRB审查过程的质量和效率。系统重新设计原则在成功提高退伍军人事务部各种工作流程的质量和效率方面有着良好的记录，尽管系统重新设计框架尚未应用于退伍军人事务部内部审查委员会的审查过程，但已在退伍军人事务部以外的类似情况下成功使用。因此，我们建议与VA匹兹堡医疗系统(VAPHS)退伍军人工程资源中心(VERC)/系统重新设计办公室(OSR)合作，以评估和提高VA IRB审查过程的质量和效率。VAPHS VERC/OSR是负责应用系统工程原则促进创新解决方案以应对医疗系统挑战的四个国家退伍军人中心之一。我们与VERC/OSR在这方面的合作：(1)与退伍军人管理局持续改进的文化保持一致；(2)支持我们产生与多个退伍军人管理局利益相关者相关的研究结果的能力；(3)为实施我们的研究结果提供坚实的基础。拟议的研究将使用系统工程、定性和定量方法相结合的方法，对包括中央IRB在内的10个具有实质性研究计划的退伍军人事务部的IRB过程进行深入分析。这一分析对于确定IRB审查过程中的质量和效率障碍至关重要 并确定IRB克服这些障碍的最佳实践。拟议研究的具体目标是：(1)制定每个选定地点IRB审查过程的当前状态流程图；(2)根据IRB审查次数、调查员和IRB成员负担来衡量IRB审查效率的差异；(3)使用IRB研究员评估工具、IRB审查的共同规则标准和人类研究保护办公室确定适当审查类型(例如，加速、豁免、全面审查)的算法来衡量IRB审查质量的差异；以及(4)使用质量和效率数据对IRB审查过程进行建模，以确定可在未来研究中测试的高影响、高可行性的过程改进倡议。探索性分析还将开始：(A)评估组织文化与内部审查机构效率和质量之间的关系；(B)审查内部审查机构标准作业程序中规定的组织氛围。我们的长期目标是确定和实施退伍军人管理局IRBs的最佳做法。这里建议的工作将直接为旨在测试IRB过程改进的倡议的后续研究提供信息。被证明成功的举措将被用来开发可在整个退伍军人管理局实施的IRB最佳实践。

* DESCRIPTION (provided by applicant): The VA Human Research Protection Program (HRPP) is a comprehensive system designed to ensure the protection of human subjects participating in VA research. While each VA Medical Center (VAMC) HRPP includes a variety of individuals and committees, the Institutional Review Board (IRB) is the primary committee responsible for reviewing, approving, and providing ongoing oversight for all research activities in accordance with VHA Handbook 1200.05. Despite the VA's commitment to ensure the protection of human research subjects, there is variation in the quality and efficiency of research oversight in the VA. This variation supports the need for a systematic approach for understanding and measuring the quality and efficiency of IRB review processes. The principles of Systems Redesign have a proven track record for successfully improving the quality and efficiency of a diverse range of work processes throughout the VA, and although the framework of Systems Redesign has not yet been applied to the IRB review process in the VA, it has been successfully used outside the VA in similar contexts. Thus, we propose to partner with the VA Pittsburgh Healthcare System (VAPHS) Veterans Engineering Resource Center (VERC)/ Office of Systems Redesign (OSR) to evaluate and improve the quality and efficiency of the VA IRB review process. The VAPHS VERC/OSR is one of four national VA centers charged to apply the principles of systems engineering to facilitate innovative solutions to health system challenges. Our partnership with VERC/OSR on this effort: (1) is consistent with the VA culture of continuous improvement; (2) supports our ability to produce findings relevant to multiple VA stakeholders; and (3) provides a strong foundation for the implementation of our research findings. The proposed research will use a combination of systems engineering, qualitative, and quantitative methods to perform an in-depth analysis of IRB processes at 10 VA sites with substantial research programs, including the Central IRB. This analysis is critical to identifying barriers to quality and efficiency in IRB review processes and identifying best IRB practices to overcome these barriers. The specific aims of the proposed research are to: (1) develop current-state process flow maps of the IRB review processes at each selected site; (2) measure variation in the efficiency of IRB review in terms of IRB review times and investigator and IRB member burden; (3) measure variation in the quality of IRB review using the IRB Researcher Assessment Tool, the Common Rule Criteria for IRB review, and the Office of Human Research Protections' algorithm for determining the appropriate type of review (e.g., expedited, exempt, full board); and (4) model the IRB review process using quality and efficiency data to identify high-impact, high- feasibility initiatives for process improvement that can be tested in future research. Exploratory analyses will also begin to: (A) assess the relationship between organizational culture and IRB efficiency and quality; and (B) examine the organizational climate as set forth in the IRB SOPs. Our long term goal is to identify and implement best practices for VA IRBs. The work proposed here will directly inform subsequent research aimed at testing initiatives for IRB process improvement. Initiatives that prove successful will be then be used to develop IRB best practices that can be implemented throughout the VA.