Describing Variation in IRB Efficiency, Quality and Procedures

* 描述（由申请人提供）： VA人类研究保护计划（HRPP）是一个旨在确保保护参与VA研究的人类受试者的综合系统。虽然每个VA医学中心（VAMC）HRPP包括各种个人和委员会，但机构审查委员会（IRB）是负责根据VHA手册1200.05审查、批准和持续监督所有研究活动的主要委员会。尽管退伍军人管理局承诺确保保护人类研究受试者，但退伍军人管理局的研究监督质量和效率存在差异。这种变化支持了理解和衡量IRB审查过程的质量和效率的系统方法的需求。系统重新设计的原则在成功提高VA各种工作流程的质量和效率方面有着良好的记录，尽管系统重新设计的框架尚未应用于VA的IRB审查流程，但它已在VA之外的类似环境中成功使用。因此，我们建议与VA匹兹堡医疗保健系统（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是四个国家VA中心之一，负责应用系统工程的原则，以促进卫生系统挑战的创新解决方案。我们与VERC/OSR在这方面的合作：（1）与VA持续改进的文化相一致;（2）支持我们产生与多个VA利益相关者相关的发现的能力;（3）为我们的研究结果的实施提供了坚实的基础。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10个具有大量研究项目的VA研究中心（包括中央IRB）的IRB流程进行深入分析。该分析对于识别IRB审查过程中质量和效率的障碍至关重要 并找出克服这些障碍的最佳IRB实践。拟议研究的具体目的是：（1）制定每个选定研究中心IRB审查流程的当前状态流程图;（2）测量IRB审查时间和研究者及IRB成员负担方面的IRB审查效率变化;（3）使用IRB研究人员评估工具、IRB审查的通用规则标准，以及人类研究保护办公室用于确定适当类型的审查的算法（例如，加速、豁免、全面）;以及（4）使用质量和效率数据对IRB审查流程进行建模，以确定可在未来研究中测试的流程改进的高影响力、高可行性举措。探索性分析也将开始：（A）评估组织文化与IRB效率和质量之间的关系;（B）检查IRB SOP中规定的组织氛围。我们的长期目标是确定和实施VA IRB的最佳实践。这里提出的工作将直接通知后续的研究，旨在测试IRB流程改进的举措。证明成功的举措将被用于制定IRB最佳实践，可在整个VA实施。

* 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.