Describing Variation in IRB Efficiency, Quality and Procedures

描述 IRB 效率、质量和程序的变化

• 批准号: 8279692
• 负责人: Daniel E Hall
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8279692
• 关键词: Algorithms; Charge; Confusion; Data; Engineering; Ensure; Foundations; Goals; Health Insurance Portability and Accountability Act; Health system; Healthcare Systems; Human; Human Subject Research; Hypertension; Individual; Institutional Review Boards; Knowledge; Maps; Measures; Medical center; Methods; Modeling; Office for Human Research Protections; Organizational Culture; Participant; Play; Policies; Principal Investigator; Procedures; Process; Regulation; Research; Research Activity; Research Personnel; Resources; Rights; Role; Shapes; Site; Social Welfare; Solutions; Specialist; Statutes and Laws; Structure; System; Testing; Time; Variant; Veterans; Work; base; common rule; design; diabetic; effectiveness research; handbook; human subject protection; improved; innovation; meetings; member; organizational climate; programs; research and development; systems research; tool; volunteer

* 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.

* 描述（由申请人提供）： VA人类研究保护计划（HRPP）是一个综合系统，旨在确保对参与VA研究的人类受试者的保护。虽然每个VA医疗中心（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 Handbook 1200.05的所有研究活动进行审查，批准和提供持续监督的主要委员会。尽管VA致力于确保保护人类研究对象，但VA研究监督的质量和效率却有所不同。这种差异支持采用系统的方法来理解和衡量IRB审查过程的质量和效率。系统重新设计的原理具有成功的记录，可以成功地提高整个VA的各种工作流程的质量和效率，尽管系统重新设计的框架尚未应用于VA中的IRB审查过程，但在类似情况下，它已在VA之外成功使用。因此，我们建议与VA Pittsburgh Healthcare System（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理的四个国家VA中心之一，以促进创新的解决方案应对卫生系统的挑战。我们与VERC/OSR在这项工作中的合作伙伴关系：（1）与持续改进的VA文化一致； （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）为实施我们的研究结果奠定了坚实的基础。拟议的研究将结合系统工程，定性和定量方法的组合，对具有大量研究计划（包括Central IRB）的10个VA站点的IRB过程进行深入分析。该分析对于确定IRB审查过程中质量和效率的障碍至关重要 并确定最佳的IRB实践来克服这些障碍。拟议的研究的具体目的是：（1）在每个选定站点上开发IRB审查过程的电流过程流程图； （2）根据IRB审查时间和研究人员和IRB成员负担来衡量IRB审查效率的变化； （3）使用IRB研究人员评估工具，IRB审查的常见规则标准以及人类研究保护办公室的算法来衡量IRB审查质量的差异，以确定适当类型的审查类型（例如，加快，豁免，全部董事会）； （4）使用质量和效率数据对IRB审查过程进行建模，以识别可以在未来的研究中测试的高影响，高可行性的过程。探索性分析还将开始：（a）评估组织文化与IRB效率和质量之间的关系； （b）检查IRB SOP中规定的组织气候。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为旨在测试IRB过程改进的计划的随后研究提供信息。然后将使用证明成功的计划来开发IRB最佳实践，这些实践可以在整个VA中实施。