Describing Variation in IRB Efficiency, Quality and Procedures

描述 IRB 效率、质量和程序的变化

• 批准号: 8597960
• 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/8597960
• 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，旨在确保参与 VA 研究的人类受试者得到保护。虽然每个 VA 医疗中心 (VAMC) HRPP 都包括各种个人和委员会，但机构审查委员会 (IRB) 是主要委员会，负责根据 VHA 手册 1200.05 审查、批准和提供对所有研究活动的持续监督。尽管 VA 致力于确保保护人类研究对象，但 VA 的研究监督质量和效率存在差异。这种变化支持需要一种系统方法来理解和衡量 IRB 审核流程的质量和效率。系统重新设计的原则在成功提高整个 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，评估和提高 VA IRB 审核流程的质量和效率。 VAPHS VERC/OSR 是四个国家 VA 中心之一，负责应用系统工程原理，以促进针对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) 符合 VA 持续改进的文化； (2) 支持我们得出与多个 VA 利益相关者相关的调查结果的能力； (3)为我们的研究成果的实施提供了坚实的基础。拟议的研究将结合系统工程、定性和定量方法，对 10 个 VA 站点（包括中央 IRB）的 IRB 流程进行深入分析，并开展大量研究项目。该分析对于识别 IRB 审核流程中的质量和效率障碍至关重要 并确定 IRB 的最佳实践来克服这些障碍。拟议研究的具体目标是：(1) 制定每个选定地点 IRB 审查流程的现状流程图； (2) 根据IRB审查时间以及研究者和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 审查通用规则标准以及人类研究保护办公室的算法来衡量 IRB 审查质量的变化，以确定适当的审查类型（例如加急、豁免、全面审查）； (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高影响力、高可行性的流程改进举措。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 中规定的组织氛围。我们的长期目标是确定并实施 VA IRB 的最佳实践。这里提出的工作将直接为后续旨在测试 IRB 流程改进举措的研究提供信息。事实证明成功的举措将用于制定可在整个 VA 实施的 IRB 最佳实践。

项目成果

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.

• DOI: 10.1177/1556264620956795
• 发表时间: 2020-12
• 期刊: Journal of empirical research on human research ethics : JERHRE
• 作者: Tsan MF;Ling B;Feske U;Zickmund S;Stone R;Sonel A;Arnold RM;Fine M;Hall DE
• 通讯作者: Hall DE

Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.

• DOI: 10.1080/23294515.2016.1186757
• 发表时间: 2016-01-01
• 期刊: AJOB empirical bioethics
• 作者: Hall, Daniel E;Feske, Ulrike;Arnold, Robert M
• 通讯作者: Arnold, Robert M