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.

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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