The Quality Improvement Review Board: An Innovative Approach to Oversight of Projects That Do Not Meet Criteria of Human Subject Research.

IF 1.2 4区 医学 Q4 HEALTH CARE SCIENCES & SERVICES
Toni L Denison, Kristyn U Sorensen, Michael P Blanton, Lara Johnson, Theresa Byrd, Steven E Pass, Lacy Philips, Joyce Miller, Lance R McMahon, Barbara Cherry
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Abstract

This article describes the development of an institutional quality improvement review board (QIRB) as an effective and efficient method for reviewing and overseeing institutional quality improvement (QI) initiatives. QI projects involve the systematic collection and analysis of data and the implementation of interventions designed to improve the quality of clinical care and/or educational programs for a distinct population in a specific setting. QI projects are fundamentally distinct from human subjects research (HuSR); however, the differences between them are subtle and highly nuanced. Determining whether a project meets the definition of QI or qualifies as HuSR, thus requiring institutional review board (IRB) review, can be confusing and frustrating. Nevertheless, this distinction is highly consequential due to the heavy regulatory requirements involved in HuSR and IRB oversight. Making the correct determination of a project's regulatory status is essential before the project begins. Project leaders may not realize that their work meets the definition of HuSR and, therefore, might conduct the project without appropriate IRB review. Therefore, best practices dictate that project leaders should not decide which type of institutional review is appropriate for their projects. In addition, when QI project teams attempt to disseminate the results of their work, documentation of formal review and approval is generally required by peer-reviewed journals and professional organizations. However, institutional review mechanisms are rarely available. Projects that do not meet the definition of HuSR fall outside the purview of IRBs and most institutions do not have an alternative review body. This creates frustration for both project leaders and IRB administrators. Apart from IRB review, a separate process for reviewing QI projects offers several benefits. These include (1) relieving the burden on busy IRB staff; (2) promoting scholarly activity; (3) protecting the institution, project leaders, and participants from HuSR conducted outside of appropriate IRB review; and (4) promoting rigorous QI methods.

质量改进审查委员会:对不符合人体课题研究标准的项目进行监督的创新方法。
本文介绍了机构质量改进审查委员会(QIRB)的发展情况,它是审查和监督机构质量改进(QI)计划的一种有效且高效的方法。质量改进项目涉及系统地收集和分析数据,并实施干预措施,旨在改善特定环境中不同人群的临床护理和/或教育计划的质量。QI 项目从根本上有别于人类受试者研究 (HuSR);然而,两者之间的区别是微妙的、高度细微的。确定一个项目是符合 QI 的定义,还是符合 HuSR 的定义,从而需要接受机构审查委员会 (IRB) 的审查,可能会让人感到困惑和沮丧。然而,由于 HuSR 和 IRB 监督涉及到大量的监管要求,这种区别是非常重要的。在项目开始之前,正确确定项目的监管状态至关重要。项目负责人可能没有意识到他们的工作符合 HuSR 的定义,因此可能会在未经 IRB 适当审查的情况下开展项目。因此,最佳实践规定,项目负责人不应决定哪种类型的机构审查适合其项目。此外,当质量创新项目团队试图传播其工作成果时,同行评审期刊和专业组织通常会要求提供正式审查和批准的文件。然而,机构审查机制很少可用。不符合 "HuSR "定义的项目不属于 IRB 的管辖范围,大多数机构也没有其他审查机构。这让项目负责人和 IRB 管理人员都很苦恼。除了 IRB 审查之外,单独的 QI 项目审查程序还能带来一些好处。这些好处包括:(1) 减轻繁忙的 IRB 工作人员的负担;(2) 促进学术活动;(3) 保护机构、项目负责人和参与者免受在适当的 IRB 审查之外进行的 HuSR 的影响;(4) 推广严格的 QI 方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Quality Management in Health Care
Quality Management in Health Care HEALTH CARE SCIENCES & SERVICES-
CiteScore
1.90
自引率
8.30%
发文量
108
期刊介绍: Quality Management in Health Care (QMHC) is a peer-reviewed journal that provides a forum for our readers to explore the theoretical, technical, and strategic elements of health care quality management. The journal''s primary focus is on organizational structure and processes as these affect the quality of care and patient outcomes. In particular, it: -Builds knowledge about the application of statistical tools, control charts, benchmarking, and other devices used in the ongoing monitoring and evaluation of care and of patient outcomes; -Encourages research in and evaluation of the results of various organizational strategies designed to bring about quantifiable improvements in patient outcomes; -Fosters the application of quality management science to patient care processes and clinical decision-making; -Fosters cooperation and communication among health care providers, payers and regulators in their efforts to improve the quality of patient outcomes; -Explores links among the various clinical, technical, administrative, and managerial disciplines involved in patient care, as well as the role and responsibilities of organizational governance in ongoing quality management.
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