Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.
Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.
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DOI：
10.1080/23294515.2016.1186757
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发表时间：
2016-01-01
影响因子：
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通讯作者：
Arnold, Robert M
中科院分区：
文献类型：
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作者：
Hall, Daniel E;Feske, Ulrike;Arnold, Robert M
背景技术背景：机构审查委员会（IRB）因不一致、拖延和偏见而受到批评，这表明有机会提高质量。为了帮助提高质量，本研究旨在确定10个退伍军人事务部（VA）IRB的IRB成员和研究者对IRB审查的优先事项。方法：向9个退伍军人事务部医疗中心和VA中央IRB的252名IRB成员和工作人员以及428名主要研究者和项目协调员发送了680份匿名互联网调查。调查包括改编自Koocher和Kieth-Spiegel的IRB-RAT描述IRB活动或功能的27个声明（例如，“一个愿意推翻其先前决定的IRB”）。受访者指出，每个陈述如何描述他们的“理想”和“实际”的IRB。计算每个项目的实际和理想IRB评分之间的差异，沿着估计95%置信区间。在这些区间之外的评级表示与理想IRB相比具有相对较好或较差性能的活动或功能。390（57.4%）来自165名IRB成员和工作人员的回复（65.5%）和225名调查员和项目协调员（52.6%）表明，这些IRB在保护人类受试者、尊重研究者、并对涉嫌的科学不端行为采取适当行动。在重复表格、审评的及时性和提供完整的决策依据方面，IRB离理想状态最远。尽管IRB成员报告说，他们愿意推翻先前的决定，但调查人员认为这种能力远非理想。调查者认为IRB成员对程序和政策的了解接近理想，但IRB成员自己认为这方面远非理想。值得注意的网站一级的IRB功能和活动的评级差异也identified.CONCLUSIONS：虽然这些VA IRB在某些领域表现良好，这些数据支持需要持续的质量改进。所描述的管理和分析IRB-RAT的方法可以帮助识别和监控用于质量改进的站点和活动特定的主动性。
BACKGROUND: Institutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs.METHODS: 680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB.RESULTS: 390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified.CONCLUSIONS: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.