评估机构审查委员会的质量和业绩：经修订的共同规则的影响

IF 1.7 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics Pub Date : 2022-04-26 DOI:10.1177/15562646221094407

M. Tsan, Hannah Van Hook

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引用次数: 1

摘要

《共同规则》于2019年1月19日实施，该规则进行了广泛修订，以加强对受试者的保护，减轻调查人员和机构审查委员会（IRB）的负担。我们分析了2016年至2021年的IRB绩效指标数据，以评估修订后的通用规则对IRB质量和绩效的潜在影响。从2016年到2021年，豁免协议增加了159%，需要IRB持续审查的协议减少了28%。由于2021年只有48%的协议符合修订后的共同规则要求，因此在未来几年，豁免协议和需要IRB持续审查的协议的数量将分别继续增加和减少。在总共研究的16个IRB绩效指标中，从2016年到2021年，有4个指标改善，4个指标恶化，8个指标保持不变。这项研究首次评估了修订后的通用规则对IRB质量和性能的影响。

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Assessing the Quality and Performance of Institutional Review Boards: Impact of the Revised Common Rule

The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.

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来源期刊

Journal of Empirical Research on Human Research Ethics 医学-医学：伦理

CiteScore

3.50

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.