Variability in Ethics Review for Multicenter Protocols in Buenos Aires, Argentina. An Observational Study.

IF 1.7 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics Pub Date : 2023-02-01 DOI:10.1177/15562646221134620

Javier Mariani, María Laura Garau, Adriel Jonas Roitman, Claudia Vukotich, Leonardo Perelis, Fernando Ferrero, Adriana Gladys Domínguez, Cecilia Campos, Cecilia Serrano, Gabriel González Villa Monte

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Abstract

It has been reported that significant variability in the ethics review process affects multisite studies. We analyzed 1,305 applications for multicenter studies (409 unique protocols), from 1^st January 2020 to 20^th September 2021. We examined the variability in the times to approval and the first observation and the variation in the level of risk assigned. The median [IQR] variabilities were 42.19 [15.23-82.36] days and 8.00 [3.12-16.68] days, for the times to approval and to the first observation, respectively. There was disagreement in the level of risk assigned by the Research Ethics Committee (REC) in 24.0% of cases. Independent predictors of variability included the number of REC members. In our study, we found substantial variability in the ethics review process among health research protocols. Also, we describe methods to readily measure the delays and the variations in the ethics review process.

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阿根廷布宜诺斯艾利斯多中心方案伦理审查的可变性。观察性研究。

据报道，伦理审查过程中的显著差异会影响多地点研究。从2020年1月1日至2021年9月20日，我们分析了1305份多中心研究申请(409个独特方案)。我们检查了批准时间的可变性第一次观察和分配的风险水平的变化。批准时间和首次观察时间的中位[IQR]变异率分别为42.19[15.23-82.36]天和8.00[3.12-16.68]天。在研究伦理委员会(REC)分配的风险水平中，有24.0%的病例存在分歧。变异的独立预测因子包括REC成员的数量。在我们的研究中，我们发现在卫生研究方案的伦理审查过程中存在很大的差异。此外，我们还描述了在伦理审查过程中容易测量延迟和变化的方法。

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

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.