理解伦理审查周转时间的制约因素和推动因素:坦桑尼亚机构审查委员会的案例。

IF 1.7 4区 哲学 Q2 ETHICS Journal of Empirical Research on Human Research Ethics Pub Date : 2021-12-01 Epub Date: 2021-06-28 DOI:10.1177/15562646211026855
Mwifadhi Mrisho, Zaynab Essack
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引用次数: 2

摘要

背景在实施所有涉及人类参与者的健康研究之前,需要对研究进行独立的伦理审查。然而,伦理审查过程面临着漫长的周转时间的挑战,这可能会对社会价值研究的实施产生负面影响。先前的研究记录了发达国家和发展中国家在伦理审查方面的延误。本研究旨在确定坦桑尼亚不同机构审查委员会(IRB)之间方案审查周转时间的可变性程度。方法。这项描述性横断面研究采用了定性和定量相结合的混合方法。在2017年4月至2018年4月的研究期间,从坦桑尼亚运营的15家经认证的IRB中抽取了7家IRB。使用STATA软件对定量数据进行分析,并对定性数据进行专题分析。后果所有IRB的审查中位时间为32天,范围为1-396天。定性结果从对参与者的访谈中确定了与周转时间有关的五个关键主题。其中包括:(1)方案的接收和分发程序,(2)分配给方案的审查人员数量,(3)审查方案的持续时间,(4)延迟反馈的原因,以及(5)研究伦理委员会成员的培训。结论研究表明,坦桑尼亚获得伦理批准的平均天数为32天。我们从这项研究中观察到,电子提交系统有助于加快周转时间。未能遵守提交清单和准则是周转时间的主要障碍。
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Understanding Constraints and Enablers of Turnaround Time for Ethics Review: The Case of Institutional Review Boards in Tanzania.

Background. Independent ethics review of research is required prior to the implementation of all health research involving human participants. However, ethics review processes are challenged by protracted turnaround times, which may negatively impact the implementation of socially valuable research. Previous research has documented delays in ethics review in developed and developing countries. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. Methods. This descriptive cross-sectional study employed a mixed-method approach, with qualitative and quantitative components. Seven IRBs were purposively sampled from the 15 accredited IRBs operational in Tanzania during the study period, April 2017-April 2018. Quantitative data were analysed using STATA software and qualitative data were analysed thematically. Results. The median time for review across all IRBs was 32 days, with a range of 1-396 days. Qualitative results identified five key themes related to turnaround time from interviews with participants. These included: (1) procedures for receiving and distribution of protocols, (2) number of reviewers assigned to protocols, (3) duration of reviewing protocols, (4) reasons for delayed feedback, and (5) training of research ethics committee members. Conclusion. The study showed that the median days for ethical approval in Tanzania was 32 days. We observed from this study that electronic submission systems facilitated faster turnaround times. Failure to adhere to the submission checklists and guidelines was a major obstacle to the turnaround time.

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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
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.
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