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理解伦理审查周转时间的限制因素和促进因素:以坦桑尼亚机构审查委员会为例。

Understanding Constraints and Enablers of Turnaround Time for Ethics Review: The Case of Institutional Review Boards in Tanzania.

机构信息

298427Ifakara Health Institute, Dar es Salaam, Tanzania.

University of KwaZulu-Natal, School of Applied Human Sciences, Psychology, Pietermaritzburg, South Africa.

出版信息

J Empir Res Hum Res Ethics. 2021 Dec;16(5):514-524. doi: 10.1177/15562646211026855. Epub 2021 Jun 28.

Abstract

. 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. . 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. . 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. 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.

摘要

在实施所有涉及人类参与者的健康研究之前,需要进行独立的伦理审查。然而,伦理审查过程受到周转时间延长的挑战,这可能会对实施具有社会价值的研究产生负面影响。先前的研究已经记录了在发达国家和发展中国家伦理审查的延迟。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变化的程度。这是一项描述性的横断面研究,采用了混合方法,包括定性和定量部分。在研究期间(2017 年 4 月至 2018 年 4 月),从坦桑尼亚 15 个认可的 IRB 中选择了 7 个 IRB 进行了有针对性的抽样。使用 STATA 软件对定量数据进行分析,对定性数据进行主题分析。所有 IRB 的审查中位数为 32 天,范围为 1-396 天。从与参与者的访谈中确定了与周转时间相关的五个关键主题:(1)接收和分发方案的程序,(2)分配给方案的评审员人数,(3)评审方案的持续时间,(4)延迟反馈的原因,(5)研究伦理委员会成员的培训。该研究表明,坦桑尼亚的伦理批准中位数为 32 天。我们从这项研究中观察到,电子提交系统促进了更快的周转时间。未能遵守提交清单和指南是周转时间的主要障碍。

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