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在三个非洲国家(喀麦隆、马里和坦桑尼亚)的研究伦理委员会成员中进行研究伦理评估的培训需求评估。

Training needs assessment in research ethics evaluation among research ethics committee members in three African countries: Cameroon, Mali and Tanzania.

机构信息

Faculty of Medicine and Biomedical Sciences; University of Yaoundé 1, Cameroon--Centre for the Study and Control of Communicable Diseases, Melen Street, Yaoundé Centre, Cameroon.

出版信息

Dev World Bioeth. 2010 Aug;10(2):88-98. doi: 10.1111/j.1471-8847.2009.00266.x. Epub 2009 Nov 12.

DOI:10.1111/j.1471-8847.2009.00266.x
PMID:19912281
Abstract

BACKGROUND

As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.

OBJECTIVE

To assess training needs for biomedical research ethics evaluation among targeted countries.

METHODS

Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.

RESULTS

A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.

CONCLUSION

Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.

摘要

背景

作为保护人类研究参与者的主要责任人,研究伦理委员会(RECs)需要具备能力并拥有充足的资源,才能履行其职责。尽管最近有一些旨在加强非洲 RECs 的计划,但在这些委员会能够最佳运作之前,还有很多工作要做。

目的

评估目标国家生物医学研究伦理评估的培训需求。

方法

2007 年 8 月至 11 月期间对三个目标非洲国家的 REC 成员进行了调查。在实施调查之前,已从瑞士、喀麦隆、马里和坦桑尼亚的 REC 获得了伦理批准。数据是使用英语和法语的半结构化问卷收集的。

结果

共有 74 名受访者参加了这项研究。参与率为 68%。71%的受访者报告说他们接受过一些研究伦理评估方面的培训。培训是由国家机构(31%)和国际机构(69%)提供的。研究人员和 REC 成员被列为需要培训的首要目标受众。在 32 个主题中,培训的前五个重点是:基本伦理原则、适用法律法规的涵盖范围、如何进行伦理审查、评估知情同意过程以及 REC 的作用。

结论

尽管目标非洲国家的大多数 REC 成员都接受过伦理培训,但他们表示需要额外的培训。这项调查的结果已被用于设计一个满足这一需求的研究伦理评估培训计划。

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