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三年培训对尼日利亚研究伦理委员会运营能力的影响。

Impact of three years training on operations capacities of research ethics committees in Nigeria.

出版信息

Dev World Bioeth. 2014 Apr;14(1):1-14. doi: 10.1111/j.1471-8847.2012.00340.x. Epub 2012 Sep 24.

DOI:10.1111/j.1471-8847.2012.00340.x
PMID:22998425
Abstract

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants' knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically.

摘要

本文描述了一个为期三年的项目,旨在提高研究伦理委员会成员有效履行职责的能力。项目参与者由 13 个在尼日利亚运作的研究伦理委员会(RECs)的成员组成。他们接受了培训,以提高他们评估研究方案、监测试验实施、向试验工作人员提供建设性意见以及评估试验在促进社区参与研究方面的成功的能力。培训后,持续向参与者提供技术援助,并对项目的影响进行了定量和定性评估。结果表明,对能力建设工作(包括培训、持续的技术援助和提供多种工具)的持续投资提高了参与者对与生物医学研究相关的伦理原则以及有效 REC 应如何运作的知识。这种投资还对其他 REC 成员(未接受培训的成员)的知识水平以及参与者所属的 REC 的整体运作产生了积极影响。有效地履行 REC 成员的职责需要持续的努力和投资,而通过使 REC 能够履行其确保试验安全和符合伦理的基本使命,这种投资得到了回报。

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