加强非洲的研究伦理监督:肯尼亚的例子

IF 0.5 Q4 MEDICAL ETHICS South African Journal of Bioethics and Law Pub Date : 2023-05-08 DOI:10.7196/sajbl.2023.v16i1.199
L. Omutoko, MSc Global Bioethics B Amugune PhD, PgDip Res. Ethics, T. Nyawira, C. Muchoki, M. Masika, PhD MB ChB, G. Omosa-Manyonyi, MSc MB ChC, C. Kamau, MSc L K’Apiyo, Mba Jaoko, W. Jaoko
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引用次数: 0

摘要

背景非洲大陆正在进行的健康研究项目数量有所增加,特别是临床试验。理想情况下,这应该伴随着研究伦理审查能力的相应提高,以胜任提供急需的研究伦理监督。不幸的是,许多非洲国家的情况并非如此,这些国家仍在努力应对国家层面和机构层面研究伦理监督能力薄弱的问题。目标。描述肯尼亚国家研究伦理监管机构国家科学技术与创新委员会(NACOSTI)提出的建设其国家科学与伦理委员会(NSEC)能力的建议,该委员会负责在该国提供所需的研究伦理监督。方法。这是NACOSTI向欧洲和发展中国家临床试验伙伴关系提交的提案,旨在资助题为“加强肯尼亚的研究伦理和监督”(STReK)的项目。它描述了加强NSEC以在国内提供所需研究伦理的活动,以及通过培训和指导计划建立其认可的研究伦理委员会(REC)的研究伦理能力,使其能够有效审查研究提案。后果介绍了该项目的拟议活动。正在执行所述活动。结论这方面的经验教训可能有利于资源有限国家的其他研究伦理监管机构,旨在加强其研究伦理监督能力。
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Strengthening research ethics oversight in Africa: The Kenyan example
Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To describe the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity.
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CiteScore
1.10
自引率
11.10%
发文量
18
审稿时长
14 weeks
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