Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?
Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?
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DOI：
10.1136/jme.2008.025189
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发表时间：
2009-03-01
影响因子：
4.1
通讯作者：
Ikingura, J.
中科院分区：
文献类型：
--
作者：
Nyika, A.;Kilama, W.;Ikingura, J.
背景：非洲的高疾病负担、新疾病的出现以及解决10/90差距的努力导致非洲卫生研究活动空前增加。因此，非洲伦理审查委员会必须审查的议定书的数量和复杂性都有所增加。方法：在比尔和梅林达•盖茨基金会的资助下，非洲疟疾网络信托基金（AMANET）对撒哈拉以南非洲的31个伦理审查委员会（ERCs）进行了调查，作为全面能力加强规划的第一步。每个委员会的成员人数从3人到21人不等，平均为11人。10个机构委员会的成员都来自委员会所在的机构，这就提出了这些委员会的审查工作是否能够保证独立性和客观性的初步问题。结果：大多数委员会（92%）认为临床试验的科学设计是培训方面最需要关注的领域，其次是确定风险和收益以及监测研究。调查显示，38%的伦理委员会成员没有接受过任何形式的培训。鉴于在非洲进行的卫生研究日益复杂和数量日益增多，这一缺陷需要立即予以注意。结果：调查确定了非洲伦理委员会业务中的薄弱环节。因此，AMANET正在通过一个为期四年的能力建设项目解决已确定的需求和弱点。
Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review.Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees.Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention.Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project.