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非洲各地伦理审查委员会的构成、培训需求及独立性:把关者能否应对新出现的挑战?

Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?

作者信息

Nyika A, Kilama W, Chilengi R, Tangwa G, Tindana P, Ndebele P, Ikingura J

机构信息

African Malaria Network Trust, Dar es Salaam, Tanzania.

出版信息

J Med Ethics. 2009 Mar;35(3):189-93. doi: 10.1136/jme.2008.025189.

Abstract

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.

摘要

背景

非洲疾病负担沉重、新疾病不断出现以及为解决10/90差距所做的努力,导致非洲的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方案数量和复杂性都有所增加。

方法

在比尔及梅琳达·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(ERC)进行了一项调查,作为全面能力建设计划的第一步。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均来自委员会所在的机构,这就引发了一个初步问题,即此类委员会的审查工作能否保证独立性和客观性。

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,其次是风险和益处的确定以及研究监测。调查显示,38%的ERC成员未接受过任何形式的培训。鉴于非洲开展的卫生研究的复杂性和数量不断增加,这一不足需要立即得到关注。

结果

该调查确定了非洲ERC运作中的薄弱环节。因此,AMANET正在通过一个为期4年的能力建设项目来满足已确定的需求并弥补薄弱环节。

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