Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada
Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada
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DOI：
10.1136/jme.2009.033142
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发表时间：
2010-04-01
影响因子：
4.1
通讯作者：
Duguet, Anne-Marie
中科院分区：
文献类型：
--
作者：
Rwabihama, Jean-Paul;Girre, Catherine;Duguet, Anne-Marie
北方国家在发展中国家领导的医学研究引起了伦理问题。对研究方案的评估必须从两个方面进行，在来源国进行第一次阅读，在进行研究的国家进行第二次阅读。这种阅读应受益于对方案的独立的当地伦理审查。因此，医学研究伦理委员会正在发展中Africa.Objective探讨建立伦理委员会和他们的independence.Method描述性研究的25个非洲国家和两个北美国家的过程。数据通过问卷调查和访谈记录。两次伦理委员会会议的实地考察：在基加利（卢旺达）为期3个月，在华盛顿DC（美国）为期2个月。结果22个国家参加了这项研究，20个来自非洲和两个来自北美。应答率为80%。75%的非洲地方委员会发展成为国家伦理委员会。在过去五年中，这些国家委员会在结构上有所发展。创建环境和不发达的总体背景仍然是非洲的主要挑战。如果没有持续的培训和有效的供资机制，就无法确保他们的独立性。机构伦理委员会是建立在美国和加拿大，而伦理委员会在北美被削弱的机构附属机构的members.Conclusion建立伦理委员会的过程可能会影响他们的运作和妥协，在一些非洲国家和北美的独立性。
Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa.Objective To investigate the process of establishing ethics committees and their independence.Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA).Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members.Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America.