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一些非洲新兴国家的生物医学研究伦理委员会:哪个机构具有何种独立性?与美国和加拿大的比较。

Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada.

机构信息

Joffre-Dupuytren Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), 91210 Draveil, France.

出版信息

J Med Ethics. 2010 Apr;36(4):243-9. doi: 10.1136/jme.2009.033142.

DOI:10.1136/jme.2009.033142
PMID:20338938
Abstract

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.

摘要

背景

北方国家在发展中国家开展的医学研究引发了伦理问题。研究方案的评估必须是双重的,首先在原籍国进行评估,然后在研究开展的国家进行评估。这种评估应该受益于对方案的独立的当地伦理审查。因此,非洲的医学研究伦理委员会正在发展。

目的

调查建立伦理委员会及其独立性的过程。

方法

对 25 个非洲国家和两个北美国家进行描述性研究。数据通过问卷和访谈记录。在实地进行了两次伦理委员会会议的访问:在卢旺达基加利进行了为期 3 个月的访问,在美国华盛顿特区进行了为期 2 个月的访问。

结果

22 个国家参与了这项研究,其中 20 个来自非洲,2 个来自北美。回应率为 80%。75%的本地非洲委员会发展成为国家伦理委员会。在过去的 5 年中,这些国家伦理委员会在结构层面上有所发展。创建的情况和欠发达的总体背景仍然是非洲的主要挑战。没有持续的培训和有效的资金机制,就无法确保其独立性。机构伦理委员会在美国和加拿大已经建立得很好,而北美的伦理委员会由于其成员的机构隶属关系而受到削弱。

结论

建立伦理委员会的过程可能会影响其运作,并在一些非洲国家和北美国家损害其独立性。

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