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[发展中国家的临床试验:应由谁来界定伦理规范?]

[Clinical trials in developing countries: who should define ethics?].

作者信息

Béréterbide F, Hirsch F

机构信息

Faculté de médecine, Département de recherche éthique, Université Paris-Sud-XI, France.

出版信息

Bull Soc Pathol Exot. 2008 Apr;101(2):102-5.

Abstract

Many clinical trials have proved much more difficult to implement in developing countries than in the Northern countries if not totally impossible. Should we therefore just observe this situation and approve a "double ethical standard"? Clinical trials in developing countries are also a means for volunteers to have access to medical care, therefore how could the process of informed consent keep its significance? In this context, should the participation in clinical trials be restricted or even stopped? If so, we would thus justify the superiority of an international duty of charity compared with the right of autonomy of these populations. This theoretical analysis cannot be precisely justified. On the contrary, it reveals that while informed consent, international organisations and guidelines have the tendency to play a major role in this debate, local ethics committee are too absent although they represent the more relevant and legitimate discussion partners in this dilemma.

摘要

许多临床试验已证明,在发展中国家实施比在北方国家困难得多,甚至可能根本无法实施。那么,我们是否应该就此接受这种情况并认可一种“双重道德标准”呢?在发展中国家开展临床试验也是志愿者获得医疗服务的一种途径,那么知情同意程序又如何能保持其意义呢?在这种情况下,是否应该限制甚至停止参与临床试验呢?如果这样做,我们就等于认可了国际慈善义务相较于这些人群的自主权具有优越性。这种理论分析无法得到确切的论证。相反,它表明,虽然知情同意、国际组织和指导方针往往在这场辩论中发挥重要作用,但当地伦理委员会却严重缺席,尽管在这一困境中,它们才是更相关、更合法的讨论伙伴。

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