Chapitre 2. L’autonomisation des comités nationaux d’éthique de la recherche en Afrique : perspective historique et enjeux actuels.

V Martin-Schmets, O Bah-Sow, M Boko, F Gangbo, C Giquel, E Ouattara, D Pathé, L Penali, V Pirard, A-L Morin
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Abstract

Since the 60s, and particularly after various scandals in the 90s, national research ethics committees in Africa have established themselves as key players in the field of international clinical research. Notably based on the principle of double ethical review, their existence has historically been aimed at preventing a form of ethical dumping, a temptation that still exists today on the part of some research promoters. While the international framework of “soft” law has favored their emergence and legitimacy, a legal and regulatory framework of “hard” law is also necessary at local level for each national research ethics committee, to ensure its proper functioning and the optimal fulfillment of its missions. The aim of this article is to analyze the similarities and differences between three national ethics committees in Africa, specifically the CNERS of Guinea, the CNERS of Benin and the CNESVS of Côte d’Ivoire, in terms of status, missions, legal or regulatory ground and, more generally, autonomy. This analysis will enable us, on the one hand, to take account of common logistical difficulties and, on the other, to go beyond differences in legal status and missions to define what enables this type of committee to fully exercise its role(s). Finally, this article proposes to model the various elements that contribute to the autonomy and resilience of a national research ethics committee, around a notion proposed on this occasion: the “circles of autonomy”.

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第 2 章.增强非洲国家研究伦理委员会的能力:历史视角与当前问题。
自 20 世纪 60 年代以来,特别是在 90 年代的各种丑闻之后,非洲的国家研究伦理委员 会已成为国际临床研究领域的主要参与者。特别是在双重伦理审查原则的基础上,这些委员会的存在历来旨在防止某种形式的伦理倾销,而这种诱惑在今天对某些研究促进者来说依然存在。虽然国际软法框架有利于伦理委员会的出现和合法化,但在地方一级,每个国家的研究伦理委员会也需要一个硬法的法律和监管框架,以确保其正常运作并以最佳方式履行其使命。本文旨在分析非洲三个国家伦理委员会,特别是几内亚的 CNERS、贝宁的 CNERS 和 Côte d’Ivoire 的 CNESVS,在地位、使命、法律或监管依据以及更广泛的自主权方面的异同。这种分析一方面使我们能够考虑到后勤方面的共同困难,另一方面使我们能够超越法律地位和任务方面的差异,确定是什么使这类委员会能够充分发挥其作用。最后,本文建议围绕本次会议提出的一个概念:"自治圈"(“circle of autonomy”),对有助于国家研究伦理委员会自主性和复原力的各种因素进行建模。
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C. Castets-Renard, J. Eynard, Un droit de l’intelligence artificielle, Bruylant, Bruxelles, 2023. Centre de recherche de l’Académie militaire de Saint-Cyr Coëtquidan et la Croix-Rouge française, Les enjeux de l’autonomie des systèmes d’armes létaux, Pédone, Paris, 2022. Chapitre 1. Essais cliniques et bioéthique en Inde. Chapitre 2. L’autonomisation des comités nationaux d’éthique de la recherche en Afrique : perspective historique et enjeux actuels. Chapitre 3. Inégalités dans le dépistage et la prévention du VIH/SIDA.
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