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肯尼亚西部儿童抗逆转录病毒疗法剂量研究中的儿童同意参与:国际研究合作案例分析

Pediatric assent for a study of antiretroviral therapy dosing for children in Western Kenya: a case study in international research collaboration.

作者信息

Vreeman Rachel C, Nyandiko Winstone M, Meslin Eric M

机构信息

Indiana University School of Medicine, Indianapolis, IN 46202, USA.

出版信息

J Empir Res Hum Res Ethics. 2009 Mar;4(1):3-16. doi: 10.1525/jer.2009.4.1.3.

DOI:10.1525/jer.2009.4.1.3
PMID:19374483
Abstract

MULTINATIONAL COLLABORATORS IN health research face particular ethical challenges when conducting studies involving vulnerable populations such as children. We use an example from our first attempt to implement pediatric assent in the context of a longstanding research and clinical partnership between Kenyan and American medical schools to highlight the ethical and procedural issues related to pediatric assent that must be considered for multinational, pediatric studies. We consider relevant domestic, professional, and international guidelines for assent in pediatric research subjects, and we discuss the particular ethical challenges related to pediatric assent in the Kenyan context. Finally, we propose a way forward for approaching pediatric assent within our collaborative research program in Kenya that may apply to other multinational research partnerships.

摘要

参与健康研究的跨国合作团队在开展涉及儿童等弱势群体的研究时面临着特殊的伦理挑战。我们以首次尝试在肯尼亚和美国医学院长期研究与临床合作的背景下实施儿童同意程序为例,来突出在跨国儿童研究中必须考虑的与儿童同意相关的伦理和程序问题。我们考虑了国内、专业和国际上关于儿童研究对象同意的相关指南,并讨论了肯尼亚背景下与儿童同意相关的特殊伦理挑战。最后,我们提出了在肯尼亚的合作研究项目中处理儿童同意问题的前进方向,这可能适用于其他跨国研究伙伴关系。

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