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发展中国家针对感染艾滋病毒的孕妇开展的随机安慰剂对照试验。是道德帝国主义还是不道德的剥削?

Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation?

作者信息

de Zulueta P

机构信息

Imperial College School of Medicine, 27a Landsdowne Crescent, London W11 2NS.

出版信息

Bioethics. 2001 Aug;15(4):289-311. doi: 10.1111/1467-8519.00240.

DOI:10.1111/1467-8519.00240
PMID:11697387
Abstract

The maternal-fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki--the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against the controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow 'local conditions' to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta-ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects.

摘要

20世纪90年代在发展中国家开展的母婴HIV传播试验,无疑引发了国际研究伦理领域最激烈、最受瞩目的争议之一。它们引发了一场持久而激烈的公开辩论,使科学界产生了深刻分歧。它们还推动了《赫尔辛基宣言》的修订,该宣言是国际研究领域最广为人知的指导方针。在本文中,我简要概述了相关背景,概述了支持和反对有争议地使用安慰剂对照的论点,并聚焦于我认为值得进一步讨论或阐明的特定领域。总体而言,我认为研究人员未能履行保护研究对象最大利益以及促进分配正义的职责。我讨论了在这种研究背景下获得有效同意的困难,并认为在至少不为未出生子女提供预防性治疗的情况下告知女性其HIV感染状况是不道德的。支持国际公平的全球正义观,与允许“当地情况”界定对对照组责任范围的国际研究准则无法协调一致。最后,我认为这场激烈辩论反映了支撑涉及人类受试者的科学研究的两种相互冲突的元伦理体系或不可通约范式之间的紧张关系,甚至可以说是一场全面战争。

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Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation?发展中国家针对感染艾滋病毒的孕妇开展的随机安慰剂对照试验。是道德帝国主义还是不道德的剥削?
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