对正在进行医学实验的人的国际保护:保护知情同意权

B. Meier
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引用次数: 40

摘要

该条侧重于对医学实验的知情同意权,即"个人在被告知与参加决定有关的试验的所有方面之后,自愿表示愿意参加某一特定试验的过程"。在理解知情同意所必需的风险和理性决策方面存在许多障碍。这些障碍在发展中国家尤为严重。在非洲进行的“短期”AZT试验就是这一问题的现代例子。在这个典型案例中,科学对治疗方法的追求导致了对知情同意原则的侵蚀和对个人权利的诋毁。这篇文章的第二部分解释了美国医生对hiv阳性的非洲受试者进行的短期AZT试验。第二部分特别概述了研究对象知情同意权的侵犯。第三部分描述了二战期间纳粹医生的实验,在纽伦堡对这些医生的审判,以及纽伦堡法庭对《纽伦堡法典》的发展,《纽伦堡法典》是现代国际人体实验规则的基础。第四部分详细介绍了根据《纽伦堡法典》制定的人体实验国际规则的发展情况。第五部分强调了这些国际条例的弱点,因为它们允许在非洲对艾滋病毒阳性受试者进行非自愿医学实验的情况有增无减。第六部分建议制定一项国际解决办法,保障每一个医学实验对象有意义的知情同意权,并建议制定一项保护知情同意的国际公约。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent
This Article focuses on the right of informed consent to medical experimentation, the "process by which an individual voluntarily expresses his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the decision to participate." There are many barriers to the comprehension of risk and rational decision-making necessary for informed consent. These barriers are particularly acute in developing nations. The "short course" AZT trials in Africa are a modern example of this problem. In this paradigmatic case, science's quest for a cure has led to the erosion of principles of in-formed consent and the denigration of individual rights. Part II of this Article explains the short course AZT trials conducted on HIV-positive African subjects by U.S. physicians. In particular, Part II outlines violations of the research subject's right of informed consent. Part III describes the experiments of Nazi physicians during World War II, the trial of these physicians at Nuremberg, and the Nuremberg Tribunal's development of the Nuremberg Code, the foundation of modern international regulation of human experimentation. Part IV details the development of international regulation of human experimentation following the Nuremberg Code. Part V highlights the weaknesses of these international regulations insofar as they permitted involuntary medical experimentation with HIV-positive subjects in Africa to continue unabated. Part VI recommends the development of an international solution to guarantee the right of meaningful informed consent to each subject of medical experimentation and proposes the creation of an international convention for the protection of informed consent.
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