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灵长类动物感染挑战的伦理问题。

The Ethics of Infection Challenges in Primates.

出版信息

Hastings Cent Rep. 2016 Jul;46(4):20-6. doi: 10.1002/hast.580. Epub 2016 Mar 21.

Abstract

In the midst of the recent Ebola outbreak, scientific developments involving infection challenge experiments on nonhuman primates (NHPs) sparked hope that successful treatments and vaccines may soon become available. Yet these studies pose a stark ethical quandary. On the one hand, they represent an important step in developing novel therapies and vaccines for Ebola and the Marburg virus, with the potential to save thousands of human lives and to protect whole communities from devastation; on the other hand, they intentionally expose sophisticated animals to severe suffering and a high risk of death. Other studies that infect NHPs with a lethal disease in order to test interventions that may prove beneficial for humans pose the same ethical difficulty. Some advocates have argued that all research on primates should be phased out, and ethicists have questioned whether a moral justification of primate research is possible. A 2010 European Union directive banned virtually all research on great apes, and 2013 guidelines from the National Institutes of Health (NIH), based upon recommendations in an influential 2011 Institute of Medicine (IOM) report, eliminated most biomedical research with chimpanzees in the United States. But studies involving other NHPs face no comparable restrictions. Should research on NHPs other than great apes be subject to tighter restrictions than it currently is? In this article, we explore this general question in the context of one particular type of biomedical research: infection challenge studies. We advocate a presumptive prohibition on infection challenge experiments in NHPs, but we also argue that exceptions to this prohibition are permissible, subject to strict substantive and procedural safeguards, when necessary to avert substantial loss of human life or severe morbidity for a substantial number of people.

摘要

在最近的埃博拉疫情爆发期间,涉及对非人类灵长类动物(NHPs)进行感染挑战实验的科学进展带来了希望,即不久将有可能获得成功的治疗方法和疫苗。然而,这些研究提出了一个严峻的伦理困境。一方面,它们代表了为埃博拉病毒和马尔堡病毒开发新疗法和疫苗的重要一步,有可能挽救数千人的生命,并保护整个社区免受破坏;另一方面,它们故意使复杂的动物遭受严重的痛苦和死亡的高风险。其他研究也会使 NHP 感染致命疾病,以测试可能对人类有益的干预措施,这些研究也同样存在伦理上的困难。一些倡导者认为,应该逐步淘汰对灵长类动物的所有研究,伦理学家也质疑对灵长类动物研究进行道德辩护是否可能。2010 年,欧盟指令几乎禁止了所有关于大型猿类的研究,而美国国立卫生研究院(NIH)根据 2011 年医学研究所(IOM)报告中的建议,于 2013 年发布的指南取消了美国大多数涉及黑猩猩的生物医学研究。但涉及其他 NHP 的研究则没有面临类似的限制。除了大型猿类之外,对 NHP 的研究是否应该受到比目前更严格的限制?在本文中,我们将在感染挑战研究这一特定类型的生物医学研究背景下探讨这个一般性问题。我们主张对 NHP 的感染挑战实验进行推定禁止,但我们也认为,在必要时,为了避免大量人口的生命损失或严重发病率,在严格的实质性和程序性保障下,对这一禁令进行例外是可以接受的。

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