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新型冠状病毒2型人体挑战试验:重新思考首先招募健康年轻成年人的做法。

SARS-CoV-2 Human Challenge Trials: Rethinking the Recruitment of Healthy Young Adults First.

作者信息

Matsui Kenji, Inoue Yusuke, Yamamoto Keiichiro

机构信息

Director of the Division of Bioethics and Healthcare Law at the Center for Public Health Sciences at the National Cancer Center in Japan.

Associate professor in the Department of Public Policy in the Institute of Medical Science at the University of Tokyo.

出版信息

Ethics Hum Res. 2021 May;43(3):37-41. doi: 10.1002/eahr.500089. Epub 2021 Apr 6.

Abstract

In the midst of the ongoing Covid-19 pandemic, researchers across the globe are still working to develop effective vaccines. To expedite this process even further, human challenge trials have been proposed by the World Health Organization (WHO) as an alternative to conventional approaches. In such trials, healthy volunteers are deliberately infected with the pathogen of interest, enabling scientists to study the infection process and facilitate further research on treatments or prophylactics, including vaccines. While human challenge trials would offer a collective benefit to society, minimizing the risks is always difficult. Ethical controversy thus inevitably surrounds these trials. Typically, healthy young adults are recruited to serve as the first candidate subjects for human challenge trials because they are generally considered to represent a low-risk population. Here, we present three reasons for doubt about this healthy-young-adults-first criterion and give justification for also recruiting healthy older adults (or not-young adults), meaning those over 30 years of age, to participate in such trials for SARS-CoV-2.

摘要

在新冠疫情持续期间,全球的研究人员仍在努力研发有效的疫苗。为了进一步加快这一进程,世界卫生组织(WHO)提议进行人体挑战试验,作为传统方法的替代方案。在这类试验中,健康志愿者会被故意感染目标病原体,使科学家能够研究感染过程,并促进对治疗方法或预防措施(包括疫苗)的进一步研究。虽然人体挑战试验会给社会带来共同利益,但将风险降至最低始终困难重重。因此,这些试验不可避免地引发了伦理争议。通常,健康的年轻人会被招募为人体挑战试验的首批候选受试者,因为他们一般被认为属于低风险人群。在此,我们对这一“健康年轻人优先”标准提出三点质疑理由,并论证招募健康的老年人(或非年轻人),即30岁以上的人,参与针对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的此类试验的合理性。

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