新冠肺炎人类挑战研究中的风险、收益和社会价值:历史背景下的大流行决策

IF 1.6 Q2 ETHICS Monash Bioethics Review Pub Date : 2022-12-01 Epub Date: 2022-06-15 DOI:10.1007/s40592-022-00156-6
Mabel Rosenheck
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引用次数: 0

摘要

在 Covid-19 大流行期间,伦理学家和研究人员提议进行人体挑战研究,以此加快疫苗的研发,从而预防疾病,结束全球公共卫生危机。蓄意感染一种致命的新型病原体对健康志愿者造成的风险并不低,但带来的益处却可能是巨大的。本文记录了为建立挑战模型并在 2020 年和 2021 年开展挑战研究而做出的三大努力。强生制药公司、美国国立卫生研究院和英国的一个由企业、大学和政府合作伙伴组成的公私合作组织都进行了准备工作。除了记录每项工作外,这篇文章还将这些科学和伦理辩论与大流行病的社会、流行病学和机构条件以及医学研究和 Covid-19 挑战研究运作的商业、知识和政治体系进行了对话。它展示了不同机构如何根据其具体情况理解风险、利益和社会价值。最终,Covid-19 挑战研究的例子凸显了此类评估的建构性,并揭示了回溯解构此类评估的效用,从而更好地理解医学研究和研究伦理与更大的社会体系和历史背景之间的相互作用。
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Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.

During the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom's consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts.

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来源期刊
CiteScore
2.70
自引率
6.20%
发文量
16
期刊介绍: Monash Bioethics Review provides comprehensive coverage of traditional topics and emerging issues in bioethics. The Journal is especially concerned with empirically-informed philosophical bioethical analysis with policy relevance. Monash Bioethics Review also regularly publishes empirical studies providing explicit ethical analysis and/or with significant ethical or policy implications. Produced by the Monash University Centre for Human Bioethics since 1981 (originally as Bioethics News), Monash Bioethics Review is the oldest peer reviewed bioethics journal based in Australia–and one of the oldest bioethics journals in the world. An international forum for empirically-informed philosophical bioethical analysis with policy relevance. Includes empirical studies providing explicit ethical analysis and/or with significant ethical or policy implications. One of the oldest bioethics journals, produced by a world-leading bioethics centre. Publishes papers up to 13,000 words in length. Unique New Feature: All Articles Open for Commentary
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