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“我的身体是最优质的商品之一”:探究I期健康志愿者临床试验中商品化的伦理问题

"My Body is One of the Best Commodities": Exploring the Ethics of Commodification in Phase I Healthy Volunteer Clinical Trials.

作者信息

Walker Rebecca L, Fisher Jill A

出版信息

Kennedy Inst Ethics J. 2019;29(4):305-331. doi: 10.1353/ken.2019.0028.

DOI:10.1353/ken.2019.0028
PMID:31983696
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6989025/
Abstract

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures while they are confined to clinic spaces. In exchange, they are paid. These participants are, in a direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. However, commodification is rarely investigated as an ethical dimension of phase I trial participation. We address this gap in the literature by bringing the voices of phase I healthy volunteers into conversation with philosophical perspectives on body commodification. Querying the intersection of commodification and phase I clinical trials illuminates important features of healthy volunteers' experiences, disentangles commodification from a dominant narrative about exploitation, and brings focus to the question of what, if any, market norms will best protect the multiple ways in which healthy volunteers' welfare is impacted by clinical trial participation.

摘要

在一期临床试验中,健康志愿者会服用试验药物,并在被限制在临床空间内时接受抽血及其他身体监测程序。作为交换,他们会获得报酬。从直接意义上讲,这些参与者是在将自己的身体提供给制药公司及其关联方,以供其对药物进行试验。然而,商品化很少被作为一期试验参与的一个伦理维度来研究。我们通过让一期健康志愿者的声音与关于身体商品化的哲学观点进行对话,来填补文献中的这一空白。探究商品化与一期临床试验的交叉点,能够揭示健康志愿者经历的重要特征,将商品化与关于剥削的主流叙事区分开来,并聚焦于一个问题:什么样的市场规范(如果有的话)能最好地保护健康志愿者因参与临床试验而受到影响的多种福利方式。

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本文引用的文献

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Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework.通过模式生物框架推进健康志愿者研究的伦理与政策
Ethics Hum Res. 2019 Jan;41(1):4-14. doi: 10.1002/eahr.500001.
2
Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions.受制于临床机构:作为时间性总体机构的一期临床试验
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Healthy volunteers' perceptions of risk in US Phase I clinical trials: A mixed-methods study.健康志愿者对美国 I 期临床试验风险的认知:一项混合方法研究。
PLoS Med. 2018 Nov 20;15(11):e1002698. doi: 10.1371/journal.pmed.1002698. eCollection 2018 Nov.
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J Med Philos. 2018 Jan 12;43(1):83-114. doi: 10.1093/jmp/jhx033.
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Paying Research Participants: The Outsized Influence of "Undue Influence".向研究参与者支付报酬:“不当影响”的巨大影响。
IRB. 2017 Jul-Aug;39(4):1-9.
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Risk and Emotion Among Healthy Volunteers in Clinical Trials.临床试验中健康志愿者的风险与情绪
Soc Psychol Q. 2016 Sep;79(3):222-242. doi: 10.1177/0190272516657655. Epub 2016 Jul 29.
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