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参与新冠病毒临床试验的付费。

Paying Participants in COVID-19 Trials.

机构信息

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

出版信息

J Infect Dis. 2020 Jul 6;222(3):356-361. doi: 10.1093/infdis/jiaa284.

DOI:10.1093/infdis/jiaa284
PMID:32469074
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7313938/
Abstract

Trials are in development and underway to examine potential interventions for treatment and prophylaxis of coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances. Here, we review 3 functions of research payment-reimbursement, compensation, and incentive-and identify heightened and novel ethical concerns in the context of a global pandemic. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances. Given increased risk of undue influence against pandemic background conditions, incentive payment should be avoided unless essential to recruitment and retention in important trials whose social value outweighs this risk. Where essential, however, incentives can be ethically permissible, so long as reasonable efforts are made to minimize the possibility of undue influence.

摘要

正在开发和进行临床试验,以研究针对 2019 年冠状病毒病 (COVID-19) 的治疗和预防的潜在干预措施。我们应该如何考虑向这些试验的参与者提供报酬?即使在理想的情况下,研究报酬的支付在伦理上也存在争议。在这里,我们回顾了研究报酬的 3 种功能——报销、补偿和激励,并在全球大流行的背景下确定了新的、更突出的伦理问题。我们认为,在通常情况下,COVID-19 试验参与者通常应该获得与研究相关的费用报销,以及对他们的时间和精力的补偿,就像其他类型的研究一样。鉴于在大流行背景条件下不当影响的风险增加,除非在重要试验的招募和保留中必不可少,否则应避免激励性报酬,而这些试验的社会价值大于这种风险。然而,在必要的情况下,只要做出合理的努力将不当影响的可能性降到最低,激励措施在伦理上是可以允许的。

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本文引用的文献

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Lancet Respir Med. 2020 Jun;8(6):547-548. doi: 10.1016/S2213-2600(20)30228-9. Epub 2020 May 10.
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Ethics of controlled human infection to address COVID-19.用于应对新冠疫情的人体感染对照试验伦理问题。
Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7.
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A real-time dashboard of clinical trials for COVID-19.新冠肺炎临床试验实时信息平台。
Lancet Digit Health. 2020 Jun;2(6):e286-e287. doi: 10.1016/S2589-7500(20)30086-8. Epub 2020 Apr 24.
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COVID-19 and African Americans.新冠病毒与非裔美国人。
JAMA. 2020 May 19;323(19):1891-1892. doi: 10.1001/jama.2020.6548.
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Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.人类挑战研究加速冠状病毒疫苗许可。
J Infect Dis. 2020 May 11;221(11):1752-1756. doi: 10.1093/infdis/jiaa152.
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Compensation for cures: Why we should pay a premium for participation in 'challenge studies'.治愈的补偿:我们为何应为参与“挑战性研究”而获得额外报酬。
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Differential payment to research participants in the same study: an ethical analysis.同一研究中对研究参与者的差异化支付:伦理分析。
J Med Ethics. 2019 May;45(5):318-322. doi: 10.1136/medethics-2018-105140. Epub 2019 Mar 7.
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Precarity, clinical labour and graduation from Ebola clinical research in West Africa.不稳定状况、临床工作及从西非埃博拉临床研究中“毕业”
Glob Bioeth. 2019 Jan 17;30(1):1-18. doi: 10.1080/11287462.2019.1566973. eCollection 2019.
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JAMA Netw Open. 2019 Jan 4;2(1):e187355. doi: 10.1001/jamanetworkopen.2018.7355.