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人体感染挑战研究:研究伦理社会价值标准的检验。

Human Infection Challenge Studies: a Test for the Social Value Criterion of Research Ethics.

机构信息

Department of Philosophy, University of Massachusetts Lowell, Lowell, Massachusetts, USA

出版信息

mSphere. 2020 Jul 15;5(4):e00669-20. doi: 10.1128/mSphere.00669-20.

DOI:10.1128/mSphere.00669-20
PMID:32669462
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7364225/
Abstract

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Calls for challenge studies, however, rely on the expected social value of these studies. This value represents more than the simple possibility that a successful study will lead to the rapid development and dissemination of vaccines but also some expectation that this will actually occur. I show how this expectation may not be realistic in the current political moment and offer potential ways to make sure that any challenge trials that arise actually achieve their goals.

摘要

人体感染挑战研究,即故意使研究参与者感染致病因子,最近被提议作为加快寻找针对持续的 2019 年冠状病毒病(COVID-19)爆发的疫苗的一种手段。然而,对挑战研究的呼吁取决于这些研究的预期社会价值。这种价值不仅仅是成功的研究会迅速开发和传播疫苗的可能性,还包括对这种情况发生的某种期望。我展示了在当前的政治环境下,这种期望可能并不现实,并提供了确保任何出现的挑战试验都能实现其目标的潜在方法。

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Proc Natl Acad Sci U S A. 2020 Nov 17;117(46):28538-28542. doi: 10.1073/pnas.2021189117. Epub 2020 Oct 29.

本文引用的文献

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AIDS Behav. 2020 Dec;24(12):3302-3305. doi: 10.1007/s10461-020-02953-8.
2
COVID-19 human challenge studies: ethical issues.COVID-19 人体挑战研究:伦理问题。
Lancet Infect Dis. 2020 Aug;20(8):e198-e203. doi: 10.1016/S1473-3099(20)30438-2. Epub 2020 May 29.
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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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Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.人类挑战研究加速冠状病毒疫苗许可。
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Developing Covid-19 Vaccines at Pandemic Speed.以大流行速度研发新冠疫苗。
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When could human challenge trials be deployed to combat emerging infectious diseases? Lessons from the case of a Zika virus human challenge trial.人类挑战试验何时可用于应对新发传染病?寨卡病毒人体挑战试验案例带来的启示。
Trials. 2019 Dec 19;20(Suppl 2):702. doi: 10.1186/s13063-019-3843-0.
7
Public Health Law and Institutional Vaccine Skepticism.公共卫生法与机构性疫苗怀疑论
J Health Polit Policy Law. 2016 Dec;41(6):1137-1149. doi: 10.1215/03616878-3666204. Epub 2016 Aug 16.
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The social value of candidate HIV cures: actualism versus possibilism.候选艾滋病治愈方法的社会价值:现实论与可能论
J Med Ethics. 2017 Feb;43(2):118-123. doi: 10.1136/medethics-2015-103125. Epub 2016 Jul 8.
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The ethical challenge of infection-inducing challenge experiments.感染诱导挑战实验的伦理挑战。
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Intranasal interferon as protection against experimental respiratory coronavirus infection in volunteers.经鼻给予干扰素对志愿者实验性呼吸道冠状病毒感染的防护作用
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