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不确定性、误差与知情同意挑战新冠疫苗试验:回应斯蒂尔。

Uncertainty, error and informed consent to challenge trials of COVID-19 vaccines: response to Steel .

机构信息

Department of Philosophy, University of Haifa, Haifa, Israel

Department of Public Policy and Administration, Sapir Academic College, Hof Ashkelon, Israel.

出版信息

J Med Ethics. 2020 Dec;46(12):813-814. doi: 10.1136/medethics-2020-106793. Epub 2020 Sep 8.

DOI:10.1136/medethics-2020-106793
PMID:32900846
Abstract

In a recent article, Steel, Buchak and Eyal (SBE) argue that current levels of uncertainty do not present a good reason to bar controlled human infection (CHI) trials of COVID-19 vaccines from proceeding. We argue that their argumentation for this conclusion is flawed. SBE are mistaken about the effects which different forms of ignorance have on participants' ability to provide valid informed consent. Decision-makers considering whether to allow such trials, we argue, must ultimately consider the likelihood that consent to participation in such trials under current conditions would be valid, and whether this likelihood is high enough to permit such trials. This is a question that SBE completely ignore. We conclude that there indeed are valid concerns about conducting CHI trials given the current state of knowledge about COVID-19, concerns which SBE fail to address.

摘要

在最近的一篇文章中,Steel、Buchak 和 Eyal(SBE)认为,目前的不确定性水平并没有很好的理由阻止正在进行的 COVID-19 疫苗的受控人体感染(CHI)试验。我们认为,他们得出这一结论的论证存在缺陷。SBE 对不同形式的无知对参与者提供有效知情同意的能力的影响存在误解。我们认为,考虑是否允许进行此类试验的决策者,最终必须考虑在当前条件下同意参与此类试验的可能性,以及这种可能性是否足够高以允许进行此类试验。这是 SBE 完全忽略的一个问题。我们的结论是,鉴于目前对 COVID-19 的了解,进行 CHI 试验确实存在合理的担忧,而这些担忧是 SBE 未能解决的。

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