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Uncertainty, error and informed consent to challenge trials of COVID-19 vaccines: response to Steel et al
  1. Arnon Keren1,
  2. Ori Lev2
  1. 1Department of Philosophy, University of Haifa, Haifa, Israel
  2. 2Department of Public Policy and Administration, Sapir Academic College, Hof Ashkelon, Israel
  1. Correspondence to Dr Arnon Keren, Department of Philosophy, University of Haifa, Haifa 3498838, Israel; akeren{at}research.haifa.ac.il

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.

  • informed consent
  • autonomy
  • clinical trials
  • research ethics

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

https://doi.org/10.1136/medethics-2020-106793

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    Footnotes

    • Contributors AK and OL developed the idea for this manuscript in discussion and AK wrote a first draft. AK and OL both contributed to subsequent revisions over multiple drafts, and both approved the final version of the manuscript.

    • Funding This study was funded by Israel Science Foundation (650/18).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; internally peer reviewed.

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