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Delaying and withholding interventions: ethics and the stepped wedge trial
  1. Ariella Binik1,2
  1. 1Department of Philosophy, McMaster University, Hamilton, Ontario, Canada
  2. 2Institute on Ethics & Policy for Innovation, McMaster University, Hamilton, Ontario, Canada
  1. Correspondence to Dr Ariella Binik, Department of Philosophy, McMaster University, Hamilton, ON L8S4K1, Canada; binika{at}mcmaster.ca

Abstract

Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: (1) when the study intervention appears especially likely to be effective and (2) when the consequences of not receiving the intervention may be dire. But despite an increase in the use of the stepped wedge design and appeals to its ethical superiority as the motivation for its selection, there has been limited attention to the stepped wedge trial in the ethics literature. In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial. I argue that while the stepped wedge design is ethically permissible, it is not morally superior to other kinds of trials. To this end, I examine the ethical justification for providing, withholding, and delaying interventions in research.

  • research ethics
  • clinical trials
  • ethics
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Footnotes

  • Contributors I am the sole author of this submission.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

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

  • Patient consent for publication Not required.

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