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Beyond regulatory approaches to ethics: making space for ethical preparedness in healthcare research
  1. Kate Lyle1,2,
  2. Susie Weller1,2,
  3. Gabby Samuel1,3,
  4. Anneke M Lucassen1,2,4
  1. 1Clinical Ethics, Law and Society (CELS), Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK
  2. 2Clinical Ethics, Law and Society (CELS), Primary Care, Population Sciences and Medical Education, University of Southampton Faculty of Medicine, Southampton, UK
  3. 3Global Health and Social Medicine, King's College London, Strand, UK
  4. 4Centre for Personalised Medicine, University of Oxford, Oxford, UK
  1. Correspondence to Dr Kate Lyle, Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK; kate.lyle{at}well.ox.ac.uk

Abstract

Centralised, compliance-focused approaches to research ethics have been normalised in practice. In this paper, we argue that the dominance of such systems has been driven by neoliberal approaches to governance, where the focus on controlling and individualising risk has led to an overemphasis of decontextualised ethical principles and the conflation of ethical requirements with the documentation of ‘informed consent’. Using a UK-based case study, involving a point-of-care-genetic test as an illustration, we argue that rather than ensuring ethical practice such compliance-focused approaches may obstruct valuable research. We call for an approach that encourages researchers and research communities—including regulators, ethics committees, funders and publishers of academic research—to acquire skills to make morally appropriate decisions, and not base decision-making solely on compliance with prescriptive regulations. We call this ‘ethical preparedness’ and outline how a research ethics system might make space for this approach.

  • Ethics
  • Ethics Committees
  • Ethics- Research
  • Informed Consent

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https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Twitter @annekeluc

  • Correction notice This article has been corrected since it was first published. The open access licence has been updated to CC BY. 17th May 2023.

  • Contributors KL developed the concept for the paper, and wrote the initial draft of the manuscript with support from SW, GS and AML. All authors were involved in editing the manuscript and producing its final version. AML is responsible for the overall content as guarantor.

  • Funding This study was funded by Wellcome Trust (208053/Z/17/Z).

  • Competing interests None declared.

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