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Beyond regulatory approaches to ethics: Making space for ethical preparedness in healthcare research

Research output: Contribution to journalArticlepeer-review

Kate Lyle, Susie Weller, Gabrielle Samuel, Anneke Lucassen

Original languageEnglish
Article number108102
JournalJournal of Medical Ethics
Early online date20 Jun 2022
Accepted/In press23 May 2022
E-pub ahead of print20 Jun 2022

Bibliographical note

Funding Information: This study was funded by Wellcome Trust (208053/Z/17/Z). Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.


  • medethics-2021-108102.full

    medethics_2021_108102.full.pdf, 261 KB, application/pdf

    Uploaded date:18 Aug 2022

    Version:Final published version

King's Authors


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.

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