Beyond regulatory approaches to ethics: making space for ethical preparedness in healthcare research
Beyond regulatory approaches to ethics: making space for ethical preparedness in healthcare research
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
Lyle, Kate
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Weller, Susie
6ad1e079-1a7c-41bf-8678-bff11c55142b
Samuel, Gabby
dd9c127c-6a6b-4cd8-8c65-f13f985dfdf0
Lucassen, Anneke M.
2eb85efc-c6e8-4c3f-b963-0290f6c038a5
20 June 2022
Lyle, Kate
ff88e501-884c-423a-8050-f915fc19f0a8
Weller, Susie
6ad1e079-1a7c-41bf-8678-bff11c55142b
Samuel, Gabby
dd9c127c-6a6b-4cd8-8c65-f13f985dfdf0
Lucassen, Anneke M.
2eb85efc-c6e8-4c3f-b963-0290f6c038a5
Lyle, Kate, Weller, Susie, Samuel, Gabby and Lucassen, Anneke M.
(2022)
Beyond regulatory approaches to ethics: making space for ethical preparedness in healthcare research.
Journal of Medical Ethics, [108102].
(doi:10.1136/medethics-2021-108102).
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.
Text
medethics-2021-108102.full
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More information
Accepted/In Press date: 23 May 2022
e-pub ahead of print date: 20 June 2022
Published date: 20 June 2022
Additional Information:
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.
Keywords:
Ethics, Ethics Committees, Ethics- Research, Informed Consent
Identifiers
Local EPrints ID: 467758
URI: http://eprints.soton.ac.uk/id/eprint/467758
ISSN: 1473-4257
PURE UUID: d40c18dc-747e-4785-8280-ef8d12b29ec6
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Date deposited: 21 Jul 2022 17:04
Last modified: 17 Mar 2024 03:38
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Author:
Susie Weller
Author:
Gabby Samuel
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