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

Journal article

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.

Authors: Lyle, K; Weller, S; Samuel, G; Lucassen, AM

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BMJ Publishing Group
• Journal: Journal of Medical Ethics
• Volume: 49
• Issue: 5
• Pages: 352-356
• Publication date: 2022-06-20
• Acceptance date: 2022-05-23
• DOI: 10.1136/medethics-2021-108102
• EISSN: 1473-4257
• ISSN: 0306-6800
• Language: English
• Keywords: Law; Alternative medicine; Information ethics; Sociology; Computer science; Political science; Research ethics; Applied ethics; Business; Engineering ethics; Informed consent; Corporate governance; Preparedness; Medicine; Health care; Public relations; Documentation