By Kate Lyle, Susie Weller, Gabby Samuel, Anneke Lucassen

Neoliberalism promotes the rights and responsibilities of individuals to make their own choices and
manage their own risks, and as a political approach dominates Western societies. As such,
neoliberalism has driven a preoccupation with quantifying and managing risks within society; the
idea being that clarifying the risks associated with particular activities liberates individuals to make
informed choices and, crucially, accept responsibility for the consequences of their decisions.

The main governmental tool for controlling risk and protecting individual autonomy is regulation. We live in an increasingly regulated society in the UK, with new legislations and updates plugging
apparent policy gaps as they are revealed. Nowhere is this more visible than in healthcare, which is
increasingly regulated by a myriad of legislation, regulatory bodies, codes of practice, and
professional bodies acting to control the permitted activity of healthcare professionals and
researchers. A series of high-profile scandals – such as the unauthorised retention of organs in
hospitals, or Dr Shipman murdering hundreds of his patients – have been catalyst for new laws and
regulations. Medical research in particular is strictly controlled, usually requiring extensive review
and compliance with a range of regulations, the aim being to protect individuals from harm whilst at
the same time enabling research to improve healthcare delivery. But is it possible to meet these
aims simultaneously by relying on regulation alone, and are there attendant risks?

The emphasis on quantifying risks and individualising responsibility within neoliberal systems has
encouraged an approach to research ethics that is preoccupied with compliance to regulation, and
for example, the detailed documentation of consent rather than attention to the content of that
consent. We argue this can risk overlooking the real ethical issues at stake in particular contexts. In
our paper ‘Beyond regulatory approaches to ethics: Making space for ethical preparedness in
healthcare research’, we use a case study involving a point-of-care genetic test to demonstrate how
a focus on regulation can lose sight of the contextual issues and obstruct valuable research.

We argue that we need to broaden the focus from compliance with regulation, towards a system
that facilitates ‘ethical preparedness’ within the research community. We describe ethical
preparedness as being willing and able to work in morally appropriate ways. In practice, this means
forsaking notions of universal, ‘off the shelf’ solutions to problems, and resisting the dominance of
regulatory and procedural approaches, including the over-reliance on consent as a means of
managing risks. Instead, emphasis should be placed on creating spaces, and providing the resources
and support necessary to empower clinicians and researchers to work through ethical issues as they
arise.

Without attending to ethical preparedness, research ethics too often falls to the neoliberal approach
of regulation, which not only does little to ensure ethics in practice, but may also stifle valuable
research – and this is not in the interests of anybody’s health.

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

Author: Kate Lyle 1,2 ; Susie Weller 1,2 ; Gabby Samuel 1,3 ; Anneke Lucassen 1,2,4

Affiliations:
1 Clinical Ethics, Law and Society (CELS); Wellcome Centre for Human Genetics, University of Oxford,
UK
2 Clinical Ethics, Law and Society (CELS) – Southampton, Faculty of Medicine, University of
Southampton, UK
3 Department of Global Health and Social Medicine, King’s College London, Strand, UK
4 Centre for Personalised Medicine, University of Oxford, Oxford, UK

Competing interests: There are no competing interests

Social media accounts of post authors: @kvlyle @cels_uos @eppigen