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Nayha Sethi
I’m also interested in the different values and value systems which shape our practices and policies towards new technologies in health, particularly data-driven technologies

Nayha Sethi

Legal, ethical and social issues in health research regulation

Welcome to the grey areas
Embracing uncertainty and entering the blurred spaces that exist between medical innovation, research and treatment may sound antithetical to the nature of health research regulation, which is, after all, about ensuring high ethical standards, establishing safeguards and maintaining boundaries. Yet it is precisely in this ‘liminal’ territory that Nayha Sethi sees opportunities to explore the ethical, legal and social issues within health research and in developing richer and context-sensitive understandings of what it means to talk of each of these terms, particularly ‘innovation’. A 2016 doctoral graduate of the University, Dr Sethi has published on topics ranging from the regulatory challenges of doing research during global health emergencies, to exploring rule, principle and best practice approaches to decision-making. “My research often encompasses interdisciplinary working,” she says, “and I have worked on projects relating to the ethical and legal issues around data re-use in health research and on the relationships between standard medical practice, research and innovation. I’m also interested in the different values and value systems which shape our practices and policies towards new technologies in health, particularly data-driven technologies. I am especially interested in understanding what ‘innovation’ means in different contexts, and how we can develop frameworks for responsible research and innovation ”

Prior to taking up her post as a Chancellor’s Fellow, Nayha has worked as a research fellow on three projects. Most recently, she was a socio-legal research fellow in the Wellcome Trust funded project Confronting the Liminal Spaces of Health Research Regulation, Dr Sethi continues to be active in debates over the respective and overlapping roles of ethics and law in regulating health research. She organised a 2018 workshop on Regulating for Uncertainty, which looked at the difficulties in separating activities, actors and objects in regulatory spaces and which considered how we can better develop approaches to regulation and governance which avoid regulatory compression and which accept necessary flexibility and inevitable uncertainty.

Developing related concepts in a recent paper for the journal Law, Innovation and Technology, Dr Sethi highlights the confusion arising from the inconsistent use of the terms ‘practice/treatment’, ‘research’ and ‘medical innovation’ and the blurred conceptual boundaries between them. Her argument is that a more holistic approach to regulatory ‘landscapes’ is needed, one which better reflects overlapping processes and activities and which accounts for contextual sensitivity. Adapting the anthropological concept of liminality (which emphasises transformation and human experience) offers “a new conceptualisation of medical innovation as a shared space where both practice/treatment and research can co-exist.”

Dr Sethi is a Chancellor’s Fellow at the Centre for Biomedicine, Self and Society within the Usher Institute of Population Health Sciences and Informatics. She is also a deputy director of the JK Mason Institute for Medicine, Life Sciences and the Law, where she is responsible for Internationalisation, including the Institute’s Visiting Fellow Scheme.

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