Abstract
In this article, we argue that the relationship between 'subject' and 'object' is poorly understood in health research regulation (HRR), and that it is a fallacy to suppose that they can operate in separate, fixed silos. By seeking to perpetuate this fallacy HRR risks, among other things, objectifying persons by paying insufficient attention to human subjectivity, and the experiences and interests related to being involved in research. We deploy the anthropological concept of liminality – concerned with processes of transformation and change over time – in order to emphasise the enduring connectedness between subject and object in these contexts. By these means, we posit that regulatory frameworks based on processual regulation can better recognise and encompass the fluidity and significance of these relationships, and so ground more securely the moral legitimacy and social licence for human health research.
Highlights
It is a near-universal legal truism that almost all regulated entities are held to fall into one of two categories: subject or object
As a technocratic domain that is fundamentally concerned with managing risks to humans, health research regulation (HRR) regimes are understandably focussed on the definition and categorisation of suitable objects of regulatory capture – such as what counts as ‘personal data’2 or which kinds of embryo can be created for research purposes3 – but there is often a deep irony that arises, viz., the focus is lost from the person(s) to whom these objects relate or from whom they have been derived, or who have contributed materially to the creation of these objects
We have argued that a rigid separation of the categories of subject and object in HRR fails to reflect the reality of research practices, where, for example, tissue becomes data
Summary
LAW, INNOVATION AND TECHNOLOGY health research regulation (HRR). The objects of HRR are myriad; they include ‘personal data’, DNA and RNA, cell lines, ‘human tissue’, ‘gametes’, and a range of legally prescribed embryos’, and all are bounded in law by their own definitions, frameworks, and rules of production, storage and use in health research. As a technocratic domain that is fundamentally concerned with managing risks to humans, HRR regimes are understandably focussed on the definition and categorisation of suitable objects of regulatory capture – such as what counts as ‘personal data’ or which kinds of embryo can be created for research purposes3 – but there is often a deep irony that arises, viz., the focus is lost from the person(s) to whom these objects relate or from whom they have been derived, or who have contributed materially to the creation of these objects.. [d]eveloped to make sense of ritual, structure, and agency, the notion of liminality refers to a threshold phase characterised by uncertainty, possibility, marginality, and transformation.’ Given that health research is precisely concerned with uncertainty and transforming materials to produce new human understandings, this conceptual lens helps to reveal – as we will argue – that the relationship between the legal categories of ‘subject’ and ‘object’ is poorly understood, and that existing categorisations within HRR are inflexible and insufficient by obscuring the important transformations that take place between subjects and objects. We posit that the processes of conducting human health research can usefully be subjected to the lens of liminality This is so for two reasons: first, the nature of research itself is inherently transformative and uncertain, as suggested above..
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