Abstract
This article fundamentally challenges the way in which law currently regulates human health research. It invokes the anthropological concept of liminality—the quality of in-between-ness—to suggest deeper ways of understanding ongoing challenges in delivering acceptable and effective regulation of research involving human participants. In stark contrast to the structural regulatory spaces constructed by law, the metaphor of the liminal space is explored to explain what is lost through our failure to see health research regulation as an inherently human experiential process, involving potentially profound transformative events for participants and researchers alike. The implications for the future of health research regulation are then examined. In particular, the analysis calls into question key features of the current regulatory paradigm, and demands that we reconsider our own demands of law in this context. The argument is made that health research is a liminal process and that we fail to treat it as such. This requires a rethink of corollary regulation also in processual terms. Ultimately, the charge is to undertake a radical reimagining of regulatory space to accommodate and promote liminal regulatory spaces.
Highlights
UNDERSTANDING REGULATORY SPACE IN HEALTH RESEARCHThe metaphor of the ‘regulatory space’[1] is commonly invoked to describe the metaphysical environment occupied by institutional actors and bounded by law
In stark contrast to the structural regulatory spaces constructed by law, the metaphor of the liminal space is explored to explain what is lost through our failure to see health research regulation as an inherently human experiential process, involving potentially profound transformative events for participants and researchers alike
Within the European Union, the UK and its 27 fellow Member States must comply with the new Clinical Trials Regulation,[4] the Data Protection Directive with respect to data use for research,[5] medical devices directives,[6] and hybrid provisions such as Advanced Therapy Medicinal Products (ATMPs: subject to centralised legislative reform).[7]
Summary
The metaphor of the ‘regulatory space’[1] is commonly invoked to describe the metaphysical environment occupied by institutional actors and bounded by law. The UK instituted the labyrinthine Human Tissue Act 2004 with its associated licensing Authority as a direct result of the Bristol and Alder Hey organ retention scandals that arose from suboptimal (or non-existent) consent practices relating to forensic and research uses of deceased children’s tissues This regulatory endeavour replaced one legislative instrument of four sections with a new law 25 times its length.[3] Arising in parallel have been European and other supranational influences. Liminality and the Limits of Law in Health Research Regulation 3 taxonomy of regulated ‘objects’ such as ‘data’, ‘tissue’, ‘embryos’, ‘devices’, ‘ATMPs’, and ‘clinical trials’, each bounded by its own legal definition and bespoke sets of regulatory rules of production, storage, use, and market approval This pattern of command-and-control regulation[8] whereby a state authority has dominant oversight and power over health research is repeated throughout the western world and beyond. The literature on liminality helps us to think about those spaces in radically different ways—notably as processes of transformation and change—and with important consequences for health research regulation; Section IV offers a range of examples that show why this perspective matters; Section V invites the reader to reconceive the research enterprise as involving liminal regulatory spaces, and the consequences of this are fully explored
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