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'.
In this article we draw on the concept of a social licence to explain public concern at the introduction of care.data, a recent English initiative designed to extract data from primary care medical ...records for commissioning and other purposes, including research. The concept of a social licence describes how the expectations of society regarding some activities may go beyond compliance with the requirements of formal regulation; those who do not fulfil the conditions for the social licence (even if formally compliant) may experience ongoing challenge and contestation. Previous work suggests that people's cooperation with specific research studies depends on their perceptions that their participation is voluntary and is governed by values of reciprocity, non-exploitation and service of the public good. When these conditions are not seen to obtain, threats to the social licence for research may emerge. We propose that care.data failed to adequately secure a social licence because of: (i) defects in the warrants of trust provided for care.data, (ii) the implied rupture in the traditional role, expectations and duties of general practitioners, and (iii) uncertainty about the status of care.data as a public good. The concept of a social licence may be useful in explaining the specifics of care.data, and also in reinforcing the more general lesson for policy-makers that legal authority does not necessarily command social legitimacy.
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