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Beyond regulatory compression:Confronting the liminal spaces of health research regulation

机译:超越监管压缩:面对健康研究法规的限制空间

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摘要

Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this ‘regulatory turn’ by drawing on the anthropological concept of liminality. We offer the term ‘regulatory compression’ to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the ‘in-between’, liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) and curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of ‘processual regulation’, a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation.
机译:生物医学和生命科学不断地重新排列文化与生物学之间的关系。因此,我们越来越多地寻求适当的监管对策,以减少感知到的不确定性和不稳定性。本文通过人类学上的“合法性”概念,研究了这种“监管转向”的全部含义。我们提供“监管压缩”一词来表征现有监管方法对健康研究实践的影响。通过关注转换和“中间”,限制性使我们能够看到监管框架如何依靠基于筒仓的方法对研究对象进行分类和调节,从而使它们:(1)限制了临床和实验室研究所必需的灵活性; (2)导致在有限制的监管领域之间出现不受监管的空间; (三)减少公众参与卫生研究企业的方式。我们建议有必要发展“过程性监管”的概念,这是一个新颖的框架,要求对所有参与者(包括参与者与监管对象的关系)所经历的监管空间和实践进行时空检查。

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