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12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research

Contributor(s): Resource type: Ressourcentyp: Buch (Online)Book (Online)Language: English Publisher: Cheltenham, UK : Edward Elgar Publishing : Edward Elgar Publishing [Imprint], 2025ISBN:
  • 9781788116671
Subject(s): Online resources: Summary: The regulatory sandbox is an experimental place to test new products and services before they come to market. Beginning in the realm of financial services, the sandbox has now been extended into the biomedical sector, notably for health-related technologies such as telemedicine and to the biomedical data protection arena. Responding to this (still under-theorised) regulatory innovation, this chapter casts the sandbox as a novel—and relatively empty—regulatory space designed to promote exploration and play. The central argument builds on the anthropological literature on liminality—concerned with the human experience of transition and change—to offer a robust foundational basis for such spaces as unconstrained by existing formalistic structures, such as legislative instruments and rules-based regulation. The concept of the liminoid regulatory space is offered in this regard. The focus of the analysis is on health research regulation where the twin objectives of protecting research subjects while promoting sound research are constantly in tension. Reimagining regulation as play serves an important role in providing both an opportunity for mutual learning for stakeholders and a means to deliver a missing component in the effective sequencing of health research regulation. Conceptualising the sandbox as a regulatory space that is determinedly open, inclusive, and values-driven can go a long way to addressing uncertainty, difference and disagreement at early and productive stages of the regulatory processPPN: PPN: 198398759XPackage identifier: Produktsigel: ZDB-94-OAB
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https://creativecommons.org/licenses/by-nc-nd/4.0/

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