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

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...

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Váldodahkki: Laurie, Graeme
Materiálatiipa: Online
Giella:eaŋgalasgiella
Almmustuhtton: Edward Elgar Publishing 2026
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Liŋkkat:https://directory.doabooks.org/handle/20.500.12854/171022
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author Laurie, Graeme
author_browse Laurie, Graeme
author_facet Laurie, Graeme
author_sort Laurie, Graeme
collection Directory of Open Access Books
description 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 process.
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spelling doab-20.500.12854ir-1710222026-01-22T15:43:05Z 12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research Laurie, Graeme Ethics; Human health research; Law; Liminality; Liminoid; Play; Regulation; Sandbox LAB PSAD GBC 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 process. Published 2026-01-22T15:43:02Z 2026-01-22T15:43:02Z 2025-12-05 chapter 9781788116671 https://directory.doabooks.org/handle/20.500.12854/171022 eng image/jpeg Attribution-NonCommercial-NoDerivatives 4.0 International https://www.e-elgar.com/shop/gbp/research-handbook-on-law-governance-and-bioethics-9781788116664.html https://www.elgaronline.com/edcollchap-oa/book/9781788116671/chapter12.xml Edward Elgar Publishing Edward Elgar Publishing 10.4337/9781788116671.00019 10.4337/9781788116671.00019 01ceac28-75b4-492a-8eec-f9b98bc6b28c https://creativecommons.org/licenses/by-sa/4.0/ 9781788116671 Edward Elgar Publishing Cheltenham, UK open access
spellingShingle Ethics; Human health research; Law; Liminality; Liminoid; Play; Regulation; Sandbox
LAB
PSAD
GBC
Laurie, Graeme
12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research
title 12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research
title_full 12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research
title_fullStr 12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research
title_full_unstemmed 12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research
title_short 12: Regulation as play: establishing a normative basis for the regulatory sandbox in human health research
title_sort 12 regulation as play establishing a normative basis for the regulatory sandbox in human health research
topic Ethics; Human health research; Law; Liminality; Liminoid; Play; Regulation; Sandbox
LAB
PSAD
GBC
topic_facet Ethics; Human health research; Law; Liminality; Liminoid; Play; Regulation; Sandbox
LAB
PSAD
GBC
url https://directory.doabooks.org/handle/20.500.12854/171022
work_keys_str_mv AT lauriegraeme 12regulationasplayestablishinganormativebasisfortheregulatorysandboxinhumanhealthresearch