Regulation as Play: Establishing a normative basis for the regulatory sandbox in Human Health Research

Research output: Chapter in Book/Report/Conference proceedingChapter (peer-reviewed)peer-review

Abstract / Description of output

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. Notwithstanding, the nature of, and justification for this regulatory approach are currently woefully under-theorised. This chapter seeks to remedy this by casting 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 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. Reimaging 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. This, however, is contingent on a deep understanding of the liminoid nature of that space and the potentially powerful normative force of play - subject to appropriate guidance and limits – examples of which are offered at the end of this chapter.
Original languageEnglish
Title of host publicationLaw, Governance and Bioethics
Subtitle of host publicationConcepts, Challenges, and Future Directions
EditorsRoger Brownsword, Deryck Beyleveld, Marcus Duwell
PublisherEdward Elgar Publishing
Number of pages29
Publication statusAccepted/In press - 2024

Keywords / Materials (for Non-textual outputs)

  • law
  • theory
  • regulation
  • sandbox
  • human health research
  • liminoid
  • liminality
  • play
  • ethics

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