Abstract / Description of output

European and international regulation of human health research is typified by a morass of interconnecting laws and divergent ethical frameworks. Often, legislators regulate in ‘siloed’ fields of scientific activity without regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the researchers and regulators attempting navigate these landscapes. This Delphi study was undertaken in order to provide the first interdisciplinary and crosscutting analysis of health research regulation as it is experienced by such stakeholders.As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration within health research regulation. Our analysis offers insights about how a wider range of stakeholders – researchers,regulators, publics and research sponsors – can engage better with health researchregulation. We claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principles-based regimes that allow researchers, regulators and publics to contribute to co-production of effective regulation. Our results show the potential to situate and breathe new life into certain existing regulatory concepts and practices – proportionality, the public interest and public engagement – that are at the heart of health research regulation. Our results also demonstrate that we must move beyond mere risk-management towards an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators. Embracing uncertainty – as a human practice and a regulatory objective – may represent a brighter future for health research.
Original languageEnglish
Pages (from-to)99-120
JournalHealth care analysis
Issue number2
Early online date31 Aug 2019
Publication statusPublished - 1 Jun 2020

Keywords / Materials (for Non-textual outputs)

  • collaboration
  • co-production
  • health research regulation
  • proportionality
  • public interest
  • regulatory stewardship
  • stakeholders


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