Co-production and managing uncertainty in health research regulation: A Delphi study

摘要: European and international regulation of human health research is typified by a morass interconnecting laws, diverse divergent ethical frameworks, national transnational standards. There also tendency for legislators to regulate in silos—that is, discrete fields scientific activity without due regard the need make new knowledge as generalisable possible. are myriad challenges stakeholders—researchers regulators alike—who attempt navigate these landscapes. This Delphi study was undertaken order provide first interdisciplinary crosscutting analysis regulation, it experienced such stakeholders UK context. As well reinforcing existing understandings regulatory environment, participants called greater collaboration, even co-production, processes involved regulation. On basis this research, we offer insights about how can become matter with which wider range stakeholders—including researchers, regulators, publics sponsors—can engage. The evidence supports normative claim that should continue move away from strict, prescriptive rules-based approaches, towards flexible principle-based regimes allow co-produce systems serving core principles. By unpacking thorny concepts practices at heart regulation—including public interest engagement—our results have potential situate breathe life into them. demonstrate while proportionality well-recognised crucial element systems, more must be done operationalise an assessment values risks stake multiple junctures trajectory. required if beyond mere risk-management tool. Compliance culture no longer accurately reflects needs expectations researchers or nor does necessarily produce best research. Embracing uncertainty—both practice objective—may represent brighter future