J. Kenyon Mason Institute for Medicine, Life Sciences and the Law, School of Law, University of Edinburgh, Old College, South Bridge, Edinburgh, EH8 9YL, UK.
School of Public Health, University of Montreal, 7101, Avenue du Parc, 3e étage, Montréal, QC, H3N 1X9, Canada.
Health Care Anal. 2020 Jun;28(2):99-120. doi: 10.1007/s10728-019-00383-9.
European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos-that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders-researchers and regulators alike-who attempt to 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 in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders-including researchers, regulators, publics and research sponsors-can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation-including the public interest and public engagement-our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty-both as a human practice and a regulatory objective-may represent the brighter future for health research.
欧洲和国际的人类健康研究法规以相互交织的法律、多样化和不同的伦理框架以及国家和跨国标准为特点。立法者也倾向于在孤立的领域进行监管，即在没有充分考虑到使新知识尽可能具有普遍性的必要性的情况下，在科学活动的离散领域进行监管。对于试图在这些领域中导航的利益相关者（研究人员和监管者）来说，存在着无数的挑战。这项德尔菲研究旨在提供对健康研究监管的首次跨学科和跨领域分析，因为这是英国背景下的利益相关者所经历的。除了加强对监管环境的现有理解外，德尔菲参与者还呼吁在健康研究监管所涉及的过程中进行更多的合作，甚至是共同制定。基于这项研究，我们提供了一些关于如何使健康研究监管成为更广泛的利益相关者（包括研究人员、监管者、公众和研究赞助商）参与的问题的见解。证据支持规范性主张，即健康研究监管应继续摆脱严格的、基于规定的方法，转向允许研究人员、监管者和公众共同制定符合核心原则的监管制度的灵活原则为基础的制度。通过剖析健康研究监管核心的棘手概念和实践，包括公共利益和公众参与，我们的研究结果有可能使这些概念和实践具体化并赋予其生命力。研究结果还表明，虽然相称性被认为是灵活监管制度的关键要素，但需要做更多的工作来将其作为对研究轨迹多个阶段的利害关系的价值和风险的伦理评估来实施。如果我们要超越相称性作为一种仅仅是风险管理工具，这是必要的。合规文化不再准确反映研究人员或监管者的需求和期望，也不一定能产生最好的研究。接受不确定性——既是一种人类实践，也是一种监管目标——可能代表着健康研究的更美好未来。
