Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

Area of Science:

• Health research regulation
• Bioethics
• Regulatory science

Background:

• European and international human health research regulation is complex, fragmented, and often siloed.
• Stakeholders face significant challenges navigating diverse laws, ethical frameworks, and standards.
• Existing regulatory approaches may not adequately support generalizable knowledge creation.

Purpose of the Study:

• To provide an interdisciplinary, crosscutting analysis of health research regulation from stakeholder perspectives in the UK.
• To identify opportunities for greater collaboration and co-production in regulatory processes.
• To offer insights for a more engaged and flexible health research regulatory landscape.

Main Methods:

• A Delphi study involving diverse stakeholders (researchers, regulators, etc.) in the UK context.
• Interdisciplinary and crosscutting analysis of regulatory experiences.
• Examination of core concepts like public interest and public engagement.

Main Results:

• Reinforced existing understandings of the regulatory environment.
• Participants called for increased collaboration and co-production in health research regulation.
• Evidence supports a shift from prescriptive rules to flexible, principle-based regimes.

Conclusions:

• Health research regulation should evolve towards flexible, principle-based systems enabling co-production among researchers, regulators, and the public.
• Operationalizing proportionality as an ethical assessment beyond risk management is crucial.
• Embracing uncertainty is key for a future-oriented regulatory approach that better serves research and societal needs.