Regulating international clinical research: an ethical framework for policy-makers

Area of Science:

• Global Health
• Bioethics
• Regulatory Science

Background:

• Clinical trials are increasingly conducted in low- and middle-income countries (LMICs).
• Ensuring robust ethical and regulatory oversight is critical for protecting research participants in these regions.
• LMIC policymakers face a dilemma: strict regulations may deter research, limiting local benefit.

Purpose of the Study:

• To propose a novel three-step ethical framework for LMIC policymakers.
• To guide decision-making in balancing participant protection with research site attractiveness.
• To address the ethical trade-off in global clinical trial distribution.

Main Methods:

• Development of a three-step ethical framework.
• Case study analysis of recent regulatory protections in Chile.
• Original ethical analysis and utilization of previously unpublished data from Chile via freedom of information requests.

Main Results:

• The proposed framework offers a structured approach to navigating regulatory challenges.
• Chile's regulatory changes provide a practical illustration of the framework's application.
• Data reveals specific insights into the impact of regulatory decisions on clinical research.

Conclusions:

• The ethical framework provides a practical tool for LMIC policymakers.
• Balancing participant rights and research opportunities is achievable.
• Informed regulatory strategies can foster equitable participation in global clinical research.