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Ethical approval for controlled human infectious model clinical trial protocols - A workshop report
Euzebiusz Jamrozik1, Katherine Littler2, Irina Meln3
1The Ethox Centre & Wellcome Centre for Ethics and Humanities, University of Oxford, Oxford, United Kingdom.
Summary
Controlled Human Infectious Model (CHIM) studies ethically require robust participant information and scientifically sound documentation. Recommendations emphasize minimizing harm and clearly justifying CHIM use over alternative designs for public trust.
Area of Science:
- Clinical Research Ethics
- Infectious Disease Modeling
- Vaccine Development
Background:
- Controlled Human Infectious Model (CHIM) studies involve deliberate pathogen exposure of volunteers.
- Ethical considerations are paramount in CHIM study design and execution.
- Balancing scientific advancement with participant safety and welfare is critical.
Purpose of the Study:
- To examine ethical criteria and the role of CHIM in pharmaceutical development.
- To foster discussion among researchers, regulators, ethics committee members, and ethicists.
- To develop recommendations for ethical approval of CHIM clinical trial protocols.
Main Methods:
- A workshop titled "Ethical Approval for CHIM Clinical Trial Protocols" was organized.
- Discussions involved key stakeholders including researchers, regulators, and ethicists.
- Recommendations were formulated based on collaborative examination of ethical challenges.
Main Results:
- Key recommendations include ensuring routine ethical requirements are met and participants are well-informed.
- Study documents must be ethically and scientifically sound from the outset.
- Applications need to clearly justify the use of CHIM compared to alternative study designs.
Conclusions:
- Ethics committees (ECs) require clear guidance for evaluating social value and third-party risks.
- Minimizing harm to volunteers and third-party risk is essential for public trust.
- Stakeholder engagement, public education, and post-study healthcare access are vital considerations.
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