Selecting participants fairly for controlled human infection studies
Douglas MacKay1, Nancy S Jecker2, Punnee Pitisuttithum3
1University of North Carolina, Dept. of Public Policy, Chapel Hill, North Carolina, USA.
Bioethics
|June 17, 2020
Summary
Controlled human infection (CHI) studies ethically select participants by balancing risks and generalizability. This research offers a framework for fair subject selection in CHI studies, guiding investigators and ethics committees.
Area of Science:
- Infectious Diseases
- Clinical Research Ethics
- Biomedical Ethics
Background:
- Controlled human infection (CHI) studies are efficient models for studying disease pathogenesis and evaluating interventions.
- CHI studies present unique advantages but also ethical challenges, particularly in participant selection.
- Fair subject selection in CHI studies requires balancing participant safety with the need for generalizable results.
Purpose of the Study:
- To propose a framework for fair subject selection in controlled human infection studies.
- To address the ethical complexities of excluding or including participants with comorbidities.
- To provide guidance for investigators and Institutional Review Boards (IRBs) / Research Ethics Committees (RECs).
Main Methods:
- Ethical analysis of subject selection principles in the context of CHI studies.
- Identification of specific fairness considerations relevant to CHI study design.
- Development of a principled approach to navigate conflicting ethical imperatives.
Main Results:
- Fairness in CHI subject selection involves navigating competing ethical duties.
- Excluding participants with comorbidities may enhance safety but reduce generalizability.
- Including participants with comorbidities enhances generalizability but may increase risks.
Conclusions:
- A tailored ethical framework is necessary for fair subject selection in CHI studies.
- The proposed approach assists investigators and ethics committees in making principled decisions.
- Balancing participant risk and study generalizability is central to ethical CHI research.
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