Decision analysis approach to risk/benefit evaluation in the ethical review of controlled human infection studies. (26th June 2020)

• Record Type: Journal Article
• Authors: Yu, Michael; Darton, Thomas C.; Kimmelman, Jonathan
• Other Names: Shah Seema K. guestEditor.; Rid Annette guestEditor.
• Is Part Of: Bioethics. Volume 34:Number 8(2020)
• Page Start: 764
• Page End: 770
• Publication Date: 2020-06-26
• Subjects: controlled human infection -- decision analysis -- research ethics -- risk and benefit -- vaccine development; Bioethics -- Periodicals; 174.957
• DOI: 10.1111/bioe.12773
• Languages: English
• ISSNs: 0269-9702

Abstract

Abstract: Risks and benefit evaluation for controlled human infection studies, where healthy volunteers are deliberately exposed to infectious agents to evaluate vaccine efficacy, should be explicit, systematic, thorough, and non‐arbitrary. Decision analysis promotes these qualities using four steps: (1) determining explicit criteria and measures for evaluation, (2) identifying alternatives to the study, (3) defining the models used to estimate the measures for each alternative, and (4) running the models to produce the estimates and compare the alternatives. In this paper, we describe how decision analysis might be applied by funders and regulators, as well as by others contemplating the use of novel controlled human infection studies for vaccine development and evaluation.