To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...

The peer commentaries on our Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” offer a number of insights that will help advance the co...

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. (shrink)