Clarifying Risk-Benefit Ratios: the Case of Coronavirus Challenge Trials
Saturday, October 14, 2023
1:15 PM – 2:30 PM ET
Location: Galena (Fourth Floor)
Bioethicists broadly agree that ethical research must have a “favorable risk-benefit ratio.” However, this requirement is quite difficult to apply in practice, as illustrated by recent debates over the permissibility of controlled human infection—or “challenge”—trials using the novel coronavirus (hereafter: CCs), a debate which turned centrally on the disputed balance of their risks and benefits and which remains unresolved.
This talk has three aims. First, this talk aims to show that the notion of a favorable risk-benefit ratio is difficult to apply to potential trials, like CCs, not just because it is difficult to generate well-grounded estimates of hypothetical trials’ risks and benefits, but also because there is insufficient theoretical clarity regarding what their risks and benefits would need to be to count as favorable, even if, per impossibile, both were perfectly known. Second, this talk aims to take a common method for reasoning about acceptable research risks even in the absence of a clear underlying theory, namely the method of reasoning through analogy to comparator activities, and to show how this method can be improved. Third, this talk aims to show that, once those improvements are made, the case of CCs can be resolved in a way favorable to their ethical conduct. The upshot of the first two aims is largely theoretical, but the final result has practical implications for how we should assess challenge trials not just in current pandemic, but in future pandemics as well.