When understanding fails: how diverging norms in medicine and research led to informed consent failures during the pandemic.

Abstract

During the COVID-19 pandemic, there were many vaccine trials which had significant purposes which participants needed to understand to validly consent. For example, participants needed to understand that the purpose of dose-escalation vaccine trials was to give incremental doses of a vaccine until participants became ill. Likewise, participants needed to understand that even if they received placebos, they could not take a genuine vaccine to preserve the integrity of the trials. Yet, these intuitive judgements about what participants need to understand to validly consent are rejected by recent accounts of consent. According to these accounts, as long as participants were given a good opportunity to learn these purposes, they do not need to actually understand them to consent. In this paper, I reject this consensus, and I argue that participants who failed to understand these aims associated with vaccine trials failed to provide legitimate consent. I defend this claim by developing and defending a new understanding condition for valid consent. According to this understanding condition, a participant must understand when a consent transaction has features which violate the norms which govern the medical practice with which they are acquainted. I argue that this condition is independently plausible and best explains why participants needed to understand these aims associated with vaccine trials to validly consent.