Research ethics in and out of crises: cluster randomized trials without consent

Cluster-randomized trials (CRTs), where interventions are implemented and evaluated at the group level, can provide essential evidence in the choice of public health policy. However, often such trials cannot be performed without waiving the ethical requirement of informed consent. Then, we are left with the following dilemma: Either we abandon the consent requirement, or we have to forego essential evidence for public health policies. In this article, we discuss different solutions to this dilemma and how they play out in a crisis, where the dilemma is particularly acute. We identify the moral factors relevant to the permissibility of CRTs without consent and discuss how the balancing of such moral factors and the social utility of research may vary between normal situations and crises. We identify five ideal-typical positions on the permissibility of CRTs without consent and discuss how robust they are in a crisis. Finally, we address the question of who should have the authority to make decisions about CRTs without consent in a crisis: ethics committees or democratically accountable governments?