The New Role of Ethics Committees in Emergency Use of Unproven Interventions Outside Research

Abstract

Recent ethics guidelines from the World Health Organization´s (WHO) on monitored emergency use (MEURI) state that, during a public health emergency, prospective ethical review and oversight of the use of unproven interventions outside of the context of research is an ethical principle or criterion for its permissible use. In this chapter, we argue that this new role of ethics committees in the review, authorization and oversight of emergency use outside research is a developing conceptual innovation against the background of ethics documents such as the Declaration of Helsinki of the World Medical Association and the WHO earlier guidelines on "compassionate use" and MEURI. To support this claim, we offer definitions of key terms in this emerging literature and a clear methodological framework of practical analysis before presenting a literature review of relevant guidelines that focus on the presence or absence of the criterion of independent ethical review of emergency use of unproven interventions outside research. We close by discussing the future of the criterion of ethical review and oversight including questions around the greater normative complexity, both ethical and regulatory of monitored emergency use in comparison with research, the mutual influence between emergency and non-emergency use contexts, and questions of access pathways with and without committees as part of a rapidly-evolving emerging ethical literature.