Destabilizing the ‘equipoise’ framework in clinical trials: prioritizing non-exploitation as an ethical framework in clinical research

Abstract

The framework of equipoise has been promulgated as an underlying requirement for conducting ethical clinical research. Equipoise is the term used for a state of indifference about which treatment intervention or innovation will provide the most benefit and the least harm to recipients. Drawing on healthcare, research, and ethics literature, this paper analyses the implications of equipoise from the perspective of several proponents and critics. Specifically the historical evolution of the concept based on Fried and Freedman's arguments is traced. A critique of the concept, informed by contrasting perspectives, is offered. An alternative framework of non-exploitation as presented by Miller and Brody is argued to be superior in facilitating both the ultimate goals of research on human subjects and those of the healthcare professions'.