title: Uncertainty and equipoise: at interplay between epistemology, decision making and ethics.
abstract: In recent years, various authors have proposed that the concept of equipoise be abandoned because it conflates the practice of clinical care with clinical research. At the same time, the equipoise opponents acknowledge the necessity of clinical research if there are unresolved uncertainties about the effects of proposed healthcare interventions. As equipoise represents just 1 measure of uncertainty, proposals to abandon equipoise while maintaining a requirement for addressing uncertainties are contradictory and ultimately not valid. As acknowledgment and articulation of uncertainties represent key scientific and moral requirements for human experimentation, the concept of equipoise remains the most useful framework to link the theory of human experimentation with the theory of rational choice. In this article, I show how uncertainty (equipoise) is at the intersection between epistemology, decision making and ethics of clinical research. In particular, I show how our formulation of responses to uncertainties of hoped-for benefits and unknown harms of testing is a function of the way humans cognitively process information. This approach is based on the view that considerations of ethics and rationality cannot be separated. I analyze the response to uncertainties as it relates to the dual-processing theory, which postulates that rational approach to (clinical research) decision making depends both on analytical, deliberative processes embodied in scientific method (system II), and good human intuition (system I). Ultimately, our choices can only become wiser if we understand a close and intertwined relationship between irreducible uncertainty, inevitable errors and unavoidable injustice.
authors.affiliation: Center and Division for Evidence-based Medicine and Health Outcome Research, Clinical Translational Science Institute, University of South Florida, Tampa, Florida, USA. bdjulbeg@health.usf.edu
authors.forename: Benjamin
authors.initials: B
authors.lastname: Djulbegovic
mesh_terms: D026688:Bioethical Issues; D002986:Clinical Trials as Topic / Q000941:ethics; D003657:Decision Making / Q000941:ethics; D006801:Humans; D019359:Knowledge; D012306:Risk; D057212:Therapeutic Equipoise; D035501:Uncertainty