ABSTRACT
Clinical equipoise is an ethical standard for the inception of random-controlled trials and a normative vehicle for the calibration of acceptable therapeutic risks to human research subjects. It requires a null hypothesis or a state of honest, professional disagreement among members of the expert clinical community as to the relative merits of the treatments being compared in the trial. If those treatments are in clinical equipoise, then trial subjects are not randomized to a treatment that is known to be inferior. It was first introduced by the late philosopher Benjamin Freedman in a seminal article published in the New England Journal of Medicine in 1987 (Freedman, 1987) and has since become an influential, some would say foundational, standard in North American biomedical research ethics. It is endorsed in Canada's Tri-Council Policy Statement (2005) as pivotal to the assessment of benefits and harms and the use of placebos in clinical trials. It is also an important concept in the recommendations of the US National Bioethics Advisory Commission (NBAC) for reforming the federal regulations that prescribe standards for the Institutional Review Board (IRB) analysis of benefits and harms in research (NBAC, 2000; Miller and Weijer, 2003, p93).
