Pragmatic Clinical Research, Informed Consent, and Clinical Equipoise

There is a growing movement within contemporary medical ethics to blur the boundaries between clinical medicine and clinical research. Some writers now argue that the research-practice distinction is outdated and the importance of distinguishing between research and medicine is no longer as pressing as it once was or seemed to be. Instead, we are now urged to view the health-care system as a dynamic learning health-care system in which research components are embedded within standard clinical care. This essay defends the ethical significance of the research-practice distinction while acknowledging the reality and usefulness of integrated health care. A key claim that this essay advances is that the principle of clinical equipoise, which has largely been rejected by research ethicists, can be reinterpreted and repurposed to help distinguish medical practices that call for more demanding forms of informed consent from those that do not.