Document Type


Publication Date

Fall 2013




The Catholic University of America




Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is 2 determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research and therapy, ",3 scientist and physician, and subject and patient. It was suggested that a major reason for the blurring was to "lower the standards for obtaining informed consent." To prevent this, it was further suggested that it is necessary to firmly establish that the modem informed consent doctrine applies to both research and treatment.4 In this article we explore the recurrent problem of equating research and treatment, and its recurring (but misinformed) rationale-that in practice, informed consent only applies to research, and not treatment. Historically, misleading and confusing terms such as "therapeutic research," "experimental treatment," and "invalidated treatment" have been used to blur the distinction between research and treatment. Similar misleading terms are being deployed in an effort to make evidence-based medicine research (including comparative-effectiveness research) easier to do by dispensing with or watering down disclosure requirements. We agree with the great need to do more research on the safety and efficacy of currently used treatments, but strongly disagree that such research requires abandoning or diluting informed consent, or treating patients simply as passive objects for the valid purpose of improving the quality of care for all.

The latest term for conflating research and treatment is "standard of care research," and the leading example that illustrates the problems with employing new and confusing terms for research is a study on extremely premature infants, the "Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial" (known as the SUPPORT study and described below). 5 The (mistaken) belief that clinical practice on children does not require the informed consent of the parents explains, we think, why this seductive term, standard-of-care research, was invented. It seemed to justify, for example, not informing parents of the risks of death in each of the two possible groups to which their infant would be randomized in the SUPPORT study. Viewing research as treatment is a common mistake patients also make, so common that it has been given a name, the "therapeutic misconception," or the "therapeutic illusion."6 We will suggest that in the SUPPORT study the therapeutic illusion was strongest on the part of the researchers, sponsors, Institutional Review Boards ("IRBs"), and institutions, rather than, as is usual, on the part of the patient-subjects.

Link to Publisher Site (BU Community Subscription)



To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.