For over three decades, bioethics scholarship and research ethics guidelines have identified concerns about the boundaries between research and standard clinical care [1,2]. Ethicists have argued that informed consent to participate in research should include clarification of the differences between these two activities [3–10]. In 1982, Appelbaum and colleagues reported on findings from interviews with patients with psychiatric disorders that documented failure to appreciate the difference between research and treatment, labeling the phenomenon “therapeutic misconception” (TM) .
Despite considerable empirical research on TM in the intervening years, a consistent definition has not emerged in the literature. Without such a definition, meaningful empirical work to measure and assess the prevalence of TM, or to test interventions to reduce it, is difficult to conduct. Progress is further impeded when studies use measures that reflect inconsistent definitions of research and clinical care, which are fundamental to the definition of TM.
Scholars who have contributed to this literature, including this paper's authors, met at the University of North Carolina at Chapel Hill in September 2005 to address the debate on defining TM. The workshop included a University of North Carolina team funded to study TM in early-phase gene transfer research (R01 HG 02087) [11–17] and others from the fields of medicine, oncology, public health, sociology, philosophy, anthropology, law, and bioethics. Following guidelines on scale development , we debated definitions based on the literature, evaluated questions that could be used in a TM scale, and participated in ongoing discussion during the following year. In this article, we summarize the controversies, propose a definition with specific dimensions, and describe how these dimensions can be operationalized to produce a valid measure of TM.
- A key component of informed consent to participate in medical research is the understanding that research is not the same as treatment.
- However, studies have found that some research participants do not appreciate important differences between research and treatment, a phenomenon called “therapeutic misconception.”
- A consistent definition of therapeutic misconception is missing from the literature, and this hinders attempts to define its prevalence or ways to reduce it.
- This paper proposes a new definition and describes how it can be operationalized.