Clinical trials and medical care: defining the therapeutic misconception

Gail E. Henderson, University of North Carolina
Larry R. Churchill, Vanderbilt University
Arlene M. Davis, University of North Carolina
Michele M. Easter, University of North Carolina
Christine Grady, National Institutes of Health Clinical Center
Steven Joffe, Harvard University
Nancy Kass, Johns Hopkins University
Nancy M. P. King, Wake Forest University
Charles W. Lidz, University of Massachusetts Medical School
Franklin G. Miller, National Institutes of Health Clinical Center
Daniel K. Nelson, University of North Carolina
Jeffrey Peppercorn, University of North Carolina
Barbra Bluestone Rothschild, University of North Carolina
Pamela Sankar, University of Pennsylvania
Benjamin S. Wilfond, University of Washington
Catherine R. Zimmer, University of North Carolina

Abstract

Summary Points:

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.