ABSTRACT
To maintain a therapeutic misconception is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself. It could be argued that the research project has been peer-reviewed for scientific merit and approved for ethical acceptability by an institutional review board (IRB), the problem of the therapeutic misconception is not significant enough to warrant intervention. The neutral explainer would be responsible to the IRB and would be trained to emphasize those aspects of the research situation about which the IRB has the greatest concern. This approach might be especially appropriate when the investigator is also the subject's treating physician and the methodology used is likely to be interpreted as therapeutic in intent. The unique aspects of clinical research include the goal of creating generalizable knowledge; the techniques of randomization; and the use of a study protocol, control groups, and double-blind procedures.
