Therapeutic misconception and the appreciation of risks in clinical trials

Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the “therapeutic misconception”. Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA.