It is widely accepted that a meaningful informed consent is a precondition to the ethical involvement of human subjects in clinical research. For consent to be meaningful subjects must be able to do more than repeat back a list of facts;they must appreciate the issues involved in the decision. The Therapeutic Misconception (TM) involves patient/subjects failing to grasp the difference between participating in a clinical trial and receiving ordinary clinical care. For this reason, therapeutic misconception has become one of the major ethical issues in informed consent to clinical trials. Although many have expressed the concern that therapeutic misconception facilitates recruitment to clinical trials and removing it would reduce recruitment, this may come at the cost of subsequent dropouts if the subjects come to believe that, although the research in which they are participating is in some ways better than ordinary treatment, it is also, in ways significant to them, something less than ordinary treatment. Thus, not only is it ethically important, but it also may be in the long-term interests of the validity of clinical trials that potential subjects have a clear sense of the distinction between the nature of the care that they receive in ordinary clinical practice and the care in clinical trials. This study will take a major step in the direction of determining how to reduce TM in clinical trials. It will provide the basis for a transformation of the manner in which clinical researchers gain consent from participants, and substantially reduce one of the major barriers to genuine informed consent to research. This study is designed as a hypothetical randomized trial comparing an enhanced disclosure using scientific reframing designed to reduce TM versus disclosure as usual. The hypothetical study will be as close to a real one as possible, including gaining consent in real clinical settings with real patients who would be eligible for the mock protocol that will be very similar to a recently closed protocol. The study wll involve three different clinical services at a university medical center. This design will be used o test the ability of a scientific reframing disclosure to reduce TM and also test whether such disclosure reduces the inclination of potential subjects to volunteer for a clinical trial.
Therapeutic Misconceptions of subjects in clinical trials is a serious public health matter. Subjects'confusion between treatment and research risks undermines the validity of their informed consent. Establishing effective methods for reducing Therapeutic Misconception will provide an important contribution to public health.