By Melissa Lopes
Paul Appelbaum’s keynote address was both reflective and forward-looking in nature. He reflected back on his late ‘80s groundbreaking research introducing the concept of “therapeutic misconception” and challenged the audience to apply the results of such research to the examination of efforts to reduce this phenomenon. Therapeutic misconception manifests itself in the incorrect belief on a research participant’s part that their individualized needs will determine their treatment in clinical research and/or an unreasonable belief regarding the nature or likelihood of benefit based on the research participant’s misunderstanding of research methodology.
In reflecting back, Appelbaum acknowledged the hurdles encountered in gaining acceptance of the concept of therapeutic misconception. Initially, the theory was viewed by some as a phenomenon particular to the psychiatric patients in whom it was initially studied. As studies broadened to include more diverse research subjects, however, it became clear that a trial participant’s disbelief that a physician-researcher would offer treatment not in the patient/subject’s best interest was more widespread than initially surmised.
Understanding and accepting the existence of therapeutic misconception in clinical research was the first step towards addressing and perhaps ameliorating the issue. Appelbaum pointed out that on-going effort to develop a measure to validly and reliably measure therapeutic misconception represents the intermediary step in the process. The development of such a measure should pave the way for efforts to reduce therapeutic misconception.
At one point in his talk, Dr. Appelbaum queried, “why should we care” about this phenomenon? Not only do such misconceptions undermine the concept of “knowing consent” in the informed consent process, they undermine the general public consensus that has supported research as a reliable and trustworthy endeavor. However, evidence revealed in the research into this phenomenon poses incredible challenges for the elimination of this issue. Evidence such as the following:
- The sicker the research participant is, the more likely he or she is to suffer from therapeutic misconception,
- The risk of death may make research subjects more likely to suffer therapeutic misconception
The mere disclosure of risks and benefits in lengthy and legalistic forms may not be sufficient in light of such evidence. Such evidence counsels in favor of transforming the informed consent process from mere passive disclosure to more active education and interaction with patient participants in clinical research.
