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A less accurate but more important definition?

Posted by plosmedicine on 31 Mar 2009 at 00:16 GMT

Author: David Wendler
Position: Bioethics
Institution: Department Bioethics, NIH
E-mail: dwendler@nih.gov
Submitted Date: November 28, 2007
Published Date: November 29, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

A memorable or “sticky” label can be as vital to the acceptance of an idea, as to the success of a commercial product or service. Yet, the example of “therapeutic misconception” teaches us that, in this regard at least, more adhesion is not necessarily a good thing. This particular label has stuck, or been stuck to such a wide range of misunderstandings in clinical research that it has become almost impossible to discern, from the label itself, what type of confusion is being discussed, how problematic that confusion is, and which steps might be needed to correct it.

The manuscript by Gail Henderson and colleagues provides much needed conceptual therapy. The authors propose a consensus definition of the therapeutic misconception which, it is hoped, will lead to the label being removed from at least some of the many misunderstandings to which it has been incorrectly applied. In the words of the authors, the therapeutic misconception “exists when individuals do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled in the trial may potentially benefit from the intervention under study or from other aspects of the clinical trial.”

Notice that this definition appears to be satisfied by anyone who does not understand the defining purpose of clinical research, no matter what the source of their confusion. However, the therapeutic misconception standardly is thought to include a specific, and apparently common explanation for why individuals do not understand the purpose of clinical research. They fail to understand because they confuse clinical research with clinical care. Presumably, it is an open question whether an individual who fails to understand the defining purpose of clinical research because they were not paying attention when the investigator explained it suffers from the therapeutic misconception. This conclusion suggests that the authors’ definition, while an important advance, will need to be supplemented with a clause regarding confusion between research and clinical care.

While the explanation for individuals’ failure to understand is central to the therapeutic misconception, it is only of secondary importance to the ethics of clinical research. The important question is what individuals need to understand to give informed consent for clinical research, and whether potential research participants understand these things. In addition to offering a consensus definition of the therapeutic misconception, the authors also address what individuals need to understand to understand clinical research. While their proposed definition of the therapeutic misconception is likely to receive most of the attention, it is the draft suggestions regarding what individuals need to understand that are more important. In this way, the authors’ truncated definition may serve as a useful reminder of the need to focus more on the understanding of research participants as less on the confusion of bioethicists.

Competing interests declared: I declare that I have no competing interests.