title: Problems with the consensus definition of the therapeutic misconception.
abstract: In a previous article,' I attempted to assess the likely impact of the most prominent versions of the therapeutic misconception (TM) on research subjects' informed consent. I concluded that the TM is not nearly as significant a concern as is commonly thought, and that focusing on it is more likely to undermine than promote research subjects' informed consent. A recent commentary rejects these conclusions, as least as they pertain to the "consensus" definition of the TM.2 The authors of the commentary argue that work on the TM remains central to ensuring the appropriateness of research subjects' consent and, by implication, the ethical acceptability of clinical research. The present work evaluates the arguments offered in support of these claims. This analysis reveals that the authors offer few substantive responses to my arguments, and the responses they do offer fail to undermine my prior conclusions. Furthermore, consideration of an additional issue-the emergence of learning healthcare systems-suggests that the TM is likely to be even less significant in the future, hence, focusing on it may be even more problematic than I argued previously.
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA. dwendler@nih.gov
authors.forename: David S
authors.initials: DS
authors.lastname: Wendler
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D035842:Research Subjects; D055990:Therapeutic Misconception / Q000941:ethics*