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Why Is Therapeutic Misconception So Prevalent?


Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.

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25. See note 4, Appelbaum et al. 1987.

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27. See note 23 Goffman 1974.

28. Lidz, C, Appelbaum, P. The therapeutic misconception: Problems and solutions. Medical Care 2002;40(Suppl):v5563.

The authors thank Scott Kim, M.D., Ph.D., and Katy Downs for their assistance with data collection. No author has any material or financial conflicts of interest. The study discussed in this article was funded by NINR Grant #5RC1NR011612.

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

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Cambridge Quarterly of Healthcare Ethics
  • ISSN: 0963-1801
  • EISSN: 1469-2147
  • URL: /core/journals/cambridge-quarterly-of-healthcare-ethics
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