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Re-evaluating the therapeutic misconception: response to Miller and Joffe
Paul S Appelbaum1, Charles W Lidz
1Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Abstract:
Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach ends up largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research.
Insights
Therapeutic misconception (TM) undermines informed consent in clinical research, harming participants' dignity and decision-making. Efforts to dispel TM are crucial, not premature, despite ongoing debate.
Area of Science:
- Bioethics
- Clinical Research Ethics
- Informed Consent
Background:
- The concept of therapeutic misconception (TM) is reviewed in response to Miller and Joffe.
- Concerns about TM focus on its impact on informed consent, not necessarily poorer participant outcomes.
- TM impairs participants' ability to provide adequate informed consent, infringing on dignitary interests and decision-making autonomy.
Discussion:
- The authors argue that Miller and Joffe's position largely aligns with their own, despite claims to the contrary.
- The debate centers on whether the prospect of poorer outcomes should be the primary motivator for dispelling TM.
- The paper critiques the premature acceptance of widespread tolerance for TM in clinical research.
Key Insights:
- Therapeutic misconception compromises the ethical foundation of informed consent in research.
- Protecting participants' dignitary interests and decision-making capacity is paramount.
- Empirical data on dispelling TM and its effects on recruitment are currently lacking.
Outlook:
- Further empirical research is needed to understand effective strategies for dispelling TM.
- The impact of interventions to address TM on participant recruitment requires investigation.
- A cautious approach is warranted regarding the tolerance of TM in clinical research settings.
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