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Ethical issues with psychedelic-assisted treatments in psychiatry: A systematic scoping review.

Psychological medicine·2025
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Transient or transformative? Psychedelics, agency and informed consent.

Chiara Caporuscio1,2,3

  • 1Psychedelic Substances Research Group, Department of Psychiatry and Neurosciences, Campus Charité Mitte, Charite - Universitatsmedizin Berlin, Berlin, Berlin, Germany caporusciochiara1@gmail.com.

Journal of Medical Ethics
|March 10, 2026
PubMed
Summary

In psychedelic-assisted therapy, valid informed consent is questioned due to potential value system shifts. This research proposes a two-step transformation model, where sober reflection post-psychedelic experience validates consent.

Keywords:
Informed ConsentPsychiatryPsychopharmacologyPsychotherapy

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Area of Science:

  • Neuroscience
  • Psychology
  • Bioethics

Background:

  • Psychedelic experiences are often linked to profound personal transformation.
  • This transformative potential raises ethical concerns regarding informed consent in psychedelic-assisted therapy.
  • Specifically, the capacity of altered states of consciousness to change core values challenges the validity of prior consent.

Purpose of the Study:

  • To address the ethical challenge of informed consent in psychedelic-assisted therapy.
  • To re-evaluate the understanding of psychedelic-mediated transformation.
  • To propose a framework that supports the validity of informed consent.

Main Methods:

  • Philosophical analysis of existing literature on psychedelic experiences and informed consent.
  • Conceptual framework development for understanding psychedelic-mediated transformation.
  • Argumentation based on a two-step model of transformation.

Main Results:

  • The view that psychedelic experiences invalidate consent stems from an oversimplified understanding of transformation.
  • Psychedelic-mediated transformation is not solely dependent on the acute psychedelic experience.
  • Lasting change requires a subsequent sober, agentic process of integration.

Conclusions:

  • A nuanced, two-step model of psychedelic transformation, encompassing both the experience and subsequent integration, alleviates ethical concerns regarding informed consent.
  • This model emphasizes the patient's active role in achieving lasting change.
  • Valid informed consent can be maintained within psychedelic-assisted therapy frameworks.