Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis.

Informed consent documents from U.S. psilocybin clinical trials often emphasize mental health and physical risks but rarely include psychedelic-specific elements like ineffability or therapeutic touch, despite calls from bioethicists for tailored consent forms. A content analysis of 28 documents from 13 sites found good coder reliability. The results suggest that while general risks are well covered, the unique features of psychedelic experiences are not consistently addressed in consent materials. The authors recommend ongoing debate about which elements are most important for potential participants to consider when deciding whether to join a study.

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Abstract

Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been discussed as posing challenges to the informed consent process. A growing call for tailored informed consent documents (ICDs) in the psychedelic bioethics literature raises the question of how closely ICDs used in contemporary psychedelic trials reflect the concrete suggestions and proposals offered by psychedelic bioethicists. In this article, we review ICDs from psilocybin clinical trials in the United States. Using a content analysis approach, we provide a systematic qualitative description of the ICDs which comprise our final sample (N = 28; 28 clinical trials across 13 unique sites). Coders demonstrated good reliability (κ = .683). Qualitative analyses revealed that most of the coding aligned with expectations based upon the psychedelics bioethics literature, such as the emphasis on mental health risks and physical risks in ICDs. Notably, psychedelic-specific codes (e.g., ineffability, therapeutic touch) did not appear as frequently in ICDs. Scholars in psychedelic bioethics have called for the inclusion of a variety of potential risks and benefits in ICDs. It will be important to continue debating which elements are worth including in ICDs such that potential research participants are presented with the most salient factors relevant to their decision about joining a study. We provide a table of best practices applied by our sample of ICDs.