Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis.
AJOB empirical bioethics July 16, 2025 Katherine Cheung, Caleigh Propes, Marianna Graziosi et al. 4 citations
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.