Informed consent forms from U.S. trials of psychedelic-assisted therapy generally meet federal requirements, but they often omit information about the unique vulnerability participants experience while under the influence of psychedelics. A review of 19 publicly available consent forms from trials using psilocybin, LSD, MDMA, or ketamine alongside psychotherapy found that while risks, benefits, and safety protocols were covered, missing elements related to participant vulnerability should be included to ensure truly informed consent. The authors suggest modifying existing policy to address these gaps.
Psychedelic-assisted therapy raises urgent ethical concerns, particularly regarding power imbalances that can lead to sexual abuse. This paper examines how altered states of consciousness in therapeutic settings create vulnerabilities, and it outlines pathways for developing ethical practices and regulatory frameworks to prevent misconduct. The authors argue that understanding therapeutic dynamics is critical to protecting patients and ensuring professional accountability in this emerging field.