Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials
Journal of Psychedelic Studies November 20, 2023 Tahlia R. Harrison 23 citations
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.