Ethical Complexities and Best Practices in Informed Consent Processes for Psilocybin Services: A Qualitative Study

Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. The current study sought expert recommendations on informed consent challenges, best practices and recommendations for supervised psilocybin experiences across various settings. Participants with psilocybin content expertise and psilocybin providers were recruited with purposive sampling. Qualitative interviews on informed consent best practices and recommendations were analyzed using Thematic Analysis. Participants (N = 36; 71% white; 53% female) reported providing psilocybin services (64%) for a mean of 15.2 (SD = 13.1) years in clinical trial, underground, or ceremonial settings. Participants viewed informed consent as a process (Theme 1), necessitating a strong therapeutic relationship, centering client empowerment, and occurring as an ongoing process. Potential risks and benefits should be comprehensively conveyed (Theme 2), including potential long-term psychological and social changes from psychedelic use, and the potential for disappointing experiences. Participants specifically recommended detailed consent processes around touch and boundaries (Theme 3), including explicitly establishing boundaries prior to psychedelic administration, maintaining those boundaries throughout, and recognizing subtle non-verbal cues that may indicate lack of true consent. For provider training (Theme 4), participants emphasized cultivating a deep respect for client agency, and experientially learning relational and boundary setting skills. Findings may inform provider training programs, consent practices in varied psychedelic service settings, and improved safety practices.