Essentials of Informed Consent to Psychedelic Medicine
JAMA Psychiatry April 10, 2024 Mason Marks, Rebecca Weintraub Brendel, Carmel Shachar et al. 46 citations
As interest in psychedelics for mental health treatment grows, legal reforms and regulatory approvals are advancing faster than standards for informed consent. Psychedelics pose unique challenges for consent, including perceptual disturbances, personality changes, altered metaphysical beliefs, risks of abuse or coercion, and the role of touch and data collection. Current consent documents in clinical trials often overlook these elements. Seven essential components for psychedelic informed consent are identified, and sample language and procedures are proposed to address the gap.