Although psychedelics were banned from medical research for about fifty years, recent early-phase studies indicate they may offer unique therapeutic benefits for various mental health and substance use disorders. When effective, psychedelic experiences often involve phenomena not typically observed in other medical or psychiatric interventions, such as a diminished sense of self-importance, insights that are difficult to articulate, feelings of connection and unity with others, and encounters with “deep” reality or a divine presence. Beyond symptom relief, these experiences can lead to substantial shifts in an individual’s personality and worldview. Using psilocybin as a primary example, we argue that the distinct effects of psychedelics introduce specific risks that necessitate an expanded informed consent process, extending beyond standard procedures in psychiatry. We outline key considerations for consent discussions and propose prompts for enhancing informed consent in the context of psychedelic therapy. We also address possible objections and conclude by examining ethical issues likely to emerge as psychedelics transition from tightly controlled research settings to broader clinical practice.
