Ethics of psychedelics in clinical research: a state-of-the-field review

Abstract

Psychedelics—psychoactive substances that have characteristic effects on perception, cognition and mood—are attracting renewed clinical and policy attention for their potential to treat a range of conditions. Various ethical tensions are present in psychedelic clinical trials due to several characteristics of psychedelics and the psychedelic experience, including acute alterations of consciousness, the potential for long-term changes in personality and values, participant vulnerability and the depth of facilitator-participant relationships. These features generate ethical considerations for informed consent, risk communication, scientific integrity and post-trial responsibilities, among others. This article provides a state-of-the-field narrative review of ethical issues in psychedelic trials, organised according to key stages of a psychedelic clinical trial: study design, recruitment, screening, informed consent, preparation, drug administration, follow-up and post-trial. It identifies both stage-specific and cross-cutting challenges, and cautions against taking a stance of psychedelic ethical exceptionalism, or the belief that psychedelics are so radically different that higher or lower normative standards should be applied to them in research and practice. By mapping ethical considerations onto the clinical trial lifecycle, this review offers a framework to assist investigators, Institutional Review Boards and policymakers in anticipating and addressing the evolving ethical landscape of psychedelic clinical research and medicine.