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I. Glenn Cohen

Environmental Law Institute

6 papers in the library · 177 citations · publishing 2021-2025

Papers

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.

DOI: 10.1001/jamapsychiatry.2024.0184 Informed consent Psychology Medline Psychiatry +4

Psychedelic Medicine Exceptionalism.

The American journal of bioethics : AJOB January 1, 2025 I. Glenn Cohen, Mason Marks 22 citations

Psychedelic medicines are undergoing a research revival, prompting debate over whether they require unique regulatory and ethical treatment or should be held to the same standards as other medical interventions. This article analyzes the arguments for and against special consideration, examining how psychedelics are researched, regulated, commercialized, and administered. It concludes that while psychedelics present distinct features, they do not inherently warrant a separate regulatory framework; instead, existing standards can be adapted to address their specific risks and benefits.

DOI: 10.1080/15265161.2025.2434398 Full text MDMA Psilocybin FDA Informed consent +7