Journal of Medical Ethics
May 27, 2020
William Smith, Dominic Sisti
142 citations
Recent early-phase trials suggest psychedelics offer novel benefits for treating mental health and substance use disorders, producing experiences unlike other treatments, such as feelings of unity, loss of self-importance, and encountering deep reality or God. Focusing on psilocybin, the authors argue these unique features pose novel risks that require an enhanced informed consent process—more comprehensive than typical for psychiatric medications. They highlight key issues for consent, suggest discussion prompts, and respond to objections, concluding with ethical considerations as psychedelics move from controlled research into mainstream clinical psychiatry.
AJOB neuroscience
January 1, 2023
Andrew Peterson, Emily A Largent, Holly Fernandez Lynch et al.
42 citations
Psychedelic drugs are not currently offered to people with Alzheimer's disease and related dementias, but interest is growing in using them to treat underlying causes and psychiatric symptoms. This paper proposes a research agenda for examining the ethics of psychedelic medicine and research involving persons with AD/ADRD. It offers preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; the effect of "ego dissolution" on those experiencing a pathology of self; how psychedelics might affect caregiving; the potential exploitation of patient desperation; institutional review boards' orientation to psychedelic research; and methods to reduce inequity. These issues are magnified for AD/ADRD but also relevant to other clinical populations.
JAMA network open
June 3, 2024
Amy L McGuire, I Glenn Cohen, Dominic Sisti et al.
41 citations
A consensus statement from a 2023 meeting of 27 experts identifies 20 points of consensus across five ethical issues for integrating psychedelic medicines into mainstream medical practice: reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping. The meeting included clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists. The statement focuses on government-approved medical use in the US and abroad, emphasizing that policymakers must address challenges ahead while acknowledging the hopeful moment.
Frontiers in Psychiatry
May 25, 2022
Kevin Mintz, Brinn Gammer, Amanda Khan et al.
13 citations
Clinical trials for psychedelic therapies have increased but often exclude individuals with physical and sensory disabilities, risking structural ableism. Drawing on disability studies and medical ethics, the authors recommend prioritizing inclusion, providing accommodations, training facilitators in disability awareness, and practicing cultural humility. These steps aim to address mental health burdens faced by disability communities and spur further debate on accessibility.
Hastings Cent Rep
July 1, 2024
Daniel Rosenbaum, Crystal Hare, Emma Hapke et al.
10 citations
Experiential training—where aspiring therapists undergo psychedelic-assisted therapy themselves—should not be mandatory, according to an ethical analysis applying Sandell et al.'s framework of training therapy functions. The analysis identifies five potential benefits (therapeutic, modeling, empathic, persuasive, and theoretical functions) but weighs them against six domains of risk: physical and psychological harms, negative effects on therapeutic skill, justice and equity concerns, dual relationships, privacy breaches, and undue pressure. Because many programs already include experiential components, the authors argue that the analysis can inform risk-mitigation strategies rather than justify a requirement.
Frontiers in Psychiatry
June 17, 2022
Andrew Beswerchij, Dominic Sisti
9 citations
Adopting precise, non-stigmatizing terminology grounded in the medical model can advance both the science and public acceptance of psychedelics. Researchers and clinicians should distinguish between medical, recreational, and spiritual uses to set clear boundaries and expectations for patients. Replacing colloquial names with scientific names for medicines and therapies may help correct misconceptions held by professionals and the public. A harmonized medical lexicon provides a common language for important communication, such as informed consent. Recommendations draw on communications research in addiction medicine to encourage development and implementation of non-stigmatizing terminology in psychedelic research and treatment.
Nature Medicine
January 1, 2024
William Smith, Dominic Sisti, Paul S. Appelbaum
8 citations
No Summary
Perspectives in biology and medicine
January 1, 2023
Gail A. Edelsohn, Dominic Sisti
8 citations
Recent clinical trials of psychedelic drugs such as MDMA and psilocybin, administered with psychotherapy, have shown promise for treating PTSD and treatment-resistant depression in adults, leading to FDA breakthrough therapy designations. This raises the question of whether such treatments should be tested in minors, who suffer from many of the same conditions. Examining historical psychedelic research on children from 1959 to 1974 reveals significant methodological and ethical flaws. The essay argues that the ineffable nature of the psychedelic experience makes informed proxy consent especially challenging for parents and guardians.
Perspectives in biology and medicine
January 1, 2024
Logan Neitzke-Spruill, Neşe Devenot, Dominic Sisti et al.
7 citations
Psychedelics are again being studied for their traditional uses, medical applications, and social implications. As evidence for their clinical potential grows, researchers seek mechanisms explaining psychedelic effects and therapeutic efficacy. This paper reviews three frameworks—neurobiological, psychological, and spiritual—for understanding these effects and explores their implications for ethics and professional competencies in psychedelic medicine. The authors suggest interdisciplinary education to improve communication, develop multi-level models, and foster collaboration. They caution against overemphasizing neuro-mechanisms, risks from inducing vulnerable states, and challenges integrating spiritual frameworks. Developing new models that reflect emerging knowledge is a central goal for psychedelic science.
Journal of Psychedelic Studies
July 15, 2024
Christopher Quasti, Dominic Sisti
5 citations
Psychedelic-assisted therapy (PAT) is experiencing renewed clinical interest for treating mental health conditions. Philosophers can contribute to PAT during both the preparation and integration phases by offering philosophical insights and providing conceptual language to articulate the complex philosophical aspects of a psychedelic experience.
Perspectives in biology and medicine
January 1, 2024
Dominic Sisti
1 citation
A special section introduction describes the resurgence of interest in psychedelics as psychotherapeutic agents after half a century of prohibition following the 1971 War on Drugs. The authors note that from roughly 1940 to 1970, psychedelics like psilocybin and LSD were studied for treating alcoholism, depression, and childhood autism. In June 2023, an interdisciplinary group met at Cold Spring Harbor Laboratory to develop a bioethical framework for responsible clinical use. The section presents three papers on ethical issues, including explanatory models of therapeutic mechanisms, neuroreductionism versus subjective experience, and the possibility of informed consent for transformative psychedelic experiences. The authors argue that consent remains possible despite the unique nature of these treatments.
Psychiatric services (Washington, D.C.)
July 1, 2026
Joshua Mitchell, Benjamin Bregman, Renuka Surujnarain et al.
Telehealth platforms expanded access to mental health care during the COVID-19 pandemic, including online prescribing of ketamine for off-label psychiatric use. A wrongful death lawsuit against a telehealth ketamine provider illustrates how combining off-label prescribing with on-demand delivery can weaken clinical safeguards. With limited oversight of many telehealth platforms and the drugs they prescribe, responsibility for patient safety falls heavily on clinicians. To sustain responsible care, structures must support robust clinical relationships, monitoring, and accountability.
Psychedelic Medicine
April 23, 2026
Jill Oliver Robinson, Ruiying (aria) Xiong, Logan Neitzke-Spruill et al.
A survey of 212 US institutional review board (IRB) chairs found that many lack knowledge about psychedelic risks and benefits, with 35–51% reporting gaps. Most chairs expressed neutral attitudes toward psychedelics (35–47%) and similar confidence reviewing psychedelic and nonpsychedelic protocols (61–78%). However, 33–53% reported heightened concern about psychedelic administration research, including legal, employment, and social risks, participant safety, consent challenges, and vulnerable populations. About half (47.2%) saw heightened institutional risk. Most (82.9%) agreed with requiring extensive monitoring of psychedelic sessions, but views on other protections varied widely. The findings suggest IRBs are not broadly conservative but uncertain, with concerns mirroring unsettled issues in the field.