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...
As jurisdictions across the U.S. consider enacting policies that facilitate access to psychedelics, they must determine how the desire to expand access to these substances should be weighed against the need to adequately protect safety. Oregon's psilocybin services program offers an important early case study of this balance in practice. Under the Psilocybin Services Act, adults over 21 are...
A number of proposals across different fields have suggested incorporating "independent" actors into the research process as a way to manage potential bias. For example, in response to allegations of bias in psychedelic science, some have suggested the idea of independent auditors for adverse events, as well as the incorporation of independent researchers into the research teams of psychedelic...
We are grateful to those who commented on our Target Article on ethical exceptionalism around psychedelics (see Box 1 for a summary of our main points) and to Cohen and Marks (2025) for their compl...
Classic psychedelic studies involve interpersonal interactions with participants before, during, and after the acute effects of psychedelics. In the field of psychedelic research, there is currently a debate about whether this interpersonal interaction is most accurately considered "psychological support," "psychotherapy," or something else. Proponents of the psychological support label...
This Viewpoint discusses how to fill policy gaps surrounding the use of psychedelics to treat mental health and substance use conditions, should they be approved by the US Food and Drug Administration.
The current revival of interest in classic psychedelics and other psychoactives such as ketamine and MDMA, coupled with changes to their regulatory status in many jurisdictions, necessitates rigorous ethical guidelines both within and beyond clinical and scientific contexts. This paper examines crucial ethical, philosophical, and policy considerations needed to ensure psychedelic use across...
The potential use of psychedelic-assisted therapy for adolescents with mental illness has sparked both interest and concern. Modern psychedelic research has focused on adults, and adolescents younger than 18 years are typically excluded due to ethical and legal challenges. To explore whether adolescents have been included in 21st century psychedelic research, we conducted a scoping review of...
Informed consent aims, amongst other goals, to provide robust information to prospective participants on the risks and benefits that they may incur during a study. However, participant misconceptio...
Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been discussed as posing challenges to the informed consent process. A growing call for tailored informed consent documents (ICDs) in the psychedelic bioethics literature raises the question of how closely...
Recent discussions about the methodological rigor of psychedelic clinical trials have focused on potential underreporting or misreporting of adverse events (AEs), with many calling for their systematic assessment to help mitigate these issues. In their recent paper, Palitsky et al. offer a comprehensive framework for the assessment of AEs in psychedelic-assisted therapies, with consideration of...
Randomized controlled trials (RCTs) are considered the gold standard for demonstrating the efficacy of a treatment or intervention; however, the RCT study design alone is insufficient to prevent all forms of bias. In this paper, we review conflicts of interest and other biases that pose challenges to the methodological rigor of psychedelic RCTs, and explore recommended bias mitigation measures....
A prominent critique of cognitive or athletic enhancement claims that certain performance-improving drugs or technologies may 'cheapen' resulting achievements. Considerably less attention has been paid to the impact of enhancement on the value of moral achievements. Would the use of moral enhancement (bio)technologies, rather than (solely) 'traditional' means of moral development like schooling...
Objective: This article outlines recommendations from 30 psychedelic researchers on how to create a better psychedelic safety net. Methods: A survey of 30 psychedelic researchers asked them to identify key critical research gaps around psychedelic harm and safety. Results: The critical research gaps identified by the authors included defining the main types of psychedelic harm, the predictors...
Wellcome Open ResearchJanuary 13, 2025Samuel Streicher, Christopher Register, Xiu Lim et al.2 citations
Background: Moral bioenhancement typically refers to the deliberate use of drugs or biotechnologies, potentially alongside other practices, to attempt to improve oneself morally. In addition to general concerns regarding moral self-bioenhancement, the possibility of using psychedelic substances for such purposes raises distinct ethical questions. As a first step in analysing these questions, we...
When used clinically, psychedelics may appear unusual or even unique when compared to more familiar or long-standing medical interventions, prompting some to suggest that the ethical issues raised may likewise be exceptional. If that is correct, then perhaps psychedelics should be treated differently from other medical substances: for example, by being subjected to different ethical or...
Abstract Psychedelic treatment with psilocybin is receiving increased attention following clinical trials showing it may help treat end-of-life anxiety, depression, and several other conditions. Despite this, physicians may be reluctant to prescribe psilocybin and carry out psilocybin treatment because of the stigma surrounding psychedelics and the potential for medical malpractice liability....
A number of organizations have developed or are developing psychedelic integration groups, held in person or online. In parallel, there have been calls to make enhanced integration available in the community after clinical trials. Here, we explore a potential reason why individuals may seek out these groups: namely, the feelings of disconnection and loneliness that may arise after the...
The first Hopkins-Oxford Psychedelic Ethics (HOPE) workshop convened to discuss ethical matters relating to psychedelics in August 2023 at the University of Oxford.The organizers (BDE, DBY, EJ) aim...
Background: Internationally, there is a growing interest in the potential benefits of psilocybin-assisted therapy to treat existential distress at the end of life. However, the social acceptability of this therapy is not yet well known. Aim: This study assesses the social acceptability of the medical use of psilocybin to treat existential distress at the end of life. Design: An online survey...
ABSTRACT: Psychedelics, including psilocybin, and other consciousness-altering compounds such as 3,4-methylenedioxymethamphetamine (MDMA), currently are being scientifically investigated for their potential therapeutic uses, with a primary focus on measurable outcomes: for example, alleviation of symptoms or increases in self-reported well-being. Accordingly, much recent discussion about the...
Psychedelics such as psilocybin reliably produce significantly altered states of consciousness with a variety of subjectively experienced effects. These include certain changes to perception, cognition, and affect,1 which we refer to here as the acute subjective effects of psychedelics. In recent years, psychedelics such as psilocybin have also shown considerable promise as therapeutic agents...