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 evidentiary standards. Alternatively, it may be that psychedelics have more in common with various existing medical interventions than first meets the eye. We argue in (...) favor of the latter position, drawing on parallels from earlier debates around genetic exceptionalism in bioethics. We suggest there are risks to adopting a stance of “psychedelic ethical exceptionalism,” and propose that consistent ethical rules and evidentiary standards should be applied across all relevant areas of clinical medicine. Importantly, this does not preclude the possibility that changes to existing standards should be made; but if so, this should not be justified by appealing to the alleged uniqueness of psychedelics. (shrink)

Psychedelics are experiencing a renaissance in mental healthcare. In recent years, more and more early phase trials on psychedelic-assisted therapy have been conducted, with promising results overall. However, ethical analyses of this rediscovered form of treatment remain rare. The present paper contributes to the ethical inquiry of psychedelic-assisted therapy by analysing the ethical implications of its therapeutic mechanisms proposed by the relaxed beliefs under psychedelics (REBUS) hypothesis. In short, the REBUS hypothesis states that psychedelics make rigid beliefs revisable by increasing (...) the influence of bottom-up input. Put differently, patients become highly suggestible and sensitive to context during a psychedelic session, amplifying therapeutic influence and effects. Due to that, patients are more vulnerable in psychedelic-assisted therapy than in other therapeutic interventions; they lose control during a psychedelic session and become dependent on the therapeutic setting (including the therapist). This enhanced vulnerability is ethically relevant and has been exploited by some therapists in the past. Therefore, patients in current research settings and starting mainstream medical settings need to be well informed about psychedelics’ mechanisms and their implications to give valid informed consent to treatment. Furthermore, other security measures are warranted to protect patients from the vulnerability coming with psychedelic-assisted therapy. (shrink)

Psychedelic experiences are often compared to “transformative experiences” due to their potential to change how people think and behave. This study empirically examines whether psychedelic experiences constitute transformative experiences. Given psychedelics’ prospective applications as treatments for mental health disorders, this study also explores neuroethical issues raised by the possibility of biomedically directed transformation—namely, consent and moral psychopharmacology. To achieve these aims, we used both inductive and deductive coding techniques to analyze transcripts from interviews with 26 participants in psychedelic retreats. Results (...) indicate that psychedelic experiences can constitute transformative experiences. Twenty participants reported experiences or insights that were seemingly inaccessible or impossible to attain if not for the psychoactive effects of psychedelics. All participants besides one reported some change in identity, values, beliefs, desires, and behavior—changes in behavior being the most common. Participants also reported feeling capable deciding to use psychedelics in part due to information seeking prior to their retreats. Finally, several participants reported an enhanced capacity for enacting changes in their lives. Our results underscore both the importance of subjective embodiment to transformation and the role of transformative agency in shaping outcomes of the psychedelic experience. We examine our results relative to neuroethical issues and advocate for centering the person in psychedelic research and neuroethical inquiry about psychedelics to avoid pitfalls associated with psychedelics’ potential as moral psychopharmacological agents. (shrink)

In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem to informed consent. (...) The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

A psychedelic renaissance is currently taking place in mental healthcare. The number of psychedelic-assisted therapy trials is growing steadily, and some countries already grant psychiatrists special permission to use psychedelics in non-research contexts under certain conditions. These clinical advances must be accompanied by ethical inquiry. One pressing ethical question involves whether patients can even give informed consent to psychedelic-assisted therapy: the treatment’s transformative nature seems to block its assessment, suggesting that patients are unable to understand what undergoing psychedelic-assisted therapy actually (...) means for them and whether it aligns with their values. The present paper argues that patients often have sufficient knowledge to give informed consent because they know that they want to change their negative status quo and that psychedelic-assisted therapy offers an effective way to do so. Accordingly, patients can understand what the transformative nature of psychedelic-assisted therapy means for them and a make a value-aligned choice even if they are unable to anticipate the manifestation of a psychedelic experience. (shrink)

In the historical context of a crisis in biological psychiatry, psychedelic drugs paired with psychotherapy are globally re-emerging in research clinics as a potential transdiagnostic therapy for treating mood disorders, addictions, and other forms of psychological distress. The treatments are poised to soon shift from clinical trials to widespread service delivery in places like Australia, North America, and Europe, which has prompted ethical questions by social scientists and bioethicists. Taking a broader view, we argue that the ethics of psychedelic therapy (...) concerns not simply how psychotherapies are different when paired with psychedelic drugs, but how psychedelic therapies shape and are shaped by different values, norms, and metaphysical commitments. Drawing from the published literature and interviews with seven psychedelic therapists working in clinical trials in the United States, Germany, Switzerland, and Australia, this article opens the black box of the treatments to consider the values and informal debates currently animating the therapies. Considering questions of patient autonomy, mechanisms of therapeutic action, and which therapies are best suited to pair with psychedelic substances, we examine the ethics of psychedelic therapy as an emergent form of life. To bring this form of life out in fuller relief, we conclude by comparing and contrasting it with ayahuasca use in Amazonian shamanism. (shrink)

Peterson et al. (2023) present a range of ethical issues that arise when considering the use of psychedelic substances within medicine. But psychedelics are, by their nature, boundary-dissolving, a...

This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and information handle (...) transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these. (shrink)

More and more, we face AI-based products and services. Using these services often requires our explicit consent, e.g., by agreeing to the services’ Terms and Conditions clause. Current advances introduce the ability of AI to evolve and change its own modus operandi over time in such a way that we cannot know, at the moment of consent, what it is in the future to which we are now agreeing. Therefore, informed consent is impossible regarding certain kinds of AI. Call this (...) the problem of radical ignorance. Interestingly, radical ignorance exists in consent contexts other than AI, where it seems that individuals can provide informed consent. The article argues that radical ignorance can undermine informed consent in some contexts but not others because, under certain institutional, autonomy-protecting conditions, consent can be valid without being (perfectly) informed. By understanding these institutional conditions, we can formulate practical solutions to foster valid, albeit imperfectly informed consent across various decision contexts and within different institutions. (shrink)

Moral enhancement proposals struggle to be both plausible and ethically defensible while nevertheless interestingly distinct from both cognitive enhancement as well as (mere) moral education. Brian Earp (_Royal Institute of Philosophy Supplement_ 83:415–439, 12 ) suggests that a promising middle ground lies in focusing on the (suitably qualified) use of psychedelics as _adjuncts_ to moral development. But what would such an adjunctive use of psychedelics look like in practice? In this paper, I draw on literature from three areas where techniques (...) for moral development have been discussed: psychotherapy (e.g., Overholser 2010; Burns 1980) education (e.g., Uhl and Lütge, 2018), and AI-assisted enhancement (e.g., Lara and Deckers, _Neuroethics_ 13(3):275–287, 17 ) in order to propose more concrete ways in which to use psychedelics as adjuncts to moral development. It is shown that in each of these areas, we can see that _trusting_ relationships (e.g., Baier 1986; Hawley 2019) between the facilitator and the agent will very plausibly maximize the success of this type of moral enhancement. Finally, I appeal to literature on informed consent for use of psychedelics (e.g., Smith and Sisti, _Journal of Medical Ethics_, 22 ; Johnson et al., _The Journal of Psychopharmacology_ 22(6):603–20, 23 ) and on the therapeutic relationship in psychotherapy (e.g., Dryden and Reeves 2013; Horvath et al. 2011) to outline concrete suggestions for facilitating dimensions of trust most likely to maximize the benefits of (adjunctive) psychedelic moral enhancement. The result is a newly detailed practical proposal for how we might best facilitate moral enhancement by using drugs as adjuncts to moral development. (shrink)

In this opinion piece we propose the investigation of psychedelic-assisted psychotherapy for the treatment of body dysmorphic disorder (BDD). BDD is a psychiatric disorder characterised by appearance-based preoccupations and accompanying compulsions. While safe and effective treatments for BDD exist, non-response and relapse rates remain high. Therefore, there is a need to investigate promising new treatment options for this highly debilitating condition. Preliminary evidence suggests safety, feasibility, and potential efficacy of psychedelic treatments in disorders that share similar psychopathological mechanisms with BDD. (...) Drawing on this evidence, as well as on relevant qualitative reports and theoretical proposals, we argue that it would be worthwhile to conduct a phase 2a study aimed at assessing the safety and feasibility of psychedelic-assisted psychotherapy in BDD. We also offer some suggestions for how future research ought to proceed. (shrink)

Background: Psychedelics are known for their powerful mental effects due to the activation of 5HT-2A receptors in the brain. During the 1950s and 1960s, research was conducted on these molecules until their criminalization. However, their clinical investigation as therapeutic tools for psychiatric disorders has revived the deontological ethics surrounding this subject. Questions arise as research on their therapeutic outcome becomes a reality. We aim to explore deontological ethics to understand the implications of psychedelics for the clinician, patient, and society. Results: (...) A total of 42 articles were considered for this review. Methods: A methodological search of psychedelic studies from 2017 to 2022 was conducted in PubMed, Scopus, EBSCOhost, and ScienceDirect to address the deontological ethics of clinical psychedelic use. Conclusion: Psychedelics need to be culturally contextualized, epistemic harm minimized and represented to ensure informed consent. Open data and commissions are needed to ensure safe and equal distribution. (shrink)

Eating disorders are debilitating diseases that have twin impacts on the body and mind and are associated with a number of physiological and psychological comorbidities (Blinder, Cumella, and Sanathara 2006; Casiero and Frishman 2006), including increased suicide risk (Arcelus et al. 2011; Lipson and Sonneville 2020). In addition, eating disorders are growing in prevalence (Gilmache et al. 2019) and impact women at much higher rates than men (Bearman, Martinez, and Stice 2006), especially in adolescence (Spriggs, Kettner, and Carhart-Harris 2021). Anorexia (...) nervosa (AN) is a particularly devastating eating disorder, with one of the highest mortality rates of any psychiatric disorder (Sullivan 1995). Despite the severity of the condition, current treatments for AN are limited in their efficacy (Khalsa et al. 2017). Based on the growing body of evidence demonstrating the short-term and long-term efficacy of psychedelic-assisted psychotherapy for the treatment of other mental illnesses, I argue that research into psychedelic-assisted psychotherapy for AN should be funded. (shrink)

Classic serotonergic psychedelics are experiencing a clinical revival, which has also revived ethical debates about psychedelic-assisted therapy. A particular issue here is how to prepare and protect patients from the vulnerability that the psychedelic state creates. This article first examines how this vulnerability manifests itself, revealing that it results from an impairment of autonomy: psychedelics diminish decision-making capacity, reduce controllability, and limit resistance to external influences. It then analyzes the strengths and weaknesses of five safety measures proposed in the literature, (...) what aspect of the patient’s vulnerability they seek to reduce, and how they can be optimized. The analysis shows that while preparatory sessions, advance directives, and specific training and oversight are useful, starting with a lower dosage and no therapy is less so. Finally, the article presents a safety measure that has been overlooked in the literature but could be highly effective and feasible: bringing a close person to the psychedelic session. (shrink)

Serotonergic (or “classic”) psychedelics have struck many researchers as raising significant philosophical questions that, until recently, were largely unexplored by academic philosophers. This paper provides an overview of four emerging lines of research at the intersection of academic philosophy and psychedelic science that have gained considerable traction in the last decade: selfless consciousness, psychedelic epistemology, psychedelic ethics, and spiritual/religious naturalism. In this paper, we highlight philosophical questions concerning (i) psychedelics, self-consciousness, and phenomenal consciousness, (ii) the epistemic profile of the psychedelic (...) experience; (iii) ethical concerns about the appropriate use of psychedelics; and (iv) whether spiritual or religious dimensions of psychedelic use are compatible with a naturalistic worldview. (shrink)

The nascent for-profit psychedelic industry has begun to engage in corporate practices like funding scientific research and research programs. There is substantial evidence that such practices from other industries like tobacco, alcohol, pharmaceuticals and food create conflicts of interest and can negatively influence population health. However, in a context of funding pressures, low publicly funded success rates and precarious academic labor, there is limited ethics guidance for researchers working at the intersection of clinical practice and population health as to how (...) they should approach potential financial sponsorship from for-profit entities, such as the psychedelic industry. This article reports on a reflective exercise among a group of clinician scientists working in psychedelic science, where we applied Adams’ (2016) PERIL (Purpose, Extent, Relevant harm, Identifiers, Link) ethical decision-making framework to a fictionalized case of corporate psychedelic financial sponsorship. Our analysis suggests financial relationships with the corporate psychedelic sector may create varying degrees of risk to a research program’s purpose, autonomy and integrity. We argue that the commercial determinants of health provide a useful framework for understanding the ethics of industry-healthcare entanglements and can provide an important population health ethics lens to examine nascent industries such as psychedelics, and work toward potential solutions. (shrink)

Psychedelic treatments, particularly 3,4-methylenedioxymethamphetamine (MDMA)-assisted and psilocybin-assisted therapies, have recently seen renewed interest in their clinical potential to treat various mental health conditions. Clinical trials for both MDMA-assisted and psilocybin-assisted therapies have shown to be highly efficacious for post-traumatic stress disorder and major depression. Recent research trials for psychedelic-assisted therapies (PAT) have demonstrated that although they are resource-intensive, their effects are rapid-acting, durable and cost-effective. These results have generated enthusiasm among researchers seeking to investigate psychedelic therapies in active-duty service members (...) of the US military, particularly those with treatment refractory mental health conditions. At the same time, psychedelics remain in early stages of clinical investigation, have not yet achieved regulatory approval for general clinical use and may confer unique psychological and neurobiological effects that could raise novel ethical considerations when treating active-duty service members. Should psychedelics achieve regulatory approval, military relevant considerations may include issues of access to these treatments, appropriate procedures for informed consent, confidentiality standards, and possible unanticipated mental health risks and other psychological sequelae. A service member’s deployability, as well as their ability to return to full military duty following PAT, may also be of unique concern. The authors argue that MDMA-assisted therapy currently represents a promising treatment that should be more rapidly investigated as a clinical therapy for service members while still taking a measured approach that accounts for the many military-specific uncertainties that remain. (shrink)

This essay engages with the (re)emergence of psychedelic medicine and the idea of psychedelics drugs and the experiences they induce as a developing therapeutic modality. It does so in the context of the provision of psychedelics to terminally ill patients experiencing existential distress as they approach the end of their lives. Reflecting on such suggestions facilitates an examination of a specific aspect of psychedelics and/ as medicine (or palliative care), namely questions of meaning and meaninglessness. Understood as impacting one’s ability (...) to make or _realise_ meaning in life, existential distress commonly entails a degree of demoralisation. In some cases, individuals can be thought of as inhabiting (and being inhabited by) a sense of meaninglessness. In contrast, the experiences psychedelics seem to induce are often imbued with a great deal of meaning, a sense of which seems to continue long after the psychoactive effects of such drugs have ceased. Whilst briefly considering whether or not meaning can properly be thought of as a matter for healthcare or a medical concern, this paper seeks to highlight some of the implications that the advent of psychedelic medicine might have. By way of a conclusion, I enjoin bioethics in recognising itself as a meaningful cultural discourse that is implicated in the future(s) of medicine, psychedelics and being human. (shrink)

According to L.A. Paul, undergoing an experience is transformative if we learn something we cannot learn without having the experience and if it substantially changes our point of view. While the implications of transformative experiences have primarily been discussed in the context of rational choice, their underlying concept has also proven fruitful in the context of unchosen occurrences. The present paper examines mental disorder and its treatment from a transformative experiential perspective, using major depressive disorder as an exemplary case. It (...) shows that developing a mental disorder typically requires a transformative experience since the two popular mental disorder classification systems primarily classify such disorders on an experiential basis. This provides an explanation for the lack of understanding mentally disordered people often face: their experiential state is epistemically inaccessible for those who have not experienced a similar state before. Furthermore, successful treatment of mental disorder again requires a (personally) transformative experience that results in the disorder’s overcoming. The paper examines pharmacological, psychological, and psychedelic-assisted treatment and reveals that each of them uses a different transformative route to recovery: a finding relevant, for example, to ongoing debates in medical ethics about informed consent. (shrink)

Après des cas très médiatisés d’agressions sexuelles et d’autres comportements contraires à l’éthique de la part de thérapeutes, la recherche clinique récente sur les drogues psychédéliques a généralement rendu obligatoire l’enregistrement vidéo de toutes les séances de thérapie. Dans cet article, j’examine les questions éthiques liées à l’enregistrement vidéo dans le contexte unique des séances de thérapie psychédélique. Je commence par résumer les avantages et les risques importants liés à l’enregistrement vidéo, puis ensuite les préoccupations éthiques concernant l’enregistrement obligatoire des (...) séances de thérapie psychédélique du point de vue du patient, et je soutiens que ces préoccupations doivent être prises au sérieux par les cliniciens et chercheurs. J’examine également le point de vue selon lequel l’enregistrement vidéo est essentiel pour la sécurité des cliniciens. Acceptant la légitimité des préoccupations des deux points de vue, j’expose quelques considérations de base sur le consentement éclairé qui pourraient générer un dialogue autour des préoccupations potentielles des patients. Je défends l’option de refuser, tant pour les patients que pour les cliniciens. En conclusion, je souligne l’importance de poursuivre l’enquête bioéthique critique et la recherche qualitative concernant les pratiques d’enregistrement vidéo dans le contexte des thérapies assistées par les psychédéliques. (shrink)

In chapter “Epiphanies and Aspirations: How Psychedelic Experiences Affect Values”, Juuso Kähönen attempts to provide a better understanding of psychedelic drug-induced value changes and reconnections in the user. And he does so by examining the relation between epiphanic transformative experiences, on the one hand, and aspirations—both before and after said experiences—on the other. Specifically, Kähönen argues that psychedelic experiences can temporarily expand, both in width and depth, one’s understanding of values, thereby producing epiphanic transformative experiences and inspiring long-term aspirations toward (...) values. And he contends that, because the user’s prior aspirations shape the context and content of psychedelic experience while epiphanic transformative experiences can inspire subsequent aspirations, such experiences and aspirations can potentially reinforce each other, resulting in what he refers to as a “hermeneutic” process of value learning. (shrink)

In their target article, Peterson et al. discuss the intriguing prospect of using psychedelics as a treatment for patients with Alzheimer’s Disease and Related Dementias (AD/ADRD) (Peterson et al....

Background Psychedelic medicine is a rapidly growing area of research and policy change. Australia recently became the first country to legalize the prescription of psychedelics and serves as a case study of issues that may emerge in other jurisdictions. Despite their influence as a stakeholder group, there has been little empirical exploration of psychedelic researchers’ views on the development of psychedelic research and the ethical concerns. Methods We thematically analysed fourteen interviews with Australian psychedelic researchers. Results Three themes were constructed (...) from the data: 1) coming out of the shadow of the 1960s, 2) challenges and affordances in engaging stakeholders, and 3) growing pains in innovation and translation. Conclusion The results illustrated tensions arising from the rapid growth of psychedelic research from a small group of dedicated individuals with a similar worldview, to a multi-interest, regulated industry. Participants’ experiences and viewpoints were influenced by the history of psychedelic research, and this was met with an overarching concern for protecting the field from premature discontinuation, as well as maximizing potential positive impacts. Targets for stakeholder collaboration and initiatives to support responsible innovation in psychedelics include equitable access, sustainable industry involvement, productive research agendas, responsible reporting of evidence, and risk-taking within the relative safety of clinical trials. (shrink)

Cheung et al. (2025) rightly argue that psychedelics should be subject to ethical and evidentiary standards consistent with clinical medicine at large, rather than exceptionalism based on their uni...

The presence of unusual features in psychedelic treatments has led to the argument that these treatments are exceptional within medicine and should therefore also be treated as exceptional when ana...

Both ethicists and lawyers accept that a provider – be it a researcher or a clinician – should provide sufficient information for a reasonable person to make an informed decision about whether they wish to go ahead with the proposed intervention or treatment.1 They are bound to do so both because they have an ethical responsibility to preserve the individual’s autonomous decision making, and, in many countries, because the law obliges them to. In this month’s issue of the JME, three (...) articles tackle ethical issues relating to consent in different contexts. Overarching these analyses is the pragmatic question of whether the process of taking consent in itself might alter the outcomes, and whether, in doing so, it can undermine the initial therapeutic or research goal – so creating another ethical question of what to prioritise. Psilocybin is entering Phase III trials to evaluate its effect on treatment resistant depression and cancer related depression and anxiety; earlier trials have shown sustained symptom reduction in these populations. Smith and Sisti examine whether a form of enhanced consent is ethically required for these drugs.2 They explore how to adequately consent for ‘therapeutic touch’ in a future altered state; the rare but significant mental health risks including trauma re-exposure; and the potential for a personality change given the intense experiences which many subjects have reported. They illustrate the potential for personality change with an example regarding the spiritual experiences which can occur with serotonergic psychedelics, and suggest that ‘agnostic or atheist patients may take the development of a newfound sense of spirituality or belief in God to …. (shrink)

Recent evidence shows significant potential for therapies involving psychedelic substances such as psilocybin and MDMA to improve clinical outcomes for patients experiencing various mental disorders. However, research to date focuses almost exclusively on adults. I argue that adolescents should be included in research into psychedelic therapies. First, I demonstrate the pressing need for novel interventions to address the growing mental health burden of adolescents, and I draw on empirical evidence to show that research into psychedelic therapies presents an opportunity to (...) address this shortfall. Secondly, I argue that psychedelics pose low risk to young patients, particularly relative to existing psychiatric medications. I then address two major concerns specific to adolescent contexts. First, I address the risks of using psychedelic substances at earlier stages of physiological and cognitive development. I note that the lack of understanding of the risks underscores the need for including adolescents in research. I then address the added complexity of consent in the adolescent context. I highlight some additional concerns that should be addressed in an “enhanced” informed consent process for adolescents and defend the view that capable adolescents should be able to consent to psychedelic interventions. I ultimately hold that including adolescents in emerging psychedelic research has the potential to substantiate innovative treatments that could improve their clinical outcomes, long-term mental health and quality of life. (shrink)