Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement.

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group. Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified. Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

Bio-Psycho-Spiritual Perspectives on Psychedelics: Clinical and Ethical Implications.

Psychedelics have again become a subject of widespread interest, owing to the reinvigoration of research into their traditional uses, possible medical applications, and social implications. As evidence for psychedelics' clinical potential mounts, the field has increasingly focused on searching for mechanisms to explain the effects of psychedelics and therapeutic efficacy of psychedelic-assisted therapy (PAT). This paper reviews three general frameworks that encompass several prominent models for understanding psychedelics' effects-specifically, neurobiological, psychological, and spiritual frameworks. Following our review, the implications of each framework for ethics and professional competencies in the implementation of psychedelics as medicines are explored. We suggest that interdisciplinary education may be necessary to improve communication between researchers, develop models that effectively incorporate multiple levels of analysis, and facilitate collaboration between professionals with diverse backgrounds in the implementation of psychedelic medicines. We also address pitfalls associated with overemphasis on neuro-mechanisms, risks associated with instigating vulnerable states of consciousness, and hurdles associated with the integration of spiritual frameworks in medicine. Ultimately, as psychedelics push the boundaries of explanatory frameworks focused on one level of analysis, developing new and more useful models to reflect knowledge being produced in this field should be a central aim of psychedelic science going forward.

Knowledge of evidence-based practices for PTSD among mental health court judges.

Mental health courts offer access to community-based care for defendants with psychiatric disorders, including posttraumatic stress disorder (PTSD). However, limited information is available on how judges make treatment decisions about evidence-based practices. In this qualitative study, we interviewed mental health court judges to evaluate: (1) perspectives toward the role of PTSD in criminal behavior; (2) knowledge about evidence-based practice for PTSD; (3) treatment decisions for defendants with PTSD; and (4) treatment decisions for defendants at risk for suicide, a common comorbidity with PTSD. We hypothesized that mental health court judges would report low familiarity with evidence-based practices for PTSD despite wide recognition of the impact of trauma on criminal behavior. Methods: Mental health court judges (N = 11, 60% women, 60% between 50-59 years) were recruited from 7 states in the US and completed a demographics questionnaire and semi-structured qualitative interview that was transcribed and double-coded. Results: Judges in mental health court unanimously agreed that PTSD is highly prevalent among their defendants, but that they had not having received formal education about evidence-based practices for PTSD. They reported relying on their team members to provide recommendations for treatment planning and viewed their role as the enforcer of the treatment teams' suggestions. Finally, judges also reported that suicide prevention is an important consideration and that there is a need for universal suicide risk assessments. Conclusions: These findings have implications for continuing education among judges in mental health court, and we recommend mandated training to increase awareness of evidence-based practices for PTSD and suicide prevention.

Journeying to Ixtlan: Ethics of Psychedelic Medicine and Research for Alzheimer's Disease and Related Dementias.

In this paper, we examine the case of psychedelic medicine for Alzheimer's disease and related dementias (AD/ADRD). These "mind-altering" drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; the impact of "ego dissolution" on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards' orientation to psychedelic research; and methods to mitigate inequity. These ethical issues are magnified for AD/ADRD but bear broader relevance to psychedelic medicine and research in other clinical populations.

Past Is Prologue: Ethical Issues in Pediatric Psychedelics Research and Treatment.

Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened with many of the same disorders, calls to expand experimentation to minors are inevitable. This essay examines psychedelic research conducted on children from 1959 to 1974, highlighting methodological and ethical flaws. It provides ethics and policy recommendations for psychedelics research involving children and adolescents, including recognizing that the psychedelic experience is an ineffable one that makes informed proxy consent for parents, guardians, and others especially challenging. Psychedelic experiences are associated with novel benefits and risks, such as significant personality changes, shifts in fundamental values, and possible re-exposure to traumatic memories. These effects may alter the process of personality development in minors. Recommendations for ethically sound psychedelics research in minors include strict adherence to eligibility criteria, including a comprehensive family and individual psychiatric, substance use, and trauma history. An age-appropriate assent process that includes considerations related to the use of therapeutic touch should be developed. In addition, oversight by data safety monitoring boards and patient and family advocates, coupled with the adoption of pharmacoequity best practices, will help to ensure safety and fairness of psychedelics research in children.

From Underground to Mainstream: Establishing a Medical Lexicon for Psychedelic Therapy.

We argue that non-stigmatizing and precise terminology grounded in the medical model will advance both the science and public acceptance of psychedelics. Researchers and clinicians should take care to distinguish between medical, recreational, and spiritual uses to set clear boundaries and expectations for patients. Ethically fraught or stigmatizing terms should be replaced with terminology that is medically and scientifically descriptive and accurate. A medicalized linguistic framework around psychedelics will potentially yield benefits and mitigate risks. Replacing colloquial names with scientific names for medicines and therapies may help correct misconceptions about psychedelics commonly held by both professionals and the public. A harmonized medical lexicon will also provide a common language for important instances of communication-such as the informed consent process-between professionals and participants. Our recommendations draw upon communications research in addiction medicine and aim to encourage the development, acceptance, and implementation of non-stigmatizing terminology in psychedelic research and treatment.

Physical Disability and Psychedelic Therapies: An Agenda for Inclusive Research and Practice.

Over the past decade, there has been an increase in the number of clinical trials for psychedelic therapies as treatments for a wide range of psychiatric conditions. We are concerned that research organizations overseeing these trials have neglected the inclusion of individuals with physical and sensory disabilities. We suggest that psychedelic research organizations should prioritize and plan for the inclusion of individuals with physical and sensory disabilities to address the mental health burdens they confront. Not doing so risks reinforcing structural ableism in healthcare: the discriminatory manifestation of lowered expectations toward people with disabilities on the part of medical providers. Drawing on scholarship from disability studies and medical ethics, we offer four recommendations for disability inclusion in research. We recognize particular populations shoulder significant mental health burdens; these populations deserve priority and should be given a range of accommodations. We emphasize the need for extensive disability awareness training for those facilitating psychedelic therapies and encourage psychedelic researchers and therapists to exercise cultural humility toward individuals with physical and sensory disabilities. This article should be the impetus for further scholarship and debate about how psychedelic research and therapies can be made accessible to members of disability communities who might benefit.

Rapprochement and Reform: Overcoming Factionalism in Policy Making for Serious Mental Illness.

This article traces the history of factionalism in policy making and advocacy for persons with serious mental illness from deinstitutionalization to the present. The authors draw on deliberative democratic theory to illustrate how factionalist advocacy causes advocates and policy makers to fail in their duties to represent and develop policy in support of people with serious mental illness. The authors discuss how this factionalism has bred distrust and undermined efforts to address the needs of people with serious mental illness. They propose the formation of a Public Mental Health Policy Commission, guided by principles of deliberative democracy, to overcome factionalism and to improve policy making to meet the needs of people with serious mental illness. The commission must include a diverse array of stakeholders, especially individuals with lived experience of serious mental illness.

Borderline personality disorder, therapeutic privilege, integrated care: is it ethical to withhold a psychiatric diagnosis?

Once common, therapeutic privilege-the practice whereby a physician withholds diagnostic or prognostic information from a patient intending to protect the patient-is now generally seen as unethical. However, instances of therapeutic privilege are common in some areas of clinical psychiatry. We describe therapeutic privilege in the context of borderline personality disorder, discuss the implications of diagnostic non-disclosure on integrated care and offer recommendations to promote diagnostic disclosure for this patient population.

Futility and Terminal Mental Illness: The Conceptual Clarification Continues.

Conceptual parity posits that both medical and mental illness are both simply illness, and thus should be considered as fundamentally the same, especially in health services and policy. Recent controversy over medical assistance in dying (MAID) highlights both the unequal treatment of physical and mental illnesses in end-of-life care and the need for more conceptual clarification of terminal mental illness. This article presents an argument for the necessary elements in terminal mental illness, the value of qualitative assessments, and important areas that require further research and clarity in order for terminal mental illness to be appropriately identified. Given current conceptual limitations, palliative psychiatry, and not MAID, is recommended in severely treatment-resistant cases of mental illness.

Expanding Therapeutic Jurisprudence Across the Federal Judiciary.

A patchwork of drug courts and other problem-solving courts currently exists to divert individuals with mental illness and substance use disorders away from the criminal justice system. We call for a broader implementation of problem-solving courts, particularly at the federal level, that would operate according to the principles of therapeutic jurisprudence (i.e., a framework that aims to maximize the health benefits of judicial and legislative policies and practices). Expanding federal problem-solving courts will better serve individuals with mental illness and substance use disorders in the federal criminal justice system and allow them to benefit from rehabilitation and diversion programs. This effort will also signal that the federal judiciary has recognized the criminal justice system's failure to address inmate mental health care, and that it is willing to institute changes to provide appropriate, evidence-based interventions.

When patients refuse COVID-19 testing, quarantine, and social distancing in inpatient psychiatry: clinical and ethical challenges.

The COVID-19 pandemic has introduced new ethical challenges in the care of patients with serious psychiatric illness who require inpatient treatment and who may have beeen exposed to COVID-19 or have mild to moderate COVID-19 but refuse testing and adherence to infection prevention protocols. Such situations increase the risk of infection to other patients and staff on psychiatric inpatient units. We discuss medical and ethical considerations for navigating this dilemma and offer a set of policy recommendations.