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.

A projection for psychiatry in the post-COVID-19 era: potential trends, challenges, and directions.

The COVID-19 pandemic has transformed the face of psychiatry over a very short time period. Given the detrimental impact of the pandemic on mental health and the economy, more difficult days are ahead for psychiatry. The rising public health burden of mental illnesses will inevitably exceed the capacity of psychiatric services in the United States and worldwide. The pandemic has also profoundly affected psychiatric research due to safety concerns and containment efforts. Intermediate and long-term ramifications may even be more serious. In addition to the effects of the economic downturn on available research funding, existing research tools and protocols may not meet the emerging needs in the post-COVID-19 era. This paper discusses potential trends and challenges that psychiatric practice and research may encounter in this period from the viewpoint of workers in the field. We outline some measures that clinicians and researchers can implement to adapt to the emerging changes in psychiatry and to mitigate the forthcoming effects of the crisis.