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

Author:

McGuire Amy L.1,Cohen I. Glenn2,Sisti Dominic3,Baggott Matthew4,Celidwen Yuria5,Devenot Neşe6,Gracias Sabrina7,Grob Charles8,Harvey Ifetayo9,Kious Brent10,Marks Mason11,Mithoefer Michael12,Nielson Elizabeth13,Öngür Dost14,Pallas Alexandra15,Peterson Andrew16,Schenberg Eduardo E.17,Summergrad Paul18,Waters Brett19,Williams Monnica T.20,Yaden David B.21

Affiliation:

1. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas

2. Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School, Cambridge, Massachusetts

3. Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia

4. Tactogen Inc, Palo Alto, California

5. Othering and Belonging Institute, Department of Psychology, University of California Berkeley

6. Johns Hopkins University, Baltimore, Maryland

7. Ortus Foundation, Jackson, Wyoming

8. Harbor-UCLA Medical Center, Torrance, California

9. People of Color Psychedelic Collective, New York, New York

10. Department of Psychiatry, University of Utah Health, Salt Lake City

11. Florida State University College of Law, Tallahassee

12. Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation, New York, New York

13. Fluence Training, New York, New York

14. McLean Hospital, Harvard Medical School, Boston, Massachusetts

15. Beckley Retreats, Frederick, Maryland

16. Department of Philosophy, George Mason University, Fairfax, Virginia

17. Instituto Phaneros, Brazil

18. Departments of Psychiatry and Medicine, Tufts University School of Medicine, Boston, Massachusetts

19. Reason for Hope, New York, New York

20. School of Psychology & Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada

21. Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, Maryland

Abstract

ImportanceAs government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice.ObjectiveTo identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice.Evidence ReviewFrom 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.FindingsThis 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 RelevanceThis 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.

Publisher

American Medical Association (AMA)

Reference38 articles.

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3. The psychedelic renaissance and the limitations of a White-dominant medical framework: a call for indigenous and ethnic minority inclusion.;George;J Psychedelic Stud,2020

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