Psychedelic Ethics: Learning from the Past to Inform the Future

Abstract: Modern research on psychedelics’ therapeutic potential continues to expand, learning from the shortcomings that led FDA to reject the first new drug application (NDA) for a psychedelic compound in 2024. At the same time, states and local jurisdictions are making psychedelics legally accessible outside the healthcare system, and unregulated use is becoming more mainstream. As American culture becomes increasingly polarized, and biomedical research faces increased scrutiny and budget cuts, how can we ensure that the potential benefits of psychedelics aren’t once again thwarted by unethical practices and political interference? What can we learn from the past to help guide our present and future? This panel will explore these issues and present data to help inform ethical practice. The first panelist will present a historical perspective of psychedelic research and culture in the U.S., highlighting lessons learned. The second panelist will examine the role of IRBs as gatekeepers of psychedelic research in the present-day, presenting results from a national survey of IRB chairs regarding their perspectives and understanding of central scientific and ethical considerations for psychedelic research review. The third panelist will examine what lessons can be learned from the emergence of off-label ketamine clinics across the U.S., presenting results from a study of 40 ketamine clinics and underscoring the need for evidence-based policies to promote both safety and patient access. The final panelist will explore facilitators and barriers to the eventual clinical integration of regulated psychedelic medicines, presenting data from interviews with psychedelic researchers in the U.S.

Keywords: Psychedelics, Ethics, Research Review