Summary:
At the U.S. Department of Health and Human Services (HHS), we are committed to addressing the suffering many Americans experience from mental health and substance use issues, many of which have been exacerbated by the COVID-19 pandemic. With the aim of considering all promising and innovative approaches to addressing our nation’s mental health and substance use crisis, HHS is interested in exploring the potential of psychedelic-assisted therapies as treatments for a myriad of mental health conditions.
Psychedelics are powerful psychoactive substances that alter perception and mood and affect numerous cognitive processes. Their origins predate written history, and traditional use as a sacred sacrament in religious ceremonial healing practices continues to this day. Renewed interest in the therapeutic potential of psychedelics has grown in recent years, evidenced by an increase in basic science and clinical research, and a growing amount of legislative activity in states across the nation. While there are many completed and ongoing studies with such products for treatment of diseases and medical conditions, more clinical trials are needed to establish the safety, efficacy, and appropriate use criteria for psychedelics. The Food and Drug Administration has recently published draft guidance providing general considerations to sponsors developing psychedelic drugs for treatment of medical conditions, including considerations for non-clinical studies and clinical trials. The conduct of psychedelic research with human participants also requires robust and nuanced consideration of several ethical, legal, and practical issues.
The mission of the Office for Human Research Protections (OHRP) is to protect the rights, welfare, and well-being of people who participate in research studies that HHS supports or conducts. On Thursday, September 14, 2023, OHRP will host its 6th Annual Exploratory Workshop: Exploring the Ethical and Practical Considerations of Psychedelics Research. The workshop provides a platform for a group of experts to deliberate on the ethical, practical, and legal questions pertaining to psychedelic research, including issues around informed consent, study design and integrity, protection and inclusion of vulnerable groups, the unique risk considerations, as well as preserving public trust. This is a timely and important discussion that responds to tremendous interest in this topic from diverse stakeholders, including patients, researchers, funders, regulators, and policymakers at both the state and federal levels. I hope that you will join me and my OHRP colleagues at this event!
This free event will be streamed live around the world on Thursday, September 14, 2023 from 9:45 a.m. to 4:15 p.m. EST. Visit the event website for details and access to the video.
