At the US Department of Health and Human Services (HHS), we are committed to addressing the suffering many Americans experience due to mental health and substance use issues, many of which have been exacerbated by the pandemic. COVID-19. In order to consider 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 wide variety of health conditions. mental.
Psychedelics are powerful psychoactive substances that alter perception and mood and affect numerous cognitive processes. Its origins predate recorded history and its traditional use as a sacred sacrament in religious ceremonial healing practices continues to this day. Renewed interest in the therapeutic potential of psychedelics has increased in recent years, as evidenced by an increase in basic science and clinical research, and an increasing amount of legislative activity in states across the country. While there are many completed and ongoing studies with such products for the treatment of diseases and medical conditions, more clinical trials are needed to establish criteria for the safety, efficacy, and appropriate use of psychedelics. The Food and Drug Administration has recently released draft guidance that provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions, including considerations for non-clinical studies and clinical trials. Conducting psychedelic research with human participants also requires a robust and nuanced consideration of various ethical, legal, and practical issues.
The mission of the Office for Human Research Protections (OHRP) is to protect the rights and welfare of individuals who participate in HHS-supported or conducted research studies. In On Thursday, September 14, 2023, OHRP will host its sixth annual exploratory workshop: Exploring the ethical and practical considerations of psychedelic research. The workshop provides a platform for a group of experts to deliberate on ethical, practical and legal issues related to psychedelic research, including issues related to informed consent, study design and integrity, protection and inclusion of vulnerable groups, unique risk considerations, as well as preserving public trust. This is an important and timely discussion that responds to the enormous interest in this topic from various stakeholders, including patients, researchers, funders, regulators, and policymakers at both the state and federal levels. I hope you will join me and my OHRP colleagues at this event!
This free event will be broadcast live worldwide on Thursday, September 14, 2023 from 9:45 am to 4:15 pm EST. Visit the event website for details and to access the video.