C03 - [IN-PERSON/RECORDED] Ethical, Legal, and Regulatory Challenges of Conducting Research on Psychedelic Substances

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Psychedelic drugs are gaining increased favor as potential treatments for a number of psychiatric conditions. Recent data has shown promise for the use of MDMA, psilocybin, and LSD to treat depression and trauma-based conditions, not to mention the increasingly widespread use of FDA-approved ketamine for treatment refectory depression. The FDA has designated psilocybin a "breakthrough therapy,” while two states (Colorado and Oregon) and a number of cities across the US have decriminalized the use of psilocybin for therapeutic and non-therapeutic purposes. Yet, it remains illegal as a Schedule 1 substance (with “no currently accepted medical use and a high potential for abuse”) under the federal Controlled Substances Act. In recent years, driven by both unmet medical needs and potential for commercialization, interest in research on psychedelic drugs has skyrocketed. Conducting research on psychedelic drugs raises unique ethical, legal, and regulatory challenges, with which HRPPs/IRBs are currently grappling. How do we appropriately inform subjects about expectations for taking such study drugs, e.g., including the possibility of profound psychedelic experience? These drugs often put participants in an altered state of consciousness and a potentially vulnerable position. Which extra safeguards must researchers consider in conducting these types of studies? How do we handle issues of therapeutic misconception, given the strong public interest in this work? How must institutions handle and store such “illegal” controlled substances? Where is it acceptable for researchers to obtain product and when do FDA regulations apply? How should HRPPs/IRBs resolve conflicting federal and state laws? What issues arise in accepting funding from a psychedelic manufacturer for research? What issues arise when conducting social-behavioral observational studies about psychedelics (i.e., when the researcher is not actively providing the drug as part of research? How are issues of equal access and bias playing out in psychedelic research? What other legal and regulatory concerns must IRBs consider?)? This session will pull together expert researchers, lawyers, ethicists, and HRPP/IRB staff to discuss the above questions and to provide a framework for IRBs to consider in reviewing these types of studies.