Norrsken Mind is funding the Independent Psychedelic Evidence Assessment Working Group (IPEA-WG) to develop rigorous and multidisciplinary standards for evaluating evidence related to psychedelic therapies. The project is led by Eduardo Schenberg, MSc, PhD, with co-chairs Franklin King, MD and Marion Haberkamp, MD.
As psychedelic therapies move closer to medical approval in several countries, regulatory bodies are tasked with assessing their safety and effectiveness. These treatments combine pharmacological, psychological, and contextual components, creating unique challenges for evidence assessment. To overcome these obstacles, the IPEA-WG seeks to develop expert recommendations grounded in multidisciplinary perspectives and informed by contemporary advances in the philosophy of evidence and causality in medicine.
The working group brings together distinguished scientists, philosophers, and health professionals who are independent of psychedelic research and have no commercial conflicts of interest. Invited speakers include leading researchers across pharmacology, neuroimaging, clinical trials, psychotherapy, cellular biology, and causal inference, alongside experts representing patient experience and indigenous knowledge. All participants disclose potential conflicts of interest, and selection is guided by principles of independence and diversity.
The IPEA-WG convenes through a series of online sessions featuring keynote lectures and structured discussions. Its aim is to evaluate the adequacy of existing frameworks for evidence assessment—such as Evidence-Based Medicine and Evidential Pluralism—when applied to psychedelic therapies. Core themes include clinical trial design, statistical modeling of efficacy, sources of bias and unblinding, expectancy effects, standardized adverse event reporting, and the contribution of psychotherapy to treatment outcomes.
The project’s outcomes will include academic publications, such as a consensus statement or a collection of different perspectives on key topics. In addition, a white paper will synthesize the group’s discussions and conclusions to provide a rigorous, transparent, and multidisciplinary framework for evaluating evidence in psychedelic therapies, offering guidance for decision-makers engaged in the assessment and implementation of such evidence.
This initiative represents a timely and independent effort to ensure that psychedelic treatments are assessed through rigorous, pluralistic, and ethically grounded procedures.
Project Chairs
Eduardo Schenberg, MSc, PhD (Faculty of Medicine, University of Lisbon): Brazilian neuroscientist specializing in psychopharmacology and neuroscience.
Email: eduardoschenberg@medicina.ulisboa.pt
Franklin King, MD, Director of Training and Education of the Center for Neuroscience of Psychedelics (Massachusetts General Hospital): Psychiatrist and researcher focused on clinical translation and safety in psychedelic-assisted therapies.
Marion Haberkamp, MD, Head of Unit Neurology, Psychiatry and Ophthalmology (German Federal Institute for Drugs and Medical Devices, BfArM): Expert in regulatory affairs and evidence assessment for neurological and psychiatric drug development
The project is managed with support from the Association for Research and Development of the Faculty of Medicine (AIDFM) in Lisbon and is currently underway, expected to conclude by the end of 2026. To learn more about the initiative, visit the IPEA-WG website: https://www.ipeawg.org/
