This Viewpoint discusses the executive order supporting the development and approval of psychedelic drugs and outlines issues surrounding their ethical and evidence-based integration into clinical care.
Background: Institutional review boards (IRBs) are gatekeepers of psychedelic research, deciding whether and under what conditions it may proceed. Yet IRB understanding, attitudes, perspectives, and concerns regarding psychedelics and psychedelic research have not previously been studied. These factors are important to assessing whether US IRBs are likely to be over- or underprotective of...
Psychedelic medicines hold the promise of therapeutic benefit for many suffering from serious unmet mental health needs, leading to substantial demand even before these drugs receive FDA approval based on demonstrated safety and effectiveness for particular conditions. Recognizing FDA approval as the ideal path for psychedelics intended for medical use and drawing on lessons from medical...
The first Hopkins-Oxford Psychedelic Ethics (HOPE) workshop convened to discuss ethical matters relating to psychedelics in August 2023 at the University of Oxford.The organizers (BDE, DBY, EJ) aim...
In this paper, we examine the case of psychedelic medicine for Alzheimer's disease and related dementias (AD/ADRD). These "mind-altering" drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine...