Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials
Journal of Psychedelic Studies – November 20, 2023
Source: OpenAlex
Summary
A review of nineteen informed consent forms from psychedelic clinical trials, a biomedical innovation, revealed a critical neuroethics gap. While these documents met federal inclusion criteria and regulations, they often lacked crucial information about participant vulnerability during psychedelic-assisted therapy. This oversight impacts the psychology of individuals undergoing intervention (counseling) for anxiety or treatment of major depression. Robust informed consent protocols are vital for the future of psychiatry and medicine, particularly given the unique nature of psychedelics and drug studies.
Abstract
Abstract Background and aims Psychedelic-assisted therapy (P-AT) has been shown to reduce post-traumatic stress disorder (PTSD), depression, and anxiety symptoms, and is likely to be approved in the United States (US) in the coming years. However, concerns about participant safety in these early trials have surfaced, including allegations of sexual misconduct. This paper aims to illuminate how potential risks have been communicated to P-AT participants via informed consent documents and to suggest how existing policy might be modified given the unique risks involved in P-AT trials. Methods Publicly available informed consent forms (ICFs) were gathered by searching clinicaltrials.gov . Queries were applied to filter trials involving the use of a classical psychedelic (psilocybin, LSD) or psychedelic-adjacent substance (MDMA, ketamine) in tandem with psychotherapeutic intervention and those with a status of “completed,” “recruiting,” or “active.” Results Nineteen ICFs met inclusion criteria and were reviewed to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials. The primary finding from this review of ICFs from P-AT trials revealed that studies were in compliance with federal regulation. However, there were missing elements related to the vulnerability experienced while under the effects of psychedelics that warrant inclusion in future ICFs in P-AT trials. Conclusion Although the ICFs for P-AT trials examined in this study covered several important areas related to risk, benefits, safety, and accountability as required by federal regulations in the US, future research should consider ways to expand this content in order to assure that consent is truly informed prior to enrolling subjects.