Introduction

The paper by Tahlia R. Harrison delves into critical concerns about the adequacy of informed consent in psychedelic-assisted therapy (P-AT) trials, especially regarding potential risks and participant safety.

Detail

Harrison's investigation focused on publicly available informed consent forms (ICFs) from P-AT trials listed on clinicaltrials.gov, targeting trials involving classic psychedelics like psilocybin and LSD, or psychedelic-adjacent substances such as MDMA and ketamine.The review of nineteen ICFs revealed that while they adhered to federal regulations on risk and benefit disclosure, they failed to adequately address the unique vulnerabilities induced by psychedelic substances, particularly the profound subjective experiences and altered states of consciousness.The gap in the informed consent process highlights the need for future ICFs to include comprehensive information about the psychological and emotional risks of psychedelic therapy to ensure truly informed consent and protect participants' well-being.

Implications

Revising the informed consent process in P-AT trials to account for the unique risks associated with psychedelic substances is crucial for safeguarding participants' rights and enhancing the ethical standards of psychedelic research and therapy.Conclusion:This paper serves as a call to action for researchers, ethicists, and regulatory bodies to address gaps in informed consent practices in P-AT trials and implement more comprehensive measures to respect and protect participants' unique vulnerabilities.