ImportanceInterest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system.ObservationsDespite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings.Conclusions and RelevanceAnalysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

中文翻译：

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迷幻医学知情同意的要点

重要性人们对使用迷幻剂作为心理健康治疗的兴趣正在迅速增长。随着制药商投资开发用于多种精神疾病的迷幻药物，立法者正在制定法律改革以加快全球使用速度，卫生机构也准备批准这些治疗方法。与此同时，美国各州，如俄勒冈州和科罗拉多州，正在将致幻剂用于传统医疗保健系统之外的监督使用。 观察尽管一些国家进行了法律变更，并且可能即将获得监管批准，但将致幻剂纳入医疗保健的标准仍然滞后，包括用于医疗保健的规范设计和实施知情同意流程。由于致幻剂及其给药方式的独特特征，知情同意变得复杂。由于没有政府批准任何经典致幻剂用于一般医疗或精神科用途，因此只有临床研究人员获得了试验参与者的知情同意。因此，针对在非研究环境中使用迷幻剂的挑战而定制的知情同意流程的需求尚未得到满足。 结论和相关性对设计和实施迷幻剂知情同意实践的挑战的分析揭示了 7 个基本组成部分，包括短期和长期的可能性术语知觉障碍、潜在的人格变化和形而上学信仰的改变、令人放心的身体接触的有限作用、患者虐待或胁迫的可能性、数据收集的作用和风险、相关从业者的披露以及交互式患者教育和理解评估。由于公开的致幻剂临床试验知情同意文件经常忽视或低估这些基本要素，因此提出了样本语言和程序来填补空白。