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对心理治疗药物的知情同意的基本要素
Mason Marks1,2, Rebecca W Brendel3, Carmel Shachar4
1Project on Psychedelics Law and Regulation (POPLAR), Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, Massachusetts.
JAMA psychiatry
|April 10, 2024
概括
心理治疗的知情同意需要具体的指导方针,因为独特的风险,如感知障碍和改变的信念. 制定这些标准对于安全地融入心理健康护理至关重要.
科学领域:
- 精神病学是一个精神病学.
- 神经科学是一个神经科学.
- 心理健康 心理健康
背景情况:
- 对用于治疗精神疾病的迷幻药物的兴趣正在迅速增加.
- 法律改革和监管批准正在加速全球获取迷幻药物的速度.
- 美国各州正在允许在传统医疗机构之外监督使用迷幻药.
研究的目的:
- 解决将迷幻药物纳入医疗保健中的落后标准,特别是知情同意过程.
- 确定针对非研究环境中的迷幻药物管理量身定制的知情同意的基本组成部分.
- 提出示例语言和程序,以弥合当前知情同意文件中的差距.
主要方法:
- 分析设计和实施迷幻知情同意实践的挑战.
- 识别了精神幻觉知情同意的7个基本组成部分.
- 审查现有的心理临床试验知情同意文件.
主要成果:
- 心理药物的知情同意是复杂的,因为独特的管理特征和潜在的影响.
- 关键组成部分包括感知障碍,人格变化,改变信念和从业者披露的风险.
- 现有的临床试验同意表格往往忽视或低估了这些关键要素.
结论:
- 在研究之外,对特定于迷幻疗法的知情同意流程存在未满足的需求.
- 标准化指导方针是必要的,以确保患者的安全和理解.
- 拟议的语言和程序可以加强对迷幻治疗的知情同意.
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