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心理学临床试验的知情同意文件:描述性的伦理分析
Katherine Cheung1, Caleigh Propes1, Marianna Graziosi2,3
1Berman Institute of Bioethics & Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
AJOB empirical bioethics
|July 16, 2025
概括
在迷幻药试验中的知情同意文件 (ICD) 通常强调精神和身体风险. 然而,它们不太频繁地包括特定于迷幻药的经历,如不可形容性,生物伦理学家认为这对参与者理解至关重要.
科学领域:
- 神经科学是一个神经科学.
- 精神病学是一个精神病学.
- 生物伦理学生物伦理学
背景情况:
- 经典的迷幻药物如psilocybin和LSD诱导意识的改变状态.
- 迷幻体验的独特性质,如不可形容性,对知情同意提出了挑战.
- 关于将知情同意文件 (ICD) 定制为迷幻研究的辩论日益激烈.
研究的目的:
- 分析和描述当代西临床试验中使用的ICD的内容.
- 将这些ICD的内容与来自迷幻生物伦理文学的建议进行比较.
主要方法:
- 使用内容分析方法,对来自美国13个地区28个psilocybin临床试验的28个ICD进行了审查.
- 编码器表现出良好的评分器间可靠性 (κ = .683).
主要成果:
- ICD主要关注一般风险,如心理健康和身体风险,与生物伦理期望保持一致.
- 心理学特有的元素,包括不可形容性和治疗性触摸,在分析的ICD中显著不足.
结论:
- 虽然ICD涵盖了常见的风险,但它们往往忽略了生物伦理讨论中强调的重要迷幻药特异性方面.
- 需要进一步讨论,以确定ICDs最突出的信息,以确保在迷幻研究中获得真正知情同意.
- 该研究提供了分析的ICD中观察到的最佳实践表.
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