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在癌症临床试验中优化知情同意.
Subha Perni1, Rachel Jimenez2, Reshma Jagsi3
1Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Seminars in radiation oncology
|September 8, 2023
概括
知情同意是美国生物医学研究伦理学的基石. 由于系统性,临床医生和患者因素,获得知情同意的挑战仍然存在,需要持续的干预.
科学领域:
- 生物医学伦理 生物医学伦理
- 临床试验 临床试验
- 卫生政策 卫生政策
背景情况:
- 知情同意在整个20世纪发展成为美国生物医学研究的基本伦理原则.
- 尽管有监管,但在癌症研究中获得知情同意面临着重大系统性,临床医生和患者相关的障碍.
研究的目的:
- 审查临床试验中知情同意的历史发展,政策格局和实际挑战.
- 根据新兴技术和研究方法,研究知情同意的不断变化的作用.
主要方法:
- 对历史文件,政策声明和关于知情同意的当代研究的文献评论.
- 分析阻碍临床研究中知情同意过程的因素.
- 讨论基因组测序,编辑和人工智能带来的新挑战.
主要成果:
- 知情同意是临床试验中的关键伦理原则,但其实施经常受到阻碍.
- 试验设计,基因组学和人工智能的创新为知情同意过程带来了新的复杂性.
- 系统性,临床医生和患者层面的因素需要多方面的干预措施来改善获得同意的情况.
结论:
- 临床试验中知情同意的伦理原则需要不断适应,以应对不断变化的研究实践和技术进步.
- 解决知情同意的务实挑战对于伦理和有效的生物医学研究至关重要.
- 未来的研究和政策应该专注于减轻障碍,确保在精准医学和人工智能时代的强有力的知情同意.
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