标准护理实用临床试验中的个性化临床决策:对同意的含义
Isabel M Astrachan1, James Flory2, Scott Yh Kim1
1Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Clinical trials (London, England)
|August 16, 2024
概括
实用性临床试验可以在没有传统的知情同意的情况下进行,如果设计的研究风险最小. 这涉及在随机分配期间适应个性化的临床决策,以确保患者的安全.
科学领域:
- 临床试验 临床试验
- 医学伦理 医学伦理
- 医疗保健服务研究 医疗服务研究
背景情况:
- 实用临床试验评估标准护理干预措施.
- 传统的知情同意程序阻碍了这些试验.
- 最小的研究风险是改变美国同意的先决条件.
研究的目的:
- 确定实用性临床试验是否可以在改变或放弃知情同意的情况下进行.
- 提出一个设计,确保在这样的试验中最小的研究风险.
- 建立使用修改与放弃知情同意的标准.
主要方法:
- 提倡设计实用试验,以确保研究风险最小化.
- 建议在随机分配中适应个性化,临床动机的决策.
- 将三个场景进行比较:标准知情同意,没有知情同意和决策架构随机化试验.
主要成果:
- 标准护理实用试验可以设计成最小的风险.
- 随机化中的个性化决策确保风险不会超过临床风险.
- 拟议的设计为确定改变与放弃同意的框架提供了一个框架.
结论:
- 在实用试验中,通过将临床决策融入随机化中,可以实现最小的风险.
- 这种方法促进了改变或放弃知情同意的使用.
- 为更有效地进行重要的临床研究提供了一条途径.
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