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在设计和进行人工智能临床试验时的伦理考虑
Alaa Youssef1, Ariadne A Nichol2, Nicole Martinez-Martin2,3
1Departments of Radiology, Stanford University School of Medicine, Stanford, California.
JAMA network open
|September 6, 2024
概括
对糖尿病视网膜病变 (DR) 查的人工智能 (AI) 临床试验的调查揭示了独特的伦理挑战. 需要进一步的指导来应对这些复杂性,并确保人工智能医疗研究参与者的安全.
科学领域:
- 临床研究 临床研究
- 人工智能的人工智能
- 眼科医生 眼科 眼科
背景情况:
- 人工智能 (AI) 在临床环境中的安全整合需要通过随机临床试验 (RCT) 进行严格的评估.
- 糖尿病视网膜病变 (DR) 查是临床AI的领先应用,自主AI系统获得监管授权.
- 对于在医疗保健中负责任地实施人工智能,道德考虑至关重要.
研究的目的:
- 评估已建立的伦理研究原则对AI临床试验的通用性.
- 识别和描述与涉及人工智能的临床试验相关的伦理问题.
主要方法:
- 一项使用半结构面试的定性研究,对11名参与DR查临床试验AI的研究人员进行了半结构面试.
- 利用有目的和雪球采样的组合来招募参与者.
- 分析整合了演和归纳方法,以检查伦理原则和更广泛的AI试验考虑.
主要成果:
- 11名具有不同专业知识的研究人员参与了这项研究.
- 确定的主要伦理挑战包括衡量社会价值,建立科学有效性,并确保公平的参与者选择.
- 还强调了对不同患者子组的风险益处评估和对数据使用的知情同意的复杂性.
结论:
- 这项研究强调了AI临床试验中研究人员面临的实际伦理挑战,以DR查为案例.
- 需要加强伦理指导,以支持AI临床试验的进行.
- 专注于道德努力至关重要,以尽量减少人工智能医疗保健研究中试验参与者的意外伤害.
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