"例行测试的风险"和对最小风险评估中的类似推理
1Core Learning, College of Interdisciplinary and Experiential Learning, Singapore University of Social Sciences, Singapore.
The Journal of medicine and philosophy
|October 7, 2023
概括
确定研究中的"最小风险"对于加速伦理审查至关重要. 这项研究发现",例行测试的风险"最符合用于评估研究风险的模拟推理.
科学领域:
- 生物伦理学生物伦理学
- 研究伦理学研究伦理学
- 监管科学 监管科学
背景情况:
- 最小的风险是加速伦理审查,豁免或在研究中豁免同意的关键门.
- 共同规则通过将研究风险与日常生活或例行测试的风险进行比较来定义最小风险.
- 对于最小风险评估的现有比较器已经面临批评,促使人们提出替代方案.
研究的目的:
- 探索可行的比较器,以评估研究伦理中的最小风险.
- 分析风险最小的伦理评估中固有的类比推理.
- 建立一个适当的最小风险概念的标准.
主要方法:
- 该研究将对比器的搜索置于类比推理的背景下.
- 为了制定一个适当的最小风险概念,开发了两个必要条件.
- 根据这些发展条件,评估了三个不同的比较器.
主要成果:
- 评估显示",例行测试的风险"是最合适的比较.
- 这种比较器最好地支持最小风险评估中的模拟推理过程.
- 开发的条件为评估风险比较器的充分性提供了一个框架.
结论:
- 建议使用"常规测试风险"比较器来评估研究中的最小风险.
- 这一发现支持了更一致,更道德的最小风险确定.
- 该研究有助于完善研究监督和参与者保护的伦理框架.
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