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量化联邦最低风险标准:对儿科研究的影响,没有直接利益的前景
David Wendler1, Leah Belsky, Kimberly M Thompson
1Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, Md 20892, USA. dwendler@nih.gov
JAMA
|August 18, 2005
概括
机构审查委员会 (IRB) 经常过于谨慎地应用儿科研究风险标准. 对日常生活中的风险 (如汽车旅行和体育运动) 需要经验数据来指导IRB的决策并确保儿童的保护.
科学领域:
- 儿科研究的伦理学.
- 临床试验中的风险评估
- 在人类受试者研究中遵守法规.
背景情况:
- 美国联邦法规允许机构审查委员会 (IRB) 批准带有最小风险或略高于最小风险的儿科研究.
- 最小风险是由日常生活或例行检查中通常遇到的风险来定义的.
- 由于缺乏关于儿科风险的经验数据,IRB成员经常依赖直觉判断.
研究的目的:
- 提供关于儿童在日常生活和日常活动中遇到的风险的经验数据.
- 评估IRB在儿科研究中的联邦最低风险标准的应用的一致性.
- 为了告知联邦法规对儿科研究监督的潜在修订.
主要方法:
- 对与日常活动,特别是汽车旅行相关的死亡风险现有数据的分析.
- 检查与参加常见儿童体育运动相关的发病风险,以篮球为例.
- 经验风险数据与联邦对儿科研究最低风险的定义进行比较.
主要成果:
- 汽车旅行对儿童来说是常规风险的重要来源,死亡风险在百万分之0.06至4之间,具体取决于年龄和旅行类型.
- 参与篮球等体育运动会带来更高的患病风险,每百万例中约有1900例受伤,包括骨折和永久残疾.
- 调查结果表明,IRB在应用最小风险标准时可能过于谨慎,可能会阻碍有益的儿科研究.
结论:
- 关于日常生活和体育风险的经验数据挑战了IRB目前对最低风险标准的保守应用.
- 联邦最低风险标准可能需要重新评估,以确保它充分保护儿童,同时促进必要的研究.
- 需要基于证据的指导方针来支持IRB在儿科研究批准方面的决策.
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