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最小风险 Minimal Risk


  最小风险指试验中预期风险的可能性和程度不大于日常生活、或进行常规体格检查或心理测试的风险。1)

  Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.2)



1)
药物临床试验伦理审查工作指导原则, 国家食品药品监督管理局, 2010
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