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临床试验中对照选择的国际伦理要求
International ethical guidelines for the choice of control in clinical trials Extracted from CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
【摘要】 在人体生物医学研究中 ,对照组的受试者应得到公认有效的干预。然而 ,在有些特定的情况下 ,使用安慰剂、不治疗或其他替代的方法作对照在伦理上是可接受的。本文从伦理学角度对这些特定的情况做了详细的阐述 ,并提出了安慰剂对照试验中最小化风险的方法
【Abstract】 As a general rule, research subjects in the control group of a biomedical research involving human subjects should receive an established effective intervention. In some circumstances, however, it may be ethically acceptable to use an alternative comparator, such as placebo, “no treatment” or other effective alternative. This article discusses these special circumstances in detail, and puts forward means of minimizing harm to placebo control subjects.
【关键词】 医学伦理学;
临床试验;
国际医学科学组织;
指南;
伦理;
研究设计;
【Key words】 medical ethics; clinical trial; Council for International Organizations of Medical Sciences; guideline; ethical; thedesign of study;
【Key words】 medical ethics; clinical trial; Council for International Organizations of Medical Sciences; guideline; ethical; thedesign of study;
【基金】 国家科学技术部“临床试验关键技术及平台研究”课题资助(№ 2 0 0 2AA2Z34 1i)
- 【文献出处】 中国临床药理学与治疗学 ,Chinese Journal of Clinical Pharmacology and Therapeutics , 编辑部邮箱 ,2003年02期
- 【分类号】R-052
- 【被引频次】26
- 【下载频次】481