| 儿童药物临床试验研究知情同意的伦理审查 |
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| 引用本文： | 李艺影,潘岳松,任佩娟.儿童药物临床试验研究知情同意的伦理审查[J].临床和实验医学杂志,2013,12(8):612-614. |
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| 作者姓名： | 李艺影 潘岳松 任佩娟 |
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| 作者单位： | 1. 首都医科大学附属北京天坛医院 北京市神经外科研究所 北京100050
2. 首都医科大学附属北京天坛医院科研处 北京100050 |
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| 摘 要： | 由于儿童的生理、药理、心理及认知和自主权与成人有较大的差异,且各年龄段儿童又呈现不同的特点,儿童药物临床试验研究的知情同意除需遵循一般临床试验研究知情同意的基本原则外,在知情告知的信息、知情同意过程和同意的决定等各个环节又有其特殊要求。文章对儿童药物临床试验研究知情同意的伦理学和特殊性进行了辨析,以更好地指导开展儿童药物临床试验研究知情同意的伦理审查。
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| 关 键 词： | 儿童 临床试验 知情同意 伦理委员会 |
Ethic review of informed consent in pediatric medicine clinical and trial study |
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| LI Yi-ying
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PAN Yue-song
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REN Pei-juan.Ethic review of informed consent in pediatric medicine clinical and trial study[J].Journal of Clinical and Experimental Medicine,2013,12(8):612-614. |
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| Authors: | LI Yi-ying PAN Yue-song REN Pei-juan |
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| Affiliation: | LI Yi - ying , PAN Yue - song , REN Pei -juan. 1 Bei- jing Neurosurgical Institute; 2. Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, China. |
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| Abstract: | The significant difference between children and adult have been identified in physiology, pharmacology, psychology, recogni- tion and autonomy. There was different characteristics among different children age group. Besides complying with the basic principle of general clinical and trial study, informed consent in clinical and trial study involving children has special requirements in informed information, informed consent procedure, and consent decision. This paper focused on the ethic issues and specificity of informed consent in pediatric clinical and trial study involving children. The paper might provide guidance on the ethic review of informed consent in pediatric clinical and trial study. |
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| Keywords: | Children Clinical and Trim Study Informed Consent Ethics Committee |
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