| 日本机构伦理委员会关于研究规程的审议要点 |
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| 引用本文： | 毛敬洁,沈永新,池田博昭,龟田美保,粟屋智一,川上由育.日本机构伦理委员会关于研究规程的审议要点[J].中国医学伦理学,2011,24(5):670-672. |
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| 作者姓名： | 毛敬洁 沈永新 池田博昭 龟田美保 粟屋智一 川上由育 |
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| 作者单位： | 1. 福建中医药大学中西医结合研究院,福建福州,350108
2. 广岛大学病院临床研究部,日本广岛 |
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| 摘 要： | 随着临床试验国际化进程的加快，在中国进行的国际合作临床试验逐渐增多。保证临床试验的科学性和维护受试者的权益，需要伦理委员会的审查和监督管理。介绍日本伦理委员会审查研究规程的视点，旨在使我国广大临床工作者了解国外的伦理审查工作，以期对提高国内的临床试验水平和质量控制提供参考。
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| 关 键 词： | 伦理委员会 伦理审查 临床试验 临床研究规程 医学伦理学 |
Review Points on the Study Protocols in Ethics Committee in Japan |
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| MAO Jing-jie,SHEN Yong-xin,Ikeda Hiroaki,Kameda Miho,Awaya Tomohito,Kawakami Yui.Review Points on the Study Protocols in Ethics Committee in Japan[J].Chinese Medical Ethics,2011,24(5):670-672. |
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| Authors: | MAO Jing-jie SHEN Yong-xin Ikeda Hiroaki Kameda Miho Awaya Tomohito Kawakami Yui |
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| Institution: | MAO Jing-jie1,SHEN Yong-xin2,Ikeda Hiroaki2,Kameda Miho2,Awaya Tomohito2,Kawakami Yui2(1 Association of Combination of Traditional Chinese Medicine and Western Medicine,Fujian University of Traditional Chinese Medicine,Fuzhou 350108,China,2 Central Clinical Divisions of Hiroshima University Hospital,Hiroshima,Japan) |
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| Abstract: | With the acceleration process of the internationalization of clinical trials,global multi-center clinical trials gradually increased in China,which requires ethics review and supervision to ensure the scientific nature,the implementation of patient's rights and interests of clinical trials.This paper introduced the review points on the study protocols in Japanese ethics committee,aiming at improving the domestic clinical trials level and quality controls by summarizing the foreign experiences. |
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| Keywords: | Ethics Committee Ethics Review Clinical Trial Clinical Study Protocol Medical Ethics |
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