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中国临床药理学与治疗学 ›› 2003, Vol. 8 ›› Issue (6): 718-720.

• 设计与统计 • 上一篇    

临床试验的伦理审查:风险与受益分析

汪秀琴, 熊宁宁, 刘沈林, 李七一, 蒋萌, 刘芳, 邹建东, 卜擎燕, 高维敏   

  1. 南京中医药大学附属医院国家药品临床研究基地,南京 210029,江苏
  • 收稿日期:2003-06-11 修回日期:2003-07-13 出版日期:2003-12-26 发布日期:2020-11-19
  • 通讯作者: 熊宁宁,男,教授,主任医师,博士生导师,主要从事临床药理研究。Tel:025-6506055  Fax:025-6555033 E-mail:jsszyyjd@jlonline.com ,xiongnin@public1.ptt.js.cn
  • 作者简介:汪秀琴,女,硕士研究生,从事临床试验伦理学研究。
  • 基金资助:
    科技部“临床试验关键技术及平台研究”项目(No2002AA2Z341i)

Ethic review in clinical research :risk/benefit analysis

WANG Xiu-Qin, XIONG Ning-Ning, LIU Shen-LIn, LI Qi-Yi, JIANG Meng, LIU Fang, ZOU Jian-Dong, BO Qing-Yan, GAO Wei-Min   

  1. National Base for Drug Clinical Trial,Affiliated Hospital of NanjingUniversity of Traditional Chinese Medicine,210029,Jiangsu,Nanjing,China
  • Received:2003-06-11 Revised:2003-07-13 Online:2003-12-26 Published:2020-11-19

摘要: 伦理委员会的主要职责之一是评估所提议临床试验的风险和受益。伦理审查对风险与受益分析一般采取以下步骤:风险的鉴别与评估,确定风险已在可能的范围内最小化;预期受益的评估,确定风险与受益比是合理的;公开风险与受益,跟踪审查。

关键词: 医学伦理学, 临床试验, 伦理委员会, 伦理审查, 风险与受益

Abstract: One of the major responsibilities of the IRB is how to assess the risks and benefits ofProposed research.The IRB' s assessment involves a series of steps,including identification and assessment of risks,determination of minimized risks,assessment of anticipated benefits,determination of reasonable risks in related to anticipated benefits,disclosure of risks and benefits,and continuing review.

Key words: medical ethic, clinical research, institutional review board, ethic review, risk benefit

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