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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (11): 1313-1316.

• 设计·统计·方法 • 上一篇    下一篇

临床试验的伦理审查:招募受试者

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

  1. 南京中医药大学附属医院临床药理科,南京 210029,江苏
  • 收稿日期:2004-11-17 修回日期:2004-11-25 出版日期:2004-11-26 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: 025-86506055 Fax:025-86555033 E-mail: jsszyyjd@jlonliue.com, xiongnin@publicl.ptt.js.cn
  • 作者简介:汪秀琴,女,医学硕士,从事临床试验伦理学研究
  • 基金资助:
    国家科学技术部“临床试验关键技术及平台研究”课题资助(NQ2004AA2Z3766)

Ethic Review in Clinical Research: Subjects Recruitment

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

  1. Department of Clinical Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nan-jing,210029, Jiangsu, China
  • Received:2004-11-17 Revised:2004-11-25 Online:2004-11-26 Published:2020-11-19

摘要: 招募合格的受试者在临床试验过程中是至关重要的,而且可能是最困难、最富有挑战性的工作。受试者招募的伦理审查主要包括招募的方式,受试人群的选择与激励补偿措施。招募方式必须考虑尊重隐私与自愿参加的原则,避免强迫和不正当影响。受试人群的选择必须考虑受益和负担公平分担和试验人群的代表性问题。对受试者参加试验的激励补偿必须考虑合理补偿与避免过度劝诱的问题。

关键词: 临床试验, 伦理委员会, 伦理审查, 招募受试者

Abstract: Recruitment of eligible subjects is of para-mount importance and probably the most difficult and changeling aspect of a clinical trial. Ethic review of sub-jectsJ recruitment mainly includes the mode of recmit-ment,the selection of subject population, recompense and incentives to subjects. For reviewing of mode of re-cruitment,respect for privacy and voluntary participation, avoiding any possibility of coercion or undue influence must be taken into account; while for reviewing of selec-tion of subject population, apportion of research burdens and benefits must be equally considered among population and the representative of study cohort? The reasonable recompense and free from undue inducement must be con-sidered when reviewing recompense and incentives to sub-jects.

Key words: clinical trial, institutional review board, ethic review, subjects recruitment

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