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关于医疗机构伦理委员会审查中值得注意的几个问题
引用本文:李红英,侯建全,葛建一,李惠玲,郭亚男,杨炳华.关于医疗机构伦理委员会审查中值得注意的几个问题[J].中国医学伦理学,2010,23(4):84-85,126.
作者姓名:李红英  侯建全  葛建一  李惠玲  郭亚男  杨炳华
作者单位:苏州大学附属第一医院伦理委员会,江苏,苏州,215006
基金项目:2004年苏州大学附属第一医院科研自选课题:医院伦理委员会管理规范的研究与探讨.课题,2009年苏州市科技局专项科研课题:医疗机构伦理委员会运作及策略.课题 
摘    要:为了维护受试者/患者的权益,创建和谐的医患环境和宽松的科研环境,保护国家的生物医学资源,促进临床研究和临床试验的正常进行,我们对伦理审查中经常遇到的问题(如临床试验样本的使用及管理问题、损害赔偿等)进行分析,从而提出了一些用于提高医疗机构伦理委员会审查质量的有效措施,包括加强管理、提高认识,建议国家行政管理部门出台和完善相应的管理办法,加强各级伦理委员会的监督和相关人员的生命伦理学及法规教育,提倡开展临床试验及研究项目伦理盲审法,保证伦理委员会专家的审阅时间、施行有记名投票等方法。

关 键 词:医疗机构  伦理委员会  伦理审查  临床试验  知情同意

Issues in Ethics Review Committee in Medical Institutions
LI Hong-ying,HOU Jian-quan,GE Jian-yi,LI Hui-ling,GUO Ya-nan,YANG Bing-hua.Issues in Ethics Review Committee in Medical Institutions[J].Chinese Medical Ethics,2010,23(4):84-85,126.
Authors:LI Hong-ying  HOU Jian-quan  GE Jian-yi  LI Hui-ling  GUO Ya-nan  YANG Bing-hua
Institution:LI Hong - ying , HOU Jian -quan, GE Jian - yi , LI Hui - ling, GUO Ya - nan, YANG Bing - hua (Ethics Review Committee, First Affiliated Hospital of Suzhou University, Suzhou 215006, China )
Abstract:To safeguard the rights of patients/subjects, create harmonious medical surroundings and liberal environment for scientific research, protect our national biomedical resources, promote the normal for clinical research and clinical experiments, we analyzed the encounter problems of ethical review ( such as the use and management of clinical test samples, compensation of damages and so on ). Then we put forward a series of medical institutions for higher ethical committees review of the effective measures, include strengthen the management of recognition, suggest the state administrative authorities issue and improve relevant management measures, strengthen the supervision of all ethical committees and the education of the ethics and relevant laws and regulations, promote ethical blind review for clinical research and clinical experiments, ensure ethical committee of experts for review and so on.
Keywords:Medical Institution : Ethics Committee : Ethics Review: Clinical Trail : Informed Consent
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