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临床研究中的受试者权益保障面临的挑战 被引量:4

Challenges to Ethics Committee and Investigators of Protecting the Rights of Subjects in Clinical Trials
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摘要 伦理委员会是保障受试者权益的监督、管理者,研究者是保障受试者权益的直接实施者。面对日益增多的国际多中心临床研究,中国的伦理委员会和研究者面临很大的挑战。只有提高伦理委员会和研究者的能力并切实改进临床研究中存在的常见问题,才能更好地保障受试者权益。 Ethics Committee is the supervisor and regulator in protecting the rights of subjects, and investigators are those who put something into practice. There are great challenges to Chinese ethics committee and investigators when we con- front more and more global trials. Only after ethics committee and investigators boost their ability and improve common problems in clinical trials, then can we safeguard the rights of subjects better.
作者 茅益民
出处 《医学与哲学(A)》 北大核心 2010年第3期6-7,70,共3页 Medicine & Philosophy:Humanistic & Social Medicine Edition
基金 国家科技部十一五科技重大专项"重大新药创制"课题"新药临床研究技术平台建设--抗慢性乙型病毒性肝炎新药临床评价研究平台的构筑" 项目编号:2008ZX09312-007
关键词 国际多中心临床研究 受试者 权益 伦理委员会 研究者 multicenter clinical trial,subject, right, ethics committee,investigators
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