中国医学伦理学2013，Vol.26Issue(3)：293-294,2.
药物临床试验伦理委员会运作实践
The Operation of Ethics Committees in Drug Clinical Trials
鲁瑞萍 1单志桂 1申洁1
作者信息
- 1. 新疆医科大学第一附属医院药物临床试验机构,新疆乌鲁木齐 830054
- 折叠
摘要
Abstract
In the process of drug clinical trials,it is necessary to give full guarantee of personal rights of the subjects,and ensure the scientific nature and reliability of the test.Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.In order to protect the clinical trial subjects'rights and interests,it should set up an independent ethics committee,and put on records in the State Food and Drug Administration.In this paper,the authors also introduced the construction and records,standard business,existing problems and solving countermeasures in a hospital ethics committee.关键词
临床试验/伦理委员会/伦理审查/知情同意/受试者权益Key words
Clinical Trail/ Ethics Committee/ Ethical Review/ Informed Consent/ Rights and Interests of the Subjects分类
医药卫生引用本文复制引用
鲁瑞萍,单志桂,申洁..药物临床试验伦理委员会运作实践[J].中国医学伦理学,2013,26(3):293-294,2.
