药物临床试验受试者知情同意的影响因素调查及分析  

Investigation and Analysis of the Influencing Factors of Informed Consent of Subjects in Drug Clinical Trial

作　　者：张跃 陈晓云[2] 尤圣富[2] 

机构地区：[1]上海中医药大学设备与房产管理处,上海200032 [2]上海中医药大学附属龙华医院伦理委员会,上海200032

出　　处：《中国医学伦理学》2018年第2期213-219,共7页Chinese Medical Ethics

基　　金：上海市卫计委中医药新三年行动计划资助;项目编号为:ZY3-RCPY-3-1058;ZY3-CCCX-2-1002

摘　　要：以上海市某三甲医院为中心,通过电话访谈完成问卷调查的方式了解药物临床试验受试者在研究结束之后(6~18个月内)对受试参与研究和作为受试者对自身权利了解情况,分析知情同意过程存在的问题,并与国外知情同意现状相比较,归纳了受试者自身权利被告知的多种可行方式,为今后我国医学科研管理和伦理工作的发展和完善提出建议。Taking a class A tertiary hospital in Shanghai as center, this paper understood the awareness of the subjects of drug clinical trials on their participation in the research and their own rights as subjects after the end of research （6 - 18 months） by questionnaire survey completed by telephone interview, analyzed the problems existing in the process of informed consent, compared with the foreign status, and summed up a variety of feasible ways of subject＇s own right to be informed, to put forward feasible suggestions for the development and improvement of medical scientific research management and the ethical work in China.

关 键 词：药物临床试验 知情同意 受试者权利告知 

分 类 号：R-052[医药卫生]