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药物临床试验受试者知情同意的影响因素调查及分析

张跃 陈晓云 尤圣富

中国医学伦理学2018,Vol.31Issue(2):213-219,7.
中国医学伦理学2018,Vol.31Issue(2):213-219,7.DOI:10.12026/j.issn.1001-8565.2018.02.14

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

张跃 1陈晓云 2尤圣富2

作者信息

  • 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
  • 折叠

摘要

Abstract

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

Key words

Drug Clinical Trials/Informed Consent/Subjects' Rights Informed

分类

医药卫生

引用本文复制引用

张跃,陈晓云,尤圣富..药物临床试验受试者知情同意的影响因素调查及分析[J].中国医学伦理学,2018,31(2):213-219,7.

基金项目

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 ()

中国医学伦理学

OACSTPCD

1001-8565

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