中国医疗设备Issue(6)：148-150,3.DOI:10.3969/j.issn.1674-1633.2015.06.044
医疗器械临床试验中知情同意常见的问题与对策
Common Problems of Informed Consent in Medical Equipment Clinical Trials and Relevant Solutions
杨春梅 1袁丹江1
作者信息
- 1. 华中科技大学同济医学院附属荆州医院 药物临床试验机构，湖北 荆州 434020
- 折叠
摘要
Abstract
This paper analyzed the problems of informed consent during medical equipment clinical trials, including the poor writing, nonstandard signing, formalized content and loss of signed informed consent. Moreover, this paper also discussed relevant solutions to improve the writing of informed consent, ethical reviews and file management, regulate the researchers’ behavior and strengthen the awareness of protecting the right of informed consent.关键词
医疗器械临床试验/知情同意书/伦理审查/档案管理Key words
medical equipment clinical trials/informed consent/ethical reviews/ifle management分类
医药卫生引用本文复制引用
杨春梅,袁丹江..医疗器械临床试验中知情同意常见的问题与对策[J].中国医疗设备,2015,(6):148-150,3.
