摘要
本文就目前医疗器械临床试验中知情同意存在的:知情同意书撰写质量不高、签署欠规范,告知与知情同意流于形式、签署的知情同意书发生丢失等问题进行分析;就如何提高知情同意书撰写质量、伦理审查质量及档案管理水平,如何规范研究者行为、强化受试者知情同意权的保护意识等措施进行了探讨。
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.
出处
《中国医疗设备》
2015年第6期148-150,共3页
China Medical Devices
关键词
医疗器械临床试验
知情同意书
伦理审查
档案管理
medical equipment clinical trials
informed consent
ethical reviews
ifle management
