摘要
文章对现阶段医疗器械临床试验中知情同意书和知情同意过程出现的问题进行了归纳分析和总结,包括知情同意书内容不充分、签署不规范、版本混乱、知情同意书保管不规范、知情同意过程流于形式、落实不到位等,并从研究者、受试者、监管层面分析归纳原因,并就优化知情同意质量提出系列措施,包括知情同意书的内容、表达、审核、签署、保管的建议和措施以及知情同意过程中法规、操作规程、相关人员的教育培训以及监管层面的可行性建议和措施。
Under the current situation, this paper analyzes the problems about the informed consent and informed consent process of the medical equipmentin the clinical trials, including the insufficient writing and nonstandard signing, order-less versions, nonstandard storage and the formalization of the informed consent process and not implementation. Therefore, this paper also analyzes some reasons in terms of the researchers, subjects and regulatory.Moreover, this paper puts forward a series of counter measures to improve the quality of informed consent, including the suggestions and measures about the content, the expression, the audit, the sign, the custody of informed consent and some feasibility proposals about regulations, procedures, related personnel education and the related regulation of the informed consent process.
出处
《江苏科技信息》
2018年第3期70-73,共4页
Jiangsu Science and Technology Information
关键词
医疗器械临床试验
伦理审查
知情同意书
medical equipment clinical trials
ethical reviews
informed consent
