摘要
调查分析我国公立医院人员对干细胞临床研究知情同意的认知情况。对上海市、天津市和贵州省10所公立医院进行干细胞临床研究相关人员的问卷调查发现,干细胞临床研究知情同意书需特别告知干细胞制剂质量、研究主要风险和研究过程的风险控制措施。此外,公立医院人员对干细胞临床研究知情同意要求认知不足,超过1/3的人员将夸大研究对象可能获得的收益列为前3位干细胞临床研究的伦理问题。干细胞临床研究的伦理审核应更关注知情同意的审核,以充分保护受试者的权益。
To analyze the cognition of informed consent of stem cell clinical research among public hospital personnel in China, a questionnaire survey in 10 public hospitals from Shanghai, Tianjin, and Guizhou province is conducted. The study results show that the quality assurance of stem cell products, main risks and risk control measures especially should be shown in the consent forms in stem cell research. In addition, the personnel in public hospitals do not exactly understand the requirements of informed consent, and over one third of participants regard over-statements on research benefits as the top three ethical problems in stem cell clinical research. Ethical review of informed consent in stem cell clinical research should be paid more attentions to fully protect the rights and interests of research subjects.
作者
马晨光
雷颖
白莉华
王剑萍
林云
薛迪
MA Chen-guang;LEI Ying;BAI Li-hua(School of Public Health,Fudan University/ Key Laboratory of Health Technology Assessment,National Health Commission,Shanghai 200032,China)
出处
《医学与哲学》
2019年第19期35-37,共3页
Medicine and Philosophy
基金
2016年国家重点研发计划“干细胞及转化研究”重点专项资助项目(2016YFA0101303)
关键词
干细胞
临床研究
知情同意
认知调查
stem cell
clinical research
informed consent
cognition survey
