摘要
目的分析我国公立医院干细胞临床研究伦理审查的状况。方法对上海市、天津市和贵州省10所公立医院进行了相关伦理委员会的问卷调查。结果干细胞临床研究伦理审查基本把握了伦理审查的要素;但收益与风险评估是伦理审核的难点,风险告知仍有不足。结论我国伦理委员会应进一步重视干细胞临床研究收益与风险的权衡,重视干细胞临床研究的特殊性风险,完善知情同意的伦理审核要素。
Objective: To analyze the ethical review of Clinical Stem-cell research in public hospitals in China. Methods: A questionnaire survey of related ethics committees was conducted among 10 public hospitals in Shanghai,Tianjin and Guizhou. Results: The ethical review of Clinical Stem-cell research basically grasped the elements of ethical review,but benefit and risk assessments were the difficult parts in ethical review,and risk disclosure was still insufficient. Conclusion: Ethics Committees in china should pay more attention to the trade-off between benefits and risks of Clinical Stem-cell research,specific risks of Clinical Stem-cell research and the improvement of ethical review elements of informed consent.
作者
张勘
马晨光
王剑萍
白莉华
雷颖
薛迪
ZHANG Kan;MA Chenguang;WANG Jianping;BAI Lihua;LEI Ying;XUE Di(Shanghai Municipal Health Commission, Shanghai 200125, China;School of Public Health, Fudan University,NHC key Laboratory of Health Technology Assessment (Fudan University) , Shanghai 200032, China;Tong Ren Hospital, School of Medicine Shanghai Jiao Tong University, Shanghai 200336, China;Shanghai East Hospital, Shanghai 200120, China)
出处
《中国医学伦理学》
2019年第1期18-21,共4页
Chinese Medical Ethics
基金
2016年度国家重点研发计划"干细胞转化研究"重点专项"神经系统和心脏相关重大疾病组织干细胞和病理组织库"项目(2016YFA0101303)的资助
关键词
伦理审核
知情同意
干细胞
临床研究
公立医院
Ethical Review
Informed Consent
Stem Cell
Clinical Research
Public Hospital
