摘要
从医疗机构视角出发,针对《涉及人的生命科学和医学研究伦理审查办法》中第三十二条关于“免除伦理审查”的内容进行梳理,同时结合国内外法规,对条款中的适用前提和特殊情形从执行层面深入思考与分析,从医疗机构实际操作角度提出了建议,以期为医疗机构伦理从业人员提供一定的实践指引参考。
From the perspective of medical institutions,this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding exemption from ethical review.At the same time,combined with domestic and foreign regulations,this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level,and then put forward suggestions from the perspective of practical operation of medical institutions,with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.
作者
陈仲林
杨梦婕
陈晓云
凌丽
侯旭敏
李雪宁
冯钰
CHEN Zhonglin;YANG Mengjie;CHEN Xiaoyun;LING Li;HOU Xumin;LI Xuening;FENG Yu(Office of Ethics,Shanghai Chest Hospital/Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200030,China;Committee of Medical Ethics,Zhongshan Hospital Affiliated to Fudan University,Shanghai 200032,China;Office of Medical Ethics,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Office of Ethics Management,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)
出处
《中国医学伦理学》
2023年第7期736-741,共6页
Chinese Medical Ethics
关键词
临床医学研究
伦理审查
免除伦理审查
医疗机构
Clinical Medical Research
Ethical Review
Exemption from Ethics Review
Medical Institutions
