外科临床研究中伦理问题的思考与策略  

Thoughts and strategies on ethical issues in clinical research of surgery

作　　者：谭黎杰 李子禹[2] 张燕[2] 王继洲 刘连新 王剑明[4] 陆芸 马超群 花苏榕[5] 吴文铭[5] 赵玉沛[5] 姚宏伟 何晶晶[7] 孔媛媛 张忠涛 刘子文[5] Tart Lijie;Li Ziyu;Zhang Yan;Wang Jizhou;Liu Lianxin;Wang Jianming;Lu Yun;Ma Chaoqun;Hua Surong;Wu Wenming;Zhao Yupei;Yao Hongwei;He Jingiing;Kong Yuartyuan;Zhang Zhongtaon;Liu Ziwen(Department of Thoracic Surgery,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Center of Gastrointestinal Tumor,Peking University Cancer Hospital,Belling 100042, China;Department of Hepatobiliary Surgery,the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital ),Hefei 230000,China;Department of Biliarypancreatie Surgery,Tongfi Hospital,Tongji Medical College,Hnazhong University of Science and Technology,Wuhan 430030,China;Department of General Surgery,Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medical Sciences,Beijing 100730,China;Department of General Surgery,Beijing Friendship Hospital, Capital Medical University (National Clinical Research Center for Digestive Diseases),Belling 100050,China;Institute of lnternational Law of the Chinese Academy of Social Sciences,Belling100720,China;Splatform of Methodology,Beijing Friendship Hospital,Capital Medical University (National Clinical Research Center for Digestive Diseases),Beijing 100050,China)

机构地区：[1]复旦大学附属中山医院胸外科,上海200032 [2]北京大学肿瘤医院胃肠肿瘤中心,100142 [3]中国科学技术大学附属第一医院(安徽省立医院)南区肝胆外科,合肥230000 [4]华中科技大学同济医学院附属同济医院胆胰外科,武汉430030 [5]中国医学科学院北京协和医学院北京协和医院基本外科,100730 [6]首都医科大学附属北京友谊医院(国家消化系统疾病临床医学研究中心)普通外科,100050 [7]中国社会科学院国际法研究所,北京100720 [8]首都医科大学附属北京友谊医院(国家消化系统疾病临床医学研究中心)方法学平台,100050

出　　处：《中华消化外科杂志》2019年第1期57-64,共8页Chinese Journal of Digestive Surgery

基　　金：国家自然科学基金面上项目(81773292).

摘　　要：医学伦理起源悠久,内涵丰富,从古代朴素的“医德学”发展为近现代医学伦理学。医学伦理学的核心精神包括自主、无害、善行、公正。研究者常在成果获得与伦理规范的平衡中开展临床研究。外科的临床研究者应深刻理解医学伦理原则,严格遵从医学伦理学规范;伦理委员会严格履行职责,充分发挥审查监管作用:全社会范围内普及现代医学知识,正确认识临床研究;秉承临床科研伦理为先,以人为本,合作实践的原则,始终以患者的利益为最主要的衡量标准,才能达到外科道与术的平衡。[Medical ethics has a long history and rich connotations.It has developed from the simple "medical morality" of ancient times to the modem medical ethics.The basic principles of medical ethics include autonomy,non-maleficence, beneficence,justice,and so on.Researchers often conduct clinical researches in the balance between achievements and ethical norms.Clinical researchers of surgery should have a deep understanding of medical ethical principles and strictly abide by medical ethics.Ethics committee should strictly perform their duties and play the role of inspection and supervision.Modem medical knowledges should be popularized throughout the society to make clinical research correctly understood.Adhering principles of ethics first,people orientation and cooperation practice, with patients'benefit as evaluation criteria,balance of surgical "Dao"and "Shu"can be achieved.

关 键 词：临床研究 外科学 伦理学 生物伦理学 决策 

分 类 号：R61[医药卫生—外科学]