儿科人群临床研究中“同意”的伦理探讨及对策  

Ethical Discussion and Countermeasures of “Assent” of Clinical Research in Pediatric Population

作　　者：王晓敏[1] 虢毅[2] 袁秀洪[3] 阳国平[1] 邓昊[4] WANG Xiaomin;GUO Yi;YUAN Xiuhong;YANG Guoping;DENG Hao(Center of Clinical Pharmacology,the Third Xiangya Hospital of Central South University,Changsha 410013,China;Information Security and Big Data Research Institute,Central South University,Changsha 410013,China;Department of Clinical Psychology,the Third Xiangya Hospital of Central South University,Changsha 410013,China;Medicine Experimental Center,the Third Xiangya Hospital of Central South University,Changsha 410013,China)

机构地区：[1]中南大学湘雅三医院临床药理中心,湖南长沙410013 [2]中南大学信息安全与大数据研究院,湖南长沙410013 [3]中南大学湘雅三医院临床心理科,湖南长沙410013 [4]中南大学湘雅三医院医学实验中心,湖南长沙410013

出　　处：《中国医学伦理学》2018年第11期1403-1407,共5页Chinese Medical Ethics

基　　金：中南大学研究生教育教学改革研究项目:临床科研实验技能教学改革研究(2016JGB19);中南大学教育教学改革研究项目:医学生临床医学伦理决策能力培养模式研究(2017jy98);中南大学教育教学改革研究项目"<临床科研实验技能>教学改革与探索"(编号:2018jy127);中南大学教育教学改革研究项目"全球化背景下医学伦理学课程设置及教学模式探索"(编号:2018jy066);2018年度中南大学研究生精品课程项目"医学实验技术与方法新进展";2018年湖南省普通高等学校教学改革研究项目:<临床科研实验技能>教学改革与探索

摘　　要：临床研究时,"同意"被视为是儿科临床研究的重要法律和伦理要求,但同意的概念却一直饱受争议。而且,由于儿科人群不断成长变化的生理特点,使得在何时以及如何同意变得非常复杂。通过辨析临床研究英文"Assent"与"Consent"的概念差别,分析目前儿科人群临床研究中同意能力和同意过程等存在的问题,从而提出加强儿童同意的能力评估,构建儿童共享决策同意过程,伦理委员会的全生命周期审查等相应对策,以期促进儿科人群临床研究的科学合理发展。In clinical research, ＂assent＂ is considered an important legal and ethical requirement for pediatric clinical research, but the concept of assent has been controversial. Moreover, due to the physiological characteristics of continuous growth and change of pediatric population, when and how to make assent or consent becomes more complicated. By analyzing the difference of concept between the English version of ＂assent＂ and ＂consent＂ in clinical research, this paper analyzed the existing problems in assent ability and assent process of clinical research in pediatric population, thus put forward corresponding countermeasures of strengthening ability assessment of children＇ s assent, building a child shared decision -making assent process and the complete cycle review of ethics committee, in order to promote the scientific and ethical development of clinical research in pediatric population.

关 键 词：临床研究 同意 儿科人群 儿童共享决策 

分 类 号：R-052[医药卫生]