摘要
目的:鉴于我国关于知情同意的实证调查不够的事实,本研究旨在详细调查受试者知情同意后,对知情同意书及过程的理解及满意度。方法:本研究以中南大学湘雅医院近期招收的药物临床试验受试者为调查对象,共面谈了56位受试者,调查和分析了受试者对知情同意的理解度和满意度等方面的情况。结果:94. 6%的受试者对知情同意书的内容基本了解和完全了解; 93. 6%的受试者对知情同意的有关过程基本满意和非常满意。高龄和受教育程度较低的受试者对知情同意书的理解程度较差;受试者对损害赔偿或治疗及申诉等方面的问题认知较低。结论:针对已发现的问题,为了更好地保护受试者的权益并促进药物临床试验顺利进行,知情同意书的设计应该更加人性化,研究者应该加强共情能力及责任感的培养,伦理委员会也应该加强自身建设。
Objective:To analyze the subjects' understanding of informed consent form and satisfaction for the process after signing the form based on the fact that there is no enough evidence-based survey on informed consent.Methods:Fifty-six subjects enrolled by Xiangya Hospital affiliated to Central South University were interviewed and their attitude toward the informed consent were analyzed.Results:There were around 94.6% subjects who could basically or fully understand the content of informed consent form,while 93.6% subjects showed their basic and full satisfaction to the process of informed consent.Elderly and poorly-educated people showed poor understanding of the informed consent.Subjects have low acknowledgement to the issues regarding to the compensation,therapy and appeals to the damages.Conclusion:In order to protect the subjects and promote the progress of clinical trials,the design of informed consent should be more humanized,the empathy of the researchers should be strengthened,and the competence of institutional review board (IRB)should be enhanced.
作者
冯龙飞
FENG Long-fei(Medical School,Yichun University,Yichun 336000,China;School of Public Management, Central South University,Changsha 410083,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第24期2911-2915,共5页
Chinese Journal of New Drugs
基金
国家社科基金青年项目(16CZX022)
湖南省科技创新咨询暨软科学重点项目(2017ZK3059)
中南大学教改项目(2018jy066)
关键词
药物临床试验
满意度
理解度
知情同意
drug clinical trial
satisfaction
understanding
informed consent
