临床研究项目伦理审查中的知情同意问题  

Issues of Informed Consent in Ethics Review of Clinical Research Projects

作　　者：廖绮霞[1] 赖永洪[1] 刘俊荣[2] LIAO Qi-xia;LAI Yong-hong;LIU Jun-rong(Medical Affair Department,The Third Affiliated Hospital of Guangzhou Medical University,Guangzhou 510150,China)

机构地区：[1]广州医科大学附属第三医院医务科,广东广州510150 [2]广州医科大学马克思主义学院,广东广州511436

出　　处：《医学与哲学》2021年第19期34-37,44,共5页Medicine and Philosophy

基　　金：2016年国家社会科学基金项目(16BZX1080)。

摘　　要：知情同意的目的在于尊重受试者的自主权,维护受试者的利益,绝不能当作临床研究者自我保护的手段,也不能认为没有伤害风险的就可以不履行知情同意。当前临床研究项目的伦理审查实践中,知情同意存在受益、风险、补偿等事项的告知说明不充分、不准确等问题,明确同意执行不到位问题,知情告知不及时问题。建议细化告知说明事项、切实履行知情权,在知情同意过程中切实保障受试者真正理解、确保明确同意,提高研究者的伦理意识、强化多个部门的监管责任。The purpose of informed consent is to respect the autonomy of subjects and safeguard the interests of subjects.It must not be used as a means of self-protection by clinical researchers,nor can it be considered that there is no risk of harm to fail to perform informed consent.In current ethical review of clinical research projects,the practice of informed consent shows problems of insufficient and inaccurate notification and explanation of benefits,risks,compensation,improper execution of explicit consent,and delayed informed notification.It is recommended that detailed notifications and explanations should be made,the right to be informed should be fulfilled,the subjects'true understanding and clear consent should be ensured during the informed consent process,the ethical awareness of researchers should be improved,and the supervisory functions of multiple departments should be strengthened.

关 键 词：伦理审查 知情同意 临床研究 

分 类 号：R-05[医药卫生]