CAJ | 학술논문

为提高患者（包括受试者）权益保护水平，世界医学协会2013版《赫尔辛基宣言》将知情同意作为单独部分予以规定，区分知情同意能力、增加告知研究结果、强化知情同意主体法律地位。我国自2008年“李丽云事件”发生后已对知情同意制度进行修订，但其签署过程中仍存在以作用取代目的、自主权尚未受到充分保护、告知程序内容不完善、医患沟通欠缺等问题。因此，应借鉴2013版《赫尔辛基宣言》规定，加强医患双方法律教育、明确知情同意主体能力、规范知情同意签署过程、提高医务人员沟通能力，以切实保护患者知情同意权。
위제고환자（포괄수시자）권익보호수평，세계의학협회2013판《혁이신기선언》장지정동의작위단독부분여이규정，구분지정동의능력、증가고지연구결과、강화지정동의주체법률지위。아국자2008년“리려운사건”발생후이대지정동의제도진행수정，단기첨서과정중잉존재이작용취대목적、자주권상미수도충분보호、고지정서내용불완선、의환구통흠결등문제。인차，응차감2013판《혁이신기선언》규정，가강의환쌍방법률교육、명학지정동의주체능력、규범지정동의첨서과정、제고의무인원구통능력，이절실보호환자지정동의권。
To improve the protection of patients rights ,including human subjects rights ,informed consent was specified as a separate part by the World Medical Association in the Declaration of Helsinki in 2013 .At the same time ,the capability of informed consent was further clarified ,the outcome and results must be informed to all medical research subjects and the position of subjects was strengthened .Although the regulations on informed consent has been revised since the case of Li Liyun in 2008 ,there are still some problems have not been resolved ,such as the purpose of informed consent was replaced by the impact ,the patients have not been protected adequately ,the procedure and content were defective ,doctors and patients were lack of communication . After the comparison of different provisions , the paper recommends that the education of laws and regulations should be strengthened for both doctors and patients ,provisions should be improved and the communication skills of medical personnel should be trained .Only by these methods ,the right of informed consent could be protected effectively .