《药物临床试验质量管理规范》背景下的临床试验受试者损害救济研究  

Research on the damage relief of clinical trial subjects from the perspective of new version of the Good Clinical Practice (GCP)

作　　者：郑秋实 Zheng Qiushi(Medical Affairs Department,Peking University Cancer Hospital&Institute,Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院,北京100142

出　　处：《中国卫生法制》2023年第1期114-117,共4页China Health Law

摘　　要：《民法典》第一千零八条以专门性条文将临床试验受试者权益保障提高到了人格权高度,彰显了国家对于受试者权益保护的重视。新版《药物临床试验质量管理规范》在旧版规范补偿责任的基础上增加了赔偿责任,为临床试验类案件参照人身损害赔偿标准计算赔偿奠定了初步基础,为该类案件的公正解决划定了可参考的统一标准。在责任承担主体方面,新版《药物临床试验质量管理规范》再一次明确了申办方是临床试验导致受试者损害的责任主体,并进一步完善了例外情形与一般医疗损害赔偿责任相对接。在补偿或赔偿范围方面,法律尚未完全明确。因临床试验损害所造成的诊疗费用等相关费用,申办方应当全额承担。而对于具有精神抚慰性质的相关费用,则应平衡受试者权益保护与临床试验发展的关系,考虑患者原发病及临床试验与损害后果之间的因果关系要素,公正评价赔偿或补偿金额,妥善处理临床试验相关医疗争议。Article 1008 of the Civil Code reflects the importance of the rights of clinical trial subjects in Chinese law. The new version of GCP adds the liability for damages to further protect the rights and interests of the subjects, which provide the primary basis for calculate the compensation standard. The new version of GCP makes it clear that the applicant is the subject of responsibility in clinical trial cases and further aligned liability for general and exception medical damage cases. In terms of the scope of compensation and liability, the regulations do not specify. The author thought that the sponsor should bear all the relevant medical expenses for damages resulted from clinical trials. For the related expenses with the nature of spiritual comfort, we should consider the primary disease and other related factors to determine the amount of compensation fairly.

关 键 词：民法典 新版GCP 受试者 损害赔偿 

分 类 号：D902[政治法律—法学理论]