入罪与出罪:药物临床试验过失的刑法限度  

Entry and Exit:The Criminal Law Limits of Negligence in Drug Clinical Trials

作　　者：李丞铭 卢微羽 Li Chengming;Lu Weiyu(School of Criminal Justice,Zhongnan University of Economics and Law,Wuhan 430070,China;School of Law,Beijing Normal University,Beijing 100875,China)

机构地区：[1]中南财经政法大学刑事司法学院,湖北武汉430070 [2]北京师范大学法学院,北京100875

出　　处：《锦州医科大学学报（社会科学版）》2024年第5期17-21,共5页Journal of Jinzhou Medical University(Social Science Edition)

基　　金：中南财经政法大学中央高校基本科研业务基金项目“‘权利束’视角下网游虚拟财产的刑法保护研究”(编号:202310714)的研究成果。

摘　　要：药物临床试验过失的刑法介入虚置化,不利于临床试验的正常开展与受试者合法权益的保障。药物临床试验是科学系统与医疗系统结构耦合的表现,以“申办者/负责人、研究医生、护士、药师、受试者”为主体,可能涉及监督过失、选任过失、过失竞合等复杂过失类型。本文以修正的危惧感说作为分析工具,恪守罪刑法定的形式理性,结合社会系统论的合目的性解释,可以一体式解决各过失类型的归责难题,从而明确药物临床试验过失的刑法限度。对于结构耦合和非结构耦合情形应当分类评价,后期则应当增设相应的业务过失类犯罪。The virtualization of criminal law intervention in drug clinical trial negligence is not conducive to the normal conduct of clinical trials and the protection of the legitimate rights and interests of the subjects.Drug clinical trial is an emanation of structural coupling between scientific system and medical system,with“sponsor/responsible person,investigating doctor,nurse,pharmacist,and subjects”as the main body,which may involve complex types of negligence such as supervisory negligence,selection negligence,general negligence,and competing negligence.By using the modified sense of jeopardy theory as an analytical tool,adhering to the formal rationality of the criminal law,and combining with the purposive interpretation of social system theory,the problem of attributing responsibility to each type of negligence can be solved in an integrated manner,so as to clarify the criminal law limit of negligence in drug clinical trials.Structural and non-structural coupling situations should be evaluated in a categorized manner,and in the long term,a corresponding category of operational negligence should be added.

关 键 词：药物临床试验 过失犯罪 修正的危惧感说 社会系统论 

分 类 号：R19[医药卫生—卫生事业管理] D9[医药卫生—公共卫生与预防医学]