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
Key words
drug clinical trial/negligent offense/modified sense of jeopardy/social system theory
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