Study On The Tort Liability Of New-drug Clinical Trial

This dissertation, with the present theory of tort law, is aimed at studying the independence of tort liability of new-drug clinical trial and to theoretically explicit the liability principle and constitutive elements and its confirmation of such tort liability from the perspective of the protection for human subjects, further provide the future completion of law and legal practice with reference. The dissertation will begin with analyzing the present situation of new-drug clinical trial and protection of human subjects in terms of the related sources of law. Then the dissertation will seek to achieve the aims by using the method of case study, literature study, explanation of legal theory and logical inference, etc. The dissertation will be divided into the following6parts:By figuring out the related sources of law in terms of new-drug clinical trial and protection for human subjects and the corresponding problems existed, the first part will present the practical significance and determine the research purpose and research scope.The second part will study on the concurrence between tort liability and contractual liability, and analyze the reasons for the preference of tort liability in the case of such concurrence.In order to explicit the independence of tort liability of new-drug clinical trial, the third part will study on the distinctions between new-drug clinical trial and ordinary medical behavior, including distinctions with respect to meanings, purposes, properties, characteristics and legal relationships.In order to theoretically explicit the liability principle of tort liability of new-drug clinical trial, the fourth part will study on the liability principle, including the analysis of the liability principle on the basis of3related cases in the legal practice and present laws and regulations, then from the perspective of protection for human subjects, study on the independent tort liability of new-drug clinical trial and explicit its liability principle theoretically.In order to theoretically explicit the constitutive elements of tort liability of new-drug clinical trial and its confirmation, the fifth part will study on the constitutive elements and its confirmation from the perspective of protection for human subjects. This part will analyze the constitutive elements of each responsible subject on the basis of above study on liability principle, and the standards for confirmation of fault, tort act, causality and fact of damage.The sixth part will make conclusions for the dissertation.