Discussion On The Tortious Liability In Biomedical Research Involving Human Subjects

In the actions of Biomedical Research Involving Human Subjects, the sponsor initiates a research project and is responsible for the launch, administration, finance and supervision of the research program. The investigator carries out the research project and is responsible for the research quality and the security, rights and interests of human subjects. The human subjects have to stand the research which operated on his body. Among the participations of Biomedical Research Involving Human Subjects, the subjects are in junior position with the economy vulnerability and information vulnerability. The subject protection is a problem with extensive scope, and this article aims at provision of an access to private law protection through the tort law.This article is written surround the point of the liability in human subject research, which divided into six parts.The first part gives the overview of basic problems about Biomedical Research Involving Human Subjects and subject protection, and this part of the article tries to put those problems into the view of tort law. Biomedical Research Involving Human Subjects means all the biomedical research which treat human as the object of study, that is, all the biomedical research which try to obtain material, date and information which is necessary for medical research by the way of intervene human body or other methods. The scope of human subject research is extensive and the most common form is Clinical Trial. In the actions of human subject research, a kind of civil legal relationship shapes between subjects and research institutions which is independent from ordinary medicine. In the view of tort law, the sponsor or/and the research institutions who violate law or statute and trespass the legal rights and interests of subjects for undue interests became tortfeasors, and the subjects who endure damage became victims. Tort law should become the common tool used to regulate the interest relationship between tortfeasor and victim.From the second part to the sixth part, this article discusses some specific issues about human subject research tort liability, such as the imputation criterion, liability cognizance, exemptions, responsibility patterns and compensation for damage.Firstly, the imputation criterion of human subject research tort liability should be presumption of fault, because the neither the no-fault liability nor the fault liability is available.Secondly, on the problem of liability cognizance in human subject research tort, this article discusses three questions which include the cognizance of infringing act, the cognizance of fault, the cognizance of causation. Human subject research tort means the actions that the executors, which include the sponsor, investigator and Contract Research Organization (CRO) and so on, violate the related law and ethic rules and result in the damage of subjects. The categories of human subject research tort, involves defective performance of informed consent, defect of protocol, defect of subjects recruitment and violation to the legal procedure. On the question of cognizance of fault, this article deems that the standard should be the theory of statutory behavior standard. On the question of cognizance of causation, this article considers that the probable standard of causation is of usability.Thirdly, the exemptions of human subject research tort liability consist of the consent of victim, the fault of victim, the fault of third party and force majeure.Fourthly, on the responsibility patterns of human subject research tort, this article aims at the vicarious liability, the joint liability and the respective liability.Fifthly, on the compensation for damage of human subject research tort liability, this article discusses the problem of contributory negligence and counterbalance between errors.The last part is conclusion. The system of tort law is opening up, and the protection to vulnerable groups should be the righteous topic of tort law. Facing the new-style tort actions, the established theories of tort law should be adapted somewhere, and this article gives some preliminary recommendation. Tort law is not the whole system of subject protection, but the most accessible, the most acquirable and the most unnegligible protection mechanism. Only on the precondition of compensation the subject's damages, it's appropriate to discuss the broader compositive subject protection system. The road of pursuing subject's benefits starts from the tort law.