Study on the judicial status and problems in protecting the rights and interests of human clinical trial subjects
In judicial practice,cases of disputes over damages to human clinical trial subjects are heard and adju-dicated in accordance with general medical torts.With the exception of special cases where medical institutions cause medical malpractice,in the vast majority of cases,subjects lose their cases because they are unable to prove the fault of the researchers,the causal relationship between the trial behavior and the results of the damage,and are unable to obtain compensation at all.Sponsors and researchers,as the dominant players in human clinical trials,often occupy an absolute advantage.From the perspective of fairness,it's necessary to increase the burden of proof of sponsors and researchers as a dangerous manufacturer,and reduce the subject's burden of proof in order to better protect the legitimate rights and interests of the subject.And the human clinical trial tort liability is independent from the gen-eral medical tort,as an independent special tort liability type to regulate.Meeting the basic international law princi-ples of the protection of the rights and interests of subjects and the primacy of safety.
Human clinical trialSubjectTort liabilityFaultInformed consent
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