人体临床试验受试者权益保护的司法现状及问题研究

Study on the judicial status and problems in protecting the rights and interests of human clinical trial subjects

司法实践中,人体临床试验受试者的损害赔偿纠纷案件是按照一般医疗侵权行为进行审理和判决的。除医疗机构导致医疗事故的特殊情形外,绝大多数案件中受试者都因为无法证明研究者的过错、试验行为和损害结果的因果关系而败诉,根本无法获得赔偿。申办者和研究者作为人体临床试验的主导者,往往占据绝对的优势。从公平的角度出发,应当加大作为危险制造者的申办者和研究者的举证责任,减轻受试者的举证责任以便于更好地保护受试者的合法权益。将人体临床试验侵权责任从一般医疗侵权中分离出来,作为一种独立的特殊侵权责任类型加以规范,以实现受试者权益保护和安全至上的基本国际法原则。

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.