摘要
根据现行法律,临床试验中受试者受到损害只能适用过错责任归责原则。临床试验这种特殊医疗活动中发生的损害,对于专门知识、理解力均处于劣势的受试者而言,意味着损害将由受试者独自承担。这种规定违背了公平、公正的法律精神。严格责任通过公平合理地分配责任,可以更好地保护申办者和/或研究者的利益,又能保护受试者的利益。
According to valid law,injuries of subjeets in elinieal trials can only be judged by the principle of fauh responsibility. The subjeets who are short of expertise and understanding will bear the injuries alone which take place in clinical trials, a kind of medical activities. Such provisions run counter to fairness and impartiality. To protect both the host and / or researehers＇and the subjeets＇benefits more effectively, striet liability is needed to achieve fair and reasonable allocation of responsibility.
出处
《医学与社会》
2008年第11期27-29,共3页
Medicine and Society
关键词
临床试验
严格责任
受试者
clinical trial
strict liability
subjects
