摘要
根据现行法律,在临床试验中受试者受到损害只能适用过错责任归责原则。在临床试验这种特殊医疗活动中发生的损害,对于在专门知识、理解力均处于劣势的受试者而言,意味着这种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,更好地既保护申办者和/或研究者的利益,又保护受试者的利益。
According to valid law,injuries of subjects in clinical trials can only apply the principle of fault responsibility. The subjects who are short of expertise and understanding will bear the injuries alone which take place in clinical trials that is a kind of medical activities. Such provisions run counter to fair and impartial. To protect both the host and / or researchers’ and the subjects’ benefits more effectively, strict liability which is a kind of fair and reasonable allocation of responsibility is nee...
出处
《中外医疗》
2008年第26期163-164,共2页
China & Foreign Medical Treatment
关键词
临床试验
严格责任
受试者
Clinical Trial
Strict liability
Subjects
