论民法视野下人体医学试验损害的救济

On the Relief of Damage Caused by Human Body Medicine Experiment in Civil Law

人体医学试验不应因其具有公益性质而漠视受试者的权利。为了保护受试者的利益,研究者和受试者订立的知情同意书应该视为合同。试验过程中,受试者受到人身损害,可以选择向研究者提起违约之诉或者侵权之诉要求研究者承担损害赔偿责任。无论选择违约之诉还是选择侵权之诉,均应适用无过错责任原则。受试者的自冒风险行为可以作为免除研究者民事责任的事由,当然,研究者和受试者也可以就受试者自冒风险行为所招致的损害约定分担。

The rights of the subjects should not be ignored in human body medicine experiment because of their public nature. In order to protect the interests of the subjects, the informed consent agreement made by researchers and subjects should be regarded as a contract. In human body medicine experiment process, if the physical damage of the subjects were suffered, the subjects could choose liability for breach of contract law or torts law to appeal against researchers to compensate and the principle of no fault liability should be applied. Assumption of risk can be used as the reason of avoiding the researchers＇ civil liability. Of course, researchers and subjects can also act on sharing agreement to damage of the subjects.