摘要
《药品临床试验质量管理规范》规定了我国药物临床试验的主要制度,但对试药导致损害的救济立法上不甚明确。建议通过侵权责任的方式对受试者的损害进行救济。试药人身损害的责任可适用过错推定责任原则,其构成要件应由损害后果、加害行为、因果关系、过错四部分组成。
＂Regulations for Quality Management in Clinical Drug Trials＂ stimulates the main system of clinical drug trials of our country,but it is not clear about reparation for damage caused by drug test in legislation.It is suggested that the testees damaged by drug test should be relieved through the tort liability.The responsibility of damage caused by drug test can be applied with the principle of presumption of fault liability,whose constituent elements consist of consequences of the damage,tortious action,causal relationship,and fault.
出处
《山西省政法管理干部学院学报》
2011年第4期32-34,共3页
Journal of Shanxi Politics and Law Institute for Administrators
关键词
试药
侵权责任
归责原则
构成要件
drug test
tort liability
principle of attribution
constituent elements
