1例临床试验受试者损害的赔偿

One case of clinical trial subjects damage compensation

《药物临床试验质量管理规范》第43条:申办者应对参加临床试验的受试者提供保险,对于发生与试验相关的损害或死亡的受试者承担治疗的费用及相应的经济补偿。申办者应当为发生与临床试验相关的伤害或者死亡的受试者承担治疗的费用以及相应的经济补偿,即无过错赔偿原则。诉讼中应采取受试者损害与临床试验的因果关系鉴定,应避免对临床试验机构和申办方都存在较大风险的过错鉴定及赔偿。

Abstract： Article 43 of sponsor shall insure the compensate the medical good clinical practice （GCP） stipulates that the subject participates in clinical trial and shall charges and economic loss for injury or death as- sociated with trial. The injured research subject should be compensated on a no fault basis. It remains necessary for the research subject to demonstrate that his injuries were caused by participation in the trial. If the injured research subject should be compensated on a fault basis, there is heavy risk for both sponsors and hospital.