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《药物临床试验质量管理规范》规定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。从4个药物临床试验赔偿案例证明:如果申办者不破产,责任保险对医疗机构和受试者实际价值不明显。如果申办者破产或者申办者不在国内,责任保险是保障医疗机构足额赔偿受试者后能够获得保险公司赔偿。因此,责任保险赔偿限额应当根据《侵权责任法》确定。
The Code of Practice for the Quality of Clinical Trials of Drugs stipulates that sponsors should provide insurance coverage for those participating in the clinical trial and bear the cost of treatment and corresponding financial compensation for those who experience damage or death related to the trial. The evidence from clinical trial compensation of 4 drugs proves that if the sponsor is not bankrupt, the actual value of liability insurance to medical institutions and subjects is not obvious. If the sponsor bankruptcy or the sponsor is not in the country, liability insurance is to ensure that medical institutions can fully compensate the subjects after the insurer compensation. Therefore, the liability insurance indemnity limit should be determined according to the Tort Liability Act.