国际(药品注册)协调会议  ICH Topic E 6 (R1) Guideline for Good Clinical Practice 中的规定

     5.8 Compensation to Subjects and Investigators

   5.8.1  If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.

   5.8.2  The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s).  

中国  <<药物临床试验质量管理规范>>（GCP）第43条规定

         四十三条　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。申办者应向研究者提供法律上与经济上的担保，但由医疗事故所致者除外。

台湾 《藥品優良臨床試驗準則》第47条有明确规定

   “第四十七條 試驗委託者應負責試驗主持人或試驗機構因試驗所生之賠償責任或投保責任保險。但因試驗主持人或試驗機構之醫療疏失所致者，不在此限。”

欧盟  欧盟医药产品临床试验指令《DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001》

《欧洲议会和理事会指令2001/20/EC，各成员国有关执行供人类使用的医药产品临床试验行为的良好临床行为的法律、法规和管理规定的协调与统一》中Article 3：Protection of clinical trial subjects 2（f）规定“provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.”

法国France

France requires insurance of 1 million euros per participant and 6 million euros per clinical trial, and policies must insure liability for 10 years after the trial ends.

保加利亚Bulgaria

Insurance should be in local language. Insurance must cover both investigators and subjects. Provide certificate of insurance and policy, with site address, study title and code, and approximate number of subjects.

智利Chile

Sponsor must provide insurance for medical treatment for adverse events that are a consequence of investigational drug administration or subjects participation in the study.