临床研究中的保险。
Insurance in clinical research.
作者信息
Ghooi Ravindra B, Divekar Deepa
机构信息
Sahyadri Clinical Research and Development Centre, Erandwane, Pune, Maharashtra, India.
出版信息
Perspect Clin Res. 2014 Oct;5(4):145-50. doi: 10.4103/2229-3485.140541.
AIMS AND OBJECTIVES
Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation.
MATERIALS AND METHODS
Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any.
RESULTS
All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects.
CONCLUSIONS
Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents.
目的与目标
赞助商需要为临床试验中受试者所遭受的所有严重不良事件的管理支付费用，并对与试验相关的伤害或死亡进行赔偿。本研究考察试验的保险政策是否涵盖所有需要报销或赔偿的意外情况。
材料与方法
研究了2013年1月至2013年12月提交给萨亚德里医院的试验保险政策，涉及保险期限、责任限额、免赔额以及任何前提条件。
结果
所有研究的政策在某些方面都存在一些缺陷，而且没有一项政策规定在需要时支付全额赔偿。一些保险公司设定了可能危及向受试者支付赔偿的前提条件。
结论
保险文件复杂，在研究文件获批前，伦理委员会需要对其进行严格审查。
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