临床试验受试者补偿存在的问题及改进措施探讨

通过对补偿等相关概念界定,对临床试验受试者补偿的范围界定不明确、补偿金额缺乏具体核算标准及报销手续繁琐与兑现时间长、补偿方式单一,未体现不同受试者多样化需求、受试者维权能力与维权意识薄弱、伦理委员会履职能力也影响受试者权益维护等问题进行了分析,针对问题探讨其改进措施,如明确补偿的具体内容与范围,制定具体补偿标准及提高补偿兑现效率,采取合理的多样化补偿和激励方式,充分向受试者告知补偿权益,提高受试者的维权意识,提高伦理委员的审查能力等,为制定受试者补偿相关指导意见及保护受试者权益提供一定的理论参考。

Discussion on the Problems and Improving Measures of Compensation for Clinical Trial Subjects

This paper aims to clarify definitions in compensation,and to analyze problems such as unclear compensation scope,non-standard accounting on amount,excessive red tape,long cashing time,single compensation mode,unable to meet diverse needs from different subjects,weak right-protection awareness,and skeptical competence of the ethics committee to perform its duties.Improvement measures are put forward,such as to clarify the specific content and scope of compensation,to build specific compensation standards and increase efficiency,to diversify compensation and incentive methods,to fully inform subjects,to help raise their awareness in self-protection,to enhance capacity of ethics committee.All these efforts aim to provide some theoretical references for formulating the relevant guidance and protecting the rights and interests of the subjects.