临床试验受试者补偿兑付平台实践专家共识

Expert Consensus on Compensation Payment Platform for Subjects in Clinical Trials

申办者和研究者应当及时兑付给予受试者的补偿或者赔偿[《药物临床试验质量管理规范》(2020版)],是伦理委员会保障受试者/参与者权益的重要关注点,也是申办者和研究者需要履行的法定职责。受试者/参与者补偿发放平台(以下简称“发放平台”)是一类具备申请、审核、兑付、监督受试者/参与者补偿功能模块的电子服务平台,可帮助申办者和研究者及时审核兑付受试者/参与者补偿费用,提高补偿兑付的效率和可追溯性。本研究通过调研近400家使用发放平台的机构,结合研究者、伦理专家和申办者代表的意见,在探讨基于受试者/参与者补偿发放平台的补偿兑付模式基础上,形成《临床试验受试者补偿兑付平台实践专家共识》(以下简称《共识》),强调①知情同意书中应包含发放平台相关信息的重要性;②提出发放平台的资质要求、发放流程和协议准备的具体内容;③强调个人信息保护的重要性和风险预案的制定。该《共识》旨在为受试者/参与者补偿兑付模式的实施提供指导,为行业提供参考,并促进该模式的持续完善。

In drug clinical trials,the sponsors and the investigators should timely pay the compensation or compensation given to the subject《Good Clinical Practice》(GCP,2020 version),which is an important concern of the ethics committee to protect the rights and interests of the subjects/participants,and is also a statutory duty to be performed by the sponsors and investigators.Subject/participant compensation payment platform(hereinafter referred to as“payment platform”)is a class of E-services platform with the function module of application,audit,payment,and supervision of subject/participant compensation,which can help the sponsors and investigators to audit the payment of compensation to the subjects/participants in time and improve the efficiency and traceability of compensation payment.Based on the survey of nearly 400 institutions using the payment platform,and the opinions of representative of the investigators,ethics experts and sponsors,on the basis of discussing the compensation payment model based on the subject/participant compensation payment platform,the“expert consensus on compensation payment platform for subjects”(hereinafter referred to as the“Consensus”)was formed.The consensus emphasizes①the importance of including relevant information about the payment platform in the informed consent form;②presents specific requirements for the qualifications of the payment platform,the payment process,and the preparation of agreements;③the importance of protecting personal information and the establishment of risk emergency plans.This consensus aims to provide guidance for the implementation of compensation payment models for subjects/participants,serve as a reference for the industry,and promote continuous improvement of this model.