医疗卫生机构泛知情同意实施指南

Guidelines for the Implementation of Broad Informed Consent in Medical and Health Institutions

泛知情同意是知情同意的特殊形式,在医疗机构实施泛知情同意必须明确其实施范围,应首先建立医院管理层面严格的“治理体系”,来保证受试者的随时退出权、研究信息知晓权和隐私保护权等,在这样的体系架构下才可以实施泛知情同意的具体操作。对生物样本入库前的泛知情同意、临床诊疗数据授权使用的泛知情同意和临床研究剩余样本和数据的授权使用三种情形的泛知情同意书的设计进行了分类要点举例,并对医疗卫生机构的伦理审查侧重点,样本或数据的转移管理要求,研究结果的分享进行了全过程的实施指导。

Broad informed consent is a special form of informed consent.To implement broad informed consent in medical institutions,its implementation scope must be clarified,and a strict“governance system”at the hospital management level should be established first to ensure that the subjects’exit right at any time,the research information about rights and privacy protection,etc.Under this architecture,the specific operation of informed consent can be implemented.This study gave examples of the key points of classification for the design of broad informed consent in three situations,including:the broad informed consent before the biological samples would put into the database,the broad informed consent for the authorized use of clinical diagnosis and treatment data,and the authorization of the remaining samples and data of clinical research.The focus of the ethical review of medical and health institutions,the transfer management requirements of samples or data,and the sharing of research results have been guided throughout the implementation process.