摘要
保障受试者权益是临床研究实施过程中必须遵循的基本准则。保护受试者不仅是伦理委员会的责任,更是参与临床研究各方共同承担的责任。传染病患者作为特定的受试人群,研究机构建立完善的传染病受试者保护体系,是切实落实传染病受试者权益保护的基础。伦理审查互认、人才队伍培养、信息化建设等都是完善传染病受试者保护体系建设的有效手段。
The protection of subjects'rights and interests is a basic principle that must be followed in the implementation of clinical research.The protection of subjects is not only the responsibility of the ethics committee,but also the responsibility of all parties involved in clinical research.As a special group of subjects,the establishment of a perfect protection system for subjects of infectious diseases is the basis for the protection of subjects of infectious diseases.CAP and other industry certifications,mutual recognition of ethical review,talent team training and informatization construction are effective means to improve the construction of infectious disease subject protection system.
作者
周运翱
周宁
杨志云
ZHOU Yunao;ZHOU Ning;YANG Zhiyun(Ethics Committee,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China;Material Management and Purchasing Center, Beijing Chest Hospital,Capital Medical University, Beijing 101149,China)
出处
《中国医学伦理学》
2021年第2期216-219,共4页
Chinese Medical Ethics
基金
北京市属医院科研培育计划项目“基于健康受试者参加临床试验动机调查探索受试者权益保护的策略研究”(PG2020033)。
关键词
传染病
受试者保护体系
伦理委员会
受试者权益
Infectious Diseases
Subject Protection System
Ethics Committees
Subjects’Rights and Interests
