摘要
2020版《药物临床试验质量管理规范》明确伦理委员会的职责是保护受试者的权益和安全,应特别关注弱势受试者。对伦理委员会的制度指南、标准操作规程和审查能力提出了更高要求。为应对挑战以更好地保护受试者,伦理委员会可尝试修改章程和制定利益冲突管理政策,修改标准操作规程中的审查方式、审查文件类别、安全性信息报告和附件表格。要结合伦理审查的难点和不足,落实新要点,如弱势受试者、病历中记录知情同意信息、现有的安全性资料、研究者手册和独立的数据监查委员会。有利于加快伦理委员会建设和提升审查能力,切实保护受试者。
Good Clinical Practice of Version 2020 clarifies that the ethics committee’s responsibility is to protect the rights and safety of participants,and special attention should be paid to vulnerable participants.It puts forward higher requirements for the institutional guidelines,standard operating procedures and review capabilities of the ethics committee.In order to meet the challenges and better protect participants,the ethics committee may try to modify review methods,review document types,safety information reports and attachment forms in the standard operating procedures by amending the regulation of ethics committee and formulating conflicts of interest management policies.It is necessary to combine the difficulties and deficiencies of ethics review and implement new elements,such as vulnerable participants,recording informed consent information in medical records,existing safety information,investigator brochures,and the rationality of setting up an independent data monitoring committee.It is conducive to accelerating the construction of ethics committees,enhancing review capabilities,and protecting participants effectively.
作者
周吉银
ZHOU Ji-yin(National Drug Clinical Trial Institution,The Second Affiliated Hospital,Army Medical University,Chongqing 400037,China)
出处
《医学与哲学》
2020年第14期1-5,共5页
Medicine and Philosophy
基金
2019年陆军军医大学人文社会科学基金重点项目(2019XRW04)
2019年陕西省健康文化研究中心立项资助课题(JKWH2019-Q07)。
