中国医学伦理学2025，Vol.38Issue(1)：40-45,6.DOI:10.12026/j.issn.1001-8565.2025.01.06
去中心化药物临床试验伦理审查的实践探索
Practical exploration of ethical review in decentralized drug clinical trials
摘要
Abstract
Objective:To explore the process and guidelines for ethical review in decentralized drug clinical trials,promote clinical trial progress,and ensure drug development progress.Methods:The key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials,analyzing the advantages and challenges of decentralized drug clinical trials,and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials.Results:Relevant laws and regulations were the basis for the ethical review,and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures.The ethics committee should focus on the feasibility,applicability,and rationality,the adequacy of informed consent,the protection of rights and interests and privacy of subjects,as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials.Conclusion:Decentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations.Ethical review is also constantly being refined through exploration.It is necessary to supervise the implementation of responsibilities by all parties,pay attention to the rights and interests of subjects,and gradually promote the implementation of decentralized drug clinical trials.关键词
去中心化/药物临床试验/伦理审查/受试者权益Key words
decentralization/drug clinical trial/ethical review/right and interest of subjects引用本文复制引用
左旭,黄樱硕,李悦,邢荔函,杨春秀,崔焱..去中心化药物临床试验伦理审查的实践探索[J].中国医学伦理学,2025,38(1):40-45,6.基金项目
北京友谊医院科研启动基金"药物临床试验利益相关者2E使用意愿及影响因素研究"(yyqdktgl2021-5) （yyqdktgl2021-5）
