研究者发起的未上市产品临床研究的挑战、对策和伦理审查要点  

Challenges,countermeasures,and key points of ethics review in investigator-initiated clinical trials of unlisted products

作　　者：年宏蕾 李继红 周吉银 NIAN Honglei;LI Jihong;ZHOU Jiyin(Office of Ethics Committee,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China;Clinical Medical Research Center,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)

机构地区：[1]首都医科大学附属北京世纪坛医院伦理委员会办公室,北京100038 [2]陆军军医大学第二附属医院临床医学研究中心,重庆400037

出　　处：《中国医学伦理学》2025年第1期31-39,共9页Chinese Medical Ethics

基　　金：2022年陆军军医大学人文社会科学基金重点项目“我市涉及人的健康相关研究伦理治理的现状与对策研究”(2022XRW02)。

摘　　要：研究者发起的临床研究是涉及以人为研究参与者的科技活动的重要组成部分,其中高质量的研究者发起的临床研究在条件许可时可用于支持药物、医疗器械等产品上市、注册申请。目前研究者发起的临床研究与企业发起的临床试验有着巨大差距,未上市产品用于研究者发起的临床研究存在法规尚不支持、研究经费支持力度不足、临床研究管理部门能力有待提升、临床研究专业化团队薄弱、伦理审查难以匹配需求等问题。可通过完善法规并小范围先行试行、保障充足的研究经费、加强临床研究管理体系建设、打造临床研究专业化团队、确保伦理审查质量和严格跟踪审查、从伦理审查向研究参与者保护体系转变、加强培训研究者等措施应对挑战。伦理委员会应严格审查风险获益比,知情同意,研究经费,损害的赔偿,研究团队成员资质和设备,利益冲突管理等要点。Investigator-initiated clinical trials(IIT)are an important part of scientific and technological activities involving human study participants.Among them,high-quality IIT can be used to support the marketing and registration application of drugs,medical devices,and other products when conditions permit.Currently,there is a huge gap between IIT and industry-initiated clinical trials.The use of unlisted products in IIT has problems,such as lack of regulatory support,insufficient research funding support,the need to improve the ability of clinical research management departments,the weakness of professional clinical research teams,and the difficulty of ethics review to match the demands.The challenges could be addressed by improving regulations and conducting pilot trials on a small scale,guaranteeing adequate research funding,strengthening the construction of clinical research management systems,building professional clinical research teams,ensuring the quality of ethical reviews and strict follow-up reviews,shifting from ethical reviews to a system for protecting research participants,and reinforcing training for researchers.Ethics committees should strictly review key points,such as the risk-benefit ratio,informed consent,research funding,compensation for damages,qualifications and equipment of research team members,and management of conflict of interest.

关 键 词：研究者发起的临床研究 未上市产品 伦理审查 伦理委员会 

分 类 号：R-052[医药卫生]