中国医学伦理学2025，Vol.38Issue(1)：31-39,9.DOI:10.12026/j.issn.1001-8565.2025.01.05
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
摘要
Abstract
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Key words
investigator-initiated clinical trial/unlisted product/ethical review/ethics committee引用本文复制引用
年宏蕾,李继红,周吉银..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[J].中国医学伦理学,2025,38(1):31-39,9.基金项目
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) （2022XRW02）
