临床研究数据安全监察计划与伦理审查

Data Safety Monitoring Plan and Ethical Review of Clinical Research

国内外临床研究与伦理审查法律法规、指导原则等多处提及数据安全监察计划(DSMP)及数据安全监察委员会(DSMB)。研究者作为受试者保护的第一责任人应把相关要求落实在方案设计中。作为临床研究保驾护航的伦理委员会,应从伦理审查的视角出发思考如何通过对临床研究方案中数据与安全监察计划的审查,以更好地对其科学性进行把关。在介绍临床研究DSMP及DSMB内涵的基础上,提出如何通过伦理审查促进临床研究数据监察计划的落实与实践的构想。

Data Safety Monitoring Program (DSMP) and Data Safety Monitoring Board (DSMB) are mentioned in clinical research and ethical review laws, regulations and guidelines at home and abroad. The investigator, as the first person being responsible for the subject protection, should implement the relevant requirements in the design of the project. Ethics committee should consider how to improve scientific review of the clinical research by reviewing DSMP. Based on the introduction of DSMP and DSMB of clinical research, this paper proposes a framework on how to promote the implementation and practice of the clinical research data monitoring plan through ethical review.