Otsuka Toshiaki, Matsuyama Kotone
Department of Hygiene and Public Health, Nippon Medical School.
Center for Clinical Research, Nippon Medical School Hospital.
J Nippon Med Sch. 2024;91(2):136-139. doi: 10.1272/jnms.JNMS.2024_91-216.
All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.
所有涉及人类受试者的生命科学和医学研究都必须按照《赫尔辛基宣言》以及相关法律和准则进行。此外，其科学和伦理适用性必须由精通研究性质和内容的委员会进行审查。在进行涉及人类受试者的研究时，若不遵守这些要求，将严重违反日本法律、准则和地方法规，因此日本医科大学（NMS）基金会及其附属机构内部已设立了多个伦理委员会和机构审查委员会。研究人员必须及时了解伦理审查过程的最新进展，并确保他们提议开展的任何项目在研究启动前都经过适当的伦理审查。为帮助NMS基金会的研究人员和其他工作人员了解这些进展，本报告概述了NMS目前针对涉及人类受试者研究的伦理审查流程。
