Abstract:
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.
摘要:
所有涉及人类受试者的生命科学和医学研究都必须遵守《赫尔辛基宣言》和相关法律和准则。此外,它的科学和道德适用性必须由一个精通研究性质和内容的委员会审查。在进行涉及人类受试者的研究时,不遵守这些要求是严重违反日本法律的行为,指导方针,和当地法规,因此,在日本医学院(NMS)基金会及其附属机构内成立了几个道德委员会和机构审查委员会。调查人员必须及时了解伦理审查过程的最新发展,并确保他们提议开展的任何项目在研究开始之前都经过适当的伦理审查。为了帮助研究人员和NMS基金会的其他工作人员及时了解这些进展,本报告概述了NMS目前对涉及人类受试者的研究的伦理审查过程。