2023 Volume 7 Article ID: 2023-019
The “Ethical Guidelines for Medical and Health Research Involving Human Subjects” must be followed when conducting clinical research involving humans. As such approval from an ethics review board and the research institution’s head is required in order to begin the research. Although some pharmaceutical research initiatives are not subject to these guidelines, there is a current situation in which ethical review is required by academic societies when publishing research. To address this, the Ethics Committee for Research at Kitasato University has established a system to efficiently conduct ethical review and administrative tasks for unregulated in research. It is considered useful to establish a system for conducting ethical review in a rational and accurate manner in unregulated pharmaceutical research.