Table 3.

Research allocated to category 1B in the ISSCR guidelines and the corresponding regulations in Japan.

ISSCR Guidelines – Research activities that are reportable, but not typically reviewed by a specialized oversight process	The Japanese Regulations
a. Research that entails the in vitro formation of human stem cell-based embryo models that are not intended to represent the integrated development of the entire embryo including its extraembryonic membranes.	In cases in which ESCs are not used, such research should be conducted in accordance with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects. In cases in which ESCs are used, such research should be conducted in accordance with the Guidelines on the Utilization of Human ES Cells.
b. Chimeric embryo research in which human pluripotent stem cells are transferred into non- human, mammalian embryos and cultured in vitro for the minimum time necessary to achieve the scientific objective without gestation.	Such research should be conducted in accordance with the Act on the Regulation of Human Cloning Techniques.
c. Research on in vitro gametogenesis from human cells including genetically modified pluripotent stem cells, which does not involve attempts at fertilization and the generation of embryos.	In cases of gametogenesis from iPSCs, such research should be conducted in accordance with the Guidelines on the Research on Producing Germ Cells from Human iPS Cells or Human Tissue Stem Cells. In cases of gametogenesis from ESCs, such research should be conducted in accordance with the Guidelines on the Utilization of Human ES Cells.