Table 2.

Research allocated under category 1A in the ISSCR guidelines and the corresponding regulations in Japan.

ISSCR Guidelines – Research activities that are exempt from review by a specialized oversight process	The Japanese Regulations
a. Research with human pluripotent stem cell lines that is confined to cell culture and involves routine research practices, such as differentiation into tissue-specific cell types.	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. Research that entails the reprogramming of human somatic cells to pluripotency (for example, the generation of induced pluripotent stem cells).	Such research should be conducted in accordance with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects.
c. Research that entails the use of human fetal tissue and cells.	Such research can be conducted in accordance with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects.
d. Research on stem cell culture systems that model specific stages of development or specific anatomic structures rather than the continuous development of an intact embryo or fetus.	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.
e. The transplantation of human stem cells, their derivatives, or other human cells into postnatal animal hosts.