TOKYO-research involving human embryonic stem cells (ES) cells become easier in Japan as a result of new ethical requirements that take effect today.
Previously, research groups had to get approval for each project involving human ES cells from their own Institutional Review Board (IRB), and a national committee under the Ministry of education, culture, science, sports, and technology. This two-step process took three months or more, the researchers frustrating trying to keep up with a fast moving field. Even simply add members to a research team needed this dual approval.
The new policy drops the review requirement at national level. Institutions must also inform the Department of each project. "But researchers can start working as soon as the project is approved by the IRB," said Junichi Iwata, deputy director of the office of the Department of Bioethics and security.
The changes put more responsibility the hands of the team leaders and their IRB, said Shin-ichi Nishikawa, a researcher in stem cell biology RIKEN Centre for development in Kobe. planning Groups to still obtain human ES cells require both institutional and national exams their plans and there are strict requirements of informed consent by embryo donors. Nishikawa, who chairs the review committee of the Department of education, said ongoing review of ES cell derivation is justified because of concerns about the handling of tissue "with the potential to become a human being." So far, only two Japanese groups were allowed to obtain human embryonic stem cells; a group actually did.
Nishikawa said some 30 groups have permission to some 50 projects involving human embryonic stem cells. Many researchers are now focusing on induced pluripotent (iPS), which can be derived without sacrificing an embryo. One of the latest researchers to go through the approval process in two stages was Shinya Yamanaka, a researcher at Kyoto University who first reported the derivation of iPS cells. Nishikawa believes Yamanaka plans to compare the characteristics of iPS cells and ES, a theme Nishikawa expects other groups to take as well.
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