Japan streamlines embryonic stem cell reviews

TOKYO—Research involving human embryonic stem (ES) cells will become easier in Japan as a result of new ethical review 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 then from a national committee under the Ministry of Education, Culture, Science, Sports, and Technology. This two-step process took 3 months or more, frustrating researchers trying to keep up with a fast-moving field. Even simply adding members to a research team required this dual approval.

The new policy drops the national level review requirement. Institutions must still inform the ministry of each project. "But the researchers can start work as soon as the project is approved by the IRB," says Junichi Iwata, deputy director of the ministry's office of bioethics and safety.

The changes put more responsibility in the hands of team leaders and their IRB, says Shin-ichi Nishikawa, a stem cell researcher at the RIKEN Center for Developmental Biology in Kobe. Groups planning to derive human ES cells still need both institutional and national reviews of their plans and there are strict requirements for informed consent by embryo donors. Nishikawa, who chairs the education ministry's review committee, says continuing scrutiny of ES cell derivation is warranted because of concerns about handling tissue "with the potential to become a human being." So far only two Japanese groups have been authorized to derive human embryonic stem cells; one group has actually done so.

Nishikawa says some 30 groups have permission for 50 or so projects involving human ES cells. Many researchers are now focusing on induced pluripotent (iPS) cells, which can be derived without sacrificing an embryo. One of the last researchers to go through the two-stage approval process was Shinya Yamanaka, the Kyoto University researcher who first reported the derivation of iPS cells. Nishikawa believes Yamanaka is planning to compare the characteristics of iPS and ES cells, a theme Nishikawa expects other groups to take up as well.

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