Ethical Issues for Clinical Studies That use Human Embryonic Stem Cells: The 2014 Revisions to the Japanese Guidelines.

The use of human embryonic stem cells (hESCs) in clinical studies has been expanding in recent years. The application of hESCs in clinical studies raises ethical issues from a different standpoint compared with the use of other types of stem cells. In Japan, the Guidelines on the Derivation of Human Embryonic Stem Cells, and Guidelines on the Distribution and Utilization of Human Embryonic Stem Cells had been revised for clinical studies in 2014. In the revised guidelines, the method for protection of personal information was changed to offer the choice between unlinkable anonymization and linkable anonymization, to enable the use of information on diseases suffered by donors and the assurance of traceability for safety. Procedures for re-consent are generally prohibited out of consideration for donors' feelings. However, obtaining re-consent is permitted when consent for re-consent has been received in advance and approval has been given by an ethical review board, in which case the donors may be contacted. Incidental findings obtained from hESCs are not disclosed individually to donors, while the research results should be actively published for the common good. These guidelines have enabled the derivation, distribution, and use of hESCs for clinical studies.