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

Abstract

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.

The ethical issues in the clinical application of stem cells

“…13 To answer these questions, we need to distinguish the biological significance between human being and personality in the sense of people. As a "person", there should have three levels of significance at least.…”

Recommended Ethical Safeguards on Fertilization of Human Germ Cells Derived from Pluripotent Stem Cells Solely for Research Purposes

“…Some ethical notions need to be adjusted as the stage of research progresses. When ES cell research had developed technically to the point that it could be used for medical use, the relevant guidelines were revised in Japan: a change from the use of unlinkable to linkable anonymization, the additional recommendation of obtaining permission for re-consent, and the introduction of the policy that incidental findings will not be disclosed [11]. The bioethical conditions for the destruction of human fertilized embryos are the same stringent requirements that previously had to be met for use in basic research.…”

“…The Hinxton group recommended that, to maximize the benefit obtained from precious human embryos, the methods used, and the results, should be made openly available for the common good [22]. Application of this policy might be excluded in cases in which it would run counter to the protection of personal information or intellectual property rights, as in the case of using surplus embryos for human ES-cell production [11]. In any case, human embryos produced from PSCs should be treated with caution, on the assumption that they are equivalent to human embryos with the potential to develop into humans.…”

“…Although Japanese guidelines permit the production of germ cells from human PSCs, fertilization of PSCderived germ cells is prohibited [9,10]. In light of recent progress in stem cell research, the panel recently considered ethical issues on the fertilization of PSC-derived germ cells, clinical use of ES cells [11], and human-animal chimeric embryos [12]. Since 2011, it has also surveyed research trends and regulations in other countries [13] and held hearings with outside experts.…”