Ethical, legal, and social issues associated with human fetal tissue research in Japan

The Informed Consent Standards for Human Fetal Tissue Donation for Research, published by the International Society for Stem Cell Research, provide important guidance for ethical research. They are particularly relevant in countries such as Japan, where clear legal frameworks for the use of human fetal and associated tissues obtained through induced abortion are lacking. However, because such guidelines do not fully account for national regulatory and legal frameworks, additional considerations are required to support their effective global implementation. Here, we describe three ethical, legal, and social issues in Japan - also shared in part by other countries - as examples of considerations relevant to the wider implementation of internationally recognized ethical standards. We discuss possible approaches to these issues, including: (1) appropriate selection of medical institutions capable of minimizing the burden on potential donors, (2) consideration of whether consent from the male partner should be obtained, and (3) clarification of the "Ena (placenta)" ordinance related to the use and disposal of dead fetuses. Ensuring appropriate integration between such ethical standards and local regulations is essential for the sustainable and ethical development of fetal tissue research.