Toward the responsible conduct of human fetal tissue research

Background

Human fetal tissue research has contributed to advances in developmental biology, the study of congenital diseases, regenerative medicine, and vaccine development. As it involves fetal tissue obtained following induced abortion, such research must be conducted with the utmost care and respect. This includes careful attention to the information provided to potential donors, the process of obtaining consent, and transparency in research practices.

In 2022, the ISSCR published informed consent standards for fetal tissue donation, outlining the information that should be provided when obtaining consent from tissue donors. Internationally recognized standards, however, do not automatically determine the legal or regulatory requirements of individual countries. As Japan currently has no dedicated framework of its own governing fetal tissue research, implementing these standards calls for careful consideration of its specific legal system and social context.

Methods and Findings

The authors reviewed laws, regulations, and guidelines relating to fetal tissue research in Japan, Europe, and North America, and examined Japan’s legal framework, administrative documents, academic society statements, and historical background. Their analysis identified three challenges that cannot be fully addressed through the ISSCR standards alone.

The first concerns the burden placed on women undergoing induced abortion who may be asked to donate fetal tissue for research. In Japan, abortion costs are generally borne by the individual, and abortion procedures are often provided within the same medical institutions that also offer maternity and fertility services. The authors note that particular care is needed to ensure that requests for tissue donation do not place additional burdens or pressure on potential donors.

The second concerns the role of male partners in decisions regarding fetal tissue donation. While the ISSCR standards primarily focus on decision-making by the woman herself, Japan’s Maternal Health Act requires the consent of a spouse or comparable partner in certain circumstances. This raises questions about how male partners should be involved in decisions relating to fetal tissue donation. In addition, where research involves fetal genetic information, consideration must also be given to the protection of personal information relating to the male biological parent.

The third challenge concerns legal uncertainties surrounding the storage, use, and disposal of fetal tissue. In Japan, the legal status of fetuses before 12 weeks of gestation is not clearly defined, and local regulations governing the handling of fetuses, placentas, and related materials differ across jurisdictions. The authors therefore emphasize the importance of confirming applicable local regulations when conducting fetal tissue research and when determining how tissues should be handled after research is completed.

The study shows that while the ISSCR standards can serve as useful guidance for fetal tissue research in Japan, their application must be adapted to domestic legal and social circumstances. Some of the issues identified are not unique to Japan and may also be relevant to other countries seeking to develop or refine frameworks for fetal tissue research.

Outlook

The responsible conduct of human fetal tissue research contributes to ethically sound basic research and lays the groundwork for future advances in regenerative medicine and cell therapy. Because no laws or guidelines in Japan clearly prohibit or permit such research, a practical way forward may be to develop research systems and ethical governance gradually, beginning with small-scale basic research. The goal going forward is to build a sustainable and trustworthy research foundation that balances internationally shared standards with national legal systems and social contexts.

Researcher’s Comment

Human fetal tissue research is grounded in deep respect and consideration for those who choose to donate. We therefore believe it is important to discuss thoughtfully the conditions under which such research should be conducted. The development of governance frameworks requires not only reference to international standards but also careful consideration of each country’s legal, regulatory, and cultural context. In Japan, for example, the handling of human biological materials such as placentas and umbilical cords has been shaped by longstanding cultural practices and regional regulations.

We hope this study will provide an opportunity to reconsider how fetal tissue research should be governed in different countries, and what institutional and ethical frameworks are needed to support it.

For further reading: “Ena-osame” and Science. CiRA Reporter vol.32, 2022. https://www.cira.kyoto-u.ac.jp/e/pressrelease/cira-reporter/vol32/#/bioethics