Annual Report 2024
Division of Bioethics and Healthcare Law
Kenji Matsui, Tsunakuni Ikka, Waki Toya, Hoko Nakagawa, Hitomi Harada
Introduction
The mission of the Division of Bioethics and Healthcare Law is to investigate ethical, legal, and socio-political issues (ELSI) regarding biomedical research, medical practice, and public health, as well as to study methodologies of research ethics education.
The Team and What We Do
The Division currently consists of one full-time research staff, one research assistant, one research fellow, and two concurrent staff from the Bioethics Division at the Center for Research Administration and Support (CRAS).
Research Activities
Research methodologies in bioethics and healthcare law include both theoretical and empirical approaches, since bioethics and healthcare law are interdisciplinary research fields. We are currently interested in topics that are diversified from research and clinical ethics to bioethics in general, such as ELSI on vulnerable subjects in research, research for fetal therapy, research on new vaccines, research with patient-derived xenograft (PDX) models, research on innovative/emerging medical interventions, and medical practice without scientific evidence. We have also developed educational programs and a model framework of certification programs for research ethics consultants, as well as educational materials on the ethics of perinatal and pediatric clinical research.
Education
Since 2020, we have been collaborating with the Research Ethics Section of the Japan Association for Bioethics, organizing a regular bimonthly research conference and a bimonthly reading club on various topics of research ethics. We have also been working since 2022 to cultivate future “research ethics consultants” under a research grant provided by the Japan Agency for Medical Research and Development (the total number of participants in the FY2024 training workshops was 31).
Future Prospects
We will strengthen and expand our activities regarding research and human resources development through various, timely, and innovative ELSI studies.
List of papers published in 2024
Journal
1. Matsui K, Israsena N, Kaewkungwal J, Adams P, Wendler D, Lie RK. Review Mechanisms for Advanced Medical Therapies in Japan and Thailand: A Proposal for the Use of Expert Clinical Benefit Assessments at Designated Institutions. Asian bioethics review, 17:101-115, 2025
2. Fujita M, Hatta T, Ikka T, Onishi T. The urgent need for clear and concise regulations on exosome-based interventions. Stem cell reports, 19:1517-1519, 2024
3. Matsui K, Yagishita S, Hamada A. Need for Ethical Governance on the Implementation and Use of Patient-derived Xenograft (PDX) Models for Anti-cancer Drug Discovery and Development: Ethical Considerations and Policy Proposal. JMA journal, 7:605-609, 2024
4. Ikka T, Hatta T, Fujita M. Amendments to ASRM: Can we move away from a "Therapeutic Haven"? Stem cell reports, 19:1648-1650, 2024
5. Nakada A, Katayama K, Yamamoto K, Yanagibashi A, Matsui K. Development of Case-Based Rubrics to Assess the Achieved Competencies and Performance of Novice Research Ethics Consultant Trainees through Case-Scenario Discussions. CBEL Report, 7:13-34, 2024
Book
1. Lepola P, Nelson R, Matsui K. Ethical consideration in the design and conduct of pediatric clinical trials. In: Gasthuys E, Allegaert K, Dossche L, Turner M (ed), Essentials of translational pediatric drug development: from past needs to future opportunities. Chapter 17., Academic Press, pp 421-449, 2024