Annual Report 2023

Division of Bioethics and Healthcare Law

Kenji Matsui, Tsunakuni Ikka , Haruka Nakada , 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 three concurrent staff from the Bioethics Division at the Center for Research Administration and Support (CRAS) whose role is to support ethical research activities at the National Cancer Center, such as providing educational training on research ethics, managing conflicts of interest (COI) about research, and providing research ethics consultation services.

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, PPI (patient and public involvement) in research, research on innovative/emerging medical interventions, and medical practice without scientific evidence. We are also developing educational programs and a framework of certification programs for research ethics consultants.

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 FY2023 training workshops was 34).

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 2023

Journal

1. Nakada H, Watanabe S, Takashima K, Suzuki S, Kawamura Y, Takai Y, Matsui K, Yamamoto K. General public's understanding of rare diseases and their opinions on medical resource allocation in Japan: a cross-sectional study. Orphanet journal of rare diseases, 18:143, 2023

2. Ikka T, Hatta T, Saito Y, Fujita M. Does the Act on the Safety of Regenerative Medicine in Japan ensure "safety"?: Implications of low adverse event reporting. Stem cell reports, 18:2297-2299, 2023