research | 加藤和人研究室　大阪大学大学院医学系研究科医の倫理と公共政策学

The development of medical and life sciences research and advanced medical care has benefited many people in society. On the other hand, addressing the ethical, legal and social implications (ELSI) accompanying research and medicine is essential in order for research to be understood by society and for medicine to be trusted.

We conduct research to analyze the challenges associated with the development of medicine, life sciences, and medical care, and propose strategies and solutions based on our findings.

Traditionally, bioethics was sometimes seen as a constraint on the development of science and medicine. However, our aim is to move beyond this outdated image of bioethics by fostering collaboration with researchers and health care providers in the field, humanities and sociology specialists, as well as patients and the general public.

1. Research on ethical, legal, and social implications and policies in medical and life sciences research

New technologies, such as iPS cells and genome editing, are attracting attention as useful in the development of novel healthcare and medical research, including regenerative medicine. In addition, the advent of high-speed sequencers has made it possible to decode a large number of human genomes in a short period of time and at a low cost, which has led to a large scale of research. In addition, some of the results of this research are already being used in clinical settings. With the development of such research, there is an increasing need to address ethical, legal and social implications. In this regard, we are investigating and analyzing the content of the government guidelines and the system for their development, as well as discussing policies at the project and government levels, including international perspectives, in close cooperation with the research community.

From FY2016 to FY2018, we conducted research on new ELSIs that are emerging in the realm of genomic research, funded by the Japan Agency for Medical Research and Development (AMED). See this page for an overview and results.
Since information sharing, dialogue and discussion with people from various perspectives are very important, we are also involved in planning and organizing symposiums for the public, and symposiums and webinars primarily aimed at people and researchers involved in the ethical review of research (“Human Genome ELSI meetings“), as part of the research project of the Ministry of Education, Culture, Sports, Science and Technology.

2. Ethics of clinical care

We will continue to address issues related to the ethics of clinical care that we have been working on since the establishment of the Department of Medical Ethics (the predecessor of our department) in 2001. Themes for graduate students include assisted reproductive health, advanced directives, end-of-life care, and spiritual care. Recent themes include analyzing the ethical issues associated with the introduction of robotic technology into medical and nursing care settings.

3. Addressing ELSIs regarding the sharing of clinical genome information

We are addressing ELSIs and ethics related issues surrounding the sharing of clinical genome information and building a databases, including appropriate responses in the sharing and handling of human genome information and clinical information. We also aim to develop policies such as the Genome Information Sharing Policy, as well as participating in international collaborations through GA4GH and others. The research has been supported by the Japan Agency for Medical Research and Development (AMED) since FY2016. See this page for an overview and results.

4. Patient-centered medical research using ICT (information and communication technology)

Research approaches that involve patients and the public more proactively have expanded in recent years and will become even more important in the future. We aim to create a new framework for medical research in partnership with patients and the public and in December 2017, we released RUDY JAPAN, an online research platform built for this purpose. To advance this research, we are working with a variety of people, including patients with intractable and rare diseases, experts in multiple disease areas, and experts in medical information and ICT.

Related Links
RUDY JAPAN Top Page
For more information, please see RUDY JAPAN info and the RUDY JAPAN Facebook page.

5. The formation of an Evidence Generation Commons using ICT for medicine and health care and its application to policy

The importance of incorporating the patient’s perspective is beginning to be recognized in terms of healthcare and medical research policy. We will establish an Evidence Generation Commons, a place for stakeholders such as patients, medical researchers, and policy makers to continuously discuss and examine suggestions that can be useful in policy formation through ICT, with the aim of creating a framework and generating evidence that increases the feasibility of policy.

Introduction to the Commons Project

6. AI in healthcare for all – towards designing a platform for sustainable stakeholder engagement

There are high expectations for the development and spread of AI in order to advance the technology of healthcare and reduce the workload in clinical settings. As new technologies such as AI are introduced, understanding the needs of the public, patients, healthcare professionals, AI developers, among others, and reflecting those needs in policy is essential in building trust in AI technology as well as in improving quality and safety. We aim to realize a platform for stakeholders to engage, involve and contribute to decision-making related to the implementation and utilization of AI technology in healthcare. This research is being conducted as a joint research project supported by JST-RISTEX (*1) and the UK’s ESRC (*2). Please see the project webpage for more information.

*1 Research Institute of Science and Technology for Society, Japan Science and Technology Agency
*2 Economic and Social Research Council

7. Addressing ELSI and governance with patient and public involvement regarding research on human stem cell-derived germ cells (G-STEP project)

In this research, we focus on the study of In vitro Gametogenesis (IVG), which involves the creation of reproductive cells (e.g. sperm and eggs) from stem cells such as induced pluripotent stem cells (iPS cells) within a culture dish. We aim to identify and address the ethical, legal, and social issues (ELSI) associated with IVG for research purposes, which allows us to uncover valuable foundational knowledge by replicating phenomena that are otherwise challenging to study in vivo. However, IVG research also raises ethical questions, including the implications of creating children if the generation of human reproductive cells becomes successful in the future. As we carry out our research, we are actively engaging non-experts such as patients and public representative panels to collaboratively examine the challenges of cutting-edge medical research in its foundational stages. In doing so, we propose a methodology that involves diverse stakeholders in the evaluation process.