Research projects

The purpose of this research project was to systematically and comprehensively clarify the current situation and issues regarding the distribution of information on complementary and alternative medicine (CAM), and to consider and make recommendations on appropriate legal control in Japan. During the research period, an interdisciplinary research team comprising experts in the fields of constitutional law, medical law, consumer law, information law and international law, as well as social psychology, clarified the current situation and issues of information distribution on CAM in Japan in comparison with trends in other countries, and published a conference report and an article on appropriate legal control in Japan in the future.

本研究は、大規模ゲノム解析を始めゲノム医学・医療が飛躍的進展を見せる一方で、ゲノムに関する法律問題の検討がほとんどなされていない現状を踏まえ、[1]ゲノムに関して阿dレガどのような権利を有するかなど、基本的法律関係に関する理論的検討を行い、その上で、[2]現在のゲノムデータベース等の運用を踏まえつつ、どのような場合にゲノム情報の利用を認めるべきかに関する検討を行い、最終的に、[3]提供者等の権利保護を確保しつつ適切な利活用が行われ、将来のゲノム医学・医療の発展に資するような、ゲノム情報利用の包括的法制度を構築できるよう提言を行うことを目的とする。

医療事故が発生した場合に、原因究明と再発防止を目的とする医療安全の観点からのアプローチと被害に対する損害賠償と制裁を目的とする法的責任の観点からのアプローチがある。いずれのアプローチであっても事故に関する調査は欠かせない。医療事故が紛争化した場合に、事故調査の結果を紛争解決のために用いることができれば、医学的見地から妥当性のある原因究明・再発防止と法的見地から妥当性のある損失補償・制裁を実現するための合理的な制度を構築することが可能となる。本研究は、法律家と医療安全を担当する医師が共同研究を行い、医療安全と紛争解決における透明性とコミュニケーションを確保することを目的とする。

The objective of this research was to examine infectious diseases legislation across time (history), countries (comparative studies) and disciplines (various legal studies, ethics, history, political science, etc.) and to identify interpretive guiding principles specific to infectious diseases legislation. As COVID-19 occurred after the application for this project, the legislation on it was additionally examined. As a result, we considered that the guiding principle of Japan's infectious disease legislation is to reconcile infectious disease control with fundamental rights protection by improving the health index of society as a whole through the accumulation of the health of individual citizens. However, since the guiding principle has not been sufficiently discussed by academia and by legislator, COVID-19 has revealed its issues such as the consistency of legislation based on the guiding principle, its establishment in administrative practice and social acceptance.

We surveyed investigation systems, dispute resolution systems, and compensation systems for medical accidents in Japan and other countries (the United States, France, Sweden, and Australia), and analyzed how medical accident investigations from the perspective of medical safety are used to prevent and resolve disputes. As a result, we found that objective medical accident investigations are not only indispensable for analyzing the causes of medical accidents and preventing their recurrence, but also effective in preventing disputes between medical institutions and patients/families arising from accidents, and in providing basic data for prompt and appropriate resolution when disputes do arise. The future challenge is to develop institutional and operational measures to link accident investigation and dispute resolution, while dispelling concerns about the pursuit of responsibility by medical personnel.

In this study, we examined the reasonable design of legal regulations for biomedical research. In Japan, the Clinical Research Act was enacted in 2017, but there are many criticisms about the act especially from medical researchers. We investigated practical issues on clinical research regulation and compiled legislative proposals. In conclusion, the Clinical Research Act has arbitrariness and irrationality in the definition of regulated research, mainly because the purpose of regulation is unclear. The Act has two purposes: protection of research subject and prevention of research misconduct. At present, these two purposes are simultaneously operated within a single system, so the regulations are inadequate from both perspectives. In the future, it is reasonable to divide the Clinical Research Act into two systems: pre-review for the purpose of research ethics and post-review for the purpose of preventing research misconduct.

This study analyzed the current status and challenges of Japanese laws and regulations on complementary and alternative medicine through the interdisciplinary approach of constitutional law, administrative law, consumer law, international law, political science, and social psychology. What became particularly clear through this study was that while complementary and alternative medicine is spreading globally, legal regulation has not kept pace. In particular, it became clear that it is necessary to establish an appropriate information control system for complementary and alternative medicine through laws and other regulations.

We examined how the network formed by the various parties involved in the management of the medical and care delivery system in Japan can be understood from a jurisprudential perspective, and what position each party is given in the legal system, what acts they are supposed to perform, and what responsibilities they are subjected to. In doing so, attention was paid to the position in which freedom and willingness are given. In particular, issues related to the basic theory of local self-government, issues related to the relationships among public organizations (institutions), and various problems arising in the field of medicine were examined.

This research examines how the national government, local governments, social insurance organizations, and health care providers intersect each other in terms of their functional autonomies in maintaining and developing the health care system. The research group especially pays attention to the authority of local governments in managing spaces, because they are entitled to decide where to deploy what kind of health care providers in their territories, consulting with other actors about managing the health care system. However, at the same time, the research group becomes aware that the non-registered residents should be taken in considerations in maintaining and developing the health care system, and that the subjects without spaces can provide medical services. Therefore, we should conduct further research on maintaining and developing the health care system as the space management to analyze it in more detail.

We analyzed bioethical arguments in Japan through various areas such as end-of life care, reproductive medicine, medical genetics and based on three level analysis, i.e., the level of medical practices, concrete principles and ethical theories, and so we made clear the feature of bioethics in Japan, such as bottom up character. Also we found out, by reexamining the relationships among three levels, that so called bioethical principles are universal because they are abstracted from various practices, and that the first level and the third level are closely connected with each other.

This research project compared the two types of autonomy, namely, the local autonomy and the functional autonomy of the public health insurance sectors, to reveal the difference between them and examine whether we could define what constitutes the concept of autonomy, based on their common characters. The project revealed that there was in fact controversy on whether the two types of autonomy could be treated as the same kind of concept. Nevertheless, we found that it was necessary to analyze and compare both types of autonomy in the common fields of research. For, such analysis brings valuable insights to topics such as the ways of legitimizing autonomy as well as the characteristics of solidarity which underlie autonomy.

The purpose of this research is to analyze fundamental theory of research regulation, to detect trend of research regulation in foreign countries, to investigate practical problems in research, and finally to propose a new legal system of biomedical research regulation. According to our analysis, we obtained the finding that the following points are important bases of the new research regulation system: (1) coexistence of guideline regulations and legal regulations in Japan is seriously harmful due to conflict with existing rules and inefficiency in ethical review of research, (2) it is necessary to respect freedom of research and to construct a neutral system of research review that is independent from public authority and expert group, (3) efficacy and practical feasibility should also be considered in designing a regulation system. We published a detailed plan of legislation in order to resolve most problems on research regulation and promote the development of biomedical research.