北尾 仁宏
KITAO, Masahiro
筑波大学
ビジネスサイエンス系
助教
Assistant Professor
Institute of Business Sciences
University of Tsukuba
専門分野
Research fields
刑法、医事法
Criminal Law, Medical Law
研究テーマ
Research project
先端的臨床研究の持続的発展を支える制度設計に向けた倫理的・法的・社会的課題の学際的討究
Designing Institutions for the Sustainable Development of Advanced Clinical Research: Transdisciplinary Inquiries into the Ethical, Legal and Social Implications
キーワード
Keywords
危険引受け 研究参加者保護 レギュラトリーサイエンス 倫理委員会 薬事規制
Risk Assumption, Protection of Research Participants, Regulatory Science, Research Ethics Commission, Pharmaceutical Regulations
研究者総覧
Researchers Information
https://trios.tsukuba.ac.jp/researcher/0000005035
researchmap
https://researchmap.jp/masahirokitao
経歴
Biography
職歴
2025年4月- 現 在 筑波大学ビジネスサイエンス系助教
2023年4月-2025年3月 東京大学医科学研究所特任研究員
2021年4月-2023年3月 早稲田大学先端社会科学研究所助教
学歴
2015年4月-2020年3月 早稲田大学大学院法学研究科博士後期課程 博士（法学）
2013年4月-2015年3月 早稲田大学大学院法学研究科修士課程 修士（法学）
2010年4月-2013年3月 早稲田大学法学部〔三年卒業〕 学士（法学）
Professional History
April 2025-Present: Assistant Professor, Institute of Business Sciences, University of Tsukuba
April 2023-March 2025: Project Researcher, Institute of Medical Science, the University of Tokyo
April 2021-March 2023: Assistant Professor, Institute for Advanced Social Sciences, Waseda University
Educational History
April 2015-March 2020: Doctoral Programme, Graduate School of Law, Waseda University
April 2013-March 2015: Master’s Programme, Graduate School of Law, Waseda University
April 2010-March 2013: Faculty of Law, Waseda University
研究概要
Research Outline
本研究課題は、いわゆるcontrolled human infection model（CHIM）研究その他の先端的臨床研究（以下「CHIM研究等」）の日本国内における早期実現・安定運用に向けて、その克服されるべき倫理的・法的・社会的課題（ELSI）を析出し、具体的な制度設計への基盤を提供することを目的とする。
2021年G7サミットで合意された100日ミッションに基づき、次のパンデミックではCHIM研究等も活用して新ワクチン等を100日以内に実戦投入するという野心的計画が各国で進展中である。日本でも各種の研究が進行中だが、その大半は新ワクチン等自体の開発や候補株の析出・選定方法、解析手段といった「物」自体に焦点を当てたものであり、その「物」を迅速かつ健全な社会実装に繋げる「制度」や「法」、「思想」、それらにより担保される「大衆の受容態度」といった社会的・人文的側面の検討は現状極めて手薄である。無論、新規の制度設計には、産学における開発から行政による承認、さらには流通まで見越した包括的な俯瞰も要する。
そこで、人為的な疾患惹起の刑法的意味、臨床研究に起因する有害事象への法的対応、新ワクチン等の社会実装や実地投入に際した法的課題の検討などに加え、想定される具体的な試験参加者層から企業までをも含む開発の一翼を担うアクターに対しても、本事業の枠組を通じて検討のアプローチを拡げ、広範にELSIを析出し、それらを申請者が専門とする医事法の観点から統合して、最終的に上記100日ミッションを総体的に支える法制度の提言へと繋げたい。
This research project seeks to elucidate the ethical, legal, and social implications (ELSI) that must be addressed in order to facilitate the early realisation and stable implementation in Japan of so-called controlled human infection model (CHIM) studies and other advanced forms of clinical research (hereinafter collectively referred to as “CHIM studies, etc.”). Its ultimate objective is to establish a foundation for the formulation of concrete institutional and regulatory frameworks.
Pursuant to the 100 Days Mission, endorsed at the 2021 G7 Summit, ambitious international initiatives are underway to ensure that, in the event of a future pandemic, new vaccines and related countermeasures can be deployed within 100 days through the utilisation of CHIM studies, etc. In Japan, a number of research projects are likewise in progress. However, the overwhelming majority of these initiatives remain focused on the “substantive” dimension: the development of novel vaccines themselves, the methodologies for the identification and selection of candidate strains, and the refinement of analytical techniques. By contrast, significantly less scholarly attention has been directed towards the “institutional,” “legal,” and “conceptual” dimensions that are indispensable for ensuring the prompt and sound social implementation of such “substances,” as well as towards the cultivation of the “public attitudes of acceptance” upon which their legitimacy ultimately depends. It is self-evident that the design of new institutional arrangements demands a comprehensive perspective that encompasses the entire trajectory from development within industry and academia, through regulatory approval by competent authorities, to subsequent distribution.
Accordingly, this project will not only address issues such as the criminal law implications of deliberate disease induction, the legal mechanisms for responding to adverse events associated with clinical research, and the legal challenges arising in the course of the social implementation and practical deployment of novel vaccines, but will also broaden its analytical scope to include the diverse range of actors engaged in such development—including prospective trial participants and corporate entities. Through this integrated framework, a wide spectrum of ELSI will be systematically identified and, from the standpoint of medical law (the applicant’s principal field of expertise), synthesised into a coherent whole. The ultimate aim is to translate these insights into rigorous proposals for a legal and institutional architecture capable of comprehensively supporting the 100 Days Mission.
私が目指すトランスボーダー研究者とは
What is my goal as a transborder researcher?
私が目指すトランスボーダー研究者とは、専門分野の深い知識に基づきつつ、異なる領域を架橋し、新しい知を生み出す存在です。
私は刑事法・医事法を専門としつつ、政策論や生命倫理、社会学などの専門家と協業し、医療やAI、統計に携わる研究者とも日常的に交流しています。法学は実験を行う学問ではありませんが、不確実性や価値判断を整理し、制度設計を通じて科学の成果を社会に適切に位置づけてその還元を促す、独自の役割を担います。
そのように実務と理論を往復し、分野を越えて協働する柔軟さを備えることが、私の考えるトランスボーダー研究者像です。
The transborder researcher I aspire to be is one who, grounded in profound expertise, bridges distinct fields and thereby generates new knowledge.
My primary fields are criminal and medical law, yet I also work in collaboration with experts in policy studies, bioethics, and sociology, whilst engaging on a daily basis with researchers in medicine, artificial intelligence, and statistics. Law is not an experimental discipline, but it plays a distinctive role in clarifying uncertainty and value judgements, and in designing institutional frameworks that situate scientific achievements appropriately within society and help to facilitate their translation into practice.
To move continuously between theory and practice, and to collaborate flexibly across disciplinary boundaries, is what I regard as the essence of the transborder researcher.