Policy and Plan

About the Ethics Support Team for Brain/MINDS 2.0

The Brain/MINDS 2.0 Program is a research and development initiative supported by the Japan Agency for Medical Research and Development (AMED). Launched in FY2024 as a reorganization of the previous Program for Brain and Mental Health Research, Brain/MINDS 2.0 aims to elucidate the mechanisms of the brain and overcome neurological and psychiatric disorders.

The program consists of three main pillars:
(1) the Core Organization,
(2) Projects for the Priority Research Themes, and
(3) the Practical Application Support Team.

Our Ethics Support Team primarily provides research ethics support to the Core Organization and Projects for the Priority Research Themes. However, our activities are not limited to ethical support within this program. Rather, Brain/MINDS 2.0 serves as a foundation from which we aim to address ethical, legal, and social issues (ELSI) in neuroscience more broadly and comprehensively.

Our specific activities include the following:

  1. Research Ethics Support for Investigators Participating in the Brain/MINDS 2.0 Program
    We support investigators involved in this program to ensure that their research proceeds smoothly with careful attention to ethical considerations.
    The program encompasses a wide range of research topics in the field of neuroscience. These include “human research”—such as studies involving the analysis of human-derived biological specimens or the secondary use of data obtained through the cooperation of research participants—as well as diverse research involving non-human primates and other animal models aimed at understanding brain function.
    Ethical issues may arise at various stages of these studies. We provide a responsive and responsible consultation system that enables us to work collaboratively with researchers to identify and address such issues in a timely and thoughtful manner.
  2. Advancing Neuroethics Research
    Neuroethics is an interdisciplinary field that addresses the ethical, legal, and social issues (ELSI) associated with neuroscience and neurotechnology.
    Topics in this field include, for example:
    – privacy concerns surrounding the collection, databasing, and secondary use of brain data;
    – ethical and legal challenges related to brain organoid research and its applications;
    – philosophical and practical questions of free will and responsibility raised by brain-machine interfaces (BMI). We actively promote research in neuroethics and disseminate related findings, while also applying these insights to enhance our real-world research ethics support activities.
  3. Promoting Patient and Public Involvement (PPI)
    Patient and Public Involvement (PPI) refers to the active engagement of patients and members of the public in the planning, implementation, and evaluation of research. By incorporating diverse perspectives beyond those of researchers alone, PPI aims to enhance the ethical and social validity of scientific studies.
    In Japan, PPI is increasingly being introduced, particularly in clinical research and health policy domains.
    Building on our work in ethics support within Brain/MINDS 2.0 and our research in neuroethics, we are committed to promoting PPI in the field of neuroscience. Our efforts include public outreach, information dissemination, and organizing events to foster awareness and implementation of PPI practices.
    [Reference] AMED: “Patient and Public Involvement in Research”
  4. Providing Information and Educational Opportunities in Neuroethics
    We strive to stay abreast of the latest developments in neuroethics, both internationally and domestically, and to communicate this information in an accessible and understandable manner. We also offer ongoing educational opportunities in research ethics—an essential foundation for conducting neuroscience research responsibly.
    These activities are not limited to participants in the Brain/MINDS 2.0 Program; rather, we aim to make them widely available to society at large.
    As neuroscience advances, ethical questions are becoming increasingly important. Yet we believe that ethics should not be seen as an obstacle to research. On the contrary, ethical reflection deepens the significance of research and opens channels for dialogue with society.
    Through both practical engagement and theoretical inquiry, we are committed to addressing the ethical challenges of neuroscience. We hope that this portal will serve as a gateway connecting neuroscience and society.

From the Ethics Support Team

Eisuke Nakazawa

Neuroscience is a field that delves deeply into the essence of humanity while also being directly connected to medicine. As such, it is an area of great public interest and expectation.

Contemporary neuroscience research is rapidly expanding on a global scale, transcending the boundaries between the real and virtual worlds. In response to this ever-evolving landscape, we believe that Neuroethics—a field that bridges science and society—must also be reimagined and revitalized.

At Brain/MINDS 2.0 Ethics Support, we are committed to supporting the advancement of Japanese neuroscience through the lens of the humanities. Our work is grounded in two key pillars: ethics support and ethics research.

On one hand, we provide direct research ethics support to investigators participating in the Brain/MINDS 2.0 program—through consultation services, site visits, and ongoing engagement. On the other hand, we also conduct empirical and conceptual research on ethical issues that arise in neuroscience R&D, aiming to accelerate scientific progress responsibly. By introducing humanities-based perspectives unique to Japan into the global discourse on Neuroethics, we seek to plant a philosophical stake at the heart of Japanese neuroscience. Through the integration of ethics support and Neuroethics research, we aim to contribute to the development of neuroscience in Japan and beyond.

Toshiyuki Araki

Brain/MINDS 2.0
Director, Department of Peripheral Nervous System Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry (NCNP)

At the launch of the Brain/MINDS 2.0 Program, it was anticipated that a wide range of data—such as those derived from non-human primates and rodents (i.e., model organisms) as part of the “digital brain” initiative—would be integrated with brain imaging and gene expression data obtained from human participants. This process may bring about new situations in which researchers with little or no prior experience handling human-derived data, or those from institutions that do not routinely conduct human subject research, gain access to such data for the first time.

Furthermore, it is expected that various types of human-derived data—such as brain MRI images—will be databased or biobanked and shared with researchers at domestic and international institutions, including those in the private sector.

The Brain/MINDS 2.0 Ethics Support Team offers guidance on appropriate responses in such circumstances. Naturally, ethics committees at individual institutions operate independently and retain sole responsibility for making decisions regarding the ethical review of research. While we do not interfere with those decisions, our team—composed of individuals with expertise in research ethics—strives to provide timely and appropriate advice to researchers whenever possible.

Patient and Public Involvement (PPI) is increasingly recognized as an essential component of research and development efforts. In practice, when we hold public outreach events such as open lectures, we are often struck by the high level of interest that members of the public show toward neuroscience research and its development. With the cooperation of all involved, the Brain/MINDS 2.0 Ethics Support Team is working to promote PPI by sharing information, organizing events, and supporting research institutions and investigators in designing their own outreach activities and public engagement initiatives related to the program.