Research on "Brain Organoids" brings unlimited possibilities to the medical field, but the accompanying legal and ethical challenges are also of great concern. Associate Professor Tsung-Ling Lee from Taipei Medical University participates in an interdisciplinary collaborative study with Hiroshima University in Japan, proposing five key categories that should be regulated and protected for brain organoids, including consciousness, legal status, informed consent, ownership, and organ transplantation.

On August 23, Taipei Medical University and Hiroshima University in Japan simultaneously released the results of their research. The study, led by Professor Tsutomu Sawai from the Graduate School of Humanities and Social Sciences at Hiroshima University, has been published in the Journal of Bioethical Inquiry. This research is the first to propose five major aspects in which brain organoids should be regulated: consciousness, legal status, informed consent, ownership, and organ transplantation. Among these, one of the most controversial issues is whether human brain organoids might develop consciousness during the research process. This issue requires broader and more in-depth moral and legal discussions. The research has already been published in the Journal of Bioethical Inquiry [1], and the research team from Hiroshima University will hold a seminar at the National University of Singapore on November 11-12.

Brain organoids are three-dimensional neural tissues cultivated from human stem cells, offering scientists a new horizon for studying the human brain, particularly for researching brain-related diseases such as dementia. Current studies have used brain organoids to develop brain systems that further investigate mechanisms of learning, neural development, and disease. However, as brain organoids can mimic the brain, the experimental systems may develop "consciousness," leading to significant ethical concerns. Considering the future ethical and legal controversies that may arise from different levels of application, Professor Tsutomu Sawai's research team at Hiroshima University clearly identified five key areas in urgent need of regulation and protection: consciousness, legal status, informed consent, ownership, and organ transplantation. Associate Professor Tsung-Ling Lee from Taipei Medical University stated that legal frameworks often lag behind technological developments, and with the rapid advancement of AI, the legal system's insufficiency becomes even more pronounced. As brain organoid research progresses, governments should also consider potential legal issues that may arise from such research.

Hiroshima University's research evaluated the various potential issues that brain organoids could bring. Notably, brain organoids are currently regarded as "property," much like other human organs. However, as research progresses, the question of whether brain organoids, when integrated into AI systems, might transition from being considered property to gaining legal personhood remains open for discussion. Donors may also face ownership disputes regarding the development and outcomes of research using their donated brain cells. Furthermore, if brain organoids are transplanted into animals or even humans for experimental research, new legal and ethical challenges will emerge. This underscores the urgency of establishing comprehensive regulations for brain organoids.

Professor Tsutomu Sawai emphasized that the five categories proposed in the study represent a significant step toward improving the environment for brain organoid research.
 

(Note 1): Kataoka, M., Lee, T.L., & Sawai, T. Human brain organoid research and applications: Where and how to meet legal challenges? Bioethical Inquiry (2024). https://doi.org/10.1007/s11673-024-10349-9

Hiroshima University PR page: https://www.hiroshima-u.ac.jp/en/news/84787
Kyoto University PR page: https://ashbi.kyoto-u.ac.jp/news/20240822_research-result_sawai/