Brain Organoids and the Law

Brain organoids generated from induced pluripotent stem (iPS) cells hold promise in the fields of research and development, and yield many questions as to ethical and productive use. The law has yet to fully grapple with the potential of regenerative medicine products and “living” tissue-based tools both in research and on the market, let alone those that attempt to recapture the intricacies of the human brain. Yet effective legislation and regulation is critical for continued innovation and safety, and to adapt, the law needs to consider the uniqueness of brain organoids and their implications in several fields. This chapter explores the state of brain organoid research and discusses several complications posed by brain organoids for presumably “settled” areas of the law—adding new dimensions to research regulation, contract law, and public policy—to begin a critical discussion for the future of research ethics and biotechnology.