Brain Organoids in Research and Therapy

Hans-Georg Dederer is Full Professor at the University of Passau and holds the Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law. His areas of research include biotechnology and biomedical law. Against that backdrop, he acted since 2010 as principal investigator of several interdisciplinary research projects funded by the Federal Ministry of Education and Research (BMBF). Those research projects dealt with ethical and legal issues of embryo protection, stem cell research and genome editing. From 2019 to 2023 he receives a grant by the Bavarian State Ministry of Science and the Arts for a research project on the legal and ethical implications of brain organoid technology. Hans-Georg Dederer is co-editor of a commentary on international biotechnology law and of the book series “Life Sciences and Law” (LIT Publishing House). He is also a member of the Permanent Senate Commission on Genetic Research of the German Research Foundation (DFG).David Hamburger is research associate at the Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law of the University of Passau. His research is focused on the regulation of the application of genome-editing in agriculture and medicine. From 2017 to 2019 he was part of a research project that reconsidered from scratch the EU’s regulatory framework for genetically modified organisms (GMOs) in view of the latest biological insights into the genome editing techniques. Since 2019 his research shifted to an analysis of the legal framework for research and therapies with genome-edited brain cells which is part of a research project funded by the Bavarian State Ministry of Science and the Arts. David Hamburger is co-editor of a contributed volume on the regulation of genome-edited plants (Regulation of Genome Editing in Plant Biotechnology. A Comparative Analysis of Regulatory Frameworks of Selected Countries and the EU, Springer, Cham 2019).

• Chapter 1) Introductory Remarks.- Part I) Scientific Background.- Chapter 2) Development of Brain Organoids on the Basis of Genome-Edited iPSC-Derived Brain Cells.- Chapter 3) Cell-Based Therapy and Genome Editing in Parkinson's Disease: Quo Vadis.- Part II) The Status Debate.- Chapter 4) Human Cerebral Organoids: Evolving Entities and Their Moral Status.- Chapter 5). Legal perspective: What is, or Should Be, the Legal Status of Brain Organoids?.- Part III) The Informed Consent Challenge.- Chapter 6) Ethical Perspective: Ethics Considerations Regarding Donors’ and Patients’ Consent.- Chapter 7) The Legal Perspective: The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent.- Part IV) The Chimera Issue.- Chapter 8) Moral Permissibility of Transplantation of Human Brain Organoids into Animals.- Chapter 9) Transplantation of Human Brain Organoids into Animals - The Legal Issues.- Part V) The Enhancement Conundrum.- Chapter 10) Building a Better Beast: Enhancing the Minds of Animals.- Chapter 11) Legal Arguments in Favour of and Against Neuroenhancement by Means of Brain Organoids.- Part VI) The Harmonization Problem.- Chapter 12) Legal Perspective: A Global Harmonisation of Legal Standards for Brain Organoid Research and Therapy?.