Bøger af Hans-Georg Dederer

This volume elucidates the pivotal ethical and legal issues arising from the use of brain organoids for research, therapeutic and enhancement purposes.The function of the human brain is still a mystery. Until recently, only post-mortem tissue was available for a structural examination of the brain. Consequently, the examination results could only reflect the state at the end of life. However, in order to better understand the development and function of the human brain, dynamic and functional investigations of different human brain cells are necessary. This is where brain organoids, artificially grown in vitro miniature brains, provide the opportunity for more flexible research scenarios.At the same time, however, the use of brain organoids in research and therapy raises the question of how these new entities are to be treated from an ethical and legal point of view. Against this background, this volume aims at clarifying the normative implications of the use of brain organoids in research and therapy.  The ethical reflections on the status of brain organoids, informed consent, human-to-animal chimeras and neuro-enhancement are mirrored by corresponding legal analyses. The ethical and legal assessments are preceded by an introduction to the scientific and medical background of the brain organoid technology. A final chapter will be devoted to the issue of whether international harmonization of normative standards for brain organoid research and therapy is feasible and advisable.

The book provides a concise overview of currently applicable regulatory frameworks of states which are among the world leaders in research and development (R&D) of cell and gene therapies. Developments in genome editing are expected to lead to new possibilities for the treatment of hereditary diseases in humans. The treatment of such often severe but hitherto uncurable diseases can be based on genome-edited induced pluripotent stem cells (iPS cells). Such treatments constitute combined cell/gene therapies. These therapies need to be governed by a regulatory framework which ensures quality, safety, and efficacy of the relevant therapeutic products. On the other hand, such regulations may retard product approval and impede R&D. Accordingly, national regulations for therapies based on genome-edited iPS cells are an important and, as the case may be, decisive factor for both researchers and industry regarding their decision where to locate their R&D activities. Therefore, regulatory frameworks impact significantly on the competitiveness of states and their economies. This is why a comparative analysis of laws and regulations of different countries matters. Such a comparative legal analysis provides an important insight into regulatory concepts which, in turn, may inspire adjustments of, or amendments to, domestic legal regimes. For this purpose, experts present country reports on France, Germany, Japan, South Korea, Switzerland, and the USA. The reports on France and Germany also refer to the parameters and implications arising from pertinent EU law. This contributed volume is aimed at researchers, but also at, e.g., legal scholars, lawmakers, regulators, and political decision makers.