The use of human organoids is a breakthrough with respect to the animal models in biomedical research and is a new alternative platform for the translational medicine by combining the emerging technologies such as the gene editing and the organ chip. Human organoids have broad application prospects in establishing disease models, screening drugs, organ transplantation, gene therapy and precision medicine. However, while the whole innovation cycle of the biomedical research is greatly shortened, the use of human organoids also blurs the traditional boundaries between subject and object, public and private, research and treatment, which will cause many ethical and legal challenges. This paper reviews the research progress and the application prospect of human organoids, including a systematic discussion of the main ethical issues such as the moral status of organoids, the informed consent, the commercialization and the benefit sharing. It is concluded that a multi-dimensional governance strategy is needed to guide a healthy and sustainable development of studies of organoids.
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