{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T05:48:34Z","timestamp":1788500914890,"version":"build-2803163510"},"reference-count":59,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T00:00:00Z","timestamp":1783382400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100011198","name":"State Key Laboratory of Drug Research","doi-asserted-by":"crossref","award":["2026SKLDRS03080"],"award-info":[{"award-number":["2026SKLDRS03080"]}],"id":[{"id":"10.13039\/501100011198","id-type":"DOI","asserted-by":"crossref"}]},{"award":["2026SKLDRS03080"],"award-info":[{"award-number":["2026SKLDRS03080"]}],"id":[{"id":"https:\/\/ror.org\/058t7w767","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Biology"],"abstract":"<jats:p>Microphysiological Systems (MPS) have emerged as a transformative platform in biomedical research, enabling the investigation of disease mechanisms, drug screening, and toxicity prediction by closely simulating human physiological functions. However, the rapid advancement of MPS technology has raised a series of complex ethical challenges. These include the sourcing and application of human-derived stem cells, the protection of donors\u2019 personal and genetic data, the potential for brain organoids to develop consciousness-like characteristics, and the challenges to species boundaries posed by human\u2013animal chimera research. Meanwhile, although regulatory authorities encourage innovation, specialized certification standards and ethical review guidelines for MPS are yet to be fully established. The lack of technical standardization and a coherent ethical governance framework remain a major bottleneck hindering the broader application and industrialization of MPS. This review systematically outlines the key ethical issues facing MPS, compares the evolution and differences in international ethical regulatory frameworks, and discusses strategies for addressing these challenges\u2014including the establishment of dynamic ethical governance mechanisms, harmonization of international standards, and the promotion of benefit-sharing and public engagement. Finally, we highlight the need to develop a scientific, unified, and actionable ethical governance system that balances technological innovation with responsible translation, supporting the sustainable development of MPS technology.<\/jats:p>","DOI":"10.3390\/biology15131092","type":"journal-article","created":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T14:27:23Z","timestamp":1783520843000},"page":"1092","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Ethical Challenges and Governance Strategies for Microphysiological Systems Technology"],"prefix":"10.3390","volume":"15","author":[{"given":"Manman","family":"Zhao","sequence":"first","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tian","family":"Lin","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"},{"name":"State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 211198, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruiqiu","family":"Zhang","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"},{"name":"National Institutes for Food and Drug Control, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haodong","family":"Zhong","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"},{"name":"State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 211198, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qianyi","family":"Niu","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"},{"name":"School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaobing","family":"Zhou","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingli","family":"Wang","sequence":"additional","affiliation":[{"name":"National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Sunildutt, N., Parihar, P., Chethikkattuveli Salih, A.R., Lee, S.H., and Choi, K.H. 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