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Ethical Challenges and Governance Strategies for Microphysiological Systems Technology
by
Manman Zhao
1, 
Tian Lin
1,2,
Ruiqiu Zhang
1,3,
Haodong Zhong
1,2,
Qianyi Niu
1,4,
Xiaobing Zhou
1,* and
Qingli Wang
1,* 1
National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 102600, China
2
State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 211198, China
3
National Institutes for Food and Drug Control, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
4
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
*
Authors to whom correspondence should be addressed.
Biology 2026, 15(13), 1092; https://doi.org/10.3390/biology15131092 (registering DOI)
Submission received: 27 April 2026
/
Revised: 15 June 2026
/
Accepted: 24 June 2026
/
Published: 7 July 2026
Simple Summary
Microphysiological Systems, new lab tools that mimic human body functions, advance medical research and drug testing yet raise various ethical concerns. These involve the collection and use of human cells, genetic privacy protection, potential risks of lab-grown brain tissues, and controversies over human–animal research. Lacking complete official rules and unified technical standards, the technology is held back from wide adoption and industrialization. This paper addresses major ethical dilemmas, compares global regulations, and puts forward solutions including flexible ethical management, coordinated international standards, public participation and fair benefit sharing. A sound ethical framework balances technological progress and safe use, drives the steady development of Microphysiological Systems, and ultimately benefits public health and society.
Abstract
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’ personal and genetic data, the potential for brain organoids to develop consciousness-like characteristics, and the challenges to species boundaries posed by human–animal 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—including 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.
