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REVIEW article

Front. Cell Dev. Biol.

Sec. Stem Cell Research

Ethical Review Key Considerations for Organoid Applications in Biomedical Research-a systematic review

Provisionally accepted
  • Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, China

The final, formatted version of the article will be published soon.

The organoid co-culture model, a novel tool for reconstructing three-dimensional microenvironments to study cell-cell interactions, has demonstrated significant potential in biomedical research in recent years. It holds considerable value for elucidating tumor immunosuppression mechanisms, conducting drug sensitivity tests, studying immune responses in infectious diseases, and revealing pathological features of neurodegenerative diseases. However, this model still faces challenges related to standardization, large-scale cultivation, and ethical regulation.The cellular sources of organoids—such as human pluripotent stem cells, adult stem cells, fetal tissues, or genetically edited cells—raise numerous ethical questions. These include: Is ongoing donor informed consent required? Does commercial use violate the original intent of donation? And do organoids possess attributes of "potential life"? Furthermore, the clinical translation of organoid technology continues to push ethical boundaries, necessitating appropriate governance frameworks. Each field of science and technology presents specific ethical questions regarding its application; risks, benefits, and monitoring procedures vary, thus requiring tailored review guidelines. This article aims to address how to resolve the ethical challenges associated with organoid technology and to clarify key considerations for ethical review.

Keywords: benefit-risk assessment, biomedical ethics, Ethical Review, Organoid, Stem Cells

Received: 10 Oct 2025; Accepted: 09 Feb 2026.

Copyright: © 2026 Zhili. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Guo Zhili

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