Ethical review key considerations for organoid applications in biomedical research—a systematic review

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.