From:  Innovations in hydrocephalus modeling: bridging animal models, bioengineering platforms, and precision therapies

 Ethical and translational concerns in hydrocephalus research and potential solutions.

ChallengeDescriptionPotential solutions/InnovationsReferences
Animal use and welfareEthical concerns over animal suffering and limited clinical predictabilityApplication of 3Rs (replacement, reduction, refinement) and transition to human-relevant models[126, 127, 136]
Translational failurePoor predictability of animal models; therapies often fail clinicallyDevelopment of patient-derived organoids and organ-on-chip systems to improve human relevance[130–132]
Model complexity & regulatory hurdlesDifficulty standardizing advanced in vitro models; evolving rules for regenerative/gene therapiesCross-disciplinary collaboration, harmonized OECD/FDA/EMA guidelines, and early regulatory engagement[87, 89, 125]
Patient safety, ethics & reproducibilityLong-term safety concerns, need for rigorous validation, bias, and lack of transparencyRigorous preclinical validation, patient-centered monitoring, open science practices, FAIR data sharing, and preregistration[133, 141, 142]
Economic & accessibilityHigh costs limit equitable patient accessConsideration of cost-effectiveness and policies for equitable access[147–149]
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This table compiles major ethical and translational concerns, including animal welfare, translational failure, complexity of models and regulatory hurdles, patient safety, data reproducibility, and economic accessibility, and proposes potential solutions. These are 3Rs implementation, creation of organoids and organ-on-chip models relevant to humans, collaborative research work from different disciplines, harmonized regulatory interaction, implementation of FAIR practices and preregistration, and addressing cost-efficiency and equitable accessibility. FAIR: Findable, Accessible, Interoperable, Reusable.