The ethical aspects of human organ-on-chip models: A mapping review.

Organ-on-chips (OoCs) are controlled microfluidic platforms that replicate specific organ-level functionalities and pathological processes using cultured cells. OoCs promise to enhance drug discovery, reduce dependence on animal models, and enable personalized treatments. However, OoCs also introduce ethical challenges. This article provides a mapping review of the philosophical and ethical issues associated with developing and using OoCs. Given the limited literature on OoC ethics, the review takes a comparative analytical approach, drawing on organoid, digital twin, and precision medicine literature. Ethical issues are categorized across three consecutive phases-research, clinical testing, and implementation. Nine key themes are identified: privacy and confidentiality, informed consent, evidence, ontology and moral status, animal experimentation, evidence standards, patient care, intellectual property and commercialization, and distributive justice. Overall, the review highlights several key challenges that require further normative inquiry and hold significance for both research and policy. These include underrepresented groups in OoC research, complexities and limitations related to different consent models, the need for clear criteria to determine evidence standards for replacing animal models, accountability in the standardization of OoC research, and sustainability.