Structural Epistemic Uncertainty and Epistemic Responsibility in Platform-Based Biomedical Interventions

Recent developments in gene-based biomedical technologies, particularly mRNA-based platforms, have introduced new modes of intervention characterised by reusability, modularity, and rapid scalability. While ethical discussions have largely focused on risk–benefit assessment, informed consent, and regulatory decision-making, comparatively less attention has been given to the epistemic conditions under which such evaluations are conducted. This article argues that platform-based biomedical interventions operate under conditions of structural epistemic uncertainty. Drawing on an analysis of technological architecture and biological complexity, it shows that uncertainty in these contexts may be dynamic, multi-layered, and distributed across time and populations. Under such conditions, uncertainty cannot be fully reduced to calculable risk, as relevant mechanisms, interactions, and system boundaries remain subject to ongoing revision. On this basis, the paper suggests that risk-based ethical frameworks, while indispensable, may be insufficient to capture the normative challenges posed by platform-based technologies. It develops epistemic responsibility, as articulated under conditions of structural epistemic uncertainty, as an extension of existing ethical approaches, emphasising the recognition, governance, communication, and distribution of uncertainty. By clarifying the epistemic structure of contemporary biomedical interventions, the article aims to contribute to a more comprehensive understanding of responsibility in contexts of evolving knowledge.