Abstract 

The biomedical research landscape is undergoing a significant transformation, driven by large-scale population genome projects as well as data aggregation and reuse through biobanks and other health databases. These developments have increased the complexity of research governance and ethical frameworks, which were originally designed for interventional studies and which are being challenged by new models of ongoing data and biospecimen use.

The Declaration of Helsinki remains the cornerstone of ethical oversight for research involving human participants through its emphasis on autonomy, risk proportionality and independent review of research studies. On the other hand, the Declaration of Taipei, which governs the ethical use of data and samples stored in health databases and biobanks, has seen limited incorporation into national policies and regulatory oversight systems.

This article examines the complementary roles of these two declarations and argues for a unified governance framework that integrates participant protection across the entire research lifecycle.