From ICH to IBH in Biobanking? A Legal Perspective on Harmonization, Standardization and Unification

Abstract Biobanking activities are increasingly at the core of research practices. Access to such resources is a major interest as it allows the creation of very large datasets and optimizes the use of previously collected research material. The last decade has witnessed the creation of major international research consortia, such as ENGAGE and BioSHaRE.EU, but promoting biobank networking and maximizing public health benefits requires at least some degree of harmonization. In international research initiatives, any discrepancy between national/regional legal frameworks creates hurdles for the development and implementation of cross-border research activities. Unification, standardization and harmonization of national/regional legal frameworks are necessary to minimize these legal discrepancies. However, these concepts have precise legal meanings, and the use of one framework or another leads to specific and different consequences. In order to provide a broad overview of consent issues and solutions emerging from international genetic and genomic research consortia, both the ENGAGE and BioSHaRE.EU consortia are used as a proof of concept. Through a theoretical legal perspective on harmonization, standardization and unification, consent challenges raised by international genetic and genomic research consortia are identified, and solutions proposed. It is essential to discuss the most appropriate solution to promote international research consortia interoperability while respecting both legal and ethical frameworks.