Biobank Norway 3 - a national biobank infrastructure

Biobank Norge (BN) was established in 2010 as an infrastructure for optimal use of biobank resources in a consortium with equal partners; NTNU (coordinator), the Universities of Oslo, Bergen and Tromsø, the Institute of Public Health (FHI), the four regional health enterprises (RHFs), Oslo University Hospital (OUS) and the Cancer Registry with the Janus serum bank. As a national research infrastructure, Biobank Norway (BN1 2011-15, BN2 2016-20, BN3 2020-24) has been instrumental in the establishment of a modern and advanced nationwide biobank network for all partner institutions and has fulfilled a primary objective of promoting outstanding research. Clinical and population-based research biobanks have undergone a remarkable development within this infrastructure both in numbers and quality, with a significant growth in the number of researchers requesting biobank services, biological samples, and not the least, data (analysis results) derived from biobank samples, so-called digital biobanking. In BN3, we have prioritized the following areas: i) establish an integrated model for precision medicine with the establishment of national "use cases", ii) further development of hospital-based (clinical) biobanks across the health regions, iii) establish biobanks within the municipal health service (primary care), iv) develop models for cooperation between industrial partners and clinical biobanks, v) clarify legal and ethical challenges for hospital-based research biobanks, vi) continue our national investment program through the acquisition and installation of an automated - 80 warehouse at OUS, vii) develop data handling solutions and analysis tools for the use of register data viii) establish good principles and guidelines for the management and development of digital biobank collections (databanks) to increase the value of digitized data, ix) improve biobank quality through quality studies and accreditation, based on the new biobanking standard (ISO 20387, Biotechnology-Biobanking) and x) have a continuously strong focus on ethics, data privacy and participant communication. BN represents Norway as a full member of BBMRI-ERIC, the official and legal European research infrastructure for biobanks, in the "Manangement Committee" and "Assembly of Members". Ever since the establishment of BBMRI-ERIC in 2013, BN has been strongly involved in this European cooperation and leads through NTNU, in collaboration with BBMRI-ERIC, a recently started (01.01.2024) EU project to develop a new concept for a European research infrastructure for large medical cohorts (INTEGRATE LMedC).

In Biobank Norway 3, we will establish an operating team, with a special focus on the establishment of a national forum for an integrated model for precision medicine, quality biobanking, HAP-integration and investments. The team functions will be established as a virtual organization. As an infrastructure, we have reached a point where sufficient resources and dedicated focus on driving the infrastructure on a daily basis is a clear necessity. Management will be lead by the project PI and the coordinator. In summary the other work streams are i) establish a national forum for an integrated model for precision medicine, ii) building hospital based (clinical) biobanks bridging regional boundaries, biobanking within community health care, develop models for collaboration between industrial partner and clinical biobanks, and clarify legal and ethical challenges for hospital based research biobanks, iii) continue our investment program through installation of a fully automated - 80 storage facility at OUS, iv) develop data processing solutions and analysis tools for re-use of register data in alignment with the “Helseanalyseplattformen” (HAP-integration), in collaboration with the Norwegian Directorate for e-Health, v) to study and establish better principles for management and development of digital biobank collections to increase the value of digitized data vi) improved biobank quality through evidenced base quality studies and accreditation and vii) a continuous focus on ethics issues. privacy matters and donor communication, establishing a digital two-way communication between study participants and researchers. Common Service ELSI will also focus on return of results, genetic re-call and informed consent under GDPR.