Available online 7 May 2025, 104842

Author links open overlay panel, , , , , , , , , , , , , , , , , AbstractObjective

Digitalization is a pillar of reproducible research and a mandatory requirement for Research Infrastructures. Biobanks must ensure a fully engineered and digitalized process towards data FAIRification. To this aim, the first step is to assess the current level of digitalization using quantitative metrics, which is particularly challenging given the multi-faceted regulatory and logistical nature of biobanking.

Methods

We developed a Biobanking digital assessment maturity framework, BB4FAIR, comprising a survey divided into three macro areas, namely IT infrastructure, personnel, and data annotation richness. Furthermore, we implemented an automated R/Shiny system to analyse survey responses and generate visual data representations. We piloted the tool on 46 Italian biobanks that in 2023 had signed the partner charter with BBMRI. A scoring table facilitated the tiering of digital maturity, highlighting areas requiring corrective action.

Results

The assessment revealed significant heterogeneity across the three macro-areas of digitalization: almost half of the biobanks feature adequate IT infrastructure and personnel, and a smaller proportion have robust data annotation capabilities. Notably, most biobanks reported having a Biobank IT Management System (BIMS) or an alternative that serves their purposes, yet they still collect the consent to biobanking for future purposes in paper format; the digitalization of informed consent is generally lacking. These findings highlight the need for targeted improvements in Biobank digitalization to enhance overall data FAIRness.

ConclusionThe survey results underscore a pressing need for enhanced IT training and improved data annotation resources within the BBMRI.it. Corrective actions on many lacking features and desiderata are ongoing in the context of the #NextGenerationEu “Strengthening BBMRI.it” project.Graphical abstractDownload: Download high-res image (112KB)Download: Download full-size imageAbbreviationsBBMRI.it

Biobanking and Biomolecular Resources Research Infrastructure of Italy

BIMS

Biobank Information Management System

BRCs

Biological Resource Centers

EHR

Electronic Health Records

ELSI

Ethical, Legal, and Social Issues

FAIR

Findable, Accessible, Interoperable, and Reusable

HL7-FHIR

Health Level Seven International Fast Healthcare Interoperability Resources

ISO

International Organization for Standardization

LIMS

Laboratory Information Management System

OMOP

Observational Medical Outcomes Partnership

Keywords

Biobanking

Biobanks

Data Management

Digital Framework

FAIR Principles

BBMRI

Research Infrastructures

© 2025 The Author(s). Published by Elsevier Inc.