Development of a Pilot Project on Data Sharing among Partners of the Italian Hub of Population Biobanks (HIBP): Association between Lipid Profile and Socio-Demographic Variables

Abstract

The Italian Hub of Population Biobanks (HIBP) includes both ongoing and completed studies that are heterogeneous in both their purpose and in the specimens collected. The heterogeneity in starting conditions makes sharing study data very difficult because of technical, ethical, and collection rights issues that hamper collaboration and synergy. With the aim of overcoming these difficulties and establishing the "proof-of-concept" that sharing studies is achievable among Italian collections, a data-sharing pilot project has been agreed to by HIBP members. Participants agreed to the general methodology and signed a shared Data Transfer Agreement. The biobanks involved were: EURAC (Micros study), CIG (GEHA project), CNESPS (FINE, MATISS, MONICA, OEC1998, ITR (Italian Twin Register), and IPREA studies, and MOLIBANK (Moli-Sani project). Biobank data were uploaded into a common database using a dedicated informatics infrastructure. Demographic data, and anthropometric and hematochemical parameters were shared for each record. Each biobank uploaded into the common database a dataset with a minimum of 1000 subjects, for a total of 5071 records. After a harmonization process, the final dataset included 3882 records. Subjects were grouped into three main geographic areas of Italy (North, Center, and South) and separate analyses were performed for men and women. The 3882 records were analyzed through multivariate logistic regression analysis. Results were expressed as odds ratios with 95% confidence interval. Results show several geographical differences in the lipidemic pattern, mostly regarding cholesterol-HDL, which represents a strong basis for further, deeper sample-based studies. This HIBP pilot study aimed to prove the feasibility of such collaborations and it provides a methodological prototype for future studies based on the participation in the partnership of well-established quality collections.

The Cooperative Health Research in South Tyrol (CHRIS) study: rationale, objectives, and preliminary results

“…In fact, population-based research is under two opposite ethical pressures: on the one hand it is imperative to protect data privacy and security, on the other hand, an ethically responsible research should aim at maximizing the use of stored data and samples, so as to guarantee the maximal benefit to the community [ 16 ]. For this reason, with the aim of maximizing the scientific harvest of the CHRIS study, collaborations that are instrumental to data harmonization within the Italian Hub of Population Biobanks [ 63 ] and the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE) initiative [ 62 , 64 ] were set up. In particular, the BioSHaRE project framework allows sharing data analysis results without real sharing of the personal-level data, thanks to the new DataSHIELD technology [ 65 ].…”