|TITLE:||PILOT PROJECT FOR THE CREATION OF A RESEARCH FOCUSED BIOBANK NETWORK IN THE VENETO REGION (ITALY)|
|CO-SPONSOR:||University Hospital of Verona (Italy) [11,5% of total costs]|
October 2013 – October 2015 (2 Years)
|PARTNERS INVOLVED:||University of Verona (Italy, LEADER), University Hospital of Verona (Italy), University Hospital of Padua (Italy)|
|P.I. :||Prof. Aldo SCARPA, MD|
SUMMARY: The activity of storage and distribution of human cells and tissues for medical applications on humans is regulated by the European legislation (ED 23/2004 EC, ED 17/2006 EC, ED 86/2006 EC) and implemented by the Italian national laws, ensuring a top level of quality and safety. Nevertheless, the management of same tissues and cells for scopes different than “application on humans”, such as scientific research, is not regulated in those documents. Biomedical research needs the availability of biological samples. This condition has raised the interest towards the so-called “biobanks”, institutions where biological materials are collected and stored together with several other datas (e.g., clinical and pathological datas of donors, etc.). Biobanks are a young recent experience in Italy, but they benefit of from the competitive advantage given by multiple previous international experiences. Nowadays, in Italy, many research scientistsers collect biological materials individually within their working institutions, with a low level of organization and, therefore, a consequential less efficient research.
OBJECTIVES/SCOPE : This project aims to draw a model of regional interaction for the definition of minimum requirements concerning the organization, structures and technologies of biobanking activities research-focused, respecting existing guidelines.
SUMMARY OF METHODS: There will be four different groups of work, corresponding to four different biobanking activities carried out in the Veneto Region:
– Biobank for the Oncological Research (University Hospital of Verona)
– Biobank for the Oncological Research (University Hospital of Padova)
– Veneto Eye Bank Foundation
– Treviso Tissue Bank Foundation
A definition of tipology and roles of different ‘human’ biobanks, based on national and international documentation, will be carried out, in order to set SOPs (Standard Operating Procedures). Biobanking activities that are already regulated will not be taken into account (e.g. blood-related or sperm-related biobanks).
All critical aspects will be considered, such as:
– Definition of scientific rationale
– Choice of samples to be stored
– Choice of relevant clinical and anamnestic information
– Preanalysis: collection, processing and storage of biological samples
– Ethical and juridical aspects
– Biobankk’s governance
– IT implementation process
EXPECTED RESULTS: The organizational model that should result from this pilot project lay the foundations for:
1. the creation of a regional biobanking network, through the definition of shared procedures;
2. the promotion and realization of cooperations synergies between the institutions that carry out common biobank-related activities;
3. the development of high valuable scientific studies and researches;
4. the promotion of operating programmes that foster the technological transfert and the creation of stable relations between the world of research and the industrial production.
ABSTRACTS/POSTERS TO CONFERENCES: –