The Preparatory Phase for a pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) focuses on technical, legal, governance, and financial issues to:

• prepare to construct BBMRI, building on existing biobanks, resources and technologies, specifically complemented with innovative components and properly embedded into European scientific, ethical, legal and societal frameworks,
• provide the concept for a key resource to increase excellence and efficacy in biomedical sciences, drug development and public health,
• expand and secure competitiveness of European research and industry in a global context, and
• develop a sustainable financial framework.

BBMRI  comprises:

• biobanks of different formats (collections of blood, DNA, tissue, etc., together with medical, environmental, life-style and follow-up data),
• biomolecular resources (antibody and affinity binder collections, ORF clone collections, siRNA libraries, proteins, cellular resources etc.),
• enabling technologies and high-throughput analysis platforms and molecular tools to decipher gene, protein and metabolite functions and their interactions,
• harmonized standards for sample collection, storage, preanalytics and analysis,
• harmonized databases and biocomputing infrastructure and
• ethical, legal and societal guidance platform

The European Commission is funding this preparatory phase (grant agreement 212111).

Policy Context

Continuous improvement in the health of European citizens relies on biomedical research and on citizens who participate in that research. Research today needs new, bigger and better resources.

Over 200 organisations - including national funders - in 24 EU Member States are jointly planning EU infrastructure to deliver those resources. The samples. The data. The tools. Our infrastructures already manage over 10 million samples. Our goals are to increase this number, to improve quality, to reduce fragmentation, to extend the reach of European researchers.

Europe has sophisticated health delivery systems. Its citizens understand the need for health research. Now we plan to realise more fully the potential of European biomedical research.

The vision of BBMRI is to sustainably secure access to biological resources required for health-related research and development intended to improve the prevention, diagnosis and treatment of disease and to promote the health of the citizens of Europe. 

Description of target users and groups

BBMRI was set up to coordinate a large scale biobanking network to share access to available biological samples and biomolecular tools in Europe. This infrastructure will cover major biobanks, molecular resources and biocomputing centres to ensure that the samples are linked to existing databases, scientific literature and statistical expertise. Pursuing these activities, BBMRI is dedicated to be properly embedded in the European legal framework.

 

Description of the way to implement the initiative

BBMRI currently comprises 51 participants and more than 200 associated organisations.

The objectives of the BBMRI during the preparatory phase are to develop the plan to integrate existing quality controlled biobanks, biomolecular resources and enabling technologies into a pan-European biomedical research infrastructure, and to provide a concept for its operation and codes of conduct for European biobanks, particularly considering the different technical standards and types of integration into health care registries and databases currently available.

Furthermore, the aim of BBMRI is to evaluate the heterogeneous European ethical and legal frameworks and to find solutions how to implement a pan-European infrastructure, as well as to elaborate sustained funding and financing solutions for this key resource.

The objectives during the preparatory phase in BBMRI project were and will be:

1. To define the interaction and terms and conditions of members and partners with BBMRI and securing compliance with sample and data sources

 

2. To negotiate contracts between BBMRI and/or members with funding organizations to solidify the long-term funding for this European infrastructure

 

3. To agreed IP and data-sharing policies for users and associated

 

4. To incorporate of appropriate legal structure

Technology solution

BBMRI has established the new MolMeth database for molecular methods, providing best practice-based protocols for molecular analyses of different types of samples. See http://www.molmeth.org.

BBMRI has established a catalogue intended to be used as a reference for scientists seeking information about biological samples and data suitable for their research. The work has been performed in close collaboration with P3G-project (www.p3g.org) to avoid overlapping work and also repeated contacts towards the biobanks. See http://www.bbmri.eu/index.php/catalog-of-european-biobanks.

BBMRI is dedicated to be properly embedded in the European legal framework. To that end, it pioneers an interactive approach to address the complex legal issues associated with pan and cross European biobanking: the WIKI Legal Platform. See http://www.legalpathways.eu/">http://www.legalpathways.eu/ .

Lessons learnt

Biomedical quality-assessed samples and data as well as biomolecular resources and molecular analysis tools are essential for academic and industry-driven research to treat and prevent human diseases. Although currently established national biobanks and biomolecular resources are a unique European strength, valuable collections typically suffer from fragmentation of the European biobanking-related research community. This hampers the collation of biological samples and data from different biobanks required to achieve sufficient statistical power (lesson 1). Moreover, it results in duplication of effort (lesson 2) and jeopardises sustainability due to the lack of long-term funding (lesson3).

The main challenges for BBMRI are to improve the quality and interoperability of national biobanks/biomolecular resources, to manage and to oversee ethical and corresponding legal aspects of biobanking in practice and to provide global solutions, thus sustaining the development and the use of biological resources.

These challenges are faced by BBMRI in a joint effort of its 51 participants and more than 200 associated organisations during the preparatory phase (2008-2010).