EURORDIS at the BBMRI Stakeholder's Forum

National and regional biobanks play a vital role in modern health research by providing a goldmine of stored human biological samples and data. Can we make better use of these invaluable resources by collaborating across national borders on a larger scale? This is the idea behind the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI)

BBMRI was set up in 2008 to coordinate a large-scale biobanking network to share access to available biological samples, such as tissues, cells, blood or DNA, and biomolecular tools in Europe. Existing national collections suffer from fragmentation and underutilisation due to a lack of commonly applied standards and limited access by investigators. This has slowed research into potential new treatments for diseases.

BBMRI seeks to counteract this problem by establishing the first pan-European legal entity designed to help biobanks interoperate and collaborate in order to improve European research capabilities. More than 300 biobanks have been identified and recruited so far. BBMRI has currently 51 members (universities, research centres, ministries, research councils) and more than 190 associated partners from 29 different European countries.

Coordination and harmonisation of biobanks is particularly crucial to rare disease research, which inherently has small sample pools from which to draw. This is why EURORDIS has been actively involved in the BBMRI initiative from the start. As a member of the BBMRI Stakeholders Forum, EURORDIS’ contribution has been twofold: ensuring that patients’ needs and expectations in the field of biobanking are taken into account and, sharing its experience as coordinator of the rare disease biobank network (Eurobiobank).

“Rare disease biobanking has a great deal to contribute to this field. For example, the Telethon biobanks in Italy may serve as a prototype for networking rare disease biobanks on a national level, while EuroBioBank can be used as a prototype for networking rare disease biobanks on a European level” explains Fabrizia Bignami, Research & Therapeutics Development Director at EURORDIS.

Rare disease biobanks have common objectives with BBMRI and recognise BBMRI as an important mechanism to secure the long-term sustainability of biobanks in Europe. The BBMRI preparatory phase (2008-2010), funded within the EU framework programme 7 (FP7), aimed to provide the basis and the ethical and legal framework for the future operational biobanking infrastructure.

Before the end of the preparatory phase of the project, BBMRI partners and members of the BBMRI Stakeholder’s Forum, including EURORDIS, met in Brussels in June 2010 to take stock of the work performed so far and discuss the way forward. This second Stakeholder’s Forum entitled “The European Biobanking Research Infrastructure: a Step Closer” brought together patients, clinicians, funding organisations, associated project partners, and industry. The meeting is part of a comprehensive consultation and engagement process with all concerned stakeholders, in order to take their vision into account when designing the future European network of biobanks.

Neil Formstone from the Wales Cancer Bank explains, “Before setting up our biobank we asked a group of patient representatives to come in and discuss what was important in the design of the structure and if it was worthwhile doing. Later, patient representatives, like myself, formulated the patient information sheets, the consent forms and helped in the approval process, getting it through the ethics committees. We gave the patients perspective the whole way through. Lay membership is vital.”

As part of the final session of the June meeting, Fabrizia Bignami of EURORDIS, representing patient stakeholders, officially presented the coordinator of BBMRI, Kurt Zatloukal, with a document delineating the basic principles to govern patient participation in biobanking. These basic principles have been reviewed and endorsed by all members of EURORDIS’ European Public Affairs Committee.

The “Patient Participation in BBMRI” consultation document is expected to be used in the drafting of policies and procedures for the implementation of the upcoming BBMRI infrastructure. It includes principles to guide active participation of patients, including training of patient organisations and regular and reasonable feedback to patients regarding use, sharing and transfer of samples. It also includes ethical guidelines addressing delicate issues for patients such as transparency, consent, privacy, confidentiality, use and withdrawal. The document outlines patients’ rights and expectations regarding their donations, as well as a list of examples of good practices in regard to active participation of patients and patient organisations in biobanking and related activities. This consultation is open to other examples of good practices. Patient organisations interested in adding their specific experience are welcome to add their contribution online at the bottom of the document (p.13).

“We are proud that EuroBioBank is included as an example of good practice and that the EurobioBank model has served as a reference in what will be the largest research infrastructure in Europe,” says Fabrizia Bignami. “The next step is to ensure that patients are present in the governance structure of BBMRI and that they are represented in each biobank - beyond tokenism.”

Read and contribute to the Patient Participation in BBMRI consultation document
More information on the 2010 BBMRI Stakeholders Meeting

Author: Paloma Tejada
Photo credits: © Derick Mitchell & EURORDIS

This article was first published in the November 2010 issue of the EURORDIS newsletter