Biobanks: Patients’ Role and Expectations

Fabrizia BIGNAMI, PhD Eurordis Therapeutic Development Director EuroBioBank Administrative Coordinator www.eurordis.org www.eurobiobank.org Biobanks: Patients’ Role and Expectations

Outline 1. The EuroBioBank network:  when patients take the initiative 2. Patients as actors in research 3. Patients' expectations from BBMRI 4. Patients' contribution to BBMRI

The EuroBioBank Network ACTIVITIES  Rare diseases are defined as affecting less than one citizen in 2,000.  30 million people in the 27 EU member states are affected.
EuroBioBank® is the first operating network of biological banks in Europe providing human DNA cell and tissue samples for research on rare diseases.
The EuroBioBank network tackles two of the main problems facing European research on rare diseases:
lack of human biological material
quality of samples.
Identify and localise rare disease biological material of interest to researchers
Process and store a critical mass of rare disease sample collections
Maintain a centralised website with an online catalogue offering an easy access to the referenced samples available
Distribute high quality material and associated data to users
Promote quality biobanking practices (collection, transport, storage and exchange of biological material) adapted to each type of material (DNA, tissue, cell)
Map ethical issues related to the use of biomaterial samples
Disseminate knowledge and know-how to the scientific community
Identify collaboration with the medical and scientific community in the field of rare diseases

Initiated in 2001 by 2 Patient Organisations:
the European Organisation for Rare Diseases (Eurordis) and
the French Association against Myopathies (AFM)
Financed by the European Commission between 2003-2006 (FP5) ( 12 founding biobanks from 8 EU countries: Belgium, France, Germany, Hungary, Italy, Malta, Slovenia and Spain)
EuroBioBank was awarded the Newropeans Grand Prix 2004 for Research and Technology
In 2006, the EuroBioBank network was cited by the IPTS/ESTO work group as a European model of coordination and of integration of Biological Resources Centres for the optimisation and improvement of the use of human biomaterial at European level
Since January 2007, EuroBioBank has been a partner of the TREAT-NMD network of excellence in charge of the workpackage “Develop and Manage Supernational BioBanks”
In 2008 EuroBioBank joined the BBMRI as associated partner
History of the network

Key results
A network of 13 biobanks from 7 EU countries and Israel all complying with a common Charter
More than 400,000 samples available across the network
Approximately 13,000 samples collected and 7,000 samples distributed each year
A web-based central catalogue ( www.eurobiobank.org ) enables a search by type of biological material, disease and biobank
Consensus documents developed by the network:
30 Standard Operating Procedures (SOPs)
An Informed Consent form
A Material Transfer Agreement (MTA)
93 high profile research publications acknowledging EuroBioBank (2003-2008)
A book “ Outstanding Legal and Ethical Issues on Biobanks”

Patients as actors: a specificity of the EuroBioBank Model
Two Rare Disease patient groups instigated the EuroBioBank network (AFM and Eurordis).
They have transformed an urgent need into a concrete and long lasting structure.
They will continue putting the patient at the centre of all the EuroBioBank activities.
Patients are not just samples providers, but front-line actors who:
Organise and conduct bio-samples collection campaigns
Spread easily accessible information about biobanks
Make and consolidate the links between all involved
parties (researchers, physicians and biobankers) for a
more effective research on rare diseases

Patients as actors: Other examples
Registries and databases that patients:
Create
Support financially
Have legal responsibility and rights and contributed to manage
Clinical trials that patients:
Instigate
Contribute to the design and management
Benefit from ( e.g. rapid access to all results)
Support financially
Research projects for which patients:
Establish the network of specialists
Provide or identify the sources of funding
Help to reduce burdens

Patients as actors: expectations from the BBMRI
Patients expect BBMRI:
To be the place where international harmonisation of biobank practices is achieved in the respect of the international recommendations already existing. Today, very different practices have a different impact on patients’ rights (e.g. different type and use of inform consent or methodology to withdraw consent)
To actively involve patients in the concrete reflections on the governance of the future Biobank Infrastructure. (e.g. consultation of patients for collection campaigns, for defining priorities for use of rare samples, for information to lay public,…)

Patients as actors: expectations from the BBMRI
Patients expect BBMRI:
To be recognised as the reference infrastructure for biobanking activities for research in EU so:
to easily attract concerned professionals’ and people/patients for collaboration
to optimise resources and provide centralised efficacious tools to make high quality biological material available for the research community. (e.g. central database allowing rapid identification of the required sample wherever it is stored)
to ensure sustainable long term services that will contribute to accelerate the progresses of research on diseases

Patients as actors in BBMRI
Patients can concretely contribute to several BBMRI activities, such as:
The definition of rules and best practices for:
the collection and distribution of samples (incentives for donors, consent, evaluation of requests, etc.)
the collection management and use of sample-associated sensitive data
the return of information on the results issued from the use of the samples
the ownership of material and results
The awareness campaign on biobanking activities towards lay public and policy makers, so to ensure that biobanks will be recognised as a fundamental element to progress in the scientific and medical knowledge benefiting to the whole society. (  consequence on the long-term funding)

Patients as actors in the BBMRI The BBMRI Stakeholders’ Forum: a good starting point A more direct and official involvement of patients in specific BBMRI activities should be systematically seek identifying most appropriate patients’ representatives for each activity.

Thank you ! www.eurobiobank.org [email_address] [email_address] EURORDIS Plateforme Maladies Rares 102 rue Didot – Paris 75014 – France Tel + 33 1 56 53 52 10 Fax + 33 1 56 53 52 15

Biobanks: Patients’ Role and Expectations

by BBMRI Stakeholder's Forum on Dec 18, 2009

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