Joined up thinking needed for bio, tissue, blood and stem cell data banks

There is precedence around the world for large public population-based biobanks. National population-based biobanks now exist, or are being developed, in Estonia, Canada, Iceland, Japan, Latvia, Singapore, Sweden and the United Kingdom.

Where some of these biobanks involve the compilation of genetic, life style and genealogical information, others are more extensive, with links to individual medical records. These large biobanks range in size, seeking from 60,000 to as many as a1m volunteers. All are public population-based biobanks, managed in partnership with the national government. A few also receive partial funding from research foundations.

Many lessons have been learned from these international efforts that inform important considerations for future national biobanks. For instance, a planned biobank in the Kingdom of Tonga was unsuccessful because it awarded exclusive licensing to a private company without public consultation.

In contrast, the population-based biobank in Estonia has been very successful, partly because its policies have been transparent and responsive to thepublic. The biobank infrastructure in the United Kingdom, perhaps in response to these contrasting events, has developed policies that provide for active public involvement.

ID codes for bio-banks and governing genetic databases
All bio-banks (collections of human biological samples) should be given a unique identification code argue EU-funded scientists. Writing in the Journal of the American Medical Association, they urge that such a scheme would optimise the use of these resources and open up new avenues for genetics studies.

Biobanks consist of samples of human biological material such as blood or tissue, together with the data associated with them such as clinical information. They are often used in wide-ranging studies designed to identify the genes associated with a particular disease or condition, for example. Ultimately the results of these studies can lead to the development of new treatments.

                                                                                                         

However, the studies require large numbers of samples to carry out reliable statistical analyses. Obtaining this critical mass of samples would be easier if researchers could find and access data from other biobanks. The problem is that it is currently very difficult to trace biobanks.

To overcome this problem, the authors propose that each biobank be allocated a unique, structured code, similar to the International Standard Book Number (ISBN), which has been used in the book world for over 40 years. The ISBN is made up of a number of elements identifying the language or geographical region, the publisher and the specific edition of the publication.

Laboratory researchers are used to implant systems carrying a unique ID code. The graphy illustrates how each animal carries an implant with a unique ID-code. Each implant sends data to the receiver when it is addressed by the system. The receiver can distinguish the individual implants, even when several animals are housed together. Courtesy http://www.telemetronics.com. However, humans seem less willing to uniquely identify the data bases to which humans contribute.

A similar system could be applied to biobanks, with the different elements identifying the custodian of the biobank, its home country, and the individual collection. If set up along the same lines as the ISBN system, 'it would be easy to identify a biological collection, the various surveys in a longitudinal study, or an international programme made of collections built up in various countries,' the authors claim. Biobanks would receive their code at the time of ethical approval, and the system could be applied retroactively to existing studies and collections.

The authors are clear about the advantages offered by their system. Firstly, it would permit individuals to trace the uses made of a given biobank and find out the results generated. By including information on the collector of the samples and data, such a system could also provide recognition of the hard work involved in building up a biobank.

The registration number could also be given to study participants, enabling them to follow the use of the collection and see how their sample and data are being used, even if they are anonymised.

Unanswered questions
Some questions still remain to be answered: such as who would maintain the system, who would fund it, and how uptake would be ensured?

The EU projects supporting this proposal are:

• GA2LEN ('Global allergy and asthma European network')
• PHOEBE ('Promoting the harmonisation of epidemiological biobanks in Europe'),
• GEN2PHEN ('Genotype to phenotype databases: a holistic solution') and
• BBMRI ('Biobanking and biomolecular resources research infrastructure')

EU biobanks roadmap: Timeline and estimated costs:
Preparatory phase: Years1-3 (70 M€).
Construction phase: Years 2-7 (100 M€).
Operation: total over years 3-10 (100 M€).

Source:http://cordis.europa.eu
Web: http://www.biobanks.eu/

Tissue banking has different issues
No mention of a similar coding system is made for tissue banking and ID does not seem to be at issue in the  5th World Congress on Tissue Banking at Kuala Lumpur from 2-6 June. In line with the theme 'What's New In Tissue Banking', the Congress provides the opportunity to participants to strengthen and establish new contacts and to promote global linkages and collobrations in facing new challenges of tissue banking.

Three pre-congress workshop will convene to cover three pertinent issues in tissue banking: Radiation sterilisation of tissue grafts;
tissue donation coordination & procurement: and
biomechanics for biomaterials & tissue engineering.

Web:http://www.eatb.de
http://www.aatb.org/

Source: http://www.bioscience.co.uk/

Governance is the genetic database UK interest
In June, 2008 an International Conference on Governing Genetic Databases Projects is being held. Some of the questions it will raise are :

• What are the appropriate governance mechanisms for data- sharing in a global civil society?
• What is the role of law and national regulators in global research? 
• Is informed consent possible, in a world where datasets are shared or networked across national boundaries, and biobanks are used as resources by many different researchers for multiple different projects over many years?
• What is the relationship between individual privacy, family rights or interests and the ‘public interest’?
• How should the perspectives of research participants be incorporated into governance structures?How do the different paradigms or research models of clinical and statistical research affect the ways in which biobanks are, or should be, governed?
• Who are the key actors in the regulation of biobanks at the national level, and how do they exercise power?
• What accountability mechanisms currently exist, or should be put in place?
•  How should the benefits of genomic research be distributed individually and globally?
  Source: http://ggd.org.uk/index.cfm?fuseaction=resources.content&cmid=27

  Biobanking & Biomolecular Resources Research Infrastructure
Associated Partners:
    *  GenomEUtwin (www.genomeutwin.org)
    * Finnish biobank (www.nationalbiobanks.fi)
    * European Research Council (http://erc.europa.eu/index_en.cfm)
    * Swedish biobank (http://www.biobanks.se/)
    * German biobank, KORA (http://epi.gsf.de/kora-gen/index_e.html)
    * Centre of Medical Systems Biology ( http://www.cmsb.nl/home/index.php)
    * UK DNA Banking Network - (http://www.dna-network.ac.uk)
    * British biobank (http://www.alspac.bris.ac.uk/welcome/index.shtml)
    * Estonian biobank: (www.geenivaramu.ee)
    * UK biobank (wwwukbiobank.ac.uk)
    * Nordic Center of Excellence links family-based collections of Nordic countries (www.ncoedg.org)
    * Generation Scotland (www.generationscotland.org)
    * HUNT, a Norwegian biobank targeted to cardiovascular health (www.hunt.ntnu.no)
    * Biohealth Norway (http://www.fhi.no/biohealth)
    * EPIC, (http://www.iarc.fr/epic/) European prospective study of nutrition and cancer
    * Danubian Biobank Consortium (http://www.danubianbiobank.de/DanubPublic/misc/mscHome.jsp)
    * GATiB (www.gen-au.at) Genome Austria Tissue Bank (www.bioresource-med.at)
    * Biobank Hungary (www.biobank.hu)

The US clearing house is a slow build
In the US  Biobanks are seen as the meeting point of two major information trends in biomedical research: the generation of huge amounts of genomic and other laboratory data, and the electronic capture and integration of patient clinical records. They are comprised of large numbers of human biospecimens supplemented with clinical data.

Biobanks – when implemented effectively – can harness the power of both genomic and clinical data and serve as a critical bridge between basic and applied research, linking laboratory to patient and getting to cures faster.

As science and technology leaders work to address the many challenges facing US biobanks – logistical, technical, ethical, financial, intellectual property, and IT – BioBank Central hopes to serve as an accurate and timely source of knowledge and news about biorepositories and their role in drug R&D development.

Set up by Faster Cures, the website built by Feinstein Kean Healthcare, based in Cambridge, Massachusetts, with sponsorship  currently limited to  Affymetrix, Bioaccelerate, IBM, and Invitrogen  seems to need more players  to be a central banking institution.
Source: http://www.biobankcentral.org
                                                                                                   
Stem Cell Banks next                                                                                                                      
Representatives of 21 stem-cell funding agencies from 19 countries — members of the International Stem Cell Forum — met in San Francisco at the end of February 2008 to discuss collaborations and how to coordinate cell banks and registries. Their findings are in subscription only publications. In the UK in December 2005 The Stem Cell Bank received in full its request for £9.4m to build, equip and run a new permanent UK Stem Cell Bank and develop the planned activities. 
                                                                                                                                                            Courtesy www.usask.ca

Europe likes banking registers
Two years later In 2007 the European Commission  announced the creation of a European registry providing comprehensive information about all human embryonic stem cell lines in Europe.  It is funded through a Specific Support Action within the ‘Life Sciences, Genomics, and Biotechnology for Human Health’ Priority of the outgoing Sixth Framework Research Programme of the European Union.

 It is expected to last for 3 years with EU funding of just over €1m.  This European Registry is  jointly operated by Anna Veiga from the Stem Cell Bank of the Centre of Regenerative Medicine in Barcelona (CRMB) and Joeri Borstlap from the CellNet initiative at Berlin-Brandenburg Centre for Regenerative Therapies in Berlin (BCRT).

US values European banking links
In the USA an Institute of Medicine committee reviewed  the options for a national system for the collection, distribution, and use of cord blood in and to make recommendations on the ideal structure of a national program. The committee proposes the creation of a National Cord Blood Stem Cell Bank Program in 1989 making specific recommendations for the organisation and administration, data management, and quality control in the national program that would best serve the needs of both the donors and the patients requiring stem cell transplants.

The New York Blood Center's National Cord Blood Program was launched in  1992 with a grant for the National Institutes of Health, and National Heart, Lung and Blood Institute. It is affiliated to the Dutch based Bone Marrow Donors Worldwide programme. Participants are 59 stem cell donor registries from 43 countries, and 40 cord blood banks from 25 countries and the Dutch registered Netcord Organisation
 
http://www.ukstemcellbank.org.uk
http://www.hescreg.eu/
http://www.nationalcordbloodprogram.org/
http://www.bmdw.org/
https://www.netcord.org/

The more that human body's parts are banked and registered, the more difficult it  becomes to hope for anything more globally integrated than an identification number.