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BBMRI Stakeholders’ Forum Session 3: Brussels - 16 September
                           2009
Fair Access: a practical appr...
What is special about human samples?

• Biomolecular reagents and biobanked human
  samples are worthless without annotati...
Access policy

• Narrow definition
   – I will enable another biomedical scientist to use “my”
     resources. Who what wh...
Fair access

• UNESCO International Declaration on
  Human Genetic Data 2003 Article 18 :
  Circulation and International ...
Fair to whom?

•   Donor
•   Collector
•   Researcher
•   Biobank
•   Legal entities

    – All stakeholders
Donor
• Privacy and confidentiality
   – Sample databases should have alphanumeric IDs. Key
     (linking sample ID to don...
Collector

• Exploration rights
   – Right to sole access when accrual and research
     are funded simultaneously
   – So...
Researcher

• Collaboration management: ensure transparency
   – Biobank tracks all website communications between
     co...
Biobank

• Sustainability
   – Long-term peer-reviewed funding based on
     criteria appropriate to a research infrastruc...
Legal entities

• Intellectual property rights management: long
  term tracking of samples and data
   – Biobank keeps log...
Elaboration of a practical access policy

• There are three basic types of investigation
  that a researcher might underta...
Experimental investigation

• Researchers need first to assess the
  suitability of resources in the biobank:
   – Do the ...
Access via collaboration

• In practise, a researcher, on his or her own,
  when visiting the biobank website, will find i...
Finally… citizen scientists

• Manchester Academic Health Science Centre is
  supporting a ‘Citizen Scientists’ project
  ...
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Fair Access: a practical approach to policy on access for European biobanking

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Martin Yuille
University of Manchester

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Fair Access: a practical approach to policy on access for European biobanking

  1. 1. BBMRI Stakeholders’ Forum Session 3: Brussels - 16 September 2009 Fair Access: a practical approach to policy on access for European biobanking Martin Yuille University of Manchester
  2. 2. What is special about human samples? • Biomolecular reagents and biobanked human samples are worthless without annotation. • Annotation of samples - not reagents - may include ‘personal’ data. • Society treats reagents as commodities – I pay for access and do as I wish • Society does not treat annotated human samples as commodities. – They were treated as ‘gifts to the doctor’ – They are now treated as ‘national resources’ • I agree to ‘share’ and cannot do as I wish
  3. 3. Access policy • Narrow definition – I will enable another biomedical scientist to use “my” resources. Who what when how and why? • Broad definition – All stakeholders - including donors - can enrich existing resources. – I will combine with all stakeholders to optimise the research carried out on existing and new resources.
  4. 4. Fair access • UNESCO International Declaration on Human Genetic Data 2003 Article 18 : Circulation and International Cooperation – States should regulate the cross-border flow of data and samples “so as to foster international…cooperation and ensure fair access”
  5. 5. Fair to whom? • Donor • Collector • Researcher • Biobank • Legal entities – All stakeholders
  6. 6. Donor • Privacy and confidentiality – Sample databases should have alphanumeric IDs. Key (linking sample ID to donor details) held by collector. – Access is restricted to bona fide researchers. Biobank defines who has bona fides (not the collector). • Ethical use of samples and data – All deposits and withdrawals must be backed with evidence of research ethics committee approval – Consent management: national open methods to permit effective withdrawal of consent – A national regulatory agency to approve use of key • Public engagement: understanding and goal-setting – Funding for public meetings, patient groups etc – Promotion of research that requires ‘citizen scientists’
  7. 7. Collector • Exploration rights – Right to sole access when accrual and research are funded simultaneously – Sole access restricted to the specified experiments.
  8. 8. Researcher • Collaboration management: ensure transparency – Biobank tracks all website communications between collectors and researchers • Access to usable published / unpublished data – Biobank links sample data, phenotype data, genotype data • Long term availability of sample: stock control – Conserve native sample – Use replenishment strategies • Minimum of administration – Initiate collaboration online • Experimental data quality and data return – Biobank commissions genotyping
  9. 9. Biobank • Sustainability – Long-term peer-reviewed funding based on criteria appropriate to a research infrastructure • Recognition – Appropriate authorship or acknowledgements in papers using biobank capacities and resources
  10. 10. Legal entities • Intellectual property rights management: long term tracking of samples and data – Biobank keeps log of all aliquot movements
  11. 11. Elaboration of a practical access policy • There are three basic types of investigation that a researcher might undertake using the resources of a biobank: – Meta-analysis • requires solely that published data analyses are accessible – Experimental investigation • requires that both the material and the data resources are accessible – Mega-analysis • requires that the data resources are accessible
  12. 12. Experimental investigation • Researchers need first to assess the suitability of resources in the biobank: – Do the sample types correspond to their needs? – Are there sufficient numbers of the appropriate sample type? – Is the quality of the sample fit for purpose? – Are the types of annotations of samples appropriate? – Is the quality of data for each of those types fit for purpose (completeness, sensitivity, specificity)?
  13. 13. Access via collaboration • In practise, a researcher, on his or her own, when visiting the biobank website, will find it impossible fully to assess resource quality. • The researcher needs to work with the collector (and sometimes the biobank) to ensure that quality is adequate for the study that he or she has conceived. • This work is collaborative. • This reasoning provides the justification for a policy of “access via collaboration”.
  14. 14. Finally… citizen scientists • Manchester Academic Health Science Centre is supporting a ‘Citizen Scientists’ project – Citizens opt-in to participate in research – They are ‘flagged’ in the health care record – ‘Loyalty card’ scheme to be devised • Effects – Consent to research is separated from consent to treatment – Citizens becomes advocates of and participants in research – New types of research are enabled – ‘Collector’ and ‘biobank’ become synonymous, affecting access policy

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