Martin Yuille University of Manchester

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. 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. 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. 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. Fair to whom?
• Donor
• Collector
• Researcher
• Biobank
• Legal entities
– All stakeholders

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. Collector
• Exploration rights
– Right to sole access when accrual and research
are funded simultaneously
– Sole access restricted to the specified
experiments.

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• Access to usable published / unpublished data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. 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. Legal entities
• Intellectual property rights management: long
term tracking of samples and data
– Biobank keeps log of all aliquot movements

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. 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. 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. 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