BBMRI Stakeholders’ Forum Session 3: Brussels - 16 September
Fair Access: a practical approach to policy
on access for European biobanking
University of Manchester
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
• 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
– I will combine with all stakeholders to optimise the
research carried out on existing and new resources.
• 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
Fair to whom?
• Legal entities
– All stakeholders
• 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’
• Exploration rights
– Right to sole access when accrual and research
are funded simultaneously
– Sole access restricted to the specified
• 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• Access to usable published / unpublished data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
– Long-term peer-reviewed funding based on
criteria appropriate to a research infrastructure
– Appropriate authorship or acknowledgements in
papers using biobank capacities and resources
• Intellectual property rights management: long
term tracking of samples and data
– Biobank keeps log of all aliquot movements
Elaboration of a practical access policy
• There are three basic types of investigation
that a researcher might undertake using the
resources of a biobank:
• requires solely that published data analyses are
– Experimental investigation
• requires that both the material and the data resources
• requires that the data resources are accessible
• 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
– Is the quality of the sample fit for purpose?
– Are the types of annotations of samples
– Is the quality of data for each of those types fit
for purpose (completeness, sensitivity,
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”.
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
– Consent to research is separated from consent to
– Citizens becomes advocates of and participants in research
– New types of research are enabled
– ‘Collector’ and ‘biobank’ become synonymous, affecting