BBMRI Stakeholders’ Forum Session 3: Brussels - 16 September 2009

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

Martin YuilleUniversity 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

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.

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”

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 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’

Collector

• Exploration rights– Right to sole access when accrual and research

are funded simultaneously– Sole access restricted to the specified

experiments.

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• Access to usable published / unpublished data– Biobank links sample data, phenotype data, genotype data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

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

Legal entities

• 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: – 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

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)?

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

• 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