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

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

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Martin Yuille

Martin Yuille
University of Manchester

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

    • 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
    • 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