The UK Biobank will

2. The UK Biobank will • follow the health of half a million volunteers for many years (40-69 years) • collect information on environmental and lifestyle factors • link these to medical records and stored biological samples • samples can be used for biochemical and genetic analysis

3. Scientific Objectives • Determine separate and combinedeffects of genes and environment on common causes of health and illness • Nested case-control studies • Prevalence studies • Cohort studies (exposure based) • Genotype-driven clinical investigation • Biomarker detection as markers or risk factors

4. How has UK Biobank been established? EGC UK Biobank science committee UK Biobank board UK Biobank management group RCCs RCCs RCCs RCCs RCCs RCCs

5. Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar 2004 2005 2006 UK Biobank Pilot Studies Strategy Main Cohort Recruitment Target Recruitment Rate = One-Person- Every-5-Mins Phase-1 Clinical Pilot Phase-2 Integrated Pilot Main Study (Target Recruitment Close: Sept-2010) Phase-1 Molecular Pilot Molecular Pilot Extensions (if required) RED AMBER GREEN

6. How will it work? • Recruitment • Assessment visits • Questionnaire(s) • Measurements • IT systems • Sample storage • Ethical considerations

7. Recruitment • GP practices as sampling frames • Exeter system identifies names and addresses of eligible individuals • NHS agencies send personalised letters and leaflet • Participants respond to UK Biobank • Central booking and helpline

8. The project is being designed with an accelerating recruitment plan…. • Different recruitment settings will be used throughout the project • We will balance coverage vs. cost vs. quality control

9. Participants will come to assessment centres…… 1.Primary sample/data collection at spoke 2.Overnight transport to processingcentre 3.Processingat centre 4. Sample/data archiving 5.Distribute samples/datafor studies • Questionnaire • Clinical measures • Biological samples

10. Assessment visits • Dedicated peripatetic facilities • 20-40 participants per day • Receptionist, ward clerk, 2 nurses, 3 measurement staff • 60 to 90 minutes in clinic • GCP standard quality control

11. Baseline Follow-Up Pre-Clinic Clinic Post-Clinic NHS Medical Record* Participant Questionnaire Interview Phys. Assess Bio. Samples Assessment of Risk Factors/ Exposures/Confounding/Bias • Selected participants • also re-invited for further assessment Assessment of Outcomes Data collection

12. IT and information • Novel clinic systems – web-based always on-line • Key-coded anonymous data storage • HL 7 standards harmonised internationally • GP2GP standard record for health record repository

13. Samples will be collected from each participant Spray-dried K2EDTA (plastic) Acid citrate dextrose additives (ACD) Clot activator and gel for serum separation Plastic Conical Urinalysis F/Ox • 750 participants per day • 3750 tubes of blood • 750 tubes of urine • 14 million 1ml tubes • 10 million 50ul tubes • 5000 gallons of blood and 1000 gallons of urine 4.5 10 10 10 10 8 Glucose 40C Transport RT Transport 40C Transport RT Transport Plasma, Buffy coat, DNA (FTA),RBCs, cell counts Plasma, Buffy coat, PBLs, Serum blood chemistry Urine Metabolites Bioanalytes

14. Sample storage: automated retrieval at -80 degrees

15. Modern, efficient methodology in patient recruitment, statistics, IT, genotyping, LIMS and genomics Industrial scale processes, project planning and quality assurance Distributed scientific collaboration – strong central co-ordination and quality control The Approach

16. Recruitment of Senior Management Team at Coordinating Centre ongoing Pilot studies start later in 2004 Full recruitment expected 2005 UK Biobank Canada Europe Japan USA The need for collaboration

17. Current activities • Piloting the clinical and molecular processes • Establishing the IT infrastructure and clinical applications • Developing the communications strategy to support recruitment • Writing the scientific protocol and participant questionnaire • Refining the EGF • Implementing the laboratory facilities and processes

18. Size of project (persons x time) Biological resource for study of biomarkers and genes Recall of subsets for intensive phenotyping Extensive use of routine health records Ethical approach – public participation UK Biobank special features…

19. Challenges • Delivery against project timelines in a distributed organization • Ensuring ethical approvals for complex studies • Negotiating access to required information • To invite and maintain contact with participants • To access longitudinal and secondary data sources • Ensuring continuity and security of data chain

21. Towards an IP and Access policy • An open resource • Managed to optimise its use and value for research in the public interest • Appropriate safeguards and controls

22. Safeguards? • Honour commitments to participants • Ensure compliance with legal and regulatory requirements • Prioritise access to depletable resources • Manage IP rights appropriately

23. Intellectual Property • Licenses for use of background IP • Identify and protect new IP in the resource • IP from research uses rests with the researchers

24. Protected resource Managed resource Public resource

25. Access to the managed/protected resource • No exclusive access • Access on “merit” • No police or forensic access without Court Order • Identifying information removed and other steps to protect participants’ privacy

26. Criteria for access • Absolute criteria – positive scientific and ethical review, EGC support • Relative criteria – scientific value, congruence with the purpose of UK Biobank, importance of health problem, EGC advice • Fees – access and service

27. Access to samples and participants • Samples will not be released • Access to participants will be through UK Biobank initially

28. Dissemination of findings • UK Biobank will publish titles/abstracts of approved access requests • Users must disseminate results within • 6 months(?) • Users must copy back results to UK Biobank for use by others within 6 months(?)