1. March 2009 From policy to strategy Peter Dukes Policy Lead – Data Sharing & Preservation ESDS - Sharing Research Data: Pioneers, Policies and Protocols 13th March 2009

2. “Sharing” is a good thing Data diversity Other challenges MRC Data Support Service project

3. Internationally : Data sharing is a good thing OECD policy study “Publicly-funded research data are a public good produced in the public interest”

4. Nationally: Data sharing is a good thing 7 UK Research Councils Common datasharing policy Wellcome Trust Archives & repositories ESRC: Archive and Data service NERC & STFC: Data Centres Informatics Databases & tools Research E-science Infrastructure Software tools Grids

5. “Sharing” can mean… Comparative analyses between independent data sets Replication of findings from one dataset in another Pooling of like data from different studies E.g. Individual patient data meta analysis – randomised clinical trials Gain in statistical power  definitive answers Linkage of different kinds of data that relate to a common set of individuals Interactions between causative factors Re-analysis Validation, audit Methodology development Testing of new hypotheses

6. Leadership, partnership, investment Data sharing: Realizing the value of our data for new knowledge and better health “Omics” Cohorts & Trials Bio Banks Patient groups Demographic data Investment in methodology, strategic skills & infrastructure Connecting for new knowledge  better health Educational Environmental & Social Data NHS Clinical Data

7. Strategies for promoting sharing Fund excellent research Innovate methods & develop capacity Support & value great data management Rich, diverse, high quality Cross cohort e.g. HALCyon Determinants of healthy ageing Diverse, routine patient data NHS Research Capability Programme Outcomes of interventions Population health science E-health records research Data capture ITC & data infrastructure Study design Analysis Asking the Q Methods development Skills Nurture research participants Research cohorts Patients Communication

9. MRC policy Data sharing is the norm – in the public interest Researchers should submit DSP plans as part of grant proposals The plans will be assessed as part of peer review Access rules should be clear Transparent governance MRC does not prescribe the period for PI’s exclusive use Recognition that creators add value MRC will fund preservation & sharing

10. MRC is a diverse & devolved organisation Hitherto Hardly ever… Never!

11. “Sharing” is a good thing Data diversity Other challenges MRC Data Support Service project

12. Data-resources are diverse Databases, archives, biobanks… Community resources Set up & funded to ingests & share data Data user-led oversight Funded as a resource & service Performance: data service quality Clinical & population studies… Science-focused Set up by Principal Investigators Nurtures the cohort Collects, cleans & analyses data Funded as research grants Performance: science outputs

13. Some data-resources are not set up for research Routine data of value for policy & research Data not collected for research NHS clinical & management data Social services data… Education… Data to support service improvement and policy

14. Data Preservation: Sustaining the value of our data for new knowledge and better health Real issue of non-digital data Fragility and corruptibility of paper, fiche & digital media Real issues with digital data Hardware, software and formats become obsolete Without metadata, the research data have little or no value Selectivity Cost, value and ethics

15. “Sharing” is a good thing Data diversity Other challenges MRC Data Support Service project

16. “Sharing” is a good thing Data diversity Why doesn’t MRC just get on with it! MRC Data Support Service project

17. “Sharing” is a good thing Data diversity ESRC, NERC… have been doing it for decades! MRC Data Support Service project

18. What MRC Council says… MRC Council says Data sharing is the norm – in the public interest Researchers should submit DSP plans as part of grant proposals The plans will be assessed as part of peer review Access rules should be clear Transparent governance MRC does not prescribe the period for PI’s exclusive use MRC will fund preservation & sharing Hierarchy MRC Council & Executive Funding Boards Unit Directors Study PIs Data scientists & Managers

19. What science leaders say… Science leaders say The benefits include Validation of research findings Testing of new & alternative hypotheses Validation of new methods Creation of new data sets Mining new “seams” in large data sets Systematic analysis of trials data Data linkage “Encourages diversity of analysis and opinion” Challenge previous findings MRC Council & Executive Funding Boards Unit Directors Study PIs Data scientists & Managers

20. What PIs are actually doing now… National Survey of Health & Development HALCyon Focused on healthy ageing Physical & cognitive capability Psychological & social well-being Biology of ageing 23 scientists in nine UK cohorts Methodology Knowledge transfer Collaborative science –Inter-relationships between indicators –Changes in indicators with age –Common lifetime determinants Data Access Project Unit Directors Professor Di Kuh

21. Some scientists have concerns… But some study PIs say… “The idea is OK, but for many investigators restricted access to their data set is their intellectual capital” “Not everyone can be a scavenger feeding off the work of others” “You can’t just put it all up there on the web!” “Data protection regulation places scientists at risk” MRC Council & Executive Funding Boards Unit Directors Study PIs Data scientists & Managers

22. We need to address risks… Concerns PIs have identified… Risk to competitive advantage Intellectual property Lack of recognition Reputational risks to the study to their science Risk of participant withdrawal Loss of statistical power MRC Council & Executive Funding Boards Unit Directors Study PIs Data scientists & Managers

23. What Data Managers say (2008) Hierarchy Benefits of an Infrastructure for Sharing Preventing loss of knowledge Preserving the value of historic investment New opportunities for collaboration Discovery Open up legacy assets Networking & spread of good practice MRC Council Funding Boards Unit Directors Study PIs Data scientists & Managers

24. What Data Managers say (2008) Hierarchy Benefits of an Infrastructure for Sharing Technical enhancements Automation – reduced burden Up to date guidance “No need to ‘roll your own’” More effective induction & training Greater cost effectiveness across MRC Confident partnerships – NHS, other RCs But we need resources and support from the top MRC Council Funding Boards Unit Directors Study PIs Data scientists & Managers

25. What and say Public survey shows The public has concerns about (mis-)handling of personal information Most people do not distinguish between health records and research records Some people object to their anonymised health data being shared But also “Won’t someone please use my health records to help someone else suffer less!” Acceptance is high following patient / public engagement in a specific research study Patients & Public Media

26. Some barriers to policy implementation 1.Little evidence of real benefits and costs 2.Uncertainty about researchers real needs and solutions 3.Complex regulatory environment 4.Complexity: everything is connected to everything else MRC Data Support Service to address barriers

27. “Sharing” is a good thing Data diversity Challenges MRC Data Support Service project

28. The Data Support Service Project March 2009: DSS Project “soft launch” Consortium Science and Technology Facilities Council (STFC) University College London (UCL) University of Oxford Working with MRC community 6 pioneer Units / Programmes 2006: MRC Council approval in principle for a Data Support Service

29. In two years, we expect to see… A web-based directory of 100+ population studies With evidence of use & value Accessible guidance, targeted to real needs With evidence of use & value Study-specific strategies for preservation & sharing With evidence of benefits & costs Evidence of cultural & practice changes Unaware  aware  informed  advocate Community engagement in standards development Experience informing an evolving DSP strategy