march 2009 from policy to strategy peter dukes policy lead – data sharing & preservation esds...

March 2009

From policy to strategy

Peter DukesPolicy Lead – Data Sharing & Preservation

ESDS - Sharing Research Data: Pioneers, Policies and Protocols

13th March 2009

• “Sharing” is a good thing

• Data diversity

• Other challenges

• MRC Data Support Service project

Internationally : Data sharing is a good thing

OECD policy study

• “Publicly-funded research data are a public good produced in the public interest”

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

“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

Leadership, partnership, investment

Data sharing: Realizing the value of our data for new knowledge and better health

“Omics” Cohorts &Trials

BioBanks

Patient groups

Demographicdata

Investment in methodology, strategic skills

& infrastructure

Connecting for new knowledge better health

EducationalEnvironmental

& SocialData

NHSClinicalData

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 PatientsCommunication

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

MRC is a diverse & devolved organisation

• Hitherto

• Hardly ever…

• Never!

• “Sharing” is a good thing

• Data diversity

• Other challenges

• MRC Data Support Service project

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

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

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

• “Sharing” is a good thing

• Data diversity

• Other challenges

• MRC Data Support Service project

• “Sharing” is a good thing

• Data diversity

• Why doesn’t MRC just get on with it!

• MRC Data Support Service project

• “Sharing” is a good thing

• Data diversity

• ESRC, NERC… have been doing it for decades!

• MRC Data Support Service project

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

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

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

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

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

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

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

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

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

• “Sharing” is a good thing

• Data diversity

• Challenges

• MRC Data Support Service project

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

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