Open data – MRC and RCUK policies M25 Consortium of Academic Libraries 20 March 2017

1. Open data – MRC and RCUK policies M25 Consortium of Academic Libraries 20 March 2017 Tony Peatfield Medical Research Council/RCUK

2. Definition of ‘Open’ • “Open means anyone can freely access, use, modify, and share for any purpose (subject, at most, to requirements that preserve provenance and openness).” (2006/2014) • The Open Definition makes precise the meaning of “open” with respect to knowledge, promoting a robust commons in which anyone may participate, and interoperability is maximized. (http://opendefinition.org) • The intellectual property rights over open content are retained by the creator/author but licensed with open terms for anyone to re-use. In context of scientific research, there is also an expectation that the original creator is acknowledged.

3. Open Science By Andreas E. Neuhold - Own work, CC BY 3.0, https://commons.wikimedia.org/w/index.php?curid=33542838

4. Data sharing – high level principles Publicly-funded research data are a public good, produced in the public interest, and they should be openly available to the maximum extent possible. Aim to promote a culture of openness and sharing to increase “the return on public investments in scientific research”.

5. Data sharing landscape – the Data Spectrum http://theodi.org/data-spectrum

6. Main policies, principles and guidance • MRC ‘Good Research Practice’ (2000/2012) • www.mrc.ac.uk/research/policies-and-guidance-for-researchers/good-research-practice/ • MRC Data sharing policy (2005/2016) • www.mrc.ac.uk/documents/pdf/mrc-data-sharing-policy/ • RCUK Common Principles on Data Policy (and guidance) (2011/2015) • www.rcuk.ac.uk/research/datapolicy/ • OECD Principles and Guidelines for Access to Research Data from Public Funding(2007) • http://www.oecd.org/science/sci-tech/38500813.pdf • Concordat on Open Research Data (2016) • www.rcuk.ac.uk/documents/documents/concordatonopenresearchdata-pdf/ The policies are in line with the ‘FAIR’ principles — Findability, Accessibility, Interoperability and Reusability - developed to provide a guideline for data producers and publishers to enhance the reusability of scientific data.

7. MRC data policy principles The MRC’s overarching policy aim for data-sharing is to maximise the life-time value of research data assets for human health and to do so in a way that is timely, responsible, with as few restrictions as possible, and consistent with the law, regulations and recognised good practice.

8. MRC Good Research Practice: Principles and Guidance All research data generated through MRC-funded research must be managed and curated effectively throughout its lifecycle, including archiving, • to ensure integrity, security and quality • to support new research and research data sharing • to maximise the benefit and impact of MRC research funding. Records should be kept to enable understanding of what was done, how and why, and which allow the work to be assessed retrospectively and repeated if necessary.

9. MRC Expectations – Data management • The principles, standards and technical processes for data management, retention and preservation will be determined by the area of science • Processes should be supported by appropriate data standards addressing confidentiality and information security, monitoring and quality assurance, data recovery and data management reviews where suitable. • MRC-funded research must be retained in an appropriate format in line with agreed retention periods: • Basic research: 10 years after the study was completed • Population health and clinical studies: 20 years after completion of the study (25 years in some circumstances) • National importance – permanent preservation

10. MRC Policy on Data Sharing • MRC first data management policy issued in 2005. Last reviewed in 2016. Now includes: • MRC policy on sharing of research data from population and patient studies (2011) • MRC Policy on Open Research Data from Clinical Trials and Public Health Intervention Studies (collated/extended 2016) • Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials (2015) • Requirement for all MRC funded researchers to include a Data Management Plan in their applications, and for all MRC units/institutes to include DMP(s) in their QQR, either at unit or programme level • The MRC Regulatory Support Centre and theMRC Head Office Knowledge and Management team offer bespoke guidance.

11. Data Sharing guidance on MRC website https://www.mrc.ac.uk/research/policies-and-guidance-for-researchers/data-sharing

12. Funding and infrastructure • Costs for data management and activities are • allowable within a grant applications • covered in part by indirect costs (no double costing!) • included in MRC Unit (QQR) budgets • The MRC does not prescribe where or how researchers should preserve and share data • The MRC funds a number of data infrastructures, including the European Bioinformatics Institute, Biobank, several populations studies, Farr Institute • New project to explore ways to share clinical trials data • [Support set-up of Trusted Research Environments (TREs) for health data (eg through the Farr Institute)]

13. Compliance monitoring and assurance process • Data Sharing policy questions are included in the ‘DASIC’ • Data Sharing section in Unit Quinquennial Reviews • AASG audits (Data sharing and management policy in 2015) • Recommendation was to identify better ways to systematically monitor implementation of the policy • Compliance is not currently systematically measured on an annual basis, but we hope to analyse ResearchFish data • Working with JISC and other stakeholders to develop better ways to cite data, and therefore to track re-use

14. Some issues for the MRC/medical research • Consents for sharing participant data • Deductive disclosure of patient identities • More focus on non-human studies? • Repositories for clinical Trials data • Better recognition of researchers who share data • [Public confidence (health data) - Independent patient data taskforce (Chair: Nicola Perrin, Wellcome)] Currently seeking views from our research community: to be discussed by MRC Council in July……

15. ….Questions -1 • Should the MRC be doing more to promote access to research data following the publication of the Concordat on Open Research Data? • In view of the costs involved in curation and archiving, is it reasonable to aim for all data from MRC-funded research to be openly accessible? • Should the main focus of MRC activity remain on data from cohorts and clinical studies or should we also do more to promote access to data from animal research and basic laboratory research? • Should the MRC be doing more to promote other aspects of open science (for example, pre-publication of protocols or registered reports) in addition to our work on open access publishing?

16. Questions -2 • Should the MRC have a means of ensuring the quality of studies using data generated from MRC research or is it sufficient to leave this to the procedures governing data access and journal peer-review? • Should specific measures be developed to track the secondary use of data from MRC research in order to evaluate better the impact of MRC funding? • Should there be general principles governing the equity of access to the coordinated release of large datasets (such as the genetic or imaging data generated by UK Biobank), where early access can provide a significant advantage over scientific competitors?

17. RCUK – Policies and guidance • Common principles on data policy published 2011/2015 • Guide to the interpretation of these common principles, independent of the specific data policy of the Council(s) that may be funding a particular project (2015) • Research Councils each has its own policies and guidance; eg • ESRC: suggests deposit of data underlying research publications in the UK Data Archive (1967?) • EPSRC: mandates deposit of data underlying research publications with explicit reference to sanctions (from May 2015) • RCUK was involved in, and is signatory to, the Concordat on Open Research Data (RCUK/HEFCE/UUK/Wellcome)

18. Some issues for RCUK and nationally • ? Revise/replace RCUK principles to ‘de-duplicate’ the Concordat • ? Develop FAQs for the Concordat • UKRI? – more centralisation? • Task Force for open research data (Chair: Pam Thomas, Warwick) – invited by Jo Johnson • EU General Data Protection Regulation (takes effect from May 2018) – issue of re-consenting/research exemption http://ec.europa.eu/justice/data-protection/reform/index_en.htm https://wellcome.ac.uk/sites/default/files/uk-data-protection-regulation-implementation-sep16.pdf

19. Some more detailed policies/guidance • MRC policy on sharing of research data from population and patient studies (2011) • https://www.mrc.ac.uk/publications/browse/mrc-policy-and-guidance-on-sharing-of-research-data-from-population-and-patient-studies/ • MRC Policy on Open Research Data from Clinical Trials and Public Health Intervention Studies (collated/extended 2016) • https://www.mrc.ac.uk/documents/pdf/mrc-policy-on-open-research-data/ • Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials (2015) • https://www.methodologyhubs.mrc.ac.uk/files/7114/3682/3831/Datasharingguidance2015.pdf • RCUK Responses to questions raised at the DCC/RDMF Special Event on funding for Research Data Management (Aston University, 25th April 2013) • http://blogs.rcuk.ac.uk/files/2013/07/RCUK-Responses-to-DCC-RDMF-Funder-Questions-.pdf

20. RCUK Research Outputs Network (‘RON’) /contacts Alex Vincent (RCUK Executive Directorate) (Chair) Andrew Wright (RCUK ED) Pam Hicks (RCUK ED) Ian Broadbridge (AHRC) Sophia Abbasi (BBSRC) Rachel Spencer (BBSRC) Claire Williamson (EPSRC) Becky Leithall (ESRC) Geraldine Clement-Stoneham (MRC) Tony Peatfield (MRC) Mark Thorley (NERC) Juan Bicarregui (STFC) Andrew Le Masurier (STFC)

21. Questions?