Questions
- Why share research data?
- Who should read the policy and guidance?
- What outcomes does MRC expect to see?
- What force does the guidance have?
- When is the effective start date for this policy?
- How will this guidance be reviewed?
- How was this guidance developed and approved?
- How do the policy and guidance relate to those of other funders?
- Other related MRC policies and activities
Why share research data?
Responsible sharing of research data allows further high-quality, ethical research and has as benefits:
- new research questions to be answered in existing data
- collaboration between different scientists
- data linkage and meta-analysis
- sharing of knowledge about best methods for data collection
- ensures collected data are cleaned, well documented, with value added
- established research findings to be independently verified
- new research methods to be developed and tested
- helps to maximise the benefit obtained from the gift of data that study participants make It therefore represents efficient use of public money and supports more timely scientific discovery.
Who should read the policy and guidance?
The guidance has been written principally for:
- Directors and principal investigators (PIs) of research studies funded wholly or partly by the Medical Research Council and involving significant population or patient data collection; i.e. study leaders responsible for defining and implementing study policies and managing significant data resources
- Informaticians, data managers, statisticians and others responsible for the detailed processes of creating, managing, analysing and otherwise adding value to significant resources research data
- Peer reviewers, in particular MRC research Board Members, who will assess the summary Data Management Plans as well the science and make funding recommendations for research and data management
In addition it may be helpful for:
- Study participants interested in how MRC aims both to promote research and respect the interests of participants in research, who generously provide information (and often also samples of tissue or DNA) for research for the public good.
What outcomes does MRC expect to see?
This new guidance and related activities should lead to the following outcomes:
- Greater clarity about the resources needed to support data-sharing, with allocation of appropriate levels of MRC funding for these activities.
- Greater transparency with easier discovery of valuable data collections and of the governance of access, leading to easier access for new research uses.
- Better reporting of data-sharing, with better evidence of the extent and diversity of sharing activities - and of new science through data-sharing.
- Better recognition of altruism by researchers and of technical innovation and other achievements in data-sharing.
- Harmonisation with the requirements of other funders.
- Alongside related work by MRC and its partners in public engagement, strengthened public support for responsible sharing and management of valuable collections of research data and tissues.
- Overall, more and better research with greater impact
What force does the guidance have?
The requirement to comply with MRC’s data-sharing policy forms part of the terms and conditions of an MRC grant or fellowship award and of MRC Institute and Unit funding. In principle, they also apply to other forms of MRC funding.
Directors, principal investigators (PIs) and data managers should discuss with their MRC research Programme Manager any significant challenges in meeting the requirements so as to identify a reasonable way forward.
When is the effective start date for this policy?
The effective publication date of this documentation is 24 November 2011. A period of six months (until 30 June 2012) will be available for written comment.
Compliance
MRC population and patient studies in receipt of MRC funding and that are actively collecting and/or analysing data or otherwise managing datasets with significant potential for new uses, should have taken reasonable steps to comply with the requirements of this guidance by 30 May 2012 or to have plans in place and action under way to ensure compliance within a reasonable period.
Active studies do not need to have fully cleaned, coded or documented their data in order to comply with the guidance. Nevertheless, Directors/PIs are expected to plan to maximise value from the data – including through sharing - over an appropriate time period consistent with the study aims and design (i.e. with the study lifecycle). These plans can be discussed with the MRC science programme managers and, potentially, form part of funding proposals.
For datasets that are no longer or rarely used, Directors of MRC Institutes and Units or programmes, should use their judgement as to whether and how to make the data available for sharing. The quality of research data and the metadata, their likely value for new research and the nature of any consent of such “legacy” datasets, will have a bearing on whether they are shareable and merit the necessary investment.
Relationship to summary Data Management Plans
For funding proposals submitted after 1 December 2011, the summary Data Management Plan should reflect the key elements of a study’s policy on data-sharing. Revised MRC guidance on summary DMPs will be issued in December 2011.
Directors of MRC Units and Institutes with custodianship of population and patient datasets should discuss how best to report their data-sharing performance and plans for the next quinquennium with their research MRC Programme Manager before writing their quinquennial review (QQR) report. The approach will reflect the extent and complexity of the Unit’s cohort collection.
How will this guidance be reviewed?
The guidance will be reviewed by MRC, taking account of comments, and the implementation experience of the research Boards, principal investigators and data managers. MRC will, if necessary, clarify the guidance through an amendment later during 2012.
How was this guidance developed and approved?
The overarching policy on data-sharing was approved by the MRC Council in March 2005. An MRC workshop in October 2010 on Big Data Strategy identified several priorities for strengthening MRC’s use of research data. They included better guidance for researchers on how to interpret MRC data-sharing policy, in particular on the governance of access. This new guidance attempts to fill that gap. MRC is currently working on the other priorities identified at the workshop, such as increasing the visibility (discoverability) of MRC data resources and improving the design and review of data management plans.
The principles of this guidance were approved by the MRC Population Health Sciences Group and commended by the PHSG to MRC’s Strategy Board in March 2011.
Recommendations on the content of the guidance were prepared for MRC Head Office under the auspices of the Data Support Service project by a consortium comprising partners from the Science and Technology Facilities Council, University College London and Oxford University. Leading MRC scientists, informaticians and data managers were consulted at several stages. MRC Head Office reworked the consortium’s final recommendations into its current form.
How do the policy and guidance relate to those of other funders?
To help harmonize research data policies, the MRC consulted an ad hoc group of funders that have similar, well-developed research data policies: The Wellcome Trust, the Economic and Social Research Council (ESRC), Cancer Research UK (CRUK) and the National Cancer Research Institute (NCRI). The MRC has attempted to align this guidance with that of the other funders and with the NCRI Template for Access Policy Development.
CRUK, ESRC, MRC and The Wellcome Trust are content that their data policies are aligned on all the main principles. There are some differences in detail, recognising the diversity in research community practices and different kinds of study. For example, the ESRC data policy requires ESRC-funded investigators to make research data available to other researchers within three months of the end of a grant. MRC by contrast puts the onus on investigators to propose a specific policy for any exclusive use of data, for peer reviewers to consider carefully as part of the funding proposal.
Approvals and funding processes to support sound data management and sharing may also differ between funders. Where studies are co-funded, principal investigators should establish which one funder is taking the lead (e.g. in peer review) and follow their guidance or consult with the respective funders. Funders reserve the right to request compliance with their policies, e.g. for cross council-funded research.
If a principal investigator finds that the policies of a stakeholder in MRC-funded research are at odds with those of the MRC (e.g. the other stakeholder requires immediate destruction of data at the end of a study), they should bring the discrepancy to the attention of their MRC Research Programme Manager.
Other related MRC policies and activities
New MRC guidance is also being developed on:
Research Data Management Plans
Updated guidance on what should be in data management plans (DMPs) and how – as part of funding proposals to MRC - they should be assessed in peer review (planned for end 2011).
Human Tissue Sharing
MRC and other UK funders will launch a shared vision for human tissue sharing, which will then be supplemented by new policy and guidance following detailed consultation with patients, the general public and research professionals. The tissues consultation has the potential to further inform the review of this guidance on research data.
The MRC Data and Tissues Toolkit provides practical guidance on compliance with ethical, statutory and other regulatory requirements for use of data (and tissue) arising from studies involving human participants.
The MRC Research Data Gateway and Population and Patient Research Data Directory is a prototype gateway and directory developed to enable the discovery of MRC-funded studies and their variables.
Open Access Publishing
MRC champions Open Access publishing in science through its policy; the focus is primarily on published research outputs.
Freedom of Information
MRC makes information widely available primarily through publications, the website and other communications. We are committed to openness, good record-keeping and effective communication in our handling of requests for information under the Freedom of Information Act (2000). All information will be made freely available unless there is a good reason not to do so, in line with relevant exemptions under the Act.
Genomic and structural data
The principles in this policy guidance are consistent with the Fort Lauderdale Principles and the Toronto Statement, which reflect good practice on prepublication data-sharing in large scale genomic data projects.