Purpose and scope
This policy sets out the Medical Research Council’s (MRC) expectations and requirements for data sharing. The aim of this policy is to support a research culture where:
- there are policies and activities in place to support good data sharing practice
- everyone involved in the research process can discuss, adopt and develop good data-sharing practice and receive recognition for doing so
- barriers that prevent or inhibit data sharing are recognised and appropriate steps taken to rectify these
- data sharing is carried out fairly, safely, transparently and in accordance with policy and law
- the value of research data is maximised for the benefit of society
This policy applies to all MRC-funded research including:
- MRC-funded activities, and applications for funding, irrespective of whether they take place in the UK or in other countries
- organisations that apply for or receive funding from MRC irrespective of whether they are based in the UK or in other countries
- individuals engaged in research (including making funding applications) at such organisations, whether directly employed by them or not
Definitions
Data: aligns with Organisation for Economic Co-operation and Development (OECD) standards as any data or research-relevant digital objects, such as metadata, algorithms, code, software and workflows, used as sources for research or generated as a result of research.
Data sharing: any activity where data is provided, or made available, beyond primary research purposes.
FAIR principles: guidelines to improve the findability, accessibility, interoperability, and reuse (FAIR) of digital assets.
Five Safes framework: a set of principles which enable data services to provide safe research access to data.
UKRI open access policy: policy to ensure that findings from research funded by the public through UKRI can be freely accessed, used and built on.
UKRI knowledge exchange principles: principles designed to facilitate knowledge exchange for research.
UKRI trusted research and innovation principles: a set of principles developed to ensure that effective international collaboration in research and innovation takes place with integrity and within strong ethical frameworks.
In this this policy:
- ‘must’ denotes a requirement, which when not fulfilled and in the absence of a justifiable reason, is a breach of this policy and may result in sanctions
- ‘should’ and ‘encourage’ is used with principles and actions that represent best practice and form part of this policy but are not mandated requirements
Principles
Data must be made available with as few restrictions as possible, to maximise the value of the data, improve research reproducibility and for patient and public benefit. Data must be shared in a timely and responsible manner and in line with relevant legal, policy and ethical standards, including when operating internationally.
MRC fully supports the FAIR principles. Data should be appropriately curated throughout its lifecycle and data sharing must include appropriate metadata to ensure that it is findable, accessible, interoperable, and reusable.
To better foster an inclusive, representative, and transparent data-sharing environment, MRC strongly encourages direct engagement with relevant people, groups and organisations during all stages of research, including data sharing.
Those involved in generating, curating, analysing and sharing data should receive appropriate recognition by funders, research organisations and other data users. Unique and persistent identifiers must be used allowing data users to cite data sources, and data providers to include citations in reports and funding applications.
Data sharing should not impede the primary research team from realising the benefits of the research (for example publications and patents). A limited and defined period of exclusive data use is reasonable according to the nature and value of the data.
For research involving personal or confidential data, appropriate research governance (ethical, legal and institutional) that facilitates data sharing must be considered and implemented throughout the research lifecycle.
Data-sharing processes must follow institutional policies, project policies or both. These must be transparent, equitable, practicable, and provide clear accountability. Where appropriate, processes should follow the principles of the Five Safes framework in terms of:
- safe data
- safe projects
- safe people
- safe settings
- safe outputs
Details of planned data-sharing activities must be submitted to MRC as part of any funding proposal or review, and must be in line with this policy.
1. Planning research
1.1 Data management plans
Full funding proposals and funding reviews should include a data management plan. Data management plans must include details of planned data-sharing activities and be in line with this policy.
1.2 Funding proposal costs
Funding proposals to MRC should differentiate in broad terms between the proposed costs of:
- collecting or generating data
- the research project
- ongoing data curation
- data sharing
- data archiving
Costings should be proportionate to the intended activities.
1.3 Data use
In addition to the primary research purposes, project design must consider the widest range of potential uses of data and seek to establish broad and enduring legal avenues for data sharing. When consent to share data will be obtained, the consent should reflect this policy as far as possible.
1.4 Data sharing
Where appropriate, plans for data sharing must involve meaningful and proportionate public involvement and engagement. Funding proposals and data management plans should be clear on how this engagement is reflected in data-sharing activities.
1.5 Data protection law
Projects must be designed to comply with relevant data protection law and provide proportionate transparency information that facilitates data sharing.
1.6 Data providers
Where other organisations act as data providers (for example the NHS), all potential data sharing should be discussed with the data providers as early as possible.
2. Data collection, generation or curation
2.1 Metadata standards
Accurate and consistent metadata standards must be utilised in a way that supports high-quality research and data sharing. These standards should use a vocabulary that is consistent with FAIR principles.
2.2 Metadata documentation
Metadata documentation, a metadata catalogue, or personnel with relevant knowledge and expertise, that can support the understanding and use of datasets, must be available to facilitate data sharing. This documentation should be reviewed regularly to ensure that data remains usable.
2.3 Metadata accessibility
Metadata must be readily findable by the research community to facilitate data sharing. For example, unique and persistent identifiers, searchable registers, must be used to aid discoverability.
2.4 Data sharing policy or protocol
A data-sharing policy or protocol must be freely and readily discoverable. This should be available by the time of the first publication. The priorities and criteria for data sharing and any constraints, must be transparent and clearly justified. The type and extent of exclusive use by the research team must be defined and justified.
2.5 Data access statement
Peer-reviewed publications must include a data access statement. This must include sufficient information to allow others to understand how to access the underlying data and comply with the UKRI open access policy.
3. Data analysis
3.1 Intellectual property (IP)
IP relating to the use of data must be suitably protected and managed, in line with the UKRI knowledge exchange principles. Any delays or restrictions on data sharing due to managing IP must be minimised as far as possible.
3.2 Research outputs
In terms of research outputs, a limited and defined period of exclusive data use to realise the benefits of the research is reasonable. Details of this must be outlined in the data management plan.
3.3 Recognising contributions
The contributions of those who are involved in generating, collating, linking and analysing data should receive appropriate recognition. Therefore, adequate and permanent references (for example Contributor Roles Taxonomy (CRediT)) must be provided in publications to increase the visibility and recognition of all those involved.
4. Data sharing
4.1 Partnerships
MRC encourages researchers to work in productive, equitable partnerships, for example, with other research organisations, medical charities and industry. Data sharing involving commercial or non-UK based organisations must conform to the same principles and practices as the UK academic community, including UKRI trusted research and innovation principles.
4.2 Revenue generation
Unless otherwise approved by MRC, projects should not seek to generate revenue through data sharing, although cost-recovery for data sharing is acceptable.
4.3 The Five Safes framework
Where appropriate, projects must follow the principles and procedures of the Five Safes framework, which protects the confidentiality and rights of research participants and the security of datasets when shared.
4.4 Data access governance
Data access governance processes should be appropriate and proportionate to the nature and scale of the project, the level of risk and the likely demand for access.
4.5 Transparency
The criteria and processes governing data access should be transparent and readily discoverable. The principal stages and decisions should be clearly documented, along with effective mechanisms for enquiry and timely feedback.
4.6 Accountability
Data access processes should include accountable independent input, and this must be outlined in funding proposals and reviews. Additionally, MRC strongly encourages public involvement in the data access process.
4.7 Data sharing agreements
Data sharing must only proceed with an appropriate data sharing agreement. Data sharing agreements must follow recognised standards (for example the Information Commissioner’s Office).
4.8 Reporting to MRC
Data-sharing activities must be reported to MRC during a given period of funding. Data-sharing activities should also be made public via a data use register.
4.9 Acknowledging contributors
Acknowledgement of the significant contributions of all parties creating new value through data sharing should be promoted. Data providers must provide persistent identifiers (such as DOIs and ORCID iDs) that allow data to be appropriately cited, and data users must acknowledge data sources by using these citations.
4.10 Restrictions to sharing
MRC recognises that for legal, ethical or contractual reasons, some datasets cannot be shared beyond the primary research. When this is the case, the reasons for this should be made clear in funding proposals and reviews, and data access statements.
5. Archiving
Archiving of data must align with this policy and good research practice, and be adequately described in funding proposals and reviews.