Data sharing requirements for population and patient studies
The following 21 requirements are mandatory for MRC-funded cohort studies and are likely to be readily applicable to MRC population and patient-based research more broadly. More detail about each of the requirements can be found by clicking on the relevant topic heading (for requirement R1, further detail is accessed by clicking “Data Standards”). Each topical section details:
- Requirements: mandatory principles for MRC funded population and patient cohort studies (and likely to be applicable to MRC research more broadly)
- Expectations: the kind of evidence MRC is looking for in assessing compliance with this policy
- Further good practice: recommendations for additional data sharing measures
- Resources: authoritative and relevant information
The ‘In practice’ page illustrates how certain topical aspects can be put into practice. Studies should use their best judgement, authoritative good practice and advice in adapting the expectations to their particular circumstances.
Data standards
R1. Studies must take an active and collaborative approach to ensuring timely development and adoption of appropriate data standards to support high quality research and data-sharing.
Study policy on sharing
R2. A simple study policy on data-sharing must be readily discoverable by the research community on the study website, in a manner sensitive to the interests of participants. The study policy must be consistent with MRC’s overarching policy on data-sharing and preservation.
R3. The priorities and criteria for sharing and access, and the various constraints, must be transparent and clearly justified. The type and extent of privileged use by the study team must be clearly defined and justified in relation to the funder-approved research programme.
R4. When designing the study and seeking participants’ consent and ethics approval, the Director should aim to promote the widest range of possible good uses of the data and seek to establish broad and enduring consent for data-sharing.
R5. The study must have robust policies for managing confidentiality and for data security, consistent with legal, good practice and MRC policy requirements.
R6. MRC encourages researchers to work in productive, equitable partnerships, e.g. with medical charities and industry. Sharing involving commercial or non-UK based organisations must conform to the same principles and practices as that required of the academic community.
R7. Directors/PIs must ensure that intellectual property relating to the value they create is suitably protected and managed, in line with RCUK Knowledge Exchange Principles. Any delays or restrictions on sharing due to managing IP must be minimised as far as possible.
The governance of data access
R8. Study governance of access, the criteria and processes, must be appropriate and proportionate to the nature and scale of the study, the level of risk and the likely demand for access.
R9. The access process must include independent advice and/or oversight.
R10. Directors shall ensure that the criteria and processes governing access are transparent and readily discoverable.
Facilitation
R11. The principal stages and decisions in providing access and facilitating use are clearly documented, and the mechanisms for informal enquiry and timely feedback are effective.
Data-sharing agreements
R12. Directors/PIs shall ensure that a data-sharing agreement is issued and signed by appropriate authorities before data are released or analyses are performed on behalf of the requester.
R13. Data-sharing agreements must prohibit any attempt to (a) identify study participants from the released data or otherwise breach confidentiality, (b) make unapproved contact with study participants.
Data preparation and transfer
R14. Directors / PIs shall ensure that measures are in place to protect the confidentiality of study participants and the security of data sets when they are shared with, or analysed on behalf of, new users, and that practice complies with legal and regulatory requirements, MRC policies and relevant best practice.
R15. Studies must ensure that metadata documentation, a metadata catalogue or personnel with relevant knowledge and expertise can support the reasonable understanding and use of study datasets by new and external researchers.
R16. Studies must document data transfers and ensure that the data and accompanying documentation (metadata) are prepared to the agreed standards.
Funding
R17. Funding proposals to MRC should differentiate in broad terms between the proposed costs of (i) collecting and cleaning new data and the associated cohort costs; (ii) the study team’s proposed research programme; (iii) ongoing data curation and preservation; (iv) data-sharing.
R18. Unless otherwise approved by MRC, studies should not seek to generate revenue through sharing.
Recognition
R19. Studies shall promote appropriate acknowledgement of the significant contributions of all parties to creating new value through data-sharing.
Reporting
R20. Directors / PIs must be able to report to MRC as a funder on the performance and outputs of sharing achieved during a given period of funding.
Discovery of MRC-funded studies
R21. An MRC study that is collecting data (or has collected data) must be readily discoverable by the research community for the purposes of new research, and presented in a manner that is sensitive to the interests and continued support of the cohort participants.
