Data-sharing agreements
Requirements
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.
Expectations
1. The data-sharing agreement specifies the following:
- The parties to whom data are released. Both the (bona-fide) researchers and their institutions should be specified with precision.
- The specification of the dataset(s) to be prepared and released, and/or the analyses to be run securely on behalf of the requester.
- The purposes for which data are released or analysed (annexing a copy of the research protocol for the new use).
- The conditions under which the data may be used, particularly in relation to ethics committee approvals.
- The specific obligations and arrangements to maintain confidentiality and data security.
- The handling of intellectual property, publication, authorship, acknowledgement and whether data are provided on an “exclusive” or “non-exclusive” basis to the requester.
- Any constraints on publication related to the study’s privileged use of its data or to manage specified risks.
- A requirement that research publications and other outputs based on the transferred data (or analyses conducted by the study on the new users' behalf) are reported to the study.
- A requirement for the study and MRC to be appropriately acknowledged in publications and other outputs.
- Other requirements in relation to preventing or controlling onward transfer of the data (or the data derived thereof by the requester) to a third-party, and for conferring to third parties the appropriate obligations for custodianship, use and reporting).
- A requirement to notify the study systematically of all research publications based on the use of the study data, and similarly other information needed to allow the study to report on its data-sharing performance and outputs (see Section 11).
- Whether a copy of data derived by the requester must be made available to the study, possibly after a reasonable delay (i.e. a period of exclusive use by the external user). It may be stipulated that the derived data are to be retained by the external user.
- Individual roles and responsibilities in relation to supporting the agreement, including arrangements for ongoing support from the study to facilitate use of the data.
- Arrangements for data destruction or secure archiving.
- Any costs that need to be contributed by the requester
2. The agreement reflects the nature of the relationship between the study and the new user, which can range from direct provision of data, data analysis collaboration and/or scientific collaboration.
3. Roles and responsibilities are appropriately allocated. IPR, recognition (authorship and acknowledgement) and other benefits are distributed according to the specific contributions of the individuals and organisations involved.
4. The agreement is signed by authorised organisational representatives from both parties. Organisations who have signed the data-sharing agreement ensure that users of shared study data fulfil the obligations stipulated in it.
Further good practice
Data-sharing Agreements may also specify the following:
1. A time period for which the approval has been granted
2. Whether the external researchers should report progress.
3. How the originally supplied datasets, subsequently derived data and analysis files should be managed, in accordance with ethics committee stipulations and in proportion to the confidentiality risks.
4. An obligation on data recipients to commit to and apply security and confidentiality measures to the study data they receive (and derive from the data) that are equivalent to those under which the source dataset are held; and informing a study of any incidents of breach or unauthorised disclosure.
5. The research endpoint that should trigger secure archiving and/or destruction of data.
6. A requirement for the requester to provide the study with evidence of their security and of data destruction policies.
7. An obligation to delete the records of any participant who has withdrawn from a study if they are identifiable.
8. Whether pre-publication permission is required from the study and the scope of any constraints on publication, e.g. a limited publication moratorium to allow the study to publish the results of the funder approved programme. Agreements should specify a rapid-response mechanism for pre-publication approvals.
9. The criteria on which study team members, including study data managers, informaticians and statisticians, should be included as co-authors, or otherwise recognised, in publications and other outputs derived from the study data.
10. A requirement that publication is consistent with the RCUK position statement on Open Access.
11. Agreements should include any constraints and licensing requirements specified by the funder or organisation with custodianship of the data.
Different data sharing agreements may be needed for different types of data, e.g. for anonymised versus disclosive data.
Resources
- Example data-sharing agreements are available via the Regional Contracts Manager at MRC Regional Centres.
- Open Data Commons has a set of tools to enable provision and use of ‘open data,’ suitable perhaps for summary data tables of ‘unrestricted availability
- The NCRI has created templates for access policy development, which includes a template Data and Material Transfer Agreement
- The Digital Curation Centre has guidance on How to License Research Data.