NIHR position on the sharing of research data
This statement sets out the NIHR’s current position on the sharing of data produced during research funded by NIHR under its standard research contract terms and conditions. The position is in line with the UK Policy Framework for Health and Social Care Research.
The NIHR strongly supports the sharing of data in the most appropriate way, to help deliver research that maximises benefits to patients and the wider public, the health and care system and which contributes to economic growth in the UK.
The NIHR recognises that the sharing of research data must: protect the confidentiality and privacy of individuals; respect the terms of consent by individuals who are involved in research; be consistent with relevant legal, ethical and regulatory frameworks; and guard against unreasonable costs.
It should also be noted that the NIHR promotes openness and transparency in research through a number of its policies, guidance and platforms, including those listed below:
- NIHR Adding Value in Research framework
- NIHR Open Data
- NIHR Journals Library
- NIHR Open Access policy
- NIHR guidance on Intellectual Property
This statement applies to research studies where all of the research costs (as defined by AcoRD) are funded by the NIHR. This includes studies in receipt of research costs through any NIHR scheme (e.g. NIHR Academy, programmes, infrastructure, etc).
Any queries about the scope and application of this statement should be submitted to the relevant NIHR Coordinating Centre in the first instance.
Sharing Research Data
To enable research data to be discoverable and effectively re-used by the scientific community, researchers are required to take the actions outlined below with respect to data arising from research that is within the scope described above.
- Provide to NIHR a data management and access plan, which must be published (for example through a trial registry, the NIHR Funding and Awards website or a study website). NIHR will monitor the submission and implementation of data management and access plans.
- Include information on how to access the data, through a data sharing statement, when publishing the findings of the research.
The data generated by NIHR-funded research will remain the responsibility of the organisation that has been contracted to perform research by the Department of Health and Social Care (“the contractor”). The data must be managed as specified in the research contract.
All requests for data should be directed to the contractor and managed by the contractor, in accordance with the relevant data sharing statement.
Data access requests from a third party should be managed following the relevant policies and practices of the institution hosting the research. These are expected to be transparent, robust, fair and demonstrate that appropriate mechanisms are in place to provide assurances as to the integrity of the research data.
Release of data will be subject to a data use agreement between the contractor and the third party requesting the data.
The data use agreement must detail the agreed use and appropriate management of the research data to be shared and include a requirement for recognition of the contribution of the researchers who generated the data and the original funder.
The contractor’s policy and procedures for data access must include a dispute resolution process to resolve situations where the contractor and a third party requesting data disagree about data access.
In exceptional circumstances, where data are not shared in accordance with NIHR’s expectations, including the failure of a contractor’s dispute resolution process to adequately address a data access issue, the matter should be raised with NIHR.
Any complaint will initially be dealt with by the NIHR Coordinating Centre secretariat for the programme that funded the original study that generated the data being sought. For details of the coordinating centres please contact us. The Coordinating Centre team will escalate issues to ensure that they are dealt with in a consistent way across NIHR. Ultimately, if resolution cannot be achieved, the Department of Health and Social Care will decide whether it has a reason to use its contractual rights under the NIHR research contract.
NIHR is committed to continuous improvement in the field of research openness and transparency. As such, this position will be kept under review at least annually, with the results of the next review due on or before 20 May 2020.