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 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. We are committed to support open access to research data, 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 Research
• NIHR Open Access policy
• NIHR guidance on Intellectual Property
• NIHR Policy on Clinical Trial Registration and Disclosure of Results

Scope

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 openaccess@nihr.ac.uk in the first instance.

Sharing Research Data

To enable research data to be discoverable, and effectively and ethically re-used, we encourage researchers' data to be deposited in an appropriate repository where possible. However, the minimum requirements for the research teams are outlined below with respect to data arising from research that is within the scope described above.

• Data sharing statements must be included when publishing the findings of the research describing how to access the underpinning research data.
• Data management and access plans (DAMPs) are required for appropriate funded studies across all NIHR funding programmes contracted from 1 July 2023. To minimise researcher burden these are completed during the startup of the research and will be made available on the NIHR Funding and Awards website. We will monitor the submission and implementation of these plans through the usual programme progress and reporting mechanisms. This requirement aligns with UKRI guidance and HRA requirements for ethical approval, and HRA submissions may be used in substitution.

The management of data generated by NIHR funded research will remain the responsibility of the "Contractor" (the organisation that has been contracted to perform research by the Department of Health and Social Care). 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 agreed use and appropriate management of the research data to be shared. Studies shall promote appropriate acknowledgement of the significant contributions of all parties to creating new value through data-sharing, including 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.

Prior to publishing, appropriate measures must be in place to ensure that Foreground IP, Arising Know How and Research Data are adequately protected. This includes, but is not limited to, applying for registration of Intellectual Property and ensuring that the proposed publication does not contain any commercially sensitive information.

Escalation procedure

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 or Scheme that funded the original study that generated the data being sought. For details of the coordinating centres please contact us at openaccess@nihr.ac.uk 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.

Review

We are committed to continuous improvement of research openness and transparency. As such, we will review our position on the sharing of research data regularly and as appropriate.  The last review and update of this page was completed in September 2024.

For any comments or queries please contact openaccess@nihr.ac.uk