Researchers wishing to conduct research in the NHS (or Health and Social Care (HSC) in Northern Ireland) must have confirmation of management permission from each site for the study to begin. Without this management permission, indemnity cover cannot be assumed to be in place to cover the proposed research activity.
The process for obtaining confirmation of NHS/HSC management permission varies across the UK:
In England, the process changed on the 31st March 2016 when Health Research Authority (HRA) Approval became the route for applications to conduct research in the NHS. The HRA web pages describe the process for obtaining HRA Approval. For studies applying for support from the NIHR Clinical Research Network (CRN), the HRA will ensure that the NIHR CRN Coordinating Centre has access to information to allow it to make decisions on eligibility of the study for the NIHR CRN Portfolio.
If your project is led from Scotland, Wales or Northern Ireland and involves NHS/ HSC sites then you will not apply to the HRA. You should apply through the appropriate NHS/HSC permission process for that lead nation.
The Integrated Research Application System (IRAS) provides guidance on the completion and submission of the NHS R&D form and, where required, NHS SSI forms* for NHS organisations participating in the trial. For trials to be conducted across the UK, the NHS permission process should be initiated via the system that is in operation in the part of the UK where the Chief Investigator is located.
*From 31 March 2016, NHS Site Specific Information (SSI) forms are not required for NHS sites in England for projects seeking HRA Approval.
Non NHS Sites: Where studies do not involve the NHS (i.e. patients, their data, tissues or NHS resources) then application for NHS permission is not required. In addition, the investigator should be aware of any local policies relating to the gaining approval from their non-NHS sponsor/host organisation and requirements for non-NHS SSI Forms to be provided to the REC.
Patient Identification Centres (PICs): In England and Wales, PICs are organisations from which clinicians or clinical units refer potential participants to a research team based in another organisation, for assessment and possible recruitment to a study. The HRA web pages provide further information on PIC sites and the NIHR have produced PIC guidance. The Integrated Research Application System (IRAS) provides guidance on the arrangements for setting up PICs via the system that is in operation in the part of the UK where the PIC is based.
The Research Passport and Honorary Research Contracts: Researchers who have no contractual arrangements with NHS organisations hosting research and who want to carry out research in the NHS (that affects patient care or requires access to NHS facilities) may require a research passport. If the research only requires access to patient identifiable data and does not have a direct impact on quality of care, then only a Letter of Access may be required. To facilitate the process of obtaining Honorary Research Contracts or Letters of Access, the Research Passport scheme has been developed. Researchers should visit the NIHR research passport scheme for more information.