Clinical trials conducted on the premises of an NHS organisation, with NHS patients or with NHS staff, require permission from the local NHS R&D office. Coordinated systems for NHS R&D review are in place across the UK. The system available will depend on where the lead NHS R&D office is based (the part of the UK where the Chief Investigator is located).
- Since March 2016, HRA Approval has been the process for applying for approvals for all project-based research in the NHS led from England. In April 2018 this has been extended to include all project-based research in the NHS in Wales, and HRA Approval is now referred to as ‘HRA and HCRW Approval’. The HRA Web Pages contain detailed guidance on the application process and the HCRW website contains further information relating to site set up in Wales.
- Researchers wishing to conduct research in the NHS in Scotland (or Health and Social Care (HSC) in Northern Ireland) must obtain ‘NHS (or HSC) management permission’ (also referred to as ‘R&D approval’ or ‘R&D permission’) for each NHS/HSC research site.
Further information on cross-border research within the UK can be found on the Four Nations NHS/HSC Compatibility Programme.
The Integrated Research Application System (IRAS) provides guidance on the completion and submission of applications to all countries in the UK.
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): 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 NIHR have produced PIC guidance and 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.