If your research involves undertaking research on the premises of a NHS/HSC organisation, with NHS/HSC patients or with NHS/HSC staff, then you should always contact the local NHS/HSC R&D office as early as possible.
Contact details for NHS R&D offices are available on the NHS R&D Forum [external link] website.
Guidance on how to apply to conduct research in NHS/HSC organisations is provided in the relevant section below and is based on where the lead NHS/HSC R&D office is located.
Lead R&D office
The NHS organisation that employs or holds an honorary contract with the Chief Investigator will normally act as the Lead NHS R&D office for a project. Where the Chief Investigator is employed by a university, a suitable NHS organisation should be selected as the Lead NHS R&D office.
For non-commercial studies the Lead R&D office should be contacted prior to grant application, if the research involves NHS premises, NHS patients or NHS staff to advise on the practicality of running studies in the NHS. This is particularly important if the sponsor is not an NHS organisation as the Lead R&D office can ensure appropriate costing of grant applications, advise on study designs that are practicable in the NHS, and provide support with patient and public involvement.
For commercial studies the Lead R&D office should be contacted as early as possible to advise on managing the study in the NHS.
Project level review
For multi-centre studies with a lead R&D office in Wales or Scotland or Northern Ireland and single centre studies in Wales, the Chief Investigator (CI) or sponsor should send an R&D application to the relevant NHS/ HSC permissions coordinating function. For single centre studies in Scotland and Northern Ireland there is no separate project level review.
For studies with a lead R&D office in England, the CI or sponsor should submit an application for HRA Approval [internal link]. HRA Approval replaces the need for separate REC and R&D applications.
Cross-border studies in the UK
Compatible arrangements are in place for the coordinated handling of UK-wide studies (i.e. studies with sites in more than one UK nation), which streamline the review process by conducting a single review of all the aspects that are relevant to the whole project. The lead nation will undertake the UK-wide review and share the application and the outcome of the UK-wide review with the other participating nations.
Information should also be provided to each NHS/HSC participating organisation in accordance with the guidance provided by the relevant nation (see relevant section below).
Setting up NHS participating organisations in England
In parallel to the project level review, individual NHS participating organisations in England can be set up. The Chief Investigator or sponsor should ensure that local Principal Investigators and any other relevant staff, including the R&D office (and Local Clinical Research Network, where relevant) are provided with any necessary information and documentation they may need to set up the study and confirm the organisation’s agreement to participate in the study. There is no separate local R&D application, but it is vital that the R&D office is copied into the correspondence with the local research team, in order to ensure that the organisation can confirm that it has the capacity and capability to conduct the study. The set-up process follows standard steps [internal link].
You should note that one R&D office may provide services to a consortium or network of NHS organisations. For primary care, regional R&D support is provided.
Contact details for NHS R&D offices and the Local Clinical Research Networks are available on the NHS R&D Forum [external link] website.
Setting up participating organisations in the NHS in Scotland or Wales / HSC in Northern Ireland
Applications for NHS/HSC management permission are prepared in IRAS. An NHS Site Specific Information (SSI) form should be prepared in IRAS and transferred to the local research team for completion. The NHS/HSC SSI application should be submitted with supporting documents by email as instructed in IRAS.
Please note that it is the Chief Investigator or sponsor’s responsibility to ensure that Principal Investigators and local research teams have all the relevant study documents for their own use. If the Chief Investigator or sponsor submits all NHS/HSC SSI applications to R&D offices on behalf of the Principal Investigator, the R&D office is not responsible for supplying the study documents to local research teams.