Any research requiring the collaboration of the NHS requires a research sponsor. The research sponsor "...takes responsibility for the initiation, management and financing (or arranging the financing) of that trial" (Medicines for Human Use (Clinical Trials) Regulations 2004, Part 1, 3 (1)).
If you are uncertain as to whether or not your project should be classified as ‘research’, we can help to advise you. Alternatively, researchers are advised to use the following decision tools provided by the Health Research Authority (HRA):
Research requires formal confirmation from the designated sponsor before an application for Host Organisation, NHS Research Ethics Committee (REC) or Medicines and Healthcare products Regulatory Agency (MHRA) approval can be made, in some circumstances before applying for funding. The current process for obtaining approval for research is that all research conducted within the NHS in England requires approval from the Health Research Authority (HRA). For more information on applying for HRA approval, please visit the HRA website. Please contact our Research Governance Office if you have any queries regarding which approvals your project may require.
Applying for NHS Blood and Transplant (NHSBT) sponsorship
NHSBT's Research Governance Office will undertake the role of research sponsor where appropriate. An application for sponsorship must be made to the Research Governance Office, using the appropriate forms. If you are applying for sponsorship from within NHSBT, please use the following documents:
- FRM5208 – Risk Assessment for NHSBT R&D Sponsorship
- FRM5209 – Request for NHSBT R&D Sponsorship
- MPD1183 – NHSBT Research Sponsorship
If you are external to NHSBT, please email the Research Governance Office who will be able to advise you which documents are required, and guide you through the process.
For projects applying for sponsorship in advance of obtaining funding, the standard application process still applies. On approval of the Clinical Research Group or Directorate Senior Management Team (CDSMT), ‘Sponsorship in Principle’ will be granted, which will allow full sponsorship to be granted upon confirmation of funding.
The Research Governance Office works closely with the operational areas of NHSBT to ensure that all research undertaken is aligned as closely as possible with the wider strategy of the area of planned work. During the sponsorship application process, the relevant Strategy/CARE groups will be made aware of your proposal.
The final decision over sponsorship lies with the CDSMT, and all decisions will be communicated directly to the applicant by the Research Governance Office. Investigators must not formally identify NHSBT R&D as sponsor without the prior approval of CDSMT.
We advise that you make early contact with us if you have a proposal or project that you wish us to support, so that we can help to ensure that the process is as smooth as possible for you.
NHSBT sponsored research
Researchers are reminded of the conditions of sponsorship as stipulated within each Sponsorship Approval Letter. All NHS Research Ethics Committee (REC) approved projects are required to submit an Annual Progress Report to the REC that approved the research. It is a requirement of all NHSBT R&D sponsored research that the Research Governance Office receives a copy of this report.
If you have any queries about your NHSBT R&D sponsored research, please get in touch with us, we will be happy to assist you.