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Setting up a research study

The attached flowchart highlights the different stages in the research approval process.

Protocol

All research should be protocol driven. A protocol should include sufficient detail to inform all other information requirements and, if circumstances were to require it, enable someone previously unfamiliar with the study to continue from the point that another researcher has left it. Information sheets are available outlining the minimum dataset for a protocol.

A flowchart outlining departments and individuals  which should be consulted as part of protocol development is available. 

Sponsorship

All research conducted within the NHS is required to have a research sponsor. This is the organisation which takes responsibility for the quality and conduct of the research and is not the same as a funder.

Researchers should identify a sponsor at an early stage in the research planning process as the sponsor may have requirements related to the protocol to assure themselves of the quality of the study. Sponsors are also responsible for the scientific review of the study.

Funding

When applying for grant funding it is important that NHS costs are included in the application. Whilst grant funding may be paid into a university account arrangements must be put in place to refund the NHS any eligible costs.

Further information on what is an eligible cost is set out in the document AcoRD which can be found here. This document aims to clarify the distinction between research costs, NHS support costs and treatment costs in relation to activity specified in the research application/protocol; and to help attribution between the NHS and the external funder of: 1) patient-related activity; 2) clinical staffing; and 3) placebos and medicines

The document should be read in conjunction with the Guidance on funding excess treatment costs related to non-commercial research studies and applying for a subvention.

The Research Management Office has prepared additional information to assist researchers in preparing their grant applications. You can also look at this process map on how to apply for NIHR funding (open and press F5 for full view)

Plans should be discussed with the Research Management Office or Finance as early as possible.  A minimum of two weeks notice must be given prior to application deadline.

Study approval

Study approval includes those approvals needed for the study as a whole and will include REC approval and, where required, MHRA approval. For more information see Research Guidance Sheets on gaining local R&D approval and study wide approval.

Site approval

Site approval will include REC Site Specific Assessment, if required, and R&D approval. These will need to be gained independently for each site and is the responsibility of the Principal Investigator or Local Collaborator at the site to apply for approval. With the exception of postal surveys of staff, all research conducted at UH Bristol should have a Principal Investigator or Local Collaborator with a UH Bristol substantive or honorary contract. For single site research the Chief Investigator will usually also be the Principal Investigator.

More information is available on the study approval pages.