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 'Attributing revenue costs of externally funded
non-commercial research in the NHS (ARCO)'. 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 ARCO 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.
