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National Health Service Research Ethics Committee Submissions –
Involvement of Newcastle University
Projects involving the NHS where the University is asked to act as ‘Sponsor’ or be involved as a ‘nonNHS site’.
Where the University is asked to act as a ‘sponsor’ for a Research project (as defined as by the
Research Governance Framework for Health and Social Care - Department of Health 2001
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/D
H_4108962), it is important to recognise that the institution is taking responsibility for the overall
governance, monitoring and management of the Research and the associated behaviour of all the
research staff involved in the project (including those outside of the University). Whilst wanting to
limit duplication and administration, it is important that we are satisfied that we can discharge our
responsibilities therefore it is important that the institution grants formal approval – therefore
please see below for scenarios and appropriate processes.
Process where the University is asked to act as Research Sponsor – Decision Tree
Yes
Is the University
being asked to
act as Research
Sponsor?
No
An NHS Research Ethics
Committee (REC) opinion is
required – the Sponsor must
sign the submission to REC &
also the University insurance
team must be notified in
advance of submission
The protocol/draft REC submission should
be sent to the Research & Innovation Office
(Lois Neal) together with the attached
completed form (page 3). The
documentation will be reviewed and a
recommendation made to the Dean of
Research & Innovation /Chair of FMS Ethics
Committee for consideration or further
escalation the Faculty Ethics Committee.
Yes
Is the University being
identified specifically as
a non-NHS site in a
project being submitted
to an NHS REC from
another organisation?
No
Proposal should
be put through
the University’s
Preliminary
Ethics procedure
and escalated as
needed
Scenario One: The University will be acting as Sponsor. E.g. the Project will be sponsored by the
University but will involve patients so will go through NHS REC process to secure an opinion
The opinion of an NHS Research Ethics Committee (REC) will always supersede any other ethical
review system and, consequently, will be entirely sufficient for the University to approve a research
project.
To allow the REC submission to go forward, please complete the form below and send together with
the protocol and draft REC submission to the Research & Innovation Office (FAO Lois Neal) for
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review. Once ‘other organisation’ approval has been given you will need to fill in Newcastle’s’
preliminary ethical form, noting ethical approval has been obtained inc. Organisation and reference
number.
Scenario Two: The University will not be acting as Sponsor, but has been identified as a non-NHS
site. E.g. the Project will be sponsored by an NHS organisation or other Academic Institution but
involve Newcastle Staff and has therefore been identified as a non-NHS research site
In these cases the University will be identified as a non-NHS site and a specific ‘site submission
information’ (SSI) form will be generated as part of the REC application process. To allow for the
non-NHS SSI to be submitted to the REC, the academic should complete the form below and send,
together with the protocol and draft SSI form to the Research & Innovation office (FAO Lois Neal) for
review.
Scenario Three: The University will be acting as sponsor & the project will go through its ethical
approval. E.g. Newcastle University led Project.
This project has to go through the Preliminary Ethical process completing all sections. There is no
need to complete the form below.
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Request to Newcastle University to act as Research Project Sponsor or is
being identified specifically as a non-NHS site in an NHS REC submission
Funding Scheme
Lead Applicant / Project PI
Project Title
Sponsor
Proposed Start Date
Proposed Duration
Project fEC
Grant Applied for (£)
Application Submission Date
Date this form submitted to Joint
Research Office.
Section One: Proposed Project Overview
Please include a short synopsis of the aims and methods (Max 750 Words)
Section Two: Issues affecting decision for University to act as Sponsor (if required)
Please flag up any potential issues involved in the University acting as sponsor (Max 750 Words)
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Section Three: Issues affecting decision for University to be identified as a non-NHS site (if required)
Please flag up any potential issues involved if the University is to be identified as a non-NHS site as
part of an NHS REC submission sponsored from elsewhere (Max 750 Words)
Section Four: Sign off (For Office Use only)
Research Office Recommendation
Please include comments and recommendations
Faculty Approval on Behalf of Institution / Institutional Approval
Please include confirmation of sign off or decision to escalate to
Faculty Ethical Committee.
Please submit via email to Lois Neal (lois.neal@ncl.ac.uk)
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