Sponsorship is when a Sponsor, normally an organisation, takes responsibility for a number of different aspects of the research.
For studies defined by the UK Policy Framework for Health and Social Care, sponsorship includes:
- Assessing the quality of the research (through peer review);
- Ensuring that the researcher(s) has the skills, knowledge and expertise to undertake the research;
- Ensuring that the research team can access the resources and support to deliver the research;
- Having in place any necessary agreements for the management and monitoring of research (co–sponsorship framework agreement);
- Ensuring that arrangements are in place to review significant developments, particularly those which put the safety of individuals at risk, and to approve modifications to the research.
If your study is defined as a Category B, C or D you must apply to the Research Governance Team for sponsorship for it, and the documents listed below should be submitted for review:
- Protocol, to include:
- Participant Information Sheet (on appropriate headed paper);
- Consent form (on appropriate headed paper);
- Questionnaires and/or semi-structured interview questions;
- Other data collection tools, as relevant;
- Peer Review comments and the researchers responses (if required Please see Peer Review section below);
- CVs for researchers involved these must be dated (and signed for CTIMPs only);
- Evidence of appropriate training, e.g. Good Clinical Practice Certificates;
- Copy of Integrated Research Application System (IRAS) form.
- You will also need to contact the information compliance unit for advice regarding a Privacy Notice. If they advise that one is required this will also need to be submitted with the project documents before the project can be reviewed. You can contact the information compliance unit at: firstname.lastname@example.org
For clinical trials of investigational medicinal products or clinical investigation of a medical device these must be reviewed by the Clinical Trial Sponsorship Group. Please contact email@example.com to arrange for your study to be considered by them.
All projects must be subjected to independent peer review as a first step within the governance process. This is to ensure that the project is viable, scientifically valid and the methodology well-considered for the delivery of the study.
How many peer reviewers do I need?
If you have received funding from a recognised and rigorous panel you would not normally be asked for a further peer review, though this can be the case in exceptional circumstances. However, if your research has not been subject to robust external peer review, the following applies:
|Project Type||Peer Review Requirements|
|Undergraduate/taught Postgraduate||It is recommended that one member of University academic staff, (not supervising the project) undertakes peer review; however, this is not mandatory.|
|Research student (PhD, MPhil, MD)||Two members of University academic staff.|
|University Staff – University Research Sponsor||Two reviewers (can be external to the University).|
|University Staff – University/Trust Research Co–sponsor||Two reviewers, preferably one appointed by each organisation, but both could be appointed by either the University or Trust.|
|University Staff – Trust Research Sponsor||Two reviewers appointed by the Trust (can be University staff or external).|
Peer Review Forms
There are two standard forms available. The basic application for peer review form (Gov 1) should be completed for studies seeking ethical approval from a School Research Ethics Committee (SREC). Where the peer reviewer wishes to provide more detailed guidance, the full application for peer review form can be used (Gov 4).
- Basic application for peer review form (Gov 1) (doc)
- Full Application for Peer Review Form (Gov 4) (doc)
For studies that require ethical approval from ORECNI or an equivalent NHS REC, a full application for peer review form (Gov 4) will need to be completed.
Will the Trust accept the peer reviews?
It has been agreed with the Trust that they will accept our satisfactory peer reviews, when QUB is the lead sponsor; and vice–versa, we will accept theirs.
Health and Social Care Research / Trusts
All research involving patients and/or clients of Health and Social Care Trusts must be considered by the Office for Research Ethics Committees Northern Ireland. Therefore, you will need to ensure that either the University and/or the Trust agree to act as sponsor for the study and submit the relevant documentation.
Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will have to complete a UK Local Information Pack as part of the NHS/HSC Trust governance processes. The Local Information Pack replaces the Site Specific Information (SSI) form, which was used in Northern Ireland and Scotland and the Statement of Activities that was used in England and Wales. You can find out more information here.
Health and Social Care Trusts – Guidance & Contact Details
Where your study involves patients, clients, staff or HSC premises, then you must seek Trust Research & Development approval.
When conducting research in a Trust, ensure that you identify and gain the support of a Principal Investigator/local collaborator at an early stage in the process. Additionally, consider the resources – staff time, equipment, an interview room, any consumables that you will require for the completion of your study. These will be reflected in your Schedule of Events, which forms part of the Local Information Pack.
For further information and guidance on HSC Trust Permissions please examine the HSC Trust Research Governance Permission – Guidance for Applicants.
For more HSC Trust information please see:
A HSC R&D Application Gateway has been established to support applicants wishing to gain HSC Research Governance Permission for multi-centre research studies. Detailed information and guidance can be found in the HSC Trust Research Governance Permission – Guidance for Applicants.
The Gateway co-ordinates the process of gaining Research Governance Permissions for multi-centre studies with the five Trust R&D Offices in Northern Ireland. The Gateway does not give HSC Research Governance Permission for a research study. Its role is to facilitate and support the process in a coordinated and streamlined approach by working in partnership with the relevant HSC Trusts, to ensure that multi-centre research applications are managed efficiently.
For further information on the HSC R&D Application Gateway please contact:
HSC R&D Application Gateway (Northern Ireland), C-TRIC, Altnagelvin Area Hospital, Glenshane Road, Londonderry BT47 6SB
Tel: 028 71 611126
Participant Identification Centres (PICS)
Guidance, information and exemplars of PICS can be found in the Participant Identification Centres (PICS) leaflet.
If a PIC site, a Local Information Pack is not required and Model Non-Commercial PIC Agreement (m-NC-PICA) should be used
Northern Ireland Honest Broker Service (HBS)
The aims of the Honest Broker Service are:
- To ensure good Information Governance and provide data in line with Data Protection, Confidentiality Requirements and the Information Commissioners Office Codes of Practice. The Honest Broker Governance Board will oversee ethically approved research applications.
- To enable anonymised data to be shared within HSC to maximise the uses and health service benefits which can be gained from it including informing planning, commissioning of services and public health monitoring.