TASC support for researchers - sponsorship
Requirements for sponsorship in research.
Sponsorship is organised through Research Governance who conduct a risk assessment behalf of both the NHS Tayside and the University of Dundee and remain you primary Sponsor contact for the duration of your research.
What approvals may I need?
If your project is:
- to understand if a service is following best practice guidelines, or if the care is being delivered effectively
- to assess the effectiveness of a service or of an intervention already in place-
- to implement new practice with no research question
If your project is to derive generalizable new knowledge by addressing clearly defined research questions relevant to health and social care, by means of systematic and rigorous methods, this is classified as research. It is likely to require Sponsorship, ethical approve and potentially NHS R&D approvals.
Research Governance firstname.lastname@example.org are responsible for determining the appropriate approval pathway for projects and must be contacted if you are unclear.
What is Sponsorship?
The UK Policy Framework for Health and Social Care Research requires that all clinical research involving human participants, their organs, tissues or data must have an identified Sponsor who takes responsibility for the initiation, management and the financing of a clinical study. For Studies falling under the Medicines for Human Use (Clinical Trials) Regulations 2004, there are additional legal requirements that the Sponsor must be responsible for. It should be noted that a “Sponsor “is not the same as ‘Funder’.
A research project can be co-sponsored between two or more organisations, with the responsibilities delegated in a formal co-sponsorship agreement.
Here in Tayside, sponsorship may be accepted by NHS Tayside and/or the University of Dundee; and is organized through the Research Governance team, who represents both organisations. They review your study documents and conduct a risk assessment of your study to make sure any risks are identified and mitigated against. Further information on Sponsorship can be found in TASC’s SOPs.
It must not be assumed that the University of Dundee or NHS Tayside will sponsor your study until your project has been risk assessed and you have received confirmation on the Sponsorship arrangements for the study from the Research Governance Team.
Conditions of non-commercial sponsorship by NHS Tayside and / or the University of Dundee
- The substantive employer of the Chief Investigator is NHS-T or UoD, or if a student project, the awarding institute is UoD.
- The Protocol is written by the CI as part of their employment of the Sponsoring Institution.
- The Protocol is not written by a Commercial Company.
- Funding is in place.
- The funder may receive a summary of results at the end of the study but does not have access while live.
Applying for sponsorship
If you wish the University of Dundee and/or NHS Tayside to sponsor your study, you should contact the Research Governance Team as early as possible. Research Governance will offer advice where required on protocol development, therefore this early contact is advisable. It must be noted that Research Governance require a minimum of 3 weeks for all new study reviews.
Grant applications are authorised conditional on a favourable risk assessment and you must not assume that the University of Dundee and/or NHS Tayside will sponsor your study until your project has been reviewed and you have received formal confirmation of Sponsorship and approval to apply to the REC and R&D. Other approvals may be required depending on study type.
The Sponsor remains responsible for the research project from date of Confirmation of Sponsorship until end of archiving period and subsequent destruction of files.
The Research Governance team must review and approve be made aware of any changes requested to the documents approved by the REC, MHRA, R&D or other and be forwarded all updated or new versions of any documents. The research governance team can be contacted on email@example.com.
Further information on Sponsorship can be found in SOP RG028 (Clinical Trials) and SOP RG029 (Non-Clinical Research).
Essential documents required for sponsorship
Project essential documents
Essential documents include but are not limited to:
- Protocol and all participant fronted documents such as Participant information and Informed consent forms
- IRAS Forms (submitted to Sponsor as full dataset PDF document)
- Grant award letter or other confirmation of funding
- CV and GCP certificate of Chief Investigator
- Investigator Brochure or SMPC for studies involving drugs
IRAS – The Integrated Research Application System
The Integrated Research Application System (IRAS) Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK.
The system enables you to enter the information about your project once instead of duplicating information in separate application forms; uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently to the permissions and approvals required; and helps you to meet regulatory and governance requirements. All applications for NHS REC and NHS R&D approvals must go through this system.