According to the Research Governance Framework (2005) a sponsor is defined as ‘the individual, organisation or group taking responsibility for securing arrangements to initiate manage and finance a study’.
All studies being undertaken within the NHS must identify a sponsor.
Sponsors may be:
- Universities/Higher Education Institutions
- NHS Trusts
- Other NHS organisations
- Commercial organisations
A group of individuals may take on sponsorship responsibilities and distribute them by agreement among members of the group provided that they collectively make arrangement to allocate all the responsibilities.
Bradford District Care Foundation Trust (BDCFT) will undertake sponsorship for non-CTIMP (Clinical Trials of Investigational Medicinal Products, aka. drug trials) studies on a case by case basis. The investigator seeking sponsorship must be a Trust employee or hold an honorary contract with BDCFT.
- Prior to a sponsorship request the researcher must ensure:
- They have a substantive or honorary contract with BDCFT
- The definition of study is confirmed : evaluation/research/audit:
For further information: http://www.hra.nhs.uk/documents/2013/10/differentiating-audit-service-evaluation-and-research-version-1-1.pdf
- The type of study is within the Trust areas of research interest: See our Research Strategy: Available here XXXXXX
- That they have presented your project to the Heads/Managers of Service and have obtained evidence of approval (in principle)
- Obtain the following reviews for your project/proposals/protocol:
a. Independent academic/clinical review (to be undertaken by suitably qualified individual, other than members of the research team) to ensure quality of study – Scientific Review form available in here
b. Public Patient (PP) review: Local contact: PPI RAG Angela Ross PPI R&D Lead. INVOLVE: Information available: http://www.invo.org.uk/about-involve/how-we-work-with-others/
- Ensure appropriate costings have been undertaken and confirmed by BDCFT R&D Finance Manager (this should be part of your protocol).
- Ensure funding is in place: Agreed by R&D Finance Manager and commissioning services, if excess treatment and support costs are required see link: https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research
The Local R&D Finance Manager: Sarah.Dickenson@bdct.nhs.uk
- The arrangements describesd in the IRAS and grant application forms meets the Trust policies
2. Complete the Request BDCFT Sponsorship Form 4 weeks prior to IRAS submission and forward to the Research Governance Office at firstname.lastname@example.org along with the protocol, your CV, Scientific and PPI reviews.
Please note that you must obtain Research Ethics Committee (REC) approval (If required) and Trust Confirmation of capacity and Capability prior to starting any research on BDCFT site, involving BDCFT staff, or patients, service users of carers thereof, recruited by virtue of their current relationship with BDCFT.
For guidance to obtaining Trust and ethical approval please see accompanying documents and guidance below
Available from the Research Governance office: email@example.com
- Trust R&D Strategy XXXXX
- R&D Registration and NHS Permissions Approval Procedure XXXXX
- NIHR RSS framework checks XXXXX
For students following courses at Higher Education Institutions (HEI), it is usual for those HEIs to take on the role of sponsor, as described in the UK Policy Framework for Health and Social Care Research XXXXXX
There is expectation that HEIs will therefore fulfill this role, and Sponsorship will only be granted by the Trust in exceptional circumstances