The approval process | Sponsorship arrangements for research
The Research Governance Framework for Health and Social Care states that all research projects must have an identified sponsor. The sponsor is the organisation which acts as guarantor for the research, ensuring it complies with standards of good practice. Critically, if an organisation is to act as a sponsor, it must have
Any organisation which funds, initiates, hosts research or employs staff involved in research can be a sponsor. Locally, the Trust, QMUL and City University have all indicated their willingness to act as a sponsor.
Because of the nature of the responsibilities of a sponsor, even though it is technically possible for an individual to act in this capacity, they would be extremely ill advised to do so. Researchers should note that neither the Trust nor QMUL will indemnify research where the Principal or Chief Investigator of a study is named in the NRES form (question A59) as the sponsor.
In general, you should follow the following order – funder, employer, research host. Whichever organisation agrees, you need a letter from them confirming that they will be a sponsor. You should keep a copy of this as it is an essential document for demonstrating you have exercised due diligence.
1. Check with the funding body whether they are willing to be the sponsor.
Commercial companies should sponsor all the clinical trials taking place within the Trust. However, many charities and public bodies are reluctant to act as sponsor either because of the volume of research they support or their limited infrastructure.
2. Approach the principal employing body for the research part of your contract.
For NHS staff conducting research the Trust will be the Sponsor.
Clinical academics should approach the university they have a contract of employment with. If the university does not agree the Trust may act as sponsor provided
3. Students should contact their university
All student research must be sponsored by the university the student is registered with. Also, if the research involves Trust staff or patients, access must be agreed by the appropriate Trust department.
4. Multi-centre Research
The position on multi-centre research is less clear as few organisations are in a position to fulfil sponsor responsibilities across a number of locations. As a first step we would recommend you approach the funder, then, if they are unable to sponsor the study, the Co-ordinating Centre for the study. If these routes are unsuccessful the Trust may act as overall sponsor, but formally delegate sponsor’s responsibilities to the non-Trust sites. In order to do this we would need full details of all the sites participating in the research.
When you are preparing your ethics application please send the following documents to the Joint Research Management Office:
You will be asked to complete and sign a form which accepts the terms of Trust or QMUL sponsorship and return it to the JRMD by fax, post or as an email attachment.
The JRMO will issue a Sponsorship Letter which you should keep in your project files. Again, this helps to demonstrate that you are following governance procedures.