The Research Governance Team is committed to supporting the research community at every stage of the research. The review process is designed to ensure that the University can meet its responsibilities as Sponsor in relation to the project, and to provide assurance about the quality, safety and integrity of the research. Therefore early contact, ideally prior to grant submission, is crucial to ensure that the University of Birmingham can Sponsor the project.
Please see our criteria for Sponsorship and the UoB definition of clinical research for general information at the pre-award stage.
In most cases you will need to apply for Sponsorship once you have received confirmation that your project has been funded. However, it is essential that you contact the Research Governance Team prior to applying for grants if you are hoping for the University of Birmingham to Sponsor projects involving any of the following:
- Clinical research in countries outside the U.K., particularly clinical trials.
- Research on conception or obstetrics.
- Research involving the administration of drugs.
- Trials of a novel intervention or 'first-in-human' trials.
- Research involving children under 5 years old.
- Research involving the use of surgery (other than biopsy).
- Genetic engineering.
- Anything else which may raise issues around insurance and management of the research (e.g. investigating non-CE marked devices involving patients).
One of the most important reasons it is important to contact the Research Governance team early if your research involves any of the above is insurance. If your project includes any of the activities listed above, the Research Governance team will need some further information in order to liaise with insurers (a process sometimes known as 'referral') to either confirm that the study can be included in the standard UoB portfolio insurance, or if not, to discuss the insurance implications and any bespoke policy arrangements which may be needed.
In such cases, when you contact the Research Governance team to discuss your project, please include a completed copy of this questionnaire to help streamline the referral process.
For CTU-supported studies there may be additional processes alongside the above, as well as alternative documents which may need to be used. Please refer to CTU internal QMS guidance.
The UoB trials Insurance and Liabilities process document describes the process for securing insurance where your trial falls outside of the University’s standard arrangements (currently being updated - please contact us if details are required in the meantime). Usually this is because the research falls into one of the above categories. The document also describes the standard arrangements and cover in place for various liabilities.
Please see our how to apply for University Sponsorship page.