Research Sponsorship at the University of Birmingham

Research involving NHS staff or patients or Social Care clients requires a number of different approvals and can take a number of months to initiate.

Details of the roles and responsibilities of researchers, sponsor and the sites involved in research are detailed in the UK Policy Framework for Health and Social Research.

Study Registration and Sponsorship of research

If you are a University of Birmingham researcher or student, with an appropriate research project then your study would need to be logged on the Research Governance database. An RG number is generated when the study has been logged on the database, following completion of the self assessment form.

If the study has been designed and will be managed by the University and requires research sponsorship under the UK Policy Framework for Health and Social Research then the University of Birmingham will Sponsor your project. This includes studies:

That involve NHS staff, patients, their carers or their data
That involve social care and their clients (adults only)
That involve human tissues
That involve healthcare research in prisoners
That involves adults lacking capacity

The Research Governance Team will undertake a Sponsor review to ensure that the University can meet its responsibilities as Sponsor in relation to the project and to support you in submitting documents that ethics committees and regulatory bodies will accept.

Research approvals and permissions

As soon as Sponsorship is agreed, you will be able to apply for the range of other approvals that may apply to your research.

Many of these are accessed through IRAS (the ‘Integrated Research Application System’) and you will need a Sponsor authorisation on your form in order to apply for the appropriate approval.

For research involving NHS patients, service users or their families, you will require:

Favourable Ethical Opinion from the Research Ethics Service as an element of the Health Research Authority Processes (application through IRAS)
Confirmation of ‘Capacity and Capability’ from any research sites that you will be using.

For Clinical Trials of Investigatory Medicinal Products (CTIMPS) and trials of non-CE marked devices:

Medicines and Healthcare Regulatory Agency approval (application through IRAS).

Please note researchers that lead projects classified as CTIMPs will be required to work in close collaboration with a UK Clinical Research Collaboration registered Clinical Trials Unit at the University of Birmingham.

When to contact the Research Governance Team

Pre-award

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 office prior to applying for grants if you are hoping for the University of Birmingham to accept Sponsorship of any of the following projects:

Clinical research in countries outside the UK, particularly clinical trials (for definition of clinical research please see online)
Research on conception or obstetrics
Research involving the administration of drugs
Trials of a novel intervention or ‘first in man’ trials
Research involving children under 5
Research involving the use of surgery (other than biopsy)
Genetic Engineering
Anything else that may raise issue around insurance and management of the research (e.g. investigating non CE marked devices involving patients)

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, to provide assurance about the quality, safety and integrity of the research and early contact, prior to grant submission, is crucial to ensure University of Birmingham can Sponsor the project.

Our criteria for Sponsorship are listed here.

Post award

Please see our how to apply for University sponsorship page.

People to contact early

The University of Birmingham has considerable expertise in clinical research and excellent facilities to support research. In addition to the Research Governance Team, colleagues who can provide support for your research include:

The Research Design Service: this NIHR funded service offers help in developing research grant applications at the initial stages of project design.

The NIHR Clinical Research Network Study Support Service (CRN): CRN colleagues will help with identifying sites and clinicians with specific expertise required for your research as well as calculating the NHS costs for projects (according to the AcoRD guidelines). The CRN team will also be able to assist with the preparation of the UK Local Information Pack for commercial and non-commercial research. They can be contacted here: studysupport.crnwestmidlands@nihr.ac.uk

Clinical Research Compliance Team (CRCT): CRCT manage the University’s Quality Management System and conduct monitoring, audit and sponsor support visits in order to support researchers in delivering high quality research. They may be contacted at the design stage of a project.
University of Birmingham Clinical Trial Units: the University of Birmingham has two UK Clinical Research Collaboration registered Clinical Trials units: the Birmingham Clinical Trials Unit and the Cancer Research Clinical Trials Unit. The units have the capability of delivering large and complicated clinical trials and are able to offer support from original idea, through study design, funding application, trial delivery, publication and archiving.