Research Governance

 

Notice for Clinical Trials of Investigational Medicinal Products (CTIMPs) from 2022 onwards

From the first of January 2022, all CTIMP applications must be made via the new Combined Review Service (formerly Combined Ways of Working).  The Research Governance team will be happy discuss and advise on matters relating to the new process.  See below for contact information.

The Research Governance team manages the Sponsorship of research projects under the UK Policy Framework for Health and Social Care Research, which sets out principles of good practice in the management of health and social care research in the UK.

The policy framework applies to health and social care research that involves NHS staff, patients, their carers or their data as well as to Adult Social Care and their clients. Further information on the framework and a link to the framework itself are available on the HRA website.  Research conducted under this policy requires a Sponsor, i.e. an organisation which takes formal responsibility for ensuring that the funding, ethics, quality and management of the research meet the standards set out in the framework.

The Research Governance Team is available to advise University of Birmingham staff and students on all matters relating to ethics and governance requirements, including:

 

Contacting the Research Governance Team

If you require information or guidance about research governance at the University of Birmingham, including information about university sponsorship, application to research ethics committees, and advice on regulatory requirements, please email researchgovernance@contacts.bham.ac.uk. All new enquiries should be directed to this address in the first instance.

For specifically insurance-related enquiries, please email ctinsurance@contacts.bham.ac.uk.

Members of the Research Governance Team can also be contacted directly:

When to contact the Research Governance Team

Pre-award

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.

Post award

Please see our how to apply for University Sponsorship page.

Other 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:

 

Colleges

Professional Services