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Clinical Governance @ BU

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With a growing clinical research portfolio at BU, there is likewise the growing need for clinical governance. The processes surrounding implementing clinical research in the NHS can often be quite daunting, however there is plenty of guidance and advice on offer at BU to help guide those requiring assistance.

Under the UK Policy Framework for Health and Social Care Research, when a student or a member of staff is undertaking their own research within the NHS, then the organisation at which they study or work, should take on the role of the research Sponsor. The Sponsor is defined as an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research. The study will likewise need a Chief Investigator who should sign the declaration form, in applying for BU sponsorship.

The Research & Knowledge Exchange Office’s ethics team (the Research Governance Advisor, and for clinical research, primarily the Clinical Governance Advisor: Suzy Wignall) are responsible for coordinating the process of applying for BU sponsorship, as well as ensuring that applications for external approvals are made with full support and guidance. We can also advise on setting up the study at the research site, and will maintain oversight of your research once implemented within the NHS, in line with our duty as the Sponsor.

This oversight allows for guidance and advice with regard to documentation, amendments, general clinical governance, as well as study closure. We also have good links with neighbouring NHS Research departments, and the local NIHR Clinical Research Network, so can put you in touch with the people you may need to work with, in answering your research question.

If you have any queries surrounding research in the NHS, please get in touch as early as possible via the Research Ethics mailbox.


Training opportunities

If you’re interested in any of the below opportunities, please email Research Ethics to reserve a space/find out how to book.

  • Completing and submitting your IRAS application – Thursday 23rd August – 1pm – 4pm, S103 Lansdowne Campus;
  • Valid Informed Consent – various dates – contact Research Ethics for further information.

Useful links

Is my study research? Sometimes what is deemed research at BU, is not classed as such within the NHS. The tool can help decide for you, as well as the Defining Research table.

Do I need NHS REC approval? – in the majority of cases, you will need to apply to the NHS Research Ethics Service for approval for your project. This tool helps you decide if this is a requirement. Email Research Ethics for further guidance.

Do I need a clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA)?

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority. Email Research Ethics for further guidance.

The UK Policy Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK.

It’s important to register your study – the BU Research Ethics team have the appropriate access to provide user accounts.


Useful documents

There are plenty of template documents available to help you with study conduct, through the NIHR website (you will be aware of them through GCP training). Remember to check with your research site as well, as they may have templates they wish you to use.

In addition to your study documents (protocol, PI Sheet, etc.) the Health Research Authority also require you to submit a Statement of Activities and Schedule of Events. Further guidance can be found here and by emailing Research Ethics.

Suggested index for your study files (site and Sponsor).

Clinical Governance workflows are now available via Sharepoint for the following procedures:

Amendments
Archiving
BU Ethics 
BU Sponsorship
Informed Consent
IRAS Application (an overview)
Monitoring
Progress Reporting
Reporting Deviations, Violations and Serious Breaches
Safety Reporting
Staffing and Delegation