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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.
*Please remember to use this document, and not the form found within the current SOP. Changes to the SOP are being reviewed, and the new declaration form shall be incorporated once that document has been ratified.
Support @ BU
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.
Get in touch
If you have any queries surrounding research in the NHS, please get in touch as early as possible via the Research Ethics mailbox. Keep an eye on the ‘clinical governance’ blog tag too, for updates, news and notices.