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Brighton & Sussex Medical School

Sponsorship principles

Sponsorship principles

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What is Sponsorship?

A Sponsor is required for all studies involving NHS patients or staff, or involving community populations e.g. care home residents, other health and social care populations, or involving administration of a controlled substance to healthy volunteers. The Sponsor is the institution/organisation assuming responsibility for the initiation, insurance and/or indemnity, management and/or financing of that research. Risks attached to assuming the Sponsor role vary from financial to legal risks and also damage to reputation.The role of Sponsor is clearly defined by the Department of Health Research Governance Framework (2005), and other regulatory requirements.Chief Investigators (and Supervisors) are required to obtain approval from an appropriate Sponsor prior to submitting an application for ethical review and governance assessment to the Health Research Authority (HRA).

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What type of projects need Sponsorship?

Examples of project types requiring Sponsorship are clinical research (CR) involving patients, studies involving NHS staff, as well as social care research and research in local authority settings (non-CT or CR).

What organisations act as Sponsors?

NHS Trusts and Higher Education Institutions (Universities), also commercial companies (for e.g. Pharmaceutical) are all examples of Sponsoring organisations.

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Which organisation is the right Sponsor for my study?

Which organisation is the right Sponsor for my study

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Which organisation is right for my study? 

a) If your Supervisor has only an NHS Trust contract (for e.g. BSUH is their substantive employer) your Supervisor should seek Sponsorship through their respective substantive employing Trust.  

b) If your Supervisor has a dual contract, i.e. they are employed by BSMS (via the University of Sussex) and an NHS Trust then Sponsorship can be sought at either the Trust or the University. However, the Medical School prefer NHS partner Trusts to Sponsor wherever possible.

c) If your Supervisor is solely employed by the University, then the University should be approached for Sponsorship of the study.  

I need Sponsorship: what should I do?

From November 2017, BSMS staff and student projects applying for Sponsorship are reviewed by the University of Sussex URGC Sponsorship Sub-Committee. As the Medical School is not a legal entity, review is undertaken on behalf of the University of Sussex, the Sponsoring organisation.

a) Agreement for University Sponsorship Approval is reached on case-by-case basis. 

b) The Supervisor must be substantively employed by the University and named as CI (in IRAS Form), to be eligible for University of Sussex Sponsorship. (Formal employment contracts must be in place to enable the Sponsor to insure and indemnify the research). 

c) Insurance is a significant driver; Sponsor must ensure insurance and/or indemnity to meet potential legal liability of the Sponsor for harm to participants arising from the management of the research, and provide Public Liability, Employers Liability, Professional Negligence Research certificates.

d) While the Medical School would prefer NHS partner Trusts to Sponsor where their patients (and clinical material) are involved, to mitigate risk, the HRA’s Draft UK Policy Framework for Health and Social Care Research (developed in 2015), requires Universities to accept the role of sponsor for all educational research conducted by their own students (unless a student’s employment indicates otherwise) i.e. institutional sponsorship.

"It is expected that where projects are undertaken by a student(s) in fulfilment of educational qualifications below doctoral level, the academic supervisor will take on the role of Chief Investigator."  

"9.12. Universities and colleges should accept the role of sponsor for all educational research conducted by their own students, unless the student is employed by a health or social care provider that prefers to do this." (page ref reqd)

e) From 1st April 2016, the HRA intensified its expectations for Sponsoring organisations fulfilling their responsibilities, requiring closer management and oversight of Sponsored projects.

Find out more about University of Sussex sponsorship and download the sponsorship forms.

Read more >

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When will the University of Sussex not consider Sponsoring a student study

  • The PI/Supervisor is not substantively employed by UoS. 
  • The Student is not registered at UoS (including BSMS).
  • It has been agreed that the relevant NHS Trust is more appropriate to Sponsor
  • Any reason (be it legal, financial, liability, insurance, risk or governance reasons) for why the study could not proceed or be considered for sponsored by the University of Sussex and therefore unable to fulfil the sponsorship responsibilities expected of the Research Governance Framework. 
  • As a matter of principle, high risk interventional studies and those with a direct bearing on the care of individuals in receipt of care or treatment in a clinical setting should be Sponsored by those organisations over the University.