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Sponsorship

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SPONSORSHIP – NHS/HSC RESEARCH

Research governed by the UK Policy Framework for Health and Social Care Research, must have a Sponsor that is responsible for the management and oversight of the study. As a Sponsor the University is responsible for:

  • Assessing the quality of the research (through peer review);
  • Ensuring that the researcher(s) has the skills, knowledge and expertise to undertake the research;
  • Ensuring that the research team can access the resources and support to deliver the research;
  • Having in place any necessary agreements for the management and monitoring of research;
  • Ensuring that arrangements are in place to review significant developments, particularly those which put the safety of individuals at risk, and to approve modifications to the research.
  • APPLYING FOR QUB SPONSORSHIP

    If you are an employee or student at QUB, you can apply for QUB to sponsor your research study. If this is agreed, the Research Governance Team will act as the Sponsor's Representatives.

    You should contact Research Governance researchgovernance@qub.ac.uk  at QUB as early as possible in relation to sponsorship and advice on what documentation will be required.

    A flowchart of the procedure for applying for QUB sponsorship, NHS/HSC REC and NI Trust governance is available here.

    The documents listed below should be submitted to researchgovernance@qub.ac.uk  for review:

    • Draft Integrated Research Application System (IRAS) form.
    • Protocol
    • Supporting documentation, as applicable (eg Participant Information Sheet, Informed Consent Forms, questionnaires, semi-structured interview questions or topic guides, adverts/posters, GP letters)
    • Evidence of peer review  & responses as applicable
    • CVs for research team (Chief Investigator, research students & academic supervisors)
    • Draft Outline OID and SoE
    • Data Privacy Impact Assessment response from Information Compliance
    • Evidence of appropriate training, e.g. Good Clinical Practice Certificates;

    All supporting documents should be version controlled and dated and considered draft versions prior to sponsor review and approval.

     

     

     

  • HEALTH AND SOCIAL CARE RESEARCH / TRUSTS

    All research involving patients and/or clients of HSC/NHS Trusts must be considered by a HSC/NHS REC. Therefore, you will need to ensure that either the University and/or the Trust agree to act as sponsor for the study and submit the relevant documentation.

    Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will have to complete a UK Local Information Pack as part of the NHS/HSC Trust governance processes.

    The UK Local Information Pack includes an Organisation Information Document (OID)  - Non-Commercially Sponsored Studies and a Schedule of Events (SoE) or SoECAT (if a SoECAT has been completed as part of a funding application, then you should supply the SoECAT), in addition to other study documents. These are used for setting up NHS/HSC sites.

    Examples of completed SoE and OID templates are available on the Four Nations NHS/HSC Compatibility UK Local Information Pack: Questions and Answers page. Further information and guidance, including the template emails to be used when distributing the Local Information Packs to NHS/HSC Trusts is available here on IRAS Help. When initiating a new study always use the latest version of the OID/SoE from IRAS.

    QUB Research Governance will confirm the contractual terms as part of the sponsorship review. If any payments are to be made to the HSC/NHS sites under the OID, then QUB Finance will need to agree and confirm the payment and invoicing details in Appendix 2 prior to submission. You can find out more information here.

    Please note that there are different mechanisms for sharing the Local Information Pack with participating NHS/HSC organisations across the four nations. The process for each nation is summarised here.

     

     

  • PARTICIPANT IDENTIFICATION CENTRES (PICs)

    Guidance, information and exemplars of PICs can be found here.

    If a PIC site, a Local Information Pack is not required and the Model Non-Commercial PIC Agreement (mNC-PICA sponsor to PIC) is used rather than the OID/SoE.

  • RESEARCH INVOLVING HSC STAFF

    Research involving NHS/HSC staff recruited as research participants by virtue of their professional role and via NHS/HSC Trusts must have a research sponsor.  In instances where staff are being recruited from HSC/NHS Trusts and an IRAS  form is required as part of the Trust governance approvals process. The Faculty REC will accept the IRAS form in lieu of the OREM application form. The draft IRAS form and supporting documentation should be submitted via OREM and sponsorship and ethical review will occur in parallel. A flowchart of the procedure for applying for QUB sponsorship, Faculty REC and NI Trust governance is available here.

  • NORTHERN IRELAND HONEST BROKER SERVICE (HBS)

    Applications to the Honest Brokers service also require Sponsor review and sign-off.

    A flowchart of the procedure for applying for QUB sponsorship, NHS/HSC REC and NI Trust governance is available here.

    Where the research project involves linking external datasets to the HSC Regional Warehouse data, an NHS/HSC REC approval will be required.

     

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