NHS Sponsorship

Research requiring the collaboration of the NHS must have an individual or organisation willing and able to take on the responsibilities of the research sponsor* under the UK Framework for Health and Social Care Research. (*To note, in this context, the sponsor is the individual, company, institution or organisation which takes on ultimate responsibility for the management of the research.) 

If you wish to name Lancaster as your sponsor on your NHS (IRAS) application form please follow the guidance below to apply for ‘sponsorship’.

Student applicants should refer to the HRA guidance here: student research. Please note that Lancaster University processes require that students who need R&D approval for one site only need to submit an IRAS form, following the guidance laid out here.

  • Step 1 - IRAS Form

    Complete an IRAS application form using the Integrated Research Application System (IRAS). Please note if you have any technical difficulties in IRAS you can contact the IRAS Technical Helpdesk on 0207 043 0734 or email them at helpdesk@myresearchproject.org.uk. For other queries, contact the HRA queries line.

    Notes on completing the IRAS form:

    • Clinical trials/investigations – please bear in mind that this has a very specific meaning within the NHS. If you are unsure whether your study may be a clinical trial or investigation please email the ethics team
    • Student applicants: Sections A2-2 & A3-1.  HRA guidance notes that students should not normally take the role of chief investigator.  Exception is made for an experienced care practitioner or manager undertaking an educational qualification for continuing professional development or a doctoral-level study while employed by a health or social care provider or a university, or for a researcher undertaking a doctoral-level study in receipt of a fellowship.  Please discuss this with your supervisor before completing these sections.
    • Sections A4 & A64 The contact on behalf of the sponsor is Becky Gordon, Research Support and Systems Manager, Research Services, Lancaster University, Tel: +44 (0)1524 592981, email ethics@lancaster.ac.uk
    • Section A51 – it is important that you tick all reports and dissemination methods that  apply
    • Section A76 – 1,2,3 Please read the notes in the insurance section(s) on the IRAS form: if   Lancaster University’s insurance cover applies insert the phrase ‘Lancaster University legal liability cover will apply’ in the insurance section(s) as appropriate and ensure that you append the Lancaster University insurance documents to your application
    • Section A78 Please answer ‘yes’ to this question: one can usually expect to generate intellectual property in research.
    • Section D2 Please do not complete the ‘declaration by the sponsor's representative’ section (this must be completed by the University).
  • Step 2 - Supporting Documents

    Create a single pdf containing all the documents in the order that you will use them (including, but not limited to, IRAS form, participant information sheet, consent form, interview schedule, questionnaires).

  • Step 3 - Email FREC

    Attach to an email the single pdf (as described at 2 above) and send the email to the secretary of the Faculty Research Ethics Committee.

  • Step 4 - HRA Forms

    HRA Statement of Activities (SoA) form and Schedule of Events (SoE)

    You are normally required to complete these two documents as part of the HRA review process. Templates can be found on the NHS HRA website. 

    Please note that student projects (educational studies) that are taking place at a single NHS site in England AND which do not require review by an NHS REC are not required to submit these documents.

     

    5.1 In completing SoA, Schedule 2 (Material Transfer Provisions), consider whether your study involves the transfer of material to or from the Participating Organisation(s):

    • If you are not exchanging any materials with the Participating Organisation(s), please tick the first box;
    • If you are exchanging any materials with the Participating Organisation(s), please tick the second box and contact the Contracts Team with full details of the project, so that they can put a suitable Material Transfer Agreement in place for the project.

     

    5.2 IMPORTANT: in completing SoA Schedule 3 (Confidentiality, Data Protection and Freedom of Information), consider whether your study involves the transfer of Personal Data AND/OR confidential information from/to the Participating Organisation(s):

    • If you are not exchanging any Personal Data or confidential information with the Participating

    Organisation(s) then please tick the first box; or

    • If you are exchanging Personal Data or confidential information with the Participating Organisation(s) please tick the second box and append the document here to your application. (Please ensure that you have read the additional document and comply with the terms in the course of your study). 
    • Under no circumstances should the third box of Schedule 3 be ticked.

     

    Please email the SoA and SoE as separate documents (at the same time as your application documents) to the ethics team.  

     

  • Step 5 - FREC Approval

    (i) If your application needs to be reviewed by NHS REC (for example projects involving patients) it will be considered first by the Chair of the Faculty Research Ethics Committee, who decides whether the University can act as sponsor for your research. Shortly after submitting your application you will receive an email to let you know whether the University can act as the sponsor for your project. At that stage you may be asked to make some amendments to your application before it can be signed off electronically in the IRAS system. You will also receive an email outlining the next steps in the process.

     

    (ii) If your application does not require review by a NHS REC (for example projects which involve NHS staff only) it will need to be reviewed by the Faculty Research Ethics Committee. The application will be reviewed by the FREC and considered for sponsorship at the same time. Please see the FREC webpages for more information about the review process and dates of committee meetings:

    FHMREC
    FSTREC
    FASS/LUMS

  • Step 6 - Following HRA Approval

    When the application is ready to be signed off, you will be notified by email, and will be sent the letter confirming Lancaster University sponsorship and a copy of the University’s insurance documents.

    Please remember that you must provide the NHS with annual reports, progress reports and end of study reports. This is a condition laid down by the NHS and it is also a condition of University sponsorship.

    Please note that, if your project is externally funded, it will need to be referred to the Contracts Team, by Research Services, so that, once financial approvals are in place, the Contracts Team can negotiate an appropriate research contract with the funder and collaborators/sub-contractors.  If your project is funded, please contact the Research Development Officer in pre-award dealing with your project as soon as possible regarding a referral to the Contracts Team.